LIBRARY OF THE UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN 616.46 Un36r v .4 The person charging this material is re- sponsible for its return to the library from which it was withdrawn on or before the Latest Date stamped below. Theft, mutilation, and underlining of books are reasons for disciplinary action and may result in dismissal from the University. UNIVERSITY OF ILLINOIS LIBRARY AT URBANA-CHAMPAIGN Digitized by the Internet Archive in 2013 http://archive.org/details/reportofnational04unit Report of the National Commission on Diabetes to the Congress of the United States DEPOSITORY, FEB ■ IINIV Qt Volume IV SUPPORTING MATERIALS TO THE COMMISSION REPORTS ^ U S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Public Health Service National Institutes of Health 'The National Diabetes Mellitus Research and Education Act" (Public Law 93-354), signed by the President on July 23, 1974, directed the appointment of a National Commission on Diabetes whose charge was to formulate a long-range plan of research and education to combat diabetes mellitus. The Commission submitted its report to Congress on December 10, 1975. REPORT OF THE NATIONAL COMMISSION ON DIABETES Volume I - The Long-Range Plan to Combat Diabetes Volume II - Contributors to the Deliberations of the Commission Part 1 - Public Testimony (Public Hearings 1-5) Part 2 - A. Public Testimony (Public Hearing 6 and Interviews) B. Biographical Sketches of Commission Members and Consultants Volume III - Reports of Committees, Subcommittees, and Workgroups Part 1 - Scope and Impact of Diabetes (I) Part 2 - Scope and Impact of Diabetes (II) Part 3 - Etiology and Pathology of Diabetes Part 4 - Treatment of Diabetes Part 5 - Diabetes Education for Health Professionals, Patients, and the Publi Part 6 - Workgroup Reports A. Diabetes Research and Training Centers B. Veterans Administration Programs for Diabetes C. Center for Disease Control: Diabetes Control Programs D. National System for Diabetes Data Resources E. Federal Resources Volume IV - Supporting Materials to the Commission Reports A. Summary of Federal Health Legislation Pertaining to Diabetes B. Summary of Diabetes Program Funding C. Special Reports Report of the National Commission on Diabetes to the Congress of the United States Volume IV SUPPORTING MATERIALS TO THE COMMISSION REPORTS ^ ^ U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Public Health Service National Institutes of Health DHEW Publication No. (NIH) 76-1033 NATIONAL COMMISSION ON DIABETES OSCAR B. CROFFORD, M. D. - Chairman Director, Diabetes - Endocrinology Center Vanderbilt University School of Medicine Nashville, Tennessee BURIS R. BOSHELL, M. D. Medical Director Diabetes Research and Education Hospital University of Alabama School of Medicine Birmingham, Alabama GEORGE F. CAHILL, JR., M. D. Director Elliott P. Joslin Research Laboratory Boston, Massachusetts CARL KUPFER, M. D. Director National Eye Institute Bethesda, Maryland PAUL E. LACY, M. D. , Ph.D. Chairman Department of Pathology Washington University School of Medicine St. Louis, Missouri LEATRICE DUCAT National President Juvenile Diabetes Foundation Philadelphia, Pennsylvania DONNELL D. ETZWILER, M. D. Pediatrician St. Louis Park Medical Center Minneapolis, Minnesota CLAIR L. GARDNER, D. D. S. Acting Director National Institute of Dental Research Bethesda, Maryland LILLIAN HADDOCK-SUAREZ, M. D. Director Division of Endocrinology and Diabetes University of Puerto Rico School of Medicine San Juan, Puerto Rico RUTH L. KIRSCHSTEIN, M. D. Director National Institute of General Medical Sciences Bethesda, Maryland NORMAN KRETCHMER, M. D. , Ph.D. Director National Institute of Child Health and Human Development Bethesda, Maryland ROBERT I. LEVY, M. D. Director National Heart and Lung Institute Bethesda, Maryland WILLIAM D. NELLIGAN Executive Director American College of Cardiology Bethesda, Maryland DOROTHEA WEBB PUCKETT, R.N. , Ph.D. Assistant Professor of Community Health Nursing College of Nursing Wayne State University Detroit, Michigan DONALD B. TOWER, M. D. , Ph. D. Director National Institute of Neurological and Communicative Disorders and Stroke Bethesda, Maryland G. DONALD WHEDON, M. D. Director National Institute of Arthritis, Metabolism, and Digestive Diseases Bethesda, Maryland LOUINIA MAE WHITTLESEY Executive Director Diabetes Association of Greater Cleveland Cleveland, Ohio KEATHA K. KRUEGER, Ph. D. - Executive Secretary Diabetes Program Director National Institute of Arthritis, Metabolism, and Digestive Diseases Bethesda, Maryland \A4 VOLUME IV SUPPORTING MATERIALS TO THE COMMISSION REPORTS A. Summary of the Health Legislation Perte_nin£ to Diabetes B. Summary of Diabetes Program Funding C. Special Reports TABLE OF CONTENTS Page Number A. SUMMARY OF THE HEALTH LEGISLATION PERTAINING TO DIABETES 1 INTRODUCTION SUMMARY 3 I. THE DEPARTMENT OF HEALTH, EDUCATION AND WELFARE 4 A. The Public Health Service 4 1. The Center for Disease Control 4 2. The Health Services Administration 4 a. The Bureau of Community Health Services 5 b. The Indian Health Service 6 c. The Bureau of Medical Sciences 6 d. The Bureau of Quality Assurance 6 3. The Food and Drug Administration 7 4. The Health Resources Administration 7 a. The Bureau of Health Manpower 7 b. The National Center for Health Services 7 Research c. The National Center for Health Statistics 8 d. The Bureau of Health Planning and Resources 8 Development 5. The National Institutes of Health 8 a. The National Eye Institute 8 b. The National Heart and Lung Institute 9 c. The National Institute of Arthritis, 9 Metabolism and Digestive Diseases d. The National Institute of Child Health 10 and Human Development e. The National Institute of Dental Research 10 f. The National Institute of General Medical 10 Sciences g. The National Institute of Neurological and 11 Communicative Disorders and Stroke h. The National Cancer Institute 11 i. The National Institute on the Aging 12 TABLE OF CONTENTS (CONT'D) Page Number j. The National Institute of Allergy and 12 Infectious Disease k. The National Institute of Environmental 12 Health Sciences 1. The Division of Research Resources 13 m. The National Library of Medicine 13 n. The Clinical Center 13 6. The Alcohol, Drug Abuse, and Mental Health 14 Adminis tration B. The Social Security Administration 14 C. The Social and Rehabilitation Service 15 1. Migration and Refugee Assistance Program 15 a. The Cuban Refugee Program 15 b. The Indochina Migration and Refugee Program 15 2. The Medical Services Administration 15 3. The Community Services Administration 15 4. The Assistance Payments Administration 15 D. The Office of Human Development 16 1. The Office of Developmental Disabilities 16 2. The Rehabilitation Services Administration 16 3. The Administration on Aging 16 4. The Office of Native American Programs 17 5. The Office of Child Development 17 E. The Education Division 17 II. THE DEPARTMENT OF DEFENSE 17 III. THE DEPARTMENT OF AGRICULTURE 18 TABLE OF CONTENTS (CONT'D) IV. INDEPENDENT AGENCIES A. The National Science Foundation B. The Veterans Administration C. The Energy Research and Development Administration V. APPENDICES A. The Public Health Service B. The Center for Disease Control C. The Health Services Administration D. The Food and Drug Administration E. The Health Resources Administration F. The National Institutes of Health G. The Alcohol, Drug Abuse, and Mental Health Adminitration Administration H. The Social Security Administration I. The Social and Rehabilitation Service J. The Office of Human Development K. The Department of Agriculture B. SUMMARY OF DIABETES PROGRAM FUNDING INTRODUCTION FY 1975 Program Level Methods and Procedures for Estimating Diabetes Program Funding Page Number 19 19 19 20 21 23 29 45 55 68 85 99 107 125 151 159 165 167 167 168 The National Plan FY 1977-1978 170 TABLE OF CONTENTS (CONT'D) Page Number Table I: Diabetes Research, FY 1975 171 Table II: NIH Extramural Research, FY 1975 172 Table III: Composition of FY 1975 NIH Obligations 173 Chart I: Research Categories 174 Exhibit I: NIH Extramural Diabetes REsearch, FY 1975 175 Exhibit II: NIH Extramural Research on Diabetes 176 Complications, FY 1975 Exhibit III: Organ System Function Extramural 177 Research, FY 1975 Exhibit IV: NIH Hormones Extramural Research, FY 1975 178 Exhibit V: Metabolism Extramural Research, FY 1975 179 Table IV: Diabetes Share of NIH Extramural Research 18 ° Table V: NIH Diabetes Related Extramural Research, l 81 FY 1973-1975 Table VI: NIAMDD Share of Obligated Research Funds 182 Table VII: NIH/NIAMDD Training FY 1970-1975 183 Table VIII: NIH Quarterly REsearch Obligations Pattern 183 (FY 1971-75) Table IX: Budget Summary for all Recommendations l 8 ^ Table X: NIH Recommendations (By Institute) 185 Table Xa: National Institute of Arthritis, Metabolism, and Digestive Diseases 186 Table Xb: National Eye Institute 187 Table Xc: National Institute of Neurological and Communicative Disorders and Stroke 188 TABLE OF CONTENTES (CONT'D) C. Table Xd: National Institute of Dental Research Table Xe: National Institute of Child Health and Human Development Table Xf: National Heart and Lung Institute Table Xg : General Clinical Research Centers Table XI: Diabetes Research and Training Centers Table XII: Health Care, Education, and Control Programs Table XIII: Prototype Staffing and Budget for Diabetes Research and Training Centers Table XIV: Diabetes Control Program Table XV: National Diabetes Information and Education Clearinghouse Table XVI: National Diabetes Data Group Table XVII: Research Manpower - Positions SPECIAL REPORTS 1. Diabetes in the Indian People and the Alaska Native Population 2. Diabetes-Related Research and Education Programs of the Department of Agriculture 3. Recommendations for Members of the National Commission on Diabetes Mellitus, by Robert L. Jackson, M.D. 4. Proposed International Biomedical Summit Conference 5. Presentations to the Commission a. Introduction to Diabetes Mellitus, by Noel K. MacLaren, M.D. (Presented by Pollyann Toll) b. Presentation of Caroline Lurie Page Number 189 190 191 191 192 192 193 194 195 196 197 199 201 211 223 231 247 249 255 A. FEDERAL HEALTH LEGISLATION RELATED TO DIABETES AS OF OCTOBER 1, 19 75 INTRODUCTION AND SUMMARY The following report reviews federal health legislation in order to determine whether existing legal authority provides for, or per- mits, the inclusion of programs for diabetes research, education, and treatment. The report was developed through a careful review of all federal programs relating to health, and with consultation of officials within the various agencies, and commissions, particularly in the Diabetes Mellitus Coordinating Committee, the Office of Management and Budget, and the National Institutes of Health. Federal health programs are frequently authorized by general legislation from which there can be drawn more than one specific health program. Accordingly, authority for a diabetes component to a program would appear to be permissible in almost all health programs unless specifically excluded. In those other programs which are categorical, with specific authority focused on a particular disease entity, dia- betes components would appear to be authorized only when such are related to that particular program category. In summary, there is broad general authority for inclusion of dia- betes components within almost all existing federal health programs. Such authority itself, however, does not insure the existence of a diabetes component in a particular program. Non-statutory factors, such as program priorities, budget limitations, agency promulgated regulations, and the like may mitigate against the establishment and operation of diabetes components. STYLE OF THE REPORT The report is divided into a text and appendix. The text provides a succinct statement of each relevant federal program, organized by executive department and agency. The programs of each agency are functionally described with references to detailed organizational state- ments and specific authorizing statutes. The organizational statements are to be found in the appendix. References to U.S. Code citations are in the form of 42 U.S.C. 201 where the 42 refers to the Title of the U.S. Code and 201 refers to the specific section. References to the Federal Register are in the form of 34 F.R. 1279 where 34 refers to the Title and 1279 refers to the page number. I. THE DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE (HEW) HEW (42 U.S.C. 3501 et seq. , Reorganization Plan #1 of 1953) is the executive department responsible for most health programs, and consequently, it has the broadest authority to provide for or permit programs for diabetes research, education, and treatment. HEW has four relevant organizational components: the Public Health Service; the Social and Rehabilitation Service; the Social Security Administra- tion, and the Office of Human Development. A. THE PUBLIC HEALTH SERVICE (PHS) PHS (42 U.S.C. 201 et seq., 38 F.R. 18261) is subdivided into six organizational components, all of which may conduct diabetes-related projects. 1. The Center for Disease Control (CDC) Statutory authority: Specific: 42 U.S.C. 247b(h)(l) General: 42 U.S.C. 241, 2421, 243, 246, 254a, 263a, 264 Organizational statement: 39 F.R. 1461 CDC has general authority to assist and direct programs for disease prevention and control, improvement of laboratory performance, and the assurance of safe and healthful working conditions. The National Diabetes Mellitus Research and Education Act, (P.L. 93-354, 42 U.S.C. 247b(h)(l)), specifically includes diabetes among CDC pre- vention and control programs. CDC is divided into eight components, five of which are generally authorized to provide for or permit programs related to dia- betes research, treatment, and education: the Bureau of Epidemiology, the Bureau of Health Education, the Bureau of Laboratories, the Bureau of State Services, and the Bureau of Training. 2. The Health Services Administration (HSA) Statutory authority: Specific: None General: 42 U.S.C. 234, 241, 243, 246, 247b, 248, 249, 251, 253, 253a, 253b, 254a, 254b, 254c, 300d-300d-9, 300-e-300-e-14, 701, et seq., 1320c-1320c-19 Organizational statement: 39 F.R. 10463 HSA is mandated to administer health service delivery programs and to assist in the integration of such programs with public and pri- vate financing systems. HSA is divided into four major components, each of which appears authorized to provide for or permit programs directly or indirectly related to diabetes. a. The Bureau of Community Health Services encourages the development of locally based programs of health services delivery, and attempts to find approaches designed to bring them within the major health financing systems. 1) The Community Health Centers program (P.L. 94-63, 42 U.S.C. 254c) provides primary and supplemental health care services, especially to the medically underserved population. 2) The Comprehensive Public Health Services program (P.L. 94-63, 42 U.S.C. 246) provides financial sup- port to state health and mental health agencies. 3) The Maternal and Child Health and Crippled Children's Services program (Social Security Act, Title V, 42 U.S.C. 701 et seq.) provides financial support to states to extend and improve medical services to crippled children. 4) The Maternal and Child Health Formula Grants program (Social Security Act, Title V, 42 U.S.C. 701 et seq.) provides financial support to states to extend and improve services to reduce infant mortality and improve the health of mothers and children. 5) The Migrant Health Centers program (P.L. 94-63, 42 U.S.C. 247d) provides primary and supplemental health services to migrant and seasonal farm workers and their families. 6) The Health Maintenance Organizations program (P.L. 93- 222, 42 U.S.C. 300e-300e-14) provides basic and supple- mental health services for the development of such care delivery systems. 7) The National Health Service Corps program (P.L. 91- 613 as amended by P.L. 94-63, 42 U.S.C. 254b) provides the delivery of health care services in areas with critical health personnel shortages. 8) The Comprehensive Health Services program (P.L. 93- 644, 42 U.S.C. 2901) is designed to develop and imple- ment health service projects for low income persons. The program is the successor to CHS under the Office of Economic Opportunity, 42 U.S.C. 2809(a)(4). b. The Indian Health Service provides a comprehensive health service delivery system for American Indians and Alaskan Natives. c. The Bureau of Medical Services is mainly concerned with the provision of health care service to certain categories of eligible federal beneficiaries. 1) The Emergency Medical Services Systems program (P.L. 93- 154, 33 U.S.C. 763c, 42 U.S.C. 211a, 212a, 295f-2,4,6, 300d-300d-9) mandates the demonstration and provision of assistance and encouragement for the development of comprehensive emergency medical services systems. 2) The Federal Employee Health Service program (P.L. 79- 658, 5 U.S.C. 7901) permits the head of each govern- ment agency to establish a health care service program for employees under his agency jurisdiction. 3) The PHS Hospitals (P.L. 93-155, 42 U.S.C. 248, 251, 254a, 254b) provide outpatient care and hospitaliza- tion to statutory beneficiaries such as merchant seamen and uniform service members. 4) The Coast Guard Medical Services program (42 U.S.C. 253) enables members of the Coast Guard to receive outpatient treatment and hospitalization. d. The Bureau of Quality Assurance is the quality control division for federal health care programs. The Bureau is authorized to develop health service standards and to as- sure the necessity, quality, and economy of such services through Professional Standards Review Organizations, (P.L. 92-603, 42 U.S.C. 1320c). The PSRO's must review the professional activities of health care providers to whom payments are to be made under the Social Security Act. 3. The Food and Drug Administration (FDA) Statutory authority: Specific: None General: 21 U.S.C. 301, 321, 331, 351, 352, 355, 356, 371, 372, 373, 374, 375, 381, and 42 U.S.C. 241, 243, 246, 262, 263 Organizational statement: 35 F.R. 3685 The FDA is the food and drug public health protection agency. FDA performs research and develops standards to insure the safety and effectiveness of foods, drugs, biological products, medical devices, diagnostic products, and the like. FDA has no programs related solely to diabetes mellitus. Although no FDA statutory section refers specifi- cally to the disease of diabetes, 21 U.S.C. 356 concerns the require- ments for certification of drugs containing insulin. FDA is divided into six components, three of which appear authorized to provide for or permit programs related to diabetes: the Bureau of Drugs, the Bureau of Foods, and the Bureau of Medical and Diagnostic Products. 4. The Health Resources Administration (HRA) Statutory authority: Specific: None General: 42 U.S.C. 241, 242c, 242k, 243, 245a, 300k-300t Organizational statement: 39 F.R. 1456 HRA has as its mission the identification, analysis, and devel- opment of health personnel, physical and financial resources to achieve optimal deployment and utilization. HRA has no specific authority focusing on diabetes although programs appear authorized to provide for or permit components related to diabetes. HRA is organized into four major divisions: a. The Bureau of Health Manpower is designed to determine the nation's resources and requirements for health professions manpower . b. The National Center for Health Services Research (P.L. 93- 353, 42 U.S.C. 242c) is mandated to support and undertake research and analyze projects respecting the design and development of health systems and facilities. c. The National Center for Health Statistics (P.L. 93-353, 42 U.S.C. 242k) is to develop and maintain informational systems for national, descriptive health statistics. d. The Bureau of Health Planning and Resources Development (P.L. 93-641, 42 U.S.C. 300k, 3001, 300m, 300n, 300o, 300p, 300q, 300r, 300s, 300t) provides leadership and administration for a program of federal, state, and area- wide health planning and health delivery systems development. 5. The National Institutes of Health (NIH) Statutory authority: Specific: None General: Reorganization Plan #3 of 1966, 42 U.S.C. 203, 241, 242o, 289a, 2891, 2891-2 Organizational statement: 40 F.R. 22859 NIH (42 U.S.C. 203, Reorganization Plan of 1966, 40 F.R. 22859) is the organization with the broadest focus on diabetes mellitus research. NIH conducts and supports a wide range of research, train- ing, and education programs in the causes, diagnosis, prevention, and cure of diseases in man. NIH is composed of eleven national institutes, each of which is described herein. There are, in addition, several other divisions within NIH that have activities related to diabetes. a. The National Eye Institute (NEI) Statutory authority: Specific: None General: P.L. 90-489, 42 U.S.C. 2891 Organizational statement: 40 F.R. 22859 NEI was established in 1968 to engage in research and gain new knowledge about the functioning of the eye. The Institute appears authorized to provide for or permit projects directly related to diabetes. Diabetic retin- opathy research is performed as part of a "Collaborative Retinopathy Study," as well as through independent studies funded by extramural grants. Other investigations that relate to diabetes are also being conducted by NEI, for example in the field of diabetic cataracts. b. The National Heart and Lung Institute (NHLI) Statutory authority: Specific: None General: P.L. 80-655, 42 U.S.C. 287 Organizational statement: 40 F.R. 22859 NHLI was originally established by the National Heart Act in 1948. The Institute appears to be authorized to provide for or permit programs related to diabetes. It now performs a few research projects directly focused on diabetes, but engages in many projects that indirectly concern the disease. NHLI is involved in numerous metabolic studies and supports a large education and control effort. c. The National Institute of Arthritis, Metabolism, and Digestive Diseases (NIAMDD) Statutory authority: Specific: P.L. 81-629, P.L. 93-354, 42 U.S.C. 289c-l, 289c-la, 289c-2, 289c-3 General: None Organizational statement: 40 F.R. 22859 NIAMDD was established in 1950 as authorized by the Omnibus Medical Research Act. NIAMDD was empowered to study the broad spectrum of metabolic diseases including diabetes and currently places a heavy emphasis upon dia- betes within the Diabetes Program. Other NIAMDD programs engaged in diabetes related studies are the Metabolism, Endocrinology, Nutrition, and Kidney Programs. Both the Intramural Research Program and the Extramural Activities Program are authorized. The National Diabetes Mellitus Research and Education Act authorized the Director of NIAMDD to support research and training in the diagnosis, prevention, and treatment of the disease and established programs of evaluation, planning, and dissemination of knowledge related to dia- betes research and training center. This act also authorized a new position for an associate director for diabetes. d. The National Institute of Child Health and Human Development (NICHD) Statutory authority: Specific: None General: P.L. 87-383, 42 U.S.C. 289d, 289f, 300a-2, 300c-ll Organizational statement: 40 F.R. 22859 NICHD was established in 1963. NICHD is authorized to provide for or permit programs related to diabetes in the areas of its main concern: family planning, child health, maternal health, and human development. NICHD engages in a few projects that relate to diabetes during pregnancy and its effects upon mother and child. Other projects concern carbohydrate matabolism in infants of diabetic mothers. e. The National Institute of Dental Research (NIDR) Statutory authority: Specific: None General: P.L. 80-755, 42 U.S.C. 288 Organizational statement: 40 F.R. 22859 NIDR was created by the National Dental Research Act in 1948. NIDR is authorized to provide for or permit programs related to diabetes insofar as the disease affects the oral cavity. f . The National Institute of General Medical Sciences (NIGMS) Statutory authority: Specific: None General: P.L. 87-838, 42 U.S.C. 289d, 289f Organizational statement: 40 F.R. 22859 10 NIGMS was established in 1963. NIGMS appears author- ized to provide for or permit programs related to diabetes since its mission is to support research that may have significance for two or more institutes within NIH. Dia- betes related research projects are funded through grants and contracts. Among the program areas that relate to diabetes are pharmacology, toxicology, genetics, and cellular and molecular bases of disease. g. The National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) Statutory authority: Specific: None General: P.L. 81-692, 42 U.S.C. 289a, 289b Organizational statement: 40 F.R. 22859 NINCDS was originally established in 1950. NINCDS has authority to sponsor and conduct research and training in the causes, prevention, diagnosis, and treatment of numerous diseases including some metabolic and endocrine disorders. As a result of this authorization, NINCDS engages in a variety of neurological research projects. h. The National Cancer Institute (NCI) Statutory authority: Specific: None General: P.L. 75-244, 42 U.S.C. 281, 282, 284, 286a, 286c Organizational statement: 40 F.R. 22859 NCI was established pursuant to the National Cancer Institute Act. It sponsors and conducts research, train- ing, and education programs relating to the causes, pre- vention, diagnosis, and treatment of cancer. NCI engages in no activities directly related to diabetes. Certain projects, however, are tangentially related. The Institute has an intramural metabolism branch and endocrinology section, wherein research is performed concerning growth hormones. 11 i. The National Institute of the Aging (NIA) Statutory authority: Specific: None General: P.L. 93-296, 42 U.S.C. 289k-2, k-3, k-4, k-5 Organizational statement: 40 F.R. 22859 NIA was established in 1974. NIA appears authorized to provide aging programs related to diabetes. It is em- powered to conduct and support research and training related to problems of the aged. Diabetes related intramural research is conducted within the metabolism and endocrine sections of the Clinical Physiology Branch. j . The National Institute of Allergy and Infectious Diseases (NIAID) Statutory authority: Specific: None General 42 U.S.C. 289a, 289b Organizational statement: 40 F.R. 22859 NIAID appears authorized to provide for or permit pro- grams related to diabetes although there are programs within the Institute related to the disease, such as immu- nization and basic work on viruses. k. The National Institute of Environmental Health Sciences (NIEHS) Statutory authority: Specific: None General: Reorganization Plan #3 of 1966 Organizational statement: 40 F.R. 22859 NIEHS appears authorized to provide for or permit pro- grams related to diabetes although there are no programs within the Institute solely related to the disease. 12 1. The Division of Research Resources (DRR) Statutory authority: Specific: None General: 42 U.S.C. 235, 242b, 292-295 Organizational statement: 40 F.R. 22859 DRR was originally established within NIH in 1962. DRR appears authorized to provide for or permit programs related to diabetes. The Division aids in the establish- ment and operation of research centers through grants and training awards. General Clinical Research Centers which provide basic clinical support are utilized for diabetes studies as well as studies for categorical diseases. Other programs, such as the Regional Primate Research Centers, also involve the study of diabetes related problems. m. The National Library of Medicine (NLM) Statutory authority: Specific: None General: 42 U.S.C. 274 et seq. Organizational statement: 40 F.R. 22859 NLM was established to collect and disseminate medi- cal information. The library provides material for the Diabetes Literature Index and Endocrine Index; the library is also authorized to provide reference and research assistance to all federal health programs. n. The Clinical Center (CC) Statutory authority: Specific: None General: Organizational statement: 40 F.R. 22859 The CC is the research hospital of NIH. It provides a patient care facility to complement the biomedical research performed by the categorical Institutes. The Center is authorized to provide for or permit diabetes related programs. 13 6. The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) Statutory authority: Specific: None General: 42 U.S.C. 218, 225a, 232, 241, 242a, 289k-l, 2891-4, 2661, 2665, 2671, 2672, 2674, 2677, 2678d, 2681, 2684, 2687, 2688a, 2688d, 2691 et seq. Organizational statement: 40 F.R. 36163 ADAMHA is organizationally divided into three national insti- tutes: the National Institute of Mental Health, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute on Drug Abuse. Although there is no statutory focus upon diabetes mellitus, each institute appears authorized to provide for or permit programs related to diabetes within its specific categorical disease emphasis. The greatest likelihood for diabetes related activities would appear to be in the National Institute of Mental Health for studies of the psychological concomitants of diabetics and their families. B. THE SOCIAL SECURITY ADMINISTRATION (SSA) Statutory authority: Specific: None General: 42 U.S.C. 401, 401a, 402, 418, 426, 603, 907, 1301, 1309, 1315, 1395 Organizational statement: 33 F.R. 5828 SSA was established by the Federal Security Agency Reorganization Plan II, effective July, 1946. The Administration was transferred to the Department of Health, Education, and Welfare by the Reorganization Plan I of 1953. SSA administers Medicare, a national program of contributory health insurance for the aged and disabled. In connection therewith, SSA engages in research and makes recommendations on the problems of providing health care to such individuals. Medicare pays for diabetes and transplants of diabetic patients, however, the Administra- tion has no special programs solely related to diabetes. However, SSA is authorized to provide for or permit programs related to the disease. 14 C. THE SOCIAL AND REHABILITATION SERVICE (SRS) Statutory authority: Specific: None General: 22 U.S.C. 2601-2605, 42 U.S.C. 601, 1396, 1397 Organizational statement: 34 F.R. 1279 SRS administers Federal programs that assist state and local com- munities in the provision of social, rehabilitative, medical, and other services to needy persons. SRS appears authorized to provide for or permit programs related to diabetes. 1. Migration and Refugee Assistance Programs a. T he Cuban Refugee Program (P.L. 87-510, 8 U.S.C. 1104, 22 U..S.C. 2601-2605) provides welfare, medical, and edu- cation services to any person qualifying as a refugee from Cuba. b. The Indochina Migration and Refugee Act of 1975 (P.L. 94- 23, 22 U.S.C. 2601) authorizes the use of federal funds for the provision of welfare, medical, and education ser- vices to Cambodian and Vietnamese refugees. 2. The Medical Services Administration (MSA) MSA assists in the development and administration of Medicaid programs under Title XIX of the Social Security Act: Grants to States for Medical Assistance Programs (42 U.S.C. 1396 et seq.). These pro- grams provide medical services to needy persons. 3. The Community Services Administration (CSA) CSA assists in the planning, development, and coordination of all SRS social service programs under the Social Security Act. This includes the Public Assistance Social Service Programs (P.L. 93-64, 42 U.S.C. 1397) which provide for health support services and other appropriate combinations of services for alcoholics, drug addicts, the mentally disturbed, and the physically handicapped. 4. The Assistance Payments Administration (APA) APA administers income maintenance programs under the Social Security Act (42 U.S.C. 601 et seq.) and provides financial aid to aged and disabled persons in Puerto Rico, the Virgin Islands, and Guam. 15 D. THE OFFICE OF HUMAN DEVELOPMENT (OHD) Statutory authority: Specific: None General: 29 U.S.C. 701 et seq. , 42 U.S.C. 295, 2661-2666, 2670-2677c, 2691, 2693-2696, 2828, 2829, 2991, 3001 et seq., 3045 et seq., 5101 et seq. Organizational statement: 38 F.R. 17260 OHD was established to administer and coordinate service programs including health service programs for special groups of persons such as: children, the aged, the physically and mentally disabled, and Native Americans. Although there are no programs specifically focus- ing upon diabetes, OHD is authorized to service diabetics. 1. The Office of Development Disabilities (ODD) ODD (42 U.S.C. 295-295e, 2661-2666, 2670-2677c, 2691, 2693- 2696) provides assistance in servicing persons with developmental disabilities, and aids in programming, education, and construction of facilities for individuals afflicted with congenital, physiologi- cal, physical, and mental abnormalities. 1 2. The Rehabilitation Services Administration (RSA) RSA (P.L. 93-112, 29 U.S.C. 701 et seq.) aids in the provision of vocational services to handicapped individuals through research, education, demonstration, and construction programs. 2 3. The Administration on Aging (AoA) AoA (P.L. 89-73 as amended, 42 U.S.C. 3001 et seq.) provides a wide variety of services for the elderly. The National Nutrition Program for the Elderly (P.L. 92-258, 42 U.S.C. 3045 et seq.) assists in the provision of low cost, nutritious meals for the aged and potentially could provide services to the elderly diabetic. In It is not clear whether diabetes can fall within the purview of the Developmental Disabilities program. The class of beneficiaries is defined loosely, and so, there is no reason to believe that diabetics are to be excluded. 2 It is not clear whether diabetes can fall within the purview of RSA program. The class of beneficiaries is defined loosely, and so, there is no reason to believe that diabetics are to be excluded. 16 addition, AoA supports a federal-state-local program to establish coordinated service programs for the aged. 4. The Office of Native Americans Programs (ONAP) ONAP (P.L. 93-644, 42 U.S.C. 2991) promotes the goals of economic and social self-sufficiency for American Indians, Hawaiian Natives, and Alaskan Natives. 5. The Office of Child Development (OCD) OCD (P.L. 93-247, 42 U.S.C. 5101 et seq. , 42 U.S.C. 2828, 2829) conducts research in the causes, prevention, and treatment of child abuse, and provides assistance to outside organizations in their child abuse programs. OCD also administers the Head Start and Follow Through programs which provide comprehensive medical services to children of low income families. E. THE EDUCATION DIVISION Statutory authority: Specific: None General: 20 U.S.C. 1221a, 1221c, 1831 Organizational statement: The Education Division is responsible for administering the edu- cation activities of the Department of Health, Education, and Welfare. Within the Division, the Bureau of School Systems maintains a Health and Nutrition Program Branch. It is authorized to provide grants to states for health education programming for school children of low income families. There is no focus upon diabetes, although information relating to the disease may be dispersed, and diabetic children receive special instruction. II. THE DEPARTMENT OF DEFENSE (DOD) Statutory authority: Specific: None General: 10 U.S.C. 131, 136, 1971 et seq. DOD is authorized to provide for or permit programs related to diabetes. Within the Office of the Secretary of Defense is an Assistant Secretary who is responsible for health affairs. This 17 office is responsible for the treatment of patients, clinical research, and education and training and personnel in health matters. The department does not place any emphasis upon diabetes, except to the extent this disease affects military personnel and beneficiaries. See 10 U.S.C. 1071 et seq. Each of the military departments within DOD has authority to pro- vide health services either through direct care or contract facilities for military personnel and their dependents. In the event that dia- betes causes a disability, military personnel receive disability retirement, and subsequently receive care through the Veterans Administration (VA) . III. THE DEPARTMENT OF AGRICULTURE (DOA) Statutory authority: Specific: None General: 7 U.S.C. 2201 et seq. Organizational statement: 40 F.R. 39912 DOA is authorized to provide for or permit studies that relate to diabetes but it does not appear to engage in any activities solely related to the disease. DOA conducts programs related to nutrition through the Agricul- tural Research Service (ARS) but does not conduct any research solely related to the specific nutritional needs of diabetics. Within ARS, the Nutrition Institute is responsible for studies concerning nutri- ent requirements. The Institute is composed of numerous laboratories that perform research in specified areas. Those that tangentially concern diabetes are the Carbohydrate Nutrition Laboratory, Lipid Nutrition Laboratory, Vitamin and Mineral Nutrition Laboratory, and the Protein Nutrition Laboratory. Many of these programs are complemented by extramural research projects funded by ARS through the Foods and Nutrition Service, State Cooperative Research Service, and the Extension Service. 18 IV. INDEPENDENT AGENCIES A. THE NATIONAL SCIENCE FOUNDATION (NSF) Statutory authority: Specific: None General: 42 U.S.C. 1861-1875, 1876-1879 NSF was established by the National Science Foundation Act of 1950 and given additional authority by the National Defense Education Act of 1958. Further responsibilities were transferred to the Foundation by the Reorganization Plan //l of 1973. NSF supports extramural research programs in many scientific dis- ciplines. The Foundation funds research organizations through grants, contracts, and cooperative agreements. NSF does not engage in any activities solely related to diabetes, however, it appears authorized to provide for and permit programs related to diabetes and provides support for basic research potentially related. B. THE VETERANS ADMINISTRATION (VA) Statutory authority: Specific: None General: 38 U.S.C. 201 et seq. , 4101-4124, 5051-5057, 5070- 5091 The VA (38 U.S.C. 201 et seq.) appears authorized to provide for or permit programs related to diabetes. It has extensive medical research, education, and manpower training programs within its depart- ment of Medicine and Surgery (38 U.S.C. 4101-4124). The Department is specifically authorized to share its medical facilities, equipment, and information with other agencies and organizations. Additionally, the Administrator is empowered to coordinate VA programs with those of HEW (see 38 U.S.C. 5051-5057, 5070-5096) and to lend assistance in the establishment of new medical schools. The VA has research projects that relate directly and indirectly to diabetes. 19 C. THE ENERGY RESEARCH AND DEVELOPMENT ADMINISTRATION (ERDA) Statutory authority: Specific: None General: P.L. 93-438, 42 U.S.C. 5811 et seq. ERDA was established by the Energy Reorganization Act of 1974 (P.L. 93-438, 42 U.S.C. 5811 et seq.) and was activated on 1/19/75 by Executive Order 11834. The Administration is authorized to per- form basic research and development functions in the field of energy resources. ERDA maintains laboratories that engage in medically related research, and it appears authorized to provide for or permit programs related to diabetes. The Atomic Energy Commission, a predecessor of ERDA, was involved with studies of radioactive and stable isotopes as a tool in basic metabolic studies. 20 V. APPENDICES 21 A. THE PUBLIC HEALTH SERVICE 23 NOTICES DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Office of the Secretary ADMINISTRATOR, HEALTH RESOURCES ADMINISTRATION Delegation of Authority I hereby revoke the delegations pre- viously made by me to the Administra- tor, Health Services and Mental Health Administration and the Director, Na- tional Institutes of Health, insofar as such delegations pertain to the functions assigned to the Health Resources Admin- istration in the Reorganization Order effective July 1, 1973. I hereby delegate to the Administra- tor, Health Resources Administration, all authority delegated to me by the Secre- tary of Health, Education, and Welfare which pertains to the functions assigned to the Health Resources Administration by the Reorganization Order effective July 1, 1973. These authorities may be redelegated. Pending issuances of redelegations, all delegations or redelegations to any other officer or employee of any office, bureau, division, center or other organizational unit which were in effect immediately prior to July 1, 1973, shall continue in effect in them or their successors. This delegation becomes effective July 1, 1973. Dated June 18, 1973. Charles C. Edwards, Assistant Secretary for Health. [FR Doc.73-13792 Filed 7-6-73;8:45 am] ADMINISTRATOR, HEALTH RESOURCES ADMINISTRATION Delegation of Authority I hereby delegate to the Commissioner of Pood and Drugs and the Director, Na- tional Institutes of Health all those ad- ministrative management and financial management authorities previously del- egated to them by the Assistant Secre- tary for Administration and Manage- ment and the Assistant Secretary Comp- troller and which pertain to those functions assigned to their respective or- ganizations by the Reorganization Order effective July 1, 1973. I hereby delegate to the Administra- tor, Health Resources Administration, the Administrator, Health Services Ad- ministration, and the Director, Center for Disease Control the authority to ex- ercise for their respective agencies all those administrative management and financial management authorities per- taining to those functions assigned to their respective organizations by the Reorganization Order effective Jul" 1, 1973, which were formerly specifk illy delegated to the Administrator, Health Services and Mental Health Adminis- tration and the Director, National Insti- tutes of Health. Pending issuance of redelegations, all delegations or redelegations to any offi- cer or employee of any office, bureau, division, center, or other organizational unit which were in effect immediately prior to July 1, 1973, shall continue in effect in them or their successors. This delegation becomes effective July 1, 1973. Dated July 2, 1973. Charles C. Edwards, Assistant Secretary for Health. [FR Doc.73-13799 Filed 7-6-73;8:45 am] ADMINISTRATOR, HEALTH SERVICES ADMINISTRATION Delegation of Authority I hereby revoke the delegations previ- ously made by me to the Administrator, Health Services and Mental Health Ad- ministration, insofar as such delegations pertain to the functions assigned to the Health Services Administration in the Reorganization Order effective July 1, 1973. I hereby delegate to the Administrator, Health Services Administration, all au- thority delegated to me by the Secretary of Health, Education, and Welfare which pertains to the functions assigned to the Health Services Administration by the Reorganization Order effective Julv i These authorities may be redelegated Pending issuances of redelegations Til delegations or redelegations to any other officer or employee of any office bureau division, center or other organizational unit which were in effect immediateiv prior to July I. 1973, shall continue in effect in them or their successors This delegation becomes effective juir 1, 1973. ' Dated June 18, 1973. Charles C. Edward, Assistant Secretary for Health. [FR Doc.73-13791 Filed 7-6-73;8:45 am| ASSISTANT SECRETARY FOR HEALTH Delegation of Authority I hereby revoke the current delegations of those-Administratlve Management au- thorities previously made by me to the Administrator, Health Services and Mental Health Administration, the Di- rector, National Institutes of Health and the Commissioner of Pood and Drugs. I hereby delegate to the Assistant Sec- retary for Health all the aforementioned administrative management authorities previously delegated to the Adminis- trator, HSMHA, the Director, NTH, and the Commissioner of Pood and Drugs within the Public Health Service, Depart- ment of Health, Education, and Welfare These authorities may be redelegated within the restri otions specified within pertinent DHEW manual instructions or other issuances. Pending Issuance of redelegations by the Assistant Secretary for Health, all delegations or redelegations to any other officer or employee of any office, bureau, division, center or other organizational unit which were In effect immediately prior to July 1, 1973, shall continue in Owan or their eucceaaors. This delegation becomes effective July 1,191*. Dated June 29, 1978. Robert H. Marek, Assistant Secretary for Administration and Management. IFR DOC.73-187M Piled 7-6-73;8:45 «m| ASSISTANT SECRETARY FOR HEALTH Delegation of Authority I hereby revoke the current delegatioa< of these financial management authori- ties previously made by me to the Admin- istrator, Health Services and Men ml Health Administration, the Director, Na- tional Institutes of Health and the Com- missioner of Pood and Drugs. I hereby delegate to the Assistant Secretary for Health all the afore- mentioned financial management au- thorities previously delegated to the Administrator, HSMHA, the Director. NTH, and the Commissioner of Pood and Drugs wittoln the Public Health Service. Department of Health, Education, and Welfare. fEDERAL REGISTER, VOL. 38, NO. 130 — MONDAY, JULY 9, 1973 25 These authorities may be redelegated within the restri ctions specified within pertinent DHEW manual fcustmctions or other issuances. Pending Issuance of redelegations by the Assistant Secretary for Health, all delegations or redelegation to any other officer or employee of any office, bureau, division, center or other organizational unit which were in effect immediately prior to July 1, 1973, shall continue in effect In them or their successors. This delegation becomes effective July 1. 19*?3. Suaxs B. CiMiwiu, Assistant Secretary, Comptroller: Dated June 27, 1873. J ^ JFR DO0.73-18TO8 JUetf 7-«-78;S:4* sinj' - ^ DIRECTOR, CENTER FOR DISEASE ' CONTROL Ealegatfcia ««* Aaahority I hereby revoke the delegations pre- viously made by me to the Administrator, Health Services and Mental'Health Ad- ministration, Insofar as such delegations pertain to the functions assigned to the Center for Disease ConSroLln the Re- organization Order effective July 1, 1973. I hereby delegate to the Director. Cen- ter for Disease Control, all authority delegated to me by the Secretary , of Health, Education, said Welfare which pertains to the functions assigned to the Center for Disease Control by the Re- organization Order effective. July 1, 1973. These authorities may be redelegated. Pending Issuances of redelegations, all delegations or redelegations tc any other officer or employee of any office, bureau, division, center or other organizational unit which were in effect immediately prior to July 1, 1973, shall continue in effect In them or their successors. This delegation becomes effective July 1. 1973. Dated June 18, 1973. Cmia»s C. Edward, Assistant Secretary lor Health. (fr Soo/ra-i37ds fu«j 7-a-?s;8:« «») . DIRECTOR, NATIONAL INSTITUTES OF HEALTH Delegation of Authority I hereby revoke the delegations prevl- - ously made by me to the Administrator, Health Services and Mental Health Ad- ministration, Insofar as such delegations pertain to the functions assigned to the National Institutes of Health in the Re- organization Order effective July 1, 1973. I hereby delegate to the Director, Na- tional Institutes of Health, all authority delegated to me by the Secretary of Health, Education, and Welfare which Pertains to the functions assigned to the National Institutes of Health by the Re- organization Order effective July 1, 1973. These authorities may be redelegated. Pending issuances of redelegations, all delegations or redelegations to any other officer, op employee of any office, bureau, division, center or other organizational NOTICES unit which were in effect immediately prior to July 1, 1973, shall continue in effect in them or their successors. This delegation becomes effective July 1, 1973. Dated June 18, 1973. Charles C. Edward, Assistant Secretary for Health. [FR Doc.73-13790 Filed 6-7-73; 8:45 am J PUBLIC HEALTH SERVICE Reorganization Order Under the authority of section 6 of Reorganization Plan No. 1 of 1953 and section 2 of reorganization Plan No. 3 of 1966, and pursuant to the authorities vested in me as Secretary of Health, Ed- ucation, and Welfare, I hereby order the reorganization of the Public Health Service which shall consist of five health agencies as hereinafter provided. The Health Services and Mental Health Ad- ministration is hereby abolished. Its functions shall be performed by three separate health agencies which are here- by established: the Center for Disease Control, the Health Resources Adminis- tration, and the Health Services Admin- istration. There are hereby transferred: To the National Institutes of Health, the National Institute of Mental Health . for- merly a part of "HSMHA; to the new Health Resources Administration the Bureau of Health Manpower Education formerly a part of the National Institute: oi Health; to the Center for Disease Con- trol the National Institute for Occupa- tional Safety and Health, formerly a part of HSMHA. The lead-based paint poisoning and rat control functions for- merly in the Bureau of Community En- vironmental Management, HSMHA will be performed by the Center for Disease Control. Section 1. Organization. The Public Health Service shall consist of the Office of the Assistant Secretary ior Health and the following health agencies: (1) Center for Disease Cont; (J) Food and Drug Administration; ■ 3) Health Resources Administration; (4) Health Services Administration; (5) National Institutes of Health. The restructured Public Health Serv- ice shall be under the direction and con- trol of the Assistant Secretary for Health, who shall also serve as the prin- cipal Health Officer of the Department, and within the Office of the Secretary serves as principal advisor to the Secre- tary on all health matters. Functions and Responsibilities Office of the Assistant Secretary for Health. The Assistant Secretary for Health shall be responsible for the direc- tion and control of the functions herein assigned to the restructured Public Health Service. The Assistant Secretary for Health is also responsible for provid- ing leadership and guidance for health- related activities throughout the Depart- m;nt and for maintaining relationships with other governmental and private atencies concerned with health. 18261 Center j o Control. The Center for Disease Control shall be responsible for all of the functions presently assigned to it and to the National Institute for Occupational Safety and Health, as well as the functions for the prevention of lead-based paint poisoning, the rat con- trol programs, and the Arctic Health Services Research Centers assigned to the lormer Bureau of Community Envi- ronmental Management. The Center for Disease Control shall be headed by a Director who reports to the Assistant. Si : ur Health. The Center for Disease Control shall carry out its re.- es through the fol- • and the ed bureau-level organiza- tions which shall perform those func- iormerly carried out by those orga- reunder: of Director I e tor Occupational Safety and He<. of the presently assigned functions) au of Epidemiology Epidemiology Program Bureau of Labort. Laboratory D1-. Bureau of ■ State and Community Services Division Bureau of Community Environmental Mt 'only lead-based paint poisoning, rat control, and the Arctic Health Services Research Center func- tions) Sma! :tion Program (All of the presently assigned functions) ■ Program ' of the presently assigned functions) ■ at Disease. Program Malaria Program National Clearinghouse for Smoking and Health (All of the presently assigned functions) rations Pr<. (All of the presently assigned functions) Food and Drug Administration. The Food and Drug Administration shall be responsible for all of the functions pres- ently assigned to the Food and Drug Administration. The Food and Drug Ad- ministration shall continue to be headed by a Commissioner who reports to the Assistant Secretary for Health. Health Resources Administration. The Health Resources Administration shall be responsible for a monitoring, intelli- gence, assessment function on health statu' nance of the health delivery system; health services research and evaluation; development and test- ing of health delivery innovations; and development, testing and dissemination of methods for measuring and assuring the quality of health care; supporting recruitment an of professional and non-professional personnel. Consist- ent with these functions, the Health Re- sources Admini HI be a primary source of technical and professional as- sistance to the Assistant Secretary for Health and to the Department of Health,' Education, and Welfare in policy analysis and policy research. The Health Resources Administration shall be headed by an Administrator who reports to the Assistant Secretary for Health. The Health Resources Adminis- tration shall cany out its responsibilities FEDERAL REGISTER, VOL. 38, NO. 1 30— MONDAY, JULY 9, 1973 26 18262 NOTICE' through the following Office of the Ad- ministrator and the newly established bureau-level organizations which shall perform those functions formerly car- ried out by those organizational units listed thereunder: Office of the Administrator Rational Center for Health Statistics National Center for Health Statistics Bureau of Health Services Research and Eval- uation National Center for Health Services Re- search and Development Regional Medical Programs Service Plans, organizes, and administers programs of specialized experience for foreign health workers: (2) provides for the reception and orientation of foreign visitors to the Center; (3) designs, de- velops, and implements seminar services on current international health affairs for Center staff; (4i coordinates the Special Foreign Currency Program (P.L. 480 activities overseas) ; (5) maintains liaison with the Office of International Health, Office of the Assistant Secretary for Health; and with other organizations concerned with international health. Office of Program Planning and Evalu- ation (9A15). (1) Develops the Center's multi-year program plans for input into the overall plans of the Office of the As- sistant Secretary for Health and the DHEW; (2) implements the Depart- ment's Operational Planning System within CDC; (3) evaluates the Center's progress toward program goals and ob- jectives, and coordinates evaluation ef- forts; (4) conducts continuing studies and analyses of major program activi- ties; <5> develops and maintains a Center-wide program information sys- tem; (6) analyzes major health care pro- grams and proposed legislation with re- spect to the Center's program goals and objectives. Office of Administrative Management (9A19). Under the direction of the Ex- ecutive Officer: (1) Assists and advises in the development, coordination, direc- tion, and assessment of management ac- tivities throughout the Center and as- sures consideration of management Im- plications in program decisions; (2) conducts the Center's activities in the areas of financial management, person- nel management, management analysts computer systems, engineering services general services, procurement and mate- riel management, publications manage ment, library, legislation reference and other delegated authorities as may be assigned; (3) provides technical leader- ship and guidance to management serv- ices performed at field stations and evaluates technical performance- <4> maintains liaison with officials of the Office of the Assistant Secretary for Health and the Office of the Secretary on management matters; (5) provides financial data and systems development in support of overall planning and budg- eting systems; (6) participates in the development of the Center's goals and objectives. ■-<■■ General Services Office (9A1902) evaluates and recommends selection of suitable data processing equipment and services, and determines the need and extent to which new de- velopments within this field can be used to better accomplish Center objectives: <3) conducts and coordinates overall and special studies of the Center's technical and management -data processing sys- tems; . ^ ■ • "-r-c.-.j ■-,.-' - - - <4V -operates electric accounting ma- chine and electronic data processing equipment to produce reports and infor- mataco. *> . .Engineering 'Services Office maintains physical security for the Chamblee and Lawrenceville facilities ; (4) provides technical assistance for and reviews maintenance and operation pro- grams of field Installations and recom- mends appropriate action; (5) provides engineering advice and consultation on new or expanded facilities; (6) collabo- rates with facilities planning officials in developing plans for a major repair and Improvement program that Includes plans, design, and specifications; <7) provides guidance on repairs which are done by contract, and administers repair and improvement projects done by the Center staff. ■», ' Financial - Management Office (9A1905). (1) Provides leadership and coordination in the development and ad- ministration of the Center's financial management - policies; (2) develops FEDERAL REGISTER, VOL. 39, NO. 6 — WEDNESDAY, JANUARY 9, 1974 32 NOTICES 1463 bu^b-i. ouomissions for the Center; (3) collaborates with the Center's Office of Program Planning and Evaluation in the development and implemen 1 ation of long range program and financing plans; (4) participates in budget revie vs and hear- ings; (5) manages the Center's system of internal budgetary planning and con- trol of funds; (6) develops and imple- ments Center-wide budgetary, account- ing, and fiscal systems and procedures: (7) provides accounting and auditing services; (8) develops, coordinates, and implements the cost advisory activities for the Center; <9) prepares financial re- ports; (10) serves as focal point for do- mestic and international travel authori- zation policy and procedures; (11) pro- vides legislation reference services; (12) maintains liaison with the Office of the Assistant Secretary for Health, the Office of the Secretary, and other Government organizations on financial management matters. CDC Library (9A1906). (1) Maintains a technical reference library of books, journals, and pamphlets for use of head- quarters and field staff; (2) furnishes loan, reference, bibliographic, and trans- lation services; (3) maintains a Union Catalog and publishes periodically a list of recent acquisitions, current journals, and translations. Management Analysis Office (9A1907) . (1) Conducts a continuing analysis pro- gram of the Center's organization, de- lineation of functions and responsibili- ties, use of delegations of authority, and administrative management policy, pro- cedures, methods, and techniques; (2) conducts, serves as the focal point for, and assists with studies, surveys, and ap- praisal or evaluation reviews; (3) devel- ops, maintains, and operates paperwork management programs, including rec- ords, reports, forms, and correspondence; (4) administers security and committee management programs; (5) operates a system for the control and release of is- suances concerned with administrative management matters; (6) organizes and presents training courses for Center per- sonnel in records, correspondence, issu- ances, forms, and security. Personnel Management Office (9A1908). (1) Conducts and coordinates personnel management lor the Center's civil service and Commissioned Corps personnel arid for the Center's fellowship program; (2) provides personnel man- agement services for employees assigned or detailed overseas; (3) coordinates and directs the planned assistance program of personnel management assistance to supervisors; (4) develops and issues pro- cedures, conducts staffing, position clas- sification, pay administration, perform- ance evaluation, employee training and development, and employee relations and services programs; (5) coordinates and conducts a position management pro- gram; (6) maintains personnel records and reports, and processes personnel ac- tions and documents; (7) administers the Federal life and health insurance plans and employee recognition and in- centives program; (8) furnishes advice and assistance in the processing of Bu- reau of Employees' Compensation claims; (9) advises and assists Center of- ficials and employees in all areas of per- sonnel management. Procurement and Materiel Manage- ment Office (9A1909). (1) Plans and di- rects the procurement of research and development, technical services, equip- ment and supplies; personal property; transportation; and warehousing; (2) develops and implements policies and procedures in these areas; (3) maintains liaison with DHEW, GSA, other Federal agencies, and private organizations. National Institute For Occupational Safety and Health (9C00) Plans, directs, and coordinates the na- tional program effort to develop and es- tablish recommended occupational safe- ty and health standards and to conduct research, training, and related activities to assure safe and healthful working con- ditions for every working man and woman. Specifically: (1) Administers research in the field of occupational safety and health, including the psycho- logical factors involved; (2) develops in- novative methods and approaches for dealing with occupational safety and health problems; (3) provides medical criteria which will ensure, insofar as practicable, that no employee will suffer diminished health, functional capacity, or life expectancy as a result of his work experience, with emphasis on ways to discover latent disease, establishing causal relationship between diseases and work conditions; (4) serves as a principal focus for training programs to increase the number and competence of personnel engaged in the practice and occupational safety and health; (5) develops and co- ordinates the appropriate reporting pro- cedures which assist in accurately de- scribing the nature of the national occu- pational safety and health problems; (6) consults with the U.S. Department of Labor; other Federal agencies; and, in cooperation with the PHS Regional Of- fices, State and local government agen- cies; Industry and employee organiza- tions; and other appropriate individuals, institutes, and organizations with regard to promotion of occupational safety and health. Office of the Director (9C01). (1) Plan, directs, and coordinates, and evaluates the operations of the Institute; (2) maintains liaison with, and provides ad- vice and assistance to, the U.S. Depart- ment of Labor, the U.S. Department of the Interior, other Federal agencies. State and local government agencies; in- ternational health organizations, and outside groups; <3) provides coordination with the Federal Health Programs Serv- ice's occupational health activities for Federal employees; (4) provides poLicy guidance and coordination to occupa- tional safety and health activities in the PHS Regional Offices. Office of Technical Publications (9C16). (1) Coordinates the develop- ment, publication, and distribution of various technical report series, docu- ments, and instructional materials, such as fact sheets, technical bulletins, and abstracts; (2) coordinate* the exchange of technical developments and research results within and outside the Institute; (3) provides audiovisual sendees for the Institute; (4) coordinates all technical and non-technical public inquiries for the Institute. Office of Extramural Activities (.9C19). (1) Advises the Institute Director on matters relating to the development and progress of Institute-supported external research: (2) in cooperation with the offices and operating divisions of the In- stitute, stimulates research, training, and demonstration grants in relevant priority areas; (3) administers the management aspects of the Institute's grants pro- grams by receiving, reviewing, analyzing, and evaluating all grant applications/ Office of Administrative Management (9C191. (1) Provides management infor- matlon, advice, and guidance to the In- stitute Director; (2) coordinates all man- agement activities in the conduct of finance, personnel, and procurement functions; (3) relates administrative management activities to programs; (4) develops necessary policies, procedures, and operations, and provides such spe- cial reports and studies as may he re- quired in the management area; (5) maintains liaison with the Executive Officer and other Staff Service official'! of the Center. Office of Planning and Resource ManA agement (9C21), (1) Plans and coordi- nates the strategy and philosophy of op^ eration of the Institute regarding mis- sion and objectives; (2) conducts or participates in special studies for pro- gram planning and evaluation; (3) con- ducts the necessary control functions to assure operational compliance toward program objectives within the Institute: (4) provides management systems con- sultation and analyses. Office of Research and Standards Development (9C23). (1) Reviews exist- ing scientific criteria for health and safety standards and assesses through priority systems the needs for additional research program areas for criteria development; (2) coordinates and main- tains an overview of research activities in the operating divisions of the Institute with the ultimate aim toward flnalization of criteria and standards. Office of Manpower Development (9C25). (1) Provides policy guidance and evaluates the Institute's manpower development and training activities; t2> advises the Institute Director on national health manpower needs related to oc- cupational safety and health, and relates to other Federal agencies- regarding oc- cupational safety and health manpower needs; (3) conducts equal employment opportunity activities of the Institute. Office of Occupational Health Surveil- lance and Biometrics (9C27). (1) Op- erates as the principal statistical and data research unit in the Institute; (2) monitors new as well as existing occupa- tional hazards, and maintains surveil- lance on the incidence of occupational illness and disease; (3) in coordination with the UJ3. Department of Labor, es- tablishes a priority list for the conduct of FEDERAL REGISTER, VOL 39, NO. 6 — WEDNESDAY, JANUARY 9, 1974 33 14W research and the development of stand- ards; (4) develops and cond icts record studies of work population groups to determine the national trend: and prob- lem areas related to job health and safety, and provides health jolicy guid- ance in epidemiology; (5) coordinates the Institute's electronic data processing requirements to ensure that adequate computer facilities and services are available. Division of Laboratories and Criteria Development (9C43) . (1) Develops cri- teria for standards for the control of chemical, biological, and physical hazards to the health and safety of the working population, and initiates stand- ard methodology and instrumentation for the detection, evaluation, and control of such hazards; (2) evaluates the toxic- ity, health, and safety hazards of indus- trial substances, processes, and other agents, as well as current research re- quirements and regulations; (3) con- ducts methodology studies for evaluating the varying capacity of workers to with- stand physical and psychological re- sponses; (4) provides for equipment development, analytical service, and cali- bration needs of other operating divi- sions within the Institute, and maintains an analytical and calibrations service for the U.S. Department of Labor; (5) evalu- ates and certifies the performance of safety and health equipment. Division of Field Studies and Clinical Investigations (9C47). (1) Conducts na- tionwide studies, surveys, and compre- hensive analyses to determine the health status of the working population, includ- ing the incidence and prevalence of disease and injury; (2) Initiates studies to determine chronic and long-term cliects of work-related exposures to toxic and hazardous substances. Division of Technical Services (9C53) . (1) Provides demonstrations, technical assistance, and consultation to public and private agencies responsible for the control of occupational diseases and ac- cidental work Injuries; (2) through the PHS Regional Offices serves as the focal point for the review of State plans and giants with the U.S. Department of Labor and makes the initial responses to requests for hazards evaluations; (3) in cooperation with the Office of Ex- tramural Activities, stimulates, pro- grams, and monitors demonstration granst for new and innovative methods of recognizing, evaluating, and control- ling occupational hazards; (4) prepares manuals of good practice for safe work procedures; (5) operates the technical Information inquiry service of the Institute. Division of Occupational Health Pro- grams (9Q57) . (1) Promotes occupational health programs at the State and local governmental levels as weli as in industry and argriculture; (2) provides technical guidance in the development of occupa- tional health programs; (3) correlates the practice of occupational medicine in industry with the total delivery of health services. Division of Training (9C63) . (1) De- velops and plans short-term training ac- I OTICES tivities for Fet.Tal, State, and local governments, industry, and other appro- priate organizations in the field of occu- pational safety and health; (2) conducts such short-term training. Appalachian Laboratory for Occupa- tional Respiratory Diseases (9C67). (1) Conducts studies of the incidence and prevalence of occupational respiratory diseases in specific work groups with par- ticular emphasis on coal workers' pneu- moconiosis; (2) provides medical and engineering researcn and service to ful- fill the Institute's responsibilities under the Federal Coal Mine Health and Safety Act of 1969. Bureau of Epidemiology (9E00) (1) Maintains surveillance over com- municable diseases and certain prevent- able conditions of national importance, and develops programs of international surveillance in collaboration with the Office of International Health, Agency for International Development, the De- partment of Defense, the Department of State, the World Health Organization, and the Pan American Health Organiza- tion; (2) plans, directs, and conducts the national quarantine program which en- forces quarantine regulations to protect the United States agaLnst the introduc- tion of diseases from foreign countries; (3) implements the provisions of the In- ternational Health Regulations; (4> collaborates with the health administra- tions of foreign countries in implement- ing the International Health Regula- tions; (5) im'estigates special disease problems and recommends control meas- ures; (6) participates in the evaluation of experimental vaccines and immuniz- ing agents and procedures; (7) provides epidemic aid and epidemiological serv- ices and consultation to States, Federal agencies, foreign countries, and other private and public recipients; (8) col- laborates with the Food and Drug Ad- ministration, National Institutes of Health, Health Services Administration, Health Resources Administration, and other Federal agencies in areas of mutual program interest; (9) recruits and trains public health epidemiologists; (10> collects, analyzes, and publishes re- ports of morbidity and mortality 'statis- tical data; (11) serves as the WHO Re- gional Reference Laboratory for Rabies in the Americas; (12) provides consul- tation and technical assistance to re- gional personnel on surveillance and epidemiologic matters. Office of the Director (9E01) . (1) Plans, directs, and coordinates activities of the Bureau; <2) advises on the en- forcement of medical aspects of inter- national quarantine regulations; (3) pro- vides epidemiological consultation to other components of the Center, other Federal and State agencies, and health related international organizations; (4) conducts surveillance and epidemiologic studies of prevalent diseases in Alaskan communities; (5) provides Bureau-wide services for scientific and technical pub- lications and ' training aids, and is re- sponsible for the Morbidity and Mortality Weekly Report and various surveillance reports; (6) develops administrative pol- icies, procedures, Bureau plans, and other services to meet Bureau needs; <7) pro. vides administrative and logistical sup- port, and serves as liaison with the ailministrativ© staff in the Office of the Center Director; (8) recruits, trains, arid assigns epidemiologists to programs of the Center; maintains liaison with medi- cal schools, teaching hospitals, and other sources of recruitment for epidemiologists. Bacterial Diseases Division (9E41) qi Conducts surveillance programs and In- vestigations of bacterial diseases, includ- ing bacterial zoonoses; (2) provides epidemic aid and epidemiological consul- tation, upon request, to State and local health departments, other Federal agen- cies, and International organizations; (3 1 conducts investigations on the applica- tion of biological and physical techniques in disease control, including studies on the relation of the environment to the transmission of diseases, particularly in institutions; (4) provides laboratory sup- port required for investigations of epi- demics, including mobile teams to staff field laboratory.. Cancer, and Birth Defects Division (9E43). (lr Develops and maintains systems of case surveillance concerning cancer, birth defects, and related disor- ders in cooperation with the National Cancer Institute and the National Insti- tute of Child Health and Human devel- opment! (2) conducts epidemiologic in- vestigations when indicated in field sit- uations concerning unusual local oc- currences of cancer and/or birth defects; (3) conducts -epidemiologic research. often In collaboration with other public health agencies at Federal and 8tate levels, concerning etiologlc questions In oncogenesis and teratogenesis, especially as related to possible infectious disease etiology; <4> provides consultation as re- quested within and outside the United States concerning the epidemiology of cancer and birth defects. • -.Family Planning Evaluation Division (9E47). (1) Conducts epidemiologic sur- .vefllance of family planning services in specified demonstration areas, and pro- vides on-site assistance with demonstra- tion projects m conjunction with the Office of Populations Affairs, Office of the Assistant Secretary for Health; and the Health Services Administration; (2) evaluates demographic changes in pop- ulations served by family planning pro- grams; <3> conducts surveys to evaluate family planning programs and to meas- ure fertility changes; (4) conducts abor- tion surveillance in conjunction with the Health Resources Administration; (6) conducts epidemiologic studies of con- traceptive complications; (6) provides technical assistance in family planning evaluation. •. Field Services Division (9E49). <1> Maintains field services for the surveil- lance of diseases of national importance through the assignment of medical and veterinary epidemiologists to State and local health departments; (2) conducts investigations and surveillance of mea- sles, rubella, and mumps; (3) provides epidemic aid and consultation to States FEDERAL REGISTER, VOL. 39, NO. 6— WEDNESDAY, JANUARY 9, 1974 34 NOTICES U In inf coiTtrol (4) in col- laboration with the Bureau of State Services, performs Intensive surveillance and individual C3se investigations of vac- ires in anticipa- tion of vaccini i Parasitic Diseases arai Health Division (9E01) . <1) Con- ducts surveillance and investigations of parasitic and zoonotic dis 5) pro- vides consultation o itic diseases and veterinary i e and local health ''epartments, other Federal agencies, medical centers, tnd research institutes in the United States and abroad; (3) pi ary assist- ance, in cooperation with the Pan Amer- ican Health C ion, in dealing with health problems of the U.S. -Mexico Border; (4) provide. 1 : irasitic chemotherapeuti ts that are in- vestigational new dru ;s (under agree- ment with the Food idmin- istration) or difficult to obtain in the United States to troi pecial- ists, parasitologists ler medical specialists. Phoenix Labor at 'o; (1) Conducts clinical, fi Mora- tory invest iga I- with primary emphasis on hepatitis; (2) develop.-; and methods for diagnosis, prevention, and control of these dise;; ollnborates, and mail. State, lot al nical developnu a field exten: i Epidemiology in United States and on o Border, provides CO) riemic aid and oth Slate and local health departments in graphic area Quarantine Divisio i Ad- ministers a national to protect the Unite. introduction of countries: i2) i overseas program for the ion of hers with excludable health conditio economic burde; liaison with and p on quar- antine matters t mental agencie health departments, an industries; (4) provides liaison actional health organizations, such as the Pan American Health Oi d the World Health Organizati ticipates in the develops- erna- tlona! agreements affecting quarantine; (5) conducts studies to provide new in- formation about, health hazards abroad, measures for their potential threat of disease introdu into the United SI i provides logistic support to other programs of the Center in the distribution of requested bioloKicals. Viral Diseases Divisio: Conducts surveillance programs and in- vestigations of vir? ! including viral zoonoses; (2) provide; aid and epidemiological consult upon request, to State and local health departments, o'lier Federal agencies, and international organizations; (3) con- ducts field and laboratory research stud- ies in developing prophylactic agents and diagnostic tests and performing eco- itions for the control of rabies; (4) serves as the WHO Regional Reference Center for Rabies in the Americas. Bureau of Laboratoiuf.3 (9G00) Administers a comprehensive na- tional laboratory improvement program; (2) conducts research for improving laboratory methodology; (3) conducts and coordinates a program to standard- ise clinical laboratory methods and ma- terials; (4) evaluates techniques, ma- terials, and reagents used in public health laboratories; (5) provides refer- ence and typing center services related to clinical laboratory procedures lor national and international organisa- tions; (6) directs and conducts the ad- ministration of the licensure and evalua- tion of clinical laboratories engaged in interstate commerce under the authority and provisions of the Clinical Labora- tories Improvement Act of 1967; <7) develops diagnostic products specifica- tions and evaluates commercial products; (8i produces and distributes microbiolcg- and working reagents not commercially available or of unreliable supply; (9) (provides consultation, train- nd informational services in labor- techniques and laboratory man- it to States and other recipients; (10) distributes experimental vaccines and special immune globulins to prevent and control laboratory infections; ill) provides consultation, laboratory serv- ices, and epidemic aid in the area of vec- torborne infections to State, Federal, and cies. Office of the Director (0G0V. (1) Pro- vides leadership and guidance on policy and pro inning and development, and program management and opera- tions; <2) manages a comprehensive na- Le program for improving medical laboratory (3) provides coor- >n and liaison relating to Bureau activities which serve as national and international reference centers and vari- ous national groups and the World Health Organization; (4) provides co- ordination for other international activ- r the Bureau: (5) coordinates the activities of the Bureau that provide technical support to the Food and Drug istration program for regulation of diagnostic products; (6) supports the "research and other programs of the Bu- reau through assistance in experimental leal analyses, quality con- trol, and technical editing service. Bacteriology Division (9G41). (1) Pro- vides reference laboratory diagnostic services and consultation to State and Federal agencies in medical and public health bacteriology and immunology: (2) serves as a laboratory referee for proficiency testing programs; (3) pro- vides leadership for upgrading bacterio- logical sen ices in public health and clin- ical laboratories; (4) collaborates with other component of the Center and with national and international health agen- cies and academic institutions in pro- viding training, consultation, and epi- demic aid In the laboratory aspects of bacterial or other related diseases: (5> serves as designated national, regional, and m'ernational reference centers; (6) conducts research to develop means of diagnosing infectioi is; -7) con- ducts, promotes, and supports in -house and field evaluations of new techniques for public health and clinical laboratory use; (8) investigates and defines the re- lationship of bacteria and host respon ;es to the disease process: (9) plans, directs, and coordinates proficiency testing and evaluation programs in syphilis serology; (10) maintains standard tuberculins and other sensitins and a treponemal bank of pathogenic and non-pathogenic tnsp- oi i ernes. Biological ProdwAs Division <9C«3). d> Develops guidelines for the prodUC tion and utilization of microbiological re- nostic aids; (2> pro- Itoxfns, skin test antigens, and erum globulins to control ai ibo-'a- tory infections and to pi mini- mize disease in particul nation groups; (3) develop.- produ tions, and . pre- pared biol< .ducts i'li on h: t produc- •i (9G45). ( l » Conducts and ational ternntion: n prove ical and ;mmu- fnostic procedures for the it ol of di ease; (2) develo] ecting disease; (3) ipports rational and i ratory h] standaj i pro- .id toxicol- i) evaluates techniq erials, vices used in health lab- irnishes laboratory serv- ices and consultation to. and conducts joint programs with, other components of the Center and the Department; (6> collaborates in laboratory training and evaluation, and provides support to State and other public health, labora- tories for improvemei mdardiza- tion of public health and clinical labora- tory procedures: (7) serves as the WHO International Reference Center for Lipid Determination in Cardiovascular Re- search, and conducts other collaborative standardization programs with the World Health Organization. Hematology Division (DG49). (1) Plans, conducts, and coordinates national and international programs for improve- ment and standardization of laboratory procedures in clinical hematology and immunohematology for the prevention and control of disease; (2 > investigates, develops, and evaluates methods, stand- ards, reagents, blood reference materials, instruments, and automated sytems in diagnostic hematology: (3) provides ref- erence analyses for selected hematologic determinations, and conducts joint pro- grams and investigations in clinical and FEDERAL REGISTER, VOL 39, NO. 6— WEDNESDAY, JANUARY 9, 1974 35 lloG NfTICES laboratory hematology with other com- ponents of the Center, the Department, and national and international health agencies; (4) conducts or collaborates in hematology proficiency testing programs; (5) provides consultation and tr. lining in laboratory procedures to State and other public health laboratories for improve- . rnent and standardization of public health and clinical laboratory proce- dures; (6) serves as the International Standardization Laboratory for Hema- globinopatliies and Coagulation, and conducts other collaborative standardi- zation programs with the World Health Organization; (7) serves as the National Hematology Standardization Laboratory for the initiation, evaluation, and devel- opment of national standards. Laboratory Training and Consultation Division (9G53) . (1) Administers a na- tional laboratory training and consulta- tion program directed primarily to State public health and other health labora- tories; (2) conducts laboratory manage- ment reviews, and provides consultation to local. State, and Federal health lab- oratories; (3) coordinates the Center's health laboratory manpower develop- ment program. Licensure and Proficiency Testing Division (9G55). (1) Plans and conducts a national laboratory licensure program; (2) evaluates and licenses clinical labora- tories engaged in interstate commerce, as provided for in the Clinical Laboratories Improvement Act (CLIA) of 1967, insures compliance by licensees with standards promulgated, and issues letters of exemp- tion, as appropriate; (3 J develops and recommends regulations, criteria, and standards of laboratory licensure; (4) collaborates with the General Counsel's office in the development and revision of legislation and regulations relating to proficiency testing and licensure of lab- oratories engaged in interstate com- merce; (5) evaluates the proficiency test- ing and examination programs offered by States, professional organizations, local public agencies, and non-profit private organizations to determine their suita- bility for use in lieu of the piogram administered under the authority of the CLIA; (6) administers a proficiency test- ing program for clinical laboratories li- censed under the Act, Peder: I laborato- ries, and State and local public health laboratories; (7) provides referee testing service for intrastate proficiency testing programs; (8) works with State and professional organizations in developing laboratory improvement programs, and develops prototype systems for use in im- plementing these programs; <9> collab- orates with other programs of the Center in providing training and consultation; (10) insures that laboratories do not en- gage in interstate commerce unless licensed or exempted in accordance with tho provisions of the CLIA. Mycology Division iOG57). (1) Pro- vides medical mycological reference lab- oratory services to Federal and State agencies for the diagnosis of actinomy- cotic and fungal diseases; (2) serves as the National Center for Fungal Serology; (3) conducts applied research studies for the development : i.d evaluation of more rapid and reliable laboratory procedures for the diagnosis of mycotic diseases; (4) plans and conducts ecologic, epidemio- logical, and taxonomic, and therapeutic studies of fungus diseases and their etio- logic agents; (5) collaborates with other components of the Center and with Fed- eral. State, national and international health organizations to provide training, consultation, and assistance in inter- and intrastate proficiency testing programs and epidemic aid in the laboratory aspects of actinomycotic and fungus diseases. Parasitology Division (9G59). (1) Serves as a national reference laboratory center for parasitic diseases and as a laboratory referee for performance eval- uation programs; (2) conducts method- ology research to develop more rapid and accurate laboratory means of diag- nosing parasitic diseases; (3) provides leadership for upgrading parasitology services in public health and clinical lab- oratories; (4) plans and conducts lab- oratory epidemiologic and immunologic studies of parasitic diseases; (5) collab- orates with other Center activities and with State, national, and international health agencies in providing training, consultation, and epidemic aid in the laboratory aspects of parasitic infections. Pathology Division (9G61). (1) Con- ducts or participates in national and re- gional programs for evaluation and improvement of histopathological, cyto- pathological, genetic, and immunopatho- logical diagnostic procedures; (2) maintains a national repository of histo- chemical control material; and develops, adapts, and evaluates histochemical and ancillary procedures; (3) conducts ex- periments for development of quality control methods in cytopathology ; (4) provides tissue-processing service to Center epidemiologists and laboratory investigators, and provides reference di- agnostic and technical consultation to the Center and other health personnel; (5) trains individuals in tissue proces- sing, cytogenetics, and electron micro- scopic techniques, and provides practical and theoretical instruction in histology, pathology, and genetics; (f>> conducts research for development of new im- munological, histological, and cytologi- cal techniques for the study of existing problems and for the application of avail- able capabilities to emerging problems; (8) advises and supports the interstate licensure and performance evaluation ac- tivity of the Bureau of Laboratories in histopathology and cytology. Scientific Services Division (9GG3) . (1) Directs and administers a program of providing animals, glassware, media, reagents, and other services in support of research and service activities of the Bureau of Laboratories and other pro- grams of the Center; (2) manages data and specimen handling of specimens re- ceived at the Center for reference diag- nosis; (3) maintains a bank of serum specimens of epidemiological, clinical, or research interest; (4> provides consulta- tion and participates in training activi- ties of the Center. Vector-Borne ' Diseases Division (9G65). (1) Provides consultation, lab- oratory services, and epidemic aid in the area of arthropod-borne infections to State, Federal, and international agen- cies; (2) 'studies and evaluates the mechanisms of maintenance and dis- semination of arthropod-borne, viral. bacterial, parasitic, and rickettsial dis- eases as a basis for control and preven- tion of infection in man; (3) develops and applies new techniques for the study and control of arthropod-borne diseases; (4) trains technical and professional personnel in field and laboratory ap- proaches to investigation of arthropod - borne disease problems; (5) serves as the World Health Organization's Arthropod- Borne Virus Regional Reference Labora- tory for the Americas. -Vtrolooy Division i9G67) . (1) Provides reference laboratory diagnostic services, consultation, collaborative investigation, and epidemic aid In the areas of viral and rickettsial diseases to State and Fed- eral agencies; (2) conducts methodology research to develop laboratory diagnos- tic tests for viral diseases; (3) provides leadership for upgrading diagnostic sen- Ices m public health and other labora- tories; <4> evaluates and defines the relationships of -viruses and viral anti- bodies to disease processes; (5) collabo- rates with other Center activities and with State, national, and international health agencies in defining virual disease problems and in providing training in the laboratory aspects of these diseases; (6> serves as designated regional and inter- national reference centers. , .Bureau of State Services <9JO0) <1) Plans, directs, and coordinates a national program for the prevention, control, or eventual eradication of serious diseases,, such as gonorrhea, measles,, poliomyelitis, rubella, syphilis, and tuberculosis, for which specific pre- ventive measures are available; (2) administers Intramural and extramural programs for the control, or eventual eradication, of preventable conditions, and for the control of environmentally induced human health problems; <3> conducts research relative to health problems of concern to the Bureau; <4> provides assistance in analyzing the in- fluence of various factors such as socio- economic status, nutritional status, ar.d demographic characteristics on the in- cidence and severity of preventable dis- eases; (5) cooperates with PHS Regional Office staff in the provision of assistance and services to State and local health agencies, particularly with respect to grant supported disease control pro- grams; (6) provides technical assistance to, and maintains liaison with, other U.S. Government agencies. State anc: local health agencies, international anv. national organizations, and industry. Ojptce of the Director (9J01). .«' Manages the activities of the Bureau, (2) provides leadership in policy formu- lation, coordination, and conduct of ye Bureau's activities; and, in cooperation with the Regional Offices, assists Sta^e .and local governments and communuj groups in carrying out nationwide ax- FEDERAL REGISTER, VOL. 39, NO. 6 — WEDNESDAY, JANUARY 9, 1 974 36 ease control programs; (3) recruits and, in cooperation with PHS Regional Of- fices, coordinates the assign nents, and provides career development t i State and local assignees; (4) formulates, plans, conducts, and participates ir studies to improve effectiveness and eiliciency of Individual and group participation; (5) provides assistance in the analysis and planning for preventive services; (6) provides assistance in the analysis and evaluation of the relationship of mal- nutrition to infectious diseases and other preventable conditions; (7) provides administrative, fiscal, and technical in- formation services to the Bureau. Environmental Health Services Divi- sion (9J41). (1) Conducts research, in- vestigations, demonstrations, and pro- grams directed toward the control of environmentally induced human health problems; (2) assists States and local governments in the development of man- power, training programs, and other services to deal with preventable condi- tions, such as rodent control activities and prevention of lead poisoning in chil- dren; (3) maintains liaison with, and provides advice and assistance to, other Federal agencies, such ns the Depart- ment of Housing and Urban Develop- ment and the Department of the In- terior, and to international health organizations and other outside groups on human health problems associated with environmental factors; (4) serves as the focal point in the Bureau for epi- demiological information and statistical data on environmental hazards to human health; (5) develops and recommends criteria and standards to be u=ed in pro- gram planning and evaluation of envi- ronmental health services. Immunization Division (9J45). (1) Provides consultation, training, statisti- cal, promotiona.l, educational, epidemio- logical, and other technical services to assist and stimulate State and local health departments in the planning, de- velopment, implementation, and overall improvement of programs for the preven- tion, control, and eventual eradication of serious diseases for which effective im- munizing agents are available; (2) sup- ports a nationwide framework for effec- tive surveillance of diseases for which effective immunizing agents are avail- able; (3) develops improved immuniza- tion techniques and methods; (4) pro- vides technical supervision to State and local assignees in cooperation with PHS Regional Offices. Tuberculosis Control Division (9J49). (1) Administers research and operational programs for the prevention and con- trol of tuberculosis and other respiratory diseases; (2) provides consultation, training, statistical, promotional, educa- tional, epidemiological, and other tech- nical services to assist and stimulate State and local health departments in the planning, development, implementa- tion, and overall improvement of tuber- culosis control programs; (3) supports a nationwide framework for effective surveillance of tuberculosis; (4) provides technical supervision to State and local assignees in cooperation with PHS Re- gional Offices. I OTICES Venereal Di > asc Control Division (9J51). (1) Administers research and operational programs for the prevention and control of syphilis, gonorrhea, and other venereal diseases; (2) provides consultation, training, statistical, promo- tional, educational, epidemiological, and other technical services to assist and stimulate State and local health depart- ments in the planning, development, im- plementation, and overall improvement of venereal disease control programs; (3) supports a nationwide framework for effective surveillance of veneral diseases; (4) provides technical supervision to State and local assignees in cooperation with PHS Regional Offices. Bureau of Smallpox Eradication (9M00) (1) Directs and coordinates the sur- veillance of smallpox and smallpox vac- cinations within the United Statesi in- cluding consultative assistance to the States on suspect smallpox cases and continuing assessment of smallpox vac- cine reactions; (2) provides overall con- sultation, direction, coordination, and management for the United States' par- ticipation in the worldwide program for eradication of smallpox; (3) works with other government agencies and with other countries and international agen- cies to develop public health programs based on techniques and methodologies developed in smallpox eradication activi- ties. Office of the Director (9M01). (1) Plans, directs, and coordinates the over- all activities of the Bureau of Smallpox Eradication; (2) participates and main- tains liaison with national and interna- tional agencies in the eradication or con- trol of smallpox and other preventable diseases. Operations Division (9M45). (1) Di- rects and coordinates smallpox and vac- cination surveillance within the United States, including consultative assistance to the States on suspect smallpox cases and continuing assessment of smallpox vaccine reactions; (2) directs, coordi- nates, and manages U.S. participation in the global smallpox eradication program. When feasible, provides similar services for other international immunization programs; (3) directs and coordinates, in conjunction with the Agency for In- ternational Development, disease and demography cluster sample survey. Research and Development Division (9M49). (1) Develops, field tests, and makes recommendations on adoption of new and improved procedures to assist developing countries in improving their public health programs; (2) plans, con- ducts, and evaluates research activities in various aspects of disease control for immunization programs. Bureau of Training (9N00) (1) Conducts a program to update and improve the performance of practicing health professionals in the methods and techniques of disease prevention and con- trol; (2) promotes the establishment, maintenance, and improvement of State and other health training programs; (3) provides disease control training and consultation in natural disasters and 1467* epidemics; (4) develops, and provides consultation on, advance training tech- nology and methodologies through the above activities; (5) coordinates the Center's training activities. Office of the Director (9N01). (1). Plans, directs, and evaluates the activi- ties of the Bureau; (2) coordinates as-- sistance provided by the Bureau to the Center and to other agencies; (3) coor- dinates the Center's preventive medicine residency program, and provides the. Center's focal point for liaison in univer- sity affairs; (4) provides administrative, fiscal, publications, and distribution serv- ices to the Bureau, and manages the Center's implementation of the direct training reimbursement policy. Instructional Media Division (9M41). (1) Provides and/or produces photo- graphic services for the Bureau; (2)' de- signs and prepares various instructional aids in support of training activities: (3) manages the operation of the Atlanta training facilities, and provides techni- cal services for conferences, meetings, seminars, and special functions. Instructional Services Division (9M45) . (1) Assists disease prevention and con- trol agencies in the implementation of training activities designed to qualify manpower to perform those work func- tions necessary to achieve their program purposes; (2) conducts training courses in the principles and application of epi- demiologic methods In disease prevention and control, and in the control of hospital Infections and foodborne diseases; and develops and implements homestudy courses; (3) assists disease prevention and control agencies In evaluating the success of implemented training solu- tions in removing training problems. Instructional Systems Division 19N49). (1) Assists the Center's programs and other disease prevention and control agencies to (a) identify and analyze pro- gram performance problems caused by inadequately qualified manpower; and (b) specify explicit standards and effi- cient systems of work for achieving their program purposes; (2) constructs de- tailed plans for developing. Implement- ing, and evaluating training solutions designed to remove identified training problems, and develops appropriate in- structional materials; (3) utilizes effec- tive and efficient procedures of perform- ance problem analysis, plan specification, and instructional systems design. — - ■ Buriau or Tropical Diseases (9P00) (1) Plans, directs, and coordinates a program of research and Investigation of selected communicable diseases; (2) assesses the extent and significance of certain vector-borne and tropical dis- eases, such as Chagas' disease," onchocer- ciasis, shigella, malaria, and other parasitic diseases; (3) develops and evaluates methods of controlling insect vectors, including insectlcldal and bio- logical control measures, and the diseases they transmit; (4) conducts investiga- tions on the bionomics of insect vectors, and researches the. host-parasite rela- tionship of such diseases; (5) through interrelated laboratories in the United FEDERAL REGISTER, VOL. 39, NO. 6— WEDNESDAY, JANUARY 9, 1974 37 1468 NCI ICES States and the Tropics, provides assist- ance to other scientific, educational, and health organizations in develop ng com- petencies in the epidemiology i.nd con- trol of tropical and vector-be me dis- eases; (6) collaborates with, and provides technical consultation to, other U.S. Gov- ernment agencies and international or- ganizations in the development, evalua- tion, and application of control measures. Office of the Director (.9P0D . (1) Plans, directs, coordinates, and evaluates activities of the Bureau; (2) provides leadership and technical guidance on re- search projects; (3) establishes Bureau objectives and policies; (4) provides liai- son with other agencies, including the U.S. Department of Agriculture, United States Armed Forces, Agency for Inter- national Development, and the World Health Organization; (6) provides ad- ministrative and other staff services to the Bureau. Central America Research Station (9P85) . (1) Plans and conducts research projects on selected communicable dis- eases; (2) develops, demonstrates, and recommends measures for use in disease control programs; (3) collaborates in field trials for inquiries on new methods for control of vector-borne diseases; (4) maintains surveillance of disease prob- lems of the area which may pose a threat to the United States; (5) provides career development opportunities for appropri- ate professional staff of the Center; (6) collects and provides to other programs of the Center indigenous materials needed in laboratory improvement activi- ties; (7) when appropriate, conducts stud- ies on other disease entities which are o? mutual interest and importance to the United States and the host country or countries of the Central America region. Vector Biology and Control Division (.9P45) . (1) Serves as the Center's re- source for pesticide development, formu- lation, application, and analysis; (2) conducts investigations on the biology, ecology, host-parasite relationships and vector ability, and control of arthropod vectors; (3) provides technical guidance on methods for controlling insect vectors and the diseases they transmit; i4) de- velops, prepares, coordinates, and pre- sents regular training courses at, CDC, field courses, workshops and seminars In the general field of vector-borne diseases and selected tropical diseases. National Clearinghouse for Smoking and Health (9S00) (1) Provides leadership and direction for a national program to reduce death and disability due to smoking; (2) acts as coordinator for Department activities related to smoking and health, maintain- ing liaison, through the Office of the Cen- ter Director or directly as deemed appro- priate by CDC, with other Federal agen- cies and with official and voluntary groups concerned with the problem; (3) participates in the activities of the Na- tional Interagency Council on Smoking and Health; (4) provides consultation to State and local interagency- councils and to industrial and local groups in develop- ing coordinated community approaches to smoking contn i programs; (5) pre- pares an annual report to Congress re- viewing the medical and scientific evi- dence on the health consequences of smoking; (6) collects and disseminates scientific information, and maintains the Clearinghouse literature collection; (7) works with groups and organizations, within and outside government, carrying out public awareness and education pro- grams on smoking and health directed toward specific target groups as well as the general public; (8) works with health and education programs on smoking and health in developing and conducting health education on smoking and health in the schools; (9) plans and carries out studies to furnish a better understanding of the dynamics of smoking behavior, and to evaluate program progress and effectiveness. Office of the Director (9S01) . (1) Plans, directs, coordinates, and evaluates activities of the Clearinghouse; (2) maintains liaison with other Federal agencies and official and voluntary groups; (3) participates in the activities of the National Interagency Council on Smoking and Health, and provides tech- nical consultation and assistance to State and local interagency councils and other groups in developing programs to control smoking; (4) prepares an an- nual report to Congress on the health consequences of smoking; (5) develops administrative policies, procedures, pro- gram plans, and other services to meet Clearinghouse needs; (6) provides over- all administrative services to the Clear- inghouse. Community Program Development Division (9S43) . Works with National, State, and local officials and voluntary, professional health and education groups to plan, develop, test, and provide prac- tical models of community education programs on smoking and health, includ- ing: (1) Development and support of interdisciplinary-interorganizational mechanisms at all levels to improve the use of existing financial and mm power resources and services, (2) primary pre- vention activities for youth in school and in non-school programs, (3) pre- and inservice training and curriculum devel- opment for teachers, (4) pre- and post- graduate training for health profes- sionals and prototype program activities for use in direct health care facilities, Federal and private; (5) establishment, supervision, and reporting on community projects to test and evaluate community smoking control efforts. Health Education Division (9S45). (1) Plans, develops, and carries out national programs of information and education on smoking and health; (2) collects, or- ganizes, and disseminates scientific in- formation, and maintains a literature and bibliographic collection; (3) con- ducts public awareness activities, and maintains liaison with the press and other media representatives, citizen groups, and other organizations on co- operative awa~eness and education pro- grams; (4) develops and distributes edu- cational materials and special informa- tion reports on smoking and health to professional audiences, radio, television, and other media, both commercial and educational. Program Research Division (SF49). (1) Flans and carries out studies on the dynamics of smoking behavior; (2) con- ducts research to determine the factors involved in taking up smoking and in the cessation of smoking; <3) experiments with and evaluates the effectiveness of methods aimed at cessation of smoking; (4) conducts surveys to assess the in- cidence of smoking and changes in the attitudes, beliefs, and knowledge about smoking; (5) evaluates the effectiveness of school and community programs in re- ducing the incidence of smoking; (6) provides technical consultation and as- sistance in the design and analysis of studies of smoking behavior. Sec. 9-C Ordzr of Succession, During the absence or disability of the Center Director, or in the event of a vacancy m that office, the first official l'sted below who is available shall act as Director, except that during a planned period ol absence, the Director may specify a dif- ferent order of succession : (1) Assistant Director for Op: . lions', (2) Assistant Director for Program; (3) Executive Officer. Sec. 9-D Dal~:j it, ,ns of Authority. (1) The Center Dirr: t •.;■ . hall continue to exercise all the authorities given to him. under the Delegations of Authority made by the Assistant Secretary for Health (38 FR 18260, July 9, 19731. All delega- tions or rcdelegations to any officers or employees of the Center for Disease Con- trol which were in effect immediately prior to the effective df te hereof con- tinue in effect in them cr th'ir succes- sors, pending further redeleg.ition. Dated: January 2, 1974. Robert H. Marik, Assistant Secretary for Administration and Management. [FR Doc.74-«87 Filed l-8-74;8:45 am] PUBLIC HEALTH SERVICE Organization, Functions, and Delegations of Authority Part 1 in the Statement of Organiza- tion, Functions, and Delegations of Au- thority of the Department of Health, Education, and Welfare, Chapter IN, en- titled Office of the Assistant Secretary for Health, (38 FR 18571, July 12, 1973) is hereby amended as follows: I. Section IN. 10 2 Special Functions, is amended to delete "Regional Health Administrators." Section lN.20B2a., "Re- gional Health Administrators," is deleted in total. H. Section 1N.10 is amended to add a new subsection 3 titled Public Health Service Regional Offices. Section 1N.20B is amended to add a new subsection 3 as follows: 3. Public Health Service (PHS) Re- gional Offices. (1N81-1N8A) Each PHS Regional Office is responsible for direct- ing PHS Regional Office programs and activities in order to assure a coordinated regional effort In tune with national poll- FEDERAL REGISTER, VOL. 39, NO. 6— WEDNESDAY, JANUARY 9, 1974 38 NOTICES hlfrj cies and state and local needs within each region. Interprets national policies and guide- lines, establishes regional goals and ob- jectives, monitors progress and accom- plishments and reviews and redirects the regional effort accordingly. Develops the overall regional budget proposal (funds and positions) based on national priorities and regional work plans. Determines types of personnel needed, recruits and selects, anil evaluates per- formance of regional staff. Cooperates with the Regional Director, who is the regional program coordinator, in coordinating health programs with other Department of Health, Education, and Welfare programs and with pro- grams of other agencies impacting upon the needs of people. Awards decentralized health grants and contracts in accord with national policies and guidelines and State and local needs. Provides reionsl input into the for- mulation and analysis of national policies, priority determination, and pro- gram plans and serves as the principal health advisor to the Regional Director. Assures program implementation and continuity and establishes program focal points to provide for categorical program identification. Each PHS Regional Office shall be headed by a Regional Health Adminis- trator who reports to the Assistant Sec- retary for Health. Programs and authorities administered by the Food and Drug Administration are delegated from the Assistant Secre- tary for Health to the Commissioner of Food and Drugs and will be coordinated with the Regional Health Administrator as required. a. Office of Planning and Evaluation. (1N8115) Conducts and i uides for the Regional Health Administrator a process of PHS Regional Office planning in sup- port of national health strategies and Regional Director's planning policies. Coordinates the development of spe- cific PHS regional goals; operational plans, including work plans and Opera- tional Planning System (OPS) objec- tives; proposals for the allocation of resources to carry out those plans and objectives; input into the Forward Plan for Health; and input into the Regional Director's Operational Planning System. Provides evaluation of regional health program goals in relation to national priorities and local needs, recommends corrective action and assists in imple- mentation. Serves as the Regional Health Admin- istrator's coordinator for input into health planning policy matters with the Office of the Assistant Secretary for Health, PHS agencies, and the Regional Director's Office. b. Office 0/ Management Support. (1N8119) Advises and assists the Re- gional Health Administrator in the in- ternal management of the PHS Regional Office. Provides administrative services support for the PHS Regional Office in conjunction with the Regional Director's management staff. Serves a ■ the Regional Health Admin- istrator's coordinator for input -into the Central Office budget and staffing al- location process, and in conjunction with the Office of Regional Operations and Regional Director's Office, maintains a •system for monitoring the use of per- sonnel and funds allocated to the health programs in the PHS Regional Office. Maintains the regional health man- agement information system in coopera- tion with the Office of Regional Opera- tions and Regional Director's Office, in- volving data collection, monitoring, and reporting. Responds to health data needs of the Regional Office, including requests from the public. Serves as the Regional Health Admin- istrator's coordinator on management matters with the Office of the Assistant Secretary for Health and the Regional Director's Office. c. Office of State Coordination. (1N8122) Serves as key advisor to the Regional Health Administrator on the health needs and resources of each State and local area within the region's juris- diction. In concert with the Office of the Re- gional Director, serves as a contact point for the States, provides assistance to them, and facilitates their access to and receipt of services from cross-organiza- tional components of the PHS Regional Office. Cooperates with PHS Regional Office components, the Regional Director's .staff, and other agencies in efforts di- rected toward matching health resources with State and local needs. d. Division of Financing and Health Economics. (1N8141) Provides advice and assistance to State and local agencies as well as private institutions in establish- ing relationships with health financing programs on reimbursement funding of health service activities. Serves as focal point in the region for increasing capabilities to utilize available funding programs such as health insur- ance, revenue sharing, and third party payment systems. Provides technical assistance on orga- nization and administration of financial and related business management aspects of health service delivery systems. Directs activities to assist projects, agencies, and institutions within the re- gion to improve relationships with health financing and reimbursement programs. Participates in the development of measures and monitors progress in im- plementing strategies to achieve cost control and maximized third party reim- bursement. Services as PHS regional counsel on developing flexibility for programs such as national health insurance, special health revenue sharing, and third party payment systems. Develops for the Regional Health Ad- ministrator information and recom- mendations to the Assistant Secretary for Health on problems suggesting changes in national health financial policy or authority. e. Division of Quality and Standards. (1N8143) Serves as the principal PHS adviser on quality assurance activities In- cluding interpretation and compliance with established standards for medical ■care. Provides technical consultation to Si ate and local health officials in the inter- pretation and application of Ilea, th standards and policy, and in correcting deficiencies. Serves as the PHS regional focal poi: for implementation of quality assuna.. and utilization review requirements the Medicaid and Medicare Program, ... coordination with the Regional LVLrector and with Social and Rehabilitation Serv- ice and Social Security Administration regional staffs. Participates in the development and monitoring of institutions and com- pliance with standards lor health ca r o provided under Medicaid and Medicar* Coordinates the review and apptica ■tion of medical standards and quality an i cost control methods used in Federally sponsored direct and grant supporteJ health service delivery programs. Participates in the d<'\clopme*it And implementation of standards for health •care related activities f. Division of lie , Services. (1N8145) Directs and < i. .,..r,?>s pro- grams and activities designed to promote and provide quality health services with- in the rcr.i Admin i:- 1- : s Federally supported health service delivery programs including in- terpretation of policies and guidelines, site assessments, project development and project monito. ing. Provides profes?iona) consultation and guidance in medical and health related services and tech; ical assistance in pro- grams and projec dovolonmon! Serves as regional foe: \ point for promoting and directin i ."its to in- terna : service delivery pro.ii\ is in a more comprehensive manner and maximi^u services available in health scarcity areas. Monitors grants for compliance with applicable laws, regulations, policies, anc, guidelines. g. Division of Resource Development (1N8147) Directs and coordinates pro- grams and activities designed to increase the capacity and capability of thehcaltn care system in the region. Provides assistance and support for State and local health planning activi- ties including the assessment of health care needs and resources. Cooperates with the health agencies ir> the disseriination of research findings and the development arid testing of new approaches to improved health care de- livery. Monitors and assesses results o". regional health delivery innovations ir relationship to both local and national objectives. Supports activities designed to improve the recruitment, production and utiliza- tion of health manpower. Provides professional and technical assistance to the health community in the design and development of all health care resources. Monitors grants for compliance with applicable laws, regulations, policies, and guidelines. FEDERAL REGISTER, VOL 39, NO. 6 — WEDNESDAY, JANUARY 9, 1974 39 1170 h. Division of Prevention. (1N8149) Directs and coordinates programs and activities designed to improve health by preventing or controlling diseases, in- cluding environmentally induced human health problems. Provides a regional locus of respon- sibility for input to national program development in areas of preventive health services and for the regional im- plementation of national preventive health policies, plans, and programs. Provides liaison with specif 1 national impact programs, such as venereal dis- ease control, and assures access to head- quarters epidemiologic and laboratory specialists and other specialized assist- ance. Provides technical program consulta- tion, information and guidance to State and local health departments and agen- cies, communities and industries on dis- ease prevention, preventive health services, environmental and occupational health services. Serves as regional focal point for pro- viding continuity and leadership to other regional office functional Divisions in the interpretation of the Departmental priorities in preventive health and coor- dinates activities with the other Divi- sions. Monitors grants for compliance with applicable laws, regulations, policies and guidelines. Provides a locus of responsibility for supervision of personnel assigned from the Center for Disease Control to State and local health departments. III. A new Section 1N.30 Delegations of Authority is created: Section 1N30 Delegations of Author- ity. (1) Pending further redelegations the Regional Health Administrator shall exercise all the authorities previously given to the Regional Health Director by the Administrator of the former Health Services and Mental Health Ad- ministration and all authorities given to the Regional Health Director by any other official of the Department of Health, Education, and Welfare that is not inconsistent with any action subse- quently taken by the Secretary of the Department or his designee. Dated: December 26, 1973. Robert H. Marik, Assistant Secretary for Administration and Management. [FR Doc.74-666 Filed l-8-74;8:45 am] Public Health Service CENTER FOR DfSEASE CONTROL Statement of Organization, Functions, and Delegations of Authority Part 9 (Center for Disease ControB-of the Statement of Organization, Func- tions, and Delegations of Authority for the Department of Health, Edueation,- and Welfare (39 FR 1461, January 9, 1974) Is hereby amended to reflect the establishment of the Bureau of Health Education (9F00) and the transfer of the National Clearinghouse for Smoking and Health (9S00) to the Bureau qf Health Education as indicated hrthe following changes to Section £PB, .Organization end Functions: 1. After the chapter entitled "Bureau of Epidemiology (9E00),~ add a new chapter entitled "Bureau of Health Edu- cation (9P00) **• by inserting the follow- ing heading and succeeding paragraphs: Bttkzau or Health Education (9F00> (1) Provides leadership and direction to a comprehensive national health edu- cation program for the prevention of disease, disability, premature death, and undesirable and unnecessary health problems; (2) recommends health edu- cation goals, objectives, and priorities for the Department of Health, Education, and Welfare; and develops collaborative efforts to accomplish health education objectives; (3) coordinates major health education activities of the Department; (4) develops and evaluates standards, criteria, and methodologies for improved health education programs; (5) serves as a clearinghouse on health education; (6) working with and through the Regional Offices, encourages and assi-ts in the broader application of effective health ' education programs at the State and community level; (7) develops mecha- nisms for coordinating health education activities o£ the private sector; (8) par- ticipates in, and provides staff support for, the Intradepartmental Health Edu- 34315 cation Board; (9> provides leadership and direction fop' a national program to reduce death and disability due to smok- ing; (10) maintains liaison with other Federal agencies and with public and private organizations engaged in health, education activities. . . Office of the Director (3F0D... "Ci Plans, directs, coordinates, and evaluate-. activities of tbe_ Bureau; (2) provide.<; leadership and guidance in policy formu- lation and program planning and de- velopment; (3) participates in, and pro- vides staff support for, the Intradepart-- mental Health Education Board; (4) de- velops mechanisms <■ for coordinating health education activities of the private sector: (5> provides consultation and as- - sistance to CDC organizations In develop- ing and implementing health education activities; (6) maintains liaison with other Federal agencies engaged in health education activities; <7) provides overall administrative services to the Bureau. iL National Clearinghouse ior Smoking - and Health (9F41). (1) Administers a national program to reduce death -and disability due to smoking: (2), develops "standards, criteria, -and methodologies for Improved health education programs ; and evaluates effec ti veness of sdectcci ongoinc programs; (3) serves as a dear-" inghouse on health educatton;~colTects ■ and disseminates Information about ef- ■■ -fectlve techniques, strategies, and ap- proaches; and handles health education mqulries; (4) conducts and stimulates ..behavioral research; (5) coordinates De- partment activities related to smoking and health, and maintains liaison with official and voluntary groups concerned with the problem of smoking; (6) con- ducts surveys to assess the incidence of smoking. Community Program. Development Di- vision (9F45). (1) Develops, conducts,, and evaluates health education demon- stration projects, in cooperation with State and local health depa r tments and. with public and. private organizations, to develop and apply effective, eompre-^ hensive programs In- selected eommuni-v ties; (2) develops and applies new com- binations of approaches and methods to unmet public health education needs. Professional Services and Consultation Division (9F49) . (1) Provides technical advice and consultation to State and local health agencies, and to public and private organizations in planning and imple- menting health education activities; (2) working with and through the Regional Offices, encourages and assists in the broader application of effective health education programs at the State and community level; (3) assists the Office of the Bureau Director in coordi- nating health education activities of the private sector. 2. Delete the chapter entitled "National Clearinghouse for Smoking and Health (SS00) .*' Dated: September 16, 1974. Johw Otttwa, Assistant Secretary for Administration and Management. {FR Doc.74-22089 Filed 9-23-74;8:45 am} FEDERAL REGISTER, VOL 39 fc NO. 186 — TUESDAY, SEPTEMBER 24, 1974 40 34316 NOTICES FOOD AND DRUG ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Part 6 (Pood and Drug Administra- tion) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health, Education, and Welfare (35 PR 3685-92, dated Feb- ruary 25, 1970, as amended) is amended to reflect the reorganization of the Bu- reau of Drugs: Section 6-B is amended as follows : Sec. 6-B Organization. * * • • • * * • (1) Bureau of drugs (6A11). Develops PDA policy with regard to the safety, ef- fectiveness, and labeling of all drugs for human use. -Reviews and evaluates new drug ap- plications (NDA's) and notices of claimed investigational exemption for new drugs (IND's) . Develops and imple- ments standards for the safety and ef- fectiveness of all over-the-counter (OTC) drugs. Monitors the quality of marketed drugs through product testing, surveillance, and compliance programs. Develops and promulgates guidelines on current good manufacturing practices for use by the drug industry. Develops and disseminates informa- tion and educational material dealing with drugs to the medical community and the public in coordination with the Of- fice of Professional and Consumer Pro- grams: Conducts research and develops scientific standards on the composition, quality, safety, and efficacy of human drugs.'- . • Collects and evaluates information on the effects and use trends of marketed drugs. -Monitors prescription drug advertising and promotional labeling to assure their accuracy and Integrity. Analyzes data on accidental poison- ings; disseminates toxicity and treat- ment information on household products . and medicines, Evaluates applications for operation of methadone treatment centers and other activities using-, methadone or other drugs. - - " ■" Directs the FDA antibiotic and insulin certification program. <1-J.) Office of the Director (6A1101) . Develops FDA human drug policy and provides executive direction to Bureau scientific and regulatory programs and activities. " Develops and implements regulatory policy regarding human drugs. Provides advice and expertise to the Commissioner and the Department on all human drug matters. Promotes collaboration and exchange of drug information with scientists and scientific bodies. ': Coordinates with other bureaus on scientific and technical programs. Recommends to the Office of the Com- ■ missioner new and revised legislation and participates in the preparation of legis- lative proposals and testimony for pres- entation at congressional hearings. Develops and interprets compliance and surveillance programs and current good manufacturing practices. Coordinates the Bureau's intramural and extramural scientific and regulatory programs within FDA. Develops and implements Bureau pro- gram and resource plans. Evaluates the effectiveness of Bureau operating pro- grams. Provides overall direction to the Bu- reau's utilization of research grants and research and service contracts program. (1-1-i) Office of Planning and Evalua- tion (6A11012). Advises and assists the Bureau Director and other key Bureau officials regarding strategic and opera- tional planning and substantive program policy development. Develops and implements Bureau plan- ning and programming strategy and the annual budget. Identifies operational goals and eval- uation measures; develops and applies appropriate effectiveness measures to Bureau programs. Provides planning and evaluation con- sulting services to Bureau program and management officials. Represents the Bureau in matters re- lated to planning and evaluation within FDA and with Federal agencies and the regulated industries. Develops policy and provides tech- nical and professional services to the Bureau's contract and grant program including the Bureau Contract and Grant Review Committee. Develops compliance and surveillance programs for field implementation, in- cluding appropriate evaluation and re- porting requirements. Plans allocations of field resources and monitors the status of implementation of plans. Acts as the Director's principal ad- visor and coordinator for Bureau posi- tion allocations, financial management, contract and grant program, and field resources; develops and implements re- lated plans. Directs Bureau program management system operations including goal-setting, performance review, and Telated utiliza- tion reporting systems. (1-2-i) Division of OTC-Drug Evalua- tion (6 All 022). Identifies and classifies over-the-counter (OTC) drugs into categories for review by appropriate panels; coordinates the collection of safety and effectiveness data on drugs to be reviewed. Coordinates the establishment of, and provides technical and clerical support to, OTC advisory panels which . make recommendations on standards for-OTC drugs. Receives, controls, and screens all OTC drug submissions including protocols; notifies sponsor of inadequate or defi- cient data; schedules and participates in - industry/agency conferences. Notifies Bureau components of OTC panel recommendations ; obtains concur- rence for final OTC recommendations from respective reviewing Bureau com- ponents. Provides information . regarding OTc advisory panel activities; assists in pre- paring official summary minutes, infor- mation memoranda," panel reports, and drug monographs. Recommends Bureau actions based on OTC advisory panel evaluations. Coordinates the development of each proposed, tentative final, and final drug monograph; provides technical assist- ance to the Associate Director for Com- pliance as required in implementing final drug monographs. Develops and implements, in coordl- nation with the Office of Professional and Consumer Programs, consumer and pro- fessional educational programs includ- ing formal presentations relating to the OTC drug program: participates in agency sponsored OTC drug consumer education programs. (1-2-ii) Division of Biopharmaceutict (6A11023). Evaluates bioavailability and pharmacokinetic protocols and data in notices of claimed investigational ex- emption for new drugs (IND's) , abbrevi- ated new drug applications (ANDA's), new drug applications (NDA's), anti- biotic applications (Forms 5 and 6) and their supplements and amendments. Approves, disapproves, or recommends new bioavailability and pharmacokinetic studies and/or protocols. Identifies potential bioavailability problems and prepares protocols and guidelines for conducting bioavailability studies: Reviews and evaluates drug disposi- tion data, dosing regimen, and special- ized drug delivery systems to assure bio- availability of drugs. Coordinates the establishment of and provides technical and clerical support to blopharmaceutic advisory panels. Assists in developing or revising drui monographs on the basis of bioavaila- bility data. Initiates, monitors, and conducts In- tramural blopharmaceutic research: identifies extramural research needs: initiates, monitors, and coordinates ex- tramural research contracts with in- house activities. (1-2-iii) Division of Generic Dnt Monographs (6A11024). 'Evaluates med- ical and scientific data and determines approvability of original and amended abbreviated new drug applications (ANDA's), abbreviated antibiotic appli- cations (Forms 6), and their supple- ments. Recommends withdrawal of approval of ANDA's. Coordinates the review of ANDA and abbreviated antibiotic bioavailability protocols and resultant studies with th* Division of Biopharmaceutics. Serves as the primary source for in- formation on current labeling, methods -validation, and establishment inspec- tion reports of • ANDA's, abbreviated antibiotic applications, and old dntf monographs. Coordinates development of and pf°* FEDERAL REGISTER, VOL 39, NO. 186— TUESDAY, SEPTEMBM .24, 1974 41 NOTICES 34317 _^es scientific inputs to generic drug monographs and subsequent revisions.. Evaluates the nonmedical aspects- of human drug products, in abbreviated antibiotic applications and their, sup- P Recommends and reviews regulations concerning human -antibiotic products. 1 1-3-1) Diirision of Biometrics - (6AH032). Provides comprehensive sta- tistical and biomathematicai services to- Bureau programs. Conducts research and development in statistical, biomathematicai and. other scientific decision- making methodolo- gies. Evaluates and applies new statistical methodologies in support- of scientific decisions. Develops statistical methodologies for. analyzing epidemiological data and col- laborates with other Bureau units . on juch methodologies to be used in intra- mural and extramural programs. Develops computational computer pro- grams. Division %f Drug Manufac- turing. .(6A11049) . Develops the basic strategy for and approves, directs, co- ordinates, and monitors compliance pro~ grams issued with regard to drug mariu- • facturing practices. . . - Evaluates field report submissions, in- cluding inspections!, investigations, and recommendations .* for compliance ac- tions; recommends, directs, and/or co» i ;ordinates case development and con- tested case assistance in the handling of compliance actions regarding drug manufacturing problems, •'•,... . . *, : ! Develops, coordinates, reviews, and revises, current good manufacturing practice (CGMP) regulations; provides for their uniform interpretation. Serves as the primary source of in- ' formation concerning compliance by in- dividual firms with CGMP in connection "with NDA's, ANDA's, supplements, and antibiotic • and : insulin certification, evaluations. Promotes a better understanding. of the requirements and objectives of the law3 and regulations regarding CGMP and encourages compliance on a volun- tary basis; plans and conducts educa- tional and informational activities in. conjunction with, other agency units, trade associations, and academic groups. . (1-5-i) Division of Drug Biology (8A11052). Provides expert advice to the- drug review divisions and other scientific and regulatory units of the Bureau on. drug pharmacology .and toxicology. Plans and conducts research to inves- tigate the utility of diverse animal and biochemical systems for the assay of drug products. Performs bioassays by official and nonofficial methods to determine drug potency including testing insulin, for the certification program. Correlates bioanalytical findings with results of newly devised physicochemical methods of drug analysis in conjunction with the Division of Drug Chemistry. Plans and conducts research to deter- mine the nature, extent, and significance of microbial and other microscopic con- taminants in drugs and investigates their effects in microbiological systems. Devises microanalytical and biological methods for the study and analysis of drugs. FEDERAL REGISTER, VOL 39, NO. 18* — TUESDAY, SEPTEMBER 24, 1974 42 o U».»0 NOTi :s Plans and conducts research to inves- tigate the nature .and properties of phar- macologically significant substances in drugs and investigates their effects in biological systems. Conducts research to investigate the metabolism of drags, the mechanisms and identity of adverse drug reactions, the interactions between drugs and be- tween drugs and chemicals in the envi- ronment, the neuroendocrine relation- ships, and the effects of drugs on behavior. (l-5-ii> Division of Drug Chemistry (6A110. r i3>. Provides expert advice to the drug review divisions and other scientific and regulatory units of the Bureau on the chemistry of drugs and the methods of physiocochemical identification of drugs and conducts special investiga- tions upon request. Appraises and improves current and proposed drug standards and specifica- tions; validates NDA analytical proce- dures and reviews validation data from field laboratories. Investigates the principles underlying the chemical reactions employed in the analysis of drugs. Proposes and establishes specifications to standardize drugs and reference sub- stances and cooperates with the United States Pharmacopoeia (USP>, the Na- tional Formulary (NF) , and the As tion of Official Analytical Chemists (AOAC) , in preparing official drag mono- graphs which incorporate these specifi- cations. Participates in collaborative studies to test the validity of analytical methods proposed for adoption by the USP, NF, ind AOAC. Plan:; and conducts research to d new methods to detect, isolate, and dis- close the chemical nature of potent and toxic substances occurring in drug products. Plans and conducts research to investi- gate the utility of electronic, optica!, radiometric, and other physicochemicc 1 instalments for the analysts of drags. Devises new methods for the examina- tion of indvidual drugs that present ana- lytical problems in accepted procedures and for the examination of minute drug Quantities; subjects these new methods to collaborative study. (1-5-iii) National Center for Anti- biotics Analysis (6A11054). Tests large numbers of antibiotics samples obtained through the certification program, sur- veillance programs, or other Federal agencies; provides expert advice on the analysis of the samples to the review divisions and other scientific and regula- tory units of the Bureau. Plans and conducts research or. new and improved methods for the rapid analysis of large numbers of antibiotic samples and for the examination of in- dividual antibiotics; subjects these new methods to collaborative study. Devises and applies new methods for the analysis of antibiotic residues In tissues, body fluids, and other sub- stances. Participates in c< aborative studies to test the validity of analytical meth- ods proposed for adoption by the United States Pharmacopoeia (USP), National Formulary (NF), and Associ- ation of Official Analytical Chemists (AOAC), or in Antibiotic Forms 5 and 6. Reviews and validates the analytical procedures included in Antibiotic Forms 5 and 6; assists in developing monographs for inclusion in the Code of Federal Regulations. Cooperates with the World Health Organization, USP, and NF in testing and establishing reference standard drag substances for use in antibiotic analysis. Tests, establishes, and maintains a collection of authenticated official anti- biotic reference standard drug sub- stances' for distribution to FDA field laboratories, other Federal agencies, and to industry participants in the anti- biotic and insulin certification program. (1-5-iv) National Center for Drug Analysis (6A11055). Tests large num- bers of drug samples obtained through surveillance programs, FDA field con- sumer safety officers, and other Federal agencies to obtain drag analysis data for use by the review divisions and other scientific and regulatory units of the Bureau. Devises new automated methods for the rapid analysis of large numbers of dosage forms; establishes and maintains the Drug Auto Analysis Manual. Devises new methods and develops and/or acquires new equipment for the examination of individual drugs which present analytical problems in ac< procedures and new methods for the analysis of minute drug quantities of single dosage entities; subjects these new methods to collaborative study. Participates in- collaborative studies to test the validity of analytical meth- ods proposed for adoption by the United States Pharmacopoeia (USP), National Formulary (NF), and Associ- ation of Official Analytical Chemists (AOAC>. Cooperates with the USP and NF in testing drag reference substances (other than antibiotics) for compliance with specifications. < 1-6— i) Division of Anti-Infective Drug Products (6A11062). Performs tl e following IND/ NDA review process with regard to anti-infective, dcnnatologie, ophthalmologic, and antibiotic drug products, develops related policy apply- ing to this category of drag products: Reviews notices of claimed inves tional exemption for ne-' drugs (IND's) and recommends action including ap- proval of research plans and protocols, modifications, and restrictions, or dis- approval. Evaluates for safety and effective- ness, new drag applications (NDA's) submitted by manufacturers for per- misson to market new drugs. evaluates adequacy of directions fo. use and warnings in proposed labeun,' Conducts (continuing surveillance aS medical evaluation of ttie labeling, clim. eal experience, and reports, subroitw by an applicant under the records ar«i reports requirements, of all drugs fo- which an approved NDA is in effect. Evaluates manufacturing and labor- atory roettiods, facilities, and controls exercised in firms producing new drug* Makes recommendations -concenuo. withdrawal of approval of NDA's. Provides advice and serves as the pri- mary source of Information withfe FDA on anti-infective, dermatolcr*. ophthalmologic, and antibiotic dn» products with regard to the 6tatus « these drug applications, existing poBc» decisions, proposed regulatory actiara, and the state of product development. (1-6-ii) Dwsion vf Cardio-Rmg Drug Products <6A11063). Performs tt* same functions as described above (1. S-l) with regard to oardlac, anti-hyper- tensive/renal, and gastro-mtestinal drug products. ^1-6-tH) Division of Surgical-Dentel Drag Products <6A11064> . Performs tte same functions as described above 11- . B-l> with regard to surgi cal dental tad. pulmonary-anesthesia drug products, (1-6-rrt Division -of Metabolism nef Endocrine Drug Products {6A11065). Performs the same functions as described above with regard to obstetric gynecological, and all other metabolic and endocrine drug products. tl-6-v) Division oj Neuropharmoah logical Drug Products <6A11066). Per- forms the same functions as described above T1-4F-1) with regard to neuroiosi- cal psyrihophannacoiogical, and firoj abase drug products. Serves as the FDA resource on art* abuse information, Evaluates InvestUt* tional and marketed drugs for abuse po- tential as requested by XND7NDA revta-* .staffs. Recommends special studies sr safeguards. Recommends drugs for addi- tion to. removal from, or transfer wiuas schedules provided by the Comprehen- sive Drug Abuse "Prevention and Conlnl Act Of 1970. il-6-jri) Division of Oncology oat Radiopharmaceutical Drug Prodvdi rfiAllOBD- Performs the same func- tions as described above (1-6-i) *** regard to oncology, radiopharmaceutiai and anti- In flam m alary drug product* (l-6~vil) Division of Drug Advertuiat X£A1106D) . Monitors and evaluates pre- scription drug promotional material •*• wertisements. practices, and rel*»- Provides guidance and support iu Iff jnulation ttl policy, regulations, and •** visory opinions in advertising and pf*" .-notional labeling. initiates or recommends adminirf-*- Utrt action to remedy violative advert** tog «nd promotional labeling; reo*** mends fleda Investigations; assists to t» preparation £& prospective cases. Ff* sides training lor Bureau and *&& FEDERAL REGISTER, VOL. S9, NO. 186— TUESDAY, SEPTEMBER 24, 974 43 personnel in drug promotional literature and practices. -- : < 1-7-1) Division of Drug Information Resources (6A11072). Operates systems for the collection, processing, and re- trieval of information required to -meet research and operating needs. Reviews, abstracts, and retrieves scien- tific and technical information contained t drug applications and other scientific documents. Provides data input services within the Bureau and coordinates operational data processing activities. - >--■'-- Creates and maintains data files for medical and scientific purposes. • (1-7-ii) Division of Information Sys- tems Design (6A11073). Designs, imple- ments, and monitors -management and scientific/technical information systems for the Bureau. ! ' Establishes and monitors implementa- tion of Bureau policies regarding all Bu- reau automated data processing activi- ties Including planning, contracts, equip- ment and software procurement, train- tag, and utilization of automatic data processing (ADP) systems and facilities. Serves as the" Bureau point of con- tact with the agency's ADP operations. Develops dictionaries, listings of terms, uxd thesauri to assure standardization of terminology within Bureau information systems. Maintains overall Bureau responsibil- ity for the FDA Chemical Structure Pile *r.d conducts research on the design of systems and routines for chemical sub- structure searching. U-7-iii) Medical Library (6A11074). Acquires, catalogs, and disseminates pharmaco-medical and scientific infor- mation for use by Bureau and FDA sci- entists and administrators. Provides manual and automated serv- ices in support of compiling and dis- seminating medical and scientific infor-t. mation. Serves as liaison with drug informa- tion centers outside of FDA such as the National Library of Medicine. • • ~~i» • • These functional statements supersede the previous functional statements for the entire Bureau of Drugs published in J7 FR 4972, March 8, 1972, and 38 FR 13574, May 23, 1973. ;' Effective Date. This order, shall be ef- fective September 24, 1974. Dated: September 16, 1974. John Ottina, Assistant Secretary for Administration and Management. !FR Dcc.74-22088 Filed 9-23-74; 8:45 am] 44 C. THE HEALTH SERVICES ADMINISTRATION 45 IM83 Office of the Secretary HEALTH SERVICES ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority ' This amendment to the Statement of Organization, Functions, and Delegations of Authority of the Department of Health, Education, and Welfare, reflects the implementation of the Reorganiza- tion Order effective July 1, 1973 signed by Acting Secretary Prank Carlucci (36 FR 18261, July 9, 1973), with respect to the organization, of the Health Services Administration as an. operating, health agency of the Department. There is hereby established a new Part 3, Health Services Administration, as set forth below. Sec 3-A Mission. The Health Services Administration (3000) provides a na- tional focus for programs and health services for all people of the United States with emphasis on achieving the integration of service delivery and public and private financing systems to assure their responsiveness to the needs of in- dividuals and families in all levels of" society.. To these ends, the Health Service.'! Administration (3000): (1) Administers health service delivery programs sup- ported by project grants., contracts or other arrangements; (2) provides lead- ership to and supports efforts designed -to integrate health service delivery pro- grams with public and private health financing programs: (3) administers for- mula grant-supported health services programs; (4) assures quality and con- tain costs of service provided through the public financing programs; (5) pro- vides or arranges for personal health services, including both hospital and out-patient care, to designated benefici- aries; and (S) provides advice and suo- port to the Assistant Secretary for Health in the formulation of health policies. Sec. 3-B Organization and functions. The Health Services Administration (3000) is directed by an Administrator (HSA) who is responsible to the Assistant Secretary for Health. The Administration consists of the following major compo- nents, with functions as indicated: -. Office of the Adjhnistrato« (3AA0) Provides leadership and direction to the programs and activities of the Health Services Administration. Immediate Office of the Administrator (3AA1>. (1) Manages and directs the ac- tivities, of the Health Services Adminis- tration; (2) provides leadership for the execution of Administration responsibili- ties related to the conduct and hnprove- ment of health services for the people of all socioeconomic levels in the United States; and (3) provides advice and sup- port to the Assistant Secretary for Health in coordinating health services facilities and in the formulation of national health policy. Executive Secretariat (3AA105) . (1) Serves as the focal point in the control of written communications from and to the Administrator including their receipt, re- view, action assignment and follow-up to insure timely and appropriate action; (2) establishes standards for and insures the quality of written communications throughout the Administration; (3) maintains for the Administrator a docket of pending requests and a structured de- vice for insuring timeliness of response: (4) plans, develops and maintains a cen- tral system of response to public and of- ficial requests for program information and guidance; (5) establishes and main- FEDERAt REGISTER, VOL 39, NO. 55 — WEDNESDAY, MARCH 20, 1974 /. "7 10-IM NO 'CES tains central files for the Administrator; and (6) establishes and assures imple- mentation of Administration correspond- ence procedures and policies. Office of Equal Employment Oppor- tunity (3AA107). (1) Provides leadership and policy and program direction to Equal Employment Opportunity Pro- grams of the Health Services Adminis- tration; (2) provides staff advice and support to the Administrator in executing Federal equal employment opportunity policies; (3) plans and develops programs and procedures designed to eliminate dis- criminatory employment practices; (4) receives and provides for the investiga- tion of complaints of alleged discrimina- tion; and (5) maintains liaison with the Equal Employment Opportunity staff of the Assistant Secretary for Health re- garding program administration and the resolution of complaints. Office of Communications and Public Affairs (3AA3). Under the direction of the Associate Administrator for Com- munications and Public Affairs, who is a member of the Administrator's immedi- ate staff: (1) Provides leadership and general policy and program direction, conducts and coordinates communica- tions and public affairs activities of the Health Services Administration; (2) pro- vides communications and public affairs expertise, and staff advice and support to the Administrator in program and policy formulation and execution; (3) develops and implements policies related to ex- ternal media relations and internal em- ployee communications; (4) establishes and implements procedures for develop- ment, review, processing, quality control, and dissemination of HSA communica- tions materials; (5) serves as Communi- cations and Public Affairs Officer for the Administrator including the establish- ment and maintenance of productive re- lationships with the communications media; (6) provides central communica- tions services to all HSA programs in such areas as graphics and audio-Usual; and (7) serves as focal point for coor- dination of HSA communications activi- ties with those of other health agencies within HEW and with regional, State, local, voluntary and professional organi- zations. Office of Public Information (3AA303) . <1) Provides information to the news gathering and reporting media on HSA activities; <2) prepares news releases and other news material issued by the Administrator and other key officials of HSA; (3) coordinates and arranges news conferences, briefings, interviews, and appearance of the Administrator and key HSA officials on radio and television and with the print media, and (4) carries out projects on special information programs. Office of Editorial Operations (3AA305). (1) Develops and coordinates the application of HSA policies, plans, and strategies for dissemination of health information to the public; (2) plans the preparation of, coordinates the gathering of material for, edits, and pro- duces both public and scientific publi- cations with HSA-v i le implications; (3) prepares speech ma' erial and background information for the Administrator and other key HSA officials; and (4) pre- pares fact sheets on various elements of the Agency for dissemination internally and externally. Office of Service Support (3AA307) . (1) Develops and implements policies and practices for coordinating, review- ing, and approving publishing plans and activities; <2) reviews and approves dis- tribution plans for health publications produced by the Agency; (3) maintains liaison with key HSA officials to foster informational programs and activities; (4) establishes and provides technical assistance on standards, procedures, and systems governing the management of public affairs operations within HSA; and (5) insures effectiveness of public affairs programs and operations through ongo- ing evaluation for accuracy and appro- priateness. Office of Audiovisual Communications (3AA309) . (1) Develops and implements policies and guidelines on the use of audiovisual materials in fostering HSA programs and projects; (2) provides technical assistance to HSA operating Bureaus on the application of audiovis- ual techniques and the production of audiovisual materials; and (3) provides complete audiovisual services as required, including the planning and production of audiovisual materials for use by the media and the overseeing of produc- tion of audiovisual materials by contractors. Office of Planning, Evaluation and Legislation (3AA5) . Under the direction of the Associate Administrator for Plan- ning, Evaluation and Legislation who is a member of the Administrator's imme- diate staff: (D Serves as the Admin- istrator's primary staff unit and principal source of advice on program planning, program evaluation, operational plan- ning, regulation development, and leg- islative affairs; (2) develops in collab- oration with financial management staff the long-range program and financial plan for the Administration; (3) over- sees, in coordination with the Office of the Assistant Secretary for Health, com- munications between HSA and higher levels of government (including the Office of the Secretary, the Office of Management and Budget, and Congress) on all matters that involve long range plans, the regulation development proc- ess, evaluations of program perform- ance, or legislative affairs; (4) develops long range goals, objectives, and priori- ties for HSA; (5) directs all activities within HSA which have the goal of comparing the costs of the agency's pro- grams with their benefits, including the preparation and implementation of comprehensive program evaluation plans; (6) oversees the development of annual operating objectives and coordi- nates HSA's participation in the opera- tional planning system; (7) directs all the legislative affairs of HSA, includ- ing the development of legislative pro- posals and a legislative program; <8) acts as the focal point in HSA for the prep- aration, development, and monitoring of program regulations; and (9) con- ducts policy analyses and develops pol- icy positions in programmaix areas for HSA. Office of Analysis (3AA503). (1) Participates in the analysis of policy issues in the planning, evaluation, regula- tion, and legislative areas, using its own staff expertise on each one of HSA's pro- grams; (2> provides technical assistance to support the statistical, economic, operations research, and other scientific analyses of policy questions undertaken in HSA; (3) provides technical assist- ance to the other components of th>' Office of Planning, Evaluation, and Legislation; (4) analyzes trends and makes forecasts about national health services delivery systems for use in the program management and decision-mak- ing process: and <5» develops appropr .;: roles for Federal health service delivery programs in achieving solutions to prob- lems of illness and disease. Office of Evaluation and Operational Planning (34/4505). (1) Serves f-.s the Administrator's primary staff >:> ' . :.A principal source of advice on oi -r ii.i<-jidi planning and program evaluation; <2) oversees communications between HSA and higher level:. •■• uovemment on all matters that invoi'v operational objec- tives or evaluation oi program perform- ance; <3) maintains liaison with other Federal and non-Federal health agen- cies on matters within its area of respon- sibility: (4 1 directs all activities within HSA which have the goal of comparing the costs of the agency's nro Tarns with their benefits; (5> identif ?s lor the Ad- ministrator any mi monitors on-going information systems which produce evaluative data about the agency's programs; <8> per- forms analyses of the impact of agency programs on specific groups within the population including minorities; <9) oversees the development of annual op- erating objectives and coordinates HSA's participation in the operational planning system: (10) collects and analyzes pe- riodic reports oi' progress toward the achievement of annual objectives; (11> identifies problem areas in achieving operational objectives and recommends actions to be taken in response to those problems; and (I'.i) provides staff sup- port for the Administrator on matters ■involving management conferences with higher level officials. Office of Program Planning (344507). (1) Serves as the Administrator's pri- mary staff unit and principal source of advice on program planning; (2) over- sees communications between HSA and higher levels of government on all mat- ters that involve program plans; (3) maintains liaison with other Federal and non-Federal health agencies on matters witliin its areas .of responsibility; (4) FEDERAL REGISTER, VOL. 39, NO. 55 — WEDNESDAY, MARCH 20, 1974 48 NOTICES 10165 develops long range goals, objectives, and priorities for HSA; (5) develops in col- laboration with financia management staff the long-range program and finan- cial plan for the Admir istration; (6) analyzes budgetary data vith regard to planning guidelines; (7) prepares policy analysis papers and other planning doc- uments as required in HSA's forward planning process and (8) collaborates with the Office of Management in the de- velopment of the current and budget year financial plans. Office of Legislation '3AA509). (1) Serves as the Administrator's primary staff unit and principal source of advice on legislative affairs; (2) acts as the focal point In the agency for the preparation, development, and monitoring of HSA's regulations; (3) oversees communica- tions between HSA and higher levels of government on all matters that involve legislative affairs and regulation develop- ment; (4) oversees the legislative affairs of HSA; (5) develops legislative pro- posals and a legislative program for HSA's area of responsibility; (6) prepares HSA's analyses, position papers, and re- ports on proposed legislation; (7) assists in the preparation of testimony and backup materials on HSA legislative pro- gram for presentation to Congressional Committees; (8) monitors hearings and Congressional activities affecting HSA; (9) coordinates the preparation of in- formation requested by, and provides technical assistance to, Congressional Committees, Members of Congress, or their staffs in relation to HSA's legisla- tive program and (10) coordinates the distribution of legislative materials and serves as a legislative reference center. Office of Management (3AA9). Under the direction of the Associate Adminis- trator for Management, who is a member of the Administrator's immediate staff: il) Provides Administration-wide leader- ship, program direction, and coordina- tion of all phases of management; (2) provides management expertise, and staff advice and support to the Administrator in program and policy formulation and execution; (3) plans, directs and coor- dinates the Administration's activities in the areas of management policy, finan- cial management, personnel manage- ment, grants and contracts management, procurement, real and personal property accountability and management, systems management, and administrative serv- ices; (4) plans and conducts an Equal Employment Opportunity program for the Office of the Administrator; and (5) provides direction to the Executive Of- ficer for the Office of the Administrator. Office of Contracts and Grants (3AA903) . (1) Formulates and issues Ad- ministration policies, procedures, stand- ards and instructions for procurement management (including negotiated con- tracts) and grants management; (2) provides advice and consultation on in- terpretation and application of regula- tory Issuances, and Department and PHS policies and procedures affecting pro- curement (contracting) and grants man- agement; (3) establishes standards and guides for, and evaluates the Adminis- tration's ' giv Is and procurement man- agement op'.iations; (4) compiles, ana- lyzes and publishes data essential to the administration of contracting and grants activities; (5) executes, administers and terminates negotiated contracts; (6) re- views and recommends action concerning requests for waivers, appeals, deviations, determinations and findings, and pro- tects against awards required to be di- rected to the Office of the Secretary; (7) coordinates Administration positions and actions with respect to grants audit re- quirements and results; and (8) exer- cises surveillance over the exercise of delegated procurement authorities by HSA filed installations. Office of Financial Management (3AA905). (1) Collaborates in the de- velopment of the long range program and financial plan for the Administra- tion; (2) develops policies and instruc- tions for budget preparation and presen- tation; (3) prepares budget submissions; (4) participates in budget hearings; (5) allocates resources, dollars and positions: (6) manages a system of budgetary fund and position controls; (7) directs plan- ning and implementation of fiscal sys- tems and procedures; (8) provides ac- counting services for activities of the Of- fice of the Assistant Secretary for Health, Health Services Administration, Health Resources Administration. Alco- hol, Drug Abase, and Mental Health Ad- ministration, and Center for Dli Control; (9) prepares financial reports; (10) participates in development of poli- cies and procedures concerning financial aspects of grants and negotiated con- tracts; (11) furnishes financial advice to contracting officers; and (12) maintains liaison with the Office of the Assistant Secretary for Health, Office of the Secre- tary, and Office of Management and Budget. Office of Management Policy (3AA907) . (1) Conducts organization and manage- ment studies and surveys; (2) initiates or reviews proposals for establishing or modifying organizational structure or function, delegations of authority, and management objectives, policies, and standards; (3) negotiates solutions to intra- and inter-agency problems of or- ganization, functions, delegations, pro- cedures, or coordination; (4) conducts Administration-wide management im- provement programs including man- power utilization and productivity meas- urement; (5) participates In program and legislative planning to assure recog- nition of management problems; (G) manages the documentation and issuance system of the Administration; (7) pro- vides staff support in the establishment, organization, operation, and termination of HSA public advisory committees; and (8) conducts the records and forms man- agement programs of the Administration. Office of Personnel (3AA909). (1) Plans, directs, and coordinates personnel management programs to meet the par- ticular needs of the Health Services Ad- ministration; (2) provides personnel management advisory services to the Ad- ministrator, Associate Administrator for Management, and other key officials throughout the Administration: (3} de- velops policies, procedures, and standards for personnel matters involving both Commissioned Officers and civil service employees in those areas where special Health Services Administration require- ments exist; (4) provides staC guidance and support to headquarters and field components In the aieas of manpower planning, employment, employee de- velopment, upward mobility, labor rela- tions, employee relations, security, posi- tion and pay management and ii the self-evaluation of personnel activities: and '5) maintains liaison with the Office of the Assistant Secretary for Heall h, the Office of the Secretary, the Civi. oervice Commission, and oti.er agencies con- cerned with personnel managemer t. Office of Property Management (3AA911). (1) Plans, directs, and coordi- nates property management programs (including personal and real properly) covering Headquarters and field activi- ties; i2> provides advice on matters re- lating to the development and execu- tion of property management po Icies and programs; (3) develo , : uceoures and provides training for y man- agement operations; (4) ;• legu- latory issuances and provides guidance and technical assistance In property management areas; (5) evaluates Health Services Administration property man- agement programs, systems and activi- including on-site reviews) ; (6) ad- ministers a Health Services Administra- tion-wide program for safety manage- ment; (7) administers the Perry Point Suorly Sei vice Center and (8) maintains necessary liaison w ; th other on?; niza- tions concerned wit i property manage- ment activj Office of Systems Mane 3AA- 913). (1) Serves as the int in HSA for the development of Agency- wide systems and for ADP policy, rlan- ning, and evaluation: <2> Facilitates co- ordination within the Administration to ensure comoatibility between Adminis- tration. PHS. and Department ADP ac- tivities; (3' Develops HSA information systems; (4) Develops and implements an HSA ADP evaluation program to eval- uate ADP resource utilization an! to as- sess the utility of computer application systems: (5) Establishes the Data B ise Administration program within HSA; (6) Develops, operates, and manages the Parklawn central computer facility per- forming a service function for CDC, HRA, HSA, OASH. and ADAMHA, and provid- ing services to other Federal components as requested; (7) Coordinates with of- ficials of these organizations to ensure that operational equipment and systems needs are met and that adjustments are made as changes in Program emphasis occur; (8) Participate; in the develop- ment of Public Health Service- v. ide in- formation systems: (9' Evaluates and obtains data management systems and other software to meet user information system requirements: (10) Participates In audits of information systems; (11) Participates in the development and im- plementation of a PHS National-wide communications network; and (12) De- FEDERAl REGISTER, VOL. 39, NO. 55 — WEDNESDAY, MARCH 20, 1974 49 104*56 •■'■ and Ji; ., a pro ;ram to ource utilization within the Parklawn complex. utive Office (3AA91S). (a! For the lice of the Administrator plant, directs, and coordinates administrative nanage- nt activities; (b) Provides udminis- tive management services Including personnel, financial, materiel manage- nt and general administrative serv- ices; (c; Develops and implements man- agement policies, procedures, systems and practices; (d) Serves as the focal point for liaison with the Office of the Assistant Secretary for Health on finan- cial, personnel, organization, supply, and other management concerns of OA; and (e) Acts for the Associate Administrator for Management concerning space, park- and communications management for USA headquarters and represents him in matters relating to the management of the Parklawn Building. Bureau or Community Health Services (3B00) The Bureau of Community Health Services serves as a national focus for efforts to Improve the organization and delivery of health services in the con- text of the major health care financing programs. To this end. the Bureau (1) facilitates the development of locally- based programs of health services deliv- ery; (2) initiates activities which pro- vide alternate methods of health serv- ice delivery and health maintenance; (3) enhances the capacity of existing health service programs for full partici- pation in the major public health financing systems — Medicare and Medic- aid; (4) administers programs provid- ing specific services to specific popula- tions Including family planning, mater- nal and child health care, and migrant care; (5) directs programs, including the National Health Service Corps, which assure accessibility to health care in underscrved areas; and (6) Improves quality and contains costs of services provided in grant-initiated health serv- ice delivery programs. Oj^ce o/ the Director (3B01) . (1) Pro- vides leadership and direction for Bureau activities including Equal Em- ployment Opportunity, and control of written communications; (2) provides guidance and coordination to each major categorial program provided for by leg- islation or appropriation, by acting as a central point of reference for program continuity and information; (3) estab- lishes program policies, goals and ob- jectives; (4) provides program develop- ment and support services for Bureau activities; (5> communicates and inter- prets program policies, guidelines, and priorities to Regional Offices; (6) stim- ulates, coordinates and evaluates devel- opment and progress of the Bureau ac- ;es: (7) maintains relationships with HSA. other HEW operating agencies, other Federal agencies, and through the Regional Offices, State and local gov- ernments, consumer groups, and national organizations concerned with health affairs. W ICES Program Office or National Health Service. Corps (3,.1-t); Program Office lor Maternal and Child Health (3B05) ; Program Office for Family Planning (3B0C); Program Office /or Migrant Health (3U07) ; Program Office lor Ncigliborhood Health Centers (3B08) ; Program Office lor Health Maintenance Organizations (3B09) , Under the direction of an Associate Bureau Director who is a member of the Bureau Director's immediate staff: (1) Carries out the Bureau of Community Health Service's nationwide role in ef- forts to Improve the organization and delivery of health services by serving as both the advocate and pcint of account- ability for the specific categorical pro- grams; (2) develops and establishes na- tional policies and objectives for such programs; (3) provides leadership and direction for legislative activities in the program area, including both the devel- opment of proposals and plans and the interpretation of enacted legislation and reports; (4) develops long and short- range program goals and objectives; (5) is accountable for the administration of funds and other resources for grants, contracts, and technical assistance, uti- lizing the full resources of the Bureau in fulfilling the program's mission and re- sponsibilities; (6) tracks BCHS and Regional Office activities in program matters to insure that delegated re- sponsibilities are being carried out, including direct and indirect communi- cations, Regional Office conferences and field visits as warranted; (7) coordinates the development of, and establishes reg- ulations, guidelines, and standards for professional services, and for the effec- tive organization and administration of health programs, and the improvement of health services and staff development specific to the program of concern; <8) interprets policies, regulations, guide- lines, standards, and priorities to higher echelons, within PHS, to Regional Offices, grantee agencies. Institutions and or- ganizations; (9) provides coordination with other programs providing health services including voluntary official and other community agencies; (10) estab- lishes and provides liaison in program matters with other programs within BCHS and HSA, within PHS. with the Department and with other Federal agencies, consumer groups and national organizations concerned with health matters, and through the Regional Of- fices, with State and local governments. Office of Program Support (3B19). (1) Plans, directs, and evaluates the admin- istrative management support activities of the Bureau; (2) provides guidance to the Bureau on financial management ac- tivities, including program policy inter- pretation in budget formulation and ex- ecution, preparation of program plan- ning and budgeting data and financial management of grants; (3) participates and advises the Bureau Director in the allocation of the Bureau's personnel and funding resources; (4) interprets and implements agency management policies, procedures and systems and develops ad- ditional policies and procedures to satlsi . other Internal management requlremenu of the Bureau; <5> Interprets policy an* provides direction in the conduct of u ! Bureau's contract and formula and pro ect grant activities; (6) provides proemm support services to the operating com ponents of the Bureau on matters relat ing to the professional public and other Federal and non-Federal organizations- (7) provides administrative support sen-' ices to the programs of the Bureau in the conduct of day-to-day operations- (8* serves as the Bureau Director's principal advisor on all matters relating to Bureau management and administrative support activities; and (») maintains close liai son with the Associate Administrator for Management, H8A, with other officials of the Office of the Administrator, hsa, and as required and appropriate with of- ficials of the Office of Assistant Secretary for Jiealth and the Office of the Secretary on matters relating to the Bureau man- agement and administrative support ac- tivities. Office of Program Development 13B31). Serves as t&e Bureau Di- rector's principal staff arm for program pl a nn i ng and coordination, including the development of program alternatives and policy positions; aj. oversees planning and tracking functions in support of pol- icy formulation and program Implemen- tation; tt> advises the Bureau Director • and his Immediate staff on program pol- icy and operational implications arising from activities of the Office; (4) col- laborates with the Program Support Of- fice in the development and implemen- tation of the 6-year program and financial plan for the Bureau's program p la nning and budgeting system; (5> coordinates the development of legisla- tive program with planning; and (6) conducts special Inquiries and studies. Division of Poltcv Development (JB<;>. U.) Directs and administers the develop- ment of policy, regulations, guide- lines, related standards necessary for the operation, management and evaluation of legislated health care programs ad- ministered by the Bureau; and (b) cri- teria, methods and guides for program performance, and for the annual alloca- tion of funding resources; <2) provides related consultation to Regional Office staffs, and through the Regional Offices. to State and local agencies, grantees and other representatives of the health care delivery system. - Division of Clinical Service* (3B4S) (1) Plans, directs, administers and co- ordinates the Bureau's Clinical Services and related professional health care ac- tivities at both the national and interna- tional level through programs of grants, contracts and direct staff consultation. guidance and technical assistance sup- port: 12) establishes program objectives, standards and policies for guidance. through the Regional Offices, of state, local and other concerned organizations; (3> administers programs for: (a) re- search and development, (b) applied re- search in maternal and child health, crippled children and family planning FEDERAt REGISTER, VOL 39, NO. 55 — WEDNESDAY, MARCH 20, 1974 50 services, (c) staff training aid develop- ment for regional, state and local agen- cies and grantees, and (d) areas of spe- cial concern such as mental retardation, lead poisoning, metabolic disorders, etc.: (4) collaborates in the development and dissemination of materials on research findings, trends and developments and other appropriate informational and edu- cational matters. Division of Health Services Finn S3B51). (1) Directs and administers the development of (a) policy, standard strategies in the organization run ministration of financial and related business management aspects of care programs administered by the Bu- reau, (b) mechanisms for determining the need, the present status, and the potential capability for maximizing third party reimbursement, (c) new or im- proved technologies, and practices for management of financial systems, and (d) measures nnd indicators ol tiveness of these systems; (2) pr related technical advice and consulta- tion to Regional Office staffs, and ti, Regional Offices to State and local cies, grantees ^nd other representatives Of the health care delivery system; (3) collaborates with other Bureau organiza- tions to facility te *he use and dissemina- tion of research findings and to inform the public about the health del needs, trends, and developments of spe- cial population groups served by the Bureau. Division of Organization Develop (,'B55). (1) Directs and administers a program to improve the organizatio structure of health care delivery systems based on analyses of deficiencies in ex- isting systems so as to reduce costs and Increase quality and efficiency; (2) par- ticipates in the development and assess- ment of measures and Indicators of pro- gram effectiveness; (3) provides related consultation to Associate Bureau Direc- tors, PHS Regional Office staffs, State and local agencies, grantees and other representatives of the health care deliv- ery system. Division of Monitoring and Ai. UB59): (1) Plans, directs, and Adminis- ters: (a) the development, management, tad application of evaluative tools and Indicators to measure State, local and other grantee performance, (b) the moni- toring, through Regional Offices, of the performance of Bureau h< projects, including PHS Regional Office management of these projects, as it re- 'ittes to the efficiency and quality of serv- ices provided, and (c^ the conducting of analyses and studies designed to supple- Bent knowledge of existing patterns and trends in health care delivery systems in order to identify gaps in services and de- velop cost and quality comparison relative benefits of delivery mechanisms; ind (2) provides and coorc'.i Biltative services to PHS Regional Offices, tnd through the Regional Offices, to State ■ tnd local agencies, and others r« tUble for the health care delivery system. i Bureau of Quality Assurance (3HOO) •Provides national leadership and wection to efforts to assure that health I OTICES care services j ■ vlded under the Medi- care, Medi' I other Federal pro- grams are medically necessary and fur- nished in the most economical manner consistent with recognized professional standards of care, and serves as tl tional focv uring accountability to health care consumers for the q of health care services. To this end, the Bureau: ( 1 ) In coordination with the So- cial Security Administration CSS.' Social and Rehabilitation Service < SRS> . and components of the Pui> Servi- surance standards and appropriate health ■ordinates their implen tion among the hea'th | rograms for the Federal government has re- sponsibility, and eva eir impact on the utl I develops con- ditions and standards of participation for providers and of health serv- and M' programs, inclu standards, and coordinates their a; tion. monitoring, and appraisal: i velops, in and impl< policies for proi and related pe and utilization review programs under Medican Medicaid including respoir entering into a sional Standards Review Organi (PSROs^ and Professional Sta view (PSR) Stal Is; (d) d< interprets, implementation of the End-St Disease provision or nd coordinates with Medica' implementation and monitoring of policies: (e) d principles of reimbursement for PSROs, PSR State Councils, and develop: cies with respect to c tional as- pects of peer and utilization review pro- grams includim evaluation, (2) . Office of the General Counsel (OGC on such lei peer review, utilizat'.. standards policies; (3) d ion and data reporting, collection. and systems requirements for PSRO. and coordinates their implement a tlor SSA. SRS, and the Health Resource ministration (HRA); (4) in cooperation with SSA and HRA. determines informa- tion requlr to implement such requirements to assure the quality of services provided under the End-Stage Renal Disease Program: (5 1 coordinates activities of othei involved in the monitoring and appi of peer review eral programs to determine the imp quality, utilization, access, and co care; (6) in collaboration with HRA undertakes demonstration and projects to develop improved methods and techniques for conducting peer i and assuring quality of ducts ongoing programs of informational and technical advice and assistance to peer review organizations and the medi- cal community generally; (2) provides programmatic and technical direct: the PHS Regional Office staffs responsl- 10467:- ble for peer review and health standards- programs; and (9) provides analytic and technical support to the National Pro- fessional Standards Review Council. Office of the Director (SHOD. (1) Pro- vides leadership and general direction to Bureau activities Including Equal Em- ployment Opportunity and the control of written communication, and provides guidance and coordination to each major Bureau component by acting as a cen- tral point of reference for program con- tinuity and information; (2) establishes Bureau policies, goals, and objectives; (3> communicates and interprets pro- gram policies, guidelines, and priorities to PHS Regional Offices, (4) coordinates and evaluates development and progress of the Bureau, activities: and (5) main- tain; -relationships with . other HEW operating agencies, other Federal agen- cies, State and local governments, con- sumer groups-, and national organiza- tions concerned with health affairs. - Office of Program Support (3H19). (1) Plans, directs, and evaluates the adminis- trative management support activities of the Bureau; (3> Provides guidance to the Bureau on financial management activi- ties, including program policy interpreta- tion in budget formulation and execution, preparation of program, planning and budgeting data and financial manage- ment of agreements; (3) participates and advises the Bureau Director in the al- location, of the Bureau's personnel and funding resources; (4) interprets and implements agency management poli- cies, procedures and systems . and :iops additional policies and proce- durea to aatisfy other Internal manage- ment requirements of the Bureau; (5) •. Interprets policy and provides direction In the conduct of the Bureau's contract and agreement activities: (6) provides program support services to the operat- ing components of the Bureau on matters relating to the professional public and other Federal and non-Federal organiza- tions; 17) provides administrative sup- port services to the programs of the Bu- reau in the conduct of day-to-day opera- tions; (8) serves as the Bureau Director's principal advisor on all matters relat- ing to Bureau management and adminis- trative support activities: and <£> main- tains close liaison with the Associate Ad- ministrator for Management, HSA, with other officials of the Office of the Ad- ministrator. HSA, and as required and appropriate with officials of the Office of Assistant Secretary for Health and the Office of the Secretary on matters relat- ing to the Bureau management and ad- minlstratlve support activities. Office of Program Development (3H31). (1) Serves as the Bureau Direc- tor's principal staff arm for program planning and coordination, including the development of program alternatives and policy positions; (2) oversees planning and tracking functions in support of policy formulation and program imple- mentation; (3) advises the Bureau Director and his immediate staff on pro- gram policy and operational implications arising from activities of the Bureau; (4) collaborates with the Office of Program Support and operating Divisions in the FEDERAL REGISTER, VOL 39, NO. 55— WEDNESDAY, MARCH 20, 1974 51 10468 NOTICE development and implementation of the 5-year program and financial plan ior the Bureau's program planning aid budgeting system; (5) coord mates the development of information relating to the legislative needs of the Bureau; a ad <6> conducts special inquiries and .studies. Division of Provider Standards and Certification (.3H41). (1) In coordina- tion with SSA, SRS, and compone- PKS, develops, evaluates, and imple- ments health and safety standards and other medical care policies for providers and suppliers cf health services under Medicare, Medicaid, and other Federal reimbursement and support programs; (2) in participation with SSA. SRS, and other components of HEW, administers, monitors and evaluates the HEW health provider and supplier certification pro- grams; <3) participates with SSA and SRS in the conduct of training, informa- tional, and other activities for improv- ing the provider and supplier certifica- tion program; (4) provides consultation on provider and supplier standards and their implementation to other Federal agencies. Regional Offices. State health departments, and other State and local agencies; (5) in cooperation with SSA, plans, develops, and implements the medical and other health-related poli- cies for the End-Stage Rental Disease Program; and c6) participates as the Bureau focal point in policy operations and procedural matters relative to long- term care activities. Division of Peer Review (3H43) . In coordination with SRS and SSA: (1) Plans, directs, and develops peer review and quality assurance policies, including utilization review, medical r >view, and independent professional revit v; (2) de- velops policies and procedure s for the application of norms and pi ofessional standards of care; and (3) dt fines and develops policies and procedures related to the application and implementation of peer review programs. Division of PSRO Program Operations (3H45>. (1) Coordinates with SSA and SRS the implementation and ongolrg operational activities of Federal pro- grams, including Medicare and Me. with respect to peer and utilization pro- grams, and other quality assurance pol'- cies; (2) develops, implements, and applies with SSA and SRS on an ongoing basis policies relating to fiscal manage- ment of peer review program, including the principles of reimbursement for PSROs and PSR State Councils, the budgeting, accounting, reports manage- ment, statistical reporting, and auditing requirements applicable to such peer re- view organizations and PSR State Coun- cils; <3) directs the administration in coordination with SSA-SRS, and evalu- ation of peer review and quality assur- ance program management policies in- cluding the application of policies and guidelines relating to the organization, .membership, and management of PSROs and State Councils, the negotiation of PSRO agreements in collaboration with PH3 Regional staff, and the coordina- tion with the Office of ' gional Opera- tions, Office of the As*' *ant Secretary for Health, the Regional operations and relationships among SSA-SRS-PHS Re- gional staffs; (4) provides advice and nee to PHS Regional offices, PSROs, and State Councils with respect to fiscal and program management ac- : and (5) prepares issues for OGC analyses relating to legal aspects of peer review and quality assurance and coordi- nates with SSA-SRS-OGC the develop- ment of appropriate policies with re- spect to legal aspects of peer review and quality assurance programs. Division of Program. Appraisal and Data Planning (3H47>. <1) Develops, in collaboration with SSA-SRS-HRA. peer review data systems policies, procedures, and requirements, including specifica- tions of peer review data systems required for effective implementation of the PSRO provisions of the Social Security Act; (2) in coordination with other ap- propriate components of DHEW, devel- ops policies for the evaluation and eval- uates the impact of peer review activi- ties on the utilization, quality and cost of health services; (3) coordinates the development, monitoring, and evaluation of peer review demonstration projects, experimental projects and special re- search projects designed to elicit infor- mation or data relevant to the formu- lation and implementation of policies on peer review, health standards, and the End-Stage Renal Disease Program; (4) in collaboration with SSA, and other Bu- reau components, assists in evaluating the impact of End-State Renal Disease Program; and (5) designs and imple- ments statistical and other reporting systems necessary to carry out effectively health program monitoring and evalua- tion activities. Indian Health Service (3S00> The Indian Health Service (IHS) as- sures a comprehensive health services delivery system for American Indians and Alaska Natives with sufficient op- tions to provide for maximum tribal in- volvement in meeting their health needs. The goal for the Indian Health Service is to raise the health level of the Indian and Alaska Native people to the highest possible level. To carry out its mission and to attain its goal, the Indian Health Service: (1) Assists Indian tribes in developing their capacity to man and manage their health programs through activities including health and management training, tech- nical-assistance, and human resource de- velopment; (2) facilitates and assists In- dian tribes in coordinating health plan- ning in obtaining and utilizing health resources available through Federal, State, and local programs, in operation of comprehensive health programs, and in health program evaluation; (3) provides comprehensive health care services, in- cluding hospital and ambulatory medical care, preventive and rehabilitative serv- ices, and development of community san- itation facilities; (4) serves as the prin- cipal Federal advocate for Indians in the health field to assure comprehensive health services for American Indians and Alaska Natives. Office of the Director i3S01). Provides overall direction and leadership for the Indian Health Service by : (1) Establish- ing goals, objectives, policies and priori- ties in pursuit of the IHS mission; (2) delivering high quality, comprehensive health services; (3) coordinating the In- dian Health Service activities and re- sources internally and externally with those of other governmental and non- governmental programs, promoting op- timum utilization of all available health resources; (4) developing and demon- strating alternative methods and tech- niques of health services management and delivery providing Indian tribes and other Indian community groups with op- tional ways of participating in the In- dian health program; and (5) developing individual and trib.il capacities to partic- ipate in the operation commensurate with means and modalities which they deem appropriate to their needs and cir- cumstances. Office of Tribal Affairs (3S12< Office: (1) Advises on the tribal aft; i.: implications of Service policies, and programs and operations; (2) co- ordinates the development of optimal, supportive relationships v it li tribal gov- ernments, intertribal povcruing bodies, national Indian interest groups, and other individuals and groups interested and active in Indian affairs: (3 1 partic- ipates in the Service-wide executive policy formulation and execution. Office of Pror/rtnn Sunnort (3S19) .The Office: (1) Provides management sup- port services for the Indian He dth Serv- ice; (2) maintains official po.icy man- uals; (3> advises on tin management services implications of the Servio cies, plans, programs and operations. Office of Research crd Development (3S20). The Office: (1) Develops and demonstrates new methods and tech- niques for Indian community participa- tion in and management of their health program: (2) provides consultation and technical assistance to all operating and management levels of the Indian Health Service and Indian tribes in the evalua- tion, design and implication of health management systems and health delivery systems; (3) coordinates health research and development activities within the Service directed to the improvement of the health of the Indian people. Division of Program Formulation (3S32). (1) Coordinates formulation of Service-wide executive policy and par- ticipates in its execution: (2) coordinates the development of program strategies and innovative directions for the Service, and advises on the strategic implications of program and management policies, plans and operations; <3> assists in the formulation, and evaluation of legisla- tion and regulations; (4) provides Service-wide leadership in the develop- ment of long-range plans and planning strategies, and the evaluation of health needs and operations in relation to FEDERAL REGISTER, VOL 39, NO. 55— WEDNESDAY, MARCH 20, 1974 52 MOTICES !<)H provides di- rection and coordination for day-to-day operations of Area Offices. Division of Indian Community Devel- opment (3S42) . (1) Participates in Service-wide executive policy formula- tion and execution; (2) identified the needs for and characteristics of optional methods and techniques for Indian pro- gram participation; (3) implements new methods and techniques for Indian com- munity participation in and management of their health programs; (4' coordi- nates provision of technical assistance. training and consultation to tribes and other Indian communities desiring to im • plement local control options; '5) ad- vises on the Indian community develop- ment implications of the Service's plans. programs and operations; (6' provides direction and coordination for day-to- day operations of special programs. Division of Resource Coordination (3S44) . (1) Participates in the Service- wide executive policy formulation and execution; (2) provides leadership in coordinating development of optimal liaison with governmental agencies and organizations within the Department of Health, Education, and Welfare and without, which have authorities, pro- grams and resources applicable, or po- tentially applicable to Indian health needs; (3) advises on the resource coor- dination implications of Service policies, plans,, programs and operations: <4> co- ordinates development of the Service budget; (5) coordinates the development and implementation of health services standards, quality control, evaluation of health programs, and operational plan- ning activities. Bureau of Medical Services t3U00> The Bureau of Medical Services pro- vides direct health care services and sup- port for such services to certain legal beneficiaries of the Public Health Service, including meeting the occupational health needs of Federal employees, and provides national leadership to assist and encourage the development of compre- hensive area emergency medical services systems. To this end the Bureau pro- vides: (1) Comprehensive direct health care for designated Federal beneficiaries and selected community groups; (2) Oc- cupational health care and safety serv- ices for Federal employees; (3) Train- ing for health services personnel; (4) The conduct of intramural clinical and health services research; (5) National leadership for assistance and guidance in the development, improvement, expan- sion, and integration of comprehensive area emergency medical services systems. Office of the "rector (3U01 1 . (1) Pro- vides leadersh p and general direction to Bureau activities, including Equal Em- ployment Opportunity and the control of written communication, and provides guidance and coordination to each major Bureau component by acting as a central point of reference for program continu- ity and information; (2) Establishes Bureau policies, goals, and objective-; (3) Communicates and interprets pro- gram policies, guidelines, and priorities to the PHS Regional Offices; <4i Coordi- nates and evaluates development and progress of the Bureau activities; and < 5 > Develops and directs a comprehensive medical program for prisoners in Fed- eral prisons and correctional institutions; and development and progress of the Bureau activities; and <6> Maintains re- lationships with other HEW operating agencies, other Federal agencies. State and local governments, consumer groups, and national organizations concerned with health affairs. Office of Program Development <3U14< Provides staff support to the Bureau Di- rector for: (1) Program planning and evaluation, including development of im- proved methodologies for planning and evaluation; (2) consultation and guid- ance in policy development for the Bu- reau; and <3> leadership, guidance, and coordination for Bureau professional and technical health manpower development responsibilities. OiTicc of Program Support >3U19~> Plans, directs, and coordinate, the Bu reau's management activities, including: 'li The development, coordination, and evaluation of administrative program, policies and procedures; i2) the conduct and coordination of the Bureau's finan- cial management, materiel management, and data management programs; <3i participation in administrative staff re- cruitment, training and assignment; '4> provision of consultative services to arid continuing' liaison with other programs of the Public Health Service; '51 pro- vision of architectural and engineering services in collaboration with the PHS Office of Resource Management; and the formulation, implementation, co- ordination, and evaluation of legislation, regulations, policies, instructions, and procedures as they, affect the Bureau Division of Federal Employee Health i3U45>. il> Provides on, and stimulates the development of, and improved occu- pational health and safety programs throughout the Government; (2) elevates upon request Federal agency occupational health services in relation to standards: i3> administers employee occupational health programs for other Federal agen- cies on a reimbursable basis; (4) con- ducts research studies, training and demonstration projects; (5) develops oc- cupational medical standards and meth- ods for Federal employee occupational health programs; and (Gi promotes ac- tivities designed to protect the working health and safety of Federal employees in order to maximize their productivity. Division of Hospitals and Clinics (3U55) . (1) Directs and coordinates the provision of direct health and medical .services to certain legal authorized ber»e- ficiaries in PHS hospitals and outpatient clinics, including care by contract physi- cians and hospitals; '2 i coordinates, vvitli other elements of the Bureau, the re- quirements and resources necessary for effective beneficial 1 }' services: (3) pro- vides for training and manpower develop- ment, the coordination of research ac- tivities, and special health programs and projects of the Bureau; and <4 1 develops and directs a comprehensive medical services program for Federal employees who sustain an injury or illness as a re- sult of their employment and p . ,des technical advice in the adjudication ol compensation claims. Division of Emergency Medical Serv- i3U61>. Provides national leader- ship for assistance, guidance, and en- ement in the development i/h ii i, t. expansion, and inUv atioil of comprehensive area emergency medi- cal services systems to meet the needs oi and local communities and other eligible entities pursuant to la BrrxJr- gency Medical Services Act of 1973 iPub. L. 93-154). To I. CD as I he focal point :,e De- partmenl foi Hie development ol objec- tives, plan, and for all aspects of an emei gi • . ■ ■ I ems am; < : iinu nates national standards an.. emergency medical services system : >3i coordinates emergency medical services systems a< - tivitii within the Department and with I and other agencies, coi groups, and professional organizations: •4' providi mi support for the Interagency Committ :e on Emergency al Service ■ • collect' :u ,d../.e... catalogues and disseminates a I d; tause- n '. in the development and ■ . ion oi cmcrgeno medical services sj i (6' providi i budget authority and tec-mural cooperation to the Health Resources Ad- ministration for impli m of emergency medical servii ms re- search and training: (7) through the PHS Regional Offices, provides grants and contracts to States, communities, and other eligible entities in th<- plan- ning, development, initial operation, and improvement and expansion of their emergency medical services systems and subsystems; >8) through the PHS Re- gional Offices and the Headquarters of- fice, provides technical assistance and consultation to States, communities, and organizations in the development of emergency medical services systems and subsystems. Division of .Coast Guard Medical Serv- 3U71). <1> Develops and directs a comprehensive medical program for mili- tary personnel of the Coast Guard; and (2) provides medical and dental care to Coast Guard military personnel and eli- gible dependents through hospitals, clin- ics, infirmaries, sick bays, motorized den- tal units, and contract resources located throughout the United States and for- eign countries and aboard Coast Guard vessels. FEDERAL REGISTER, VOL. 39, NO. 55— WEDNESDAY, MARCH 20, 1974 53 101.0 Sec. 3-C Order of succession. During the absence or disability of the Adminis- trator or in the even of a vacancy in that oiTu c the first official listed below who is available shall act as Administra or, ex- cept that during a planned perioc of ab- sence the Administrator may specify a different order of succession. (1) Deputy Administrator; (2) Asso- ciate Administrator; (3) Director of In- dian Health Service; (4) Director of Fed- eral Health Programs Service; (5) Di- rector of the Bureau of Community Health Services; and (6) Director of the Bureau of Quality Assurance. Sec. 3-D Delegations of authorities. < 1 > The Administrator shall continue to exercise all authorities given to him under the Reorganization Order, effective July 1, 1973 (38 FR 18261, July 9, 1973), and under the Redelegation by the As- sistant Secretary for Health, effective July 1, 1973 (38 FR 18260, July 9, 1973). All delegations or redelegations to any other officer or employee of the Health Services Administration which were in effect immediately prior to July 1, 1973. continue in effect in them or their suc- cessors, pending issuances of redelega- tions. Dated: March 12, 1974. S. H. Clarke, Acting Assistant Secretary for Administration and Management . | PR Doc.74-6373 Filed 3-19-74; 8: 45 am] 54 D. THE FOOD AND DRUG ADMINISTRATION 55 17521 Office of the Secretary FOOD AND DRUG ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Part 6 (Food and Drug Administra- tion) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health, Education, and Welfare (35 F.R. 3685-92, dated February 25, 1970, as amended) is amended to reflect the disestablishment of the Bureau of Product Safety: 1. Section 6A is amended as follows: Sec. 6A Mission. The mission of the Food and Drug Administration (FDA) is to protect the public health of the Na- tion as it may be impaired by foods, dings, biological products, cosmetics, medical devices, ionizing and nonionizing radiation-emitting products and sub- stances, poisons, pesticides, and food ad- ditives. FDA's regulatory functions are geared to insure that: Foods are safe, pure, and wholesome; drugs, medical de- vices, and biological products are safe and effective; cosmetics are harmless; all of the above are honestly and informa- tively packaged; and that exposure tr potentially injurious radiation is mini- mized. 2. Section 6B is amended as follows: Section 6B Organization. • * * • • (p) Deleted. * • • * • Effective Date. May 14, 1973. Dated June 22, 1973. Robert H. Marik, Assistant Secretary for Administration and Management. [FR Doc.73-13335 Filed 6-29-73:8:45 am] FEDERAL REGISTER, VOL 38, NO. 126— MONDAY, JULY 2, 1973 57 368f DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Office of the Secretary FOOD AND DRUG ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority This amendment to the Statement of Organization, Functions, and Delega- tions of Authority of the Department of Health, Education, and Welfare, reflects the implementation of the Reorganiza- tion Order signed by the Secretary on January 5, 1970 (35 F.R. 606-7) effective February 1, 1970, with respect to the or- ganization of the Food and Drug Admin- istration as an operating agency of the Department. There is hereby established a new Part 10 of the Department's State- ment for the Food and Drug Administra- tion as set forth below. Those provisions in Part 3 (Consumer Protection and Environmental Health Service) of the Department's Statement of Organiza- tion, Functions, and Delegations of Au- thority which are inconsistent with the provisions of the new Part 10 are super- seded herewith. Sec. 10-A Mission. The mission of the Food and Drug Administration (FDA) is to protect the public health of the Nation as it may be impaired by foods, drugs, cosmetics, therapeutic devices, hazardous household substances, poisons. pesticides, food additives,' flammable fabrics and various other types of con- sumer product*. FDA's regulatory func- tions are geared to insure that: Foods are safe, pure, and wholesome; drugs are safe and effective; cosmetics are harm- less; therapeutic devices are safe and effective; all of the above are honestly and informatively labeled and packaged; dangerous household products carry adequate warnings for safe use and are property labeled; counterfeiting of drugs is stopped; and that hazards incident to the use of . various types of consumer products are reduced. S>& 10-B Organization. The Food and Drug Administration is administered by a Commissioner under the direction of the Assistant Secretary for Health and Scientific Affairs. The Food and Drug Administration consists of the following major components with the functions as indicated: . . - 3 :'.._■ (a) Immediate office of the Commis- sioner. The Commissioner and the Deputy Commissioner are responsible for the efficient and effective implemen- tation of FDA's mission. ■ Cb) Office of the Associate Commis- sioner for Compliance. Functions as principal advisor to the Commissioner on regulations and compliance-oriented matters which impact on policy and di- rection and long-range program goals. Evaluates and coordinates FDA's overall compliance effort to assure optimum use of FDA resources (combined with other Federal, State, and local resources), a balance between voluntary and regula- tory compliance, and FDA responsive- ness to consumer needs. Stimulates an awareness within the Agency of the need for prompt and 'positive action to secure compliance by the regulated Industries. Directs and coordinates the regulation- making activities of the Food and Drug Administration and the preparation of Federal Register material. ... Operates FDA emergency prepared- ness and civil defense program . Coordinates relationships with other nations, foreign firms, and international groups concerning compliance matters. (c) Office of the Associate Commis- sioner for Science, Functions as principal advisor to the Commissioner on scientific matters which impact on FDA policy and direction and long-range program goals. Provides leadership on scientific mat- ters and stimulates scientific and tech- nological achievement in FDA. Serves as chairman of an internal science advisory council composed of scientists representing the bureaus which advise on scientific policy and in the coordination of the scientific activities of FDA. Provides program and professional leadership concerning the development, application, and evaluation of research, training, and fellowship grant activities. Coordinates scientific relationships with international groups and other na- tions; coordinates the preparation of international travel plans and prepares FEOERAl REGISTER, VOL. 35, NO. 38 — WEDNESDAY, FEBRUARY 25, 1970 58 3686 NOTICES the annual international travel plan for the Commissioner's approval. Provides for the continuing appraisal of FDA scientific research programs in- cluding research performed by contract. Responsible for committee manage- ment within FDA. Directs the FDA safety program. (d) Office of the Hearing Examiner. Responsible for scheduling and conduct- ing prehearing conferences and admin- istrative hearings of an adjudicative and rule-making nature, pursuant to the Federal Food, Drug and Cosmetic Act, as amended, as well as other related laws and the Administrative Procedure Act (5 UJS.C. 551 et seq.) . Evaluates the evidence of record after hearings and prepares all necessary re- ports, tentative findings of fact, conclu- sions of law, and tentative orders used by the Commissioner in making a final agency decision. (e) Office of Legislative Services. Ad- vises the Commissioner concerning legis- lative needs and in the analysis of pend- ing Congressional legislation which may affect FDA. Prepares and clears FDA position papers and Departmental reports on pro- posed legislation for approval of the Commissioner. Coordinates and assists in the develop- ment and preparation of FDA legislative proposals for the Commissioner's review. Assists in the preparation of testimony for presentation to congressional com- mittees; monitors hearings and congres- sional activities affecting FDA; and dis- tributes legislative materials. Directs or coordinates the preparation of data requested by congressional in- vestigative committees; provides tech- nical and other assistance to members of Congress, congressional committees, and their staffs. Provides a central FDA control for correspondence referred by the White House and the Department; controls and processes congressional, international, State, and local correspondence. (f) Office of the Assistant Commis~ tioner for Administration. Serves as principal advisor to the Commissioner on all phases of management Inherent in the operations of FDA. Responsible for the effective utiliza- tion of all management resources and the Implementation of operating programs by coordinating the funding, manpower, facilities, and equipment needs of the Agency. Provides leadership and direction to administrative management Including budget, finance, personnel, organization, management information, methods, pro- curement and property, records and sim- ilar supporting activities. Assures that conduct of these efforts effectively supports program operations. (f-1) Division of Financial Manage- ment. Plans, directs, and coordinates a comprehensive financial management program for the FDA encompassing the areas of budget analysis, formulation and execution, fiscal accounting, voucher audit and finan cial reporting. Provides staff assistance in justifying budgets through executive and congressional echelons. After appropriation, develops an orderly expenditure plan. Develops apportionment plans and is- sues allotments for expenditures. Makes periodic reports regarding the status of FDA's financial management. Develops financial inputs for the Agen- cy's 5-year program and financial plans. (f-2) Division of General Services. Provides leadership and guidance to headquarters staff officers, headquarters operating activities, and District Offices for all general services programs, includ- ing: Procurement, contracts, administra- tive aspects of grants and fellowships, personal property management and ac- countability, real property management, space management and utilization, con- struction and engineering services, com- munications, physical security, printing and reproduction, and mails and files. Responsible for maintaining effective liaison with the Government Printing Office, and for the centralized clearance and coordination of all printing and pub- lication services. Coordinates the development of agen- cywlde policies and procedures for such services and plans; executes, evaluates and adjusts efforts in these activities. (f-3) Division of Management Sys- tems. Provides assistance in organiza- tion and operations analysis; planning and evaluation; effective and econom- ical use of resources; and analysis, de- sign, and maintenance of operating sys- tems and procedures. Conducts organization studies and provides advisory services on organiza- tion matters. Conducts management surveys and analytical studies of FDA administrative and program operations. Develops and implements management information systems and operates an executive reporting system for top management. Develops systems for automatic data processing and other forms of data automation. Develops and conducts management programs in directives management, re- ports and forms management, records, and correspondence management, and other management areas as assigned. (f-4) Division of Personnel Manage- ment. Plans, develops, and carries out a comprehensive personnel management program for FDA including recruitment, placement, classification, pay adminis- tration, employee relations, employee services, and employee-management relations. Through this program, assists top management as well as operating units to expeditiously and effectively achieve its program objectives while insuring the application of the Federal Merit System. i) Division of Food Chemistry and Technology. Originates, plans, and con- victs research to elucidate the nature a "'d properties of significant substances >n foods and related commodities, de- velops analytical methodology as new hazards to man are uncovered. Devises new methods for analysis of foods and related commodities; investigates the mechanism of the underlying chemical reactions. Originates and conducts a planned program, including appropriate laboratory investigations, for developing standards of identity, quality, and fill of container for food products; develops and processes proposals for regulations establishing such standards. Evaluates food additive petitions regarding their chemical identity and purity, stability, intended effect data, and methodology. (ii) Division of Nutrition. Originates, plans, and conducts research to eluci- date nature and properties of nutrition- ally significant substances in foods and related commodities and factors affect- ing the action of these substances; to determine the effects of these substances on reproduction, growth, and develop- ment in biological and microbiological systems ; and to study the metabolic fate of these substances and their interaction with other food components such as food additives. Devises new methods for the analysis of nutritionally significant substances in foods (including special dietary foods), investigates the mechanisms of the un- derlying biochemical reactions as poten- tial approaches to the development of suitable analytical methods. Evaluates labeling of special dietary foods. Examines surveillance and compliance samples of foods for nutritional factors. (iii) Division of Microbiology. Origi- nates, plans and conducts research to determine the nature, extent, and sig- nificance of microbial and other micro- scopic contaminates occurring in foods; studies causes and develops methods for the detection and prevention of food poisoning. Devises microanalytical and biological methods for the analysis of foods and cosmetics. Develops procedures for protecting foods, Including milk and other dairy products, against contamination; evalu- ates and improves concepts and methods used in food protection. Conducts research into the technology and engineering aspects of food process- ing procedures designed to eliminate contamination that may be responsible for food-borne illness. Conducts reviews, for standardization and certification, of State and local milk and food laboratories and officials. Operates the National Center for Microbiological Analysis. (iv) Division of Toxicology. Origi- nates, plans and conducts research with regard to the toxic effects of substances occurring in foods, cosmetics, colorants, and related commodities through direct addition or inadvertent adulteration. Establishes for toxic substances the quantitative aspects of the dose response relationship in a variety of animal spe- cies for various toxicological manifesta- tions with particular relevance to appli- cability to man. Investigates and develops new, stand- ardized, or improved bases for establish- ing and evaluating toxicological injury to animals from chemicals permitted in foods, cosmetics or from metabolites of these chemicals. Conducts toxicological studies on vari- ous classes of food additives, colorants and cosmetics to provide data for evalu- ation of new proposals and petitions for their industrial use as well as for the review of current tolerances, modified tolerances, and applications. (v) Division of Pathology. Investigates the nature and significance of the gross microscopic changes which occur in ani- mal tissues and organs as the result of short-term and long-term exposure to pesticides and other economic poisons, to food additives, and to toxic contami- nants of either chemical or microbio- logical origin. - Reviews and evaluates pathological data submitted in support of petitions for pesticides, food additives, and color additive regulations. Provides pathological support to other elements of the Bureau of Foods, Pesti- cides and Product Safety as necessary for the complete evaluation of toxicolog- ical experiments, Including the perform- ance of autopsies on experimental animals, and the preparation and ex- amination of histological material. . Maintains a complete registry of path- ological Information and material to serve as a repository of information con- cerning the pathological effects of toxic stress on animals. Develops new methods of anatomical and histocbemical examination of or- gans and tissues from animals subjected to treatment with pesticides, food addi- tives, natural toxins, and other environ- mental contaminants. (vi) Division of Colors and Cosmetics. Originates, plans and conducts research to elucidate chemical composition of cosmetic materials. Devices new methods diluents, and related commodities, and to identify compounds formed by reac- tions between colors and food, drug, and cosmetic materials. Devises new methods for analysis of cosmetics, colors, di- luents, and related commodities, and in- vestigates the mechanism of the under- lying chemical reactions. Administers the color additive listing and the color certification program. Examines samples of cosmetics in- volved in consumer complaints. (k-2) Office of Pesticides and Product Safety. Develops and conducts programs to reduce injuries, morbidity and mor- tality from accidental hazards through the use of consumer products. Conducts epidemiological studies of pesticides and their effects on man.. Develops scientific standards and conducts research relating to the com- position, quality and safety of pesticides. Reviews and evaluates industry pesti- cide petitions and registration applica- tions and recommends regulations and labeling designed to reduce any poten- tial health hazard. Provides advice and guidance concern- ing the hazards of household products and the development of precautionary labeling. (i) Division of Pesticide Chemistry and Toxicology. Originates, plans, and FEDERAL REGISTER, VOL. 35, NO. 38 — WEDNESDAY, FEBRUARY 25, 1970 60 3688 NOTICES conducts research on pharmacologically and toxicologlcally active substances oc- curring in man and his environment, arising out of the use of pesticides. Per- forms research on a number of different animal species, including primates, to assess hazards to man from exposure to pesticides. Investigates the mechanism of the un- derlying chemical, biochemical, and tox- icological reactions which may directly or indirectly lead to disease in man. Studies the metabolic fate, the physio- logical, and pathological response from pesticides and related chemicals in vari- ous substrates. Devises and develops new chemical and biological methods for studying the biological effects of pesticides and re- lated chemicals. Devises new and im- proved methods for identification of and analyses for pesticides and their residues. Evaluates petitions for the use of pesticides to assure adequacy of chemical data to support proposed tolerances and to determine if any hazards to man may result from their use. Coordinates with the Division of Pesti- cide Community Studies in investigating the factors which contribute to storage of pesticide residues in the general population. Provides guidance, assistance, and training for other Federal, State, local, and international agencies on toxicology, pharmacology, and chemistry of pesti- cides, related chemicals, and their resi- dues. Provides laboratory support and other assistance to FDA units as required. (11) Division of Pesticide Community Studies. Plans, Institutes, and directs a national epidemiological investigation program for the assessment of acute and chronic human health hazards arising from the manufacture and use of pesticides. Investigates potentially harmful ex- posure of man to pesticides. Defines the health hazards Involved in the use of or Incidental exposure to pesticides and recommends appropriate safeguards when necessary. Provides epidemiological assistance, consultation, and technical training in the prevention, diagnosis, and treatment of pesticides poisoning In humans, with emphasis on collaboration with State and local health departments and other In- terested groups, to aid them In develop- ing additional competence in this field. Conducts a nationwide monitoring program to determine levels of pesticides 6tored In the human population. Cooperates with the Division of Pesti- cide Chemistry and Toxicology, in the development of chemical and toxicologl- cal studies in support of human exposure investigations. Prepares and distributes pesticide re- search and monitoring information. (lii) Division of Poison Control. Pro- vides a network of poison control centers with toxicity and treatment information on household products, medicines, and other toxic substances that may acci- dentally be Ingested. Collects and Issues clinical and sta- tistical date on accidental Ingestion of hazardous substances and deaths result- ing therefrom. Supports research on poisoning treat- ment problems through contracts and grants. Stimulates education and training in methods and techniques of managing the total problem of accidental poisoning. Studies poisoning trends and stimu- lates the development of improved poison prevention and treatment methods. Investigates poisonings having major public health implications and initiates preventive measures. (iv) Division of Hazardous Substances. Collects and evaluates human and ani- mal injury and toxicologlcal data on household products. Conducts research on potentially hazardous products and on extent, causes and effects of poison- ing and methods of prevention and treatment. Provides medical guidance in develop- ing warning and first aid statements for hazardous chemicals. Develops proper precautionary labeling of potentially hazardous substances and recommends banning of substances found too hazardous to market under any labeling. (v) Division of Product Safety Studies. Develops and conducts programs de- signed to reduce the injury hazards of consumer products, equipment, and appliances. Conducts surveillance studies to de- termine the extent, nature and effect of Injuries due to consumer products. Studies and investigates deaths, in- juries, and economic losses resulting from the accidental burning of products, fabrics, and related materials. Develops criteria for standards and codes for products designed to reduce their injury producing characteristics. Supports research through contracts and grants designed to uncover the rea- sons for product injuries and the product modifications considered necessary to reduce their injury producing charac- teristics. Plans, conducts and participates in projects and demonstrations for the pur- pose of developing and encouraging the application of new methods, techniques, and equipment for the prevention and control of injuries due to the use of consumer products. (vi) Division of Product Research. Conducts research on design, environ- mental and behavioral hazards associ- ated with the use of consumer products. Tests consumer products for thermal, electrical, and mechanical hazards asso- ciated with their use. Establishes safety standards for con- sumer products used in the home environment. (k-3) Office of Compliance (FPPS) . Advises the Bureau Director and other FDA officials on the law, regulations, legal adrninlstrative problems, regulatory problems, and administrative policies concerning FDA's regulatory responsi- bilities relating to foods, colors and cos- metics, pesticides and product safety. Develops compliance and surveillance programs covering regulated industries in the food, pesticide and product safely areas. Fosters development of good manufac- turing practices and improved food sanitation. Develops or coordinates the develop- ment of regulations, model codes, and other standards covering industry prac- tices and for the control of health hazards associated with food, including shellfish and milk and with interstate travel. Develops and carries out programs de- signed to encourage compliance by in- dustry on a voluntary basis. Provides technical assistance to pub- lic and public service institutions and agencies for the control of hazards to health associated with interstate ship- ment of food, including shellfish and milk and with interstate travel. Provides support and guidance upon request to the district offices In the handling of legal actions and provides headquarters case development, coordi- nation, and contested case assistance. Develops and coordinates studies to measure degree of compliance by regu- lated industries with statutes and regu- lations enforced by FDA. Operates a petition control system for all pesticide and food additive petitions submitted to FDA for review and evaluation. (1) Division of Case Guidance (FPPS) . Provides support and guidance upon re- quest to the district offices in the hand- ling of legal actions concerning foods, pesticides and harmful products. Provides headquarters case develop- ment, coordination, and contested case assistance. Develops and maintains legal guide- lines. Reviews and approves actions in cases of national scope requiring headquarters coordination. ■ Issues advisory opinions resulting from specific requests from industry, trade associations, Government agencies, and Congress. Manages and coordinates headquar- ters activities associated with recalls and seizures; provides advice and assistance to recall staff; correlates recall actions with other regulatory activities. Reviews applications for permits and reports of examinations conducted by foreign countries in connection with the Import Milk Act; recommends action on the permit applications. (il) Division of Regulations and Peti- tions Control. Interprets new legislation. drafts regulations for implementation and develops guidelines setting forth administrative-legal procedures for ap- plying the new or changed authority. Develops and maintains a codified sys- tem for compiling and issuing regulatory policy and procedures on foods, pesticide and product safety matters for the guidance of FDA Headquarters and field personnel. • Develops or coordinates the develop- ment of regulations, good manufacturing practices, and other standards covering desirable industry practices. FEDERAL REGISTER, VOL 3S, NO. 38— WEDNESDAY, FEBRUARY 25, 1970 61 NOTICES 3685 initiates and recommends changes in insulation and prepares Bureau position 'on proposed legislation referred from the Department through the Office of Legis- lative Services. Operates a petition control system for ail pesticide and iood additive petitions submitted to FDA for review and evaluation. Prepares briefing memorandum ana regulations to be submitted via super- v'sory channels for approval of the As- sociate Commissioner for Compliance and the Commissioner on all petitions deemed acceptable for publication in the Federal Register. (iil) Division of Industry Services (FPPS) ■ Promotes a better understand- ing in the food, pesticide and product saiety area of the requirements and ob- jectives of the laws and regulations en- forced by the FDA among regulated in- dustry and encourages compliance on a voluntary basis. Assists in the implementation of industry self-inspection and quality assurance programs. Plans and conducts national seminars, symposia and conferences on specific Industry compliance problems. Assists FDA field offices, upon re- quest, in planning and conducting in- dustry workshops and seminars on Good Manufacturing Practices (GMP) and other types of problem-oriented workshops and conferences- Develops and maintains effective chan- nels of communication with industry trade associations, and initiates and co- sponsors with trade associations, profes- sional and academic groups, national seminars on specific compliance problems. (iv) Division of Compliance Programs (FPPS) . Develops and issues surveillance and compliance programs relating to the food industry and other Industries which may be associated with cosmetics, pesti- cides, hazardous substances and product safety; coordinates the establishment of priorities for compliance activities Involved in such programs. Serves as the focal point of informa- tion concerning the compliance status of specific food industries and faculties, and provides information on the latest technological developments in these industries. Identifies needs for new and revised standards to be met by industry and to support ongoing and contemplated compliance programs. Identifies needs and is responsible for the development of new and revised, programs, Including special programs directed toward unique and isolated problem areas. . Identifies and recommends research needed to develop better monitoring and compliance methods and techniques. De- velops programs to support FDA re- search activities. Plans and develops an appraisal sys- tem for each program; assists in the development of reporting systems de- signed to furnish 'information on com- pliance programs. Evaluates program effectiveness. (r) Division of Sanitation Control. Provides advice and assistance to State and local agencies and concerned indus- tries in regard to milk sanitation^ food service sanitation, shellfish sanitation and interstate travel sanitation. Administers the cooperative interstate milk shippers program designed to main- tain a high quality of milk shipped in interstate commerce. Administers the national shellfish sanitation program for the maintenance and improvement of the sanitary quality of commercial shellfish. Administers the interstate travel sani- tation program designed to protect the health of travelers and of crews on com- mercial transportation conveyances. Encourages the adoption, of adequate sanitation standards by States and municipalities and provides technical assistance to State and local agencies and to industries on sanitation problems and new developments which have pub- he health significance. Participates with industry health organizations and others in the develop- ment of sanitary standards for the de- sign and construction of dairy and food equipment (1) Bureau of Drugs. Develops stand- ards and medical policy and conducts re- search with respect to the efficacy, reliability and safety of drugs and de- vices for man. Reviews and evaluates new drug appli- cations and claims for Investigational drugs. Conducts a program of clinical studies related to the safety and efficacy of drugs and devices. Operates an adverse drug reaction re- porting system. Plans, coordinates, and evaluates FDA's surveillance and compliance pro- grams relating to drugs and devices. Provides scientific and technical sup- port in the areas of drug biology and drug chemistry. Develops or coordinates the develop- ment of regulations, model codes and other standards covering drug industry practices; fosters development of good manfacturing practices. Coordinates, directs, and reviews FDA's antibiotic and insulin certification program. (1-1) Office of New Drugs. Evaluates, for safety and efficacy, new drug appli- cations (NDA), submitted by manufac- turers for permission to market new drugs. Evaluates adequacy of directions for use and warnings against misuses ap- pearing in proposed labeling. Evaluates manufacturing and labora- tory methods, facilities and controls ex- ercised in factories producing new drugs. Reviews notices of claimed investiga- tional exemption for new drug (IND) and recommends action to restrict or stop further testing. Conducts reviews of clinical investiga- tors and scientific investigations in the Investigational new drug and the new drug application areas and coordinates appropriate followup with the Office of Compliance. (i> Division of Anti-Infective Drugs. Evaluates, for safety and efficacy, new drug applications (NDA), submitted by manufacturers for permission to market new drugs. Evaluates adequacy of directions for use and warnings against misuses ap- pearing in proposed labeling. Evaluates manufacturing and labora- tory methods, facilities and controls ex- ercised in factories producing new drugs. Reviews notices of claimed investi- gational exemption for new drug (IND) and recommends action to restrict or stop further testing. (ii> Division of Cardiopulmonary and Renal Drugs. Performs the functions as described above, with regard to drugs classified as cardiopulmonary renal drugs. (iii> Division of Dental and Surgical Adjuncts. Performs the functions as de- scribed above, with regard to drugs class- ified as dental and surgical adjuncts. (iv) Division of Metabolism and Endo- crine Drugs. Performs the functions as described above, with regard to drugs classified as metabolism and endocrine drugs. Cv) Division of Neuropharmacological Drugs. Performs the functions as de- scribed above, with regard to drugs classified as neuropharmacological drugs. (vi) Division of Oncology and Radio- pharmaceuticals. Perfroms the functions as described above with regard to drugs that will be classified oncology and radio- pharmaceutical drugs. (vii) Division of Scientific Investiga- tions. Conducts special, field, and record reviews of clinical investigators and in- vestigations in tile NDA and IND areas. Contacts clinical and academic sources to encourage standards for the conduct of clinical investigations. (1-2) Office of Marketed Drugs. Evalu- atesthe safety and efficacy data and pro- posed labeling in supplements to new drug applications. Conducts continuing surveillance and medical evaluation of the labeling, clin- ical experience and reports submitted by an applicant under the records and re- ports requirements, of all drugs and de- vices for which a new drug approval is in effect. Reviews inspection and other findings designed to reveal whether new drugs are being marketed in accord with commitment contained in new drug applications. Makes recommendations concerning withdrawal of approval of the NDA. Takes final action concerning antibi- otic and insulin samples submitted for certification and on requests for exemp- tions from antibiotic certification. Reviews new and marketed therapeutic and clinical devices for safety, reliability and effectiveness and recommends action to correct significant hazards or poten- tial danger from inadequate directions for use and inadequate warning and cau- tionary information. Obtains and evaluates reports of ad- verse drug reactions. (1> Division of Certification Services. Takes action concerning antibiotic and No. 38— Pt. I- FEDERAl REGISTER, VOL. 35, NO. 38 — WEDNESDAY, FEBRUARY 25, 1970 62 3690 NOTICES insulin samples submitted for certifica- tion. Reviews and takes action on requests for exemption from antibiotic certifica- tion. Recommends and reviews the prepa- ration of regulations concerning the an- tibiotic and insulin certification program. (ii) Division of Clinical and Medical Devices. Reviews new and marketed therapeutic devices and clinical devices intended for use in hospitals, clinics, and physicians' offices to determine those that should (1) be exempt from any controls, (2) be subject to manufacturing stand- ards and (3) be reviewed to determine safety and efficacy prior to marketing. Designs, directs, and monitors investi- gations and physical testing of marketed therapeutic and clinical devices; devel- ops standards for the manufacture of clinical and therapeutic devices to insure safety, reliability, and effectiveness. Recommends field investigations of marketed devices and, where required assists the field in making these investigatons. Collects and evaluates data on signifi- cant hazards to the public health caused by the use of clinical and therapeutic devices and proposes necessary laws and regulations to protect the public. (ill) Division of Drug Experience. Collects and evaluates reports of adverse drug experiences. Coordinates and monitors the review of professional performance of research contracts providing adverse drug experi- ence data. Develops, tests, and coordinates oper- ational systems for the processing of ad- verse reaction information. Disseminates a semimonthly Alert Report to achieve a valid and meaning- ful "Early Warning System." Monitors FDA participation in World Health Organization's program to im- plement an international drug monl- l*>ring system. (iv) Division of Cardiopulmonary- Renal Drug Surveillance. Performs the following functions with regard to drugs classified as cardiopulmonary- renal drugs : Evaluates the safety and efficacy data and proposed labeling in supplements to new drug applications. Makes recommendations concerning withdrawal of approval of the NDA. Conducts continuing surveillance and medical evaluation of the labeling, clin- ical experience and reports submitted by an applicant under the records and re- ports requirements of all drugs for which a new drug approval is in effect. (v) Division of Metabolic Endocrine Drug Surveillance. Performs functions as described above, with regard to drugs classified as metabolic, endocrine and anti-infective drugs. (vi) Division of Neuropharmacologi- cal Drug Surveillance. Performs func- tions as described above, with regard to drugs classified as neuropharmacological drugs. (vii) Division of Surgical-Dental Drug Surveillance. Performs functions as de- scribed above, with regard to drugs classi- fied as surgical adjuncts, dental, oncol- ogy, and radiopharmacological drugs. (1-3) Office of Compliance (Drugs). Advises the Bureau Director and other FDA officials on the law, regulations, le- gal-administrative problems, regulatory problems, and administrative policies concerning FDA's regulatory responsi- bilities relating to drugs and devices. Directs, designs and monitors studies to develop facts necessary for determina- tion of medical policy and to support regulatory action on violative drugs and devices. Develops compliance and surveillance programs covering regulated industries in drugs and related areas. Develops or coordinates the develop- ment of regulations and other standards covering drug and device industry prac- tices and fosters development of good manufacturing practices. Develops and carries out programs de- signed to encourage compliance by In- dustry on a voluntary basis. Provides support and guidance upon request to the district offices in the han- dling of legal actions and provides head- quarters case development, coordination, and contested case assistance. Develops and coordinates studies to measure degree of compliance by regu- lated Industries with statutes and regu- lations enforced by FDA. Monitors and evaluates professional journal advertising, and promotional and related labeling to determine veracity of claims. (i) Division of Case Guidance (Drugs) . Provides support and guidance, upon re- quest, to the District Offices in the han- dling of legal actions relating to general drugs, prescription drug advertising, new drug and investigational new drugs, de- vices, antibiotics, and insulin. Provides headquarters case develop- ment, coordination and contested case assistance. Develops and maintains legal guide- lines. Reviews and approves legal actions in cases of national scope requiring head- quarters coordination. Performs necessary liaison with the Division of Certification Services and the District Offices in connection with regu- latory activities relating to antibiotics and insulin. Manages and coordinates headquarters activities associated with recalls and seizures; provides advice and assistance to recall staff; correlates recall actions with other regulatory activities. Issues advisory opinions resulting from specific requests from industry, trade as- sociation, Government agencies, and Congress. (ii) Division of Compliance Programs (Drags) . Develops and issues surveillance and compliance programs covering the drug industry; coordinates the establish- ment of priorities for compliance activi- ties involved in such programs. Serves as the focal point of informa- tion concerning the compliance status of specific drug industries and facilities, and provides information on the latest technological developments in these industries. Identifies needs for new and revised standards to be met by industry and to support ongoing and contemplated com- pliance programs. Identifies needs and is responsible for the development of new and revised pro- grams, including special programs di- rected toward unique and isolated prob- lem areas. Identifies and recommends research needed to develop better monitoring and compliance methods and techniques. De- velops programs to support FDA re- search activities. Plans and develops an appraisal sys- tem for each program; assists in the development of reporting systems de- signed to furnish information on compli- ance programs; evaluates program effectiveness. (hi) Division of Drug Advertising. Monitors and provides medical evalua- tions of prescription drug advertisements and promotional and related labeling. Formulates expert medical opinion which is used as a basis for regulatory actions to deal with false or misleading promotions or those otherwise inconsist- ent with the provisions of the laws and regulations enforced by FDA. (iv) Division of Industry Services (Drugs) . Promotes a better understand- ing in the drug and device area of the re- quirements and objectives of the laws and regulations enforced by FDA among regulated industry and encourages com- pliance on a voluntary basis. Plans and conducts national seminars, symposia and conferences on specific in- dustry compliance problems. Assists FDA field offices, upon request, in planning and conducting industry workshops and seminars on Good Manu- facturing Practices (GMP) and other types of problem -oriented workshops and conferences. Develops and maintains effective chan- nels of communications with industry trade associations, and initiates and co- sponsors with trade associations, profes- sional and academic groups, national seminars on specific compliance problems. Works with the Office of New Drugs to provide guidelines to the drug industry for improvement in the quality of IN'D and NDA submissions. (v) Division of Medical Review. Pro- vides expert guidance and opinion on medical issues involved in proposed legal actions on drUfcS (other than medical advertising cases) . Procures expert medical witnesses and provides medical support in administra- tive hearings and court cases, including preparing and answering interrogatories and depositions, and sitting with Gov- ernment attorneys in court cases to ad- vise on direct and cross-examination of medical and scientific witnesses. Directs, designs, and monitors clinical studies required to support FDA legal actions. Provides the Post Office Department with technical reviews, opinions, testi- mony and medical guidance necessary for preparing and presenting medical fraud cases. FEDERAl REGISTER, VOL. 35, NO. 38 — WEDNESDAY, FEBRUARY 25, 1970 63 NOTICES 3691 provides medical and scientific guid- ance, background, and opinion lor policy, legislation, regulations, press releases, ft^ns, exhibits, speeches, publications, compliance seminars- and conferences, and responses to industry and consum er inquiries. (vi) Division of Policy and Regula- tions. Interprets new legislation, drafts regulations for implementation and de- velops guidelines setting forth admin- istrative-legal procedures for applying the new or changed authority. Develops and maintains a codified sys- tem for compiling and issuing regulatory policy and procedures for the guidance ot FDA Headquarters and field personnel and proposes remedial changes in policy and regulations. Develops or coordinates the develop- ment of regulations, model codes, and other standards and guides covering in- dustry practices. Prepares new or revised material for the Bureau of Drugs Manual of Policies and Procedures. Initiates and recommends changes in legislation and prepares Bureau position on proposed legislation referred from the Department through the Office- of Legislative Services. (1-4) Office of Pharmaceutical Sci- ences. Provides scientific support for FDA's drug compliance programs. Develops scientific standards and con- ducts research relating to the com- position, quality and safety of drugs; operates the PDA system for continuous appraisal and improvement of current and proposed drug standards and specifications. Devises new chemical, physical and biological methods for the analysis of drugs in pharmaceutical preparations and in tissues and body fluids; investi- gates the mechanisms of the underlying chemical reactions; and explores the utilization of novel instruments and equipment. Designs and participates in collabora- tive studies to establish the reliability of new methods and validating im- portant discoveries relating to drug examinations. Operates the National Center for Drug Analysis. Operates the National Center for Anti- biotics and Insulin Analysis. Cooperates with the Committee of Re- vision of the United States Pharmaco- poeia (USP) and National Formulary INF) to compose and assemble mono- graphs for inclusion in official drug compendia. (i) Division of Drug Biology. Origi- nates, plans and conducts research to investigate the nature and properties of pharmacologically significant substances in drugs and investigates their effects in biological and microbiological systems. Devises and develops new methods for studying the biological activity of drugs. Conducts research to determine the nature, extent and significance of micro- bial and other microscopic contaminants in drugs. Devises microanalytical and biological methods for the analysis of drugs. Cenceives, plans and executes a re- search program to investigate the utility of diverse animal systems and biochemi- cal reactions for the examination of drug products. Devises new and improved methods for the determination of minute concen- trations of drugs in such biological ma- terials as blood, urine, feces, muscle tissue, kidney, liver, eggs, and milk. Per- forms bioassays to determine the potency of drugs such as digitalis, chorionic gonadotropins, estogenic hormones and thyroid. Cooperates with the Division of Drug Chemistry to correlate bioanalytical findings with the results obtained by the use of newly devised physiocoehemical methods of analysis for drugs. Advises District laboratory chemists on the application of biochemical analyti- cal methods to the assay of such drugs as heparin and hyaluronidase. Develops new methods of anatomical and histochemical examination of organs and tissues from animals subjected to treatment with drugs. (fa> Division of Drag Chemistry. Con- ceives, plans and executes a research program to detect, isolate and disclose the chemical nature of potent and toxic substances occurring in drug products. Operates the FDA system for the con- tinuous appraisal and improvement of current and proposed drug standards and specifications. Makes final decisions on the validity of all NDA analytical procedures referred to this Division or a field laboratory. Devises original physicochemical methods to measure the quantities of potent and toxic substances in drug products, including those subject to drug abuse control. Investigates the principles underlying the chemical reactions employed in the analysis of drugs. Proposes and establishes specifications for the standardization of drugs and analytical reference substances, and co- operates with the United States Phar- macopeia and the National Formulary in composing appropriate official mono- graphs which incorporate these specifi- cations. Establishes and maintains au- thoritative manuals and directories for drug analysis. Participates, in cooperation with the National Center for Drug Analysis, in collaborative studies to test the validity of analytical methods proposed for adop- tion by the USP, NF and Association of Official Analytical Chemists (AOAC) , or in new drug applications. Provides expert advice on the chem- istry of drugs and physicochemical iden- tification of drugs to the District labora- tories, and the Bureau of Narcotics and Dangerous Drugs, Department of Justice. Conceives, plans and executes a re- search program to investigate the utility of new, complex electronic, optical and radiometric instruments for the analysis of drugs. (iii> National Center for Antibiotics and. Insulin Analytic. Tests large num- bers of antibiotic and insulin samples obtained through the certification pro- gram, or collected for examination by the FDA District laboratories in planned surveillance programs or submitted by other agencies such as Department of Defense, Veterans Administration, and other agencies of the Public Health Service. Devises new methods for the rapid and accurate analysis of large numbers of drugs containing antibiotics and insulin, employing combinations of complex instruments in physical, chemi- cal, biological, and microbiological methods. Devises new methods for the examina- tion of individual drugs containing anti- biotics and insulin which present ana- lytical problems in accepted procedures, and subjects these new methods to col- laborative study. Devises new and rapid methods appli- cable to the analysis of single dosage entities, and to the analysis of antibiotic residues in tissues, body fluids, and edible substances. -....•■ In cooperation with other components of the Office of Pharmaceutical Sciences, participates in collaborative studies to test the validity of analytical methods proposed for adoption by the USP, NF, and Association of Official Analytical Chemists, or in new drug applications. Cooperates with the World Health Or- ganization, USP, and NF In testing and establishing reference standard drug sub- stances for use in the analysis of anti- biotics and insulin. Maintains a library of authenticated antibiotic and insulin reference drug sub- stances for distribution to FDA District laboratories and other authorized Gov- ernment agencies, as well as to industry participants in the antibiotic certifica- tion service. Provides expert advice to other units In FDA on the analysis of samples con- taining antibiotics and insulin, and in- terprets the results of its findings. (iv) National Center for Drug' Analy- sis. Tests large numbers of drug samples obtained in planned surveillance pro- grams or submitted for examination by the FDA District laboratories or by other agencies such as Department of Justice, Veterans Administration, and other agencies of the Public Health Service. Devises new methods for the rapid and accurate analysis of large numbers of drugs, employing combinations of com- plex instruments in automated systems of original design. Devises new methods for the examina- tion of individual drugs which present analytical problems in accepted proce- dures, and subjects these new methods to collaborative study. Devises new rapid methods applicable to minute quantities of drugs for the analysis of single dosage entities. In cooperation with other parts of the Office of Pharmaceutical Sciences, par- ticipates in collaborative studies to test FEDERAL REGISTER, VOL. 35, NO. 38 — WEDNESDAY, FEBRUARY 25, 1970 64 3692 NOTICES the validity of analytical methods pro- posed for adoption by the USP, NF, and AOAC, or in NDA's. Cooperates with the USP and NF in testing reference standard drug substances for compliance with specifications. Maintains a library of authenticated reference drug substances for distribu- tion to FDA District laboratories and other authorized Government agencies. Performs check analyses upon request to confirm results obtained by other FDA laboratories in drug analysis, and oper- ates a program to monitor the reliability of analytical results obtained in FDA laboratories. (m) Bureau of Veterinary Medicine. Develops and recommends the veterinary medical policy of the Food and Drug Administration with respect to the safety and efficacy of veterinary preparations and devices. Evaluates proposed use of veterinary preparations for animal safety and efficacy. Coordinates the veterinary medical as- pects of the FDA Inspection and in- vestigational programs and provides veterinary medical opinion in drug hear- ings and court cases. . - Plans, directs, and evaluates FDA's surveillance and compliance programs relating to veterinary drugs and other veterinary medical matters. (m-1) Division of Veterinary Re- search. Conducts studies to evaluate the validity of data supporting the safety and efficacy of veterinary drugs intended for the prevention of treatment of animal diseases. - - Conducts acute and chronic toxicity studies in large domestic animals follow- ing reports of contaminated animal feeds, such as heavy metals, weed seeds, -pesticides, etc . Studies the therapeutic properties of specific products and substances and the experimental reproduction of various disease conditions. Cooperates with other parts of FDA in the development of actual evidence based on animal experimentation to sup- port legal action under the Federal Food, Drug, and Cosmetic Act. Directs research to develop methods for studying the effects of therapeutic agents and various disease conditions. Conducts experiments to develop In- formation regarding food additive prob- lems arising from the use of drugs in veterinary medicine. Main line colonies, of laboratory animals for experimental tests and studies. (m-2) Division of Veterinary New Drugs. Evaluates for animal safety and efficacy proposed new veterinary preparations. Reviews the use of such preparations in veterinary medical practice to deter- mine the effect on animals. (If the prepa- ration is administered to food producing animals, the use of the product is con- sidered as it relates to safety in humans.) Evaluates proposed labels to assure that they clearly indicate the use and limitations of the product. Evaluates manufacturing facilities and procedures as described In the applica- tion to assure that such controls are adequate. Recommends action to be taken on proposed new veterinary preparations submitted for FDA review. Determines data required to estab- lish safety and efficacy and provides such information to investigators and manufacturers. Initiates research projects to gain fur- ther information on new drugs. (m-3) Division of Veterinary Medical Review. Maintains surveillance of veter- inary preparations and devices to assure safety and efficacy. Evaluates drug experience reports, establishment inspection information, advertising, and other clinical or re- search data bearing on marketed veter- inary preparations. Evaluates and recommends action on medicated feed applications for those preparations that have been approved for marketing. Recommends or supports regulatory and research activity. Prepares veterinary medical reports for the Post Office Department In sup- port of Postal Laws and Regulations. (n) Office of the Regional Food and Drug Director. As the representative of the Commissioner of Food and Drugs in the Region, the Regional Food and Drug Director directs and coordinates the pro- grams of the Food and Drug Adminis- tration carried out through the DHEW Regional Office and th:; Ban Francisco HI - 618, Federal Office Bldg., 60 Fulton St. Colorado: Denver Room 613. New Customhouse Bldj., 721 19th St. K£5T «0 Eighth St., NE. 3>re*> Illinois: Chicago Room 222, Post Office Bldg., 433 West Van Buren St. f....C Louisiana: New Orleans . Room 222. U.S. Customhouse Bldg., 423 Canal St. :civ Maryland: Baltimore 900 Madison Ave. nri Massachusetts: Boston . 685 Commercial ?t. IV'."- Michigan; Detroit , 1590 East Jefferson Ave. tV Minnesota: Minneapolis 240 Hnnnepln Ave. 55401 Missouri: Kansas City. _ 1009 Cherry St. MM New York: Brooklyn Room 700, Federal 113." Office Bldg., 860 Third Ave. Buffalo 699 Delaware Ave Ohio: Cincinnati 1141 Central Parkway. Pennsylvania: PhUadel- Room 1204, U.S. Cus- phia. tomhouse Bldg., Second and Chest- nut Sts. Texas: Dallas 3032 Bryan St. Washington: Seattle Room 501, Federal Office Bldg., 909 First Ave. 4.'.'t-' 1<.K« TOM 9>M [F.B. Doc. 70-2277; Filed, Feb. 24, 19"°: 8:48 a.m. J FEDERAL BEGISTW, VOL. 35, NO. 38— WEDNESDAY, FEMUAtY 25, 1970 65 E. THE HEALTH RESOURCES ADMINISTRATION 67 ORGANIZATION Health Resources Adml^i^.ration CHAPTER 7 HEALTH RESOURCES ADMINISTRATION' 7-A Mission 7-B Organization and Functions 7-C Order of Succession 7-D Delegations of Authority 39 FR 1456 1/9/74 39 FR 1456 1/9/74 Skctiok7-A ^fission. The Health Re- sources Arimlnisl ration (7000) provides leadership with respect to the identifica- tion, deployment nnd utilization of per- sonnel, educational, physical, financial and organizational resources In tho achievement of optimal health services for tho people- of the United States. To theso ends, t lie Health Resources Admin- istration dlltA) : (1) Conducts and sup- ports analyses, research, developmental activities, technical assistance and evalu- ation programs, and informational serv- ices designed to improve the overall health services system of the Nation; i2) collcrls, analyzes, and disseminates data on vital nnd health statistics, health ctotnn, health resources assessment and utilisation, organisation and manage- ment of health services, health expendi- tures, and related matters for the use of the Administration, oilier clrmcnts of tho Department, and the health services in- dustry Kcncrally ; (3) provides leadership nnd support for the development of Stale, area, and local comprehensive health planning and services and for re- gional cooperative arrangements among medical schools, research Institutions, medical care facilities, and practitioners; (4) administers programs to meet health manpower requirements for the Nation through the support of education, train- ing, and Institutions engaged in educa- tion and research In the health Held, and hy inainlaiiilni: relationships with na- tional. State, and local ujllcl:d ruul volun- tary organizations and Institutions work- ing in these areas; and (5) piovldes leadership to and supports activities con- cerned with health facilities, financing, and economics. Sec, 7-R Organisation and Function. Tho Health Resources Administration is directed by an Administrator who Is re- sponsible to the Assistant Secret aiy for Health. The Administration consists of the following ma lor components, with functions Indicated: Office or the ADMiNisTnATort (7A00) Provides leadership and direction to the programs and activities of the Health Resources Administration. Immediate OiHcc of Die Administrato r (7 API) . (1) Provides leadership for the execution of Administration responsibili- ties related to the development of a na- tional policy with respect to the Identifi- cation, deployment and utilization of physical, financial and personnel re- sources In tho achievement of optimal health services for tiro people of tho United Stales; (2) manages and directs the activities of tire Administration: (3) supports and stimulates programs de- signed to encourage tho training and full utilization of minority and disadvan- taged persons both within the Adminis- tration and, for tho health professions, on a Nation-wide basis; and (4) directs the coordination of the Administration's activities to assure adequate resources for a comprchcnslvo health-service system. HEW TN-7^.26 (9/16/7*0 69 HEALTH RESOURCES ADMINISTRATION Page 2 39 FR 1456 1/9/74 39 FR 1456 1/9/74 Office of Health Resources O pportun- ity (7A01V3) . (1) Providers the focal jwint for tho development and Implementation of HUA objectives n.s they relate to the disadvantaged; (2) recommend.; legisla- tion necessary for new program direction and financing necessary to improvo health resources nnd health career op-- portunity for tho disadvantaged: (3) serves as the advocacy focus for J IRA to nssurc access to health profession and allied health educational opportunities. and to assure an equitable health de- livery system for non-whites and other disadvantaged; (4) initiates, supports. and coordinates in conjunction with HRA units the development of research, statistics, and continual comprehensive data systems and analyses on require- ments, resources, accessibility, and ac- countability of health delivery systems to tho disadvantaged; (5) assists other government health agencies and private agencies in planning for and extending tho scope, content, and quality of their programs n.s they relate to Oilico of Health Resources Opportunity goals and objectives; (G) promotes and provides technical advico and assistance to insti- tutions, organizations, Individuals, and projects to develop in conjunction with HRA units, curricula, training programs, methodologies and demonstrations de- signed to overcome problems imolvcd in recruiting and retraining disadvantaged persons for health professions and _ allied health career;.; rind (7) assure/:, In con- Junction Willi appropriate IIHA units, tho provision of health services and health career opportunities for the dis- advantaged through specific considera- tion of their needs In comprehensive health planning and In tho allocation of health facilities. OOhc of f.'t/imf F.mnUiuvic 'tt Onnnr- tunilv (7/ifl/c.;>. - (1) l'lunf. directs, ami cooidlnntns Kqu.'l Ilmployincnt Oppor- tunity (Ei:0) pngnam.-; covering l.ead- quarters and Held employee.; (2) pro- vides bind advice lo Iho Administrator and to other key oliUlnls throughout the Health ltc:4>urr.i'.i Administration v.llh respect to pillelis, plans, procedures, regulations, and icports pmlalnlng to tho general e'l't.d employment opportun- ity policy of Iho federal fJovcumunt and thii J>''p.Tl mint's pro,;!. mi;; estab- lished under 1 Incentive Older 11470; (3) plans und "dovt.lops programs and procedures ele; lgni'd to eliminate dis- criminatory emp|o\ment pruclhcs; (4) receives nnd provides for the inve .liga- tion of complain) . of alleged discrimina- tion; and (5) maintains Mil son with tho Olflco of tho Assistant Secretary for Health, the Civil Jlcr^lrn Commi.,slon, nnd other orgaui/.ntioiw outsldo the HRA concerned with equal employment op- portunity. 0/,ii:c vf Citmmuulcutinnt (.7 AIT). (1) Directs, formulates polity for, conducts, nnd coordinates communication 1 ; activ- ities of the Health Resources Adminis- tration; (2) provide; communications expertise and etuif advice to tlio Admin- istrator In Mipport of program and policy fonmil.itlon and i>;:cr:iitlnn; <3) estab- lishes nnd maintains pioductive relation- ship.; with trie communications media; (4) establfj lir^ and Implements policies for review, processing, quality control. and dissemination of HRA program com- municalions rrnlcrlah; (&) provides cen- tral communication, services to all HRA programs; and i(,t serves as focal point for coordination of HUA tommunicalions activities RlMi tho:o of other health agencies within IN;V7 mid wllh regional. Slate, local, voluntary und professional orgs ni/atlr. n;;. ORGANIZATION 70 HEW TN-7^.26 (9/16/7 1 *) Pag« 3 lir.AI.TI! RF.SOURCF.S ADMINISTRATION 40 FR 3797 1/2A/75 - 1/ 39 FR 1457 1/9/74 (7/W9 > . < 1 > .'jl'i vf~ iu', the Ad mini tea tor's principal staff f>>r pioviding Administra- tion-wide leadership hi nJ I phases of management and for direct conduct or Crucial supervision of Admlnl .tralion- uldc operational functions; i2) directs and coordinate:; llic Administration's ac- tivities In the sirens of management policy, operational planning, systems management, financial management, procurement and mateilel management, grants management, and personnel man- ARcmenl: (3) advises the Administrator on management implications of Admin- istration plans and programs; M) pro- vides slafT support and facilities for advisory council .. conferences, and meet- ings; ( r j) collaborates with the Ofliec of Planning, Evaluation, and Legislation in Uio development and Implementation of the five-year program and f.v.ancla! plan for the Admiui' trator; provides fa- cility and space management services for Administration field element.-; and directs Die Agency's rifely mannceinent pro- gram; (7) coordinates A::ene.v programs with PUS Iteemnal Office functions by providing liaison to the Office of Re- p.lonal Operations, PUS; and. (gi dinvts data systems management and the Agency's mana;:cment Information sup- jMit systems. 39 FR_ 1457 _ V?/n Pit ivio» (i/ M a i) a o rmrn l_ I'jtJ it j % • 'i A l '.>(> :' ' . 1 1 1 Conducts organization and management .• Indies and surveys; <2) initiates or reviews proposals for estab- lishing or modifying organizational structure or function, delegations of on - tlioilty. and management objectives, policies, and standards; i3i negotiates solutions to intra- and inter-agency prolilems of urpani 'at.ion, functions, dele- gations, procedures, or coordination; <4> conducts Administration -wide manage- ment improvement programs, including manpower ulili/ation and productivity measurement; '. r )' participates in pro- pram and legislative planning to assure recognition of management problems; manages the documentation and is- suance system of the Administration; and i7> conducts the records mid forms management programs of llic Adminis- tration. 1/ Amends 39 FR 145d-7 1/9/74 Division o/ Fi iumcial , Management <7Al) participates In development of policies and procedures concerning financial aspects of grants and negotiated research and development contracts; and (7) maintains liaison with the Oflice of the Assistant Secretary for Health, and the Ollicc of the Secretary. Divi sion of Mana ge mrvt Srrvic.es (7 A !!>()!>) ,• > 1 ' Plans, directs, and co~ ordinates administrative management activities of the Ofii< e of the Administra- tor: (2) provides a full range of admin- istrative support services for the Olliee of the Administrator, including per- sonnel, materiel procurement and con- trol, space allocations, and graphic arts; (3) develops and implements manage- ment policies, procedures, systems, and practices for the conduct of Office of the Administrator affahs; i41 serves as the focal point for liaison with the Oflice of the Assistant Secretary for Health and the Ofliec of the Secretary on personnel, procurement, supply, space and other management concerns of the Oflice of the Administrator; <5) organizes and man- ages the committee management system of the Administration; and plans, organizes, and directs the Executive Secretariat of the Administration with primary responsibility for the control of written communications to and from the Administrator. Divis io n of Grants and Procur ement Maini'icyiicnt (7Al '.'Q^' (1) Provides leadership in the planning, development, and Implementation of policies and pro- ccduics of grants and contracts; (2) pro- vides advice and consultation on inter- pretation and application of PUS and Departmental policies and procedures affecting contracts and grants manage- ment; <3) develops and issues policy and procedural materials for the Admin- istration's contract and grant program: (4) establishes standards and guides for and evaluates contracts and grants man- agement operations throughout the Ad- ministration; i.">» cooordinates Admin- istration positions and action, with respect to grants audit requirements and results; and <(>> maintains liaison, directly or through the Regional Health Administrators, with grantee institutions and organizations and with the OHicc of the Assistant Secretary for Health and other components of the Department. Supi>rsock>p l'.'iRe 3, TN-74.26 71 ORGANIZATION iir.Ai.Tii i rsoi i:n:s adminisi 'ration p.-ij.. V) 7-8 1/4/74 Otl icc of 1' li miiivi.i, }' v a luation, and Legisla t ion ("A jTT Selves its the Admin- istrator's principal iul visor on long and short-range coals for mooting the health resource needs of the Nation. Develops plans, establishes evaluative require- ments, and designs legislative proposals to support Departmental goals. To these ends: (1) Assumes leadership in plan- ning for the most effective use of HRA resources; (2) promotes evaluative and monitoring activities which v.111 provide objective measurements of program per- formanee and the total effectiveness of agency efforts; (3) contributes to legisla- tive analyses ta assure the fullest possible consideration of programmatic rcquire- ments in meeting established Depart- mental and PUS goals; (4) as deter- mined by the Administrator, I1HA, main- tains liaison, directly or through the Regional Health Administrators, with State or local health ofllcials and with the private health sector to achieve com- mon understanding and effective co- ordination; and <(S) maintains surveil- lance of HHA data collection, R&D and other intelligence' which contributes to policy analysis within the Ollice of the Assistant Secretary for Health and an- ticipates issues w%ich may require Fed- eral intervention. /Jinwim nf FraJvatioH (7A3103). (1) Responsible for the creation within"! 1R A of disciplined profHNim evaluation as an inherent part of all agency activities; <2> establishes through I lit A Bureaus an ap- preciation of the need for objective measurements of the results of all pro- grams supported by grants and con- tracts; (3) works closely with relevant data and Informal urn gatlterlng activi- ties to enhance the quantification of evaluation studies; and (4) reviews plans for evaluations of programs and projects with siveculc attention to tlic study de- sign and appropriateness to 1I11A Objec- tives. IHl'i^Lvn (>/ I ' liinniiicj i7AT10, r ><. ( 1 ) Responsible lor HP A eonti i but ions to the Forward Planning document and Its adaptation to budgetary processes; <2> reviews Bureau work plans and their Impact on current or future planning and monitors their implementation; (3) co- ordinates Interrelated Bureau activities which may influence programmatic planning; and '4) maintains surveillance over long-term analytic and research activities. Division of J.roHntinn (7A3107i. <1) Maintains continuous, review of legisla- tion which affects the activities of BRA; <2i prepares materials for testim >uy be- fore Congressional committees; i3) as- sists in the Intcpretation of relevant leg- islation;' (4) coordinates agency re- sponses to Departmental and PUS legis- lative needs; (5) keeps IIHA activities informed on legislative matters and pro- vides analyses of pending bills and new laws; '6) promotes a rational approach to health legislation, identifying con- flicts, gaps, or other barriers to the achievement of Departmental goals; (7) maintains current data on major changes in State laws which influence health resources, with particular atten- tion to conflicts between Federal and State laws; (8) anticipates the need for data and analyses which may be de- manded by Congressional or Depart- mental legislative interests; and (9) serves as liaison between IIP A and the Office of the Assistant Secretary for Health on legislative matters. National Center Fou Health Statistics (7B0O) (1) Collects, analyzes, and dissemi- nates national health statistics on vital events and health activities, including the physical, mental, and physiological characteristics of the population. Illness, injury, impairment, the supply and utili- zation of health facilities and manpower, the operation of the health services sys- tem/health economic expenditures, and changes in the health status of people; (2) administers the Cooperative Health Statistics System; (3) stimulates and conducts basic and applied research in health data systems and statistical methodology; (4) coordinates the overall health statistical activities of the pro- grams and agencies of the Health Re- sources Administration and provides technical assistance In the management of statistical information; (5) maintains operational liaison v ttu statistical gath- ering and processing services of other health agencies, public ajui private, and provides technical assistance within the limitations of staff resources: (C) lostcrs research, consultation and training pro- grams in international statistical activi- ties; (7) participates in the development ORGANIZATION Swpersfck'S I'n^p A 'IN- 7 A, 2n 72 flRf ") .Ai.rii Ri::;oi;un:s administration 39 KR 14'>8. Xl-KOA of national health statistics policy with other Federal agencies; and <0>.in Its role, as the government's general-purpose statistical agency In the health held, as designated by the Office of Management and Budget, pi ovules the Assistant Sec- retary for Health with consultation and ad\1( e on .statistical methods and health statistical lnfoi ination. 40 PR 379 7 1/2 4/75 Office of the Center Director \7!'0t \, (1) Plans, directs, ndmlnl. trrs. coordi- nates and evaluates the total vital. health, and health related statistics pro- prams of the Center; <2> stimulates basic and applied research and developmental activities; (1!> provides national and In- ternational leadership In vital nnd health statistics; ('I' conducts a variety of pro- fessional activities to provide assistance to government agencies, to fo ;ter Inter- national relationships, and to Improve the broad fields of vital and health statistics; (5) coordinates the Center's activities with public and private health statistical agencies : provides man- agement and administrative support for the Center; (fi> provides pro, nam plan- ning and development for the Center; nnd O) develops and coordinates legis- lative activities. Once ol I'rouram Suvvort Plans, directs, administers, coordinates nnd evaluates the Center's fiscal, man- agement, nnd administrative support activities; (2) develops, analyzes, im- proves and Implements Internal man- agement policies, methods and proce- dures; (3) In cooperation with the Division of Financial Management, HUA, provides financial guidance and Infor- mation to NC1IS program managers In the operation of the Center's financial management system, Including program policy Intel pretatlon In budget formula- tion and execution, and preparation of program planning and budgetary support data; (4) coordinates the Center's con- tracts activities. > directs the Center's employee development and training activities; (O advises the Center Direr- tor on administrative policy mailers af- fecting the Center's program.;, and (7) maintains close liaison with the Oltirc of the Associate Administrator for Op- erations and Management, 11RA. and with other governmental agencies, nnd outside groups. ,o 37'-7 1/24 4/ / J 1/ Dpi ci\ o± le.tci i 'nt\:>nnl ' S lati ./ir.t (7/tf).i), (li Plans, direct •:. cool iHnatcs nild evaluates the Center's International statistical programs: •'.!> plans and con- ducts training programs In vital nnd health stall tics fur foreign sfntlstli Inns and demographers; ij> determine": need:; for teclmlcal assistance In various foreign count lies and arranges for consultant.) nnd advisors to provide such assistance; (■1) stimulates Center professional stair to conduct research in vital and health statistics hi foreign countries; > de- .Vclops and maintains an International statistical data file and conducts Inter- national studies of demographic and health statistics; (6) provides advice and guidance on disease classifications and disease classification problems In the Center; coordinates activities within the Center on classifical ion of diseases and procedures; nnd has responsibility for development of revi ion proposals and U.S. position on decennial revisions of the International Classification of Dis- eases; (7) provides an Executive Secre- tary for the US National Committee on Vital and Health Statistics; nnd maintains llaDon with key officials In IIHA. the Department and International ngeneies on requests for data and con- su'tnnt services. O flier of Pio'iKim I 'crrtopmrnt (7/?05) . (1) Provides a focus for short- nnd long-range program planning, coordina- tion, nnd evaluation of the adequacy and completeness of new and existing programs In meet in- the Center's mis- sion; <2i serves as liaison with orunnl/a- tions planning or conducting new Initia- tives In Federal health statistics: <3) provides stall advice on the development of new health statistics programs based on assessment of emerging needs; < in collaboration with the Associate Direc- tor for Management translates planning Into program arid budget proposals for Center operations; > assists the Center Director In the assessment of program accomplishments through a program re- view process; (C) develops and coordi- nates the Center's legislative activities; • 7) administers a program of project review ns roqui red by the federal Iteivir'.:! Act. Including official bureau rlearanec oflicer rcsponslbilitii •;; HP serves as the Center coordinator lor Interdisciplinary nnd luterprogram activities; if)> provides liaison with counterparts at higher lev- els; and (10) provides support services for the Center's conference,, advisory commit lees, and other ndviorv groups. ^Amends 39 FR 1458 1/9/74 Supersedes page 5, TN-74.26 ORCANI ZATION 73 HF.ALTII RKS'it'KCr.S ADMINISTRATION Pap.v ft 40 I'R 3797 1/24/75 39 FR 14 58 1/9/74 Or'u\ r-f Stuti'-timl llrtenrrh Provides tnu'ial ) develops and applies actuarial methodology in a wide ramie of vital events nnd health phenomena; nnd (7) conducts a pro- gram of research related to the health statistics activities. Including analytic incthodolony, techniques and procedures. Division <>/ the. C o operative Hea lth Statistics S'i-.tciu (7H33>. (I) Serves a"s the Director's principal advisor on Held relations with State, local and p.ovcrn- ment ngencles; <2> coonlinal.es all NCHS activities related to the develop- ment and implementation of the Coop- erative Health Statistics System; (3) supports and stimulates research and developmental activities aimed at the in- tegration, development and improvement in the Cooperative Health Statistics Sys- tem; (1) plans, organizes, and directs the Applied Statistics Training Institute; (5) assists users of Cooperative System's data in the utilization of statistical data and methodology through Uie operation of tho Data Use Laboratory; (6) admin- isters a grants and contracts program lor the implementation of the Coopera- tive Health Statistics System; and (7) monitors and evaluates the Center's pro- grams in meeting state and local health .statistical needs. . Division of Health Interview Statistics (77)35) . ( 1 ) Plans and administers statis- tical programs based on a systematic nationwide health interview survey; (2) 'produces statistical data In tabular and machine-readable form; (3) conducts a research program on survey methodology, data quality and reliability; <4) prepares statistical reports for publication; and <5) collects and evaluates economic data as it relates to individual medical care costs. git'ision. of Health Manpower and Faciiiiles~ Statistic s (7 HIV) (1) Plans and administers statistical programs based on systematic nationwide surveys and inventories of health manpower and facilities; (2) produces statistical data in tabular and machine-readable form; (3) conducts a research program on survey methodology, data quality and reliabil- ity; (4) prepares statistical reports for publications', and (5) plans, support and conducts special projects on health man- power and facilities. Die h ion o/ Health Resources Utilha - fioa Statistics ( 7 1130) . ( 1 ) Plans and ad- ministers statistical programs based on a systematic nationwide collection of data on the utilization of health resources; <2) produces statistical data in tabular and machine-readable form; (3) conducts a research program on sur- vey methodology, data quality and reli- ability; (4) prepares statistical reports for publication; and (5) plans, supports and conducts special projects on health resources utilization. /)iri.sion of Heaitti Examination St a - tint irs (7I1 M) . (1) Plans and administers statistical programs bused on systematic nationwide health examination surveys of Individuals; (2> produces statistical data in tabular and machine-readable form; <3> conducts a research program on survey methodology, data quality unci reliability; (4) prepares statistical re- ports for publication; and (5) plans, supports and conducts special projects on the health examination of individ- uals. (IRCANIZATION Supersedes Page h, TN-74.26 74 PaRC 7 HEALTH RESOURCES ADMINISTRATION 39 FR 1458 1/9/74 39 FR 1458-9 1/9/74 Divi s ion of Vita l S tatistics (7D43). (1) Plans and administers statistical pro- grams serving demographic and public health needs of vital statistics, and pro- vides for the analysis and relca.se of data on vital events; (2) promotes utilization of data through expansion of the U.S. vital registration systems and through conduct of sampling surveys to provide demographic and health Information: (3) conducts methodological research on evaluating and presenting vital statistics data; (4) develops standards for data collection, data reduction, and tabulation Including quality control measures ns the basis for a national cooperative vital statistics system at federal, State, and local levels; (5) prepares and releases for publication summary and descriptive analysis of datJi from the vital statistics system; (C) serves as the focal ix>int in the Federal government for liaison with the registration area:, on matters of legal and statistical concern regarding thf registration system; (7) monitors and evaluates the vital statistics process to ensure the timeliness of the Center's an- nual vital statistics series; and (8) pub- lishes life tab.es and special analysis of life tables phenomena. Division of O pcral inns _U_B45± . ( P Plans, directs, coordinates, and evaluates technical support and data collection operations for all of the Center's pro- grams; (.2) conducts data reduction and data preparation services in support of data collection and analysis programs; (3) manages 11. J computer operations and provides system programming serv- ices; (•!) conducts a research program to improve the computer processing tech- nology and methodology; and (5) pro- vides technical information, data dis- semination, and technical publication services for all Center procrams. NiUlonnj_(Vnier for Health \J Services Bc bc areh '7C0(); Conducts or. by means of grants and contracts, supports and stimulates a na- tional program of health services re- search, development, demonstration, evaluation and health services research training. Responsible for providing in- formation, analyses and advice for policy making, planning and development of national health services strategics. Serves as lead agency in design and sup- port of research and development proj- ects which are nrotot.vi>cs and models for health services programs and pro- viders of health services with emphasis on: (1) Assessing the impact of Innova- tions In planning, organization, financ- ing, management technology, and quality of care on the health care delivery sys- tem; (2) investigating the c fleets of fi- nancing and reimbursement methods on the cost, utilization, and availability of health care services; (3) analyzing alternatives for national health insur- ance, testing different options, and evaluating the Impact of different ap- proaches; (4) studying the interaction of public jxillcy and Federal, State and local laws and regulations with the health system; (5) analyzing and testing options for Increased participation of the community and the consumer In the health care process; (G> evaluation of health services and health services In- novations with respect to cost effective- ness, quality and availability of per- sonal health services; (7) supporting training of individuals to plan, conduct and manage research, development, dem- onstration and evaluation of health care delivery systems; (8) assisting in the development of an overall health serv- ices research strategy for DIIFW and coordinating health services research activities in other health agencies; (9) serving as a primary source of technical and professional assistance to the As- sistant Secretary for Health in the area of health policy research and develop- ment of a National Health Strategy; and (10) disseminating the results of re- search, and providing technical assist- OQlcr of the D irector ( 7C0/J . (1 ) Fos- ters and stimulates a national program of health services research and develop- ment activities; <2) plans, directs, rul- . ministers, coordinates, and evaluates the program and management operations of the Bureau; (3) coordinates the Bureau's activities with other Administration or- ganizational elements, other Federal or- ganizations within and outside the De- partment. State and local bodies, and professional and scientific organizations; J4J administers and Implements grant and contract policies and procedures emanating from the Office of the Secre- tary; (5) provides secretariat services to the Bureau's Advisory Councils and ad- ministers a system of review for the Bu- reau's grants and contracts; and (f.) plans, coordinates and develops methods for the systematic collection and dis- semination of new scientific and tech- nical Information among health services researchers and health care practi- tioners. 1/ Title Change, 40 FR 4183 1/28/75 Supersedes p«» R e 7, TN-74.26 ORGANIZATION 75 HEALTH RESOURCES ADMINISTRATION Page 39 FR 1459 1/9/74 39 FR 1459 1/9/74 Hi. t- /">; of lli-iil l h Si'tvii-ix Uc-itirrli Shiil cn!/ i7CU '. Develops i.on'ial health soviet s k: earth stratcr.y for the bureau and lor IIUA mid Hl-.'W, and develops |uo"iaiii plans for the Bureau. Develops lnt( lli.'.eiic -e, iiml piovidcs infounailon, anaH: i ;; and advice lor poliry making unit plmnmi; vv ill) ic ret I to lieallli serv- Icrs reseat eh. To achieve Ihcj-c objec- tives: ill Snppoils, directs, and coor- dinates in! raniui al research aimed at Identifying and deftniu;; health care de- livery problems within a comprehensive frame wot k; <2) i u: asrs In cooperative. coinpaialive international studies of lieallli ;■ i vices; Cii icrves as the lead unit ol (lie Huieau to provide technical evl lance to Keilonal Offices and the genera] health mi vices community; and (•!> selves as lir.iilativc and rcp.ulalory Unison for bureau programs and lutiv Hie;. ])[ '. i.'-iii'i o f Hi til th Scrriirs I'.vulu uliun JxlliiL. ' -'I'lid'it l:» evaluation inwslli'.a- lltiiis tin i'ii; h in- house Muff or hy urnnt mil! conduit to liileimnu: Ihe validity, effect Ivcnc s and hnpait, and reucral- Ir.abillty ol Innovative health care ex- luntiiii nts conducted both by the liurcau el !(«■ iih .Viiviies lfosrnrch and oilier iT.ciH'ii ,; To aeeoinplish these objective s: (1) 11. v. lop:, ( oil. bora! ive studies with ctber I'eil. r.d health sv.cnclcs; c_>) eval- uates tin Imp. n;t of ot hi r HI IA pi or rams nnd of nlhir MSA. Mil, IDA, !',:iA, and liK'j pro "am:, as n: lined; t3) n: suits that majoi research, development and (lemon: tialinll pro In .Is i i.iuln: led liy the lane; m.l Mi allh !Vi vie.i-i He.,e.iH:h have im ( \ . 1 1 1 1 : 1 1 sin (omponeut wlifcli is pail ol tlii: ba Ic ) a eauh di ii n and will not Je.juiio : -p. irate evaluation invtsttm- t ■•iii*:; cj) i-c n- 1 1 if Is Jndep, ml, nt, evaltia- tiiii.'; n[ hrallli civiics activities, or cl.i'tci. oi niltvilies i ■ icijuiiis; nnd ' (l » ii \il \vi aipropilate evaluation IIV Mas a io i •::. Inr.itii ol ln .iif-'iV 1 ,,;! One i7(.'.1. f )> . II vi ;..p ■. ii),| i.. ,.■,;,,, hales pi ov hie r- and roi'U.un Ii mil .ted appi cache'; lu hn- Piovini'. loi! !; -tcim car:: health services for the disabled nnd elderly. Hf sponsible for lmpli i. a ntlni: the i'usldonf '.; Nurln:' Home linpiovemi nt Pioriam t'j improvn tho (pialHy of life and health care In these futilities. To cany out these re- Kponslbilitie;: <1) Develops mid tests models inul prototypes to iinpiove the distribution, (itlli/ntton and ce l-ciri.c- tiveness ot resources and services: (2) provides technical assistance In collabo- ration with Ri clonal (Cilices U> fcitute agencies, provldeis, and ori;n nidations to Implement innovative approaches; (3) directs experiment:; and demon; I rations in alternatives for rcimburr.cna nt; (4) supports studies of quality of life nnd health-related care ollercd by providers; (5) collects, analyzes and disseminates data on status and utilization of and Innovative approaches to health services to the elderly and disabled; > supports fci vices improvement projects, IncludlnR short-term training of provider person- nel; < 7) Identifies need for and develops and supports Intra- and extramural analyses nnd research on the orc.aui; i- tion, delivery and llnaiicini; ol health Kei vices and develops national .si raliT.ii s; and (81 collaborates with oilier pro- •■rnins of lll;W, and with those in other federal nuclides on matters relating lu lonir-term cure health services; for the disnblcd and elderly. ORGANIZATION 76 HEW 1*1,-7*4.26 (9/16/7U) Page 9 HEALTH RESOURCES ADMINISTRATION 39 FR 1459 1/9/74 39 FR 1459-60 1/9/74 Division of Health Services Uevenrch aiid Analysis <7<;.;9 > . lsngagcs In research aiid analysis to liluilify ami dt line health services delivery pioblcms am! to develop solutions to them. To accomplish these ends, conceptualizes, structure:;, fosters, supports and comiucts extra mural and Intramural research on economic, politi- cal, legal, social nncl behavioral factors winch influence the delivery of health care, Including, but not limited to the following: (1) Maldistribution end In- appropriate utilization of rcrources, in- cluding manpower productivity, pcr- formanco cud licensure; (2^ hralth behavior, knowledge and attitudes nt consumers and piovideis of care; <3> the Interaction of public policy and Federal, delivery system; and (8)' collabiwatlve State, and local regulatory activities; t4i community decision-making procisscs: (5) organisational and logistical elements of health care delivery systems in rela- tion to cost, quality, and access; . Supports and conducts research into problems of measuring find monitoring the eflicncy and quality of medical care. To accomplish tills end: (1) Develops and tests alternate methods of assessing and assuring high quality health care delivery; (2) examines the validity and genera lizabillty of current and proposed measures, of quality, includ- ing the validity of proxy measures and sampling techniques; (3) performs studies on input, process and outcome measures of quality and the relationships among them; (4) assesses the validity and gcncrallzabillty of current and pro- posed indices of health status, and thrir relationships to the delivery of health services; (5) analyzes the effecls of vari- ous consumer and provider rolrs In set- ting standards for quality, and examines the Impact of local versus national stand- ards; (G) analyzes the effectiveness ol efforts to improve the quality of care tluough positive and negative Incentives designed to change behavior; (7) ex- amines the costs of alternative quality assessment and assurance programs in terms of direct costs and resultant costs of providing health care; <0) in conjunc- tion with other agencies and organiza- tions, assesses the efficacy and quality of health care by relating commonly ac- cepted medical procedures to outcomes under controlled conditions and under conditions of usual community practice; (9) examines the effects of organiza- tional and structural factors in health care delivery systems on the quality of care; and (10) provides technical as- sistance to the Health Services Admin- istration in setting criteria and stand- ards. Division of Health Systems DcsUni ami Development (7C11). Kngas.cs in applied research in health systems cicsi m and development to solve health services de- livery problems. To accompli.'!] this end: (1) Designs, develop.;, and implements demonstration projects In appropriate settings to test innovation In urbaniza- tion and inanagn.i" ut, delivery, financ- ing, and technology; (2) develops dele- gated Federal inittullvM for In r; e-scale research and development and for sub- sequent phasiiu; into implementation units; (3) provides technical m^islance to tho health servicn rielivciy nystcui at regional, State and local levels; (4) de- velops national testing of Innovations with full specification of design, time- phasing and analysis; <5) sperilies measurable objectives and operational procedures of development and demon- stration projects and examines their cost effectiveness and impact; . (1) Provides personnel man- agement advice an J assistance to the Administrator and to managers and su- pervisors within its servicing area: (2) participate; In the development of agency goals and operating plans related to per- sonnel management; (3) within its serv- icing area, provides personnel manage- ment and personnel administration serv- ices, including manpov er planning and utilization, employment, recruitment, compensation and classification, execu- tive and career dev 'opment, upward mobility, labor relation •. employee rela- tions and occupational health; (4) pre- pares staff studies and recommendations to agency management on personnel needs and problems; identifies the need for personnel p:>ii: ies and programs oPHS and collaborates van PHS, as ap- propriate, in the development cf such polidlcs and programs i?i develops and implements operating procedures and interprets policiss to the extent necessary to meet the sp*?' h I p.eods of the Health Resources Aim: rat t.i in the applica- tion of PHS. DHE'W, CSC and other Gov- cnimer.t. :^:. '} re ^u 1 .?. lions; ',7> Repre- sents the H dtb Resources Administra- tion in personnel management matters with PHS, liH! ■", CSC, other Govern- ment agencies, i rofe?=:o:ial sccier-les, and colleges and uru\ : :; Lti?s, Dated: April 14, 3975. JOTIN OTT1NA, Assistant Secretary for Adminiiiraiion end Management. [FR Doc.75-".0218 Filed 4-17-75,8:45 am| FEDERAL REGISTER, VOL 40, NO 76 -FRIDAY, APSil 18 Atttachment B Public Health Service HEALTH RESOURCES ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Amendments Part 7 'Health Resources Administra- tion! of the Statement of Organization. Functions, and Delegations of Authority for the Department of Health, Education, and Welfare (39 FR 145(5, January 9. 1971>. as amended, is amended to reflect the following changes under Section 7-B: Organization and Fiuictions. 1. The statement for the "Bureau of Health Services Research <7C00» " is amended by deleting the statement for the "Division of Regional Medical Programs (7C37)". 2. The statement for the "Bureau of Health Resources Development c7E00 through 7E43>" is deleted and the fol- lowing statement is substituted: Bureau of H ealth Man newer <7F.00)_. Provides national leadership in coordi- nating, evaluating, and supporting the development and utilization of the Na- tion's health manpower. To this end Die Bureau: <1> Assesses the Nation's health manpower supply and requirements and forecasts supply and requirements for future time periods under a variety of health resources utilization strategies; (2) collects and analyzes data and dis- seminates information on the character- istics and capacities of the Nation's . health manpower production systems; (3> proposes modifications of or new Departmental legislation. i>o!icies, and programs related to health manpower development and utilization; (4) devel- ops, tests, and demonstrates new and improved approaches to the development and utilization of health personnel with- in various patterns of health care de- livery and financing systems; (5) ad- ministers Federal programs for targeted manpower development and utilization; 1975 (6) provides technical assistance, con- sultation, and special financial assistance co national, State and local agencies, organizations, and institutions fur the development, production, utilization, and evaluation of Ileal Hi manpower; '7> pro- vides linkage between Bureau head- quarters and PHS Regional Ofiice ac- tivities related to manpower education and utilization by providing training, technical assistance, and consultation to Regional Office staff; <8> coordinate-; its activities with the programs of other agencies within PHS, the Department. and in other Federal Departments and agencies concerned with health man- power development and health care services; i9> provides liaison and co- ordination with non-Federal organiza- tions and agencies concerned with health manpower development and utilization; and 1 10) in coordination with the Onice of International Health. PHS. serves as a focus for technical assistance activities in the international aspects of health manpower development, including the conduct of special international projects relevant to domestic health manpower problems. OPice of ttie Director (7E01). Provides leadership and direction for the pro- grams and activities of the Bureau. Spe- cifically: (1) Develops program objec- tives, alternatives, and policy positions consistent with broad administration guidelines; <2) evaluates program ac- complishments; (3> develops -and administers operating policies and pro- cedures and provides assistance to Bu- reau constituents to achieve effective- ness and economy in the management of Bureau programs; (4) coordinates Bureau activities, with special emphasis on developing, implementing, and evalu- ating multidisciplinary programs for the education and utilization of the health professions and the development of an adequate and balanced health manpower supply, and on achieving an integrated approach to the planning, utilization, and deployment of the Nation's health manpower; to' provides selected man- agement services for the Bureau and carries out necessary coordination with respect to management services provided for the Bureau by the Oifice of the Ad- ministrator. IIKA; i6> directs and co- ordinates Bureau activities carried out in support of Equal Employment Oppor- tunity programs; i7> provides guidance and assistance to PHS Regional Offices in executing the Bureau's responsibili- ties for the efficient and effective conduct of decentralized grant and contract pro- grams; and provides information about Bureau programs to Hie general public, health professions associations, and other interested groups and orga- nizations. Office of Interdisciplinary Programs (7E03>. Plans, coordinates and directs selected multidisciplinary or niultidivl- sional health manpower development ac- tivities. Specifically: (1) Identifies Bu- reau activities thai are interdisciplinary or inul' [divisional in nature and provides leadership for coordinated management; '2 1 provides Bureau direction to such programs, including Interdisciplinary 80 FEDERAL tEClSTEH, VOL 40, NO. «7— MONDAY, MAY 5, 1975 10316 NOTICES education, remote site health profession- al education activities, "fond development of learning resources: and >J> coordi- nates Bureau programs in relation to equal access lor health career opportuni- ties. Office of Pronram Support (7/705). De- velops n'.id administers policies and pro- cedures to achieve elfectivcncss and econ- omy In the management of Bureau pro- grams. Specifically: Guides, coordi- nates, and evaluates the administrative management aspects of Bureau pro- grams; (2) promotes the application of improved management systems and prac- tices; (3) provides specialized manage- ment services and consultation to Divi- sions and stuff offices of the Bureau, in- cluding library services, records and cor- respondence management, oflicc services. personnel management, equal employ- ment opportunity services, and manage- ment analysis; <4i in cooperation with the Division of Financial Management, BRA, provides financial guidance and Information to Bureau pro.iram manag- ers In the operation of the Bureau's financial management system, including program policy interpretation m budget formulation and execution; and <5) co- ordinates administrative management aspects of the Bureau's contract activi- ties. Office of Program Development (7FAS). Serves as the Bureau focus for program development activities to pro- Vide a coordinated approach for future- oriented Bureau policies and directives. Specifically: «l) Develops and carries out program planning and evaluation activi- ties, imiiK'.iii',' objectives, alternatives, policy positions, and assessment of pro- gram effectiveness; *2) coordinates the development of new legislative proposals from within the Bureau; and (3j devel- ops and conducts manpower data collec- tion and analysis appropriate for the Bureau and coordinates such collection and analysis perfoimed in Bureau divi- sions and externally. Of/ice o/ Program Operations *7£17). Provides a Bureau focus for grant and contiact policy and, in cooperation with the Oflicc of Regional Operations, PUS, coordinates Bureau programs with PHS Regional Oliice operations. .Specifically: (1) Develops and promulgates criteria, guideline-;, and operating procedures for new and rcvi cd health manpower plan- ning, development, and utilization pro- grams; ill) facilitates and coordinates communications, technical assistance, training, and consultation between re- gional and he idquarters operations; i3) serves as liaison between Bureau pro- grams and BRA. Office of the Assistant Secretary for Health tOASH). and PUS regional Intcrc. is; (-1) provides techni- cal, admir.l- native, and management support for the Bureau's Health Profes- sions Education Council; to) provides direct technical and management assist- ance to PHS Rerlonal Ol'lces on all as- pects of Health Professions am! Nursing Student Assistance activities: and (0) provides financial management services to the Bureau and to PBS Regional Of- fices with respect to student loans and fcholarshlps, including accounting and loan repayment functions. •»/ Division of Medicine ubiic and private organiza- tions, v '-. nnd institutions, includ- ing i "■. ■ of tin? Federal Government and PHS Regional Otaces. on nil aspects of manpower relevant to the Division's functions. 3. Add the following immediately fol- lowing Die statement for the "Bureau of Health Manpower i7E00>". Bureau of Health P'.anjii-i'i and Re- Dcvcl OPffl"; [ZJSML, Provides national leadership and administration ot a program of Federal, State, and area- wide health planning and health delivery systems development. To this end the Bureau will: (1> Facilitate the creation of a nationwide network of local health systems agencies responsible for prepar- ing and implementing plans to improve the health of the residents of their re- spective lie.-' 1th service areas, to increase the accessibility, acceptability, continu- ity, and quality of health services in the areas, and to restrain increases in the costs" of the areas' health services; (2> provide for the designation, and support the effective functioning', of State Health Planning and Development Agencies re- sponsible for performing the State gov- ernment's health planning and health delivery systems development activities and the coordination of the local Health Systems Agencies within the State's geo- graphical boundaries through the aegis of the Statewide Health Coordinating uncils; (3* administer a program of mcial assistance for State and local iicalth planning and delivery systems de- velopment activities through a system of grants, contracts, loans and loan guaran- tees; (4) provide technical and other non-financial assistance ana support to the planning agencies by conducting studies and analyses of health planning, health resources, and health delivery systems development, engendering im- proved health planning approaches, methodologies, policies and standards, and establishing multidisciplinary cen- ters for health planning; <5" focus the use of resources for medical facilities construction on the highest priority needs and combine the administration of the facilities program at the State level with the administration of State health plan- ning and health delivery systems devel- opment activities: (6) review grantee in- stitution.-; to assure and enforce com- pliance with the requirements applicable to the receipt of assistance under the facilities construction and modernization portions of the program; (7) develop and apply performance standards, guidelines, and criteria for governing the structure, operation, and performance of the func- tions of the Health Systems Agencies and State Agencies; and (8) coordinate Bu- reau activities with the Office of the As- sistant Secretary for Health (OASH), with the programs of PHS Agencies and other operating components within the Department, and with other Federal, State and local agencies and groups con- L^-rned with health planning, health re- sources, and health delivery systems de- velopment. Office of the Director (7F0f>. Provides leadership and direction for the pro- grams and activities of the Bureau cifioali;, : ili Coordinates the internal functions of the Bureau and its rehi 1 i m- ships with other national health pro- grams; (2 1 develops program objectives. alternatives, and policy positions con- sistent with legislation and broad Ad- ministration guidelines; (3 1 develops and administers operating policies and pro- cedures and, m consultation with the Office of Regional Operations, PHS, pro- vides guidance and assistance to PHS Regional Office personnel who execute the Bureau's responsibilities and conduct, and assist in developing the Bureau's programs; i-ii evaluates program ac- complishments; (5 1 provides selected management services for the Bureau and coordinates them with management serv- ices provided for the Bureau by the Office of the Administrator KRV <6> serves as a principal contact and advisor to the Department. OASH. the Health Re- sources Administration end other PHS Agencies, the National Advisory Council on Health Planning and Development. air; other parties concerned with ma l ei s relating to planning and development of health delivery systems; (1) directs and coordinates Bureau activities carried out in support of Equal Employment Oppor- tunity programs; and 18) provides. through trie Office of Communications, HRA, information about Bureau pro- grams to the general public, health pro- fessions associations, and other inter- ested groupv and organizations. Office o] Policy Coordination (7F03). Serves as the Bureau Director's staff component for policy coordination. Spe- cifically: tl.i Insures that Bureau pro- gram policies and operating procedures are consistent with general HEW, PHS, I1RA. and ether Federal policies and re- quirements; (2) assists in the develop- ment, clearance, and issuance of such policies and procedures; (3) coordinates, performs analysis of, and assesses the impact of diverse program policy on the mission of the Bureau; (4; brings to the attention of the Eureau Director and executive staff policy issues which have not been resolved at lower levels; (5) assures that Bureau personnel are in- formed of policy evolution on a periodic basis; (6) serves as a Bureau focal point for communicating with PHS and ether HEW components with regard to policy clearance; (7> reviews controlled cor- respondence for potential policy ramifi- cations or impact, makes action assign- ments, follows up to assure timely r.nd appropriate action, and maintains a schedule of pending requests for man- agement uses; and (8) establishes and maintains central files for the Bureau. ■Office of Evaivation and Legislation (7F05K Serves as the Director's primary staff unit and source of advice on pro- gram evaluation and legislative affairs. Specifically: (1) Prepares and direct': the implementation of comprehensive program evaluation strategies to obtain needed evaluative data; (2) exercises leadership In formulating Indices and measures for evaluating program prog- ress ami accomplishments: (3) works closely v.i'h the Bureau's data and in- zormati'.'i.i gathering activities to en- hance their relevance and usefulness for evaluation purposes; (4> stimulates, oversees and or assists in the conduct of evaluation studies; <5> participates in the dissemination and implementation of evaluation fmdinss and recommenda- tions: <6> monitors health legislation affect::.!'; the Bureau's programs; (7) participates in the development of mod- ifications in and extensions of the pro- gram's enabling legislation; and (8) provides leadership for task-oriented problem resolution at the discretion of the Director. Office of Operations Monitoring (7F17). Provides, in close liaison with the Offce of Regional Operations, PHS, a Bureau local point for monitoring op- erational activii.i(!«s carried mit" through the PHS Regional Offices. Specifically: (1) Plans, directs, and coordinates the Bureau'- monitoring and assessment programs; (2) participates in Bureau policy tormulaiion by advising on the operational implications of the Bureau's plans and programs: t3) devises, con- trols, and operates the Bureau's man- agement control and information sys- tems; (4) collaborates with the program divisions to establish criteria, param- eters, and content of information re- quired for the effective monitoring of program operations; and (5) provides analysis of Regional operational prob- lems and suggests solutions. Ofjlc" of Program Support (7Ff9>. Plans, directs, and evaluate, tne admin- istrative management support activities of the Bureau and provides or acquires requisite management services and re- sources for the Bureau. Specifically: (I) Plans, directs, and coordinates those per- sonnel management and training pro- grams which meet the particular needs of the Bureau; (2> plans, directs, and coordinates property management and procurement programs; <3> conducts or- ganization and management surveys and develops necessary' systems and controls to maintain and further the organiza- tion and management practices of the Bureau; (4) in cooperation with the Division of Financial Management, HRA, provides financial guidance to Bureau program managers in the operation of the Bureau's financial management sys- tem, including program policy interpre- tation in budget, formulation and execu- tion, and preparation of program plan- ning and budgetary support data; (5) serves as the Bnre tu focal point for the formulation of ADP policy and for the planning, development, and evaluation of ADP systems; (6; develops proce- dures for and maintains the Bureau's reports management system; (7) co- ordinates Bureau activities in manage- ment planning arc! prepares such docu- ments a.; the forward plan. OPS, and Bureau contributions to higher level planning activities; <8> conducts Bureau management improvement programs; participates with the Office of Evalu- ation and Legislation in program and FEDERAL REGISTER, VOL. 40, NO. 87 — MONDAY, MAY 5, 1V75 82 19518 NOTICES legislative planning to assure recogni- tion of management and resource con- cerns; and (10) maintains close liaison with the Office of Operations and Man- agement, HRA, and with other govern- mental agencies and outside groups. Division of Agency Development <7F31). Provides a Bureau focus for the •management and operational develop- ment of health systems agencies and State agencies. Specifically: (1) Serves as a central reference and problem re- volving point to assist PHS Regional Office personnel In agency management and operational development; (2) pre- pares prototype plans of organization and operation of agencies; <3) prepares and provides for PUS Regional Office use various determinants and guides to meet the needs of a broad variety of agency situations and levels of development; (4) participates In the development and maintenance of agency performance standards and assessment criteria; (5) provides assistance to agencies through the PHS Regional Offices in the form of Information, guides, and interpretations including, but not limited to: Guides to incorporation, revisions of by-laws, staff- ing patterns, personnel policies, organ- ization models, administrative manuals, salary determinations, position descrip- tions, and agency policy and procedures; (6) serves as a consultative resource with respect to agency development matters as they relate to other program activities of the Bureau; (7) coordinates agency development activities closely with other program activities of the Bureau; and <8) participates in establishing Manage- ment Information System data sets and reporting criteria that are relevant to agency development and problem deter- mination and resolution. Division of Planning Methods end Technology (7F331. Provides a Bureau and national focal point for the develop- ment and dissemination of technical materials, planning approaches, meth- odologies, policies, standards, and guide- lines for the use of health systems agen- cies, State agencies, and concerned par- ties in planning and developing health delivery systems to meet the public need. Specifically: (1) Develops ana dissemi- nates guidelines for the conduct of plan- ning and specifies the minimum data needs for determining the healtti status ,<■ .,, develops programmatic guides prescribing con- duct of regulatory activities of grantee agencies; (6) establishes and maintains systems for interpreting regulatory pol- icy to PHS Regional Office staff and grantee agencies; (7) interprets and ex- plains regulatory policies to PHS Agen- cies and other operating components within the Department, other Federal departments and agencies, and the pub- he; (8) cooperates with PHS Agencies and other operating components of the Department and with other'Federal de- partments and' agencies in the develop- ment and operation of enforcement mechanisms for regulation; (9> reviews and assesses State and local regulatory programs employing regulatory concepts and mechanisms outside the purview of health planning and resources develop- ment legislation; '10; prepares and re- vises monitoring criteria for use by the Office of Operations Monitoring to insure that requisite information for regulatory assessment and evaluation are provided; (11) participates in executive staff con- siderations of policy or program changes which impact on regulatory activities; and (12) suggests State and Federal leg- islative actions which will further at- tainment of regulatory goals. Dated: March 20. 1975. John Ottiija, Assistant Secretary for Administration and Management. IFR Doc.75-11583 Filed 5-2-75:8:45 am) FEDERAL REGISTER, VOt. 40, NO. 87— MONDAY, MAY 5, 1975 83 * F. THE NATIONAL INSTITUTES OF HEALTH I 85 NOTICES NATIONAL /A/STiTVT&S Of 21859 H£ALTH Public Health Service NATIONAL INSTITUTES OF HEALTH Statement of Organization, Functions, and Delegations of Authority Part 8 of the Statement of Organiza- tion, Functions, and Delegations of Au- thority of the Department of Health, Education, and Welfare is hereby amended to reflect the implementation of the Reorganization Order effective July 1, 1973, and the Reorganization Order effective September 25, 1973, with respect to the organization of the Na- tional Institutes of Health (NIH) as a Public Health Service agency. Current statements for the National Institutes of Health are to be deleted and replaced by those given below. Section 8.-A Mission. The National Institutes of Health provides leadership and direction to programs designed to Improve the health of the people of the United States through the following ac- tivities : (1) Conducts and supports research in the causes, diagnosis, prevention, .and cure of diseases of man, in the processes of human growth and development, in the biological effects of environmental contaminants, and in related sciences, and supports the training of research personnel, the construction of research facil ities, and the development of other research resources . (2) Directs programs for the collec- tion, dissemination, and exchange of In- formation in medicine and health, in- cluding the i.i i velopment and support of medical libraries and the training of medical librarians and other health in- formation specialists. Sec. 8-B Organization and functions. The National Institutes of Health is ad- ministered by the Director of the Na- tional Institutes of Health, under the direction of the Assistant Secretary for Health. NIH consists of the following major components with functions as in- dicated : Office of the Director (8A). Provides leadership and direction to the programs and activities. of the National Institutes of Health. Office of the Director and Deputy Di- rectors (8A01) . (1) Assists the Assistant Secretary for Health in the formulation of national health policy; (2) provides leadership in the development and im- plementation of policies and programs in iiupport of biomedical research and com- munications; (3) manages and coordi- nates the activities of the National In- stitutes of Health. Division of Equal Employment Oppor- tunity (8A0106). (1) Advises the NIH Director and his staff on matters related to the equal employment opportunity programs and policies of the NIH; (2) plans, coordinates, provides policy direc- tion, monitors, and evaluates execution of the equal employment opportunity program; (3) provides for investigation of complaints of discrimination and for fair and judicious processing of such complaints; (4) coordinates with the Di- vision of Personnel Management and other responsible organizational ele- ments in the development and implemen- tation of plans for achieving definite and measurable progress in the equal employ- ment opportunity program; (5) consults with. and advises responsible officials in bureaus, institutes, and divisions regard- ing problems and progress of equal em- ployment opportunity programs in their respective organizations; (6) represents- the Director, NIH, in contacts with groups, both within and outside NIH, concerned with equal employment op- portunity; <7) maintains liaison with CSC, DHEW, PHS, and other Federal agencies concerned with Federal equaJ employment opportunity programs. Office of Collaborative Research (8A02). ( 1) Advises the Director, NIH , and his staff on collaborative and re - search contract programs; (2) provides guidance t o NIH compon ent s in the de - velopment an d mana gement of collabora - tive re search p rograms . Office of Extramural Research and Training {8A03) . (1) Advises the Direc- tor, NIH, and his staff, and provides guidance to the bureaus, institutes, and divisions on the extramural research and training programs of the NIH; (2) coor- dinates grants policy for the whole of NIH, and represents the NIH to the As- sistant Secretary for Health on overall grants policy. Office of Intramural Affairs (8A04) . Advises the Director, NIH, and his staff, and provides guidance to research bu- reaus and institutes on the intramural research programs of the NIH. Office of Clinical Care (8A05). (1) Ad- vises the Director, NIH, and his staff on policies relating to clinical care; (2) pro- vides guidance to research bu/eaus and institutes on matters affecting clinical care. Office of Program Planning and Evalu- ation (8A06). (1) Advises the Director. NIH, and his staff on program plans and policies and on legislative proposals; <2> evaluates the programs of the operating organizations of the NIH and makes rec- ommendations thereon to the Director; ( 3) directs staff activities relating to pro- gram development, program analysis, re- sources analvsis. and legislative iiaison and development. Division of Program Analysis (8A0t 02) . (1) Prepares annually an overall 1 >ng- range program plan for NIH and co< rd ; - nates and 'or carries out associated uro- gram planning activities; (2) prer.ii s annual Research and Evaluation ^lan for NIH and manages ail NIH program evaluation activities conducted as part of the Department's Health Evaluation Program: (3) prepares a variety of una- lytic studies and reports to a, i ! the Di- rector of NTH and his top sl.itl In malting broad policy and program decisions af- fecting the si .\ scope, and direction of NIH program; (4) performs the OMB project revir and clearance function for NIH. Division of Resources Analysis (8A0603). (1) Provides systematic, con- tinuing analysis of national resources for Ural research, education, and com- munication : f2i Identifies significant na- tional trends in allocation of resources for biomedical reseai :h and analyzes im- plications for NTH policy and program planning; (3) develops long-range pro- jections of biomedical research require- ments and resources; (4) designs and manages surveys and monitors contrac- tual arrangements to obtain data on: (a) flow of funds for biomedical research, and (b) supply, utilization, characteris- tics, and training of manpower for bio- medical research and education; (5) in coordination with PHS develops special reports on national needs and '-o sources capabilities for the Executive Branch and the Congress. Division of Legislative Analysis (8A0604). (1) Identifies, analyzes, and reports on legislative developments rele- vant to NIH programs and activities; (2) assesses the need for and proposes changes in the statutory base of NIH ac- tivities; (3) pians and develops new leg- islative proposals; (4) coordinates and controls NIH Congressional communica- tions; (5) provides coordination on NIH legislative matters with the Office of the Assistant Secretary for Health, the De- partment, the Congress, and other bodies; (6) coordinates preparation of testimony or statements for the use of staff of the Office of the Director before Congressional committees or other groups; (7) develops special reports, staff documents, or other studies concerning NIH interests, activities, and relation- ships. Office of Administration (8A07). (1) Advises the Director, NIH, and his staff FEDERAL REGISTER, VOL. 40, NO. 102— TUESDAY, MAY 27, 1975 87 22S60 NOTICES on administration and man; gement; (2) provides leadership and gu dance in all phases of management; (3) directs staff and service functions in Ihe areas of budget and financial management, per- sonnel management, management policy, engineering services, grant md contract management, general administration, and management surveys. Division of Financial Management (8A0702). (1) Advises the Director. NIH, and his staff and provides leadership and direction for NIH financial management activities; (2) collaborates with the Office of Program Planning and Evaluation in the development and implementation of the long-ra,nge plan; (3) develops policies and instructions for budget preparations and presentation; (4) administers allo- cation of funds and manages a system of fund and budgetary controls; (5) pro- vides an NIH manpower resource con- trol system designed to allocate re- sources; (6) provides, through develop- ment and maintenance, an NIH Manage- ment Account Structure; (7) directs planning and implementation of NIH fis- cal systems and procedures and provides accounting services to all NIH compo- nents; (8) provides a central grant ac- counting and financial reporting point for all DHEW grants to educational and nonprofit institutions; (9) participates in the development of policies and proce- dures pertaining to grants and contracts. Division of Personnel Management (.8A0703). (1) Advises the Director, NIH, and his staff on personnel management; (2) directs central personnel manage- ment services; (3) provides NIH leader- ship and planning on personnel program development, salary administration, Up- ward Mobility, and other personnel func- tions; (4 1 makes studies and recommen- dations to top management at NIH and PHS for new or redirected personnel ef- forts and policies and participates, as ap- propriate, in the development of such policies. Division of Administrative Services (8A0705). (1) Plans and conducts a cen- tralized program of technical and admin- istrative services in support of biomedi- cal research, patient care, and adminis- trative and plant operations; (2) advises the Associate Director for Administration on central services matters arid acts as his representative with PHS, DHEW, GAO, and GSA; (3) collaborates with sci- entific, technical, and administrative staff of NIH components in the manage- ment of programs to meet NIH needs for administrative services and logistical support; (4) develops and implements policies and procedures in areas of responsibility. Division of Engineering Services (8A- 0706). (1) Plans and conducts a central- ized program in support of the construc- tion, operation, and maintenance of NIH facilities and advises the Associate Di- rector for Administration in these areas; (2) provides engineering design and architectural services in the (a) planning of NIH facilities and improvements, (b) the administration and inspection of NTH construction under direct contract, and (c) liaison wit' . and inspection of projects administered by the GSA or the Office of Facilities Engineering and Property Management, DHEW, in coordination with PHS; (3) provides engineering craft and labor services in operating and main- taining NIH buildings, grounds, utility plants, and related equipment; (4) main- tains liaison with state and local review and governing authorities. Division of Contracts and GraJits (8A0707). (1) Advises the Director, NIH, and his staff and provides leadership and direction for NIH contracting and grants management activities; (2) plans, de- velops, and recommends NIH-wide re- search and development negotiated con- tracting policies, procedures, and prac- tices; (3) provides contracting officer services to those NIH components which have a small volume of research con- tracts; (4) maintains a continuing review of contracting operations in those bu- reaus, institutes, and divisions with de- centralized authority to insure adherence to FPR, DHEW, PHS, and NIH policies and standards; (5) provides NIH re- search contracting operating units with price/cost analysis services and compre- hensive advice on the financial responsi- bility of prospective contractors; (6) par- ticipates with other offices in the Office of the Director, NIH, and with NIH awarding components in the formulation, coordination, and implementation of DHEW, PHS, and NIH policies and pro- cedures pertaining to grants administra- tion, and serves as focal point of liaison with the management staffs of grantee institutions; (7) in coordination with PHS, maintains liaison with the Audit Agency, Office of the Assistant Secretary Comptroller, and with the Office of Grants and Procurement Management, OS, on contracts and grants management policy, procedural, and operating matters including the resolution of audit reports. Division of Management Policy. (8A- 0708). (1) Advises and assists OD staff and operating officials on management policy, procedures, organization, business ADP systems, and related management matters; (2) provides staff assistance and coordination in management planning and in related policy development and implementation; (3) conducts manage- ment studies and evaluates studies of NIH made by outside organizations; (4) re- views, monitors, and advises on the de- velopment of business ADP systems at NIH and furnishes assistance in the analysis, design, and coordination of data systems in the administrative areas; (5) conducts a management program cover- ing directives, forms, reports, records, and other aspects of paper work manage- ment; (6) maintains liaison with and, as assigned, serves as NIH coordinator for PHS and Department-wide efforts to improve management and administration. Division of Management Survey and Rcvieu (8A0709). Provides advice and assistance to OD staff and operating of- ficials on management problems: (1) Plans and organizes a management sur- vey program throughout NIH ; (2 j plans, schedules, and conducts reviews designed to appraise soundness and adequacy of management control systems; (-3) devel- ops recommendations to the OD staff, NIH, and the head of the organization' surveyed, fox improving the system of management controls and follows up to verify if corrective actions have been, taken and if results are satisfactory; (4) j investigates specific problem areas at the request of top management; (5) In co- ordination with PHS, acts as the central NIH liaison point for relationships on internal audit matters with the GAO and the HEW Audit Agency. Office of Communications (8A09)'. (1) Advises the Director, NIH, with particu- lar reference to the communications as- pects of NIH policies and programs; (2) "plans and directs activities designed to achieve better understanding of NIH pro- grams, and accomplishments on the part of the general public. Congress, biomedi- cal institutions, and the medical profes- sion; (3) plans' and directs programs de- signed to facilitate dissemination of sci- entific and technical information arising from NIH research to professional^ audiences; (4) advises the Director, NIH,! on applications of the Freedom of In- formation Act and serves as the principal NIH spokesman in these matters; (5) assures effective communication on policy and program between the Office of the Director and operating components of NIH. Division of Public Information (8A0902). Cl> Advises the Associate Di- rector for Communications on policies and programs relating to public informa- tion and public affairs activities of the NIH; (2) plans and directs the public information program ; (3) identifies NIH needs in the area oi public information and plans and carries out special efforts to meet those needs; (4) provides for orderly and expenditious processing and Dissemination of NUT public information materials. - Division of Scientific Reports (8A0903). <1> Advises the Associate Director for Communications en policy and program aspects of NTH's murtrcategorical effort to interpret, present, and disseminate re- search findings and scientific and health mformation to the biomedical com- munity and other special audiences; (2) provides guidance and coordination to and evaluates bureau, institute, and division programs of scientific and health reporting r (3) directs the public inquiry function for tire Office of the Director; advises and assists operating components of NTH in establishing policies and pro- cedures to insure prompt and informative answers to inquiries concerning their activities; (4) prepares and publishes scientific and technical publications and reports relating: to NTH programs and ac- compl ishmentsT, C5) serves as principal advisor to the. Associate Director for Communications on the requirements of the Freedom of Information Act as It applies to NIH and on Departmental and OMB regulations governing scientific re- porting and puttie inquiries,* develops and issues guideBnes to insure eorrf orm- FEDERAL REGISTER, VOL. 40, NO. 102— TUESDAY, MAY 27, 1975 NOTICES 22841 ance with laws, policies, and regulations in these areas throughout NIH. National Cancer Institute (8C ) . Plans, conducts and coordinates a national pro- gram involving (a) research on the de- tection, diagnosis, cause, prevention, treatment, and palliation of cancers and on rehabilitation of the cancer patient and (b) demonstration of the effective- ness of cancer control methods and tech- niques. Specifically: (1) Conducts and directs research performed in its own laboratories and through contracts; (2) supports and coordinates research pro- jects by scientific institutions and indi- viduals through research grants; (3) supports manpower training in funda- mental sciences and clinical disciplines through individual and institutional re- search training awards and clinical edu- cation awards; (4) supports construction of laboratories and related facilities nec- essary for research on cancer: (5) sup- ports field tests and community demon- stration projects of methods and tech- niques for cancer control; (6) collabo- rates with voluntary organizations and other institutions engaged in cancer re- search, training, and control activities; (7) encourages and coordinates cancer research by industrial concerns where such concerns evidence a particular ca- pability for programmatic research; (8) collects and disseminates information on cancer research and cancer control; (9) consults with appropriate individuals and agencies in the development, coordina- tion, and support of cancer research pro- grams in other countries. Office of the Director (8C01). (1) Serves as the focal point for ths National Cancer Program; (2) develops a Na- tional Cancer Plan and monitors imple- mentation of the Plan; (3) directs and coordinates the Institute's programs and activities; and (4) develops and provides policy guidance and staff direction to the Institute's programs in areas such as program coordination, program plan- ning, clinical care, and administrative management. Office of Program Planning and Anal- ysis (8C02). (1) Manages the develop- ment and updating of the National Can- cer Plan and monitors implementation of the Plan; (2) plans and analyzes the program plans for the Institute ; (3) pro- vides leadership for and coordinates In- stitute scientific and technical informa- tion activities, including development of a research data bank and a management information system for the National Cancer Program; (4) provides staff sup- port to the Office of the Director for co- ordination of the National Cancer Program. Office of Administrative Management (8C07) . (1) Directs and conducts admin- istrative management activities of the Institute by providing services in areas of financial management, contract man- agement, personnel management, and administrative services; (2) advises the Director and the Divisions of the Insti- tute on developments in administrative management and their implications and effects on program management; (3) co- ordinates administrative management activities of the Divisions; (4) develops policies on administrative management and prepares and issues procedures and guidelines for implementation of admin- istrative policies and requirements. Office of Cancer Communications (8C08). (1) Develops and manages the program communications activities of the National Cancer Institute/National Cancer Program; '2) interprets program and organizes, prepares, and disseminates reports on cancer research and treat- ment for Congress, HEW, and other Fed- eral departments, and for research in- stitutions and other organizations par- ticipating in the National Cancer Pro- gram; (3) maintains liaison with Na- tional Cancer Program constituents on behalf of the Director to facilitate pro- gram management and reporting and in- terpretation and information exchange, and advises the Director on these mat- ters; (4) responds to public inquiries; (5) prepares and coordinates internal re- ports for dissemination within the In- stitute and other parts of the Executive Branch, and to the Congress; (0) serves as a focal point for information on leg- islation and other Congressional develop- ments affecting the National Cancer Program; (7) supports the Cancer Con- trol Program in developing cancer edu- cation programs for professionals treat- ing cancer patients and for individuals with cancer and at risk to cancer. Division of Cancer Treatment (8C10). (1> Plans, directs, and coordinat- an integrated program of cancer treatment activities with the objective of curing or controlling cancer in man by utilizing combination modalities including chemi- cal, surgical, radiological, and certain immunological techniques, through in- tramural laboratory and clinical studies, contracted research, and research con- ducted in cooperation with other Federal agencies; (2) administers a total drug development program encompassing all phases from drug acquisition up to and including clinical trials; (3) serves as the national focal point for information and data on experimental and clinical studies related to cancer treatment and for the distribution of such information to ap 1 propriate scientists and physicians, (4> participates in the evaluation of and ad- vises the Institute Director on program related aspects of cancer control activ- ities and of grants and grant applica- tions as they relate to cancer treatment. Clinical Oncology Program (8C1006). (1> Plans, directs, coordinates, and evaluates patient care activities of the NCI and a program of basic, applied and clinical research in cancer treatment; (2) establishes program priorities, al- locates clinical resources, integrates the projects of the various branches, evalu- ates program effectiveness and repre- sents the program area in management and scientific decision-making meetings within the Institute; (3) through in- tramural studies and contracts, adminis- ters research in surgery, radiotherapy, chemotherapy and combined modalities of treatment; (4) advises the Director of the Division, the National Cancer Ad- visory Board and other scientific ad- visory committees. Baltimore Cancer Research Center Program i8C1007>. (1) Plans, directs, coordinates, and evaluates a program of laboratory and clinical research carried on by the NCI Baltimore Cancer Re- search Center; (2) establishes program priorities, allocates resources, integrates the projects of the various branches, evaluates program effectiveness, and rep- resents program areas in managem nt and scientific decision-making meetings within the Institute; (3) though intra- mural, studies and contracts, administer research and clinical support in general medical services including surgical, chemotherapeutic, and radiotherapevile services; <4i advises the Director of *2ie Division and supports the activities of the National Cancer Advisory Board snd other s< ientific advisory committees. lixP'Tiviental Therapeutics Program [8C100SK 1 1 > Pians. directs, coordinates, and applies research concerning Che pharmacologic and toxicologic a pecrtsof cancer chemotherapy: (2i i ilislies program priorities, allocates i ources, integrates the projects of the various branches, 'evaluates program cilective- ness, and rep;e .' program area in management .1 scientific decision- making meetin within the Institute; »3' through intramural laboratories and contracts, administer; research in cell biology, toxicology, pharmo-kinetics and dynamics, drug metabolism, experi- mental therapeutics, and molecular, chemical, and biochemical pharmacol- ogy; ' 4) advises the Eireetor of the Divi- sion and supports ths activities of the National Cancer Advisory Board and other scientific advisory committees. Drug Research and Development Pro- arum iSC1009>. (1) Plans, directs, co- ordinates, and evaluates a program of basic and applied research in drug de- velopment and evaluation; (21 estab- lishes program priorities, allocates resources, integrates the projects of the various branches, evaluates program ef- fectiveness, and represents program area in management and scientific decision- making meetings within the Institute: (3) through intramural laboratories and contracts, administers research in ge- netics, molecular biology, experimental chemotherapy, and drug development, procurement, distribution, and .evalua- tion; (4' advises the Director of the Di- vision and sur. ports the activities of the National Cancer Advisory Board and other scientific advisory committees. Cancer Therapy and Evaluation Pro- gram (8C100B). (1) Plans, directs, co- ordinates, and evaluates a clinical con- tract program of cancer therapy evalua- tion; (2) establishes program priorities, allocates resources, integrates the proj- ects of the various branches, evalu.^tes program effectiveness, and represents program area in management and scien- tific decision-making meetings within the Institute; (3)" through intramural and contract activities, administers FEDERAL REGISTER, VOL. 40, NO. 102— TUESDAY, MAY 27, 1975 89 22862 NOTICES studies in literature research, anti-can- cer drugs, therapeutic methods, and maintains liaison with the Pood and Drug Administration; (4) advises the Director of the Division and supports the activities of the National Cuncer Ad- visory Board and other scientif c advisory- committees. Division of Cancer Cause and Preven- tion (8C11) . (1) Plans and directs a pro- gram of laboratory, field, and demo- graphic research on the cause and natural history of cancer and means for preventing cancer through iirect in- house research and through research contracts; (2) evaluates mechanisms of cancer induction by viruses and by en- vironmental carcinogenic hazards; (3) serves as the focal point for the Federal Government on the synthesis of clinical, epidemiological, and experimental data relating to the cause of cancer; (4) par- ticipates in the evaluation of and advises the Institute Director on program aspects of cancer control activities and of grants and grant applications as they relate to cancer cause and prevention. Carcinogenesis Program (SCUDS'). (1) Plans, directs, coordinates, and evaluates a program of basic and applied research on the cancer-causative factors and the prevention of carcinogenesis; (2> estab- lishes program priorities, allocates re- sources, integrates the projects of the various branches, evaluates program ef- fectiveness, and represents program area in management and scientific decision- making meetings within the Institute; (3) through intramural laboratories and contracts, administers research in car- cinogenesis and related toxicology, me- tabolism, chemistry, immunology, cell biology, experimental tumor pathology, carcinogen bioassays, and information sciences; (4) advises the Director of the Division and supports the activities of the National Cancer Advisory Board arid other scientific advisory committees. Field Studies and Statistics Program (8C1104). (1) Plans, directs, coordinates, and evaluates a program of epidemio- logic, statistical, and mathematical re- search activities and statistical and auto- matic data processing services for all NCI research programs; (2) establishes pro- gram priorities, allocates resources, inte- grates the projects of various branches, evaluates program effectiveness, and rep- resents program area in management and scientific decision-making meetings within the Institute; (3) through intra- mural and contract activities, adminis- ters research in biometry and epi- demiology and the development of mathematical models and statistical methodology; (4) advises the Director of the Division and supports the activities of the National Cancer Advisory Board and other scientific advisory committees. Viral Oncology Program (8C11G5). (1) Plans, directs, coordinates, and evaluates a program of basic and applied research regarding viruses as etiological agents of cancer; (2) establishes program priorities, allocates resources, integrates the projects of the various branches, evaluates program effectiveness, and rep- resents progran area in management and scientific di Lision-making meetings within the Institute; (3) through intra- mural laboratories and contracts, admin- isters research in biochemistry, tumors, genetics, pathology, biohazards, immu- nology, the environment, and viral and cell biology; (4) advises the Director of the Division and supports the activities of the National Cancer Advisory Board and other scientific advisory committees. Division of Cancer Research Resources and Centers (8C12). (1) Plans and di- rects the Institute's grant-supported activities including research grants, cen- ters grants, manpower training, and fa- cilities construction; ' 2) recommends Institute policy relating to the adminis- tration of grant programs; (3) develops, reviews, and coordinates plans and criteria for the implementation of grants and evaluates effectiveness of grant- supported activities in achieving the In- stitute's missions; (4) advises the Insti- tute Director, the National Cancer Advisory Board, and other advisory bodies of grant activities and develop- ments, as they apply to programs sup- ported by contracts and the overall mis- sion of the National Cancer Program. Biomedical Research Program (8C- 1209). (1) Plans, directs, coordinates, and evaluates grant-supported ac- tivities in multidisciplinary biomedical and clincial research, including research grants, individual and institutional re- search training awards, and awards for support of scientific meetings, and rec- ommends Institute policies regarding these program grants; (2) establishes program priorities, allocates resources, integrates the projects of the various branches, evaluates program effective- ness, and represents program area in management and scientific decision- making meetings within the Institute; (3) advises the Director of the Division and supports the activities of the Na- tional Cancer Advisory Board and other scientific advisory committees. Cancer Center Program (8C1210) . (1) Plans, directs, coordinates, and evaluates the Cancer Center Program the Research Facilities Construction Program, and the Cancer Clinical Education Program; (2) establishes program priorities, allocates resources, integrates the projects of the various branches, evaluates program ef- fectiveness, and represents program area in management and scientific decision- making meetings within the Institute; (3) advises the Director of the Division and supports the activities of the Na- tional Cancer Advisory Board and other scientific advisory committees. Division of Cancer Biology and Diag- nosis (8C13). (1) Plans and directs the general laboratory and clinical research activities of the National Cancer Insti- tute; (2) cooperates with other divisions of the Institute in conducting basic re- search which is supportive of targeted activities of the Institute; (3) serves as the national focal point for programs to improve the detection and diagnosis of human cancers; (4) plans and manages a collaborative program in immunology, diagnosis, and breast cancer; (5) par- ticipates in evaluation of and advises the Institute Director on program related aspects of cancer 'control activities and of grants and grant applications as they relate to cancer biology and diagnosis. Clinical Research Program (8C1302). (1) Plans, directs, coordinates, and eval- uates a program of basic, applied, and clinical research; (2) establishes pro- gram priorities, allocates resources, in- tegrates the projects of the various branches, evaluates program effective- ness, and represents program area in management and scientific decision- making meetings within the Institute; (3) through contracts and intramural laboratory and clinical studies, admin- isters research in immunology, der- matology, metabolism, endocrinology, breast oncology, radiation' oncology, pathology, physiology, genetics, bio- chemistry, cytology, and molecular and general biology; (4) advises the Director of the Division and supports the activi- ties of the National Cancer Advisory Board, and other scientific advisory committees. Immunology Program (8C1313). (1) Plans, directs, coordinates, and evaluates a program of basic and applied research on tumor immunology and cell biology; (2) establishes program priorities, allo- cates resources, integrates the projects of the various branches, evaluates pro- gram effectiveness, and represents pro- gram area in management and scientific decision-making meetings within the In- stitute; (3) through intramural labora- tories, administers research in tumor, im- munology, immunochemistry, cellular immunology, transplantation immunol- ogy, and other aspects of general im- munology as applied to the study of the biology, diagnosis and treatment of neo- plastic diseases; (iLdevelops and imple- ments a single research program in tu- mor immunology for the National Can- cer Institute utilizing the contract mech- anism; (5) advises the Director of the Division and supports the activities of the National Cancer Advisory Board and other scientific advisory committees. Collaborative " Research Program (8C1316). (1) Plans, directs, coordinates, and evaluates a broad program of basic and applied research and also monitors the professional aspects of research con- tract management; (2) establishes pro- gram priorities, allocates resources, in- tegrates the projects of the various branches, evaluates program effective- ness, and represents program area in management and scientific decision- making meetings within the Institute; (3) through research contracts, admin- isters studies in cancer diagnosis and the diagnosis, therapy, and epidemiology of breast cancer; (4) advises the Director of the Division and supports the activi- ties of the National Cancer Advisory Board and other scientific advisory committees. ' Division of Cancer Control and Re- habilitation i8C14). (1) Plans, directs, and coordinates an integrated program of cancer control and rehabilitation ac- FEDERAL REGISTER, VOL. 40, NO. 102 — TUESDAY, MAY 27, 1975 90 NOTICES lt(>.] tivities with the goal of identifying, test- ing, evaluating, demonstrating, com- municating, and promoting the wide- spread application of available and new methods for reducing the incidence, morbidity, and mortality from cancer; (2) serves as the focal point of a coordi- nated national effort to control cancer, involving all appropriate elements of the Deparment of Health, Education, and Welfare, other Federal agencies, state and local health departments, vol- untary health agencies and other ele- ments of the private health community: (3) in collaboration with the research divisions of the National Cancer Insti- tute, identifies candidate control tech- niques and methods for inclusion in the field test and demonstration activities of the Division: (4) serves as the focal point of the National Cancer Institute for research in cancer rehabilitation; (5) participates in evaluation of and advises the Institute Director on program re- lated aspects of grants and contracts as they relate to cancer control and rehabilitation. Intervention Program (8C1412) . (1) Plans, directs, coordinates, and evalu- ates the identification and field testing of new and improved intervention meth- ods and techniques to be used on a wide scale in community settings; (2) estab- lishes program priorities, allocates re- sources, integrates the projects of the various branches, evaluates program ef- fectiveness, and represents program area in management and scientific decision- making meetings within the Institute; (3) through contracts and grants, ad- ministers a broad program in cancer con- trol intervention including prevention, detection, diagnosis, pretreatment evalu- ation, treatment, rehabilitation, and con- tinuing care; (4) advises the Director of the Division and the Director of the In- stitute; supports the activities of the Na- tional Cancer Advisory Board and other advisory committees. Community Program (8CJ413). (1) Plans, directs, coordinates, and evaluates the demonstration and promotion of ap- proved intervention techniques and methods in community settings; (2) es- tablishes program priorities, allocates re- sources, integrates projects relative to, intervention at the commu lity level, evaluates program effectiveness, and rep- resents the program area in management and scientific decision-making meetings within the Institute; (3) through con- tracts and grants, administers a broad program in cancer control intervention in community settings including preven- tion, detection, diagnosis, pretreatment evaluation, treatment, rehabilitation, and continuing care; (4) advises the Di- rector of the Division and the Director of the Institute; supports the activities of the National Cancer Advisory Board and other scientific advisory committees. National Heart and Lung histitute (8G). (1) Provides leadership for a na- tional program in diseases of the heart, blood vessels, blood, and lungs; (2) plans, conducts, fosters, and supports an inte- ■grated and coordinated program of re- search, investigations, clinical trials, and demonstration relating to the causes, prevention, i .ethods of diagnosis, and treatment (including emergency medical treatment) of the heart, blood vessel, lung, and blood diseases through: re- search performed in its own laboratories and through contracts and research grants to scientific institutions and to in- dividuals; '3) plans and directs research in the development, trial, and evaluation of drugs and devices relating to the pre- vention and treatment of, and the re- habilitation of patients suffering from, such diseases; (4) conducts studies and research into the clinical use of blood and all aspects of the management of its re- sources; (5) supports training of man- power in fundamental sciences and clini- cal disciplines for participation in basic and clinical research programs relating to heart, blood vessel, blood, and lung diseases by individual and institutional research training awards; maintains continuing re- lationships with institutions and profes- sional associations and with interna- tional, national, state, and local officials, and voluntary agencies and organiza- tions working in these areas. Office of the Director (8G01). (1) De- velops and provides leadership for the national heart, blood vessel, blood, and lung program, including the coordina- tion of all Federal health programs re- lating to the above diseases as author- ized; (2) provides overall planning, di- rection, coordinaton, and evaluation of the Institute's programs; (3) collects, develops, and disseminates information on the above diseases, with emphasis upon factors in their prevention, and conducts and fosters related educational programs for scientists and clinicians; (4) provides overall management and administrative services for the Institute; (5) establishes internal Institute policies for program and administrative opera- tions and maintains surveillance over their execution. Office of Program Planning and Eval- uation (8G03) . (1> Advises the Director on program plans and policies; (2) as- sists in the establishment of Institute goals and in the development of pro- grams to meet these objectives; (3) per- forms analysis and evaluation of data on cardiovascular, respiratory, and blood diseases and on blood resources for use in program planning and development; (4) coordinates the presentation of the Institute's varied activities in plans and reports tD higher echelons. Office of Administrative Mariagcment (8G04). (1) Advises and assists the Di- rector on administrative matters; (2) plans and directs management functions of the Institute and provides leadership and coordination of Institute manage- ment activities; (3) participates in pro- gram and legislative review, interpreta- tion, analysis, and implementation to insure compliance with laws, regula- tions, and DHEW and PHS management policies, procedures, and goals: <4» pro- vides coordination and selected support- ing ard staff services in fiscal manage- ment, personnel management, manage- ment analysis, and admi-iistrative services. Office of Prevention, Control, and Education admin- isters a cleann house for scientific and technical information on cardiovascular, respiratory, ;... . blood diseases and blood resources. Division of Heart and Vascular Dis- eases (8G15K <1) Plans end directs the Institute's research grant, contract, and training programs in heart and vascular diseases, encompassing basic research, targeted research, clinical trials and demonstrations, natii mil cardiovascular centers, technolo 1 i- al dcveloi i.r, and application of '.(search fiulu ;; (2) rnainh.ins surveillance over d?velop- menls in its program area and :^.sesse« the national need for research in the causes, prevention, diagnosis, and treat- ment of cardiovascular diseases, in tech- nological development, in the application of research findings, and for manpower training in these areas; (3) maintains the necessary scientific management capability to foster and guide an effective attack upon cardiovascular diseases. Etiology of Arteriosclerosis and Hyptr- tciision Program (SGi5i0>. (1) Plans and directs a program of grant and con- tract support for research on the etiology of arteriosclerosis and hypertension to insure maximum utilization of available resources in attainment of Institute ob- jectives; (2) assesses need for research in program areas; (3) recommends pri- orities and funding levels for programs to be recommended to the advisory coun- cil for support by grants; <4) determines priorities and allocates funds for re- search to be supported by contract; (5) collaborates with intramural programs in the Institute and NIK-wide and main- tains an awareness of national research efforts in program areas; (6) prepares reports and analyses to assist Institute staff and advisory groups in carrying out their responsibilities; (7) consults wich voluntary health organizations and with professional associations in identifying FEDERAL REGISTER, VOL. 40, NO. 102— TUESDAY, MAY 27, 1975 91 228G4 NO. ICES research needs and developing programs to meet them. Cardiology Program (8G151>). (1) Plans and directs a program of grant and contract support for research in cardi- ology, in its clinical and fundamental aspects, and in the relevant technological and bioengineering devices areas, to in- sure maximum utilization of available resources in attainment of Institute ob- jectives; (2) assesses need for research in program areas; (3) recommends pri- orities and funding levels for programs to be recommended to the advisory coun- cil for support by grants; (4) determines priorities and allocates funds for re- search to be supported by contract; (5) collaborates with intramural program in the Institute and NIH-wide and main- tains an awareness of national research efforts in program area; <6) prepares reports and analyses to assist Institute staff and advisory groups in carrying out their responsibilities; (7) consults with voluntary health organizations and with professional associations in identifying research needs and developing programs to meet them. Clinical Applications and Prevention Program (8G1513). (1) Plans and directs programs of basic and applied research and grant and contract support for re- search in biometrics, epidemiology, clin- ical trials, and preventive cardiology to insure maximum utilization of available resources in attainment of Institute ob- jectives; (2) assesses need for research in these program areas ; (3) recommends priorities and funding levels for pro- grams to be recommended to the advi- sory council for support by grants; (4) determines priorities and allocates funds for research to be supported by contract; (5) collaborates with intramural pro- gram in the Institute and NIH-wide and maintains an awareness of national re- search efforts in program areas; (6) pre- pares reports and analyses to assist Insti- tute staff and .advisory groups in carry- ing out their responsibilities; (7) con- sults with voluntary health organizations and with professional associations in identifying research needs and develop- ing programs to meet them. Division of Lung Diseases (8GU>). (1) Plans and directs the Institute's research grant, contract, and training programs in lung diseases, encompassing basic re- search, targeted research, clinical trials and demonstrations, national pulmonary centers, technological development, and application of research findings; (2) maintains surveillance over develop- ments in program area and assesses the national need for research in the causes, prevention, diagnosis, and treatment of lung diseases, in technological develop- ment, in the application of research find- ings, and for manpower training in these areas; (3) maintains the necessary scientific management capability to foster and guide an effective attack upon lung diseases. Diviskni of Blood Diseases and Re- sources (8G17) . (1) Plans and directs the Institute's research grant, contract, and training programs in blood diseases and resources, encompn s ,ing basic research, targeted research, and clinical trials and demonstrations; (2) maintains surveil- lance over developments in this program area; (3) conducts research and demon- strations to improve the national sys- tems of blood procurement, manage- ment, and distribution; (4) coordinates Federal sickle cell disease activities, and operates a national clearinghouse for information on sickle cell disease; (5) maintains the necessary scientific man- agement capability to foster and guide an elf ective attack upon blood diseases and to improve use of blood and blood products. Division of Extramural Affairs (8G19) . < 1 ) Advises the Director on research contract, grant, and training program policy; (2) represents the Institute on overall NIH extramural and collaborative program policy committees, coordinates such policy within the Institute and co- ordinates the Institute's research grant and training programs with the National Heart and Lung Advisory Council; (3) provides the Institute's program divi- sions with grant and contract manage- ment and processing services; (4) pro- vides reports and statistics related to the Institute's grant and contract programs; (5) provides initial scientific merit re- view of project grants and research con- tracts for the Institute. Division of Intramural Research (8G20) . (1) Plans and directs a program of general laboratory and clinical re- search in heart, blood vessel, lung, and kidney diseases; certain blood diseases such as sickle cell anemia, hemophilia, hepatitis; and development of technology related to cardiovascular and pulmonary diseases; (2) maintains communication with other programs of the Institute to facilitate . early practical application of basic research findings. Areas of major interest are: the biology of experimental and clinical arteriosclerosis and its mani- festations; the pathophysiology of hy- pertensive vascular disease; functions of the lung; clinical and experimental studies on physiological and pharmaco- logical aspects of heart, blood, and lung diseases, and a broad program of other basic research and technical develop- ments related to them. National Library of Medicine ( 8Z) . (1) Assists the advancement of medical and related sciences through the collection, dissemination, and exchange of informa- tion important to the progress of medi- cine and health; (2) serves as a national medical information resource for medical education, research, and service activi- ties of Federal and private agencies, organizations, institutions, and individ- uals (3) publishes and distributes guides to medical literature and audiovisual ma- terials in the form of catalogs, indexes, and bibliographies; (4) develops, pro- duces, and disseminates audiovisual ma- terials and systems and other aids to medical education, research, and prac- tice; (5) supports the translation and publication of biomedical literature; (6) provides support for medical library de- velopment and for training of biomedical librarians and other health information specialists; (7) conducts and supports re- search in techniques and methods for recording, storing, retrieving, and com- municating health information; (8) pro- vides technical consultation services and research assistance. Office of the Director (8Z01). (1) Di- rects and coordinates library activities; (2) advises the Director, NIH, on policy relating to the management and control of biomedical communication media; (3) studies, identifies, and defines needs in biomedical communications; (4) pro- vides the secretariat for the Board of Regents of the National Library of Medi- cine. Office of Administration (.8Z02). (1) Plans and directs administrative man- agement functions of the Library in- cluding financial management, personnel management, contracts management, administrative services, program an- alysis, and legislation; (2) advises the Director and the Divisions on develop- ments in administrative management and their implications and effects on pro- gram management; (3) coordinate; ad- ministrative management activities of the Divisions of the Library. Office of Computer and Communica- tions Systems (8Zni>. Hi Performs sys- tems analysis in collaboration with user organizations to determine requirements for data processing support, and per- forms systems analysis a: id computer programming for the implementation of data processing systems; (2) guides the development of new systems developed under contract for the National Library of Medicine; (3) coordir. itos the plan- ning for the provision of on-line informa- tion services from the NLM; c4) con- ducts inioi.nr lion system analyses o. mi- going programs of the NLM to identify areas requiring improvement: (5) as ap- proprialc. coordinates the digital net- work planning and operations of the Na- tional Library of Medicine; (6) advises the Director on EDP and digital com- munications activities; (7) provides data processing technical interf ace with Medi- cal Literature Analysis and Retrieval System (MEDLARS) Centers; (8) main- tains operating systems; (9) operates and maintains digital computer phototype- setting and related data processing stor- age retrieval and transmission equip- ment; (10) establishes production sched- ules and performs production control for NLM machine based production; (11) produces magnetic tape for distribution to MEDLARS ScEiixh Centers and other authorized users in the United States and abroad. Lister Hill National Center for Bio- medical Communications (8Z10). (1) De- signs, develops, implements, and manages, a Biomedical Communications Network; (2) assists the biomedical community in identifying and developing products and services for dissemination through the network; (3) develops network and in- formation systems to improve health education, medical research, and the de- livery of health services; (4) applies FEDERAL REGISTER, VOL 40, NO. 102— TUESDAY, MAY 17, 1975 92 NOTICES 22865 technology to the improvemer t of bio- medical communications; (5) ;n coordi- nation with the Department und PHS, represents DHEW in Federal activities related to biomedical commi nications activities; (6) in coordination with the Department and PHS, serves as the focal point in the Department for develop- ment and coordination of biomedical communications, systems, and network projects. Division of Extranuiral Programs (SZll) . (1) Administers programs to augment and strengthen the health sciences libraries of the nation and to improve biomedical communications through grants to, or contracts with, non-Federal and private institutions; (2) analyzes and evaluates extramural programs in relation to program objec- tives and national needs to achieve bal- anced and effective support; (3) pro- vides grants management, grants proc- essing, and administrative management services. Division of Library Operations (8Z12) . (1) Selects, acquires, catalogs, and pre- serves biomedical publications; (2) in- dexes and provides access to the mate- rial through manual and machine pro- duced bibliographies; (3) furnishes ref- erence and loan services; (4) prepares and publishes indexes, catalogs, and other publications for the use of the bio- medical community; (5) manages the Library component of the Biomedical Communications Network. Division of Specialised Information Services (8Z13). (1) Coordinates the de- velopment and operation of specialized information services throughout the NLM; (2) plans, develops, and operates a national toxicological information sys- tem; (3) develops and administers a program to organize and analyze' pub- lished information on the effects of drugs and chemicals on man, and pre- pares special bibliographies and reports on that subject. National Medical Audiovisual Center (8Z14) . Plans and administers a na- tional program to improve the quality and the use of biomedical audiovisual materials in schools of the health pro- fessions and throughout the biomedical community through: (1) The acquisi- tion and distribution of films and other audiovisual resource materials; (2) au- diovisual reference and research serv- ices; (3) consultation and assistance in the development and use of audiovisual materials and systems; (4) audiovisual research, training, experimental produc- tion, and other activities in the develop- ment of media to support medical edu- cation; (5) encouragement of the pro- duction, dissemination, and use of audio- visual materials. National Eye Institute (8E) . Conducts, fosters, and supports research on the causes, natural history, prevention, di- agnosis, and treatment of disorders of the eye and visual system, and in re- lated fields (including rehabilitation) through: (1) Research performed in its own laboratories and through contracts; (2) a program of research grants and individual and institutional research training awards; (3) cooperation and collaboration with voluntary organiza- tions and other institutions engaged in research and training in the special health problems of the blind; (4) col- lection and dissemination of informa- tion on research and findings in these areas. Intramural Research Program (8E10) . (1) Plans and conducts the Institute's laboratory and clinical research pro- gram, which encompasses five major dis- ease areas: retinal and choroidal dis- eases, corneal diseases, cataract, glau- coma, and sensory and motor disorders of vision, to insure maximum utilization of available resources in the attainment of Institute objectives; (2) evaluates re- search efforts and establishes program priorities; (3) allocates funds, space, and personnel ceilings and integrates ongoing and new research activities into the program structure; (4) collaborates .with other Institute and NIH programs and maintains an awareness of national research efforts in program areas; (5) provides advice to Institute Director and staff on matters of scientific interest. Extramural and Collaborative Pro- gram (8E10). (1) Plans and directs a program of grant and contract support for research and research training in five major disease areas: retinal and choroidal diseases, corneal diseases, cataract, glaucoma, and sensory and mo- tor disorders of vision to insure maxi- mum utilization of available resources in attainment of Institute objectives ; ( 2 > assesses need for research and research training in program areas: (3) deter- mines program priorities and recom- mends funding levels for programs to be supported by grants; (4) determines priorities and allocates funds for re- search to' be supported by contract; *5) collaborates with intramural program in the Institute and NIH-wide and main- tains an awareness of national research efforts in program area; (6) prepares le- ports and analyses to assist Instituta staff and advisory groups in carrying out their responsibilities; (7) consults with voluntary health organizations and with professional associations in identifying research needs and developing programs to meet them. National Institute of Allergy and In - fect ious Diseases (8J). Conducts, fosters, and supports research and research training programs directed at finding the causes of and improved methods for diagnosing, treating, and preventing im- munologic and infectious diseases through: (1) Research performed in its own laboratories; (2> research grants to scientific institutions and individuals; (3) individual and institutional research training awards; (4) a contract program aimed at the adaption and application of laboratory findings to the development of specific disease control measures and solutions to infectious and immunological disease problems; (5) collection and dis- semination of research findings and related information. Intramural Research Program (8J10). (1) Plans and conducts the Institute's laboratory and clinical research pro- gram, which encompasses allergic, im- munologic, and infectious diseases, to insure maximum utilization of available resources in the attainment of Institute objectives; (2) evaluates research e forts and establishes program priorities; (3) allocates funds, space, and personnel ceilings and integrates ongoing and new research activities into the program structure; (4) collaborates with other Institute and NIH programs and main- tains an awareness of national resen :vn efforts in program areas: (5) advises Director and staff on the intramural re- search and areas of science of interest to the Institute. Extramural Program (8J12). (1) Plans and directs the Institute's grant pro- gram, which supports research and re- search I raining in allergic, immunologic, and infectious diseases, to assure maxi- mum utilization of available resources in attainment of Institute ' objectives : (2) assesses need for research anci iv < ■■■•■ch training in program areas; (3i ai'! er- mines program priorities and recom- mends funding levels for programs to be supported by grants; (4) collaborates with Institute anci NIH intramural and collaborative activities and maintains awareness of national research efforts in program area; (5) prepaies reports and analyses to assist Institute staff and ad- visory groups in carrying out their re- sponsibilities; (6) consults with volun- tary health organizations and with professional associations in identifying research needs and develc ping program; to meet them. Collaborative Program iSJIZ' <\> Plans and lirccts the Institute's re contract program in support of research on allergic, immunologic, and infectious diseases to assure maximum utilization of available resources in the attainment of Institute objectives; (2) assesses need for research in program areas; '3) determines priorities and allocates funds for research to be supported by contract; (4) collaborates with Institute and NIH intramural and extramural activities and maintains awareness of national re- search efforts in program area; (5) pre- pares reports and analyses to assist In- stitute staff and advisory' groups in carry- ing out their responsibilities; <6> dis- seminates information on the Institute's programs and interests through an- nouncements, workshops, and notices in appropriate publications; (7) consults with voluntary health organizations and with professional associations in identi- fying research needs and developing pro- grams to meet them. Nati onal Institut e o f Arthritis, Me- tabolism, and Digestive D iseases (.8L) . Conducts, fosters, and supports basic and clinical research into the causes . prevention, diagnosis, and treatment o f the various arth ritic, metabolic, and di - gest ive diseases, and covers the broad areas of a rthritis, bone, and skin dis - eases; diabetes, blood, endocrine, an d metabolic diseases; digestive diseases FEDERAL REGISTER, VOL. 40, NO. 102— TUESDAY, MAY 27, 1975 93 228G6 NOT' ES and nutrition; and kidne y and urMogic diseases (joined" with the Artificial' Kid- ney/Chronic Uremia Program) thr )Ugh : ' 1 ) Research performed in its own labora torie s grants; (3) and clinics; (2) mearch i n d ivid ua l and institutional research training awards; (4> applied research and development programs through the con t ract mec hanism; (5) field epid emio logic and c linical investi- gation studies on selected populations in the TLS,; (6) collection and diss emina - tion o f information on Institute p ro- grams. Intramural Research Program <8L11). (1) Plans and conducts the Institute's laboratory and clinical research pro - gram, whi ch encompas ses the various arthritic, rheumatic and collagen dis- eases, the broad spectrum of metabolic diseases such as diabetes , other inborn errors of metabolism, digestive disease s, orthopedics, dermatology, hematology , nutrition, e ndocrine disorders, urolog y and ren al disease, mine ral metabolism , and subjects re l ated to the above to in - sure maxim u m ~utiIi za tion of available resources in atta inment of Institute ob - j ectives ; (2) co nducts basic research in b iochemistry; nutrition; pathology; his - t ochem ist ry; chemistry: physical, chem - ical, a nd" molecu lar biology ; phahha - c ology; and toxic ology ; (3> evaluates re- searc h" effofFs and establishes program priorities; (4' allocates funds, space, and p erson nel ceilings an d integrates new re - search activ ities in to the program stru c- ture; (5) collaborates with other Inst i- tute an d NIH programs and maintains, an awareness of na tional research effort s in program areasTa nd (6> advises Direc - tor and sFaff on in tr amural research pro- gram and areas o f science of interest t o Institute. Digestive Diseases and Nutrition Pro- gram (8L12) . (1) Plans and directs a program of grants, contracts, and in- dividual and institutior.il research train- ing awards for digestive diseases and nutrition to insure maximum utilization of available resources to attain program objectives; (2) determines program pri- orities and recommends funding levels within program area; (3) prepares anal- yses of national research efforts to assist advisory groups in recommending new and/or continuing program em- phases; (4) maintains surveillance over developments in designated categorical areas and assesses need for research into causes, diagnosis, prevention, and treat- ment of digestive diseases and nutrition and for training related thereto; (5) de- velops and manages an information sys- tem, covering research developments and identifying areas where additional re- search and training efforts are required, for research scientists and other inter- ested groups; (6) consults with voluntary and professional health organizations in identifying and meeting research needs in digestive diseases and nutrition. Kidney, Urologic, and Blood Diseases Program (8 LI 3). il) Plans and directs a program of research grants, contracts, and individual and institutional research training awards for kidney, urologic, and blood diseases to insure maximum utili- zation of available resources to attain program objectives; (2) determines pro- gram priorities and recommends funding levels within program area; (3) prepares analyses of national research efforts to assist advisory groups in recommending new and/or continuing program em- phases; (4) maintains surveillance over developments in designated categorical areas and assesses need for research into the causes, diagnosis, prevention, and treatment of kidney, urologic, and blood diseases and for training related thereto; (5) develops and manages an informa- tion system, covering research develop- ments and identifying areas where addi- tional research and training efforts are required, for research scientists and other interested groups; (6) consults with vol- untary and professional health organiza- tions in identifying and meeting research needs in kidney, urologic, and blood dis- eases. Arthritis, Bone, and Skin Diseases Pro- gram (8L14). (1) Plans and directs a program of research grants, contracts, and individual and institutional research training awards for arthritis, bone, and skin diseases to insure maximum utiliza- tion of available resources to attain pro- gram objectives; (2) determines program priorities and recommends funding levels within program area; (3) prepares analyses of national research efforts to" assist advisory groups in recommending new and/or continuing program em- phases; (4) maintains surveillance over developments in desienated categorical areas and assesses need for research into the causes, diagnosis, prevention, and treatment of arthritis, bone, and skin diseases and for training related thereto; (5) develops and manages an informa- tion system, covering research develop- ments and identifying areas where addi- tional research and training efforts are required for research scientists and other interested groups; (6) consults with vol- untary and professional health organiza- tions in identifying and meeting research needs in arthritis, bone, and skin dis- eases. Diabetes , Endocrine, and Metaboli c Diseases Program (8L15K (1) Plans and directs a program of research grants , contracts, and individual and ins titu- t ional research trainin g awards for dia- kels s, endocri ne, a nd m etabolic dise'aseTs to insure m a x i mum utiliz ation of avail - able resources to at tain program objec - tives; (2) determines program priori ti es a nd recommends funding levels withi i i nationaf research efforts to ass i st ad - visory groups in recommending new and/or continuing program emphases ; (4 ) maintains surveillance over develop - ments in designated categorical areas and assesses nee d for research into the causes, diagn osi s, preven tion , and treat - ment of diabetes, endocrine, and meta - bolic diseases and for training relate d t hereto; (5) develops~ and manages an info rmation system, covering research deve lopments and identifying areas wher e additional rese arch and training efforts are required, for research scien- tists arvi other interest ed groups: (g ) consults w ith voluntary and professiona l heal th organizations in ide ntifying and meeting research needs in diabetes, en- docrine, and metaboli c disease s. _Extra mural Activities Progr'am (SL1G) . ( j2j^jses_the Dire ctor on the Institute' s extramu ral program, identifies areas where further efforts are needed and recomme nds funding levels for the four categori cal programs; (2) coordinate s program plan ning in the extramural area and assesses progress toward objective s within th e broad held represented by Trie c a t egorical disease programs; (3) keeps budget, perso nnel ceilings, and othe r matters of mutua l concern to the extra- mural p rogram area; (4) provides ope r- ational an d techni cal support activities in pro g r a m analysis, administrative serv - ices, and grants management ! National institute on Aging (8M) . Con- ducts, fosters, and supports biomedical, social, and behavioral research and train- ing pertaining to the aging process i.d related health fields through: (1> re- search performed in its own laborat ■■ and through contracts; (2) aprogr.vn >i research grants and individual and insti- tutional research trnininr: awards; i3) cooperation and co'l ■.-, .ration with other Departmental agei..\os, voluntary or- ganizations, and oth r institutions; (4) collection and dissemination of the find- ings of aging research and studies and other information about the process of aging. Gerontology Research Center (8M10). <1) Plans and conducts the Institute's laboratory and clinical rcsei rch program, which encompasses research designed u> obtain fundamental knowledge of the na- ture of tiie a 'ir ; process, to insure maxi- mum utilization of available resources in the attainment of Institute objectives; (2) evoiw. t' research efforts and estab- lishes pro.'jritm priorities; (3) allocates funds, space, and personnel ceilings and integrates new research activities into the program structure; (4) collaborates with other Institute and NIH programs and maintains an awareness of national research efforts in program areas; (5) advises Institute Director and staff on intramural research programs and mat- ters of scientific interest; (6) serves as a center for national and regional research by Federal or non-Federal investigators working on problems of the aging. Extramural and Collaborative Program <8M12) . (1) Plans end directs a program of grant and contract support for re- search and research training in the bio- logical, behavioral, and social processes as they bear on adult development and aging to insure maximum utilization of available resources in attainment of In- stitute objectives; (2) assesses need for research and research training in pro- gram areas; (3) determines program priorities and recommends funding levels for programs to be supported by grants; (4) determines priorities and allocates funds for research to be supported by contract; (5) collaborates with intramu- ral program in the Institute and NIH- FEOERAL REGISTER, VOL. 40, NO. 102— TUESDAY, MAY 27, 1975 94 NOTICES 22867 wide and maintains an awareness of na- tional research efforts in p -ogram area; (6) prepares reports and analyses to as- sist Institute staff and ad'isory groups in carrying out their resporsibilities; (7) consults with voluntary health organiza- tions and with professional associations in identifying research needs and devel- oping programs to meet them. National Institute of Child Health and Human Development (8N ) . (1) Conducts, fosters, and supports biomedical and be- havioral research through research grants, research contracts, and research performed in its own laboratories on: child health, maternal health, problems of human development with special refer- ence to mental retardation: and on fam- ily structure, the dynamics of human population, and the reproductive process; (2) promotes the application of research findings to clinical practice; (3) initiates and cooperates in government-wide ef- forts on unique problems that emerge affecting the health of children and their families; (4) provides consultation to Federal agencies and non-Federal groups in the development of programs to im- prove the health of children and their families; (5) coordinates and integrates research efforts with service-oriented health agencies and the Office of Child Development; (6) disseminates informa- tion related to research findings to prac- titioners and the general public for im- proving the health of children and their families. Center for Population Research (8N11). (1) Serves as the cognizant agency for population research and re- search training activities throughout the Federal government and provides a cen- tral source of information, referral, and consultation for all agencies with popula- tion related research in the biomedical, social, and behavioral sciences; (2) establishes program priorities and allo- cates program resources for population research; (3) plans and directs a col- laborative (contract) research program in contraceptive development, the med- ical effects of contraception, the social, psychological, and demographic aspects of population change, and infertility; (4) plans and directs extramural (grant) programs in population related research and research training in the biomedical, social, and behavioral sciences; (5) maintains close liaison with intramural units having population research pro- grams to stimulate and coordinate im- proved and expanded activities in popu- lation research and to recommend to the Institute Director new directions and ap- proaches for these units in order to en- hance research in this field; (6) co- ordinates population studies supported by the special foreign currency (P.L. 480) program. Center for Research for Mothers and Children (8N16). (1) Serves as the cog- nizant agency for research, throughout the Federal government, on the special health problems of mothers and children; (2) establishes program priorities and allocates program resources in support of research and research training activi- ties in tliis fir] j; (3) provides a central source of information, referral, and con- sultation for all agencies with programs of research related to mothers and chil- dren in the biomedical, social, and be- havioral sciences; (4) directs biomedical, social, and behavioral sciences extra- mural (grant) and collaborative (con- tract) research, and a program of indi- vidual and institutional research training awards in "pregnancy and perinatal biology, infancy, disabilities in human development, and mental retardation; (5> maintains liaison with intramural units having similar research programs to stimulate and coordinate improved and expanded activities in research for mothers and children, and recommends to the Institute Director new directions and approaches for these units in order to enhance research in this field. Intramural Research Program (8N13). (1) Plans and conducts the Institute's laboratory and clinical research pro- grams which encompass the biomedical and behavioral aspects of human devel- opment relating to reproductive biology, population, maternal health, and child health; (2) insures maximum utilization of available resources in the attainment of Institute objectives; (3) evaluates re- search efforts and establishes program priorities; '4> allocates funds, space, and personnel ceilings and integrates ongoing and new research activities into the pro- gram structure; (5) provides advice to Institute Director and staff on matters of scientific interest. Epidemiology and Biometry Research Program (8N14) . (1) Plans and directs an epidemiology and biometry research pro- gram on human development relating to reproduction, population, maternal health, and child health; (2) assesses the need for such research; (3) establishes program priorities; selects epidemiologic and biometric studies to be done in-house and those to be conducted by contracts: (4) insures the maximum utilization of available resources in the attainment of Institute objectives; <5> collaborates with the Institute's intramural and extramural program staff in the man- agement of statistical and epidemiologi- cal phases of research projects. Nat ional Institute of Dental R esearch (8P>. Conducts, fosters, and supports re- search and research training in the causes, diagnosis, prevention, and cure of oral diseases and disorders through: (1) Laboratory, clinical, and field re- search; (2) grants for research projects and dental research institutes and indi- vidual and institutional research training awards; (3) collaborative and develop- mental research programs aimed at specific dental problems where major advance seems clearly possible; (4) col- lection and dissemination of research findi; 3s and related information. Extramural Program (8P11). (1) Plans and directs the Institute's programs which support research and research training through grants and contracts in periodontal and soft tissues diseases, craniofacial anomalies, pain control and behavioral studies to insure maximum utilization of available resources in at- tainment of Institute objectives; (2) as- sesses need for research and research training in program areas; (3) deter- mines program priorities and recom- mends funding levels; (4) collaborate*! with Institute and NIH intramural and collaborative activities and maintain* awareness of national research efforts in program areas; (5> prepares reports and analyses to assist Institute staff and ad- visory groups in carrying out their re- sponsibilities; (6) establishes and main- tains effective relationships with dental schools, professional dental organiza- tions, and other institutions concerned with extramural programs; (7) consults with voluntary health organizations and professional associations in identifying research needs and developing programs to meet them. Intramural Research Program (8P12). (1) Plans and conducts the Institute's laboratory and clinical research program, which encompasses research efforts in caries, periodontal and soft tissues dis- eases, developmental biology, pain con- trol and behavioral studies to insure maximum utilization of available re- sources in the attainment of Institute objectives; (2) evaluates research efforts and establishes program priorities; (3) allocates funds, space, and personnel ceilings and integrates new research ac- tivities into the program structure; (4) collaborates with other Institute and NIH programs and maintains an aware- ness of national research efforts in pro- gram areas; (5) provides advice on in- tramural research and science in genera) to the Institute Director. National Caries Program (8P13). (1) Plans and directs the Institute's applied research and development activities di- rected toward the prevention of dental caries; assures maximum utilization of available resources to attain Institute objectives in this area; (2) determines program priorities and allocates funds for epidemiological and biometrlcal re- search, field trials, demonstrations, and related laboratory and clinical research; recommends funding levels for programs to be supported by grants; (3) collabo- rates with intramural, extramural and collaborative staffs to insure consistency of research efforts with Institute policies and goals; (4) maintains an awareness of national programs in area of prevention of dental caries s nd works toward appli- cation of research findings in dental pub- lic health and practice and in dental school curricula; (5) prepares analyses and reports to assist Institute staff and advisory groups in carrying out their re- sponsibilities; (6) consults with volun- tary health organizations and profes- sional associations in identifying re- search needs and developing programs to meet them. National Institute of Environmental Health Sciences (8Q) . Conducts, fosters, and coordinates (in its own laboratories and through contracts, grants, and sup- port of Environmental Health Sciences FEDERAL REGISTER, VOL. 40, NO. 102— TUESDAY, MAY 27, 1975 95 22868 NOTICES Centers) research and research tiaining on the biological effects of chemical, physical, and biological substance* in the environment to: (1) develop undei stand- ing of the mechanism of action ( f such substances; (2) provide the sc entitle basis for evaluating their extent and severity on a national scale; (3) define and develop methods for diagnosis and treatment of environmentally induced illnesses; (4) collect and disseminate in- formation in furtherance of program. Extramural Program (8Q12 S . (1) Plans, directs, and evaluates the Insti- tute's grant program which supports re- search and research training in environ- mental health; (2) develops program priorities and recommends funding levels to assure maximum utilization of avail- able resources in attainment of Institute objectives; (3) through cooperative rela- tionships within the NIH and with public and private institutions and organiza- tions, maintains an awareness of national research efforts and assesses the need for research and research training in en- vironmental health: (4) prepares reports for, and provides advice to the Institute Director, staff, and advisory groups to assist them in carrying out their respon- sibilities; (5) represents the Institute Director in the development and imple- mentation of grant policy. National Institute of General Medica l Sciences (8R) . Administers, fosters, and supports research in the basic medical and biological sciences and the clinical and related natural or behavioral sci- ences which have significance for two or more other institutes, are outside the general area of responsibility of any other institute, and will benefit by administra- tion from a single point. Programs are carried out through: (1) Grants to sci- entific institutions and to individuals for biomedical research including broad multidisciplinary research programs and studies; (2) individual and institutional research training awards; (3) applied re- search and development utilizing the contract mechanism. National Institute of Neurological and Communicative Disorders and Stroke (8S). Conducts, fosters, and supports research and research training on the causes, prevention, diagnosis, and treat- ment of neurological, sensory, communi- cative, and muscle disorders through: (1) Intramural, collaborative, and field re- search in its own laboratories, branches, and clinics and through contracts; (2) research grants to scientific institutions and to individuals; (3) individual and in- stitutional research training awards to increase trained professional research manpower in neurological and communi- cative fields; and (4) cooperation with various agencies in collecting and dis- seminating educational and information- al material related to neurological and communicative disorders. Intramural Research Program (8S11). (D Plans and conducts the Institute's laboratory and clinical research pro- gram, which encompasses neurological and communicative disorders and stroke, to insure maximum utilization of avail- able resources in th" attainment of In- stitute objectives; (2) evaluates research efforts and establishes program priori- ties; (3) allocates funds, space, and per- sonnel ceilings and integrates new research activities into the program structure; (4) collaborates with other Institute and NIH programs and main- tains an awareness of national research efforts in program areas; (5) provides advice to Institute Director and staff on intramural program and areas of science of interest to the Institute. Fundamental Neuroscicnccs Program (8S13). (1) Plans and directs a program of research grants, contracts, and in- dividual and institutional research train- ing awards, for fundamental neuro- sciences to insure maximum utilization of available resources to attain program objectives: (2) determines program pri- orities and recommends funding levels within program area; (3) prepares an- alyses of national research efforts and assists advisory groups in recommending new and/or continuing program empha- ses; (4) maintains surveillance over de- velopments in designated areas and as- sesses need for research into the per- tinent areas and for training related hereto; (5) develops and manages infor- mation systems, covering research devel- opments and identifying areas where ad- ditional research efforts are required, for research scientists and other inter- ested groups: (6) consults with outside scientific and professional organizations in identifying and meeting research re- quirements in fundamental neurosci- ences. Communicative Disorders Program (8S14). (1) Plans and directs a program of grant and contract support for re- search and research training on com- municative disorders to insure maximum utilization' of available resources in at- tainment of Institute objectives; (2) as- sesses need for research and research training in program areas; (3) deter- mines program priorities and recom- mends funding levels for programs to be supported by grants; (4) determines pri- orities and funding levels for research to be supported by contracts; (5) collabo- rates with intramural program in the Institute and NIH-wide and maintains an awareness of national research efforts in program area; (6) prepares reports and analyses to assist Institute staff and advisory groups In carrying out their re- sponsibilities: (7) consults with volun- tary health organizations and with pro- fessional associations in identifying re- search needs and developing programs to meet them. Neurological Disorders Program (8S15) . (1) Plans and directs a program of grant and contract support for re- search and research training on neu- rological disorders to insure maximum utilization of available resources in at- tainment of Institute objectives; (2) assesses need for research and i - esearch training in program areas; (3) deter- mines program priorities and recom- mends funding levels for programs to be supported by grants; (4) determines pri- orities and funding levels for research to be supported by contracts; (5) col- laboratis with intramural program in the Institute and NIH-wide and main- tains an awareness of national research efforts in program area; (6) prepares re- ports and analyses to assist Institute staff and advisory groups in currying out their responsibilities; (1) consults with voluntary health organizations and with professional associations in identi- fying research needs and developing pro- grams to meet them. Stroke and Trauma Program <8S>6>. (1) Plans and directs a program of grant and contract support for research and re- search training on stroke and trauma to insure maximum utilization of available resources in attainment of Institute ob- jectives; (2) assesses need for research and research training in program ^reas: (3) determines program priorities and recommends funding levels for program • to be supported by grants; <4> determines priorities and fnndin" levels for research to be supported >y contracts: '">■ col- laborates with intramural prom '•"■ in the Institute and NIH-wide pml <- tains an awareness of national v i l\ efforts in program area; (6) prep : v ,o- ports and analyses to assist Institute staff and advisory groin-. •nrryingr out their responsibilities: 17 ■ ■ .. , ills with volun- tary health organ/ . ions an.1 with pro- fessional association? in ioentlfying re- search needs and developing programs to meet them. Extramural Activities Program (8S/7>. (1) Advises the Director on the Insti- tute's extramural programs; (2) repre- sents the Institute Director as required in extramural relationships; <3 coordi- nates program planning in the csi - mural area' (4) coordinates recommen- dations for lunding levels for the categorical progiams; (5) provides tech- nical support activities, including tech- nical merit review of grant and contract applications and proposals, and grants and contract management services; (G) has operational responsibiiity.for the ex- tramural data system. Clinical Center <8T). (1) Provides pa- tient facilities and services, other than physician care, for clinical invest) gatiens in uhe Clinical Center; (2) conducts re- search in clinical care, hospital adminis- tration, and related areas; (3> supervises residency and other training programs. John E. Fogarty International Center for Advanced Study in the Health Sci- ences (8U). (1) Provides the facility for the assembly of scientists and leaders in the biomedical, behavioral, and related fields for discussion, study, and research in the health sciences at an international level; (2) conceives, designs, develops, and conducts studies on current and emerging health problems; (3) awards scholarships to outstanding individuals for the purpose of encouraging creative, speculative thought and contributions to advanced study; (4) awards fellowships for training in the United States and abroad; promotes international exchange of individuals for teaching, research, and study in the health related sciences; and FEDERAL REGISTER, VOL. 40, NO. 102— TUESDAY, MAY 27, 1975 96 NUTICES provides programming serv ces for health professional training for inter- national organizations; (5) collects, translates, publishes, and disseminates information concerning health related activities outside the United Stites; (6) furthers international coopera:ion and collaboration in the life sciences through its research programs, conferences, semi- nars, and publications; (7) provides re- search grants to individuals and sci- entific institutions; (8) coordinates NIH activities and functions concerned gen- erally with the health sciences at an in- ternational level; (9) administers the NIH Special Foreign Currency Pro- gram; (10) provides central point for receiving, assisting, and/or programming foreign visitors to the National Institutes of Health and provides administrative support to the NIH visiting program. Division of Research Grants (8D) . (1) Provides staff support to the Office of the Director, NIH, in the formulation of grant and award policies and procedures; (2) provides central receipt of all PHS applications for research and research training support and makes initial refer- ral to PHS components; (3) assigns NIH applications to supporting bureaus, in- stitutes, and divisions and to DRG initial review groups; (4) provides for scientific review of NIH research grants, National Research Service Awards, and research career development applications; (5) col- lects, stores, retrieves, analyzes, and evaluates management and program data needed in the administration of ex- tramural programs; <6) reviews and analyzes the character and direction of research and training supported through NIH grants and the resources involved in providing such support; (7) admin- isters the Grants Associates Program. Division of Research Services (,8H). (1) Plans and conducts a centralized program of scientific, engineering, and technical services in support of NIH ac- tivities; (2) collaborates with research scientists in providing support during the research planning stage, in carrying out the research project, and in the presen- tation of findings; (3) furnishes services and specialized assistance in the follow- ing areas: (a) biomedical engineering and instrumentation design and develop- ment; (b) research animal production, care, procurement, and animal disease Identification and control; (c) central- ized glassware, tissue culture, and media preparation and issuance; (d) biomed- ical library and translation services; (e) environmental health and safety; (f) medical arts and photography. Division of Computer Research and Technology (SW) . Plans and conducts an integrated computer research and service program in support of the NIH mission. In fulfilling this responsibility, the Division: (1) Provides professional programming and computational and automatic data processing capability to meet NIH program needs; (2) conducts theoretical and applied research in mathematical st ' istics, mathematics, and other (physical and life) sciences; (3) provides resources for research, de- velopment, and consultation for the de- sign and implementation of project- supporting computer systems; (4) provides scientific and administrative direction in the formulation of NIH-wide policies, standards, methods, and proce- dures on computation and automatic data processing activities; (5) partici- pates in the analysis of requirements, de- sign, and development of automatic data processing systems to make effective use of advanced techniques and equip- ment. Division of Research Resources (8X) . (1) Serves as the focal point within the National Institutes of Health for the de- velopment and support of multicate- gorical research resources needed on an institutional, regional, or national basis for health related research; (2) collab- orates with the categorical Institutes in the identification of research resources needs, required by ongoing activities, and planned new directions relating to the overall NIH mission; (3) through re- search grants, individual and institu- tional research training awards, and research and development contracts to institutions involved in biomedical re- search, assures the availability of ade- quate tools, the necessary environment, and stability of funding for multicate- gorical research resources which provide support for the NHTs research mission. These awards provide: (a) support for specialized resources for multidiscipli- nary research programs of institutions conducting health related research; (b) general support for research and re- search training programs at universities and other institutions. Sec 8.C Order of succession. During the absence or disability of the Director, or in the event of a vacancy in that office, the first official listed below who is available shall act as Director, except during a planned absence for which dif- ferent order has been specified: (1) (a) Deputy Director (b) Deputy Director for Science (2) For a planned period of absence the Director may specify a different order of succession. Sec. 8.D Delegations of authorities. The Director shall continue to exercise all the authorities given him under the Redelegation of Authority by the As- sistant Secretary for Health, dated June 18, 1973 (38 FR 18261), as may be amended, and Reorganization Order, dated September 25, 1973 (39 FR 27316), as may be amended, and those admin- istrative authorities which NIH receives from the Assistant Secretary for Health and the Executive Officer, PHS. Dated: May 19, 1975. John Ottina, Assistarit Secretary for Admin- istration and Management. [FR Doc.75-13719 Piled 5-23-75;8:45 am] FEDERAL REGISTER, VOL 40, NO. 102— TUESDAY, MAY 27, 1975 97 G. THE ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 99 PubSc Heaftft Service ALCOHOL, DRUG ABUSE, AND MENTAL. .-";•> HEALTH ADMINISTRATION »t ' Statement of Organization, Functions, and , Delegations of Authority The organizational structure of the ] Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) was ap- " proved by the Cecretary on December 26, 1973, which reflected Implementation of '. a Reorganization Order, effective Sep- tember 26, 1973, signed by the Secre- tary. Numerous changes in the ADAMHA structure and functional statements are now. necessary to reflect current opera' tional requirements. '' ; ., These changes include the placement of specific responsibility for quality as- surance and service financing activities in the Office of the Administrator; abol- ishment of the Division of State and Community Assistance and establishment of a Division of Resource Development within the National Institute on Alcohol Abuse and Alcoholism; transfer of the mental health epidemiology function from the National Institute of Mental Health's Division of Extramural Re- search Programs to the Division of Biometry; and a number of other minor changes. . , ' '.'"' . Part 13 of the Statement of Organiza- tion, Functions, and Delegations of Au- thority for the Department of Health, Education, and Welfare entitled Al- cohol, Drug Abuse, pnd Mental Health AdrnimVxation (COOO) (38 FR 2731) as amended by 3S FR 1654-1658 is amended by deleting Section 13-B, Organization and Functions, and inserting the fol- lowing: Section 13-B, Orgajuzattow awo FTTNcnows ALCOHOI^ DRTJO ABTTSW, AJTD MTNTAX HEALTH AJ MLM 13 1 & ATTOW (000) Provides leed«T»hir>, policies, and goals for the Federal effort designed to assure the treatment and rehabilitation of persons with alcohol, drug abire, and mental health problems and to prevent such problems. In carrying out these responslbUltles the Ad- ministration : ( 1 ) Conducts and supports re- search on the biological, psychological, so- ciological, and epidemiological aspects of alcoholism, drug abuse, and mental health and Illness: (2) supports the training of professional and paraprofesslonal personnel In the prevention, treatment and control of alcoholism and drug abuse; and in the pro- motion of mental health and the prevention and treatment of mental Illness; (3) con- 101 36164 NOTICES ducts and supports research and develop- ment on the delivery of alcoholism, drug abuse, and mental health services and sup- ports services programs and projects, In- cluding facilities construction as appropri- ate; (4) develops standards and regulations for assuring the quality of alcoholism, drug abuse, and mental health services and pro- vides assistance to regional, State, and local professional standards review organizations In cooperation with appropriate PHS or- ganization components; (5) provides anal- ysis and consultation concerning the Inclu- sion of alcoholism, drug abuse, and mental health services as part of the basic range of health services and their eligibility under Federal and other health financing sources, Including third party payment through In- surance programs; (6) facilitates linkages of alcohol, drug abuse, and mental health serv- ices with social, law enforcement, and other human services; (7) collaborates with and .provides technical assistance to State au- thorities and Regional Offices, and supports State and community efforts In planning, -establishing, maintaining, coordinating and evaluating more effective alcoholism, drug Mb use, and mental health programs; (8) col- laborates with, provides assistance to, and encourages other Federal agencies, national, (foreign, State and local organizations, hos- pitals, and voluntary groups to facilitate and expand programs for the prevention of . alcohol, drug abuse, and mental health prob- lems and for the care, treatment, and re- habilitation of persons with these problems; (0) provides Information on alcoholism, drug abuse, and mental health to the public and to the scientific community. Office of the Administrator (CAOO) (1) Provides leadership and direction In the development of programs concerned with ftie prevention, treatment, and control of ulcohollsm, drug abuse, and mental illness; and the promotion of mental health gener- ally; (2) coordinates ADAMHA programs and activities concerned with: (a) the develop- ment of standards and regulations for assur- ing the quality of alcoholism, drug abuse, and mental health services; and (b) nego- tiations with providers and Insurers regard- ing third party and other financing of such swrices; (3) carries out such ADAMHA-wide functions as coordination of International activities, provision of executive secretariat < services, coordination of EEO activities, de- velopment of extramural program policy, analysis of legislative Issues and development of related policy and position papers, referral of grant applications, and committee man- agement; (4) maintains liaison with the Office of the Assistant Secretary for Health on matters related to program activities of regional interest and such other activities as may be required*- ;-• 5P?§9$sjst5i- Offioe of Program Planning and Evaluation -\CAtl) ■ (1) Coordinates the Administration's pro- gram planning, analytical, and evaluation activities; (2) develops and implements the ADAMHA's forward plans and' operational plans with the participation of the Office of Administrative Management and the Office of Program Coordination; (8) analyzes policy Issues having' Administration-wide implica- tions and provides related resources analyses; <4) provides -a continuing assessment of ADAMHA research, resources development and service programs as related to Agency- -.vide objectives, including the analysis of Agency trends and developments and the derivation of long-term projections; (5) col- lects and maintains programmatic data on ADAMHA grant and contract activities. Office of Program Coordination (CA13) (1) Coordinates ADAMHA program activi- ties with other components of the Depart- ment, other Federal agencies and States, in- cluding a state program developmsnt effort to demonstrate how combined Federal, Re- gional, and State technical assistance and consultative resources can be more effectively coordinated to Improve the alcoholism, drug abuse, and mental health delivery system within a given State; (2) serves as central liaison and coordinating point between the three 'ADAMHA Institutes and the Regional Offices, Including those activities relating to implementation of the Regional Health Ad- ministrator's Work Plan; (3) facilitates co- ordination and collaboration between com- ponents of ADAMHA and professional orga- nizations, citizen organizations, and public Interest groups (including minority groups) with common interests in preventing and reducing mental illness, alcoholism, and drug abuse, and improving mental health; (4) promotes the internal integration of alcohol, drug abuse, and mental health pro- gram activities at the operational level; (5) collaborates with the Office of Program Plan- ning and Evaluation in the development and Implementation of the ADAMHA's forward plans and operational plans as they impinge upon program coordination matters. Office of Administrative Management (CA15) (1) Develops policies, guidelines, and pro- cedures concerning ADAMHA administrative management; (2) provides administrative services to the ADAMHA In such areas as (a) financial management, including budget and accounting, (b) management policy, (&) grants and contracts policy and review. Including cost advisory services, (d) com- puter systems, (e) personnel management, and (f) general services; (3) advises the Office of Program Planning and Evaluation and other ADAMHA components regarding the implications of administrative policy on program planning and operations; (4) par- ticipates in the development of the Admin- istration's forward and operational plans; (6) maintains liaison and coordination with the appropriate staff elements in the Office of the Assistant Secretary for Health. Division of Financial Management - ( i (CA1S03) ■ (1) Plans and coordinates the Adminis- tration's financial management activities; (2) provides financial data input for the Administration's forward and operational plans; (3) develops the ADAMHA's annual budget and participates In budget hearings; (4) develops policies and procedures for ac- • counting and other resources control systems; (5) provides accounting and other fiscal serv- ices to the ADAMHA; (6) develops financial- . management reporting systems to meet the needs of ADAMHA planning and decision making. Division of Management Policy (CA1S04) (l) Develops and recommends plans, poll- cine, organizational patterns, systems, meth- . , ods, and procedures for the general manage- nwnt of ADAMHA activities; (2) provides advice' and assistance to improve manage- ment and coordinates the implementation of policies, systems, methods, and procedures; ■ (3) performs or coordinates studies and sur- . veys of the management of ADAMHA activi- ties, including those related to manpower ' utilization, cost of operations, and effective- ness; (4) insures the Integration of program and management planning; (5) maintains a management Issuance system; (6) negotiates solutions to intra-agency problems of or- ganization, functions, policy, procedures, and coordination; (7) furnishes' forms and records management services for the ADAMHA. Division of General Services (CA1S05) (1) Plans and coordinates the provision of general services for the Administration in- cluding supply, space, safety, mall, facilities acquisition and utilization, and printing and publications management; (2) advises ADAM HA management on policy, procedures, and other requirements In connection with these services; (3) establishes and coordinates ar- rangements with other agencies to provide supplies, equipment, and services; (4) pro- vides general services for those components of the Administration located in Head- quarters office. Division of Grants and Contracts Management (CA1507) (1) Develops and Issues policies, standards, procedures, forms, and guides for the man- agement of ADAMHA grants and negotiated contracts, and monitors their application or use; (2) serves as focal point' for interpret- ing regulations, policies, and procedures con- cerning ADAMHA grants and contracts; (3) develops and operates a system for gather- ing, analyzing, and reporting management data; (4) provides grants and contracts cost advisory services to ADAMHA; (5) adminis- ters the ADAMHA system of Informal grantee appeal on adverse, actions; (6) coordinates Administration actions on audit reports and determines final resolution; (7) reviews pro- posals for ADAMHA contracts in excess of stipulated dollar levels and negotiates con- tracts for the Office of the Administrator. Division of Computer Systems (CA150S) (1) Develops policies, standards, and pro- cedures for Administration ADP activities Including the ADAMHA's annual ADP plan; (2) participates In establishing ADAMHA requirements for computer-based data proc- essing systems in both program and adminis- trative areas; (3) develops computer systems for the ADAMHA, including systems analysis, programming, and related activities; (4) pro- vides mathematical and statistical data processing capability and consultation to Ad- ministration components; (5) operates auto- matic data processing equipment; (8) initi- ates and/or coordinates the acquisition of data processing equipment and outside serv- ices for the Administration; (7) provides technical assistance and clearance to ADAMHA components on grants and con- tracts where ADP elements are Involved; (8) conducts research on ADP systems and equip- ment for application to present and future operations. ~~ m ' Division of Personnel Management (CA1509) ' (1) Provides personnel management ad- vice and assistance to the Administrator, Alcohol, Drug Abuse, and Mental Health Ad- ministration and to managers and super- visors within Its servicing area; (2) partici- pates in the development of agency goals and operating plans related to personnel management; (3) within Its servicing area, provides personnel management and person- nel administration services, including man- power planning and utilization, employment, • recruitment, compensation and classifica- tion, executive and career development, up- ward mobility, labor relations, employee re- lations and occupational health; (4) co- ordinates and provides technical assistance and guidance to the personnel office of Saint Elizabeths Hospital in the above areas of personnel management and administration; FEDERAL REGISTER, VOL. 40, NO. 161— TUESOAY, AUGUST 19, 1975 102 NOTICES 36165 (5) prepares staff studies and recommenda- tions to adamha management on personnel needs and problems; (6) Identifies the need for personnel policies and programs to PHS and collaborates with PHS, as appropriate, in the development of such policies and pro- grams; (7) develops and implements operat- ing procedures and Interprets policies to the extent necessary to meet the special needs of Alcohol, Drug Abuse, and Mental Health Administration in the application of PHS, DHEW, CSC and other Government agency regulations;- (8) represents Alcohol, • Drug Abuse, and Mental Health Administration la personnel management matters with PHS, DHEW, CSC, other Government agencies, professional societies, and colleges and uni- versities. O^ce of Communications and Public Affair* (CA17) (1) Provides for the public affairs aspects of ADAMHA's programs through relation- ships with the media, professional and citizen organizations and public interest groups, and sponsorship of special events; (2) serves as central liaison and coordinating point for In- stitute and ADAMHA-wide communications projects and activities, promotes collabora- tion among the three Institutes In these activities, and assures that they are in accord with ADAMHA goals; (3) reviews and clears publications, audio visuals, press releases and contracts which are designed for or include material of a communication nature for the scientific or general public, and serves as clearance liaison with OASH and OS Offices of Public Affairs; (4) advises the Administra- tor on policy matters related to ADAMHA communications and public affairs activities; (5) coordinates ADAMHA activities under the Freedom of Information Act and insures the availability of information to the public. National Institute on Drug Abuse (CCOO) Provides leadership, policies, and goals for the Federal effort In the prevention, control, and treatment of narcotic addiction and drug abuse, and the rehabilitation of affected In- dividuals, In carrying out these responsibili- ties the Institute: (1) conducts and supports research on the biological, psychological, sociological, and epidemiological aspects of narcotic addiction, and drug abuse; (2)- sup- ports the training of professional and para- professlonal personnel in prevention, treat- ment and control of drug abuse; (3) con- ducts and supports research on the develop- ment and Improvement of drug abuse serv- ices delivery, administration, and financing and supports services programs and projects including facilities construction as appropri- ate; (4) collaborates with and provides tech- nical assistance to State authorities and Re- gional Offices, and supports State and com- munity efforts in planning, establishing, maintaining, coordinating and evaluating more effective narcotic addiction and drug abuse programs; (5) collaborates with, pro- vides assistance to, and encourages other Fed- eral agencies, national, foreign. State and local organizations, hospitals, and volunteer groups to facilitate and extend programs for the prevention of narcotic addiction, and for the care, treatment, and rehabilitation of ad- dicted persons; (6) carries out administrative and financial management, policy develop- ment, planning and evaluation, and public information functions which are required to Implement su.ch programs. Office of the Director (CC01) ( 1 j Provides leadership, direction, and poUcy in the development of Institute goals, prlovitles, policies, and programs; and serves as tr.e focal point for the Department's efforts on drug abuse; (2) provides overall program coordination; (3) co'nducts and coordinates Institute interagency, intergovernmental, and international activities, including liaison . with the Regional Offices; (4) analyzes legis- lative Issues and develops related policy and position papers, (5) assesses the impact of Institute programs; (8) provides support to the Institute in various areas of admlnlstva- tlve management, equal employment oppor- tunity, and in program development, policy analysis and legislative analysis; (7) admin- isters committee management activities and provides correspondence control services for the Institute. Office of Program Development and Analysis (CC11) (1) Develops program plans and monitors progress toward established objectives; (3) analyzes program policy and activities and develops recommendations for critical pro- gram changes; (3) develops Institute pro- gram evaluation policy and plans and ini- tiates proposals for, and participates in, pro-' gram evaluation; (4) develops date, require- ments pertinent to planning and evaluating program actlvtles; (5) conducts surveillance activities to measure the impact of Institute programs on national and international trends. Office of Program Support (C015) Provides support to the Institute In vari- ous areas of administrative management such as the following: Awarding and ad- ministering Institute-sponsored grants, con- tracts, and interagency agreements; de- veloping Institute budget proposals and establishing and maintaining controls to assure maximum utilization of Institute funds, facilities, and manpower; providing general logistical support for the Institute; and maintaining liaison with management staff of the Office of the Administrator, and implementing within the NTDA general man- agement policies prescribed by ADAMHA, Division of Research (CC41) (1) Plans, develops and administers a broad program of biomedical and psycho- social drug abuse research involving both intramural and extramural activities; (2) collaborates with the Division of Commu- nity Assistance and organizations outside the Institute including State and local agen- cies to facilitate research program devel- opment; (3) stimulates communication of appropriate Information through consulta- tion and the development of conferences, committees, and publications; (4) conducts studies to develop recommendations to the Secretary, DHEW on the scheduling of drugs having abuse potential. Division of Resource Development {CC43) (1) Plans, develops and supports programs designed to Insure the training and avail- ability of qualified and competent manpower in the drug abuse field; (2) conducts and supports educational programs directed at reducing the incidence of drug abuse; (3) designs and develops innovative programs of drug abuse treatment and rehabilitation; (4) plans, develops and carries out programs to identify changing patterns and predict future problem areas of drug abuse; (5) collaborates with the Division of Community Assistance in assisting States and communi- ties in developing drug abuse prevention and control programs. Division of Community Assistance (CC45) (1) Plans, develops and administers the Institute's treatment and rehabilitation pro- grams; (2) assumes primary Institute re- sponsibility for the rendering of technical assistance to States in collaboration with Regional Offices; (3) Insures the develop- ment, implementation and compliance with quality treatment standards at reasonable- cost; (4) tnltlateo and administers program* for the treatment and rehabilitation of rlrug dependent persona within the criminal jus- tice system. Division of Scientific and Program Information (CC47) (1) Maintains program and management information emanating from Federal and State drug abuse prevention efforts and pre - vldes periodic and special reports and analy- ses for operational and planning purpose— (2) develops drug abuse information systems for the Institute; (3) in collaboration with the Division of Community Assistance, pro- vides consultation to and liaison with other •Federal, State and private agencies concerned with information programs on drug abuse; (4) operates the. National Clearinghouse for Drug Abuse Information which (a) collects and disseminates information on Federal and State drug abuse programs utilizing as source material publications, community ac- tion programs, and reports of Federal, Stete and local agencies; (b) classifies, procer.sM and stores Information In both computerized and printed form; and (c) distributes pro- gram information to the lay and profernlonal public and other Federal and non -Federal agencies. National Institute on Alcohol Abuse and Alcoholism (CEOO) Provides leadership, policies, and goal* for the Federal effort in the prevention, control, and treatment of alcohol abuse and alcohol- ism and the rehabilitation of affected indi- viduals. In carrying out these responsibili- ties the Institute: (1) conducts and support* research on the biological, psychological, so- ciological, and epidemiological aspects of al- cohol abuse and alcoholism; (2) support; the training of professional and parft'pro- fesslonal personnel in prevention, treatment and control of alcoholism; (3) conducts and supports research on the development and Improvement of alcoholism services delivery, administration, and financing, and supports alcoholism services programs and projects, including facilities construction as appropri- ate; (4) collaborates with and provides tech- nical assistance to State authorities and Re- gional Offices and supports State and com- munity efforts in planning, establishing, maintaining, coordinating and evaluating more effective alconol abuse and alcoholism programs; (5) collaborates with, provides assistance to. and encourages other Federal agencies, national, foreign. State and local organizations, hospitals, and voluntary groups to facilitate and expand programs for the prevention of alcohol abuse and alco- holism, and for the care, treatment, and re- habilitation of alcoholic persons; (6) devel- ops, implements, and administers an alco- holism detection, referral, and treatment program for Federal civilian employees with- in the Public Health Service; (7) carries out administrative and financial management, policy development, planning and evalua- tion, and public information functions which are required to Implement such programs. Office of the Director (CE01) (1) Provides leadership, direction and pol- icy in the development of Institute goals, priorities, policies, and programs; and serves as a focal point for the Department's efforts on alcoholism; (2) provides overall program coordination; (3) conducts and coordinates Institute interagency, Intergovernmental, and international activities, including liaison with the Regional Offices; (4) assesses the Impact of Institute programs; (5) provides support to the Institute in various areas of administrative management, equal employ- ment opportunity, and In program develop- ment, policy analysis, and legislative analysis; FEDERAL REGISTER, VOL. 40, NO. 161— TUESDAY, AUGUST 19, 1975 103 36166 NOTICES (6) provides correspondence control services for the Institute. Office of Program Development and Analysis (CEU) (1) Develops program plans and monitors progress toward established objectives; (2) analyzes program policy and activities and develops recommendation for critical pro- gram changes; (3) -develops Institute pro- gram evaluation policy and plans and ini- .tiates proposals lor, and participates in, program evaluation; (4) develops data re- quirements pertinent to planning and evalu- ating program activities; (5) conducts sur- veillance activities to measure the impact of Institute programs on national and inter- national trends. ' _ } Office of Program Support (CE15) Provides support to the Institute In various areas of administrative management such as the following: awarding and administering Institute-sponsored grants, contracts, and interagency agreements, developing Institute budget proposals and establishing and main- taining controls to assure maximum utiliza- tion of Institute funds, facilities and man- power; administering committee manage- ment activities for the Institute; providing general logistical support for the Institute; and maintaining liaison with management staff of the Office- of the Administrator, and implementing within the NIAAA general management policies prescribed by ADAMHA, '\.' Division oj Prevention LCE41) •' (1) Plans, develops, supports and evaluates programs of public- education for the pre- vention and control of alcoholism in such areas as school curricula and community education; (2> collaborates with and assists Federal, State, and local agencies and non- profit organizations in the development of such prevention and control programs; (3) stimulates and supports the communication of appropriate information and educational material through conferences, committees, publications, and other means. ■ Dirraion of Resource Development (CS42) ' (I) Plans and administers programs of nationwide services. ' for the prevention of alcoholism and the treatment and rehabilita- tion of alcoholics, under the alcohol formula jjrsiiits to States program, which supports State efforts in planning, establishing, main- taining, coordinating, and evaluating projects for the development^ of more effective pre- vention, treatment, And rehabilitation pro- grams to deal with alcohol abuse and alco- holism; (2) develops the policy and regu- latory framework: for comprehensive State plans for the establishment and delivery of aleholism services, and reviews and evaluates individual plans; (3) collaborates with, pro- Tides assistance to and encourages national. State, and local governments, hospitals, and 'voluntary groups to facilitate and extend programs for the care, treatment, and reha- bilitation of alcoholics; (4) develops broad programs of training In the field of alco- holism; (6) develops and administers special projects designed to increase third-party pay- ments for alcoholism treatment and rehabili- tation services; and <-6> administers the pro— gram of special grants to States to Implement the provisions of the Uniform Alcoholism and Intoxication Treatment Act. *■"" • Division of Special Treatment and Rehabilitation (CE45) (1 ) Plans, develops, and administers a wide raoge of innovative treatment and rehablli- , tatlon programs directed toward the solution of alcohol abuse and alcoholism among spe- cial population group*; (2) coordinates In- aaiiata activities with the efforts of other Federal. State, and local agencies and bodies involved with public safety, employee popu- lations, and other special groups; (3) devel- ops regulations, policies, standards and pro- •cedares for programs administered by the J>Ws*on. ( Division of Research (CE47) v 11) Plans, directs, and evaluates programs of basic and clinical research on the multiple determinants of alcoholism and on the treat- ment and rehabilitation of alcoholic persons and alcohol abusers; (2) stimulates, sup- ports, and conducts biological, pharmacolog- ical, behavioral, and sociological research in alcoholism through grants and contracts and «n intramural research program in these areas (3) conducts and supports programs of training to Increase the number and Im- prove! the utilization of research manpower; •<4) coordinates and stimulates statistical and ibkunetric programs necessary for the epidemiological and longitudinal studies of problems of alcohol- usage and alcoholic persons. ( liional Institute of Mental Health (CHOQ) 'fiat i Provides leadership, policies, and goals for the Federal effort in the promotion of mental health, the prevention and treatment of mental Illness, and the rehabilitation of af- fected' individuals. (In carrying out these re- sponsibilities the Institute: (1) conducts and supports research on: the biological, psycho- logical, sociological, and epidemiological as- pects of mental health and Illness; (2) sup- ports the training of professional and para- proressionai personnel in the promotion of mental health and the prevention and treat- ment of mental illness; (3) conducts and supports research on the development and -improvement of mental health services de- livery, administration,- and financing and supports mental health services programs and projects including facilities construc- tion as appropriate; (4) collaborates with and provides technical assistance to State authorities and Regional Offices, and supports State and community efforts in planning, es- tablishing, .maintaining, coordinating and evaluating more«ffectlve mental health pro- grams: <5) collaborates with, provides as- sistance 'to, and encouragesi other Federal 'agencies, national, foreign. State, and local organizations, 'hospitals, c and volunteer groups to facilitate and extend programs to promote mental health and prevent mental Illness, and for the care, treatment, and re- habilitation of mentally ill persons; (6) car- ries out administrative and financial man- agement, policy development, planning and evaluation and public Information functions which are required to implement such programs. ' Office of the Director {CHOI ) '., (1) Provides leadership, direction, and policy in the development of Institute goals, priorities, policies and programs^ Including equal employment opportunity, and serves as the focal point for the Department's efforts in mental health and illness; (2) provides overall program coordination; (3) conducts and coordinates Institute interagency, inter- governmental, and International Activities, including liaison with the Begipnal Offices; (4) assesses the Impact of Institute pro- . grams; (5) provides support to the Institute in various areas of administrative manage- ment and in program development, policy analysts, and legislative analysis; (6) con- ducts Intramural education programs for the continuing development of NIMH personnel and mental health personnel in DHEW Re- gions, State, and local programs; <7) ad- ministers committee management activitiee and provides correspondence control services for the Institute. Office of Program Development and Analysis 1CHU) i (1) Develops program plans and monitors progress toward established objectives; (2) analyzes program policy and activities and develops recommendations for critical pro- gram changes: (3) develops Institute pro- gram evaluation policy and plans and ini- tiates proposals for, and participates in, program evaluation; (4) develops data re- quirements pertinent to planning and eval- uating program activities; (5) analyzes and forecasts social and cultural trends and iden- tifies implications for Institute programs; \6) coordinates Institute field and Inter- agency liaison activities; (7) provides legis- lative services and the review of Judicial decisions affecting mental health programs. Office of Program. Support (CH15) Provides support to the Institute In vari- ous areas of administrative . management such as the following: awarding and admin- istering Institute-sponsored grants, con- tracts, and Interagency agreements; devel- oping Institute budget proposals and estab- lishing and maintaining controls to assure maximum utilization of Institute funds, facilities, and manpower; providing general logistical support, for the' Institute; and maintaining liaison with management staff of the Office of the Administrator, and im- plementing within the NIMH general man- agement policies prescribed by ADAMHA. I Division of Manpower and Training- '■ • Programs (CH14) '■ .<. *•••■■■ (1) Plans, administers, and supports pro- grams In the planning, development, train- ing, and utilization. of mental health man- power to meet mental health service delivery system and research needs Including: (a) manpower -research and demonstration proj- ects; (b) training in the mental health core disciplines and related fields; and (c) tech- nical and related financial assistance. In col- laboration with Regional Offices, to States. local governments, service .agencies, and training Institutions; (2) collects and ana- lyzes data and conducts studies related to nationwide perspectives and needs regard- ing mental health. man power planning, train- ing, development, and utilization. Division of Mental Health Service Programs ,{CH43) (1) Plans, develops, and administers pro- grams to Improve the organization and deliv- ery of mental health services responsive to changing national needs; (2) coordinates ac- tivities concerned with the mental health aspects of health insurance and other service payment programs, and the relationship be- tween the organization and delivery of .men- tal health services and fiscal resources; (3) provides advice and consultation to national, regional, State, and community agencies; (4) plans and administers programs for Improved services delivery methods In a community Context: (5) conducts research on, evaluates, and implements methods for improvement of mental health services through Identifica- tion of new and Innovative services models and practices; (6) fosters the dissemination and adoption of new Knowledge obtained through the convergence of research and op- erational experience. Division of Special Mental Health Programs {CH4S) (1) Plans and administers integrated pro- grams of research, training, and related ac- tivities directed toward the meeting of criti- cal national needs In social problem areas such as child and family mental health, crime end delinquency, metropolitan mental health, mental health disaster assistance, and men- tal health of the aging; (2) reviews and eval- FEOERAL REGISTER, VOL 40, NO. 161— TUESDAY, AUGUST 19, 1975 104 mites sucii programs in terms of performance in relation to stated goals and objectives and changing national needs; (3) coordinates and Integrates these programs with other perti- nent components of the Institute, ADAMHA, pHS, DHEW, and the Federal Government. Division of Scientific and Public Information (CH46) (1) Plans" and directs the acquisition and dissemination of scientific and technical in- formation related to mental health; the prep- aration of papers, reports, and other scien- tific Information materials; the development of health education materials; and the prep- aration of special program reports; (2) op- erates a mental health technical library; (3) provides public information services for the Institute and prepares responses to public In- quiries. -'''.'"•_ Saint Elizabeths Hospital-Division of Clinical and Community Services (CH49) . (1) Provides treatment, care, and rehabili- tation services for psychiatric patients. In- cluding a security treatment facility; (2) op- erates a model comprehensive community mental health center; (3) conducts and co- ordinates hospital training and research pro- grams; (4) provides administrative and logis- tical support to other ADAMHA research activities located in the facilities of the hospital. -:..... Division of Biometry and Epidemiology ' ■ (CH52) (1) Advises and assists In the development of blostatlstlcal and other statistical analysis programs in the operating components of NIMH and the other ADAMHA Institutes, recommends policies and standards for the operation of such programs and provides statistical and mathematical services to other ADAMHA Institutes as requested; (2) conducts research and develops quantita- tive models for research and data collection In the areas of biometrlc, epidemiologic and demographic significance; (3) coordinates Institute activities in mental health epi- demiology; develops and supports programs of research, training, field trials and dem- onstrations pertaining to epidemiology; and operates field stations for the conduct of epidemiology studies; (4) carries out a na- - tlonal reporting program and stimulates the development of projects for the collection and analysis of data on the characteristics and patterns of use of mental health and related facilities on a national, regional, State or local level; (5) provides technical assistance in statistical and epidemiologic methodology, development of mental health information systems and In the use of statis- tical, epidemiologic and demographic data In program management and research through consultation, conferences, work- shops, seminars and publications. Division of Extramural Research Programs (CH53) (1) Plans and administers programs of support for research into the causes, preven- tion, diagnosis and treatment of mental dis- eases, Including behavioral, clinical, applied, biological, and psychopharmacological re- search; (2) coordinates NIMH programs In schizophrenia. Mental Health Intramural Research Program {CH54) (1) Plans and administers a comprehen- sive long-term intramural research program of clinical and behavioral, biological, and special research dealing -with the causes, diagnosis, treatment, and prevention of mental disorders and the biological and NOTICE* psychosocial factors that determine human behavior and development; (2) provides a focus for national attention In the area of mental health research; (3) provides tech- nical support through development and maintenance of electronic and mechanical instrumentation and equipment. Division of Special Mental Health Research (CH5403) Under the direction of the Mental Health Intramural Research Program, (1) plans and conducts a program of intramural research on special mental health problems, such as psychopharmacology, neuropharmacology, memory, human behavior, and biochemistry of learning; (2) performs clinical evalua- tion and followup activities In connection with research patients. Division of Clinical and Behavioral Research (CHS405) Under the direction of the Mental Health Intramural Research Program, plans and conducts a coordinated program of clinical and behavioral research dealing wtth the causes, diagnosis, treatment, and prevention of mental disease. Division of Biological and Biochemical Research (CH5407) Under the direction of the Mental Health Intramural Research Program, plans and con- ducts a coordinated program of biological and biochemical research dealing with the basic biological processes that determine both adaptive and maladaptive behavior. Part 13 is further amended by deleting Section 13-C, Order of Succession, and Inserting the following; ^. Section 13-C, Order or Succession During the absence or disability of the Administrator, ADAMHA, or In the event of a vacancy In that office, the first official Usted below who Is avaUable shall act as Admin- istrator, except that during a planned period of absence, the Administrator may specify a different order of succession: (1) Deputy Ad- ministrator; (2) Associate Administrator for Program Coordination. t Dated: August 11, 1975. John Ottxna, Assistant Secretary for Administration and Management. (FR Doc.75-21807 Piled 8-18-76;8:45 wn] 105 H. THE SOCIAL SECURITY ADMINISTRATION 107 NOTICES SOCIAL j&CV&iTy DEPARTMENT OF HEALTH, EDU- CATION, AND WELFARE Office of the Secretary SOCIAL SECJT.iTY ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Part 8 (Social Security Administra- tion) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health, Education, and Welfare >32 F.R. 10458 et scq., July 15, 1967), is hereby revised to read as follows: 8-A. Mission. The Social Security Administration administers the Federal retirement, survivors, disability, and health insurance for the aged programs Mid the Federal Credit Union Act. It is responsible for studying the problems of poverty, insecurity, and the health care needs of the aged and the contributions that can be made to their solution by social insurance and related programs, and for making recommendations as to the most effective methods of improving social and economic security through social insurance. 8-B.- Organization and functions. The Social Security Administration is under the supervision and direction of the Commissioner of Social Security, and is composed of the following organizational components: Office of the Commissioner (OO. Gives overall executive leadership to the administration of the Federal retire- ment, survivors, disability, and health ir.suiar.ee for the aged programs, and the Federal Credit Union Act. Establishes objectives within the broad and general statutory requirements, and provides program and policy formulation and guidance. Gir : cc of ttic Assistant Commissioner, Field, OC. Provides day-to-day guidance to the Regional Assistant Commis- lo s; interprets policies and objec- identifi.es major program and administrative problems alTecting the ,nd takes, initiates, or recommends action on them. Assures for the Com- missioner that interregional and intra - regional problems arising Lii the field are given prompt att< ntion. Assesses, through day-to-day contacts with the Regional As tant Commissioners, the eff2Ctiveness and adequacy of social security program administration in tire field and the: responsiveness of the field organization to the public and to the policies, directives, and values of the Commissioner; keeps the Commissioner fully informer: on these matters. Carries out for the Commissioner personal and confidential assignments relating to any aspect of program administration. Office of the Regional Assistant Com- missioner, OC. Serves as the personal representative of the Commissioner in the Social Security region and is account- able to the Commissioner, Field. Provides broad general leadership and direction to the bureaus' regional representatives. Assures timely and integrated implemen- tation of SSA policies to achieve program objectives, evaluates program a:com- plishments, identifies significant problem areas, and initiates or recommends cor- rective measures. Represents SSA in dealings with the DHEW Regional Directors, and with officials of public and private organizations. Office of tlic Actuary. Conducts and di- rects the actuarial program of SSA, Performs actuarial and demographic re- search into social insurance and related programs, and makes actuarial appraisals of existing and pro;x>sed programs Studies, for both the immediate and dis- tant future, problems of financing pro- gram costs, estimating future workloads, and evaluating operations of the four Trust Funds. Develops an i analyzes actuarial data for benefit estimates and valuations. Provides technical and con- sultative services to Congressional com- mittees Congressmen, public ad 1 committees, and other Federal ai Testifies concerning actuarial estimates before Congressional cominituxs consid- ering legislative changes in the Social Security programs. Perfo ms actuarial valuation work for the Retired Service- man's Family Protection-. .?lan. Office, of Administration (OA). Plans and directs the management program of SSA. Provides overall administrative leadership for the Commissioner in co- ordinating program adminisl throughout SSA, and in planning, dirr ■ ing, and controlling management i grams, policies, and activities. Admin ters SSA-wide programs in the anas , Personnel and employee development ; administrative appraisal and planning; budget and financial n. ana: . ; ....- r.ing, analysis, and coordn- . n of : ■' SSA systems; professional opf.a. research; overall operalini facilil eluding procurement and : ippl; . ployce communications; audits a. ■'< investigations; and employee health services. Represents SSA on matters of overall program administration and management with DHEW, other Feder; - cies, and non-Federal organizations. Employee i ' liitions and rmiul Employment Opportunity Staff, OA. Assists the Deputy Assistant Com- missioner (Employee delations) in di- recting and co adinaing SSA-widi trams of employee-management coopcr- ation (EMC) and equal employmeM opportunity (EEO) as provided for uno>* Executive Orders 10988 and li '« respectively. Develops and coordinate policy for, and appraises the effecUven^. of SSA's EMC and EEO program! Reviews the employment posture or health insurance intermediaries unav- contract'with SSA for compliance *-•»', the requirements of Executive Odc- 11246. Conducts liaison with DHEW ar-< other agencies on matters concerru-'- EMC, EEO, and civil rights. Represent! SSA in contacts with public and private organizations interested in EMC and EEO. Management Coordination and Specie] Projects Staff, OA. Serves as the personal staff to the Assistant Commissioner for Administration, performing for him a broad spectrum of personally assigned tasks in projects, negotiations, and wort areas in which the Assistant Commis- sioner has a special interest or concern. Aids the Assistant Commissioner in co- ordinating and integrating the many- faceted and interrelated activities of the Office of Administration. Steps in and guides for the Assistant Commissioner important projects and assignments by providing advice, assistance, problem Identification, and recommendations for problem resolution. Conducts or direct* projects of major SSA-wide importance and significance on assignment by the Assistant Commissioner. Division of Administrative Appraisal and Planning, OA. Directs the ap- praisal of total SSA administration and the planning for efficient SSA organiza- tion and operations. Develops major op- crating .and administrative goals and measures of effectiveness for program administration. Identifies current and emerging . problems and recommends remedial actions. Continually appraises organizational ' effectiveness. Develops consistent and progressive administra- tive policies and philosophy. Conducts, coordinates, and integrates long-range operational, organizational, and admin- istrative planning and provides leader- ship in administrative planning for pending legislation. > , Division of Audits' and Investigations. OA. Directs the internal audits and investigations programs of SSA. Con- ducts comprehensive audits in head- quarters and, in collaboration with DHEW or independently, conducts field audits. .Appraises existing practices for compliance with law, regulations, poli- cies, and procedures. Analyzes DHEW and GAO audit reports, prepares SSA responses, and oversees implementation of necessary consequent actions. Repre- sents SSA in dealings with DHEW Audit Agency and GAO site audit teams. Re- ports to the Commissioner on internal audit -and investigative "findings, and recommends corrective action. Investi- gates alleged .program and criminal vio- lations, employee misconduct, and other irregularities. Develops policies and pro- cedures for, olicies, standards, and procedures. Directs SSA activities in the areas of: Buildings construction and leasing, space utilization, forms and rec- ords management, printing and graphics, real and personal property, procurement, supply and mail systems, and civil de- fense. Provides SSA liaison with the Gen- eral Services Administration on matters related to the maintenance and servicing of headquarters facilities. Manages the SSA Library and related services. Pro- vides a variety of headquarters services such as: centralized secretarial services, centralized dictation facilities, parking, and transportation. Division of Personnel, OA. Directs the personnel management program of SSA. Develops personnel management objec- tives, policies, standards and procedures. Conducts and coordinates position classi- fication, recruitment, placement, and employee relations programs. Partici- pates in administration of programs for employee-management cooperation, equal employment opportunity, and em- ployee communications. Evaluates per- sonnel administration in SSA and recommends or takes action to improve deficiencies. Assists SSA components, field ini nations, and SSA component personn offices in their personnel op- erations Provides personnel operations services for headquarters offices. Division of Systems Coordination and Planning, OA. Provides SSA-wide leader- ship and direction for systems planning, encompassing both EDP and non-EDP, and operational and management sys- tems. Develops, maintains, and improves the total data processing system for SSA. Establishes systems policies and stand- ards, and plans overall specifications for SSA systems. Reviews and evaluates pro- posed systems and equipment changes for conformance with longer range SSA systems planning goals and to assure in- tegration of SSA systems. Employee llealtli Service, OA. Directs the employee preventive health program of SSA. Promotes health, efficiency, and productive longevity of employees. Treats directly all types of medical emergencies in work situations, and arranges avail- ability of other Government and private services. Assists employees in the de- tection of health problems through the administration of mass screening pro- grams and offering of individual services. Conducts physical examination pro- grams. Provides referrals to appropriate private and community resources. Es- tablishes and enforces standards of health and comfort through u broad en- vironmental health program. Directs an SSA-wide safety program, and conducts a continuing health education program. SSA Employee Communications Staff, OA. Directs the management-employee communications program of SSA. Pub- lishes a variety of informational ma- terials, including a monthly employee magazine, a semimonthly management newsletter, and a weekly central office bulletin. Prepares and odits administra- tive reports and presentations. Provides assistance to and appraises manage- ment-employee communications activi- ties in the field. Identifies weaknesses in management-employee communica- tions and recommends improvements. Piwides advice and consultation on management communications with em- ployees. SSA Operations Research Staff, OA. Provides operations research capability for application to and solution of 3A management and operational problems. Applies operations research techniques to the analysis of individual problems. Utilizes mathematical analysis, statisti- cal techniques, model -tinkling, and cost 'benefit analysis for tin purpose of analyzing problem areas and pro"! clear, definitive alternative com., action to facilitate management . sions. Provides staff support in the . of systems planning, and management and operatic as analysis, and participates in the development and improvement of programs designed to optimize the opera- tion of the entire system. Ofhce of Information iO/). Plans and directs a nationwide public information program to assure public undertanding of rights and responsibilities under the Social Security program. Develops guide- lines, techniques, and key materials ap- plicable to all information media En- gages in cooperative public information, activities with both public and private organizations. Conducts surveys and studies to identify- problems of public understanding of Social Security, and to determine the effectiveness of informa- tional activities. Provides advisory and technical services to 'the Commissioner, SSA Bureaus and Offices, and the Office of the Secretary on public information and public relations aspects of SSA pro- grams. Directs SSA's public inquiry and correspondence activities, and prepares replies to much of SSA's high priority correspondence. • -t, Divsion of Operations, 01, \ Develop* and evaluates nationwide objectives, themes, and action messages. Conducts surveys and studies of levels of public understanding. Issues instructions and guidelines on public. Information mate- rials, activities, and techniques. Origi- nates contacts and/or responds to out- side requests resulting in comprehensive programs to reach the public through national groups and organizations. Con- ducts a program of community relations in Baltimore. Provides tour and recep- tionist services for the Social Security Building. Conducts the SSA Speakers' Service. Operates a Washington inquiries program serving Congressional offices. Departmental and other- Governmental offices, and the public. "--:--- Division of Production, OR Plans, and produces materials for use by ail major media (publications, magazines, radio, television, motion pictures, direct matt, exhibits, posters, and speeches) . Develops and implements policy on the nature, style, content, and use of informational materials. Directs production of mate- rials by contractors. Provides technical assistance to SSA components in the preparation and production of issuances having public information aspects; clears such materials for conformance to policy, ■ editorial and aesthetic suitability of presentation, and public relations and understanding. Prepares speech mate- rials and background information for use by SSA, Department, and other Fed- eral officials, -x • *•-■ - Division of Public Inquiries, OI. Estab- lishes, promulgates, and assesses SSA policy governing public and Congres- sional correspondence. Conducts studies and surveys to detect and evaluate SSA procedures and practices which may create misunderstanding, adverse public .reaction, or other public relations problems. Recommends corrective action as necessary. Provides advice and assist- ance to SSA officials and liaison with the Department on public correspondence matters. Conducts a program to improve correspondence with the public. Re- ceives, analyzes, and controls high priority written and telephone inquiries. Replies to many of these inquiries, and reviews all written replies to such in- quiries prepared elsewhere in SSA Office of Program. Evaluation and Planning iOPSP) . Directs the legislative planning and analysis program of SSA Evaluates the effectiveness of the Social Security program in providing security through retirement, survivors, disability, and health insurance. Develops and FEDERAL REGISTER, VOL. 33, NO. 74— TUESDAY, APRIL 16, 1968 110 5S30 N< "ICES interprets program philosophy and ob- jectives. Develops and evaluates recom- itions concerning legislative pro- posals for . ill the Social Security Lin. Analyzes and makes recom- mendations on related income main- tenance and health insurance pre: • particularly those which may involve [nation with the Social Security in, and on other methods of pro- viding economic security through social insurance. Provides technical and ad- visory services to officials within the Executive Branch, Congressional com- :s and individual Congressmen, and private organizations interested in Social Security legislation. Division of Coverage and Disability Its, OPEP. Develops and eve' legislative proposals for extending social security protection to groups not yet ed. Evaluates proposals for program changes in the light of their effect on special coverage groups. Studies and ; recommendations on mca concerning the provision of income maintenance for the disabled and their tdents through the social security i. Recommends methods for co- ordinating the protection afforded under social security with that afforded under other public retirement or disability programs. Division of Health Insurance, OPEP. Evaluates the health insurance pro in terms of its effectiveness in providing adequate health insurance protection for i fed. Develops and analyzes legis- lative proposals designed to improve the protection provided and to change the health Insurance provisions in other re- spects. Evaluates the need for t insurance on the part of social security •iaries under C5, and develops al- ternative courses of actum for meeting the.se needs through legislation. Makes recommendations on methods and sources of financing the health insurance program. Recommends methods for co- ordinating the health insurance protec- tion afforded under social security with that afforded under other public retire- ment programs. Division of Retirement and Survivors Benefits, OPEP. Develops and elucidates overall program principles and philos- ophy. Evaluates and prepares proposals for social security program legislative changes in the area of retirement and survivors beni fits, and also in those as- pects of the program that are not pri- marily concerned with coverage, disabil- ity, or health insurance. Analyzes and makes recommendations on related in- come maintenance proposals. Conducts studies to aid in definin" and resolving various program issues such as the level of social security benefits, the ran dependents who should receive benefits, and the establishment of priority among dependents. Ojtcc of Research and Statistics (ORS). Conducts ami directs the broad research and statistical programs of SSA. Conducts research relating to retiri age, methods of financing, redistribu- tional effects of social security, and ade- quacy of cash and health benefits. Studies and mates recommendations concerning problems of pov ty, insecurity, and health costs, and lie contributions that social insurance and related programs can make toward t : ir solution. Conducts national surveys of the aged, the disabled, and families with children. Provides con- tinuing evaluation of national policies and procedures for effectiveness in meet- ing program goals. Publishes statistical data and research findings. Represents SSA on matters of research and statistics with DREW, other agencies, univer- sities, research centers, and international organizations. Evaluation and Measurement System Staff, ORS. Plans, directs, and coordi- the development and operation of a system of continuous statistical evalua- tions and measurement of basic claims and related policies and procedures. International Staff, ORS. Develops, co- ordinates, and implements programs tied to assemble and analyze infor- mation about social security programs of all countries. Conducts comparative eco- nomic studies of selected aspects of foreign programs. Coordinates relation- ships between SSA and intematioi cial security organizations, interchang- ing information on program matters. Provides technical guidance and partici- pates in the development and implemen- tation of U.S. international ]>oiicy in th„ social insurance field. Directs social se- curity study and training programs for n nationals. Advises AID and other Les and governments on training resources in the United States, and as- sists in trainii:" for technical .is. [stance. Coordinates SSA activities concerned with the reception and orientation of n visitors. Publicalio?^ Staff, ORS. Plans, stimu- lates, and guides an overall research and statistics publications program. Plans, edits, and publishes the Social Security Bulletin, Annual Statistical Supplement, the Research Report series, and other reports. Provides professional-level writ- ing and editing services to assist in preparing research and statistical docu- ments for publication. Research Gra)its Staff. ORS. Develops, coordinates, and implements SSA ties in the cooperative research program. Stimulates interest in thi gram and identifies new or existing areas of knowledge or problems which may be usefully studied under the program. Pro- vides guidance to research Reviews applications and prelimin: proposals for grant research. Reports progress and findings of SSA-i projects. Division of Disability Studies, ORS. Plans and directs a continuii economic and social survey program to collect data on and to study the disabled population. Plans and directs studies of significant program issues requirii i into such areas as: Tin of prol ivailable to disabl ers and their dependents; the causes and effects of disability; the proportion of al- lowances and disallowances in the dis- ability insurance program; trcn is in ami effects of the rehabilitation of disabled Rciaries; problems of representative payment to both institutionalized and nonmstrtutionallzed beneficiaries; and comparative studies of beneficiaries wUfc and without representative payees. Studies, ORS. Plans and directs long. range program-oriented research, proj- ecting and interpreting changing demo- graphic, economic, and social trends as they relate to the broad field of economic security and to overall economic arid social policy. Studies such major areas as: Social security financing; economic impacts of social security; income main- tenance alternatives; effects of social se- curity on lifetime income redistribution; alternative measures of income ade- quacy; the relationship of social security to other public and to private income maintenance programs; and the develop- ment and publication of aggregate measures such as the social welfare ex- penditures series, economic projectioni, and labor market studies. Division of Health Insurance Studies ORS. Develops and directs the su-' fcistical system for the health insurance program. Conducts special studies and analyses of the operation of the program. including utilization of services and trends in costs. Directs and conducts re- search on the impact of the program on: Public and private health insurance pro- grams, financial situations of hospital*. and total medical expenditures and cost*. Conducts studies of unmet needs and re- lated questions. Coordinates SSA re- search programs in the area with related studies conducted or supported by other agencies. Including the Public KeiUth Service and the Social and RebabilitaUca Service. Division of OASDI Statistics, ORS. Plans and directs the development and maintenance of a broad statistical pro- gram concerning basic retirement, sur- vivors, and disability insurance program statistics. Provides statistical services throughout SSA, and technical consulta- tion to users of SSA statistics both within and outside the agency. Division of Retirement and Survivors Studies. ORS. Plans and directs a con- tinuing national economic and social sur- ves program to collect data on and to study the aged population and survivor* of deceased workers. Conducts cross- section surveys of the aged, new retired young" survivors, and related funCy i groups. Plans and directs studies of sSc- rdficant program issues requiring re- search into such areas as: Retirement patterns: problems of "early" retire- ment; tiie needs of widows without children before they become eligible for retirement benefits; the treatment ec women under social security; the rela- tion of benefit levels to standards of ade- quacy; effects of the retirement test: and the situation of individuals recerrtnj minimum benefits. Bureau of Data Processing and Ac- counts WDPA). Provides direction fcr the nationwide operations of a cen- tralized EDP and telecommunicetlanj facility for SSA, including system analysis; programming, computer opcr»- tions, and data transmission. Establish* and maintains the basic records suppc^r* tag Social Security programs, incnidttf records and accounts for determining « -_ fEDE*AL REGISTER, VOL, 33, NO. 74 — TUESDAY, APRIL 16, 1963 111 OTICES 5831- titlcmcnt to and computation of retire- ment, survivors, and disability insurance benefits, and for determining entitlement to and utilization of health insurance benefits. Develops earnings reporting standards and procedures for employers and the self-employed. Investigates and resolves reporting and earnings record discrepancies. Furnishes necessary data to the Department of the Treasury for proper crediting of FICA contributions to the Trust Funds. Directs and operates a large scale system for compiling compre- hensive statistical data for program and management studies. Participates in leg- islative planning. Division of Accounts and Adjustments, BDPA. Identifies and reinstates earnings items, health insurance inquiries, doctor bills, and hospital notices reported in- correctly or incompletely as to name or account number. Processes notices re- ceived from the Internal Revenue Service correcting reported earnings, periods, or account numbers. Processes evidence postings based on district office investi- gations. Adjusts accounts when accou.it holders' identities have been confused. Maintains registers of accounts estab- lished, health Insurance records, files of suspense and reinstated items, employer wage reports, self-employed income re- ports, and detailed earnings listings. Answers and/or initiates correspondence relating to earnings and health insurance records. Division of Certification, BDPA. Analyzes, determines, and certifies to dis- trict offices and payment centers all data concerning earnings, primary insurance amounts, and insured status for ad- judicating all original claims and recom- putations. Resolves discrepancies be- tween SSA records and individuals' state- ments of earnings and employment. Re- views district office determinations or makes determinations based on evidence submitted by district offices as to whether alleged employment is employment as defined by the Social Security Act. Division of Management Coordina- tion, BDPA. Analyzes, appraises, and co- ordinates the Bureau's management activities. Administers management pro- grams in the areas of fiscal management, medical group premium collections, clerk time and production controls, organiza- tion planning, procurement, training and staff development, work planning and reporting, personnel management, incen- tive awards, records management, and related management functions. Provides study programs and informational serv- ices to visitors. Surveys Bureau opera- tions, procedures, and management. Pro- rides a continuing program of cor- respondence review. Provides mail and messenger, electrical and mechanical equipment maintenance, special equip- ment fabrication, and various labor services for Headquarters. Performs special assignments and administrative duties for the Bureau Director. Division of Registration, BDPA. Con- trols printing and distribution of pre- numbered account cards. Issues duplicate account cards and furnishes missing ac- count numbers. Maintains files of Bu- reau's corresp idence, employee, and employer app] ations. Answers corre- spondence concerning individual and employer numbers. Initiates BDPA proc- essing of claims and related actions. Audits wage and self-employment re- ports prior to electronic processing. Re- ceives and medically codes a sampling of medical bills. Establishes and main- tains the Bureau's State and local gov- ernment accounts. Records Minister Waiver Certificates. Furnishes photo- graphic services. Provides safe storage of key duplicate records. Division of Statistical Services, BDPA. Provides advisory services to other SSA components. Government agencies, and non-Government organi- zations on availability and adequacy of Bureau data for projects wherein SSA records would.be used. Develops syste ns, plans, procedures and EDP programs for, and processes a variety of project* cover- ing data on health insurance, disability, routine and special management studies, claims, employer, and employee earnings or self-employment income including employee lifetime employment history. Conducts studies jointly with other com- ponents on problems of mutual concern. Provides liaison with other components regarding requests for statistical data. Assistant Bureau Director, EDP Oper- ations, BDPA. Directs EDP and support operations necessary to the receipt, audit, correction, adjustment, and posting of all earnings reports, and the mainte- nance of health insurance eligibility and payment records. Directs the EDP opera- tions which analyze data and provide: Informational earnings statements to ac- count holders; earnings data and compu- tations for claims processing; data to payment centers from bcne.it-in-force rolls; and data to intermediaries from health insurance benefit rolls. Directs operational control of a nationwide EDP and telecommunications system for SSA. Division of Central EDP (Derations, BDPA. Converts earnings data from employer wage reports to magnetic tape, and performs a series of EDP operations to update summary records for individ- ual accounts. Analyzes earnings data by EDP process, and prepares computations to derive primary insurance amounts ap- plicable to the certification of original claims cases, disability benefit cases, and recomputations. Identifies and reinstates earnings items reported incorrectly. Maintains and updates benefit-i.i- force rolls and provides data to paymc ■:< -en- ters. Maintains and updates health in- surance benefit rolls and provides data to intermediaries. Provides operational control of the SSA telecommunication network. Division of Report Proccssina, BDPA. Processes employer wage and self- employment income reports. Transfers earnings data from reports to punch cards. Perform.-, sorting, listing, block- ing, and auditing operations. Corre- sponds with the Internal Revenue Serv- ice and with employers concerning earnings discrepancies. Performs cleri- cal operations necessary for the audit and control of the quarterly updating of employee accounts and the reinstate- ment of rejected items. Audits earnings data and adjusts discrepancies. Main- tains eligibility records for the health Insurance programs. Audita and con- trols the processing of payment records. Corresponds with health insurance in- termediaries and providers dealing directly with SSA. Assistant Bureau Director, Methods and EDP Systems, BDPA. Directs the planning and development, and makes recommendations concerning the use of SSA EDP, telecommunications, and micro-photographic facilities. Directs e methods and EDP systems program for the design and implementation of pol- icies, procedures, methods, and systems for all the Bureau's functions as well a* the data processing activities of SSA components. Participates in continuing activities designed to keep abreast of the latest techniques and developments in the uses ofofflce machines, wire trans- mission, micro-photographic and EDP equipment as related to SSA needs. Division of Accounting EDP Systems, BDPA. Designs and implements EDP systems for: Establishing and maintain- ing employee/employer accounts; proc- essing improperly reported earnings items; and establishing and maintain- ing various management controls. De* signs health Insurance EDP record- keeping systems for: Establishing and maintaining beneficiary, provider, and group premium files; processing queries, replies, bills, and payment records; and preparing identification cards, premium and utilization notices. Provides tech- nical systems advice and assistance to SSA components, State, Federal, do- mestic, and foreign organizations. Eval- uates latest techniques and acquires latest equipment pertinent to the Bu- reau's mission In data processing. Division of Claims and State Cover- age Methods, BDPA. Develops operating policies, systems, and instructions for: Claims certification, interbureau and Interagency claims process coordination, earnings statement issuance, reconcilia- tion of disagreements to earnings and health insurance utilization statements, disclosure of confidential information from SSA records, and administration of contractual coverage of State and local government employees, including the collection and accounting of all related payments. Analyzes and advises re- garding related policy positions, legis- lative proposals, and program objec- tives. J • Division of EDP Claims Processing, BDPA. Designs and implements EDP systems for: The initial establishment and certification of the master benefici- ary record, and the preparation and maintenance of related subsidiary tape and microfilm files; processing requests for earnings record information and claims action; providing various service, control, and statistic-related operations for initial claims; furnishing health In- surance entitlement and billing data for new claims to appropriate EDP proc- esses; utilizing the earnings record and employer address files for reference ca- pability to service requests for data from these files; and producing management, FEDERAL REGISTFR, VOL. 33, NO. 7 A — TUESDAY, APRIL lorts as required from the beneficiary record. Division of EDP Postentitlement Proc- essing, BDPA. Designs and implements EDP systems for: The continuing main- tenance and adjustment of master bene- fit records resulting from postentitlement actions; providing numerous service, control, and statistic-related operations to provide statistics, management, or study data as required; furnishing data concerning changes in health insurance enrollment and billing to appropriate EDP processes; providing a reference capability to service requests for data from these files; continuing maintenance of related beneficiary record files; pro- viding the capability for supplementary medical insurance billing, accounting, control of overpayment recovery, and similar related processes. Division of Reporting and Accounting Methods, BDPA. Develops and issues new or revised operating policies and pro- cedures for establishing the social secu- rity records, processing all earnings data to update these records, and processing various segments of the health insurance program. Devises system for furnishing Trust Fund information to Treasury De- partment. Analyzes proposed legislation, policy changes, and demands for statis- tical data for procedural and operational Implications and for administrative fea- sibility. Coordinates, the Division's oper- ating procedures with other SSA com- ponents, governmental agencies, and with the EDP systems divisions to assure desired integration of clerical and man- ual procedures with EDP operations. Division of Telecommunications Man- agement, BDPA. Provides management planning, direction, and appraisal of record and voice telecommunications systems to support SSA programs. De- velops and implements policies and pro- cedures to assure efficient, economical, and effective communications services and facilities. Develops and issues tech- nical operating manuals, directories, and training programs. Approves major changes of SSA telephone plant. Man- ages and operates central office tele- phone systems. Maintains technical liai- son with SSA components. Federal agencies, private concerns, carriers, and vendors with regard to policy set by legis- lation, directives, contracts, and tariffs. Bureau of Disability Insurance (BDI). Provides direction and technical guid- ance for nationwide administration of the disability insurance program. De- velops, recommends, and issues substan- tive policies, procedures, and interpreta- tions to provide program direction to disability insurance administration throughout SSA and in State agencies. Develops, in cooperation with SRS, poli- cies and procedures for administration of the disability beneficiary rehabilita- tion program. Negotiates agreements, advances funds, establishes administra- tive and fiscal controls, and provides di- rection for management of State agency disability operations. Appraises the quality and effectiveness of disability insurance administration. Administers central disability operations Including review and a horizatlon of disability claims, certifi< .tion of benefit payments, and maintenance of disability benefi- ciary rolls. Conducts studies and statis- tical analyses to evaluate the effect of program policies and operations. Partic- ipates in legislative planning. Medical Consultant Staff, BDI. Devel- ops broad medical concepts and policies for administration of the disability in- surance program. Provides consultation on all medical aspects of disability pro- gram planning and administration. Di- rects and/or provides consultation for re- search studies to develop improved medi- cal techniques for reevaluating and measuring disability. Develops and con- ducts orientation and training pro- grams for medical personnel in the Bureau and in State agencies. Develops medical evaluation and development policies and guides. Provides medical consultation and review on certain in- dividual claims determinations. Estab- lishes and maintains liaison with pro- fessional medical organizations to pro- mote program goals. Represents SSA and the Bureau with other agencies and organizations. Assistant Bureau Director, Disability Policy and Procedures, Division of Dis- ability Policy and Procedures. BDI. Promulgates policies and procedures for processing disability claims through all stages of operations in district offices. State agencies, and the Bureau of Dis- ability Insurance. Adapts the Bureau's methods of processing disability claims to SSA operating procedures for claims authorization and payment. Renders technical assistance in the preparation of regulations, rulings, and program materials. Acts as consul, ant on dis- ability policy matters. Provides inter- program coordination with public and private organizations concerned with dis- ability. Participates in legislative planning. Assistant Bureau Director, Field Dis- ability Operations, Division of Field Dis- ability Operations, BDI. Develops and maintains a continuing program of surveillance and evaluation of disability program operations at regional and State a-gency levels. Provides guidano and assistance to regional offices carrying out their responsibilities fo. program direction in the field. Develops and carries out Bureau activities to stimulate the vocational rehabilitation of disability applicants and be i I ri-s Cooperates with the Social and Ren tation Service In the formulation regulations, policies, and procedures Trust Fund payment of disability bene- ficiary rehabilitation services. Develops and maintains f comprehen ;ive national system of policies, standards, and pro- cedures for the administrative and fiscal management of contracting Statu agencies. Assistant Bureau Director, Manage- ment and Apriraisal, Dii ision of Manage- ment and Appraisal, Bid. Directs fiscal, statistical analysis, management im- provement, and administrative manage- ment programs for the Bureau. Directs a program of training and personnel ernani. Formulates Bureau work plsnir and wort emphases. Surveys and appraises operating and administrate systems, methods, and organization to develop Mid implement management miprorementa. Appraises the quality & adjoriies tinrt at all stages of the £u- ability claim* process. Directs and co- ordinates a program of studies and sta- tistical analyses to appraise and kn;>rt>^ admJTristratiTe policies, procedures! a.-«j operations. Provides a system of stati*. tieal data for use within and ouu«ie the Bureau. Assistant Bureau Director, Operation BDI. Administers the review and so.' tborisation of disability claims, certifies. tion of benefits, and maintenance erf toe beneficiary rolls. Directs the rcrtrs and reconsideration of State agency do. tannins* tons of disability, and necoU*i«» any issues arising for the purpose at evaluating quality, assuring conformity. and providing guidance. Directs u* claims reconsideration activities of Um Bureau. Directs the analysis of appelate decisions for administrative impUcaUoox the preparation of SSA positions for dla- ability determinations In litigation, and a public inquiries program in the anas of puhlie and congressional correepood- Dmrtskm of Benefit Payments, BDI. Operates and maintains the Bureau'* benefit payment system. Adjusts, sus- pends, and terminates benefits of ta» diriduals and their dependents on U* disability rolls. Prepares benefit paj- ment data for Introduction into the com- puter system, and maintains accouatioc controls, using EDP techniques as wt£ as manual and other methods. Proc- esses all actions to maintain benefidarr payment rolls. Assures by sample aud* that magnetic tape records reflect actual authorized payment actions. Coordinalts computer operations with the Bureau at Data Processing and Accounts. Recom- mends disability policy, procedural, and legislative changes. Coordinates Dirinoa operations with SSA bureaus, SU*» agencies, the Treasury Department, aad the General Accounting Office. Division of Benefit Services, BDI. Op- erates and. maintains a compreberulrt •workflow management system for B3C Operations, Operates the Bureau's caw control and folder location systems aad assures the timely association of clai-t>*^ related material. Processes incoming aa* outgoing mall, and prepares and rele*»« award certificates, denial letters, aad other claims-related notices. Estabu*ao and maintains the Bureau's files u pi«im« folders. Examines disability e»*» 1o determine whether a review of coa- tinuing entitlement Is necessary. B«- ceives and processes payee accouaUa* reports. Recommends disability po^o- procedural and legislative chances c*- ordlnates Division operations with &>* bureaus. State agencies, and the w» Office Department. ■ .Division of Evaluation and Av^orr- action, BDI. Reviews State agency drtti- mrnations .of disability in initial cW=s« and in cases involving issues of c -^ utng disability. Reviews district cct^ determinations- of nondisabllity facw FEDERAl REGISTER, VOC 33, NO. /4 — TUESDAY, APRIL To, I960 113 NC CES 5S33 'ia entitlement to primary or auxiliary .•^ability insurance benefits, and au- thorizes allowance or disallowance of inability claims. Negotiates issues arls- lr,, In review of State agency determl- r. '.ions. Adjudicates disability cases ex- cluded from State agency jurisdiction. R-. -commends disability policy, proce- dural, and legislative program changes. Evaluates and reports on quality of State t;cncy disability determinations, and provides guidance to assure conformity In Initial determinations. Coordinates «rth the Railroad Retirement Board on i. Ability determinations involving the social security and railroad retirement programs. Division of Reconsideration, BDI. Reviews disability determinations recon- sidered by State agencies in cases where claimants disagree with the initial deter- Eination, and approves, revises, or re- rerscs State agency determinations in accordance with authority granted by V.e Act. Negotiates issues arising in re- view of State agency disability determi- r...:,ons. Reconsiders disability cases ex- :.;ded from State agency jurisdiction, md those cases contested for issues other lira existence and duration of disability. Hi- rovers or waives amounts incorrectly p*.d to beneficiaries. Analyzes decisions of hearing examiners, Appeals Council, e .J the courts for impact upon admin- U.ation of the disability program. Eval- uates claims to recommend Administra- te , position for disability determina- ;::.., in litigation. Office of the Regional Representative, l;..:bility Insurance, BDI. Provides di- ction and leadership for the disability tr-surance program at the regional level. Reviews and evaluates State agency ac- v. ivies, providing guidance in the sub- iU.aive program and administrative irer.s. Reviews State agency budgets. Provides technical direction for disabil- liy insurance program operations in the cjtrict oflices. Coordinates with other S3* regional representatives or with DKHW regional officials cencerned with the disability program. Establishes and maintains relationships with profession- ii organizations. Participates in public information activities for the disability program. I ireau of District Office Operations <3:.00). Provides direction for the op- erations of a nationwide network of dis- trict offices, branch offices, and other f a- d..ies which servo as the interface be- tween SSA and the public, and which have responsibility for: Informing the public on the purposes and provisions of Social Security programs, and their rVhts and responsibilities thereunder; agisting the public in filing claims for retirement, survivors, disability, and health insurance benefits; developing aiici adjudicating claims; assisting bene- lic. :Ics in claiming reimbursement for c.?'i:cal expenses; conducting earnings rtc-.rd, coverage, fraua, and related in- vestigations; making rehabilitation serv- ice referrals; issuing Social Security ac- count numbers; assisting claimants in f_.:.,i appeals from SSA determinations on benefit entitlement or amount; and rc-presenting SSA with numerous govern- mental and prlva organizations. Par- ticipates In legislat e planning. Operations Andysis and Standards Staff, BDOO. Provides the Director with a detailed overview of operations. Initi- ates or, as directed, conducts special analyses, studies, and investigations. Develops, In concert with Bureau com- ponents, criteria for objective measure- ment of overall Bureau operations. Designs and directs a Bureau-wide pro- gram of surveys. Establishes standards for claims processing time and work production rates for field facilities. Receives and evaluates periodic statis- tical and other management reports, organizing for the Director a compre- hensive and coherent picture of opera- tions. Assistant Bureau Director, Field Operations and Management, Division of Field Operations and Management, BDOO. Provides leadership to regional and district offices throughout the country to assure effective and econom- ical fiscal, personnel, and other manage- ment activities. Develops management policies and procedures, assists in their implementation, and appraises their effectiveness. Contributes to the develop- ment, appraisal, and modification of SSA management policies and procedures from the viewpoint of administrative feasibility, public reaction, and district office experience. Represents the Bureau in coordinating regional and district office management operations with other ' SSA components and with outside organizations. Assistant Bureau Director, Field Organization and Methods, Division of Field Organization and Methods, BDOO. Directs a broad organization and meth- ods program affecting the design and nature of district and branch offices and resident and contact stations throughout the country. Conducts long-range studies leading to improved organizational arrangements and a continuing pro- gram of systems analysis and planning. Develops criteria and specifications for the Bureau reports system based on analysis of the need for operational data and information. Participates In a con- tinuing nationwide review of field in- stallation operations and management designed to identify problems end con- tribute to the overall appraisal of SSA policies and procedures. Assistant Bureau Director, Operating Policy and Procedure, Division of Operat- ing Policy and Procedure, BDOO. P j- vides leadership to regional and distiict offices to assure effective and economical implementation of social security pro- gram provisions. Develops operating policies and procedures, assists in the implementation of substantive policies and procedures, and prizes assistance to regional offices. Contributes to the devel- opment, appraisal, and modification of substantive policy and procedure and legislative program planning from the viewpoint of administrative feasibility and public and distiict office reaction and experience. Represents the Bureau in coordinating regional and district office operations with other SSA and outside organizations. Office of the.- Regional Representative District Office Operations, BDOO. Server. as. focal point of Hue authority through which management and: operational as- pects of district office responsibility and performance are supervised and coor- dinated. Provide* leadership, guidance, and direction to from 20 to 80 or more district and branch offices through the principal line officer,, the regional rep- resentative, and: his assistant regional representatives, each of whom is respon- sible for supervision of a network of 10 to 13 district offices. Ensures consistency of operations with regional and: central, office policies and procedures: Bureatt of Federal Credit Union,') (BFCU) . Provides direction for- nation- wide administration of the Federal Credit Union program. Prescribes standards, procedures, and accounting forms for use by Federal credit unionsr establishes Federal credit union rules and regula- tions; issues manuals and instructional material r and provides advice and tech- nical assistance to credit union officials. Compiles and analyzes flnnndni and sta- tistical data on Federal credit union operations; conducts studies of credit union conditions and trends. Directs a nationwide field organization engaged in. chartering, examining, and supervising • Federal credit unions. Develops legislative I proposals concerning' changes in the • Federal Credit Union program. • " ' Division of Administration, BTCJ7-.' ' Directs the Bureau's administrative, financial, and personnel management '. programs. Directs Bureau activities In the ; areas of: Budget preparation and con- 'i trol; fiscal accounting and auditing for j administrative funds, fees, and accounts of liquidated Federal credit unions; records management; - property account- ing; and services for travel, procurement, time and leave, printing, and supplies. Administers the personnel program of the Bureau, Including- classification, recruit- ment, placement, appointment, promo- tion, and employee relations. Coordinates the Bureau work planning activities. Division of Examination and Account'- tna. BFCU. Develops the Bureau's pro- gram for the examination of Federal credit unions, and establishes standards and procedures for such examinations. Reviews examination reports and partici- pates in field examinations to assure conformity to and appraise the effective- ness of established policies and pro- cedures. Analyzes all proposed Bureau actions on problem cases, suspensions, and special reserve requirements. Estab- lishes standards and requirements for accounting procedures and forms for Federal credit unions. Coordinates prep- aration and revision of Examiner's Guide, Accounting Manual, and Super- visory Committee Manual. Division of Organization and Stand" ards, BFCU. Directs the development of standards, policies, and procedures for: Investigating groups applying for char- ters to establish Federal credit unions; granting charters r approving bylaws, and charter and bylaw amendments; han- dling mergers, conversions from State to Federal charters and vice versa, and liquidations. Reviews and analyzes ap- FEDERAL REGISTES, VOL. 33, NO. 7 A — TUESDAY, APXIL 16, 19S8 114 5834 Ni ICL'S plication for charters and bylaw and charter revisions, and recommends ap- proval or disapproval. Reviews proposed mergers and conversions for conformity to legal and regulatory requirements. Gives guidance and service to regional offices in the above areas of responsi- bility. Division of Statistical Research and Analysis, BFCU. Develops and conducts programs of research in the field of co- operative thrift and credit, with special emphasis on the role of credit unions in the national financial community. Pre- pares periodic reports on research activi- ties for use of the Bureau, credit uivon officials, and private groups. Prepares Interpretive articles and memoranda on credit union operations. Designs, estab- lishes, and supervises regular data collec- tion programs involving Federal and State-chartered credit union operations in the consumer saving and credit fields. Analyzes financial, statistical, and other call reports from Federal credit unions. Prepares internal management reports. Compiles regional check list and district assignment lists. Office of Vie Regional Representative, Federal Credit Unions, BFCU. Directs the execution of all phases of the Federal credit union program in the regions. Con- ducts regional programs for: Recruit- ment and development of staff; investi- gation of applications for proposed new credit unions; examination of the opera- tions of individual credit unions; com- prehensive review of examination reports for conformance with policies and proce- dures, and for accuracy, completeness, and effectiveness; control of shortage, problem, retarded, and liquidation cases; approval or recommendation as to the acceptability of nonstandard accounting systems and forms, and amendments to charters and bylaws; maintenance of ef- fective working relationships with State Credit Union Leagues and State super- visory agencies. Bureau of Health I?isurance (BHI). Provides direction and technical guidance for nationwide administration of the hos- pital and supplementary medical insur- ance programs. Develops, recommends, and issues substantive policies, proce- dures, and interpretations to provide program direction to health insurance administration throught SSA, and in State agencies and intermediaries. De- velops and modifies, in cooperation with other Governmental agencies, conditions of participation for providers of services. Develops principles for reimbursing pro- viders for their costs, and criteria for determining charges for physicians and related medical services. Negotiates agreements and contracts with, and monitors performance of State agencies and intermediaries in administering cer- tain health Insurance provisions. Reim- burses providers that choose to receive payment directly from SSA. Appraises the quality and effectiveness of health Insurance administration. Conducts liai- son with medical and other professional groups. Participates in legislative plan- ning. Office of the Chief Medical Officer, BHI. Advises the Bureau on professional medical aspects < the overall admin- istration of the H> Ith Insurance for the Aged program, luulntains liaison with leadership of professional organizations representing the medical community In the United States to promote under- standing of program objectives and to improve program cooperation. Assistant Bureau Director, Intermedi- ary Operations, Division of Intermediary Operations, BHI. Establishes qualifica- tion standards, guidelines, and proce- dures for the selection of Intel mediants. Negotiates, renegotiates, and recom- mends termination of contracts with In- termediaries. Reviews, evaluates, and approves intermediaries' operating bud- gets and requests for advance of funds: maintains continuing control of amounts expended; and establishes • intermedi- ary reporting procedures. Reviews and evaluates the effectiveness of intermedi- aries' performance through analysis of reports, audit reports, and comprehen- sive surveys. Participates In the develop- ment of policies and procedures for au- dits of intermediaries. Serves as the primary center for intermediary-SSA. communication. Assists intermediaries in resolving program and operating prob- lems. Coordinates activities of inter- mediaries with the Administration. Assistant Bureau Director, Manuoc- ment, Division of Management, Bill. Develops, coordinates, and Implements a total management program for the Bureau. Provides management analysis services, and plans and operates the financial management program. Con- ducts programs for manpower selec- tion and placement, employee develop- ment, fair employment, employee-man- agement relations, position control, and manpower utilization. Develops and is- sues internal administrative communi- cations. Provides project control, prob- lem area reporting, coordinatio 1 of Bu- reau work planning activities, manage- ment information (including collection and preparation of operating data >, ad- ministrative services for advisory groups, and a variety of administrative support services. Receives, controls, analyzes, and answers inquiries about the health in- surance program. Assistant Bureau Director, Policy and Standards, Division of Policy and Stand- ards, BHI. Develops, issues, and appraises policies concerning: The entitlement of individuals to and enrollment for health insurance coverage; coverage of services, benefit amounts, coverr riods, and supplementary medical insur- ance premiums; and intermediaries' and providers' participation and transfer agreements. Provides leadership in the development of heaith insurance policies and procedures for: Determinations, re- considerations, appeals, disclosure o/" in- formation, and detection and handling of fraud. Provides leadership in the de- velopment of conditions of participation for provider;: and independent laborato- ries. Prepares specifications for ieg"la- tions. Furnishes technical services in connection with appeals, and to advisory groups. Assistant Bureau Director, State Operations, Division of State Operations, BHI. Establishes and maintains Nation ships with State agencies for certificat'on of providers and independent labora- tories. Negotiates agreements with state agencies. Conducts training sessions with regional offices. State, and local agencies Participates in developing conditions o' participation for providers of services and provides Instructions and procedu-os for certification, recertification, and re- consideration. Reviews and evaluates State agency and regional office app; -ca- tion ' of conditions of participation Directs and evaluates application of the emergency services provision of the lnw Establishes fiscal policy for State acency operations, and reviews and approve* State agency operating budgets. Provides for expenditure reporting. Reviews ail provider certification reconsideration decisions. Assistant Bureau Director, Systems Division of Systems, BHI. Directs the de-' velopment and issuance of specifications, procedures, and other instructional material to Implement and maintain operational systems applicable to : Inter- mediaries, providers, and other supplier of services; the enrollment and eligibility of beneficiaries, their notification as to utilization of services, and the collection of premiums; and methods for direct reimbursement of providers where ap- plicable. Assures effective coordination with all major operational component*. Evaluates the total system in terms of processing time, accuracy, cost and serv- ice. Plans, conducts, and evaluate* studies aimed at long-range improve- ments in systems, methods, and proce- dures. Coordinates Issuance of all In- structions to Intermediaries and pro- viders. Assistant Bureau Director, Reimburse- ment, Division of Reimbursement, BHI. Develops, issues, and appraises account- ing principles, policies, and procedure* for determining reasonable cost of serr- ices of physicians and others under the hospital insurance program, and for establishing reasonable charges for serr- Ices of physicians and others under the supplementary medical insurance pro- gram. Establishes and maintains lialsor. with key representatives of professiori»l organisations in the field of provider and medic al insu rance reimbursement. Wort* with DHEW Audit Agency in developlnj audit programs and guides for provider audits. Provides consultative, claim authorization, and auditing services for direct dealing providers. Office of the Regional Representative. Health Insurance, BHI. Represents U* Bureau on a regional level. Coordinate*, reviews, and evaluates provider certiH- cation and recertification activities of State agencies, and approves provider agreements. Advises Intermediaries oc claims operations. Participates in uv evaluation of intermediary activiUf* Coordinates health insurance actividrt of intermediaries, State agencies. SSA components, State welfare agencies, tx other organizations. Negotiates SU|» "buy-in" -agreements. Establishes «« maintains relationships with profession*! organizations, and participates in p"W* information activities for the health w- FEDERAL REGISHR, VOL. 33, NO. 74~TUESDAY, APRIL 15, 1968 115 no :es ,)t'oO iSurance program. Evaluates operations of the health insurance program in the jregion, and participates in policy devel- opment and administrative planning. Bureau of Hearings and Appeals <.BHA). Provides broad direction to the S.-.A api>eais process. Directs a nation- wide organization of hearing examiner's engaged in conducting independent, im- partial hearings and in making decisions on appealed determinations involving re- tirement, survivors, disability, or health insurance. Performs a central review of appealed hearing examiner decisions and renders the Secretary's anal decision. De - velops operating instructions to assist uie hearing examiners and to assure fair hearings. Conducts liaison with other components of SSA and the Department, and with other governmental, profes- sional, and private organizations. Appeals Council, BHA. Reviews hear- ing examiner decisions on motion of ai>- pellants or on its own motion. Examir.es case records, obtains additional evidence, hears testimony, and renders a written decision or order which is the Secretary's anal decision on cases accepted for re- view. Recommends whether to request remand of the Secretary's final decisions appealed to the courts. Obtains addi- tional evidence and prepares supple- mental decisions on remanded cases. Recommends whether an appeal should be taken to a higher court on court reversals of Secretary's decisions. Medical Advisory Staff, BHA. Provides consultative services to the Appeals Council and other Bureau components in the evaluation of disability. Plans and conducts continuing medical training of Bureau staff. Negotiates for the services of medical specialists to serve as ad- visors to hearing examiners and regional hearings representatives. Provides lead- ership and guidance in stimulating ef- fective utilization of medical advisors through a coir inning liaison program Tith medical advisors, regional hearings representatives, and hearing examiners. Participates in the formulation of medi- cal policies used in the evaluation of disability. Maintains liaison with medical groups to promote program understand- ing and to keep abreast of disability evaluation developments. Division of Administration, BHA. Di- rects the Bureau's administrative, finan- cial, and personnel management pro- grams. Provides a variety of management services. Directs Bureau activities in the areas of: Management studies and analysis; reports and directives manage- ment; work planning; work reporting wid measurement; budget development M.d execution ; fiscal operations; recruit- Bent, appointment, placement, classifi- cation, position management, employee di-ve.opmunt. and employee-management relations; supply, equipment, and con- tract procurement; property and records management; central docket and files; flenographic, clerical, transcribing, and typing services; duplicating, mail, and distribution services to the central office. Controls priority inquiries and replies, deluding congressionals, and prepares replies. Assistant Bureau Director, Field Oper- ations, Division of Field Operations, BHA. Administers a nationwide orga- nization of hearing examiners en- gaged in conducting impartial and inde- pendent hearings, and in rendering decisions on appeals by claimants from original determinations involving retire- ment, survivors, disability, or hospital insurance benefits, as well as appeals from institutions with respect to their right to participate in the health insur- ance program. Provides administrative direction and substantive guidance to tiie field organization, consisting of regional hearings representatives, hear- ing examiners, and supporting staffs. Develops and executes technical orienta- tion and training for all field personnel. Issues manuals and other directives for field office operations. Conducts field surveys, research, and analysis of field hearings activities. Coordinates Bureau field activities, and conducts liason with governmental and private agencies. Assista7it Bureau Director, Program Opcratio7is, Division of Program Oper- ations, BHA. Develops, issues, and ap- praises operating instructions for hear- ing examiners to provide basic informa- tion and promote fair hearings. Provides advice and assistance to the Appeals Council and other Bureau officials on complex issues and national policies concerning the hearings and appeals process. Provides centralized staff review of hearing examiner decisions to assist the Appeals Council in deciding whether to assume jurisdiction. Analyzes cases and recommends Appeals Council action on appealed claims and litigated cases. Identifies problem areas and makes recommendations for improving the hearings and appeals process. Develops regulations to implement procedural changes. Participates hi development of rulings and legislative planning. Office of the Regional Hearings Repre- sentative, BHA. Represents the Bureau on a regional level. Administers regional programs for the conduct, by hearing examiners, of impartial and independent hearings, and the rendering of decisions on appeals by .claimants contesting de- terminations as to retirement, survivor, disability, or hospital insurance benefits; and institutions contesting determina- tions as to their status with regard to the health insurance program. Provides sub- stantive guidance and administraii' .: direction to the hearing examiners and their supporting staffs. Coordinates oper- ations and administrative activities with DHEW regional offices. State agencies, and others. Conducts periodic inspections of the hearing and appeals offices, which serve as centers of operations for hearing examiners. Bureau of Retirement and Survivors Insurance (BRSI). Provides direction and technical guidance for nationwide administration of the retirement and survivors insurance program. Develops, recommends, and issues substantive poli- cies, procedures, and interpretations to provide program direction to retirement and survivors insurance administra- tion, and to processes and issues common to several " Sbcfid Security programs. Issues Social Security Rulings, Regula- tion^ Compilation of Social Security Laws; and Soda! Security Handbooks. Appraises the quality of retirement and survivors insurance program administra- tion. Negotiates, agreements with. Stater for coverage- of State and local govern- ment employees. Directs admroistrataoB of star payment centers responsible for review and authorization 'or retirement and survivors claims, health insurance entitlement,. SMI premium collection certification of benefit payments, and maintenance of retirement and survivor,: insurance beneficiary rolls. Directs ad- ministration of Social S ec urit y programs abroad. Participates, in legislative pfen- ning. • - > : - Assistant: Bmrta* Director, Adxninit~~ trutkm\. B.BS1. Directs the Bureaus ma*w agement programs, rncrndtngt. Fiscal- management,, organization and staffing analysis and planning, personnel man-, agement, equal employment opportunity and union-management relations, paper- work, management, resources and facil- ities management, and employee develop- ment. Directs the Bureau's long range management planning, including; Eval- uation of long range systems require- ment* for payment center operations and management^ integration of Bureau planning with. SSA planning: sad the: Bureau's management and operations analysis activities. Directs the adminis- tration of program operations in foreign. countries, including the central process-^, ing of foreign claims - .-■• .- * - and a)). - - b. The functions vested in the Secre- tary relating to the Mission of the Soda- Security Administration, as described t= section 8-A of this Statement, under U* Social Security Act which are not ob- tained in the Act but which are contained in the Acts cited in Exhibit X8-2. c The functions vested in the Secrt- tary by section 5(K) (2) of the R* 113 ^? Retirement Act, as amended (45 U-5-t- 228e) , having to do with the determina- tion and certification for the trantfrr of funds between the Federal OlA-At* and Survivors Insurance Trust Fund, v* FEDERAL REGISTEP, VOL. 33, NO. 74 — "'JESDAY, APRIL 16, 1968 117 OTiCES Federal Disability Insurance Trust Fund, the Federal Hospital Insurance Trust Fund, and the Railroad Retirement Accoui.t. d. Authority vested in the Secretary by letter dated September 1, 1960, to the Secretary of the Treasury from the Di- rector, Bureau of the Budget, authorizing the carrying out of programs under sec- tion 104(h) of the Agricultural Trade De- velopment and Assistance Act of 1954, as amended, insofar as this authority per- tains to the Mission of the Social Security Administration as described in section 8-A of this Statement; provided that this authority shall be exercised in accord- ance with applicable policies and pro- cedures established by appropriate au- thorities to ensure consistency with basic foreign policy and with related Federal programs. e. Authority vested in the Secretary 'by section 4 of Public Law 80-610. approved July 12, 1960 (74 Stat. 364) with respect to responsibilities relating to the Mission of the Social Security Administration as described in section 8-A of this State- ment; provided that this authority shall be exercised in accordance with appli- cable polices and procedures established by appropriate authorities to ensure con- sistency with basic foreign policy and with related Federal programs. 2. Delegations of authority to the Bureau of Hearings and Appeals. In ac- cordance with applicable rules and regu- lations, the Appeals Council, its mem- bers, and Hearing Examiners in the Bureau of Hearings and Appeals, shall exercise all duties, powers, and functions of the Secretary relating to the holding of hearings, the administration cf oaths and affirmations, the issuance of sub- poenas, the examination of witnesses, the receipt of evidence, the rendition of de- cisions, and the review of decisions in connection with administrative appeals: a. By individuals from determinations made under Title II of the Social Security Act, as amended, and affecting their rights to benefits, lump sum payments, earnings credited to accounts, and dis- ability determinations; ■ b. By individuals from determinations made under Title XVIII of the Social Security Act and affecting their rights to, i and amounts of, benefits; c. By institutions or agencies from determinations described in section 1869(c) of the Social Security Act; and d. By independent laboratories from determinations made pursuant to section 1861 (s) of the Social Security Act, as amended, that they do not meet the conditions for coverage of their services. 3. Delegations of authority to the Bureau of Federal Credit Unions. The functions, powers, and duties of the Bureau of Federal Credit Unions under the Federal Credit Union Act, as amended (Public Law 86-354; 12 U.S.C. 1751-1772), shall be exercised by the Director of the Bureau of Federal Credit Unions under the general direction and supervision of the Commissioner of Social Security. 8-E. Rescrva ons of authority. 1. The Secretary shall erve as a member of the Board of Tru ices of the (1) Federal Old-Age and Survivors Insurance Trust Fund, (2) Federal Disability Insurance Trust Fund, (3) Federal Hospital In- surance Trust Fund, and (4) Federal Supplementary Medical Insurance Trust Fund. During the absence of the Secre- tary, the Under Secretary or the Assist- ant Secretary for Legislation shall serve. During the absence or disability of the Secretary, the Under Secretary, and the Assistant Secretary for Legis- lation, the Commissioner of Social Se- curity shall represent the Secretary. 2. Authority conferred by sections 218i j), 706. 1813(b) (2), 1839 «b) (2), and 1867 of the Social Security Act, as amended, shall be exercised only by the Secretary. 3. Authority to terminate agreements with States entered into pursuant to section 1864 of the Social Security Act, as amended, shall be exercised only by the Secretary. 4. Authority contained in subpara- graph 8-Dlc of this Statement ma? be redelcgated only to the Deputy Commis- sioner of Social Security. 5. Authority conferred by section 218(g) (2) of the Social Security Act, as amended, shall be exercised only t ■>■ the Commissioner and Deputy Commissioner of Social Security. Notwithstanding such limitation, the Commissioner may re- delegate the authority to terminate an agreement with respect to one or more coverage groups hi any case where a State waives the required notice and hearing provided in section 218(g) (2) of the Act, as amended, and consents to the removal of a group or groups from the agreement because the group (s) is dissolved, or is no lon-er legally able to function although not legally dis- solved. 6. Authority conferred by section 218(s) of the Social Security Act, as amended, shall be exercised only by the Commissioner of Social Security. Not- withstanding such limitation, the Com- missioner mar redeleg&te the authority to grant, upon application by a State and for "good cause" shown, extensions of the time allowed for filing additional Information or argument In connection with a request for review filed pursuant to section 218(s). - ■:■ ^ 7. Authority conferred • by section" 1866(d) of the Social Security Act, a* amended; to withhold payment for in- patient hospital services or for poet- hospital extended care services for fail- ure to make timely utilization reviews, shall be exercised only by the Com- missioner and Deputy Commissioner of Social Security. '•"-''•* 8. Authority conferred by sections 1816(b) and 1842(b>(2) of the Social Security Act, as amended, where the determination is that an agency, or- ganization, or carrier will be unable to carry out the terms of an agreement (contract), shall be exercised only by the Commissioner of Social Security. 9. Authority conferred by sections 1816(e)(2) and 1842(b) (4) to terminate an agreement (contract) with an agency. Organization, or carrier shall be exercised only by the Commissioner of Social Se- curity: Provided further, That he shall exercise such authority only after a. Such agency, organization, or car- rier has been given an opportunity to request (within such time as is provided for by regulations) the Secretary to re- view the Commissioner's conclusions and findings and, where such request is made. b. The Secretary has declined to re- view or has concurred in the Commis- sioner's proposal to terminate such agree- ment (contract) . . •_*„"-^»> i 10. Agreements and modifications of agreements under section 218, 221(b), 1818(a). 1842(a), 1843(a); 1864(a), 1866(a), or 18T4 of the Social Security Act, as amended, shall be reviewed by the Office of the General Counsel for legal form and substance. 8-P. Redelegation of authority. Unless otherwise stated, authority delegated In section 8-D of this statement may. be redelegated. .-...=. ,-.-. • L-« Kxhu.it XS-1 SOCIAL SiiCUMTT AT>M1MS".'H. TICIN I-KRMAM' •■ ; > . H. |ji Type of office Address ZIP cod* Alabama: Andalusia - -- T'.rancli Off* 408 South Three-Notch St., Post Office Dtnrar 34420 47. Aniii lions liirn ni'T _ 'lu 11 'IK-ItlS Decatur.. Dollisin .. Florence . Gadsden.. 11(11. isvillc Mobile... M< District Office 301 East 13th St., Post Offloe Box98 .. ._ 118-18thSt. North ; . : ,'. '_ 2121 8th Ave. North ■. . 908 South 20th St . 3d Ave. and 23d St .. .: :.jjijir.-.i.^. „ . 400 Wells St. NE., Port Office Box 489... . lOOTCest Troy St., Port Office Box2107. 412 SoutbCourt St., Post Office Box 778 ' il" -201 College St., Post Office Box 950 ; ; <|n... . 2318 WbitesburgDr. South, Post Office Box 1488. do 218St. Francis St., Post Office Box E parities mid Appeals 118 North Hoyal St. lo.. . . . rinci • lid \ V nn, -nl ( ',■1,1, District Oll.ce.. ncry. ... 1 listriet miic olika I'raiicli (Hiiro Si Iiii i 1 'istricl < Hi ci T:i!. ,<;,. -:i l'nnct: Oil cc Tuscaloosa. District Oil o Ala*k,i: Anchorage llraneh Oifcc Juneau.. District ; »,,jc<- Arizomi: Phoenix .-do 1300 North Central Ave., Port Office Box 13118. Hearings mid Appeals 3033 North CentralAw 474 South Court St., Port Office Box 4010 415 First Ave., Post Office Box2U7 908 Alabama Ave :.. _ ... :.. '. . 138 North Court St., Port Office Box 286— ,- . 615 Queen City Ave . 617 Q St : — •_: — .I..:..—.. . 709 West 9th St., Port Office Box 1327 _ 36201 35020 35203 352 OS 35203 35601 36301 35630 35902 36807 36601 36602 36104 36801 36701 35160 36401 99501 99801 85003 85012 FEDERAL REGISTER, VOL. 33, NO. 74— TUESDAY, APRIL 16, 1963 118 3478 NOTICES DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Office of the Secretary SOCIAL SECURITY ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Part 8 (Social Security Administra- tion) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health, Education, and Welfare (33 Fit. 5828 et seq., Apr. 16, 1968) is hereby amended as follows : 8-B Assistant Bureau Director, Inter- mediary Operations, Division of Inter- mediary Operations (BHI) through the Office of the Regional Representative, Health Insurance (BHI) is superseded by the following; Deputy Bureau Director, Program Policy (BHI). Provides national leader- ship and executive direction in initiating, developing, promulgating and interpret- ing Medicare program policies, standards and directives. This includes: Substan- tive policies relating to services provided by hospitals, extended care facilities, home health agencies, physicians (in- cluding provider-based and teaching physicians) , and other suppliers of serv- ices; policies for., reimbursement under the medical insurance program; provider reimbursement and accounting policies and procedures and technical policies on eligibility requirements for beneficiaries, nonmedical coverage exclusions, hearings and appeals, deductibles and coinsur- ance, etc. Sets standards for and coordi- nates the issuance of HI program-related manuals, policy directives and other in- structional issuances. Ensures that inter- related policy areas are meshed into well-coordinated overall policies for the Medicare program. Provides Bureau leadership in developing legislative pro- posals and considering and making rec- ommendations to the Bureau Director on Issues concerning national health care administration and financing. Division of Provider and Medical Serv- ices Policy (BHI). Develops, evaluates and maintains policies for the coverage of Medicare services; policies for reim- bursing physicians (including provider- based and teaching physicians) and other suppliers of services under the medical insurance program; and stand- ards and criteria for use by intermediary personnelin adjudicating claims submit- ted for payment. Studies and evaluates existing policies to determine their ef- fectiveness and develops new or Tevised policies where necessary. Prepares guide- lines for regional office review of inter- mediary performance in applying rea- sonable charge criteria. Division of Provider Reimbursement and Accounting Policy (BHI) . Develops, evaluates and maintains policies for re- imbursement of reasonable costs of Medicare providers and related account- ing policies and procedures. Maintains liaison on reimbursement policy and Re- counting with the American Institute of Certified Public Accountants, inter- mediary advisory groups, the American Hospital Association and others. Devel- ops and maintains a provider cost anal- ysis program. Determines the nature and extent of deviations by intermediaries from the reasonable cost concept of pro- vider reimbursement and recommends appropriate corrective action. Evaluates the propriety of intermediaries' inter- pretations of reimbursement principles. Division of Technical Policy (BHI). Develops, evaluates and maintains poli- cies pertaining to technical and nonmedical program issues such as beneficiary eligibility, deductibles and coinsurance, overpayments, nonmedical exclusions from coverage, etc.; and poli- cies and procedures for reconsiderations, hearing and appeals. Coordinates the de- velopment of specifications for health insurance regulations. Develops stand- ards, coordinates and arranges for the issuance of all HI program- related man- ual and instructional issuances. Prepares the Bureau's case and represents it at hearings involving determinations on provider participation and other admin- istrative determinations. Deputy Bureau Director, Program Op- erations (BHI) . Provides national lead- ership and executive direction for Medicare operating systems and pro- gram operations involving contractual relationships with intermediaries and carriers and the certification of Medi- care providers through State agencies. Develops and monitors systems, meth- ods and procedures for Medicare pro- gram operations, including systems involving intermediaries, carriers, pro- viders, and other suppliers of services, enrollment and collection of premiums from beneficiaries. State buy-in and group premium operations. Develops and maintains conditions of participation for providers of services. Directs negotiation of agreements with State agencies for certifying providers and directs the ad- ministrative and fiscal relationships with these agencies. Directs the Bureau cen- tral and regional administrative and fiscal relationships with intermediaries and carriers including the development of administrative and fiscal policies, procedures and controls relating to con- tractor operations; preparing the na- tional contractor budget and developing the contents of national subcontracts. Maintains relations with national con- tractors (Blue Cross Association, Travel- ers Insurance Co., Railroad Retirement Board, etc.) . Provides Bureau leadership in considering and making recommenda- tions to the Bureau Director on issues concerning national health care' admin- istration and financing. Takes part in development of legislative proposals. Division of Contractor Operations (BHI). Develops regulations, policies and procedures for the selection of in- termediaries and carriers. Develops and evaluates the terms of intermediary and carrier contracts; policies and procedures regarding contract renewals; and cri- teria for the approval of subcontracts. Develops, evaluates and maintains fiscal and operating policies, standards ar.d ! -i structions for contractor perform' a .-ii> and guidelines for regional office adriun.' istrative and financial management r^ lationships with contractors. Conduce the Bureau's relations with the E ■-, Cross Association and other nauan-- contractors. Formulates the nation? budget for contractor operations. iy~. velops a program for analysis o[ co*. tractor operations and analyzes the ej! fectiveness of contractor operations o:\ national basis. Division of State Operations (BHli Develops and evaluates the contents o,' State agency agreements. Develops, evaj. uates and maintains policies, standard! and instructions for State agency ad- ministrative and fiscal activities, and guidelines for the regional office rela- tionships with State agencies and re- gional office review of State agency op- erations. Formulates the national budee: for State agencies. Develops the condi- tions of participation for providers a! services; develops and maintains policia and procedures for provider certification. Reviews and evaluates the provider cer- tification process. Coordinates Bureau activities related to title XDC Control* the processing of emergency sen-ices claims. Reviews regional office decisions on HEW Audit Agency audit exceptions of State agencies and aproves sensitiv? audit exceptions. Division of Systems (BHL). Directs the development and issuance of speci- fications, procedures, and other in- structional material to implement and maintain operational systems for inter- mediaries, carriers, providers and other suppliers of services; the enrollment and •eligibility of beneficiaries, their noti- fication as to utilization of services, and the collection of premiums. Within the framework of overall SSA systems plan- ning, prepares general systems plans and develops requirements for the detailed design and programing for model sys- tems used by intermediaries and carriers. Plans, conducts, and evaluates studies aimed at long-range improvements in systems, methods, and procedures. Assistant Bureau Director, Program Review (BHI) . Provides national lead- ership and executive direction for the review and evaluation of the Medicare program. Is responsible for assessing the extent to which program objectives are being met and how they might be better met. Evaluates the performance of all Bureau components, including regional office surveillance of contractor and State agency operations. Develops and manages a national program to prevent. detect, and document fraud and program abuse situations and assure appropriate 'follow-through actions, and to validate the effectiveness of Bureau policies, pro- cedures, and screening techniques. Iden- tifies patterns and trends of aberrant payments for health services and appro- priately refers identified problems. De- velops and negotiates techniques for de- termining the amount of and means to recover overpayments to institutional providers, physicians, and other supplied of services. Appraises the provider aum- FEOERAl HEGISTE*, VOL.'' 36, NO. 38— THURSDAY, FEBRUARY 25,1971 119 NOTICES 3479 arogram, as to resources, costs, effective- ness, etc., and the responsiveness of the or ogram to the Bureau's requirements. Considers and evaluates alternatives to the existing audit program. Advisory Groups Staff (BHI). Pro- vides technical program support and staff ^rvices for the Health Insurance Bene- *is Advisory Council, its subcommittees Jud other health insurance advisory bodies. Coordinates BHI legislative activ- ••.y in connection with Congressional "•y and other activities in connection srith Congressional hearings in which the Bureau is involved. Drafts the an- nual report on Medicare. Obtains infor- mation for special projects from compo- nents throughout BBX SSA and DHEW jad prepares necessary presentations. Appraisal Staff (BHI). Appraises the Medicare program. Examines the ex- tent to which program objectives are being met and how. they might be better met. Evaluates the quality and effective- ness of program administration, program regulations, policies, procedures and op- erating systems. Serves as Bureau focal point for audit liaison with the Office of Administration and is responsible for co- ordinating the preparation and assuring the appropriateness of the Bureau's replies to GAO and HEW Audit Agency reports. Program Evaluation Staff (BHI>. De- relops policies and procedures for ensur-' tag the integrity of the health insurance program, Including the detection of po- tential fraud and program abuse situa- tions and improving contractor and re- gional office program integrity activities. Coordinates the Bureau's program in- tegrity activities, including the review of and referral to the Office of Ad- ministration and/or the Office of General Counsel of fraud and program abuse cases referred by the regional offices. Develops » program to validate the effectiveness of Bureau policies, procedures, screening techniques, etc., including a system for the acquisition and analysis of opera- tional data to identify aberrant pro- riders. Provides leadership and technical direction to and develops guidelines for the use of regional offices in conducting on-site validation reviews. Conducts selected on-site validation reviews of critical or sensitive cases, to evaluate regional office performance and to main- tain the expertise necessary to direct Medicare validation activities. Provider Audit Program Appraisal Staff (BHI) . Evaluates the provider audit Program (including postreview of com- pleted cost settlements) in terms of re- sources employed, costs incurred, degree °f effectiveness and the responsiveness of *e program to Bureau requirements. Considers and evaluates provider audit Program alternatives. Recovery Staff (BHI). In unusually sensitive or complex cases, develops the amount of overpayment to providers, Physicians and other suppliers of serv- ices. Negotiates with providers, physi- C; ans and other suppliers as to the ac- c ertability of the statistical and sampling techniques used to determine the amount of the overpayment and nego- tiates the method of repayment. Provides •consultation to other governmental com- ponents (including Department of Justice) where resort to the courts is nec- essary to recover an overpayment. • Assistant Bureau Director, Central Op- erations (BHI). Provides national lead- ership and executive direction for a variety of the Bureau's centralized staff and operating functions. Directs SSA's function as the intermediary for a na- tionwide mix of direct-dealing providers and group practice prepayment plans. Directs the Bureau's experimentation and demonstration projects programs, in- cluding the incentive reimbursement ex- perimentation program. Makes determi- nations on intermediaries' decisions for all Part A claims where the beneficiary or his representative has requested reconsideration. Reviews overpayment cases involving beneficiaries to determine the amount of overpayment and com- pleteness of documentation. Plans, di- rects and coordinates the BHI health Insurance inquiries program. Plans, de- velops, coordinates and conducts a com- prehensive program to establish and maintain effective professional relations with individuals and organizations in the health community. Develops, coordinates and implements a total management program for the Bureau, including Bu- reau-wide organization planning, opera- tional planning and other management analysis functions; internal Bureau financial management; manpower selec- tion and placement; employee develop- ment; manpower utilization and admin- istrative services. Division of Direct Reimbursement (BHI). Plans, directs, coordinates and performs the examination, review, au- thorization or disallowance, and deter- mination on payments of bills submitted by direct-dealing providers and group practice prepayment plans. Develops methods and procedures for processing the bills of direct-dealers. Directs and coordinates liaison and communication as needed by direct-dealers on all aspects of the health insurance program. Col- laborates and follows up with other BHI and SSA components, as necessary, on problems involving direct-dealing pro- viders determines the methods, proce- dures, policies and reimbursement for- mulas for current payments to direct- dealing providers, and the amounts, methods and frequency of retroactive adjustments. Analyzes cost reports from direct-dealing entities to validate ag- gregate costs previously reimbursed and, as part of a continuing aduit program, to determine final program liability for specific accounting periods. Division of Management (BHI). De- velops, coordinates, and implements a • total management program for the Bu- reau, including Bureau-wide organiza- tion planning and other management analysis functions, internal Bureau fi- nancial management, manpower selec- tion and placement, employee develop- ment, position control and manpower utilization. Develops and issues Bureau- wide administrative directives. Provides Bureau-wide project control, problem area reporting, coordination of Bureau operational planning activities, manage- ment information and a variety of ad- ministrative-support services. - ,"• Division of Special Operations (BHI) . Makes determinations to affirm or re- verse intermediaries' decisions on all Part A claims on which a beneficiary or his representative has requested re- consideration. Reviews liability and the amount of overpayment in individual beneficiary overpayment cases, and re- fers case files to the proper components for appropriate action. Plans, directs and coordinates the BHI inquiries analysis program, including responses to complex health insurance inquiries and analysis of inquiries to determine trends in Con- gressional and public thinking. Reports trends to top management. Directs the Bureau's experimentation and demon- stration projects programs, including the incentive reimbursement expert - : mentation program. Coordinates with related experimentation activities of other DHEW components, e.g., Public Health Service. Conducts studies of non- governmental reimbursement programs and management controls which show promise of cost containment. Professional Relations Staff (BHI), Plans, develops, coordinates, and con- ducts a comprehensive program to estab- lish and maintain effective professional relations with individuals and organi- zations in the health community. Par- ticipates with the Office of Public Affairs in the preparation of information for professional organizations and profes- sional media covering the administra- tion, operations and provisions of the health insurance program. Office of the Regional Representative, Health Insurance (BHI) . Represents the Bureau on a regional level. Assures effec- tive administration of the Medicare pro- gram through day-to-day liaison, coordi- •nation, and continuing appraisal of Medicare contractors, State agencies r direct-dealing providers, State buy-in agencies, district offices, providers of services and other organizations and in- dividuals involved In Medicare opera- tions. Insures that SSA policies and pro- cedures are implemented, initiates action to resolve problems and reports problems and trends needing national attention to central office. Conducts in-depth surveys to evaluate the health insurance pro- gram including contractor performance appraisals, program validation studies, and participation in State agency and district office comprehensive reviews. Di- rects and participates in program integ- rity activities in the region. Develops and implements a professional relations pro- gram for the region. Reviews, evaluates and approves (within limits of delegated authority) a variety of actions such as full renewal of intermediary and carrier contracts, certain subcontracts, budget actions and annual settlements, State FEDERAL REGISTER, VOL. 36, NO. 38 — THURSDAY, FEBRUARY 25, 1971 120 3480 agency agreements, provider agreements and terminations, State agency budgets, and State buy-in agreements. (Sec 6 Reorganization Plan No. 1 of 1953) Dated: February 17, 1971. Rodney H. Brady, Assistant Secretary for Administration and Management. By: Ronald Brand, Deputy Assistant Secretary for Management Systems. IFR Doc.71-2560 Filed 2-24-71;8:49 ami DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Center for Disease Control NOTICE OF MEETINGS The Director, Center for Disease Con- trol announces the meeting dates and other required information for the fol- lowing National Advisory bodies sched- uled to assemble during the month of September 1973. Committee' Date, Type of meeting time, place and/or contact person Committee name Date, time, place Type of meeting and/or contact person Venereal Die- Bept. 12-14, ease Control 8:00 a^n^, Adrisorv Koom 207, Committee. Bide. 1, Cen- ter lor DIs- ■ ease Control, Atlanta, Ga. Open— Contact Mr. J op H. Miller, Room 320, Bldg. B, Center for Disease Control, Atlanta, Ga. Code 404-633-3937 NOTICES Agenda items are subject to change as priorities dictate. A roster of members and other relevant Information regarding the open/closed sessions may be obtained from the con- tact persons listed above. Dated August 29, 1973. David J. Sencer. Director, Center for Disease Control. IFR Doc.73-19112 Piled 9-7-73:8:45 am] •Setoiy and Bept. 13-14, Open— fcOO ajn.— Occupational 9:00 a.m., 2:35 pan. on Health Study Parklawn Sept. IS. Closed- Section; Bldg., H00 remainder of Fishers - meeting. Contact Lane, Dr. John F. Bester, RockviDe, Room 9A-1A, Park- Mo. lawn Bldg., MOO Fishers Lane, Rock- viUe. Md. Code 301- 443-4483 Pnrpoee: The committee Is charged with the initial review of research, training, demonstration, and fellow- ship grant applications for Federal assistance in programs >veas administered by the National Institute for Oc- cupational Safety and Health, and with advising the Institute staff on training and research needs. Agenda: From IfcOO a.m. to 2:36 p.m. on September 13 'he Study Section will be open for administrative and itaff reports, current status of support for training, NIOSH manpower development plans, occupational iXMdicine residence support, retention of existing training programs and stimulation of additional programs, and planned conference on training for black colleges. From 2:35 p jn. on September 13 through the end of the meeting, the Study Section will be reviewing research and demon- ttrstion grant applications and will not be open to the public, m accordance with the determination by the Director, Center (or Disease Control, pursuant to the provision* of Public Law 92-463, Section 10 (d). Office of the Secretary BOARD OF ADVISORS TO THE FUND FOR THE IMPROVEMENT OF POSTSECOND- ARY EDUCATION Notice of Meeting Notice of Public Meeting of the Board of Advisors to the Fund for the Improve- ment of Postsecondary Education. Notice is hereby given, pursuant to .section 10(a) (2) of the Federal Advisory Committee Act (Pi. 92-463). that a meeting of the Board of Advisors to the Fund for the Improvement of Postsec- ondary Education will be held on Sep- tember 12, 1973, beginning at 7:30 pm., and on September 13 and 14, beginning at 9:00 am., at Glen wood Manor, Over- land Park, Kansas. The purpose of the meeting Is to con- sider priorities and procedures for fiscal 1974 guidelines for the prograr of Sup- port for Improvement of Postsecondary Education authorized by section 404 of the General Education Provisions Act. The meeting shall be open to the pub- lic. Records shall be kept of all proceed- ings and shall be available for public inspection at the Fund for the Improve- ment of Postsecondary Education, 400 Maryland Avenue SW„ Room 3139, Washington, D.C. 20202, telephone num- ber 202-962-3704. Signed at Washington, D.C, on Sep- tember 5, 1973. Virginia B. Smith, Director, Fund for the Improve- ment of Postsecondary Educa- tion. (FR Doc.73-19184 Filed »-7-79;8 :45 am] Purpose: The committee Is charged with advising on l^e&ns and methods -of implementing venereal disease ooatrol programs, reviewing current end proposed pro- &r«n operations and suggesting new areas of control ^laphasis. Agenda: Items will Include a status report on venereal •iisease, orientation and background discussion of current pr-^ram emphasis, the ''Venereal Disease Communica- tions Plan" and its Implementation, current and future operational research, and new areas of program emphasis. SOCIAL SECURITY ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority The Statement of Organization, Func- tions, and Delegations of Authority for the Office of Administration in the Social Security Administration (Chapter 8 of the Statement of Organization, Func- tions, and Delegations of Authority for the Department of Health, Education, and Welfare) , is hereby revised to reflect the abolishment of the two present posi- tions of Deputy Assistant Commissioner for Administration; to reflect the estab- lishment of the new position of Director of Human Resources, with responsibility for overall guidance and direction of all employee-oriented functional compo- nents witliin the Office of Administration, except the Special Staff for Labor R^' a tions and Equal Opportunity; to rc^tri the abolishment of the SSA Operation Research Staff; and to reflect the pr^r" 1 ent functions assigned to the con-p-Z nents of the Office of Admirustration. ■"* new Statement for the Office of Ads**-' istration (OA) reads as follows: Mission ■The Office of Administration plans »•*« directs the management program of cie Social Security Administration (SSV '«■ provides overall adrninistrative leaoVr." ship for the Commissioner of Soci»; Security in coordinating program adrm-,. istration throughout SSA, and in p!^. ment programs, policies, and activities. Organization The Office of Administration, unOr the supervision of the Assistant Corr/- missioner for Administration, constm of: 1. The Assistant Commissioner for Administration 2. The Immediate Office of the Assist- ant Commissioner for Administration 3. Functional Components within ih* Office of Administration The Assistant Commissioner for ju~ ministration. — A. The Assistant Cora- mlssioner for Administration is direct:* responsible to the Commissioner of So- cial Security and provides general super- vision to each component In the Offlcr of Ad mi nistration. B. In the event of the absence or &%- ability of the Assistant Commissioner fee Administration, or in the event erf a vacancy in this position, the Deputy As- sistant Commissioner for Admin Is Lt»:mc - acts for him. C. In the event of the absence or &*• ability of both the Assistant Comas»- sioner for Administration and the Depct* Assistant Commissioner for Administra- tion, or in the event of vacancies In boti positions, a designated OA Execcr** acts for them. Immediate Office of the Auisi**-' Commissioner for Administration — 7>* Immediate Office of the Assistant Coo mlssioner for Administration consists e* 1. The Assistant Commissioner tct Adniinistration. 2. The Deputy Assistant Cornmisfl«*r for Administration. 3. The Executive Officer. 4. The Management Coordination »»* Special Projects Staff. 5. The Special Staff for Labor R*£» tions and Equal Opportunity. Functional Components Wilhin 9e Office of Adminstration.—The 0^» » Administration consists of the iol!C "~* functional components, each undrr J*» immediate day-to-day supervision « * director: _ 1. Office of the Director, Humar^ **- sources. ^ 2. Division of Administrator *j- praisal and Planning. ___ n j tf 3. Division of Financial Manitro"^ 4. Division of Operating P*^ 11 ^,. 5. Division of Systems CoorcUs*-*- and Planning. ^DERAL *EGISm,'VOL 38, NO. 17*— MONDAY, SEPTEMBER. 10, 1973 121 N TICES '24673 Functions The Office of Administration is respon- sible for: L, Planning, directing, and controlling SSA management programs, policies, and activities. 2. Administering SSA-wide programs in the areas of: labor relations and equal opportunity; personnel administration; training and employee career develop- ment; administrative appraisal and planning; budget and financial manage- ment; planning, analysis and coordina- tion of all SSA systems; facilities man- agement and other management support activities; procurement and supply management; employee communica- tions: audit liaison and coordination; and employee health services. 3. Providing overall administrative leadership for the Commissioner of Social Security in coordinating program administration throughout SSA. 4. Representing SSA on matters of overall program administration and management with DHEW, other Federal agencies, and non-Federal organizations. Immediate Office of the Assistant Commissioner for Administration. — A. The Assistant Commissioner for Admin- istration : 1. Is responsible to the Commissioner of Social Security for provision of over- all executive leadership in coordinating program administration throughout SSA, so as to achieve the total program mis- sion of SSA. 2. Plans, directs and controls the man- agement, personnel and administrative programs of SSA, in order to meet the needs of SSA program administration, goals and objectives. B. The Deputy Assistant Commis- sioner for Administration assists the As- sistant Commissioner for Administration in the carrying out of his responsibilities and performs such duties as the Assistant Commissioner prescribes. C. The Executive OiTicer assists the As- sistant Commissioner for Administration and Deputy Assistant Commissioner for Administration in the overall manage- ment of OA. D. The Management Coordination and Special Projects Staff: 1. Serves as the personal staff to the Assistant Commissioner for Administra- tion by aiding him in coordinating and integrating the many-faceted and in- terrelated activities of OA, and by pro- viding him with advice, assistance, prob- lem identification, and recommendations for problem resolution with respect to projects, negotiations or work areas of special interest or concern to the Assist- ant Commissioner. 2. Conducts or directs projects of major SSA-wide importance and signif- icance on assignment by the Assistant Commissioner for Administration. E. The Special Staff for Labor Rela- tions and Equal Opportunity: 1. Assists the Assistant Commissioner for Administration in directing, coordi- nating, developing, and appraising the effectiveness of policies for SSA-wide programs of labor relations (LR) and equal opportunit: iEO), as provided for under Executive Orders 10988, 1124(5, 11375 and 11491, as amended. 2. Reviews the employment posture cf health insurance intermediaries under contract with SSA, for compliance with the EO requirements of Executive Order 11246. 3. Conducts liaison with DHEW, other Federal agencies and various other pub- lic or private organizations on matters concerning LR. EO and civil rights. Functional Components Within the Office of Administration. — The func- tional components within the Office of Administration have the following re- sponsibilities: 1. Office of Hie Director, Human Re- sources. — The Director of Human Re- sources is responsible for: a. Providing direction to the develop- ment, implementation, and maintenance of a totally integrated and coordinated SSA program responsive to the needs of SSA's human resources. b. Representing SSA in dealings with DHEW, other Federal agencies, and sources outside the Federal establish- ment with respect to matters concerning personnel and human resources manage- ment programs. c. Providing executive-level line direc- tion and supervision to the following Human Resources components: U> The Division of Personnel, which is responsible for: (ai Directing the personnel manage- ment program of SSA and developing its personnel management objectives, poli- cies, standards and procedures. Directing the management-em- ployee communications program of SSA; identifying weaknesses In management- employee communications and recom- mending improvements; providing advice and consultation on management com- munications with employees; and pro- viding assistance to and appraising man- agement-employee communications ac- tivities in the field. . (b) Publishing a variety of Informa- tional materials, including a monthly employee magazine, a semi-monthly management newsletter, and a weekly central office bulletin ; and preparing and editing administrative reports and presentations. (4) The SSA Employee Health Service, which is responsible for: (a) Directing the preventive health program for SSA and promoting the health, efficiency, and productive lon- gevity of its employees, through admin- istering mass screening programs, offer- ing Individual services, and conducting physical examination programs." (b) Treating all types of medical emer- gencies in work situations, arranging other Governmental and private medical or surgical services, and providing refer- rals to appropriate private and commu- nity resources. - (c) Establishing and enforcing stand- ards of employee health and comfort through a broad environmental health program, and conducting a continuing health education program. 2. The Division of Administrative Ap- praisal and. Planning, which Is respon- . siblefor; a. Directing the appraisal of total SSA administration, planning for efficient SSA organization and operations, and developing major operating and admin- istrative goals and measures of effective- ness for SSA program administration. • b. Identifying current and emerging administrative problems, recommending remedial actions, and continually ap- praising organizational effectiveness. c. Appraising the need for and promul- gating delegations of program and ad- ministrative authority throughout SSA. d. Conducting, coordinating, and inte- grating leng-range operational, organi- zational, and administrative planning; providing leadership in administrative planning for pending legislation; and developing consistent and progressive administrative policy and philosophy. e. Representing SSA in dealings with' DHEW Audit Agency and GAO site audit teams. f. Investigating alleged program and criminal violations, employee miscon- duct, and other lrregularitiesr g. Conducting an SSA historical re- search program and. directing SSA emer- gency preparedness activities. h. Representing SSA in dealings with DHEW, other Federal agencies, and vari- ous other public or private organizations on matters of concern to the adminis- tration of SSA programs and the fulfill- ment of the Division's mission. 3. The Division of Financial Manage- ment, which is responsible^ for: FEDERAL REGISTER, VOL. 33, NO. 174— -MONDAY, SEPTEMBER 10, 1973 122 M-C7 1 N TICES a. Directing the financial management program or SSA; developing its financial management objectives, policies, stand- ards, and procedure:;; and providing fi- nancial advice en program matters and initiating cost studies. b. Planning, preparing, justifying, and executing the SSA budget and preparing urd justifying budget estimates to fi- nunce program and other legislative changes. c. Conducting continuing evaluation of expenditures of funds, taking actions to improve fiscal effectiveness; conducting continuing evaluation of financial sys- tems and implementing improvements; and insuring that financial systems are integrated within SSA and with DHEW. d. Maintaining administrative ac- counts, certain trust fund expenditure and receipt accounts; auditing and cer- tifying of vouchers for administrative expenses; and preparing basic and re- quired financial reports. e. Representing SSA in financial man- agement dealings with DHEW, other Federal agencies and various other pub- lic or private organizations. •i. The Division of Operating Facili- ties, which is responsible for: i a. Directing the management support program of SSA and developing its management support objectives, policies, standards, and procedures. . b. Directing SSA activities in the areas of: the SSA library and related services; centralized headquarters sec- retarial, dictation, transportation end parking s>ervices; construction or leasing of buildings; space utilization: forms and records management: printing and graphics; real and personal property management; procurement; supply and mail systems; employee safety; civii de- fense; and physical security. c. Providing SSA liaison with the General Services Administration on matters related to the maintenance and servicing of headquarters facilities, and with DREW, other Federal agencies and various other public or private organiza- tions on matters related to the Division's mission. • 5. The Division of Systems Coordina- tion and Planning, which is responsible for: a. Providing SSA-wide leadership and direction for systems planning and co- ordination, and developing, maintaining, and improving its total data processing system and plans. b. Establishing systems policies and standards; planning overall specifica- tions for SSA systems; and reviewing and evaluating proposed systems and equipment changes for conformance with longer range SSA systems planning goals and integration with existing SSA systems. c. Representing SSA in dealings with DHEW, other Federal agencies, and various other public or private organiza- tions on systems and policy mattei Dated August 3 J, >ordination, planning 1973. S. H. Clarke, Acting Assistant Secretary for Administration and Management. [FR Doc.73-19158 Filed 9-7-73;8:45 am] 123 I. THE SOCIAL AND REHABILITATION SERVICE 125 NOTICES 1279 SOCIAL AND REHABILITATION . -, SERVICE ■■-■ • Stotement of Organizotion, Functions,. and Delegations of Authority ~ The following statement supersedes all orerious material issued in Part T (Social and Rehabilitation Service) of the State- ment of Organization, Functions, and Delegations of Authority for the Depart- ment of Health, Education, and Welfare. ~-\. Mission. The Social and Rehabili- tation Service administers the Federal Government programs providing tech- nical, consultative, and financial support to states, local communities, other or- ganizations and individuals in the provi- sion of social, rehabilitation, income maintenance, medical, maternal and child health, family and child ^welfare, and other necessary services to the aged and aging, children and youth, the dis- abled, and families in need. 7-B. Organization and functions. The Social and Rehabilitation Service, under the supervision and direction of the Ad- ministrator, Social and Rehabilitation Service, is composed of the Office of the Administrator, five major central office program organizations (hereinafter "The Bureaus"), and the regional office or- pmlzation. Specifically, SRS consist* of the following components, and functions -• Division of Administration. Plans and carries out the administrative manage- ment functions of the Administration on Aging, in coordination with the SRS Of- fice of Program Planning and the SRS Office of Administration. Serves as the focal point for the annual development of the 5-year Program and Financial Plan and the next year's budget; the justification of the budget to the Bureau of the Budget and the Congress; budget execution; manpower utilization; finan- i cial accountability; and the provision ! of program support services. Coordinates the development of grants management policies and procedures, and the analysis of, and response to, audit reports. -Conducts grants management activ- ities for the Division of Research, Dem- onstrations, and Training. Division of Program and Legislative Analysis. Plans and carries out a sys- tematic program of analysis of existing legislation and programs affecting older persons to identify needed Improvements. Develops and maintains relationships with public and private agencies which -have programs serving or affecting older persons; identifies efforts by these agen- cies to provide opportunities and services for older persons, and the interrelation- ships between them; participates in joint planning operations; and evaluates the impact of these efforts on the needs of the elderly. Conducts studies of special problems of the elderly and is- sues analyses and reports. Provides secretariat services for the President's Council on Aging and the Advisory Com- mittee on Older Americans. Coordinates preparation of periodic reports by thf .President's Council on Aging on prog- ress in the field and recommendations for future action by the Advisory Com- mittee. Analyzes and interprets statis- tics related to older persons generatec by the National Center for Social Statis- tics >and other .sources, identifies trend: and changes in patterns ; and makes pro- jections for planning purposes. Develops Administration on Agim legislative proposalERAl MOISTED VOJL 34. WO. 17— (SATURDAY, JANUAtY 25, 1*69 NOTICES 1287 contained in the Act but w» — * are con- tained in other acts which relate to but do not amend the Act. including, but not limited to, the following Acts: Section 9 of the Act of April 19, 1950, Public Law 474, 81st Congress (re- lating to Navajo and Hopi Indians) . (c) Public Welfare Amendments of 1962, Public Law 87-543, 76 Stat. 172, section 141 (b) and (f). (d> Social Security Amendments of 1965, Public Law 89-97, 79 Stat. 286, sec- tion 121(b). • ■" :, (e) Social Security Amendments of 1067, Public Law 90-248, 81 Stat. 821, sections 201 (g) and (h), 202 (c) and (d), 203(b), 220(b), 234(c), 240(e)(3), 248(c), and 402 (a) and (b). (3) The functions vested In the Sec- retary by the Juvenile Delinquency and Youth Offenses Control Act of 1961 (Pub- lic Law 87-274, as amended, 42 U.S.C. 2541 et seq.), and the Juvenile Delin- quency Prevention and Control Act of 1968 (Public Law 90-445) . (4) The functions vested in the Sec- retary by Public Law 86-571 (24 TJ.S.C. 321 et seq.) (pertaining to hospitalization of mentally ill nationals returned from foreign countries) with the exception of the issuance of regulations under section 1(d)(2) (24 TJ.S.C. 321 (d) (2) ) . (In exer- cising this authority, the Administrator shall work with the Administrator, Health Services and Mental Health Ad- ministration, In arranging for appro- priate use of its resources to provide the most effective and economical adminis- tration of this law.) (5) The functions vested in the Sec- retary by letter dated September 1, 1960, to the Secretary of the Treasury from the Director, Bureau of the Budget, au- thorizing the carrying out of programs under section 104(k) (now sec. 104(b) (3) of the Agricultural Trade Development and Assistance Act of 1954, as amended <7 DSC. 1704(b)(3)), insofar as this authority pertains to the mission of the Social and Rehabilitation Service as described in section 7-A of this state- ment: Provided, That this authority shall be exercised in accordance with ap- plicable policies and procedures estab- lished by appropriate authorities to in-sure consistency with basic foreign Policy and with related Federal procrams. «'6> The functions vested in the Sec- retary by section 4 of the International Health Research Act of 1960, Public Law fi^-610; 74 Stat. 364, 22 U.S.C. 2102. with respect to responsibilities relating to the mission of the Social and Rehabilitation Service as described in section 7-A of this statement: Provided, however, That such authority, with respect to the exercise of •"' sensibilities under the Act entitled An Act To Establish in the Department o- Commerce and Labor a Bureau .To Be j-.nown as the Children's Bureau" (42 <- *C. ch. 6) , shall be administered under the Administrator's supervision and direction through the Children's Bureau: Provided further, That this authority shall be exercised in accordance with ap- plicable policies and procedures estab- lished by appropriate authorities to insure consistency with basic foreign pol- icy and with related Federal programs. (7) The functions under Executive Order 11001, sections 3(g), (4), and those portions of sections 6, 7, 9, 10, 11, and 12 pertaining to emergency welfare and the development of preparedness pro- grams covering rehabilitation of dis- abled survivors. In the performance of these emergency functions the Adminis- trator shall coordinate the health activ- ities of the Social and Rehabilitation Service with the Administrator, Health Services and Mental Health Administra- tion, in order that preemergency plans shall be developed in consonance with postattack- organizational plans and structure of the Department for the Emergency Health Services. . . (8) The functions under the Migra- tion and Refugee Assistance Act of 1962, Public Law 87-510: 76 Stat. 121, 22 UJS.C. 2601 delegated to the Secretary by Execu- tive Order 11077 of January 22, 1963, effective as of July 1, 1962. . ' (9) Functions vested in the Secretary by the Vocational Rehabilitation Act, as amended (29 UJS.C. ch. 4). (10)- Functions of the Secretary as Chairman of the National Advisory Council on Correctional Manpower and Training; functions of the Secretary as Chairman of the National Policy and Performance Council; functions of the Secretary as Chairman of the National Advisory Council on Vocational Rehabilitation; functions of the Secre- tary as Chairman of the Executive Com- mittee of the President's Council on Ag- ing (Executive Order 11376, Oct. 17, 1967). . (11) Functions under section 9 of the Federal Employees' Compensation Act, as amended (5 U.S.C. 759) , retained In the Federal Security Administrator by Re- organization Plan No. 19 of 1950, and transferred to the Secretary by Reor- ganization Plan No. 1 of 1953. " (12) Functions transferred by Reor- ganization Plan No. 2 of 1946 and Re- organization Plan No. 1 of 1953, to the Secretary from the Office of. Education and Commissioner of Education under the Act of June 20, 1936, 49 Stat. 1559 (Randolph-Sheppard Act, 20 U.S.C. ch. 6A). (13) Functions vested in the Secretary by amendments to the statutes cited In Items (9)-(12), above, enacted subse- quent to Reorganization Plan No. 1 of 1953. (14) Authority vested in the Secretary under sections 602(f) and 605(b) of the Public Health Service Act, as amended, to approve applications and requests re- , lating to rehabilitation faculties. (15) The functions vested in the Sec- retary and the Administration on Aging by the Older Americans Act of" 1965, as amended (42 U.S.C. 3001 et seq.) . (16) The functions under title XVn of the Social Security Act, as amended 135 (42 UJ3.C. 1391 et seq.), relating to grants to States for planning compre- hensive action to combat mental retardation. (17) The functions under parts B, C and D of title I and the functions relat- ing to grants for the construction of facilities for the mentally retarded of title IV of the Mental Retardation Fa- cilities and Community. Mental Health Centers Construction Act of 1963, as amended (42 UJS.C. 2661 et seq.) . (18) Such of the authority under the Public Health Service Act, as amended, as Is necessary to carry out the functions exercised, as of August 1, 1967, by the Division of Mental Retardation, more particularly for the following purposes under the following sections of that act: (a> Section 301, 42 UJS.C. 241, to make grants for research or research training projects in the field of mental retarda- tion recommended by the National Ad- visory Health Council ; and (b) Section 303(a), 42 U.S.C. 242a. to make hospital improvement project grants, including institutional improve- ment project grants and inservice train- ing project grants to hospitals or other institutions for the mentally retarded (such grants to be made only upon the recommendation of the National Ad- visory Mental Health Council and to be paid in advance or by way of reimburse- ment as may be determined by, and on such conditions as found necessary by, the Administrator, Social and Rehabili- tation Service ) . ■<* • (19) The functions performed by the Children's Bureau under the Act of April 9, 1912, as amended (42 U.S.C. ch. 6) , shall continue to be performed by the Chief of the Children's Bureau under the supervision and direction of the Ad- ministrator, Social and Rehabilitation Service. ' • '• -" 7 (20) The functions under the Eco- nomic Opportunity Act of 1964, Public Law 88-452, 78 Stat. 508 as amended, 42 UJS.C. 2701 et seq.: (a) Delegated to the Secretary pur- suant to the Delegation of Authorities from the Director, Office of Economic Opportunity, dated October 24, 1964 (29 F R. 14764, Oct. 29, 1964) , pertaining to Title V, Part A, Work Experience Pro- grams, including related authority, and subject to the limitations, set forth in such Delegation ; and (b) To be performed by the Secretary pursuant to the Agreement signed by the Director, Office of Economic Oppor- tunity, on March 10, 1965, and by the Secretary on March 31, 1965, pertaining to the furnishing of services in the ad- ministration of the Foster Grandparent Program authorized under such Act. (b) Continuation of ot?»er delegations. All delegations heretofore made to the Commissioner of Welfare, the Commis- sioner of Vocational Rehabilitation, the Commissioner on Aging, and the Chief of the Children's Bureau shall be deemed to have been made to the Administrator, Social and Rehabilitation Service. (c) Advisory functions. All functions of committees (including councils, boards, and other advisory bodies) FEDERAL REGISTER, VOL 34, NO. 1 7— SATURDAY, JANUARY 25, 1969^ 1288 established as of August 15, 1967, serv- ing in an advisory capacity to the Wel- fare Administration, the Vocational Re- habilitation Administration, and the Ad- ministration on Aging, are -continued and revested in such committees. 7-E. Limitations on authority, (a) The authority to appoint members to the Advisory Council on Public Welfare, the Advisory Council on Medical Assistance, the National Advisory Council on Nurs- ing Home Administration, the National Advisory Council on Vocational Rehabil- itation, the National Policy and Per- formance Council, the National Advisory Council on Correctional Manpower and Training, and the Advisory Committee on Older Americans shall be exercised only by the Secretary. (b) No State plan or amendment thereto submitted pursuant to any stat- ute administered by the Social and Re- habilitation Service shall be finally dis- approved without prior consultation and discussion by the Administrator with the Secretary: -' - (c) An application for designation as a State licensing agency under the Act of June 50, 1936, as amended (Randolph- Sheppard Act, -20TJJ5.C. cK. 6A), shall not be disapproved, nor shall a desig- nation made pursuant to that Act be re- voked, without Trior consultation and discussion by the Administrator with the Secretary. . 7 \_ 7-P. Redelegation of authority.' Au- thority contained iiusection 7-D of this Statement may be redelegated by the Administrator to such officers and em- ployees of the Social and Rehabilitation Service as he may deem appropriate. 7-G. Continuation of regulations. All regulations, -rules, orders, authorities or statements of policy or Interpretation heretofore issued with respect to the for- mer Welfare Administration, the former Vocational --Rehabilitation Administra- tion, the Administration on Aging, the Children's Bureau and the Division of Mental Retardation are continued in full force and -effect, -under the authority of the Administrator, until revised, super- seded, -or revoked. Approved: January 17, 1969. - Wn.BOR J. Cohen, • - Secretary. IF.B. Doc. S8-3085; Piled, .Jan. 84 1969; B:80 aan.] DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE ' Office of the Secretary SOCIAL AND REHABILITATION SERVICE Statement of Organization, Functions, and Delegations of Authority Part 7 of the Statement of Organiza- tion, Functions, and Delegations of Au- thority for the Department of Health, Education, and Welfare (34 F.R. 127y, Jan. 25, 1969, as amended) is hereb? further amended to reflect the reorga- nization of the Medical Services Adminis- tration. For such purposes, section 7-B is amended as follows: . By striking out all that follows under the heading "Medical Services Adminis. tration" and inserting in lieu thereof the following: ..--. : .-, Provides national leadership in the ad- ministration of title XTX programs. Di- rects the planning, coordination, and development of these programs and the development of effective relationships between them and other federally supported health and health-related programs - '-■■-..:.- Within broad Department of Health, Education, and Welfare and Social and Rehabilitation Service policy and guide- lines and subject to the health policy direction and other authority of the As- sistant Secretary for Health and Scien- tific Affairs, the Medical Services Administration establishes program goali and objectives; develops policies, stand- ards, and guidelines to accomplish stated goals; provides professional guidance and assistance to State and local organiza- tions and leadership -to regional office staff; develops modifications and innova- tions in program and in administration: works with and coordinates with other Social and Rehabilitation Service orga- nisations and related health component! of the Department to organize training and assistance programs in the States to promote and provide skilled medical and medically related manpower to bet- ter assist the needy; obtains, analyzes. and provides information related to med- ical assistance; develops and implement* appropriate Information and payment systems, main tains relationships with a variety of Federal, State, local, and non- governmental organizations who have an interest in the health and welfare of the Nation and who have an impact on Medi- cal Services Administration programs: evaluates progress in State and national administration of the title XDC programs and takes action to direct or redirect national and State efforts; conduce organizational management analysis ai» planning (including PPBS coordination). suuninistrative and program budget staffing, legislative, and other general to- ministrative services activities, conduce public information, public inquiries, 8^» public education activities; prop#* legislation to provide for changing need* of program directions and for financm* 136 NOTICES . be tter health care to program recip- «its- promotes experimental programs n financing of health delivery systems. p-ovides management support to ad- :' y councils. The Medical Services Ad- ministration has assigned functional re- sponsibilities to the various offices and divisions as follows: Office of Program Planning and Evalu- ,':on. Develops policies and plans for the development and coordination of the fi- nancing aspects of the Federal/State -edical care programs for persons eligi- ble under applicable titles of the Social Security Act. Determines statistical data to be collected; and maintains records of characteristics of State title XIX plans. Conducts studies of the economy with emphasis on areas relating to the medical aspects of the title XIX program. Coordinates with all other health-related DHEW policymaking organizations and works with Federal, State, MSA, and nongovernment advisory groups. Sets ob- jectives and goals for MSA; guides pro- gram and administrative planning; re- views total program effort and prepares appraisal of programs of national impact. Office of Program Innovation. Devel- ops modifications and innovations in the administration of title XTX programs; promotes experiments in funding ar- rangements for health plans; collabo- rates with related Federal, State, re- gional, and community agencies in de- veloping and implementing new health systems concepts to assure that title XDJ activities are supportive of general systems improvements; coordinates title XIX support of research, demonstration projects, and analytic studies concerned with reducing the cost of making high quality health care available to the indigent. Division of Management Information and Payment Systems. Plans and de- velops specifications for management in- formation and payment systems; admin- isters a management information system for the medicaid program; evaluates and improves the claims payment process; assists States and regions in the develop- ment and implementation of systems, provides regional, State, and headquar- ters liaison for EDP systems; provides staff coordination, direction, and advice to MSA organizations on reporting re- quirements and information; makes analyses and prepares management data and information necessary to administer the programs. Division of Program Operations and Standards. Develops and prepares poli- ces, standards and guides to regions and States for program participation, opera- tions, administration and related areas; reviews State administration and opera- '■'•ox\s; insures that program activities, '■andards, and other issuances are con- : tent with those of the Public Health Service and witn the Social Security Ad- ministration; develops reimbursement ''■indards for skilled nursing homes, hos- ^•ils, and other providers of medical °are under the title XTX program; co- ordinates with regions on individual ^••ate problems; assists States in plan- ning for and in extending the scope, content and quality of programs; co- operates with Assistance Payments Ad- ministration in the development of policies, methods, and guides for deter- mination of eligibility for medical as- sistance. In coordination with other SRS organizations, formulates medical eligi- bility criteria for Aid to the Blind, Aid to Families with Dependent Children, and Aid to the Permanently and Totally Disabled. Division of Technical Assistance and Training. Provides technical assistance and consultation to State agencies on organization, management methods and staffing for the title XIX program; pro- vides liaison functions on expertise for interchange of personnel; develops per- sonnel training and development pro- grams for regional offices and State agencies. Works with States and regions on contracts for procurement of assist- ance, arranges for technical assistance and development not assigned to other divisions and offices/ Approved: March 5, 1970. • Robert H. Ptjcch, Secretary. IPJL Doc 70-3066; Piled, Mar. Iff, 1870; 8:46 *.m.J Public Health Servk* LICENSED BIOLOGICAL PRODUCTS Notice is hereby given that pursuant to section 351 of the Public Health Service Act, as amended (42 U.S.C. 262), and regulations issued thereunder (42 CFR Part 73) , the following establishment license and product license actions have been taken from July 1, 1969, to December 31, 1969,. inclusive. * These lists are supplementary to the lists of licensed establishments and products in effect on June 30, 1969. These were published on March 27, 1969, in FJR. Vol. 34, No. 60, and on August 30, 1969, In FJl. Vol. 34, No. 167. Establishment License* Issued Establishment City snd Stat* License No. Georgia Blood Bank and Serum Laboratories, Ino Columbus, Ga American Blood Bank Service, Inc.. _ Miami, Fla ___ GCI Laboratories, Inc Clearwater, Fla .„ Kb Bio Laboratories, Inc Cincinnati, Ohio Homer-D. Cobb Memorial Hospital c Phenii City, Ala Regional Blood Components, Ltd Los Angeles, Calif Wellcome Reagents Limited _ Beckennam, Kent, England 42; 422 42$ 424 426 426 427 Establishment Licenses Revoked at the Request or the Manutactubeb Establishment City and Stats License No. Cambridge Nuclear Corp Cambridge Mast „. Chicago Wesley Memorial Hospital Blood Bank Chicago, nl „ Illinois Department of PubLto Health, Boreaa of Btologlo Chicago, 111 Products, Division of Laboratories. Sherman Laboratories Detroit, Mich Establishment Licenses Revoked Without Pbejudice and Reissued 350 318 120 Establishment City and State Licensa No. Action Advance Biofactures Corp Lynbrook, N.Y Allied Plasma Corp Miami, Fla. and New . Orleans, La. Barry Laboratories, Inc Detroit, Mich, and Pom- pano Beach, Fla. Behrlng Diagnostics, Inc Woodbury, N.Y Central Florida Blood Bank, Inc Orlando, Fla Qeorgla Blood Bank and Serum Labora- tories, Inc. Metrix Clinical and Diagnostics Division Armour Pharmaceutical Co. Miles Laboratories, Inc Ohio Biomedical, Inc Spectra Biologicals Division Becton, Dickin- son & Co. W. E.and Lela I. Stewart Blood Center, Inc.. Augusta, Ga. and Columbus,, Ga. Chicago, IlL and Kankakee, IU. Elkhart, Ind. and West Haven, Conn. Cincinnati, Ohio Omard, Calif. Tyler, Tei. . 383 Name change. 418 Location added: New Orleans, La. Location added: Pompons Beach, Fla. Name change. 227 Locations added: Enstia, Fla. Roc kl edge. Fla. Seminole, Fla. Tltusvflle, Fla. Location added: Augusta, Oa. Name change and location added: Chicago, 111. Location added: Elkbart, Ind. Name change. Move to Omard, Calif. 119 167 421 149 362 424 344 265 Name change. Peodoct Licenses Ls3ued Product Establi hment License No. Antl-A Blood Grouping Serum Metrix clinical and Diagnostics Division Annoor Phannaceutlcal Co. Anti-B Blood Grouping Serum ..do Do North American Biologicals, Inc Auti-A, B Blood Grouping Serum Metabolic Research Foundation, Inc Do.. Metrix Clinical and Diagnostics Division Armour Pharmaceutical Co. 149 413 41S 149 FEDERAL REGISTER, VOi. 35, NO. 52 — TUESDAY, MARCH 17, 1970 137 DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Social and Rehabilitation Service STATEMENT OF ORGANIZATION^. FUNCTIONS, AND DELEGATIONS OF AUTHORITY The following statement supersedes that portion of Part 7 (Social and Re- habilitation Service) of the Statement of Organization, Functions, and Delega- tions of Authority for the Department of Health, Education, and Welfare (34 P.R. 138 8712 NOTICES 1279, Jan. 25. 1969, as amended), be- ginning with Part 7-A and ending with the Division of Cuban Refugee Program: 7-A. Mission. The Social and Rehabili- tation Service administers the Federal Government programs providing tech- nical, consultative, and financial support to States, local communities, other orga- nizations and individuals in the provision of social, rehabilitation, income main- tenance, medical, family and child wel- fare, and other necessary services to the aged and aging, children and youth, the disabled, and families in need. 7-B. Organization and Functions. The Social and Rehabilitation Service, under the supervision and direction of the Ad- ministrator, Social and Rehabilitation Service, is composed of the Office of the Administrator, the Staff Offices, six major central office program organiza- tions (hereinafter "The Bureaus"), and the Regional Office organization. Specifi- cally, SRS consists of the following com- ponents, and functions (as indicated). " Omci or the Administrator Provides leadership and common serv- ices for all programs and components of the Social and Rehabilitation Service. Immediate Office of the Administra- tor. Provides executive direction to all program components of the Social and Rehabilitation Service in the adminis- tration of social; rehabilitation; income maintenance; research, demonstrations and -training; medical assistance; youth development and delinquency .preven- tion; and other services programs for or relating to the aged and aging, chil- dren and youth, the disabled, and fam- ilies in need. Acts as the focal point in the Federal Government in these fields. Provides leadership; develops legislative proposals; establishes policies and objec- tives; directs and oversees the planning and execution of programs; provides overall management, coordinates pro- gram operations and activities; takes ac- tion to achieve improvements in program eiftcciveness; measures and evaluates re- sults. Maintains relationships with the Congress, Federals state, national, and international and other professional and voluntary agencies and organizations in- volved or interested in the Social and Rehabilitation Service programs. • - The Immediate Office of the Adminis- trator includes the Administrator, the Deputy Administrator, and immediate staff. * Ofwce or Priority Programs Provides leadership and direction in coordinating activities of agency com- ponents to achieve the program objec- tives determined to be of the highest priority ; determines resources and re- sponsibilities for achieving those priority objectives; serves as the, central focus for reporting priority program develop- ments, progress, and problems; provides Central Office guidance and assistance for priority program operations in the Regional Offices; assesses the overall effectiveness of priority program achieve- ments and makes recommendations to the Administrator for strengthening the capabilities for carrying out those responsibilities. Office- of Legislative Affairs. Coordi- nates, plans, and participates in the development of new legislation; coordi- nates the development of testimony, cost estimates and other materials related to legislative proposals; coordinates the preparation of Congressional and other reports on all bills. Reviews and obtains approvals on correspondence with mem- bers of Congress and the public on legislative proposals. Keeps the Adminis- trator and affected staff organizations informed regarding legislation and co- ordinates all recommendations for new legislation. Coordinates all Congressional relations and functions of the various SRS components. Furnishes technical assistance to Congressional committees, committee staffs, individual members of Congress, and public and private orga- nizations in relation to proposals or bills. Serves as the SRS contact point with the Office of the Assistant Secretary for Legislation and the Assistant General Counsel, Legislation Division. Maintains liaison with legislative offices of other agencies of the Department and of other Departments of the Executive Branch. Develops legislative histories of signifi- cant laws and prepares other summaries of the status of legislation and reports of hearings. < ■ • " .■* . Office, of Public Affairs. Plans, directs, and coordinates the public affairs pro- grams of the Social and Rehabilitation Service. Advices on public information considerations and needs involved in program and policy recommendations and decisions. Provides guidance and leadership to all components of SRS in matters involving public affairs. Pro- vides central news, television, radio and film services for all SRS components. With the collaboration of the bureaus and regional offices, assists the States in conducting their information programs. Develops basic SRS policy in the area of public affairs. Serves as the SRS con- tact point on public affairs with the Office of the Secretary, other agencies of the Department, and other Federal departments and agencies. Division of News Media Services. Pro- vides day-to-day relationships with the news media. Plans, prepares, coor- dinates, and evaluates news releases, other news materials, news conferences, and briefings with the press, news mag- azines, and radio and television news departments. Division of Editorial Services. Plans, prepares, coordinates, and evaluates written materials — i.e., speeches, reports, articles, etc. Division of Publications. Plans, pre- pares, coordinates, and evaluates -pub- lications and exhibits. Division of Television, Radio, and Films. Plans, prepares, coordinates, and evaluates television, radio, and film activities and projects. Division of Special Projects. Plans, carries out, and coordinates special proj- ects in the areas of public affairs information. - Associate Administrator for Planning, research, and training Provides leadership and coordination for program planning and evaluation, research and demonstrations, externa! manpower development and traininc and grants management activities of the Social and Rehabilitation Service. Serves as the advisor to the Administrator in these areas. Directs and coordinates the activities of the Assistant Administrator'; in the Office of Program Planning and Evaluation, the Office of Research and Demonstrations, and the Office of Man- power Development and Training. Office of the Assistant ADMiNisTRuor Program Planning and Evaluation Provides staff leadership, advice, di- rection, and coordination for the overall planning and evaluation activities of the Social and Rehabilitation Service. Serves as the contact point for the Office of the Administrator with the Office ol the Assistant Secretary for Planning and Evaluation and the Bureau of the Budget on program planning and evaluation activities. Division of Program Planning. Pro- vides policy direction and coordination for all SRS program planning activities Develops planning systems for use by the Bureaus and Regional Offices. Co- ordinates the Program Planning and Evaluation System program of SRS, in- cluding the translation of the long-range goals into incremental annual opera- tional plans. Provides agencywide direc- tion in the development of the SRS multiyear Program and Financial Plan. Division of Program Evaluation. Di- rects studies and analyses of program objectives and accomplishments, com- pares the benefits and costs of alternative programs and explores future needs in relation to planning programs. Directs and coordinates evaluation activities to appraise the relation of Federal pro- grams to the social and rehabilitative needs and goals of the Nation. In coordi- nation with the Office of Program Statistics and Data Systems, prescribes measures and indicators of program progress which can be used in achieving program objectives. OmcE of the Assistant Administrator. Manpower Development and Traininc Provides staff coordination, direction and advice on the development of train- ing goals and policies for State and local agency staff development programs. Co- ordinates the development of standards and guidelines for State and local agen- cies. Participates in planning and execut- ing policies and programs for meeting State manpower needs in programs ad- ministered by the Social and Rehabilita- -tion Service, including estimating re- quirements and developing effective methods and resources to meet these needs. Works with national organizations and associations and educational insti- tutions to stimulate resources and cur- riculum development for training o< professional, sub-professional and lay persons in social and rehabilitation services. Division of In-Service Training Pro- grams. Cooperates with regional offices in providing assistance to State and loca- agencies in the development of in-service training programs designed to increase the skills and competence of State and FEDERAL REGfSfEK, VOL 15, NO. 108 — THURSDAY, JUNE 4, 1970 139 NOTICES 8713 'ocal agency personnel. Identifies operat- '„, problems of those agencies and rec- ommends training programs to meet their needs. Provides financial support for continuing education of personnel in all fields and for staff development pro- grams of State agencies. Division of Professional Programs. Co- operates with regional offices in provid- ing guidance to State and local agencies and groups in the development of long- term training programs designed to de- velop a balanced, coordinated and ef- ficient approach to the critical problem of professional and managerial man- power in the delivery of social and re- habilitation services. Provides teaching and traineeship grants to public and voluntary nonprofit agencies and edu- cational institutions. Division of Subprofessional Programs. Cooperates with regional offices in pro- viding guidance to State and local agen- cies and groups in the development of long-term training programs designed to develop subprofessional and ad- ministrative support capability for the State and local SRS programs. Provides teaching and traineeship grants to public and voluntary nonprofit agencies and educational institutions. Office of the Assistant Administrator, Research and Demonstrations Provides staff direction and coordina- tion for all SRS activities in the develop- ment of the research, training, demon- strations, research training, research and training centers, direct and contract re- search, research utilization, grants man- agement, and international activities of the Service. Directs and operates certain research, training and demonstration ac- tivities as described below: Division of Research and Demonstra- tions. Directs and promotes a nationwide program of research and demonstrations- to solve problems of physical, mental, social, cultural, and economic depriva- tion. Provides staff direction and coordi- nation for the development of policies, regulations, and procedures covering these organizations throughout SRS. Directs the evaluation, interpretation, and application of research findings. Maintains relationships with public and private agencies in relevant research areas. Stimulates research to meet pro- gram needs. Division of Intramural Research. Pro- vides staff direction and coordination of all SRS intramural research. Formulates and executes, directly or by contract, selected research projects to solve prob- lems in adjustment to physical, mental, cial, cultural, and economic depriva- tion. Develops priorities for this research ■ ■■d policies and procedures concerning ese operations. Division of Research and Training Centers. Is responsible for the establish- ment of special centers for research and -lining in areas of concern to the Serv- ice, including the National Center for : .e Deaf-Blind, and similar institutions. Provides staff assistance and coordina- tion for the development of policies and Procedures and makes grants for such research, training, and client services. Encourages coordinated research, train- ing, and client services to meet program needs. Division of International Activities. Directs SRS programs for international research in social and rehabilitation services and related areas and the inter- -change of research scientists and ex- perts. Works with the Department of State and appropriate American embas- sies to insure that programs are in agree- ment with TJ.S. foreign policy. Develops program policies, standards, and proce- dures for the foreign research program in social and rehabilitation services and related areas. Provides- awards for the interchange between the United States and foreign countries of research scien- tists and experts. Conducts training pro- grams for nationals ofother countries in U.S. methods and techniques In social and rehabilitation services. Evaluates policy statements and program proposals of the United Nations, International Labor Organization, World Health Or- ganization, and related agencies. Pro- vides technical assistance to and col- laborates with foreign and international organizations and agencies. Division of Grants Management. De- velops fiscal plans, policies and proce- dures, and manages research, demon- stration, and training grants and contracts. Furnishes' consultative serv- ices to grantees in these areas on grants management. Directs the project referral system for divisional or other review. Directs grants financing and expendi- tures reports review. Develops audit policies, standards, and resolution of audit exceptions for the office. Assists in development of annual budget of the office. Coordinates all SRS project grants management activities and in coordina- tion with the Office of Administration, maintains a centralized SRS project grants management information system. Associate Administrator for Management Coordinates the planning and directs operation of all administrative, budget- ing, and financial management activities of the Social and Rehabilitation Service. Coordinates and directs the Social and Rehabilitation Service management in- formation system; provides statistical, data reporting, and data processing services and provides such assistance to all SRS organizations; provides advice, consultation and assistance to the States on administrative systems, data automa- tion, systems analysis, information sys- tems, statistical analysis and forecasting and utilization of these tools for more effective management. (Such activities will still allow the direction and admin- istration of management information systems to reside at the program level where appropriate. This commitment has already been made for the Medicaid program.) Office of the Assistant Administrator, Financial Management Provides overall financial management for the Social and Rehabilitation Service and its programs. Functions of this Office include staff leadership, guidance, and direction on: budget development and execution; development of budget policies and procedures; accounting and auditing policies and procedures. Division of Budget. Responsible for the preparation, justification and execution of the total Social and Rehabilitation Service budget and for the coordination of , all SRS budget activities. Division of Finance. Responsible for auditing, accounting and fiscal manage- ment necessary for control of all Social and Rehabilitation Service accounting operations. Coordinates SRS responses to all audit reports from GAO, the HEW audit agency and other sources. OmcE of the Assistant Administrator for Administration ,, ' Provides staff coordination, direction, leadership,- and advice on the adminis- trative management functions of SRS. Advises the Associate Administrator for Management and other officials on the managerial implications of program and policy decisions and recommendations. Coordinates the planning and operation of all the administrative activities of SRS. Provides centralized support serv- ices to all SRS components tin personnel management; manpower utilization; general services administration; and date processing. Serves as the contact point for the Social and Rehabilitation Serv- ice with the Office of the Secretary; the Civil Service Commission; and the Gen- eral Services Adrninistration on admin- istrative matters. Division of General Services. Provides consultative assistance and advice on all general services activities for the Social and Rehabilitation Service including: Contract development and administra- tion; technical procurement man-- agement; personal and real property management; paperwork management; printing management and reproduction services; communications services; safety management; and all related activities. Provides administrative support services and develops policy in these areas for SRS. v : . Division of Personnel. Develops per- sonnel management and training policies for Social and Rehabilitation Service employees. Provides services, consultative assistance, and advice concerning plan- ning and operation of effective employ- ment, career development and training. Provides advice on personnel policies and procedures to the Associate Administra- tor for Management and other SRS officials. Division of Data Processing. Provides internal SRS planning, policy, direction, and technical services in the field of automatic data processing. Conducts studies to* determine the method of ap- plication of data processing systems to existing SRS internal systems. Promotes utilization of data processing as a sup- port for other management and program services. Provides data processing facili- ties for SRS (operations, contracts or ar- rangement with other HEW data proc- essing installations). Monitors data processing utilization by all SRS activi- ties. No. 108 12 FEDERAL REGISTER, VOL. 35, NO. 108 — THURSDAY, JUNE 4, 1970 140 8714 NOTICES Division of Methods and Manpower Utilization. Provides leadership, plans, conducts and directs organization and methods, manpower utilization and cost reduction activities for SRS. Makes spe- cial studies, develops measures of effec- tive utilization, analyzes organizations and determines the most effective meth- ods of achieving results, and deyelops more effective organizational and work arrangements. Provides leadership and technical assistance in the develop- ment of the Agency's Manpower Uti- lization Program, -and the President's Cost Reduction Program. Conducts an Agency-level program for the develop- ment and maintenance of functional statements and delegations of authority. Recommends staffing patterns and aver- age grade allowances for components. Recommends policies and provides con- sultant services to the Administrator and other SRS officials In the above areas: Seeks and facilitates the implementation of new ideas, new skills, and new methods to Improve the administration of agency programs, and develops standards to , measure ongoing effectiveness. Oma or the Assistant -Administrator <- for Program Statistics and Data Sys- ~~ Provides planning, policy, direction, staff coordination, and technical assist- ance In the Improvement of procedures for decision making, management in- formation handling processes, statistical activities, Information systems, data automation, management improvement, administrative systems, etc., where two or more programs are involved or when re- quested. (Such activities will still allow the direction and administration of management information systems to re- aide at the program level where appro- priate. This commitment has already been made for the Medicaid program.) * - National Center for Social Statistics. Provides staff coordination, direction end advice on all statistical compilation prob- lems in SRS; provides technical advice on statistics and survey methods; main- tains a national respository of statistical data on social and rehabilitation serv- ices, including those services provided in the private as well as the public sectors. Operates the SRS management informa- tion system and provides central data .collection, compilation and processing for all SRS. - Division of State Systems Manage- ment. Provides planning, direction, co- ordination, leadership and technical as- sistance to SRS grantees in the fields of management improvement, data auto- mation, information systems, admin- istrative systems, etc., when two or more programs are involved or when requested. Conducts demonstrations (in coopera- tion with the Office -x>f Research and .Demonstration; upon request toy other contracting, granting and program of- fices; or where two or more programs are involved) , reviews, approves and moni- tors SRS grants and contracts in these fields. Establishes standards for and -evaluates the utilization of data proc- essing equipment by SRS grantees (where uosts are shared by the Federal Government. Division of Internal Systems and Re- port Development. Serves as the principal staff resource for planning, direction, coordination and leadership in the de- velopment of systems for automation of internal SRS activities; conducts sur- veys and determines SRS information requirements ; coordinates development and installation of all internal systems involving two or more SRS activities; conducts studies and provides internal system analysis services to SRS organiza- tions; and designs, develops and installs SRS internal reports and reporting sys- tems with the advice and assistance of the programs involved, the National Center for Social Statistics and the Division of State Systems Management. Division of Forecasting and Trend Analysis. Provides advice to SRS manage- ment on the significance of changes and trends in statistics; analyzes data, deter- mines trends, and develops forecasts; provides data and analyses for the budget; examines forecasts and data and develops guidelines for assistance of management; and designs special studies. Plans, directs, coordinates and leads SRS programs of assistance to the States in the development and utilization of sta- tistical analysis and forecasting tech- niques for budgeting, program planning, and management of State programs. Conducts demonstrations and studies. Associate Administrator roR Field Operations The Associate Administrator for Field Operations is responsible for the direc- tion, management and program coordi- nation of the field activities of the Social and Rehabilitation Service. Serves as the focal point for identifying trends, pat- terns and problems in the field. Assists the Administrator and the Regional Commissioners in developing program operating plans in consonance with Social and Rehabilitation Service priority objectives. ~ Directs and coordinates the activities of the Director, Cuban Refugee Program; and the Regional Commissioners. Cuban Rktocee Program Administers the Cuban Refugee Pro- gram including: Financial assistance, resettlement services, emergency health services, assistance to public schools in impacted areas, loans to refugee students and protective care of minors. These pro- grams are carried out through the Fed-- eral Cuban Refugee Emergency Center, voluntary resettlement agencies, and other Federal, State and local agencies. Note: Organisation charts filed as part of the original document. Approved: June 1, 1970. ' « -John G. Veneman, Acting Secretary. {FJR — Doc. "70-6939; Piled, June *, 1970; . - _•:■" ' % -B:61 *JBl.] ■: ■ ■ 141 NOTICES Social and Rehabilitation Service REHABILITATION SERVICES ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Part 5 of the Statement of Organiza- tion, Functions, and Delegations of Au- thority for the Department of Health, Education, and Welfare (34 F.R. 1279, Jan. 25, 1969, as amended) is hereby further amended to reflect the reorgani- zation of the Rehabilitation Services Administration. For such purposes, section 5-B is amended as follows: - 1. Strike out all that appears under the heading "Division of Special Popu- lations" and insert under the same heading the following: Provides for the full development of projects, programs and services for indi- viduals and groups who suffer from specific disabilities, except for blindness and visual handicaps, for deafness and communicative disorders, and for devel- opmental disabilities, or who share common conditions or characteristics, medical or otherwise, which permit cate- gorical identification. Reviews project grant applications as assigned to the Division of Special Populations, in ac- cordance with agency guidelines, appro- priate evaluative criteria, and central- regional office responsibilities. Assumes leadership for the achievement of agency •missions as assigned by the Commis- sioner on the basis of the division's par- ticular expertise. Provides leadership and consultation to regional offices, State agencies, and other grantees in the devel- opment and expansion of rehabilitation programs and services for all disability groups, except for the blind and visually handicapped, for those suffering from deafness and communicative disorders, and those with developmental disabil- ities. Develops and implements program strategies and approaches to reach pub- lic assistance recipients and the disabled ;j3idents of target poverty communities ( e.g., migratory agricultural workers) . Within assigned area of responsibility, •xulaborates with the Office of Planning and Policy Development and other ap- propriate agency staff in the develop- ment of guidelines, manual issuances and other directives for existing pro- grams serving various disability groups and for those programs mandated by legislative amendment such as vocational education and juvenile delinquency. 'Develops appropriate techniques to facil- itate client participation in the formula- tion of program objectives within the agency and at the State agency and »;ther grantee level. 2. Add directly after the paragraph headed "Division of Special Populations" under the heading "Office for the Blind and Visually Handicapped" the follow- ing: Provides for the full development of projects, programs, and services for in- dividuals who suffer from blindness and visual handicaps. Reviews project grant applications as assigned to the Office for the Blind and Visually Handicapped, in accordance with agency guidelines, ap- propriate evaluative criteria, and cen- tral-regional office responsibilities. As- sumes leadership for achievement of agency missions as assigned by the Com- missioner on the basis of the office's spe- cial expertise. Provides leadership and consultation to regional offices, State agencies, and other grantees in the de- velopment and expansion of rehabilita- tion programs and services for the blind and visually handicapped. Maintains li- aison and consultation with national or- ganizations of and for the blind and with the blind community nationwide to serve as a focal point and to provide in- creased leadership and advocacy for the Nation's blind and visually handicapped. In collaboration with the Division of Special Populations and other appro- priate agency staff, develops and imple- ments program strategies and ap- proaches to reach blind public assistance recipients and the blind and visually handicapped residents of target poverty communities (e.g., migratory agricul- tural workers) . Within assigned area of responsibility, collaborates with the Office of Planning and Policy Develop- ment and other appropriate agency staff in the development of guidelines, manual issuances, and other directives for exist- ing proKtams serving the blind and visually handicapped and for those pro- grams mandated by legislative amend- .ment, such as vocational education and juvenile delinquency. Develops appro- priate methods to facilitate client par- ticipation in the formulation of program objectives within the agency and at the State agency and other grantee level. 3. Add directly after the paragraph headed "Office for the Blind and Visu- ally Handicapped" under the heading "Office for Deafness and Communicative Disorders" the following: Provides for the full development of projects, programs, and services for in- dividuals v/ho suffer from deafness and communicative disorders/Reviews proj- ect grant -applications as assigned to the Office for Deafness and Communi- cative Disorders, in accordance with -agency guidelines, appropriate evalua- - tive criteria, and central-regional office responsibilities. Assumes leadership for achievement of agency missions as as- signed by the Commissioner on the basis of the office's special expertise. Provides leadership and consultation to regional offices, State agencies, and other grantees in the development and expansion of rehabilitation programs and services for those perilous suffering from deafness and communicative disorders. Mam- tains lials ■■:■ and consultation with na- tional organizations of and for the dc' and with the deaf community natio'jl wide to serve as a focal point mid to provide increased leadership and cd vocacy for the Nation's deaf and those suffering from communicative disorder* In collaboration with the Division of Special Populations and other appro- priate agency staff, develops and imple- ments program strategies and an. .proaches to reach those persons suffer- tog from deafness and communicative disorders who are on public assistance as well as such persons who are resident in target poverty communities (e.g mi- gratory agricultural workers) . Within as- signed area of responsibility, collabo- rates with the Office of Planning and Pol- icy Development and other appropriate agency staff in the development of guidelines, manual issuances, and other directives for existing programs serving those suffering from deafness and com- municative disorders and for those pro- grams mandated by legislative amend- ment, such as vocational education and juvenile delinquency. Develops appro- priate methods to facilitate client par- ticipation in the formulation of program objectives within the agency and at the State agency and other grantee level. 4. Strike out all that appears under the heading "Division of Planning and Management Assistance" and insert un- der the same heading the following: Provides nonfinancial technical sup- port and assistance to regional offices. State agencies and other grantees across agency programs. Develops planning and management procedures and methods of common application and implements such systems leading to improvement in overall program performance and goal achievement. Provides leadership in de- velopment of planning, operations, and management tools and methods to sent State agency and other grantee pro- grams. With the assistance of the divi- sions concerned with program develop- ment, designs and provides consultative assistance in implementation of new pro- gram techniques through manual chap- ter instructions, guide materials, and on- site visits. Provides staff support and as- sistance to facilitate decentralization of agency functions in cooperation with field operations staff. Evaluates and as- sists State agencies in the development of comprehensive State plans. 5. Strike the heading "Division of Grant Administration" and all that fol- lows under that heading and substitute the heading "Division of State Program Financial Operations" and the following : Provides for the financial management of RSA formula grant programs. Provides support services in financial manage- ment within RSA and to regional offices. State agencies and across all agency pro- grams, Develops and provides to the Divi- sion of Grants Administration, SRS. a financial plan for the administration of RSA project grants. Develops procedures. provides leadership, and evaluates the ae- velopment and implementation of pro- gram and financial planning activities ?SOERAl REGISTfitf, VOt 36, MO. 1 TT— WEDNESDAY, JUNE 9, 1971 142 NOTICES ■ f the PPBS type by State agencies. As- velopment ; ..d with other program units -:.is State agencies in developing capa- in the formulation of short- and long- bihties to provide pro-ram financial in- term pro .ram financial planning puts to overall RSA short and long-term methods. program planning. Consolidates the ed- Approved: Jane 2, 1071. ministration of agency ".rant programs. Assists the Budget Division in the for- Elliot L. Richardson. nutation, justification and execution of Secretary. ;.,e legislation budget, including the jfh Doc.7i aoii Filed c 8-7l;8 40 araj budgetary call for estimates from State agencies. In cooperation with the Divi- sion of Planning and Management As- >:stance, provides financial consultative rt to regional offices and State agencies, including preparation of per- tinent manual chapters, forms, and other itance. Applies statutory formulae for allotment of funds across all agency ap- propriations, Makes analyses of and co- ordinates all audit reports and negoti- ates audit exceptions for the agency. Monitors the accuracy and timeliness of State agency fiscal reports and financial data. Designs and develops systems for processing program financial data and reports with the assistance of the Divi- sion of Monitoring and Program Anal- ysis. Develops and interprets adminis- trative and fiscal policies and procedures governing the use cf formula grants funds including the cost principles to be applied in the preparation of grant ap- plications and budgets. Makes special studies of problem areas in the applica- tion of fiscal management policies, pro- cedures and standards. Prepares uni- form terminology standards oi policies and procedures for grants administra- tion and fiscal management. In support of the Office of Planning and Policy De- velopment, reviews new legislation and legislative proposals relating to grants to determine their conformance with estab- lished grant policies and recommends policy revisions when necessary. Under the coordination of the Office of Plan- ning and Policy Development, establishes- and maintains working relationships vitli other Federal agencies, grantee in- stitutions and State agencies in order to develop and coordinate grant policies ..nd procedures. Establishes and main- tains proper fiscal management, includ- ing the accountability of funds, for grant programs administered by RSA which arc delegated to Regional Offices. 6. Strike out all that appears under the heading "Budget Division" and insert under the same heading the following: Provides budgetary services and assi; i- :o the agency and maintains asso- ciated liaison services with the depart- ment and SRS. In conjunction with the Division of Slate Program Financial Operation^ and in cooperation with the Office of Planum • and Policy Develop- ment and other program uniis, formu- lates, justifies, and executes the lcgisla- iudget. Provides technical assistance :ii ensuring implementation of depart- mental budgetary directives'. Assists Hie Division of State Program Financial Operations m preparation of financial reports and .summaries, and adoption of improved internal financial analysis pro- 143 cedures and met hods. Cooperates with the Office of Planning and Policy De- NOTICES 15335 DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Office of the Secretary SOCIAL AND REHABILITATION SERVICE Statement of Organization, Functions, and Delegations of Authority Part 5 of the Statement of Organiza- -on. Functions, and Delegations of Au- ^r.ority for the Department of Health, ^■icauon, and Welfare, Social and Re- nabihtation Service (34 F.R. 1279, Janu- '~ f u^' 1969, as am£n ded) is hereby ''-inner amended to reflect the reorgani- zation of the Medical Services Adminis- tration. For such purposes, section 5-B is amended as follows: By striking out all that fallows under the heading "Medical Services Admin- istration" and inserting in lieu thereof the following: "The mission of the Medical O ei vic e s Administration is to provide leadership in the planning, development, coordina- tion, and administration of the programs under title XIX of the Social Security Act, as amended. Office or the Commxssionek The Commissioner, with the assistance of the Associate Commissioners, directs the planning, coordination, and dev elop- ment of the programs under title XIX of the Social Security Act, as amended, and the development of effective rela- tionships between these programs and other federally supported health and health related programs. Within broad Department of Health, Education, and Welfare and Social and Rehabilitation Service policy and guide- lines and subject to the health policy direction and other authority of the As- sistant Secretary for Health and Scien- tific Affairs, the Medical Services Ad- ministration establishes program goals and objectives; develops policies, stand- ards, and guidelines to accomplish stated goals; provides program management guidance to the regional office staffs and coordinates with the Regions on indi- vidual State problems; develops modifi- cations and innovations in program and in administration; works with and co- ordinates with other Social and Reha- bilitation Service organizations and re- lated health components of the Depart- ment to organize training programs to promote and provide skilled medical and medically related manpower to better as- sist the needy: obtains, analyzes, and provides information related to medical assistance; develops and implements ap- propriate information and payment sys- tems; maintains relationships with a va- riety of governmental and nongovern- mental organizations who have an inter- est in the health and welfare of the Nation and who have an impact on Medical Services Administration pro- grams; evaluate s pro gress in administra- tion of the title XTX programs and takes required action to direct or redirect ef- forts to achieve program objectives; pro- poses legislation to provide for changing needs of program directions and for fi- nancing of better health care to program recipients; promotes experimental pro- grams in financing of health delivery systems; provides administrative man- agement services; performs public in- formation and public inquiries activities: conducts program and administrative budget activities; and coordinates its ac- tivities and programs with other con- cerned SRS organizations. Provides management support to the Medical As- sistance Advisory Council. Office of Program Planning and Evaluation Develops policies and plans for the de- velopment and coordination of financing aspects of the Ftederal/State medical care programs for persons eligible under applicable titles of the Social Security Act. Determines statistical data to be collected; and maintains records of char- acteristics of State title XTX plans. De- velops the program budget for title tctx programs. Conducts studies of the econ- omy with emphasis on areas relating to the medical aspects of the title XTX pro- grams. Coordinates with^ all other health-related Department of Health, Education, and Welfare policymaking agencies and other governmental and nongovernmental organizations inter- ested In health care for the poor. Devel-. ops legislative proposals for improve- ments in medical assistance to the needy; serves as the focus in Medical Services Administration for activities related to support of the Department's legislative objectives. Develops objec- tives and goals for Medical Services Ad- ministration; guides program and ad- ministrative planning; reviews total pro- gram effort and prepares appraisal of programs of national impact ; serves as a focus for Medical Services Administra- tion research and evaluation activities. Omci or Program Innovation Develops modifications and innova- tions in the administration of title XTX programs; promotes experiments in funding arrangements for health plans; collaborates with related. Federal and other interested agencies in developing and implementing new health systems concepts to assure that title XTX activi- ties are supportive of general systems improvements; coordinates title XTX support of demonstration projects and analytic studies concerned with reducing the cost of making high quality care available to the indigent. Division or Policy and Standards Develops and prepares policies, stand- ards and guides except for long-term care for program participation, opera- tions, administration, and related areas; insures that program policies, standards, and other issuances are consistent with those of the Health Service and Mental Health Administration and with the So- cial Security Administration; develops reimbursement standards for skilled nursing homes, hospitals, and other pro- viders of medical care under title XTX programs; coordinates with Regions on individual State problems. Division of Long-Term: Care Develops and prepares policies, stand- ards and guides for program participa- tion, operations, administration relating to long-term care which includes skilled nursing homes, mental hospitals, inter- mediate care facilities, home health care and licensure of nursing home adminis- trators; insures that policies and issu- ances for long-term care are consistent with those of other HEW agencies; pro- vides technical assistance and con- sultation to the regions; coordinates with regions on individual State problems; proposes legislation to provide for chang- ing needs in long-term care; participates No. 121 7 FEDERAL RfGISTER, VOL 37, NO. 12T — THURSDAY, JUN6 M, 1»72 144 1233G in manpower development and training programs relating to long-term care. Division of Program Monitoring Provides technical assistance, instruc- tion and guidance to regions in monitor- ing and review of State administration of the Medicaid program; analyzes the adequacy of Medicaid monitoring and reporting activities; acts as the focal point in the Medical Services Adminis- tration for HEW and General Accounting Office audits and assures that corrective action is carried out; participates with other SRS and HEW elements in devel- oping principles and guidelines for com- bined health program monitoring sys- tems and audits. Division of Management Systems Plans and develops model systems, pro- cedures, criteria, and specifications re- quired for the improvement of the man- agement of the Medicaid programs in the area of claims processing, payments, management information, administrative systems and procedures; provides tech- nical assistance to the regions and co- ordinates with the regions on individual State problems; develops external per- sonnel training and manpower develop- ment programs for Regional Offices and State agencies; provides consultation and liaison for EDP systems. Dated: June 14, 1972. Steven D. Kohxert, Deputy Assistant Secretary for Management. |FE r>oc.72-&440 Filed 6-21-72;8:51 am] 145 NOTfCES 12865^ NATIONAL INSTITUTES OF HEALTH siotement of Organization, Functions, and Delegations of Authority part 8 (National Institutes of Health) „f the Statement of Organization, Func- j^js, and Delegations of Authority of the Department of Health, Education, ^d welfare, as amended, is hereby amended as follows: Sec. 8A Mission: Delete subsection i4>. Sec. 8B Organization and Functions: Delete the title and functional statement ,'or the Division of Biologies Standards <8V>. Dated: June 23, 1972. WAYNE M. WILSON, Acting Deputy Assistant Secretary for Management. IFR Doc.72-9890 PUed 6-2&-72;8:51 am] PUBLIC HEALTH SERVICE AND FOOD AND DRUG ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Part 6 (Food and Drug Administra- tion) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health, Education, and Welfare (35 FH. 3685-92, dated February 25, 1970, as amended) is amended to reflect the transfer of the Division of Biologies Standards, National Institutes of Health, to the Food and Drug Administration, and the elevation of the Division to Bureau status. Section 6 A is amended as follows: Sec. 6-A Mission. The mission of the Food and Drug Administration (FDA) Is to protect the public health of the Nation as it may be impaired by foods, drugs, biological products, cosmetics, therapeutic devices, hazardous house- hold substances, poisons, pesticides, food additives, flammable fabrics and various other types of consumer products. FDA's regulatory functions are geared to insure that: Foods acre safe, pure, and whole- some; drugs and biological products are safe and effective; cosmetics are harm- less; therapeutic devices are safe and effective; all of the above are honestly and informatively labeled and packaged; dangerous household products carry adequate warnings for safe use and are properly labeled ; counterfeiting of drugs is stopped ; and that hazards incident to the use of various types of consumer Products are reduced. Section 6B is amended as follows: Sec. 6B Organization • * V « » • • » 4 — TUESDAY, OCTOBER 9, 1973 147 27852 NOTICES for MIS planning. Responsible for the investigation and evaluation of auto- mated systems throughout the Federal Government relative to their potential application to SRS needs. Conducts pro- gram reviews and audits, as required, at the direction of the Associate Ad- ministrator for Information Systems. Evaluates proposed information systems to ensure that they are feasible in terms of developmental and operating costs, po- tential benefits, and are responsive to Federal, State and local objectives and capabilities. Monitors systems under de- velopment to assure that objectives are being achieved within planned schedule and cost estimates. Participates with the Office of Program Systems Development and the Office of Information Sciences in the evaluation of systems proposals to assure: adherence to established policy, inclusion of appropriate levels of infor- mation, avoidance of redundant develop- mental efforts, and effective coordination of systems and programmatic objectives. Office op Program Systems Development Responsible for liaison with appropri- ate SRS Bureaus to specify, plan, develop and deliver automated and non-auto- mated systems for management and ad- ministration of the Medical Services, As- sistance Payments, Community Services and Rehabilitation Services Programs.' Provides project management for sys- tems tasks utilizing resources from the Office of Information Sciences. Produces model systems for use by State and local agencies and provides technical assist- ance. Maintains liaison with State, local and SRS Regional components as re* quired tiirough the coordination activi- ties of the Office of State Systems Opera- tions. Provides syctems support and documentation for use by the Office of Systems Planning and Evaluation in op- erating the SRS Management Informa- tion System. Division of Medicaid Systems " Responsible for liaison with appropri- ate SRS Bureaus to specify, plan, de- velop, and deliver automated and non- automated systems for management and administration of the Medicaid program. Provides project management for sys- tems tasks approved by the Director of Program Systems Development, utilizing resources from the Office of Information Sciences as necessary. Produces model systems for use by State and local agen- cies and provides technical assistance. Maintains liaison "with State, local and SRS Regional components as required through the coordination activities of the Office of State Systems Operations. Pro- vides systems support and documenta- tion for use by the Office of Systems Plan- ning and Evaluation in operating the £>RS Management Information System. Division of Income Matntknanc* Systems Responsible for liaison with appropri- ate SRS Bureaus to specify, pian, develop, and deliver automated and non- automated systems for management and administration of the income mainte- nance program. Provides project man- agement for systems tasks approved by the Director of Program Systems Devel- opment, utilizing resources from the Of- fice of Information Sciences as necessary. Produces model systems for use by State and local agencies and provides tech- nical assistance. Maintains liaison with State, local and SRS Regional com- ponents as required through the coordi- nation activities of the Office of State Systems Operations. Provides systems support and documentation for use by the Office of Systems Planning and Evaluation in operating the SRS Man- agement Information System. Division of Human Services Systems Responsible for liaison with appropri- ate SRS Bureaus to specify, plan, develop and deliver automated and non-auto- mated systems for management and ad- ministration of human services pro- grams. Provides project management for systems tasks approved by the Director of Programs Systems Development, utilizing resources from the Office of Information Sciences. Produces model systems for use by State and local agencies and provides technical assistance. Maintains liaison with State, local and SRS Regional com- ponents as required through the coordi- nation activities of the Office of State Systems Operations. Provides systems support and documentation for use by the Office of Systems Planning and Evalua- tion in operating the SRS Management Information System. Develops service delivery management systems which sup- port both rehabilitation and social serv- ices requirements. Develops and main- tains classification systems that serve as standards for problems, services, client characteristics, service units, and needs, . in support of rehabilitation and social service requirements. OrncE of Information Sciences Directs the design, development, opera- tion and- evaKiation.of management in- formation handling processes, data proc- essing, and statistical activities. Serves as the central staff resource of technical skills involving statistics, data process- ing, systems analysis and standards development for information systems. Provides direction in areas of systems anal3'sis, * programming, statistical analysis and forecasting, modeling and simulation, management studies, re- quirements definition, standards develop- ment, program and system evaluation and development of system procedures. Participates in planning policy direction, staff coordination, and technical assist- ance in the analysis, development, man- agement and evaluation of all SRS in- formation systems. Division of Forecasting and Data Analysis Prepares forecasts (consistent with existing laws and regulations) and pro- jections (consistent with hypothetical alternative laws and regulations which are under consideration) of client pop- ulations and program expenditures lor 148 major SRS programs, by State, over pe- riods of several future years, designed to meet the information needs of SRS and DHEW policy-makers, and program managers of State government agencies administering SRS programs. Designs, develops, tests, and operates a dynamic computer simulation model system in support of the above function. Develops data bases and parametric functional relationships applicable to SRS client populations needed for Incorporation into the computer simulation model sys- tem. In performing all of the above functions, utilizes to the maximum feasi- ble extent the results of research by other government and private research agencies. Advises the National Center for Social Statistics on needs for statistical data relevant to the above functions. Plans, directs, coordinates, and leads SRS programs of assistance to the States in the development and utilization of statistical and forecasting techniques. Assists other components of the Office of the Associate Aciministrator for In- formation Systems in the development and testing of information systems prior to adoption by the State agencies or by SRS. Supports SRS program planning and evaluation by developing and analyzing statistical measures of the impact of SRS programs ; of needs for and gaps in services provided by the programs; of the effectiveness of State agency programs and operations; of the effectiveness of Federal legislation, and SRS policies. De- termines the statistical needs of SRS in cooperation with the Office of Program Planning and the SRS Bureaus; develops the necessary information systems and studies; analyzes data in relation to so- cial and economic trends and conditions. DrvisiON of Data Processing Provides planning, policy, direction and technical services in the field of au- tomatic data processing; develops and implements all information systems in support of SRS management require- ments. Programs and implements com- puter systems in support of Program Bu- reaus, Regions and States. Controls and operates all computer-based systems (software development, hardware acqui- sition, rental and maintenance) within SRS; provides data preparation; process- ing and communication services. Re- sponsible for ADP services for internal support and for programming and data processing for support of other areas. Performs all administrative duties as- sociated with ADP, including but not lim- ited to cost control, procurement, supply requisitioning, training and technical writing. Maintains direct liaison with ex- ternal offices on ADP matters and pro- vides consultation on matters pertain- ing to ADP technology. Division' of Systems Analysis and Design Serves as the principal staff resource for the analysis and design of informa- tion systems and processes for SRS Pro- gram Bureaus. Provides information in- tegration and coordination services to *EDE*AL .SEGiSrat, VOL 38, NO. 194 — TUESDAY, OCTOSE* 9, 1973 NOTICES these organizations. Conducts surveys and determines information require- ments. Develops systems method, pro- cedures and standards for SRS systems design, analysis and developmental ac- tivities. Provides analysis and planning of all activities involving the design. Im- plementation, operation or Federal spon- sorship, regardless of funding source, of information systems at the Federal, State and local levels. Plans and conducts demonstration projects whose principal purpose is to research and demonstrate information systems techniques and application. National Center for Social Statistics Collects and compiles all statistical data reported to SRS. Publishes statisti- cal data. Provides staff coordination, di- rection, and advice for all mathematical and statistical activities in SRS. Pro- vides technical direction to regional sta- tistical staff and develops and maintains methods and, procedures for controlling the quality of reported statistical data; participates in developing and carrying out staff development (training) for State staff employed in research statis- tics units. , Office of State Systems Operations Serves as the principal coordinating of- fice for systems and Management Infor- mation Systems (MIS) in support of SRS programs in the States. Develops and maintains profiles describing for each State the MIS posture, systems de- velopment and operations progress and plans, and the State organizational influ- ences upon such activities. Provides appropriate information to the other elements of the Office of the Associate Administrator for Information Systems to support their respective activ- ities, and acts as liaison between these elements and the States. Provides tech- nical assistance to States in concert with other Information Systems elements and Regional Office participation, to plan for and implement MIS improvements through adoption of model systems. Acts as the control point for review and ap- proval of all applications from States for Federal financial participation in the ac- quisition of ADP equipment or the design, development, and operation of automated management systems in support of SRS programs. To the extent cities, counties, or State regions are involved directly with SRS in management systems activi- ties, the Office of State Systems Opera- tions has the appropriate coordination responsibility. With other Information Systems ele- ments and the Regional organization evaluates the effectiveness of the systems developed and equipment utilization by toe State and local agencies through federal financial participation in sup- Port of SRS programs. Develops plans a nd proposals to improve the effective- ness of SRS funded systems utilized by toe Stales. Division of Technical Assistance Serves as the principal coordinating wice for MIS operations in support of SRS programs in the Stetes and Terri- tories. Develops and maintains profiles describing for each State and Territory the MIS posture, systems development and operations progress and plans, and the State organizational influences upon such activities. Assesses individual State MLS needs and formulates with Regional Office participation, plans and proposals for improving State systems. Evaluates State MIS requirements from a National perspective and prepares model systems proposals to meet those requirements, for development by the Office of Program Systems Development. Provides techni- cal assistance to State.",, in concert with Regional Office organizations, to plan for, and implement, MIS} improvements through adoption of model systems. Pro- vides technical assistance, to States, as required, in other matters relating to MIS activity. Division of Systems Approvals Reviews and approves applications from States for Federal financial partic- ipation in the acquisition of ADP equip- ment-or the design of automated infor- mation systems in suj port of SRS pro- grams. Provides technical guidance and direction to Regional rfflce organization relating to ADP equipment acquisition and utilization by State and local agen- cies. Develops regulations for State and local agencies to follow in applying for Federal financial participation in the cost of ADP equipment acquisition and sys- tems development in support of SRS pro- grams. Evaluates the effectiveness of the use of federally fund-;) ADP equipment by State and local agencies through re- view of surveys conducted by Regional Office, through review of periodic utiliza- tion reports and through on-site visits. Develops plans and proposals to improve the effectiveness of ADP equipment utili- zation in the States funded by SRS. Dated October 1, 1973. Robert H. Martx, Assistant Secretary for Administration and Management. [PR Doc.73-21353 FUecl 10-6-73; 8: 45 am] 149 J. THE OFFICE OF HUMAN DEVELOPMENT 151 Office of the Secretary ASSISTANT SECRETARY FOR HUMAN DEVELOPMENT Statement of Organization. Functions, and Delegations of Authority Part 1 of the Statement of Organiza- tion, Functions, and Delegations of Au- thority is amended to include these changes: (1) Amendment to Chapter 1R (38 FR 17260-i, 6/29/73). This chapter Is revised to include Information on the newly-established Office for the Handi- capped which replaces the Office of Men- tal Retardation Coordination, and on the Office of Native American Programs. 153 11614 NOTICES (2) Addition of a new Subchapter 1R55, Office for the Handicapped. This new subchapter describes in detail the mis- sion, organization, and functions of the Office for the Handicapped. (3) Addition of a new Subchapter 1R60001, President's Committee on Mental Retardation. This new subchapter describes in detail the mission, organization, and functions of the President's Committee on Mental Re- tardation. 1R00. Mission. Serves as the principal staff adviser to the Secretary and the Under Secretary on matters dealing with special populations served by the Depart- ment, Including the aging, children, youth. Native Americans, the mentally retarded, the handicapped, and those liv- ing in rural areas; recommends to the Secretary action for improving coordi- nation and government-wide effective- ness in these areas; provides responsive and effective programs for groups of peo- ple and ensures that other Department programs also recognize and serve the needs of these people; directs, coordi- nates, and manages Human Development programs, ordering priorities within the Office of Human Development, approving strategies and ensuring that lines of com- munication to the Secretary, other HEW operating programs, and interest groups are open and responsive. Provides information for departmental policy- making. 1R10. Organization. The Office of the Assistant Secretary lor Human Develop- ment, headed by the Assistant Secretary for Human Development who reports di- rectly to the Secretary, consists of; A. Immediate Office of the Assistant aecietary for Human Development. 3, Office of Administration and Man- agement. C. Office for the Handicapped. D. President's Committee on Mental Retardation. r £. President's Council on Physical Fit- ness and Sports. S". office of Child Development. 0. Office of Youth Development. II. Administration on Aging. 1. Office of Rural Development. J. Office of Native American Programs. 11420. Functions. Detailed functions of certain organizational elements of the .OlBcs of the Assistant Secretary for Hu- man Development will be described in separate subchapters. Functions. A. Immediate Office of the Assistant Secretary. Provides executive direction, leadership and guidance to all regional offices and ASHD components for the operation of Human Development programs. Determines the need for and appi oval of policy, basic systems, includ- ing handicapped program systems, and procedures, organization, program, budg- et plans, and Delegations of Authority which, guide Human Development oper- ations. Directs planning development and co- ordinates all planning activities for A-iKO, including OPS and long range planning. Tracks and reports progress on ' planning activities for the Assistant Sec- £*etary.- Functions. B. Office of Administra- tion and Management. The Office of Ad- ministration and Management provides executive administrative management to ASHD offices; develops and recommends to the ASHD policy, systems, procedures, plans, organizational changes and man- agement improvements; implements ap- proved strategies throughout the various ASHD offices ; focal point for budget ac- tivities of ASHD offices including budg- et development, justification, execution development of policies and procedures, and liaison with AS Comptroller for ASHD and its offices; liaison with ap- propriate OS offices for expenditure con- trols and responsible for expenditure controls within ASHD; develops, co- ordinates, and implements grants policy in conjunction with appropriate HEW policy and procedures; responsible for ASHD grants administration, including developing procedures and requirements for processing and review; recommends approval of certain grant actions; liaison with appropriate HEW contracting of- fices; responsible for provision of admin- istrative and technical support for con- tracts, provides staff support to ASHD offices on all management issues. The Office of Administration and Man- agement is responsible for Management Analysis including: management studies of the ASHD organization, manpower utilization, methods analysis, cost re- duction, and establishing standards; pro- vides technical and staff assistance to ASHD; and provides unified Data Sys- tems Management for ASHD organiza- tions. The office serves as a focal point for studies and initiatives for ASHD or- ganizations; responsible for administra- tive management functions, including personnel functions in conjunction with the Office of The Secretary Personnel Office, centralized support services, pro- curement, space allocation of ASHD of- fice, processing travel requests and claims and other general administrative duties. Functions. C. The Office for the Handicapped. Serves as the focal point for coordination and evaluation of De- partment-wide policies, programs, pro- cedures, and activities related to the handicapped and mentally retarded; serves in an advisory capacity to the Sec- retary in regard to issues related to the administration of the Department's handicapped and mental retardation programs. Detailed description of the functions of the Office appear in Sub- chapter 1R55. Functions. D. The President's Com- mittee on Mental Retardation. Provides service and assistance in the areas of mental retardation as the President may require; evaluates the national effort to combat mental retardation and assists in the coordination of Federal, State, local, and private program review and planning activities in the mental re- tardation field; assists in the formula- tion of new program initiatives. Functions. E. President's Council on Physical Fitness and Sports. The func- tion of the President's Council on Physi- cal Fitness and Sports Is to carry out 154 responsibilities stated in Executive Oro- 11562; these functions include establish" ing a program of Physical Fitness a_-- Sports, advising the President and &-'* retary on Physical Fitness and Spo~" coordinating the conference on Pb.ysi.-Ii Fitness and Sports, and other duties ti outlined in Executive Order 11562 Functions. F. Office of Child Devclo- ment. The function of the Office of Chi- Development is to advise the SecrtUo" through the Assistant Secretary »Z Human Development and HEW agencli on Department plans and program! re- lated to child development; to open J the Head Start and other related chii: service programs; and to provide lead*-'— ship, advice, and services which affect e» general well-being of children as ma.-- dated by the Act of April 9, 1912. Details functions of the Child Development w< follow In Chapter 1R40. Functions. G. Office of Youth Deveb^ ment. The function of the Office of Youiis Development is to provide leadership t the planning, development, and coordj. nation of those Federal programs thit provide services to youth in danger at becoming delinquent. The Office cooc- dinates its activities with other con- cerned Federal organizations to assure • unified approach to common tarrrt groups and to afford comprehensive sen- ices to the individual . Within the authorities delegated to jt. the Office of Youth Development admin- isters, under the Juvenile Delinquencr Prevention Act, Pub. L. 92-381, FederC grants and contracts designed to hd? State and local communities in provide community based preventive services In- cluding diagnosis and treatment, to youths who are in danger of becomUa delinquent, to provide assistance in th» training of personnel employed or pre- paring for employment in fields reUted to the provision of such services, and to provide technical assistance in such field A detailed description will follow in Sub- chapter 1R20. - Functions. H. Administration on Api*c The Administration on Aging (AoA> to the Federal focal point for the need* concerns, and interest of older perMW and the principal agency for carrying o** the programs of the Older Americans Art It coordinates its activities with pub^r and private organizations at the na- tional, State, and local level to asrere that the elderly are adequately consid- ered in the planning and implement*- tion of the programs of their orgar.U*- tions, and to promote the development c' comprehensive and coordinated scrrfc* systems to serve the elderly. It develops program goals and objrr • tives m terms of 5 year forward pl"» and current operational plans ; condor"-* a research, development, and demonstra- tion program to add to the basic knovi- edge about older persons' special capa- bilities and problems, and to develop »^ test new techniques designed to deal r£- tfae needs and problems of the eldertr assesses manpower requirements in «* field of «ging, makes reports and recom- mendations on meeting the manpo*^ MDERAl REGISTER, VOL. 39, WO. 6J— WIDAY. MAKCH 29, 1«74 NOTICES 11815 -**ds and designs and develops strate- \^i' ov implementing the recommends- ^K^iaalyzes the progress and problems at the programs of other agencies in Irving the elderly; develops initiatives , unprovements or innovations in these L^raras to better serve older persons: Emotes coordination of the programs 2 the various agencies which affect the. elderly. It serves as a clearinghouse on lnfor- zution related to the problems of older persons and programs designed to deal »iui those problems; convenes confer - eoces of public and private organizations concerned with the development and op- eration of programs for the elderly; uuJyzes and comments on budget and >C-siative proposals, program regula- uens. and program plans and initiatives .'rom other agencies which would have ar.pact on the elderly- - It administers a Federal-State-local irant program (Title HI of the Older Africans Act) which provides support lot: (a) State Agencies on Aging, which perform functions at the State level simi- tar to those of the Administration on A*ing at the Federal level; (b) Area Aiencies on Aging, which provide leader- ship to public and private non-profit providers of services in their area in the development and. implementation, of a cUn leading towards comprehensive and coordinated services for the elderly, and provide selective funding support to •cencies to stimulate implementation of U* plan; and (c) local community proj- ects in areas not served by an Area Agency on Aging to provide needed serv- ices which are not furnished by other *«*neies. . . r It administers a grant program for training and research (Title IV of the OWer Americans Act) which provides ■ipport for: A broad range of training responsive to the changing needs of pro- nams in the field of aging; appraising personnel needs in the field of aging: attracting qualified persons to the field of •cr.R; the study of current patterns of 2*ing conditions of older persons ; devel- oping and demonstrating approaches and aethods for Improving coordination of swnrnunity services; evaluating these ap- proaches; and grants for multidiscipli- °»J7 centers of gerontology. ;■• ^It administers a grant program (Title » of the Older Americans Act) for the Tustlon, alteration or renovation of multipurpose senior centers including «« provision of mortgage insurance for *ult (purpose senior centers, and initial «**.jig of such centers. It develops regulations, policies and *<*edures for the Title in, IV, V and vil programs; provides technical assist- *** to the State agencies in program l^^'opment and operation; and moni- •*" Progress. ^evaluates the administration of r^ rim operations in terms of progress £*«rd goals and achievements of objec- j***: uses the results of evaluations to "* P'ans and improve programs. ' A detailed description will follow in Subchapter 1R10. '■ Functions. I. Office of Rural Develop- ment. The Office of Rural Development 13 concerned with the delivery of HEW serv- ices to non-metropolitan areas in con- cert with revenue sharing. ■.. The Director of the Office reports to the Assistant Secretary for Human De- velopment. The Office will identify barriers to the delivery of services; design and recom- mend human services delivery systems in rural areas, coordinate efforts with other Federal agencies to select target areas for delivery of human services, and rep- resent the Department in interdepart- mental task forces concerned with rural development. . Functions. J, Office of Native Ameri- can Programs (ONAP). The Office of Native American Programs is concerned with the social and economic well-being ' and progress of American Indians and Alaskan Natives. The Office has primary responsibility for developing national policies and legislative proposals and for providing leadership activities designed to assist American Indians and Alaskan Natives. The Office administers a Federal grants program to eligible Indian tribes and groups and provides liaison with other Federal agencies on Indian affairs. It explores new program concepts and new methods for increasing Indian self- determination, fosters opportunities for the exercise of Indian leadership and the operation of Indian businesses, and en- courages increased involvement of the private sector in economic development programs on reservations. A detailed de- scription of the functions of the Office appears in Subchapter 1R91. 1R30. Delegations of Authority. Except as provided in section 1A-30 of the DHEW Organization Manual and in this section, the Assistant Secretary for Human Development has been delegated the following functions by the Secretary : 1. The functions vested in the Secre- tary by the Older Americans Act of 1965, (42 U.S.C. 3001 etseq.). 2. The functions vested in the Secre- tary by the Juvenile Delinquency Preven- tion Act (42 U.S.C. 3801 et seq.) . 3. The authority under section 222 (a) (1) of the Economic Opportunity Act of 1964, delegated by the Director of the Office of Economic Opportunity to the Secretary (42 U.S.C. 2809 et seq.) . 4. Such functions with respect to re- search, demonstration and training proj- ects under section 426 of the Social Se- curity Act to the extent of the funds appropriated to the Office of Child De- velopment for this purpose. Office of Hitman Development office for the handicapped; statement of organization and functions A new Subchapter 1R55 Office for the Handicapped reads as follows : 1R55.00 Mission. The Office for the Handicapped (OFH) implements the provisions of section 405 of the Rehabili- tation Act of 1973, by providing a focal point within the Office of Human Devel- opment (OHD) for review, coordination, information and planning related to pol- icies, prog rams , procedures and activi- ties within HEW and other Federal agen- cies relevant to ■• the- physically and mentally handicapped. - - 1R55.10 Organization. The- Office -for the Handicapped is under the direction of the Director, OFH, who- reports di- rectly to the Assistant Secretary for Human Development. The Office includes a staff of specialists who are responsible for planning and evaluating . programs, coordination, and the dissemination of information related to problems affect- ing the handicapped. 1R55.20 Functions. The Office for the Handicapped carries out its mission through the following functions: 1. Serves as the focal point in the De- partment for the consideration of issues and policies affecting the handicapped. 2. Prepares a long-range plan that in- cludes projection for. the provision of comprehensive services to handicapped individuals, and for programs of research, evaluation, and training, related to such - services and individuals. * 3. Analyzes on a continuing basis : pro- gram operations to determine consist- ency with applicable provisions of law; progress towards meeting the goals and priorities set forth In the long-range plan: and the effectiveness of all pro- grams providing services to ail handi- capped individuals. Seeks the elimina- tion of unnecessary duplication and overlap in such programs under the ju- risdiction of the Secretary. .-.- 4. Encourages coordinated and cooper- ative planning designed to produce maximum effectiveness, sensitivity, and continuity in the provision of services for handicapped individuals by all programs. 5. Develops means of promoting the prompt utilization of engineering and other scientific research to assist in solv- ing problems in education, health, em- ployment, rehabilitation, architectural, housing, and transportation barriers, and other areas so as to bring about full inte- gration of all handicapped individuals into all aspects of society. 6. Provides a central clearinghouse for information and resource availability for handicapped individuals. This includes evaluation of information and data sys- tems within the Department of Health, Education, and Welfare, other depart- ments and agencies of the Federal gov- ernment, public and private agencies and organizations of other sources. Office of Assistant Secretary for Hit- man Development, President's Com- mittee on Mental Retardation statement of organization and functions Part 1 of the Statement of Organiza- tion and Functions for the Department of Health, Education, and Welfare, Office of the Secretary, Assistant Secretary for Human Development is amended to add a new Subchapter 1R60001 which reads as follows: 155 FEDERAL REGISTER, VOL 39, NO. 62 — FRIDAY, MARCH 29, 1974 11616 1R60001.00 Mission. The President's Committee on Mental Retardation (PCMR) , located in the Office of Human Development, DHEW. is responsible for advising and assisting the President on all matters pertaining to mental retarda- tion. The Committee, through the Assistant Secretary for Human Development, eval- uates national, State and local mental re- tardation efforts, helps to coordinate rel- evant Federal activities, and facilitates communication between Federal, State and local agencies. In addition, the Com- mittee informs the public about mental retardation and mobilizes support for re- lated activities. The Committee was established by Ex- ecutive Order 11280 on May 11, 1966. 1R60001.10 Organization. The Com- mittee' consists of the Secretary of HEW, the Secretary of Labor, the Director of the Office of Economic Opportunity, and not more than twenty-one other mem- bers who shall be appointed by the President from public or private life. Staff support for the Committee is pro- vided by an Executive Director and staff. The Executive Director reports to the Assistant Secretary for Human Develop- ment. . 1R60001.20 Functions. A. The Presi- dent's Committee on Mental Retarda- tion shall provide such advice and as- sistance in the area of mental retarda- tion as the President may from time to iime request, including assistance with respect to: (1) Evaluation of the national effort "no combat mental retardation; (2) Coordination of activities of Fed- eral agencies in the mental retardation field; - (3) Provision of adequate liaison be- tween such Federal activities and related activities of State and local govern- ments, foundations, and other private organizations; and (4) Development of such information, designed for dissemination to the general public, as will tend to reduce the inci- dence of mental retardation and ameli- orate its effects. B. The Committee shall make such re- ports or recommendations to the Presi- dent concerning mental retardation as he may require or the Committee may deem appropriate. Such reports shall be made at least annually. -Dated : March 15, 1974. S. H. Clarke, Acting Assistant Secretary for .. . Administration and Management. [PR Doe.74-7833 Filed 3-28-74; 8:45 am] 156 Office of the Secretary ASSISTANT SECRETARY FOR HUMAN DEVELOPMENT Statement of Organization, Functions, and Delegations of Authority Part 1 of the Statement of Organiza- tion, Functions, and Delegations of Au- thority is amended to add a new Chapter 1R, "Assistant Secretary for Human De- velopment." This chapter supersedes Chapter 1L, "Assistant Secretary for Community and Field Services" and in- corporates previously approved func- tional statements as follows: From Chapter 1L — Office of Youth and Student Affairs, the President's Committee on Mental Retardation and Office of Mental Retardation Coordination ; from Chapter IT — Office of Child Development and President's Council on Physical Fitness and Sports; from Part 5 "Social and Rehabilitation Service" the Advisory Committee on Aging, the Administration on Aging, and the Youth Development and Delinquency Prevention Administra- tion. Chapter 1T03, The Office of Child Development, is redesignated 1R40. The organizational structures and the dele- gations of authority described in the fore- going functional statements will continue in effect within the new organization until officially superseded. This chapter reads as follows: 1R.00 Mission. Serves as the principal staff adviser to the Secretary and the Under Secretary on matters dealing with special populations served by the Depart- ment, including the aging, children, youth, Indians, the mentally retarded, and those living in rural areas; recom- mends to the Secretary action for im- proving coordination and government- wide effectiveness in these areas; pro- vides responsive and effective programs for groups of people identified as having special problems and ensures that other Department programs also recognize and serve the needs of these people; directs, coordinates, and manages Human De- velopment programs, ordering priorities within the Office of Human Development, approving strategies and ensuring that lines of communication to the Secretary. other HEW operating programs, and in- terest groups are open and responsive. Provides information for departmental policy -making. 1R.10 Organization. The Office of the Assistant Secretary for Human Develop- ment, headed by the Assistant Secretary for Human Development who reports di- rectly to the Secretary, consists of: A. Immediate Office of the Assistant Secretary for Human Development . B. Office of Administration and Management C. Office of Mental Retardation Coordination D. President's Committee on Mental Retardation E. President's Council on Physical Fitness and Sports NOTICES 17261 p. Office of Child Development G. Office of. Youth Development H. Administration on Aging I. Office of Rural Development 1R.20 Functions. Detailed functions of certain organizational elements of the. Office of the Assistant Secretary for Human Development will be described in separate sub-chapters. Functions. A. Immediate Office of the Assistant Secretary Provides executive direction, leadership and guidance to all regional offices and ASHD components (or the operation of Human Development programs. Determines the need for and approves of policy, basic systems, and procedures, organization, . program, budget plans, and Delegations of Author- ity which guide Human Development operations. Directs planning development and co- ordinates all planning activities for ASHD, including OPS and long range planning. Tracks and reports progress on planning activities for the Assistant Secretary. Functions. B. Office of Administration and Management. The Office of Adminis- tration and Management provides execu- tive administrative management to ASHD offices; develops and recommends to the ASHD policy, systems, procedures, plans, organizational changes and man- agement improvements; implements ap- proved strategies throughout the various ASHD offices; focal point for budget ac- tivities of ASHD offices including budget development, justification, execution, development of policies and procedures, »nd liaison with AS Comptroller for ASHD and its offices; liaison with ap- propriate OS offices for expenditure con- trols and responsible for expenditure controls within ASHD; develops, co- ordinates, and implements grants policy In conjunction with appropriate HEW policy and procedures; responsible for ASHD grants administration, including developing procedures and requirements for processing and review; recommends approval of certain grant actions; liaison with appropriate HEW contracting offices; responsible for provision of ad- ministrative and technical support for contracts; provides staff support to ASHD offices on all management issues. The Office of Administration and Management Is responsible for Manage- ment Analysis Including: management studies of the ASHD organization, man- Power utilization, methods analysis, cost reduction, and establishing standards; Provides technical and staff assistance to ASHD; and provides unified Data Sys- tems Management for ASHD organiza- tions. The office serves as a focal point for studies and initiatives for ASHD or- ganizations; responsible for administra- te management functions, including personnel functions in conjunction with ■he Office of the Secretary Personnel Office, centralized support services, pro- curement, space allocation of ASHD office, processing travel requests and c, aims, and other general administrative duties. functions C. The Office of Mental Re- ndition Coordination. Serves as a focal point for coordination and evaluation of the Department's mental retardation activities and consideration of relevant Department- wide policies, programs, pro- cedures, activities, and related -matters; serves in an advisory capacity to the Sec- retary in regard to issues related to the administration of the Department's mental retardation programs; and serves as liaison for the Department with the President's Committee on Mental Re- tardation. Functions D. The President's Commit- tee on Mental Retardation. Provides service and assistance in the areas of mental retardation as the President may require; evaluates the national effort to combat mental retardation and assists in the coordination of Federal, State, local, and private program review ind planning activities in the mental retardation field; assists in the formulation of new program initiatives. Functions. E. President's Council on Physical Fitness and Sports. The func- tion of the President's Council on Physi- cal Fitness and Sports is to carry out responsibilities stated in Executive Order 11562; these functions include establish- ing a program of Physical Fitness and Sports, advising the President and Sec- retary on Physical Fitness and Sports, coordinating the conference on Physical Fitness and Sports, and other duties as outlined in Executive Order 11562. Functions. F. Office of Child Develop- ment. The function of the Office of Child Development is to advise the Secretary through the Assistant Secretary for Hu- man Development and HEW agencies on Department plans and programs related to child development; to operate the Headstart and other related child serv- ice programs ; and to provide leadership, advice, and services which affect the general well-being of children as man- dated by the Act of April 9, 1912. De- tailed functions of the Office of Child Development will follow in Chapter 1R40. FUNCTIONS. G. Office of Youth De- velopment. The function of the Office of Youth Development is to provide lead- ership in the planning, development, and coordination of those Federal programs that provide services to youth in danger of becoming delinquent. The Office co- ordinates its activities with other con- cerned Federal organizations to assure a unified approach to common target groups and to afford comprehensive services to the individual. Within the authorities delegated to it, the Office of Youth Development ad- ministers, under the Juvenile De- linquency Prevention Act, Public Law 92-381, Federal grants and contracts designed to help States and local com- munities in providing community based preventive services, including diagnosis and treatment, to youths who are in danger of becoming delinquent, to pro- vide assistance in the training of per- sonnel employed or preparing for em- ployment in fields related to the provision of such services, and to provide technical assistance in such field. A de- tailed description will follow in sub- chapter 1R20. • 157 FUNCTIONS. H. Administration on Aging. The Administration on Aging (AoA) is the Federal focal point for the needs, concerns, and interests of older persons and the principal agency for carrying out the programs of the Older Americans Act. It coordinates its activi- ties with public and private organizations at the national, state, and local level to assure that the elderly are adequately considered in the planning and imple- mentation of the programs of their or- ganizations, and to promote the develop- ment of comprehensive and coordinated service systems to serve the elderly. It develops program goals and objec- tives in^ terms of 5~ year forward plans and current operational plans; conducts a research, development, and demonstra- tion program to add to the basic knowl- edge about older persons' special capa- bilities and problems, and to develop and test new techniques designed to deal with the needs and problems of the elderly ;- assesses manpower requirements in the field of aging, makes reports and recom- mendations on meeting the manpower needs, and designs and develops strate- gies for implementing the recommenda- tions. It analyzes the progress and problems of the programs of other agencies in serving the elderly; develops initiatives for improvements or innovations in these programs to better serve older persons; promotes coordination of the programs of the various agencies which affect the elderly. It serves as a clearinghouse on infor- mation related to the problems of older persons and programs designed to deal with those problems; convenes confer- ences of public and private organizations concerned with the development and op- eration of programs for the elderly; analyzes and comments on budget and legislative proposals, program regula- tions, and program plans and initiatives from other agencies which would have Impact on the elderly. It administers a federal-state-local grant program (Title m of the Older Americans Act) which provides support for: a) State Agencies on Aging, which perform functions at the state level simi- lar to those of the Administration on Aging at the federal level; b) Area Agencies on Aging, which provide lead- ership to public and private non-profit providers of services in their area in the development and implementation of a plan leading toward comprehensive and coordinated services for the elderly, and provide selective funding support to agencies to stimulate implementation of the plan; and c) local community proj- ects in areas not served by an Area Agency on Aging to provide needed serv- ices which are not furnished by other agencies. It administers a grant program for training and research (Title IV of the Older Americans Act) which provides support for: a broad range of training responsive to the changing needs of pro- grams in the field of aging; appraising personnel needs in the field of aging; attracting qualified persons to the field of aging; the study of current patterns FEDERAl REGISTER, VOL 38, NO. 125 — FRIDAY, JUNE 29, 1973 17262 NOTICES of living conditions of older persons; de- veloping and demonstrating approaches and methods for improving coordination of community services; evaluating these approaches; and grants for multidis- ciplinary centers of gerontology. It administers a grant program (Title V of the Older Americans Act) for the acquisition, alteration or renovation of multipurpose senior centers including the provision of mortgage insurance for multipurpose senior centers, and initial staffing of such centers. It develops regulations, policies and procedures for the Title in, IV, V and VTI programs; provides technical assist- ance to the state agencies in .program development and operation; and moni- tors progress. It evaluates the administration of pro- gram operations in terms of progress to- ward goals and achievements of objec- tives; uses the results of evaluations to revise plans and improve programs. A detailed description will follow in subchapter 1R10. Functions. I. Office of Rural Develop- ment. The Office of Rural Develo pment is concerned with the delivery of HEW services to non-metropolitan areas in concert with revenue sharing. The Director of the office reports to the Assistant Secretary for Human Develop- ment. The office will identify barriers to the delivery of services; design and recom- mend human services delivery systems in rural areas, coordinate efforts with other Federal agencies to select target areas , for delivery of Human services, and rep- resent the Department in interdepart- mental task forces concerned with rural development. 1R.30 Delegations of Authority. Except s«s provided in subsection 2-500 of the HEW Organization Manual (renumbered bs section 1A-30) , and in this section, the Assistant Secretary for Human Develop- ment has been delegated the following functions by the Secretary : - 1. The functions vested in the Secre- tary by the Older Americans Act of J 965, 42 UJS.C. 3001 et seq. 2. The functions vested in the Secre- tary by the Juvenile Delinquency Pre- vention Act, 42 U.S.C. 3801 et. seq. 3. The authority under Section 222(a) (1) of the Economic Opportunity Act of 1964, delegated by the Director of the Office of Economic Opportunity to the Secretary. 4. Such functions "With respect to re- search, demonstration and training proj- ects under Section 426 of the Social Secu- rity Act to the extent of the funds ap- propriated to the Office of Child Develop- ment for this purpose. 5. The functions of the Secretary un- der the Organic Act of the Children's Bureau (the Act of April 9, 1912) . 6. Continuation of regulations. All regulations, rules, orders, authorities or statements -of policy or interpretation heretofore issued with respect to the Administration on Aging, Youth Devel- opment and Delinquency Prevention Administration, Office of Child Develop- ment, President's Committee on Mental Retardation, President's Committee on Physical Fitness and Sports, Office of Mental Retardation Coordination and Office of Youth and Student Affairs, are continued in full force and effect, under the authority of the Assistant Secretary for Human Development, until revised, superseded, or revoked. Dated: June 15, 1973. Caspar W. Weinberger, Secretary of Health, Education and Welfare. [PR Doc.73-13112 Filed 6-28-73 ; 8 : 45 am] FOOD AND DRUG ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Part 6 (Food and Drug Administra- tion) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health, Educa- tion, and Welfare (35 PR 3685-92, dated February 25, 1970, as amended) is amended to revise the existing overall functional statements for the Office of the Assistant Commissioner for Plan- ning and Evaluation. Section 6B is amended as follows: (g) Office of the Assistant Commis- sioner for Planning and Evaluation. Ad- vises and assists the Commissioner and other key officials concerning the per- formance of FDA long-range planning, development, ' and evaluation activities. Develops program and planning strat- egy through analysis and evaluation of issues affecting policies and program performance. Develops, installs, and monitors the Agency-wide planning system including the • Five- Year Plan and the Strategic Plan. Conducts operations research, and eco- nomic and special studies as a basis for forecasting trends, needs, and major problems requiring solution; and pro- vides assistance and consultation in these areas to operating units. Evaluates impact of external factors on FDA programs, including industry economics, consumer expectations, and protective legislation. As necessary, re- commends new programs or changes In existing programs, and program priori- ties. Develops FDA evaluation programs and systems to evaluate overall FDA program accomplishments against objec- tives and priorities, recommending -changes as necessary. _ Evaluates impact of FDA programs on consumer protection. Develops and coordinates an Agency- wide system for the collection of medical data from hospitals, clinics, and other reporting units. Dated: June 22, 1973. 1 ■■ • - Robert H Marie, r Assistant Secretary for Administration and Management. IPR Doc.TS-rsne FUed 6-26-73:8:46 am] 158 Office of the Secretary ASSISTANT REGIONAL DIRECTOR FOR HUMAN DEVELOPMENT Organization, Functions, and Delegations of Authority Part 1 of the Department of Health Education, and Welfare Statement of Or- ganization, Functions, and Delegations of Authority is hereby amended to es- tablish a new Section 1E-80, Assistant Regional Director for Human Develop- ment. Part 1E-10 — Organization is also amended to delete the Assistant Regional Director, Child Development and to add the Assistant Regional Director for Human Development. The statement reads as follows: Sec 1E-80-00 — Mission. The Assistant Regional Director for Human Develop- ment is responsible for planning, direct- ing, coordinating, implementing and evaluating human development pro- grams delegated to the Regional Offices within the framework of the policies and guidelines set forth by the Assistant Secretary for Human Development. Sec. 1E-80-10 — Organization. The Office of the Assistant Regional Director for Human Development includes: Regional Program Director, Office of Child Development Regional Program Director, Administra- tion on Aging Regional Program Director, Office of Youth Development Sec. 1E-80-20 — Functions. The Assist- ant Regional Director for Human Devel- opment: (1) Serves under the direct line of authority of the Regional Director. (2) Serves as the representative of the Assistant Secretary for Human De- velopment and the Regional Director in direct official dealings with other Fed- eral agencies, State and local activities related to Human Development Pro- grams, and reports progress and status to the Regional Director and the Assist- ant Secretary for Human Development. (3.) Recommends program priorities. and policy or procedural changes to the Assistant Secretary for Human Develop- ment through the Regional Director. (4) Works with other elements of the Regional Office to ensure that all areas of OHD program operations in the Re- gion receive necessary assistance, includ- ing programmatic and administrative management assistance to perform their mission effectively and efficiently. • <5) Maintains working relationships •with other Federal agencies, State and local governments and institutions, and develops ways in which their plans and programs and those of the Department can actively complement each other. (6) Ensures intra-departmental coor- dination between the Office of Human -Development, other elements of the Of- fice of the Regional Director, and the op- erating agencies of the Department on Human Development matters; serves as the advocate for those interests repre- IfcDERAl UCGISTW, VOL 38, NO. 125 — WMDAY, JUNE 29, 19?3 K. THE DEPARTMENT OF AGRI CULTURE 159 DEPARTMENT OF AGRICULTURE AGRICULTURAL RESARCH SERVICE ORGANIZATION, FUNCTIONS, & DELEGATIONS OF AUTHORITY This notice describes the basic organi- sation of the Agricultural Research Serv- ice and the assignment of functions and delegation of authority to each of the major organization units that comprise the Service. This statement supersedes the notice of Organization, Authorities and Responsibilities of the Agricultural Research Service appearing at 33 FR 15485. I. Authority The Agricultural Research Service (ARS) was established on November 2, 1953, pursuant to authority vested in the Secretary of Agriculture by 5 TJ.S.C. 301 and Reorganization Plan No. 2 -of 1953 (18 PR 3219) . The Administrator of ARS reports to the Assistant Secretary for Conservation, Research, and Educa- tion. The delegations of authority to the Administrator of ARS to direct the activ- ities of the Service are contained in 7 CPR 2.7 and- 7 CFR.2^T. " "II. Basic "Mission The Mission of ARS research is to de- velop new knowledge and. technology which will insure an abundance of high quality agricultural commodities and products at reasonable prices to meet the increasing needs of an expanding econ- omy and to provide for the continued NOTICES improvement in the standard of living of all Americans. This Mission focuses on the development of technical informa- tion and technical products which bear directly on the needs to (1) manage and use the Nation's soil, water, air, and cli- mate resources and improve the Nation's environment; (2) provide an adequate supply of agricultural products by prac- tices that will maintain a permanent and effective agriculture; (3) improve the nutrition and well-being of the American people; (4) improve living and rural America; (5) strengthen the Na- tion's balance of payments; and (6) pro- mote world peace. In addition to the regular research program, ARS directs foreign research mutually beneficial to the United States and the host country which can be ad- vantageously conducted in foreign countries. The Agency conducts basic, applied,, and developmental research in support of farm animals, plants, soil-water-and- air resources, marketing and use of agri- cultural products, food and nutrition, consumer services, agricultural hearth hazards, and environmental quality. IEL Organization and Functions The Agency's research is conducted at appr oxim ately 175 locations in the 50 States, Puerto Rico, the Virgin Islands, and in several foreign countries. Much of the work is conducted fn direct coop- eration with the State Agricultural Ex- periment Stations or other state and federal agencies. Central offices for the Administrator and his staff are main- tained in the Washington, D.C. Metro- politan Area. The principal central staff offices and their functional responsibili- ties are described under paragraph A. The field activities are managed on a geographical basis through four Re- gional Offices, 20 Ares Offices and seven major Research Centers. The Regional and Area Offices and Major Research Centers and their functional responsi- bilities are fisted under paragraph B. A. Central offices. 1. Office of Administrator. Provides overall leadership and direction to the programs and activities assigned to the Agricultural Research Service and pro- vides advice and support to the Assist- ant Secretary for Conservation, Re- search and Education in formulation of national, agricultural, research policy and coordinating" research activities of tee Department. " 2". National .program staffr Livestock and veterinary sciences, marketing, nu- trition, and engineering sciences, plant and entomological sciences, sort, water, and air sciences. The National Program ■ StafT is comprised of Jour functional units, each headed by an Assistant, Ad- ministrator. Collectively, the National Program Staff is concerned with devel- oping" national plans for agricultural re- search, concentrating upon insuring the proper interaction, balance, and distri- bution of research effort and focusing wpearr major national policy and program issues. They serve as the AdmiMistiaturs 161 principal staff arm for exercising his au- thority in managing ARS research pro- grams nationally. To this end they are responsible for: (a) Assisting the Administrator in establishing policy for all aspects of pro- gram planning, evaluation, budgeting, and coordination with emphasis on na- tional programs, goals, and objectives. Developing, revising, and other- wise responsible for the program struc- ture which describes the ARS national programs and technological objectives and serves as the guide for the develop- ment and coordination of program plans at locations within the field organiza- tion. 3. Program analysis and coordination staff. This Staff assists the Administra- tor, participating with the National Pro- gram Staff and the Regional Deputy Ad- ministrators in establishing pohcy and developing program plans, evaluation, budgeting, and coordination as related to national programs, goals, and objec- tives with respect to: (a) Development of systems, proce- dures, models,, and- criteria needed for program review, evaluation, planning, .and budget development, arwell as pro- gram aids for resource allocation and reallocation. tt>> CorrimatioT) of the development cf the Program and Financial Plan of the agency and cooperating with Budget and Finance Division in the development of the annual budget. (c) Development of statistical method- ology and analytical techniques for use in program planning and evaluation. - (d> Development and maintenance of the comprehensive program structure with crosswalks to programs, goals, mis- sions, regions, locations, and with other task force activities. (e> Coordination of the preparation and assembly of the aids and inputs to Congressional budget presentations. .' of) Coordimtton. and .maintenance of -documentation of program plans. : _'Xg) ~T3ooperating-vrite National Pro- gram Staff in program, analysis at the national level, with emphasis on eco- nomic -justification, technology assess- ment, eest-beBerit: analysis, and special KDUAUIKISai, VOL 40,'NO.. JA9— RID*!. AUGUST 29, 1975 NOTICES 39913 studies of an economic and technological nature. ' (h) Coordination of the assembly, floWi and disposition of program plan- ning and reporting documents. 4° international programs division. This Division is responsible for adminis- tration of the foreign research contract and grant activities for the Department of Agriculture carried out by foreign governments and scientific organiza- tons under Public Law 480 and related legislation. The objectives of this pro- gram are (a) to develop fields of farm products research; (b)~ to bring about the greatest practical increase in the utilization of agricultural products; (c) to give impetus to solutions for. existing problems of basic and applied research; and (d) to channel efforts of foreign' scientists and research facilities for mu- tual economic benefit and to advance scientific knowledge. This Division is also responsible for overall ARS activi- ties in the field of international eco- nomic, technical, and cooperative as- sistance and relations, including all ARS programs located outside the U.S., all ARS activities where international or- ganizations or Participating Agency Service Agreements (PASA's) are in- volved, training in this country in ARS subject-matter fields as requested for foreign nationals, and coordination of all foreign translation activities in the Department. 5. Information division. This Division is responsible for planning and develop- ing a continuing information program that achieves the prompt widespread use of research results, and increases gen- eral public knowledge of ARS activities. It provides staff support on information matters for agency administration, and plans and conducts a broad information program, utilizing all media, in support of the objectives and goals of ARS and the Department. 6. Legislation and special assignments staff. This Staff advises and assists the Administrator on matters relating to the ARS legislative programs, TJSDA and ARS committee management proce- dures, and the preparation of corre- spondence for the signature of TJSDA officials. 7. National technical editing staff. Provides agency-wide technical editing service to ARS scientists on manu- scripts to be published in a wide variety of scientific and technical journals. 8. Administrative management. A Deputy Administrator directs and co- ordinates the administrative manage- ment activities of one Staff and four Divisions. Their assigned functions are: (a) Management improvement staff is responsible for providing assistance to agency managers in the formulation of Policies and programs to increase man- aseme;.-, effectiveness through effective organ;::.; r.ion structures, optimium uti- lization and productivity of manpower and irr.rrovement of directives and other existing systems and procedures. (b) budget and finance division is re- sponsible for providing assistance to agency managers in the formulation and presentation of the annual budget and multi year financial plans, the develop- ment of financial control and accounting systems, analysis and fiscal control of ARS funds, and the review and evalua- tion of financial management operations throughout the agency. (c) General services division is re- sponsible for providing assistance to agency managers in the formulation of policies, programs, and procedures and the evaluation of agency activities re- lated to procurement and construction; personal property management; real property management including engi- neering, design and construction of re- search facilities; records management; and research agreements including re- search gTants and contracts. Xd> Personnel division is responsible for providing assistance to agency man- agers in the formulation of policies, pro- grams, and procedures and the evalua- tion of agency activities related to posi- tion management, position classification, wage administration, recruitment and placement, employee development, safety, and employee relations. (e) Data systems application division provides technical and administrative di- rection and coordination for data proc- essing ' activities in the agency. Assists agency managers in the formulation of policies, programs, and standards relat- ing to data processing services for re- search and management activities, laboratory automation systems and procedures, statistical services, and other numerical analysis. B. Field Offices. 1. Regional Offices. Regional Deputy Administrators assist the Administrator along with the National Program Staff and other headquarters staffs in estab- lishing policy for all aspects of program planning, evaluating, budgeting, and co- ordination with emphasis on matters re- lating to the assigned Region, as well as their relationship to national programs, goals, and objectives. (a) Consistent with national program policies, plans, and objectives, the Re- gional Deputy Administrators are re- sponsible for formulating and recom- mending Regional program policies and objectives. (b) Coordinating and implementing program planning, review, and evalua- tion within the Region. (c) Directing and executing programs within the Region. (d) Participating with National Pro- gram Staff in planning and carrying out onsite reviews. (e) Representing ARS in the planning and execution of the TJSDA-SAES-In- dustry sponsored Regional planning and coordinating committee activities. (f ) Developing inputs for the Agency's budget development cycle. (g) Recommending new and revised program elements that set forth research goals of the agency and approving project plans at locations that contribute to these agency goals and objectives. 2. Area offices and major research cen- ters. Directors of Area Offices and Major Research Centers are responsible for: 162 (a) Assisting the Regional Deputy Ad- ministrator in establishing policy for all aspects of program planning, evaluating, budgeting, and coordination for the Region. (b) Formulating and recommending Area or Center policies and objectives to guide Area or Center program operations. (c) Coordinating and implementing program planning, review, and evalua- tion within the Area or Center. (d) Directing and executing programs within the Area or Center that contribute to agency goals and objectives. (e) Participating with National Pro- gram Staff, Regional Deputy Administra- tor, and scientists in carrying out onsite reviews. (f ) Advising the Regional Deputy Ad- ministrator concerning the Area or Cen- ter research programs relative to indus- try, State, and national problems and needs. (g) Working with the Regional Deputy Administrator and the Regional Staff in developing the Information and carrying out the evaluation needed from the Re- gion by National Program Staff and other headquarters staffs for program planning the evaluating at the national level. 3. Listing of regional and area offices and major research centers: . ._ NORTHXASTERIf RXCIOH Regional Headquarters. BeltsvUle, Md. Cheeapeake-Potomac Area (Md., Del., W. Va_ Wash., D.C.), Area Office, Hyattsvllle, Md. North Atlantic Area (N.Y., Pa., N.J., Vt., N.H., Maine, Conn., Mass.), Area Office, Ithaca, N.Y. -. ■' „ BeltsvUle Agriculture,) Research Center, BeltsvUle, Md.. ' I \ - - - Plum Island Animal Disease Center, Orient Point, N.Y. Eastern Regional Research Center, Wynd- moor. Pa. North Centum, Rxaxoir Regional Headquarters — Peoria, HI. Illlnols-Indlana-Ohlo Area, Area Office, La- fayette', Ind. Mlchlgan-Mlnnesota-Wlsconsln Area, Area Office, St. Paul, Minn. Iowa-Missouri Area, Area Office, Columbia, Mo. . ■-.-..- Kansas-Nebraska Area, Area Office, Clay Cen- ter, Nebr. Dakotas-Alaska Area, Area Office, Fargo, N. Dak. . Northern Regional Research Center, Peoria, SI. National Animal Disease Center, Ames, Iowa. Southern Rzoion t Regional Headquarters, New Orleans, La. Florida- AntlUes Area (Fla., pa, VX), Are* Office, Gainesville, Fla. . Athens, Ga. Area, Area Office, Athens, Oa. Georgia-South CaroUna Area, Area Office, Ttfton, Ga. Alabama-North Mississippi Area, Area Office, Mississippi State, Miss. Mississippi Valley Area (Miss., La., Ark.) , Area Office, Stonevllle, Miss. Mid-Atlantic Area (N.C., Tenn., Ky.. Va.), Area Office, Raleigh. N.C. Oklahoma-Texas Area, Area Office, College Statton, Tex. Subtropical Texas Area, Area Office, Weslaco, Tex.- Southern Regional Research Center, New Or- leans; La. FEDERAL REGISTER, VOL 40, NO. 169 — FRIDAr, AUGUST 29, 1975 3991 1 NOTICES "Wisizzx Region Regional Head quarters. Berkeley, Calif. Arizona-New Mexico Area, Area Office, Tuc- son, Ariz. CalJLforala-Hawafi-Nevada Area, Area Office, Fresno, Calif. Colorado- Wyoming Area, Area Office, Fort Collins, Colo. Idaho-Montana-'Otaii Area, Area Office, Logan.. Utah. Oregon-Washington Area, Area Office, Pull- man, Wash. Western Begional Research Center, Albany, Calif. IV. General Delegation or Authority to the Administrator In 7 CTR 2.7 the Administrator has been delegated authority to direct and supervise the employees engaged in the conduct of activities under his jurisdic- tion, and the authority to take any ac- tion, execute any ■ document, authorize any expenditure, promulgate any rule, regulation, order, or instruction required or authorized by law and deemed by him to be necessary and proper to the dis- charge of his responsibilities. This au- thority •will be exercised subject to ap- plicable administrative rules and regula- tions. Unless otherwise provided, he may, subject to his continuing responsibility for the proper discharge of delegations made to him, delegate and provide for the redelegation of his authority to appro- priate officers and employees. • V: Delegation or Authority by the Administrator 1. To the Associate Administrator. The Associate Administrator is author- ised to act for the Administrator on all matters for which the Administrator is responsible. * . , . 2. To the Assistant Administrators, Deputy Administrators, and Directors of. the Program Analysis and Coordination Staff, International Programs Division, Information Division and Heads of the Legislation b Special Assignments Staff and National Technical Editing Staff. Within their assigned functional areas of responsibility, these officials have the authority to take any action, not specifi- cally reserved in paragraph VI or to other administrative regulations of the agency or the Department, necessary to . the planning, coordination, and operation. of their respective programs. Unless otherwise provided this authority may be further redelegated. This delegation does not preclude the Administrator from ex- ercising any of the powers or functions, or from performing any of the duties listed herein, and such authority, is sub- ject at aD times to withdrawal or amend- ment. "These officials are responsible for the efficient and effective operation of their respective programs with specific respon- sibilities for: Providing overall planning, direc- tion, control, and coordination of the ■program. (b) Participating-with the Adminis- trator in the establishment- of overall policies governing program operation. (c) Keeping the Administrator' in- formed of significant program and re- lated matters. VI. Reservations of Authority The following authorities are reserved to the Administrator. (a) Issuance of ARS policy including national and regional goals, and major 6hifts in emphasis among commodities and locations of research activities. (b) Final decision on priorities and locations of research identified in the ARS Program and Financial Plan and in the budget requests submitted to Office of Secretary. (c) Allotment of all funds available to the agency and the further distribution of funds with guidelines stating their in- tended use and purpose. (d) Approval of changes in research activities at locations that are signifi- cant or involve sensitive issues and ac- tivities within guidelines furnished by the Administrator. (e) Approval of research projects funded under the Contingency Research Fund. (f) Changes in formal organization down to and including (1) Branches or equivalent in Headquarters Divisions & Staffs, (2) Branches or equivalent in Re- gional Offices, (3) Area Offices and Major Research Centers and (4) Institutes, Laboratories or their equivalent levels at locations. (g) Changes in major functions as- signed to the organization level cited in (f ) and jurisdictional shifts in Regional or Area Offices. (h) Issuance of regulations pursuant to law. (i) Establishment, relocation, or clos- ing of agency offices or facilities. (j) Distribution of manpower ceiling to Regions and. Headquarters. (k) Approval of appointment and pro- motions to GS-14 and above and reas- signments to GS-14 & above involving, a basic change in the nature of the as- signment except for actions on scientists to GS-14 & 15 under the Research Eval- uation Plan. (1) Recommendations to the Office of Secretary for foreign travel and attend- ance at foreign and international meet- ings including those held, in the United States. (m) Approval of attendance at na- tional meetings and common interest meetings in Canada and Mexico by Dep- uty Administrators, Assistant Adminis- trators, and other individuals reporting to the Administrator. Cn) Approval of nominauont> for awards having broad national signifi- cance in government or science. (o) Approval of all items of construc- tion for which specific authorization is provided in Appropriation Acts. (p) Acquisition and disposition of real property: (q) Execution of • foreign research ' contracts. . Done at Washington, D.C this 28th day of August 1975. T. W, EmirNSTER, Administrator, Agricultural Research Service. [FR EoC.75-23051 TOed 8-28-75; 8:45 am] 163 reOHUl KGlSTH r VOL 40, NO. 169 — HUDAT. AUGUST «, t975 B. SUMMARY OF DIABETES PROGRAM FUNDING 165 DIABETES PROGRAM FUNDING INTRODUCTION This portion of the report of the National Commission on Diahetes supple- ments the Program Funding Summary which appears in Volume I, and consolidates all the funding displays in one place. This section is subdivided into three subsections. The first deals with illustrating the FY 1975 level of effort in the National Institutes of Health. The second outlines the methodology which was employed to estimate the present level of research funding in diabetes. The third section is a discussion of the National Diabetes Plan during the period FY 1977 to FY 1978. FY 1975 PROGRAM LEVEL Clearly the National Commission on Diabetes could not move ahead in the right direction without knowing a good deal about past efforts in diabetes and without a firm fix on the present level of effort. With this information in hand the Commission could see where opportunities were being missed or where an expansion of an ongoing effort would be likely to be most appropriate. Tables I through III which appear both here and in Volume I, describe the FY 1975 effort in diabetes. Added detail is provided in this section by thf= inclusion of Exhibits I-V. These exhibits break the aggregated research totals into disease categories. An examination of these exhibits reveals a good deal of useful information about the composition of the diabetes research effort. For instance, nearly one-third of the present research effort is basic research on Metabolism and Hormones; further almost all of the work done on Hormones and half of the work on Metabolism is performed in the National Insti- tute for Arthritis, Metabolism and Digestive Diseases. Another one-third of the present research is on complications arising from diabetes. The majority of this research is carried out in Institutes other than NIAMDD, most notably the National Heart and Lung Institute which focuses on angiopathy and the National Eye Institute which concentrates on retinopathy. Most of the remainder of the present research funding is scattered among Epide- miology, Treatment (The University Group Diabetes Program), Animal Models and Genetics, Organ System Functions, Transplantation and Pharmacology. 16 7 METHODS AND PROCEDURES FOR ESTIMATING DIABETES PROGRAM FUNDING As previously described in the summary volume of the Commission recommenda- tions, a three step process was followed in making estimates of recent extra- mural diabetes research funding. The three steps were: — identification of research projects which were likely to be directly diabetes-related by using the Computer Retrieval of Information on Scientific Projects (CRISP) system. — a review by the Diabetes Program staff of the NIAMDD of the projects which were identified by CRISP in order to group the projects into research categories and to eliminate any projects which had been incorrectly identified as directly diabetes-related . — a review, by the staff of each institute, of the list of projects which had been previously identified by CRISP and reviewed by the Diabetes Program staff. The CRISP system is a computer data base system maintained by the Division of Research Grants of NIH. The system contains scientific and fiscal data on research grants and contracts of the Public Health Service. In addition to such information as grant number, fiscal year of award, amount of award, and name of principal investigator, the abstract as submitted by the principal investigator with his application is also included. These applications are indexed, using not only index terms designated by the principal investigator, but also using further in-depth indexing of the application itself. The searches which were made for the purposes of locating diabetes research projects made use of key words or key word combinations. During the reviews by the Diabetes Program staff, approximately one-third of the projects identified through the key word search were found not to be directly related to diabetes. The key word list defines a broad search and the project list that results still requires a knowledgeable professional review, in order to avoid errors in identifying diabetes research projects. Even though the key word list is broadly defined, it still is this list that will provide a consistent basis for esti- mating the funding of diabetes research in future years and allow one to judge the extent to which recommendations have been carried out. It is, of course, difficult to draw a sharp boundary as to what research is "directly" related to diabetes and that which is not so direct. This is particu- larly hard when dealing with general research relating to categorical disease areas that often occur as complications arising from diabetes. Thus it would 168 be possible to identify much of the research done in the National Heart and Lung Insitute, the National Eye Institute, and the National Institute of Neurologi- cal and Communicative Diseases and Stroke as having relevance to diabetes. How- ever, the Commission focused its recommendations on those research opportunities directed specifically towards diabetes and therefore only that portion of the work in those Institutes was included when identifying diabetes research. The CRISP system does not contain data on intramural research or training programs. That information was provided to the Commission by each Institute Director. The effort to identify the recent funding history for diabetes extramural research began in late August of 1975 • Prior to that time, the Workgroups of the Commission had been given briefings on the nature of the effort to identify the FY 1975 funding patterns. The first CRISP runs were made in late August. Based on the results of this initial run, the key word list was revised and a CRISP search for FY 197^ was made in early September. The output, a list of projects sorted by key words, was the first to be screened by the Diabetes Program staff. The projects were sorted by disease category within each institute (see chart I for these categories). The screened project list was compared with submissions made by the Institutes, to the Diabetes Mellitus Coordinating Committee for FY 197*+. There was a high degree of correlation, indicating the utility of the CRISP system for creating valid representations of diabetes funding in recent years. Therefore the re- maining runs for FY 1972, 1973 and 1975 were made during September. Each year's output was carefully screened and reviewed by the Diabetes Program staff and the results were presented to the National Commission on Diabetes in early November. At the same time, complete project lists for each Institute were distributed to the respective staffs for their review. This resulted in the discovery of a few projects which either had not been included in the CRISP data base at the time of the search, or which the key word search had somehow overlooked. The inclusions of these projects resulted in a quite definitive picture of the diabetes project lest for FY 1975- Also, the lessons learned allow the key word list to be refined and recalibrated to insure that none of the types of projects overlooked in these first CRISP runs will be missed again. Thus the system can provide comparable project lists and program funding levels in a consistent manner in the years ahead. The project and key word lists are lengthy and are not included in this report but are part of the working file documentation of the National Commis- sion on Diabetes. 169 THE NATIONAL PLAN FY 1977-1978 In Volume I of the National Commission on Diabetes' Report, the reasons for beginning the implementation of the National Plan for Diabetes in 1977 are explained. Essentially, the submission of the Commissions report in the middle of a fiscal year and at a point when no new appropriations have been made for the National Institutes of Health makes it seem likely that the amount and composition of research funding for diabetes in FY 1976 will be very similar to that for FY 1975. The Commission's recommendations for 1976 do, however, indicate where available resources should be allocated. The Commission's recommendations for 1977 should be fully funded in the manner and amounts indicated by Tables IX through XII. Supplementary Tables XIII through XVI are included in this report for the Diabetes Research and Training Centers, the Diabetes Control Program, the Information and Education Clearinghouse, the National Diabetes Data Group, and Research Manpower. These tables are presented to show, in greater detail, the funding patterns within each of the Commission recommendations. A final point of clarification is in order with regard to the General Clinical Research Centers (GCRC). Throughout the Program Funding Summary in Volume I, and in this report, only the prorated portion of the GRCS's which is diabetes related has been shown. The National Commissions recommen- dations, interpreted literally, involve the GCRC's as a whole. Thus the total recommended NIH program beyond FY 1975 is: ($ in thousands) FY 75 FY 76 FY 77 FY 78 FY 79 FY 80 NIH Diabetes Program W/0 GCRC's: 3^,0^5 ^5,716 57, ^0U 69,303 8?,UUU 95,392 GCRC Recommendations Pro-Rated Diabetes Portion 5,733 6,075 6,750 7,088 7,^25 7,763 Other 36,593 38,925 U3,250 U5,Ul2 Ut,575 ^9,737 Total GCRC U2,326 U5,000 50,000 52,500 55,000 57,500 ?otal NIH Recommenda- tions 76,371 90,775 107, UOU 121,803 137, kkk 152,892 170 TABLE I DIABETES RESEARCH, FY 1975 ($ in thousands) Federal National Institutes of Health Veterans Administration National Science Foundation Voluntary Health Agencies Private Industry 39. .778 2 ,139 1 ,122 43, 039 2 ,664 Unknown 45,703+ 171 TABLE II NIH EXTRAMURAL RESEARCH, FY 1975 Institute Share Diabetes of Total Portion Diabetes Extramural of Total Research Diabetes Total Research Extramural Institute ($ in thousands) Research (%) ($ in thousands) Research NIAMDD 14,777 41.9% 129,259 11.4% NCI 822 2.3 469,835 .2 NHLI 5,588 15.8 263,123 2.1 NIDR 117 .3 30,941 .4 NINCDS 1,365 3.8 100,780 1.4 NIAID 289 .8 82,021 .4 NIGMS 730 2.1 129,308 .6 NICHD 1,073 3.0 97,023 1.1 NEI 4,491 12.7 32,042 14.0 DRR 5,733 16.3 42,326 13.5 Other 212 .6 112,479 .2 TOTAL 35,197 100.0% 1,489,137-^ 2.36 1/ Total NIH Extramural Research, including research funded by Institutes not involved directly in diabetes related research. 172 TABLE III COMPOSITION OF FY 1975 NIH OBLIGATIONS ($ in thousands) Total Intramural Research Training Administrative Overhead Cancer Control and Construction Library of Medicine Amount Percent $1,489,137 71.2% 193,356 9.2 154,432 7.4 139,025 6.6 87,962 4.2 28,848 1.4 $2,092,760 100.0% 173 CHART I RESEARCH CATEGORIES EPIDEMIOLOGY AND NATURAL HISTORY TREATMENT ANIMAL MODELS & GENETICS COMPLICATIONS Cataract Dental Hypoglycemia Infection In j ury/Trauma Macroangiopathy Microangiopathy Neoplasm, Pancreas Neoplasm, Other Nephropathy Neuropathy Retinopathy Obesity ORGAN SYSTEM FUNCTION HORMONES, OTHER METABLOISM Carbohydrate Lipid Protein Trace Minerals Metabolism, Gen. TRANSPLANTATION & CELL CULTURE Cell Culture Pancreas (includes islet cells) Renal PHARMACOLOGY Diabetogenic Agents Hypoglycemic Agents Misc. INFORMATION ACTIVITIES DIABETES -ENDOCRINOLOGY CENTERS Cardiac Eye Food Intake Behavior GENERAL CLINICAL RESEARCH CENTERS Gastro-Intestinal (liver, spleen, (diabetes-related projects) Neurologic exocrine pancreas) Pancreatic (only endocrine) OTHER Reproductive Other PANCREATIC HORMONES Glucagon Action of Blucagon Binding/Receptor Production/Secretion Insulin Action of Insulin Antagonism Binding/Receptor Degradation Production/Secretion Sensitivity/Resistance Proinsulin Pancreatic Hormones Gen. Hormone Interactions New Pancreatic Hormones 174 M in a -h r» CO 4J en c m -H < Eh b fc X ^> 1 u in xi e 05 TJ B X M "s H Q 0) X CO 3 c c S co 2 c CD 4J H (A ■U u X tr co c w O >i 3 CO fc, X M z 1 CO ■H C ^H a -h e +j UJ U O e > OJ u< •V o V M IX J Q X H Z Z - en a: ^ x x co « swi £hhu 4J z z z 175 *■■ g- 5". c > a *i at at 4J to OS o \ o e ft . u ac to e o o ra u n 3 03 nj jj ^h id U u Q Q (J w Z -< S X W ■C M w o -*- 1 2 2 Z O — 176 En H CO H EC X w m r- cr> DC w co Eh X w O H Eh U 2 D Pm g W in x m < o U5 T) G id en 4-1 C ■H > ■H 4J o g O SH £J -P w en ITS CO m VD CN in r~- \ \ kO rH CO CN U3 r- r-4 CM in in ro ro cn \ \ CN .H oo CN Q Q 2 2 05 Q M 2 co O 2 G H < H 2 r- oo oo cti CO Q a u CTi oo en in CN m H en ro \ CO w 2 g a o CO CN \ Oi o CN o oo co CN CO EC u 2 — - CO EC C4 W W M PC 2 Eh — O < Eh O Eh 177 PQ M K X w fx fn «. ^_^ I M U T3 « C < id w to en 3 § +j oo Sh <* l-> X vD in o X m o oo X CN o oo CD X o oo X m m CO CM X CN oo ■^ vD in r^ X X vD H P Q y 2 in o CN vD in in oo in in CO X CN vD CN X J X 2 Q in m vo m m Q CD Q M < H 2 CO Q s m o u H w 2 g Q a Eh o o CN VD X -a* CN en vo CN VD CO m CO CN O X vD oo oo O vD •ST En O &H 178 CQ H X X en rH u u rC 0) Eh -H s CTi m CN 00 m m rH VD co rn \ \ o o CN \ m 0> CD n \ T) o •H 0> ft ■5T •H \ h^ H H a) +j is M CM 13 O >, r^ js \ r^ X3 H H R) CJ Q Q en H \ CN in ro CD CN <7l 0> \ CN 2 ^ vD <^ ro m o O CN <£> rH c^ CN \ CO N CO O u in CO Q s E U U M M M w s 2 2 O Q a; w E Eh o CO CN in r- o CN cr> ro CTi CN CO ro \ o CO rH CN ro CO ro O ro CN < O Eh 179 TABLE IV DIABETES SHARE OF NIH EXTRAMURAL RESEARCH ($ in mi! Llions) Diabetes Total Extramural Extramural Diabetes Year Research Research Share (%). FY 1972 25.0 $1,065.3 2.3 % FY 1973 23.5 1,122.0 2.09 FY 1974 25.7 1,456.8 1.76 FY 1975 35.2 1,489.1 2.36 Annual Growth Rate of Diabetes Research = 9% Annual Growth Rate in Constant Dollars = 5% 180 TABLE V NIH DIABETES RELATED EXTRAMURAL RESEARCH FY 1973-1975 ($ in thousands) Institute FY 1972 FY 1973 FY 1974 FY 1975 NIAMDD 9,648 10,734 14,154 14,777 NCI 1,184 815 965 822 NHLI 3,150 3,040 2,323 5,588 NIDR 165 69 68 117 NINCDS 826 688 679 1,365 NIAID 258 112 106 289 NIGMS 1,944 1,465 530 730 NICHD 1,530 1,141 925 1,073 NEI 2,124 2,562 3,376 4,491 Other — 37 — 212 DRR— 4,216 2,802 2,619 5,733 Total 25,045 23,465 25,745 35,197 Constant 1972 Dollar si/ 25,045 22,470 23,076 28,502 1/ Portion of the DRR (GCRC) budget which is for diabetes. Obtained by pro-rating total GCRC budget by the number of diabetes projects per- formed in GCRC's in that year. 2/ The Biomedical deflators used to convert to constant dollars (on a 1970 base) : FY 1972 FY 1973 FY 1974 FY 1975 110.7 115.6 123.5 136.7 (est.) 181 TABLE VI NIAMDD SHARE OF OBLIGATED RESEARCH FUNDS ($ Millions) Total NIH Institute Research Program!/ NIAMDD NIAMDD Share (%) Extramural Diabetes Research in NIAMDD Extramural Diabetes Share of NIAMDD obligations (%) FY 1972 FY 1973 FY 1974 FY 1975 $1,465 $1,484 $1,945 $2,064 $155.3 $142.8 $177.4 $173.4 10.6% 9.6% 9.1% 8.4% $9.6 $10.7 $14.2 $14.8 6.2% 7.5% 9.9% 8.5% 1/ Source : Basic Data Relating to NIH, Office of Program Planning and Evaluation, February, 1975. (Excludes the National Library of Medicine.) 182 TABLE VII NIH/NIAMDD TRAINING FY 1970-1975 (Training, Fellowships, Research Career Programs) ($ in Millions) Diabetes, Endocrinology, Metabolism 70 71 72 73 74 75 $7.2 $6.9 $6.6 $5.5 $7.3 $6.0 No. of Postdoctoral Positions 344 365 332 254 266 246 TABLE VIII NIH QUARTERLY RESEARCH OBLIGATIONS PATTERN (FY 1971-75) First Second Third Fourth Quarter Quarter Quarter Quarter Total Average Quarterly Percentage of Annual Obligation 10.9% 19.3% 28.7% 41.1% 100.0% 183 TABLE IX BUDGET SUMMARY FOR ALL RECOMMENDATIONS ($ in thousands) FY 1975 FY 1976 FY 1977 FY 1978 FY 1979 FY 1980 (PY 1) (PY 2) (PY 3) (PY 4) • 1. National Diabetes 500 500 500 500 500 Advisory- Bo ardi-/ 2. NIH Programs 39,778 51,791 64,154 76,391 89,869 103,155 3. Research and Training 8,000 12,000 20,000 20,000 Centers 4. Health Care & Control 2,139 3,339 7,712 9,812 13,820 16,841 Program TOTAL (Recommenda- 41,917 55,630 80,306 98,703 124,189 140,496 tions) NSF-/ 1,122 1,122 1,122 1,122 1,122 1,122 TOTAL 43,039 56,752 81,428 99,825 125,311 141,618 1/ These amounts include only the diabetes share of the budget increases recom- mended for the General Clinical Research Centers (see Table Xg) . 2/ No specific recommendations were directed towards the National Science Founda- tion (NSF) . 184 TABLE X NIH RECOMMENDATIONS (BY INSTITUTE) ($ in thousands) INIAMDD NEI NINCDS NIDR NICHD NHL I DRR(GCRC) Other 1/ TOTAL FY 1975 FY 1976 FY 1977 FY 1978 FY 1979 FY 1980 (PY 1) (PY 2) (PY 3) (PY 4) 18,373 25,653 32,909 40,473 49,009 58,241 4,763 6,324 8,207 10,331 13,034 14,463 1,365 1,606 1,792 1,997 2,218 2,459 427 702 917 1,132 1,347 1,562 1,476 2,892 4,016 4,758 5,724 7,055 5,588 6,486 7,450 8,559 9,059 9,559 5,733 6,075 6,750 7,088 7,425 7,763 2,053 2,053 2,053 2,053 2,053 2,053 2/ 39,778- 51,791 64,094 76,391 89,869 103,155 1/ Diabetes research effort in Institutes not directly affected by Commission recommendations (NCI, NIGMS, NIAID, NIEHS) 2/ Total NIH dollars spent on intramural ($4,581) and extramural ($35,197, as shown in Table II) research. 185 TABLE Xa NATIONAL INSTITUTE OF ARTHRITIS, METABOLISM AND DIGESTIVE DISEASES ($ in thousands) Present FY 76 FY 77 (PY 1) FY 78 (PY 2) 1 . Manpower TOTAL MANPOWER Extramural Research 1,494 2,000 2,490 3,080 FY 79 (PY 3) 3,670 FY 80 (PY 4) Training grants & 1,074 1,260 1,460 1,660 1,860 2,060 fellowships RCDA 420 500 750 1,000 1,250 1,250 Distinguished Scientiese ~ 240 280 420 560 700 4,010 a. Basic Endocriniology 7 ,996 10,400 13,520 17,576 22,850 29,705 & Metabolism b. Etiology • Viruses 365 500 650 845 1,098 1,428 • Genetics 318 418 523 653 816 918 c. Angiopathy 389 750 1,000 1,250 1,500 1,500 d. Nutrition & Obesity • General Research & 487 1,000 1,500 1,500 1,500 1,500 Obesity Centers • Caloric intake & — 200 260 338 440 572 Nutritional Patterns Studies • Neurophysiology of — 200 260 338 440 572 appetite - Control Studies e. Transplantation & Devices • Transplantation 684 889 1,156 1,503 1,954 2,540 • Devices — 500 1,500 3,000 3,000 3,000 f. Epidemiology 394 545 754 1,044 1,445 2,000 g. Resources facilities — 750 1,000 1,250 1,500 1,500 h. Clinical Study of Juvenile-onset Diabetes — 500 1,000 1,000 1,000 1,000 (joint with NHLI) i. Other V 4 ,144 4,144 4,144 4,144 4,144 4,144 TOTAL EXTRAMURAL RESEARCH 14 ,777 20,796 27,267 33,941 41,687 50,379 Intramural Research 2 ,000 2,200 2,400 2,600 2,800 3,000 Research Information 102 207 302 402 402 402 New Administrative — 450 450 450 450 450 5. Positions TOTAL 18,373 25,653 32,909 40,473 49,009 58,241 1/ This is the amount currently spent in areas of extramural diabetes research that are not directly addressed by Commission recommendations. These areas are (in thousands): University Group Diabetes Program ($863), Hypoglycemia ($78), Neuropathy ($80) , Food intake functions ($77) , Gastrointestinal functions ($546) , Neurology ($280), Pancreatic functions ($333), Pharmacology ($213), Diabetes Centers ($1,652). 186 TABLE Xb NATIONAL EYE INSTITUTE ($ in thousands) Present FY 76 FY 77 FY 78 FY 79 FY 80 (PY 1) (PY 2) (PY 3) (PY 4) 1 . Manpower a. Training 73 240 400 560 800 920 Grants & Fellowships b. Res. Career 12 75 150 225 300 375 Development c. Distinguished — 35 70 105 140 175 Scientists TOTAL MANPOWER 85 350 620 890 1,240 1,470 2. Extramural 4,491 5>614 7,017 8,771 10,964 12,063 Research 3. Intramural 187 300 450 550 650 750 Research 4. New Administra- ~ 60 120 120 180 180 tive Positions TOTAL 4,763 6,324 8,207 10,331 13,034 14,463 187 TABLE Xc NATIONAL INSTITUTE OF NEUROLOGICAL AND COMMUNICATIVE DISORDERS AND STROKE ($ in thousands) Present 1. Manpower a. Fellows 2. Extramural Research 3. Intramural Research 4. New Administra- tive Positions TOTAL 1,365 FY 76 40 1,506 60 FY 77 (PY 1) 80 1,652 60 FY 78 (PY 2) 60 FY 79 (PY 3) 120 160 1,817 1,998 60 1,365 1,606 1,792 1,997 2,218 FY 80 (PY 4) 200 2,199 60 2,459 188 TABLE Xd NATIONAL INSTITUTE OF DENTAL RESEARCH ($ in thousands) Present FY 76 FY 77 FY 78 FY 79 FY 80 (PY 1) (PY 2) (PY 3) (PY 4) 1. Manpower a. Training — 40 80 120 160 200 Grants & Fellowships b. Res. Career -- 25 50 75 100 125 Development Total Manpower — 65 130 195 260 325 2. Extramural 117 217 317 417 517 617 Research 3. Intramural 310 360 410 460 510 560 Research 4. New Administra- — 60 60 60 60 60 tive Positions TOTAL 427 702 917 1,132 1,347 1,562 189 TABLE Xe NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT ($ in thousands) Present FY 76 FY 77 FY 78 FY 79 FY 80 (PY 1) (PY 2) (PY 3) (PY 4) 1 . Manpower a. Training groups & Fellowships — 200 240 280 320 400 b. Res. Career De- velopment Awards 41 125 150 175 200 250 41 325 390 455 520 650 2. Extramural Research a. General Research 889 1,156 1,502 1,953 2,539 3,300 b. Infant feeding 184 239 311 404 525 683 c. Infants of diabetic mothers follow-up study — 100 200 200 200 200 d. Contraception studies — 450 900 900 900 900 e. Expanded Research on Pregnancy and Diabetes _^ 200 291 424 618 900 Sub-total 1,073 2,145 3,204 3,881 4,782 5,983 3. Intramural Research 362 362 362 362 362 362 4. New Administrative Positions — 60 6(3 60 60 60 TOTAL 1,476 2,892 4,016 4,758 5,724 7,055 190 TABLE Xf NATIONAL HEART AND LUNG INSTITUTE Present ($ in thousands) FY 76 FY 77 FY 78 FY 79 FY 80 (PY 1) (PY 2) (PY 3) (PY 4) Extramural Research 5,588 6,426 7,390 8,499 8,999 9,499 New Administra- tive Positions — 60 60 60 60 60 TOTAL 5,588 6,486 7,450 8,559 9,059 9,559 TABLE Xg GENERAL CLINICAL RESEARCH CENTERS ($ in thousands) Present FY 76 FY 77 FY 78 FY 79 FY 80 (PY 1) (PY 2) (PY 3) (PY 4) Pro Rata Share Attributable to Diabetes Projects (13.5%) 5,733 6,075 6,750 7,088 7,425 7,763 Total GCRC Funds 42,326 45,000 50,000 52,500 55,000 57,500 191 TABLE XI DIABETES RESEARCH AND TRAINING CENTERS ($ in thousands) Present FY 1977 FY 1978 FY 1979 FY 1980 (PY 1) (PY 2) (PY 3) (PY 4) 8,000 12,000 20,000 20,000 TABLE XII HEALTH CARE, EDUCATION, AND CONTROL PROGRAMS ($ in thousands) Present FY 1976 FY 1977 FY 1978 FY 1979 FY 1980 (PY 1) (PY 2) (PY 3) (PY 4) Center for Disease Control 3,600 5,100 8,400 10,600 Veterans Admin. Manpower Project Research Cooperative Project Special Units Total Add-on Base 2,139 79 157 229 314 400 160 314 458 628 800 126 249 363 498 640 298 591 861 1,179 1,500 663 1 ,311 1 ,911 2,619 3,340 2,139 2 ,139 2 ,139 2,139 2,139 2,802 3,450 4,050 4,758 5,479 Education Clearinghouse National Diabetes Datat Group TOTAL 340 465 465 465 465 197 197 197 197 297 3,339 7,712 9,812 13,820 16,841 192 TABLE XIII PROTOTYPE STAFFING AND BUDGET FOR DIABETES RESEARCH AND TRAINING CENTERS ($ thousands) 1 Director (M.D.) 50,000 1 Associate Director (M.D.) 50,000 6 Staff (M.D.) 300,000 6 Staff (Ph.D.) 210,000 1 Contracts Officer 20,000 3 Support Staff 60,000 4 Clerical 48,000 738,000 Overhead (38%) 280,000 1,018,000 19 3 TABLE XIV DIABETES CONTROL PROGRAM ($ thousands) FY 77 FY 78 FY 79 FY 80 CDC Community Program 1,500* 3,000* Contracts CDC Program Costs 2,100 2,000 2,400 2,600 Community Program * * 6,000 8,000 Grants 3,600 5,100 8,400 10,600 Personnel HQ 40 40 45 50 Community Programs 10 50 20 60 40 85 60 110 * In the first two years of the program, community program costs will be done through a contract mechanism with CDC. In subsequent years these programs will be funded by grants as authorized in recent amendments to Par. 4, Section 317 of the Public Health Services Act. 194 TABLE XV NATIONAL DIABETES INFORMATION AND EDUCATION CLEARINGHOUSE {$ in thousands) FY 76 FY 77 FY 78 FY 79 FY 80 Staff Task Force Support* Total Overhead Surveys Professional & Patient 150 Public 100 Total Surveys 250 80 200 200 200 200 10 60 60 60 60 90 260 260 260 260 40 25 65 40 25 65 40 25 65 40 25 65 Materials Development Professional Patient Public Total Materials Devel. - 10 10 10 10 - 40 40 40 40 - 30 30 30 30 _ 80 80 80 80 Materials Purchase & Reproduction Professional Patient Public Total Purch. & Reprod . TOTAL 340 465 *Consultant fees, travel, per diem, etc. - 6 6 6 6 - 24 24 24 24 - 30 30 30 30 _ 60 60 60 60 465 465 465 195 TABLE XVI NATIONAL DIABETES DATA GROUP ($ in thousands) Present FY 76 FY 77 FY 78 FY 79 FY 80 Chairman 10 10 10 10 10 Support Staff 25 25 25 25 25 Meeting Support 12 12 12 12 12 Health Sta- tistics Data 50 50 50 50 50 Library Diabetes Pub- - - - - 200 lications Special Studies 100 100 100 100 - TOTAL 197 197 197 197 297 196 Table XVII RESEARCH MANPOWER - POSITIONS FY 75 FY 76 FY 77 FY 78 FY 79 FY 80 NIAMDD Fellowships 43 60 70 80 90 100 Research Career 10 20 30 40 50 50 Development Awards Distinguished 4 8 12 16 20 Scientist Awards NEI Fellowships 2 12 20 28 40 46 Research Career 3 6 9 12 15 Development Awards Distinguished 1 2 3 4 5 Scientist Awards NINCDS Fellowships 2 4 6 8 10 NIDR Fellowships Research Career 1 2 3 4 5 Development Awards NICHD Fellowships Research Career Development Awards 10 5 12 5 14 7 16 8 20 10 TOTAL 55 120 164 208 256 291 197 C. SPECIAL REPORTS 199 1 . DIABETES in the INDIAN PEOPLE and the ALASKA NATIVE POPULATION 201 DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE INDIAN HEALTH SERVICE PHOENIX INDIAN MEDICAL CENTER 4*U NORTH SIXTEENTH STREET PHOENIX. ARIZONA SSOIS September 30, 1975 Our Reference: PHX: SC (IM&CR) Dr. Keatha Krueger National Commission on Diabetes National Institutes of Health Blair Building, Room 220 Bethesda, Maryland 20014 Dear Dr. Krueger: In accordance with our recent telephone discussion, I am submitting material, which I hope will be useful to the National Commission on Diabetes in its considerations concerning diabetes in the Indian people and the Alaska Native population. I am enclosing a narrative summary and some copies of selected publi- cations " which describe some aspects of the enormous extent of diabetes in many tribes. Thank you for this opportunity to contribute this information for the consideration of the Commission. Sincerely, Maurice L. Sievers, M.D. Senior Clinician, Internal Medicine and Clinical Research cc: Director, Indian Health Service Acting Director, Office of Professional Standard & Evaluation Deputy Director, Office of Program Operations (1) Editor's note: See References at the end of Dr. Siever's summary. 203 SUMMARY: DIABETES MELLITUS IN AMERICAN INDIANS A brief outline of the organizational structure of the Indian Health Service (IHS) should provide a basis for consideration of health services for diabetes mellitus among American Indians. The IHS Head- quarters serves as a resource for field staff personnel. For the delivery of health care, the IHS is organized into eight geographic areas, which are generally designated by the name of the city where the respective IHS Area offices are located. These IHS Areas include: (1) Aberdeen (South Dakota, North Dakota, Minnesota, Wisconsin, Michigan, Iowa, Nebraska); (2) Alaska or Anchorage (Alaska); (3) Albuquerque (New Mexico, Colorado — except for the Navajo Reserva- tion); (4) Billings (Montana, Wyoming); (5) Navajo, or Window Rock (all of the Navajo Reservation); (6) Oklahoma City (Oklahoma, Kansas); (7) Phoenix (Arizona, California, Nevada, Utah — except for the Navajo Reservation); and (8) Portland (Oregon, Washington, Idaho). In addition, two separate jurisdictions should be mentioned: (1) United Southeastern Tribes (Florida, North Carolina, Mississippi); and (2) Office of Research and Development (Reservations of Papago; in Arizona). The IHS Areas are subdivided into Service Units, which serve one or more reservations through clinics, health centers, and hospitals, as well as through field health and school health programs. Service Units are the basic IHS health organizations, being defined Areas with various health facilities staffed by health teams. Among the comprehensive health services which the IHS health workers provide the Indian people and Alaska Natives, the diagnosis and treat- ment of diabetes mellitus and associated conditions are major activities in most Service Units. Diabetes mellitus is much more prevalent in most American Indian tribes than it is among the non-Indians (see references 1, 2, 3). Indeed, some tribes, such as the Pima and Papago, have diabetic rates 10 to 15 times the presumed frequency among whites, although diabetes prevalence data for the white population usually has not been obtained with the precision of the Indian studies (reference 4). In their study of computerized health records of Papago Indians, Reinhard and Greenwalt (reference 5) noted that diabetics have significantly greater frequencies of large varieties of illnesses than is the experience of an age-sex-geographically matched nondiabetic control population. In a recent article, West (reference 3) reviewed published reports of diabetic prevalences in aboriginal groups (table 1, page 844 of article) and concluded that most of the American Indian tribes which have been studied currently have high rates of diabetes. He also con- cluded that diabetes was probably unusual in American Indians before 205 about 1940 and that, in addition to genetic aspects, environmental factors are of considerable importance in the emergence of diabetes. This review article notes that high diabetic rates have been reported for at least 41 Indian tribes. Some IHS Service Units have given diabetes major emphasis in their program plans (reference 6, pages 29-30 of the Gila River Indian Community Health Delivery System Program Plan for Fiscal Year 1976) . Because of increasing concern by health professionals and the Indian people with the epidemic proportions of diabetes among many tribes, the Phoenix IHS Area conducted a workshop on control and prevention of diabetes mellitus on May 22, 1967 to obtain the guidance of expert consultants (see reference 7 for selected portions of the proceedings). The recommendations ranged from weight control programs to careful foot care of diabetics. Amputation of gangrenous feet and legs is a frequent event in the diabetic Indians (currently being studied by Nadel WN) . Diabetes is a major factor in fetal loss and congenital malforma- tions in some tribes. Careful control of diabetes may reduce the frequency of these conditions (see reference 8). The IHS internists have stressed the importance of diabetic detection and treatment (see reference 9) . They also endorsed the Recommendations of the Diabetic Subcommittee (of the Health Information System Advisory Committee, IHS) for Detection, Diagnosis, and Management of Diabetes Mellitus (see Diabetes Mellitus: Standards for Diagnosis and Management , attached to reference 9). Among the purposes of these guidelines are to: (1) limit "diabetic" diagnoses to those most likely to be affected by the disease; (2) intensify diabetic case finding in high risk groups or individuals; (3) base diabetic management upon staging criteria; (4) involve nonphysicians (CHMs, or PAs ; Pharmacist practitioners; LPNs; Community Health Representatives, or CHRs) to a major extent in diabetic management of asymptomatic diabetics, so that physicians can give greater attention to diabetics with symptoms and/or remediable complications; (5) stress that early diagnosis and careful management of diabetic pregnancies can markedly reduce the complications (spontaneous abortion, stillbirth, congenital malformations, macrosomia, etc.). RECOMMENDATIONS FOR IMPROVED DIABETIC DIAGNOSIS AND MANAGEMENT PROGRAMS FOR INDIANS 1. Implement a diabetic case finding program as outlined on page 8 in reference 9, Diabetes Mellitus: Standards for Diagnosis and Manage- ment and in the following table: 206 Recommended Frequency of GTT for Diabetes Case Finding in Indians Diabetes Prevalence in Population > 35 years 15 - 29 Age of Person (Years) 30 - 49 > 50 High Prevalence (> 35%) Medium Prevalence (15% - 34%) Low Prevalence (0% - 14%) At 5 Year Intervals Female : Once (At Leaving High School) Male : None None At 2 Year Intervals At 5 Year Intervals (Both Sexes) Once During Period At 5 Year Intervals At 5 Year Intervals Only When "High Risk"* (See Below) *HIGH RISK FACTORS (To Be Used As Guidelines For Special Surveillance) A. TRIBE (wide range of diabetic probability; many tribes not adequately categorized — but this evaluation should be done ) . 1. Highest — Pima, Papago, Maricopa, Mohave, Cocopah. 2. Medium — Hopi, Yavapai, Hualapai, Apache, Cochtaw, Cherokee, Paiute, Washoe, Seneca, Seminole. 3. Low — Alaskan Athapascan, Navajo, Eskimo. B. Delivery of infant >^ 9 lbs.; stillbirth; neonatal death; infant with congenital malformation. C. Diabetes family history (Order of priority: Both parents, 1 or more siblings, 1 parent). D. >_ 150% desirable weight. E. Coronary heart disease; peripheral or cerebral vascular disease. F. Peripheral neuropathy and cranial (motor or sensory) neuropathy. G. Active tuberculosis. 207 H. Recurrent infections, especially skin or vagina (Monilia) . 1. Hypertension. J. Proteinuria of unknown cause. K. Hypercholesterolemia (>_ 250 mg%) . L. Acute refractive eye changes. 2. Intensified programs for detection of diabetes in pregnancy; every pregnant Indian woman should be screened for diabetes and GTT performed unless she is previously known to be diabetic. (See Flow Sheet on page 7 of reference 9). All diabetic pregnant women should have very careful management to decrease serious fetal complications. 3. Increased diabetic education (live and taped illustrated talks at schools, fairs, clinics, and public meetings, and in various publica- tions and materials), especially concentrated among: A. Tribes with high diabetic prevalence. B. Young (13-20 Years) females (before pregnant) regarding the importance of early detection, and careful management of diabetes in pregnancy. C. Pregnant women (regarding importance of diabetic screening and management of diabetes in pregnancy) . D. Known diabetics (on such topics as foot care). 4. Extensive programs using nonphysicians — PAs (CHMs) , Pharmacist Practitioners, Public Health Nurses (PHNs) , Community Health Representa- tives, and others — for many of the routine diabetic visits (as out- lined on page 5 of reference 9) , with physicians involved mainly in initial visits and annual diabetic examinations ( exception : significantly more often for patients with symptoms or complications), should improve management by more frequent contact of diabetics with health workers for routine followup and by permitting physicians to concentrate on the initial and annual evaluation of all diabetics and on more frequent evaluation of the diabetics with symptoms or complications. N.B.: Diabetic foot care programs should involve all of the above, plus optimally having a podiatrist available periodically. In addition, dietitians/nutritionists are important for weight control programs. (Some of the nonphysician personnel required for above recommended programs: Physician's Assistants (PAs, CHMs), Pharmacist Practitioners, 208 Public Health Nurses, Community Health Representatives, Dietitians/ nutritionists, Health Educators, Podiatrists). REFERENCES 1. Sievers, Maurice L. Disease Patterns Among Southwestern Indians. Public Health Reports, 81:1078-1079 (1966). 2. Diabetes Source Book. U.S. Department of Health, Education and Welfare. Public Health Service, Division of Chronic Diseases, Diabetes and Arthritis Program Public Health Service Publication No. 1168, May 1964. 3. West, Kelly M. Diabetes in American Indians and Other Native Populations of the New World. Diabetes 23:841-55 (1974). 4. Bennett, Peter H. and Miller, Max. Diabetes Mellitus in Indians of the Southwestern United States. Proceedings of the VII Congress of the International Diabetes Federation, Buenos Aires, 23-28 August 1970. 5. Reinhard, Karl R. and Greenwalt, Naomi I. Epidemiological Definition of the Cohort of Diseases Associated with Diabetes in Southwestern American Indians. Med Care 13:160-173 (1975). 6. Gila River Indian Community Health Delivery System, Program Plan Fiscal Year 1976. 7. Proceedings of a Workshop on Control and Prevention of Diabetes Mellitus (Revised October 1967). Department of Health, Education and Welfare, U.S. Public Health Service, Division of Indian Health, Indian Health Area Office, Phoenix, Arizona. 8. Comess, L. J. et al. Congenital Anomalies and Diabetes in the Pima Indians of Arizona. Diabetes 18:471-477 (1969). 9. Letter from Maurice L. Sievers to All Indian Health Service Medical Officers, January 29, 1973 (attachment: Diabetes Mellitus: Standards for Diagnosis and Management). 209 2. DIABETES - RELATED RESEARCH AND EDUCATION PROGRAMS of the DEPARTMENT OF AGRICULTURE 211 UNITED STATES DEPARTMENT OF AGRICULTURE AGRICULTURAL RESEARCH SERVICE NORTHEASTERN REGION AGRICULTURAL. RESEARCH CENTER BEL.TSVIL.l_E, MARYLAND 20705 November 5, 1975 Dr. Keatha K. Krueger Executive Secretary DMCC 8300 Colesville Road, Room 220 Silver Spring, Maryland 20910 Dear Dr. Krueger: It became quite evident in our discussion of this morning that the definition of "diabetes" and "diabetes-related activities" is a very critical point in the activity of the Diabetes Commission as well as of the Coordinating Committee. While I am personally convinced that nutrition is an important factor, among others, in the etiology of diabetes, I have no strong feelings as to the inclusion or omission of this field from the consideration of the Commission. If the Commission applies a rather conservative definition to diabetes- related activities and wants information on these activities from the Committee, this is fine. I don't believe that the Committee should feel compelled to widen this scope. One \/ery important point, which was also discussed this morning, is the need to apply whatever criteria have been established uniformly. This is clearly not the case in the report of the Commission, as shown by the following example Nutrition research was mentioned repeatedly as part of programs of institutes of the National Institutes of Health. Several recommenda- tions were made to expand on-going nutritional investigations (page 20, 21 and 22), and increases in funding of programs studying obesity, including nutrition research within NIH were recommended (page 59). The existing programs of human nutrition research within the Department of Agriculture are never mentioned, in spite of our submission of narrative summaries and budget figures. If -nutrition research is accepted as diabetes-related by the Commission, the substantial intramural effort within USDA should be at least acknow- ledged. The only recommendation of the Commission concerning the USDA is related to work of the Extension Service (page 99). It would appear necessary to insert a recommendation which relates to our on-going nutrition research: At least, that it be continued; better, that it be expanded and intensified. ^Sincerely, * Walter Mertz, M.D. Chairman Nutrition Institute 213 FY 75 Statement for Diabetes Committee Department of Agriculture 1. Mission : It is the mission of the USDA to safeguard a continuous, reliable supply of wholesome food and clothing to the American consumer, and where possible, to populations abroad. With particular reference to nutrition, the mission can be described in four categories A. Nutrition Research : (1) To identify the nutrient requirements of man for optimal health and (2) to define foods and diets that meet these requirements. B. Nutrition Education : To communicate to the public guidelines for nutritional habits conducive to optimal health. C. Surveillance of Food Consumption : To monitor food comsumption patterns and assess their adequacy in relation to the Recommended Dietary Allowances. D. Food and Meal Distribution Programs : To assure an adequate nutrient intake for population groups at risk because of age or of economic circumstances. 2. Programs : A. Research I. Intramural: The research activities relevant to diabetes of the Agricultural Research Service are all in the area of human nutrition. These activities are not concerned with pathology or therapy of the disease, but with the definition of human nutrient requirements which, when met, contribute to the maintenance of normal glucose metabolism. Of particular interest to these activities is the continuous decline of the efficiency of glucose utilization with age in the U.S.A. and its relation to the intake of macro and micro nutrients. At present most of these studies are conducted at the Nutrition Institute, Beltsville, Maryland, but it is expected that the Human Nutrition Laboratory at Grand Forks, North Dakota, with its nine-bed metabolic ward will partici- pate in human studies in the future. 215 The following projects are identified: Carbohydrate Nutrition Laboratory , Nutrition Institute, ARS, Beltsville, Maryland Project 5950-001 Patterns of Carbohydrate Metabolism and Individual Responses to Dietary Sources. Project 5950-002 Kinds of Dietary Carbohydrate and Constituents of Human Parotid Saliva, Blood. Extramural : HN-07-05-04 Effect of Exercise on the Metabolic Response of Rats Fed Diets Containing Different Kinds of Carbohydrates. (In cooperation with the University of Maryland) Commitment: Eight scientist man years. Funds: Approximately $500,000/yr. Category I. Vitamin and Mineral Nutrition Laboratory , Nutrition Institute, ARS, Beltsville, Maryland Project 15895-001 Chemical Forms and Biological Availability of Chromium in Natural Materials Project 15895-003 Analytical Methods for Trace Elements in Natural Materials Project 15922-001 Identification of New Essential Trace Elements, Requirements and Modes of Action Commitment: Four scientist man years. Funds: Approximately $300,000/yr. Category I. Lipid Nutrition Laboratory , Nutrition Institute, ARS, Beltsville, Maryland. Project 15910-002 Relationship of essential fatty acid intake to prostaglandin metabolism and function Project 15910-004 Influence of dietary fat and calcium on lipid metabolism Project 15910-006 Moderate reduction of blood lipids of man and animals by dietary means. Effect of dietary fat on physical chemical properties and biological function of platelet membranes. Identification of trace lipid constituents of animal tissues. 216 Commitment: 7.3 scientist man years Funds: Approximately $500,000. Category 2. Nutrient Composition Laboratory , Nutrition Institute, ARS, Beltsville, Maryland Project 15891 Nutrient Composition of Agricultural Commodities and Food Products Commitment: 5 scientist man years Funds: Approximately $440,000. This activity is expected to expand considerably in the future. Narrative Summary: Acquisition of Knowledge - Etiology and Pathology (Human Nutrition Studies ) . The major effort of USDA relevant to diabetes mellitus is intramural; it is performed within the Agricultural Research Service, as part of its research activities of human nutrition. These activities are not concerned with the pathology or therapy of the disease, but with the definition of human nutrient requirements which, when met, contribute to the maintenance of normal glucose met oolism. Of particular interest to these activities is the continuous decline of the efficiency of glucose utilization with age in the United States and its relation to the intake of macro and micro nutrients. At present, most of these studies are conducted in experimental animals and man at the Nutrition Institute, Beltsville, Maryland but it is expected that the Human Nutrition Laboratory at Grand Forks, North Dakota, with its nine bed metabolic ward will partici- pate in human studies in the future. These programs are now located in three laboratories of the Nutrition Institute; they involve approximately 16 scientists man years on a continuing basis and a budget commitment of approximately $1.3 million per year. Most of these activities are complemented by extramural research projects within the U.S. and abroad, funded by ARS or by special currency funds. There are three major approaches. The first, the Carbohydrate Nutrition Laboratory is studying the physiological effects of complex versus simple carbohydrates on intestinal 'absorption and on hormone levels as well as on the activity and induction of lipogenic and gluconeogenic enzymes. A project of high priority is the attempt to identify metabolic patterns of "carbohydrate sensitive" subjects as a predictive diagnostic tool. The effects of the nature of dietary carbohydrate and lipid on the insulin intensivity of adipose tissue is investi- gated, as is the effect of oral contraceptive agents on parameters of glucose metabolism. The effects of dietary fibers on glucose and lipid metabolism are investigated, and methods are established to accurately measure the amount and type of dietary fiber in the 217 diet. The effects of various reducing regimes, i.e., fasting- refeeding, are investigated in experimental animals particularly sensitive to dietary carbohydrate. The second, the Vitamin and Mineral Nutrition Laboratory is concerned with requirements for trace elements for the maintenance of normal glucose tolerance. Manganese, zinc and chromium have been implicated in the regulation of glucose metabolism: the main effort is concentrated on chromium. Deficiency of this element results in impaired glucose tolerance of experimental animals and, under severe conditions, in a syndrome resembling diabetes mellitus. There is circumstantial evidence for the existence of marginal chromium deficiency in certain population groups in the United States, particularly multiparous women, elderly persons, and perhaps, insulin requiring diabetics. Pilot studies have shown beneficial effects of trace supplementation with chromium in certain subject's with impaired glucose tolerance in the U.S.A. and abroad. A chromium containing compound occurring in various foods has been found to be much superior to inorganic chromium salts in the prevention of chromium deficiency. This compound has been isolated, it can be synthesized and it is now being tested for acute and chronic toxicity. Methods to assess the chromium nutritional status in human subjects with impaired glucose tolerance are being developed in order to identify those subjects whose abnormal carbohydrate metabolism may be due to chromium deficiency. And the third is the Lipid Nutrition Laboratory which is concerned with the effects of diet on the lipid components of blood and tissues, mainly as they relate to atherosclerotic disease. Although this program is not directly related to diabetes mellitus, many of the parameters studied are of great importance in diabetics. As of July, 1975, a nutrient composition laboratory will begin functioning within the Nutrition Institute. Part of its mission will be to establish valid analytical data for nutrients of importance to the diabetic. For example, it will establish analytical data for various types of carbohydrates, including fiber, as well as qualitative and quantitative analysis of the various lipid components of our diet. In addition to these continuing and directed efforts in human nutrition research related to diabetes mellitus, the Department of Agriculture, through the Foods and Nutrition Service and the State Cooperative Research Service and the Extension Service has traditionally funded extramural research and evaluation projects which are related to carbohydrate metabolism and to diabetes mellitus. However, a relation to diabetes of these projects is coincidental to other research interests, as the Department has no mission related to the pathology or therapy of a disease. 218 II. Extramural: See computer printouts (Attachment I). B. Nutrition Education I. Extension Service: Nutrition Education Program (Category 3, with 10-20% Category 1) a) Directed to the General Public - More than 3,100 Extension Service home economists and nutrition specialists across the country are providing education to improve the diets of individuals and families. Their priority audiences include those most likely to have poor diets - school - age children, adolescents, young homemakers and the elderly. Program emphases during the past two years have been food safety, food preservation and consumer education in relation to food buying and understanding the food market. For example, a short course of sessions "Feeding the Family - Smarter Not Harder," offered in Iowa reached 1569 homemakers with new information on management of money, food and energy. These program activities are supported by regular staff and general Extension funds. Special effort is concentrated on reaching the poor and near-poor through Extension's Food and Nutrition Education Program. On December 1974, approximately 6,858 aides and 18,447 volunteers were working with adults and youth in this program to help them improve their diets and nutrition related food practices. This program is supported by special funds earmarked by the Congress. A million adults have been taught in-depth and two million youths have participated. b) Designed for Diabetic Person - Extension through its nutrition and related health programs in cooperation with Public Health Units, Dietetic Associations, and medical professionals have contributed to the nutrition education of diabetic persons. Extension professionals work directly with small groups of people in diabetes detection and information programs; and with groups and families of diabetics in food prepara- tion and meal management for the diabetic as prescribed by the physician. Instructional lessons with appropriate audio-visual materials are used. Diabetes, Food and You - 1971, a series of lessons developed by Dr. Catherine Justice, Extension Specialists, Purdue University, in cooperation with the Indiana State Medical Association has been used extensively in that State by Extension groups. The series explores how to live with and how to follow a diabetic diet prescription. 219 The State Reports 1974 , National Extension Homemaker Council, documents similar efforts in other States: Awareness and detection clinics: Nutrition information -- Missouri, Kansas, Arkansas, Ohio, South Dakota, Delaware, Maine, South Carolina, Florida Nu trition lessons in homes and groups : Arkansas , South Carolina, Indiana, Oklahoma II. Food and Nutrition Service: (Category 4) These extramural programs are not designed for diabetic subjects, but are potentially related, as they emphasize good nutritional practices. The Food and Nutrition Service (FNS) of the USDA administers nutritional training and education projects, studies, and surveys under Section 6 of the National School Lunch Act of 1946 (NSLA) and Section 10 of the Child Nutrition Act of 1966 (CNA). Section 6(3) of the NSLA makes available to the Secretary funds to supplement the nutritional benefits of the programs through grants to States and Other means for: a) Nutritional training and education of workers, cooperators, and participants in these programs, and b) Necessary surveys and studies of requirements for food service programs. Each year FNS sets aside a portion of available Section 6(3) funds for grants to States for nutritional training and education. The amount and area(s) of interest to FNS are announced to the public via the Federal Register annually, prior to May 15. Remaining funds for nutritional training and education are expended by FNS via Requests for Proposals (RFP) resulting in contractual agreements with States or nonprofit institutions, universities, or private industry. Topics to be covered by RFP's are announced in the same public Notice mentioned above. (Details see Attachment II). III. Consumer and Food Economics Institute, ARS, Hyattsville, Md. None of the following activities are directly designed for diabetic subjects, but they are potentially related to diabetes mellitus, because of their emphasis on good nutritional practices. a) Development of research-based guidelines for food selection Research findings on nutritional needs, food composition, and food consumption are used in developing dietary guidance materials 220 These include the Daily Food Guide (Basic Four) used nationally to help consumers choose food for nutritional health; and family food plans at different levels of cost, used as guides by social workers, food managers, program planners, and others to help families select good diets that they can afford. Consumer bulletins and other materials are developed interpreting the guide and the food plans. Also, a new bulletin, "Nutrition Labeling—Tools for Its Use," and a NUTRIMETER, have been developed to help people use nutrition information on food labels to check and improve their diets. Guidance is given on request to the food assistance programs of the Department, such as school lunch and school breakfast. Research-based meal patterns (types and amounts of foods that must be served) are developed and interpreted. Consultant help is given in developing educational materials used with these programs and with the food stamp and commodity distri- bution programs. b) Nutrition programs service A bimonthly periodical, Nutrition Program News, is issued to provide an exchange of nutrition education information among members of State nutrition committees and other workers in nutrition education. Staff members serve as consultants on nutrition education, participate in planning and conducting workshops, record radio and TV tapes on nutrition for educational use throughout the country, and develop appropriate publications for consumers, teachers, and leaders. c) Development of tables of food composition From findings on food composition from the world's scientific literature and other sources, and from information about food production, food preparation practices, and analytical methods employed with food, tables of food composition are developed. These tables are valuable tools for evaluating diets and food supplies and for developing guidance materials on food selection. They are the basis for the food exchange lists designed for use by the diabetic person in meal planning. Recommendations for conserving nutritive values of foods are also prepared based on scientific findings. 18.3 scientific man-years and $880,000 are allocated to these programs. 221 3. RECOMMENDATIONS FOR MEMBERS OF THE NATIONAL COMMISSION ON DIABETES MELLITUS by ROBERT L. JACKSON, M.D. 223 RECOMMENDATIONS FOR MEMBERS OF THE NATIONAL COMMISSION ON DIABETES MELLITUS Robert L. Jackson, M.D. Initially, we suggest that a limited number of well established clinics for children with diabetes be identified and be made optimal in order to serve as model care, training, and research centers. The availability of a few model diabetic centers for children should make possible the gradual development of regional diabetes centers in all sections of our country for optimal treatment of children and young adults with insulin dependent diabetes. For the present and near future, we would recommend separate centers for the management of children and young adults with insulin dependent diabetes from centers primarily concerned with maturity onset diabetes. It is unrealistic to believe that optimal care and education can be done effectively and economically by independent practicing physicians in community hospitals primarily designed for the diagnosis and treatment of children with acute medical and surgical conditions. We strongly recommend the concept of having combined care, teaching, training, and research diabetic centers for children and that each of these centers have both independent and collaborative research programs. Clinical studies in each of the centers should emphasize the importance of early diagnosis and prompt treatment of children with diabetes as well as defined programs for the objective evaluation of therapeutic regimens designed to delay progression of the disease and the rate of development of vascular complications. Optimal care, education, and clinical research can only be done at centers with adequate physical facilities, patient resources, and with a sufficient number of professional staff members knowledgeable and ex- perienced in the care of children with diabetes. It is well documented that one of the major factors in maintaining metabolic control of diabetes is intensive and continuing education of the patient and the family. Adequate and continuous education is not only substandard for children but also for adults in most existing diabetic clinics. We propose that methods to improve education including teaching aids be developed in the centers not only for the patients and their families but also for the education and training of medical and other allied health professionals. The centers should not only improve methods of education but also develop objective criteria to evaluate the relative effectiveness of 225 various educational techniques designed to improve care and decrease hospital and medical costs. Facilities and personnel for evaluation and treatment of psycho-social problems should be an essential ingredi- ent of each center. Improved techniques are needed to help families resolve problems of adjustment before they reach disturbing proportions. Further, such centers should provide training not only for medical students, house officers, and physicians but also for allied health pro- fessionals at both the undergraduate and postgraduate levels including nursing specialists, dietitians, social workers, psychologists, psychiatrists, and medical sociologists. Although we urgently need to extend both basic and clinical research, we should recognize that a considerable gap already exists in applying current knowledge in treating patients with diabetes, to permit them to attain an improved state of health and to delay or prevent the pro- gressive development of vascular complications . Basic and clinical research activities and training programs in centers should be funded in part through center grants but primarily by independent research grants from multiple sources. Individual research activities within centers should vary widely. It is preferable that research data be obtained on well defined small homogeneous groups of patients maintained under close observation over extended periods of time. Adequate facilities for continued observations relating to vascular complications should be included in each center. An urgent need exists to establish more objective criteria to better define degree of control and to standardize methods for the early detection of micro- vascular and macrovascular changes. As stated before, each center should pursue its own independent research programs but each center should also participate in national and international collaborative research efforts. For example, collabo- rative studies are needed to determine the role of specific viruses and auto- immune mechanisms in the etiology of insulin dependent diabetes. An epidemiological component of the clinical research in each center should begin to participate in determining the incidence and prevalence of diabetes within a fixed area. Ultimately, specific individuals trained to obtain family histories for genetic evaluation should be present in each center. Great strides in the understanding and management of diabetes mellitus in the child can be achieved in the near future by the immediate development of a limited number of model diabetic treatment and research centers. More rapid advancement of knowledge will be possible by en- couragement of collaborative basic and clinical research in national and international diabetic centers. It will be more effective and consider- ably less expensive to establish a limited number of model treatment and research centers for patients with insulin dependent diabetes before 226 encouraging the development of numerous centers in various regions. It also is essential to have more experienced and trained personnel before establishing additional centers. 227 BACKGROUND INFORMATION REGARDING NEEDS OF CHILDREN WITH DIABETES MELLITUS Diabetes in children and young adults is so different from diabetes in the middle-aged or elderly patient that it requires special consider- ation. The onset of overt diabetes in a child constitutes a serious lifetime problem. The prognosis of the child with diabetes depends upon the social and economic situation of the family, early optimal treatment, adequate education of the parents and the child, and continuity of care. It is important for the child with diabetes to have immediate and con- tinuous expert care in order to conserve his health, permit normal growth and development, and aid him or her to reach adulthood free of vascular complications and capable of meeting the problems of life. An ever increasing number of juvenile diabetics are finding them- selves handicapped by progressive vascular disease in early adult life. The insidious development of these serious complications over a period of years indicates that, too often, the disease is managed inadequately. Anatomic, biochemical, and clinical evidence that the vascular compli- cations are related to the degree of regulation of diabetes is accumu- lating. Both human and animal studies indicate that the degree of control of the diabetes is the only identifiable factor bearing a constantly significant relationship to the incidence, rate of develop- ment, and severity of the vascular complications. Accumulated clinical experience also indicates that decrease in the rate of physical growth and delayed maturation occur only in diabetic children who receive inappropriate insulin therapy and/or suboptimal dietary supervision. Every child with overt diabetes should receive insulin therapy as soon as the diagnosis is confirmed. Many if not most children with overt diabetes receive delayed and inadequate treatment at the time of onset of symptoms. Institution of insulin therapy and careful meal planning as soon as the diagnosis is confirmed will permit complete regulation of the disorder. The earlier the diagnosis is made, the lower the amount of insulin needed and the easier it will be to attain and maintain a high degree of control with little risk of hypoglycemia. At the time of onset, the maintenance insulin requirement is low because the child's pancreas is still able to produce some endogenous insulin. This state of partial remission persists for a variable period of time depending on how early insulin treatment is initiated and how capable the family is to continue the treatment program at home. During this period of partial remission, glycosuria can be controlled completely with small, twice daily doses of insulin and with little likelihood of even a mild insulin reaction. If a high degree of control is maintained, the period of partial remission usually persists for several years. This so called "honeymoon" period provides assurance to the parents and 228 the child that diabetes can be controlled and that their child can lead an active normal life. There is a growing body of evidence that the glucose tolerance test of children as well as of adults may be abnormal (chemical diabetes) for years before the onset of clinical or overt diabetes. Studies of children with a family history of diabetes* during intercurrent in- fections or during their growth spurt verify the desirability of doing oral glucose tolerance tests to detect chemical diabetes in the pre- clinical state. The early identification of children with chemical diabetes years before they have any symptoms or signs of the disease provides an oppor- tunity to observe the natural pattern of development of the disease, to extend our knowledge of the pathophysiology of the disorder, to estab- lish criteria to define the various preclinical stages of the disease, and to evaluate measures designed to alter the progression of the disease to the advanced, overt stage in which insulin therapy is re- quired to control the disease. It is well to remember that all adults were once children. If we can detect the child destined to develop the clinical disease in the early years of life, we should be able not only to delay or prevent progression of the disease but also to better con- trol transmission of the disease to future generations. At the time of onset, children with overt diabetes should be hospitalized as soon as possible in a medical center with a staff ex- perienced in management of children with diabetes. The medical center should have a children's division having a hospital school and recre- ational outlets available for the child to continue his education and have supervised physical activity. Hospital care is needed not only for the treatment of acute complications but also to re-establish nutritional status, to determine the maintenance insulin requirement, to explore and identify difficult psycho-social areas, and to educate both the parents and the child. To attain these goals, the under- nourished young diabetic child usually requires hospital care for about three to five weeks. In addition to expert medical care, the child and family need to receive intensive and continuous education from a nurse and dietitian experienced in management of children with diabetes and who are available to spend considerable time with the child and his parents both in the hospital and when the child and parents return to the clinic for periodic visits. Detailed social information also is needed to determine the family and community resources in order to individualize the treatment program in keeping with the family's social and economic status. The *First degree diabetic relatives (siblings or a parent). 229 combined efforts of a health team are necessary to evaluate and prepare the family how to continue the regimen of treatment after the child returns home and to provide continuity of support and education during growth and development. If the child is to make a good adjustment, not only the family but also the community needs to be educated by the family physician and local health agencies. Most diabetic children from stable family settings continue to do very well if they receive early treatment and the parents understand how to continue the program of management under home conditions. Current knowledge makes possible good control of diabetes which can delay or prevent the insidious development of progressive vascular disease. At present, most children and young adults with insulin de- pendent diabetes are not receiving optimal care and education. The importance of early institution of insulin treatment and the necessity of intensive and continuous education for families of children with diabetes needs to be better appreciated. Recent advances in diabetes research have been encouraging. We are looking forward to the day when we will know the cause of diabetes and how to prevent it. Until then, we need to develop resources to better apply current knowledge. 2 30 4. PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE 231 THE PLAN FOR ATTACK ON THE UNRESOLVED DIABETIC COMPLICATIONS: BLINDNESS HEART DISEASES KIDNEY DISEASES NERVOUS SYSTEM DISEASES GENETICS ACUTE OVERT DIABETES By: Carl Stenzler - Consultant for the National Commission on Diabetes - President, Pennsylvania Diabetes Institute As President and Chairman of the Pennsylvania Diabetes Institute, I was charged by the board of directors of the Pennsylvania Diabetes Institute with the task of addressing and recommending a proposal for an International Biomedical Summit Conference to the National Commission on Diabetes. "Diabetes Mellitus is a syndrome composed of a sequence of events about which there is considerable knowledge in the middle and gross lack of knowledge at either end. In other words, the underlying primary abnormality is poorly defined and the causes of the complications which result are subject to much speculation with little solid physiological or biochemical understanding." George F. Cahill, Jr., M.D. Diabetes Mellitus, Vol. 2, Page 1 "A dense fog of ignorance still covers the chemical event preceding hypoglycemia as well as those disturbances of cell metabolism which ultimately lead to angiopathy and neuropathy. " Rachmiel Levine , M.D. Diabetes Mellitus, Vol. 1, Page 5 .233 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE Philosophy of the recommendation The Diabetes Mellitus Syndrome is a genetic time bomb that is exploding in uncontrolled chain reactions, splattering frightening morbidity and mortality. Ascending casualties and mortality each day are reflected in the vital statistics ledger. Syndrome complications... eye, heart, vascular and neurological diseases, kidney poisoning, genetics and acute overt diabetes are pyramiding national tragedy and national cost into unprecedented millions of lives in jeopardy, millions of casualties, and a multi-billion dollar drain on the national treasury. There is no research on the horizon that offers more than "possible stability" for the immediate 10 million people - diabetic population. Therefore, it behooves us to seek assistance, guidance and recom- mendations from the highest level of authorities whose disciplines impact on one or another part of the syndrome. .. in the hope that their collaborations and consultations will produce new thrust, new vigor and new concepts that will open new avenues for investigation. How can we translate need for fusion of brain power into a valid mechanism for expanded research; into an increased study of the target organs? IN BRIEF: 1. Increase exposure to diabetes as a research problem. 2. Enhance the potential for productivity of research scientists in the multiple diseases that are diabetes. 3. Broaden the scope of experimental ideas being investigated. 4. Broaden the scope for innovative research. ***** 235 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE Basis of Recommendation After nine months of arduous deliberations, workshops and consultation, the National Commission on Diabetes — Committee on Etiology and Pathogenesis — has codified vital information and addressed its major projections for research to quality academic hypotheses related to insulin deficiencies and metabolic abnormalities. It is generally agreed that one or more of these may provide a "stabilization therapy" and the investigation of viral causes holds modest promise for immunization of young people from future advent of juvenile type diabetes. While these new advances will contribute important information to man's meager, basic knowledge of the diabetes syndrome, it is reasonable to assume that they provide little or no hope of diminishing or arresting the frightening complications which represent the priority risks that currently tarnish and reduce the life span of a diabetic. Dr. Theodore Cooper, Assistant Secretary of Health - HEW, when testifying before the House Appropriations Committee, April 1975, as the senior administration representative, identified the priority risks as blindness, heart disease, nervous system diseases, kidney malfunction, genetics and acute overt diabetes which is the locus of the problem. At the same time, Dr. Cooper mapped with clarity the intent of the Congress to seek mollification, melioration and therapy for these system-related problems. 236 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE Basis of Recommendation (continued) Statements by Dr. Cooper : "Diabetes is an extremely important health problem. In some statistical reports, it is listed as the third cause of death in this country. .. .it afflicts 300,000 diagnosed diabetics." "Besides being recognized as a metabolic abnormality, it has sequential effects on a wide variety of organ systems throughout the body." "That is why the Congress mandated that all Institutes participate in this deliberation." EYES: "The primary cause of blindness in this country results from diabetic retinopathy." HEART: "Diabetes is a very important factor in the problem of arteriosclerotic heart disease." "50 to 75% of all diabetics die from cardiovascular renal causes." "Perhaps 50 to 75% of the people that have arteriosclerosis also have diabetes, and the metabolic linkage here may be a most important contribution not only to the control of diabetes but control of heart disease as well." NERVOUS SYSTEM: "It is a factor in neurological disease as it affects the circulation to the brain." GENETICS: "It is a factor from a genetic standpoint because some of it is not of an acquired nature." KIDNEY POISONING AND INSULIN INSUFFICIENCY: "It affects the kidneys as well as primary organs of insulin deficiency from which it was originally studied." "This was the reason the call came from the community that if there were to be a Commission to study this problem. .. that it should encompass all the peripheral manifestations of the problem." "What is being called for here now is an expanded effort to study its impact on the target organs that it affects." 237 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE Basis of Recommendation (continued) Ten million diabetics - or is it thirty million diabetics - are in jeopardy of blindness, heart disease, large and small blood vessel deterioration, nervous system diseases, kidney malfunction. All appear to be transmitted by little understood genetic factors. All are housed in acute overt diabetes. All are without known cause or causes and without clinically dependable preventative, curative or arrest therapies. The public ledgers bear witness to annually ascending morbidity and mortality. Diabetes is a family of diseases that stand in orderly disorder. The organs and systems are positioned separately but adjacent. Like falling dominoes, the malfunction of any one organ or body system will trigger the malfunction of one or several or all body systems and organs. It makes no difference which part of the body is affected first in time, deterioration will be general throughout the body. It is generally agreed that, in addition to beta cell degeneration and metabolic imbalance, diabetes can be caused by malfunction of the hypothalmus — a part of the brain, pituitary and hormonal error, nervous system abberation and vascular dysfunction. The cause and/or effect of diabetes can derive from the individual or collective interrelations between these body and/or organ systems. How can one supplement Dr. Cooper's mandate? "What is being called for here now is an expanded effort to study its impact on the target organs that it affects." 238 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE Basis of Recommendation (continued) Answer : Invite, stimulate new brain potential. Open new avenues of research. Expand the base of research. Expand and interrelate leadership to include all parts of the syndrome. As of this time, we are without identification of the weakest link or links in a chain of events. Therefore, it is proposed: (see next page) 2 39 A PROPOSAL FOR AN INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE: SYSTEMIC DISEASES PROJECT I DIABETES MELLITUS SYNDROME Sixty research scientists drawn from any or every part of the world, each representing the apex of knowledge, respect and authority in his discipline, brought together for a series of skull sessions involving all major body systems impacted by the diabetes mellitus syndrome. They are to be divided into six affinity groups for the purpose of formulating innovative concepts which could evolve into preventive and/or arrest therapies for the multitude of sequential complications borne of diabetes. Affinity group chart appended. 240 A PROPOSAL FOR AN INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE: SYSTEMIC DISEASES AFFINITY GROUP CHART Each of the six groups described is to be chaired by the specialist in the field underlined. Each "peer" specialist is to contribute his specific knowledge to the problem. A diabetologist is to be part of each group to contribute knowledge and experience with the problem. ACUTE OVERT DIABETES will be led and chaired by (1) a clinical diabetologist or (2) a research diabetologist. All other "peers" will contribute their innovative recommendations to expand the diabetologist ' s working knowledge. HEART DISEASES OPHTHALMOLOGY NEPHROLOGY 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. (a) (b) (a) (b) Microvascular Macrovascular Peripheral artery Metabolic Kidney Ophthalmology Heart diseases Nervous systems: Peripheral Central Neurovascular Genetics Diabetes : Mature type Juvenile type Microvascular Macrovascular Peripheral artery Metabolic Kidney Ophthalmology Heart diseases Nervous systems: Peripheral Central Neurovascular Genetics Diabetes : Mature type Juvenile type Microvascular Macrovascular Peripheral artery Metabolic Kidney Ophthalmology Heart diseases Nervous systems: Peripheral Central Neurovascular Genetics Diabetes : Mature type Juvenile type NEUROPATHY 1. Microvascular 2. Macrovascular 3. Peripheral artery 4. Metabolic 5. Kidney 6. Ophthalmology 7. Heart diseases 8. Nervous systems: (a) Peripheral (b) Central 9. Neurovascular 10. Genetics 11. Diabetes : (a) Mature type (b) Juvenile type ACUTE OVERT DIABETES Microvascular Macrovascular Peripheral artery Metabolic Kidney Ophthalmology Heart diseases Nervous systems: Peripheral Central Neurovascular Genetics Diabetes : Mature type Juvenile type GENETICS Microvascular Macrovascular Metabolic Kidney Ophthalmology Heart diseases Nervous systems Peripheral Central Neurovascular Genetics Diabetes : Mature type Juvenile type 241 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE Mechanics for accomplishment of International Biomedical Summit Conference 1. Approval and sponsorship by the National Commission on Diabetes — A. Base form designed to accomodate: (a) Prime goal — develop new concepts, new directions innovative investigations, upgrade public and congressional awareness of the enormity of the problem, correct national and world attitudes regarding diabetes, maintain continuity and expand momentum and importance of diabetes as a health threat, expand research capabilities into all disciplines that compose the syndrome. (b) Make the disease attractive in it's ugliness, so that political leaders can lead. Without their awareness and overt support, diabetes is an undesirable "disease of the month." 2. Active sponsorship by the National Institutes of Health — spearheaded by the John Fogarty International Center. 3. Nominees for attendance would be developed from lists submitted by all Institutes. 4. International Biomedical Conference Staff (see appended budget) would assume detail, planning and coordination responsibilities. 5. Invitations will be initiated by the International Biomedical Conference Staff or respective Institutes — whichever is deemed best. 242 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE Mechanics for accomplishment of International Biomedical Summit Conference (continued) 6. Two workshops for each discipline or twelve workshops convenient and appropriate anywhere in the world — devoted to establishing and developing collective thinking by inter-related researchers. 7. Final Conference: one, two or three days — to present and discuss proposed new concepts. Day meeting or meetings must be open to dialogue with doctors and scientists and press (?). Evening meetings arranged with dignity and a climate or urgent concern. .. .attractive to policy-maker attendance. Evening meetings are responsibility of major national interest groups involved in the disease. Recommended national interest groups: American Diabetes Association Juvenile Diabetes Foundation Pennsylvania Diabetes Institute American Heart Association American College of Cardiology Cardiovascular Institute National Society for Prevention of Blindness American Society for Contemporary Ophthalmology American Academy of Ophthalmologists American Academy of Neurology Kidney Foundation American Academy of Pediatrics American Association of Immunologists American Association of Obstetricians and Gynecologists American Geriatric Society American College of Angiology Endocrine Society World Medical Association World Health Organization 243 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE Mechanics for accomplishment of International Biomedical Summit Conference (continued) 7. Final Conference: (continued) All preliminary discussions should be edited, published and distributed to all interested research groups, lay leadership groups, and that part of the press capable of transmitting the conclusions to world laity. Final recommendations must be published and be made available. .. .or distributed to all interested doctors, scientists, world leaders and world laity. 8. A mechanism such as the recommended International Biomedical Conference Staff must be available. Functioning under guide- lines manifest by a body like the National Commission, or the Commission's proposed Council, the continuing body should be structured as to be partially - or totally - self-supporting. ***** 244 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE International Biomedical Summit Conference First Objectives : 1. To expand research pertinent to reducing, arresting, preventing and curing the complications of diabetes. (a) Open new directions for innovative research. (b) Broaden the base for diabetic research into all affected organ and body systems. 2. To expand the concept of diabetes in a manner that gives due recognition to the fact the diabetes syndrome is a systemic disease of extraordinary size. ... composed of a family of diseases; each with deadly impact on virtually all organs and body systems. 3. Establish diabetes as the Diabetes Mellitus Syndrome. ... a family of diseases of which Acute Overt Diabetes is one part that could be diagnosed in the beginning, or middle, or end of a sequence of events. Second Objectives : 1. An important workshop and workshops would help keep and maintain focus or attention on diabetes and associated problems. 2. With its multidisciplinary nature, it would increase awareness of research groups in diabetes and its problems and, therefore, hopefully motivate or activate more research interest or involvement by these groups in diabetes and related problems. 3. It would allow an intermixing of some of the international views that have not thus far been measured on the topic and allow, therefore, for the exchanging of new approaches and new ideas. 245 PROPOSED INTERNATIONAL BIOMEDICAL SUMMIT CONFERENCE International Biomedical Summit Conference (continued) Third Objectives : 1. Amend national and international attitudes. 2. Collate the total scientific community. 3. Function with dignity so as not to offend the scientific community — and with significant importance so as to attract world and national leaders' interest and respect. 4. Function with important reasons for extending the life of the National Commission on Diabetes. 5. Bases for establishing a permanent organization: (a) To continue the work of the National Commission. (b) To plan and properly accomplish a successful meeting or meetings. (c) To collect and disseminate — to all interested research groups — new concepts and results. (d) To generate subsequent meetings on a limited workshop basis, or bi-annually on a large scale. (e) To publish the results of all workshops and accomplishment. (f) To report to the Congress and the people. .. .accomplishment or lack of accomplishment. (g) To establish: (1) Medical leadership (2) Political competence ***** 246 5. PRESENTATIONS TO THE COMMISSION 247 a. INTRODUCTION TO DIABETES MELLITUS Noel K. MacLaren, M.D. (presented by Pollyann Toll) Diabetes mellitus is characterized by inappropriately elevated blood sugar (glucose) levels. Transient elevations of blood glucose may be seen in association with stressful illnesses ; however, diabetes mellitus refers to states of persistently raised blood glucose levels. In its mildest form , diabetes may be diagnosed in relatively asympto- matic individuals by glucose loading tests. Advancing age and obesity are common factors associated with diabetes of this type, but these are not exclusive associations. In its most severe form , diabetes is a rapidly fatal disease unless treated by insulin injections which must be given at least once daily. Most of the latter cases have their onset during childhood or early adulthood. Other cases of diabetes are inter- mediate in severity, and insulin therapy although not mandatory to sus- tain life, is sometimes offered to control the symptoms of diabetes. Diabetes mellitus probably refers to several disease entities, with a common manifestation of deranged glucose metabolism. However, two general categories can be delineated. 1. Insulin Dependent Diabetes or "Juvenile Diabetes" In this type, there is a severe deficiency of insulin and insulin injections are required to prevent loss of life. Most patients are infants, children, adolescents, or young adults. However, occasional cases appear even among the elderly. 2. Insulin Independent Diabetes or Maturity Diabetes This type of diabetes is associated with considerable insulin preservation; however, in most cases a relative insulin deficiency probably exists. Often patients are obese adults who can be treated by diet and weight reduction alone. However, other affected individuals may be normal weight for age and/or even children. Oral hypoglycemic drugs which either increase insulin secretion or effectiveness of insulin, may improve the degree of diabetes mellitus and its symptoms in such patients; however, there is increasing uncertainty concerning the long-term safety of these drugs. Consequently, insulin itself may be offered as therapy to control symptoms. Several different pathologies are associated with diabetes, whatever the type. Most important is that of premature aging of blood vessels (atherosclerosis). For example, coronary artery disease, strokes, and 249 arterial occlusive disease to the legs are more frequent and occur at a generally early age in diabetic individuals than among the general popu- lation. In insulin dependent diabetes, other complications begin to occur with duration of the disease, often first appearing some 15 to 20 years after the onset. One of the most important of these complications is that of microangiopathy , a disease state of small blood vessels wherein the walls become thickened and perhaps more porous. Microangi- opathy leads to retinopathy (retinal eye disease) and accounts for diabetes being a leading cause of blindness. Further, microangiopathy accounts for the high incidence of nephropathy (kidney disease) which often progresses to kidney failure. Whereas the cause of these arterial complications of diabetes are unknown, other problems associated with diabetes such as cataracts (opacity of the lens) and neuropathy (nerve disease) appear to be the results of wide fluctuation of blood glucose. There is increasing speculation that other previously mentioned complications of diabetes may have the same origin. However, proof of this contention is not yet at hand. Other researchers have suggested that the disease states associated with diabetes are companion disorders to that of diabetes, rather than the result of this disease. These possibilities have grave implications in diabetic management, especially for the insulin dependent type of diabetes . Currently the majority of diabetic children, given one or two insulin injections daily by their parents or taking insulin by self-administration, are destined to develop the complications enumerated above. It may well be that if it were possible to control the metabolic derangements including that affecting blood glucose, diabetic complications might occur infrequently. However, with available therapies, this goal is virtually unattainable. There is no doubt, however, that blood glucose levels may more closely resemble normal levels, if the diabetic requiring insulin is placed under tight control . Tight or rigid control implies multiple injections of insulin coupled with regulated activities and diet. In essence, such a treat- ment modality imposes considerable restrictions of life style. Com- pliance with less rigid schedules of therapy not infrequently has proved to be bad. Rigid regimens should increase this problem of patient compliance. It needs to be emphasized that therapeutic attempts to normalize blood glucose elevations are not without risk. Excessive falls in blood glucose ( hypoglycemia ) may cause severe symptoms such as disturbances in behavior, mental confusion, coma, or convulsions resulting from insuf- ficient energy flow to the brain. Exercise has a glucose lowering effect. Insulin given at sufficient doses to minimize blood glucose rises after food, may cause hypoglycemia between meals. This is most frequently observed in active children with diabetes who, for example, may be late with meals especially if occupied with exciting games, or may be "too tired to eat" after a strenuous day. The ever present risk of inducing hypoglycemia ("insulin shock") especially in children is a barrier against "tight control" treatments. However, physicians still 250 lack, the proof and thus the conviction, that such therapeutic impositions are worthwhile and of long-term benefit to the diabetic requiring insulin for life. To resolve this question properly by scientific inquiry, certain resolutions concerning present organization of health delivery professionals concerned with diabetic management and treatment need to be made. 1. Research Funds Allocations of research funds are essentially for short-term activities. However, to resolve questions as to long-term effective- ness of therapies in chronic diseases such as diabetes, long-term commitments have to be made. 2. Medical or Professional Separations The pediatrician is best equipped to provide his skills to the infant or child with diabetes. Yet the pediatrician seldom has responsi- bility for the adult with manifest complications of this disease. In addition, it is rare that the pediatrician can share with the adult physician his experiences with diabetes as a disease which lasts a life- time. There is a need for special centers where this kind of cooperation can exist, for the resolution of the effectiveness of treatment modalities. 3. Data Gathering There is an almost total absence of any centralized agency re- sponsible for assessing diabetes therapy as provided by the multitude of health professionals in the field. Cooperative clinical diabetes research ventures have been few to date, and have raised further doubts in therapy, rather than provided resolutions of recognized problems. The future for diabetics with their associated host of complications lies in the hands of the researcher. Improvement of the lot of such individuals depends on new knowledge in three main areas. 1. Possible Prevention The first step to cure is that of understanding the cause. From genetic and tissue typing studies, there is new evidence to suggest that certain individuals are predisposed to develop diabetes in one form or another. Further, the insulin dependent diabetic may have undergone destruction of his insulin secreting cells by viral infections, or by a process of self-rejection analogous to "rejections" now familiar in transplantation surgery. Such early and preliminary studies need to be greatly extended to allow for understanding of the cause and thus the first attempts at diabetes prevention. 251 2. Efficacy of Therapy Normal individuals secrete pancreatic insulin after food in- gestion into the blood flow of the liver, and via the liver to other tissues. The insulin so liberated, carries with it a signal which dictates that ingested nourishment is deposited as fuel stores. The insulin dependent diabetic has a severe deficiency of insulin or no insulin, and without it, energy fuel stores are released and become de- pleted. At present, insulin has to be given by injection and usually it is given under the skin and never into liver blood flow directly. Consequently, large doses are required since the liver is a major organ affected by the action of insulin. Further, the relative hardships of taking normally acting insulin before each meal and snack are obvious. Although insulins can be purified and altered to have their duration actions extended, limitations in the mode of delivery of insulin at present cannot mimic the normal and thus cannot completely correct the resultant metabolic derangements. Thus, some preliminary research has dealt with the possibility of developing a device capable of delivering insulin in response to minute to minute variations of blood glucose, i.e., an artificial pancreas . It is already certain that the quantity of insulin required to "control" blood glucose by such a device, would be considerably reduced from that necessary at present. This might have implications on the rate of diabetic complications. The restrictions of life style would also be minimized. Other researchers have sought to develop the technology to transplant insulin secretory cells . Whereas the latter research endeavors have not been as yet realized, it may be anticipated that these advents would provide the means of better treat- ment for diabetes, a common and chronic disease. While the possible development of such medical advances is awaited, dependent on continued financial support, it would appear that a number of diabetic individuals are not receiving optimum care such as exists at present. The reasons for this state of affairs are multiple. A feeling of hopelessness by the patient in regard to future disease complications, inadequate edu- cation of patients, and lack of adequately trained health care personnel are a few of the factors. 3. Prevention of Complications Again until the causative factors are clearly identified, a logical approach to prevention is impossible. Knowledge concerning causation may be stated to be primitive. However, it may yet be proven that many of the complications result from inadequacies to deliver insulin physiologically. Longitudinal studies to substantiate this hypothesis are greatly needed. Atherosclerosis, common to insulin dependent and independent types of diabetes, remains inadequately under- stood. Suggestions that atherosclerosis may be accelerated by certain drugs used for diabetes needs further substantiation by large collabo- rative studies. Information regarding the role of dietary fats or other 252 foodstuffs in premature arterial aging is needed similarly. There is great need for basic research in these areas as well, if specific pre- ventative measures are to be forthcoming. Diabetes mellitus is among the most frequent chronic disease of childhood, and a major disease of adults. It results from the absolute or relative failure of an endocrine gland found in specialized areas of the pancreas. The disease is conspicuously the most frequently en- countered and the most severe of all diseases involving endocrine glands. The cause of diabetes and its associated pathologies remain largely mysterious. There are no curative or preventative measures yet available. Current therapeutic uncertainties, directly attributable to research deficiencies, reflect adversely on health care delivery and its patient reception, in all areas of diabetes. Perhaps the winds of change may yet blow for the long-suffering diabetic, and restore both his/her physical and mental well being. 253 b. PRESENTATION OF CAROLINE LURIE — THE NATIONAL DIABETES COMMISSION Ladies and gentlemen of the Commission, thank you for allowing me to speak to you. I admire and congratulate you for the hours, the effort, the conscientious devotion that you have put into the work of the Com- mission. Mine has been but a minor part — I can only assume the degree of fatigue you must be experiencing. I know the time pressure under which you are working. However, as President-Elect of the JDF I feel an obligation to our vast membership to make a statement, the sense of which, hopefully, will be included in your final report to Congress, though I run the risk of repeating what you might already be planning to say or have already said. We all share the objectives of this Commission. We also recognize the need to have our goals implemented. And if I could title this presentation I would give it the title "Courage." The members of Congress who read the report of the Commission must understand what diabetes is, what it means to the health as well as the economy of the nation, what the long-term effects of diabetes can be, and what the debilitating effects of diabetes are on our ever-growing aged population. This report will be incomplete without the distinction between adult-onset diabetes and insulin-dependent diabetes. Congress must understand the unique problems of the infant, the child, the adolescent, the young adult as well as the mature older citizen with diabetes. This encompasses some ten million Americans and your report must make Con- gress understand this. Diabetes, if we are to be courageously frank, is a serious debili- tating chronic disease. It is invisible, yet accelerating in its complications and incidence. Fifty years have gone by since the dis- covery of insulin, and we are no closer to uncovering the mysteries of cause and cure than we were then. And we are still using the same technique of inadequate treatment now as we did 50 years ago. We do believe that diabetic children and their parents experience life in a way peculiar to very few chronic conditions. There is a seriousness and an urgency, and this must be communicated. One of the dramatic realities about the parents discovering that their child has diabetes is that they do not have the luxury of waiting to adjust — they are then immediately dependent on an alcohol swab, a syringe, and a bottle of insulin. One, two, or three shots a day begin and must last a lifetime. They face sporadic incidence of acidosis and insulin shock. Every illness or surgical procedure becomes a major problem. 255 Ordinary life situations such as adolescence, sport participation, dating, driving, marriage, husband and wife relationships are emotional- ly complicated for them, and need expertise management and guidance. In fact, they may face a shortened life expectancy and a possible grab bag of major serious complications. They must adjust with an ever increasing anxiety, knowing that the treatment may not forestall the onset of the debilitating disease and the onset of increasing complications . The child grows up with the great chance that 15 or 20 years later he may pay the price for our lack of understanding of this disease. You must convey to Congress that our young people are paying too stiff a price because of inadequate knowledge. The problems to convey are in multiples. The insulin-dependent diabetic has specific problems regardless of age. Certainly, few con- gressmen have ever given much thought to the problems of obtaining a urine sample from a seven-month-old baby, or what do you do with the youngster who refuses to eat after his injection of insulin. Not too many of us have had to wonder if the "terrible two-year-old" is simply being terrible or is on the brink of an insulin reaction. Certainly few members of Congress have had to decide whether their children were unconscious because of too much insulin or not enough insulin. Certainly few members of Congress have had to view a simple stomach virus as a potential crisis. And certainly few members of Congress have had to cope with the anxious questioning of their children, who can't fully comprehend the unpleasantness of their daily injections and of their urine testing, their frequent insulin reactions with the concomitant unpleasant physical sensations and mental confusion. An ordinary cold, a normal injection, the hormonal changes common to all pubescents — these are all precipitants to possibly another unbalanced day or week in the lives of our children. Informed mothers and fathers of children of all ages are tired of hearing "take your shot," "exercise," "watch your diet . . . and you'll live happily ever after." We know that is not always true, and the time is ripe for courage, truth and action, and this is what bothers me most. You have had facts and figures presented here that give you the reason to ACT and REACT. The crudeness of insulin therapy must be drastically improved, and only through research can this be achieved. There must finally be scientific answers to the constant disputes on loose control versus tight control, one injection a day versus two or three injections a day, and constant doses of insulin versus varying amounts of insulin. 256 Ladies and gentlemen, please make Congress understand that the young diabetic today is the diabetic of ten years from now with the possible onset of complications of retinopathy, kidney disease, and the multiple of all other vascular problems. We at the Juvenile Diabetes Foundation are most concerned about the present and future treatment of the insulin-dependent or juvenile dia- betic. We believe wholeheartedly that the base supporting all of our hopes is adequate research which will bring forth an abundance of sci- entific knowledge for all diabetics; research that will improve the treatment, research that will arrest the complications, and research that will eventually prevent and finally cure the disease. 257 DISCRIMINATION PROHIBITED - Title VI of the Civil Rights Act of 1964 states: "No person in the United States shall on the ground of race, color, sex, age, or national origin, be excluded from partici- pation in, be denied the benefit of, or be subjected to discrimination under any program or activity receiving Federal financial assistance." Therefore, the National Commission on Diabetes Mellitus, like every program or activity receiving financial assistance from the Department of Health, Education, and Welfare, must be operated in compliance with this law. DHEW Publication No. (NIH) 76-1033