< Back to H.R. 2409 (99th Congress, 1985–1986)

Text of the Health Research Extension Act of 1985

This bill was enacted after a congressional override of the President's veto on November 20, 1985. The text of the bill below is as of Nov 20, 1985 (Passed Congress/Enrolled Bill).

99 STAT. 820                            PUBLIC LAW 99-158—NOV. 20, 1985

                     Public Law 99-158
                     99th Congress
                                                            An Act
 Nov. 20, 1985       To amend the Public Health Service Act to revise and extend the authorities under
                       that Act relating to the National Institutes of Health and National Research
  [H.R. 2409]
                       Institutes, and for other purposes.

                      Be it enacted by the Senate and House of Representatives of the
Health Research      United States of America in Congress assembled,
Extension Act of
1985.                SECTION 1, SHORT TITLE; REFERENCE TO ACT; AND TABLE OF CONTENTS.
Research and
development.           (a) SHORT TITLE.—This Act may be cited as the "Health Research
42 u s e 201 note.   Extension Act of 1985".
                       (b) REFERENCE TO ACT.—Except as otherwise specifically provided,
                     whenever in this Act an amendment or repeal is expressed in terms
                     of an amendment to, or repeal of, a section or other provision, the
                     reference shall be considered to be a reference to a section or other
                     provision of the Public Health Service Act.
                       (c) TABLE OF CONTENTS.—
                     Sec. 1. Short title; reference to Act; and table of contents.
                     Sec. 2. Revision of title IV of the Public Health Service Act.
                                        "TITLE IV—NATIONAL RESEARCH INSTITUTES
                                             "PART A—NATIONAL INSTITXTTES OF HEALTH
                         "Sec. 401. Organization of the National Institutes of Health.
                         "Sec. 402. Appointment and authority of Director of NIH.
                         "Sec. 403. Report of Director of NIH.
                         "PART B—GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES
                         "Sec. 405. Appointment and authority of the Directors of the National Re-
                                      search Institutes.
                         "Sec. 406. Advisory councils.
                         "Sec. 407. Biennial report.
                         "Sec. 408. Authorizations of appropriations.
                          "PART C—SPECIFIC PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES

                                                "Subpart 1—National Cancer Institute
                         "Sec.   410.   Purpose of Institute.
                         "Sec.   411.   National cancer program.
                         "Sec.   412.   Cancer control programs.
                         "Sec.   413.   Special authorities of the Director.
                         "Sec.   414.   National cancer research and demonstration centers.
                         "Sec.   415.   President's cancer panel.
                         "Sec.   416.   Associate Director for Prevention.
                                   "Subpart 2—National Heart, Lung, and Blood Institute
                         "Sec. 418. Purpose of the Institute.
                         "Sec. 419. Heart, blood vessel, lung, and blood disease prevention and control
                                      programs.
                         "Sec. 420. Information and education.
                         "Sec. 421. National heart, blood vessel, lung, and blood diseases and blood re-
                                      sources program.
                         "Sec. 422. National research and demonstration centers for heart, blood vessel,
                                      lung, and blood diseases, sickle cell anemia, and blood resources.
                         "Sec. 423. Interagency technical committee.
                         "Sec. 424. Associate Director for Prevention.

PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 821 "Subpart 3—National Institute of Diabetes and Digestive and Kidney Diseases "Sec. 426. Purpose of the Institute. "Sec. 427. Data systems and information clearinghouses. "Sec. 428. Division Directors for diabetes, endocrinology, and metabolic dis- eases, digestive diseases and nutrition, and kidney, urologic, and hematologic diseases. "Sec. 429. Interagency coordinating committees. "Sec. 430. Advisory boards. "Sec. 431. Research and training centers. "Sec. 432. Advisory council subcommittees. "Sec. 433. Biennial report. 'Subpart 4—National Institute of Arthritis and Musculoskeletal and Skin Diseases "Sec. 435. Purpose of the Institute. "Sec. 436. National arthritis and musculoskeletal diseeises program. "Sec. 437. Research and training. "Sec. 438. Data systems and information clearinghouses. "Sec. 439. Interagency coordinating committees. "Sec. 440. Arthritis and musculoskeletal diseases demonstration projects. "Sec. 441. Multipurpose arthritis and musculoskeletal diseases centers. "Sec. 442. Advisory board. "Subpart 5—National Institute on Aging "Sec. 443. Purpose of the Institute. "Sec. 444. Special functions. "Sec. 445. Alzheimer's Disease Centers. "Subpart 6—National Institute of Allergy and Infectious Diseases "Sec. 446. Purpose of the Institute. "Subpart 7—National Institute of Child Health and Human Development "Sec. 448. Purpose of the Institute. "Sec. 449. Sudden infant death syndrome. "Sec. 450. Mental retardation research. "Sec. 451. Associate Director for Prevention. "Subpart 8—National Institute of Dental Research "Sec. 453. Purpose of the Institute. "Subpart 9—National Eye Institute "Sec. 455. Purpose of the Institute. 'Subpart 10—National Institute of Neurological and Communicative Disorders and Stroke "Sec. 457. Purpose of the Institute. "Sec. 458. Spinal cord regeneration research. "Sec. 459. Bioengineering research. "Subpart 11—National Institute of General Medical Sciences "Sec. 461. Purpose of the Institute. "Subpart 12—National Institute of Environmental Health Sciences "Sec. 463. Purpose of the Institute. "PART D—NATIONAL LIBRARY OF MEDICINE "Subpart 1—General provisions "Sec. 465. Purpose, establishment, and functions of the National Library of Medicine. "Sec. 466. Board of Regents. "Sec. 467. Library facilities. "Subpart 2—Financial Assistance "Sec. 469. Authorization of appropriations. "Sec. 470. Definitions. "Sec. 471. National Medical Libraries Assistance Advisory Board. "Sec. 472. Grants for training in medical library sciences.
99 STAT. 822 PUBLIC LAW 99-158—NOV. 20, 1985 "Sec. 473. Assistance for special scientific projects and for research and devel- opment in medical library science and related fields. "Sec. 474. Grants for establishing, expanding, and improving the basic re- sources of medical libraries and related instrumentalities. "Sec. 475. Grants and contracts for establishment of regional medical libraries. "Sec. 476. Financialsupportof biomedical scientific publications. "Sec. 477. Grant payments, records, and audit. "PART E—OTHER AGENCIES OF N I H "Subpart 1—Division of Research Resources "Sec. 479. General purpose. "Sec. 480. Advisory council. "Sec. 481. Biennial report. "Subpart 2—John E. Fogarty International Center for Advanced Study in the Health Sciences "Sec. 482. General purpose. "Subpart 3—National Center for Nursing Research "Sec. 483. Purpose of the Center. "Sec. 484. Specific authorities. "Sec. 485. Advisory council. "Sec. 486. Biennial report. "PART F—AWARDS AND TRAINING "Sec. 487. National research service awards. "Sec. 488. Visiting scientist awards. "Sec. 489. Studies respecting biomedical and behavioral research personnel. "PART G—GENERAL PROVISIONS "Sec. 491. Institutional review boards; ethics guidance program. "Sec. 492. Peer review requirements. "Sec. 493. Protection against scientific fraud. "Sec. 494. Research on public health emergencies. "Sec. 495. Animals in research. "Sec. 496. Use of appropriations. "Sec. 497. Gifts. "Sec. 498. Fetal research. "Sec. 499. Construction of title.". Sec. 3. Conforming amendments. Sec. 4. Plan for research involving animals. Sec. 5. Research on lupus erjrthematosus. Sec. 6. National Research Service Award study. Sec. 7. Interagency Committee on Spinal Cord Injury. Sec. 8. Study of personnel for health needs of the elderly. Sec. 9. Interagency Committee on Learning Disabilities. Sec. 10. Review of disease research programs of the National Institute of Diabetes and Digestive and Kidney Diseases. Sec. 11. Biomedical ethics. Sec. 12. Alzheimer's disease registry. SEC. 2. REVISION OF TITLE IV OF THE PUBLIC HEALTH SERVICE ACT. Title IV of the Public Health Service Act is amended to read as follows: "TITLE IV—NATIONAL RESEARCH INSTITUTES "PART A—NATIONAL INSTITUTES OP HEALTH "ORGANIZATION O F THE NATIONAL INSTITUTES OF HEALTH 42 use 281. "SEC. 401. (a) The National Institutes of Health is an agency of the Service, "(bXD The following national research institutes are agencies of the National Institutes of Health:
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 823 "(A) The National Cancer Institute. "(B) The National Heart, Lung, and Blood Institute. "(C) The National Institute of Diabetes and Digestive and Kidney Diseases. "(D) The National Institute of Arthritis and Musculoskeletal and Skin Diseases. "(E) The National Institute on Aging. "(F) The National Institute of Allergy and Infectious Diseases. "(G) The National Institute of Child Health and Human Development. "(H) The National Institute of Dental Research. "(I) The National Eye Institute. "(J) The National Institute of Neurological and Communica- tive Disorders and Stroke. "(K) The National Institute of General Medical Sciences. * ?' "(L) The National Institute of Environmental Health Sciences. "(2) The following entities are agencies of the National Institutes of Health: "(A) The National Library of Medicine. "(B) The Division of Research Resources. "(C) The John E. Fogarty International Center for Advanced Study in the Health Sciences. "(D) The National Center for Nursing Research. "(cXD The Secretary may establish in the National Institutes of Health one or more additional national research institutes to con- duct and support research, training, health information, and other programs with respect to any particular disease or groups of dis- eases or any other aspect of human health if— "(A) the Secretary determines that an additional institute is necessary to carry out such activities; and "(B) the additional institute is not established before the expiration of 180 days after the Secretary has provided the Committee on Energy and Commerce of the House of Represent- atives £ind the Committee on Labor and Human Resources of the Senate written notice of the determination made under subparagraph (A) with respect to the institute. "(2) The Secretary may reorganize the functions of any national research institute and may abolish any national research institute if the Secretary determines that the institute is no longer required. A reorganization or abolition may not take effect under this paragraph before the expiration of 180 days after the Secretary has provided the C!ommittee on Energy and Commerce of the House of Represent- atives and the Committee on Labor and Human Resources of the Senate written notice of the reorganization or abolition. "(d) For purposes of this title, the term 'national research institute' means a national research institute listed in subsection (b) or established under subsection (c). A reference to the National Institutes of Health includes its agencies. "APPOINTMENT AND AUTHORITY OF DIRECTOR OF NIH "SEC. 402. (a) The Nationed Institutes of Health shall be headed by 42 use 282. the Director of the National Institutes of Health (hereafter in this title referred to as the 'Director of NIH') who shall be appointed by the President by £ind with the advice and consent of the Senate. The
99 STAT. 824 PUBLIC LAW 99-158—NOV. 20, 1985 Director of NIH shall perform functions as provided under subsec- tion (b) and as the Secretary may otherwise prescribe. 42 use 241. "(b) In carrying out the purposes of section 301, the Secretary, acting through the Director of NIH— "(1) shall be responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health; "(2) shall coordinate and oversee the operation of the national research institutes and administrative entities within the National Institutes of Health; "(3) shall £issure that research at or supported by the National Institutes of Health is subject to review in accordance with Post, p. 874. section 492; "(4) for the national research institutes and administrative entities within the National Institutes of Health— Real property. "(A) may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and entities, labora- tories, and other research facilities, other facilities, equip- ment, and other real or personal property, and Public buildings "(B) may acquire, without regard to the Act of March 3, and grounds. 1877 (40 U.S.C. 34), by lease or otherwise through the District of Administrator of General Services, buildings or parts of Columbia. buildings in the District of Columbia or communities located adjacent to the District of Columbia for use for a period not to exceed ten years; "(5) may secure resources for research conducted by or through the National Institutes of Health; "(6) may, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, 5 u s e 5101. and without regard to the provisions of chapter 51 and sub- 5 u s e 5331. chapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific peer review groups as are needed to carry out the requirements of this title and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups; "(7) may secure for the National Institutes of Health consulta- tion services and advice of persons from the United States or abroad; "(8) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor; "(9) may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment; "(10) may accept voluntary and uncompensated services; and "(11) may perform such other administrative functions £is the Secretary determines are needed to effectively carry out this title. Prohibition. The Federal Advisory Committee Act shall not apply to the duration 5 use app. of a peer review group appointed under paragraph (6). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review func-
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 825 tions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States. "(c) The Director of NIH may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate. "(d)(1) The Director of NIH may obtain (in accordance with section 3109 of title 5, United States Code, but without regard to the limitation in such section on the period of service) the services of not more than two hundred experts or consultants, with scientific or • '^] other professional qualifications, for the National Institutes of .-> o Health. "(2)(A) Except as provided in subparagraph (B), experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, United States '^'' "' * "' ^ Code, for their travel to and from their place of service and for other expenses associated with their assignment. "(B) Expenses specified in subparagraph (A) shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recover- able from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under this subparagraph. "(e) The Director of NIH shall— "(1) advise the agencies of the National Institutes of Health on medical applications of research; "(2) coordinate, review, and facilitate the systematic identi- fication and evaluation of, clinically relevant information from .M& IMs f research conducted by or through the national research institutes; "(3) promote the effective transfer of the information de- scribed in paragraph (2) to the health care community and to entities that require such information; and • ^' m.! t^ "(4) monitor the effectiveness of the activities described in paragraph (3). "(f) There shall be in the National Institutes of Health an Associ- ate Director for Prevention. The Director of NIH shall delegate to the Associate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research pro- grams of the national research institutes and the coordination of such programs among the national research institutes and between the national research institutes and other public and private enti- ties. The Associate Director shall annually report to the Director of Report NIH on the prevention activities undertaken by the Associate Direc- tor. The report shall include a detailed statement of the expend! tures made for the activities reported on and the personnel used in connection with such activities.
99 STAT. 826 PUBLIC LAW 99-158—NOV. 20, 1985 "REPORT OF DIRECTOR OF NIH 42 use 283. "SEC. 403. The Secretary shall transmit to the President and to the Congress a biennial report which shall be prepared by the Director of NIH and which shall consist of— "(1) a description of the activities carried out by and through the National Institutes of Health and the policies respecting the programs of the National Institutes of Health and such rec- ommendations respecting such policies as the Secretary consid- ers appropriate; Grants. "(2) a description of the activities undertaken to improve Contracts. grants and contracting accountability and technical and sci- entific peer review procedures of the National Institutes of Health and the national research institutes; "(3) the reports made by the Associate Director for Prevention Ante, p. 823. under section 402(f) during the period for which the biennial report is prepared; and "(4) the biennial reports of the Directors of each of the national research institutes, the Director of the Division of Research Resources, and the Director of the National Center for Nursing Research. The first report under this section shall be submitted not later than July 1,1986, and shall relate to the fiscal year ending September 30, 1985. The next report shall be submitted not later than Decem- ber 30, 1988, and shall relate to the two-fiscal-year period ending on the preceding September 30. Each subsequent report shall be submitted not later than 90 days after the end of the two-fiscal-year period for which the report is to be submitted. "PART B—GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES "APPOINTMENT AND AUTHORITY OF THE DIRECTORS OF THE NATIONAL RESEARCH INSTITUTES 42 use 284. "SEC. 405. (a) The Director of the National Cancer Institute shall be appointed by the President and the Directors of the other na- tional research institutes shall be appointed by the Secretary. Each Director of a national research institute shall report directly to the Director of NIH. 42 use 241. "(b)(1) In carrying out the purposes of section 301 with respect to the human diseases or disorders or other aspects of human health for which the national research institutes were, established, the Secretary, acting through the Director of each national research institute— "(A) shall encourage and support research, investigations, experiments, demonstrations, and studies in the health sciences related to— "(i) the maintenance of health, "(ii) the detection, diagnosis, treatment, and prevention of human diseases and disorders, "(iii) the rehabilitation of individuals with human dis- eases, disorders, and disabilities, and "(iv) the expansion of knowledge of the processes underly- ing human diseases, disorders, and disabilities, the proc- esses underlying the normal and pathological functioning of the body and its organ systems, and the processes underly-
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 827 ing the interactions between the human organism and the environment; "(B) may, subject to the peer review prescribed under section 492(b) and any advisory council review under section Post, p. 874. 406(a)(3)(AXi), conduct the research, investigations, experiments, Post, p. 828. demonstrations, and studies referred to in subparagraph (A); "(C) may conduct and support research training (i) for which fellowship support is not provided under section 487, and (ii) Post, p. 869. which is Aot residency training of physicians or other health professionals; "(D) may develop, implement, and support demonstrations and programs for the application of the results of the activities of the institute to clinical practice and disease prevention activities; "(E) may develop, conduct, and support public and profes- Education. sional education and information programs; "(F) may secure, develop and maintain, distribute, and sup- port the development and maintenance of resources needed for research; .'4* h "(G) may make available the facilities of the institute to appropriate entities and individuals engaged in research activi- ties and cooperate with and assist Federal and State agencies charged with protecting the public health; "(H) may accept unconditional gifts made to the institute for Gifts and its activities, and, in the case of gifts of a value in excess of property. $50,000, establish suitable memorials to the donor; "(I) may secure for the institute consultation services and advice of persons from the United States or abroad; "(J) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor; "(K) may accept voluntary and uncompensated services; and Voluntarism. "(L) may perform such other functions as the Secretary deter- mines are needed to carry out effectively the purposes of the institute. The indemnification provisions of section 2354, title 10, United Contracts. States Code, shall apply with respect to contracts entered into under this subsection and section 402(b). Ante, p. 823. "(2) Support for an activity or program under this subsection may Grants. be provided through grants, contracts, and cooperative agreements. Contracts. The Secretary, acting through the Director of each national research institute— "(A) may enter into a contract for research, training, or demonstrations only if the contract has been recommended after technical and scientific peer review required by regula- tions under section 492; and Post, p. 874. "(B) may make grants and cooperative agreements under paragraph (1) for research, training, or demonstrations, except that— "(i) if the direct cost of the grant or cooperative agree- ment to be made does not exceed $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after tech- nical and scientific peer review required by regulations under section 492, and "(ii) if the direct cost of the grant or cooperative agree- ment to be made exceeds $50,000, such grant or cooperative
99 STAT. 828 PUBLIC LAW 99-158—NOV. 20, 1985 agreement may be made only if such grant or coopera- tive agreement has been recommended after technical and scientific peer review required by regulations under section Post, p. 874; 492 and is recommended under section 406(a)(3)(A)(ii) by the f"/^"- advisory council for the national research institute involved. "(c) In carrying out subsection (b), each Director of a national research institute— "(1) shall coordinate, as appropriate, the activities of the institute with similar programs of other public and private entities; "(2) shall cooperate with the Directors of the other national research institutes in the development and support of multi- disciplinary research and research that involves more than one institute; and "(3) may, with the approval of the advisory council for the institute and the Director of NIH, appoint technical and sci- entific peer review groups in addition to those appointed under Ante, p. 823. section 402(b)(6). ADVISORY COUNCILS 42 use 284a. "SEC. 406. (a)(1) Except as provided in subsection (h), the Secretary shall appoint an advisory council for each national research in- stitute which (A) shall advise, assist, consult with, and make rec- ommendations to the Secretary and the Director of such institute on matters related to the activities carried out by and through the institute and the policies respecting such activities, and (B) shall carry out the special functions prescribed by part C. Gifts. "(2) Each advisory council for a national research institute may recommend to the Secretary acceptance, in accordance with section 42USC300aa. 2101, of conditional gifts for study, investigation, or research respecting the diseases, disorders, or other aspect of human health with respect to which the institute was established, for the acquisi- tion of grounds, or for the construction, equipping, or maintenance of facilities for the institute. "(3) Each advisory council for a national research institute— "(A)(i) may on the basis of the materials provided under Post, p. 874. section 492(b)(2) respecting research conducted at the institute, make recommendations to the Director of the institute respect- ing such research. Grants. "(ii) may review applications for grants and cooperative agreements for research or training and for which advisory Ante, p. 826. council approval is required under section 405(b)(2) and rec- ommend for approval applications for projects which show promise of making valuable contributions to human knowledge, and Grants. "(iii) may review any grant, contract, or cooperative agree- Contracts. ment proposed to be made or entered into by the institute; Study. "(B) may collect, by correspondence or by personal investiga- Public tion, information as to studies which are being carried on in the information. United States or any other country as to the diseases, disorders, or other aspect of human health with respect to which the institute was established and with the approval of the Director of the institute make available such information through appro- priate publications for the benefit of public and private health
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 829 entities and health professions personnel and scientists and for the information of the general public; and "(C) may appoint subcommittees and convene workshops and conferences. "(b)(1) Each advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary. "(2) The ex officio members of an advisory council shall consist of— "(A) the Secretary, the Director of NIH, the Director of the national research institute for which the council is established, the Chief Medical Director of the Veterans' Administration or the Chief Dental Director of the Veterans' Administration, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and "(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions. "(3) The members of an advisory council who are not ex officio members shall be appointed as follows: "(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including public health and the behav- ioral or social sciences) relevant to the activities of the national research institute for which the advisory council is established, "(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management. "(4) Members of an advisory council who are officers or employees Government of the United States shall not receive any compensation for service organization and on the advisory council. The other members of an advisory council employees. Prohibition. shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensa- tion at rates not to exceed the daily equivalent of the annual rate in effect for grade GS-18 of the General Schedule. 5 u s e 5332 "(c) The term of office of an appointed member of an advisory note. council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member's term until a successor has taken office. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs. (d) The chairman of an advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the national research institute for which the advisory council is established to be the chairman of the advisory council. The term of office of the chairman shall be two years. "(e) The advisory council shall meet at the call of the chairman or upon the request of the Director of the national research institute for which it was established, but at least three times each fiscal
99 STAT. 830 PUBLIC LAW 99-158—NOV. 20, 1985 year. The location of the meetings of each advisory council is subject to the approval of the Director of the national research institute for which the advisory council was established. "(f) The Director of the national research institute for which an advisory council is established shall designate a member of the staff of the institute to serve as the executive secretary of the advisory council. The Director of such institute shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of such institute shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the func- tions of the advisory council. Report. "(g) Each advisory council may prepare, for inclusion in the Post, p. 831. biennial report made under section 407, (1) comments respecting the activities of the advisory council in the fiscal years respecting which the report is prepared, (2) comments on the progress of the national research institute for which it was established in meeting its objec- tives, and (3) recommendations respecting the future directions and Report. program and policy emphasis of the institute. Each advisory council may prepare such additional reports as it may determine appropriate. "(h)(1) Except as provided in paragraph (2), this section does not terminate the membership of any advisory council for a national research institute which was in existence on the date of enactment Ante, p. 820. of the Health Research Extension Act of 1985. After such date— "(A) the Secretary shall make appointments to each such advisory council in such a manner as to bring about as soon as practicable the composition for such council prescribed by this section; "(B) each advisory council shall organize itself in accordance with this section and exercise the functions prescribed by this section; and "(C) the Director of each national research institute shall perform for such advisory council the functions prescribed by this section. "(2)(A) The National Cancer Advisory Board shall be the advisory council for the National Cancer Institute. This section applies to the National Cancer Advisory Board, except that— "(i) appointments to such Board shall be made by the President; "(ii) the term of office of an appointed member shall be 6 years; "(iii) of the members appointed to the Board not less than five members shall be individuals knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors); "(iv) the chairman of the Board shall be selected by the President from the appointed members and shall serve as chair- man for a term of two years; "(v) the ex officio members of the Board shall be the Sec- retary, the Director of the Office of Science and Technology Policy, the Director of NIH, the Chief Medical Director of the Veterans' Administration, the Director of the National Institute for Occupational Safety and Health, the Director of the Na- tional Institute of Environmental Health Sciences, the Sec- retary of Labor, the Commissioner of the Food and Drug
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 831 Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers); and "(vi) the Board shall meet at least four times each fiscal year. "(B) This section applies to the advisory council to the National Heart, Lung, and Blood Institute, except that the advisory council shall meet at least four times each fiscal year. "BIENNIAL REPORT "SEC. 407. The Director of each national research institute, after 42 use 284b. consultation with the advisory council for the institute, shall pre- pare for inclusion in the biennial report made under section 403 a Ante, p. 826. biennial report which shall consist of a description of the activities of the institute and program policies of the Director of the institute in the fiscal years respecting which the report is prepared. The Director of each national research institute may prepare such addi- tional reports as the Director determines appropriate. The Director of each national research institute shall provide the advisory council for the institute an opportunity for the submission of the written comments referred to in section 406(g). Ante, p. 828. "AUTHORIZATIONS OF APPROPRIATIONS "SEC. 408. (a) In addition to amounts otherwise authorized to be 42 use 284c. appropriated under this title for the National Institutes of Health, the following amounts are authorized to be appropriated: "(1)(A) For the National Cancer Institute (other than its programs under section 412), there are authorized to be appro- Post, p. 832. priated $1,194,000,000 for fiscal year 1986, $1,270,000,000 for fiscal year 1987, and $1,344,000,000 for fiscal year 1988. "(B) For the programs under section 412, there are authorized to be appropriated $68,000,000 for fiscal year 1986, $74,000,000 for fiscal year 1987, and $80,000,000 for fiscal year 1988. "(2)(A) For the National Heart, Lung, and Blood Institute (other than its programs under section 419), there are au- Post, p. 836. thorized to be appropriated $809,000,000 for fiscal year 1986, $871,000,000 for fiscal year 1987, and $927,000,000 for fiscal year 1988. Of the amount appropriated under this subsection for such fiscal year, not less than 15 percent of such amount shall be reserved for programs respecting diseases of the lung and not less than 15 percent of such amount shall be reserved for programs respecting blood diseases and blood resources. "(B) For the programs under section 419, there are authorized to be appropriated $82,000,000 for fiscal year 1986, $90,000,000 for fiscal year 1987, and $98,000,000 for fiscal year 1988. "Ot>Xl) Except as provided in paragraph (2), the sum of the amounts obligated in any fiscal year for administrative expenses of the National Institutes of Health may not exceed an amount which is 5.5 percent of the total amount appropriated for such fiscal year for the National Institutes of Health. "(2) Paragraph (1) does not apply to the National Library of Medicine, the National Center for Nursing Research, the John E. Fogarty International Center for Advanced Study in the Health Sciences, the Warren G. Magnuson Clinical Center, and the Office of Medical Applications of Research.
99 STAT. 832 PUBLIC LAW 99-158—NOV. 20, 1985 "(3) For purposes of paragraph (1), the term 'administrative ex- penses' means expenses incurred for the support of activities rel- evant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health. In identifying expenses incurred for such support and administration the Secretary shall consult with the Comptroller General of the United States. Report. "(4) Not later than December 31, 1987, and December 31 of each succeeding year, the Secretary shall report to the Congress the amount obligated in the fiscal year preceding such date for adminis- trative expenses of the National Institutes of Health and the total amount appropriated for the National Institutes of Health for such fiscal year. The Secretary shall consult with the Comptroller General of the United States in preparing each report. "PART C—SPECIFIC PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES "Subpart 1—National Cancer Institute "PURPOSE OF INSTITUTE 42 use 285. "SEC. 410. The general purpose of the National Cancer Institute (hereafter in this subpart referred to as the 'Institute') is the con- duct and support of research, training, health information dissemi- nation, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer and the continuing care of cancer patients and the families of cancer patients. "NATIONAL CANCER PROGRAM 42 use 285a. "SEC. 411. The National Cancer Program shall consist of (1) an expanded, intensified, and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of the other na- tional research institutes, including an expanded and intensified research program for the prevention of cancer caused by occupa- tional or environmental exposure to carcinogens, and (2) the other programs and activities of the Institute. "CANCER CONTROL PROGRAMS Education. "SEC. 412. The Director of the Institute shall establish and support 42 use 285a-l. demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilita- tion and counseling respecting cancer. Programs established and supported under this section shall include— "(1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit research results and to disseminate information respecting— "(A) the detection, diagnosis, prevention, and treatment of cancer, "(B) the continuing care of cancer patients and the fami- lies of cancer patiente, and "(C) rehabilitation and counseling respecting cancer, Physicians. to physicians, and other health professionals who provide care to individuals who have cancer;
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 833 "(2) the demonstration of and the education of students of the health professions and health professionals in— "(A) effective methods for the prevention and early detec- tion of cancer and the identification of individuals with a high risk of developing cancer, and "(B) improved methods of patient referral to appropriate centers for early diagnosis and treatment of cancer; and "(3) the demonstration of new methods for the dissemination Public of information to the general public concerning the prevention, information. early detection, diagnosis, and treatment and control of cancer and information concerning unapproved and ineffective meth- ods, drugs, and devices for the diagnosis, prevention, treatment, and control of cancer. SPECIAL AUTHORITIES OF THE DIRECTOR "SEC, 413. (a) The Director of the Institute shall establish an Education. information and education center to collect, identify, analyze, and Physicians. Public disseminate on a timely basis, through publications and other appro- information. priate means, to cancer patients and their families, physicians and 42 u s e 285a-2. other health professionals, and the general public, information on cancer research, diagnosis, prevention, and treatment (including information respecting nutrition programs for cancer patients and the relationship between nutrition and cancer). The Director of the Institute may take such action as may be necessary to insure that all channels for the dissemination and exchange of scientific knowl- edge and information are maintained between the Institute and other scientific, medical, and biomedical disciplines and organiza- tions nationally and internationally. "(b) The Director of the Institute in carrying out the National Cancer P r o g r a m - "(1) shall establish or support the large-scale production or distribution of specialized biological materials and other thera- peutic substances for cancer research and set standards of safety and care for persons using such materials; "(2) shall, in consultation with the advisory council for the Institute, support (A) research in the cancer field outside the United States by highly qualified foreign nationals which can be expected to benefit the American people, (B) collaborative re- search involving American and foreign participants, and (C) the training of American scientists abroad and foreign scientists in the United States; "(3) shall, in consultation with the advisory council for the Institute, support appropriate programs of education and train- ing (including continuing education and laboratory and clinical research training); "(4) shall encourage and coordinate cancer research by indus- trial concerns where such concerns evidence a particular capability for such research; '(5) may obtain (with the approval of the advisory council for the Institute and in accordance with section 3109 of title 5, United States Code, but without regard to the limitation in such section on the period of service) the services of not more than one hundred and fifty-one experts or consultants who have scientific or professional qualifications; "(6XA) may, in consultation with the advisory council for the Real property. Institute, acquire, construct, improve, repair, operate, and
99 STAT. 834 PUBLIC LAW 99-158—NOV. 20, 1985 maintain laboratories, other research faciUties, equipment, and such other real or personal property as the Director determines necessary; Grants. "(B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facili- ties; and Public buildings "(C) may, in consultation with the advisory council for the and grounds. Institute, acquire, without regard to the Act of March 3, 1877 District of Columbia. (40 U.S.C. 34), by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the Institute for a period not to exceed ten years; "(7) may, in consultation with the advisory council for the Institute, appoint one or more advisory committees composed of such private citizens and officials of Federal, State, and local governments to advise the Director with respect to the Direc- tor's functions; Contracts. "(8) may, subject to section 405(b)(2) and without regard to Ante, p. 826. section 3324 of title 31, United States Code, and section 3709 of the Revised Statutes (41 U.S.C. 5), enter into such contracts, leases, cooperative agreements, as may be necessary in the conduct of functions of the Director, with any public agency, or with any person, firm, association, corporation, or educational institution; "(9) shall maintain and operate the International Cancer Research Data Bank, which shall collect, catalog, store, and disseminate insofar as feasible through the use of information systems accessible to the public, general practitioners, and onco- logic investigators, the results of cancer research and treatment undertaken in any country for the use of any person involved in cancer research and treatment in any country; and "(10)(A) shall, notwithstanding section 405(a), prepare and submit, directly to the President for review and transmittal to Congress, an annual budget estimate (including an estimate of the number and type of personnel needs for the Institute) for the National Cancer Program, after reasonable opportunity for comment (but without change) by the Secretary, the Director of NIH, and the Institute's advisory council; and (B) may receive from the President and the Office of Management and Budget directly all funds appropriated by Congress for obligation and expenditure by the Institute. Except as otherwise provided, experts and consultants whose serv- ices are obtained under paragraph (5) shall be paid or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place of service and for other expenses associated with Prohibition. their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (5) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 835 Secretary may waive in whole or in part a right of recovery under the preceding sentence. "NATIONAL CANCER RESEARCH AND DEMONSTRATION CENTERS "SEC. 414. (a)(1) The Director of the Institute may enter into Contracts. cooperative agreements with and make grants to public or private ^9''TIQ^ 42 u s e 285a-3. nonprofit entities to pay all or part of the cost of planning, establish- ing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and dem- onstration of advanced diagnostic, prevention, and treatment meth- ods for cancer. "(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Direc- tor of NIH and after consultation with the Institute's advisory council. "(b) Federal pajnments made under a cooperative agreement or grant under subsection (a) may be used for— "(1) construction (notwithstanding any limitation under sec- Post, p. 877. tion 496); "(2) staffing and other basic operating costs, including such patient care costs as are required for research; "(3) clinical training, including training for allied health professionals, continuing education for health professionals and allied health professions personnel, and information programs for the public respecting cancer; and "(4) demonstration purposes. As used in this paragraph, the term 'construction' does not include the acquisition of land, and the term 'training' does not include research training for which National Research Service Awards may be provided under section 487. Post, p. 869. "(c) Support of a center under subsection (a) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Direc- tor and if such group has recommended to the Director that such period should be extended. "PRESIDENT'S CANCER PANEL "SEC. 415. (aXD The President's Cancer Panel (hereafter in this 42 use 285a-4. section referred to as the 'Panel') shall be composed of three persons appointed by the President who by virtue of their training, experi- ence, and background are exceptionally qualified to appraise the National Cancer Program. At least two members of the Panel shall be distinguished scientists or physicians. "(2XA) Members of the Panel shall be appointed for three-year terms, except that (i) any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of such term, and (ii) a member may serve until the member's successor has taken office. If a vacancy occurs in the Panel, the President shall make an appointment to fill the vacancy not later than 90 days after the date the vacancy occurred. "(B) The President shall designate one of the members to serve as the chgdrman of the Panel for a term of one year.
99 STAT. 836 PUBLIC LAW 99-158—NOV. 20, 1985 "(C) Members of the Panel shall each be entitled to receive the daily equivalent of the annual rate of basic pay in effect for grade 5 use 5332. GS-18 of the General Schedule for each day (including traveltime) during which they are engaged in the actual performance of duties as members of the Panel and shall be paid or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place of service and for other expenses associated with their assignment. "(3) The Panel shall meet at the call of the chairman, but not less often than four times a year. A transcript shall be kept of the proceedings of each meeting of the Panel, and the chairman shall make such transcript available to the public. "(b) The Panel shall monitor the development and execution of the activities of the National Cancer Program, and shall report directly to the President. Any delays or blockages in rapid execution of the Program shall immediately be brought to the attention of the Reports. President. The Panel shall submit to the President periodic progress reports on the National Cancer Program and shsdl submit to the President, the Secretary, and the Congress an annual evaluation of the efficacy of the Program and suggestions for improvements, and shall submit such other reports as the President shall direct. "ASSOCIATE DIRECTOR FOR PREVENTION 42 use 285a-5. "SEC. 416. (a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of cancer. The Associate Direc- tor shall be appointed by the Director of the Institute from individ- uals who because of their professional training or experience are experts in public health or preventive medicine. "(b) The Associate Director for Prevention shall prepare for inclu- Ante, p. 831. sion in the biennial report made under section 407 a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities. "Subpart 2—National Heart, Lung, and Blood Institute "PURPOSE OF THE INSTITUTE 42 use 285b. "SEC. 418. The general purpose of the National Heart, Lung, and Blood Institute (hereafter in this subpart referred to as the 'In- stitute') is the conduct and support of research, training, health information dissemination, and other programs with respect to heart, blood vessel, lung, and blood diseases and with respect to the use of blood and blood products and the management of blood resources. HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASE PREVENTION AND CONTROL PROGRAMS ehildren and "SEC. 419. The Director of the Institute, under policies established youth. by the Director of NIH and after consultation with the advisory 42 u s e 285b-l. council for the Institute, shall establish programs as necessary for cooperation with other Federal health agencies. State, local, and regional public health agencies, and nonprofit private health agen- cies in the diagnosis, prevention, and treatment (including the provision of emergency medical services) of heart, blood vessel, lung,
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 837 and blood dise£ises, appropriately emphasizing the prevention, diag- nosis, and treatment of such diseases of children. "INFORMATION AND EDUCATION "SEC. 420. The Director of the Institute shall collect, identify, 42 use 285b-2. analyze, and disseminate on a timely basis, through publications and other appropriate means, to patients, families of patients, physi- cians and other health professionals, and the general public, information on research, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, the maintenance of health to reduce the incidence of such diseases, and on the use of blood and blood products and the management of blood resources. In carrying out this section the Director of the Institute shall place special emphasis upon— "(1) the dissemination of information regarding diet and nutrition, environmental pollutants, exercise, stress, hyper- tension, cigarette smoking, weight control, and other factors affecting the prevention of arteriosclerosis and other cardio- vascular diseases and of pulmonary and blood diseases; and "(2) the dissemination of information designed to encourage children to adopt healthful habits respecting the risk factors related to the prevention of such diseases. "NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES AND BLOOD RESOURCES PROGRAM "SEC. 421. (a)(1) The National Heart, Blood Vessel, Lung, and 42USC285b-3. Blood Diseases and Blood Resources Program (hereafter in this subpart referred to as the 'Program') may provide for— "(A) investigation into the epidemiology, etiology, and preven- tion of all forms and aspects of heart, blood vessel, lung, and blood diseases, including investigations into the social, environ- mental, behavioral, nutritional, biological, and genetic deter- minants and influences involved in the epidemiology, etiology, and prevention of such diseases; "(B) studies and research into the basic biological processes and mechanisms involved in the underlying normal and abnormal heart, blood vessel, lung, and blood phenomena; "(C) research into the development, trial, and evaluation of techniques, drugs, and devices (including computers) used in, and approaches to, the diagnosis, treatment (including the provision of emergency medical services), and prevention of heart, blood vessel, lung, and blood diseases and the rehabilita- tion of patients suffering from such diseases; "(D) establishment of programs that will focus and apply Science and scientific and technological efforts involving the biological, technology, physical, and engineering sciences to all facets of heart, blood vessel, lung, and blood diseases with emphasis on the refine- ment, development, and evaluation of technological devices that will assist, replace, or monitor vital organs and improve instrumentation for detection, diagnosis, and treatment of such diseases; "(E) establishment of programs for the conduct and direction of field studies, large-scale testing and evaluation, and dem- onstration of preventive, diagnostic, therapeutic, and rehabilita-
99 STAT. 838 PUBLIC LAW 99-158—NOV. 20, 1985 tive approaches to, and emergency medical services for, such diseases; "(F) studies and research into blood diseases and blood, and into the use of blood for clinical purposes and all aspects of the management of blood resources in the United States, including the collection, preservation, fractionation, and distribution of blood and blood products; Education. "(G) the education (including continuing education) and train- ing of scientists, clinical investigators, and educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs respecting heart, blood vessel, lung, and blood diseeises and blood resources; Education. "(H) public and professional education relating to all aspects of such diseases, including the prevention of such diseases, and the use of blood and blood products and the management of blood resources; "(I) establishment of programs for study and research into heart, blood vessel, lung, and blood diseases of children (includ- ing cystic fibrosis, hyaline membrane, hemol3^ic diseases such as sickle cell anemia and Cooley's anemia, and hemophilic diseases) and for the development and demonstration of diag- nostic, treatment, and preventive approaches to such diseeises; and "(J) establishment of programs for study, research, develop- ment, demonstrations and evaluation of emergency medical services for people who become critically ill in connection with heart, blood vessel, lung, or blood diseases. "(2) The Program shall be coordinated with other national re- search institutes to the extent that they have responsibilities respecting such diseases and shall give special emphasis to the continued development in the Institute of programs related to the causes of stroke and to effective coordination of such programs with related stroke programs in the National Institute of Neurological and Communicative Disorders and Stroke. The Director of the In- stitute, with the advice of the advisory council for the Institute, shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan. "(b) In carrying out the Program, the Director of the Institute, under policies established by the Director of NIH— (1) may, after approval of the advisory council for the In- stitute, obtain (in accordance with section 3109 of title 5, United States Code, but without regard to the limitation in such section on the period of such service) the services of not more than one hundred experts or consultants who have scientific or profes- sional qualifications; Real property. "(2XA) may, in consultation with the advisory council for the Institute, acquire and construct, improve, repair, operate, alter, renovate, and maintain, heart, blood vessel, lung, and blood disease and blood resource laboratories, research, training, and other facilities, equipment, and such other real or personal property as the Director determines necessary; Grants. "(B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facili- ties; and Public buildings "(C) may, in consultation with the advisory council for the and grounds. Institute, acquire, without regard to the Act of March 3, 1877 District of (40 U.S.C. 34), by lease or otherwise, through the Administrator Columbia.
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 839 of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the Institute for a period not to exceed ten years; "(3) subject to section 405(b)(2) and without regard to section Contracts. 3324 of title 31, United States Code, and section 3709 of the Ante, p. 826. Revised Statutes (41 U.S.C. 5), may enter into such contracts, leases, cooperative agreements, or other transactions, as may be necessary in the conduct of the Director's functions, with any public agency, or with any person, firm, association, corpora- tion, or educational institutions; and "(4) may make grants to public and nonprofit private entities Grants. to assist in meeting the cost of the care of patients in hospitals, clinics, and related facilities who are participating in research projects. Except as otherwise provided, experts and consultants whose serv- ices are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, United States Code, for their travel to and from their place of service and for other expenses associated with their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under the preceding sentence. NATIONAL RESEARCH AND DEMONSTRATION CENTERS FOR HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES, SICKLE CELL ANEMIA, AND BLOOD RESOURCES "SEC. 422. (a)(1) The Director of the Institute may provide, in 42 u s e 285b-4. accordance with subsection (c), for the development of— "(A) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods (including methods of providing emergency medical services) for heart and blood vessel diseases; "(B) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods (including methods of providing emergency medical services) for lung diseases (including bronchitis, emphy- sema, asthma, cystic fibrosis, and other lung diseases of chil- dren); and "(C) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods (including methods of providing emergency medical services) for blood diseases and research into blood, in the use of blood products and in the management of blood resources. "(2) The centers developed under paragraph (1) shall, in addition to being utilized for research, training, and demonstrations, be
99 STAT. 840 PUBLIC LAW 99-158—NOV. 20, 1985 utilized for the following prevention programs for cardiovascular, pulmonary, and blood diseases: "(A) Programs to develop improved methods of detecting individuals with a high risk of developing cardiovascular, pul- monary, and blood diseases. "(B) Programs to develop improved methods of intervention against those factors which cause individuals to have a high risk of developing such diseases. "(C) Programs to develop health professions and allied health professions personnel highly skilled in the prevention of such diseases. "(D) Programs to develop improved methods of providing emergency medical services for persons with such diseases. Education. "(E) Programs of continuing education for health and allied health professionals in the diagnosis, prevention, and treatment of such diseases and the maintenance of health to reduce the incidence of such diseases and information programs for the public respecting the prevention and early diagnosis and treat- ment of such diseases and the maintenance of health. "(3) The research, training, and demonstration activities carried out through any such center may relate to any one or more of the diseases referred to in paragraph (1) of this subsection. "(b) The Director of the Institute shall provide, in accordance with subsection (c), for the development of ten centers for basic and clinical research into the diagnosis, treatment, and control of sickle cell anemia. Contracts. "(cXl) The Director of the Institute may enter into cooperative Grants. agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of the management of blood resources and advanced diagnostic, prevention, and treatment methods for heart, blood vessel, lung, or blood diseases. "(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Direc- tor of NIH and after consultation with the Institute's advisory council. "(3) Federed payments made under a cooperative agreement or grant under paragraph (1) may be used for— "(A) construction (notwithstanding any limitation under sec- Post, p. 877. tion 496); "(B) staffing and other basic operating costs, including such patient care costs as are required for research; "(C) training, including training for allied health profes- sionals; and "(D) demonstration purposes. As used in this subsection, the term 'construction' does not include the acquisition of land, and the term 'training' does not include research training for which National Research Service Awards may Post, p. 869. be provided under section 487. "(4) Support of a center under paragraph (1) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Direc-
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 841 tor and if such group has recommended to the Director that such period should be extended. INTERAGENCY TECHNICAL COMMITTEE "SEC. 423. (a) The Secretary shall establish an Interagency Tech- Interagency nical Committee on Heart, Blood Vessel, Lung, and Blood Diseases Technical and Blood Resources which shall be responsible for coordinating Committee on Heart, Blood those aspects of all Federal health programs and activities relating Vessel, Lung, to heart, blood vessel, lung, and blood diseases and blood resources and Blood to assure the adequacy and technical soundness of such programs Diseases and Blood Resources, and activities and to provide for the full communication and ex- establishment. change of information necessary to maintain adequate coordination 42 u s e 285b-5. of such programs and activities. "(b) The Director of the Institute shall serve as chairman of the Committee and the Committee shall include representation from all Federal departments and agencies whose programs involve health functions or responsibilities relevant to the functions of the Commit- tee, as determined by the Secretary, " A S S O C I A T E DIRECTOR FOR PREVENTION "SEC. 424. (a) There shall be in the Institute an Associate Director 42 u s e 285b-6. for Prevention to coordinate and promote the programs in the Institute concerning the prevention of heart, blood vessel, lung, and blood diseases. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine. "(b) The Associate Director for Prevention shall prepare for inclu- sion in the biennial report made under section 407 a description of Ante, p. 831. the prevention activities of the Institute, including a description of the staff and resources allocated to those activities. "Subpart 3—National Institute of Diabetes and Digestive and Kidney Diseases "PURPOSE OF THE INSTITUTE "SEC. 426. The general purpose of the National Institute of Dia- 42 u s e 285c. betes and Digestive and Kidney Diseases (hereafter in this subpart referred to as the 'Institute') is the conduct and support of research, training, health information dissemination, and other programs with respect to diabetes mellitus and endocrine and metabolic dis- eases, digestive diseases and nutritional disorders, and kidney, uro- logic, and hematologic diseases. "DATA SYSTEMS AND INFORMATION CLEARINGHOUSES "SEC. 427. (a) The Director of the Institute shall (1) establish the 42 u s e 285C-1. National Diabetes Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient popu- lations with diabetes, including, where possible, data involving gen- eral populations for the purpose of detection of individuals with a risk of developing diabetes, and (2) establish the National Diabetes Information Clearinghouse to facilitate and enhance knowledge and understanding of diabetes on the part of health professionals, pa-
99 STAT. 842 PUBLIC LAW 99-158—NOV. 20, 1985 tients, and the public through the effective dissemination of information. "(b) The Director of the Institute shall (1) establish the National Digestive Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient popu- lations with digestive diseases, including, where possible, data involving general populations for the purpose of detection of individ- uals with a risk of developing digestive diseases, and (2) establish the National Digestive Diseases Information Clearinghouse to facilitate and enhance knowledge and understanding of digestive diseases on the part of health professionals, patients, and the public through the effective dissemination of information. "(c) The Director of the Institute shall (1) establish the National Kidney and Urologic Diseases Data System for the collection, stor- age, analysis, retrieval, and dissemination of data derived from patient populations with kidney and urologic diseases, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing kidney and urologic diseases, and (2) establish the National Kidney and Urologic Diseases Information Clearinghouse to facilitate and enhance knowledge and understanding of kidney and urologic diseases on the part of health professionals, patients, and the public through the effective dissemination of information. "DIVISION DIRECTORS FOR DIABETES, ENDOCRINOLOGY, AND METABOUC DISEASES, DIGESTIVE DISEASES AND NUTRITION, AND KIDNEY, URO- LOGIC, AND HEMATOLOGIC DISEASES 42 use 285C-2. "SEC. 428. (a)(1) In the Institute there shall be a Division Director for Diabetes, Endocrinology, and Metabolic Diseases, a Division Director for Digestive Diseases and Nutrition, and a Division Direc- tor for Kidney, Urologic, and Hematologic Diseases. Such Division Directors, under the supervision of the Director of the Institute, shall be responsible for— "(A) developing a coordinated plan (including recommenda- tions for expenditures) for each of the national research in- stitutes within the National Institutes of Health with respect to research and training concerning diabetes, endocrine and meta- bolic diseases, digestive diseases and nutrition, and kidney, urologic, and hematologic diseases; "(B) assessing the adequacy of management approaches for the activities within such institutes concerning such diseases and nutrition and developing improved approaches if needed; "(C) monitoring and reviewing expenditures by such in- stitutes concerning such diseases and nutrition; and "(D) identifying research opportunities concerning such dis- eases and nutrition and recommending ways to utilize such opportunities. "(2) The Director of the Institute shall transmit to the Director of NIH the plans, recommendations, and reviews of the Division Direc- tors under subparagraphs (A) through (D) of paragraph (1) together with such comments and recommendations as the Director of the Institute determines appropriate. "(b) The Director of the Institute, acting through the the Division Director for Diabetes, Endocrinology, and Metabolic Diseases, the Division Director for Digestive Diseases and Nutrition, and the
PUBLIC LAW 99-158-NOV. 20, 1985 99 STAT. 843 Division Director for Kidney, Urologic, and Hematologic Diseases, shall- "(1) carry out programs of support for research and training (other than training for which National Research Service Awards may be made under section 487) in the diagnosis, Post, p. 869. prevention, and treatment of diabetes mellitus and endocrine and metabolic diseases, digestive diseases and nutritional dis- orders, and kidney, urologic, and hematologic diseases, includ- ing support for training in medical schools, graduate clinical training, graduate training in epidemiology, epidemiology studies, clinical trials, and interdisciplinary research programs; and "(2) establish programs of evaluation, planning, and dissemi- nation of knowledge related to such research and training. "INTERAGENCY COORDINATING COMMITTEES "SEC. 429. (a) For the purpose of— 42 u s e 285C-3. "(1) better coordination of the research activities of all the national research institutes relating to diabetes mellitus, diges- tive diseases, and kidney, urologic, and hematologic diseases; and "(2) coordinating those aspects of all Federal health programs and activities relating to such diseases to assure the adequacy and technical soundness of such programs and activities and to provide for the full communication and exchange of information necessary to maintain adequate coordination of such programs and activities; the Secretary shall establish a Diabetes Mellitus Interagency Co- Diabetes ordinating Committee, a Digestive Diseases Interagency Coordinat- Mellitus Interagency ing Committee, and a Kidney, Urologic, and Hematologic Diseases Coordinating Coordinating Committee (hereafter in this section individually Committee, referred to as a 'Committee'). establishment. "(b) Each Committee shall be composed of the Directors of each of Digestive Diseases the national research institutes and divisions involved in research Interagency with respect to the diseases for which the Committee is established, Coordinating the Division Director of the Institute for the diseases for which the Committee, Committee is established, the Chief Medical Director of the Veter- establishment. ans' Administration, and the Assistant Secretary of Defense for Kidney, Urologic, and Health Affairs (or the designees of such officers) and shall include Hematologic representation from all other Federal departments and agencies Diseases whose programs involve health functions or responsibilities relevant Coordinating Committee, to such diseases, as determined by the Secretary. Each Committee establishment. shall be chaired by the Director of NIH (or the designee of the Director). Each Committee shall meet at the call of the chairman, but not less often than four times a year. "(c) Each Committee shall prepare an annual report for— Report. "(1) the Secretary; "(2) the Director of NIH; and "(8) the Advisory Board established under section 430 for the Post, p. 844. diseases for which the Committee was established, detailing the work of the Committee in carrying out paragraphs (1) and (2) of subsection (a) in the fiscal ^ear for which the report was prepared. Such report shall be submitted not later than 120 days after the end of each fiscal year.
99 STAT. 844 PUBLIC LAW 99-158—NOV. 20, 1985 ADVISORY BOARDS National "SEC. 430. (a) The Secretary shall establish in the Institute the Diabetes National Diabetes Advisory Board, the National Digestive Diseases Advisory Board, Advisory Board, and the National Kidney and Urologic Diseases establishment. National Advisory Board (hereafter in this section individually referred to as Digestive an 'Advisory Board'). Disease Advisory "(b) Each Advisory Board shall be composed of eighteen appointed Board, establishment. members and nonvoting ex officio members as follows: National Kidney "(1) The Secretary shall appoint— and Urologic "(A) twelve members from individuals who are scientists, Diseases physicians, and other health professionals, who are not Advisory Board, officers or employees of the United States, and who rep- establishment. 42 u s e 285C-4. resent the specialties and disciplines relevant to the dis- eases with respect to which the Advisory Board is estab- lished; and "(B) six members from the general public who are knowledgeable with respect to such diseases, including at least one member who is a person who has such a disease and one member who is a parent of a person who has such a disease. Of the appointed members at least five shall by virtue of training or experience be knowledgeable in the fields of health education, nursing, data systems, public information, and community program development. "(2)(A) The following shall be ex officio members of each Advisory Board: "(i) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Diabetes and Digestive and Kidney Diseases, the Director of the Centers for Disease Control, the Chief Medical Director of the Vet- erans' Administration, the Assistant Secretary of Defense for Health Affairs, and the Division Director of the Na- tional Institute of Diabetes and Digestive and Kidney Dis- eases for the diseases for which the Board is established (or the designees of such officers). "(ii) Such other officers and employees of the United States as the Secretary determines necessary for the Ad- visory Board to carry out its functions. "(B) In the case of the National Diabetes Advisory Board, the following shall also be ex officio members: The Director of the National Heart, Lung, and Blood Institute, the Director of the National Eye Institute, the Director of the National Institute of Child Health and Human Development, and the Administrator of the Health Resources and Services Administration (or the designees of such officers). Government "(c) Members of an Advisory Board who are officers or employees organization and of the Federal Government shall serve as members of the Advisory employees. Board without compensation in addition to that received in their regular public employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of 5 u s e 5332 note. the annual rate in effect for grade GS-18 of the General Schedule for each day (including traveltime) they are engaged in the perform- ance of their duties as members of the Board. "(d) The term of office of an appointed member of an Advisory Board is four years, except that no term of office may extend beyond the expiration of the Advisory Board. Any member appointed to fill
v/ PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 845 a vacancy for an unexpired term shall be appointed for the remain- der of such term. A member may serve after the expiration of the member's term until a successor has taken office. If a vacancy occurs in an Advisory Board, the Secretary shall make an appoint- ment to fill the vacancy not later than 90 days from the date the vacancy occurred. "(e) The members of each Advisory Board shall select a chairman from among the appointed members. "(f) The Secretary shall, after consultation with and consideration of the recommendations of an Advisory Board, provide the Advisory Board with an executive director and one other professional staff member. In addition, the Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with such additional professional staff members, such clerical staff members, such services of consultants, such information, and (through contracts or other arrangements) such administrative support services and facilities, as the Secretary determines are necessary for the Advisory Board to carry out its functions. "(g) Each Advisory Board shall meet at the call of the chairman or upon request of the Director of the Institute, but not less often than four times a year. "(h) The National Diabetes Advisory Board and the National Digestive Diseases Advisory Board shall— "(1) review and evaluate the implementation of the plan (referred to in section 433) respecting the diseases with respect Post, p. 848. to which the Advisory Board was established and periodically update the plan to ensure its continuing relevance; "(2) for the purpose of assuring the most effective use and organization of resources respecting such diseases, advise and make recommendations to the Congress, the Secretary, the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and "(3) maintain liaison with other advisory bodies related to Federal agencies involved in the implementation of such plan, the coordinating committee for such diseases, and with key non- Federal entities involved in activities affecting the control of such diseases, "(i) In carrying out its functions, each Advisory Board may estab- lish subcommittees, convene workshops and conferences, and collect data. Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particu- lar area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to enable them to carry out their activities. "(j) Each Advisory Board shall prepare an annual report for the Report. Secretary which— "(1) describes the Advisory Board's activities in the fiscal year for which the report is made; "(2) describes and evaluates the progress made in such fiscal year in research, treatment, education, and training with re- spect to the diseases with respect to which the Advisory Board was established; "(3) summarizes and analyzes expenditures made by the Fed- eral Government for activities respecting such diseases in such fiscal year; and
99 STAT. 846 PUBLIC LAW 99-158-NOV. 20, 1985 "(4) contains the Advisory Board's recommendations (if any) Post, p. 848. for changes in the plan referred to in section 433. Expiration date. "(k) Each Advisory Board shall expire on September 30, 1988. "(1) The National Diabetes Advisory Board and the National Digestive Diseases Advisory Board in existence on the date of enact- Ante, p. 820. ment of the Health Research Extension Act of 1985 shall terminate upon the appointment of a successor Board under subsection (a). The Secretary shall make appointments to the Advisory Boards estab- lished under subsection (a) before the expiration of 90 days after such date. The members of the Boards in existence on such date may be appointed, in accordance with subsections (b) and (d), to the Boards established under subsection (a) for diabetes and digestive diseases, except that at least one-half of the members of the Na- tional Diabetes Advisory Board in existence on the date of enact- ment of the Health Research Extension Act of 1985 shall be ap- pointed to the National Diabetes Advisory Board first established under subsection (a). RESEARCH AND TRAINING CENTERS 42 u s e 285C-5. "SEC. 431. (a)(1) Consistent with applicable recommendations of the National Commission on Diabetes, the Director of the Institute shall provide for the development or substantial expansion of cen- ters for research and training in diabetes mellitus and related endocrine and metabolic diseases. Each center developed or ex- panded under this subsection shall— "(A) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research and training qualifications as may be prescribed by the Secretary; and "(B) conduct— "(i) research in the diagnosis and treatment of diabetes mellitus and related endocrine and metabolic diseases and the complications resulting from such diseases; "(ii) training programs for physicians and allied health personnel in current methods of diagnosis and treatment of such diseases and complications, and in research in dia- betes; and "(iii) information programs for physicians and allied health personnel who provide primary care for patients with such diseases or complications. Nurses. "(2) A center may use funds provided under paragraph (1) to provide stipends for nurses and allied health professionals enrolled m research training programs described in paragraph (l)(B)(ii). "(b) Consistent with applicable recommendations of the National Digestive Diseases Advisory Board, the Director shall provide for the development or substantial expansion of centers for research in digestive diseases and related functional, congenital, metabolic dis- orders, and normal development of the digestive tract. Each center developed or expanded under this subsection— (1) shall utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research qualifications as may be prescribed by the Secretary; "(2) shall develop and conduct basic and clinical research into the cause, diagnosis, early detection, prevention, control, and treatment of digestive diseases and nutritional disorders and
PUBLIC LAW 99-158-NOV. 20, 1985 99 STAT. 847 related functional, congenital, or metabolic complications resulting from such diseases or disorders; "(3) shall encourage research into and programs for— Physiciana. "(A) providing information for patients with such dis- eases and the families of such patients, physicians and others who care for such patients, and the general public; "(B) model programs for cost effective and preventive patient care; and "(C) training physicians and scientists in research on such diseases, disorders, and complications; and "(4) may perform research and participate in epidemiological studies and data collection relevant to digestive diseases and disorders and disseminate such research, studies, and data to the health care profession and to the public. "(c) The Director shall provide for the development or substantial expansion of centers for research in kidne^^ and urologic diseases. Each center developed or expanded under this subsection— "(1) shall utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research qualifications as may be prescribed by the Secretary; "(2) shall develop and conduct basic and clinical research into the cause, dia^osis, early detection, prevention, control, and treatment of kidney and urologic diseases; "(8) shall encourage research into and programs for— Physicians. "(A) providing information for patients with such dis- eases, disorders, and complications and the families of such patients, physicians and others who care for such patients, and the general public; "(B) model programs for cost effective and preventive patient care; and "(C) training physicians and scientists in research on such diseases; and "(4) may perform research and participate in epidemiological studies and data collection relevant to kidney and urologic diseases in order to disseminate such research, studies, and data to the health care profession and to the public. "(d) Insofar as practicable, centers developed or expanded under this section should be geographically dispersed throughout the United States and in environments with proven research capabili- ties. Support of a center under this section may be for a period of not to exceed five years and such period may be extended by the Director of the Institute for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended. ADVISORY COUNCIL SUBCOMMITTEES "SEC. 432. There are established within the advisory council for 42 u s e 285C-6. the Institute appointed under section 406 a subcommittee on dia- Ante, p. 828. betes and endocrine and metabolic diseases, a subcommittee on digestive diseases and nutrition, and a subcommittee on kidney, urologic, and hematologic diseases. The subcommittees shall be composed of members of the advisory council who are outstanding in the diagnosis, prevention, and treatment of the diseases for which
99 STAT. 848 PUBLIC LAW 99-158—NOV. 20, 1985 the subcommittees are established and members of the advisory council who are leaders in the fields of education and public affairs. Grants. The subcommittees are authorized to review applications made to Contracts. the Director of the Institute for grants for research and training projects relating to the diagnosis, prevention, and treatment of the diseases for which the subcommittees are established and shall recommend to the advisory council those applications and contracts that the subcommittees determine will best carry out the purposes of the Institute. The subcommittees shall also review and evaluate the diabetes and endocrine and metabolic diseases, digestive dis- eases and nutrition, and kidney, urologic, and hematologic diseases programs of the Institute and recommend to the advisory council such changes in the administration of such programs as the sub- committees determine are necessary. "BIENNIAL REPORT 42 use 285C-7. "SEC. 433. The Director of the Institute shall prepare for inclusion Ante, p. 831. jn the biennial report made under section 407 a description of the Institute's activities— "(1) under the current diabetes plan under the National 42 use 201 note. Diabetes Mellitus Research and Education Act; and "(2) under the current digestive diseases plan formulated under the Arthritis, Diabetes, and Digestive Diseases Amend- 42 use 201 note. ments of 1976. The description submitted by the Director shall include an evalua- Ante, p. 846. tion of the activities of the centers supported under section 431. "Subpart 4—National Institute of Arthritis and Musculoskeletal and Skin Diseases "PURPOSE OF THE INSTITUTE 42 use 285d. "SEC. 435. The general purpose of the National Institute of Arthri- tis and Musculoskeletal and Skin Diseases (hereafter in this subpart referred to as the 'Institute') is the conduct and support of research and training, the dissemination of health information, and other programs with respect to arthritis and musculoskeletal and skin diseases, including sports-related disorders. "NATIONAL ARTHRITIS AND MUSCULOSKELETAL DISEASES PROGRAM 42 use 285d-i. "SEC. 436. (a) The Director of the Institute, with the advice of the Institute's advisory council, shall prepare and transmit to the Direc- tor of NIH a plan for a national arthritis and musculoskeletal diseases program to expand, intensify, and coordinate the activities of the Institute respecting arthritis and musculoskeletal diseases. The plan shall include such comments and recommendations as the Director of the Institute determines appropriate. The Director of the Institute shall periodically review and revise such plan and shall transmit any revisions of such plan to the Director of NIH. "(h) Activities under the national arthritis and musculoskeletal diseases program shall be coordinated with the other national re- search institutes to the extent that such institutes have responsibil- ities respecting arthritis and musculoskeletal diseases, and shall, at least, provide for— "(1) investigation into the epidemiology, etiology, and preven- tion of all forms of arthritis and musculoskeletal diseases,
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 849 including sports-related disorders, primarily through the sup- port of basic research in such areas as immunology, genetics, biochemistry, microbiology, physiology, bioengineering, and any other scientific discipline which can contribute important knowledge to the treatment and understanding of arthritis and musculoskeletal diseases; "(2) research into the development, trial, and evaluation of techniques, drugs, and devices used in the diagnosis, treatment, including medical rehabilitation, and prevention of arthritis and musculoskeletal diseases; "(3) research on the refinement, development, and evaluation of technological devices that will replace or be a substitute for damaged bone, muscle, and joints and other supporting struc- tures; and "(4) the establishment of mechanisms to monitor the causes of athletic injuries and identify ways of preventing such injuries on scholastic athletic fields. "(c) The Director of the Institute shall carry out the national arthritis and musculoskeletal diseases program in accordance with the plan prepared under subsection (a) and any revisions of such plan made under such subsection. "RESEARCH AND TRAINING "SEC. 437. The Director of the Institute shall— 42 use 285d-2. "(1) carry out programs of support for research and training (other than training for which National Research Service Awards may be made under section 487) in the diagnosis. Post, p. 869. prevention, and treatment of arthritis and musculoskeletal and skin diseases, including support for training in medical schools, graduate clinical training, graduate training in epidemiology, epidemiology studies, clinical trials, and interdisciplinary re- search programs; and "(2) establish programs of evaluation, planning, and dissemi- nation of knowledge related to such research and training. "DATA SYSTEM AND INFORMATION CLEARINGHOUSE "SEC. 438. (a) The Director of the Institute shall establish the 42 use 285d-3. National Arthritis and Musculoskeletal and Skin Diseases Data System for the collection, storage, analysis, retrieval, and dissemina- tion of data derived from patient populations with arthritis and musculoskeletal and skin diseases, including where possible, data involving general populations for the purpose of detection of individ- uals with a risk of developing arthritis and musculoskeletal and skin diseases. "(b) The Director of the Institute shall establish the National Arthritis and Musculoskeletal and Skin Diseases Information Clearinghouse to facilitate and enhance, through the effective dissemination of information, knowledge and understanding of arthritis and musculoskeletal and skin diseases by health profes- sionals, patients, and the public. "INTERAGENCY COORDINATING COMMITTEES "SEC. 439. (a) For the purpose of— 42 use 285d-4. "(1) better coordination of the research activities of all the national research institutes relating to arthritis,
99 STAT. 850 PUBLIC LAW 99-158-NOV. 20, 1985 musculoskeletal diseases, and skin diseases, including sports- related disorders; and "(2) coordinating the aspects of all Federal health programs and activities relating to arthritis, musculoskeletal diseases, and skin diseases in order to assure the adequacy and technical soundness of such programs and activities and in order to provide for the full communication and exchange of information necessary to maintain adequate coordination of such programs and activities, Arthritis and the Secretary shall establish an Arthritis and Musculoskeletal Dis- Musculoskeletal eases Interagency Coordinating Committee and a Skin Diseases Diseases Interagency Coordinating Committee (hereafter in this section Interagency Coordinating individually referred to as a 'Committee'). Committee, "(b) Each Committee shall be composed of the Directors of each of establishment. the national research institutes and divisions involved in research Skin Diseases Interagency regarding the diseases with respect to which the Committee is Coordinating established, the Chief Medical Director of the Veterans' Administra- Committee, tion, and tifie Assistant Secretary of Defense for Health Affairs (or establishment. the designees of such officers), and representatives of all other Federal departments and agencies (as determined by the Secretary) whose programs involve health functions or responsibilities relevant to arthritis and musculoskeletal diseases or skin diseases, as the case may be. Each Committee shall be chaired by the Director of NIH (or the designee of the Director). Each Committee shall meet at the call of the chairman, but not less often than four times a year. Report. "(c) Not later than 120 days after the end of each fiscal year, each Committee shall prepare and transmit to the Secretary, the Director of NIH, the Director of the Institute, and the advisory council for the Institute a report detailing the activities of the Committee in such fiscal year in carrying out paragraphs (1) and 12) of subsection (a). ARTHRITIS AND MUSCULOSKELETAL DISEASES DEMONSTRATION PROJECTS Grants. "SEC. 440. (a) The Director of the Institute may make grants to 42 u s e 285d-5. public and private nonprofit entities to establish and support projects for the development and demonstration of methods for screening, detection, and referral for treatment of arthritis and musculoskeletal diseases and for the dissemination of information on such methods to the health and allied health professions. Activi- ties under such projects shall be coordinated with Federal, State, local, and regional health agencies, centers assisted under section Post, p. 851. 441, and the data system established under subsection (c). "(b) Projects supported under this section shall include— "(1) programs which emphasize the development and dem- onstration of new and improved methods of screening and early detection, referral for treatment, and diagnosis of individuals with a risk of developing arthritis and musculoskeletal diseases; "(2) programs which emphasize the development and dem- onstration of new and improved methods for patient referral from local hospitals and physicians to appropriate centei-s for early diagnosis and treatment; "(3) programs which emphasize the development and dem- onstration of new and improved means of standardizing patient data and recordkeeping;
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 851 "(4) programs which emphasize the development and dem- onstration of new and improved methods of dissemination of knowledge about the programs, methods, and means referred to in paragraphs (1), (2), and (3) of this subsection to health and allied health professionals; "(5) programs which emphasize the development and dem- Public onstration of new and improved methods for the dissemination information. to the general public of information— "(A) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt treatment, and of following an appropriate regimen; and "(B) to discourage the promotion and use of unapproved and ineffective diagnostic, preventive treatment, and con- trol methods for arthritis and unapproved and ineffective drugs and devices for arthritis and musculoskeletal dis- eases; and "(6) projects for investigation into the epidemiology of all forms and aspects of arthritis and musculoskeletal diseases, including investigations into the social, environmental, behav- ioral, nutritional, and genetic determinants and influences in- volved in the epidemiology of arthritis and musculoskeletal diseases. "(c) The Director shall provide for the standardization of patient data and recordkeeping for the collection, storage, analysis, re- trieval, and dissemination of such data in cooperation with projects assisted under this section, centers assisted under section 441, and Infra. other persons engaged in arthritis and musculoskeletal disease programs. "MULTIPURPOSE ARTHRITIS AND MUSCULOSKELETAL DISEASES CENTERS "SEC. 441. (a) The Director of the Institute shall, after consultation 42 u s e 285d- with the advisory council for the Institute, provide for the develop- ment, modernization, and operation (including staffing and other operating costs such as the costs of patient care required for re- search) of new and existing centers for arthritis and musculoskeletal diseases. For purposes of this section, the term 'modernization' means the alteration, remodeling, improvement, expansion, and repair of existing buildings and the provision of equipment for such buildings to the extent necessary to make them suitable for use as centers described in the preceding sentence. "(b) Each center assisted under this section shall— "(1)(A) use the facilities of a single institution or a consortium of cooperating institutions, and (B) meet such qualifications as may be prescribed by the Secretary; and "(2) conduct— "(A) basic and clinical research into the cause, diagnosis, early detection, prevention, control, and treatment of arthritis and musculoskeletal diseases and complications resulting from arthritis and musculoskeletal diseases, including research into implantable biomaterials and biomechanical and other orthopedic procedures; "(B) training programs for physicians, scientists, and Physicians. other health and allied health professionals; "(C) information and continuing education programs for Education. physicians and other health and allied health professionals Physicians.
99 STAT. 852 PUBLIC LAW 99-158—NOV. 20, 1985 who provide care for patients with arthritis and musculoskeletal diseases; and Public "(D) programs for the dissemination to the general public information. of information— "(i) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt treat- ment, and of following an appropriate regimen; and Drugs and drug "(ii) to discourage the promotion and use of un- abuse. approved and ineffective diagnostic, preventive, treat- ment, and control methods and unapproved and ineffective drugs and devices. A center may use funds provided under subsection (a) to provide stipends for health professionals enrolled in training programs described in paragraph (2)(B). "(c) Each center assisted under this section may conduct programs to— "(1) establish the effectiveness of new and improved methods of detection, referral, and diagnosis of individuals with a risk of developing arthritis and musculoskeletal diseases; "(2) disseminate the results of research, screening, and other activities, and develop means of standardizing patient data and recordkeeping; and "(3) develop community consultative services to facilitate the referral of patients to centers for treatment. "(d) The Director of the Institute shall, insofar as practicable, provide for an equitable geographical distribution of centers assisted Children and under this section. The Director shall give appropriate consideration youth. to the need for centers especially suited to meeting the needs of children affected by arthritis and musculoskeletal disegises. "(e) Support of a center under this section may be for a period of not to exceed five years. Such period may be extended by the Director of the Institute for one or more additional periods of not more than five years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has rec- ommended to the Director that such period should be extended. ADVISORY BOARD National "SEC. 442. (a) The Secretary shall establish in the Institute the Arthritis National Arthritis Advisory Board (hereafter in this section referred Advisory Board, to as the 'Advisory Board'). establishment. 42 u s e 285d-7. "(b) The Advisory Board shall be composed of eighteen appointed members and nonvoting, ex officio members, as follows: "(1) The Secretary shall appoint— "(A) twelve members from individuals who are scientists, physicians, and other health professionals, who are not officers or employees of the United States, and who rep- resent the specialties and disciplines relevant to arthritis, musculoskeletal diseases, and skin diseases; and "(B) six members from the general public who are knowledgeable with respect to such diseases, including at least one member who is a person who has such a disease and one member who is a parent of a person who has such a disease. Of the appointed members at least five shall by virtue of training or experience be knowledgeable in health education,
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 853 nursing, data systems, public information, or community pro- gram development. "(2) The following shall be ex officio members of the Advisory Board: "(A) the Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Director of the Centers for Disease Control, the Chief Medical Director of the Veterans' Administration, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and "(B) such other officers and employees of the United States as the Secretary determines necessary for the Advisory Board to carry out its functions. "(c) Members of the Advisory Board who are officers or employees Government of the Federal Government shall serve as members of the Advisory organization Board without compensation in addition to that received in their and employees, regular public employment. Other members of the Advisory Board shall receive compensation at rates not to exceed the daily equiva- lent of the annual rate in effect for grade GS-18 of the General Schedule for each day (including traveltime) they are engaged in the 5 use 5332. performance of their duties as members of the Advisory Board. "(d) The term of office of an appointed member of the Advisory Board is four years. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member's term until a successor has taken office. If a vacancy occurs in the Ad- visory Board, the Secretary shall make an appointment to fill the vacancy not later than 90 days after the date the vacancy occurred. "(e) The members of the Advisory Board shall select a chairman from among the appointed members. "(f) The Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with an executive director and one other professional staff member. In addition, the Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with such additional professional staff members, such clerical staff members, and (through contracts or other arrangements) with such administrative support services and facilities, such information, and such services of consultants, as the Secretary determines are necessary for the Advisory Board to carry out its functions. "(g) The Advisory Board shall meet at the call of the chairman or upon request of the Director of the Institute, but not less often than four times a year. "(h) The Advisory Board shall— "(1) review and evaluate the implementation of the plan prepared under section 436(a) and periodically update the plan Ante, p. 848. to ensure its continuing relevance; "(2) for the purpose of assuring the most effective use and organization of resources respecting arthritis, musculoskeletal diseases and skin diseases, advise and make recommendations to the Congress, the Secretary, the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and "(3) maintain liaison with other advisory bodies for Federal agencies involved in the implementation of such plan, the inter-
99 STAT. 854 PUBLIC LAW 99-158-NOV. 20, 1985 agency coordinating committees for such diseases established Ante, p. 849. Under section 439, and with key non-Federal entities involved in activities affecting the control of such diseases. **(i) In carrying out its functions, the Ad\^sorv Board may estab- lish subcommittees, convene workshops and conferences, and collect data. Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particu- lar area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to enable them to carry out their activities. Report. "(j) The Advisory Board shall prepare an annual report for the Secretary which— "(1) describes the Advisory Board's activities in the fiscal year for which the report is made; Education. "(2) describes and evaluates the progress made in such fiscal year in research, treatment, education, and training with re- spect to arthritis, musculoskeletal diseases, and skin diseases; "(3) summarizes and analyzes expenditures made by the Fed- eral Government for activities respecting such diseases in such fiscal year for which the report is made; and "(4) contains the Advisory Board's recommendations (if any) Ante, p. 848. for changes in the plan prepared under section 436(a). "(k) The National Arthritis Advisory Board in existence on the Ante, p. 820. date of enactment of the Health Research Extension Act of 1985 shall terminate upon the appointment of a successor Board under subsection (a). The Secretary shall make appointments to the Ad- visory Board established under subsection (a) before the expiration of 90 days after such date. The member of the Board in existence on such date ma^ be appointed, in accordance with subsections (b) and (d), to the Advisory Board established under subsection (a). "Subpart 5—National Institute on Aging "PURPOSE OP THE INSTITUTE 42 use 286e. "SEC. 443. The general purpose of the National Institute on Aging (hereafter in this subpart referred to as the 'Institute') is the con- duct and support of biomedical, social, and behavioral research, training, health information dissemination, and other programs with respect to the aging process and the diseases and other special problems and needs of the aged. "SPECIAL FUNCTIONS Education. "SEC. 444. (a) In carrying out the training responsibilities under 42 use 285e-i. this Act or any other Act for health and allied health professions personnel, the Secretary shall take appropriate steps to insure the education and training of adequate numbers of allied health, nurs- ing, and paramedical personnel in the field of health care for the aged. "(b) The Director of the Institute shall conduct scientific studies to measure the impact on the biological, medical, social, and psycho- logical aspects of aging of programs and activities assisted or con- ducted by the Department of Health and Human Services. Public "(c) The Director of the Institute shall carry out public informa- information. tion and education programs designed to disseminate as widely as possible the findings of research sponsored by the Institute, other
PUBLIC LAW 99-158-NOV. 20, 1985 99 STAT. 855 relevant aging research and studies, and other information about the process of aging which may assist elderly and near-elderly persons in dealing with, and all Americans in understanding, the problems and processes associated with growing older. "(d) The Director of the Institute shall make grants to public and Grants. private nonprofit institutions to conduct research relating to Alz- heimer's Disease. "ALZHEIMER'S DISEASE CENTERS "SEC. -445. (a)(1) The Director of the Institute may enter into Contracts. cooperative agreements with and make grants to public or private Grants. nonprofit entities to pay all or part of the cost of planning, establish- 42 u s e 285e-2. ing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and dem- onstration of advanced diagnostic, prevention, and treatment meth- ods for Alzheimer's Disease. "(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Direc- tor of NIH and after consultation with the Institute's advisory council. "(b) Federal payments made under a cooperative agreement or grant under subsection (a) may be used for— "(1) construction (notwithstanding any limitation under sec- tion 496); Post, p. 877. "(2) staffing and other basic operating costs, including such patient care costs as are required for research; "(3) training, including training for allied health profes- sionals; and "(4) demonstration purposes. As used in this subsection, the term 'construction' does not include the acquisition of land, and the term 'training' does not include research training for which National Research Service Awards may be provided under section 487. Post, p. "(c) Support of a center under subsection (a) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Direc- tor and if such group has recommended to the Director that such period should be extended. "Subpart 6—National Institute of Allergy and Infectious Diseases "PURPOSE OP THE INSTITUTE "SEC. 446. The general purpose of the National Institute of Al- 42 u s e 285f. lergy and Infectious Diseases is the conduct and support of research, training, health information dissemination, and other programs with respect to allergic and immunologic diseases and disorders and infectious diseases.
99 STAT. 856 PUBLIC LAW 99-158—NOV. 20, 1985 "Subpart 7—National Institute of Child Health and Human Development "PURPOSE OF THE INSTITUTE 42 use 285g. "SEC. 448. The general purpose of the National Institute of Child Health and Human Development (hereafter in this subpart referred to as the 'Institute') is the conduct and support of research, training, health information dissemination, and other programs with respect to maternal health, child health, mental retardation, human growth and development, including prenatal development, population re- search, and special health problems and requirements of mothers and children. "SUDDEN INFANT DEATH SYNDROME 42 use 285g-i. "SEC. 449. The Director of the Institute shall conduct and support research which specifically relates to sudden infant death syndrome. "MENTAL RETARDATION RESEARCH 42 use 285g-2. "SEC. 450. The Director of the Institute shall conduct and support research and related activities into the causes, prevention, and treatment of mental retardation. "ASSOCIATE DIRECTOR FOR PREVENTION 42 use 285g-3. "SEC. 451. (a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of health problems of mothers and children. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine. "0?) The Associate Director for Prevention shall prepare for inclu- Ante, p. 831. sion in the biennial report made under section 407 a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities. "Subpart 8—National Institute of Dental Research "PURPOSE OF THE INSTITUTE 42 use 285h. "SEC. 453. The general purpose of the National Institute of Dental Research is the conduct and support of research, training, health information dissemination, and other programs with respect to the cause, prevention, and methods of diagnosis and treatment of dental and oral diseases and conditions. "Subpart 9—National Eye Institute "PURPOSE OF THE INSTITUTE Blind persons. "SEC. 455. The general purpose of the National Eye Institute 42 use 285i. (hereafter in this subpart referred to as the Institute') is the con- duct and support of research, training, health information dissemi- nation, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 857 blind. The Director of the Institute may carry out a program of Grants. grants for public and private nonprofit vision research facilities. "Subpart 10—National Institute of Neurological and Communicative Disorders and Stroke "PURPOSE OF THE INSTITUTE "SEC. 457. The general purpose of the National Institute of Neuro- 42 use 285j. logical and Communicative Disorders and Stroke (hereafter in this subpart referred to as the 'Institute') is the conduct and support of research, training, health information dissemination, and other pro- grams with respect to neurological disease and disorder, stroke, and disorders of human communication. "SPINAL CORD REGENERATION RESEARCH "SEC. 458. The Director of the Institute shall conduct and support 42 use 285j-i. research into spinal cord regeneration. "BIOENGINEERING RESEARCH "SEC. 459. The Director of the Institute shall make grants or enter Grants. into contracts for research on the means to overcome paralysis of ^S^\^%p-- « the extremities through electrical stimulation and the use of ^°^ 285j-2. computers. "Subpart 11—National Institute of General Medical Sciences "PURPOSE OF THE INSTITUTE "SEC. 461. The general purpose of the National Institute of Gen- 42 use 285k. eral Medical Sciences is the conduct and support of research, train- ing, and, as appropriate, health information dissemination, and other programs with respect to general or basic medical sciences and related natural or behavioral sciences which have significance for two or more other national research institutes or are outside the general area of responsibility of any other national research institute. "Subpart 12—National Institute of Environmental Health Sciences "PURPOSE OF THE INSTITUTE "SEC. 463. The general purpose of the National Institute of 42 use 285/. Environmental Health Sciences is the conduct and support of re- search, training, health information dissemination, and other pro- grams with respect to factors in the environment that affect human health, directly or indirectly. "PART D—NATIONAL LIBRARY OF MEDICINE "Subpart 1—General Provisions "PURPOSE, ESTABLISHMENT, AND FUNCTIONS OF THE NATIONAL LIBRARY OF MEDICINE "SEC. 465, (a) In order to assist the advancement of medical and 42 use 286. related sciences and to aid the dissemination and exchange of
99 STAT. 858 PUBLIC LAW 99-158-NOV. 20, 1985 scientific and other information important to the progress of medi- cine and to the i)ubhc health, there is established the National Library of Medicine (hereafter in this part referred to as the 'Library'). "(b) The Secretary, through the Library and subject to subsection (d),shall- "(1) acquire and preserve books, periodicals, prints, films, recordings, and other library materials pertinent to medicine; "(2) organize the materials specified in paragraph (1) by appropriate cataloging, indexing, and bibliographical listings; (3) publish and disseminate the catalogs, indexes, and bibliographies referred to in paragraph (2); "(4) make available, through loans, photographic or other copying procedures, or otherwise, such materials in the Library as the Secretary determines appropriate; "(5) provide reference and research assistance; and "(6) engage in such other activities as the Secretary deter- mines appropriate and as the Library's resources permit. "(c) The Secretary may exchange, destroy, or otherwise dispose of any books, periodicals, films, and other library materials not needed for the permanent use of the Library. "(d)(lj The Secretary may, after obtaining the advice and rec- ommendations of the Board of Regents, prescribe rules under which the Library will— "(A) provide copies of its publications or materials, "(B) will make available its facilities for research, or "(C) will make available its bibliographic, reference, or other services, to public and private entities and individuals. (2) Rules prescribed under paragraph (1) may provide for making available such publications, materials, facilities, or services— "(A) without charge as a public service, "(B) upon a loan, exchange, or charge basis, or "(C) in appropriate circumstances, under contract arrange- ments made with a public or other nonprofit entity. "(e) Whenever the Secretary, with the advice of the Board of Regents, determines that— "(1) in any geographic area of the United States there is no regional medical library adequate to serve such area; "(2) under criteria prescribed for the administration of section Post, p. 862. 475, there is a need for a regional medical library to serve such area; and "(3) because there is no medical library located in such area which, with financial assistance under section 475, can feasibly be developed into a regional medical library adequate to serve such area, the Secretary may establish, as a branch of the Library, a regional medical library to serve the needs of such area. Gifts and "(f) Section 2101 shall be applicable to the acceptance and property. administration of gifts made for the benefit of the Library or for 42 use aooaa. carrying out any of its functions, and the Board of Regents shall make recommendations to the Secretary relating to establishment within the Library of suitable memorials to the donors. "(g) For purposes of this part, the terms 'medicine' and 'medical', Post, p. 859. except when used in section 466, include preventive and therapeutic medicine, dentistry, pharmacy, hospitalization, nursing, public
PUBLIC LAW 99-158-NOV. 20, 1985 99 STAT. 859 health, and the fundamental sciences related thereto, and other related fields of study, research, or activity. "BOARD OF REGENTS "SEC. 466. (aXlXA) The Board of Regents of the National Library 42 USC 286a. of Medicine consists of ex officio members and ten members appointed by the Secretary. (B) The ex officio members are the Surgeons General of the Public Health Service, the Army, the Navy, and the Air Force, the Chief Medical Director of the Veterans' Administration, the Dean of the Uniformed Services University of the Health Sciences, the Assistant Director for Biological, Behavioral, and Social Sciences of the National Science Foundation, the Director of the National Agricultural Library, and the Librarian of Congress (or their designees). "(C) The appointed members shall be selected from among leaders in the various fields of the fundamental sciences, medicine, den- tistry, public health, hospital administration, pharmacology, health communications technology, or scientific or medical library work, or in public affairs. At least six of the appointed members shall be selected from among leaders in the fields of medical, dental, or public health research or education. "(2) The Board shall annually elect one of the appointed members to serve as chairman until the next election. The Secretary shall designate a member of the Library staff to act as executive secretary of the Board. "(b) The Board shall advise, consult with, and make recommenda- tions to the Secretary on matters of policy in regard to the Library, including such matters as the acquisition of materials for the Li- brary, the scope, content, and organization of the Library's services, and the rules under which its materials, publications, facilities, and services shall be made available to various kinds of users. The Secretary shall include in the annual report of the Secretary to the Congress a statement covering the recommendations made by the Board and the disposition thereof. The Secretary may use the services of any member of the Board in connection with matters related to the work of the Library, for such periods, in addition to conference periods, as the Secretary may determine. "(c) Each appointed member of the Board shall hold office for a term of four years, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which the predecessor of such member was appointed shall be appointed for the remainder of such term. None of the appointed members shall Prohibition. be eligible for reappointment within one year after the end of the preceding term of such member. UBRARY FACIUTIES "SEC. 467. There are authorized to be appropriated amounts suffi- Public buildings cient for the erection and equipment of suitable and adequate and grounds. buildings and facilities for use of the Library. The Administrator of 42 u s e 286a-l. General Services may acquire, by purchase, condemnation, dona- tion, or otherwise, a suitable site or sites, selected by the Secretary in accordance with the direction of the Board, for such buildings and facilities and to erect thereon, furnish, and equip such buildings and facilities. The amounts authorized to be appropriated by this section
99 STAT. 860 PUBLIC LAW 99-158—NOV. 20, 1985 include the cost of preparation of drawings and specifications, super- vision of construction, and other administrative expenses incident to Contracts. the work. The Administrator of General Services shall prepare the plans and specifications, make all necessary contracts, and supervise construction. "Subpart 2—Financial Assistance AUTHORIZATION OF APPROPRIATIONS Grants. "SEC. 469. For the purpose of grants and contracts under sections Contracts. 472, 473, 474, 475, and 476, there are authorized to be appropriated 42 u s e 286b. $12,000,000 for fiscal year 1986, $13,000,000 for fiscal year 1987, and Infra; post, pp. 861-863. $14,000,000 for fiscal year 1988. Funds appropriated under this section shall remain available for such purposes until the end of the fiscal year immediately following the fiscal year for which they were appropriated. "DEFINITIONS 42 u s e 286b-l. "SEC. 470. As used in this subpart— "(1) the term 'medical library' means a library related to the sciences related to health; and "(2) the term 'sciences related to health' includes medicine, osteopathy, dentistry, and public health, and fundamental and applied sciences when related thereto. "NATIONAL MEDICAL UBRARIES ASSISTANCE ADVISORY BOARD 42 u s e 286b-2. "SEC. 471. (a) The Board of Regents of the National Library of Medicine shall also serve as the National Medical Libraries Assist- ance Advisory Board (hereafter in this subpart referred to as the 'Board'). Regulations. "Oa) The Board shall advise and assist the Secretary in the preparation of general regulations and with respect to policy mat- ters arising in the administration of this subpart. "(c) The Secretary may use the services of any member of the Board, in connection with matters related to the administration of this part for such periods, in addition to conference periods, as the Secretary may determine. "(d) Appointed members of the Board who are not otherwise in the employ of the United States, while attending conferences of the Board or otherwise serving at the request of the Secretary in connection with the administration of this subpart, shall be entitled to receive compensation, per diem in lieu of subsistence, and travel expenses in the same manner and under the same conditions as that 42 u s e 210. prescribed under section 208(c) when attending conferences, travel- ing, or serving at the request of the Secretary in connection with the Board's function under this section. GRANTS FOR TRAINING IN MEDICAL LIBRARY SCIENCES 42 use 286b-3. "SEC. 472. The Secretary shall make grants— "(1) to individuals to enable them to accept traineeships and fellowships leading to postbaccalaureate academic degrees in the field of medical library science, in related fields pertaining to sciences related to health, or in the field of the communica- tion of information;
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 861 "(2) to individuals who are librarians or specialists in informa- tion on sciences relating to health, to enable them to undergo intensive training or retraining so as to attain greater com- petence in their occupations (including competence in the fields of automatic data processing and retrieval); "(3) to assist appropriate public and private nonprofit institu- tions in developing, expanding, and improving training pro- grams in library science and the field of communications of information pertaining to sciences relating to health; and "(4) to assist in the establishment of internship programs in established medical libraries meeting standards which the Sec- retary shall prescribe. "ASSISTANCE FOR SPECIAL SCIENTIFIC PROJECTS, AND FOR RESEARCH AND DEVELOPMENT IN MEDICAL UBRARY SCIENCE AND RELATED FIELDS "SEC. 473. (a) The Secretary shall make grants to physicians and Grants. other practitioners in the sciences related to health, to scientists, Physicians. 42 u s e 286b-4. and to public or nonprofit private institutions on behalf of such physicians, other practitioners, and scientists for the compilation of existing, or the writing of original, contributions relating to sci- entific, social, or cultural advancements in sciences related to health. In making such grants, the Secretary shall make appro- priate arrangements under which the facilities of the Library and the facilities of libraries of public and private nonprofit institutions of higher learning may be made available in connection with the projects for which such grants are made. "(b) The Secretary shall make grants to appropriate public or Contracts. private nonprofit institutions and enter into contracts with appro- priate persons, for purposes of carrying out projects of research, investigations, and demonstrations in the field of medical library science and related activities and for the development of new tech- niques, systems, and equipment, for processing, storing, retrieving, and distributing information pertaining to sciences related to health. GRANTS FOR ESTABUSHING, EXPANDING, AND IMPROVING THE BASIC RESOURCES OF MEDICAL UBRARIES AND RELATED INSTRUMENTALITIES "SEC. 474. (a) The Secretary shall make grants of money, mate- 42 u s e 286b-5. rials, or both, to public or private nonprofit medical libraries and related scientific communication instrumentalities for the purpose of establishing, expanding, and improving their basic medical li- brary or related resources. A grant under this subsection may be used for— "(1) the acquisition of books, journals, photographs, motion picture and other films, and other similar materials; "(2) catalojging, binding, and other services and procedures for processing library resource materials for use by those who are served by the library or related instrumentality; "(3) the acquisition of duplication devices, facsimile equip- ment, film projectors, recording equipment, and other equip- ment to facilitate the use of the resources of the library or related instrumentality by those who are served by it; and "(4) the introduction of new technologies in medical librarianship.
99 STAT. 862 PUBLIC LAW 99-158—NOV. 20, 1985 "(b)(1) The amount of any grant under this section to any medical library or related instrumentality shall be determined by the Sec- retary on the basis of the scope of library or related services provided by such library or instrumentality in relation to the popu- lation and purposes served by it. In making a determination of the scope of services served by any medical library or related instrumen- tality, the Secretary shall take into account- Students. "(A) the number of graduate and undergraduate students making use of the resources of such library or instrumentality; "(B) the number of physicians and other practitioners in the Physicians. sciences related to health utilizing the resources of such library or instrumentality; "(C) the type of supportive staffs, if any, available to such library or instrumentality; "(D) the type, size, and qualifications of the faculty of anv school with which such library or instrumentality is affiliated; Hospitals. "(E) the staff of any hospital or hospitals or of any clinic or clinics with which such library or instrumentality is affiliated; and "(F) the geographic area served by such library or instrumen- tality and the availability within such area of medical library or related services provided by other libraries or related instrumentalities. "(2) Grants to such medical libraries or related instrumentalities under this section shall be in such amounts as the Secretary may by regulation prescribe with a view to assuring adecjuate continuing financial support for such libraries or instrumentalities from other sources during and after the period for which grants are provided, except that in no case shall any grant under this section to a medical library or related instrumentality for any fiscal year exceed $500,000. "GRANTS AND CONTRACTS FOR ESTABLISHMENT OF REGIONAL MEDICAL LIBRARIES 42 use 286b-6. "SEC. 475. (a) The Secretary, with the advice of the Board, shall make grants to and enter into contracts with existing public or private nonprofit medical libraries so as to enable each of them to serve as the regional medical library for the geographical area in which it is located. "(b) The uses for which grants and contracts under this section may be employed include the— "(1) acquisition of books, journals, and other similar materials; "(2) cataloging, binding, and other procedures for processing library resource materials for use by those who are served by the library; "(3) acquisition of duplicating devices and other equipment to facilitate the use of the resources of the library by those who are served by it; "(4) acquisition of mechanisms and employment of personnel for the speedy transmission of materials from the regional library to local libraries in the geographic area served by the regional library; and (5) planning for services and activities under this section. "(c)(1) Grants and contracts under this section shall only be made to or entered into with medical libraries which agree—
PUBLIC LAW 99-158-NOV. 20, 1985 99 STAT. 863 "(A) to modify and increase their library resources, and to supplement the resources of cooperating libraries in the region, so as to be able to provide adequate supportive services to all libraries in the region as well as to individual users of library services; and "(B) to provide free loan services to qualified users and make available photoduplicated or facsimile copies of biomedical materials which qualified requesters may retain. "(2) The Secretary, in awarding grants and contracts under this section, shall give priority to medical libraries having the greatest potential of fulfilling the needs for regional medical libraries. In determining the priority to be assigned to any medical library, the Secretary shall consider— "(A) the adequacy of the librarv (in terms of collections, personnel, equipment, and other facilities) as a basis for a regional medical library; and (B) the size and nature of the population to be served in the region in which the library is located. "(d) Grants and contracts under this section for basic resource materials to a library may not exceed— "(1) 50 percent of the library's annual operating expense (exclusive of Federal financial assistance under this part) for the preceding year; or "(2) in case of the first year in which the library receives a grant under this section for basic resource materials, 50 percent of its average annual operating expenses over the past three years (or if it had been in operation for less than three years, its annual operating expenses determined by the Secretary in accordance with regulations). "FINANCIAL SUPPORT OF BIOMEDICAL SCIENTIFIC PUBUCATIONS "SEC. 476. (a) The Secretary, with the advice of the Board, shall Grants. make grants to, and enter into appropriate contracts with, public or Contracts. private nonprofit institutions of higher education and individual Education. 42 u s e 286b-7. scientists for the purpose of supporting biomedical scientific publica- tions of a nonprofit nature and to procure the compilation, writing, editing, and publication of reviews, abstracts, indices, handbooks, bibliographies, and related matter pertaining to scientiHc works and scientific developments. "(b) Grants under subsection (a) in support of any single periodical publication may not be made for more than three years, except in those cases in which the Secretary determines that further support is necessary to carry out the purposes of subsection (a). GRANT PAYMENTS, RECORDS, AND AUDIT "SEC. 477. (a) Payments under grants made under sections 472, Regulations. 473, 474, 475, and 476 may be made in advance or by way of 42 u s e 286b-8. reimbursement and in such installments as the Secretary shall Ante, pp. 860-862; prescribe by regulation after consultation with the Board. supra. "(b)(1) Each recipient of a grant under this subpart shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the project or undertak- ing in connection with which such grant is given or used, and the amount of that portion of the cost of the project or undertaking
99 STAT. 864 PUBLIC LAW 99-158—NOV. 20, 1985 supplied by other sources, and such other records as will facilitate an effective audit. "(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of such recipients that are pertinent to any grant received under this subpart. "PART E—OTHER AGENCIES OF N I H "Subpart 1—Division of Research Resources "GENERAL PURPOSE 42 use 287. " S E C 479. The general purpose of the Division of Research Re- sources is to strengthen and enhance the research environments of entities engaged in health-related research by developing and supporting essential research resources. ADVISORY COUNCIL 42 use 287a. "SEC. 480. (aXD The Secretary shall appoint an advisory council for the Division of Research Resources which shall advise, assist, consult with, and make recommendations to the Secretary and the Director of the Division on matters related to the activities carried out by and through the Division and the policies respecting such activities. Gifts and "(2) The advisory council for the Division of Research Resources property. may recommend to the Secretary acceptance, in accordeince with 42 u s e 300aa. section 2101, of conditional gifts for study, investigations, and re- search and for the acquisition of grounds or construction, equipping, or maintenance of facilities for the Division. Grants. "(3) The advisory council for the Division— Gontracts. "(AXi) may make recommendations to the Director of the Division respecting research conducted at the Division, "(ii) may review applications for grants and cooperative agreements for research or training and recommend for ap- proval applications for projects which show promise of making valuable contributions to human knowledge, and "(iii) may review any grant, contract, or cooperative agree- ment proposed to be made or entered into by the Division; Public "(B) may collect, by correspondence or by personal investiga- information. tion, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspects of human health with respect to which the Division is concerned and with the approval of the Director of the Division make available such information through appro- priate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and "(C) may appoint subcommittees and convene workshops and conferences. "(bXD The advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary.
,/ PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 865 "(2) The ex officio members of the advisory council shall consist of— "(A) the Secretary, the Director of NIH, the Director of the Division of Research Resources, the Chief Medical Director of the Veterans' Administration, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and "(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions. "(3) The members of the advisory council who are not ex officio members shall be appointed as follows: "(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including public health and the behav- ioral or social sciences) relevant to the activities of the Division. "(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management. "(4) Members of the advisory council who are officers or employ- Government ees of the United States shall not receive any compensation for organization and service on the advisory council. The other members of the advisory employees. council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS-18 of the General Schedule. 5 u s e 5332 note. "(c) The term of office of an appointed member of the advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member's term until a successor has taken office. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs. *(d) The chairman of the advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the Division of Research Re- sources to be the chairman of the advisory council. The term of office of the chairman shall be two years. "(e) The advisory council shall meet at the call of the chairman or upon the request of the Director of the Division of Research Re- sources, but at least three times each fiscal year. The location of the meetings of the advisory council is subject to the approval of the Director of the Division. "(f) The Director of the Division of Research Resources shall designate a member of the staff of the Division to serve as the executive secretary of the advisory council. The Director of the Division shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of the Division shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council.
99 STAT. 866 PUBLIC LAW 99-158-NOV. 20, 1985 "(g) The advisory council may prepare, for inclusion in the bi- infra. ennial report made under section 481, (1) comments respecting the activities of the advisory council in the fiscal years respecting which the report is prepared, (2) comments on the progress of the Division of Research Resources in meeting its objectives, and (3) rec- ommendations respecting the future directions and program and Reports. policy emphasis of the Division. The advisory council may prepare such additional reports as it may determine appropriate. "(h) This section does not terminate the membership of the ad- visory council for the Division of Research Resources which was in existence on the date of enactment of the Health Research Exten- sion Act of 1985. After such date— "(1) the Secretary shall make appointments to such advisory council in such a manner as to bring about as soon as prac- ticable the composition for such council prescribed by this section; "(2) the advisory council shall organize itself in accordance with this section and exercise the functions prescribed by this section; and "(3) the Director of the Division of Research Resources shall perform for such advisory council the functions prescribed by this section. "BIENNIAL REPORT 42 u s e 287a-l. "SEC. 481. The Director of the Division of Research Resources, after consultation with the advisory council for the Division, shall Ante, p. 826. prepare for inclusion in the biennial report made under section 403 a biennial report which shall consist of a description of the activities of the Division and program policies of the Director of the Division in the fiscal years respecting which the report is prepared. The Director of the Division may prepare such additional reports as the Director determines appropriate. The Director of the Division shall provide the advisory council of the Division an opportunity for the Ante, p. 864. submission of the written comments referred to in section 480(g). "Subpart 2—John E. Fogarty International Center for Advanced Study in the Health Sciences "GENERAL PURPOSE 42 use 287b. "SEC. 482. The general purpose of the John E. Fogarty Inter- national Center for Advanced Study in the Health Sciences is to— "(1) facilitate the assembly of scientists and others in the biomedical, behavioral, and related fields for discussion, study, and research relating to the development of health science internationally; "(2) provide research programs, conferences, and seminars to further international cooperation and collaboration in the life sciences; Fellowships. "(3) provide postdoctorate fellowships for research training in the United States and abroad and promote exchanges of senior scientists between the United States and other countries; "(4) coordinate the activities of the National Institutes of Health concerned with the health sciences internationally; and "(5) receive foreign visitors to the National Institutes of Health.
PUBLIC LAW 99-158-NOV. 20, 1985 99 STAT. 867 "Subpart 3—National Center for Nursing Research "PURPOSE OF THE CENTER "SEC. 483. The general purpose of the National Center for Nursing 42 u s e 287c. Research (hereafter in this subpart referred to as the 'Center') is the conduct and support of, and dissemination of information respect- ing, basic and clinical nursing research, training, and other pro- grams in patient care research. "SPECIFIC AUTHORITIES "SEC. 484. To carry out section 483, the Director of the Center may Fellowships. provide research training and instruction and establish, in the Supra. Center and other nonpront institutions, research traineeships and 42 u s e 287C-1. fellowships in the study and investigation of the prevention of disease, health promotion, and the nursing care of individuals with and the families of individuals with acute and chronic illnesses. The Director of the Center may provide individuals receiving such train- ing and instruction or such traineeships or fellowships with such stipends and allowances (including amounts for travel and subsist- ence and dependency allowances) as the Director determines nec- essary. The Director may make grants to nonprofit institutions to Grants. provide such training and instruction ana traineeships and fellowships. "ADVISORY COUNCIL "SEC. 485. (aXl) The Secretar^^ shall appoint an advisory council 42 u s e 287C-2. for the Center which shall advise, assist, consult with, and make recommendations to the Secretary and the Director of the Center on matters related to the activities carried out by and through the Center and the policies respecting such activities. "(2) The advisory council for the Center may recommend to the Gifts and Secretary acceptance, in accordance with section 2101, of conditional property. gifts for study, investigations, and research and for the acquisition 42 u s e SOOaa. of grounds or construction, equipping, or maintenance of facilities for the Center. "(3) The advisory council for the Center— "(AXi) may make recommendations to the Director of the Grants. Center respecting research conducted at the Center, Contracts. "(ii) may review applications for grants and cooperative agreements for research or training and recommend for ap- proval applications for projects which show promise of making valuable contributions to human knowledge, and "(ill) may review any grant, contract, or cooperative agree- ment proposed to be made or entered into by the C!enter; "(B) may collect, by correspondence or by personal investiga- Public tion, information as to studies which are being carried on in the information. United States or any other country as to the diseases, disorders, or other aspects of human health with respect to which the Center is concerned and with the approval of the Director of the Center make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and "(C) may appoint subcommittees and convene workshops and conferences.
99 STAT. 868 PUBLIC LAW 99-158—NOV. 20, 1985 "(b)(1) The advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary. "(2) The ex officio members of the advisory council shall consist of— "(A) the Secretary, the Director of NIH, the Director of the Center, the Chief Nursing Officer of the Veterans' Administra- tion, the Assistant Secretary of Defense for Health Affairs, the Director of the Division of Nursing of the Health Resources and Services Administration (or the designees of such officers), and "(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions. "(3) The members of the advisory council who are not ex officio members shall be appointed as follows: "(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including public health and the behav- ioral or social sciences) relevant to the activities of the Center. Of the members appointed pursuant to this subparagraph, at least seven shall be professional nurses who are recognized experts in the area of clinical practice, education, or research. "(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management. Government "(4) Members of the advisory council who are officers or employ- organization and ees of the United States shall not receive any compensation for employees. service on the advisory council. The other members of the advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the 5 use 5332 note, annual rate in effect for grade GS-18 of the General Schedule. "(c) The term of office of an appointed member of the advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member's term until a successor has taken office. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 davs from the date the vacancy occurs. (d) The chairman of the advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the Center to be the chairman of the advisory council. The term of office of the chairman shall be two years. "(e) The advisory council shall meet at the call of the chairman or upon the request of the Director of the Center, but at least three times each fiscal year. The location of the meetings of the advisory council is subject to the approval of the Director of the Center, "(f) The Director of the Center shall designate a member of the staff of the Center to serve as the executive secretary of the advisory council. The Director of the Center shall make available to the
PUBLIC LAW 99-158—NOV. 20, 1985 .99 STAT. 869 advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of the Center shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the func- tions of the advisory council. "(g) The advisory council may prepare, for inclusion in the bi- ennial report made under section 486, (1) comments respecting the Infra. activities of the advisory council in the fiscal years respecting which the report is prepared, (2) comments on the progress of the Center in meeting its objectives, and (3) recommendations respecting the future directions and program and policy emphasis of the Center. The advisory council may prepare such additional reports as it may determine appropriate. "BIENNIAL REPORT "SEC. 486. The Director of the Center after consultation with the 42 USC 287c-3. advisory council for the Center, shall prepare for inclusion in the biennial report made under section 403 a biennial report which shall Ante, p. 826. consist of a description of the activities of the Center and program policies of the Director of the Center in the fiscal years respecting which the report is prepared. The Director of the Center may prepare such additional reports as the Director determines appro- priate. The Director of the Center shall provide the advisory council of the Center an opportunity for the submission of the written comments referred to in section 485(g). Ante, p. 867. "PART F—AWARDS AND TRAINING "NATIONAL RESEARCH SERVICE AWARDS "SEC. 487. (aXD The Secretary shall— 42 USC 288. "(A) provide National Research Service Awards for— "(i) biomedical and behavioral research at the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration in matters relating to the cause, diagnosis, prevention, and treatment of the diseases or other health problems to which the activities of the National Institutes of Health and Administration are directed; "(ii) training at the National Institutes of Health and at the Administration of individuals to undertake such research; "(iii) biomedical and behavioral research and health serv- ices research (including research in primary medical care) at public and nonprofit private entities; and "(iv) pre-doctoral and post-doctoral training at public and private institutions of individuals to undertake biomedical and behavioral research; and "(B) make grants to public and nonprofit private institutions Grants. to enable such institutions to make National Research Service Awards for research (and training to undertake biomedical and behavioral research) in the matters described in subparagraph (A)(i) to individuals selected by such institutions. A reference in this subsection to the National Institutes of Health or the Alcohol, Drug Abuse, and Mental Health Administration shall
99 STAT. 870 PUBLIC LAW 99-158-NOV. 20, 1985 be considered to include the institutes, agencies, divisions, and bureaus included in the National Institutes of Health or under the Administration, as the case may be. Prohibition. "(2) National Research Service Awards may not be used to support Physicians. residency training of physicians and other health professionals. Physicians. "(3) In awarding National Research Service Awaras under this section, the Secretary shall take account of the Nation's overall need for biomedical research personnel by giving special consider- ation to physicians who agree to undertake a minimum of two years of biomedical research. Prohibitions. "(b)(1) No National Research Service Award may be made by the Secretary to any individual unless— "(A) the mdividual has submitted to the Secretary an applica- tion therefor and the Secretary has approved the application; Regulations. "(B) the individual provides, m such form and manner as the Secretary shall by regulation prescribe, assurances satisfactory to the Secretary that the individual will meet the service requirement of subsection (c); and Regulations. (C) in the case of a National Research Service Award for a purpose described in subsection (a)(l)(A)(iii), the individual has oeen sponsored (in such manner as the Secretary may by regu- lation require) by the institution at which the research or training under the award will be conducted. Regulations. An application for an award shall be in such form, submitted in such manner, and contain such information, as the Secretary may by regulation prescribe. Grants. "(2) The making of grants under subsection (a)(1)(B) for National Research Service Awards shall be subject to review and approval by the appropriate advisory councils witnin the Department of Healtn and Human Services (A) whose activities relate to the research or training under the awards, or (B) for the entity at which such researcn or training will be conducted. Prohibition. "(3) No grant may be made under subsection (a)(1)(B) unless an Regulations. application therefor has been submitted to and approved by the Secretary. Such application shall be in such form, suomitted in such manner, and contain such information, as the Secretary may by regulation prescribe. Subject to the provisions of this section (other than paragraph (1)), National Research Service Awards made under a grant under subsection (a)(1)(B) shall be made in accordance with such regulations as the Secretary shall prescribe. Prohibition. "(4) The period of any National Research Service Award made to any individual under subsection (a) may not exceed— "(A) five years in the aggregate for pre-doctoral training; and "(B) three years in the aggregate for post-doctoral training; unless the Secretary for good cause shown waives the application of such limit to such individual. "(5) National Research Service Awards shall provide for such stipends, tuition, fees, and allowances (including travel and subsist- ence expenses and dependency allowances), adjusted periodically to reflect increases in the cost of living, for the recipients of the awards as the Secretary may deem necessary. A National Research Service Award made to an individual for research or research training at a non-Federal public or nonprofit private institution shall also provide for payments to be made to the institution for the cost of support services (including the cost of faculty salaries, supplies, equipment, general research support, and related items) provided such individ- ual by such institution. The amount of any such payments to any
PUBLIC LAW 99-158-NOV. 20, 1985 99 STAT. 871 institution shall be determined by the Secretary and shall bear a direct relationship to the reasonable costs of the institution for establishing and maintaining the quality of its biomedical and behavioral research and training programs. "(c)(1) Each individual who is awarded a National Research Serv- ice Award (other than an individual who is a pre-baccalaureate student who is awarded a National Research Service Award for research training) shall, in accordance with paragraph (3), engage in health research or teaching or any combination thereof which is in accordance with the usual patterns of academic employment, for a period computed in accordance with paragraph (2). "(2) For each month for which an individual receives a National Research Service Award which is made for a period in excess of twelve months, such individual shall engage in one month of health research or teaching or any combination thereof which is in accord- ance with the usual patterns of academic employment. "(3) The requirement of paragraph (1) shall be complied with by Regulation. any individual to whom it applies within such reasonable period of time, after the completion of such individual's award, as the Secretary shall by regulation prescribe. The Secretary shall by regulation prescribe the type of research and teaching in which an individual may engage to comply with such requirement and such other requirements respecting research and teaching as the Sec- retary considers appropriate. "(4)(A) If any individual to whom the requirement of paragraph (1) is applicable fails, within the period prescribed by paragraph (3), to comply with such requirements, the United States shall be entitled to recover from such individual an amount determined in accord- ance with the formula— , . ( - ) in which 'A' is the amount the United States is entitled to recover; W is the sum of the total amount paid under one or more National Kesearch Service Awards to such individual; 't' is the total number of months in such individual's service obligation; and 's' is the number of months of such obligation served by such individual in accordance with paragraphs (1) and (2) of this subsection. "(B) Any amount which the United States is entitled to recover under subparagraph (A) shall, within the three-year period begin- ning on the date the United States becomes entitled to recover such amount, be paid to the United States. Until any amount due the United States under subparagraph (A) on account of any National Research Service Award is paid, there shall accrue to the United States interest on such amount at a rate fixed by the Secretary of the Treasury after taking into consideration private consumer rates of interest prevailing on the date the United States becomes entitled to such amount. "(5)(A) Any obligation of an individual under paragraph (1) shall be canceled upon the death of such individual. "(B) The Secretary shall by regulation provide for the waiver or Regulation. suspension of any such obligation applicable to any individual when- ever compliance b^^ such individual is impossible or would involve substantial hardship to such individual or would be against equity and good conscience.
99 STAT. 872 PUBLIC LAW 99-158—NOV. 20, 1985 Appropriation "(d) There are authorized to be appropriated to make payments authorization. under National Research Service Awards and under grants for such Grants. awards $244,000,000 for fiscal year 1986, $260,000,000 for fiscal year 1987, and $275,000,000 for fiscal year 1988. Of the amounts appro- priated under this subsection— "(1) not less than 15 percent shall be made available for payments under National Research Service Awards provided by the Secretary under subsection (a)(1)(A); "(2) not less than 50 percent shall be made available for grants under subsection (a)(1)(B) for National Research Service Awards; Contracts. "(3) one-half of one percent shall be made available for pay- ments under National Research Service Awards which (A) are made to individuals affiliated with entities which have received 42 u s e 295g, grants or contracts under section 780, 784, or 786, and (B) are for 295g-4, 295g-6. research in primary medical care; and one-half of one percent shall be made available for payments under National Research Service Awards made for health services research by the Na- tional Center for Health Services Research and Health Care 98 Stat. 2819. Technology Assessment under section 304(a)(3); and 42 u s e 242b. "(4) not more than 4 percent may be obligated for National Prohibition. Research Service Awards for periods of three months or less. VISITING SCIENTIST AWARDS Education. "SEC. 488. (a) The Secretary may make awards (hereafter in this Disadvantaged section referred to as 'Visiting Scientist Awards') to outstanding persons. scientists who agree to serve as visiting scientists at institutions of Schools and colleges. postsecondary education which have significant enrollments of dis- 42 u s e 288a. advantaged students. Visiting Scientist Awards shall be made by the Secretary to enable the faculty and students of such institutions to draw upon the special talents of scientists from other institutions for the purpose of receiving guidance, advice, and instruction with regard to research, teaching, and curriculum development in the biomedical and behavioral sciences and such other aspects of these sciences as the Secretary shall deem appropriate. "Ot>) The amount of each Visiting Scientist Award shall include such sum as shall be commensurate with the salary or remunera- tion which the individual receiving the award would have been entitled to receive from the institution with which the individual has, or had, a permanent or immediately prior affiliation. Eligibility for and terms of Visiting Scientist Awards shall be determined in accordance with regulations the Secretary shall prescribe. STUDIES RESPECTING BIOMEDICAL AND BEHAVIORAL RESEARCH PERSONNEL 42 use 288b. "Sec. 489. (a) The Secretary shall, in accordance with subsection Ot)), arrange for the conduct of a continuing study to— "(1) establish (A) the Nation's overall need for biomedical and behavioral research personnel, (B) the subject areas in which such personnel are needed and the number of such personnel needed in each such area, and (C) the kinds and extent of training which should be provided such personnel; "(2) assess (A) current training programs available for the training of biomedical and behavioral research personnel which are conducted under this Act, at or through national research
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 873 institutes under the National Institutes of Health and institutes under the Alcohol, Drug Abuse, and Mental Health Administra- tion, and (B) other current training programs available for the training of such personnel; "(3) identify the kinds of research positions available to and held by individuals completing such programs; "(4) determine, to the extent feasible, whether the programs referred to in clause (B) of paragraph (2) would be adequate to meet the needs established under paragraph (1) if the programs referred to in clause (A) of paragraph (2) were terminated; and "(5) determine what modifications in the programs referred to in paragraph (2) are required to meet the needs established under paragraph (1). "(b)(1) The Secretary shall request the National Academy of Sci- ences to conduct the study required by subsection (a) under an arrangement under which the actual expenses incurred by such Academy in conducting such study will be paid by the Secretary. If the National Academy of Sciences is willing to do so, the Secretary shall enter into such an arrangement with such Academy for the conduct of such study. "(2) If the National Academy of Sciences is unwilling to conduct such study under such an arrangement, then the Secretary shall enter into a similar arrangement with other appropriate nonprofit private groups or associations under which such groups or associa- tions will conduct such study and prepare and submit the reports thereon as provided in subsection (c). "(3) The National Academy of Sciences or other group or associa- tion conducting the study required by subsection (a) shall conduct such study in consultation with the Director of NIH. "(c) A report on the results of the study required under subsection Report. (a) shall be submitted by the Secretary to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate at least once every four years. "PART G—GENERAL PROVISIONS INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM "SEC. 491. (a) The Secretary shall by regulation require that each Regulations. entity which applies for a grant, contract, or cooperative agreement Grants. under this Act for any project or program which involves the Contracts. conduct of biomedical or behavioral research involving human sub- Human rights jects submit in or with its application for such grant, contract, or 42 u s e 289. cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Sec- retary shall prescribe) a board (to be known as an Institutional Review Board') to review biomedical and behavioral research involv- ing human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research. "(b)(1) The Secretary shall establish a program within the Depart- ment of Health and Human Services under which requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately. "(2) The Secretary shall establish a process for the prompt and appropriate response to information provided to the Director of NIH
99 STAT. 874 PUBLIC LAW 99-158-NOV. 20, 1985 respecting incidences of violations of the rights of human subjects of research for which funds have been made available under this Act. The i)rocess shall include procedures for the receiving of reports of such information from recipients of funds under this Act and taking appropriate action with respect to such violations. PEER REVIEW REQUIREMENTS Regulations. "SEC. 492. (a)(1) The Secretary, acting through the Director of 42 u s e 289a. NIH, shall by regulation require appropriate technical and scientific peer review of— Grants. "(A) applications made for grants and cooperative agreements Contracts. under this Act for biomedical and behavioral research; and "(B) applications made for biomedical and behavioral re- search and development contracts to be administered through the National Institutes of Health. Regulations. "(2) Regulations promulgated under paragraph (1) shall require Grants. that the review of applications made for grants, contracts, and Contracts. cooperative agreements required by the regulations be conducted— "(A) to the extent practical, in a manner consistent with the system for technical and scientific peer review applicable on the date of the date of enactment of the Health Research Extension Ante, p. 820. Act of 1985 to grants under this Act for biomedical and behav- ioral research, and "(B) to the extent practical, by technical and scientific peer review groups performing such review on or before such date, and shall authorize such review to be conducted by groups appointed Ante, pp. 823, under sections 402(b)(6) and 405(c)(3). 826. "(b) The Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the National Institutes of Health. Such procedures shall require that— "(1) the reviewing entity be provided a written description of the research to be reviewed, and "(2) the reviewing entity provide the advisory council of the national research institute involved with such description and the results of the review by the entity, and shall authorize such review to be conducted by groups appointed under sections 402(b)(6) and 405(c)(3). PROTECTION AGAINST SCIENTIFIC FRAUD Regulations. "SEC. 493. (a) The Secretary shall by regulation require that each Grants. entity which applies for a grant, contract, or cooperative agreement Contracts. under this Act for any project or program which involves the 42 u s e 289b. conduct of biomedical or behavioral research submit in or with its application for such grant, contract, or cooperative agreement assur- ances satisfactory to the Secretary that such entity— "(1) has established (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of scientific fraud in connection with biomedical and behavioral research conducted at or sponsored by such entity; and Report. "(2) will report to the Secretary any investigation of alleged scientific fraud which appears substantial. "(b) The Director of NIH snail establish a process for the prompt and appropriate response to information provided the Director of NIH respecting scientific fraud in connection with projects for
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 875 which funds have been made available under this Act. The process shall include procedures for the receiving of reports of such informa- tion from recipients of funds under this Act and taking appropriate action with respect to such fraud. "RESEARCH ON PUBUC HEALTH EMERGENCIES "SEC. 494. (a) If the Secretary determines, after consultation with Grants. the Director of NIH, the Commissioner of the Food and Drug Contracts. 42 u s e 289c. Administration, or the Director of the Centers for Disease Control, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the Director of NIH— "(1) shall expedite the review by advisory councils under section 406 and by peer review groups under section 492 of Ante, pp. 828, applications for grants for research on such disease or disorder 874. or proposals for contracts for such research; "(2) shall exercise the authority in section 3709 of the Revised Statutes (41 U.S.C. 5) respecting public exigencies to waive the advertising requirements of such section in the case of proposals for contracts for such research; "(3) may provide administrative supplemental increases in existing grants and contracts to support new research relevant to such disease or disorder; and "(4) shall disseminate, to health professionals and the public, Public information on the cause, prevention, and treatment of such information. disease or disorder that has been developed in research assisted under this section. The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half the original amount of the grant or contract. "(b) Not later than 90 days after the end of a fiscal year, the Report. Secretary shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate on actions taken under subsection (a) in such fiscal year. ANIMALS IN R E S E A R C H "SEC. 495. (a) The Secretary, acting through the Director of NIH, 42 USC 289d. shall establish guidelines for the following: "(1) The proper care of animals to be used in biomedical and behavioral research. "(2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall require— "(A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and "(B) appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals in such research. Such guidelines shall not be construed to prescribe methods of Prohibition, research. "(3) The organization and operation of animal care commit- tees in accordance with subsection (b). "(b)(1) Guidelines of the Secretary under subsection (aX3) shall require animal care committees at each entity which conducts biomedical and behavioral research with funds provided under this Act (including the National Institutes of Health and the national
99 STAT. 876 PUBLIC LAW 99-158—NOV. 20, 1985 research institutes) to assure compliance with the guideHnes estab- Hshed under subsection (a). "(2) Each animal care committee shall be appointed by the chief executive officer of the entity for which the committee is estab- lished, shall be composed of not fewer than three members, and shall include at least one individual who has no association with such entity and at least one doctor of veterinary medicine. "(3) Each animal care committee of a research entity shall— "(A) review the care and treatment of animals in all animal study areas and facilities of the research entity at least semi- annually to evaluate compliance with applicable guidelines established under subsection (a) for appropriate animal care and treatment; "(B) keep appropriate records of reviews conducted under subparagraph (A); and "(C) for each review conducted under subparagraph (A), file with the Director of NIH at least annually (i) a certification that Reports. the review has been conducted, and (ii) reports of any violations of guidelines established under subsection (a) or assurances required under paragraph (1) which were observed in such review and which have continued after notice by the committee to the research entity involved of the violations. Reports filed under subparagraph (C) shall include any minority views filed by members of the committee. Grants. "(c) The Director of NIH shall require each applicant for a grant, Contracts. contract, or cooperative agreement involving research on animals which is administered by the National Institutes of Health or any national research institute to include in its application or contract proposal, submitted after the expiration of the twelve-month period beginning on the date of enactment of this section— "(1) assurances satisfactory to the Director of NIH that— "(A) the applicant meets the requirements of the guide- lines established under paragraphs (1) and (2) of subsection (a) and has an animal care committee which meets the requirements of subsection (b); and "(B) scientists, animal technicians, and other personnel involved with animal care, treatment, and use by the ap- plicant have available to them instruction or training in the humane practice of animal maintenance and experimentation, and the concept, availability, and use of research or testing methods that limit the use of animals or limit animal distress; and "(2) a statement of the reasons for the use of animals in the research to be conducted with funds provided under such grant or contract. Notwithstanding subsection (a)(2) of section 553 of title 5, United States Code, regulations under this subsection shall be promulgated in accordance with the notice and comment requirements of such section. Grants. "(d) If the Director of NIH determines that— Contracts. "(1) the conditions of animal care, treatment, or use in an entity which is receiving a grant, contract, or cooperative agree- ment involving research on animals under this title do not meet applicable guidelines established under subsection (a); "(2) the entity has been notified by the Director of NIH of such determination and has been given a reasonable oppor- tunity to take corrective action; and
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 877 "(3) no action has been taken by the entity to correct such conditions; the Director of NIH shall suspend or revoke such grant or contract under such conditions as the Director determines appropriate. "(e) No guideline or regulation promulgated under subsection (a) Prohibition. or (c) may require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential. USE OF APPROPRIATIONS UNDER THIS TITLE "SEC. 496. Appropriations to carry out the purposes of this title District of shall be available for the acquisition of land or the erection of Columbia. buildings only if so specified. Such appropriations, unless otherwise 42 u s e 289e. expressly provided, may be expended in the District of Columbia for— "(1) personal services; "(2) stenographic recording and translating services; "(3) travel expenses (including the expenses of attendance at meetings when specifically authorized by the Secretary); "(4) rental; "(5) supplies and equipment; "(6) purchase and exchange of medical books, books of ref- erence, directories, periodicals, newspapers, and press clippings; "(7) purchase, operation, and maintenance of passenger motor vehicles; "(8) printing and binding (in addition to that otherwise pro- vided by law); and "(9) all other necessary expenses in carrying out this title. Such appropriations may be expended by contract if deemed nec- essary, without regard to section 3709 of the Revised Statutes (41 U.S.C. 5). "GIFTS "SEC. 497. The Secretary may, in accordance with section 2101, 42 u s e 300aa. accept conditional gifts for the National Institutes of Health or a 42 u s e 289f. national research institute or for the acquisition of grounds or for the erection, equipment, or maintenance of facilities for the Na- tional Institutes of Health or a national research institute. Dona- tions of $50,000 or over for the National Institutes of Health or a national research institute for carrying out the purposes of this title may be acknowledged by the establishment within the National Institutes of Healtn or a national research institute of suitable memorials to the donors. FETAL RESEARCH "SEC. 498. (a) The Secretary may not conduct or support any Prohibition. research or experimentation, in the United States or in any other 42 u s e 299g. country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation— "(1) may enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or "(2) will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the
99 STAT. 878 PUBLIC LAW 99-158—NOV. 20, 1985 development of important biomedical knowledge which cannot be obtained by other means. Regulations. "(b) In administering the regulations for the protection of human research subjects which— "(1) apply to research conducted or supported by the Secretary; "(2) involve living human fetuses in utero; and "(3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations; or any successor to such regulations, the Secretary shall require that the risk standard (published in section 46.102(g) of such part 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term. Study. "(cXD The Biomedical Ethics Advisory Committee appointed 42 u s e 275. under section 381 shall conduct a study of the nature, advisability, and biomedical and ethical implications of exercising any waiver of the risk standard'published in section 46.102(g) of such part 46 (or Report. any successor to such regulations). The Committee shall complete the study and report its findings to the Biomedical Ethics Board established under section 381 not later than the expiration of thirty Report. months after the date of enactment of this section. The report shall include the recommendations, if any, of the Committee on the advisability of the authority for such a waiver and the cir- cumstances under which such a waiver might be granted. The Biomedical Ethics Board shall transmit the report to the Secretary, the Committee on Energy and Commerce of the House of Represent- atives, and the Committee on Labor and Human Resources of the Senate. Prohibition. "(2) During the thirty-six-month period beginning on the date of enactment of this section, the Secretary may not grant (under section 46.211 of part 45 of title 46 of the Code of Federal Regula- tions or any successor to such section) a modification or waiver for Effective date. "(3) Effective October 31,1988, paragraph (2) is repealed. CONSTRUCTION OF TITLE 42 u s e 289h. "SEC. 499. This title shall not be construed as limiting (1) the 42 u s e 241. functions or authority of the Secretary under section 301 or of any officer or agency of the United States, relating to the study, preven- tion, diagnosis, and treatment of any disease for which a separate national research institute is established under this title, or (2) the expenditure of any funds therefor." SEC. 3. CONFORMING AMENDMENTS. National (a) ADVISORY COUNCILS.—(1) The National Advisory Health Coun- Advisory Health cil established under section 217 is terminated. Council, (2) Section 217(a) (42 U.S.C. 218(a)) is amended— termination. 42 u s e 218 note. (A) in the first sentence— 98 Stat. 2364. (i) by striking out "National Advisory Health Council, the National Advisory Mental Health Council, the National Advisory Council on Alcohol Abuse and Alcoholism, and the National Advisory Dental Research Council" and inserting in lieu thereof "National Advisory Mental Health Council and the National Advisory Council on Alcohol Abuse and Alcoholism"; and
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 879 (ii) by striking out "by the Surgeon General with the approval of the Secretary of Health, Education, and Wel- fare" and inserting in lieu thereof "by the Secretary"; (B) in the second sentence— (i) by striking out "in the case of the National Advisory Health Council, are skilled in the sciences related to health, and"; (ii) by striking out "the National Advisory Mental Health Council, the National Advisory Council on Alcohol Abuse and Alcoholism, the National Advisory Heart Council, and the National Advisory Dental Research Council" and inserting in lieu thereof "the National Advisory Mental Health Council and the National Advisory Council on Alco- hol Abuse and Alcoholism"; and (iii) by striking out ", alcohol abuse and alcoholism, and Alcohol and dental diseases and conditions" and inserting in lieu alcoholic thereof "and alcohol abuse and alcoholism"; and beverages. (C) by striking out the third sentence. (3) Subsection (b) of section 217 is repealed and subsections (c) 42 u s e 218. through (e) and subsection (g) are redesignated as subsections (b) through (e), respectively. (4) Section 222(c) (42 U.S.C. 217a(c)) is amended to read as follows: Grants. "(c) Upon appointment of any such council or committee, the Secretary may delegate to such council or committee such advisory functions relating to grants-in-aid for research or training projects or programs, in the areas or fields with which such council or committee is concerned, as the Secretary determines to be appropriate.". (5) Section 301(a) (42 U.S.C. 241(a)) is amended— Grants. (A) in paragraph (3), by striking out "as are recommended" through "for such fiscal year" and inserting in lieu thereof "as are recommended by the advisory council to the entity of the Department supporting such projects or, in the case of mental health projects, by the National Advisory Mental Health Coun- cil; and make, upon recommendation of the advisory council to the appropriate entity of the Department or the National Ad- visory Mental Health Council, grants-in-aid to public or non- profit universities, hospitals, laboratories, and other institutions for the general support of their research"; and (B) in paragraph (8), by striking out "recommendations of the National Advisory Health Council" through "as he deems" and inserting in lieu thereof "recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers". (6) Section 1122(a) (42 U.S.C. 300c-12(a)) is amended by striking out "under section 441". (b) NATIONAL LIBRARY OF MEDICINE.—Parts I and J of title III are Repeal. repealed. 42 use (c) ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH RESEARCH.— 275—280a-l, 280b—280b-ll. Section 506 is amended by adding at the end the following: 42 u s e 290aa-5. "(e)(1) If the direct cost of a grant, cooperative agreement, or 42 u s e 224. contract (described in subsection (a)) to be made does not exceed Grants. $50,000, the Secretary may make such grant, cooperative agree- Gontracts. ment, or contract only if such grant, cooperative agreement, or Regulations. contract is recommended after technical and scientific peer review required by regulations under subsections (a) and (b).
99 STAT. 880 PUBLIC LAW 99-158—NOV. 20, 1985 "(2) If the direct cost of a grant, cooperative agreement, or con- tract (described in subsection (a)) to be made exceeds $50,000, the Secretary may make such grant, cooperative agreement, or con- tract only if such grant, cooperative agreement, or contract is recommended— "(A) after technical and scientific peer review required by regulations under subsections (a) and (b), and "(B) by the National Advisory Council on Alcohol Abuse and Alcoholism, the National Advisory Council on Drug Abuse, or the National Mental Health Advisory Council, as is appropriate.". Repeal. (d) ORPHAN DRUG ACT.—Section 8(w) of the Orphan Drug Act 42 u s e 287i (Public Law 97-414) is repealed. note. 42 u s e 289d SEC. 4. PLAN FOR RESEARCH INVOLVING ANIMALS. note. (a) ESTABLISHMENT OF PLAN.—The Director of the National In- stitutes of Health shall establish a plan for— (1) research to be conducted by or through the National Institutes of Health and the national research institutes into methods of biomedical research and experimentation— (A) which do not require the use of animals; (B) which reduce the number of animals used in such research; or (C) which produce less pain and distress in such animals than methods currently in use; (2) establishing the validity and reliability of the methods described in subparagraph (A); (3) the development of such methods which have been found to be valid and reliable; and (4) the training of scientists in the use of such methods. The plan required by this paragraph shall be prepared not later than October 1,1986. (b) DISSEMINATION OF INFORMATION.—The Director of the National Institutes of Health shall take such actions as may be appropriate to convey to scientists and others involved with research or experimen- tation involving animals information respecting the methods found to be valid and reliable under subsection (a)(2). Establishment. (c) INTERAGENCY COORDINATING COMMITTEE.—The Director of the National Institutes of Health shall establish within the National Institutes of Health an Interagency Coordinating Committee to assist the Director of the National Institutes of Health in the development of the plan required by subsection (a). The Director of each national research institute shall serve on the Committee. Lupus SEC. 5. RESEARCH ON LUPUS ERYTHEMATOSUS. Erythematosus Coordinating (a) ESTABLISHMENT OF COMMITTEE.—The Secretary shall establish Committee. a Lupus Erythematosus Coordinating Committee to plan, develop, 42 u s e 281 note. coordinate, and implement comprehensive Federal initiatives in research on Lupus Erythematosus. (b) COMMITTEE COMPOSITION AND MEETINGS.—(1) The Committee shall be composed of— (A) the Director of the National Institute of Neurological and Communicative Disorders and Stroke (or the designee of such Director); (B) the Director of the National Institute of Allergy and Infectious Diseases (or the designee of such Director);
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 881 (C) the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseeises (or the designee of such Director); (D) the Director of the National Institute of General Medical Sciences (or the designee of such Director); (E) the Director of the National Heart, Lung, and Blood Institute (or the designee of such Director); (F) the Director of the National Institute of Diabetes and Digestive and Kidney Diseases (or the designee of such Direc- tor); and (G) the Director of the Centers for Disease Control (or the designee of such Director). (2) The Committee shall meet at least four times a year. The Secretary shall designate as chairman of the Committee the Direc- tor of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. (c) REPORT.—The Committee shall prepare a report for Congress on its activities. The report shall include a description of research projects on Lupus Erjrthematosus conducted or supported by Federal agencies in the fiscal year for which the report is made, the nature and purpose of each such project, the amounts expended for each such project, and an identification of the entity which conducted the research under each such project. Such report shall be submitted not^ later than 18 months after the date of the date of enactment of this Act. The Committee shall terminate one month after the report is submitted. SEC. 6. NATIONAL RESEARCH SERVICE AWARD STUDY. The Secretary of Health and Human Services shall conduct a study of— (1) the effect of the service obligation requirement of section 487(c) of the Public Health Service Act on the number and Ante, p. 869. quality of individuals who apply for National Research Service Awards; (2) the effect of section 487(cX4) of such Act on the number of persons who engage in health research or training as a career; (3) the number of persons who receive National Research Service Awards and who engage in health research or training as a career; and (4) the effectiveness of the grant authority under section 487(a)(1)(B) of such Act in encouraging individuals to engage in health research and training as a career. The Secretary shall complete the study within one year after the Report. date of enactment of this Act and shall report the results of the study to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate. SEC. 7. INTERAGENCY COMMITTEE ON SPINAL CORD INJURY. 42 USC 285j-l (a) EsTABUSHMENT.—Within 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall establish in the National Institute of Neurological and Communica- tive Diseases and Stroke an Interagency Committee on Spinal Cord Injury (hereafter in this section referred to as the "Interagency Committee"). The Interagency Committee shall plan, develop, co- ordinate, and implement comprehensive Federal initiatives in re- search on spinal cord injury and regeneration.
99 STAT. 882 PUBLIC LAW 99-158—NOV. 20, 1985 (b) COMMITTEE COMPOSITION AND MEETINGS.—(1) The Interagency Committee shall consist of representatives from— (A) the National Institute on Neurological and Communica- tive Disorders and Stroke; (B) the Department of Defense; (C) the Department of Education; (D) the Veterans' Administration; (E) the Office of Science and Technology Policy; and (F) the National Science Foundation; designated by the heads of such entities. (2) The Interagency Committee shall meet at least four times. The Secretary of Health and Human Services shall select the Chairman of the Interagency Committee from the members of the Interagency Committee. (c) REPORT.—Within the 18 months after the date of enactment of this Act, the Interagency Committee shall prepare and transmit to the Congress a report concerning its activities under this section. The report shall include a description of research projects on spinal cord injury and regeneration conducted or supported by Federal agencies during such 18-month period, the nature and purpose of each such project, the amounts expended for each such project, and an identification of the entity which conducted the research under each such project. (d) TERMINATION.—The Interagency Committee shall terminate 90 days after the date on which the Interagency Committee transmits the report required by subsection (c) to the Congress. 42 u s e 285e SEC. 8. STUDY OF PERSONNEL FOR HEALTH NEEDS OF THE ELDERLY. note. (a) STUDY.—The Secretary shall conduct a study on the adequacy and availability of personnel to meet the current and projected health needs (including needs for home and community-based care) of elderly Americans through the year 2020. Physicians. (h) REPORT.—The Secretary shall report the results of the study to Dentists. the Congress by March 1, 1987. The report on the study shall Medicare. contain recommendations on— (1) the number of primary care physicians, dentists, and other health personnel needed to provide adequate care for the elderly; (2) the training needs of other physicians, dentists, and health personnel to provide care responsive to the particular needs of the elderly; (3) necessary changes in medicare and other third party reimbursement programs necessary to support training of pri- mary care and other physicians to meet the needs of the elderly; and (4) necessary program changes in third party reimbursement programs (including changes in medicare programs) to support training of other health personnel in the care of the elderly. 42 u s e 281 note. SEC. 9. INTERAGENCY COMMITTEE ON LEARNING DISABILITIES. Children and (a) ESTABLISHMENT.—Not later than 90 days after the date of youth. enactment of this Act, the Director of the National Institutes of Health shall establish an Interagency Committee on Learning Disabilities to review and assess Federal research priorities, activi- ties, and findings regarding learning disabilities (including central nervous system dysfunction in children).
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 883 (b) COMPOSITION.—The Committee shall be composed of such rep- resentatives as the Director may designate, but shall include rep- resentatives from the National Institute of Neurological and Communicative Disorders and Stroke, the National Institute of Child Health and Human Development, the National Institute of Allergy and Infectious Diseases, the National Eye Institute, the National Institute of Environmental Health Sciences, the Division of Research Resources of the National Institutes of Health, the Food and Drug Administration, the National Institute of Mental Health, and the Department of Education. (c) REPORT.—Not later than 18 months after the date of enactment of this Act, the Committee shall report to the Congress on its activities under subsection (a) and shall include in the report— (1) the number of persons affected by learning disabilities and the demographic data which describes such persons; (2) a description of the current research findings on the cause, diagnosis, treatment, and prevention of learning disabilities; and (3) recommendations for legislation and administrative actions— (A) to increase the effectiveness of research on learning disabilities and to improve the dissemination of the findings of such research; and (B) respecting specific priorities for research in the cause, diagnosis, treatment, and prevention of learning disabilities. (d) TERMINATION.—The Committee shall terminate 90 days after the date of the submission of the report under subsection (c). SEC. 10. REVIEW OF DISEASE RESEARCH PROGRAMS OF THE NATION- 42 USC 285c AL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY ^°^^- DISEASES. The Secretary of Health and Human Services shall conduct an administrative review of the disease research programs of the Na- tional Institute of Diabetes and Digestive and Kidney Diseeises to determine if any of such programs could be more effectively and efficiently managed by other national research institutes. The Sec- retary shall complete such review within the one-year period begin- ning on the date of enactment of this Act. SEC. 11. BIOMEDICAL ETHICS. Title III (as amended by section 3) is amended by adding at the end the following: "PART I—BIOMEDICAL ETHICS "SEC. 381. (a) There is established in the legislative branch of the 42 USC 275. Government the Biomedical Ethics Board (hereinafter referred to as the 'Board'). "(b)(1) The Board shall consist of twelve members as follows: "(A) Six Members of the Senate appointed as follows: Three members appointed by the Majority Leader of the Senate from the majority party and three members appointed by the Minor- ity Leader from the minority party. "(B) Six Members of the House of Representatives appointed by the Speaker of the House of Representatives, three from the majority party and three from the minority party.
99 STAT. 884 PUBLIC LAW 99-158—NOV. 20, 1985 "(2) The term of office of a member of the Board shall expire when the member leaves the office of Senator or Representative, as the case may be, or upon the expiration of eight years after the date of the member's appointment to the Board, whichever occurs first. "(3) Vacancies in the membership of the Board shall not affect the power of the remaining members to execute the functions of the Board and shall be filled in the same manner as in the case of the original appointment. "(4) The Board shall select a chairman and a vice chairman from among its members at the beginning of each Congress. The vice chairman shall act as chairman in the absence of the chairman or in the event of the incapacity of the chairman. The chairmanship and vice chairmanship shall alternate between the Senate and the House of Representatives with each Congress. The chairman during each even-numbered Congress shall be selected by the Members of the House of Representatives on the Board from among their number. The vice chairman during each Congress shall be chosen in the same manner from that House of Congress other than the House of Congress of which the chairman is a Member. "(5) The Board shall meet once every three months unless such meeting is dispensed with by the chairman, and may meet at any time upon the request of four or more members of the Board or upon the call of the chairman. Studies. "(cXD The Board shall study and report to the Congress on a Reports. continuing basis on the ethical issues arising from the delivery of health care and biomedical and behavioral research, including the protection of human subjects of such research and developments in genetic engineering (including activities in recombinant DNA tech- nology) which have implications for human genetic engineering. "(2)(A) Except as provided in subparagraph (B), an annual report shall be transmitted to the Congress identifying the issues which were the subject of the study conducted under paragraph (1) and identifying areas, programs, and practices of medicine and bio- medical and behavioral research which have significant ethical implications and which would be appropriate subjects for study. "(B) A report on research and developments in genetic engineer- ing (including activities in recombinant DNA technology) which have implications for human genetic engineering shall be transmit- ted to the Congress not later than eighteen months after the appointment of the Committee under subsection (d). "(dXD To conduct the studies and make the reports required by subsection (c), the Board shall appoint a Biomedical Ethics Advisory Committee (hereinafter referred to as the 'Committee'). The Committee shall consist of fourteen members as follows: "(A) Four of the members shall be appointed by the Board from individuals who are distinguished in biomedical or behav- ioral research. "(B) Three of the members shall be appointed by the Board from individuals who are distinguished in the practice of medi- cine or otherwise distinguished in the provision of health care. "(C) Five of the members shall be appointed by the Board from individuals who are distinguished in one or more of the fields of ethics, theology, law, the natural sciences (other than the biomedical or behavioral sciences), the social sciences, the humanities, health administration, government, and public affairs.
PUBLIC LAW 99-158—NOV. 20, 1985 99 STAT. 885 "(D) Two of the members shall be appointed by the Board from individuals who are representatives of citizens with an interest in biomedical ethics but who possess no specific expertise. "(2)(A) The Committee, by majority vote, shall elect from its members a chairman and a vice chairman and appoint an executive director who shall serve for such time and under such conditions as the Committee may prescribe. In the absence of the chairman, or in the event of the incapacity of the chairman, the vice chairman shall act as chairman. "(B) The term of office of each member of the Committee shall be four years, except that any such member appointed to fill a vacancy occurring prior to the expiration of the term for which such mem- ber's predecessor was appointed shall be appointed for the remain- der of such term. Terms of the members shall be staggered so as to establish a rotating membership. "(C) The members of the Committee shall receive no pay for their services as members of the Committee, but shall be allowed nec- essary travel expenses (or, in the alternative, mileage for use of privately owned vehicles and a per diem in lieu of subsistence at not to exceed the rate prescribed in sections 5702 and 5704 of title 5, United States Code) and other necessary expenses incurred by them in the performance of duties as a member of the Committee, without regard to the provisions of subchapter 1 of chapter 57 and section 5731 of title 5, United States Code, and regulations promulgated 5 USC 5701 et thereunder. *^9- "(D) The executive director of the Committee, with the approval of the Committee, may employ such staff and consultants as necessary to prepare studies and reports for the Committee. "(3)(A) The Committee may, for the purpose of carrying out its functions, hold such public hearings, sit and act at such times and places, and take such testimony, as the Committee considers appropriate. "(B) Upon request of the Committee, the head of any Federal agency is authorized to detail, on a reimbursable basis, any of the personnel of such agency to the Committee to assist the Committee in carrying out its functions. "(C) The Committee may secure directly from any department or agency of the United States information necessary to enable it to carry out its functions. Upon request of the chairman of the Committee, the head of such department or agency shall furnish such information to the Committee. "(D) The Committee may accept, use, and dispose of gifts or ^ donations or services or property. "(E) The Committee may use the United States mails in the same manner and under the same conditions as other departments and agencies of the United States. "(e) To enable the Board and the Committee to carry out their Appropriation functions there are authorized to be appropriated $2,000,000 for authorization, fiscal year 1986, $2,500,000 for fiscal year 1987, and $3,000,000 for fiscal year 1988.". SEC. 12. ALZHEIMER'S DISEASE REGISTRY. 42 USC 285e-2 (a) GRANT AUTHORITY.— The Director of the National Institute on Aging may make a grant to develop a registry for the collection of epidemiological data about Alzheimer's disease and its incidence in
99 STAT. 886 PUBLIC LAW 99-158—NOV. 20, 1985 the United States, to train personnel in the collection of such data, and for other matters respecting such disease. Grants. (b) QUALIFICATIONS.—To qualify for a grant under subsection (a) an applicant shall— (1) be an accredited school of medicine or public health which has expertise in the collection of epidemiological data about individuals with Alzheimer's disease and in the development of disease registries, and (2) have access to a large patient population, including a patient population representative of diverse ethnic backgrounds. Grants. (c) AUTHORIZATION.—For grants under subsection (a), there are authorized to be appropriated $2,500,000 which shall remain avail- able until expended or through fiscal year 1989, whichever occurs first. T H O M A S P. O ' N E I L L , J R . GEORGE B U S H Speaker of the House of Representatives. Vice President of the United States and President of the Senate. IN T H E H O U S E O F R E P R E S E N T A T I V E S , U.S., November 12, 1985. The H o u s e of R e p r e s e n t a t i v e s h a v i n g p r o c e e d e d t o r e c o n s i d e r t h e bill (H.R. 2409) entitled "An Act to amend the Public Health Service Act to revise and extend the authorities under that Act relating to the National Institutes of Health and National Research Institutes, and for the other purposes", returned by the President of the United States with his objec- tions, to the House of Representatives, in which it originated, it was Resolved, That the said bill pass, two-thirds of the House of Representa- tives agreeing to pass the same. Attest: BENJAMIN J. GUTHRIE Clerk. I certify that this Act originated in the House of Representatives. BENJAMIN J. GUTHRIE Clerk. IN THE SENATE OF THE UNITED STATES, November 20 (legislative day, November 18), 1985. The Senate having proceeded to reconsider the bill (H.R. 2409) entitled "An Act to amend the Public Health Service Act to revise and extend the authorities under that Act relating to the National Institutes of Health and National Research Institutes, and for other purposes", returned by the President of the United States with his objections, to the House of Repre- sentatives, in which it originated, and passed by the House of Representa- tives on reconsideration of the same, it was Resolved, That the said bill pass, two-thirds of the Senators present having voted in the affirmative. Attest: JO-ANNE L. COE Secretary. LEGISLATIVE HISTORY—H.R. 2409 (S. 1309): HOUSE REPORTS: No. 99-158 (Comm. on Energy and Commerce) and No. 99-309 (Comm. of CJonference). SENATE REPORTS: No. 99-108 accompanying S. 1309 (Comm. on Labor and Human Resources) and No. 99-157 (Comm. of Conference). CONGRESSIONAL RECORD, Vol. 131 (1985): J u n e 17, considered and passed House. July 19, S. 1309 considered and passed Senate; passage vitiated and H.R. 2409, amended, passed in lieu. Oct. 18, Senate agreed to conference report. Oct. 23, House agreed to conference report. WEEKLY COMPILATION O F PRESIDENTIAL DOCUMENTS, Vol. 21, No. 45 (1985): Nov. 8, Presidential veto message. CONGRESSIONAL RECORD, Vol. 131 (1985): Nov. 12, House overrode veto. Nov. 20, Senate overrode veto.