IB
Union Calendar No. 12
103D CONGRESS
1ST SESSION
H. R. 4
[Report No. 103–28]
To amend the Public Health Service Act to revise and extend the programs
of the National Institutes of Health, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 5, 1993
Mr. WAXMAN (for himself, Mr. UPTON, Mrs. SCHROEDER, Ms. SNOWE, Mrs.
COLLINS of Illinois, Ms. DANNER, Ms. ENGLISH, Mrs. JOHNSON of Con-
necticut, Mrs. KENNELLY, Ms. LAMBERT, Mr. LEHMAN, Mrs. LOWEY of
New York, Mrs. LLOYD, Mr. MARKEY, Mrs. MINK, Mrs. MORELLA, Ms.
MOLINARI, Ms. NORTON, Mr. RICHARDSON, Ms. PELOSI, Mr. SANDERS,
Ms. SCHENK, Mr. SHARP, Ms. SLAUGHTER, Mr. STUDDS, Mr. SYNAR,
Mr. TOWNS, Mrs. UNSOELD, Ms. WATERS, Ms. WOOLSEY, and Mr.
WYDEN) introduced the following bill; which was referred to the Commit-
tee on Energy and Commerce
MARCH 9, 1993
Additional sponsors: Miss COLLINS of Michigan, Mr. SWIFT, Ms. KAPTUR, Mr.
BOUCHER, Ms. FURSE, Ms. SHEPHERD, Mrs. BYRNE, Mr. SHAYS, Mr.
DIXON, and Mr. EDWARDS of California
MARCH 9, 1993
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed in italic]
[For text of introduced bill, see copy of bill as introduced on January 5, 1993]
A BILL
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 Representa-
tives 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 ‘‘Na-
tional 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 OF PROPOSALS FOR BIOMEDICAL AND BEHAVIORAL
RESEARCH
Sec. 101. Establishment of certain provisions regarding research conducted or
supported 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
directed 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. Applicability to current projects.
PART II—OFFICE OF RESEARCH ON WOMEN’S HEALTH
Sec. 141. Establishment.
PART III—OFFICE OF RESEARCH ON MINORITY HEALTH
Sec. 151. Establishment.
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. Effective dates.
TITLE II—NATIONAL INSTITUTES OF HEALTH IN GENERAL
Sec. 201. Health promotion research dissemination.
Sec. 202. Programs for increased support regarding certain States and research-
ers.
Sec. 203. Establishment of Office of Behavioral 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 fund of Director of National Institutes of Health.
Sec. 209. 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 dis-
orders.
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.
Sec. 504. Authorization of appropriations.
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 IX—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 and contracts for research centers.
Sec. 1002. Loan repayment program for research with respect to contraception
and infertility.
Subtitle B—Program Regarding Obstetrics and Gynecology
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 research on diabetes eye care.
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.
Sec. 1302. Study of environmental and other risks contributing to incidence of
breast and prostate cancer.
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. 1501. 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
Institute 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.
Subtitle B—Acquired Immune Deficiency Syndrome
Sec. 1611. Loan repayment program.
Subtitle C—Loan Repayment for Research Generally
Sec. 1621. Establishment of program.
Subtitle D—Scholarship and Loan Repayment Programs Regarding
Professional Skills Needed by National Institutes of Health
Sec. 1631. Establishment of programs.
Sec. 1632. Funding.
Subtitle E—Funding for Awards and Training Generally
Sec. 1641. Authorization of appropriations.
TITLE XVII—NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH
Sec. 1701. Date certain for appointment of Board members.
Sec. 1702. Miscellaneous provisions.
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 XIX—STUDIES
Sec. 1901. Acquired immune deficiency syndrome.
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.
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.
TITLE XXI—EFFECTIVE DATES
Sec. 2101. Effective dates.
view in accordance with such section and has
been recommended for approval by a majority of
the members of the Board conducting such re-
view.
‘‘(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 In-
stitutes of Health, the Secretary may not author-
ize 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 applica-
tion submitted to the Secretary for financial assist-
ance to conduct research, the Secretary may not ap-
prove or fund any application that is subject to tech-
nical and scientific peer review under section 492(a)
unless the application has undergone peer review in
accordance with such section and has been rec-
ommended 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 ap-
proval for purposes of subsection (a), the Secretary
may not withhold funding for the research on ethical
grounds unless—
‘‘(A) the Secretary convenes an advisory
board in accordance with paragraph (4) to study
the ethical implications of the research; and
‘‘(B)(i) the majority of the advisory board
recommends that, on ethical grounds, the Sec-
retary withhold funds for the research; or
(ii) the majority of such board recommends
that the Secretary not withhold funds for the re-
search on ethical grounds, but the Secretary
finds, on the basis of the report submitted under
paragraph (4)(B)(ii), that the recommendation
is arbitrary and capricious.
‘‘(2) APPLICABILITY.—The limitation established
in paragraph (1) regarding the authority to withhold
funds on ethical grounds shall apply without regard
to whether the withholding of funds on such grounds
is characterized as a disapproval, a moratorium, a
prohibition, or other description.
‘‘(3) PRELIMINARY MATTERS REGARDING USE OF
PROCEDURES.—
‘‘(A) If the Secretary makes a determina-
tion that an advisory board should be convened
for purposes of paragraph (1), the Secretary
shall, through a statement published in the Fed-
eral Register, announce the intention of the Sec-
retary to convene such a board.
‘‘(B) A statement issued under subpara-
graph (A) shall include a request that interested
individuals submit to the Secretary recommenda-
tions specifying the particular individuals who
should be appointed to the advisory board in-
volved. The Secretary shall consider such rec-
ommendations in making appointments to the
board.
‘‘(C) The Secretary may not make appoint-
ments to an advisory board under paragraph (1)
until the expiration of the 30-day period begin-
ning on the date on which the statement required
in subparagraph (A) is made with respect to the
board.
‘‘(4) ETHICS ADVISORY BOARDS.—
‘‘(A) Any advisory board convened for pur-
poses of paragraph (1) shall be known as an eth-
ics advisory board (hereafter in this paragraph
referred to as an ‘ethics board’).
‘‘(B)(i) An ethics board shall advise, consult
with, and make recommendations to the Sec-
retary regarding the ethics of the project of bio-
medical or behavioral research with respect to
which the board has been convened.
‘‘(ii) Not later than 180 days after the date
on which the statement required in paragraph
(3)(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 re-
port describing the findings of the board regard-
ing the project of research involved and making
a recommendation under clause (i) of whether
the Secretary should or should not withhold
funds 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, individ-
uals who are not officers or employees of the
United States. The Secretary shall make ap-
pointments to the board from among individuals
with special qualifications and competence to
provide advice and recommendations regarding
ethical matters in biomedical and behavioral re-
search. Of the members of the board—
‘‘(i) no fewer than 1 shall be an attor-
ney;
‘‘(ii) no fewer than 1 shall be an
ethicist;
‘‘(iii) no fewer than 1 shall be a prac-
ticing physician;
‘‘(iv) no fewer than 1 shall be a theolo-
gian; and
‘‘(v) no fewer than one-third, and no
more than one-half, shall be scientists with
substantial accomplishments 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 re-
mainder of the term of the predecessor of the in-
dividual.
‘‘(E) A member of an ethics board shall be
subject to removal from the board by the Sec-
retary for neglect of duty or malfeasance or for
other good cause shown.
‘‘(K) An ethics board shall terminate 30
days after the date on which the report required
in subparagraph (B)(ii) is submitted to the Sec-
retary and the congressional committees specified
in such subparagraph.’’.
PART II—RESEARCH ON TRANSPLANTATION OF
FETAL TISSUE
SEC. 111. ESTABLISHMENT OF AUTHORITIES.
Part G of title IV of the Public Health Service Act
(42 U.S.C. 289 et seq.) is amended by inserting after section
498 the following new section:
‘‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
‘‘SEC. 498A. (a) ESTABLISHMENT OF PROGRAM.—
‘‘(1) IN GENERAL.—The Secretary may conduct
or support research on the transplantation of human
fetal tissue for therapeutic purposes.
‘‘(2) SOURCE OF TISSUE.—Human fetal tissue
may be used in research carried out under paragraph
(1) regardless of whether the tissue is obtained pursu-
ant 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 state-
ment, made in writing and signed by the woman, de-
claring that—
‘‘(A) the woman donates the fetal tissue for
use in research described in subsection (a);
‘‘(B) the donation is made without any re-
striction regarding the identity of individuals
who may be the recipients 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 car-
ried 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 the tissue to be used
in such research; and
‘‘(ii) no alteration of the timing, meth-
od, or procedures used to terminate the
pregnancy was made solely for the purposes
of obtaining the tissue;
‘‘(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 tis-
sue; 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 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 under subsection (a),
human fetal tissue may be used only if the individual with
the principal responsibility for conducting the research in-
volved 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 pur-
suant to a spontaneous or induced abortion or
subsequent to a stillbirth; and
‘‘(C) the tissue was donated for research
purposes;
‘‘(2) has provided such information to other in-
dividuals with responsibilities regarding the research;
‘‘(3) will require, prior to obtaining the consent
of an individual to be a recipient of a transplan-
tation 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 re-
search.
‘‘(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 conduct-
ing 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 in-
volved in such research, including such individuals
and entities involved in the donation, transfer, re-
ceipt, or transplantation of human fetal tissue. With
respect to any material or information obtained pur-
suant 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 information, except where required by Federal
law, in which case such material or information
shall be coded in a manner such that the identi-
ties of such individuals and entities are pro-
tected; and
‘‘(C) not maintain such material or infor-
mation 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 sup-
port for research under subsection (a) unless the ap-
plicant 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.
‘‘(f) DEFINITION.—For purposes of this section, the
term ‘human fetal tissue’ means tissue or cells obtained
from a dead human embryo or fetus after a spontaneous
or induced abortion, or after a stillbirth.’’.
SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITA-
TION OR ACCEPTANCE OF TISSUE AS DI-
RECTED DONATION FOR USE IN TRANSPLAN-
TATION.
Part G of title IV of the Public Health Service Act,
as amended by section 111 of this Act, is amended by insert-
ing after section 498A the following new section:
‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE
‘‘SEC. 498B. (a) PURCHASE OF TISSUE.—It shall be
unlawful for any person to knowingly acquire, receive, or
otherwise transfer any human fetal tissue for valuable con-
sideration if the transfer affects interstate commerce.
‘‘(b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DI-
RECTED 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 an-
other person if the donation affects interstate commerce, the
‘‘(1) The term ‘human fetal tissue’ has the mean-
ing given such term in section 498A(f).
‘‘(2) The term ‘interstate commerce’ has the
meaning given such term in section 201(b) of the Fed-
eral Food, Drug, and Cosmetic Act.
‘‘(3) The term ‘valuable consideration’ does not
include reasonable payments associated with the
transportation, implantation, processing, preserva-
tion, quality control, or storage of human fetal
tissue.’’.
SEC. 113. NULLIFICATION OF MORATORIUM.
(a) IN GENERAL.—Except as provided in subsection
(c), no official of the executive branch may impose a policy
that the Department of Health and Human Services is pro-
hibited from conducting or supporting any research on the
transplantation of human fetal tissue for therapeutic pur-
poses. 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 pol-
icy 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.—In the case of any proposal
for research on the transplantation of human fetal tis-
sue for therapeutic purposes, the Secretary of Health
and Human Services may not withhold funds for the
research if—
(A) the research has been approved for pur-
poses of section 492A(a) of the Public Health
Service Act (as added by section 101 of this Act);
(B) the research will be carried out in ac-
cordance 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 thera-
peutic 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 pur-
suant to section 492A(b)(4)(B)(ii) of the Public
Health Service Act (as added by section 101 of
this Act); and
(B) finding, on a basis that is neither arbi-
trary nor capricious, that there are no ethical
grounds for withholding funds for the research.
(c) AUTHORITY FOR WITHHOLDING FUNDS FROM RE-
SEARCH.—In the case of any research on the transplan-
tation of human fetal tissue for therapeutic purposes, the
Secretary of Health and Human Services may withhold
funds 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).
SEC. 114. REPORT BY GENERAL ACCOUNTING OFFICE ON
ADEQUACY OF REQUIREMENTS.
(a) IN GENERAL.—With respect to research on the
transplantation of human fetal tissue for therapeutic pur-
poses, the Comptroller 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 accord-
ance 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 Comp-
troller 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 Public Health Service Act (42 U.S.C. 241 et seq.)
is amended by striking part J.
(b) OTHER REPEALS.—Part G of title IV of the Public
Health Service Act (42 U.S.C. 289 et seq.) is amended—
(1) in section 498, by striking subsection (c); and
(2) by striking section 499; and
(3) by redesignating section 499A as section 499.
(c) NULLIFICATION
OF CERTAIN PROVISIONS.—The
provisions of Executive Order 12806 (57 Fed. Reg. 21589
(May 21, 1992)) shall not have any legal effect. The provi-
sions 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 Eq-
uity Regarding Women and Mi-
norities
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 insert-
ing after section 492A the following new section:
‘‘INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH
‘‘SEC. 492B. (a) REQUIREMENT OF INCLUSION.—
‘‘(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 in-
cluded as subjects in such research.
‘‘(2) OUTREACH REGARDING PARTICIPATION AS
SUBJECTS.—The Director of NIH, in consultation
with the Director of the Office of Research on Wom-
en’s Health and the Director of the Office of Research
on Minority Health, shall conduct or support out-
reach programs for the recruitment of women and
members of minority groups as subjects in projects of
clinical research.
‘‘(b) INAPPLICABILITY
OF REQUIREMENT.—The re-
quirement 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, re-
spectively—
‘‘(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 cir-
cumstances 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 under 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 Di-
rector 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 in-
clusion 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
under subsection (a).
‘‘(2) CERTAIN PROVISIONS.—With respect to the
circumstances under which the inclusion of women or
members of minority groups (as the case may be) as
subjects in a project of clinical research is inappro-
priate for purposes of subsection (b), the following ap-
plies to guidelines under paragraph (1):
‘‘(A)(i) In the case of a clinical trial, the
guidelines shall provide that the costs of such in-
clusion in the trial is not a permissible consider-
ation 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 per-
missible consideration in determining 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 or will be obtained
through other means that provide data of com-
parable 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 mem-
bers of minority groups, respectively; and
‘‘(ii) the effects that the variables have
on the individuals who would serve as sub-
jects in the trial in the event that such in-
clusion were not required.
‘‘(e) DATE CERTAIN FOR GUIDELINES; APPLICABIL-
ITY.—
‘‘(1) DATE CERTAIN.—The guidelines required in
subsection (d) shall be established and published in
the Federal Register 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 con-
ducted 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 annually
submit to the Director of NIH and the Director of the insti-
tute involved a report describing the manner in which the
agency has complied with this section.
‘‘(g) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘project of clinical research’ in-
cludes a clinical trial.
‘‘(2) The term ‘minority group’ includes sub-
populations of minority groups. The Director of NIH
shall, through the guidelines established under sub-
section (d), define the terms ‘minority group’ and
‘subpopulation’ for purposes of the preceding sen-
tence.’’.
SEC. 132. PEER REVIEW.
Section 492 of the Public Health Service Act (42
U.S.C. 289a) is amended by adding at the end the following
new subsection:
‘‘(c)(1) In technical and scientific peer review under
this section of proposals for clinical research, the consider-
ation of any such proposal (including the initial consider-
ation) shall, except as provided 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 sec-
tion 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 re-
search.’’.
SEC. 133. APPLICABILITY TO CURRENT PROJECTS.
Section 492B of the Public Health Service Act, as
added by section 131 of this Act, shall not apply with re-
spect to projects of clinical research for which initial fund-
ing 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 conducted or supported by
the National Institutes of Health, any policies of the Sec-
retary of Health and Human Services regarding such inclu-
sion that are in effect on the day before the date of the enact-
ment of this Act shall continue to apply to the projects re-
ferred to in the preceding sentence.
PART II—OFFICE OF RESEARCH ON WOMEN’S
HEALTH
SEC. 141. ESTABLISHMENT.
(a) IN GENERAL.—Title IV of the Public Health Serv-
ice Act, as amended by the preceding provisions of this title,
is amended—
(1) by redesignating section 486 as section 485A;
(2) by redesignating parts F through H as parts
G through I, respectively; and
(3) by inserting after part E the following new
part:
‘‘PART F—RESEARCH ON WOMEN’S HEALTH
‘‘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 re-
ferred 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 con-
ducted or supported;
‘‘(3) carry out paragraphs (1) and (2) with re-
spect 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 in-
stitutes;
‘‘(6) recommend an agenda for conducting and
supporting such research;
‘‘(7) promote the sufficient allocation of the re-
sources of the national research institutes for conduct-
ing 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 Coordinating Committee on Research on Wom-
en’s Health (hereafter in this subsection referred to as
the ‘Coordinating Committee’).
‘‘(2) The Coordinating Committee shall be com-
posed of the Directors of the national research insti-
tutes (or the designees of the Directors).
‘‘(3) The Director of the Office shall serve as the
chair of the Coordinating Committee.
‘‘(4) With respect to research on women’s health,
the Coordinating 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 adequately support the research;
‘‘(B) identifying needs regarding the coordi-
nation of research activities, including intra-
mural and extramural multidisciplinary activi-
ties;
‘‘(C) supporting the development of meth-
odologies to determine the circumstances in
which obtaining data specific to women (includ-
ing 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 ex-
pansion of clinical trials of treatments and
therapies for which obtaining such data has been
determined to be an appropriate function; and
‘‘(E) encouraging the national research in-
stitutes to conduct and support such research, in-
cluding 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 (hereafter in this subsection referred
to as the ‘Advisory Committee’).
‘‘(2) The Advisory Committee shall be composed
of no fewer than 12, and not more than 18 individ-
uals, who are not officers or employees of the Federal
Government. The Director of the Office shall make ap-
pointments to the Advisory Committee from among
physicians, practitioners, scientists, and other health
professionals, whose clinical practice, research spe-
cialization, or professional expertise includes a sig-
nificant focus on research on women’s health. A ma-
jority 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 ap-
propriate 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 gyne-
cological health conditions, diseases, and
treatments; and
‘‘(v) research on women’s health condi-
tions which require a multidisciplinary ap-
proach;
‘‘(B) report to the Director of the Office on
such research;
‘‘(C) provide recommendations to such Di-
rector regarding activities of the Office (includ-
ing recommendations on the development of the
methodologies described in subsection (c)(4)(C)
and recommendations on priorities in carrying
out research described in subparagraph (A)); and
‘‘(D) assist in monitoring compliance with
section 492B regarding the inclusion of women
in clinical research.
‘‘(5)(A) The Advisory Committee shall prepare a
biennial report describing the activities of the Com-
mittee, including findings made by the Committee re-
garding—
‘‘(i) compliance with section 492B;
‘‘(ii) the extent of expenditures made for re-
search 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 inclu-
sion in the report required in section 403.
‘‘(e) REPRESENTATION OF WOMEN AMONG RESEARCH-
ERS.—The Secretary, acting through the Assistant Sec-
retary 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 physicians and
scientists conducting research with funds provided by such
institutes, and as appropriate, carry out activities to in-
crease 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 diseases, disorders, and conditions (includ-
ing with respect to mental health)—
‘‘(A) unique to, more serious, or more prev-
alent in women;
‘‘(B) for which the factors of medical risk or
types 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, includ-
ing research on preventing such conditions.
‘‘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 Na-
tional Library of Medicine, shall establish a data sys-
tem for the collection, storage, analysis, retrieval, and
dissemination of information regarding research on
women’s health that is conducted or supported by the
national research institutes. Information from the
data 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 para-
graph (1) shall include a registry of clinical trials of
experimental treatments that have been developed for
research on women’s health. Such registry shall in-
clude 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 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 pertaining to the results,
including potential toxicities or adverse effects associ-
ated with the experimental treatment or treatments
evaluated.
‘‘(b) CLEARINGHOUSE.—The Director of NIH, in con-
sultation with the Director of the Office and with the Na-
tional 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.
‘‘(a) IN GENERAL.—With respect to research on wom-
en’s health, the Director of the Office shall, not later than
February 1, 1994, and biennially thereafter, prepare a re-
port—
‘‘(1) describing and evaluating the progress made
during the preceding 2 fiscal years in research and
treatment conducted or supported by the National In-
stitutes of Health;
‘‘(2) describing and analyzing the professional
status of women physicians and scientists of such In-
stitutes, including the identification of problems and
barriers regarding advancements;
‘‘(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 legisla-
tive and administrative initiatives as the Director of
the Office determines to be appropriate.
‘‘(b) INCLUSION IN BIENNIAL REPORT OF DIRECTOR
OF NIH.—The Director of the Office shall submit each re-
port 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 follow-
ing new paragraph:
‘‘(12) after 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 wom-
en’s health that are identified under section 486(b).’’.
PART III—OFFICE OF RESEARCH ON MINORITY
HEALTH
SEC. 151. ESTABLISHMENT.
Part A of title IV of the Public Health Service Act
(42 U.S.C. 281 et seq.) is amended by adding at the end
the following section:
‘‘OFFICE OF RESEARCH ON MINORITY HEALTH
‘‘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 research 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 con-
ducted 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 in-
stitutes;
‘‘(5) recommend an agenda for conducting and
supporting such research;
‘‘(6) promote the sufficient allocation of the re-
sources of the national research institutes for conduct-
ing 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 IN-
TEGRITY.
(a) IN GENERAL.—Section 493 of the Public Health
Service Act (42 U.S.C. 289b) is amended to read as follows:
‘‘OFFICE OF RESEARCH INTEGRITY
‘‘SEC. 493. (a) ESTABLISHMENT.—
‘‘(1) IN GENERAL.—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 Integrity (hereafter referred to in this sec-
tion as the ‘Office’), which shall be established as an
independent entity in the Department of Health and
Human Services.
‘‘(2) 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 inves-
tigations of research misconduct. The Secretary shall
carry out this section acting through the Director of
the Office. The Director shall report to the Secretary.
‘‘(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS
CONDITION OF FUNDING FOR RESEARCH.—The Secretary
shall by regulation require that each entity that applies for
a grant, contract, or cooperative agreement under this Act
for any project or program that involves the conduct of bio-
medical or behavioral research submit in or with its appli-
cation for such grant, contract, or cooperative agreement
assurances satisfactory to the Secretary that such entity—
‘‘(1) has established (in accordance with regula-
tions which the Secretary shall prescribe) an adminis-
trative process to review reports of research mis-
conduct in connection with biomedical and behavioral
research conducted at or sponsored by such entity;
and
‘‘(2) will report to the Director any investigation
of alleged research misconduct in connection with
projects for which funds have been made available
under this Act that appears substantial.
‘‘(c) PROCESS FOR RESPONSE OF DIRECTOR.—The
Secretary shall establish by regulation a process to be fol-
lowed by the Director for the prompt and appropriate—
‘‘(1) response to information provided to the Di-
rector respecting research misconduct in connection
with projects for which funds have been made avail-
able under this Act;
‘‘(2) receipt of reports by the Director of such in-
formation from recipients of funds under this Act;
‘‘(3) conduct of investigations, when appropriate;
and
‘‘(4) taking of other actions, including appro-
priate remedies, with respect to such misconduct.
‘‘(d) MONITORING BY DIRECTOR.—The Secretary shall
by regulation establish procedures for the Director to mon-
itor administrative processes and investigations that have
been established or carried out under this section.
‘‘(e) EFFECT ON PRESENT INVESTIGATIONS.—Nothing
in this section shall affect investigations which have been
or will be commenced prior to the promulgation of final
regulations under this section.’’.
(b) ESTABLISHMENT OF DEFINITION OF RESEARCH
MISCONDUCT.—Not later than 90 days after the date on
which the report required under section 162(d) is submitted
to the Secretary of Health and Human Services, such Sec-
retary shall by regulation establish a definition for the term
‘‘research misconduct’’ for purposes of section 493 of the
Public Health Service Act, as amended by subsection (a)
of this section.
SEC. 162. COMMISSION ON RESEARCH INTEGRITY.
(a) IN GENERAL.—Not later than 90 days after the
date of the enactment of this Act, the Secretary of Health
and Human Services shall establish a commission to be
known as the Commission on Research Integrity (in this
section referred to as the ‘‘Commission’’).
(b) DUTIES.—The Commission shall develop rec-
ommendations for the Secretary of Health and Human
Services on the administration of section 493 of the Public
Health Service Act (as amended and added by section 161
of this Act).
(c) COMPOSITION.—The Commission shall be composed
of 12 members to be appointed by the Secretary of Health
and Human Services. Not more than 3 members of the Com-
mission may be officers or employees of the United States.
Of the members of the Commission—
(1) three shall be scientists with substantial ac-
complishments in biomedical or behavioral research;
(2) three shall be individuals with experience in
investigating allegations of misconduct with respect to
research research;
(3) three shall be representatives of institutions
of higher education at which biomedical or behavioral
research is conducted; and
(4) three shall be individuals who are not de-
scribed in paragraphs (1), (2), or (3), at least one of
whom shall be an attorney and at least one of whom
shall be an ethicist.
(d) COMPENSATION.—Members of the Commission
may not receive compensation for service on the Commis-
sion. 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 Sec-
retary 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 Sen-
ate, a report containing the recommendations developed
under subsection (b).
SEC. 163. PROTECTION OF WHISTLEBLOWERS.
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 new subsection:
‘‘(f) PROTECTION OF WHISTLEBLOWERS.—
‘‘(1) IN GENERAL.—In the case of any entity re-
quired to establish administrative processes under
subsection (b), the Secretary shall by regulation estab-
lish standards for preventing, and for responding to
the occurrence of retaliation by such entity, its offi-
cials 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 allegation.
‘‘(2) MONITORING
BY
SECRETARY.—The Sec-
retary shall establish by regulation procedures for the
Director to monitor the implementation of the stand-
ards established by an entity under paragraph (1) for
the purpose of determining whether the procedures
have been established, and are being utilized, in ac-
cordance with the standards 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 re-
taliation in violation of the standards established
under paragraph (1). Such remedies may include ter-
mination 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 ap-
propriate.
‘‘(4) FINAL RULE FOR REGULATIONS.—The Sec-
retary shall issue a final rule for the regulations re-
quired in paragraph (1) not later than 180 days after
the date of the enactment of the National Institutes of
Health Revitalization Act of 1993.
‘‘(5) REQUIRED AGREEMENTS.—For any fiscal
year beginning after the date on which the regulations
required in paragraph (1) are issued, the Secretary
may not provide a grant, cooperative agreement, or
contract under this Act for biomedical or behavioral
research unless the entity seeking such financial as-
sistance agrees that the entity—
‘‘(A) will maintain the procedures described
in the regulations; and
‘‘(B) will otherwise be subject to the regula-
tions.’’.
SEC. 164. REQUIREMENT OF REGULATIONS REGARDING
PROTECTION 
AGAINST 
FINANCIAL 
CON-
FLICTS OF INTEREST IN CERTAIN PROJECTS
OF RESEARCH.
Part H of title IV of the Public Health Service Act,
as redesignated 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
‘‘SEC. 493A. (a) ISSUANCE OF REGULATIONS.—
‘‘(1) IN GENERAL.—The Secretary shall define by
regulation, 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 ob-
taining results in such project that are consistent
with such financial interest. Such definition shall
apply uniformly to each entity or individual conduct-
ing a research project under this Act. In the case of
any entity or individual receiving assistance from the
Secretary for a project of research described in para-
graph (2), the Secretary shall by regulation establish
standards for responding to, including managing, re-
ducing, or eliminating, the existence of such a finan-
cial interest. The entity may adopt individualized
procedures for implementing the standards.
‘‘(2) RELEVANT
PROJECTS.—A project of re-
search referred to in paragraph (1) is a project of
clinical research whose purpose is to evaluate the safe-
ty or effectiveness of a drug, medical device, or treat-
ment and for which such entity is receiving assistance
from the Secretary.
‘‘(3) IDENTIFYING AND REPORTING TO THE DI-
RECTOR.—The Secretary shall ensure that the stand-
ards established under paragraph (1) specify that as
a condition of receiving assistance from the Secretary
for the project involved, an entity described in such
subsection is required—
‘‘(A) to have in effect at the time the entity
applies for the assistance and throughout the pe-
riod during which the assistance is received, a
process for identifying such financial interests as
defined in paragraph (1) that exist regarding the
project; and
‘‘(B) to report to the Director such financial
interest as defined in paragraph (1) identified
by the entity and how any such financial inter-
est identified by the entity will be managed or
eliminated such that the project in question will
be protected from bias that may stem from such
financial interest.
‘‘(4) MONITORING OF PROCESS.—The Secretary
shall monitor the establishment and conduct of the
process established by an entity pursuant to para-
graph (1).
‘‘(5) RESPONSE.—In any case in which the Sec-
retary determines that an entity has failed to comply
with paragraph (3) regarding a project of research
described in paragraph (1), the Secretary—
‘‘(A) shall require that, as a condition of re-
ceiving assistance, the entity disclose the exist-
ence of a financial interest as defined in para-
graph (1) in each public presentation of the re-
sults of such project; and
‘‘(B) may take such other actions as the
Secretary determines to be appropriate.
‘‘(6) DEFINITION.—As used in this section:
‘‘(A) The term ‘financial interest’ includes
the receipt of consulting fees or honoraria and
the ownership of stock or equity.
‘‘(B) The term ‘assistance’, with respect to
conducting a project of research, means a grant,
contract, or cooperative agreement.
‘‘(b) FINAL RULE FOR REGULATIONS.—The Secretary
shall issue a final rule for the regulations required in sub-
section (a) not later than 180 days after the date of the
enactment of the National Institutes of Health Revitaliza-
tion Act of 1993.’’.
SEC. 165. EFFECTIVE DATES.
(a) IN GENERAL.—The amendments made by this sub-
title shall become effective on the date that occurs 180 days
after the date on which the final rule required under section
493(f)(4) of the Public Health Service Act, as amended by
sections 161 and 163, is published in the Federal Register.
(b) AGREEMENTS AS A CONDITION OF FUNDING.—The
requirements of subsection (f)(5) of section 493 of the Public
Health Service Act, as amended by sections 161 and 163,
with respect to agreements as a condition of funding shall
not be effective in the case of projects of research for which
initial funding under the Public Health Service Act was
provided prior to the effective date described in subsection
(a).
TITLE II—NATIONAL INSTITUTES
OF HEALTH IN GENERAL
SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINATION.
Section 402(f) of the Public 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 ele-
mentary, secondary, and post-secondary schools. The Asso-
ciate Director shall—
‘‘(1) annually review the efficacy of existing poli-
cies and techniques used by the national research in-
stitutes to disseminate the results of disease preven-
tion 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 prac-
ticable, of research results to such entities; and
‘‘(3) annually prepare and submit to the Direc-
tor 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 restructur-
ing, of such policies and techniques; and
‘‘(B) a detailed statement of the expendi-
tures made for the prevention and dissemination
activities reported on and the personnel used in
connection with such activities.’’.
SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARD-
ING CERTAIN STATES AND RESEARCHERS.
Section 402 of the Public Health Service Act (42
U.S.C. 282) is amended by adding at the end the following
new subsection:
‘‘(g)(1)(A) In the case of entities described in subpara-
graph (B), the Director of NIH, acting through the Director
of the National Center for Research Resources, shall estab-
lish a program to enhance the competitiveness of such enti-
ties in obtaining funds from the national research institutes
for conducting biomedical and behavioral 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 subparagraph (A), the Director of NIH, in car-
rying out the program established under such subpara-
graph, may—
‘‘(i) provide technical assistance to the entities
involved, including technical assistance in the prepa-
ration 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 principal 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 RE-
SEARCH.
Part A of title IV of the Public Health Service Act,
as amended by section 151 of this Act, is amended by add-
ing at the end the following new section:
‘‘OFFICE OF BEHAVIORAL RESEARCH
‘‘SEC. 404A. (a) There is established within the Office
of the Director of NIH an office to be known as the Office
of Behavioral 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 be-
tween human behavior and the development, treatment, and
prevention of medical conditions, the Director of the Office
shall coordinate research conducted or supported by the
agencies of the National Institutes of Health.
‘‘(2) Research authorized under paragraph (1) in-
cludes research on teen pregnancy, infant mortality, violent
behavior, suicide, and homelessness.
‘‘(3) The sole responsibility of the Director of the Office
shall be carrying out paragraph (1).’’.
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 add-
ing at the end the following new section:
‘‘CHILDREN’S VACCINE INITIATIVE
‘‘SEC. 404B. (a) DEVELOPMENT OF NEW VACCINES.—
The Secretary, in consultation with the Director of the Na-
tional Vaccine Program under title XXI and acting through
the Directors of the National Institute for Allergy and Infec-
tious Diseases, the National Institute for Child Health and
Human Development, the National Institute for Aging, and
other public and private programs, shall carry out activi-
ties, which shall be consistent with the global Children’s
Vaccine Initiative, to develop affordable new and improved
vaccines to be used in the United States and in the develop-
ing 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, de-
velop and make available vaccines that require fewer con-
tacts to deliver, that can be given early in life, that provide
long lasting protection, that obviate refrigeration, needles
and syringes, and that protect against a larger number of
diseases.
‘‘(b) REPORT.—In the report required in section 2104,
the Secretary, acting through the Director of the National
Vaccine Program under title XXI, shall include information
with respect to activities and the progress made in imple-
menting the provisions of this section and achieving its
goals.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—In addi-
tion to any other amounts authorized to be appropriated
for activities of the type described in this section, there are
authorized to be appropriated to carry out this section
$50,000,000 for fiscal year 1994, and such sums as may
be necessary for each of the fiscal years 1995 and 1996.’’.
SEC. 205. PLAN FOR USE OF ANIMALS IN RESEARCH.
(a) IN GENERAL.—Part A of title IV of the Public
Health Service Act, as amended by section 204 of this Act,
is amended by adding at the end the following new section:
‘‘PLAN FOR USE OF ANIMALS IN RESEARCH
‘‘SEC. 404C. (a) The Director of NIH, after consulta-
tion with the committee established under subsection (e),
shall prepare a plan—
‘‘(1) for the National Institutes of Health to con-
duct or support research into—
‘‘(A) methods of biomedical research and ex-
perimentation that do not require the use of ani-
mals;
‘‘(B) methods of such research and experi-
mentation that reduce the number of animals
used in such research;
‘‘(C) methods of such research and experi-
mentation that produce less pain and distress in
such animals; and
‘‘(D) methods of such research and experi-
mentation that involve the use of marine life
(other than marine mammals);
‘‘(2) for establishing the validity and reliability
of the methods described in paragraph (1);
‘‘(3) for encouraging the acceptance by the sci-
entific community 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 Com-
merce of the House of Representatives, and to the Committee
on Labor and Human Resources of the Senate, the plan
required in subsection (a) and shall begin implementation
of the plan.
‘‘(c) The Director of NIH shall periodically review,
and as appropriate, 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 experi-
mentation information respecting the methods found to be
valid and reliable under subsection (a)(2).
‘‘(e)(1) The Director of NIH shall establish within the
National Institutes of Health a committee to be known as
the Interagency Coordinating Committee on the Use of Ani-
mals in Research (hereafter in this subsection referred to
as the ‘Committee’).
‘‘(2) The Committee shall provide advice to the Direc-
tor of NIH on the preparation of the plan required in sub-
section (a).
‘‘(3) The Committee shall be composed of—
‘‘(A) the Directors of each of the national re-
search institutes and the Director of the Center for
Research Resources (or the designees of such Direc-
tors); and
‘‘(B) representatives of the Environmental Pro-
tection Agency, the Food and Drug Administration,
the Consumer Product Safety Commission, the Na-
tional Science Foundation, and such additional agen-
cies as the Director of NIH determines to be appro-
priate.’’.
(b) CONFORMING AMENDMENT.—Section 4 of the
Health Research Extension Act of 1985 (Public Law 99–
158; 99 Stat. 880) is repealed.
SEC. 206. INCREASED PARTICIPATION OF WOMEN AND DIS-
ADVANTAGED 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 new subsection:
‘‘(h) The Secretary, acting through the Director of NIH
and the Directors of the agencies of the National Institutes
of Health, may conduct and support programs for research,
research training, recruitment, and other activities to pro-
vide for an increase in the number of women and individ-
uals from disadvantaged backgrounds in the fields of bio-
medical and behavioral research.’’.
SEC. 207. REQUIREMENTS REGARDING SURVEYS OF SEXUAL
BEHAVIOR.
Part A of title IV of the Public Health Service Act,
as amended by section 205 of this Act, is amended by add-
ing at the end the following new section:
‘‘REQUIREMENTS REGARDING SURVEYS OF SEXUAL
BEHAVIOR
‘‘SEC. 404D. With respect to any survey of human sex-
ual behavior 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 ac-
cordance with any applicable requirements of sections
491 and 492; and
‘‘(2) the Secretary, in accordance with section
492A, makes a determination that the information ex-
pected to be obtained through the survey will assist—
‘‘(A) in reducing the incidence of sexually
transmitted diseases, the incidence of infection
with the human immunodeficiency virus, or the
incidence of any other infectious disease; or
‘‘(B) in improving reproductive health or
other conditions of health.’’.
SEC. 208. DISCRETIONARY FUND OF DIRECTOR OF NA-
TIONAL 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 new subsection:
‘‘(i)(1) There is established a fund, consisting of
amounts appropriated under 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 Na-
tional 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 mat-
ters, responding to new issues and scientific emer-
gencies, and acting on research opportunities of high
priority;
‘‘(B) supporting research that is not exclusively
within the authority of any single agency of such In-
stitutes; and
‘‘(C) purchasing or renting equipment and quar-
ters for activities of such Institutes.
‘‘(2) Not later than February 10 of each fiscal year,
the Secretary shall submit to the Committee on Energy and
Commerce of the House of Representatives, and to the Com-
mittee 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 re-
garding this section as the Secretary determines to be ap-
propriate.
‘‘(3) For the purpose of carrying out this subsection,
there are authorized to be appropriated $25,000,000 for fis-
cal year 1994, and such sums as may be necessary for each
of the fiscal years 1995 and 1996.’’.
SEC. 209. MISCELLANEOUS PROVISIONS.
(a) TERM OF OFFICE FOR MEMBERS OF ADVISORY
COUNCILS.—Section 406(c) of the Public Health Service
Act (42 U.S.C. 284a(c)) is amended in the second sentence
by striking ‘‘until a successor has taken office’’ and insert-
ing the following: ‘‘for 180 days after the date of such expi-
ration’’.
(b) LITERACY REQUIREMENTS.—Section 402(e) of the
Public Health Service Act (42 U.S.C. 282(e)) is amended—
(1) in paragraph (3), by striking ‘‘and’’ at the
end;
(2) in paragraph (4), by striking the period and
inserting ‘‘; and’’; and
(3) by adding at the end thereof the following
new paragraph:
‘‘(5) ensure that, after January 1, 1994, at least
one-half of all new or revised health education and
promotion materials developed or funded by the Na-
tional Institutes of Health is in a form that does not
exceed a level of functional literacy, as defined in the
National Literacy Act of 1991 (Public Law 102–
73).’’.
(c) DAY CARE REGARDING CHILDREN OF EMPLOY-
EES.—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 new subsection:
‘‘(j)(1) The Director of NIH may establish a program
to provide day care services for the employees of the Na-
tional 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 the 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 agreements.’’.
TITLE 
III—GENERAL 
PROVI-
SIONS 
RESPECTING 
NA-
TIONAL 
RESEARCH 
INSTI-
TUTES
SEC. 301. APPOINTMENT AND AUTHORITY OF DIRECTORS
OF NATIONAL RESEARCH INSTITUTES.
(a) ESTABLISHMENT OF GENERAL AUTHORITY RE-
GARDING DIRECT FUNDING.—
(1) IN GENERAL.—Section 405(b)(2) of the Pub-
lic 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 new
subparagraph:
‘‘(C) shall receive from the President and the Of-
fice of Management and Budget directly all funds ap-
propriated by the Congress for obligation and expend-
iture 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
Public Health Service Act (42 U.S.C. 284(c)) is amended—
(1) by amending paragraph (3) to read as fol-
lows:
‘‘(3) may, in consultation with the advisory
council for the Institute and with the approval of the
Director of NIH—
‘‘(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 established 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 duration of a peer review group appointed under para-
graph (3).’’.
SEC. 302. PROGRAM OF RESEARCH ON OSTEOPOROSIS,
PAGET’S DISEASE, AND RELATED BONE DIS-
ORDERS.
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 new section:
‘‘RESEARCH ON OSTEOPOROSIS, PAGET’S DISEASE, AND
RELATED BONE DISORDERS
‘‘SEC. 409A. (a) ESTABLISHMENT.—The Directors of
the National Institute of Arthritis and Musculoskeletal and
Skin Diseases, the National Institute on Aging, and the Na-
tional Institute of Diabetes, 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.—The Directors referred to in sub-
section (a) shall jointly coordinate the programs referred
to in such subsection and consult with the Arthritis and
Musculoskeletal Diseases Interagency Coordinating Com-
mittee and the Interagency Task Force on Aging Research.
‘‘(c) INFORMATION CLEARINGHOUSE.—
‘‘(1) IN GENERAL.—In order to assist in carry-
ing out the purpose described in subsection (a), the
Director of NIH shall provide for the establishment of
an information clearinghouse on osteoporosis and re-
lated bone disorders to facilitate and enhance knowl-
edge and understanding on the part of health profes-
sionals, patients, and the public through the effective
dissemination of information.
‘‘(2) ESTABLISHMENT THROUGH GRANT OR CON-
TRACT.—For the purpose of carrying out paragraph
(1), the Director of NIH shall enter into a grant, co-
operative agreement, or contract with a nonprofit pri-
vate entity involved in activities regarding the pre-
vention 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 Serv-
ice 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 Public Law 102–408 (106 Stat. 2084), is amended by
adding at the end the following part:
‘‘PART F—INTERAGENCY PROGRAM FOR TRAUMA
RESEARCH
‘‘SEC. 1261. ESTABLISHMENT OF PROGRAM.
‘‘(a) IN GENERAL.—The Secretary, acting through the
Director of the National Institutes of Health (hereafter in
this section referred to as the ‘Director’), shall establish a
comprehensive program of conducting basic and clinical re-
search on trauma (hereafter in this section referred to as
the ‘Program’). The Program shall include research regard-
ing 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 established under subsection (g), shall es-
tablish and implement a plan for carrying out the ac-
tivities of the Program, including the activities de-
scribed in subsection (d). All such activities shall be
carried out in accordance with the plan. The plan
shall be periodically reviewed, and revised as appro-
priate.
‘‘(2) SUBMISSION TO CONGRESS.—Not later than
June 1, 1993, the Director shall submit the plan re-
quired in paragraph (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
COLLABORATION.—The Director—
‘‘(1) shall provide for the conduct of activities
under 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 Pro-
gram are coordinated among such agencies; and
‘‘(3) shall, as appropriate, provide for collabora-
tion among such agencies in carrying out such activi-
ties.
‘‘(d) CERTAIN ACTIVITIES OF PROGRAM.—The Pro-
gram shall include—
‘‘(1) studies with respect to all phases of trauma
care, including prehospital, resuscitation, surgical
intervention, critical care, infection control, wound
healing, nutritional care and support, and medical
rehabilitation care;
‘‘(2) basic and clinical research regarding the re-
sponse 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 trau-
ma 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 trau-
ma centers.
‘‘(f) RESOURCES.—The Director shall assure the avail-
ability of appropriate resources to carry out the Program,
including the plan established under subsection (b) (includ-
ing the activities described in subsection (d)).
‘‘(g) COORDINATING COMMITTEE.—
‘‘(1) IN GENERAL.—There shall be established a
Trauma Research Interagency Coordinating Commit-
tee (hereafter in this section referred to as the ‘Coordi-
nating Committee’).
‘‘(2) DUTIES.—The Coordinating Committee
shall make recommendations regarding—
‘‘(A) the activities of the Program to be car-
ried 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 agen-
cies in carrying out the activities.
‘‘(3) COMPOSITION.—The Coordinating Commit-
tee shall be composed of the Directors of each of the
agencies that, under subsection (c), have responsibil-
ities under the Program, and any other individuals
who are practitioners in the trauma field as des-
ignated 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 in-
jury 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 209(c)
of this Act, is amended by adding at the end the following
new subsection:
‘‘(k) The Director of NIH shall carry out the program
established in part E of title XII (relating to interagency
research on trauma).’’.
TITLE IV—NATIONAL CANCER
INSTITUTE
SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVI-
TIES REGARDING 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 new section:
‘‘BREAST AND GYNECOLOGICAL CANCERS
‘‘SEC. 417. (a) EXPANSION AND COORDINATION OF AC-
TIVITIES.—The Director of the Institute, in consultation
with the National Cancer Advisory Board, shall expand,
intensify, and coordinate the activities of the Institute with
respect to research on breast cancer, ovarian 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 reproductive sys-
tem of women.
‘‘(c) PROGRAMS FOR BREAST CANCER.—
‘‘(1) IN GENERAL.—In carrying out subsection
(a), the Director of the Institute shall conduct or sup-
port research to expand the understanding of the
cause of, and to find a cure for, breast cancer. Activi-
ties under such subsection shall provide for an expan-
sion and intensification of the conduct and support
of—
‘‘(A) basic research concerning the etiology
and causes of breast cancer;
‘‘(B) clinical research and 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 under-
served populations, low-income populations, 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 oper-
ation 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 sub-
paragraph (E). Activities of such centers should in-
clude supporting new and innovative research and
training programs for new researchers. Such centers
shall give priority to expediting the transfer of re-
search advances to clinical applications.
‘‘(2) IMPLEMENTATION
OF
PLAN
FOR
PRO-
GRAMS.—
‘‘(A) The Director of the Institute shall en-
sure 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 profes-
sional judgment needs of the Institute as ex-
‘‘(1) basic research concerning the etiology and
causes of ovarian cancer and other cancers of the re-
productive 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 accordance with section 412;
‘‘(4) information and education programs with
respect to ovarian cancer and other cancers of the re-
productive system of women in accordance with sec-
tion 413; and
‘‘(5) research and demonstration centers with re-
spect to ovarian cancer and cancers of the reproduc-
tive system in accordance with section 414.
‘‘(e) REPORT.—The Director of the Institute shall pre-
pare, for inclusion in the biennial report submitted under
section 407, a report that describes the activities of the Na-
tional Cancer Institute under the research programs re-
ferred to in subsection (a), that shall include—
‘‘(1) a description of the research plan with re-
spect 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 pre-
pared, in the research programs on breast cancer and
cancers of the reproductive 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 con-
ducted 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 ACTIVI-
TIES REGARDING 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 new section:
‘‘PROSTATE CANCER
‘‘SEC. 417A. (a) EXPANSION AND COORDINATION OF
ACTIVITIES.—The Director of the Institute, in consultation
with the National Cancer Advisory Board, 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 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 Director of the Institute shall conduct or sup-
port research to expand the understanding of the
cause of, and to find a cure for, prostate cancer. Ac-
tivities under such subsection shall provide for an ex-
pansion and intensification of the conduct and sup-
port 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 de-
tection programs 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 ef-
forts on prostate cancer;
‘‘(E) control programs with respect to pros-
tate 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 cancer research
to bring together basic and clinical, biomedical
and behavioral scientists to conduct basic, clini-
cal, epidemiological, psychosocial, prevention
and control, treatment, research, and related ac-
tivities on prostate cancer.
Not less than six centers shall be operated under sub-
paragraph (G). Activities of such centers should in-
clude supporting new and innovative research and
training programs for new researchers. Such centers
shall give priority to expediting the transfer of re-
search advances to clinical applications.
‘‘(2) IMPLEMENTATION
OF
PLAN
FOR
PRO-
GRAMS.—
‘‘(A) The Director of the Institute shall en-
sure 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 profes-
sional judgment needs of the Institute as ex-
pressed in the annual budget estimate prepared
in accordance with section 413(9). The Director
of the Institute, in consultation with the Na-
tional Cancer Advisory Board, shall periodically
review and revise such plan.
‘‘(B) Not later than May 1, 1993, the Direc-
tor of the Institute shall submit a copy of the
plan to the President’s Cancer Panel, the Sec-
retary and the Director of NIH.
‘‘(C) The Director of the Institute shall sub-
mit 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 Commit-
tee on Labor and Human Resources of the Sen-
ate.’’.
SEC. 403. AUTHORIZATION OF APPROPRIATIONS.
(a) IN GENERAL.—Subpart 1 of part C of title IV of
the Public Health Service Act, as amended by section 402
of this Act, is amended by adding at the end the following
new section:
‘‘AUTHORIZATION OF APPROPRIATIONS
‘‘SEC. 417B. (a) ACTIVITIES GENERALLY.—For the
purpose of carrying out this subpart, there are authorized
to be appropriated $3,200,000,000 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 CAN-
CERS.—
‘‘(1) BREAST CANCER.—
‘‘(A) For the purpose of carrying out sub-
paragraph (A) of section 417(c)(1), there are au-
thorized to be appropriated $225,000,000 for fis-
cal year 1994, and such sums as may be nec-
essary for each of the fiscal years 1995 and 1996.
Such authorizations of appropriations are in ad-
dition to the authorizations of appropriations es-
tablished in subsection (a) with respect to such
purpose.
‘‘(B) For the purpose of carrying out sub-
paragraphs (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 appro-
priations are in addition to the authorizations of
appropriations established in subsection (a) with
respect to such purpose.
‘‘(2) OTHER CANCERS.—For the purpose of car-
rying out subsection (d) of section 417, there are au-
thorized to be appropriated $75,000,000 for fiscal
year 1994, and such sums as are necessary for each
of the fiscal years 1995 and 1996. Such authoriza-
tions of appropriations are in addition to the author-
izations of appropriations established in subsection
(a) with respect to such purpose.
‘‘(c) PROSTATE CANCER.—For the purpose of carrying
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 sub-
section (a) with respect to such purpose.
‘‘(d) ALLOCATION REGARDING CANCER CONTROL.—
‘‘(1) IN
GENERAL.—Of the amounts appro-
priated 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 ac-
tivities authorized in section 412 and for which budg-
et estimates are made under section 413(b)(9) for the
fiscal year.
‘‘(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 sub-
section (a);
(C) by redesignating paragraph (5) of sub-
section (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 insert-
ing ‘‘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 follow-
ing new paragraph:
‘‘(5) shall, in consultation with the advisory
council for the Institute, conduct appropriate intra-
mural training and education programs, including
continuing education and laboratory and clinical re-
search training programs.’’.
SEC. 502. CENTERS FOR THE STUDY OF PEDIATRIC CARDIO-
VASCULAR DISEASES.
Section 422(a)(1) of the Public Health Service Act (42
U.S.C. 285b–4(a)(1)) is amended—
(1) in subparagraph (B), by striking ‘‘and’’ at
the end;
(2) in subparagraph (C), by striking the period
and inserting ‘‘; and’’; and
(3) by adding at the end thereof the following
new subparagraph:
‘‘(D) three centers for basic and clinical research
into, training in, and demonstration of, advanced di-
agnostic, prevention, and treatment (including genetic
studies, intrauterine environment studies, postnatal
studies, heart arrhythmias, and acquired heart dis-
ease and preventive cardiology) for cardiovascular
diseases in children.’’.
SEC. 503. NATIONAL CENTER ON SLEEP DISORDERS.
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 new section:
‘‘NATIONAL CENTER ON SLEEP DISORDERS
‘‘SEC. 424. (a) Not later than 1 year after the date
of the enactment of the National Institutes of Health Revi-
talization Act of 1993, the Director of the Institute shall
establish the National Center on Sleep Disorders (in this
section referred to as the ‘Center’). The Center shall be head-
ed by a director, who shall be appointed by the Director
of the Institute.
‘‘(b) The general purpose of the Center is the conduct
and support of research, training, health information dis-
semination, and other activities with respect to sleep dis-
orders.
‘‘(c) The Director of the Center may coordinate the ac-
tivities of the Center with similar activities of other agen-
cies of the Federal Government, including the other agencies
of the National Institutes of Health, and with similar ac-
tivities of other public entities and of private entities.’’.
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
‘‘SEC. 425. For the purpose of carrying out this sub-
part, 
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.’’.
TITLE VI—NATIONAL INSTITUTE
ON DIABETES AND DIGESTIVE
AND KIDNEY DISEASES
SEC. 601. PROVISIONS REGARDING NUTRITIONAL DIS-
ORDERS.
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 new section:
‘‘NUTRITIONAL DISORDERS PROGRAM
‘‘SEC. 434. (a) The Director of the Institute, in con-
sultation with the Director of NIH, shall establish a pro-
gram of conducting and supporting research, training,
health information dissemination, and other activities with
respect to nutritional disorders, including obesity.
‘‘(b) In carrying out the program established under
subsection (a), the Director of the Institute shall conduct
and support each of the activities described in such sub-
section.
‘‘(c) In carrying out the program established under
subsection (a), the Director of the Institute shall carry out
activities to facilitate and enhance knowledge and under-
standing 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
new 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 para-
graph (1) in collaboration with the Director of the National
Cancer Institute and with the Directors of such other agen-
cies of the National Institutes of Health as the Director of
NIH determines to be appropriate.
‘‘(3) Each center developed or expanded under para-
graph (1) shall—
‘‘(A) utilize the facilities of a single institution,
or be formed from a consortium of cooperating insti-
tutions, meeting such research and training qualifica-
tions 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 obe-
sity and the impact of nutrition and diet on child de-
velopment;
‘‘(C) conduct training programs for physicians
and allied health professionals in current methods of
diagnosis and treatment of such diseases and com-
plications, and in research in such disorders; and
‘‘(D) conduct information programs for physi-
cians and allied health professionals who provide pri-
mary care for patients with such disorders or com-
plications.’’.
TITLE 
VII—NATIONAL 
INSTI-
TUTE 
ON 
ARTHRITIS 
AND
MUSCULOSKELETAL 
AND
SKIN DISEASES
SEC. 701. JUVENILE ARTHRITIS.
(a) PURPOSE.—Section 435 of the Public Health Serv-
ice 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 musculo-
skeletal and skin diseases (including sports-related dis-
orders), with particular attention to the effect of these dis-
eases on children.’’.
(b) PROGRAMS.—Section 436 (42 U.S.C. 285d–1) is
amended—
(1) in subsection (a), by inserting after the sec-
ond 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 chil-
dren.’’; and
(2) in subsection (b)—
(A) by striking ‘‘and’’ at the end of para-
graph (3);
(B) by striking the period at the end of
paragraph (4) and inserting ‘‘; and’’; and
(C) by adding at the end thereof the follow-
ing new paragraph:
‘‘(5) research into the causes of arthritis affecting
children 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 Serv-
ice Act (42 U.S.C. 286d–6) is amended by adding at the
end thereof the following new subsection:
‘‘(f) Not later than October 1, 1994, the Director shall
establish a multipurpose arthritis and musculoskeletal dis-
ease center for the purpose of expanding the level of research
into the cause, diagnosis, early detection, prevention, con-
trol, and treatment of, and rehabilitation of children with
arthritis and musculoskeletal diseases.’’.
(d) ADVISORY BOARD.—
(1) TITLE.—Section 442(a) of the Public Health
Service Act (42 U.S.C. 285d–7(a)) is amended by in-
serting after ‘‘Arthritis’’ the following: ‘‘and Musculo-
skeletal and Skin Diseases’’.
(2) COMPOSITION.—Section 442(b) of the Public
Health Service Act (42 U.S.C. 285d–7(b)) is amend-
ed—
(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 Pub-
lic Health Service Act (42 U.S.C. 285d–7(j)) is
amended—
(1) by striking ‘‘and’’ at the end of paragraph
(3);
(2) by striking the period at the end of para-
graph (4) and inserting ‘‘; and’’; and
(3) by adding at the end the following para-
graph:
‘‘(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 chil-
dren with arthritis and musculoskeletal diseases.’’.
TITLE VIII—NATIONAL
INSTITUTE ON AGING
SEC. 801. ALZHEIMER’S DISEASE REGISTRY.
(a) IN GENERAL.—Section 12 of Public Law 99–158
(99 Stat. 885) is—
(1) transferred to subpart 5 of part C of title IV
of the Public Health Service Act (42 U.S.C. 285e et
seq.);
(2) redesignated as section 445G; and
(3) inserted after section 445F of such Act.
(b) TECHNICAL
AND CONFORMING AMENDMENTS.—
Section 445G of the Public Health Service Act, as trans-
ferred 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’’; and
(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
amended by adding at the end the following new section:
‘‘AGING PROCESSES REGARDING WOMEN
‘‘SEC. 445H. The Director of the Institute, in addition
to other 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-menopause, and into
the diagnosis, disorders, and complications related to aging
and loss of ovarian hormones in women.’’.
TITLE IX—NATIONAL INSTITUTE
OF 
ALLERGY 
AND 
INFEC-
TIOUS 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 Public Health Service Act (42 U.S.C. 285f) is
amended by adding at the end the following new section:
‘‘RESEARCH CENTERS REGARDING CHRONIC FATIGUE
SYNDROME
‘‘SEC. 447. (a) The Director of the Institute, after con-
sultation with the advisory council for the Institute, may
make grants to, or enter into contracts with, public or non-
profit private entities for the development and operation of
centers to conduct basic and clinical research on chronic
fatigue syndrome.
‘‘(b) Each center assisted under this section shall use
the facilities of a single institution, or be formed from a
consortium of cooperating institutions, meeting such re-
quirements as may be prescribed by the Director of the In-
stitute.’’.
(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 extra-
mural study section for chronic fatigue syndrome research.
(c) REPRESENTATIVES.—The Secretary of Health and
Human Services, acting through the Director of the Na-
tional Institutes of Health, shall ensure that appropriate
individuals with expertise in chronic fatigue syndrome or
neuromuscular diseases and representative of a variety of
disciplines and fields within the research community are
appointed to appropriate National Institutes of Health ad-
visory committees and boards.
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 AND CONTRACTS FOR RESEARCH CEN-
TERS.
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 new
section:
‘‘RESEARCH CENTERS WITH RESPECT TO CONTRACEPTION
AND INFERTILITY
‘‘SEC. 452A. (a) The Director of the Institute, after
consultation 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 oper-
ation of centers to conduct activities for the purpose of im-
proving methods of contraception and centers to conduct ac-
tivities for the purpose of improving methods of diagnosis
and treatment of infertility.
‘‘(b) In carrying out subsection (a), the Director of the
Institute shall, subject to the extent of amounts made avail-
able in appropriations Acts, provide for the establishment
of three centers with respect to contraception and for two
centers with respect to infertility.
‘‘(c)(1) Each center assisted under this section shall,
in carrying out the purpose of the center involved—
‘‘(A) conduct clinical and other applied research,
including—
‘‘(i) for centers with respect to contracep-
tion, clinical trials of new or improved drugs
and devices for use by males and females (in-
cluding barrier methods); and
‘‘(ii) for centers with respect to infertility,
clinical trials of new or improved drugs and de-
vices for the diagnosis and treatment of infertil-
ity in males and females;
‘‘(B) develop protocols for training physicians,
scientists, nurses, and other health and allied health
professionals;
‘‘(C) conduct training programs for such indi-
viduals;
‘‘(D) develop model continuing education pro-
grams for such professionals; and
‘‘(E) disseminate information to such profes-
sionals and the public.
‘‘(2) A center may use funds provided under subsection
(a) to provide stipends for health and allied health profes-
sionals 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 para-
graph.
‘‘(d) The Director of the Institute shall, as appropriate,
provide for the coordination of information among the cen-
ters 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 of cooperating institutions, meeting such re-
quirements as may be prescribed by the Director of the In-
stitute.
‘‘(f) Support of a center under subsection (a) may be
for a period not exceeding 5 years. Such period may be ex-
tended for one or more additional periods not exceeding 5
years if the operations of such center have been reviewed
by an appropriate technical and scientific peer review
group established by the Director and if such group has rec-
ommended to the Director that such period should be ex-
tended.
‘‘(g) For the purpose of carrying out this section, there
are 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 IN-
FERTILITY.
Part G of title IV of the Public Health Service Act,
as redesignated 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
‘‘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 agreements with qualified health professionals (includ-
ing graduate students) under which such health profes-
sionals agree to conduct research with respect to contracep-
100
tion, 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 educational loans of such health professionals.
‘‘(b) The provisions of sections 338B, 338C, and 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 Repay-
ment Program established in subpart III of part D of title
III.
‘‘(c) Amounts appropriated for carrying out this sec-
tion shall remain available until the expiration of the sec-
ond fiscal year beginning after the fiscal year for which
the amounts were appropriated.’’.
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 new section:
‘‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY
‘‘SEC. 452B. The Director of the Institute shall estab-
lish and maintain within the Institute an intramural lab-
oratory and clinical research program in obstetrics and
gynecology.’’.
101
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 new section:
‘‘CHILD HEALTH RESEARCH CENTERS
‘‘SEC. 452C. The Director of the Institute shall develop
and support centers for conducting research with respect to
child health. Such centers shall give priority to the expedi-
tious transfer of advances from basic science to clinical ap-
plications 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 new section:
‘‘PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT
HEALTH
‘‘SEC. 452D. (a) IN GENERAL.—Not later than October
1, 1993, 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,
102
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 sub-
section (a) shall be a longitudinal study in which a
substantial number of adolescents participate as sub-
jects. With respect to the purpose 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 population of adolescents who are
female, the population of adolescents who are male,
various socioeconomic populations of adolescents, and
various racial and ethnic populations of adolescents.
The study shall be designed and conducted in a man-
ner sufficient to provide for a valid analysis of wheth-
er there are significant differences among such popu-
lations in health status and whether and to what ex-
103
tent any such differences are due to factors particular
to the populations involved.
‘‘(c) COORDINATION WITH WOMEN’S HEALTH INITIA-
TIVE.—With respect to the national study of women being
conducted by the Secretary and known as the Women’s
Health Initiative, the Secretary shall ensure that such study
is coordinated with the component 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 RESEARCH ON DIABETES EYE CARE.
(a) IN GENERAL.—Subpart 9 of part C of title IV of
the Public Health Service Act (42 U.S.C. 285i) is amended
by adding at the end the following new section:
‘‘CLINICAL RESEARCH ON EYE CARE AND DIABETES
‘‘SEC. 456. (a) PROGRAM OF GRANTS.—The Director
of the Institute, in consultation with the advisory council
for the Institute, may award not more than three grants
for the establishment and support of centers for clinical re-
search on eye care for individuals with diabetes.
‘‘(b) AUTHORIZED EXPENDITURES.—The purposes for
which a grant under subsection (a) may be expended in-
clude equipment for the research described in such sub-
section and the construction and modernization of facilities
for such research.’’.
104
(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 insert-
ing ‘‘Subject to section 456, the Director’’.
TITLE 
XII—NATIONAL 
INSTI-
TUTE OF NEUROLOGICAL DIS-
ORDERS 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 new section:
‘‘RESEARCH ON MULTIPLE SCLEROSIS
‘‘SEC. 460. The Director of the Institute shall conduct
and support research on multiple sclerosis, especially re-
search on effects of genetics and hormonal changes on the
progress of the disease.’’.
TITLE 
XIII—NATIONAL 
INSTI-
TUTE 
OF 
ENVIRONMENTAL
HEALTH SCIENCES
SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND TEST-
ING PROGRAM.
(a) IN GENERAL.—Subpart 12 of part C of title IV
of the Public Health Service Act (42 U.S.C. 285l) is amend-
ed by adding at the end the following new section:
105
‘‘APPLIED TOXICOLOGICAL RESEARCH AND TESTING
PROGRAM
‘‘SEC. 463A. (a) There is established within the Insti-
tute a program for conducting applied research and testing
regarding toxicology, which program shall be known as the
Applied Toxicological Research and Testing Program.
‘‘(b) In carrying out the program established under
subsection (a), the Director of the Institute shall, with re-
spect to toxicology, carry out activities—
‘‘(1) to expand knowledge of the health effects of
environmental agents;
‘‘(2) to broaden the spectrum of toxicology infor-
mation that is obtained on selected chemicals;
‘‘(3) to develop and validate assays and proto-
cols, including alternative methods that can reduce or
eliminate the use of animals in acute or chronic safe-
ty 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 reg-
ulatory use;
‘‘(5) to communicate the results of research to
government agencies, to medical, scientific, and regu-
latory communities, and to the public; and
106
‘‘(6) to integrate related activities of the Depart-
ment of Health and Human Services.’’.
(b) TECHNICAL AMENDMENT.—Section 463 of the Pub-
lic Health Service Act (42 U.S.C. 285l) is amended by in-
serting after ‘‘Sciences’’ the following: ‘‘(hereafter in this
subpart referred to as the ‘Institute’)’’.
SEC. 1302. STUDY OF ENVIRONMENTAL AND OTHER RISKS
CONTRIBUTING TO INCIDENCE OF BREAST
AND PROSTATE CANCER.
(a) IN GENERAL.—The Director of the National Insti-
tute of Environmental Health Sciences (in this section re-
ferred to as the ‘‘Director’’), in collaboration with the Direc-
tor of the National Cancer Institute, shall conduct a case-
controlled study to assess biological markers of environ-
mental and other risk factors contributing to the incidence
of breast and prostate cancer in the Counties of Nassau and
Suffolk, in the State of New York.
(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 exposure 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;
107
(3) electromagnetic fields;
(4) pesticides and other toxic chemicals;
(5) hazardous and municipal waste; and
(6) such other factors as the Director determines
to be appropriate.
(c) REPORT.—Not later than 24 months after the date
of the enactment of this Act, the Director shall complete the
study required in subsection (a) and submit to the Commit-
tee on Energy and Commerce of the House of Representa-
tives, and to the Committee on Labor and Human Re-
sources of the Senate, a report describing the findings made
as a result of the study.
(d) FUNDING.—Of the amounts appropriated for fiscal
years 1994 and 1995 for the National Institute of Environ-
mental Health Sciences and the National Cancer Institute,
the Director of the National Institutes of Health shall make
available amounts for carrying out the study required in
subsection (a).
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—
108
(1) by striking ‘‘and’’ after the semicolon at the
end of paragraph (5);
(2) by redesignating paragraph (6) as para-
graph (8); and
(3) by inserting after paragraph (5) the follow-
ing new paragraphs:
‘‘(6) publicize the availability from the Library
of the products and services described in any of para-
graphs (1) through (5);
‘‘(7) promote the use of computers and tele-
communications by health professionals (including
health professionals in rural areas) for the purpose of
improving access to biomedical information for health
care delivery and medical research; and’’.
(b) 
LIMITATION
REGARDING
GRANTS.—Section
474(b)(2) of the Public Health Service Act (42 U.S.C. 286b–
S(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 Serv-
ices Appropriations Act, 1988, as contained in section
101(h) of Public Law 100–202 (101 Stat. 1329–275),
is repealed.
109
(2) APPLICABILITY OF CERTAIN NEW AUTHOR-
ITY.—With respect to the authority established for the
National Library of Medicine in section 465(b)(6) of
the Public Health 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 Public Health Service
Act (42 U.S.C. 286 et seq.) is amended by adding at the
end the following section:
‘‘AUTHORIZATION OF APPROPRIATIONS
‘‘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 necessary
for each of the fiscal years 1995 and 1996.
‘‘(b) Amounts appropriated under subsection (a) and
made available for grants or contracts under 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.’’.
(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).
110
Subtitle B—Financial Assistance
SEC. 1411. ESTABLISHMENT OF PROGRAM OF GRANTS FOR
DEVELOPMENT 
OF 
EDUCATION 
TECH-
NOLOGIES.
Section 473 of the Public Health Service Act (42
U.S.C. 286b–4) is amended by adding at the end the follow-
ing new subsection:
‘‘(c)(1) The Secretary shall make grants to public or
nonprofit private institutions for the purpose of carrying
out projects of research on, and development and dem-
onstration of, new education technologies.
‘‘(2) The purposes for which a grant under paragraph
(1) may be made include projects concerning—
‘‘(A) computer-assisted teaching and testing of
clinical competence at health professions and research
institutions;
‘‘(B) the effective transfer of new information
from research laboratories to appropriate clinical ap-
plications;
‘‘(C) the expansion of the laboratory and clinical
uses of computer-stored research databases; and
‘‘(D) the testing of new technologies for training
health care professionals.
111
‘‘(3) The Secretary may not make a grant under para-
graph (1) unless the applicant for the grant agrees to make
the projects available with respect to—
‘‘(A) assisting in the training of health profes-
sions students; and
‘‘(B) enhancing and improving the capabilities
of health professionals regarding research and teach-
ing.’’.
Subtitle C—National Information
Center on Health Services Re-
search and Health Care Tech-
nology
SEC. 1421. ESTABLISHMENT OF CENTER.
Part D of title IV of the Public Health Service Act
(42 U.S.C. 286 et seq.) is amended by adding at the end
the following new subpart:
‘‘Subpart 4—National Information Center on Health
Services Research and Health Care Technology
‘‘NATIONAL INFORMATION CENTER
‘‘SEC. 478A. (a) There is established within the Li-
brary an entity to be known as the National Information
Center on Health Services Research and Health Care Tech-
nology (in this section referred to as the ‘Center’).
‘‘(b) The purpose of the Center is the collection, storage,
analysis, retrieval, and dissemination of information on
112
health services research, clinical practice guidelines, and on
health care technology, including the assessment of such
technology. Such purpose includes developing and main-
taining data bases and developing and implementing meth-
ods of carrying out such purpose.
‘‘(c) The Director of the Center shall ensure that infor-
mation under subsection (b) concerning clinical practice
guidelines is collected and maintained electronically and in
a convenient format. Such Director shall develop and pub-
lish 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 Adminis-
trator for Health Care Policy and Research.’’.
SEC. 1422. CONFORMING PROVISIONS.
(a) IN GENERAL.—Section 903 of the Public Health
Service Act, as amended by section 3 of Public Law 102–
410 (106 Stat. 2094), is amended by amending subsection
(e) to read as follows:
‘‘(e) REQUIRED INTERAGENCY AGREEMENT.—The Ad-
ministrator and the Director of the National Library of
Medicine shall enter into an agreement providing for the
implementation of section 478A.’’.
113
(b) RULE OF CONSTRUCTION.—The amendments made
by section 3 of Public 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 as-
sessment 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 con-
sidered 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 Public Health Service Act (42 U.S.C.
281 et seq.) is amended—
(1) in section 401(b)(2)(B), by amending such
subparagraph to read as follows:
‘‘(B) The National Center for Research Re-
sources.’’; and
114
(2) in part E—
(A) in the heading for subpart 1, by strik-
ing ‘‘Division of’’ and inserting ‘‘National Cen-
ter for’’;
(B) in section 479, by striking ‘‘the Divi-
sion of Research Resources’’ and inserting the
following: ‘‘the National Center for Research Re-
sources (hereafter in this subpart referred to as
the ‘Center’)’’;
(C) in sections 480 and 481, by striking
‘‘the Division of Research Resources’’ each place
such term appears and inserting ‘‘the Center’’;
and
(D) in sections 480 and 481, as amended by
subparagraph (C), by striking ‘‘the Division’’
each place such term appears and inserting ‘‘the
Center’’.
SEC. 1502. BIOMEDICAL AND BEHAVIORAL RESEARCH FA-
CILITIES.
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 new section:
‘‘BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES
‘‘SEC. 481A. (a) MODERNIZATION AND CONSTRUCTION
OF FACILITIES.—
115
‘‘(1) IN GENERAL.—The Director of NIH, acting
through the Director of the Center, may make grants
to public and nonprofit private entities to expand, re-
model, renovate, or alter existing research facilities or
construct new research facilities, subject to the provi-
sions of this section.
‘‘(2) CONSTRUCTION
AND
COST
OF
CONSTRUC-
TION.—For purposes of this section, the terms
‘construction’ and ‘cost of construction’ include the
construction of new buildings and the expansion, ren-
ovation, remodeling, and alteration of existing build-
ings, 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-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
(hereafter referred to in this section as the
‘Board’).
‘‘(B) The Director of the Center may ap-
prove an application for a grant under
subsection (a) only if the Board has under para-
116
graph (2) recommended the application for ap-
proval.
‘‘(2) DUTIES.—
‘‘(A) The Board shall provide advice to the
Director of the Center and the advisory council
established under section 480 (hereafter in this
section referred to as the ‘Advisory Council’) on
carrying 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 consideration of the require-
ments established in subsection (c), and shall re-
port the results of the determination to the Direc-
tor of the Center and the Advisory Council. Such
determinations shall be conducted in a manner
consistent with procedures established under sec-
tion 492.
‘‘(C) In carrying out subparagraph (A), the
Board shall, in the case of applications rec-
ommended for approval, make recommendations
to the Director and the Advisory Council on the
amount that should be provided in the grant.
‘‘(D) In carrying out subparagraph (A), the
Board shall prepare an annual report for the Di-
117
rector of the Center and the Advisory Council de-
scribing the activities of the Board in the fiscal
year for which the report is made. Each such re-
port shall be available to the public, and shall—
‘‘(i) summarize and analyze expendi-
tures made under this section;
‘‘(ii) provide a summary of the types,
numbers, and amounts of applications that
were recommended for grants under sub-
section (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 adminis-
tration of this section.
‘‘(3) MEMBERSHIP.—
‘‘(A) Subject to subparagraph (B), the
Board shall be composed of 9 appointed mem-
bers, and such ex officio members as the Director
of the Center determines to be appropriate.
‘‘(B) Not more than 3 individuals who are
officers or employees of the Federal Government
may serve as members of the Board.
‘‘(4) CERTAIN REQUIREMENTS REGARDING MEM-
BERSHIP.—In selecting individuals for membership
on the Board, the Director of the Center shall ensure
118
that the members are individuals who, by virtue of
their training or experience, are eminently qualified
to perform peer review functions. In selecting such in-
dividuals for such membership, the Director of the
Center shall ensure that the members of the Board col-
lectively—
‘‘(A) are experienced in the planning, con-
struction, financing, and administration of enti-
ties that conduct biomedical or behavioral re-
search sciences;
‘‘(B) are knowledgeable in making deter-
minations 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 priorities for applications for grants
under subsection (a) in view of the overall re-
search needs of the United States; and
‘‘(D) are experienced with emerging centers
of excellence, as described in subsection (c)(3).
‘‘(5) CERTAIN AUTHORITIES.—
‘‘(A) In carrying out paragraph (2), the
Board may convene workshops and conferences,
119
and collect data as the Board considers appro-
priate.
‘‘(B) In carrying out paragraph (2), the
Board may establish subcommittees within the
Board. Such subcommittees may hold meetings
as determined necessary to enable the sub-
committee to carry out its duties.
‘‘(6) TERMS.—
‘‘(A) Except as provided in subparagraph
(B), each appointed member of the Board shall
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 mem-
ber’s predecessor was appointed shall be ap-
pointed 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.
120
‘‘(C) No member is eligible for reappoint-
ment 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 com-
pensation at the same rate received by members of
other national advisory councils established 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 applicant is determined by such
Director to be competent to engage in the type of
research for which the proposed facility is to be
constructed.
‘‘(B) The applicant provides assurances sat-
isfactory 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;
121
‘‘(ii) sufficient funds will be available
to meet the non-Federal share of the cost of
constructing the facility;
‘‘(iii) sufficient funds will be available,
when construction is completed, for the ef-
fective use of the facility for the research for
which it is being constructed; and
‘‘(iv) the proposed construction will ex-
pand 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 quali-
fications 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 ex-
panding the capacity for biomedical or be-
havioral 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
122
the applicant’s research and training mis-
sion;
‘‘(iv) the congruence of the research ac-
tivities to be carried out within the facility
with the research and investigator man-
power 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 re-
search 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 es-
tablished in paragraph (1), consider the following fac-
tors:
‘‘(A) To what extent the applicant has the
capacity to broaden the scope of research and re-
search training programs of the applicant by
promoting—
‘‘(i) interdisciplinary research;
‘‘(ii) research on emerging technologies,
including those involving novel analytical
techniques or computational methods; or
123
‘‘(iii) other novel research mechanisms
or programs.
‘‘(B) To what extent the applicant has
broadened the scope of research and research
training programs of qualified institutions by
promoting genomic research with an emphasis
on interdisciplinary research, including research
related to pediatric investigations.
‘‘(3) 
INSTITUTIONS
OF
EMERGING
EXCEL-
LENCE.—Of the amounts appropriated under sub-
section (h) for a fiscal year, the Director of the Center
shall make available 25 percent for grants under sub-
section (a) to applicants that, in addition to meeting
the requirements established in paragraph (1), have
demonstrated emerging excellence in biomedical or be-
havioral research, as follows:
‘‘(A) The applicant has a plan for research
or training advancement and possesses the abil-
ity to carry out the plan.
‘‘(B) The applicant carries out research and
research training programs that have a special
relevance to a problem, concern, or unmet health
need of the United States.
‘‘(C) The applicant has been productive in
research or research development and training.
124
‘‘(D) The applicant—
‘‘(i) has been designated as a center of
excellence under section 739;
‘‘(ii) is located in a geographic area a
significant percentage of whose population
has a health-status deficit, and the appli-
cant provides health services to such popu-
lation; 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 car-
rying out activities with respect to protect-
ing 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 man-
ner, and contains such agreements, assurances, and infor-
mation 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
130
(ii) in paragraph (3)(A), in the first
sentence, by striking ‘‘Center’’ and inserting
‘‘Institute’’; and
(C) in subsections (d) through (g), by strik-
ing ‘‘Center’’ each place such term appears and
inserting ‘‘Institute’’; and
(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 Public Health Serv-
ice Act (42 U.S.C. 281(b)) is amended—
(A) in paragraph (1), by adding at the end
the following new subparagraph:
‘‘(Q) The National Institute of Nursing Re-
search.’’; and
(B) in paragraph (2), by striking subpara-
graph (D).
(2) TRANSFER OF STATUTORY PROVISIONS.—The
Public Health Service Act, as amended by subsection
(a) of this section and by section 124 of Public Law
102-321 (106 Stat. 364), is amended—
(A) by transferring sections 483 through
485A to part C of title IV;
161
‘‘(A) Amounts in the Fund may not be ex-
pended for the fiscal year involved for an AIDS
project, or category of such projects, for which—
‘‘(i)(I) amounts were made available
in an appropriations Act for the preceding
fiscal year; and
‘‘(II) amounts are not made available
in any appropriations 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 avail-
able in appropriations 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 Fund may not be invested.
‘‘(d) APPLICABILITY OF LIMITATION REGARDING NUM-
BER OF EMPLOYEES.—The purposes for which amounts in
the Fund may be expended include the employment of indi-
viduals necessary to carry out AIDS projects approved
under subsection (a). Any individual employed under the
preceding sentence may not be included in any determina-
tion of the number of full-time equivalent employees for the