Health Research Extension Act of 1985
PL 99-158 (H.R.2409), enacted 11/20/1985

99 STAT. 820 
PUBLIC LAW 99-158—NOV. 20, 1985 
Public Law 99-158 
99th Congress 
An Act 
Nov. 20, 1985 
[H.R. 2409] 
Health Research 
Extension Act of 
1985. 
Research and 
development. 
42 u s e 201 note. 
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. 
Be it enacted by the Senate and House of Representatives of the 
United States of 
America in Congress assembled, 
SECTION 1, SHORT TITLE; REFERENCE TO ACT; AND TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the "Health Research 
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 NIH 
"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 OF 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 i
f
— 
"(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 
Post, p. 874. 
Real property. 
Public buildings 
and grounds. 
District of 
Columbia. 
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 
section 492; 
"(4) for the national research institutes and administrative 
entities within the National Institutes of Health— 
"(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 
"(B) may acquire, without regard to the Act of March 3, 
1877 (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 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, 
and without regard to the provisions of chapter 51 and sub-
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-
5 use 5101. 
5 use 5331. 
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 
• ^' 
"(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. 
m.! t^ 
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 
406(a)(3)(AXi), conduct the research, investigations, experiments, 
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) 
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-
sional education and information programs; 
"(F) may secure, develop and maintain, distribute, and sup-
port the development and maintenance of resources needed for 
research; 
"(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 
its activities, and, in the case of gifts of a value in excess of 
$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 
"(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 
States Code, shall apply with respect to contracts entered into under 
this subsection and section 402(b). 
"(2) Support for an activity or program under this subsection may 
be provided through grants, contracts, and cooperative agreements. 
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 
"(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 
Post, p. 874. 
Post, p. 828. 
Post, p. 869. 
Education. 
.'4* h 
Gifts and 
property. 
Voluntarism. 
Contracts. 
Ante, p. 823. 
Grants. 
Contracts. 
Post, p. 874. 
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 
of the United States shall not receive any compensation for service 
on the advisory council. The other members of an advisory council 
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. 
"(c) The term of office of an appointed member of an 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 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 
Government 
organization and 
employees. 
Prohibition. 
5 u s e 5332 
note. 
99 STAT. 830 
PUBLIC LAW 99-158—NOV. 20, 1985 
Report. 
Post, p. 831. 
Report. 
Ante, p. 820. 
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. 
"(g) Each advisory council may prepare, for inclusion in the 
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 
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 
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 
of information to the general public concerning the prevention, 
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. 
Public 
information. 
SPECIAL AUTHORITIES OF THE DIRECTOR 
"SEC, 413. (a) The Director of the Institute shall establish an 
information and education center to collect, identify, analyze, and 
disseminate on a timely basis, through publications and other appro-
priate means, to cancer patients and their families, physicians and 
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 Program-
"(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 
Institute, acquire, construct, improve, repair, operate, and 
Education. 
Physicians. 
Public 
information. 
42 u s e 285a-2. 
Real property. 
99 STAT. 834 
PUBLIC LAW 99-158—NOV. 20, 1985 
Grants. 
Public buildings 
and grounds. 
District of 
Columbia. 
Contracts. 
Ante, p. 826. 
Prohibition. 
maintain laboratories, other research faciUties, equipment, and 
such other real or personal property as the Director determines 
necessary; 
"(B) may, in consultation with the advisory council for the 
Institute, make grants for construction or renovation of facili-
ties; and 
"(C) may, in consultation with the advisory council for the 
Institute, acquire, without regard to the Act of March 3, 1877 
(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; 
"(8) may, subject to section 405(b)(2) and without regard to 
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 
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 
42 u s e 285a-3. 
"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^ 
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. 
ehildren and 
youth. 
42 u s e 285b-l. 
HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASE PREVENTION AND 
CONTROL PROGRAMS 
"SEC. 419. The Director of the Institute, under policies established 
by the Director of NIH and after consultation with the advisory 
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 
Education. 
Education. 
Real property. 
Grants. 
Public buildings 
and grounds. 
District of 
Columbia. 
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; 
"(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; 
"(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; 
"(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; 
"(B) may, in consultation with the advisory council for the 
Institute, make grants for construction or renovation of facili-
ties; and 
"(C) may, in consultation with the advisory council for the 
Institute, acquire, without regard to the Act of March 3, 1877 
(40 U.S.C. 34), by lease or otherwise, through the Administrator 
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 
3324 of title 31, United States Code, and section 3709 of the 
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 
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. 
Contracts. 
Ante, p. 826. 
Grants. 
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 
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 
42 u s e 285b-4. 
99 STAT. 840 
PUBLIC LAW 99-158—NOV. 20, 1985 
Contracts. 
Grants. 
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. 
"(cXl) The Director of the Institute may enter into cooperative 
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-
nical Committee on Heart, Blood Vessel, Lung, and Blood Diseases 
and Blood Resources which shall be responsible for coordinating 
those aspects of all Federal health programs and activities relating 
to heart, blood vessel, lung, and blood diseases and blood resources 
to assure the adequacy and technical soundness of such programs 
and activities and to provide for the full communication and ex-
change of information necessary to maintain adequate coordination 
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, 
"ASSOCIATE DIRECTOR FOR PREVENTION 
"SEC. 424. (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 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 
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-
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 
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-
Interagency 
Technical 
Committee on 
Heart, Blood 
Vessel, Lung, 
and Blood 
Diseases and 
Blood Resources, 
establishment. 
42 u s e 285b-5. 
42 u s e 285b-6. 
Ante, p. 831. 
42 u s e 285c. 
42 u s e 285C-1. 
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, 
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 o
f
— 
"(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-
ordinating Committee, a Digestive Diseases Interagency Coordinat-
ing Committee, and a Kidney, Urologic, and Hematologic Diseases 
Coordinating Committee (hereafter in this section individually 
referred to as a 'Committee'). 
"(b) Each Committee shall be composed of the Directors of each of 
the national research institutes and divisions involved in research 
with respect to the diseases for which the Committee is established, 
the Division Director of the Institute for the diseases for which the 
Committee is established, the Chief Medical Director of the Veter-
ans' Administration, and the Assistant Secretary of Defense for 
Health Affairs (or the designees of such officers) and shall include 
representation from all other Federal departments and agencies 
whose programs involve health functions or responsibilities relevant 
to such diseases, as determined by the Secretary. 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. 
"(c) Each Committee shall prepare an annual report for— 
"(1) the Secretary; 
"(2) the Director of NIH; and 
"(8) the Advisory Board established under section 430 for the 
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. 
Post, p. 869. 
42 use 285C-3. 
Diabetes 
Mellitus 
Interagency 
Coordinating 
Committee, 
establishment. 
Digestive 
Diseases 
Interagency 
Coordinating 
Committee, 
establishment. 
Kidney, 
Urologic, and 
Hematologic 
Diseases 
Coordinating 
Committee, 
establishment. 
Report. 
Post, p. 844. 
99 STAT. 844 
PUBLIC LAW 99-158—NOV. 20, 1985 
National 
Diabetes 
Advisory Board, 
establishment. 
National 
Digestive 
Disease Advisory 
Board, 
establishment. 
National Kidney 
and Urologic 
Diseases 
Advisory Board, 
establishment. 
42 u s e 285C-4. 
Government 
organization and 
employees. 
5 u s e 5332 note. 
ADVISORY BOARDS 
"SEC. 430. (a) The Secretary shall establish in the Institute the 
National Diabetes Advisory Board, the National Digestive Diseases 
Advisory Board, and the National Kidney and Urologic Diseases 
Advisory Board (hereafter in this section individually referred to as 
an 'Advisory Board'). 
"(b) Each 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 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). 
"(c) Members of an Advisory Board who are officers or employees 
of the Federal Government shall serve as members of the Advisory 
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 
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 
Post, p. 848. 
Expiration date. 
Ante, p. 820. 
"(4) contains the Advisory Board's recommendations (if any) 
for changes in the plan referred to in section 433. 
"(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-
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). 
42 u s e 285C-5. 
Nurses. 
RESEARCH AND TRAINING CENTERS 
"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. 
"(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— 
"(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— 
"(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. 
Physiciana. 
Physicians. 
ADVISORY COUNCIL SUBCOMMITTEES 
"SEC. 432. There are established within the advisory council for 
the Institute appointed under section 406 a subcommittee on dia-
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 
42 u s e 285C-6. 
Ante, p. 828. 
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 
Arthritis and 
Musculoskeletal 
Diseases 
Interagency 
Coordinating 
Committee, 
establishment. 
Skin Diseases 
Interagency 
Coordinating 
Committee, 
establishment. 
Report. 
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, 
the Secretary shall establish an Arthritis and Musculoskeletal Dis-
eases Interagency Coordinating Committee and a Skin Diseases 
Interagency Coordinating Committee (hereafter in this section 
individually referred to as a 'Committee'). 
"(b) Each Committee shall be composed of the Directors of each of 
the national research institutes and divisions involved in research 
regarding the diseases with respect to which the Committee is 
established, the Chief Medical Director of the Veterans' Administra-
tion, and tifie Assistant Secretary of Defense for Health Affairs (or 
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. 
"(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). 
Grants. 
42 u s e 285d-5. 
Post, p. 851. 
ARTHRITIS AND MUSCULOSKELETAL DISEASES DEMONSTRATION 
PROJECTS 
"SEC. 440. (a) The Director of the Institute may make grants to 
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 
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-
onstration of new and improved methods for the dissemination 
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 
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 
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 
other health and allied health professionals; 
"(C) information and continuing education programs for 
physicians and other health and allied health professionals 
Public 
information. 
Infra. 
42 use 285d-
Physicians. 
Education. 
Physicians. 
99 STAT. 852 
PUBLIC LAW 99-158—NOV. 20, 1985 
Public 
information. 
Drugs and drug 
abuse. 
Children and 
youth. 
who 
provide 
care 
for 
patients 
with 
arthritis 
and 
musculoskeletal diseases; and 
"(D) programs for the dissemination to the general public 
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 
"(ii) to discourage the promotion and use of un-
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 
under this section. The Director shall give appropriate consideration 
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. 
National 
Arthritis 
Advisory Board, 
establishment. 
42 u s e 285d-7. 
ADVISORY BOARD 
"SEC. 442. (a) The Secretary shall establish in the Institute the 
National Arthritis Advisory Board (hereafter in this section referred 
to as the 'Advisory Board'). 
"(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 
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 
cooperative agreements with and make grants to public or private 
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 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); 
"(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. 
"(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-
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. 
Grants. 
Contracts. 
Grants. 
42 use 285e-2. 
Post, p. 877. 
Post, p. 
42 use 285f. 
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 U
S
C 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-
cient for the erection and equipment of suitable and adequate 
buildings and facilities for use of the Library. The Administrator of 
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 
Public buildings 
and grounds. 
42 use 286a-l. 
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 
Grants. 
Contracts. 
42 use 286b. 
Infra; post, 
pp. 861-863. 
42 use 286b-l. 
42 use 286b-2. 
Regulations. 
42 use 210. 
AUTHORIZATION OF APPROPRIATIONS 
"SEC. 469. For the purpose of grants and contracts under sections 
472, 473, 474, 475, and 476, there are authorized to be appropriated 
$12,000,000 for fiscal year 1986, $13,000,000 for fiscal year 1987, and 
$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 
"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 
"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'). 
"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 
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 
other practitioners in the sciences related to health, to scientists, 
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 
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. 
Physicians. 
42 u s e 286b-4. 
Contracts. 
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-
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. 
42 u s e 286b-5. 
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 
make grants to, and enter into appropriate contracts with, public or 
private nonprofit institutions of higher education and individual 
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). 
Grants. 
Contracts. 
Education. 
42 use 286b-7. 
GRANT PAYMENTS, RECORDS, AND AUDIT 
"SEC. 477. (a) Payments under grants made under sections 472, 
473, 474, 475, and 476 may be made in advance or by way of 
reimbursement and in such installments as the Secretary shall 
prescribe by regulation after consultation with the Board. 
"(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 
Regulations. 
42 use 286b-8. 
Ante, 
pp. 860-862; 
supra. 
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. 
"SEC 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. 
Gifts and 
property. 
42 u s e 300aa. 
Grants. 
Gontracts. 
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. 
"(2) The advisory council for the Division of Research Resources 
may recommend to the Secretary acceptance, in accordeince with 
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. 
"(3) The advisory council for the Division— 
"(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-
ees of the United States shall not receive any compensation for 
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 
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 
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. 
Government 
organization and 
employees. 
5 u s e 5332 note. 
99 STAT. 866 
PUBLIC LAW 99-158-NOV. 20, 1985 
42 use 287a-l. 
Ante, p. 826. 
"(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 
"SEC. 481. The Director of the Division of Research Resources, 
after consultation with the advisory council for the Division, shall 
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 
4
2 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 
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 
provide research training and instruction and establish, in the 
Center and other nonpront institutions, research traineeships and 
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 
provide such training and instruction ana traineeships and 
fellowships. 
"ADVISORY COUNCIL 
"SEC. 485. (aXl) The Secretar^^ shall appoint an advisory council 
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 
Secretary acceptance, in accordance with section 2101, of conditional 
gifts for study, investigations, and research and for the acquisition 
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 
Center respecting research conducted at the Center, 
"(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-
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 
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. 
42 use 287c. 
Fellowships. 
Supra. 
42 use 287C-1. 
Grants. 
42 use 287C-2. 
Gifts and 
property. 
42 use SOOaa. 
Grants. 
Contracts. 
Public 
information. 
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 
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 
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. 
Regulation. 
Regulation. 
99 STAT. 872 
PUBLIC LAW 99-158—NOV. 20, 1985 
Appropriation 
authorization. 
Grants. 
Contracts. 
42 u s e 295g, 
295g-4, 295g-6. 
98 Stat. 2819. 
42 u s e 242b. 
Prohibition. 
"(d) There are authorized to be appropriated to make payments 
under National Research Service Awards and under grants for such 
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; 
"(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 
grants or contracts under section 780, 784, or 786, and (B) are for 
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 
Technology Assessment under section 304(a)(3); and 
"(4) not more than 4 percent may be obligated for National 
Research Service Awards for periods of three months or less. 
Education. 
Disadvantaged 
persons. 
Schools and 
colleges. 
42 u s e 288a. 
VISITING SCIENTIST AWARDS 
"SEC. 488. (a) The Secretary may make awards (hereafter in this 
section referred to as 'Visiting Scientist Awards') to outstanding 
scientists who agree to serve as visiting scientists at institutions of 
postsecondary education which have significant enrollments of dis-
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 
(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 
Report. 
INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM 
"SEC. 491. (a) The Secretary shall by regulation require that each 
entity which applies for a grant, contract, or cooperative agreement 
under this Act for any project or program which involves the 
conduct of biomedical or behavioral research involving human sub-
jects submit in or with its application for such grant, contract, or 
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 
Regulations. 
Grants. 
Contracts. 
Human rights 
42 u s e 289. 
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. 
Regulations. 
42 u s e 289a. 
Grants. 
Contracts. 
Regulations. 
Grants. 
Contracts. 
Ante, p. 820. 
Ante, pp. 823, 
826. 
PEER REVIEW REQUIREMENTS 
"SEC. 492. (a)(1) The Secretary, acting through the Director of 
NIH, shall by regulation require appropriate technical and scientific 
peer review o
f
— 
"(A) applications made for grants and cooperative agreements 
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. 
"(2) Regulations promulgated under paragraph (1) shall require 
that the review of applications made for grants, contracts, and 
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 
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 
under sections 402(b)(6) and 405(c)(3). 
"(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). 
Regulations. 
Grants. 
Contracts. 
42 u s e 289b. 
Report. 
PROTECTION AGAINST SCIENTIFIC FRAUD 
"SEC. 493. (a) The Secretary shall by regulation require that each 
entity which applies for a grant, contract, or cooperative agreement 
under this Act for any project or program which involves the 
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 
"(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 
the Director of NIH, the Commissioner of the Food and Drug 
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 
applications for grants for research on such disease or disorder 
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, 
information on the cause, prevention, and treatment of such 
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 
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. 
Grants. 
Contracts. 
42 u s e 289c. 
Ante, pp. 828, 
874. 
Public 
information. 
Report. 
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 
Reports. 
Grants. 
Contracts. 
Grants. 
Contracts. 
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 
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. 
"(c) The Director of NIH shall require each applicant for a grant, 
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. 
"(d) If the Director of NIH determines that— 
"(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) 
or (c) may require a research entity to disclose publicly trade secrets 
or commercial or financial information which is privileged or 
confidential. 
Prohibition. 
USE OF APPROPRIATIONS UNDER THIS TITLE 
"SEC. 496. Appropriations to carry out the purposes of this title 
shall be available for the acquisition of land or the erection of 
buildings only if so specified. Such appropriations, unless otherwise 
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, 
accept conditional gifts for the National Institutes of Health or a 
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. 
District of 
Columbia. 
42 u s e 289e. 
42 u s e 300aa. 
42 u s e 289f. 
FETAL RESEARCH 
"SEC. 498. (a) The Secretary may not conduct or support any 
research or experimentation, in the United States or in any other 
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 
Prohibition. 
42 u s e 299g. 
99 STAT. 878 
PUBLIC LAW 99-158—NOV. 20, 1985 
Regulations. 
Study. 
42 u s e 275. 
Report. 
Report. 
Prohibition. 
Effective date. 
development of important biomedical knowledge which cannot 
be obtained by other means. 
"(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. 
"(cXD The Biomedical Ethics Advisory Committee appointed 
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 
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 
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. 
"(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 
"(3) Effective October 31,1988, paragraph (2) is repealed. 
42 u s e 289h. 
42 u s e 241. 
National 
Advisory Health 
Council, 
termination. 
42 u s e 218 note. 
98 Stat. 2364. 
CONSTRUCTION OF TITLE 
"SEC. 499. This title shall not be construed as limiting (1) the 
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. 
(a) ADVISORY COUNCILS.—(1) The National Advisory Health Coun-
cil established under section 217 is terminated. 
(2) Section 217(a) (42 U.S.C. 218(a)) is amended— 
(A) in the first sentence— 
(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 
dental diseases and conditions" and inserting in lieu 
thereof "and alcohol abuse and alcoholism"; and 
(C) by striking out the third sentence. 
(3) Subsection (b) of section 217 is repealed and subsections (c) 
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: 
"(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— 
(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 
repealed. 
(c) ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH RESEARCH.— 
Section 506 is amended by adding at the end the following: 
"(e)(1) If the direct cost of a grant, cooperative agreement, or 
contract (described in subsection (a)) to be made does not exceed 
$50,000, the Secretary may make such grant, cooperative agree-
ment, or contract only if such grant, cooperative agreement, or 
contract is recommended after technical and scientific peer review 
required by regulations under subsections (a) and (b). 
Alcohol and 
alcoholic 
beverages. 
42 u s e 218. 
Grants. 
Grants. 
Repeal. 
42 use 
275—280a-l, 
280b—280b-ll. 
42 u s e 290aa-5. 
42 u s e 224. 
Grants. 
Gontracts. 
Regulations. 
99 STAT. 880 
PUBLIC LAW 99-158—NOV. 20, 1985 
Repeal. 
42 u s e 287i 
note. 
42 u s e 289d 
note. 
Establishment. 
Lupus 
Erythematosus 
Coordinating 
Committee. 
42 u s e 281 note. 
"(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.". 
(d) ORPHAN DRUG ACT.—Section 8(w) of the Orphan Drug Act 
(Public Law 97-414) is repealed. 
SEC. 4. PLAN FOR RESEARCH INVOLVING ANIMALS. 
(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). 
(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. 
SEC. 5. RESEARCH ON LUPUS ERYTHEMATOSUS. 
(a) ESTABLISHMENT OF COMMITTEE.—The Secretary shall establish 
a Lupus Erythematosus Coordinating Committee to plan, develop, 
coordinate, and implement comprehensive Federal initiatives in 
research on Lupus Erythematosus. 
(b) COMMITTEE COMPOSITION AND MEETINGS.—(1) The Committee 
shall be composed o
f
— 
(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 
42 u s e 285e 
note. 
Physicians. 
Dentists. 
Medicare. 
42 u s e 281 note. 
Children and 
youth. 
(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. 
SEC. 
8
. 
STUDY 
OF 
PERSONNEL 
FOR 
HEALTH 
NEEDS 
OF 
THE 
ELDERLY. 
(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. 
(h) REPORT.—The Secretary shall report the results of the study to 
the Congress by March 1, 1987. The report on the study shall 
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. 
SEC. 9. INTERAGENCY COMMITTEE ON LEARNING DISABILITIES. 
(a) ESTABLISHMENT.—Not later than 90 days after the date of 
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 
Grants. 
Grants. 
the United States, to train personnel in the collection of such data, 
and for other matters respecting such disease. 
(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. 
(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. 
THOMAS P. O'NEILL, J R . 
Speaker of the House of 
Representatives. 
GEORGE BUSH 
Vice President of the United 
States 
and President of the 
Senate. 
IN T H E H O U S E O F REPRESENTATIVES, U.S., 
November 
12, 1985. 
The House of Representatives having proceeded to reconsider 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): 
June 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 OF 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.