National Institutes of Health Revitalization Act of 1993
PL 103-43 (S.1), enacted 06/10/1993

107 STAT. 122 
PUBLIC LAW 103-43—JUNE 10, 1993 
Public Law 103-43 
103d Congress 
June 10, 1993 
[S.1] 
National 
Institutes of 
Health 
Revitalization 
Act of 1993. 
Science and 
technology. 
42 u s e 201 note. 
An Act 
To amend the Public Health Service Act to revise and extend the programs of 
the National Institutes of Health, 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; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the "National 
Institutes of Health Revitalization Act of 1993". 
(b) TABLE OF CONTENTS.—^The table of contents for this Act 
is as follows: 
Sec. 1. Short title; table of contents. 
TITLE I—GENERAL PROVISIONS REGARDING TITLE IV OF PUBLIC HEALTH 
SERVICE ACT 
Subtitle A—^Research Freedom 
PART I—REVIEW OP PROPOSALS FOR BIOMEDICAL AND BEHAVIORAL RESEARCH 
Sec. 101. Establishment of certain provisions regarding research conducted or sup-
ported by National Institutes of Health. 
PART II—RESEARCH ON TRANSPLANTATION OF FETAL TISSUE 
Sec. 111. Establishment of authorities. 
Sec. 112. Purchase of human fetal tissue; solicitation or acceptance of tissue as di-
rected donation for use in transplantation. 
Sec. 113. Nullification of moratorium. 
Sec. 114. Report by General Accounting Office on adequacy of requirements. 
PART III—MISCELLANEOUS REPEALS 
Sec. 121. Repeals. 
Subtitle B—Clinical Research Equity Regarding Women and Minorities 
PART I—WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH 
Sec. 131. Requirement of inclusion in research. 
Sec. 132. Peer review. 
Sec. 133. Inapplicability to current projects. 
PART II—OFFICE OF RESEARCH ON WOMEN'S HEALTH 
Sec. 141. Establishment. 
PART III—OFFICE OF RESEARCH ON MINORHY HEALTH 
Sec. 151. Establishment. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 123 
Subtitle C—^Research Integrity 
Sec. 161. Establishment of Office of Research Integrity. 
Sec. 162. Commission on Research Integrity. 
Sec. 163. Protection of whistleblowers. 
Sec. 164. Requirement of regulations regarding protection against financial con-
flicts of interest in certain projects of research. 
Sec. 165. Regulations. 
TITLE II—NATIONAL INSTITUTES OF HEALTH IN GENERAL 
Sec. 201. Health promotion research dissemination. 
Sec. 202. Programs for increased support regarding certain States and researchers. 
Sec. 203. Establishment of Office of Behavioral and Social Sciences Research. 
Sec. 204. Children's vaccine initiative. 
Sec. 205. Plan for use of animals in research. 
Sec. 206. Increased participation of women and disadvantaged individuals in fields 
of biomedical and behavioral research. 
Sec. 207. Requirements regarding surveys of sexual behavior. 
Sec. 208. Discretionary fiind of Director of National Institutes of Health. 
Sec. 209. Establishment of Office of Alternative Medicine. 
Sec. 210. Miscellaneous provisions. 
TITLE III—GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH 
INSTITUTES 
Sec. 301. Appointment and authority of Directors of national research institutes. 
Sec. 302. Program of research on osteoporosis, Paget's disease, and related bone 
disorders. 
Sec. 303. Establishment of interagency program for trauma research. 
TITLE IV—NATIONAL CANCER INSTITUTE 
Sec. 401. Expansion and intensification of activities regarding breast cancer. 
Sec. 402. Expansion and intensification of activities regarding prostate cancer. 
Sec. 403. Authorization of appropriations. 
TITLE V—NATIONAL HEART, LUNG, AND BLOOD INSTITUTE 
Sec. 501. Education and training. 
Sec. 502. Centers for the study of pediatric cardiovascular diseases. 
Sec. 503. National Center on Sleep Disorders Research. 
Sec. 504. Authorization of appropriations. 
Sec. 505. Prevention and control programs. 
TITLE VI—NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE AND 
KIDNEY DISEASES 
Sec. 601. Provisions regarding nutritional disorders. 
TITLE VII—NATIONAL INSTITUTE ON ARTHRITIS AND MUSCULOSKELETAL 
AND SKIN DISEASES 
Sec. 701. Juvenile arthritis. 
TITLE VIII—NATIONAL INSTITUTE ON AGING 
Sec. 801. Alzheimer's disease registry. 
Sec. 802. Aging processes regarding women. 
Sec. 803. Authorization of appropriations. 
Sec. 804. Conforming amendment. 
TITLE DC—NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES 
Sec. 901. Tropical diseases. 
Sec. 902. Chronic fatigue syndrome. 
TITLE X—NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN 
DEVELOPMENT 
Subtitle A—Research Centers With Respect to Contraception and Research Centers 
With Respect to Infertility 
Sec. 1001. Grants £ind contracts for research centers. 
Sec. 1002. Loan repayment program for research with respect to contraception and 
infertility. 
Subtitle B—^Program Regarding Obstetrics and Gynecology 
107 STAT. 124 
PUBLIC LAW 103-43—JUNE 10, 1993 
Sec. 1011. Establishment of program. 
Subtitle C—Child Health Research Centers 
Sec. 1021. Establishment of centers. 
Subtitle D—Study Regarding Adolescent Health 
Sec. 1031. Prospective longitudinal study. 
TITLE XI—NATIONAL EYE INSTITUTE 
Sec. 1101. Clinical and health services research on eye care and diabetes. 
TITLE XII—NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND 
STROKE 
Sec. 1201. Research on multiple sclerosis. 
TITLE XIII—NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH 
SCIENCES 
Sec. 1301. Applied Toxicological Research and Testing Program. 
TITLE XIV—NATIONAL LIBRARY OF MEDICINE 
Subtitle A—General Provisions 
Sec. 1401. Additional authorities. 
Sec. 1402. Authorization of appropriations. 
Subtitle B—Financial Assistance 
Sec. 1411. Establishment of program of grants for development of education tech-
nologies. 
Subtitle C—National Information Center on Health Services Research and Health 
Care Technology 
Sec. 1421. Establishment of Center. 
Sec. 1422. Conforming provisions. 
TITLE XV—OTHER AGENCIES OF NATIONAL INSTITUTES OF HEALTH 
Subtitle A—Division of Research Resources 
Sec. 150,1. Redesignation of Division as National Center for Research Resources. 
Sec. 1502. Biomedical and behavioral research facilities. 
Sec. 1503. Construction program for national primate research center. 
Subtitle B—^National Center for Nursing Research 
Sec. 1511. Redesignation of National Center for Nursing Research as National In-
stitute of Nursing Research. 
Sec. 1512. Study on adequacy of number of nurses. 
Subtitle C—^National Center for Human Genome Research 
Sec. 1521. Purpose of Center. 
TITLE XVI—AWARDS AND TRAINING 
Subtitle A—^National Research Service Awards 
Sec. 1601. Requirement regarding women and individuals from disadvantaged 
backgrounds. 
Sec. 1602. Service payback requirements. 
Subtitle B—^Acquired Immune Deficiency Syndrome 
Sec. 1611. Loan repayment program. 
Subtitle C—^Loan Repajrment for Research Generally 
Sec. 1621. Establishment of program. 
Subtitle D—Scholarship and Loan Repayment Programs Regarding Professional 
Skills Needed by Certain Agencies 
Sec. 1631. Establishment of programs for National Institutes of Health. 
Sec. 1632. Funding. 
Subtitle E—^Funding for Awards and Training Generally 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 125 
Sec. 1641. Authorization of appropriations. 
TITLE XVII—NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH 
Sec. 1701. National Foundation for Biomedical Research. 
TITLE XVIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE 
DEFICIENCY SYNDROME 
Subtitle A—Office of AIDS Research 
Sec. 1801. Establishment of Office. 
Sec. 1802. Establishment of emergency discretionary fund. 
Sec. 1803. General provisions. 
Subtitle B—Certain Programs 
Sec. 1811. Revision and extension of certain programs. 
TITLE XDC—STUDIES 
Sec. 1901. Life-threatening illnesses. 
Sec. 1902. Malnutrition in the elderly. 
Sec. 1903. Research activities on chronic fatigue syndrome. 
Sec. 1904. Report on medical uses of biological agents in development of defenses 
against biological warfare. 
Sec. 1905. Personnel study of recruitment, retention and turnover. 
Sec. 1906. Procurement. 
Sec. 1907. Chronic pain conditions. 
Sec. 1908. Relationship between the consumption of legal and illegal drugs. 
Sec. 1909. Reducing administrative health care costs. 
Sec. 1910. Sentinel disease concept study. 
Sec. 1911. Potential environmental and other risks contributing to incidence of 
breast cancer. 
Sec. 1912. Support for bioengineering research. 
Sec. 1913. Cost of care in last 6 months of life. 
TITLE XX—MISCELLANEOUS PROVISIONS 
Sec. 2001. Designation of Senior Biomedical Research Service in honor of Silvio O. 
Conte; limitation on number of members. 
Sec. 2002. Master plan for physical infrastructure for research. 
Sec. 2003. Certain authorization of appropriations. 
Sec. 2004. Buy-American provisions. 
Sec. 2005. Prohibition against further funding for Project Aries. 
Sec. 2006. Loan repayment program. 
Sec. 2007. Exclusion of aliens infected with the agent for acquired immune defi-
ciency S5mdrome. 
Sec. 2008. Technical corrections. 
Sec. 2009. Biennial report on carcinogens. 
Sec. 2010. Transfer of provisions of title XXVII. 
Sec. 2011. Authorization of appropriations. 
Sec. 2012. Vaccine injury compensation program. 
Sec. 2013. Technical corrections with respect to the Agency for Health Care Policy 
and Research. 
Sec. 2014. Technical corrections with respect to the Health Professions Education 
Extension Amendments of 1992. 
Sec. 2015. Prohibitions against SHARP adult sex survey and the American teenage 
sex survey. 
Sec. 2016. Health services research. 
Sec. 2017. Childhood mental health. 
Sec. 2018. Expenditures from certain account. 
TITLE XXI—EFFECTIVE DATES 
Sec. 2101. Effective dates. 
107 STAT. 126 
PUBLIC LAW 103-43—JUNE 10, 1993 
TITLE I—GENERAL PROVISIONS 
RE-
GARBING 
TITLE 
IV 
OF 
PUBLIC 
HEALTH SERVICE ACT 
Subtitle A—^Research Freedom 
PART I—REVIEW OF PROPOSALS FOR 
BIOMEDICAL AND BEHAVIORAL RESEARCH 
SEC. 101. ESTABLISHMENT 
OF CERTAIN PROVISIONS 
REGARDING 
RESEARCH CONDUCTED OR SUPPORTED BY NATIONAL 
INSTITUTES OF HEALTH. 
Part G of title IV of the Public Health Service Act (42 U.S.C. 
289 et seq.) is amended by inserting after section 492 the following 
section: 
"CERTAIN PROVISIONS REGARDING REVIEW AND APPROVAL OF 
PROPOSALS FOR RESEARCH 
42 use 289a-l. 
"SEC. 492A. (a) REVIEW AS PRECONDITION TO RESEARCH.— 
"(1) PROTECTION OF HUMAN RESEARCH SUBJECTS.— 
"(A) In the case of any application submitted to the 
Secretary for financial assistance to conduct research, the 
Secretary may not approve or fund any application that 
is subject to review under section 491(a) by an Institutional 
Review Board unless the application has undergone review 
in accordance with such section and has been recommended 
for approval by a majority of the members of the Board 
conducting such review. 
"(B) In the case of research that is subject to review 
under procedures established by the Secretary for the 
protection of human subjects in clinical research conducted 
by the National Institutes of Health, the Secretary may 
not authorize the conduct of the research unless the 
research has, pursuant to such procedures, been rec-
ommended for approval. 
"(2) PEER REVIEW.—In the case of any proposal for the 
National Institutes of Health to conduct or support research, 
the Secretary may not approve or fund any proposal that is 
subject to technical and scientific peer review under section 
492 unless the proposal has undergone such review in accord-
ance with such section and has been recommended for approval 
by a majority of the members of the entity conducting such 
review. 
"(b) ETHICAL REVIEW OF RESEARCH.— 
"(1) PROCEDURES REGARDING WITHHOLDING OF FUNDS.—If 
research has been recommended for approval for purposes of 
subsection (a), the Secretary may not withhold funds for the 
research because of ethical considerations luiless— 
"(A) the Secretary convenes an advisory board in 
accordance with paragraph (5) to study such considerations; 
and 
"(B)(i) the majority of the advisory board recommends 
that, because of such considerations, the Secretary withhold 
funds for the research; or 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 127 
"(ii) the majority of such board recommends that the 
Secretary not withhold funds for the research because of 
such considerations, but the Secretary finds, on the basis 
of the report submitted under paragraph (5)(B)(ii), that 
the recommendation is arbitrary and capricious. 
"(2) RULES OF CONSTRUCTION.—Paragraph (1) may not be 
construed as prohibiting the Secretary from withholding funds 
for research on the basis of— 
"(A) the inadequacy of the qualifications of the entities 
that would be involved with the conduct of the research 
(including the entity that would directly receive the funds 
from the Secretary), subject to the condition that, with 
respect to the process of review through which the research 
was recommended for approval for purposes of subsection 
(a), all findings regarding such qualifications made in such 
process are conclusive; or 
"(B) the priorities established by the Secretary for the 
allocation of funds among projects of research that have 
been so recommended. 
"(3) APPLICABILITY.—The limitation established in para-
graph (1) regarding the authority to withhold funds because 
of ethical considerations shall apply without regard to whether 
the withholding of funds on such basis is characterized as 
a disapproval, a moratorium, a prohibition, or other character-
ization. 
"(4) 
PRELIMINARY MATTERS REGARDING USE OF PROCE-
DURES.— 
"(A) If the Secretary makes a determination that an 
advisory board should be convened for purposes of para-
graph (1), the Secretary shall, through a statement pub-
lished in the Federal Register, announce the intention of 
the Secretary to convene such a board. 
"(B) A statement issued under subparagraph (A) shall 
include a request that interested individuals submit to 
the Secretary recommendations specif3dng the particular 
individuals who should be appointed to the advisory board 
involved. The Secretary shall consider such recommenda-
tions in making appointments to the board. 
"(C) The Secretary may not make appointments to 
an advisory board under paragraph (1) until the expiration 
of the 30-day period beginning on the date on which the 
statement required in subparagraph (A) is made with 
respect to the board. 
"(5) ETHICS ADVISORY BOARDS.— 
"(A) Any advisory board convened for purposes of para-
graph (1) shall be known as an ethics advisory board (in 
this paragraph referred to as an 'ethics board'). 
"(B)(i) An ethics board shall advise, consult with, and 
make recommendations to the Secretary regarding the eth-
ics of the project of biomedical or behavioral research with 
respect to which the board has been convened. 
"(ii) Not later than 180 days after the date on which Reports. 
the statement required in paragraph (4)(A) is made with 
respect to an ethics board, the board shall submit to the 
Secretary, and to the Committee on Energy and Commerce 
of the House of Representatives and the Committee on 
Labor and Human Resources of the Senate, a report 
Federal 
Register, 
publication. 
107 STAT. 128 
PUBLIC LAW 103-43—JUNE 10, 1993 
Termination 
date. 
describing the findings of the board regarding the project 
of research involved and making a recommendation under 
clause (i) of whether the Secretary should or should not 
withhold fiinds for the project. The report shall include 
the information considered in making the findings. 
"(C) An ethics board shall be composed of no fewer 
than 14, and no more than 20, individuals who are not 
officers or employees of the United States. The Secretary 
shall make appointments to the board from among individ-
uals with special qualifications and competence to provide 
advice and recommendations regarding ethical matters in 
biomedical and behavioral research. Of the members of 
the board— 
"(i) no fewer than 1 shall be an attorney; 
"(ii) no fewer than 1 shall be an ethicist; 
"(iii) no fewer than 1 shall be a practicing physi-
cian; 
"(iv) no fewer than 1 shall be a theologian; and 
"(v) no fewer than one-third, and no more than 
one-half, shall be scientists with substantial accom-
plishments in biomedical or behavioral research. 
"(D) The term of service as a member of an ethics 
board shall be for the life of the board. If such a member 
does not serve the full term of such service, the individual 
appointed to fill the resulting vacancy shall be appointed 
for the remainder of the term of the predecessor of the 
individual. 
"(E) A member of an ethics board shall be subject 
to removal from the board by the Secretary for neglect 
of duty or malfeasance or for other good cause shown. 
"(F) The Secretary shall designate an individual from 
among the members of an ethics board to serve as the 
chair of the board. 
"(G) In carrying out subparagraph (B)(i) with respect 
to a project of research, an ethics board shall conduct 
inquiries and hold public hearings. 
"(H) In canying out subparagraph (B)(i) with respect 
to a project of research, an ethics board shall have access 
to all relevant information possessed by the Department 
of Health and Human Services, or available to the Sec-
retary from other agencies. 
"(I) Members of an ethics board shall receive compensa-
tion for each day engaged in carrying out the duties of 
the board, including time engaged in traveling for purposes 
of such duties. Such compensation may not be provided 
in an amount in excess of the maximum rate of basic 
pay payable for GS-18 of the General Schedule. 
"(J) The Secretary, acting through the Director of the 
National Institutes of Health, shall provide to each ethics 
board reasonable staff and assistance to carry out the 
duties of the board. 
"(K) An ethics board shall terminate 30 days after 
the date on which the report required in subparagraph 
(B)(ii) is submitted to the Secretary and the congressional 
committees specified in such subparagraph. 
"(6) DEFINITION.—For purposes of this subsection, the term 
'ethicEil considerations' means considerations as to whether the 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 129 
nature of the research involved is such that it is unethical 
to conduct or support the research.". 
PART II—RESEARCH ON TRANSPLANTATION 
A
b
o
r
t
i
o
n 
OF FETAL TISSUE 
women 
SEC. 111. ESTABLISHMENT OF AUTHORITIES. 
Part G of title IV of the PubUc Health Service Act (42 U.S.C. 
289 et seq.) is amended by inserting after section 498 the following 
section: 
"RESEARCH ON TRANSPLANTATION OF PETAL TISSUE 
"SEC. 498A. (a) ESTABLISHMENT OF PROGRAM.— 
42 use 289g-i. 
"(1) IN GENERAL.—The Secretary may conduct or support 
research on the transplantation of human fetal tissue for thera-
peutic purposes. 
"(2) SOURCE OF TISSUE.—Human fetal tissue may be used 
in research carried out imder peiragraph (1) regardless of 
whether the tissue is obtained pursuant to a spontaneous or 
induced abortion or pursuant to a stillbirth. 
"(b) INFORMED CONSENT OF DONOR.— 
"(1) IN GENERAL.—In research carried out under subsection 
(a), human fetal tissue may be used only if the woman providing 
the tissue makes a statement, made in writing and signed 
by the woman, declaring that— 
"(A) the woman donates the fetal tissue for use in 
research described in subsection (a); 
"(B) the donation is made without any restriction 
regarding the identity of individuals who may be the recipi-
ents of transplantations of the tissue; and 
"(C) the woman has not been informed of the identity 
of any such individuals. 
"(2) ADDITIONAL STATEMENT.—In research carried 
out 
under subsection (a), human fetal tissue may be used only 
if the attending physician with respect to obtaining the tissue 
from the woman involved makes a statement, made in writing 
and signed by the physician, declaring that— 
"(A) in the case of tissue obtained pursuant to an 
induced abortion— 
"(i) the consent of the woman for the abortion 
was obtained prior to requesting or obtaining consent 
for a donation of the tissue for use in such research; 
"(ii) no alteration of the timing, method, or proce-
dures used to terminate the pregnancy was made solely 
for the purposes of obtaining the tissue; and 
"(iii) the abortion was performed in accordance 
with applicable State law; 
"(B) the tissue has been donated by the woman in 
accordance with paragraph (1); and 
"(C) full disclosure has been provided to the woman 
with regard to— 
"(i) such physician's interest, if any, in the research 
to be conducted with the tissue; and 
"(ii) any known medical risks to the woman or 
risks to her privacy that might be associated with 
the donation of the tissue and that are in addition 
107 STAT. 130 
PUBLIC LAW 103-43—JUNE 10, 1993 
to risks of such type that are associated with the 
woman's medical care. 
"(c) 
INFORMED CONSENT OF RESEARCHER AND DONEE.—In 
research carried out imder subsection (a), human fetal tissue may 
be used only if the individual with the principal responsibility 
for conducting the research involved makes a statement, made 
in writing and signed by the individual, declaring that the 
individual— 
"(1) is aware that— 
"(A) the tissue is human fetal tissue; 
"(B) the tissue may have been obtained pursuant to 
a spontaneous or induced abortion or pursuant to a still-
birth; and 
"(C) the tissue was donated for research purposes; 
"(2) has provided such information to other individuals 
with responsibilities regarding the research; 
"(3) will require, prior to obtaining the consent of an 
individual to be a recipient of a transplantation of the tissue, 
written acknowledgment of receipt of such information by such 
recipient; and 
"(4) has had no part in any decisions as to the timing, 
method, or procedures used to terminate the pregnancy made 
solely for the purposes of the research. 
"(d) AVAILABILITY OF STATEMENTS FOR AUDIT.— 
"(1) IN GENERAL.—In research carried out under subsection 
(a), human fetal tissue may be used only if the head of the 
agency or other entity conducting the research involved certifies 
to the Secretary that the statements required under subsections 
(b)(2) and (c) will be available for audit by the Secretary. 
"(2) CONFIDENTIALITY OF AUDIT.—Any audit conducted by 
the Secretary pursuant to paragraph (1) shall be conducted 
in a confidential manner to protect the privacy rights of the 
individuals and entities involved in such research, including 
such individuals and entities involved in the donation, transfer, 
receipt, or transplantation of human fetal tissue. With respect 
to any material or information obtained pursuant to such audit, 
the Secretary shall— 
"(A) use such material or information only for the 
purposes of verifying compliance with the requirements 
of this section; 
"(B) not disclose or publish such material or informa-
tion, except where required by Federal law, in which case 
such material or information shall be coded in a manner 
such that the identities of such individuals and entities 
are protected; and 
"(C) not maintain such material or information after 
completion of such audit, except where necessary for the 
purposes of such audit. 
"(e) APPLICABILITY OF STATE AND LOCAL LAW.— 
"(1) RESEARCH CONDUCTED BY RECIPIENTS OF ASSISTANCE,— 
The Secretary may not provide support for reseeirch under 
subsection (a) luiless the applicsint for the financial assistance 
involved agrees to conduct the research in accordance with 
applicable State law. 
"(2) RESEARCH CONDUCTED BY SECRETARY.—The Secretary 
may conduct research under subsection (a) only in accordance 
with applicable State and local law. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 131 
"(f) REPORT.—^The Secretary shall annually submit to the 
Committee on Energy and Commerce of the House of Representa-
tives, and to the Committee on Labor and Human Resources of 
the Senate, a report describing the activities carried out under 
this section during the preceding fiscal year, including a description 
of whether and to what extent research under subsection (a) has 
been conducted in accordance with this section. 
"(g) DEFINITION,—For purposes of this section, the term Tiuman 
fetal tissue' means tissue or cells obtained from a dead humsm. 
embiyo or fetus after a spontaneous or induced abortion, or after 
a stillbirth.". 
SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITATION OR 
ACCEPTANCE OF TISSUE AS DIRECTED DONATION FOR 
USE IN TRANSPLANTATION. 
Part G of title IV of the Public Health Service Act, as amended 
by section 111 of this Act, is amended by inserting after section 
498A the following section: 
"PROHIBITIONS REGARDING HUMAN FETAL TISSUE 
"SEC. 498B. (a) PURCHASE OF TISSUE.—It shall be unlawfiil 
42usc289g-2. 
for any person to knowingly acquire, receive, or otherwise transfer 
aiw human fetal tissue for valuable consideration if the transfer 
affects interstate commerce. 
"(b) 
SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED 
DONATION FOR USE IN TRANSPLANTATION.—It shall be Unlawful 
for any person to solicit or knowingly acquire, receive, or accept 
a donation of human fetal tissue for the purpose of transplantation 
of such tissue into smother person if the donation affects interstate 
commerce, the tissue will be or is obtained pursuant to an induced 
abortion, and— 
"(1) the donation will be or is made pursuant to a promise 
to the donating individual that the donated tissue will be 
transplginted into a recipient specified by such individual; 
"(2) the donated tissue will be transplanted into a relative 
of the donating individual; or 
"(3) the person who solicits or knowingly acquires, receives, 
or accepts the donation has provided valuable consideration 
for the costs associated with such abortion. 
"(c) CRIMINAL PENALTIES FOR VIOLATIONS.— 
"(1) IN GENERAL.—^Any person who violates subsection (a) 
or (b) shall be fined in accordance with title 18, United States 
Code, subject to paragraph (2), or imprisoned for not more 
than 10 years, or both. 
"(2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSID-
ERATION.—^With respect to the imposition of a fine under para-
graph (1), if the person involved violates subsection (a) or 
(b)(3), a fine shall be imposed in an amount not less than 
twice the amount of the valuable consideration received, 
"(d) DEFINITIONS.—For purposes of this section: 
"(1) The term liuman fetal tissue' has the meaning given 
such term in section 498A(f). 
"(2) The term 'interstate commerce' has the meaning given 
such term in section 201(b) of the Federal Food, Drug, and 
Cosmetic Act. 
"(3) The term Valuable consideration' does not include 
reasonable pa5anents associated with the 
transportation. 
107 STAT. 132 
PUBLIC LAW 103-43—JUNE 10, 1993 
implantation, processing, preservation, quality control, or stor-
age of human fetal tissue.". 
42 use 289g-l 
SEC. 113. NULLIFICATION OF MORATORIUM. 
"° ^' 
(a) IN GENERAL.—Except as provided in subsection (c), no offi-
cial of the executive branch may impose a policy that the Depart-
ment of Health and Human Services is prohibited from conducting 
or supporting any research on the transplantation of human fetal 
tissue for therapeutic purposes. Such research shall be carried 
out in accordance with section 498A of the Public Health Service 
Act (as added by section 111 of this Act), without regard to any 
such policy that may have been in effect prior to the date of 
the enactment of this Act. 
(b) PROHIBITION AGAINST WITHHOLDING OF FUNDS IN CASES 
OF TECHNICAL AND SCIENTIFIC MERIT.— 
(1) IN GENERAL.—Subject to subsection (b)(2) of section 
492A of the Public Health Service Act (as added by section 
101 of this Act), in the case of any proposal for research on 
the transplantation of human fetal tissue for therapeutic pur-
poses, the Secretary of Health and Human Services may not 
withhold funds for the research if— 
(A) the research has been approved for purposes of 
subsection (a) of such section 492A; 
(B) the research will be carried out in accordance with 
section 498A of such Act (as added by section 111 of this 
Act); and 
(C) there are reasonable assurances that the research 
will not utilize any human fetal tissue that has been 
obtained in violation of section 498B(a) of such Act (as 
added by section 112 of this Act). 
(2) STANDING APPROVAL REGARDING ETHICAL STATUS.—In 
the case of any proposal for research on the transplantation 
of human fetal tissue for therapeutic purposes, the issuance 
in December 1988 of the Report of the Human Fetal Tissue 
Transplantation Research Panel shall be deemed to be a 
report— 
(A) issued by an ethics advisory board pursuant to 
section 492A(b)(5)(B)(ii) of the PubUc Health Service Act 
(as added by section 101 of this Act); and 
(B) finding, on a basis that is neither arbitrary nor 
capricious, that the nature of the research is such that 
it is not unethical to conduct or support the research. 
(c) AUTHORITY FOR WITHHOLDING FUNDS FROM RESEARCH.— 
In the case of any research on the transplantation of human fetal 
tissue for therapeutic purposes, the Secretary of Health and Human 
Services may withhold fimds for the research if any of the conditions 
specified in any of subparagraphs (A) through (C) of subsection 
(b)(1) are not met with respect to the research. 
(d) DEFINITION.—For purposes of this section, the term "human 
fetal tissue" has the meaning given such term in section 498A(f) 
of the Public Health Service Act (as added by section 111 of this 
Act). 
42 use 289g-l 
SEC. 114. REPORT BY GENERAL ACCOUNTING OFFICE ON ADEQUACY 
note 
OF REQUIREMENTS. 
(a) IN GENERAL.—^With respect to research on the transplan-
tation of human fetal tissue for therapeutic purposes, the Comptrol-
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 133 
ler General of the United States shall conduct an audit for the 
purpose of determining— 
(1) whether and to what extent such research conducted 
or supported by the Secretary of Health and Human Services 
has been conducted in accordance with section 498A of the 
Public Health Service Act (as added by section 111 of this 
Act); and 
(2) whether and to what extent there have been violations 
of section 498B of such Act (as added by section 112 of this 
Act). 
(b) REPORT.—Not later than May 19, 1995, the Comptroller 
General of the United States shall complete the audit required 
in subsection (a) and submit to the Committee on Energy and 
Commerce of the House of Representatives, and to the Committee 
on Labor and Human Resources of the Senate, a report describing 
the findings made pursuant to the audit. 
PART III—MISCELLANEOUS REPEALS 
SEC. 121. REPEALS. 
(a) CERTAIN BIOMEDICAL ETHICS BOARD.—Title III of the PubHc 
Health Service Act (42 U.S.C. 241 et seq.) is amended by striking 
part J. 
42 use 275. 
(b) OTHER REPEALS.—Part G of title IV of the Pubhc Health 
Service Act (42 U.S.C. 289 et seq.) is amended— 
(1) in section 498, by striking subsection (c); and 
42 USC 289g. 
(2) by striking section 499; and 
42 USC 289h. 
(3) by redesignating section 499A as section 499. 
42 use 290b. 
(c) NULLIFICATION OF CERTAIN PROVISIONS.—The provisions of 42 use 289g 
Executive Order 12806 (57 Fed. Reg. 21589 (May 21, 1992)) shall "°te. 
not have any legal effect. The provisions of section 204(d) of part 
46 of title 45 of the Code of Federal Regulations (45 CFR 46.204(d)) 
shall not have any legal effect. 
Subtitle B—Clinical Research Equity 
Regarding Women and Minorities 
PART I—WOMEN AND MINORITIES AS 
SUBJECTS IN CLINICAL RESEARCH 
SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH. 
Part G of title IV of the Public Health Service Act, as amended 
by section 101 of this Act, is amended by inserting after section 
492A the following section: 
"INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH 
"SEC. 492B. (a) REQUIREMENT OF INCLUSION.— 
42 use 289a-2. 
"(1) IN GENERAL.—In conducting or supporting clinical 
research for purposes of this title, the Director of NIH shall, 
subject to subsection (b), ensure that— 
"(A) women are included as subjects in each project 
of such research; and 
"(B) members of minority groups are included as sub-
jects in such research. 
107 STAT. 134 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(2) OUTREACH REGARDING PARTICIPATION AS SUBJECTS.— 
The Director of NIH, in consultation with the Director of the 
Office of Research on Women's Health and the Director of 
the Office of Research on Minority Health, shall conduct or 
support outreach programs for the recruitment of women and 
members of minority groups as subjects in projects of clinical 
research. 
"(b) 
INAPPLICABILITY OF 
REQUIREMENT.—The 
requirement 
established in subsection (a) regarding women and members of 
minority groups shall not apply to a project of clinical research 
if the inclusion, as subjects in the project, of women and members 
of minority groups, respectively— 
"(1) is inappropriate with respect to the health of the 
subjects; 
"(2) is inappropriate with respect to the purpose of the 
research; or 
"(3) is inappropriate under such other circumstances as 
the Director of NIH may designate. 
"(c) DESIGN OF CLINICAL TRIALS.—In the case of any clinical 
trial in which women or members of minority groups will imder 
subsection (a) be included as subjects, the Director of NIH shall 
ensure that the trial is designed and carried out in a manner 
sufficient to provide for a valid analysis of whether the variables 
being studied in the trial affect women or members of minority 
groups, as the case may be, differently than other subjects in 
the trial. 
"(d) GUIDELINES.— 
"(1) IN GENERAL.—Subject to paragraph (2), the Director 
of NIH, in consultation with the Director of the Office of 
Research on Women's Health and the Director of the Office 
of Research on Minority Health, shall establish guidelines 
regarding the requirements of this section. The guidelines shall 
include guidelines regarding— 
"(A) the circumstances under which the inclusion of 
women and minorities as subjects in projects of clinical 
research is inappropriate for purposes of subsection (b); 
"(B) the manner in which clinical trials are required 
to be designed and carried out for purposes of subsection 
(c); and 
"(C) the operation of outreach programs tmder sub-
section (a). 
"(2) 
CERTAIN 
PROVISIONS.—With respect 
to the 
cir-
cumstances imder which the inclusion of women or members 
of minority groups (as the case may be) as subjects in a project 
of clinical research is inappropriate for purposes of subsection 
(b), the following applies to guidelines imder paragraph (1): 
"(A)(i) In the case of a clinical trial, the guidelines 
shall provide that the costs of such inclusion in the trial 
is not a permissible consideration in determining whether 
such inclusion is inappropriate. 
"(ii) In the case of other projects of clinical research, 
the guidelines shall provide that the costs of such inclusion 
in the project is not a permissible consideration in deter-
mining whether such inclusion is inappropriate unless the 
data regarding women or members of minority groups, 
respectively, that would be obtained in such project (in 
the event that such inclusion were required) have been 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 135 
or are being obtained through other means that provide 
data of comparable quality. 
"(B) In the case of a clinical trial, the guidelines may 
provide that such inclusion in the trial is not required 
if there is substantial scientific data demonstrating that 
there is no significant difference between— 
"(i) the effects that the variables to be studied 
in the trial have on women or members of minority 
groups, respectively; and 
"(ii) the effects that the variables have on the 
individuals who would serve as subjects in the trial 
in the event that such inclusion were not required. 
"(e) DATE CERTAIN FOR GUIDELINES; APPLICABILITY.— 
"(1) DATE CERTAIN.—The guidelines required in subsection 
Federal 
(d) shall be established and published in the Federal Register ^ubiication 
not later than 180 days after the date of the enactment of ^" 
the National Institutes of Health Revitalization Act of 1993. 
"(2) APPLICABILITY.—For fiscal year 1995 and subsequent 
fiscal years, the Director of NIH may not approve any proposal 
of clinical research to be conducted or supported by any agency 
of the National Institutes of Health unless the proposal specifies 
the manner in which the research will comply with this section. 
"(f) REPORTS BY ADVISORY COUNCILS.—The advisory council 
of each national research institute shall prepare biennial reports 
describing the msmner in which the institute has complied with 
this section. Each such report shall be submitted to the Director 
of the institute involved for inclusion in the biennial report under 
section 403. 
"(g) DEFINITIONS.—For purposes of this section: 
"(1) The term 'project of clinical research' includes a clinical 
trial. 
"(2) The term 'minority group' includes subpopulations of 
minority groups. The Director of NIH shall, through the guide-
lines established under subsection (d), define the terms 'minor-
ity group' and 'subpopulation' for purposes of the preceding 
sentence.". 
SEC. 132. PEER REVIEW. 
Section 492 of the Pubhc Health Service Act (42 U.S.C. 289a) 
is amended by adding at the end the following subsection: 
"(c)(1) In technical and scientific peer review under this section 
of proposals for clinical research, the consideration of any such 
proposal (including the initial consideration) shall, except as pro-
vided in paragraph (2), include an evaluation of the technical and 
scientific merit of the proposal regarding compliance with section 
492B. 
"(2) Paragraph (1) shall not apply to any proposal for clinical 
research that, pursuant to subsection (b) of section 492B, is not 
subject to the requirement of subsection (a) of such section regarding 
the inclusion of women and members of minority groups as subjects 
in clinical research.". 
SEC. 133. INAPPLICABILITY TO CURRENT PROJECTS. 
42 USC 289a-2 
Section 492B of the Public Health Service Act, as added by 
section 131 of this Act, shall not apply with respect to projects 
of clinical research for which initial funding was provided prior 
to the date of the enactment of this Act. With respect to the 
inclusion of women and minorities as subjects in clinical research 
69-194 O - 94 - 6 : QL. 3 Part 1 
107 STAT. 136 
PUBLIC LAW 103-43—JUNE 10, 1993 
conducted or supported by the National Institutes of Health, any 
policies of the Secretary of Health and Human Services regarding 
such inclusion that are in effect on the day before the date of 
the enactment of this Act shall continue to apply to the projects 
referred to in the preceding sentence. 
PART II—OFFICE OF RESEARCH ON WOMEN'S 
HEALTH 
SEC. 141. ESTABLISHMENT. 
(a) IN GENERAL.—Title IV of the Pubhc Health Service Act, 
as amended by the preceding provisions of this title, is amended— 
42 use 287C-3. 
(1) by redesignating section 486 as section 485A; 
42 usc^ 
(2) by redesignating parts F through H as parts G through 
I, respectively; and 
(3) by inserting after part E the following part: 
288-290b. 
"PART F—RESEARCH ON WOMEN'S HEALTH 
42 u s e 287d. 
"SEC. 486. OFFICE OF RESEARCH ON WOMEN'S HEALTH. 
"(a) ESTABLISHMENT.—There is established within the Office 
of the Director of NIH an office to be known as the Office of 
Research on Women's Health (in this part referred to as the 'Office'). 
The Office shall be headed by a director, who shall be appointed 
by the Director of NIH. 
"(b) PURPOSE.—The Director of the Office shall— 
"(1) identify projects of research on women's health that 
should be conducted or supported by the national research 
institutes; 
"(2) identify multidisciplinary research relating to research 
on women's health that should be so conducted or supported; 
"(3) carry out paragraphs (1) and (2) with respect to the 
aging process in women, with priority given to menopause; 
"(4) promote coordination and collaboration among entities 
conducting research identified under any of paragraphs (1) 
through (3); 
"(5) encourage the conduct of such research by entities 
receiving funds from the national research institutes; 
"(6) recommend an agenda for conducting and supporting 
such research; 
"(7) promote the sufficient allocation of the resources of 
the national research institutes for conducting and supporting 
such research; 
"(8) assist in the administration of section 492B with 
respect to the inclusion of women as subjects in clinical 
research; and 
"(9) prepare the report required in section 486B. 
"(c) COORDINATING COMMITTEE.— 
"(1) In carrying out subsection (b), the Director of the 
Office shall establish a committee to be known as the Coordinat-
ing Committee on Research on Women's Health (in this sub-
section referred to as the 'Coordinating Committee'). 
"(2) The Coordinating Committee shall be composed of the 
Directors of the national research institutes (or the designees 
of the Directors). 
"(3) The Director of the Office shall serve as the chair 
of the Coordinating Committee. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 137 
"(4) With respect to research on women's health, the Coordi-
nating Committee shall assist the Director of the Office in— 
"(A) identifying the need for such research, and making 
an estimate each fiscal year of the funds needed to ade-
quately support the research; 
"(B) identifying needs regarding the coordination of 
research activities, including intramural and extramural 
multidisciplinary activities; 
"(C) supporting the development of methodologies to 
determine the circumstances in which obtaining data spe-
cific to women (including data relating to the age of women 
and the membership of women in ethnic or racial groups) 
is an appropriate function of clinical trials of treatments 
and therapies; 
"(D) supporting the development and expansion of clini-
cal trials of treatments and therapies for which obtaining 
such data has been determined to be an appropriate func-
tion; and 
"(E) encouraging the national research institutes to 
conduct and support such research, including such clinical 
trials. 
"(d) ADVISORY COMMITTEE.— 
"(1) In carrying out subsection (b), the Director of the 
Office shall establish an advisory committee to be known as 
the Advisory Committee on Research on Women's Health (in 
this subsection referred to as the 'Advisory Committee'). 
"(2) The Advisory Committee shall be composed of no fewer 
than 12, £ind not more than 18 individuals, who are not officers 
or employees of the Federal Government. The Director of the 
Office shall make appointments to the Advisory Committee 
from among physicians, practitioners, scientists, and other 
health professionals, whose clinical practice, research speciali-
zation, or professional expertise includes a significant focus 
on research on women's health. A majority of the members 
of the Advisory Committee shall be women. 
"(3) The Director of the Office shall serve as the chair 
of the Advisory Committee. 
"(4) The Advisory Committee shall— 
"(A) advise the Director of the Office on appropriate 
research activities to be undertaken by the national 
research institutes with respect to— 
"(i) research on women's health; 
"(ii) research on gender differences in clinical drug 
trials, including responses to pharmacological drugs; 
"(iii) research on gender differences in disease 
etiology, course, and treatment; 
"(iv) research on obstetrical and gynecological 
health conditions, diseases, and treatments; and 
"(v) research on women's health conditions which 
require a multidisciplinary approach; 
"(B) report to the Director of the Office on such 
research; 
"(C) provide recommendations to such Director regard-
ing activities of the Office (including recommendations on 
the development of the methodologies described in sub-
section (c)(4)(C) and recommendations on priorities in 
canying out research described in subparagraph (A)); and 
107 STAT. 138 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(D) assist in monitoring compliance with section 492B 
regarding the inclusion of women in clinical research. 
Reports. 
"(5)(A) 'Hie Advisory Committee shall prepare a biennial 
report describing the activities of the Committee, including 
findings made by the Committee regarding— 
"(i) compliance with section 492B; 
"(ii) the extent of expenditures made for research on 
women's health by the agencies of the National Institutes 
of Health; and 
"(iii) the level of funding needed for such research. 
"(B) The report required in subparagraph (A) shall be 
submitted to the Director of NIH for inclusion in the report 
required in section 403. 
"(e) REPRESENTATION OF WOMEN AMONG RESEARCHERS.—The 
Secretary, acting through the Assistant Secretary for Personnel 
and in collaboration with the Director of the Office, shall determine 
the extent to which women are represented among senior physicians 
and scientists of the national research institutes and among physi-
cians and scientists conducting research with funds provided by 
such institutes, and as appropriate, carry out activities to increase 
the extent of such representation. 
"(f) DEFINITIONS.—For purposes of this part: 
"(1) The term 'women's health conditions', with respect 
to women of all age, ethnic, and racial groups, means all dis-
eases, disorders, and conditions (including with respect to men-
tal health)— 
"(A) unique to, more serious, or more prevalent in 
women; 
"(B) for which the factors of medical risk or t3rpes 
of medical intervention are different for women, or for 
which it is unknown whether such factors or types are 
different for women; or 
"(C) with respect to which there has been insufficient 
clinical research involving women as subjects or insufficient 
clinical data on women. 
"(2) The term 'research on women's health' means research 
on women's health conditions, including research on preventing 
such conditions. 
42USC287d-l. 
"SEC. 486A. NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON 
RESEARCH ON WOMEN'S HEALTH. 
"(a) DATA SYSTEM.— 
"(1) The Director of NIH, in consultation with the Director 
of the Office and the Director of the National Library of Medi-
cine, shgJl establish a data system for the collection, storage, 
analysis, retrieval, and dissemination of information regarding 
research on women's health that is conducted or supported 
Public 
by the national research institutes. Information from the data 
information. 
System shall be available through information systems available 
to health care professionals and providers, researchers, and 
members of the public. 
"(2) The data system established under paragraph (1) shall 
include a registry of clinical trials of experimental treatments 
that have been developed for research on women's health. Such 
registry shall include information on subject eligibility criteria, 
sex, age, ethnicity or race, and the location of the trial site 
or sites. Principal investigators of such clinical trials shall 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 139 
provide this information to the registry within 30 days after 
it is available. Once a trial has been completed, the principal 
investigator shall provide the registry with information pertain-
ing to the results, including potential toxicities or adverse 
effects associated with the experimental treatment or treat-
ments evaluated. 
"(b) CLEARINGHOUSE.—The Director of NIH, in consultation 
with the Director of the Office and with the National Library 
of Medicine, shall establish, maintain, and operate a program to 
provide information on research and prevention activities of the 
national research institutes that relate to research on women's 
health. 
"SEC. 486B. BIENNIAL REPORT. 
42 USC 287d-2. 
"(a) IN GENERAL.—^With respect to research on women's health, 
the Director of the Office shall, not later than February 1, 1994, 
and biennially thereafter, prepare a report— 
"(1) describing and evaluating the progress made during 
the preceding 2 fiscal years in research and treatment con-
ducted or supported by the National Institutes of Health; 
"(2) describing and analyzing the professional status of 
women physicians and scientists of such Institutes, including 
the identification of problems and barriers reg£irding advance-
ments; 
"(3) summarizing and analyzing expenditures made by the 
agencies of such Institutes (and by such Office) during the 
preceding 2 fiscal years; and 
"(4) making such recommendations for legislative and 
administrative initiatives as the Director of the Office deter-
mines to be appropriate. 
"(b) INCLUSION IN BIENNIAL REPORT OF DIRECTOR OF NIH.— 
The Director of the Office shall submit each report prepared under 
subsection (a) to the Director of NIH for inclusion in the report 
submitted to the President and the Congress under section 403.". 
(b) REQUIREMENT OF SUFFICIENT ALLOCATION OF RESOURCES 
OF INSTITUTES.—Section 402(b) of the Public Health Service Act 
(42 U.S.C. 282(b)) is amended— 
(1) in paragraph (10), by striking "and" after the semicolon 
at the end; 
(2) in paragraph (11), by striking the period at the end 
and inserting "; and"; and 
(3) by inserting after paragraph (11) the following para-
graph: 
"(12) £ifter consultation with the Director of the Office 
of Research on Women's Health, shall ensure that resources 
of the National Institutes of Health are sufficiently allocated 
for projects of research on women's health that are identified 
luider section 486(b).". 
PART 
III—OFFICE 
OF 
RESEARCH 
ON 
MINORITY 
HEALTH 
SEC. 151. ESTABLISHMENT. 
Part A of title IV of the PubUc Health Service Act (42 U.S.C. 
281 et seq.) is amended by adding at the end the following section: 
107 STAT. 140 
PUBLIC LAW 103-43—JUNE 10, 1993 
"OFFICE OF RESEARCH ON MINORITY HEALTH 
42 use 283b. 
"SEC. 404. (a) ESTABLISHMENT.—There is established within 
the Office of the Director of NIH an office to be known as the 
Office of Research on Minority Health (in this section referred 
to as the 'Office'). The Office shall be headed by a director, who 
shall be appointed by the Director of NIH. 
"(b) PURPOSE.—The Director of the Office shall— 
"(1) identify projects of resc^arch on minority health that 
should be conducted or supported by the national research 
institutes; 
"(2) identify multidisciplinary research relating to research 
on minority health that should be so conducted or supported; 
"(3) promote coordination and collaboration among entities 
conducting research identified under paragraph (1) or (2); 
"(4) encourage the conduct of such research by entities 
receiving funds from the national research institutes; 
"(5) recommend an agenda for conducting and supporting 
such research; 
"(6) promote the sufficient allocation of the resources of 
the national research institutes for conducting and supporting 
such research; and 
"(7) assist in the administration of section 492B with 
respect to the inclusion of members of minority groups as 
subjects in clinical research.". 
Subtitle C—^Research Integrity 
SEC. 161. ESTABLISHMENT OF OFFICE OF RESEARCH INTEGRITY. 
Section 493 of the Public Health Service Act (42 U.S.C. 289b) 
is amended to read as follows: 
"OFFICE OF RESEARCH INTEGRITY 
Regulations. 
"SEC. 493. (a) IN GENERAL.— 
"(1) ESTABLISHMENT OF OFFICE.—Not later than 90 days 
after the date of enactment of this section, the Secretary shall 
establish an office to be known as the Office of Research Integ-
rity (referred to in this section as the 'Office'), which sh^l 
be established as an independent entity in the Department 
of Health and Human Services. 
"(2) APPOINTMENT OF DIRECTOR.—The Office shall be 
headed by a Director, who shall be appointed by the Secretary, 
be experienced and specially trained in the conduct of research, 
and have experience in the conduct of investigations of research 
misconduct. The Secretary shall carry out this section acting 
through the Director of the Office. The Director shall report 
to the Secretary. 
"(3) DEFINITIONS.— 
"(A) The Secretary shall by regulation establish a defi-
nition for the term 'research misconduct' for purposes of 
this section. 
"(B) For purposes of this section, the term 'financial 
assistance' means a grant, contract, or cooperative agree-
ment. 
"(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS CONDITION 
OF FUNDING FOR RESEARCH.—The Secretary shall by regulation 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 141 
require that each entity that appUes for financial assistance under 
this Act for any project or program that involves the conduct of 
biomedical or behavioral research submit in or with its application 
for such assistance— 
"(1) assurances satisfactory to the Secretary that such 
entity has established and has in effect (in accordance with 
regulations which the Secretary shall prescribe) an administra-
tive process to review reports of research misconduct in connec-
tion with biomedical and behavioral research conducted at or 
sponsored by such entity; 
"(2) an agreement that the entity will report to the Director 
any investigation of alleged research misconduct in connection 
with projects for which mnds have been made available under 
this Act that appears substantial; and 
"(3) an agreement that the entity will comply with regula-
tions issued under this section. 
"(c) PROCESS FOR RESPONSE OF DIRECTOR.—The Secretary shall 
by regulation establish a process to be followed by the Director 
for the prompt and appropriate— 
"(1) response to information provided to the Director 
respecting research misconduct in connection with projects for 
which funds have been made available under this Act; 
"(2) receipt of reports by the Director of such information 
from recipients of funds under this Act; 
"(3) conduct of investigations, when appropriate; and 
"(4) taking of other actions, including appropriate remedies, 
with respect to such misconduct. 
"(d) MONITORING BY DIRECTOR.—The Secretary shall by regula-
tion establish procedures for the Director to monitor administrative 
processes and investigations that have been established or c£irried 
out under this section.". 
SEC. 162. COMMISSION ON RESEARCH INTEGRITY. 
(a) IN GENERAL.—Not later than 90 days after the date of 
Establishment. 
the enactment of this Act, the Secretary of Health and Human 
Services shall establish a commission to be known as the Commis-
sion on Research Integrity (in this section referred to as the 
"Commission"). 
(b) DUTIES.—^The Commission shall develop recommendations 
for the SecretEiry of Health and Human Services on the administra-
tion of section 493 of the Public Heedth Service Act (as amended 
and added by section 161 of this Act). 
(c) COMPOSITION.—The Commission shsdl be composed of 12 
members to be appointed by the Secretary of Health and Human 
Services. Not more than 3 members of the Commission may be 
officers or employees of the United States. Of the members of 
the Commission— 
(1) three shall be scientists with substantial accomplish-
ments in biomedical or behavioral research; 
(2) three shall be individuals with experience in investigat-
ing allegations of misconduct with respect to research; 
(3) three shall be representatives of institutions of higher 
education at which biomedical or behavioral research is con-
ducted; and 
(4) three shall be individuals who are not described in 
paragraph (1), (2), or (3), at least one of whom shall be an 
attorney and at least one of whom shall be an ethicist. 
107 STAT. 142 
PUBLIC LAW 103-43—JUNE 10, 1993 
(d) COMPENSATION.—Members of the Commission may not 
receive compensation for service on the Commission. Members may 
be reimbursed for travel, subsistence, and other necessary expenses 
incurred in carrying out the duties of the Commission. 
(e) REPORT.—Not later than 120 days after the date on which 
the Commission is established under subsection (a), the Commission 
shall prepare and submit to the Secretary of Health and Human 
Services, the Committee on Energy and Commerce of the House 
of Representatives, and the Committee on Labor and Human 
Resources of the Senate, a report containing the recommendations 
developed under subsection (b). 
Regulations. 
SEC. 163. PROTECTION OF WfflSTLEBLOWERS. 
Section 493 of the Public Health Service Act, as amended 
by section 161 of this Act, is amended by adding at the end the 
following subsection: 
"(e) PROTECTION OF WHISTLEBLOWERS.— 
"(1) IN GENERAL.—In the case of any entity required to 
establish administrative processes under subsection (b), the 
Secretary shall by regulation establish standards for prevent-
ing, and for responding to the occurrence of retaliation by 
such entity, its officials or agents, against an employee in 
the terms and conditions of employment in response to the 
employee having in good faith— 
"(A) made an allegation that the entity, its officials 
or agents, has engaged in or failed to adequately respond 
to an allegation of research misconduct; or 
"(B) cooperated with an investigation of such an allega-
tion. 
"(2) MONITORING BY SECRETARY.—The Secretary shall by 
regulation establish procedures for the Director to monitor the 
implementation of the standards established by an entity under 
paragraph (1) for the purpose of determining whether the proce-
dures have been established, and are being utilized, in accord-
ance with the st£indards established under such paragraph. 
"(3) NONCOMPLIANCE.—The Secretary shall by regulation 
establish remedies for noncompliance by an entity, its officials 
or agents, which has engaged in retaliation in violation of 
the standards established under paragraph (1), Such remedies 
may include termination of funding provided by the Secretary 
for such project or recovery of funding being provided by the 
Secretary for such project, or other actions as appropriate.". 
SEC\l64. REQUIREMENT OF REGULATIONS REGARDING PROTECTION 
AGAINST FINANCIAL CONFLICTS OF INTEREST IN CER-
TAIN PROJECTS OF RESEARCH. 
Part H of title IV of the Public Health Service Act, as redesig-
nated by section 141(a)(2) of this Act, is amended by inserting 
after section 493 the following new section: 
"PROTECTION AGAINST FINANCIAL CONFLICTS OF INTEREST IN 
CERTAIN PROJECTS OF RESEARCH 
42USC289b-i. 
" S E C 493A. (a) ISSUANCE OF REGULATIONS.—The Secretary 
shall by regulation define the specific circumstances that constitute 
the existence of a financial interest in a project on the part of 
an entity or individual that will, or may be reasonably expected 
to, create a bias in favor of obtaining results in such project that 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 143 
are consistent with such financial interest. Such definition shall 
apply uniformly to each entity or individual conducting a research 
project under this Act. In the case of any entity or individual 
receiving assistance fi:om the Secretary for a project of research 
described in subsection (b), the Secretary shall by regulation estab-
lish standards for responding to, including managing, reducing, 
or eliminating, the existence of such a financial interest. The entity 
may adopt individualized procedures for implementing the stand-
ards. 
"(b) RELEVANT PROJECTS.—^A project of research referred to 
in subsection (a) is a project of clinical research whose purpose 
is to evaluate the safety or effectiveness of a drug, medical device, 
or treatment and for which such entity is receiving assistance 
from the Secretary. 
"(c) IDENTIFYING AND REPORTING TO SECRETARY.—The Sec-
retary shall by regulation require that each entity described in 
subsection (a) that applies for assistance under this Act for any 
project described in subsection (b) submit in or with its application 
for such assistance— 
"(1) assurances satisfactory to the Secretary that such 
entity has established and has in effect an administrative proc-
ess under subsection (a) to identify financial interests (as 
defined under subsection (a)) that exist regarding the project; 
and 
"(2) an agreement that the entity will report to the Sec-
retary such interests identified by the entity and how any 
such interests identified by the entity will be managed or 
eliminated in order that the project in question will be protected 
fi-om bias that may stem 
fi*om 
such interests; and 
"(3) an agreement that the entity will comply with regula-
tions issued under this section. 
"(d) MONITORING OF PROCESS.—The Secretary shall monitor 
the establishment smd conduct of the administrative process estab-
lished by an entity pursuant to subsection (a). 
"(e) RESPONSE.—In any case in which the Secretary determines 
that an entity has failed to comply with subsection (c) regarding 
a project of research described in subsection (b), the Secretary— 
"(1) shall require that, as a condition of receiving assist-
ance, the entity disclose the existence of a financial interest 
(as defined under subsection (a)) in each public presentation 
of the results of such project; and 
"(2) may take such other actions as the Secretary deter-
mines to be appropriate. 
"(f) DEFINITIONS,—For purposes of this section: 
"(1) The term 'financial interest' includes the receipt of 
consulting fees or honoraria and the ownership of stock or 
equity. 
"(2) The term 'assistance', with respect to conducting a 
project of research, means a grant, contract, or cooperative 
agreement.". 
SEC. 165. REGULATIONS. 
42 USC 289b 
(a) ISSUANCE OF FINAL RULES.— 
"°'^' 
(1) IN GENERAL.—Not later than 180 days after the date 
of the enactment of this Act, the Secretary shall, subject to 
paragraph (2), issue the final rule for each regulation required 
in section 493 or 493A of the Public Health Service Act. 
107 STAT. 144 
PUBLIC LAW 103-43—JUNE 10, 1993 
(2) DEFINITION OF RESEARCH MISCONDUCT.—Not later than 
90 days after the date on which the report required in section 
162(e) is submitted to the Secretary, the Secretary shall issue 
the final rule for the regulations required in section 493 of 
the Public Health Service Act with respect to the definition 
of the term "research misconduct". 
(b) APPLICABILITY TO ONGOING INVESTIGATIONS.—The final rule 
issued pursuant to subsection (a) for investigations under section 
493 of the Public Health Service Act does not apply to investigations 
commenced before the date of the enactment of this Act under 
authority of such section as in effect before such date. 
(c) DEFINITIONS.—For purposes of this section: 
(1) The term "section 493 of the Pubhc Health Service 
Act" means such section as amended by sections 161 and 163 
of this Act, except as indicated otherwise in subsection (b). 
(2) The term "section 493A of the PubUc Health Service 
Act" means such section as added by section 164 of this Act. 
(3) The term "Secretary" means the Secretary of Health 
and Human Services. 
TITLE II—NATIONAL INSTITUTES OF 
HEALTH IN GENERAL 
SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINATION. 
Section 402(f) of the PubUc Health Service Act (42 U.S.C. 
282(f)) is amended by striking "other public and private entities." 
and all that follows through the end and inserting "other public 
and private entities, including elementary, secondary, and post-
secondary schools. The Associate Director shall— 
"(1) annually review the efficacy of existing policies and 
techniques used by the national research institutes to dissemi-
nate the results of disease prevention and behavioral research 
programs; 
"(2) recommend, coordinate, and oversee the modification 
or reconstruction of such policies and techniques to ensure 
maximum dissemination, using advanced technologies to the 
maximum extent practicable, of research results to such enti-
ties; and 
Reports. 
"(3) annually prepare and submit to the Director of NIH 
a report concerning the prevention and dissemination activities 
undertaken by the Associate Director, including— 
"(A) a summary of the Associate Director's review of 
existing dissemination policies and techniques together 
with a detailed statement concerning any modification or 
restructuring, or recommendations for modification or 
restructuring, of such policies and techniques; and 
"(B) a detailed statement of the expenditures made 
for the prevention and dissemination activities reported 
on and the personnel used in connection with such activi-
ties.". 
SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARDING CERTAIN 
STATES AND RESEARCHERS. 
Section 402 of the PubUc Health Service Act (42 U.S.C. 282) 
is amended by adding at the end the following subsection: 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 145 
"(g)(1)(A) In the case of entities described in subparagraph 
(B), the Director of NIH, acting through the Director of the National 
Center for Research Resources, shall establish a program to enhance 
the competitiveness of such entities in obtaining funds from the 
national research institutes for conducting biomedical and behav-
ioral research. 
"(B) The entities referred to in subparagraph (A) are entities 
that conduct biomedical and behavioral research and are located 
in a State in which the aggregate success rate for applications 
to the national research institutes for assistance for such research 
by the entities in the State has historically constituted a low success 
rate of obtaining such funds, relative to such aggregate rate for 
such entities in other States. 
"(C) With respect to enhancing competitiveness for purposes 
of subpgiragraph (A), the Director of NiH, in carrying out the 
program established under such subparagraph, may— 
"(i) provide technical assistance to the entities involved, 
including technical assistance in the preparation of applications 
for obtaining funds from the national research institutes; 
"(ii) assist the entities in developing a plan for biomedical 
or behavioral research proposals; and 
"(iii) assist the entities in implementing such plan. 
"(2) The Director of NIH shall establish a program of supporting 
projects of biomedical or behavioral research whose princip^ 
researchers are individuals who have not previously served as the 
principal researchers of such projects supported by the Director.". 
SEC. 203. ESTABLISHMENT OF OFFICE OF BEHAVIORAL AND SOCIAL 
SCIENCES RESEARCH. 
(a) IN GENERAL.—Part A of title IV of the Public Health Service 
Act, as amended by section 151 of this Act, is amended by adding 
at the end the following section: 
"OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH 
" S E C 404A. (a) There is estabUshed within the Office of the 
42 use 283c. 
Director of NIH an office to be known as the Office of Behavioral 
and Social Sciences Research (in this section referred to as the 
'Office'). The Office shall be headed by a director, who shall be 
appointed by the Director of NIH. 
"(b)(1) With respect to research on the relationship between 
human behavior and the development, treatment, and prevention 
of medical conditions, the Director of the Office shall— 
"(A) coordinate research conducted or supported by the 
agencies of the National Institutes of Health; and 
"(B) identify projects of behavioral and social sciences 
research that should be conducted or supported by the national 
research institutes, and develop such projects in cooperation 
with such institutes. 
"(2) Research authorized under paragraph (1) includes research 
on teen pregnancy, infant mortality, violent behavior, suicide, and 
homelessness. Such research does not include neurobiological 
research, or research in which the behavior of an organism is 
observed for the purpose of determining activity at the cellular 
or molecular level.". 
(b) REPORT.—Not later than February 1, 1994, the Director 
of the Office of Behavioral and Social Sciences Research (established 
in section 404A of the Public Health Service Act, as added by 
107 STAT. 146 
PUBLIC LAW 103-43—JUNE 10, 1993 
subsection (a) of this section) shall submit to the Committee on 
Energy and Commerce of the House of Representatives, and to 
the Committee on Labor and Human Resources of the Senate, 
a report describing the extent to which the national research 
institutes of the National Institutes of Health conduct and support 
behavioral research and social sciences research. In preparing the 
report, such Director shall (subject to subsection (b)(2) of such 
section 404A) state the definitions used in the report for the terms 
"behavioral research" and "social sciences research", and shall apply 
the definitions uniformly to such institutes for purposes of the 
report. 
42 use 283c 
(c) EFFECTIVE DATES.—The amendment described in subsection 
(a) is made upon the date of the enactment of this Act and takes 
effect July 1,1993. Subsection (b) takes effect on such date. 
note. 
SEC. 204. CHILDREN'S VACCINE INITIATIVE. 
Part A of title IV of the Public Health Service Act, as amended 
by section 203 of this Act, is amended by adding at the end the 
following section: 
"CHILDREN'S VACCINE INITIATIVE 
42 use 283d. 
"SEC, 404B. (a) DEVELOPMENT OF NEW VACCINES.—The Sec-
retary, in consultation with the Director of the National Vaccine 
Program under title XXI and acting through the Directors of the 
National Institute for Allergy and Infectious Diseases, the National 
Institute for Child Health and Human Development, the National 
Institute for Aging, and other public and private programs, shall 
carry out activities, which shall be consistent with the global Chil-
dren's Vaccine Initiative, to develop affordable new and improved 
vaccines to be used in the United States and in the developing 
world that will increase the efficacy and efficiency of the prevention 
of infectious diseases. In carrying out such activities, the Secretary 
shall, to the extent practicable, develop and make available vaccines 
that require fewer contacts to deliver, that can be given early 
in life, that provide long lasting protection, that obviate refiiigera-
tion, needles and syringes, and that protect against a larger number 
of diseases. 
"(b) REPORT.—In the report required in section 2104, the Sec-
retary, acting through the Director of the National Vaccine Program 
under title XXI, shall include information with respect to activities 
and the progress made in implementing the provisions of this 
section and achieving its goals. 
"(c) AUTHORIZATION OF APPROPRIATIONS.—In addition to 
any 
other amoimts authorized to be appropriated for activities of the 
type described in this section, there are authorized to be appro-
priated to carry out this section $20,000,000 for fiscal year 1994, 
and such sums as may be necessary for each of the fiscal years 
1995 and 1996.". 
SEC. 
2
0
5
. 
PLAN 
FOR 
USE OF 
ANIMALS 
IN 
RESEARCH. 
(a) IN GENERAL.—Part A of title IV of the PubKc Health Service 
Act, as amended by section 204 of this Act, is amended by adding 
at the end the following section: 
PUBLIC LAW 103-43—JUNE 10, 1993 
i07 STAT. 147 
"PLAN FOR USE OF ANIMALS IN RESEARCH 
"SEC. 404C. (a) The Director of NIH, after consultation with 42 use 283e. 
the committee estabHshed under subsection (e), shall prepare a 
plan— 
"(1) for the National Institutes of Health to conduct or 
support research into— 
"(A) methods of biomedical research £ind experimen-
tation that do not require the use of animals; 
"(B) methods of such research £ind experimentation 
that reduce the number of animals used in such research; 
"(C) methods of such research and experimentation 
that produce less pain and distress in such animals; £ind 
"(D) methods of such research and experimentation 
that involve the use of marine life (other than marine 
mammals); 
"(2) for establishing the validity and reliability of the meth-
ods described in paragraph (1); 
"(3) for encouraging the acceptance by the scientific commu-
nity of such methods that have been found to be valid and 
reliable; and 
"(4) for training scientists in the use of such methods 
that have been found to be valid and reliable. 
"(b) Not later than October 1, 1993, the Director of NIH shall 
submit to the Committee on Energy and Commerce of the House 
of Representatives, and to the Committee on Labor and Human 
Resources of the Senate, the plsin required in subsection (a) and 
shall begin implementation of the plan. 
"(c) The Director of NIH shall periodically review, and as appro-
priate, make revisions in the plan required under subsection (a). 
A description of any revision made in the plan shall be included 
in the first biennial report under section 403 that is submitted 
after the revision is made. 
"(d) The Director of NIH shall take such actions as may be 
appropriate to convey to scientists and others who use animals 
in biomedical or behavioral research or experimentation information 
respecting the methods found to be valid and reliable under sub-
section (a)(2). 
"(e)(1) The Director of NIH shall estabUsh within the National 
Institutes of Health a committee to be known as the Interagency 
Coordinating Committee on the Use of Animals in Research (in 
this subsection referred to as the 'Committee'). 
"(2) The Committee shall provide advice to the Director of 
NIH on the preparation ortiie plan required in subsection (a). 
"(3) The Committee shall be composed of— 
"(A) the Directors of each of the national research institutes 
and the Director of the Center for Research Resources (or 
the designees of such Directors); and 
"(B) representatives of the Environmental 
Protection 
Agency, the Food and Drug Administration, the Consumer Prod-
uct Safety Commission, the National Science Foundation, and 
such additional agencies as the Director of NIH determineis 
to be appropriate, which representatives shall include not less 
than one veterinarian with expertise in laboratory-animal medi-
cine.". 
107 STAT. 148 
PUBLIC LAW 103-43—JUNE 10, 1993 
(b) 
CONFORMING AMENDMENT.—Section 
4 
of 
the 
Health 
42 use 289d 
Research Extension Act of 1985 (Public Law 99-158; 99 Stat. 880) 
"o*^ 
is repealed. 
SEC. 206. INCREASED PARTICIPATION OF WOMEN AND DISADVAN-
TAGED INDIVIDUALS IN FIELDS OF BIOMEDICAL AND 
BEHAVIORAL RESEARCH. 
Section 402 of the Public Health Service Act, as amended 
by section 202 of this Act, is amended by adding at the end the 
following subsection: 
"(h) The Secretary, acting through the Director of NIH and 
the Directors of the agencies of the National Institutes of Health, 
shall, in conducting and supporting programs for research, research 
training, recruitment, and other activities, provide for an increase 
in the number of women and individuals from disadvantaged back-
grounds (including racial and ethnic minorities) in the fields of 
biomedical and behavioral research.". 
SEC. 207. REQUIREMENTS REGARDING SURVEYS OF SEXUAL BEHAV-
lOR. 
Part A of title IV of the Public Health Service Act, as amended 
by section 205 of this Act, is amended by adding at the end the 
following section: 
"REQUIREMENTS REGARDING SURVEYS OF SEXUAL BEHAVIOR 
42 use 283f. 
" S E C 404D. With respect to any survey of human sexual behav-
ior proposed to be conducted or supported through the National 
Institutes of Health, the survey may not be carried out unless— 
"(1) the proposal has undergone review in accordeince with 
any applicable requirements of sections 491 and 492; and 
"(2) the Secretary, in accordance with section 492A, makes 
a determination that the information expected to be obtained 
through the survey will assist— 
"(A) in reducing the incidence of sexusJly transmitted 
diseases, the incidence of infection with the human 
immunodeficiency virus, or the incidence of any other infec-
tious disease; or 
"(B) in improving reproductive health or other condi-
tions of health.". 
SEC. 208. DISCRETIONARY FUND OF DIRECTOR OF NATIONAL 
INSTITUTES OF HEALTH. 
Section 402 of the Public Health Service Act, as amended 
by section 206 of this Act, is amended by adding at the end the 
following subsection: 
"(i)(l) There is established a fund, consisting of amoimts appro-
priated imder paragraph (3) and made available for the fund, for 
use by the Director of NIH to carry out the activities authorized 
in this Act for the National Institutes of Health. The purposes 
for which such fund may be expended include— 
"(A) providing for research on matters that have not 
received significant funding relative to other matters, respond-
ing to new issues and scientific emergencies, and acting on 
research opportunities of high priority; 
"(B) supporting research that is not exclusively within the 
authority of any single agency of such Institutes; and 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 149 
"(C) purchasing or renting equipment and quarters for 
activities of such Institutes. 
"(2) Not later than February 10 of each fiscal year, the Secretary Reports 
shall submit to the Committee on Energy and Commerce of the 
House of Representatives, and to the Committee on Labor and 
Human Resources of the Senate, a report describing the activities 
undertaken and expenditures made under this section during the 
preceding fiscal year. The report may contain such comments of 
the Secretary regarding this section as the Secretary determines 
to be appropriate. 
"(3) For the purpose of carrying out this subsection, there 
are authorized to be appropriated $25,000,000 for fiscal year 1994, 
£ind such sums as may be necessary for each of the fiscal years 
1995 and 1996.". 
SEC. 209. ESTABLISHMENT OF OFFICE OF ALTERNATIVE MEDICINE. 
Part A of title IV of the Public Health Service Act, as amended 
by section 207 of this Act, is amended by adding at the end the 
following section: 
Appropriation 
authorization. 
OFFICE OF ALTERNATIVE MEDICINE 
42 u s e 283g. 
Public 
information. 
"SEC 404E. (a) There is estabhshed within the Office of the 
Director of NIH an office to be known as the Office of Alternative 
Medicine (in this section referred to as the 'Office'), which shall 
be headed by a director appointed by the Director of NIH. 
"(b) The purpose of the Office is to facilitate the evaluation 
of alternative medical treatment modalities, including acupuncture 
and Oriental medicine, homeopathic medicine, and physical manipu-
lation therapies. 
"(c) The Secretary shall establish an advison'' council for the 
purpose of providing advice to the Director of the Office on carrying 
out this section. Section 222 applies to such council to the same 
extent and in the same manner as such section applies to commit-
tees or councils established under such section. 
"(d) In carrying out subsection (b), the Director of the Office 
shall— 
"(1) establish an information clearinghouse to exchange 
information with the public about alternative medicine; 
"(2) support research training— 
"(A) for which fellowship support is not provided under 
section 487; and 
"(B) that is not residency training of physicians or 
other health professionals; and 
"(3)(A) prepare biennial reports on the activities carried Reports. 
out or to be carried out by the Office; and 
"(B) submit each such report to the Director of NIH for 
inclusion in the biennial report under section 403.". 
SEC. 210. MISCELLANEOUS PROVISIONS. 
(a) TERM OF OFFICE FOR MEMBERS OF ADVISORY COUNCILS.— 
Section 406(c) of the PubHc Health Service Act (42 U.S.C. 284a(c)) 
is amended in the second sentence by striking "until a successor 
has taken office" and inserting the following: "for 180 days after 
the date of such expiration". 
(b) LITERACY REQUIREMENTS.—Section 402(e) of the PubHc 
Health Service Act (42 U.S.C. 282(e)) is amended— 
(1) in paragraph (3), by striking "and" at the end; 
107 STAT. 150 
PUBLIC LAW 103-43—JUNE 10, 1993 
(2) in paragraph (4), by striking the period and inserting 
"; and"; and 
(3) by adding at the end the following paragraph: 
"(5) ensure that, after January 1, 1994, all new or revised 
health education and promotion materials developed or funded 
by the National Institutes of Health and intended for the gen-
eral public are in a form that does not exceed a level of func-
tional literacy, as defined in the National Literacy Act of 1991 
(PubUc Law 102-73).". 
(c) DAY CARE REGARDING CHILDREN OF EMPLOYEES.—Section 
402 of the Public Health Service Act, as amended by section 208 
of this Act, is amended by adding at the end the following sub-
section: 
"(j)(l) The Director of NIH may establish a program to provide 
day care services for the employees of the National Institutes of 
Health similar to those services provided by other Federal agencies 
(including the availability of day care service on a 24-hour-a-day 
basis). 
"(2) Any day care provider at th^ National Institutes of Health 
shall establish a sliding scale of fees that takes into consideration 
the income and needs of the employee. 
"(3) For purposes regarding the provision of day care services, 
the Director of NIH may enter into rental or lease purchase agree-
ments.". 
TITLE III—GENERAL PROVISIONS RE-
SPECTING NATIONAL RESEARCH IN-
STITUTES 
SEC. 
301. APPOINTMENT AND AUTHORITY OF DIRECTORS OF 
NATIONAL RESEARCH INSTITUTES. 
(a) ESTABLISHMENT OF GENERAL AUTHORITY REGARDING DIRECT 
FUNDING.— 
(1) IN GENERAL.—Section 405(b)(2) of the PubHc Health 
Service Act (42 U.S.C. 284(b)(2)) is amended— 
(A) in subparagraph (A), by striking "and" after the 
semicolon at the end; 
(B) in subparagraph (B), by striking the period at 
the end and inserting "; and"; and 
(C) by adding at the end the following subparagraph: 
"(C) shall, subject to section 2353(d)(2), receive from the 
President and the Office of Management and Budget directly 
all funds appropriated by the Congress for obligation and 
expenditure by the Institute.". 
(2) CONFORMING AMENDMENT.—Section 413(b)(9) of 
the 
Public Health Service Act (42 U.S.C. 285a-2(b)(9)) is amended— 
(A) by striking "(A)" after "(9)"; and 
(B) by striking "advisory council;" and all that follows 
and inserting "advisory council.". 
(b) APPOINTMENT AND DURATION OF TECHNICAL AND SCIENTIFIC 
PEER REVIEW GROUPS.—Section 405(c) of the PubUc Health Service 
Act (42 U.S.C. 284(c)) is amended— 
(1) by amending paragraph (3) to read as follows: 
"(3) may, in consultation with the advisory council for 
the Institute and with the approval of the Director of NIH— 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 151 
"(A) establish technical and scientific peer review 
groups in addition to those appointed under section 
402(b)(6); and 
"(B) appoint the members of peer review groups estab-
lished under subparagraph (A); and"; and 
(2) by adding after and below paragraph (4) the following: 
"The Federal Advisory Committee Act shall not apply to the dura-
tion of a peer review group appointed under paragraph (3).". 
SEC. 302. PROGRAM OF RESEARCH ON OSTEOPOROSIS, PAGET'S DIS- Aged. 
EASE, AND RELATED BONE DISORDERS. 
Part B of title IV of the Public Health Service Act (42 U.S.C. 
284 et seq.), as amended by section 121(b) of Public Law 102-
321 (106 Stat. 358), is amended by adding at the end the following 
section: 
"RESEARCH ON OSTEOPOROSIS, PAGET'S DISEASE, AND RELATED BONE 
DISORDERS 
"SEC. 409A. (a) ESTABLISHMENT.—The Directors of the National 42 use 284e. 
Institute of Arthritis and Musculoskeletal and Skin Diseases, the 
National Institute on Aging, the National Institute of Dental 
Research, and the National Institute of Diabetes and Digestive 
and Kidney Diseases, shall expand and intensify the programs 
of such Institutes with respect to research and related activities 
concerning osteoporosis, Paget's disease, and related bone disorders. 
"(b) COORDINATION.—'flie Directors referred to in subsection 
(a) shall jointly coordinate the programs referred to in such sub-
section and consult with the Arthritis and Musculoskeletal Diseases 
Interagency Coordinating Committee and the Interagency Task 
Force on Aging Research. 
"(c) INFORMATION CLEARINGHOUSE.— 
"(1) IN GENERAL.—In order to assist in carrying out the 
purpose described in subsection (a), the Director of NIH shall 
provide for the establishment of an information clearinghouse 
on osteoporosis £ind related bone disorders to facilitate and 
enhance knowledge and understanding on the part of health 
professionals, patients, and the public through the effective 
dissemination of information. 
"(2) ESTABLISHMENT THROUGH GRANT OR CONTRACT.—For 
the purpose of carrying out paragraph (1), the Director of 
NIH shall enter into a grant, cooperative agreement, or contract 
with a nonprofit private entity involved in activities regarding 
the prevention and control of osteoporosis and related bone 
disorders. 
, 
"(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
$40,000,000 for fiscal year 1994, and such sums as may be necessary 
for each of the fiscal years 1995 and 1996.". 
SEC 303. ESTABLISHMENT OF INTERAGENCY PROGRAM FOR TRAUMA 
RESEARCH. 
(a) IN GENERAL.—Title XII of the Public Health Service Act 
(42 U.S.C. 300d et seq.), as amended by title VI of Public Law 
102-321 (106 Stat. 433) and section 304 of PubUc Law 102-408 
(106 Stat. 2084), is amended by adding at the end the following 
part: 
107 STAT. 152 
PUBLIC LAW 103-43—JUNE 10, 1993 
"PART F—INTERAGENCY PROGRAM FOR TRAUMA RESEARCH 
42 use 300d-61. "SEC. 1261. ESTABLISHMENT OF PROGRAM. 
"(a) IN GENERAL.—The Secretary, acting through the Director 
of the National Institutes of Health (in this section referred to 
as the 'Director'), shall establish a comprehensive program of 
conducting basic and clinical research on trauma (in this section 
referred to as the 'Program'). The Program shall include research 
regarding the diagnosis, treatment, rehabilitation, and general 
management of trauma. 
"(b) PLAN FOR PROGRAM.— 
"(1) IN GENERAL.—^The Director, in consultation with the 
Trauma Research Interagency Coordinating Committee estab-
lished under subsection (g), shall establish and implement a 
plan for carrying out the activities of the Program, including 
the activities described in subsection (d). All such activities 
shall be carried out in accordance with the plan. The plan 
shall be periodically reviewed, and revised as appropriate. 
"(2) SUBMISSION TO CONGRESS.—Not later than December 
1, 1993, the Director shall submit the plan required in para-
graph (1) to the Committee on Energy and Commerce of the 
House of Representatives, and to the Committee on Labor 
and Human Resources of the Senate, together with an estimate 
of the funds needed for each of the fiscal years 1994 through 
1996 to implement the plan. 
"(c) PARTICIPATING AGENCIES; COORDINATION AND COLLABORA-
TION.—The Director— 
"(1) shall provide for the conduct of activities luider the 
Program by the Directors of the agencies of the National 
Institutes of Health involved in research with respect to 
trauma; 
"(2) shall ensure that the activities of the Program are 
coordinated among such agencies; and 
"(3) shall, as appropriate, provide for collaboration among 
such agencies in canying out such activities. 
"(d) CERTAIN ACTIVITIES OF PROGRAM.—The Program shall 
include— 
"(1) studies with respect to all phases of trauma care, 
including prehospital, resuscitation, surgical intervention, criti-
cal care, infection control, wound healing, nutritional care and 
support, and medical rehabilitation care; 
"(2) basic and clinical research regarding the response of 
the body to trauma and the acute treatment and medical 
rehabilitation of individuals who are the victims of trauma; 
and 
"(3) basic and clinical research regarding trauma care for 
pediatric and geriatric patients. 
"(e) MECHANISMS OF SUPPORT.—In carrying out the Program, 
the Director, acting through the Directors of the agencies referred 
to in subsection (c)(1), may make grants to public and nonprofit 
entities, including designated trauma centers. 
"(f) RESOURCES.—^The Director shall assure the availability of 
appropriate resources to carry out the Program, including the plan 
established under subsection (b) (including the activities described 
in subsection (d)). 
"(g) COORDINATING COMMITTEE.— 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 153 
"(1) IN GENERAL.—There shall be established a Trauma 
Research Interagency Coordinating Committee (in this section 
referred to as the 'Coordinating Committee'). 
"(2) DUTIES.—The Coordinating Committee shall make rec-
ommendations regarding— 
"(A) the activities of the Program to be carried out 
by each of the agencies represented on the Committee 
and the amount of funds needed by each of the agencies 
for such activities; and 
"(B) effective collaboration among the agencies in carry-
ing out the activities. 
"(3) COMPOSITION.—The Coordinating Committee shall be 
composed of the Directors of each of the agencies that, under 
subsection (c), have responsibilities under the Program, and 
any other individuals who are practitioners in the traimia 
field as designated by the Director of the National Institutes 
of Health. 
"(h) DEFINITIONS.—For purposes of this section: 
"(1) The term 'designated trauma center' has the meaning 
given such term in section 1231(1). 
"(2) The term 'Director' means the Director of the National 
Institutes of Health. 
"(3) The term 'trauma' means any serious injury that could 
result in loss of life or in significant disability and that would 
meet pre-hospital triage criteria for transport to a designated 
trauma center.". 
(b) 
CONFORMING AMENDMENT.—Section 402 
of the 
Public 
Health Service Act, as amended by section 210(c) of this Act, is 
amended by adding at the end the following subsection: 
"(k) The Director of NIH shall carry out the program established 
in part F of title XII (relating to interagency research on trauma).". 
TITLE IV—NATIONAL CANCER 
INSTITUTE 
SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARD- 
Women. 
ING BREAST CANCER. 
Subpart 1 of part C of title IV of the Public Health Service 
Act (42 U.S.C. 285 et seq.) is amended by adding at the end 
the following section: 
"BREAST 
AND 
GYNECOLOGICAL 
CANCERS 
"SEC. 417. (a) EXPANSION AND COORDINATION OF ACTIVITIES.— 42 use 285a-6. 
The Director of the Institute, in consultation with the National 
Csincer Advisory Board, shall expEind, intensify, and coordinate 
the activities of the Institute with respect to research on breast 
cancer, ovEirian cancer, and other cancers of the reproductive system 
of women. 
"(b) COORDINATION WITH OTHER INSTITUTES.—The Director of 
the Institute shall coordinate the activities of the Director under 
subsection (a) with similar activities conducted by other national 
research institutes and agencies of the National Institutes of Health 
to the extent that such Institutes and agencies have responsibilities 
that are related to breast cancer and other cancers of the reproduc-
tive system of women. 
107 STAT. 154 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(c) PROGRAMS FOR BREAST CANCER.— 
"(1) IN GENERAL.—In carrying out subsection (a), the Direc-
tor of the Institute shall conduct or support research to expand 
the understanding of the cause of, and to find a cure for, 
breast cancer. Activities under such subsection shall provide 
for an expansion and intensification of the conduct and support 
of— 
"(A) basic research concerning the etiology and causes 
of breast cancer; 
"(B) clinical research £ind related activities concerning 
the causes, prevention, detection and treatment of breast 
cancer; 
"(C) control programs with respect to breast cancer 
in accordance with section 412, including community-based 
programs designed to assist women who are members of 
medically underserved 
populations, low-income 
popu-
lations, or minority groups; 
"(D) information and education programs with respect 
to breast cancer in accordance with section 413; and 
"(E) research and demonstration centers with respect 
to breast cancer in accordance with section 414, including 
the development and operation of centers for breast cancer 
research to bring together basic and clinical, biomedical 
and 
behavioral 
scientists to conduct 
basic, 
clinical, 
epidemiological, psychosocial, prevention and treatment 
research and related activities on breast cancer. 
Not less than six centers shall be operated under subparagraph 
(E). Activities of such centers should include supporting new 
and innovative research and training programs for new 
researchers. Such centers shall give priority to expediting the 
transfer of research advances to clinical applications. 
"(2) IMPLEMENTATION OF PLAN FOR PROGRAMS.— 
"(A) The Director of the Institute shall ensure that 
the research programs described in paragraph (1) are 
implemented in accordance with a plan for the programs. 
Such plan shall include comments and recommendations 
that the Director of the Institute considers appropriate, 
with due consideration provided to the professional judg-
ment needs of the Institute as expressed in the annual 
budget estimate prepared in accordance with section 413(9). 
The Director of the Institute, in consultation with the 
National Cancer Advisory Board, shall periodically review 
and revise such plan. 
"(B) Not later than October 1, 1993, the Director of 
the Institute shall submit a copy of the plan to the Presi-
dent's Cancer Panel, the Secretary and the Director of 
NIH. 
"(C) The Director of the Institute shall submit any 
revisions of the plan to the President's Cancer Panel, the 
Secretary, and the Director of NIH. 
"(D) The Secretary shall provide a copy of the plan 
submitted under subparagraph (A), and any revisions 
submitted imder subparagraph (C), to the Committee on 
Energy and Commerce of the House of Representatives 
and the Committee on Labor and Human Resources of 
the Senate. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 155 
"(d) OTHER CANCERS.—In canying out subsection (a), the Direc-
tor of the Institute shall conduct or support research on ovarian 
cancer and other cancers of the reproductive system of women. 
Activities under such subsection shall provide for the conduct and 
support of— 
"(1) basic research concerning the etiology and causes of 
ovarian cancer and other cancers of the reproductive system 
of women; 
"(2) clinical research and related activities into the causes, 
prevention, detection and treatment of ovarian cancer and other 
cancers of the reproductive system of women; 
"(3) control programs with respect to ovarian cancer and 
other cancers of the reproductive system of women in accord-
ance with section 412; 
"(4) information and education progrEims with respect to 
ovarian cancer and other cancers of the reproductive system 
of women in accordance with section 413; and 
"(5) research and demonstration centers with respect to 
ovarian cancer and cancers of the reproductive system in 
accordance with section 414. 
"(e) REPORT.—The Director of the Institute shall prepare, for 
inclusion in the biennial report submitted under section 407, a 
report that describes the activities of the National Cancer Institute 
under the research programs referred to in subsection (a), that 
shall include— 
"(1) a description of the research plan with respect to 
breast cancer prepared under subsection (c); 
"(2) an assessment of the development, revision, and 
implementation of such plan; 
"(3) a description and evaluation of the progress made, 
during the period for which such report is prepared, in the 
research programs on breast cancer and cancers of the repro-
ductive system of women; 
"(4) a summary and analysis of expenditures made, during 
the period for which such report is made, for activities with 
respect to breast cancer and cancers of the reproductive system 
of women conducted and supported by the National Institutes 
of Health; and 
"(5) such comments and recommendations as the Director 
considers appropriate.". 
SEC. 402. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARD-
ING PROSTATE CANCER. 
Subpart 1 of part C of title IV of the Public Health Service 
Act, as amended by section 401 of this Act, is amended by adding 
at the end the following section: 
"PROSTATE CANCER 
" S E C 417A. (a) EXPANSION AND COORDINATION OF ACTIVITIES.— 
42 use 285a-7. 
The Director of the Institute, in consultation with the National 
Cancer Advisory Bo£ird, shall expand, intensify, and coordinate 
the activities of the Institute with respect to research on prostate 
cancer. 
"(b) COORDINATION WITH OTHER INSTITUTES.—The Director of 
the Institute shall coordinate the activities of the Director under 
subsection (a) with similar activities conducted by other national 
research institutes and agencies of the National Institutes of Health 
107 STAT. 156 
PUBLIC LAW 103-43—JUNE 10, 1993 
to the extent that such Institutes and agencies have responsibilities 
that are related to prostate cancer. 
"(c) PROGRAMS.— 
"(1) IN GENERAL.—In carrying out subsection (a), the Direc-
tor of the Institute shall conduct or support research to expand 
the understanding of the cause of, and to find a cure for, 
prostate cancer. Activities under such subsection shall provide 
for an expansion and intensification of the conduct and support 
of— 
"(A) basic research concerning the etiology and causes 
of prostate cancer; 
"(B) clinical research and related activities concerning 
the causes, prevention, detection and treatment of prostate 
cancer; 
"(C) prevention and control and early detection pro-
grams with respect to prostate cancer in accordance with 
section 412, particularly as it relates to intensifying 
research on the role of prostate specific antigen for the 
screening and early detection of prostate cancer; 
"(D) an Inter-Institute Task Force, under the direction 
of the Director of the Institute, to provide coordination 
between relevant National Institutes of Health components 
of research efforts on prostate cancer; 
"(E) control programs with respect to prostate cancer 
in accordance with section 412; 
"(F) information and education programs with respect 
to prostate cancer in accordance with section 413; and 
"(G) research and demonstration centers with respect 
to prostate cancer in accordance with section 414, including 
the development and operation of centers for prostate can-
cer research to bring together basic and clinical, biomedical 
and behavioral 
scientists to conduct basic, 
clinical, 
epidemiological, psychosocial, prevention £ind control, treat-
ment, research, and related activities on prostate cancer. 
Not less than six centers shall be operated under subparagraph 
(G). Activities of such centers should include supporting new 
and innovative research and training programs for new 
researchers. Such centers shall give priority to expediting the 
transfer of research advances to clinical applications. 
"(2) IMPLEMENTATION OF PLAN FOR PROGRAMS.— 
"(A) The Director of the Institute shall ensure that 
the research programs described in paragraph (1) £ire 
implemented in accordance with a plan for the programs. 
Such plan shall include comments and recommendations 
that the Director of the Institute considers appropriate, 
with due consideration provided to the professional judg-
ment needs of the Institute as expressed in the annual 
budget estimate prepared in accordance with section 413(9). 
The Director of the Institute, in consultation with the 
National Cancer Advisory Board, shall periodically review 
and revise such plan. 
"(B) Not later than October 1, 1993, the Director of 
the Institute shall submit a copy of the plan to the Presi-
dent's Cancer Panel, the Secretary, and the Director of 
NIH. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 157 
"(C) The Director of the Institute shall submit any 
revisions of the plan to the President's Cancer Panel, the 
Secretary, and the Director of NIH. 
"(D) The Secretary shall provide a copy of the plan 
submitted under subparagraph (A), and any revisions 
submitted under subparagraph (C), to the Committee on 
Energy and Commerce of the House of Representatives 
and the Committee on Labor and Human Resources of 
the Senate.". 
SEC. 403. AUTHORIZATION OF APPROPRIATIONS. 
(a) IN GENERAL.—Subpart 1 of part C of title IV of the PubHc 
Health Service Act, as amended by section 402 of this Act, is 
amended by adding at the end the following section: 
"AUTHORIZATION OF APPROPRIATIONS 
"SEC. 417B. (a) ACTIVITIES GENERALLY.—For the purpose of 42USC285a-8. 
carrying out this subpart, there are authorized to be appropriated 
$2,728,000,000 for fiscal year 1994, and such sums as may be 
necessary for each of the fiscal years 1995 and 1996. 
"(b) BREAST CANCER AND GYNECOLOGICAL CANCERS.— 
"(1) BREAST CANCER.— 
"(A) For the purpose of carrjdng out subparagraph 
(A) of section 417(c)(1), there are authorized to be appro-
priated $225,000,000 for fiscal year 1994, and such sums 
as may be necessary for each of the fiscal years 1995 
and 1996. Such authorizations of appropriations are in 
addition to the authorizations of appropriations established 
in subsection (a) with respect to such purpose. 
"(B) For the purpose of canying out subparagraphs 
(B) through (E) of section 417(c)(1), there are authorized 
to be appropriated $100,000,000 for fiscal year 1994, and 
such sums as may be necessary for each of the fiscal 
years 1995 and 1996. Such authorizations of appropriations 
are in addition to the authorizations of appropriations 
established in subsection (a) with respect to such purpose. 
"(2) OTHER CANCERS.—For the purpose of carrying out sub-
section (d) of section 417, there are authorized to be appro-
priated $75,000,000 for fiscal year 1994, and such sums as 
are necessary for each of the fiscal years 1995 and 1996. Such 
authorizations of appropriations are in addition to the 
authorizations of appropriations established in subsection (a) 
with respect to such purpose. 
"(c) PROSTATE CANCER.—For the purpose of canying out section 
417A, there are authorized to be appropriated $72,000,000 for fiscal 
year 1994, and such sums as may be necessary for each of the 
fiscal years 1995 and 1996. Such authorizations of appropriations 
are in addition to the authorizations of appropriations established 
in subsection (a) with respect to such purpose. 
"(d) ALLOCATION REGARDING CANCER CONTROL.— 
"(1) IN GENERAL.—Of the amounts appropriated for the 
National Cancer Institute for a fiscal year, the Director of 
the Institute shall make available not less than the applicable 
percentage specified in paragraph (2) for carrying out the cancer 
control activities authorized in section 412 and for which budget 
estimates are made under section 413(b)(9) for the fiscal year. 
107 STAT. 158 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(2) APPLICABLE PERCENTAGE.—The percentage referred to 
in paragraph (1) is— 
"(A) 7 percent, in the case of fiscal year 1994; 
"(B) 9 percent, in the case of fiscal year 1995; and 
"(C) 10 percent, in the case of fiscal year 1996 and 
each subsequent fiscal year.", 
(b) CONFORMING AMENDMENTS.— 
(1) IN GENERAL.—Section 408 of the Public Health Service 
Act (42 U.S.C. 284c) is amended— 
(A) by striking subsection (a); 
(B) by redesignating subsection (b) as subsection (a); 
(C) by redesignating paragraph (5) of subsection (a) 
(as so redesignated) as subsection (b); and 
(D) by amending the heading for the section to read 
as follows: 
"CERTAIN USES OF FUNDS". 
(2) CROSS-REFERENCE.—Section 464F of the Public Health 
Service Act (42 U.S.C. 285m-6) is amended by striking "section 
408(b)(1)" and inserting "section 408(a)(1)". 
TITLE V—NATIONAL HEART, LUNG, AND 
BLOOD INSTITUTE 
SEC. 501. EDUCATION AND TRAINING. 
Section 421(b) of the Public Health Service Act (42 U.S.C. 
285b-3(b)) is amended— 
(1) in paragraph (3), by striking "and" after the semicolon 
at the end; 
(2) in paragraph (4), by striking the period at the end 
and inserting "; and"; and 
(3) by inserting after paragraph (4) the following para-
graph: 
"(5) shall, in consultation with the advisory council for 
the Institute, conduct appropriate intramural training and edu-
cation programs, including continuing education and laboratory 
and clinical research training programs.". 
SEC. 502. CENTERS FOR THE STUDY OF PEDIATRIC CARDIOVASCULAR 
DISEASES. 
Section 422(a)(1) of the Public Health Service Act (42 U.S.C. 
285b-4(a)(l)) is amended— 
(1) in subparagraph (B), by striking "and" at the end; 
(2) in subparagraph (C), by striking the period and insert-
ing "; and"; Eind 
(3) by adding at the end the following subpsiragraph: 
"(D) three centers for basic and clinical research into, train-
ing in, and demonstration of, advanced diagnostic, prevention, 
and treatment (including genetic studies, intrauterine environ-
ment studies, postnatal studies, heart arrhythmias, 
and 
acquired heart disease and preventive cardiology) for cardio-
vascular diseases in children.". 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 159 
SEC. 503. NATIONAL CENTER ON SLEEP DISORDERS RESEARCH. 
Subpart 2 of part C of title IV of the Public Health Service 
Act (42 U.S.C. 285b et seq.) is amended by adding at the end 
the following section: 
"NATIONAL 
CENTER 
ON 
SLEEP 
DISORDERS 
RESEARCH 
"SEC 424. (a) Not later than 1 year after the date of the Establishment 
enactment of the National Institutes of Health Revitalization Act ^^ use 285b-7. 
of 1993, the Director of the Institute shall establish the National 
Center on Sleep Disorders Research (in this section referred to 
as the 'Center'). The Center shall be headed by a director, who 
shall be appointed by the Director of the Institute. 
"(b) The general purpose of the Center is— 
"(1) the conduct and support of research, training, health 
information dissemination, and other activities with respect 
to sleep disorders, including biological £ind circadian rhythm 
research, basic understanding of sleep, chronobiological and 
other sleep related research; and 
"(2) to coordinate the activities of the Center with similar 
activities of other Federal agencies, including the other agencies 
of the National Institutes of Health, and similar activities of 
other public entities and nonprofit entities. 
"(c)(1) The Director of the National Institutes of Health shall 
establish a board to be known as the Sleep Disorders Research 
Advisory Board (in this section referred to as the 'Advisory Board'). 
"(2) The Advisory Board shall advise, assist, consult with, and 
make recommendations to the Director of the National Institutes 
of Health, through the Director of the Institute, £ind the Director 
of the Center concerning matters relating to the scientific activities 
carried out by £md through the Center and the policies respecting 
such activities, including recommendations with respect to the plan 
required in subsection (c). 
"(3)(A) The Director of the National Institutes of Health shall 
appoint to the Advisory Board 12 appropriately qualified representa-
tives of the public who are not officers or employees of the Federal 
Government. Of such members, eight shall be representatives of 
health and scientific disciplines with respect to sleep disorders 
and four shaU be individuals representing the interests of individ-
uals with or undergoing treatment for sleep disorders. 
"(B) The following officials shall serve as ex officio members 
of the Advisory Board: 
"(i) The Director of the National Institutes of Health, 
"(ii) The Director of the Center. 
"(iii) The Director of the National Heart, Lung and Blood 
Institute. 
"(iv) The Director of the National Institute of Mental 
Health. 
"(v) The Director of the National Institute on Aging, 
"(vi) The Director of the National Institute of Child Health 
and Human Development. 
"(vii) The Director of the National Institute of Neurological 
Disorders and Stroke. 
"(viii) The Assistant Secretary for Health, 
"(ix) The Assistant Secretary of Defense (Health Affairs). 
"(x) The Chief Medical Director of the Vetereins' Adminis-
tration. 
107 STAT. 160 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(4) The members of the Advisory Board shall, from among 
the members of the Advisory Board, designate an individual to 
serve as the chair of the Advisory Board. 
"(5) Except as inconsistent with, or inapplicable to, this section, 
the provisions of section 406 shall apply to the advisory board 
established under this section in the same manner as such provi-
sions apply to any advisory council established under such section. 
"(d)(1) After consultation with the Director of the Center and 
' 
the advisory board established under subsection (c), the Director 
of the National Institutes of Health shall develop a comprehensive 
plan for the conduct and support of sleep disorders research. 
"(2) The plan developed under paragraph (1) shall identify 
priorities with respect to such research and shall provide for the 
coordination of such research conducted or supported by the agen-
cies of the National Institutes of Health. 
"(3) The Director of the National Institutes of Health (after 
consultation with the Director of the Center and the advisory board 
established under subsection (c)) shall revise the plan developed 
under paragraph (1) as appropriate. 
"(e) The Director of the Center, in cooperation with the Centers 
for Disease Control and Prevention, is authorized to coordinate 
activities with the Department of Transportation, the Department 
of Defense, the Department of Education, the Department of Labor, 
and the Department of Commerce to collect data, conduct studies, 
and disseminate public information concerning the impact of sleep 
disorders and sleep deprivation.". 
SEC. 504. AUTHORIZATION OF APPROPRIATIONS. 
Subpart 2 of part C of title IV of the Public Health Service 
Act, as amended by section 503 of this Act, is amended by adding 
at the end the following section: 
"AUTHORIZATION OF APPROPRIATIONS 
42 use 285b-8. 
"SEC. 425. For the purpose of carrying out this subpart, there 
are authorized to be appropriated $1,500,000,000 for fiscal year 
1994, and such sums as may be necessary for each of the fiscal 
years 1995 and 1996.". 
SEC. 505. PREVENTION AND CONTROL PROGRAMS. 
Section 419 of the Public Health Service Act (42 U.S.C. 285b-
1) is amended by striking "The Director of the Institute" and all 
that follows and inserting the following: "(a) The Director of the 
Institute shall conduct and support programs for the prevention 
and control of heart, blood vessel, lung, and blood diseases. Such 
programs shall include community-based and population-based pro-
grams carried out in cooperation with other Federal agencies, with 
public health agencies of State or local governments, with nonprofit 
private entities that are community-based health agencies, or with 
other appropriate public or nonprofit private entities. 
"(b) In canying out programs under subsection (a), the Director 
of the Institute shall give special consideration to the prevention 
and control of heart, blood vessel, lung, and blood diseases in 
children, and in populations that are at increased risk with respect 
to such diseases.". 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 161 
TITLE VI—NATIONAL INSTITUTE ON DI-
ABETES AND DIGESTIVE AND KIDNEY 
DISEASES 
SEC. 601. PROVISIONS REGARDING NUTRITIONAL DISORDERS. 
Subpart 3 of part C of title IV of the Public Health Service 
Act (42 U.S.C. 285c et seq.) is amended by adding at the end 
the following section: 
"NUTRITIONAL DISORDERS PROGRAM 
"SEC. 434. (a) The Director of the Institute, in consultation 42 use 285c-8. 
with the Director of NIH, shall establish a program of conducting 
and supporting research, training, health information dissemina-
tion, and other activities with respect to nutritional disorders, 
including obesity. 
"(b) In canying out the program established under subsection 
(a), the Director of the Institute shall conduct and support each 
of the activities described in such subsection. 
"(c) In carrying out the program established under subsection 
(a), the Director of the Institute shall carry out activities to facilitate 
and enhance knowledge £ind understanding of nutritional disorders, 
including obesity, on the part of health professionals, patients, 
and the public through the effective dissemination of information.". 
(b) DEVELOPMENT AND EXPANSION OF RESEARCH AND TRAINING 
CENTERS.—Section 431 of the Public Health Service Act (42 U.S.C. 
285c-5) is amended— 
(1) by redesignating subsection (d) as subsection (e); and 
(2) by inserting after subsection (c) the following subsection: 
"(d)(1) The Director of the Institute shall, subject to the extent 
of amounts made available in appropriations Acts, provide for the 
development or substantial expansion of centers for research and 
training regarding nutritional disorders, including obesity. 
"(2) The Director of the Institute shall carry out paragraph 
(1) in collaboration with the Director of the National Cancer 
Institute and with the Directors of such other agencies of the 
National Institutes of Health as the Director of NIH determines 
to be appropriate. 
"(3) Each center developed or expanded imder paragraph (1) 
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 Director; 
"(B) conduct basic and clinical research into the cause, 
diagnosis, early detection, prevention, control and treatment 
of nutritional disorders, including obesity and the impact of 
nutrition and diet on child development; 
"(C) conduct training programs for physicians and allied 
health professionals in current methods of diagnosis and treat-
ment of such diseases £ind complications, and in research in 
such disorders; and 
"(D) conduct information programs for physicians and allied 
health professionals who provide primary care for patients with 
such disorders or complications.". 
107 STAT. 162 
PUBLIC LAW 103-43—JUNE 10, 1993 
TITLE VII—NATIONAL INSTITUTE ON 
ARTHRITIS AND MUSCULOSKELETAL 
AND SKIN DISEASES 
SEC. 701. JUVENILE ARTHRITIS. 
(a) PURPOSE.—Section 435 of the Public Health Service Act 
(42 U.S.C. 285d) is amended by striking "and other programs" 
and all that follows and inserting the following: "and other programs 
with respect to arthritis and musculoskeletal and skin diseases 
(including sports-related disorders), with particular attention to 
the effect of these diseases on children.". 
(b) PROGRAMS.—Section 436 (42 U.S.C. 285d-l) is amended— 
(1) in subsection (a), by inserting after the second sentence, 
the following: "The plan shall place particular emphasis upon 
expanding research into better understanding the causes and 
the development of effective treatments for arthritis affecting 
children."; and 
(2) in subsection (b)— 
(A) by strilring "and" at the end of paragraph (3); 
(B) by striking the period at the end of paragraph 
(4) and inserting "; and"; and 
(C) by adding at the end the following paragraph: 
"(5) research into the causes of arthritis affecting cluldren 
and the development, trial, and evaluation of techniques, drugs 
and devices used in the diagnosis, treatment (including medical 
rehabilitation), and prevention of arthritis in children.". 
(c) CENTERS.—Section 441 of the Public Health Service Act 
(42 U.S.C. 286d-6) is amended by adding at the end the following 
subsection: 
Establishment. 
"(f) Not later than October 1, 1993, the Director shall estabUsh 
a multipurpose arthritis and musculoskeletal disease center for 
the purpose of expanding the level of research into the cause, 
diagnosis, early detection, prevention, control, and treatment of, 
and rehabilitation of children with arthritis and musculoskeletal 
diseases.". 
(d) ADVISORY BOARD.— 
(1) TITLE.—Section 442(a) of the Pubhc Health Service 
Act (42 U.S.C. 285d-7(a)) is amended by inserting after "Arthri-
tis" the following: "and Musculoskeletal and Skin Diseases". 
(2) COMPOSITION.—Section 442(b) of the PubHc Health Serv-
ice Act (42 U.S.C. 285d-7(b)) is amended— 
(A) in the matter preceding paragraph (1), by striking 
"eighteen" and inserting "twenty"; and 
(B) in paragraph (1)(B)— 
(i) by striking "six" and inserting "eight"; and 
(ii) by striking "including" and all that follows 
and inserting the following: "including one member 
who is a person who has such a disease, one person 
who is the parent of an adult with such a disease, 
and two members who are parents of children with 
arthritis.". 
(3) ANNUAL REPORT.—Section 442(j) of the Pubhc Health 
Service Act (42 U.S.C. 285d-7(j)) is amended— 
(1) by striking "and" at the end of paragraph (3); 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 163 
(2) by striking the period at the end of paragraph (4) 
and inserting "; and"; and 
(3) by adding at the end the following paragraph: 
"(5) contains recommendations for expanding the Institute's 
funding of research directly applicable to the cause, diagnosis, 
early detection, prevention, control, and treatment of, and 
rehabilitation of children with arthritis and musculoskeletal 
diseases.". 
TITLE VIII—NATIONAL INSTITUTE ON 
AGING 
SEC. 801. ALZHEIMER'S DISEASE REGISTRY. 
(a) IN GENERAL.—Section 12 of PubUc Law 99-158 (99 Stat. 
885) is— 
42 u s e 285e-2 
(1) transferred to subpart 5 of part C of title IV of the "°*^^ 
PubUc Health Service Act (42 U.S.C. 285e et seq.); 
(2) redesignated as section 445G; and 
42 use 285e-9. 
(3) inserted after section 445F of such Act. 
(b) TECHNICAL AND CONFORMING AMENDMENTS.—Section 445G 
of the Public Health Service Act, as transferred and inserted by 
subsection (a) of this section, is amended— 
(1) by striking the section heading and all that follows 
through "may make a grant" in subsection (a) and inserting 
the following: 
"ALZHEIMER'S DISEASE REGISTRY 
"SEC. 445G. (a) IN GENERAL.—The Director of the Institute 
may make a grant"; £ind 
(2) by striking subsection (c). 
SEC. 802. AGING PROCESSES REGARDING WOMEN. 
Subpart 5 of part C of title IV of the Public Health Service 
Act, as amended by section 801 of this Act, is simended by adding 
at the end the following section: 
"AGING PROCESSES REGARDING WOMEN 
"SEC. 445H. The Director of the Institute, in addition to other 
42 use 285e-io. 
special functions specified in section 444 and in cooperation with 
the Directors of the other national research institutes and agencies 
of the National Institutes of Health, shall conduct research into 
the aging processes of women, with particular emphasis given to 
the effects of menopause and the physiological and behavioral 
changes occurring during the transition from pre- to post-meno-
pause, and into the diagnosis, disorders, and complications related 
to aging £ind loss of ovarian hormones in women.". 
SEC. 803. AUTHORIZATION OF APPROPRIATIONS. 
Subpart 5 of part C of title IV of the Public Health Service 
Act, as amended by section 802 of this Act, is amended by adding 
at the end the following section: 
107 STAT. 164 
PUBLIC LAW 103-43—JUNE 10, 1993 
"AUTHORIZATION OF APPROPRIATIONS 
42 use 285e-ii. 
"SEC. 445L For the purpose of carrying out this subpart, there 
are authorized to be appropriated $500,000,000 for fiscal year 1994, 
£ind such sums as may be necessary for each of the fiscal years 
1995 and 1996.". 
SEC. 804. CONFORMING AMENDMENT. 
Section 445C of the PubUc Health Service Act (42 U.S.C. 285e-
5), as amended by section 9 of Public Law 102-507 (106 Stat. 
3287), is amended— 
(1) in subsection (b)(1), in the first sentence, by inserting 
after "Council" the following: "on Alzheimer's Disease (in this 
section referred to as the 'Council')"; and 
(2) by adding at the end the following subsection: 
"(e) For purposes of this section, the term 'Council on Alz-
heimer's Disease' means the council established in section 911(a) 
ofPublic Law 99-660.". 
TITLE IX—NATIONAL INSTITUTE OF 
ALLERGY AND INFECTIOUS DISEASES 
SEC. 901. TROPICAL DISEASES. 
Section 446 of the Public Health Service Act (42 U.S.C. 285f) 
is amended by inserting before the period the following: ", including 
tropical diseases". 
SEC. 902. CHRONIC FATIGUE SYNDROME. 
(a) RESEARCH CENTERS.—Subpart 6 of part C of title IV of 
the PubUc Health Service Act (42 U.S.C. 285f) is amended by 
adding at the end the following section: 
"RESEARCH CENTERS REGARDING CHRONIC FATIGUE SYNDROME 
42 use 285f-i. 
«SEC. 447. (a) The Director of the Institute, after consultation 
with the advisory council for the Institute, may make grants to, 
or enter into contracts with, public or nonprofit private entities 
for the development and operation of centers to conduct basic and 
clinical research on chronic fatigue S3mdrome. 
"(b) Each center assisted under this section shall use the facili-
ties of a single institution, or be formed fi'om a consortium of 
cooperating institutions, meeting such requirements as may be pre-
scribed by the Director of the Institute.". 
42USC285f-i 
(b) EXTRAMURAL STUDY SECTION.—Not later than 6 months 
"°*^ 
after the date of enactment of this Act, the Secretary of Health 
and Human Services shall establish an extramural study section 
for chronic fatigue S5nidrome research. 
42 use 282 note. 
(c) REPRESENTATIVES.—The Secretary of Health and Human 
Services, acting through the Director of the National Institutes 
of Health, shall ensure that appropriate individuals with expertise 
in chronic fatigue syndrome or neuromuscular diseases and rep-
resentative of a variety of disciplines and fields within the research 
commimity are appointed to appropriate National Institutes of 
Health advisory committees and boards. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 165 
TITLE 
X—NATIONAL 
INSTITUTE 
OF 
CHILD HEALTH AND HUMAN DEVEL-
OPMENT 
Subtitle A—Research Centers With Respect w
o
m
e
n
. 
to Contraception and Research Centers 
With Respect to Infertility 
SEC. 1001. GRANTS AND CONTRACTS FOR RESEARCH CENTERS. 
Subpart 7 of part C of title IV of the Public Health Service 
Act, as amended by section 3 of Public Law 101-613, is amended 
by adding at the end the following section: 
"RESEARCH CENTERS WITH RESPECT TO CONTRACEPTION AND 
INFERTILITY 
"SEC. 452A. (a) The Director of the Institute, after consultation 
42 use 285g-5. 
with the advisory council for the Institute, shall make grants to, 
or enter into contracts with, public or nonprofit private entities 
for the development and operation of centers to conduct activities 
for the purpose of improving methods of contraception and centers 
to conduct activities for the purpose of improving methods of diag-
nosis and treatment of infertility. 
"(b) In carrying out subsection (a), the Director of the Institute 
shall, subject to the extent of amoimts made available in appropria-
tions Acts, provide for the establishment of three centers with 
respect to contraception and for two centers with respect to infertil-
ity. 
"(c)(1) Each center assisted imder this section shall, in carrymg 
out the purpose of the center involved— 
"(A) conduct clinical and other applied research, including— 
"(i) for centers with respect to contraception, clinical 
trials of new or improved drugs and devices for use by 
males and females (including barrier methods); and 
"(ii) for centers with respect to infertility, clinical trials 
of new or improved drugs and devices for the diagnosis 
and treatment of infertility in msQes and females; 
"(B) develop protocols for training physicians, scientists, 
nurses, and other health and allied health professionals; 
"(C) conduct training programs for such individuals; 
"(D) develop model continuing education programs for such 
professionals; and 
"(E) disseminate information to such professionals and the 
public. 
"(2) A center may use funds provided imder subsection (a) 
to provide stipends for health and allied health professionals 
enrolled in programs described in subparagraph (C) of paragraph 
(1), and to provide fees to individuals serving as subjects in clinical 
trials conducted under such paragraph. 
"(d) The Director of the Institute shall, as appropriate, provide 
for the coordination of information among the centers assisted under 
this section, 
"(e) Each center assisted under subsection (a) shall use the 
facilities of a single institution, or be formed from a consortium 
107 STAT. 166 
PUBLIC LAW 103-43—JUNE 10, 1993 
of cooperating institutions, meeting such requirements as may be 
prescribed by the Director of the Institute. 
"(f) Support of a center imder subsection (a) may be for a 
period not exceeding 5 years. Such period may be extended for 
one or more additional periods not exceeding 5 years if the oper-
ations of such center have been reviewed by an appropriate tech-
nical and scientific peer review group established by the Director 
Eind if such group has recommended to the Director that such 
period should be extended. 
Appropriation 
"(g) For the purpose of canying out this section, there are 
authorization. 
authorized to be appropriated $30,000,000 for fiscal year 1994, 
and such sums as may be necessary for each of the fiscal years 
1995 and 1996.". 
SEC. 1002. LOAN REPAYMENT PROGRAM FOR RESEARCH WITH 
RESPECT TO CONTRACEPTION AND INFERTILITY. 
Part G of title IV of the Public Health Service Act, as redesig-
nated by section 141(a)(2) of this Act, is amended by inserting 
after section 487A the following section: 
"LOAN REPAYMENT PROGRAM FOR RESEARCH WITH RESPECT TO 
CONTRACEPTION AND INFERTILITY 
42 use 288-2. 
"SEC. 487B. (a) The Secretary, in consultation with the Director 
of the National Institute of Child Health and Human Development, 
shall establish a program of entering into contracts with qualified 
health profession's (including graduate students) under which such 
health professionals agree to conduct research with respect to 
contraception, or with respect to infertility, in consideration of the 
Federal Government agreeing to repay, for each year of such service, 
not more than $20,000 of the principal and interest of the edu-
cational logins of such health professionals. 
"(b) The provisions of sections 338B, 338C, and 338E shall, 
except as inconsistent with subsection (a) of this section, apply 
' 
to the program established in subsection (a) to the same extent 
and in the same manner as such provisions apply to the National 
Health Service Corps Loan Repayment Program established in sub-
part III of part D of title III. 
"(c) Amounts available for carrying out this section shall remain 
available until the expiration of the second fiscal year beginning 
after the fiscal year for which the amoimts were made available.". 
Subtitle B—Program Regarding Obstetrics 
and Gynecology 
SEC. 1011. ESTABLISHMENT OF PROGRAM. 
Subpart 7 of part C of title IV of the Public Health Service 
Act, as amended by section 1001 of this Act, is amended by adding 
at the end the following section: 
"PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY 
42 use 285g-6. 
«SEC. 452B. The Director of the Institute shall estabhsh and 
maintain within the Institute an intramural laboratory and clinical 
research program in obstetrics and gynecology.". 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 167 
Subtitle C—Child Health Research Centers 
SEC. 1021. ESTABLISHMENT OF CENTERS. 
Subpart 7 of part C of title IV of the Public Health Service 
Act, as amended by section 1011 of this Act, is amended by adding 
at the end the following section: 
"CHILD HEALTH RESEARCH CENTERS 
"SEC. 452C. The Director of the Institute shall develop and 
42 use 28r)g-7. 
support centers for conducting research with respect to child health. 
Such centers shall give priority to the expeditious transfer of 
advances from basic science to clinical applications and improving 
the care of infants and children.". 
Subtitle D—Study Regarding Adolescent 
Health 
SEC 1031. PROSPECTIVE LONGITUDINAL STUDY. 
Subpart 7 of part C of title IV of the Public Health Service 
Act, as amended by section 1021 of this Act, is amended by adding 
at the end the following section: 
"PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT HEALTH 
"SEC. 452D. (a) IN GENERAL.—Not later than October 1, 1993, 42 use 285g-8. 
the Director of the Institute shall commence a study for the purpose 
of providing information on the general health and well-being of 
adolescents in the United States, including, with respect to such 
adolescents, information on— 
"(1) the behaviors that promote health and the behaviors 
that are detrimental to health; and 
"(2) the influence on health of factors particular to the 
communities in which the adolescents reside. 
"(b) DESIGN OF STUDY.— 
"(1) IN GENERAL.—The study required in subsection (a) 
shall be a longitudinal study in which a substantial number 
of adolescents participate as subjects. With respect to the pur-
pose described in such subsection, the study shall monitor 
the subjects throughout the period of the study to determine 
the health status of the subjects and any change in such status 
over time. 
"(2) POPULATION-SPECIFIC ANALYSES.—The study required 
in subsection (a) shall be conducted with respect to the popu-
lation of adolescents who are female, the population of adoles-
cents who are male, various socioeconomic populations of 
adolescents, and various racial and ethnic populations of adoles-
cents. The study shall be desired and conducted in a manner 
sufficient to provide for a valid analysis of whether there are 
significant differences among such populations in health status 
and whether and to what extent any such differences are due 
to factors particular to the populations involved. 
"(c) COORDINATION WITH WOMEN'S HEALTH INITIATIVE.—With 
respect to the national study of women being conducted by the 
Secretary and known as the Women's Health Initiative, the Sec-
retary shall ensure that such study is coordinated with the compo-
69-194 O - 94 - 7 : QL. 3 Part 1 
107 STAT. 168 
PUBLIC LAW 103-43—JUNE 10, 1993 
nent of the study required in subsection (a) that concerns adolescent 
females, including coordination in the design of the 2 studies.". 
TITLE XI—NATIONAL EYE INSTITUTE 
SEC. 1101. CLINICAL AND HEALTH SERVICES RESEARCH ON EYE CARE 
AND DIABETES. 
(a) IN GENERAL.—Subpart 9 of part C of title IV of the Pubhc 
Health Service Act (42 U.S.C. 285i) is amended by adding at the 
end the following section: 
"CLINICAL RESEARCH ON EYE CARE AND DIABETES 
42USC285i-i. 
«SEC. 456. (a) PROGRAM OF GRANTS.—The Director of the 
Institute, in consultation with the advisory council for the Institute, 
may award research grants to one or more Diabetes Eye Research 
Institutions for the support of programs in clinical or health services 
aimed at— 
"(1) providing comprehensive eye care services for people 
with diabetes, including a full complement of preventive, diag-
nostic and treatment procedures; 
"(2) developing new and improved techniques of patient 
care through basic and clinical research; 
"(3) assisting in tremslation of the latest research advances 
into clinical practice; and 
"(4) expanding the knowledge of the eye and diabetes 
through further research. 
"(b) USE OF FUNDS,—Amounts received under a grant awarded 
under this section shall be used for the following: 
"(1) Establishing the biochemical, cellular, and genetic 
mechanisms associated with diabetic eye disease and the earlier 
detection of pending eye abnormalities. The focus of work under 
this peiragraph shall require that ophthalmologists have train-
ing in the most up-to-date molecular and cell biological methods. 
"(2) Establishing new frontiers in technology, such as video-
based diagnostic and research resources, to— 
"(A) provide improved patient care; 
"(B) provide for the evaluation of retinal physiology 
and its affect on diabetes; and 
"(C) provide for the assessment of risks for the develop-
ment and progression of diabetic eye disease and a more 
immediate evaluation of various therapies aimed 
at 
preventing diabetic eye disease. 
Such technologies shall be designed to permit evaluations to 
be performed both in humans and in animal models. 
"(3) The translation of the results of vision research into 
the improved care of patients with diabetic eye disease. Such 
translation 
shall require the application of institutional 
resources that encompass patient care, clinical research and 
basic laboratory research. 
"(4) The conduct of research concerning the outcomes of 
eye care treatments and eye health education programs as 
they relate to patients with diabetic eye disease, including 
the evaluation of regional approaches to such research. 
"(c) AUTHORIZED EXPENDITURES.—The purposes for which a 
grant under subsection (a) may be expended include equipment 
for the research described in such subsection.". 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 169 
(b) 
CONFORMING 
AMENDMENT.—Section 455 
of the 
Public 
Health Service Act (42 U.S.C. 285i) is amended in the second 
sentence by striking "The Director" and inserting "Subject to section 
456, the Director". 
TITLE XII—NATIONAL INSTITUTE OF 
NEUROLOGICAL 
DISORDERS 
AND 
STROKE 
SEC. 1201. RESEARCH ON MULTIPLE SCLEROSIS. 
Subpart 10 of part C of title IV of the Public Health Service 
Act (42 U.S.C. 285j et seq.) is amended by adding at the end 
the following section: 
"RESEARCH ON MULTIPLE SCLEROSIS 
"SEC. 460. The Director of the Institute shall conduct and 42 use 285j-3. 
support research on multiple sclerosis, especially research on effects 
of genetics and hormonal changes on the progress of the disease.". 
TITLE XIII—NATIONAL INSTITUTE OF 
ENVIRONMENTAL HEALTH SCIENCES 
SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND TESTING PRO-
GRAM. 
(a) IN GENERAL.—Subpart 12 of part C of title IV of the PubKc 
Health Service Act (42 U.S.C. 2851) is amended by adding at the 
42 use 285/. 
end the following section: 
"APPLIED TOXICOLOGICAL RESEARCH AND TESTING PROGRAM 
"SEC. 463A. (a) There is established within the Institute a 
f^^fyyi^^s'^l-f' 
program for conducting applied research and testing regarding toxi-
cology, which program shall be known as the Applied Toxicological 
Research and Testing Program. 
"(b) In canning out the program established under subsection 
(a), the Director of the Institute shall, with respect to toxicology, 
carry out activities— 
"(1) to expand knowledge of the health effects of environ-
mental agents; 
"(2) to broaden the spectrum of toxicology information that 
is obtained on selected chemicals; 
"(3) to develop and validate assays and protocols, including 
alternative methods that can reduce or eliminate the use of 
animals in acute or chronic safety testing; 
"(4) to establish criteria for the validation and regulatory 
acceptance of alternative testing and to recommend a process 
through which scientifically validated alternative methods can 
be accepted for regulatory use; 
"(5) to communicate the results of research to government 
agencies, to medical, scientific, and regulatory communities, 
and to the public; and 
"(6) to integrate related activities of the Department of 
Health and Human Services.". 
107 STAT. 170 
PUBLIC LAW 103-43—JUNE 10, 1993 
(b) TECHNICAL AMENDMENT.—Section 463 of the Public Health 
42 use 285/. 
Service Act (42 U.S.C. 2851) is amended by inserting after "Sciences" 
the following: "(in this subpart referred to as the Institute')". 
TITLE XIV—NATIONAL LIBRARY OF 
MEDICINE 
Subtitle A—General Provisions 
SEC. 1401. ADDITIONAL AUTHORITIES. 
(a) IN GENERAL.—Section 465(b) of the Public Health Service 
Act (42 U.S.C. 286(b)) is amended— 
(1) by striking "and" after the semicolon at the end of 
paragraph (5); 
(2) by redesignating paragraph (6) as paragraph (8); and 
^ 
(3) by inserting after paragraph (5) the following para-
graphs: 
"(6) publicize the availability from the Library of the prod-
ucts £ind services described in any of paragraphs (1) through 
(5); 
"(7) promote the use of computers and telecommunications 
by health professionals (including health professionals in rural 
areas) for the purpose of improving access to biomedical 
information for health care deUvery and medical reseeirch; and". 
(b) LIMITATION REGARDING GRANTS.—Section 474(b)(2) of the 
Pubhc Health Service Act (42 U.S.C. 286b-5(b)(2)) is amended 
by striking "$750,000" and inserting "$1,000,000". 
(c) TECHNICAL AND CONFORMING AMENDMENTS.— 
(1) REPEAL OF CERTAIN AUTHORITY.—Section 215 of 
the 
Department of Health and Human Services Appropriations Act, 
1988, as contained in section 101(h) of Public Law 100-202 
42 use 286. 
(101 Stat. 1329-275), is repealed. 
42 use 286 note. 
(2) APPLICABILITY OF CERTAIN NEW AUTHORITY.—With 
respect to the authority established for the National Library 
of Medicine in section 465(b)(6) of the Public Heeilth Service 
Act, as added by subsection (a) of this section, such authority 
shall be effective as if the authority had been established on 
December 22,1987. 
SEC. 1402. AUTHORIZATION OF APPROPRIATIONS. 
(a) ESTABLISHMENT OF SINGLE AUTHORIZATION.—Subpart 1 of 
part D of title IV of the Pubhc Health Service Act (42 U.S.C. 
286 et seq.) is amended by adding at the end the following section: 
"AUTHORIZATION OF APPROPRIATIONS 
42 use 286a-2. 
"SEC. 468. (a) For the purpose of carrying out this part, there 
are authorized to be appropriated $150,000,000 for fiscal year 1994, 
and such sums as may be necesssiry for each of the fiscal years 
1995 and 1996. 
"(b) Amounts appropriated under subsection (a) and made avail-
able for grants or contracts imder any of sections 472 through 
476 shall remain available until the end of the fiscal year following 
the fiscal year for which the amounts were appropriated.". 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 171 
(b) CONFORMING AMENDMENTS.—Part D of title IV of the Public 
Health Service Act (42 U.S.C. 286 et seq.) is amended by striking 
section 469 and section 478(c). 
42 use 286b, 
286c. 
Subtitle B—Financial Assistance 
SEC. 1411. ESTABLISHMENT OF PROGRAM OF GRANTS FOR DEVELOP-
MENT OF EDUCATION TECHNOLOGIES. 
Section 473 of the PubUc Health Service Act (42 U.S.C. 286b-
4) is amended by adding at the end the foUovidng subsection: 
"(c)(1) The Secreteiry shall make grants to public or nonprofit 
private institutions for the purpose of carrying out projects of 
research on, and development and demonstration of, new education 
technologies. 
"(2) The purposes for which a grant under paragraph (1) may 
be made include projects concerning— 
"(A) computer-assisted teaching £ind testing of clinical com-
petence at health professions and research institutions; 
"(B) the effective transfer of new information fi-om research 
laboratories to appropriate clinical applications; 
"(C) the expansion of the laboratory and clinical uses of 
computer-stored research databases; and 
"(D) the testing of new technologies for treiining health 
care professionals. 
"(3) The Secretary may not make a grant under paragraph 
(1) unless the applicant for the grant agrees to make the projects 
available with respect t o ^ 
"(A) assisting in the training of health professions students; 
and 
"(B) enhancing and improving the capabilities of health 
professionals regarding research and teaching.". 
Subtitle C—^National Information Center 
on Health Services Research and Health 
Care Technology 
SEC. 1421. ESTABLISHMENT OF CENTER. 
Part D of title IV of the Pubhc Health Service Act (42 U.S.C. 
286 et seq.) is amended by adding at the end the following subpart: 
"Subpart 4—^National Information Center on He£ilth Services 
Research and Health Care Technology 
"NATIONAL INFORMATION CENTER 
" S E C 478A. (a) There is established within the Library an 42USC286d. 
entity to be known as the National Information Center on Health 
Services Research and Health Care Technology (in this section 
referred to as the 'Center'). 
"(b) The purpose of the Center is the collection, storage, analy-
sis, retrieval, and dissemination of information on health services 
research, clinical practice guidelines, and on health care technology, 
including the assessment of such technology. Such purpose includes 
developing and maintaining data bases and developing and 
implementing methods of carrying out such purpose. 
107 STAT. 172 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(c) The Director of the Center shall ensure that information 
under subsection (b) concerning clinical practice guidelines is col-
lected and maintained electronically and in a convenient format. 
Such Director shall develop £ind publish criteria for the inclusion 
of practice guidelines and technology assessments in the information 
center database. 
"(d) The Secretary, acting through the Center, shall coordinate 
the activities carried out under this section through the Center 
with related activities of the Administrator for Health Care PoHcy 
and Research.". 
SEC. 1422. CONFORMING PROVISIONS. 
(a) IN GENERAL.—Section 903 of the PubUc Health Service 
Act, as amended by section 3 of Public Law 102-410 (106 Stat. 
42 use 299a-i. 
2094), is amended by amending subsection (e) to read as follows: 
"(e) REQUIRED INTERAGENCY AGREEMENT.—The Administrator 
£ind the Director of the National Library of Medicine shall enter 
into an agreement providing for the implementation of section 
478A.". 
42 use 286d 
(b) RuLE OF CONSTRUCTION.—The amendments made by section 
"ot« 
3 of PubHc Law 102-410 (106 Stat. 2094), by section 1421 of 
this Act, and by subsection (a) of this section may not be construed 
as terminating the information center on health care technologies 
and health care technology assessment established under section 
904 of the Public Health Service Act, as in effect on the day 
before the date of the enactment of Public Law 102-410. Such 
center shall be considered to be the center established in section 
478A of the Public Health Service Act, as added by section 1421 
of this Act, and shall be subject to the provisions of such section 
478A. 
TITLE XV—OTHER AGENCIES OF 
NATIONAL INSTITUTES OF HEALTH 
Subtitle A—Division of Research 
Resources 
SEC. 1501. REDESIGNATION OF DIVISION AS NATIONAL CENTER FOR 
RESEARCH RESOURCES. 
Title IV of the PubHc Health Service Act (42 U.S.C. 281 et 
seq.) is amended— 
42 use 281. 
(1) in section 401(b)(2)(B), by amending such subparagraph 
to read as follows: 
"(B) The National Center for Research Resources."; and 
(2) in part E— 
(A) in the heading for subpart 1, by striking "Division 
of £ind inserting "National Center for"; 
42 use 287. 
(B) in section 479, by striking "the Division of Research 
Resources" £ind inserting the following: "the National Cen-
ter for Research Resources (in this subpart referred to 
as the 'Center')"; 
g use 287a, 
(C) in sections 480 and 481, by striking "the Division 
of Research Resources" each place such term appears and 
inserting "the Center"; and 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 173 
(D) in sections 480 and 481, as amended by subpara-
graph (C), by striking "the Division" each place such term 
appears and inserting "the Center". 
SEC. 1502. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES. 
Subpart 1 of part E of title IV of the Public Health Service 
Act (42 U.S.C. 287 et seq.) is amended by adding at the end 
the following section: 
"BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES 
" S E C 481A. (a) MODERNIZATION AND CONSTRUCTION OF FACILI- 
42 use 287a-2. 
TIES.— 
"(1) IN GENERAL.—The Director of NIH, acting through 
the Director of the Center, may make grants to public £md 
nonprofit private entities to expand, remodel, renovate, or alter 
existing research facilities or construct new research facilities, 
subject to the provisions of this section. 
"(2) CONSTRUCTION AND COST OF CONSTRUCTION.—For pur-
poses of this section, the terms 'construction' and 'cost of 
construction' include the construction of new buildings and 
the expansion, renovation, remodeling, and alteration of exist-
ing buildings, including architects' fees, but do not include 
the cost of acquisition of land or off-site improvements. 
"(b) SCIENTIFIC AND TECHNICAL REVIEW BOARDS FOR MERIT- Establishment. 
BASED REVIEW OF PROPOSALS.— 
"(1) IN GENERAL; APPROVAL AS PRECONDITION TO GRANTS.— 
"(A) There is established within the Center a Scientific 
and Technical Review Board on Biomedical and Behavioral 
Research Facilities (referred to in this section as the 
'Board'). 
"(B) The Director of the Center may approve an 
application for a grant under subsection (a) only if the 
Board has under paragraph (2) recommended the applica-
tion for approval. 
"(2) DUTIES.— 
"(A) The Board shall provide advice to the Director 
of the Center and the advisory council established under 
section 480 (in this section referred to as the 'Advisory 
Council') on canying out this section. 
"(B) In carrying out subparagraph (A), the Board shall 
make a determination of the merit of each application 
submitted for a grant under subsection (a), after consider-
ation of the requirements established in subsection (c), 
and shall report the results of the determination to the 
Director of the Center and the Advisory Council. Such 
determinations shall be conducted in a manner consistent 
with procedures established under section 492. 
"(C) In canying out subparagraph (A), the Board shall, 
in the case of applications recommended for approval, make 
recommendations to the Director and the Advisory Council 
on the amount that should be provided in the grant. 
"(D) In canying out subparagraph (A), the Board shall 
prepare an annual report for the Director of the Center 
and the Advisory Council describing the activities of the 
Board in the fiscal year for which the report is made. 
Each such report shall be available to the public, and 
shall— 
Reports. 
Public 
information. 
107 STAT. 174 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(i) summarize and analyze expenditures made 
under this section; 
"(ii) provide a summary of the t5T)es, numbers, 
and amoimts of appUcations that were recommended 
for grants under subsection (a) but that were not 
approved by the Director of the Center; and 
"(iii) contain the recommendations of the Board 
for any changes in the administration of this section. 
"(3) MEMBERSHIP.— 
"(A) Subject to subparagraph (B), the Board shall be 
composed of 9 appointed members, and such ex officio 
members as the Director of the Center determines to be 
appropriate. 
"(B) Not more than 3 individusds who are officers or 
employees of the Federal Government may serve as mem-
bers of the Board. 
"(4) CERTAIN REQUIREMENTS REGARDING MEMBERSHIP.—In 
selecting individuals for membership on the Board, the Director 
of the Center shall ensure that the members are individuals 
who, by virtue of their training or/experience, are eminently 
qualified to perform peer review functions. In selecting such 
individuals for such membership, the Director of the Center 
shsdl ensure that the members of the Board collectively— 
"(A) are experienced in the planning, construction, 
financing, and administration of entities that conduct bio-
medical or behavioral research sciences; 
"(B) are knowledgeable in making determinations of 
the need of entities for biomedical or behavioral research 
facilities, including such facilities for the dentistry, nursing, 
pharmacy, and allied health professions; 
"(C) are knowledgeable in evaluating the relative prior-
ities for applications for grants under subsection (a) in 
view of the overall research needs of the United States; 
and 
"(D) are experienced with emerging centers of excel-
lence, as described in subsection (c)(3). 
"(5) CERTAIN AUTHORITIES.— 
"(A) In carrying out paragraph (2), the Board may 
convene workshops and conferences, and collect data as 
the Board considers appropriate. 
"(B) In carrying out paragraph (2), the Board may 
establish subcommittees within the Board. Such sub-
committees may hold meetings as determined necessary 
to enable the subcommittee to carry out its duties. 
"(6) TERMS.— 
"(A) Except as provided in subparagraph (B), each 
appointed member of the Board shsill hold office for a 
term of 4 years. Any member appointed to fill a vacancy 
occurring prior to the expiration of the term for which 
such member's predecessor 
was 
appointed 
shall 
be 
appointed for the remainder of the term of the predecessor. 
"(B) Of the initial members appointed to the Board 
(as specified by the Director of the Center when making 
the appointments)— 
"(i) 3 shall hold office for a term of 3 years; 
"(ii) 3 shall hold office for a term of 2 years; and 
"(iii) 3 shall hold office for a term of 1 year. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 175 
"(C) No member is eligible for reappointment to the 
Board until 1 year has elapsed after the end of the most 
recent term of the member. 
"(7) COMPENSATION.—Members of the Board who 
are 
not 
officers or employees of the United States shall receive for 
each day the members are engaged in the performance of 
the functions of the Board compensation at the same rate 
received by members of other national advisory councils estab-
lished under this title. 
"(c) REQUIREMENTS FOR GRANTS.— 
"(1) IN GENERAL.—The Director of the Center may make 
a grant under subsection (a) only if the applicant for the grant 
meets the following conditions: 
"(A) The applicEint is determined by such Director to 
be competent to engage in the tj^e of research for which 
the proposed facility is to be constructed. 
"(B) The applicant provides assurances satisfactory to 
the Director that— 
"(i) for not less than 20 years after completion 
of the construction, the facility will be used for the 
purposes of research for which it is to be constructed; 
"(ii) sufficient funds will be available to meet the 
non-Federal share of the cost of constructing the facil-
ity; 
"(iii) sufficient funds will be available, when 
construction is completed, for the effective use of the 
facility for the research for which it is being con-
structed; and 
"(iv) the proposed construction will expand the 
applicant's capacity for research, or is necessary to 
improve or maintain the quality of the applicant's 
research. 
"(C) The applicant meets reasonable qualifications 
established by the Director with respect to— 
"(i) the relative scientific and technical merit of 
the applications, and the relative effectiveness of the 
proposed facilities, in expanding the capacity for bio-
medical or behavioral research and in improving the 
quality of such research; 
"(ii) the quality of the research or training, or 
both, to be carried out in the facilities involved; 
"(iii) the need of the applicant for such facilities 
in order to maintain or expand the applicant's research 
and training mission; 
"(iv) the congruence of the research activities to 
be carried out within the facility with the research 
and investigator manpower needs of the United States; 
and 
"(v) the age and condition of existing research 
facilities and equipment. 
"(D) The applicant has demonstrated a commitment 
to enhancing and expanding the research productivity of 
the applicant. 
"(2) CONSIDERATION OF CERTAIN FACTORS.—In making 
grants under subsection (a), the Director of the Center may, 
in addition to the requirements established in paragraph (1), 
consider the following factors: 
107 STAT. 176 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(A) To what extent the appUcant has the capacity 
to broaden the scope of research and research training 
programs of the appUcant by promoting— 
"(i) interdisciplinary research; 
"(ii) research on emerging technologies, including 
those involving novel analytical techniques or computa-
tional methods; or 
"(iii) other novel research mechanisms or pro-
grams. 
"(B) To what extent the applicant has broadened the 
scope of research and research training programs of quali-
fied institutions by promoting genomic research with an 
emphasis on interdisciplinary research, including research 
related to pediatric investigations. 
"(3) INSTITUTIONS OF EMERGING EXCELLENCE.—Of the 
amounts appropriated under subsection (h) for a fiscal year, 
the Director of the Center shall make available 25 percent 
for greints under subsection (a) to applicants that, in addition 
to meeting the requirements established in paragraph (1), have 
demonstrated emerging excellence in biomedical or behavioral 
research, as follows: 
"(A) The applicant has a plan for research or training 
advancement £ind possesses the ability to carry out the 
plan. 
"(B) The applic£int carries out research and research 
training programs that have a special relevance to a prob-
lem, concern, or unmet health need of the United States. 
"(C) The applicant has been productive in research 
or research development and training. 
"(D) The appUcant^ 
"(i) has been designated as a center of excellence 
under section 739; 
"(ii) is located in a geographic area whose popu-
lation includes a significant number of individuals with 
a health-status deficit, and the applicant provides 
health services to such individuals; or 
"(iii) is located in a geographic area in which a 
deficit in health care technology, services, or research 
resources may adversely affect health status of the 
population of the area in the future, and the applicant 
is carrying out activities with respect to protecting 
the health status of such population. 
\ 
"(d) REQUIREMENT OF APPLICATION.—The Director of the Center 
may make a grant under subsection (a) only if an application 
for the grant is submitted to the Director and the application 
is in such form, is made in such manner, and contains such agree-
ments, assurances, and information as the Director determines 
to be necessary to carry out this section. 
"(e) AMOUNT OF GRANT; PAYMENTS.— 
"(1) AMOUNT.—^The amount of any grant awarded under 
subsection (a) shall be determined by the Director of the Center, 
except that such amount shall not exceed— 
"(A) 50 percent of the necessary cost of the construction 
of a proposed facility as determined by the Director; or 
"(B) in the case of a multipurpose facility, 40 percent 
of that part of the necessary cost of construction that 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 177 
the Director determines to be proportionate to the con-
templated use of the facihty. 
"(2) RESERVATION OF AMOUNTS.—On approval of any 
application for a grant under subsection (a), the Director of 
the Center shall reserve, from any appropriation available 
therefore, the amount of such grant, and shall pay such amount, 
in advance or by way of reimbursement, and in such install-
ments consistent with the construction progress, as the Director 
may determine appropriate. The reservation of the Director 
of any amount by the Director under this paragraph may be 
amended by the Director, either on the approval of an amend-
ment of the application or on the revision of the estimated 
cost of construction of the facility. 
"(3) EXCLUSION OF CERTAIN COSTS.—In determining the 
amount of any grant under this subsection (a), there shall 
be excluded from the cost of construction an amount equal 
to the sum of— 
"(A) the amount of any other Federal grant that the 
applicant has obtained, or is assured of obtaining, with 
respect to construction that is to be financed in part by 
a grant authorized imder this section; and 
"(B) the amount of any non-Federal funds required 
to be expended as a condition of such other Federal grant. 
"(4) WAIVER OF LIMITATIONS.—The limitations imposed by 
paragraph (1) may be waived at the discretion of the Director 
for applicants meeting the conditions described in paragraphs 
(1) and (2) of subsection (c). 
"(f) RECAPTURE OF PAYMENTS.—If, not later than 20 years after 
the completion of construction for which a grant has been awarded 
under subsection (a)— 
"(1) the applicant or other owner of the facility shall cease 
to be a public or nonprofit private entity; or 
"(2) the facility shall cease to be used for the research 
purposes for which it was constructed (unless the Director 
determines, in accordance with regulations, that there is good 
cause for releasing the applicant or other owner from obligation 
to do so); 
the United States shall be entitled to recover from the applicant 
or other owner of the facility the amoimt bearing the same ratio 
to the current value (as determined by an agreement between 
the parties or by action brought in the United States District 
Court for the district in which such facility is situated) of the 
facility as the amount of the Federal participation bore to the 
cost of the construction of such facility. 
"(g) GUIDELINES.—Not later than 6 months after the date of 
the enactment of this section, the Director of the Center, sifter 
consultation with the Advisory Council, shall issue guidelines with 
respect to grants under subsection (a). 
"(h) AUTHORIZATION OF APPROPRLVTIONS.-For the purpose of 
carrying out this section, there are authorized to be appropriated 
$150,000,000 for fiscal yegir 1994, and such sums as may be nec-
essary for each of the fiscal years 1995 and 1996.". 
107 STAT. 178 
PUBLIC LAW 103-43—JUNE 10, 1993 
SEC. 1503. CONSTRUCTION PROGRAM FOR NATIONAL PRIMATE 
RESEARCH CENTER. 
Subpart 1 of part E of title IV of the Public Health Service 
Act, as amended by section 1502 of this Act, is amended by adding 
at the end the following section: 
"CONSTRUCTION OF REGIONAL CENTERS FOR RESEARCH ON PRIMATES 
Grants. 
"SEC. 481B. (a) With respect to activities carried out by the 
9?'i^TG^*?i,7 Q 
National Center for Research Resources to support regional centers 
4z ubc ^87a-d. 
^^^ research on primates, the Director of NIH shall, for each of 
the fiscal years 1994 through 1996, reserve fi*om the amounts 
appropriated imder section 481A(h) $5,000,000 for the purpose of 
making awards of grants and contracts to public or nonprofit private 
entities to construct, renovate, or otherwise improve such regional 
centers. The reservation of such amounts for any fiscal year is 
subject to the availability of qualified applicants for such awards. 
"(b) The Director of NIH may not make a grant or enter 
into a contract under subsection (a) unless the applicant for such 
assistance agrees, with respect to the costs to be incurred by the 
applicant in carrying out the purpose described in such subsection, 
to make available (directly or through donations firom public or 
private entities) non-Federal contributions in cash toward such 
costs in an amount equal to not less thein $1 for each $4 of Federal 
funds provided in such assistance.". 
Subtitle B—^National Center for Nursing 
Research 
SEC. 1511. REDESIGNATION OF NATIONAL CENTER FOR NURSING 
RESEARCH AS NATIONAL INSTITUTE OF NURSING 
RESEARCH. 
(a) IN GENERAL.—Subpart 3 of part E of title IV of the Public 
Health Service Act (42 U.S.C. 287c et seq.) is amended— 
42 use 287c. 
(1) in section 483— 
(A) in the heading for the section, by striking "CENTER" 
and inserting "INSTITUTE"; and 
(B) by striking "The general purpose" and all that 
follows through "is" and inserting the following: "The gen-
eral purpose of the National Institute of Nursing Research 
(in this subpart referred to as the 'Institute') is"; 
42 use 287c-1. 
(2) in section 484, by striking "Center" each place such 
term appears and inserting "Institute"; 
42 use 287C-2. 
(3) in section 485— 
(A) in subsection (a), in each of paragraphs (1) through 
(3), by striking "Center" each place such term appears 
and inserting "Institute"; 
(B) in subsection (b)— 
(i) in paragraph (2)(A), by striking "Center" and 
inserting "Institute"; and 
(ii) in paragraph (3)(A), in the first sentence, by 
striking "Center" and inserting "Institute"; and 
(C) in subsections (d) through (g), by striking "Center" 
each place such term appears and inserting "Institute"; 
eind 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 179 
(4) in section 485A (as redesignated by section 141(a)(1) 
of this Act), by striking "Center" each place such term appears 
and inserting "Institute", 
(b) CONFORMING AMENDMENTS.— 
(1) ORGANIZATION OF NATIONAL INSTITUTES OF HEALTH.— 
Section 401(b) of the PubHc Health Service Act (42 U.S.C. 
281(b)) is amended— 
(A) in paragraph (1), by adding at the end the following 
subparagraph: 
"(Q) The National Institute of Nursing Research."; and 
(B) in paragraph (2), by striking subparagraph (D). 
(2) TRANSFER OF STATUTORY PROVISIONS.—The Public 
Health Service Act, as amended by subsection (a) of this section 
and by section 124 of PubHc Law 102-321 (106 Stat. 364), 
is amended— 
(A) by transferring sections 483 through 485A to part 
42 use 287c— 
C of title IV; 
287c-3, 285q-
(B) by redesignating such sections as sections 464V 285q-3. 
through 464Y of such part; and 
(C) by adding such sections, in the 
appropriate 
sequence, at the end of such part. 
(3) HEADING FOR NEW SUBPART.—Title IV of the Public 
Health Service Act, as amended by the preceding provisions 
of this section, is amended— 
(A) in part C, by inserting before section 464V the 
following: 
"Subpart 17—National Institute of Nursing Research"; 
and 
(B) by striking the subpart designation and heading 
for subpart 3 of part E. 
(4) CROSS-REFERENCES.—Title IV of the Public Health Serv-
ice Act, as amended by the preceding provisions of this section, 
is amended in subpart 17 of part C— 
(A) in section 464W, by striking "section 483" and 
inserting "section 464V"; 
(B) in section 464X(g), by striking "section 486" and 
inserting "section 464Y"; and 
(C) in section 464Y, in the last sentence, by striking 
"section 485(g)" and inserting "section 464X(g)". 
SEC. 1512. STUDY ON ADEQUACY OF NUMBER OF NURSES. 
42 USC 285q 
(a) IN GENERAL.—The Secreteiry of Health and Human Services, Contracts. 
acting through the Director of the National Institute of Nursing 
Research, shall enter into a contract with a public or nonprofit 
private entity to conduct a study for the purpose of determining 
whether and to what extent there is a need for an increase in 
the number of nurses in hospitals and nursing homes in order 
to promote the quality of patient care and reduce the incidence 
among nurses of work-related injuries and stress. 
(b) NATIONAL ACADEMY OF SCIENCES.—The Secretary shall 
request the Institute of Medicine of the National Academy of 
Sciences to enter into the contract under subsection (a) to conduct 
the study described in such subsection. If such Institute declines 
to conduct the study, the Secretary shall carry out such subsection 
through emother public or nonprofit private entity. 
(c) DEFINITIONS.—For purposes of this section: 
107 STAT. 180 
PUBLIC LAW 103-43—JUNE 10, 1993 
(1) The term "nurse" means a registered nurse, a licensed 
practical nurse, a licensed vocational nurse, and a nurse assist-
ant. 
(2) The term "Secretary" means the Secretary of Health 
and Human Services. 
(d) REPORT.—^The Secretary shall ensure that, not later than 
18 months after the date of the enactment of this Act, the study 
required in subsection (a) is completed and a report describing 
the findings made as a result of the study is submitted to the 
Committee on Energy and Commerce of the House of Representa-
tives and to the Committee on Labor and Human Resources of 
the Senate. 
Subtitle C—^National Center for Human 
Genome Research 
SEC. 1521. PURPOSE OF CENTER. 
Title IV of the Public Health Service Act, as amended by 
section 141(a)(1) of this Act and by paragraphs (1)(B) and (3)(B) 
of section 1511(b) of this Act, is amended— 
42 use 281. 
(1) in section 401(b)(2), by adding at the end the following 
subparagraph: 
"(D) The National Center for Human Genome Research."; 
and 
(2) in pgirt E, by adding at the end the following subpart: 
"Subpart 3—National Center for Human Genome Research 
"PURPOSE OF THE CENTER 
42 use 287c. 
"SEC. 485B. (a) The general purpose of the National Center 
for Human Genome Research (in this subpart referred to as the 
'Center') is to characterize the structure and function of the human 
§enome, including the mapping and sequencing of individual genes, 
uch purpose includes— 
"(1) planning and coordinating the research goal of the 
genome project; 
"(2) reviewing and funding research proposals; 
"(3) developing training programs; 
"(4) coordinating international genome research; 
"(5) communicating advances in genome science to the pub-
lic; and 
"(6) reviewing and fiinding proposals to address the ethical 
and legal issues associated with the genome project (including 
legal issues regarding patents). 
"(b) The Director of the Center may conduct and support 
research training— 
"(1) for which fellowship support is not provided under 
section 487; and 
"(2) that is not residency training of physicians or other 
health professionals. 
"(c)(1) Except as provided in psiragraph (2), of the emaotints 
appropriated to carry out subsection (a) for a fiscal year, the Director 
of the Center shall make avsdlable not less than 5 percent for 
carrying out paragraph (6) of such subsection. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 181 
"(2) With respect to providing funds under subsection (a)(6) 
for proposals to address the ethical issues associated with the 
genome project, paragraph (1) shall not apply for a fiscal year 
if the Director of the Center certifies to the Committee on Energy 
and Commerce of the House of Representatives, and to the Commit-
tee on Labor and Human Resources of the Senate, that the Director 
has determined that an insufficient number of such proposals meet 
the applicable requirements of sections 491 and 492.". 
TITLE XVI—AWARDS AND TRAINING 
Subtitle A—^National Research Service 
Awards 
SEC. 1601. REQUIREMENT REGARDING WOMEN AND INDIVIDUALS 
FROM DISADVANTAGED BACKGROUNDS. 
Section 487(a) of the PubUc Health Service Act (42 U.S.C. 
288(a)(4)) is amended by adding at the end the following paragraph: 
"(4) The Secretary shall carry out paragraph (1) in a manner 
that will result in the recruitment of women, and individuals fi'om 
disadvantaged backgrounds (including racial and ethnic minorities), 
into fields of biomedical or behavioral research and in the provision 
of research training to women and such individuals.". 
SEC. 1602. SERVICE PAYBACK REQUIREMENTS. 
Section 487(c) of the Public Health Service Act (42 U.S.C. 
288(c)) is amended by striking paragraphs (1) and (2) and inserting 
the following: "(1) Each individu^ who is awarded a National 
Research Service Award for postdoctoral research training shall, 
in accordance with paragraph (3), engage in research training, 
research, or teaching that is health-related (or any combination 
thereof) for the period specified in paragraph (2). Such period shall 
be served in accordance with the usual patterns of scientific employ-
ment. 
"(2)(A) The period referred to in paragraph (1) is 12 months, 
or one month for each month for which the individual involved 
receives a National Research Service Award for postdoctoral 
research training, whichever is less. 
"(B) With respect to postdoctoral research training, in any 
case in which an individual receives a National Research Service 
Award for more than 12 months, the 13th month and each subse-
quent month of performing activities under the Award shall be 
considered to be activities engaged in toward satisfaction of the 
requirement established in paragraph (1) regarding a period of 
service.". 
Subtitle B—^Acquired Immune Deficiency 
Syndrome 
SEC. 1611. LOAN REPAYMENT PROGRAM. 
(a) IN GENERAL.—Section 487A of the Public Health Service 
Act (42 U.S.C. 288-1) is amended to read as follows: 
107 STAT. 182 
PUBLIC LAW 103-43—JUNE 10, 1993 
Contracts. 
42 u s e 288-1 
note. 
"LOAN REPAYMENT PROGRAM FOR RESEARCH WITH RESPECT TO 
ACQUIRED IMMUNE DEFICIENCY SYNDROME 
"SEC. 487A. (a) IN GENERAL,—The Secretary shall carry out 
a program of entering into agreements with appropriately qualified 
health professionals under which such health professionals agree 
to conduct, as employees of the National Institutes of Health, 
research with respect to acquired immune deficiency syndrome in 
consideration of the Federal Government agreeing to repay, for 
each year of such service, not more than $20,000 of the principal 
and interest of the educational loans of such health professionals. 
"(b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to 
the National Health Service Corps Loan Repajrment Progrsim estab-
lished in subpart III of part D of title III, the provisions of such 
subpart shall, except as inconsistent with subsection (a) of this 
section, apply to the program established in such subsection (a) 
in the same manner and to the same extent as such provisions 
apply to the National Health Service Corps Loan Repa3maent Pro-
gram established in such subpart. 
"(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
canying out this section, there are authorized to be appropriated 
such sums as may be necessary for each of the fiscal years 1994 
through 1996.". 
(b) APPLICABILITY.—The amendment made by subsection (a) 
does not apply to any agreement entered into under section 487A 
of the Public Health Service Act before the date of the enactment 
of this Act. Each such agreement continues to be subject to the 
terms of the agreement in effect on the day before such date. 
Subtitle C—^Loan Repayment for Research 
Generally 
SEC. 1621. ESTABLISHMENT OF PROGRAM. 
Part G of title IV of the Public Health Service Act, as redesig-
nated by section 141(a)(2) of this Act and as amended by section 
1002 of this Act, is amended by inserting after section 487B the 
following section: 
Contracts. 
42 u s e 288-3. 
"LOAN REPAYMENT PROGRAM FOR RESEARCH GENERALLY 
"SEC. 487C. (a) IN GENERAL.— 
"(1) AUTHORITY FOR PROGRAM.—Subject to paragraph (2), 
the Secretsiry shall carry out a program of entering into con-
tracts with appropriately qualified health professionals under 
which such health professionals agree to conduct resesirch, as 
employees of the National Institutes of Health, in consideration 
of the Federal Government agreeing to repay, for each year 
of such service, not more than $20,000 of the principal and 
interest of the educational loans of such health professionals. 
"(2) LIMITATION.—^The Secretary may not enter into an 
agreement with a health professional pursuant to paragraph 
(1) unless such professional— 
"(A) has a substantial amount of educational loans 
relative to income; and 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 183 
"(B) agrees to serve as an employee of the National 
Institutes of Health for purposes of paragraph (1) for a 
period of not less than 3 years. 
"(b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to 
the National Health Service Corps Lo£in Repayment Program estab-
lished in subpart III of part D of title III, the provisions of such 
subpart shall, except as inconsistent with subsection (a) of this 
section, apply to the program established in such subsection (a) 
in the same manner and to the same extent as such provisions 
apply to the National Health Service Corps Loan Repayment Pro-
gram established in such subpart.". 
Subtitle D—Scholarship and Loan Repay-
ment Programs Regarding Professional 
Skills Needed by Certain Agencies 
SEC. 1631. ESTABLISHMENT 
OF 
PROGRAMS 
FOR 
NATIONAL 
INSTITUTES OF HEALTH. 
Part G of title IV of the Public Health Service Act, as redesig-
nated by section 141(a)(2) of this Act and as amended by section 
1621 of this Act, is amended by inserting after section 487C the 
following sections: 
"UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS 
NEEDED BY NATIONAL RESEARCH INSTITUTES 
"SEC. 487D. (a) ESTABLISHMENT OF PROGRAM.— 
42 use 288-4. 
"(1) IN GENERAL.—Subject to section 487(a)(1)(C), the Sec-
retary, acting through the Director of NIH, may carry out 
a program of entering into contracts with individuals described 
in paragraph (2) under which— 
"(A) the Director of NIH agrees to provide to the 
individuals scholarships for pursuing, as imdergraduates 
at accredited institutions of higher education, academic 
programs appropriate for careers in professions needed by 
the National Institutes of Health; and 
"(B) the individuals agree to serve as employees of 
the National Institutes of Health, for the period described 
in subsection (c), in positions that £ire needed by the 
National Institutes of Health and for which the individuals 
are qualified. 
"(2) INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS.— 
The individuals referred to in paragraph (1) are individuals 
who— 
"(A) are enrolled or accepted for enrollment as full-
time undergraduates at accredited institutions of higher 
education; and 
"(B) are from disadvantaged backgroimds. 
"(b) FACILITATION OF INTEREST OF STUDENTS IN CAREERS AT 
NATIONAL INSTITUTES OF HEALTH.—In providing emplojnnent to 
individuals pursuant to contracts \inder subsection (a)(1), the Direc-
tor of NIH shall carry out activities to facilitate the interest of 
the individuals in pursuing careers as employees of the National 
Institutes of Health. 
"(c) PERIOD OF OBLIGATED SERVICE.— 
107 STAT. 184 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(1) DURATION OF SERVICE.—For purposes of subparagraph 
(B) of subsection (a)(1), the period of service for which an 
individual is obligated to serve as an employee of the National 
Institutes of Health is, subject to paragraph (2)(A), 12 months 
for each academic year for which the scholarship under such 
subsection is provided. 
"(2) SCHEDULE FOR SERVICE.— 
"(A) Subject to subparagraph (B), the Director of NIH 
may not provide a scholarship under subsection (a) imless 
the individual applying for the scholarship agrees that— 
"(i) the individual will serve as an employee of 
the National Institutes of Health full-time for not less 
than 10 consecutive weeks of each year during which 
the individual is attending the educational institution 
involved and receiving such a scholarship; 
"(ii) the period of service as such an employee 
that the individual is obligated to provide under clause 
(i) is in addition to the period of service as such an 
employee that the individual is obligated to provide 
under subsection (a)(1)(B); and 
"(iii) not later than 60 days after obtaining the 
educational degree involved, the individual will begin 
serving full-time as such an employee in satisfaction 
of the period of service that the individual is obligated 
to provide under subsection (a)(1)(B). 
"(B) The Director of NIH may defer the obligation 
of an individual to provide a period of service under sub-
section (a)(1)(B), if the Director determines that such a 
deferral is appropriate. 
"(3) APPLICABILITY OF CERTAIN PROVISIONS RELATING TO 
APPOINTMENT AND COMPENSATION.—For any period in which 
an individual provides service as an employee of the National 
Institutes of Health in satisfaction of the obligation of the 
individual under subsection (a)(1)(B) or paragraph (2)(A)(i), the 
individual may be appointed as such an employee without 
regard to the provisions of title 5, United States Code, relating 
to appointment and compensation. 
"(d) PROVISIONS REGARDING SCHOLARSHIP.— 
"(1) APPROVAL OF ACADEMIC PROGRAM.—The Director of 
NIH may not provide a scholarship under subsection (a) for 
an academic year unless— 
"(A) the individual applying for the scholarship has 
submitted to the Director a proposed academic program 
for the year and the Director has approved the program; 
and 
"(B) the individual agrees that the program will not 
be altered without the approval of the Director. 
"(2) ACADEMIC STANDING.—The Director of NIH may not 
provide a scholarship under subsection (a) for an academic 
year unless the individual applying for the scholarship agrees 
to maintain an acceptable level of academic standing, as deter-
mined by the educational institution involved in accordeuice 
with regulations issued by the Secretary. 
"(3) LIMITATION ON AMOUNT.—The Director of NIH may 
not provide a scholarship under subsection (a) for an academic 
year in an amount exceeding $20,000. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 185 
"(4) AUTHORIZED USES.—^A scholarship provided under sub-
section (a) may be expended only for tuition expenses, other 
reasonable 
educational 
expenses, 
and 
reasonable 
living 
expenses incurred in attending the school involved. 
"(5) CONTRACT REGARDING DIRECT PAYMENTS TO INSTITU-
TION.—In the case of an institution of higher education with 
respect to which a scholarship under subsection (a) is provided, 
the Director of NIH may enter into a contract with the institu-
tion under which the amounts provided in the scholarship 
for tuition and other educational expenses are paid directly 
to the institution. 
"(e) PENALTIES FOR BREACH OF SCHOLARSHIP CONTRACT.—The 
provisions of section 338E shall apply to the program established 
in subsection (a) to the same extent and in the same manner 
as such provisions apply to the National Health Service Corps 
Loan Repayment Program established in section 338B. 
"(f) REQUIREMENT OF APPLICATION.—The Director of NIH 
may 
not provide a scholarship under subsection (a) unless £in application 
for the scholarship is submitted to the Director and the application 
is in such form, is made in such manner, and contains such agree-
ments, assurances, and information as the Director determines 
to be necessary to carry out this section. 
"(g) 
AVAILABILITY OF AUTHORIZATION OF APPROPRIATIONS.— 
Amoimts appropriated for a fiscal year for scholarships under this 
section shall remain available imtil the expiration of the second 
fiscal year beginning after the fiscal year for which the amounts 
were appropriated. 
"LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS 
FROM DISADVANTAGED BACKGROUNDS 
"SEC. 487E. (a) IMPLEMENTATION OF PROGRAM.— 
42 use 288-5. 
"(1) IN GENERAL.—Subject to section 487(a)(1)(C), the Sec-
retary, acting through the Director of NIH may, subject to 
paragraph (2), carry out a program of entering into contracts 
with appropriately qualified health professionals who are from 
disadvantaged backgrounds under which such health profes-
sionals agree to conduct clinical research as employees of the 
National Institutes of Health in consideration of the Federal 
Government agreeing to pay, for each year of such service, 
not more than $20,000 of the principal and interest of the 
educational loans of the health professionals. 
"(2) LIMITATION.—The Director of NIH may not enter into 
a contract with a health professional pursuant to psiragraph 
(1) unless such professional has a substantial amount of edu-
cation loans relative to income. 
"(3) APPLICABILITY OF CERTAIN PROVISIONS REGARDING OBLI-
GATED SERVICE.—Except to the extent inconsistent with this 
section, the provisions of sections 338C and 338E shall apply 
to the program established in paragraph (1) to the same extent 
and in the same manner as such provisions apply to the 
National Health Service Corps Loan Repayment Program estab-
lished in section 338B. 
"(b) 
AVAILABILITY OF AUTHORIZATION OF APPROPRIATIONS.— 
Amounts appropriated for a fiscal year for contracts under sub-
section (a) shall remain available until the expiration of the second 
fiscal year beginning after the fiscal year for which the amounts 
were appropriated.". 
107 STAT. 186 
PUBLIC LAW 103-43—JUNE 10, 1993 
SEC. 1632. FUNDING. 
Section 487(a)(1) of the Public Health Service Act (42 U.S.C. 
288(a)(1)) is amended— 
(1) in subparagraph (A), by striking "and" after the semi-
colon at the end; 
(2) in subparagraph (B), by striking the period at the 
end and inserting "; and"; and 
(3) by inserting after subparagraph (B) the following 
subparagraph: 
"(C) provide contracts for scholarships and loan repayments 
in accordance with sections 487D and 487E, subject to providing 
not more than an aggregate 50 such contracts during the fisc^ 
years 1994 through 1996.". 
Subtitle E—Funding 
SEC. 1641. AUTHORIZATION OF APPROPRIATIONS. 
Section 487(d) of the PubUc Health Service Act (42 U.S.C. 
288(d)) is amended— 
(1) in the first sentence, by amending the sentence to 
read as follows: "For the purpose of carrying out this section, 
there are authorized to be appropriated $400,000,000 for fiscal 
year 1994, and such sums as may be necessary for each of 
the fiscal years 1995 and 1996."; and 
(2) in paragraph (3)— 
(A) by striking "one-half of one percent" each place 
such term appears and inserting "1 percent"; and 
(B) by striking "780, 784, or 786," and inserting "747, 
748, or 749,". 
TITLE XVII—NATIONAL FOUNDATION 
FOR BIOMEDICAL RESEARCH 
SEC. 1701. NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH. 
Section 499 of the Public Health Service Act, as redesignated 
by section 121(b)(3) of this Act, is amended— 
(1) in subsection (a)— 
(A) by inserting ", acting through the Director of NIH," 
eifter "Secretary shall"; and 
(B) by striking ", except for" and all that follows 
through "Transfer Act,"; 
(2) by redesignating subsections (c), (d), (e), (f), (g), (h), 
and (i) as subsections (d), (f), (g), (h), (i), (j), and (m), respec-
tively; 
(3) by striking subsection (b) and inserting the following 
subsections: 
"(b) PURPOSE OF FOUNDATION.—The purpose of the Foundation 
shall be to support the National Institutes of Health in its mission, 
and to advEince collaboration with biomedical researchers from 
universities, industry, and nonprofit organizations. 
"(c) CERTAIN ACTIVITIES OF FOUNDATION.— 
"(1) IN GENERAL.—In carrjdng out subsection (b), the 
Foundation may solicit and accept gifts, grants, and other dona-
tions, establish accounts, and invest and expend funds in sup-
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 187 
port of the following activities with respect to the purpose 
described in such subsection: 
"(A) A program to provide and administer endowed 
positions that are associated with the research program 
of the National Institutes of Health. Such endowments 
may be expended for the compensation of individuals hold-
ing the positions, for staff, equipment, quarters, travel, 
and other expenditures that are appropriate in supporting 
the endowed positions. 
"(B) A program to provide and administer fellowships 
and grants to research personnel in order to work £ind 
study in association with the National Institutes of Health. 
Such fellowships and grants may include stipends, travel, 
health insurance benefits and other appropriate expenses. 
The recipients of fellowships shall be selected by the donors 
and the Foundation upon the recommendation of the 
National Institutes of Health employees in the laboratory 
where the fellow would serve, sind shall be subject to the 
agreement of the Director of the National Institutes of 
Health and the Executive Director of the Foundation. 
"(C) Supplementary programs to provide for— 
"(i) scientists of other countries to serve in research 
capacities in the United States in association with 
the National Institutes of Health or elsewhere, or 
opportimities for employees of the National Institutes 
of Health or other public health officials in the United 
States to serve in such capacities in other countries, 
or both; 
"(ii) the conduct and support of studies, projects, 
and research, which may include stipends, travel and 
other support for personnel in collaboration with 
national and international non-profit and for-profit 
organizations; 
"(iii) the conduct and support of forums, meetings, 
conferences, courses, and training workshops that may 
include undergraduate, graduate, post-graduate, and 
post-doctoral accredited courses and the maintenance 
of accreditation of such courses by the Foundation at 
the State and national level for college or continuing 
education credits or for degrees; 
"(iv) programs to support and encourage teachers 
£uid students of science at all levels of education and 
programs for the general public which promote the 
understanding of science; 
"(v) programs 
for 
writing, 
editing, 
printing, 
publishing, and vending of books and other materials; 
and 
"(vi) the conduct of other activities to carry out 
and support the purpose described in subsection (b). 
"(2) FEES.—The Foundation may assess fees for the provi-
sion of professional, administrative and management services 
by the Foundation in amounts determined reasonable and 
appropriate by the Executive Director. 
"(3) AUTHORITY OF FOUNDATION.—The Foimdation shall be 
the sole entity responsible for ceurying out the activities 
described in this subsection."; 
(4) in subsection (d) (as so redesignated)— 
107 STAT. 188 
PUBLIC LAW 103-43—JUNE 10, 1993 
(A) in paragraph (1)— 
(i) by striking "members of the Foundation" in 
subparagraph (A) and inserting "appointed members 
of the Board"; 
(ii) by striking "Council" in subparagraph (B) and 
inserting "Board"; 
(iii) by striking "Council" in subparagraph (C) and 
inserting "Board"; and 
(iv) by adding at the end the following subpara-
graphs: 
"(D)(i) Not later than 30 days after the date of the 
enactment of the National Institutes of Health Revitaliza-
tion Act of 1993, the Director of the National Institutes 
of Health shall convene a meeting of the ex officio members 
of the Board to— 
"(I) incorporate the Foundation and establish the 
general policies of the Foundation for carrying out 
the purposes of subsection (b), including the establish-
ment of the bylaws of the Foundation; and 
"(II) appoint the members of the Board in accord-
ance with subparagraph (C). 
"(ii) Upon the appointment of the members of the Board 
under clause (i)(II), the terms of service of the ex officio 
members of the Board as members of the Board shall 
terminate. 
"(E) The agreement of not less than three-fifths of 
the members of the ex officio members of the Board shall 
be required for the appointment of each member to the 
initisil Board. 
"(F) No employee of the National Institutes of Health 
shall be appointed as a member of the Board. 
"(G) The Board may, through amendments to the 
bylaws of the Foundation, provide that the number of mem-
bers of the Board shall be greater than the niunber speci-
fied in subparagraph (C)."; 
(B) in paragraph (2)— 
(i) by striking "The ex officio" and inserting the 
following: 
"(A) The ex officio"; 
(ii) by striking "an appointed member of the Board 
to serve as the Chair" and inserting "an individual 
to serve as the initial Chair"; and 
(iii) by adding at the end the following subpara-
graph: 
"(B) Upon the termination of the term of service of the 
initial Chair of the Board, the appointed members of the Board 
shall elect a member of the Bosird to serve as the Chair of 
the Board."; 
(C) in paragraph (3)(A), by striking "(2)(C)" and insert-
ing "(1)(C)"; and 
(D) by adding at the end the following paragraphs: 
"(5) MEETINGS AND QUORUM.—A majority of the members 
of the Board shall constitute a quorum for purposes of conduct-
ing the business of the Board. 
"(6) CERTAIN BYLAWS.— 
"(A) In establishing bylaws under this subsection, the 
Board shall ensure that the following are provided for: 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 189 
"(i) Policies for the selection of the officers, employ-
ees, agents, and contractors of the Foundation. 
"(ii) Policies, including ethical standards, for the 
acceptance, solicitation, and disposition of donations 
£ind grants to the Foundation and for the disposition 
of the assets of the Foundation. Policies with respect 
to ethical standards shall ensure that officers, employ-
ees and agents of the Foundation (including members 
of the Board) avoid encumbrances that would result 
in a conffict of interest, including a financial conflict 
of interest or a divided allegiance. Such policies shall 
include requirements for the provision of information 
concerning any ownership or controlling interest in 
entities related to the activities of the Foundation by 
such officers, employees and agents and their spouses 
and relatives. 
"(iii) Policies for the conduct of the general oper-
ations of the Foundation. 
"(iv) Policies for writing, editing, printing, publish-
ing, £ind vending of books and other materials. 
"(B) In establishing bylaws under this subsection, the 
Board shall ensure that such bylaws (and activities carried 
out under the bylaws) do not— 
"(i) reflect unfavorably upon the ability of the 
Foundation or the National Institutes of Health to 
carry out its responsibilities or official duties in a fair 
and objective manner; or 
"(ii) compromise, or appear to compromise, the 
integrity of any governmental agency or program, or 
any officer or employee involved in such program."; 
(5) in subsection (i) (as so redesignated)— 
(A) in paragraph (4), by inserting ", and define the 
duties of the officers and employees" before the semicolon 
at the end; 
(B) by striking paragraph (5); 
(C) by redesignating paragraphs (6) through (14), as 
paragraphs (5) through (13), respectively; 
(D) in paragraph (7) (as so redesignated), by striking 
"this subtitle" and inserting "this part"; 
(E) by striking paragraph (8) (as so redesignated), and 
inserting the following paragraph: 
"(8) establish a process for the selection of candidates for 
positions under subsection (c);" 
(F) by inserting "solicit" after the paragraph designa-
tion in paragraph (11) (as so redesignated); 
(G) by striking "and" at the end of paragraph (13) 
(as so redesignated); 
(H) by inserting after paragraph (13) (as so redesig-
nated), the following paragraph: 
"(14) enter into such other contracts, leases, cooperative 
agreements, and other transactions as the Executive Director 
considers appropriate to conduct the activities of the Foimda-
tion; and"; £ind 
(I) in paragraph (15), by striking "this subtitle" and 
inserting "this part"; 
(6) by inserting after subsection (j) (as so redesignated), 
the following subsections: 
107 STAT. 190 
PUBLIC LAW 103-43—JUNE 10, 1993 
"(k) GENERAL PROVISIONS.— 
"(1) FOUNDATION INTEGRITY.—^The members of the Board 
shall be accountable for the integrity of the operations of the 
Foundation £ind shedl ensure such integrity through the devel-
opment and enforcement of criteria and procedures relating 
to standards of conduct (including those developed xmder sub-
section (d)(2)(B)(i)(II)), financial disclosure statements, conflict 
of interest rules, recusal and waiver rules, audits and other 
matter determined appropriate by the Board. 
"(2) FINANCIAL CONFLICTS OF INTEREST.—Any individual 
who is an officer, employee, or member of the Board of the 
Foundation may not (in accordance with policies and require-
ments developed under subsection (d)(2)(B)(i)(II)) personally or 
substantially participate in the consideration or determination 
by the Foundation of any matter that would directly or predict-
ably affect any financial interest of the individual or a relative 
(as such term is defined in section 109(16) of the Ethics in 
Government Act of 1978) of the individual, of any business 
organization or other entity, or of which the individual is an 
officer or employee, or is negotiating for employment, or in 
which the individual has any other financial interest. 
"(3) AUDITS; AVAILABILITY OF RECORDS.—The Foundation 
shall— 
"(A) provide for annual audits of the financial condition 
of the Foundation; and 
"(B) make such audits, and all other records, docu-
ments, and other papers of the Foundation, available to 
the Secretary and the Comptroller General of the United 
States for examination or audit. 
"(4) REPORTS.— 
"(A) Not later than 5 months following the end of 
each fiscal year, the Foundation shall publish a report 
describing the activities of the Foundation during the 
preceding fiscal year. Each such report shall include for 
the fiscal year involved a comprehensive statement of the 
operations, activities, financial condition, and accomplish-
ments of the Foundation. 
"(B) With respect to the finsincial condition of the 
Foundation, each report under subparagraph (A) shall 
include the source, and a description of, all gifts or grsints 
to the Foundation of real or personal property, and the 
source and amount of all gifts or grants to the Foundation 
of money. Each such report shall include a specification 
of any restrictions on the purposes for which gifts or grants 
to the Foundation may be used. 
"(C) The Foundation shall make copies of each report 
submitted under subparagraph (A) available for public 
inspection, and shall upon request provide a copy of the 
report to any individual for a charge not exceeding the 
cost of providing the copy. 
"(D) The Board shall annually hold a public meeting 
to summarize the activities of the Foimdation and distrib-
ute written reports concerning such activities and the sci-
entific results derived from such activities. 
"(5) SERVICE OF FEDERAL EMPLOYEES.—Federal employees 
may serve on committees advisory to the Foundation and other-
wise cooperate with and assist the Foundation in carrying 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 191 
out its function, so long as the employees do not direct or 
control Foundation activities. 
"(6) RELATIONSHIP WITH EXISTING ENTITIES.—The Founda-
tion may, pursuant to appropriate agreements, merge with, 
acquire, or use the resources of existing nonprofit private cor-
porations with missions similar to the purposes of the Founda-
tion, such as the Foundation for Advanced Education in the 
Sciences. 
"(7) INTELLECTUAL PROPERTY RIGHTS.—The Board shall 
adopt written standards with respect to the ownership of any 
intellectual property rights derived from the collaborative 
efforts of the Foundation prior to the commencement of such 
efforts. 
"(8) NATIONAL INSTITUTES OF HEALTH AMENDMENTS OF 
1990.—^The activities conducted in support of the National 
Institutes of Health Amendments of 1990 (Public Law 101-
613), and the amendments made by such Act, shall not be 
nullified by the enactment of this section. 
"(9) LIMITATION OF ACTIVITIES.—The Foundation shall exist 
solely as an entity to work in collaboration with the research 
programs of the National Institutes of Health. The Foundation 
may not undertake activities (such as the operation of independ-
ent laboratories or competing for Federal research funds) that 
are independent of those of the National Institutes of Health 
research programs. 
"(10) TRANSFER OF FUNDS.—The Foundation may not trans-
fer funds to the National Institutes of Health. 
"(1) DUTIES OF THE DIRECTOR.— 
"(1) APPLICABILITY OF CERTAIN STANDARDS TO NON-FEDERAL 
EMPLOYEES.—In the case of any individual who is not an 
employee of the Federal Government and who serves in associa-
tion with the National Institutes of Health, with respect to 
financial assistance received fi*om the Foundation, the Founda-
tion may not provide the assistance of, or otherwise permit 
the work at the National Institutes of Health to begin until 
a memorandum of understanding between the individual and 
the Director of the National Institutes of Health, or the designee 
of such Director, has been executed specifying that the individ-
ual shall be subject to such ethical and procedural standards 
of conduct relating to duties performed at the National 
Institutes of Health, as the Director of the National Institutes 
of Health determines is appropriate. 
"(2) SUPPORT SERVICES.—The Director of the National 
Institutes of Health may provide facilities, utilities and support 
services to the Foundation if it is determined by the Director 
to be advantageous to the research programs of the National 
Institutes of Health."; 
(7) in subsection (m) (as so redesignated), by amending 
the subsection to read as follows: 
"(m) FUNDING.— 
"(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose 
of carrying out this part, there is authorized to be appropriated 
an aggregate $200,000 for the fiscal years 1994 and 1995. 
"(2) 
LIMITATION 
REGARDING 
OTHER 
FUNDS.—Amoimts 
appropriated under any provision of law other than paragraph 
(1) may not be expended to establish or operate the Founda-
tion.": and 
107 STAT. 192 
PUBLIC LAW 103-43—JUNE 10, 1993 
(8) by adding at the end the following subsection: 
"(n) REPORT ON ADEQUACY OF COMPLIANCE.— 
"(1) IN GENERAL,—^With respect to the mission £ind ftinction 
of the Foundation, the Comptroller General of the United States 
shall conduct an audit to determine— 
"(A) whether the Foundation is in compliance with 
the guidelines established under this section; and 
"(B) whether the procedures utilized imder this section 
are adequate to prevent conflicts of interest involving the 
Foundation, the employees of the Foundation or members 
of the Board of the Foimdation. 
"(2) REPORT.—Not later than 18 months after the date 
on which the Foimdation is incorporated, the Comptroller Gen-
eral of the United States shall complete the audit required 
under paragraph (1) and prepare and submit to the Committee 
on Energy and Commerce of the House of Representatives 
and the Committee on Labor and Human Resources of the 
Senate, a report describing the findings made with respect 
to such audit, . 
TITLE XVIII—RESEARCH WITH RESPECT 
TO ACQUIRED IMMUNE DEFICIENCY 
SYNDROME 
Subtitle A—Office of AIDS Research 
SEC. 1801. ESTABLISHMENT OF OFFICE. 
(a) IN GENERAL.—Part D of title XXIII of the PubHc Health 
Service Act (42 U.S.C. 300cc-41 et seq.) is amended— 
(1) by striking the part designation and the heading for 
the part; 
42USC300CC-41. 
(2) by redesignating section 2351 as section 2354; and 
(3) by inserting before section 2354 (as so redesignated) 
the following: 
"PART D—OFFICE OF AIDS RESEARCH 
"Subpart I—Interagency Coordination of Activities 
42 u s e 300CC-40. "SEC. 2351. ESTABLISHMENT OF OFFICE. 
"(a) IN GENERAL.—There is established within the National 
Institutes of Health an office to be known as the Office of AIDS 
Research, The Office shall be headed by a director, who shall 
be appointed by the Secretary. 
"(b) DUTIES.— 
"(1) INTERAGENCY COORDINATION OF AIDS ACTIVITIES,—^With 
respect to acquired immune deficiency syndrome, the Director 
of the Office shall plan, coordinate, and evgQuate research and 
other activities conducted or supported by the agencies of the 
National Institutes of Health. In carrying out the preceding 
sentence, the Director of the Office shall evaluate the AIDS 
activities of each of such agencies and shall provide for the 
periodic reevaluation of such activities. 
"(2) CONSULTATIONS.—The Director of the Office shall carry 
out this subpart (including developing and revising the plan 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 193 
required in section 2353) in consultation with the heads of 
the agencies of the National Institutes of Health, with the 
advisory councils of the agencies, and with the advisory council 
established under section 2352. 
"(3) COORDINATION.—The Director of the Office shall act 
as the primary Federal official with responsibihty for overseeing 
all AIDS research conducted or supported by the National 
Institutes of Health, and 
"(A) shall serve to represent the Nationsd Institutes 
of Health AIDS Research Program at all relevant Executive 
branch task forces and committees; and 
"(B) shall maintain communications with all relevant 
Public Health Service agencies and with various other 
departments of the Federal Government, to ensure the 
timely transmission of information concerning advances 
in AIDS research and the clinical treatment of acquired 
immune deficiency syndrome and its related conditions, 
between these various agencies for dissemination to 
affected communities and health care providers. 
"SEC. 2352. ADVISORY COUNCIL; COORDINATING COMMITTEES. 
42 USC 
,,, . . 
_ 
300cc-40a. 
"(a) ADVISORY COUNCIL.— 
"(1) IN GENERAL.—The Secret£iry shall establish an advisory 
council for the purpose of providing advice to the Director 
of the Office on carrying out this part. (Such council is referred 
to in this subsection as the 'Advisory Coimcil'.) 
"(2) 
COMPOSITION, COMPENSATION, TERMS, CHAIR, ETC.— 
Subsections (b) through (g) of section 406 apply to the Advisory 
Coiuicil to the same extent and in the same manner as such 
subsections apply to advisory councils for the national research 
institutes, except that— 
"(A) in addition to the ex officio members specified 
in section 406(b)(2), there shall serve as such members 
of the Advisory (Council a representative fi-om the advisory 
council of each of the National Cancer Institute and the 
National Institute on Allergy and Infectious Diseases; and 
"(B) with respect to the other national research 
institutes, there shall serve as ex officio members of such 
Council, in addition to such members specified in subpara-
graph (A), a representative fi-om the advisory council of 
each of the 2 institutes that receive the greatest funding 
for AIDS activities. 
"(b) 
INDIVIDUAL 
COORDINATING 
COMMITTEES 
REGARDING 
RESEARCH DISCIPLINES.— 
"(1) IN GENERAL.—The Director of the Office shall establish, 
for each research discipline in which any activity under the 
plan required in section 2353 is carried out, a committee for 
the purpose of providing advice to the Director of the Office 
on canying out this part with respect to such discipline. (Each 
such committee is referred to in this subsection as a 'coordinat-
ing committee'.) 
"(2) COMPOSITION.—Each coordinating committee shall be 
composed of representatives of the agencies of the National 
Institutes of Health with significant responsibilities regarding 
the research discipline involved. 
107 STAT. 194 
PUBLIC LAW 103-43—JUNE 10, 1993 
42 use 
"SEC. 2353. COMPREHENSIVE PLAN FOR EXPENDITURE OF APPROPRIA-
300cc-40b. 
TIONS. 
"(a) IN GENERAL.—Subject to the provisions of this section 
and other applicable law, the Director of the Office, in carrying 
out section 2351, shall— 
"(1) establish a comprehensive plan for the conduct and 
support of all AIDS activities of the agencies of the National 
Institutes of Health (which plan shall be first established under 
this paragraph not later than 12 months after the date of 
the enactment of the National Institutes of Health Revitaliza-
tion Act of 1993); 
"(2) ensure that the Plan establishes priorities among the 
AIDS activities that such agencies are authorized to carry 
out; 
"(3) ensure that the Plan establishes objectives regarding 
such activities, describes the me£ins for achieving the objectives, 
and designates the date by which the objectives are expected 
to be achieved; 
"(4) ensure that all amounts appropriated for such activities 
are expended in accordance with the Plan; 
"(5) review the Plan not less than annually, and revise 
the Plan as appropriate; and 
"(6) ensure that the Plan serves as a broad, binding state-
ment of policies regarding AIDS activities of the agencies, but 
does not remove the responsibility of the heads of the agencies 
for the approval of specific programs or projects, or for other 
details of the daily administration of such activities, in accord-
ance with the Plan. 
"(b) CERTAIN COMPONENTS OF PLAN.—With respect to AIDS 
activities of the agencies of the National Institutes of Health, the 
Director of the Office shall ensure that the Plan— 
"(1) provides for basic research; 
"(2) provides for applied research; 
"(3) provides for research that is conducted by the agencies; 
"(4) provides for research that is supported by the agencies; 
"(5) provides for proposals developed pursuant to solicita-
tions by the agencies and for proposals developed independently 
of such solicitations; and 
"(6) provides for behavioral research and social sciences 
research. 
"(c) BUDGET ESTIMATES.— 
"(1) FULL-FUNDING BUDGET.— 
"(A) With respect to a fiscal year, the Director of the 
Office shall prepare and submit directly to the President, 
for review and transmittal to the Congress, a budget esti-
mate for carrying out the Plan for the fiscal year, after 
reasonable opportunity for comment (but without change) 
by the Secretary, the Director of the National Institutes 
of Health, and the advisory council established under sec-
tion 2352, The budget estimate shall include an estimate 
of the number and type of personnel needs for the Office. 
"(B) The budget estimate submitted under subpara-
graph (A) shall estimate the amounts necessary for the 
agencies of the National Institutes of Health to carry out 
all AIDS activities determined by the Director of the Office 
to be appropriate, without regard to the probability that 
such amounts will be appropriated. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 195 
"(2) ALTERNATIVE BUDGETS.— 
"(A) With respect to a fiscal year, the Director of the 
Office shall prepare and submit to the Secretary and the 
Director of the National Institutes of Health the budget 
estimates described in subparagraph (B) for canying out 
the Plan for the fiscal year. The Secretary and such Direc-
tor shall consider each of such estimates in making rec-
ommendations to the President regarding a budget for the 
Plan for such year. 
"(B) With respect to the fiscal year involved, the budget 
estimates referred to in subparagraph (A) for the Plan 
are as follows: 
"(i) The budget estimate submitted under para-
graph (1). 
"(ii) A budget estimate developed on the assump-
tion that the amounts appropriated will be sufficient 
only for— 
"(I) continuing the conduct by the agencies 
of the National Institutes of HegJth of existing 
AIDS activities (if approved for continuation), and 
continuing the support of such activities by the 
agencies in the case of projects or programs for 
which the agencies have made a commitment of 
continued support; and 
"(II) canying out, of activities that are in addi-
tion to activities specified in subclause (I), only 
such activities for which the Director determines 
there is the most substsintial need, 
"(iii) Such other budget estimates as the Director 
of the Office determines to be appropriate. 
"(d) FUNDING.— 
"(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose 
of canying out AIDS activities under the Plan, there are author-
ized to be appropriated such sums as may be necessary for 
each of the fiscal years 1994 through 1996. 
"(2) RECEIPT OF FUNDS.—For the first fiscal year beginning 
after the date on which the Plan first established under section 
2353(a)(1) has been in effect for 12 months, and for each subse-
quent fiscal year, the Director of the Office sheill receive directly 
from the President and the Director of the Office of Manage-
ment and Budget all funds available for AIDS activities of 
the National Institutes of Health. 
"(3) ALLOCATIONS FOR AGENCIES.— 
"(A) Each fiscal year the Director of the Office shall, 
from the amounts received under paragraph (2) for the 
fiscal year, allocate to the agencies of the National 
Institutes of Health (in accordance with the Plan) all 
eimounts available for such year for carrying out the AIDS 
activities specified in subsection (c)(2)(B)(ii)(I) for such year. 
Such allocation shall, to the extent practicable, be made 
not later than 15 days after the date on which the Director 
receives amounts under paragraph (2). 
"(B) Each fiscal year the Director of the Office shall, 
from the amounts received under paragraph (2) for the 
fiscal year, allocate to the agencies of the National 
Institutes of Health (in accordance with the Pl£in) all 
amounts available for such year for carrying out AIDS 
107 STAT. 196 
PUBLIC LAW 103-43—JUNE 10, 1993 
activities that are not referred to in subparagraph (A). 
Such allocation shall, to the extent practicable, be made 
not later than 30 days after the date on which the Director 
receives amounts imder paragraph (2).". 
(b) CONFORMING AMENDMENTS.—Section 2354 of the Public 
Health Service Act, as redesignated by subsection (a)(2) of this 
section, is amended— 
(1) 
in 
the 
heading 
for 
the 
section, 
by 
striking 
"ESTABLISHMENT OF" and inserting "ADDITIONAL"; 
(2) in subsection (a)— 
(A) in the matter preceding paragraph (1), by striking 
"In canying out" and all that follows and inserting the 
following: "In canying out AIDS research, the Director 
of the Office—"; 
(B) by striking paragraphs (1) and (2) and redesignat-
ing paragraphs (3) through (8) as paragraphs (1) through 
(6); 
(C) in paragraph (3) (as so redesignated), by striking 
"may" and all that follows in the matter preceding subpara-
graph (A) and inserting the following: "may support—"; 
(D) in paragraph (5) (as so redesignated)— 
(i) in subparagraph (A)— 
"(I) by striking "ma/' and all that follows 
through "acquire," and inserting "may acquire,"; 
and 
"(II) by striking "Director" and all that follows 
t h r o u ^ "determines" and inserting "Director of 
the Office determines"; 
(ii) in subparagraph (B), by striking "may" and 
all that follows through "make grants" and inserting 
"may make grants"; £ind 
(iii) in subparagraph (C), by striking "ma/' and 
all that follows through "acquire," and inserting "may 
acquire,"; and 
(E) in each of paragraphs (2), (3)(A), and (4) (as so 
redesignated), by striking "research relating to acquired 
immune 
deficiency 
syndrome" 
eind 
inserting 
"AIDS 
research"; 
(3) in subsection (b), in the matter preceding paragraph 
(1), by striking "The Director" and all that follows through 
"shall" and inserting "The Director of the Office shall"; and 
(4) in subsection (c), by striking "the Director" and all 
that follows through "shall" and inserting "the Director of the 
Office shall". 
SEC. 1802. ESTABLISHMENT OF EMERGENCY DISCRETIONARY FUND. 
Part D of title XXIII of the PubUc Health Service Act, as 
amended by section 1801 of this Act, is amended by adding at 
the end the following subpart: 
"Subpart II—Emergency Discretionary Fund 
42 use 
"SEC. 2356. EMERGENCY DISCRETIONARY FUND. 
300CC-43. 
«/ 
X T 
>-i 
"(a) IN GENERAL.— 
"(1) ESTABLISHMENT.—There is estabUshed a fund consist-
ing of such amounts as may be appropriated under subsection 
(g). Subject to the provisions of this section, the Director of 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 197 
the Office, after consultation with the advisory council estab-
lished under section 2352, may expend amounts in the Fund 
for the purpose of conducting and supporting such AIDS activi-
ties, including projects of AIDS research, as may be authorized 
in this Act for the National Institutes of Health. 
"(2) PRECONDITIONS TO USE OF FUND.—Amounts in 
the 
Fund may be expended only if— 
"(A) the Director identifies the particular set of AIDS 
activities for which such amounts are to be expended; 
"(B) the set of activities so identified constitutes either 
a new project or additional AIDS activities for an existing 
project; 
"(C) the Director of the Office has made a determina-
tion that there is a significant need for such set of activities; 
and 
"(D) as of June 30 of the fiscal year preceding the 
fiscal year in which the determination is made, such need 
was not provided for in any appropriations Act passed 
by the House of Representatives to make appropriations 
for the Departments of Labor, Health and Human Services 
(including the National Institutes of Health), Education, 
and related agencies for the fiscal year in which the deter-
mination is made. 
"(3) TWO-YEAR USE OF FUND FOR PROJECT INVOLVED.—In 
the case of an identified set of AIDS activities, obligations 
of amounts in the Fund may not be made for such set of 
activities after the expiration of the 2-year period beginning 
on the date on which the initial obligation of such amounts 
is made for such set. 
"(b) PEER REVIEW.—With respect to an identified set of AIDS 
activities carried out with amoimts in the Fund, this section may 
not be construed as waiving applicable requirements for peer review. 
"(c) LIMITATIONS ON USE OF FUND.— 
"(1) CONSTRUCTION OF FACILITIES.—Amounts in the Fimd 
may not be used for the construction, renovation, or relocation 
of facilities, or for the acquisition of land. 
"(2) CONGRESSIONAL DISAPPROVAL OF PROJECTS.— 
"(A) Amounts in the Fund may not be expended for 
the fiscal year involved for an identified set of AIDS activi-
ties, or a category of AIDS activities, for which— 
"(i)(I) amounts were made available in an appro-
priations Act for the preceding fiscal year; and 
"(II) amounts are not made available in any appro-
priations Act for the fiscal year involved; or 
"(ii) amounts are by law prohibited from being 
expended. 
"(B) A determination under subparagraph (A)(i) of 
whether amounts have been made available in appropria-
tions Acts for a fiscal year shall be made without regard 
to whether such Acts make available amounts for the Fund. 
"(3) INVESTMENT OF FUND AMOUNTS.—Amounts in the Fimd 
may not be invested. 
"(d) APPLICABILITY OF LIMITATION REGARDING NUMBER OF 
EMPLOYEES.—The purposes for which amounts in the Fund may 
be expended include the employment of individuals necessary to 
carry out identified sets of AIDS activities approved under sub-
section (a). Any individual employed under the preceding sentence 
107 STAT. 198 
PUBLIC LAW 103-43—JUNE 10, 1993 
may not be included in any determination of the number of full-
time equivalent employees for the Department of Health and 
Human Services for the purpose of any limitation on the number 
of such employees established by law prior to, on, or after the 
date of the enactment of the National Institutes of Health Revital-
ization Act of 1993. 
"(e) REPORT TO CONGRESS.—Not later than February 1 of each 
fiscal year, the Director of the Office shall submit to the Committee 
on Energy and Commerce of the House of Representatives, and 
to the Committee on Labor smd Human Resources of the Senate, 
a report on the identified sets of AIDS activities carried out during 
the preceding fiscal year with amounts in the Fund. The report 
shall provide a description of each such set of activities and an 
explanation of the reasons underlying the use of the Fimd for 
the set. 
"(f) DEFINITIONS.—For purposes of this section: 
"(1) The term 'Fund' means the fund established in sub-
section (a). 
"(2) The term 'identified set of AIDS activities' means a 
particular set of AIDS activities identified imder subsection 
(a)(2)(A). 
"(g) FUNDING.— 
"(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose 
of providing amounts for the Fund, there is authorized to 
be appropriated $100,000,000 for each of the fiscal years 1994 
through 1996. 
"(2) AVAILABILITY.—^Amounts appropriated for the Fund are 
available until expended.". 
SEC. 1803. GENERAL PROVISIONS. 
Part D of title XXIII of the PubHc Health Service Act, as 
amended by section 1802 of this Act, is amended by adding at 
the end the following subpart: 
"Subpart III—General Provisions 
42 use 
"SEC. 2359. GENERAL PROVISIONS REGARDING THE OFFICE. 
300cc-4'5 
"(a) ADMINISTRATIVE SUPPORT FOR OFFICE.—The Secretary, act-
ing through the Director of the National Institutes of Health, shall 
provide administrative support and support services to the Director 
of the Office and shall ensure that such support takes maximum 
advantage of existing administrative structures at the agencies 
of the National Institutes of Health. 
"(b) EVALUATION AND REPORT.— 
"(1) EVALUATION.—Not later than 5 years after the date 
of the enactment of National Institutes of Health Revitalization 
Act of 1993, the Secretary shgdl conduct an evaluation to— 
"(A) determine the effect of this section on the planning 
and coordination of the AIDS research programs at the 
institutes, centers and divisions of the National Institutes 
of Health; 
"(B) evaluate the extent to which this part has elimi-
nated the duplication of administrative resources among 
such Institutes, centers and divisions; and 
"(C) provide recommendations concerning future alter-
ations with respect to this part. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 199 
"(2) REPORT.—^Not later than 1 year after the date on 
which the evaluation is commenced under peiragraph (1), the 
Secretary shall prepare and submit to the Committee on Labor 
£ind Human Resources of the Senate, and the Committee on 
Energy and Commerce of the House of Representatives, a report 
concerning the results of such evaluation. 
"(c) DEFINITIONS.—For purposes of this part: 
"(1) The term 'AIDS activities' means AIDS research and 
other activities that relate to acquired immune deficiency syn-
drome. 
"(2) The term 'AIDS research' means research with respect 
to acquired immune deficiency syndrome. 
"(3) The term 'Office' means the Office of AIDS Research. 
"(4) The term 'Plan' means the plan required in section 
2353(a)(1).". 
Subtitle B—Certain Programs 
SEC. 1811. REVISION AND EXTENSION OF CERTAIN PROGRAMS. 
Title XXIII of the PubUc Health Service Act (42 U.S.C. 300cc 
et seq.) is sunended— 
(1) in section 2304(c)(1)— 
(A) in the matter preceding subparagraph (A), by 
inserting after "Director of such Institute" the following: 
"(and may provide advice to the Directors of other agencies 
of the National Institutes of Health, as appropriate)"; and 
(B) in subparagraph (A), by inserting before the semi-
colon the following: ", including recommendations on the 
projects of research with respect to diagnosing immune 
deficiency and with respect to predicting, diagnosing, 
preventing, and treating opportunistic cancers and infec-
tious diseases"; 
(2) in section 2311(a)(1), by inserting before the semicolon 
the following: ", including evaluations of methods of diagnosing 
immune deficiency and evgJuations of methods of predicting, 
diagnosing, preventing, and treating opportunistic cancers and 
infectious diseases"; 
(3) in section 2315— 
(A) in subsection (a)(2), by striking "international 
research" and all that follows and inserting "international 
research and training concerning the natural history and 
pathogenesis of the human immimodeficiency virus and 
the development and evaluation of vaccines and treatments 
for acquired immune deficiency syndrome and opportunistic 
infections."; £ind 
(B) in subsection (f), by striking "there are authorized" 
and all that follows and inserting "there are authorized 
to be appropriated such sums as may be necessary for 
each fiscal year."; 
(4) in section 2318— 
(A) in subsection (a)(1)— 
(i) by inserting after "The Secretary^' the following: 
", acting through the Director of the National Institutes 
of Health and after consultation with the Adminis-
trator for Health Ceire Policy and Research,"; and 
42 use 300C-3. 
42 use 
300CC-11. 
42 use 
300CC-15. 
42 use 
300CC-18. 
69-194 O - 94 - 8 : QL. 3 Part 1 
107 STAT. 200 
PUBLIC LAW 103-43—JUNE 10, 1993 
42 use 
300CC-20. 
42 use 
300CC-31. 
42 use 
300CC-51. 
(ii) by striking "syndrome" and inserting "syn-
drome, including treatment and prevention of HIV 
infection and related conditions among women"; and 
(B) in subsection (e), by striking "1991." and inserting 
the following: "1991, and such sums as may be necessary 
for each of the fiscal years 1994 through 1996."; 
(5) in section 2320(b)(1)(A), by striking "syndrome" and 
inserting "syndrome and the natural history of such infection"; 
(6) in section 2320(e)(1), by striking "there are authorized" 
and all that follows and inserting "there are authorized to 
be appropriated such sums as may be necessary for each fiscal 
year."; 
(7) in section 2341(d), by striking "there are authorized" 
and all that follows and inserting "there are authorized to 
be appropriated such sums as may be necessary for each fiscal 
year. ; and 
(8) in section 2361, by striking "For purposes" and all 
that follows and inserting the following: 
"For purposes of this title: 
"(1) The term 'infection', with respect to the etiologic agent 
for acquired immune deficiency synth-ome, includes opportun-
istic cancers and infectious diseases and any other conditions 
arising 
fi*om 
infection with such etiologic agent. 
"(2) The term 'treatment', with respect to the etiologic 
agent for acquired immune deficiency sjnidrome, includes pri-
mary and secondary prophylaxis.". 
TITLE XIX—STUDIES 
42 u s e 282 note. 
42 u s e 300cc 
note. 
SEC. 1901. LIFE-THREATENING ILLNESSES. 
(a) 
THIRD-PARTY PAYMENTS REGARDING CERTAIN CLINICAL 
TRIALS AND CERTAIN LIFE-THREATENING ILLNESSES.—The Secretary 
of Health and Human Services, acting through the Director of 
the National Institutes of Health, shall conduct a study for the 
purpose of— 
(1) determining the policies of third-party payors regarding 
the pa5nnent of the costs of appropriate health services that 
are provided incident to the participation of individuals as 
subjects in clinical trials conducted in the development of drugs 
with respect to acquired immune deficiency syndrome, cancer, 
and other life-threatening illnesses; and 
(2) developing recommendations regarding such policies. 
(b) VACCINES FOR HUMAN IMMUNODEFICIENCY VIRUS.— 
(1) IN GENERAL,—The Secretary of Health and Human 
Services, acting through the National Institutes of Health, shall 
develop a plan for the appropriate inclusion of HIV-infected 
women, including pregnant women, HIV-infected infants, and 
HIV-infected children in studies conducted by or through the 
National Institutes of Health concerning the safety and efficacy 
of HIV vaccines for the treatment and prevention of HIV infec-
tion. Such plan shall ensure the full participation of other 
Federal agencies currently conducting HIV vaccine studies and 
require that such studies conform mlly to the reqxiirements 
of part 46 of title 45, Code of Federal Regulations. 
(2) REPORT.—Not later than 180 days after the date of 
the enactment of this Act, the Secretary of Health and Human 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 201 
Services shall prepare and submit to the Committee on Energy 
and Commerce of the House of Representatives, and the 
Committee on Labor and Human Resources of the Senate, 
a report concerning the plan developed under paragraph (1). 
(3) IMPLEMENTATION.—Not later than 12 months after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall implement the plan developed under 
paragraph (1), including measures for the full participation 
of other Federal agencies currently conducting HIV vaccine 
studies. 
(4) AUTHORIZATION OF APPROPRIATIONS.—For the purpose 
of carrying out this subsection, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 1994 through 1996. 
SEC. 1902. MALNUTRITION IN THE ELDERLY. 
42 USC 285e 
(a) S T U D Y . - 
""*"• 
(1) IN GENERAL.—The Secretary of Health and Human 
Services (referred to in this section as the "Secretar/'), acting 
through the National Institute on Aging, coordinating with 
the Agency for Health Care PoUcy and Research and, to the 
degree possible, in consultation with the head of the National 
Nutrition Monitoring and Related Research Program estab-
lished by section 5311(a) of Public Law 101-445 (7 U.S.C. 
5301 et seq.), shall conduct a 3-year nutrition screening and 
intervention activities study of the elderly. 
(2) 
EFFICACY AND COST-EFFECTIVENESS OF NUTRITION 
SCREENING AND INTERVENTION ACTIVITIES.—In conducting the 
study, the Secretary shall determine the efficacy and cost-
effectiveness of nutrition screening and intervention activities 
conducted in the elderly health and long-term care continuxma, 
and of a program that would institutionalize nutrition screening 
and intervention activities. In evaluating such a program, the 
Secretary shall determine— 
(A) if health or quality of Ufe is measurably improved 
for elderly individuals who receive routine nutritional 
screening and treatment; 
(B) if federally subsidized home or institutional care 
is reduced because of increased independence of elderly 
individuals resulting from improved nutritional status; 
(C) if a multidisciplinary approach to nutritional care 
is effective in addressing the nutritional needs of elderly 
individuals; and 
(D) if reimbursement for nutrition screening and inter-
vention activities is a cost-effective approach to improving 
the health status of elderly individusJs. 
(3) POPULATIONS.—The populations of elderly individuals 
in which the study will be conducted shall include populations 
of elderly individuals who are— 
(A) living independently, including— 
(i) individuals who receive home and community-
based services or family support; 
(ii) individuals who do not receive additional serv-
ices and support; 
(iii) individuals with low incomes; and 
(iv) individuals who are minorities; 
107 STAT. 202 
PUBLIC LAW 103-43—JUNE 10, 1993 
(B) hospitalized, including individuals admitted from 
home and from institutions; and 
(C) institutionalized in residential facilities such as 
nursing homes and adult homes. 
(b) MALNUTRITION STUDY.—The Secretary, acting through the 
National Institute on Aging, shall conduct a 3-year study to deter-
mine the extent of malnutrition in elderly individuals in hospitals 
and long-term care facilities and in elderly individuals who are 
living independently. 
(c) REPORT.—The Secretary shall submit a report to the 
Committee on Labor and Human Resources of the Senate and 
the Committee on Energy and Commerce of the House of Represent-
atives containing the fmdings resulting from the studies described 
in subsections (a) and (b), including a determination regarding 
whether a program that would institutionalize nutrition screening 
and intervention activities should be adopted, and the rationale 
for the determination. 
(d) ADVISORY PANEL.— 
(1) ESTABLISHMENT.—The Secretary, acting through the 
Director of the National Institute on Aging, shall establish 
an advisory panel that shall oversee the design, implementa-
tion, and evaluation of the studies described in subsections 
(a) and (b). 
(2) COMPOSITION.—^The advisory peinel shall include rep-
resentatives appointed for the life of the panel by the Secretary 
from the Health Care Financing Administration, the Social 
Security Administration, the National Center for Health Statis-
tics, the Administration on Aging, the National Council on 
the Aging, the American Dietetic Association, the Americein 
Academy of Family Physicians, and such other agencies or 
organizations as the Secretary determines to be appropriate. 
(3) COMPENSATION AND EXPENSES.— 
(A) COMPENSATION.—Each member of the advisory 
panel who is not an employee of the Federal Government 
shall receive compensation for each day engaged in canying 
out the duties of the panel, including time engaged in 
traveling for purposes of such duties. Such compensation 
may not be jprovided in an amount in excess of the maxi-
mum rate of basic pay payable for GS-18 of the Greneral 
Schedule. 
(B) TRAVEL EXPENSES.—Each member of the advisory 
panel shall receive travel expenses, including per diem 
in lieu of subsistence, at rates authorized for employees 
of agencies imder subchapter I of chapter 57 of title 5, 
United States Code, for each day the member is engaged 
in the performance of duties away from the home or regular 
place of business of the member. 
(4) DETAIL OF FEDERAL EMPLOYEES.—On the request of 
the advisory panel, the head of any Federal agency shall detail, 
without reimbursement, any of the personnel of the agency 
to the advisory panel to assist the advisory panel in carrying 
out its duties. Any detail shall not interrupt or otherwise affect 
the civil service status or privileges of the Federal employee. 
(5) TECHNICAL ASSISTANCE.—On the request of the advisory 
panel, the head of a Federal agency shall provide such technical 
assistance to the advisory p£inel as the advisory panel deter-
mines to be necessary to carry out its duties. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 203 
Reports. 
42 use 285f-l 
note. 
42 use 281 note. 
(6) TERMINATION.—Notwithstanding section 15 of the Fed-
eral Advisory Committee Act (5 U.S.C. App.), the advisory 
panel shall terminate 3 years after the date of enactment 
of this Act. 
SEC. 1903. RESEARCH ACTIVITIES ON CHRONIC FATIGUE SYNDROME. 
The Secretary of Health and Human Services shall, not later 
than October 1, 1993, and annually thereafter for the next 3 years, 
prepare and submit to the Committee on Energy and Commerce 
of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate, a report that summarizes the 
research activities conducted or supported by the National Institutes 
of Health concerning chronic fatigue syndrome. Such report should 
include information concerning grants made, cooperative agree-
ments or contracts entered into, intramural activities, research 
priorities and needs, and a plan to address such priorities and 
needs. 
SEC. 1904. REPORT ON MEDICAL USES OF BIOLOGICAL AGENTS IN 
DEVELOPMENT OF DEFENSES AGAINST BIOLOGICAL WAR-
FARE. 
The Secretary of Health and Human Services, in consultation 
with the Secretary of Defense and with the heads of other appro-
priate executive agencies, shall report to the House Energy and 
Commerce Committee and the Senate Labor and Human Resources 
Committee on the appropriateness and impact of the National 
Institutes of Health assuming responsibility for the conduct of all 
Federal research, development, testing, and evaluation functions 
relating to medical countermeasures against biowarfare threat 
agents. In preparing the report, the Secretary of Health and Human 
Services shall identify the extent to which such activities are carried 
out by agencies other than the National Institutes of Health, and 
assess the impact (positive and negative) of the National Institutes 
of Health assuming responsibility for such activities, including the 
impact under the Budget Enforcement Act and the Omnibus Budget 
Reconciliation Act of 1990 on existing National Institutes of Health 
research programs as well as other programs within the category 
of domestic discretionary spending. Such Secretary shall submit 
the report not later than 12 months after the date of the enactment 
of this Act. The Secretary shall provide a copy of the report to 
the House and Senate Committees on Armed Services. 
SEC. 1905. PERSONNEL STUDY OF RECRUITMENT, RETENTION AND 
TURNOVER. 
(a) STUDY OF PERSONNEL SYSTEM.—Not later than 1 year after 
the date of the enactment of this Act, the Secretary of Health 
and Human Services, acting through the Director of the National 
Institutes of Health, shall conduct a study to review the retention, 
recruitment, vacancy and turnover rates of support staff, including 
firefighters, law enforcement, procurement officers, technicians, 
nurses and clerical employees, to ensure that the National Institutes 
of Health is adequately supporting the conduct of efficient, effective 
and high quality research for the American public. The Director 
of NIH shall work in conjunction with appropriate employee 
organizations and representatives in developing such a study. 
(b) SUBMISSION TO CONGRESS.—Not later than 1 year after Reports. 
the date of the enactment of this Act, the Secretary of Health 
and Human Services shall prepare and submit to the Committee 
42 use 282 note. 
107 STAT. 204 
PUBLIC LAW 103-43—JUNE 10, 1993 
on Energy and Commerce of the House of Representatives, and 
to the Committee on Labor and Human Resources of the Senate, 
a report containing the study conducted under subsection (a) 
together with the recommendations of the Secretary concerning 
the enactment of legislation to implement the results of such study. 
SEC. 1906. PROCUREMENT. 
(a) IN GENERAL.—^The Director of the National Institutes of 
Health and the Administrator of the General Services Administra-
tion shall jointly conduct a study to develop a streamlined procure-
ment system for the National Institutes of Health that complies 
with the requirements of Federal law. 
(b) REPORT.—^Not later than March 1, 1994, the officials speci-
fied in subsection (a) shall complete the study required in such 
subsection and shall submit to the Committee on Energy and Com-
merce of the House of Representatives, and the Committee on 
Labor and Human Resources of the Senate, a report describing 
the findings made as a result of the study. 
42 u s e 282 note. SEC. 1907. CHRONIC PAIN CONDITIONS. 
(a) IN GENERAL.—^The Director of the National Institutes of 
Health (in this section referred to as the 'Director'), acting through 
the Director of the National Institute of Dental Research and as 
appropriate through the heads of other agencies of such Institutes, 
shall conduct a study for the purpose of determining the incidence 
in the United States of cases of chronic pain (including chronic 
pain resulting from back injuries) and the effect of such cases 
on the costs of 
heeilth care in the United States. 
(b) CERTAIN ELEMENTS OP STUDY.—The cases of chronic pain 
with respect to which the study required in subsection (a) is con-
ducted shall include reflex sympathetic dystrophy S5^drome, 
temporomandibular joint disorder, post-herpetic neuropathy, painful 
diabetic neuropathy, phantom pain, and post-stroke pain. 
(c) REPORT.—^Not later than 2 years after the date of the enact-
ment of this Act, the Director shall complete the study required 
in subsection (a) and submit to the Committee on Energy and 
Commerce of the House of Representatives, and to the Committee 
on Labor and Himian Resources of the Senate, a report describing 
the findings made as a result of 
the study. 
42 u s e 290aa-2 
SEC. 1908. RELATIONSHIP BETWEEN THE CONSUMPTION OF LEGAL 
AND ILLEGAL DRUGS. 
(a) IN GENERAL.—^The Secretary of Health and Human Services 
shall review and consider aU existing relevant data and research 
concerning whether there is a relationship between an individual's 
receptivity to use or consume legal drugs and the consumption 
or abuse by the individual of illegal drugs. On the basis of such 
review, the Secretary shall determine whether additional research 
is necessary. If the Secretary determines additional research is 
required, the Secretary shall conduct a study of those subjects 
where the Secretars^'s review indicates additional research is 
needed, including, if necessary, a review o
f
— 
(1) the effect of advertising and marketing c£impaigns that 
promote the use of legal drugs on the public; 
(2) the correlation of legal drug abuse with illegal drug 
abuse; and 
(3) other matters that the Secretary determines appro-
priate. 
note. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 205 
(b) REPORT.—Not later than 12 months after the date of enact-
ment of this Act, the Secretary shall prepare and submit, to the 
Committee on Energy and Commerce of the House of Representa-
tives and Committee on Labor and Human Resources of the Senate, 
a report containing the results of the review conducted under sub-
section (b). If the Secretary determines additional research is 
required, no later than 2 years after the date of enactment of 
this Act, the Secretary shall prepare and submit, to the Committee 
on Energy and Commerce of the House of Representatives and 
Committee on Labor and Human Resources of the Senate, a report 
containing the results of the additional research conducted under 
subsection (b). 
SEC. 1909. REDUCING ADMINISTRATIVE HEALTH CARE COSTS. 
42 USC 299a 
The Secretary of Health and Human Services, acting through 
the Agency for Health Care Policy and Research and, to the extent 
possible, in consultation with the Health Care Financing Adminis-
tration, may fund research to develop a text-based standardized 
billing process, through the utilization of text-based information 
retrieval and natural language processing techniques applied to 
automatic coding and analysis of textual patient discharge sum-
maries and other text-based electronic medical records, within a 
parallel general purpose (shared memory) high performance comput-
ing environment. The Secretary shall determine whether such a 
standardized approach to medical billing, through the utilization 
of the text-based hospital discharge simimary as well as electronic 
patient records can reduce the administrative billing costs of health 
care delivery. 
SEC. 1910. SENTINEL DISEASE CONCEPT STUDY. 
42 USC 241 note. 
(a) IN GENERAL.—The Secretary of Health and Human Services, 
in cooperation with the Agency for Toxic Substances and Disease 
Registry and the Centers for Disease Control and Prevention, shall 
design £ind implement a pilot sentinel disease surveillance system, 
and as appropriate, a follow-up system. 
(b) PURPOSE.—The purpose of the study conducted under sub-
section (a) shall be to determine the applicability of and the difficul-
ties associated with the implementation of the sentinel disease 
concept for identifying the relationship between the occupation of 
household members and the incidence of subsequent conditions 
or diseases in other members of the household. 
(c) REPORT.—Not later than 4 years after the date of enactment 
of this Act, the Director of the National Institutes of Health shall 
prepare and submit to the appropriate committees of Congress, 
a report concerning the results of the study conducted under sub-
section (a). 
SEC. 1911. POTENTIAL ENVIRONMENTAL AND OTHER RISKS CONTRIB- 
42 USC 280e-3 
UTING TO INCIDENCE OF BREAST CANCER. 
note. 
(a) REQUIREMENT OF STUDY.— 
(1) IN GENERAL.—The Director of the National Cancer 
Institute (in this section referred to as the "Director"), in 
collaboration with the Director of the National Institute of 
Environmental Health Sciences, shall conduct a case-control 
study to assess biological markers of environmental and other 
potential risk factors contributing to the incidence of breast 
cancer in— 
107 STAT. 206 
PUBLIC LAW 103-43—JUNE 10, 1993 
(A) the Coimties of Nassau and Suffolk, in the State 
of New York; and 
(B) the 2 counties in the northeastern United States 
that, as identified in the report specified in paragraph 
(2), had the highest age-adjusted mortality rate of such 
cancer that reflected not less than 30 deaths during the 
5-year period for which findings are made in the report. 
(2) RELEVANT REPORT.—^The report referred to in paragraph 
(1)(B) is the report of the findings made in the study entitled 
"Survival, Epidemiology, and End Results", relating to cases 
of cancer during the years 1983 through 1987. 
(b) CERTAIN ELEMENTS OF STUDY.—Activities of the Director 
in carrying out the study under subsection (a) shall include the 
use of a geographic system to evaluate the current and past expo-
sure of individuals, including direct monitoring and cumulative 
estimates of exposure, to— 
(1) contaminated drinking water; 
(2) sources of indoor and ambient air pollution, including 
emissions from aircraft; 
(3) electromagnetic fields; 
(4) pesticides and other toxic chemicals; 
(5) hazardous and mtinicipal waste; and 
(6) such other factors as the Director determines to be 
appropriate. 
(c) REPORT.—^Not later than 30 months after the date of the 
enactment of this Act, the Director shall complete the study required 
in subsection (a) and submit to the Committee on Energy and 
Commerce of the House of Representatives, and to the Committee 
on Labor and Human Resources of the Senate, a report describing 
the findings made as a result of the study. 
(d) FUNDING.—Of the amoimts appropriated for fiscal years 
1994 and 1995 for the National Institute of Environmental Health 
Sciences and the National Cancer Institute, the Director of the 
Nationsd Institutes of Health shall make available amounts for 
canying out the study required in subsection (a). 
42 use 282 note. SEC. 1912. SUPPORT FOR BIOENGINEERING RESEARCH. 
(a) STUDY.—The Secretary of Health and Human Services, act-
ing through the Director of the National Institutes of Health, shall 
conduct a study for the purpose o
f
— 
(1) determining the sources and amoiuits of public and 
private funding devoted to basic research in bioengineering, 
including biomaterials sciences, cellular bioprocessing, tissue 
£ind rehabilitation engineering; 
(2) evaluating whether that commitment is sufificient to 
maintain the innovative edge that the United States has in 
these technologies; 
(3) evaluating the role of the National Institutes of Health 
or any other Federal agency to achieve a greater commitment 
to innovation in bioengineering; and 
(4) evaluating the need for better coordination and 
collaboration among Federal agencies and between the pubhc 
and private sectors. 
In conducting such study, the Director shall work in conjunction 
with appropriate organizations and representatives including aca-
demics, industry leaders, bioengineering societies, and public agen-
cies. 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 207 
(b) REPORT.—^Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health £ind Human Services shall 
prepare and submit to the Committee on Labor and Human 
Resources of the Senate, and the Committee on Energy and Com-
merce of the House of Representatives, a report containing the 
findings of the study conducted under subsection (a) together with 
recommendations concerning the enactment of legislation to imple-
ment the results of such study. 
SEC. 1913. COST OF CARE IN LAST 6 MONTHS OF LIFE. 
(a) STUDY.— 
(1) IN GENERAL.—The Secretary of Health and Human 
Services (in this section referred to as the "Secretary"), acting 
through the Agency for Health Care Policy and Research £ind, 
to the degree possible, in consultation with the Health Care 
Financing Administration, shall conduct a study, using the 
most recent National Medical Expenditure Survey database, 
to estimate the average amount of health care expenditures 
incurred during the last 6 months of life by— 
(A) the population of individuals who are 65 years 
of age and older; and 
(B) the total population, broken down based on 
noninstitutionalized and institutionalized populations. 
(2) ELEMENTS OF STUDY.—The study conducted under para-
graph (1) shall— 
(A) be designed in a manner that will produce esti-
mates of health care costs expended for health care pro-
vided to individuals during the last 6 months of life; 
(B) be designed to produce estimates of such costs 
for the populations identified in subparagraphs (A) and 
(B) of paragraph (1); 
(C) include a calculation of the estimated amount of 
total health care expenditures during such periods of time; 
and 
(D) include a calculation of the estimate described in 
subparagraph (C)— 
(i) as a percentage of the total national heedth 
care expenditures; and 
(ii) for those age 65 years and over, as a percentage 
of the total Medicare expenditures for those age 65 
years and over. 
(b) REPORT.—Not later than 6 months after the date of the 
enactment of this Act, the Secretary shall prepare and submit 
to the Committee on Labor and Human Resources of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives, a report containing the findings resulting from 
the study described in subsection (a). 
(c) 1996 NATIONAL MEDICAL EXPENDITURE SURVEY.— 
(1) IN GENERAL.—The Secretary, acting through the Agency 
for Health Care Policy £ind Research, shall ensure that the 
1996 National Medical Expenditure Survey is designed in a 
manner that will produce an estimate of the amount expended 
for health care provided to individuals during the last 6 months 
of life. 
(2) POPULATIONS.—In designing the Survey under para-
graph (1), the Secretary shall ensure that such Survey produces 
the data required imder such paragraph for the population 
107 STAT. 208 
PUBLIC LAW 103-43—JUNE 10, 1993 
of individuals who are 65 years of age or older, broken down 
based on noninstitutionalized and institutionalized populations. 
TITLE XX—MISCELLANEOUS 
PROVISIONS 
SEC. 2001. DESIGNATION OF SENIOR BIOMEDICAL RESEARCH SERVICE 
IN HONOR OF SILVIO O. CONTE; LIMITATION ON NUMBER 
OF MEMBERS. 
(a) IN GENERAL.—Section 228(a) of the Public Health Service 
Act (42 U.S.C. 237(a)), as added by section 304 of Public Law 
101-509, is amended to read as follows: 
"(a)(1) There shall be in the PubKc Health Service a Silvio 
O. Conte Senior Biomedical Research Service, not to exceed 500 
members. 
"(2) The authority established in paragraph (1) regsirding the 
number of members in the Silvio O. Conte Senior Biomedical 
Research Service is in addition to any authority established regard-
ing the number of members in the commissioned Regular Corps, 
in the Reserve Corps, and in the Senior Executive Service. Such 
paragraph may not be construed to require that the number of 
members in the commissioned Regular Corps, in the Reserve Corps, 
or in the Senior Executive Service be reduced to offset the number 
of members serving in the Silvio O. Conte Senior Biomedical 
Research Service (in this section referred to as the 'Service').". 
(b) CONFORMING AMENDMENT.—Section 228 of the PubHc 
Health Service Act (42 U.S.C. 237), as added by section 304 of 
Public Law 101-509, is amended in the heading for the section 
by amending the heading to read as follows: 
"SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH SERVICE". 
42 use 282 note. SEC. 2002. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE FOR 
RESEARCH. 
Not later than Jxine 1, 1994, the Secretary of Health and 
Human Services, acting through the Director of the National 
Institutes of Health, shall present to the Congress a master plan 
to provide for the replacement or refurbishment of less than ade-
quate buildings, utility equipment and distribution systems (includ-
ing the resources that provide electrical and other utilities, chilled 
water, air handling, and other services that the Secretary, acting 
through the Director, deems necessary), roads, walkways, parking 
areas, and grounds that luiderpin the laboratory and clmical faciK-
ties of the National Institutes of Health. Such plan may msJke 
recommendations for the undertaking of new projects that are 
consistent with the objectives of this section, such as encircling 
the National Institutes of Health Federal enclave with an adequate 
chilled water conduit. 
SEC. 2003. CERTAIN AUTHORIZATION OF APPROPRIATIONS. 
Section 399L(a) of the Public Health Service Act (42 U.S.C. 
280e-4(a)), as added by Public Law 102-515 (106 Stat. 3376), 
is amended— 
(1) in the first sentence, by striking "the Secretary" and 
all that follows and inserting the following: "there are author-
ized to be appropriated $30,000,000 for fiscal year 1994, and 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 209 
such sums as may be necessary for each of the fiscal years 
1995 through 1996."; and 
(2) in the second sentence, by striking "Out of any amounts 
used" and inserting "Of the amounts appropriated under the 
preceding sentence . 
SEC. 2004. BUY-AMERICAN PROVISIONS. 
42 USC 238f 
(a) COMPLIANCE WITH BUY AMERICAN ACT.—No funds appro-
priated pursuant to this Act for any of the fiscal years 1994 through 
1996 may be expended by an entity unless the entity agrees that 
in expending the assistance the entity will comply with sections 
2 through 4 of the Act of March 3, 1933 (41 U.S.C. lOa-lOc, 
popularly known as the "Buy American Act"). 
(b) SENSE OF CONGRESS; REQUIREMENT REGARDING NOTICE.— 
(1) PURCHASE OF AMERICAN-MADE EQUIPMENT AND PROD-
UCTS.—In the case of any equipment or product that may 
be authorized to be purchased with financial assistance pro-
vided pursuant to this Act for any of the fiscal years 1994 
through 1996, it is the sense of the Congress that entities 
receiving such assistance should, in expending the assistance, 
purchase only American-made equipment and products. 
(2) NOTICE TO RECIPIENTS OF ASSISTANCE.—In providing 
financial 
assistance pursuant to this Act, the Secretary of 
Health and Human Services shall provide to each recipient 
of the assistance a notice describing the statement made in 
paragraph (1) by the Congress. 
SEC 2005. PROHIBITION AGAINST FURTHER FUNDING FOR PROJECT 
Washington. 
ARIES. 
For fiscal year 1994 and each subsequent fiscal year, the project 
administered by the University of Washington at Seattle and known 
as Project Aries may not receive any funding fi*om any agency 
of the National Institutes of Health (other than payments under 
awards made for fiscal year 1993 or prior fiscal years) unless— 
(1) the proposal for funding for the project has undergone 
review in accordance with the applicable requirements of sec-
tion 491 of the Public Health Service Act on restrictions regard-
ing institutional review boards and ethics guidance; 
(2) the proposal for funding for the project has undergone 
review in accordance with the applicable requirements of sec-
tion 492 of such Act on restrictions regarding peer review; 
(3) the Secretary of Health and Human Services, in accord-
ance with section 492A of such Act (as added by section 101 
of this Act), makes a determination that the project will assist— 
(A) in reducing the incidence of infection with the 
human immunodeficiency virus; 
(B) in reducing the incidence of sexually transmitted 
diseases; or 
(C) in reducing the incidence of tuberculosis; and 
(4) the data to be collected through the project ceuinot 
be obtained in any other manner. 
SEC. 2006. LOAN REPAYMENT PROGRAM. 
Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 391 et seq.), as amended by Public Law 101-635, is 
amended— 
(1) by redesignating the second section 903 as section 904; 21 use 394. 
and 
107 STAT. 210 
PUBLIC LAW 103-43—JUNE 10, 1993 
(2) by adding at the end the following section: 
21 u s e 395. 
"SEC. 905. LOAN REPAYMENT PROGRAM. 
Contracts. 
"(a) IN GENERAL.— 
"(1) AUTHORITY FOR PROGRAM.—Subject to paragraph (2), 
the Secretary shall carry out a program of entering into con-
tracts with appropriately qualified health professionals under 
which such health professionals agree to conduct research, as 
employees of the Food and Drug Administration, in consider-
ation of the Federal Government agreeing to repay, for each 
year of such service, not more than $20,000 of the principal 
and interest of the educational loans of such health profes-
sionals. 
"(2) LIMITATION.—^The Secretary may not enter into an 
agreement with a health professional pursuant to paragraph 
(1) tinless such professional— 
"(A) has a substantieJ amoxmt of educational loans 
relative to income; and 
"(B) agrees to serve as an employee of the Food and 
Drug Administration for purposes of paragraph (1) for a 
period of not less than 3 years. 
"(b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to 
the National Health Service Corps Loan Repayment Program estab-
lished in subpart III of part D of title III of the Public Health 
Service Act, the provisions of such subpart shall, except as inconsist-
ent with subsection (a) of this section, apply to the program estab-
lished in such subsection in the same manner and to the same 
extent as such provisions apply to the National Health Service 
Corps Loan Repa3anent Program. 
"(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 
carrying out this section, there are authorized to be appropriated 
such sums as may be necessary for each of the fiscal years 1994 
through 1996.". 
SEC. 2007. EXCLUSION OF ALIENS INFECTED WITH THE AGENT FOR 
ACQUIRED IMMUNE DEFICIENCY SYNDROME. 
(a) EXCLUSION OF ALIENS ON HEALTH-RELATED GROUNDS.— 
Section 212(a)(l)(A)(i) of the Immigration and Nationality Act (8 
U.S.C. 1182(a)(l)(A)(i)) is amended by adding at the end the follow-
ing: "which shall include infection with the etiologic agent for 
acquired immune deficiency syndrome,". 
8 use 1182 note. 
(b) EFFECTIVE DATE.—The amendment made by subsection (a) 
shall take effect 30 days after the date of the enactment of this 
Act. 
SEC. 2008. TECHNICAL CORRECTIONS. 
(a) TITLE III.—Section 316 of the Pubhc Health Service Act 
(42 U.S.C. 247a(c)) is amended by striking subsection (c). 
(b) TITLE IV.—Title IV of the Public Health Service Act (42 
U.S.C. 281 et seq.) is amended— 
42 use 284a. 
(1) in section 406— 
(A) in subsection (b)(2)(A), by striking "Veterans' 
Administration" each place such term appears and insert-
ing "Department of Veterans Affairs"; and 
(B) in subsection (h)(2)(A)(v), by striking "Veterans' 
Administration" and inserting "Department of Veterans 
Affairs"; 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 211 
(2) in section 408, in subsection (b) (as redesignated by 42 use 284c. 
section 501(c)(1)(C) of this Act), by striking "Veterans' Adminis-
tration" and inserting "Department of Veterans Affairs"; 
(3) in section 421(b)(1), by inserting a comma after "may"; 
42 use 285b-3. 
(4) in section 428(b), in the matter preceding paragraph 
42 USC 285c-2. 
(1), by striking "the the" and inserting "the"; 
(5) in 
section 
430(b)(2)(A)(i), by striking "Veterans' 42USC285c-4. 
Administration" 
and 
inserting 
"Department 
of 
Veterans 
Affairs"" 
(6) in section 439(b), by striking "Veterans' Administration" 
42 use 285d-4. 
and inserting "Department of Veterans Affairs"; 
(7) in section 442(b)(2)(A), by striking "Veterans' Adminis- 
42 USC 285d-7. 
tration" and inserting "Department of Veterans Affairs"; 
(8) in section 464D(b)(2)(A), by striking "Veterans' Adminis- 42 use 285m-4. 
tration" and inserting "Department of Veterans Affairs"; 
(9) in section 464E— 
42 use 285m-5. 
(A) in subsection (d), in the first sentence, by inserting 
"Coordinating" before "Committee"; and 
(B) in subsection (e), by inserting "Coordinating" before 
"Committee" the first place such term appears; 
(10) in section 464P(b)(6) (as added by section 123 of Pubhc 
42 use 285o-4. 
Law 102-321 (106 Stat. 362)), by striking "Administration" 
and inserting "Institute"; 
(11) in section 466(a)(1)(B), by striking "Veterans' Adminis- 
42 use 286a. 
tration" and inserting "Department of Veterans Affairs"; 
(12) in section 480(b)(2)(A), by striking "Veterans' Adminis- 
42 use 287a. 
tration" and inserting "Department of Veterans Affairs"; 
(13) in section 485(b)(2)(A), by striking "Veterans' Adminis- 
42 use 285q-2. 
tration" and inserting "Department of Veterans Affairs"; 
(14) in section 487(d)(3), by striking "section 304(a)(3)" 42 use 288. 
and inserting "section 304(a)"; and 
(15) in section 496(a), by striking "Such appropriations," 
42 use 289e. 
and inserting the following: "Appropriations to carry out the 
purposes of this title,". 
(c) TITLE XV.— 
-
(1) LIMITED AUTHORITY REGARDING FOR-PROFIT ENTITIES.— 
Section 1501(b) of the Public Health Service Act (42 U.S.C. 
300k(b)) is amended— 
(A) by striking "STATES.—A State" and all that follows 
through 
"may expend" and 
inserting the 
following: 
"STATES.— 
"(1) IN GENERAL.—^A State receiving a grant under sub-
section (a) may, subject to paragraph (2), expend"; and 
(B) by adding at the end the following paragraph: 
"(2) LIMITED AUTHORITY REGARDING OTHER ENTITIES.—In 
addition to the authority established in paragraph (1) for a 
State mth respect to grants and contracts, the State may 
provide for screenings under subsection (a)(1) through entering 
into contracts with private entities. The amount paid by a 
State to a private entity under the preceding sentence for 
a screening procedure may not exceed the amount that would 
be paid under part B of title XVEII of the Social Security 
Act if pa3maent were made under such part for furnishing 
the procedure to a woman enrolled \mder such part.". 
(2) CONFORMING AMENDMENT.—Section 1505(3) of the Pub-
lic Health Service Act (42 U.S.C. 300n-l(3)) is amended by 
inserting before the semicolon the following: "(and additionally, 
107 STAT. 212 
PUBLIC LAW 103-43—JUNE 10, 1993 
in the case of services and activities under section 1501(a)(1), 
with any similar services or activities of private entities)". 
(d) TITLE XXIIL—Part A of title XXIII of tiie PubUc Health 
Service Act (42 U.S.C. SOOcc et seq.) is amended— 
42 use 300CC-3. 
(1) in section 2304— 
(A) in the heading for the section, by striking "CLINI-
CAL RESEARCH REVIEW COMMITTEE" and inserting 
"RESEARCH ADVISORY COMMITTEE"; and 
(B) in subsection (a), by striking "AIDS Clinical 
Research 
Review 
Committee" 
and 
inserting 
"AIDS 
Research Advisory Committee"; 
42 use 
(2) in section 2312(a)(2)(A), bjr striking "AIDS Clinical 
300CC-12. 
Research Review Committee" and inserting "AIDS Research 
Advisory Committee"; 
42 use 
(3) in section 2314(a)(1), in the matter preceding subpara-
300CC-14. 
graph (A), by striking "Clinical Research Review Committee" 
and inserting "AIDS Research Advisory Committee"; 
42 use 
(4) in section 2317(d)(1), by striking "Clinical 
Research 
300CC-17. 
Review Committee" and inserting "AIDS Research 
Advisory 
Committee established under section 2304"; and 
42 use 
(5) in section 2318(b)(3), by striking "Clinical Research 
300CC-18. 
Review Committee" and inserting "AIDS Research Advisory 
Committee". 
(e) SECRETARY.—Section 2(c) of the PubUc Health Service Act 
(42 U.S.C. 201(c)) is amended by striking "Health, Education, and 
Welfare" and inserting "Health and Human Services". 
(f) DEPARTMENT.—Section 201 of the PubUc Health Service 
Act (42 U.S.C. 202) is amended— 
(1) by striking "Health, Education, and Welfare" and insert-
ing "Health and Human Services"; and 
(2) by striking "Surgeon General" and inserting "Assistant 
Secretary for Health". 
(g) DEPARTMENT.—Section 202 of the Public Health Service 
Act (42 U.S.C. 203) is amended— 
(1) by striking "Surgeon General" the second and subse-
quent times that such term appears and inserting "Secretary"; 
and 
(2) by inserting ", £ind the Agency for Hesilth Care Policy 
and Research" before the first period. 
(h) VOLUNTEER SERVICES.—Section 223 of the Public Health 
Service Act (42 U.S.C. 217b) is amended by striking "Health, Edu-
cation, and Welfare" £ind inserting "Health and Human Services", 
(i) 
MISCELLANEOUS.— 
(1) AMENDATORY 
INSTRUCTIONS.— 
42 use 256b. 
(A) Section 602(a) of PubUc Law 102-585 (106 Stat. 
4967) is amended by striking "by adding the following 
subpart" and inserting "by adding at the end the following 
subpart". 
(B) PubUc Law 102-531 is amended— 
42 use 247b-3. 
(i) in section 303(b) (106 Stat. 3488)— 
(I) by striking "Part A of title III" and inserting 
"Part Boftitle III"; and 
(II) by striking "241 et seq." and inserting 
"243 et seq."; 
42 use 247C-1. 
(ii) in section 304 (106 Stat. 3490)— 
(I) by striking "Part A of title III" and inserting 
"Part Boftitle III"; and 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 213 
(II) by striking "241 et seq." £ind inserting 
"243 et seq."; 
(iii) in section 306 (106 Stat. 3494), by striking 
"Part A of title III" and inserting "Part B of title 
III"; and 
(iv) in section 308 (106 Stat. 3495), by striking 
"Part A of title III" and inserting "Part B of title 
III"; 
(2) TITLE III OF PUBLIC HEALTH SERVICE ACT.—Title III 
of the Public Health Service Act (42 U.S.C. 241 et seq.), as 
amended by PubUc Law 102-321, Public Law 102-515, Public 
Law 102-531, and Public Law 102-585, by section 121(a) of 
this Act, and by paragraph (1) of this subsection, is amended— 
(A) in part D— 
(i) by transferring subpart VIII from the current 
placement of the subpart and inserting the subpart 
after subpart VII; £ind 
(ii) by redesignating section 340B of subpart VIII 
as section 340C; and 
(B)(i) by redesignating parts K and L as parts J and 
K, respectively; and 
(ii) by redesignating the part M added by Public Law 
102-321 as part L. 
(3) TITLE VII OF PUBLIC HEALTH SERVICE ACT.—Section 
746(i)(l) of the Public Health Service Act (42 U.S.C. 293j(i)(l)), 
as added by section 102 of Public Law 102-408 (106 Stat. 
1994) and amended by section 313(a)(2)(B) of Pubhc Law 102-
531 (106 Stat. 3507), is amended to read as if the amendment 
made by such section 313(a)(2)(B) had not been enacted. 
SEC. 2009. BIENNIAL REPORT ON CARCINOGENS. 
Section 301(b)(4) of the Public Health Service Act (42 U.S.C. 
241(b)(4)) is amended by striking "an annual" and inserting "a 
biennial". 
SEC. 2010. TRANSFER OF PROVISIONS OF TITLE XXVIL 
(a) IN GENERAL.—The Public Health Service Act (42 U.S.C. 
201 et seq.), as amended by section 101 of Public Law 101-381 
£ind section 304 of Public Law 101-509, is amended— 
(1) by transferring sections 2701 through 2714 to title 
II; 
(2) by redesignating such sections as sections 231 through 
244, respectively; 
(3) by inserting such sections, in the appropriate sequence, 
after section 228; 
(4) by inserting before section 201 the following heading: 
"PART A—ADMINISTRATION"; and 
(5) by inserting before section 231 (as redesignated by 
paragraph (2) of this subsection) the following heading: 
"PART B—MISCELLANEOUS PROVISIONS". 
(b) CONFORMING AMENDMENTS.—The Public Health Service Act 
(42 U.S.C. 201 et seq.) is amended— 
(1) in the heading for title II, by inserting "AND MIS-
CELLANEOUS PROVISIONS" after "ADMINISTRATION"; 
42 use 247b-4. 
42 use 247b-5. 
42 use 254b et 
seq. 
42 use 256c. 
42 use 280b et 
seq., 280c et seq. 
42 use 280d et 
seq. 
42 use 300aaa— 
300aaa-13, 238-
238m. 
107 STAT. 214 
PUBLIC LAW 103-43—JUNE 10, 1993 
42 use 284a. 
(2) in section 406(a)(2), by striking "2701" and inserting 
"231"' 
42 use 286. 
(3) in section 465(f), by striking "2701" and inserting "231"; 
42 use 287a. 
(4) in section 480(a)(2), by striking "2701" and inserting 
"231"; 
42USC285q-2. 
(5) in section 485(a)(2), by striking "2701" and inserting 
"231"; 
42 use 289f. 
(6) in section 497, by striking "2701" and inserting "231"; 
42 use 290aa-4. 
(7) in section 505(a)(2), by striking "2701" and inserting 
"231"" 
42USe299c-5. 
(8) in section 926(b), by striking "2711" each place such 
term appecirs and inserting "241"; and 
(9) in title XXVII, by striking the heading for such title. 
SEC. 2011. AUTHORIZATION OF APPROPRIATIONS. 
Section 2602 of the Low-Income Home Energy Assistance Act 
of 1981 (42 U.S.C. 8621) is amended— 
(1) in the first sentence of subsection (b), by striking "1993 
and 1994" and inserting "1993,1994, and 1995"; and 
(2) in subsection (d), by striMng "in each of the fiscal 
years 1993 and 1994" and inserting "for each of the fiscal 
years 1993,1994, and 1995". 
SEC. 2012. VACCINE INJURY COMPENSATION PROGRAM. 
Section 2111(a) of the Public Health Service Act (42 U.S.C. 
300aa-ll(a)) is amended by adding at the end the following para-
graph: 
"(10) The Clerk of the United States Claims Court is 
authorized to continue to receive, and forward, petitions for 
compensation for a vaccine-related injury or death associated 
with the administration of a vaccine on or after October 1, 
1992.". 
SEC. 2013. TECHNICAL CORRECTIONS WITH RESPECT TO THE AGENCY 
FOR HEALTH CARE POLICY AND RESEARCH. 
Title IX of the Public Health Service Act is amended— 
(1) in section 904(d) (42 U.S.C. 299a-2(d))— 
(A) by striking "IN GENERAL" in paragraph (1) and 
inserting "ADDITIONAL ASSESSMENTS"; 
(B) by redesignating paragraphs (1) and (2) as para-
graphs (3) and (4), respectively; 
(C) by inserting after the subsection designation the 
following paragraphs: 
"(1) RECOMMENDATIONS WITH RESPECT TO HEALTH CARE 
TECHNOLOGY.—^The Administrator shall make recommendations 
to the Secretary with respect to whether specific health care 
technologies should be reimbursable under federally financed 
health programs, including recommendations with respect to 
any conditions and requirements under which any such 
reimbursements should be made. 
"(2) CONSIDERATIONS OF CERTAIN FACTORS.—In making rec-
ommendations 
respecting 
health 
care 
technologies, 
the 
Administrator shall consider the safety, efficacy, and effective-
ness, and, as appropriate, the appropriate uses of such tech-
nologies. The Administrator shall also consider the cost 
effectiveness of such technologies where cost information is 
available and reliable."; and 
(D) by adding at the end the following paragraph: 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 215 
"(5) CONSULTATIONS.—In carrying out this subsection, the 
Administrator shall cooperate and consult with the Director 
of the National Institutes of Health, the Commissioner of Food 
and Drugs, and the heads of £iny other interested Federal 
department or agency."; and 
(2) in section 914(a)(2)(C), by striking "904(c)(2)" and insert- 
42 use 299b-3. 
ing "904(d)(2)". 
SEC. 2014. TECHNICAL CORRECTIONS WITH RESPECT TO THE HEALTH 
PROFESSIONS EDUCATION EXTENSION AMENDMENTS OF 
1992. 
(a) INSURED HEALTH EDUCATION ASSISTANCE LOANS TO GRAD-
UATE STUDENTS.—Subpart I of part A of title VII of the Public 
Health Service Act (42 U.S.C. 292 et seq.), as added by section 
102 of Public Law 102-408 (106 Stat. 1994), is amended— 
(1) in section 705(a)(2)— 
42 use 292d. 
(A) in subparagraph (G), by inserting "and" after the 
semicolon at the end; 
(B) by striking subparagraph (H); and 
(C) by redesignating subparagraph (I) as subparagraph 
(H); and 
(2) in section 707— 
42 use 292f. 
(A) in subsection (g), by amending paragraph (1) to 
read as follows: 
"(1) after the expiration of the seven-year period beginning 
on the first date when repajnnent of such loan is required, 
exclusive of any period after such date in which the obligation 
to pay installments on the loan is suspended;"; and 
(B) by adding at the end the following subsection: 
"(j) SCHOOL COLLECTION ASSISTANCE.—An institution or post-
graduate training program attended by a borrower may assist in 
the collection of any loan of that borrower made under this subpart 
which becomes delinquent, including providing information concern-
ing the borrower to the Secretary and to past eind present lenders 
and holders of the borrower's loans, contacting the borrower in 
order to encourage repa5nnent, and withholding services in accord-
ance with regulations issued by the Secretary under section 
715(a)(7). The institution or postgraduate training program shall 
not be subject to section 809 of the Fair Debt Collection Practices 
Act for purposes of carrying out activities authorized by this sec-
tion.". 
(b) LOAN PROVISIONS.—Section 722 of the Public Health Service 
Act (42 U.S.C. 292r), as added by section 102 of Public Law 102-
408 (106 Stat. 1994), is amended— 
(1) in subsection (a), by amending the subsection to read 
as follows: 
"(a) AMOUNT OF LOAN.— 
"(1) IN GENERAL.—Loans from a student loan fund (estab-
lished under an agreement with a school under section 721) 
may not, subject to paragraph (2), exceed for £iny student for 
a school year (or its equivalent) the sum of— 
"(A) the cost of tuition for such year at such school, 
and 
"(B) $2,500. 
"(2) THIRD AND FOURTH YEARS OF MEDICAL SCHOOL.—For 
purposes of paragraph (1), the amount $2,500 may, in the 
case of the third or fourth year of a student at school of 
107 STAT. 216 
PUBLIC LAW 103-43—JUNE 10, 1993 
medicine or osteopathic medicine, be increased to the extent 
necessary (including such $2,500) to pay the balances of loans 
that, from sources other than the student loan fund imder 
section 721, were made to the individual for attendance at 
the school. The authority to make such an increase is subject 
to the school and the student agreeing that such amount (as 
increased) will be expended to pay such balances."; and 
(2) in subsection (b)— 
(A) in paragraph (1), by adding "and" after the semi-
colon at the end; 
(B) by striking paragraph (2); and 
(C) by redesignating paragraph (3) as paragraph (2). 
(c) MEDICAL SCHOOLS AND PRIMARY HEALTH CARE.— 
(1) REQUIREMENTS FOR STUDENTS.—Section 723(a) of the 
PubHc Health Service Act (42 U.S.C. 292s(a)), as added by 
section 102 of PubHc Law 102-408 (106 Stat. 1994), is amended 
by adding at the end the following paragraph: 
"(4) WAIVERS.— 
"(A) With respect to the obligation of an individual 
under an agreement made luider paragraph (1) as a stu-
dent, the Secretary shall provide for the partial or total 
waiver or suspension of the obligation whenever compliance 
by the individual is impossible, or would involve extreme 
hardship to the individual, and if enforcement of the obliga-
tion with respect to the individual would be unconscionable. 
"(B) For purposes of subparagraph (A), the obligation 
of an individual shall be waived if— 
"(i) the status of the individual as a student of 
the school involved is terminated before graduation 
from the school, whether voluntarily or involuntarily; 
and 
"(ii) the individual does not, after such termi-
nation, resume attendance at the school or begin 
attendance at any other school of medicine or osteo-
pathic medicine. 
"(C) If an individual resumes or begins attendance 
for purposes of subparagraph (B), the obligation of the 
individual under the agreement under paragraph (1) shall 
be considered to have been suspended for the period in 
which the individual was not in attendance. 
"(D) This paragraph may not be construed as authoriz-
ing the waiver or suspension of the obligation of a student 
to repay, in accordance with section 722, loans from student 
loan funds under section 721.". 
(2) REQUIREMENTS FOR SCHOOLS.—Section 723(b) of the 
PubHc Health Service Act (42 U.S.C. 292s(b)), as added by 
section 102 of PubHc Law 102-408 (106 Stat. 1994), is 
amended— 
(A) in paragraph (1)— 
(i) by striking "1994," and inserting "1997;"; and 
(ii) by striking "4 years before" and inserting "3 
years before"; 
(B) in paragraph (2)(B), by striking "15 percent" and 
inserting "25 percent"; and 
(C) in paragraph (4)(B)— 
(i) in clause (i), by striking "1994," and inserting 
"1997,"; and 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 217 
(ii) in clause (ii), by striking "1995," and inserting 
"1998,". 
(d) AUTHORIZATION OF APPROPRIATIONS REGARDING MEDICAL 
SCHOOLS.—Section 735 of the Public Health Service Act (42 U.S.C. 
292y), as added by section 102 of Public Law 102-408 (106 Stat. 
1994), is amended by adding at the end the following subsection: 
"(f) FUNDING FOR CERTAIN MEDICAL SCHOOLS.— 
"(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose 
of making Federal capital contributions to student loan funds 
established under section 721 by schools of medicine or osteo-
pathic medicine, there is authorized to be appropriated 
$10,000,000 for each of the fiscal years 1994 through 1996. 
"(2) MINIMUM REQUIREMENTS.— 
"(A) Subject to subparagraph (B), the Secretary may 
make a Federal capital contribution pursuant to paragraph 
(1) only if the school of medicine or osteopathic medicine 
involved meets the conditions described in subparagraph 
(A) of section 723(b)(2) or the conditions described in 
subparagraph (C) of such section. 
"(B) For purposes of subparagraph (A), the conditions 
referred to in such subparagraph shall be applied with 
respect to graduates of the school involved whose date 
of graduation occurred approximately 3 years before June 
30 of the fiscal year preceding the fiscal year for which 
the Federal capital contribution involved is made. 
(e) PUBLIC HEALTH TRAINEESHIPS.—Section 761(b)(3) of 
the 
Public Health Service Act (42 U.S.C. 294(b)(3)), as added by section 
102 of Pubhc Law 102-408 (106 Stat. 1994), is amended by striking 
"and nutrition" and inserting "nutrition, and maternal and child 
health". 
(f) TRAINEESHIPS FOR ADVANCED NURSE EDUCATION.—Section 
830(a) of the Public Health Service Act, as added by section 206 
of PubHc Law 102-408 (106 Stat. 2073), is amended— 
42 USC 297. 
(1) by striking "meet the cost of traineeships for individ-
uals" and inserting the following: "meet the costs of— 
"(1) traineeships for individuals"; 
(2) by striking the period at the end and inserting "; and"; 
and 
(3) by adding at the end the following paragraph: 
"(2) traineeships for participation in certificate nurse mid-
wifery programs that conform to guidelines established by the 
Secretary under section 822(b).". 
(g) 
CERTAIN 
GENERALLY APPLICABLE 
PROVISIONS.—Section 
860(d) of the Pubhc Health Service Act (42 U.S.C. 298b-7(d)), 
as added by section 209 of PubUc Law 102-408 (106 Stat. 2075), 
is amended in the first sentence by striking "821, 822, 830, and 
831" and inserting "821, 822, and 827". 
SEC. 2015. PROHIBITION AGAINST SHARP ADULT SEX SURVEY AND 42 USC 283f 
THE AMERICAN TEENAGE SEX SURVEY. 
note. 
The Secretary of Health and Human Services may not during 
fiscal year 1993 or any subsequent fiscal year conduct or support 
the SHARP survey of adult sexual behavior or the American Teen-
age Study of adolescent sexual behavior. This section becomes effec- Effective date, 
tive on the date of the enactment of this Act. 
107 STAT. 218 
PUBLIC LAW 103-43—JUNE 10, 1993 
SEC. 2016. HEALTH SERVICES RESEARCH. 
(a) DEFINITION.—Section 409 of the Public Health Service Act 
(42 U.S.C. 284d), as added by section 121(b) of PubKc Law 102-
321 (106 Stat. 358), is amended by adding at the end the following 
sentence: "Such term does not include research on the efficacy 
of services to prevent, diagnose, or treat medical conditions.". 
42 use 285n 
(b) REQUIRED ALLOCATIONS.— 
note. 
(1) IN GENERAL.—With respect to the allocation for health 
services research required in each of the provisions of law 
specified in paragraph (2), the term "15 percent" appearing 
in each of such provisions is, in the case of allocations for 
fiscal year 1993, deemed to be 12 percent. 
(2) RELEVANT PROVISIONS OF LAW.—The provisions of law 
referred to in paragraph (1) are— 
(A) section 464H(d)(2) of the PubHc Health Service 
Act, as added by section 122 of Pubhc Law 102-321 (106 
Stat. 358); 
(B) section 464L(d)(2) of the PubHc Health Service 
Act, as added by section 123 of PubHc Law 102-321 (106 
Stat. 360); and 
(C) section 464R(f)(2) of the Public Health Service Act, 
as added by section 124 of PubHc Law 102-321 (106 Stat. 
364). 
(c) REPORT.—Section 494A(b) of the Public Health Service Act 
(42 U.S.C. 289c-l(b)), as added by section 125 of PubHc Law 102-
321 (106 Stat. 366), is amended by striking "May 3, 1993," and 
inserting "September 30,1993,". 
SEC. 2017. CHnj)HOOD MENTAL HEALTH. 
Part E of title V of the Public Health Service Act (42 U.S.C. 
290ff et seq.), as added by section 119 of PubHc Law 102-321 
(106 Stat. 349), is amended— 
42 use 290ff. 
(1) in section 561— 
(A) in subsection (a)(2), by striking "this subpart" and 
inserting "this part"; and 
(B) in subsection (b)(1), by striking "is receiving such 
payments" each place such term appears and inserting 
is such a grantee ; £ind 
42 use 290fr-4. 
(2) in section 565— 
(A) in subsection (c)(1), by striking "this subpart" and 
inserting "this part"; 
(B) in subsection (d), by striking "this subpart" and 
inserting "this part"; and 
(C) in subsection (f)— 
(i) in paragraph (1), by striking "this subpart" 
and inserting "this part"; and 
(ii) by amending paragraph (2) to read as foUows: 
"(2) LIMITATION REGARDING TECHNICAL ASSISTANCE.—Not more 
than 10 percent of the amounts appropriated under paragraph 
(1) for a nscal year may be expended for canying out subsection 
(b).". 
SEC 2018. EXPENDITUBES FROM CERTAIN ACCOUNT. 
With respect to amoimts appropriated in title II of Public 
Law 102-394 for buildings and faciHties of the National Institutes 
of Health, the purposes for which such amoimts may be emended 
include repairing, improving, or constructing (or any combination 
PUBLIC LAW 103-43—JUNE 10, 1993 
107 STAT. 219 
thereof) roads on non-Federal property in close proximity to the 
main campus of the National Institutes of Health in Bethesda, 
Maryland, subject to the agreement of the appropriate officials 
of Montgomery County, Maryland, or the appropriate officials of 
the State of Marylsind, or both, as the case may be. None of 
such amounts may be used for the non-Federal share of the cost 
of any project or activity under title 23, United States Code, the 
Intermodal Surface Transportation Efficiency Act of 1991, or any 
law amended by such Act. 
TITLE XXI—EFFECTIVE DATES 
SEC. 2101. EFFECTIVE DATES. 
42 USC 201 note. 
Subject to section 203(c), this Act and the amendments made 
by this Act take effect upon the date of the enactment of this 
Act. 
Approved June 10, 1993. 
LEGISLATIVE HISTORY—S. 1 (H.R. 4): 
HOUSE REPORTS: No. 103-28, accompanying H.R. 4 (Comm. on Energy and 
Commerce) and No. 103-100 (Comm. of Conference). 
SENATE REPORTS: No. 103-2 (Comm. on Labor and Human Resources). 
CONGRESSIONAL RECORD, Vol. 139 (1993): 
Feb. 16-18, considered and passed Senate. 
Mar. 10, 11, H.R. 4 considered and passed House; S. 1, amended, passed in lieu. 
May 25, House agreed to conference report. 
May 28, Senate agreed to conference report. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 29 (1993): 
June 10, Presidential remarks. 
o