S. 1

One Hundred Third Congress

of the

United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday,

the fifth day of January, one thousand nine hundred and ninety-three

An Act

To amend the Public Health Service Act to revise and extend the programs of

the National Institutes of Health, and for other purposes.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE.—This Act may be cited as the ‘‘National

Institutes of Health Revitalization Act of 1993’’.

(b) TABLE OF CONTENTS.—The table of contents for this Act

is as follows:

Sec. 1. Short title; table of contents.

TITLE I—GENERAL PROVISIONS REGARDING TITLE IV OF PUBLIC HEALTH

SERVICE ACT

Subtitle A—Research Freedom

PART I—REVIEW 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. Inapplicability 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.
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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 conflicts of interest in certain projects of research.

Sec. 165. Regulations.

TITLE II—NATIONAL INSTITUTES OF HEALTH IN GENERAL

Sec. 201. Health promotion research dissemination.

Sec. 202. Programs for increased support regarding certain States and researchers.

Sec. 203. Establishment of Office of Behavioral and Social Sciences Research.

Sec. 204. Children’s vaccine initiative.

Sec. 205. Plan for use of animals in research.

Sec. 206. Increased participation of women and disadvantaged individuals in fields

of biomedical and behavioral research.

Sec. 207. Requirements regarding surveys of sexual behavior.

Sec. 208. Discretionary fund of Director of National Institutes of Health.

Sec. 209. Establishment of Office of Alternative Medicine.

Sec. 210. Miscellaneous provisions.

TITLE III—GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH

INSTITUTES

Sec. 301. Appointment and authority of Directors of national research institutes.

Sec. 302. Program of research on osteoporosis, Paget’s disease, and related bone

disorders.

Sec. 303. Establishment of interagency program for trauma research.

TITLE IV—NATIONAL CANCER INSTITUTE

Sec. 401. Expansion and intensification of activities regarding breast cancer.

Sec. 402. Expansion and intensification of activities regarding prostate cancer.

Sec. 403. Authorization of appropriations.

TITLE V—NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

Sec. 501. Education and training.

Sec. 502. Centers for the study of pediatric cardiovascular diseases.

Sec. 503. National Center on Sleep Disorders Research.

Sec. 504. Authorization of appropriations.

Sec. 505. Prevention and control programs.

TITLE VI—NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE AND

KIDNEY DISEASES

Sec. 601. Provisions regarding nutritional disorders.

TITLE VII—NATIONAL INSTITUTE ON ARTHRITIS AND MUSCULOSKELETAL

AND SKIN DISEASES

Sec. 701. Juvenile arthritis.

TITLE VIII—NATIONAL INSTITUTE ON AGING

Sec. 801. Alzheimer’s disease registry.

Sec. 802. Aging processes regarding women.

Sec. 803. Authorization of appropriations.

Sec. 804. Conforming amendment.

TITLE 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
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Sec. 1011. Establishment of program.

Subtitle C—Child Health Research Centers

Sec. 1021. Establishment of centers.

Subtitle D—Study Regarding Adolescent Health

Sec. 1031. Prospective longitudinal study.

TITLE XI—NATIONAL EYE INSTITUTE

Sec. 1101. Clinical and health services research on eye care and diabetes.

TITLE XII—NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND

STROKE

Sec. 1201. Research on multiple sclerosis.

TITLE XIII—NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH

SCIENCES

Sec. 1301. Applied Toxicological Research and Testing Program.

TITLE XIV—NATIONAL LIBRARY OF MEDICINE

Subtitle A—General Provisions

Sec. 1401. Additional authorities.

Sec. 1402. Authorization of appropriations.

Subtitle B—Financial Assistance

Sec. 1411. Establishment of program of grants for development of education technologies.

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.

Sec. 1602. Service payback requirements.

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 Certain Agencies

Sec. 1631. Establishment of programs for National Institutes of Health.

Sec. 1632. Funding.

Subtitle E—Funding for Awards and Training Generally
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Sec. 1641. Authorization of appropriations.

TITLE XVII—NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH

Sec. 1701. National Foundation for Biomedical Research.

TITLE XVIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE

DEFICIENCY SYNDROME

Subtitle A—Office of AIDS Research

Sec. 1801. Establishment of Office.

Sec. 1802. Establishment of emergency discretionary fund.

Sec. 1803. General provisions.

Subtitle B—Certain Programs

Sec. 1811. Revision and extension of certain programs.

TITLE XIX—STUDIES

Sec. 1901. Life-threatening illnesses.

Sec. 1902. Malnutrition in the elderly.

Sec. 1903. Research activities on chronic fatigue syndrome.

Sec. 1904. Report on medical uses of biological agents in development of defenses

against biological warfare.

Sec. 1905. Personnel study of recruitment, retention and turnover.

Sec. 1906. Procurement.

Sec. 1907. Chronic pain conditions.

Sec. 1908. Relationship between the consumption of legal and illegal drugs.

Sec. 1909. Reducing administrative health care costs.

Sec. 1910. Sentinel disease concept study.

Sec. 1911. Potential environmental and other risks contributing to incidence of

breast cancer.

Sec. 1912. Support for bioengineering research.

Sec. 1913. Cost of care in last 6 months of life.

TITLE XX—MISCELLANEOUS PROVISIONS

Sec. 2001. Designation of Senior Biomedical Research Service in honor of Silvio O.

Conte; limitation on number of members.

Sec. 2002. Master plan for physical infrastructure for research.

Sec. 2003. Certain authorization of appropriations.

Sec. 2004. Buy-American provisions.

Sec. 2005. Prohibition against further funding for Project Aries.

Sec. 2006. Loan repayment program.

Sec. 2007. Exclusion of aliens infected with the agent for acquired immune deficiency syndrome.

Sec. 2008. Technical corrections.

Sec. 2009. Biennial report on carcinogens.

Sec. 2010. Transfer of provisions of title XXVII.

Sec. 2011. Authorization of appropriations.

Sec. 2012. Vaccine injury compensation program.

Sec. 2013. Technical corrections with respect to the Agency for Health Care Policy

and Research.

Sec. 2014. Technical corrections with respect to the Health Professions Education

Extension Amendments of 1992.

Sec. 2015. Prohibitions against SHARP adult sex survey and the American teenage

sex survey.

Sec. 2016. Health services research.

Sec. 2017. Childhood mental health.

Sec. 2018. Expenditures from certain account.

TITLE XXI—EFFECTIVE DATES

Sec. 2101. Effective dates.
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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 G of title IV of the Public Health Service Act (42 U.S.C.

289 et seq.) is amended by inserting after section 492 the following

section:

‘‘CERTAIN PROVISIONS REGARDING REVIEW AND APPROVAL OF

PROPOSALS FOR RESEARCH

‘‘SEC. 492A. (a) REVIEW AS PRECONDITION TO RESEARCH.—

‘‘(1) PROTECTION OF HUMAN RESEARCH SUBJECTS.—

‘‘(A) In the case of any application submitted to the

Secretary for financial assistance to conduct research, the

Secretary may not approve or fund any application that

is subject to review under section 491(a) by an Institutional

Review Board unless the application has undergone review

in accordance with such section and has been recommended

for approval by a majority of the members of the Board

conducting such review.

‘‘(B) In the case of research that is subject to review

under procedures established by the Secretary for the

protection of human subjects in clinical research conducted

by the National Institutes of Health, the Secretary may

not authorize the conduct of the research unless the

research has, pursuant to such procedures, been recommended for approval.

‘‘(2) PEER REVIEW.—In the case of any proposal for the

National Institutes of Health to conduct or support research,

the Secretary may not approve or fund any proposal that is

subject to technical and scientific peer review under section

492 unless the proposal has undergone such review in accordance with such section and has been recommended for approval

by a majority of the members of the entity conducting such

review.

‘‘(b) ETHICAL REVIEW OF RESEARCH.— ‘‘(1) PROCEDURES REGARDING WITHHOLDING OF FUNDS.—If

research has been recommended for approval for purposes of

subsection (a), the Secretary may not withhold funds for the

research because of ethical considerations unless—

‘‘(A) the Secretary convenes an advisory board in accordance with paragraph (5) to study such considerations;

and

‘‘(B)(i) the majority of the advisory board recommends

that, because of such considerations, the Secretary withhold

funds for the research; or
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‘‘(ii) the majority of such board recommends that the

Secretary not withhold funds for the research because of

such considerations, but the Secretary finds, on the basis

of the report submitted under paragraph (5)(B)(ii), that

the recommendation is arbitrary and capricious.

‘‘(2) RULES OF CONSTRUCTION.—Paragraph (1) may not be

construed as prohibiting the Secretary from withholding funds

for research on the basis of—

‘‘(A) the inadequacy of the qualifications of the entities

that would be involved with the conduct of the research

(including the entity that would directly receive the funds

from the Secretary), subject to the condition that, with

respect to the process of review through which the research

was recommended for approval for purposes of subsection

(a), all findings regarding such qualifications made in such

process are conclusive; or

‘‘(B) the priorities established by the Secretary for the

allocation of funds among projects of research that have

been so recommended.

‘‘(3) APPLICABILITY.—The limitation established in paragraph (1) regarding the authority to withhold funds because

of ethical considerations shall apply without regard to whether

the withholding of funds on such basis is characterized as

a disapproval, a moratorium, a prohibition, or other characterization.

‘‘(4) PRELIMINARY MATTERS REGARDING USE OF PROCEDURES.—

‘‘(A) If the Secretary makes a determination that an

advisory board should be convened for purposes of paragraph (1), the Secretary shall, through a statement published in the Federal Register, announce the intention of

the Secretary to convene such a board. ‘‘(B) A statement issued under subparagraph (A) shall

include a request that interested individuals submit to

the Secretary recommendations specifying the particular

individuals who should be appointed to the advisory board

involved. The Secretary shall consider such recommendations in making appointments to the board. ‘‘(C) The Secretary may not make appointments to an advisory board under paragraph (1) until the expiration

of the 30-day period beginning on the date on which the

statement required in subparagraph (A) is made with

respect to the board.

‘‘(5) ETHICS ADVISORY BOARDS.— ‘‘(A) Any advisory board convened for purposes of paragraph (1) shall be known as an ethics advisory board (in

this paragraph referred to as an ‘ethics board’).

‘‘(B)(i) An ethics board shall advise, consult with, and

make recommendations to the Secretary regarding the ethics of the project of biomedical or behavioral research with

respect to which the board has been convened.

‘‘(ii) Not later than 180 days after the date on which

the statement required in paragraph (4)(A) is made with

respect to an ethics board, the board shall submit to the

Secretary, and to the Committee on Energy and Commerce

of the House of Representatives and the Committee on

Labor and Human Resources of the Senate, a report
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describing the findings of the board regarding the project

of research involved and making a recommendation under

clause (i) of whether the Secretary should or should not

withhold 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, individuals who are not

officers or employees of the United States. The Secretary

shall make appointments to the board from among individuals with special qualifications and competence to provide

advice and recommendations regarding ethical matters in

biomedical and behavioral research. Of the members of

the board—

‘‘(i) no fewer than 1 shall be an attorney;

‘‘(ii) no fewer than 1 shall be an ethicist;

‘‘(iii) no fewer than 1 shall be a practicing physician;

‘‘(iv) no fewer than 1 shall be a theologian; and

‘‘(v) no fewer than one-third, and no more than

one-half, shall be scientists with substantial 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 remainder of the term of the predecessor of the

individual.

‘‘(E) A member of an ethics board shall be subject

to removal from the board by the Secretary for neglect

of duty or malfeasance or for other good cause shown. ‘‘(F) The Secretary shall designate an individual from

among the members of an ethics board to serve as the

chair of the board.

‘‘(G) In carrying out subparagraph (B)(i) with respect

to a project of research, an ethics board shall conduct

inquiries and hold public hearings. ‘‘(H) In carrying out subparagraph (B)(i) with respect

to a project of research, an ethics board shall have access

to all relevant information possessed by the Department

of Health and Human Services, or available to the Secretary from other agencies. ‘‘(I) Members of an ethics board shall receive compensation for each day engaged in carrying out the duties of

the board, including time engaged in traveling for purposes

of such duties. Such compensation may not be provided

in an amount in excess of the maximum rate of basic

pay payable for GS–18 of the General Schedule.

‘‘(J) The Secretary, acting through the Director of the

National Institutes of Health, shall provide to each ethics

board reasonable staff and assistance to carry out the

duties of the board.

‘‘(K) An ethics board shall terminate 30 days after

the date on which the report required in subparagraph

(B)(ii) is submitted to the Secretary and the congressional

committees specified in such subparagraph.

‘‘(6) DEFINITION.—For purposes of this subsection, the term

‘ethical considerations’ means considerations as to whether the
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nature of the research involved is such that it is unethical

to conduct or support the research.’’.

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

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 pursuant to a spontaneous or

induced abortion or pursuant to a stillbirth.

‘‘(b) INFORMED CONSENT OF DONOR.—

‘‘(1) IN GENERAL.—In research carried out under subsection

(a), human fetal tissue may be used only if the woman providing

the tissue makes a statement, made in writing and signed

by the woman, declaring that—

‘‘(A) the woman donates the fetal tissue for use in

research described in subsection (a);

‘‘(B) the donation is made without any restriction

regarding the identity of individuals who may be the 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 carried out

under subsection (a), human fetal tissue may be used only

if the attending physician with respect to obtaining the tissue

from the woman involved makes a statement, made in writing

and signed by the physician, declaring that—

‘‘(A) in the case of tissue obtained pursuant to an

induced abortion—

‘‘(i) the consent of the woman for the abortion

was obtained prior to requesting or obtaining consent

for a donation of the tissue for use in such research;

‘‘(ii) no alteration of the timing, method, or procedures used to terminate the pregnancy was made solely

for the purposes of obtaining the tissue; and

‘‘(iii) the abortion was performed in accordance

with applicable State law;

‘‘(B) the tissue has been donated by the woman in

accordance with paragraph (1); and

‘‘(C) full disclosure has been provided to the woman

with regard to— ‘‘(i) such physician’s interest, if any, in the research

to be conducted with the tissue; and

‘‘(ii) any known medical risks to the woman or

risks to her privacy that might be associated with

the donation of the tissue and that are in addition
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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 involved makes a statement, made

in writing and signed by the individual, declaring that the

individual—

‘‘(1) is aware that—

‘‘(A) the tissue is human fetal tissue;

‘‘(B) the tissue may have been obtained pursuant to

a spontaneous or induced abortion or pursuant to a stillbirth; and

‘‘(C) the tissue was donated for research purposes;

‘‘(2) has provided such information to other individuals

with responsibilities regarding the research;

‘‘(3) will require, prior to obtaining the consent of an

individual to be a recipient of a transplantation of the tissue,

written acknowledgment of receipt of such information by such

recipient; and

‘‘(4) has had no part in any decisions as to the timing,

method, or procedures used to terminate the pregnancy made

solely for the purposes of the research.

‘‘(d) AVAILABILITY OF STATEMENTS FOR AUDIT.—

‘‘(1) IN GENERAL.—In research carried out under subsection

(a), human fetal tissue may be used only if the head of the

agency or other entity conducting the research involved certifies

to the Secretary that the statements required under subsections

(b)(2) and (c) will be available for audit by the Secretary. ‘‘(2) CONFIDENTIALITY OF AUDIT.—Any audit conducted by the Secretary pursuant to paragraph (1) shall be conducted

in a confidential manner to protect the privacy rights of the

individuals and entities involved in such research, including

such individuals and entities involved in the donation, transfer,

receipt, or transplantation of human fetal tissue. With respect

to any material or information obtained pursuant to such audit,

the Secretary shall— ‘‘(A) use such material or information only for the

purposes of verifying compliance with the requirements

of this section;

‘‘(B) not disclose or publish such material or information, except where required by Federal law, in which case

such material or information shall be coded in a manner

such that the identities of such individuals and entities

are protected; and

‘‘(C) not maintain such material or information after

completion of such audit, except where necessary for the

purposes of such audit.

‘‘(e) APPLICABILITY OF STATE AND LOCAL LAW.—

‘‘(1) RESEARCH CONDUCTED BY RECIPIENTS OF ASSISTANCE.—

The Secretary may not provide support for research under

subsection (a) unless the applicant 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.
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‘‘(f) REPORT.—The Secretary shall annually submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of

the Senate, a report describing the activities carried out under

this section during the preceding fiscal year, including a description

of whether and to what extent research under subsection (a) has

been conducted in accordance with this section.

‘‘(g) DEFINITION.—For purposes of this section, the term ‘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; SOLICITATION OR

ACCEPTANCE OF TISSUE AS DIRECTED DONATION FOR

USE IN TRANSPLANTATION.

Part G of title IV of the Public Health Service Act, as amended

by section 111 of this Act, is amended by inserting after section

498A the following section:

‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE

‘‘SEC. 498B. (a) PURCHASE OF TISSUE.—It shall be unlawful

for any person to knowingly acquire, receive, or otherwise transfer

any human fetal tissue for valuable consideration if the transfer

affects interstate commerce.

‘‘(b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED

DONATION FOR USE IN TRANSPLANTATION.—It shall be unlawful

for any person to solicit or knowingly acquire, receive, or accept

a donation of human fetal tissue for the purpose of transplantation

of such tissue into another person if the donation affects interstate

commerce, the tissue will be or is obtained pursuant to an induced

abortion, and—

‘‘(1) the donation will be or is made pursuant to a promise

to the donating individual that the donated tissue will be

transplanted into a recipient specified by such individual;

‘‘(2) the donated tissue will be transplanted into a relative

of the donating individual; or

‘‘(3) the person who solicits or knowingly acquires, receives,

or accepts the donation has provided valuable consideration

for the costs associated with such abortion.

‘‘(c) CRIMINAL PENALTIES FOR VIOLATIONS.—

‘‘(1) IN GENERAL.—Any person who violates subsection (a)

or (b) shall be fined in accordance with title 18, United States

Code, subject to paragraph (2), or imprisoned for not more

than 10 years, or both.

‘‘(2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSIDERATION.—With respect to the imposition of a fine under paragraph (1), if the person involved violates subsection (a) or

(b)(3), a fine shall be imposed in an amount not less than

twice the amount of the valuable consideration received.

‘‘(d) DEFINITIONS.—For purposes of this section:

‘‘(1) The term ‘human fetal tissue’ has the meaning given such term in section 498A(f).

‘‘(2) The term ‘interstate commerce’ has the meaning given

such term in section 201(b) of the Federal Food, Drug, and

Cosmetic Act.

‘‘(3) The term ‘valuable consideration’ does not include

reasonable payments associated with the transportation,
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implantation, processing, preservation, 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 prohibited from conducting

or supporting any research on the transplantation of human fetal

tissue for therapeutic purposes. Such research shall be carried

out in accordance with section 498A of the Public Health Service

Act (as added by section 111 of this Act), without regard to any

such policy that may have been in effect prior to the date of

the enactment of this Act.

(b) PROHIBITION AGAINST WITHHOLDING OF FUNDS IN CASES

OF TECHNICAL AND SCIENTIFIC MERIT.—

(1) IN GENERAL.—Subject to subsection (b)(2) of section

492A of the Public Health Service Act (as added by section

101 of this Act), in the case of any proposal for research on

the transplantation of human fetal tissue for therapeutic purposes, the Secretary of Health and Human Services may not

withhold funds for the research if—

(A) the research has been approved for purposes of

subsection (a) of such section 492A;

(B) the research will be carried out in accordance with

section 498A of such Act (as added by section 111 of this

Act); and

(C) there are reasonable assurances that the research

will not utilize any human fetal tissue that has been

obtained in violation of section 498B(a) of such Act (as

added by section 112 of this Act).

(2) STANDING APPROVAL REGARDING ETHICAL STATUS.—In

the case of any proposal for research on the transplantation

of human fetal tissue for therapeutic purposes, the issuance

in December 1988 of the Report of the Human Fetal Tissue

Transplantation Research Panel shall be deemed to be a

report—

(A) issued by an ethics advisory board pursuant to section 492A(b)(5)(B)(ii) of the Public Health Service Act

(as added by section 101 of this Act); and (B) finding, on a basis that is neither arbitrary nor

capricious, that the nature of the research is such that

it is not unethical to conduct or support the research.

(c) AUTHORITY FOR WITHHOLDING FUNDS FROM RESEARCH.— In the case of any research on the transplantation of human fetal

tissue for therapeutic purposes, the Secretary of Health and Human

Services may withhold 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 purposes, the Comptrol-
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ler General of the United States shall conduct an audit for the

purpose of determining—

(1) whether and to what extent such research conducted

or supported by the Secretary of Health and Human Services

has been conducted in accordance with section 498A of the

Public Health Service Act (as added by section 111 of this

Act); and

(2) whether and to what extent there have been violations

of section 498B of such Act (as added by section 112 of this

Act).

(b) REPORT.—Not later than May 19, 1995, the Comptroller

General of the United States shall complete the audit required

in subsection (a) and submit to the Committee on Energy and

Commerce of the House of Representatives, and to the Committee

on Labor and Human Resources of the Senate, a report describing

the findings made pursuant to the audit.

PART III—MISCELLANEOUS REPEALS

SEC. 121. REPEALS.

(a) CERTAIN BIOMEDICAL ETHICS BOARD.—Title III of the 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 provisions of section 204(d) of part

46 of title 45 of the Code of Federal Regulations (45 CFR 46.204(d))

shall not have any legal effect.

Subtitle B—Clinical Research Equity

Regarding Women and Minorities

PART I—WOMEN AND MINORITIES AS

SUBJECTS IN CLINICAL RESEARCH

SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.

Part G of title IV of the Public Health Service Act, as amended

by section 101 of this Act, is amended by inserting after section

492A the following section:

‘‘INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH

‘‘SEC. 492B. (a) REQUIREMENT OF INCLUSION.— ‘‘(1) IN GENERAL.—In conducting or supporting clinical

research for purposes of this title, the Director of NIH shall,

subject to subsection (b), ensure that—

‘‘(A) women are included as subjects in each project

of such research; and

‘‘(B) members of minority groups are included as subjects in such research.
S. 1—13

‘‘(2) OUTREACH REGARDING PARTICIPATION AS SUBJECTS.—

The Director of NIH, in consultation with the Director of the

Office of Research on Women’s Health and the Director of

the Office of Research on Minority Health, shall conduct or

support outreach programs for the recruitment of women and

members of minority groups as subjects in projects of clinical

research.

‘‘(b) INAPPLICABILITY OF REQUIREMENT.—The requirement

established in subsection (a) regarding women and members of

minority groups shall not apply to a project of clinical research

if the inclusion, as subjects in the project, of women and members

of minority groups, respectively—

‘‘(1) is inappropriate with respect to the health of the

subjects;

‘‘(2) is inappropriate with respect to the purpose of the

research; or

‘‘(3) is inappropriate under such other circumstances as

the Director of NIH may designate.

‘‘(c) DESIGN OF CLINICAL TRIALS.—In the case of any clinical

trial in which women or members of minority groups will 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 Director of the Office

of Research on Minority Health, shall establish guidelines

regarding the requirements of this section. The guidelines shall

include guidelines regarding— ‘‘(A) the circumstances under which the inclusion of

women and minorities as subjects in projects of clinical

research is inappropriate for purposes of subsection (b);

‘‘(B) the manner in which clinical trials are required

to be designed and carried out for purposes of subsection

(c); and

‘‘(C) the operation of outreach programs under sub- section (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 inappropriate for purposes of subsection

(b), the following applies to guidelines under paragraph (1):

‘‘(A)(i) In the case of a clinical trial, the guidelines

shall provide that the costs of such inclusion in the trial

is not a permissible consideration in determining whether

such inclusion is inappropriate.

‘‘(ii) In the case of other projects of clinical research,

the guidelines shall provide that the costs of such inclusion

in the project is not a permissible consideration in 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
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or are being obtained through other means that provide

data of comparable quality. ‘‘(B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is not required

if there is substantial scientific data demonstrating that

there is no significant difference between— ‘‘(i) the effects that the variables to be studied

in the trial have on women or members of minority

groups, respectively; and ‘‘(ii) the effects that the variables have on the

individuals who would serve as subjects in the trial

in the event that such inclusion were not required. ‘‘(e) DATE CERTAIN FOR GUIDELINES; APPLICABILITY.— ‘‘(1) DATE CERTAIN.—The guidelines required in subsection (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 conducted or supported by any agency

of the National Institutes of Health unless the proposal specifies

the manner in which the research will comply with this section.

‘‘(f) REPORTS BY ADVISORY COUNCILS.—The advisory council of each national research institute shall prepare biennial reports

describing the manner in which the institute has complied with

this section. Each such report shall be submitted to the Director

of the institute involved for inclusion in the biennial report under

section 403.

‘‘(g) DEFINITIONS.—For purposes of this section: ‘‘(1) The term ‘project of clinical research’ includes a clinical trial.

‘‘(2) The term ‘minority group’ includes subpopulations of minority groups. The Director of NIH shall, through the guidelines established under subsection (d), define the terms ‘minority group’ and ‘subpopulation’ for purposes of the preceding

sentence.’’.

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 subsection: ‘‘(c)(1) In technical and scientific peer review under this section

of proposals for clinical research, the consideration of any such

proposal (including the initial consideration) shall, except as 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 section 492B, is not

subject to the requirement of subsection (a) of such section regarding

the inclusion of women and members of minority groups as subjects

in clinical research.’’.

SEC. 133. INAPPLICABILITY TO CURRENT PROJECTS.

Section 492B of the Public Health Service Act, as added by

section 131 of this Act, shall not apply with respect to projects

of clinical research for which initial funding was provided prior

to the date of the enactment of this Act. With respect to the

inclusion of women and minorities as subjects in clinical research
S. 1—15

conducted or supported by the National Institutes of Health, any

policies of the Secretary of Health and Human Services regarding

such inclusion that are in effect on the day before the date of

the enactment of this Act shall continue to apply to the projects

referred to in the preceding sentence.

PART II—OFFICE OF RESEARCH ON WOMEN’S

HEALTH

SEC. 141. ESTABLISHMENT.

(a) IN GENERAL.—Title IV of the Public Health Service 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 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 referred to as the ‘Office’).

The Office shall be headed by a director, who shall be appointed

by the Director of NIH. ‘‘(b) PURPOSE.—The Director of the Office shall—

‘‘(1) identify projects of research on women’s health that should be conducted or supported by the national research

institutes;

‘‘(2) identify multidisciplinary research relating to research on women’s health that should be so conducted or supported; ‘‘(3) carry out paragraphs (1) and (2) with respect to the aging process in women, with priority given to menopause; ‘‘(4) promote coordination and collaboration among entities conducting research identified under any of paragraphs (1)

through (3); ‘‘(5) encourage the conduct of such research by entities receiving funds from the national research institutes; ‘‘(6) recommend an agenda for conducting and supporting such research;

‘‘(7) promote the sufficient allocation of the resources of

the national research institutes for conducting and supporting

such research;

‘‘(8) assist in the administration of section 492B with

respect to the inclusion of women as subjects in clinical

research; and

‘‘(9) prepare the report required in section 486B. ‘‘(c) COORDINATING COMMITTEE.— ‘‘(1) In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the Coordinating Committee on Research on Women’s Health (in this subsection referred to as the ‘Coordinating Committee’). ‘‘(2) The Coordinating Committee shall be composed of the Directors of the national research institutes (or the designees

of the Directors).

‘‘(3) The Director of the Office shall serve as the chair

of the Coordinating Committee.
S. 1—16

‘‘(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 coordination of

research activities, including intramural and extramural

multidisciplinary activities;

‘‘(C) supporting the development of methodologies to

determine the circumstances in which obtaining data specific to women (including data relating to the age of women

and the membership of women in ethnic or racial groups)

is an appropriate function of clinical trials of treatments

and therapies;

‘‘(D) supporting the development and expansion of 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 institutes to

conduct and support such research, including such clinical

trials.

‘‘(d) ADVISORY COMMITTEE.—

‘‘(1) In carrying out subsection (b), the Director of the

Office shall establish an advisory committee to be known as

the Advisory Committee on Research on Women’s Health (in

this subsection referred to as the ‘Advisory Committee’).

‘‘(2) The Advisory Committee shall be composed of no fewer

than 12, and not more than 18 individuals, who are not officers

or employees of the Federal Government. The Director of the

Office shall make appointments to the Advisory Committee

from among physicians, practitioners, scientists, and other

health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus

on research on women’s health. A majority of the members

of the Advisory Committee shall be women. ‘‘(3) The Director of the Office shall serve as the chair

of the Advisory Committee. ‘‘(4) The Advisory Committee shall— ‘‘(A) advise the Director of the Office on appropriate

research activities to be undertaken by the national

research institutes with respect to—

‘‘(i) research on women’s health;

‘‘(ii) research on gender differences in clinical drug

trials, including responses to pharmacological drugs; ‘‘(iii) research on gender differences in disease

etiology, course, and treatment;

‘‘(iv) research on obstetrical and gynecological

health conditions, diseases, and treatments; and

‘‘(v) research on women’s health conditions which

require a multidisciplinary approach;

‘‘(B) report to the Director of the Office on such

research;

‘‘(C) provide recommendations to such Director regarding activities of the Office (including 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
S. 1—17

‘‘(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 Committee, including

findings made by the Committee regarding—

‘‘(i) compliance with section 492B;

‘‘(ii) the extent of expenditures made for research on

women’s health by the agencies of the National Institutes

of Health; and

‘‘(iii) the level of funding needed for such research.

‘‘(B) The report required in subparagraph (A) shall be

submitted to the Director of NIH for inclusion in the report

required in section 403.

‘‘(e) REPRESENTATION OF WOMEN AMONG RESEARCHERS.—The

Secretary, acting through the Assistant Secretary for Personnel

and in collaboration with the Director of the Office, shall determine

the extent to which women are represented among senior physicians

and scientists of the national research institutes and among physicians and scientists conducting research with funds provided by

such institutes, and as appropriate, carry out activities to increase

the extent of such representation.

‘‘(f) DEFINITIONS.—For purposes of this part:

‘‘(1) The term ‘women’s health conditions’, with respect

to women of all age, ethnic, and racial groups, means all diseases, disorders, and conditions (including with respect to mental health)—

‘‘(A) unique to, more serious, or more prevalent 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, including 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 National Library of Medicine, shall establish a data system for the collection, storage,

analysis, retrieval, and dissemination of information regarding

research on women’s health that is conducted or supported

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 paragraph (1) shall

include a registry of clinical trials of experimental treatments

that have been developed for research on women’s health. Such

registry shall include information on subject eligibility criteria,

sex, age, ethnicity or race, and the location of the trial site

or sites. Principal investigators of such clinical trials shall
S. 1—18

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 associated with the experimental treatment or treatments evaluated.

‘‘(b) CLEARINGHOUSE.—The Director of NIH, in consultation

with the Director of the Office and with the National Library

of Medicine, shall establish, maintain, and operate a program to

provide information on research and prevention activities of the

national research institutes that relate to research on women’s

health.

‘‘SEC. 486B. BIENNIAL REPORT.

‘‘(a) IN GENERAL.—With respect to research on women’s health,

the Director of the Office shall, not later than February 1, 1994,

and biennially thereafter, prepare a report—

‘‘(1) describing and evaluating the progress made during

the preceding 2 fiscal years in research and treatment conducted or supported by the National Institutes of Health;

‘‘(2) describing and analyzing the professional status of

women physicians and scientists of such Institutes, including

the identification of problems and barriers 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 legislative 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 report prepared under

subsection (a) to the Director of NIH for inclusion in the report

submitted to the President and the Congress under section 403.’’.

(b) REQUIREMENT OF SUFFICIENT ALLOCATION OF RESOURCES

OF INSTITUTES.—Section 402(b) of the Public Health Service Act

(42 U.S.C. 282(b)) is amended—

(1) in paragraph (10), by striking ‘‘and’’ after the semicolon

at the end;

(2) in paragraph (11), by striking the period at the end

and inserting ‘‘; and’’; and

(3) by inserting after paragraph (11) the following 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 women’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:
S. 1—19

‘‘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 conducted or supported; ‘‘(3) promote coordination and collaboration among entities conducting research identified under paragraph (1) or (2); ‘‘(4) encourage the conduct of such research by entities receiving funds from the national research institutes; ‘‘(5) recommend an agenda for conducting and supporting

such research;

‘‘(6) promote the sufficient allocation of the resources of

the national research institutes for conducting and supporting

such research; and

‘‘(7) assist in the administration of section 492B with

respect to the inclusion of members of minority groups as

subjects in clinical research.’’.

Subtitle C—Research Integrity

SEC. 161. ESTABLISHMENT OF OFFICE OF RESEARCH INTEGRITY.

Section 493 of the Public Health Service Act (42 U.S.C. 289b)

is amended to read as follows:

‘‘OFFICE OF RESEARCH INTEGRITY

‘‘SEC. 493. (a) IN GENERAL.—

‘‘(1) ESTABLISHMENT OF OFFICE.—Not later than 90 days

after the date of enactment of this section, the Secretary shall

establish an office to be known as the Office of Research Integrity (referred to in this section as the ‘Office’), which shall

be established as an independent entity in the Department

of Health and Human Services.

‘‘(2) APPOINTMENT OF DIRECTOR.—The Office shall be

headed by a Director, who shall be appointed by the Secretary,

be experienced and specially trained in the conduct of research,

and have experience in the conduct of investigations of research

misconduct. The Secretary shall carry out this section acting

through the Director of the Office. The Director shall report

to the Secretary. ‘‘(3) DEFINITIONS.— ‘‘(A) The Secretary shall by regulation establish a definition for the term ‘research misconduct’ for purposes of

this section.

‘‘(B) For purposes of this section, the term ‘financial

assistance’ means a grant, contract, or cooperative agreement.

‘‘(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS CONDITION

OF FUNDING FOR RESEARCH.—The Secretary shall by regulation
S. 1—20

require that each entity that applies for financial assistance under

this Act for any project or program that involves the conduct of

biomedical or behavioral research submit in or with its application

for such assistance—

‘‘(1) assurances satisfactory to the Secretary that such

entity has established and has in effect (in accordance with

regulations which the Secretary shall prescribe) an administrative process to review reports of research misconduct in connection with biomedical and behavioral research conducted at or

sponsored by such entity;

‘‘(2) an agreement that the entity will report to the Director

any investigation of alleged research misconduct in connection

with projects for which funds have been made available under

this Act that appears substantial; and

‘‘(3) an agreement that the entity will comply with regulations issued under this section.

‘‘(c) PROCESS FOR RESPONSE OF DIRECTOR.—The Secretary shall

by regulation establish a process to be followed by the Director

for the prompt and appropriate—

‘‘(1) response to information provided to the Director

respecting research misconduct in connection with projects for

which funds have been made available under this Act;

‘‘(2) receipt of reports by the Director of such information

from recipients of funds under this Act;

‘‘(3) conduct of investigations, when appropriate; and

‘‘(4) taking of other actions, including appropriate remedies,

with respect to such misconduct.

‘‘(d) MONITORING BY DIRECTOR.—The Secretary shall by regulation establish procedures for the Director to monitor administrative

processes and investigations that have been established or carried

out under 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 recommendations

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 Commission may be

officers or employees of the United States. Of the members of

the Commission—

(1) three shall be scientists with substantial accomplishments in biomedical or behavioral research;

(2) three shall be individuals with experience in investigating allegations of misconduct with respect to 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 described in

paragraph (1), (2), or (3), at least one of whom shall be an

attorney and at least one of whom shall be an ethicist.
S. 1—21

(d) COMPENSATION.—Members of the Commission may not

receive compensation for service on the Commission. Members may

be reimbursed for travel, subsistence, and other necessary expenses

incurred in carrying out the duties of the Commission.

(e) REPORT.—Not later than 120 days after the date on which

the Commission is established under subsection (a), the Commission

shall prepare and submit to the Secretary of Health and Human

Services, the Committee on Energy and Commerce of the House

of Representatives, and the Committee on Labor and Human

Resources of the Senate, a report containing the recommendations

developed under subsection (b).

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 subsection: ‘‘(e) PROTECTION OF WHISTLEBLOWERS.— ‘‘(1) IN GENERAL.—In the case of any entity required to establish administrative processes under subsection (b), the

Secretary shall by regulation establish standards for preventing, and for responding to the occurrence of retaliation by

such entity, its officials or agents, against an employee in

the terms and conditions of employment in response to the

employee having in good faith— ‘‘(A) made an allegation that the entity, its officials

or agents, has engaged in or failed to adequately respond

to an allegation of research misconduct; or ‘‘(B) cooperated with an investigation of such an allegation.

‘‘(2) MONITORING BY SECRETARY.—The Secretary shall by

regulation establish procedures for the Director to monitor the

implementation of the standards established by an entity under

paragraph (1) for the purpose of determining whether the procedures have been established, and are being utilized, in accordance 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 retaliation in violation of

the standards established under paragraph (1). Such remedies

may include termination of funding provided by the Secretary

for such project or recovery of funding being provided by the

Secretary for such project, or other actions as appropriate.’’.

SEC. 164. REQUIREMENT OF REGULATIONS REGARDING PROTECTION

AGAINST FINANCIAL CONFLICTS OF INTEREST IN CERTAIN PROJECTS OF RESEARCH.

Part H of title IV of the Public Health Service Act, as redesig- nated by section 141(a)(2) of this Act, is amended by inserting

after section 493 the following new section:

‘‘PROTECTION AGAINST FINANCIAL CONFLICTS OF INTEREST IN

CERTAIN PROJECTS OF RESEARCH

‘‘SEC. 493A. (a) ISSUANCE OF REGULATIONS.—The Secretary

shall by regulation define the specific circumstances that constitute

the existence of a financial interest in a project on the part of

an entity or individual that will, or may be reasonably expected

to, create a bias in favor of obtaining results in such project that
S. 1—22

are consistent with such financial interest. Such definition shall

apply uniformly to each entity or individual conducting a research

project under this Act. In the case of any entity or individual

receiving assistance from the Secretary for a project of research

described in subsection (b), the Secretary shall by regulation establish standards for responding to, including managing, reducing,

or eliminating, the existence of such a financial interest. The entity

may adopt individualized procedures for implementing the standards.

‘‘(b) RELEVANT PROJECTS.—A project of research referred to

in subsection (a) is a project of clinical research whose purpose

is to evaluate the safety or effectiveness of a drug, medical device,

or treatment and for which such entity is receiving assistance

from the Secretary.

‘‘(c) IDENTIFYING AND REPORTING TO SECRETARY.—The Secretary shall by regulation require that each entity described in

subsection (a) that applies for assistance under this Act for any

project described in subsection (b) submit in or with its application

for such assistance—

‘‘(1) assurances satisfactory to the Secretary that such

entity has established and has in effect an administrative process under subsection (a) to identify financial interests (as

defined under subsection (a)) that exist regarding the project;

and

‘‘(2) an agreement that the entity will report to the Secretary such interests identified by the entity and how any

such interests identified by the entity will be managed or

eliminated in order that the project in question will be protected

from bias that may stem from such interests; and ‘‘(3) an agreement that the entity will comply with regulations issued under this section.

‘‘(d) MONITORING OF PROCESS.—The Secretary shall monitor

the establishment and conduct of the administrative process established by an entity pursuant to subsection (a). ‘‘(e) RESPONSE.—In any case in which the Secretary determines that an entity has failed to comply with subsection (c) regarding

a project of research described in subsection (b), the Secretary— ‘‘(1) shall require that, as a condition of receiving assistance, the entity disclose the existence of a financial interest

(as defined under subsection (a)) in each public presentation

of the results of such project; and ‘‘(2) may take such other actions as the Secretary determines to be appropriate.

‘‘(f) DEFINITIONS.—For purposes of this section:

‘‘(1) The term ‘financial interest’ includes the receipt of

consulting fees or honoraria and the ownership of stock or

equity.

‘‘(2) The term ‘assistance’, with respect to conducting a

project of research, means a grant, contract, or cooperative

agreement.’’.

SEC. 165. REGULATIONS.

(a) ISSUANCE OF FINAL RULES.—

(1) IN GENERAL.—Not later than 180 days after the date

of the enactment of this Act, the Secretary shall, subject to

paragraph (2), issue the final rule for each regulation required

in section 493 or 493A of the Public Health Service Act.
S. 1—23

(2) DEFINITION OF RESEARCH MISCONDUCT.—Not later than

90 days after the date on which the report required in section

162(e) is submitted to the Secretary, the Secretary shall issue

the final rule for the regulations required in section 493 of

the Public Health Service Act with respect to the definition

of the term ‘‘research misconduct’’.

(b) APPLICABILITY TO ONGOING INVESTIGATIONS.—The final rule

issued pursuant to subsection (a) for investigations under section

493 of the Public Health Service Act does not apply to investigations

commenced before the date of the enactment of this Act under

authority of such section as in effect before such date.

(c) DEFINITIONS.—For purposes of this section:

(1) The term ‘‘section 493 of the Public Health Service

Act’’ means such section as amended by sections 161 and 163

of this Act, except as indicated otherwise in subsection (b).

(2) The term ‘‘section 493A of the Public Health Service

Act’’ means such section as added by section 164 of this Act.

(3) The term ‘‘Secretary’’ means the Secretary of Health

and Human Services.

TITLE II—NATIONAL INSTITUTES OF

HEALTH IN GENERAL

SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINATION.

Section 402(f) of the 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 elementary, secondary, and postsecondary schools. The Associate Director shall— ‘‘(1) annually review the efficacy of existing policies and

techniques used by the national research institutes to disseminate the results of disease prevention and behavioral research

programs; ‘‘(2) recommend, coordinate, and oversee the modification

or reconstruction of such policies and techniques to ensure

maximum dissemination, using advanced technologies to the

maximum extent practicable, of research results to such entities; and

‘‘(3) annually prepare and submit to the Director of NIH

a report concerning the prevention and dissemination activities

undertaken by the Associate Director, including— ‘‘(A) a summary of the Associate Director’s review of

existing dissemination policies and techniques together

with a detailed statement concerning any modification or

restructuring, or recommendations for modification or

restructuring, of such policies and techniques; and

‘‘(B) a detailed statement of the expenditures made

for the prevention and dissemination activities reported

on and the personnel used in connection with such activities.’’.

SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARDING 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 subsection:
S. 1—24

‘‘(g)(1)(A) In the case of entities described in subparagraph (B), the Director of NIH, acting through the Director of the National

Center for Research Resources, shall establish a program to enhance

the competitiveness of such entities in obtaining funds from the

national research institutes for conducting biomedical and 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 carrying out the

program established under such subparagraph, may— ‘‘(i) provide technical assistance to the entities involved,

including technical assistance in the preparation of applications

for obtaining funds from the national research institutes; ‘‘(ii) assist the entities in developing a plan for biomedical or behavioral research proposals; and ‘‘(iii) assist the entities in implementing such plan. ‘‘(2) The Director of NIH shall establish a program of supporting projects of biomedical or behavioral research whose 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 AND SOCIAL

SCIENCES RESEARCH.

(a) IN GENERAL.—Part A of title IV of the Public Health Service

Act, as amended by section 151 of this Act, is amended by adding

at the end the following section:

‘‘OFFICE OF BEHAVIORAL AND SOCIAL SCIENCES RESEARCH

‘‘SEC. 404A. (a) There is established within the Office of the

Director of NIH an office to be known as the Office of Behavioral

and Social Sciences Research (in this section referred to as the

‘Office’). The Office shall be headed by a director, who shall be

appointed by the Director of NIH. ‘‘(b)(1) With respect to research on the relationship between

human behavior and the development, treatment, and prevention

of medical conditions, the Director of the Office shall—

‘‘(A) coordinate research conducted or supported by the

agencies of the National Institutes of Health; and ‘‘(B) identify projects of behavioral and social sciences

research that should be conducted or supported by the national

research institutes, and develop such projects in cooperation

with such institutes.

‘‘(2) Research authorized under paragraph (1) includes research

on teen pregnancy, infant mortality, violent behavior, suicide, and

homelessness. Such research does not include neurobiological

research, or research in which the behavior of an organism is

observed for the purpose of determining activity at the cellular

or molecular level.’’.

(b) REPORT.—Not later than February 1, 1994, the Director

of the Office of Behavioral and Social Sciences Research (established

in section 404A of the Public Health Service Act, as added by
S. 1—25

subsection (a) of this section) shall submit to the Committee on

Energy and Commerce of the House of Representatives, and to

the Committee on Labor and Human Resources of the Senate,

a report describing the extent to which the national research

institutes of the National Institutes of Health conduct and support

behavioral research and social sciences research. In preparing the

report, such Director shall (subject to subsection (b)(2) of such

section 404A) state the definitions used in the report for the terms

‘‘behavioral research’’ and ‘‘social sciences research’’, and shall apply

the definitions uniformly to such institutes for purposes of the

report.

(c) EFFECTIVE DATES.—The amendment described in subsection

(a) is made upon the date of the enactment of this Act and takes

effect July 1, 1993. Subsection (b) takes effect on such date.

SEC. 204. CHILDREN’S VACCINE INITIATIVE.

Part A of title IV of the Public Health Service Act, as amended

by section 203 of this Act, is amended by adding at the end the

following section:

‘‘CHILDREN’S VACCINE INITIATIVE

‘‘SEC. 404B. (a) DEVELOPMENT OF NEW VACCINES.—The Secretary, in consultation with the Director of the National Vaccine

Program under title XXI and acting through the Directors of the

National Institute for Allergy and Infectious Diseases, the National

Institute for Child Health and Human Development, the National

Institute for Aging, and other public and private programs, shall

carry out activities, which shall be consistent with the global Children’s Vaccine Initiative, to develop affordable new and improved

vaccines to be used in the United States and in the developing

world that will increase the efficacy and efficiency of the prevention

of infectious diseases. In carrying out such activities, the Secretary

shall, to the extent practicable, develop and make available vaccines

that require fewer contacts to deliver, that can be given early

in life, that provide long lasting protection, that obviate 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 implementing the provisions of this

section and achieving its goals.

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—In addition 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 $20,000,000 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 section:
S. 1—26

‘‘PLAN FOR USE OF ANIMALS IN RESEARCH

‘‘SEC. 404C. (a) The Director of NIH, after consultation with

the committee established under subsection (e), shall prepare a

plan—

‘‘(1) for the National Institutes of Health to conduct or

support research into—

‘‘(A) methods of biomedical research and experimentation that do not require the use of animals;

‘‘(B) methods of such research and experimentation

that reduce the number of animals used in such research;

‘‘(C) methods of such research and experimentation

that produce less pain and distress in such animals; and

‘‘(D) methods of such research and experimentation

that involve the use of marine life (other than marine

mammals);

‘‘(2) for establishing the validity and reliability of the methods described in paragraph (1);

‘‘(3) for encouraging the acceptance by the scientific 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 Commerce 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 experimentation 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 Animals in Research (in

this subsection referred to as the ‘Committee’).

‘‘(2) The Committee shall provide advice to the Director of

NIH on the preparation of the plan required in subsection (a).

‘‘(3) The Committee shall be composed of—

‘‘(A) the Directors of each of the national research institutes

and the Director of the Center for Research Resources (or

the designees of such Directors); and

‘‘(B) representatives of the Environmental Protection

Agency, the Food and Drug Administration, the Consumer Product Safety Commission, the National Science Foundation, and

such additional agencies as the Director of NIH determines

to be appropriate, which representatives shall include not less

than one veterinarian with expertise in laboratory-animal medicine.’’.
S. 1—27

(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 DISADVANTAGED INDIVIDUALS IN FIELDS OF BIOMEDICAL AND

BEHAVIORAL RESEARCH.

Section 402 of the Public Health Service Act, as amended

by section 202 of this Act, is amended by adding at the end the

following subsection:

‘‘(h) The Secretary, acting through the Director of NIH and

the Directors of the agencies of the National Institutes of Health,

shall, in conducting and supporting programs for research, research

training, recruitment, and other activities, provide for an increase

in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of

biomedical 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 adding at the end the

following section:

‘‘REQUIREMENTS REGARDING SURVEYS OF SEXUAL BEHAVIOR

‘‘SEC. 404D. With respect to any survey of human sexual 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 accordance with

any applicable requirements of sections 491 and 492; and

‘‘(2) the Secretary, in accordance with section 492A, makes

a determination that the information expected to be obtained

through the survey will assist—

‘‘(A) in reducing the incidence of 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 NATIONAL

INSTITUTES OF HEALTH.

Section 402 of the Public Health Service Act, as amended

by section 206 of this Act, is amended by adding at the end the

following subsection:

‘‘(i)(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 National Institutes of Health. The purposes

for which such fund may be expended include—

‘‘(A) providing for research on matters that have not

received significant funding relative to other matters, responding to new issues and scientific emergencies, and acting on

research opportunities of high priority;

‘‘(B) supporting research that is not exclusively within the

authority of any single agency of such Institutes; and
S. 1—28

‘‘(C) purchasing or renting equipment and quarters 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 Committee on Labor and

Human Resources of the Senate, a report describing the activities

undertaken and expenditures made under this section during the

preceding fiscal year. The report may contain such comments of

the Secretary regarding this section as the Secretary determines

to be appropriate.

‘‘(3) For the purpose of carrying out this subsection, there

are authorized to be appropriated $25,000,000 for fiscal year 1994,

and such sums as may be necessary for each of the fiscal years

1995 and 1996.’’.

SEC. 209. ESTABLISHMENT OF OFFICE OF ALTERNATIVE MEDICINE.

Part A of title IV of the Public Health Service Act, as amended

by section 207 of this Act, is amended by adding at the end the

following section:

‘‘OFFICE OF ALTERNATIVE MEDICINE

‘‘SEC. 404E. (a) There is established within the Office of the

Director of NIH an office to be known as the Office of Alternative

Medicine (in this section referred to as the ‘Office’), which shall

be headed by a director appointed by the Director of NIH.

‘‘(b) The purpose of the Office is to facilitate the evaluation

of alternative medical treatment modalities, including acupuncture

and Oriental medicine, homeopathic medicine, and physical manipulation therapies.

‘‘(c) The Secretary shall establish an advisory council for the

purpose of providing advice to the Director of the Office on carrying

out this section. Section 222 applies to such council to the same

extent and in the same manner as such section applies to committees or councils established under such section.

‘‘(d) In carrying out subsection (b), the Director of the Office

shall—

‘‘(1) establish an information clearinghouse to exchange

information with the public about alternative medicine;

‘‘(2) support research training—

‘‘(A) for which fellowship support is not provided under

section 487; and

‘‘(B) that is not residency training of physicians or

other health professionals; and

‘‘(3)(A) prepare biennial reports on the activities carried

out or to be carried out by the Office; and

‘‘(B) submit each such report to the Director of NIH for

inclusion in the biennial report under section 403.’’.

SEC. 210. MISCELLANEOUS PROVISIONS.

(a) TERM OF OFFICE FOR MEMBERS OF ADVISORY COUNCILS.— Section 406(c) of the 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 inserting the following: ‘‘for 180 days after

the date of such expiration’’.

(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;
S. 1—29

(2) in paragraph (4), by striking the period and inserting ‘‘; and’’; and±

(3) by adding at the end the following paragraph:

‘‘(5) ensure that, after January 1, 1994, all new or revised health education and promotion materials developed or funded

by the National Institutes of Health and intended for the general public are 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 EMPLOYEES.—Section

402 of the Public Health Service Act, as amended by section 208

of this Act, is amended by adding at the end the following subsection:

‘‘(j)(1) The Director of NIH may establish a program to provide

day care services for the employees of the National Institutes of

Health similar to those services provided by other Federal agencies

(including the availability of day care service on a 24-hour-a-day

basis).

‘‘(2) Any day care provider at 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 PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES

SEC. 301. APPOINTMENT AND AUTHORITY OF DIRECTORS OF

NATIONAL RESEARCH INSTITUTES.

(a) ESTABLISHMENT OF GENERAL AUTHORITY REGARDING DIRECT

FUNDING.—

(1) IN GENERAL.—Section 405(b)(2) of the Public Health

Service Act (42 U.S.C. 284(b)(2)) is amended—

(A) in subparagraph (A), by striking ‘‘and’’ after the

semicolon at the end;

(B) in subparagraph (B), by striking the period at

the end and inserting ‘‘; and’’; and

(C) by adding at the end the following subparagraph:

‘‘(C) shall, subject to section 2353(d)(2), receive from the

President and the Office of Management and Budget directly

all funds appropriated by the Congress for obligation and

expenditure by the Institute.’’. (2) CONFORMING AMENDMENT.—Section 413(b)(9) of the

Public Health Service Act (42 U.S.C. 285a–2(b)(9)) is amended—

(A) by striking ‘‘(A)’’ after ‘‘(9)’’; and

(B) by striking ‘‘advisory council;’’ and all that follows

and inserting ‘‘advisory council.’’. (b) APPOINTMENT AND DURATION OF TECHNICAL AND SCIENTIFIC

PEER REVIEW GROUPS.—Section 405(c) of the Public Health Service

Act (42 U.S.C. 284(c)) is amended—

(1) by amending paragraph (3) to read as follows:

‘‘(3) may, in consultation with the advisory council for

the Institute and with the approval of the Director of NIH—
S. 1—30

‘‘(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 paragraph (3).’’.

SEC. 302. PROGRAM OF RESEARCH ON OSTEOPOROSIS, PAGET’S DISEASE, AND RELATED BONE DISORDERS.

Part B of title IV of the Public Health Service Act (42 U.S.C.

284 et seq.), as amended by section 121(b) of Public Law 102–

321 (106 Stat. 358), is amended by adding at the end the following

section:

‘‘RESEARCH ON OSTEOPOROSIS, PAGET’S DISEASE, AND RELATED BONE

DISORDERS

‘‘SEC. 409A. (a) ESTABLISHMENT.—The Directors of the National

Institute of Arthritis and Musculoskeletal and Skin Diseases, the

National Institute on Aging, the National Institute of Dental

Research, and the National Institute of Diabetes and Digestive

and Kidney Diseases, shall expand and intensify the programs

of such Institutes with respect to research and related activities

concerning osteoporosis, Paget’s disease, and related bone disorders. ‘‘(b) COORDINATION.—The Directors referred to in subsection

(a) shall jointly coordinate the programs referred to in such subsection and consult with the Arthritis and Musculoskeletal Diseases

Interagency Coordinating Committee and the Interagency Task

Force on Aging Research.

‘‘(c) INFORMATION CLEARINGHOUSE.—

‘‘(1) IN GENERAL.—In order to assist in carrying out the

purpose described in subsection (a), the Director of NIH shall

provide for the establishment of an information clearinghouse

on osteoporosis and related bone disorders to facilitate and

enhance knowledge and understanding on the part of health

professionals, patients, and the public through the effective

dissemination of information.

‘‘(2) ESTABLISHMENT THROUGH GRANT OR CONTRACT.—For

the purpose of carrying out paragraph (1), the Director of

NIH shall enter into a grant, cooperative agreement, or contract

with a nonprofit private entity involved in activities regarding

the prevention and control of osteoporosis and related bone

disorders.

‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

$40,000,000 for fiscal year 1994, and such sums as may be necessary

for each of the fiscal years 1995 and 1996.’’.

SEC. 303. ESTABLISHMENT OF INTERAGENCY PROGRAM FOR TRAUMA

RESEARCH.

(a) IN GENERAL.—Title XII of the Public Health Service Act

(42 U.S.C. 300d et seq.), as amended by title VI of Public Law

102–321 (106 Stat. 433) and section 304 of Public Law 102–408

(106 Stat. 2084), is amended by adding at the end the following

part:
S. 1—31

‘‘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 (in this section referred to

as the ‘Director’), shall establish a comprehensive program of

conducting basic and clinical research on trauma (in this section

referred to as the ‘Program’). The Program shall include research

regarding the diagnosis, treatment, rehabilitation, and general

management of trauma.

‘‘(b) PLAN FOR PROGRAM.—

‘‘(1) IN GENERAL.—The Director, in consultation with the

Trauma Research Interagency Coordinating Committee established under subsection (g), shall establish and implement a

plan for carrying out the activities of the Program, including

the activities described in subsection (d). All such activities

shall be carried out in accordance with the plan. The plan

shall be periodically reviewed, and revised as appropriate.

‘‘(2) SUBMISSION TO CONGRESS.—Not later than December

1, 1993, the Director shall submit the plan required in 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 Program are

coordinated among such agencies; and

‘‘(3) shall, as appropriate, provide for collaboration among

such agencies in carrying out such activities.

‘‘(d) CERTAIN ACTIVITIES OF PROGRAM.—The Program shall

include—

‘‘(1) studies with respect to all phases of trauma care,

including prehospital, resuscitation, surgical intervention, critical care, infection control, wound healing, nutritional care and

support, and medical rehabilitation care;

‘‘(2) basic and clinical research regarding the response of

the body to trauma and the acute treatment and medical

rehabilitation of individuals who are the victims of trauma;

and

‘‘(3) basic and clinical research regarding trauma care for

pediatric and geriatric patients.

‘‘(e) MECHANISMS OF SUPPORT.—In carrying out the Program,

the Director, acting through the Directors of the agencies referred

to in subsection (c)(1), may make grants to public and nonprofit

entities, including designated trauma centers. ‘‘(f) RESOURCES.—The Director shall assure the availability of

appropriate resources to carry out the Program, including the plan

established under subsection (b) (including the activities described

in subsection (d)).

‘‘(g) COORDINATING COMMITTEE.—
S. 1—32

‘‘(1) IN GENERAL.—There shall be established a Trauma

Research Interagency Coordinating Committee (in this section

referred to as the ‘Coordinating Committee’).

‘‘(2) DUTIES.—The Coordinating Committee shall make recommendations regarding—

‘‘(A) the activities of the Program to be carried out

by each of the agencies represented on the Committee

and the amount of funds needed by each of the agencies

for such activities; and

‘‘(B) effective collaboration among the agencies in carrying out the activities.

‘‘(3) COMPOSITION.—The Coordinating Committee shall be

composed of the Directors of each of the agencies that, under

subsection (c), have responsibilities under the Program, and

any other individuals who are practitioners in the trauma

field as designated by the Director of the National Institutes

of Health.

‘‘(h) DEFINITIONS.—For purposes of this section:

‘‘(1) The term ‘designated trauma center’ has the meaning

given such term in section 1231(1).

‘‘(2) The term ‘Director’ means the Director of the National

Institutes of Health.

‘‘(3) The term ‘trauma’ means any serious injury that could

result in loss of life or in significant disability and that would

meet pre-hospital triage criteria for transport to a designated

trauma center.’’.

(b) CONFORMING AMENDMENT.—Section 402 of the Public

Health Service Act, as amended by section 210(c) of this Act, is

amended by adding at the end the following subsection: ‘‘(k) The Director of NIH shall carry out the program established in part F of title XII (relating to interagency research on trauma).’’.

TITLE IV—NATIONAL CANCER

INSTITUTE

SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVITIES 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 section:

‘‘BREAST AND GYNECOLOGICAL CANCERS

‘‘SEC. 417. (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 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 system of women.
S. 1—33

‘‘(c) PROGRAMS FOR BREAST CANCER.—

‘‘(1) IN GENERAL.—In carrying out subsection (a), the Director of the Institute shall conduct or support research to expand

the understanding of the cause of, and to find a cure for,

breast cancer. Activities under such subsection shall provide

for an expansion and intensification of the conduct and support

of—

‘‘(A) basic research concerning the etiology and causes

of breast cancer;

‘‘(B) clinical research 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 underserved 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 operation of centers for breast cancer

research to bring together basic and clinical, biomedical

and behavioral scientists to conduct basic, clinical,

epidemiological, psychosocial, prevention and treatment

research and related activities on breast cancer.

Not less than six centers shall be operated under subparagraph

(E). Activities of such centers should include supporting new

and innovative research and training programs for new

researchers. Such centers shall give priority to expediting the

transfer of research advances to clinical applications.

‘‘(2) IMPLEMENTATION OF PLAN FOR PROGRAMS.—

‘‘(A) The Director of the Institute shall ensure that

the research programs described in paragraph (1) are

implemented in accordance with a plan for the programs.

Such plan shall include comments and recommendations

that the Director of the Institute considers appropriate,

with due consideration provided to the professional judgment needs of the Institute as expressed in the annual

budget estimate prepared in accordance with section 413(9).

The Director of the Institute, in consultation with the

National Cancer Advisory Board, shall periodically review

and revise such plan.

‘‘(B) Not later than October 1, 1993, the Director of

the Institute shall submit a copy of the plan to the President’s Cancer Panel, the Secretary and the Director of

NIH.

‘‘(C) The Director of the Institute shall submit any

revisions of the plan to the President’s Cancer Panel, the

Secretary, and the Director of NIH.

‘‘(D) The Secretary shall provide a copy of the plan

submitted under subparagraph (A), and any revisions

submitted under subparagraph (C), to the Committee on

Energy and Commerce of the House of Representatives

and the Committee on Labor and Human Resources of

the Senate.
S. 1—34

‘‘(d) OTHER CANCERS.—In carrying out subsection (a), the Direc- tor of the Institute shall conduct or support research on ovarian

cancer and other cancers of the reproductive system of women.

Activities under such subsection shall provide for the conduct and

support of—‘‘(1) basic research concerning the etiology and causes of ovarian cancer and other cancers of the reproductive system

of women;

‘‘(2) clinical research and related activities into the causes,

prevention, detection and treatment of ovarian cancer and other

cancers of the reproductive system of women; ‘‘(3) control programs with respect to ovarian cancer and other cancers of the reproductive system of women in accordance with section 412;

‘‘(4) information and education programs with respect to ovarian cancer and other cancers of the reproductive system

of women in accordance with section 413; and

‘‘(5) research and demonstration centers with respect to

ovarian cancer and cancers of the reproductive system in

accordance with section 414.

‘‘(e) REPORT.—The Director of the Institute shall prepare, for

inclusion in the biennial report submitted under section 407, a

report that describes the activities of the National Cancer Institute

under the research programs referred to in subsection (a), that

shall include—

‘‘(1) a description of the research plan with respect to

breast cancer prepared under subsection (c);

‘‘(2) an assessment of the development, revision, and

implementation of such plan;

‘‘(3) a description and evaluation of the progress made,

during the period for which such report is prepared, in the

research programs on breast cancer and cancers of the 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 conducted and supported by the National Institutes

of Health; and

‘‘(5) such comments and recommendations as the Director

considers appropriate.’’.

SEC. 402. EXPANSION AND INTENSIFICATION OF ACTIVITIES 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 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
S. 1—35

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 support research to expand

the understanding of the cause of, and to find a cure for,

prostate cancer. Activities under such subsection shall provide

for an expansion and intensification of the conduct and support

of—

‘‘(A) basic research concerning the etiology and causes

of prostate cancer;

‘‘(B) clinical research and related activities concerning

the causes, prevention, detection and treatment of prostate

cancer;

‘‘(C) prevention and control and early detection 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 efforts on prostate cancer;

‘‘(E) control programs with respect to prostate cancer

in accordance with section 412;

‘‘(F) information and education programs with respect

to prostate cancer in accordance with section 413; and

‘‘(G) research and demonstration centers with respect

to prostate cancer in accordance with section 414, including

the development and operation of centers for prostate cancer research to bring together basic and clinical, biomedical

and behavioral scientists to conduct basic, clinical,

epidemiological, psychosocial, prevention and control, treatment, research, and related activities on prostate cancer.

Not less than six centers shall be operated under subparagraph

(G). Activities of such centers should include supporting new

and innovative research and training programs for new

researchers. Such centers shall give priority to expediting the

transfer of research advances to clinical applications.

‘‘(2) IMPLEMENTATION OF PLAN FOR PROGRAMS.—

‘‘(A) The Director of the Institute shall ensure that

the research programs described in paragraph (1) are

implemented in accordance with a plan for the programs.

Such plan shall include comments and recommendations

that the Director of the Institute considers appropriate,

with due consideration provided to the professional judgment needs of the Institute as expressed in the annual

budget estimate prepared in accordance with section 413(9).

The Director of the Institute, in consultation with the

National Cancer Advisory Board, shall periodically review

and revise such plan.

‘‘(B) Not later than October 1, 1993, the Director of

the Institute shall submit a copy of the plan to the President’s Cancer Panel, the Secretary, and the Director of

NIH.
S. 1—36

‘‘(C) The Director of the Institute shall submit any

revisions of the plan to the President’s Cancer Panel, the

Secretary, and the Director of NIH.

‘‘(D) The Secretary shall provide a copy of the plan

submitted under subparagraph (A), and any revisions

submitted under subparagraph (C), to the Committee on

Energy and Commerce of the House of Representatives

and the Committee on Labor and Human Resources of

the Senate.’’.

SEC. 403. AUTHORIZATION OF APPROPRIATIONS.

(a) IN GENERAL.—Subpart 1 of part C of title IV of the Public

Health Service Act, as amended by section 402 of this Act, is

amended by adding at the end the following section:

‘‘AUTHORIZATION OF APPROPRIATIONS

‘‘SEC. 417B. (a) ACTIVITIES GENERALLY.—For the purpose of

carrying out this subpart, there are authorized to be appropriated

$2,728,000,000 for fiscal year 1994, and such sums as may be

necessary for each of the fiscal years 1995 and 1996.

‘‘(b) BREAST CANCER AND GYNECOLOGICAL CANCERS.—

‘‘(1) BREAST CANCER.—

‘‘(A) For the purpose of carrying out subparagraph

(A) of section 417(c)(1), there are authorized to be appropriated $225,000,000 for fiscal year 1994, and such sums

as may be necessary for each of the fiscal years 1995

and 1996. Such authorizations of appropriations are in

addition to the authorizations of appropriations established

in subsection (a) with respect to such purpose.

‘‘(B) For the purpose of carrying out subparagraphs (B) through (E) of section 417(c)(1), there are authorized

to be appropriated $100,000,000 for fiscal year 1994, and

such sums as may be necessary for each of the fiscal

years 1995 and 1996. Such authorizations of appropriations

are in addition to the authorizations of appropriations

established in subsection (a) with respect to such purpose.

‘‘(2) OTHER CANCERS.—For the purpose of carrying out sub- section (d) of section 417, there are authorized to be appropriated $75,000,000 for fiscal year 1994, and such sums as

are necessary for each of the fiscal years 1995 and 1996. Such

authorizations of appropriations are in addition to the

authorizations of appropriations established in subsection (a)

with respect to such purpose.

‘‘(c) PROSTATE CANCER.—For the purpose of 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 subsection (a) with respect to such purpose.

‘‘(d) ALLOCATION REGARDING CANCER CONTROL.—

‘‘(1) IN GENERAL.—Of the amounts appropriated for the

National Cancer Institute for a fiscal year, the Director of

the Institute shall make available not less than the applicable

percentage specified in paragraph (2) for carrying out the cancer

control activities authorized in section 412 and for which budget

estimates are made under section 413(b)(9) for the fiscal year.
S. 1—37

‘‘(2) APPLICABLE PERCENTAGE.—The percentage referred to

in paragraph (1) is—

‘‘(A) 7 percent, in the case of fiscal year 1994;

‘‘(B) 9 percent, in the case of fiscal year 1995; and

‘‘(C) 10 percent, in the case of fiscal year 1996 and

each subsequent fiscal year.’’.

(b) CONFORMING AMENDMENTS.—

(1) IN GENERAL.—Section 408 of the Public Health Service

Act (42 U.S.C. 284c) is amended—

(A) by striking subsection (a);

(B) by redesignating subsection (b) as subsection (a);

(C) by redesignating paragraph (5) of subsection (a)

(as so redesignated) as subsection (b); and

(D) by amending the heading for the section to read

as follows:

‘‘CERTAIN USES OF FUNDS’’.

(2) CROSS-REFERENCE.—Section 464F of the Public Health

Service Act (42 U.S.C. 285m–6) is amended by striking ‘‘section

408(b)(1)’’ and inserting ‘‘section 408(a)(1)’’.

TITLE V—NATIONAL HEART, LUNG, AND

BLOOD INSTITUTE

SEC. 501. EDUCATION AND TRAINING.

Section 421(b) of the Public Health Service Act (42 U.S.C.

285b–3(b)) is amended—

(1) in paragraph (3), by striking ‘‘and’’ after the semicolon

at the end;

(2) in paragraph (4), by striking the period at the end

and inserting ‘‘; and’’; and

(3) by inserting after paragraph (4) the following paragraph:

‘‘(5) shall, in consultation with the advisory council for

the Institute, conduct appropriate intramural training and education programs, including continuing education and laboratory

and clinical research training programs.’’.

SEC. 502. CENTERS FOR THE STUDY OF PEDIATRIC CARDIOVASCULAR

DISEASES.

Section 422(a)(1) of the Public Health Service Act (42 U.S.C.

285b–4(a)(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 the following subparagraph:

‘‘(D) three centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention,

and treatment (including genetic studies, intrauterine environment studies, postnatal studies, heart arrhythmias, and

acquired heart disease and preventive cardiology) for cardiovascular diseases in children.’’.
S. 1—38

SEC. 503. NATIONAL CENTER ON SLEEP DISORDERS RESEARCH.

Subpart 2 of part C of title IV of the Public Health Service

Act (42 U.S.C. 285b et seq.) is amended by adding at the end

the following section:

‘‘NATIONAL CENTER ON SLEEP DISORDERS RESEARCH

‘‘SEC. 424. (a) Not later than 1 year after the date of the

enactment of the National Institutes of Health Revitalization Act

of 1993, the Director of the Institute shall establish the National

Center on Sleep Disorders Research (in this section referred to

as the ‘Center’). The Center shall be headed by a director, who

shall be appointed by the Director of the Institute.

‘‘(b) The general purpose of the Center is—

‘‘(1) the conduct and support of research, training, health

information dissemination, and other activities with respect

to sleep disorders, including biological and circadian rhythm

research, basic understanding of sleep, chronobiological and

other sleep related research; and

‘‘(2) to coordinate the activities of the Center with similar

activities of other Federal agencies, including the other agencies

of the National Institutes of Health, and similar activities of

other public entities and nonprofit entities.

‘‘(c)(1) The Director of the National Institutes of Health shall

establish a board to be known as the Sleep Disorders Research

Advisory Board (in this section referred to as the ‘Advisory Board’).

‘‘(2) The Advisory Board shall advise, assist, consult with, and

make recommendations to the Director of the National Institutes

of Health, through the Director of the Institute, and the Director

of the Center concerning matters relating to the scientific activities

carried out by and through the Center and the policies respecting

such activities, including recommendations with respect to the plan

required in subsection (c).

‘‘(3)(A) The Director of the National Institutes of Health shall

appoint to the Advisory Board 12 appropriately qualified representatives of the public who are not officers or employees of the Federal

Government. Of such members, eight shall be representatives of

health and scientific disciplines with respect to sleep disorders

and four shall be individuals representing the interests of individuals with or undergoing treatment for sleep disorders. ‘‘(B) The following officials shall serve as ex officio members

of the Advisory Board: ‘‘(i) The Director of the National Institutes of Health.

‘‘(ii) The Director of the Center.

‘‘(iii) The Director of the National Heart, Lung and Blood

Institute.

‘‘(iv) The Director of the National Institute of Mental

Health.

‘‘(v) The Director of the National Institute on Aging.

‘‘(vi) The Director of the National Institute of Child Health

and Human Development.

‘‘(vii) The Director of the National Institute of Neurological

Disorders and Stroke.

‘‘(viii) The Assistant Secretary for Health.

‘‘(ix) The Assistant Secretary of Defense (Health Affairs).

‘‘(x) The Chief Medical Director of the Veterans’ Administration.
S. 1—39

‘‘(4) The members of the Advisory Board shall, from among

the members of the Advisory Board, designate an individual to

serve as the chair of the Advisory Board.

‘‘(5) Except as inconsistent with, or inapplicable to, this section,

the provisions of section 406 shall apply to the advisory board

established under this section in the same manner as such provisions apply to any advisory council established under such section.

‘‘(d)(1) After consultation with the Director of the Center and

the advisory board established under subsection (c), the Director

of the National Institutes of Health shall develop a comprehensive

plan for the conduct and support of sleep disorders research.

‘‘(2) The plan developed under paragraph (1) shall identify

priorities with respect to such research and shall provide for the

coordination of such research conducted or supported by the agencies of the National Institutes of Health.

‘‘(3) The Director of the National Institutes of Health (after

consultation with the Director of the Center and the advisory board

established under subsection (c)) shall revise the plan developed

under paragraph (1) as appropriate.

‘‘(e) The Director of the Center, in cooperation with the Centers

for Disease Control and Prevention, is authorized to coordinate

activities with the Department of Transportation, the Department

of Defense, the Department of Education, the Department of Labor,

and the Department of Commerce to collect data, conduct studies,

and disseminate public information concerning the impact of sleep

disorders and sleep deprivation.’’.

SEC. 504. AUTHORIZATION OF APPROPRIATIONS.

Subpart 2 of part C of title IV of the Public Health Service

Act, as amended by section 503 of this Act, is amended by adding

at the end the following section:

‘‘AUTHORIZATION OF APPROPRIATIONS

‘‘SEC. 425. For the purpose of carrying out this subpart, there

are authorized to be appropriated $1,500,000,000 for fiscal year

1994, and such sums as may be necessary for each of the fiscal

years 1995 and 1996.’’.

SEC. 505. PREVENTION AND CONTROL PROGRAMS.

Section 419 of the Public Health Service Act (42 U.S.C. 285b–

1) is amended by striking ‘‘The Director of the Institute’’ and all

that follows and inserting the following: ‘‘(a) The Director of the

Institute shall conduct and support programs for the prevention

and control of heart, blood vessel, lung, and blood diseases. Such

programs shall include community-based and population-based programs carried out in cooperation with other Federal agencies, with

public health agencies of State or local governments, with nonprofit

private entities that are community-based health agencies, or with

other appropriate public or nonprofit private entities.

‘‘(b) In carrying out programs under subsection (a), the Director

of the Institute shall give special consideration to the prevention

and control of heart, blood vessel, lung, and blood diseases in

children, and in populations that are at increased risk with respect

to such diseases.’’.
S. 1—40

TITLE VI—NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE AND KIDNEY

DISEASES

SEC. 601. PROVISIONS REGARDING NUTRITIONAL DISORDERS.

Subpart 3 of part C of title IV of the Public Health Service

Act (42 U.S.C. 285c et seq.) is amended by adding at the end

the following section:

‘‘NUTRITIONAL DISORDERS PROGRAM

‘‘SEC. 434. (a) The Director of the Institute, in consultation

with the Director of NIH, shall establish a program 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 subsection.

‘‘(c) In carrying out the program established under subsection

(a), the Director of the Institute shall carry out activities to facilitate

and enhance knowledge and understanding of nutritional disorders,

including obesity, on the part of health professionals, patients,

and the public through the effective dissemination of information.’’.

(b) DEVELOPMENT AND EXPANSION OF RESEARCH AND TRAINING

CENTERS.—Section 431 of the Public Health Service Act (42 U.S.C.

285c–5) is amended—

(1) by redesignating subsection (d) as subsection (e); and

(2) by inserting after subsection (c) the following subsection: ‘‘(d)(1) The Director of the Institute shall, subject to the extent

of amounts made available in appropriations Acts, provide for the

development or substantial expansion of centers for research and

training regarding nutritional disorders, including obesity. ‘‘(2) The Director of the Institute shall carry out paragraph (1) in collaboration with the Director of the National Cancer

Institute and with the Directors of such other agencies of the

National Institutes of Health as the Director of NIH determines

to be appropriate.

‘‘(3) Each center developed or expanded under paragraph (1)

shall—

‘‘(A) utilize the facilities of a single institution, or be formed

from a consortium of cooperating institutions, meeting such

research and training qualifications as may be prescribed by

the Director;

‘‘(B) conduct basic and clinical research into the cause,

diagnosis, early detection, prevention, control and treatment

of nutritional disorders, including obesity and the impact of

nutrition and diet on child development;

‘‘(C) conduct training programs for physicians and allied

health professionals in current methods of diagnosis and treatment of such diseases and complications, and in research in

such disorders; and

‘‘(D) conduct information programs for physicians and allied

health professionals who provide primary care for patients with

such disorders or complications.’’.
S. 1—41

TITLE VII—NATIONAL INSTITUTE ON

ARTHRITIS AND MUSCULOSKELETAL

AND SKIN DISEASES

SEC. 701. JUVENILE ARTHRITIS.

(a) PURPOSE.—Section 435 of the Public Health Service Act

(42 U.S.C. 285d) is amended by striking ‘‘and other programs’’

and all that follows and inserting the following: ‘‘and other programs

with respect to arthritis and musculoskeletal and skin diseases

(including sports-related disorders), with particular attention to

the effect of these diseases on children.’’.

(b) PROGRAMS.—Section 436 (42 U.S.C. 285d–1) is amended—

(1) in subsection (a), by inserting after the second sentence,

the following: ‘‘The plan shall place particular emphasis upon

expanding research into better understanding the causes and

the development of effective treatments for arthritis affecting

children.’’; and

(2) in subsection (b)—

(A) by striking ‘‘and’’ at the end of paragraph (3);

(B) by striking the period at the end of paragraph

(4) and inserting ‘‘; and’’; and

(C) by adding at the end the following paragraph:

‘‘(5) research into the causes of arthritis affecting 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 Service Act

(42 U.S.C. 286d–6) is amended by adding at the end the following

subsection:

‘‘(f) Not later than October 1, 1993, the Director shall establish

a multipurpose arthritis and musculoskeletal disease center for

the purpose of expanding the level of research into the cause,

diagnosis, early detection, prevention, control, and treatment of,

and rehabilitation of children with arthritis and musculoskeletal

diseases.’’.

(d) ADVISORY BOARD.—

(1) TITLE.—Section 442(a) of the Public Health Service

Act (42 U.S.C. 285d–7(a)) is amended by inserting after ‘‘Arthritis’’ the following: ‘‘and Musculoskeletal and Skin Diseases’’.

(2) COMPOSITION.—Section 442(b) of the Public Health

Service Act (42 U.S.C. 285d–7(b)) is amended—

(A) in the matter preceding paragraph (1), by striking

‘‘eighteen’’ and inserting ‘‘twenty’’; and

(B) in paragraph (1)(B)—

(i) by striking ‘‘six’’ and inserting ‘‘eight’’; and

(ii) by striking ‘‘including’’ and all that follows

and inserting the following: ‘‘including one member

who is a person who has such a disease, one person

who is the parent of an adult with such a disease,

and two members who are parents of children with

arthritis.’’.

(3) ANNUAL REPORT.—Section 442(j) of the Public Health

Service Act (42 U.S.C. 285d–7(j)) is amended—

(1) by striking ‘‘and’’ at the end of paragraph (3);
S. 1—42

(2) by striking the period at the end of paragraph (4)

and inserting ‘‘; and’’; and

(3) by adding at the end the following paragraph:

‘‘(5) contains recommendations for expanding the Institute’s

funding of research directly applicable to the cause, diagnosis,

early detection, prevention, control, and treatment of, and

rehabilitation of children with arthritis and musculoskeletal

diseases.’’.

TITLE VIII—NATIONAL INSTITUTE ON

AGING

SEC. 801. ALZHEIMER’S DISEASE REGISTRY.

(a) IN GENERAL.—Section 12 of 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 transferred and inserted by

subsection (a) of this section, is amended—

(1) by striking the section heading and all that follows

through ‘‘may make a grant’’ in subsection (a) and inserting

the following:

‘‘ALZHEIMER’S DISEASE REGISTRY

‘‘SEC. 445G. (a) IN GENERAL.—The Director of the Institute

may make a grant’’; 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 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.’’.

SEC. 803. AUTHORIZATION OF APPROPRIATIONS.

Subpart 5 of part C of title IV of the Public Health Service

Act, as amended by section 802 of this Act, is amended by adding

at the end the following section:
S. 1—43

‘‘AUTHORIZATION OF APPROPRIATIONS

‘‘SEC. 445I. For the purpose of carrying out this subpart, there

are authorized to be appropriated $500,000,000 for fiscal year 1994,

and such sums as may be necessary for each of the fiscal years

1995 and 1996.’’.

SEC. 804. CONFORMING AMENDMENT.

Section 445C of the Public Health Service Act (42 U.S.C. 285e–

5), as amended by section 9 of Public Law 102–507 (106 Stat.

3287), is amended—

(1) in subsection (b)(1), in the first sentence, by inserting

after ‘‘Council’’ the following: ‘‘on Alzheimer’s Disease (in this

section referred to as the ‘Council’)’’; and

(2) by adding at the end the following subsection:

‘‘(e) For purposes of this section, the term ‘Council on Alzheimer’s Disease’ means the council established in section 911(a)

of Public Law 99–660.’’.

TITLE IX—NATIONAL INSTITUTE OF

ALLERGY AND INFECTIOUS DISEASES

SEC. 901. TROPICAL DISEASES.

Section 446 of the Public Health Service Act (42 U.S.C. 285f)

is amended by inserting before the period the following: ‘‘, including

tropical diseases’’.

SEC. 902. CHRONIC FATIGUE SYNDROME.

(a) RESEARCH CENTERS.—Subpart 6 of part C of title IV of

the Public Health Service Act (42 U.S.C. 285f) is amended by

adding at the end the following section:

‘‘RESEARCH CENTERS REGARDING CHRONIC FATIGUE SYNDROME

‘‘SEC. 447. (a) The Director of the Institute, after consultation

with the advisory council for the Institute, may make grants to,

or enter into contracts with, public or nonprofit private entities

for the development and operation of centers to conduct basic and

clinical research on chronic fatigue 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 requirements as may be prescribed by the Director of the Institute.’’.

(b) EXTRAMURAL STUDY SECTION.—Not later than 6 months

after the date of enactment of this Act, the Secretary of Health

and Human Services shall establish an extramural study section

for chronic fatigue syndrome research.

(c) REPRESENTATIVES.—The Secretary of Health and Human

Services, acting through the Director of the National Institutes

of Health, shall ensure that appropriate individuals with expertise

in chronic fatigue syndrome or neuromuscular diseases and representative of a variety of disciplines and fields within the research

community are appointed to appropriate National Institutes of

Health advisory committees and boards.
S. 1—44

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.

Subpart 7 of part C of title IV of the Public Health Service

Act, as amended by section 3 of Public Law 101–613, is amended

by adding at the end the following section:

‘‘RESEARCH CENTERS WITH RESPECT TO CONTRACEPTION AND

INFERTILITY

‘‘SEC. 452A. (a) The Director of the Institute, after consultation

with the advisory council for the Institute, shall make grants to,

or enter into contracts with, public or nonprofit private entities

for the development and operation of centers to conduct activities

for the purpose of improving methods of contraception and centers

to conduct activities for the purpose of improving methods of diagnosis and treatment of infertility. ‘‘(b) In carrying out subsection (a), the Director of the Institute

shall, subject to the extent of amounts made available 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 contraception, clinical

trials of new or improved drugs and devices for use by

males and females (including barrier methods); and

‘‘(ii) for centers with respect to infertility, clinical trials

of new or improved drugs and devices for the diagnosis

and treatment of infertility in males and females;

‘‘(B) develop protocols for training physicians, scientists,

nurses, and other health and allied health professionals;

‘‘(C) conduct training programs for such individuals;

‘‘(D) develop model continuing education programs for such

professionals; and

‘‘(E) disseminate information to such professionals and the

public.

‘‘(2) A center may use funds provided under subsection (a)

to provide stipends for health and allied health professionals

enrolled in programs described in subparagraph (C) of paragraph

(1), and to provide fees to individuals serving as subjects in clinical

trials conducted under such paragraph. ‘‘(d) The Director of the Institute shall, as appropriate, provide

for the coordination of information among the centers assisted under

this section.

‘‘(e) Each center assisted under subsection (a) shall use the

facilities of a single institution, or be formed from a consortium
S. 1—45

of cooperating institutions, meeting such requirements as may be

prescribed by the Director of the Institute.

‘‘(f) Support of a center under subsection (a) may be for a

period not exceeding 5 years. Such period may be extended for

one or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director

and if such group has recommended to the Director that such

period should be extended.

‘‘(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 INFERTILITY.

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 contracts with qualified

health professionals (including graduate students) under which such

health professionals agree to conduct research with respect to

contraception, or with respect to infertility, in consideration of the

Federal Government agreeing to repay, for each year of such service,

not more than $20,000 of the principal and interest of the educational loans of such health professionals.

‘‘(b) The provisions of sections 338B, 338C, and 338E shall,

except as inconsistent with subsection (a) of this section, apply

to the program established in subsection (a) to the same extent

and in the same manner as such provisions apply to the National

Health Service Corps Loan Repayment Program established in subpart III of part D of title III.

‘‘(c) Amounts available for carrying out this section shall remain

available until the expiration of the second fiscal year beginning

after the fiscal year for which the amounts were made available.’’.

Subtitle B—Program Regarding Obstetrics

and Gynecology

SEC. 1011. ESTABLISHMENT OF PROGRAM.

Subpart 7 of part C of title IV of the Public Health Service

Act, as amended by section 1001 of this Act, is amended by adding

at the end the following section:

‘‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY

‘‘SEC. 452B. The Director of the Institute shall establish and

maintain within the Institute an intramural laboratory and clinical

research program in obstetrics and gynecology.’’.
S. 1—46

Subtitle C—Child Health Research Centers

SEC. 1021. ESTABLISHMENT OF CENTERS.

Subpart 7 of part C of title IV of the Public Health Service

Act, as amended by section 1011 of this Act, is amended by adding

at the end the following section:

‘‘CHILD HEALTH RESEARCH CENTERS

‘‘SEC. 452C. The Director of the Institute shall develop and

support centers for conducting research with respect to child health.

Such centers shall give priority to the expeditious transfer of

advances from basic science to clinical applications and improving

the care of infants and children.’’.

Subtitle D—Study Regarding Adolescent

Health

SEC. 1031. PROSPECTIVE LONGITUDINAL STUDY.

Subpart 7 of part C of title IV of the Public Health Service

Act, as amended by section 1021 of this Act, is amended by adding

at the end the following section:

‘‘PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT HEALTH

‘‘SEC. 452D. (a) IN GENERAL.—Not later than October 1, 1993,

the Director of the Institute shall commence a study for the purpose

of providing information on the general health and well-being of

adolescents in the United States, including, with respect to such

adolescents, information on—

‘‘(1) the behaviors that promote health and the behaviors

that are detrimental to health; and

‘‘(2) the influence on health of factors particular to the

communities in which the adolescents reside.

‘‘(b) DESIGN OF STUDY.— ‘‘(1) IN GENERAL.—The study required in subsection (a) shall be a longitudinal study in which a substantial number

of adolescents participate as subjects. With respect to the 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 manner

sufficient to provide for a valid analysis of whether there are

significant differences among such populations in health status

and whether and to what extent any such differences are due

to factors particular to the populations involved.

‘‘(c) COORDINATION WITH WOMEN’S HEALTH INITIATIVE.—With

respect to the national study of women being conducted by the

Secretary and known as the Women’s Health Initiative, the Secretary shall ensure that such study is coordinated with the compo-
S. 1—47

nent of the study required in subsection (a) that concerns adolescent

females, including coordination in the design of the 2 studies.’’.

TITLE XI—NATIONAL EYE INSTITUTE

SEC. 1101. CLINICAL AND HEALTH SERVICES RESEARCH ON EYE CARE

AND DIABETES.

(a) IN GENERAL.—Subpart 9 of part C of title IV of the Public Health Service Act (42 U.S.C. 285i) is amended by adding at the

end the following section:

‘‘CLINICAL RESEARCH ON EYE CARE AND DIABETES

‘‘SEC. 456. (a) PROGRAM OF GRANTS.—The Director of the

Institute, in consultation with the advisory council for the Institute,

may award research grants to one or more Diabetes Eye Research

Institutions for the support of programs in clinical or health services

aimed at—

‘‘(1) providing comprehensive eye care services for people with diabetes, including a full complement of preventive, diagnostic and treatment procedures; ‘‘(2) developing new and improved techniques of patient care through basic and clinical research; ‘‘(3) assisting in translation of the latest research advances into clinical practice; and ‘‘(4) expanding the knowledge of the eye and diabetes through further research.

‘‘(b) USE OF FUNDS.—Amounts received under a grant awarded under this section shall be used for the following: ‘‘(1) Establishing the biochemical, cellular, and genetic mechanisms associated with diabetic eye disease and the earlier

detection of pending eye abnormalities. The focus of work under

this paragraph shall require that ophthalmologists have training in the most up-to-date molecular and cell biological methods. ‘‘(2) Establishing new frontiers in technology, such as video- based diagnostic and research resources, to— ‘‘(A) provide improved patient care;

‘‘(B) provide for the evaluation of retinal physiology and its affect on diabetes; and

‘‘(C) provide for the assessment of risks for the development and progression of diabetic eye disease and a more

immediate evaluation of various therapies aimed at

preventing diabetic eye disease. Such technologies shall be designed to permit evaluations to

be performed both in humans and in animal models.

‘‘(3) The translation of the results of vision research into

the improved care of patients with diabetic eye disease. Such

translation shall require the application of institutional

resources that encompass patient care, clinical research and

basic laboratory research. ‘‘(4) The conduct of research concerning the outcomes of

eye care treatments and eye health education programs as

they relate to patients with diabetic eye disease, including

the evaluation of regional approaches to such research.

‘‘(c) AUTHORIZED EXPENDITURES.—The purposes for which a

grant under subsection (a) may be expended include equipment

for the research described in such subsection.’’.
S. 1—48

(b) CONFORMING AMENDMENT.—Section 455 of the Public

Health Service Act (42 U.S.C. 285i) is amended in the second

sentence by striking ‘‘The Director’’ and inserting ‘‘Subject to section

456, the Director’’.

TITLE XII—NATIONAL INSTITUTE OF

NEUROLOGICAL DISORDERS AND

STROKE

SEC. 1201. RESEARCH ON MULTIPLE SCLEROSIS.

Subpart 10 of part C of title IV of the Public Health Service

Act (42 U.S.C. 285j et seq.) is amended by adding at the end

the following section:

‘‘RESEARCH ON MULTIPLE SCLEROSIS

‘‘SEC. 460. The Director of the Institute shall conduct and

support research on multiple sclerosis, especially research on effects

of genetics and hormonal changes on the progress of the disease.’’.

TITLE XIII—NATIONAL INSTITUTE OF

ENVIRONMENTAL HEALTH SCIENCES

SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND TESTING PROGRAM.

(a) IN GENERAL.—Subpart 12 of part C of title IV of the Public

Health Service Act (42 U.S.C. 285l) is amended by adding at the

end the following section:

‘‘APPLIED TOXICOLOGICAL RESEARCH AND TESTING PROGRAM

‘‘SEC. 463A. (a) There is established within the Institute 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 respect to toxicology,

carry out activities— ‘‘(1) to expand knowledge of the health effects of environmental agents; ‘‘(2) to broaden the spectrum of toxicology information that

is obtained on selected chemicals;

‘‘(3) to develop and validate assays and protocols, including

alternative methods that can reduce or eliminate the use of

animals in acute or chronic safety testing;

‘‘(4) to establish criteria for the validation and regulatory

acceptance of alternative testing and to recommend a process

through which scientifically validated alternative methods can

be accepted for regulatory use;

‘‘(5) to communicate the results of research to government

agencies, to medical, scientific, and regulatory communities,

and to the public; and

‘‘(6) to integrate related activities of the Department of

Health and Human Services.’’.
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(b) TECHNICAL AMENDMENT.—Section 463 of the Public Health

Service Act (42 U.S.C. 285l) is amended by inserting after ‘‘Sciences’’

the following: ‘‘(in this subpart referred to as the ‘Institute’)’’.

TITLE XIV—NATIONAL LIBRARY OF

MEDICINE

Subtitle A—General Provisions

SEC. 1401. ADDITIONAL AUTHORITIES.

(a) IN GENERAL.—Section 465(b) of the Public Health Service

Act (42 U.S.C. 286(b)) is amended—

(1) by striking ‘‘and’’ after the semicolon at the end of

paragraph (5);

(2) by redesignating paragraph (6) as paragraph (8); and

(3) by inserting after paragraph (5) the following paragraphs:

‘‘(6) publicize the availability from the Library of the products and services described in any of paragraphs (1) through

(5);

‘‘(7) promote the use of computers and telecommunications

by health professionals (including health professionals in rural

areas) for the purpose of improving access to biomedical

information for health care delivery and medical research; and’’.

(b) LIMITATION REGARDING GRANTS.—Section 474(b)(2) of the

Public Health Service Act (42 U.S.C. 286b–5(b)(2)) is amended

by striking ‘‘$750,000’’ and inserting ‘‘$1,000,000’’.

(c) TECHNICAL AND CONFORMING AMENDMENTS.—

(1) REPEAL OF CERTAIN AUTHORITY.—Section 215 of the

Department of Health and Human Services Appropriations Act,

1988, as contained in section 101(h) of Public Law 100–202

(101 Stat. 1329–275), is repealed.

(2) APPLICABILITY OF CERTAIN NEW AUTHORITY.—With

respect to the authority established for the National Library

of Medicine in section 465(b)(6) of the Public 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.’’.
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(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).

Subtitle B—Financial Assistance

SEC. 1411. ESTABLISHMENT OF PROGRAM OF GRANTS FOR DEVELOPMENT OF EDUCATION TECHNOLOGIES.

Section 473 of the Public Health Service Act (42 U.S.C. 286b–

4) is amended by adding at the end the following 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 demonstration of, new education

technologies. ‘‘(2) The purposes for which a grant under paragraph (1) may be made include projects concerning— ‘‘(A) computer-assisted teaching and testing of clinical com- petence at health professions and research institutions; ‘‘(B) the effective transfer of new information from research

laboratories to appropriate clinical applications; ‘‘(C) the expansion of the laboratory and clinical uses of computer-stored research databases; and ‘‘(D) the testing of new technologies for training health care professionals.

‘‘(3) The Secretary may not make a grant under paragraph (1) unless the applicant for the grant agrees to make the projects

available with respect to— ‘‘(A) assisting in the training of health professions students; and

‘‘(B) enhancing and improving the capabilities of health professionals regarding research and teaching.’’.

Subtitle C—National Information Center

on Health Services Research and Health

Care Technology

SEC. 1421. ESTABLISHMENT OF CENTER.

Part D of title IV of the Public Health Service Act (42 U.S.C.

286 et seq.) is amended by adding at the end the following subpart:

‘‘Subpart 4—National Information Center on Health Services

Research and Health Care Technology

‘‘NATIONAL INFORMATION CENTER

‘‘SEC. 478A. (a) There is established within the Library an

entity to be known as the National Information Center on Health

Services Research and Health Care Technology (in this section

referred to as the ‘Center’).

‘‘(b) The purpose of the Center is the collection, storage, analysis, retrieval, and dissemination of information on health services

research, clinical practice guidelines, and on health care technology,

including the assessment of such technology. Such purpose includes

developing and maintaining data bases and developing and

implementing methods of carrying out such purpose.
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‘‘(c) The Director of the Center shall ensure that information

under subsection (b) concerning clinical practice guidelines is collected and maintained electronically and in a convenient format.

Such Director shall develop and publish criteria for the inclusion

of practice guidelines and technology assessments in the information

center database.

‘‘(d) The Secretary, acting through the Center, shall coordinate

the activities carried out under this section through the Center

with related activities of the Administrator for Health Care 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 Administrator

and the Director of the National Library of Medicine shall enter

into an agreement providing for the implementation of section

478A.’’.

(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 assessment established under section

904 of the Public Health Service Act, as in effect on the day

before the date of the enactment of Public Law 102–410. Such

center shall be considered to be the center established in section

478A of the Public Health Service Act, as added by section 1421

of this Act, and shall be subject to the provisions of such section

478A.

TITLE XV—OTHER AGENCIES OF

NATIONAL INSTITUTES OF HEALTH

Subtitle A—Division of Research

Resources

SEC. 1501. REDESIGNATION OF DIVISION AS NATIONAL CENTER FOR

RESEARCH RESOURCES.

Title IV of the 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 Resources.’’; and

(2) in part E—

(A) in the heading for subpart 1, by striking ‘‘Division

of’’ and inserting ‘‘National Center for’’;

(B) in section 479, by striking ‘‘the Division of Research

Resources’’ and inserting the following: ‘‘the National Center for Research Resources (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
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(D) in sections 480 and 481, as amended by subpara- graph (C), by striking ‘‘the Division’’ each place such term

appears and inserting ‘‘the Center’’.

SEC. 1502. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

Subpart 1 of part E of title IV of the Public Health Service Act (42 U.S.C. 287 et seq.) is amended by adding at the end

the following section:

‘‘BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES

‘‘SEC. 481A. (a) MODERNIZATION AND CONSTRUCTION OF FACILITIES.— ‘‘(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, remodel, renovate, or alter

existing research facilities or construct new research facilities,

subject to the provisions of this section. ‘‘(2) CONSTRUCTION AND COST OF CONSTRUCTION.—For purposes of this section, the terms ‘construction’ and ‘cost of

construction’ include the construction of new buildings and

the expansion, renovation, remodeling, and alteration of existing buildings, including architects’ fees, but do not include

the cost of acquisition of land or off-site improvements.

‘‘(b) SCIENTIFIC AND TECHNICAL REVIEW BOARDS FOR MERIT- BASED REVIEW OF PROPOSALS.— ‘‘(1) IN GENERAL; APPROVAL AS PRECONDITION TO GRANTS.— ‘‘(A) There is established within the Center a Scientific

and Technical Review Board on Biomedical and Behavioral

Research Facilities (referred to in this section as the

‘Board’).

‘‘(B) The Director of the Center may approve an

application for a grant under subsection (a) only if the

Board has under paragraph (2) recommended the application for approval.

‘‘(2) DUTIES.— ‘‘(A) The Board shall provide advice to the Director

of the Center and the advisory council established under

section 480 (in this section referred to as the ‘Advisory

Council’) on 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 requirements established in subsection (c),

and shall report the results of the determination to the

Director of the Center and the Advisory Council. Such

determinations shall be conducted in a manner consistent

with procedures established under section 492.

‘‘(C) In carrying out subparagraph (A), the Board shall,

in the case of applications recommended for approval, make

recommendations to the Director and the Advisory Council

on the amount that should be provided in the grant.

‘‘(D) In carrying out subparagraph (A), the Board shall

prepare an annual report for the Director of the Center

and the Advisory Council describing the activities of the

Board in the fiscal year for which the report is made.

Each such report shall be available to the public, and

shall—
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‘‘(i) summarize and analyze expenditures made

under this section;

‘‘(ii) provide a summary of the types, numbers,

and amounts of applications that were recommended

for grants under subsection (a) but that were not

approved by the Director of the Center; and

‘‘(iii) contain the recommendations of the Board

for any changes in the administration of this section.

‘‘(3) MEMBERSHIP.—

‘‘(A) Subject to subparagraph (B), the Board shall be

composed of 9 appointed members, and such ex officio

members as the Director of the Center determines to be

appropriate.

‘‘(B) Not more than 3 individuals who are officers or

employees of the Federal Government may serve as members of the Board.

‘‘(4) CERTAIN REQUIREMENTS REGARDING MEMBERSHIP.—In

selecting individuals for membership on the Board, the Director

of the Center shall ensure that the members are individuals

who, by virtue of their training or experience, are eminently

qualified to perform peer review functions. In selecting such

individuals for such membership, the Director of the Center

shall ensure that the members of the Board collectively—

‘‘(A) are experienced in the planning, construction,

financing, and administration of entities that conduct biomedical or behavioral research sciences;

‘‘(B) are knowledgeable in making determinations of

the need of entities for biomedical or behavioral research

facilities, including such facilities for the dentistry, nursing,

pharmacy, and allied health professions; ‘‘(C) are knowledgeable in evaluating the relative prior- ities for applications for grants under subsection (a) in

view of the overall research needs of the United States;

and

‘‘(D) are experienced with emerging centers of excel- lence, as described in subsection (c)(3).

‘‘(5) CERTAIN AUTHORITIES.— ‘‘(A) In carrying out paragraph (2), the Board may

convene workshops and conferences, and collect data as

the Board considers appropriate.

‘‘(B) In carrying out paragraph (2), the Board may

establish subcommittees within the Board. Such subcommittees may hold meetings as determined necessary

to enable the subcommittee to carry out its duties.

‘‘(6) TERMS.—

‘‘(A) Except as provided in subparagraph (B), each

appointed member of the Board 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 member’s predecessor was appointed shall be

appointed for the remainder of the term of the predecessor.

‘‘(B) Of the initial members appointed to the Board

(as specified by the Director of the Center when making

the appointments)—

‘‘(i) 3 shall hold office for a term of 3 years;

‘‘(ii) 3 shall hold office for a term of 2 years; and

‘‘(iii) 3 shall hold office for a term of 1 year.
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‘‘(C) No member is eligible for reappointment to the

Board until 1 year has elapsed after the end of the most

recent term of the member.

‘‘(7) COMPENSATION.—Members of the Board who are not

officers or employees of the United States shall receive for

each day the members are engaged in the performance of

the functions of the Board compensation at the same rate

received by members of other national advisory councils 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 satisfactory to

the Director that—

‘‘(i) for not less than 20 years after completion

of the construction, the facility will be used for the

purposes of research for which it is to be constructed;

‘‘(ii) sufficient funds will be available to meet the

non-Federal share of the cost of constructing the facility;

‘‘(iii) sufficient funds will be available, when

construction is completed, for the effective use of the

facility for the research for which it is being constructed; and

‘‘(iv) the proposed construction will expand the

applicant’s capacity for research, or is necessary to

improve or maintain the quality of the applicant’s

research.

‘‘(C) The applicant meets reasonable qualifications

established by the Director with respect to— ‘‘(i) the relative scientific and technical merit of

the applications, and the relative effectiveness of the

proposed facilities, in expanding the capacity for biomedical or behavioral research and in improving the

quality of such research; ‘‘(ii) the quality of the research or training, or

both, to be carried out in the facilities involved;

‘‘(iii) the need of the applicant for such facilities

in order to maintain or expand the applicant’s research

and training mission; ‘‘(iv) the congruence of the research activities to

be carried out within the facility with the research

and investigator manpower needs of the United States;

and

‘‘(v) the age and condition of existing research

facilities and equipment.

‘‘(D) The applicant has demonstrated a commitment

to enhancing and expanding the research productivity of

the applicant.

‘‘(2) CONSIDERATION OF CERTAIN FACTORS.—In making

grants under subsection (a), the Director of the Center may,

in addition to the requirements established in paragraph (1),

consider the following factors:
S. 1—55

‘‘(A) To what extent the applicant has the capacity

to broaden the scope of research and research 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

‘‘(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 EXCELLENCE.—Of the

amounts appropriated under subsection (h) for a fiscal year,

the Director of the Center shall make available 25 percent

for grants under subsection (a) to applicants that, in addition

to meeting the requirements established in paragraph (1), have

demonstrated emerging excellence in biomedical or behavioral

research, as follows:

‘‘(A) The applicant has a plan for research or training

advancement and possesses the ability 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.

‘‘(D) The applicant—

‘‘(i) has been designated as a center of excellence

under section 739;

‘‘(ii) is located in a geographic area whose population includes a significant number of individuals with

a health-status deficit, and the applicant provides

health services to such individuals; or

‘‘(iii) is located in a geographic area in which a

deficit in health care technology, services, or research

resources may adversely affect health status of the

population of the area in the future, and the applicant

is carrying out activities with respect to protecting

the health status of such population.

‘‘(d) REQUIREMENT OF APPLICATION.—The Director of the Center

may make a grant under subsection (a) only if an application

for the grant is submitted to the Director and the application

is in such form, is made in such manner, and contains such agreements, assurances, and information as the Director determines

to be necessary to carry out this section.

‘‘(e) AMOUNT OF GRANT; PAYMENTS.—

‘‘(1) AMOUNT.—The amount of any grant awarded under

subsection (a) shall be determined by the Director of the Center,

except that such amount shall not exceed—

‘‘(A) 50 percent of the necessary cost of the construction

of a proposed facility as determined by the Director; or

‘‘(B) in the case of a multipurpose facility, 40 percent

of that part of the necessary cost of construction that
S. 1—56

the Director determines to be proportionate to the contemplated use of the facility.

‘‘(2) RESERVATION OF AMOUNTS.—On approval of any

application for a grant under subsection (a), the Director of

the Center shall reserve, from any appropriation available

therefore, the amount of such grant, and shall pay such amount,

in advance or by way of reimbursement, and in such installments consistent with the construction progress, as the Director

may determine appropriate. The reservation of the Director

of any amount by the Director under this paragraph may be

amended by the Director, either on the approval of an amendment of the application or on the revision of the estimated

cost of construction of the facility.

‘‘(3) EXCLUSION OF CERTAIN COSTS.—In determining the

amount of any grant under this subsection (a), there shall

be excluded from the cost of construction an amount equal

to the sum of—

‘‘(A) the amount of any other Federal grant that the

applicant has obtained, or is assured of obtaining, with

respect to construction that is to be financed in part by

a grant authorized under this section; and

‘‘(B) the amount of any non-Federal funds required

to be expended as a condition of such other Federal grant.

‘‘(4) WAIVER OF LIMITATIONS.—The limitations imposed by

paragraph (1) may be waived at the discretion of the Director

for applicants meeting the conditions described in paragraphs

(1) and (2) of subsection (c).

‘‘(f) RECAPTURE OF PAYMENTS.—If, not later than 20 years after

the completion of construction for which a grant has been awarded

under subsection (a)—

‘‘(1) the applicant or other owner of the facility shall cease

to be a public or nonprofit private entity; or

‘‘(2) the facility shall cease to be used for the research

purposes for which it was constructed (unless the Director

determines, in accordance with regulations, that there is good

cause for releasing the applicant or other owner from obligation

to do so);

the United States shall be entitled to recover from the applicant

or other owner of the facility the amount bearing the same ratio

to the current value (as determined by an agreement between

the parties or by action brought in the United States District

Court for the district in which such facility is situated) of the

facility as the amount of the Federal participation bore to the

cost of the construction of such facility.

‘‘(g) GUIDELINES.—Not later than 6 months after the date of

the enactment of this section, the Director of the Center, after

consultation with the Advisory Council, shall issue guidelines with

respect to grants under subsection (a).

‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, 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.’’.
S. 1—57

SEC. 1503. CONSTRUCTION PROGRAM FOR NATIONAL PRIMATE

RESEARCH CENTER.

Subpart 1 of part E of title IV of the Public Health Service

Act, as amended by section 1502 of this Act, is amended by adding

at the end the following section:

‘‘CONSTRUCTION OF REGIONAL CENTERS FOR RESEARCH ON PRIMATES

‘‘SEC. 481B. (a) With respect to activities carried out by the

National Center for Research Resources to support regional centers

for research on primates, the Director of NIH shall, for each of

the fiscal years 1994 through 1996, reserve from the amounts

appropriated under section 481A(h) $5,000,000 for the purpose of

making awards of grants and contracts to public or nonprofit private

entities to construct, renovate, or otherwise improve such regional

centers. The reservation of such amounts for any fiscal year is

subject to the availability of qualified applicants for such awards.

‘‘(b) The Director of NIH may not make a grant or enter

into a contract under subsection (a) unless the applicant for such

assistance agrees, with respect to the costs to be incurred by the

applicant in carrying out the purpose described in such subsection,

to make available (directly or through donations from public or

private entities) non-Federal contributions in cash toward such

costs in an amount equal to not less than $1 for each $4 of Federal

funds provided in such assistance.’’.

Subtitle B—National Center for Nursing

Research

SEC. 1511. REDESIGNATION OF NATIONAL CENTER FOR NURSING

RESEARCH AS NATIONAL INSTITUTE OF NURSING

RESEARCH.

(a) IN GENERAL.—Subpart 3 of part E of title IV of the Public

Health Service Act (42 U.S.C. 287c et seq.) is amended—

(1) in section 483—

(A) in the heading for the section, by striking ‘‘CENTER’’ and inserting ‘‘INSTITUTE’’; and

(B) by striking ‘‘The general purpose’’ and all that

follows through ‘‘is’’ and inserting the following: ‘‘The general purpose of the National Institute of Nursing Research

(in this subpart referred to as the ‘Institute’) is’’;

(2) in section 484, by striking ‘‘Center’’ each place such

term appears and inserting ‘‘Institute’’;

(3) in section 485—

(A) in subsection (a), in each of paragraphs (1) through

(3), by striking ‘‘Center’’ each place such term appears

and inserting ‘‘Institute’’;

(B) in subsection (b)—

(i) in paragraph (2)(A), by striking ‘‘Center’’ and

inserting ‘‘Institute’’; and

(ii) in paragraph (3)(A), in the first sentence, by

striking ‘‘Center’’ and inserting ‘‘Institute’’; and

(C) in subsections (d) through (g), by striking ‘‘Center’’

each place such term appears and inserting ‘‘Institute’’;

and
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(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 Service Act (42 U.S.C.

281(b)) is amended—

(A) in paragraph (1), by adding at the end the following subparagraph:

‘‘(Q) The National Institute of Nursing Research.’’; and (B) in paragraph (2), by striking subparagraph (D). (2) TRANSFER OF STATUTORY PROVISIONS.—The Public

Health Service Act, as amended by subsection (a) of this section

and by section 124 of Public Law 102–321 (106 Stat. 364),

is amended—

(A) by transferring sections 483 through 485A to part C of title IV;

(B) by redesignating such sections as sections 464V through 464Y of such part; and (C) by adding such sections, in the appropriate sequence, at the end of such part.

(3) HEADING FOR NEW SUBPART.—Title IV of the Public

Health Service Act, as amended by the preceding provisions

of this section, is amended—

(A) in part C, by inserting before section 464V the following:

‘‘Subpart 17—National Institute of Nursing Research’’;

and

(B) by striking the subpart designation and heading for subpart 3 of part E.

(4) CROSS-REFERENCES.—Title IV of the Public Health Service Act, as amended by the preceding provisions of this section,

is amended in subpart 17 of part C— (A) in section 464W, by striking ‘‘section 483’’ and

inserting ‘‘section 464V’’; (B) in section 464X(g), by striking ‘‘section 486’’ and inserting ‘‘section 464Y’’; and (C) in section 464Y, in the last sentence, by striking ‘‘section 485(g)’’ and inserting ‘‘section 464X(g)’’.

SEC. 1512. STUDY ON ADEQUACY OF NUMBER OF NURSES.

(a) IN GENERAL.—The Secretary of Health and Human Services, acting through the Director of the National Institute of Nursing

Research, shall enter into a contract with a public or nonprofit

private entity to conduct a study for the purpose of determining

whether and to what extent there is a need for an increase in

the number of nurses in hospitals and nursing homes in order

to promote the quality of patient care and reduce the incidence

among nurses of work-related injuries and stress. (b) NATIONAL ACADEMY OF SCIENCES.—The Secretary shall

request the Institute of Medicine of the National Academy of

Sciences to enter into the contract under subsection (a) to conduct

the study described in such subsection. If such Institute declines

to conduct the study, the Secretary shall carry out such subsection

through another public or nonprofit private entity.

(c) DEFINITIONS.—For purposes of this section:
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(1) The term ‘‘nurse’’ means a registered nurse, a licensed

practical nurse, a licensed vocational nurse, and a nurse assistant.

(2) The term ‘‘Secretary’’ means the Secretary of Health

and Human Services.

(d) REPORT.—The Secretary shall ensure that, not later than

18 months after the date of the enactment of this Act, the study

required in subsection (a) is completed and a report describing

the findings made as a result of the study is submitted to the

Committee on Energy and Commerce of the House of Representatives and to the Committee on Labor and Human Resources of

the Senate.

Subtitle C—National Center for Human

Genome Research

SEC. 1521. PURPOSE OF CENTER.

Title IV of the Public Health Service Act, as amended by

section 141(a)(1) of this Act and by paragraphs (1)(B) and (3)(B)

of section 1511(b) of this Act, is amended—

(1) in section 401(b)(2), by adding at the end the following

subparagraph:

‘‘(D) The National Center for Human Genome Research.’’;

and

(2) in part E, by adding at the end the following subpart:

‘‘Subpart 3—National Center for Human Genome Research

‘‘PURPOSE OF THE CENTER

‘‘SEC. 485B. (a) The general purpose of the National Center for Human Genome Research (in this subpart referred to as the

‘Center’) is to characterize the structure and function of the human

genome, including the mapping and sequencing of individual genes.

Such purpose includes—

‘‘(1) planning and coordinating the research goal of the

genome project; ‘‘(2) reviewing and funding research proposals;

‘‘(3) developing training programs;

‘‘(4) coordinating international genome research;

‘‘(5) communicating advances in genome science to the public; and

‘‘(6) reviewing and funding proposals to address the ethical

and legal issues associated with the genome project (including

legal issues regarding patents).

‘‘(b) The Director of the Center may conduct and support

research training—

‘‘(1) for which fellowship support is not provided under

section 487; and

‘‘(2) that is not residency training of physicians or other

health professionals.

‘‘(c)(1) Except as provided in paragraph (2), of the amounts

appropriated to carry out subsection (a) for a fiscal year, the Director

of the Center shall make available not less than 5 percent for

carrying out paragraph (6) of such subsection.
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‘‘(2) With respect to providing funds under subsection (a)(6)

for proposals to address the ethical issues associated with the

genome project, paragraph (1) shall not apply for a fiscal year

if the Director of the Center certifies to the Committee on Energy

and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, that the Director

has determined that an insufficient number of such proposals meet

the applicable requirements of sections 491 and 492.’’.

TITLE XVI—AWARDS AND TRAINING

Subtitle A—National Research Service

Awards

SEC. 1601. REQUIREMENT REGARDING WOMEN AND INDIVIDUALS

FROM DISADVANTAGED BACKGROUNDS.

Section 487(a) of the Public Health Service Act (42 U.S.C.

288(a)(4)) is amended by adding at the end the following paragraph:

‘‘(4) The Secretary shall carry out paragraph (1) in a manner

that will result in the recruitment of women, and individuals from

disadvantaged backgrounds (including racial and ethnic minorities),

into fields of biomedical or behavioral research and in the provision

of research training to women and such individuals.’’.

SEC. 1602. SERVICE PAYBACK REQUIREMENTS.

Section 487(c) of the Public Health Service Act (42 U.S.C.

288(c)) is amended by striking paragraphs (1) and (2) and inserting

the following: ‘‘(1) Each individual who is awarded a National

Research Service Award for postdoctoral research training shall,

in accordance with paragraph (3), engage in research training,

research, or teaching that is health-related (or any combination

thereof) for the period specified in paragraph (2). Such period shall

be served in accordance with the usual patterns of scientific employment.

‘‘(2)(A) The period referred to in paragraph (1) is 12 months,

or one month for each month for which the individual involved

receives a National Research Service Award for postdoctoral

research training, whichever is less.

‘‘(B) With respect to postdoctoral research training, in any

case in which an individual receives a National Research Service

Award for more than 12 months, the 13th month and each subsequent month of performing activities under the Award shall be

considered to be activities engaged in toward satisfaction of the

requirement established in paragraph (1) regarding a period of

service.’’.

Subtitle B—Acquired Immune Deficiency

Syndrome

SEC. 1611. LOAN REPAYMENT PROGRAM.

(a) IN GENERAL.—Section 487A of the Public Health Service

Act (42 U.S.C. 288–1) is amended to read as follows:
S. 1—61

‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH RESPECT TO

ACQUIRED IMMUNE DEFICIENCY SYNDROME

‘‘SEC. 487A. (a) IN GENERAL.—The Secretary shall carry out

a program of entering into agreements with appropriately qualified

health professionals under which such health professionals agree

to conduct, as employees of the National Institutes of Health,

research with respect to acquired immune deficiency syndrome in

consideration of the Federal Government agreeing to repay, for

each year of such service, not more than $20,000 of the principal

and interest of the educational loans of such health professionals.

‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to

the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III, the provisions of such

subpart shall, except as inconsistent with subsection (a) of this

section, apply to the program established in such subsection (a)

in the same manner and to the same extent as such provisions

apply to the National Health Service Corps Loan Repayment Program established in such subpart.

‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

such sums as may be necessary for each of the fiscal years 1994

through 1996.’’.

(b) APPLICABILITY.—The amendment made by subsection (a)

does not apply to any agreement entered into under section 487A

of the Public Health Service Act before the date of the enactment

of this Act. Each such agreement continues to be subject to the

terms of the agreement in effect on the day before such date.

Subtitle C—Loan Repayment for Research

Generally

SEC. 1621. ESTABLISHMENT OF PROGRAM.

Part G of title IV of the Public Health Service Act, as redesignated by section 141(a)(2) of this Act and as amended by section

1002 of this Act, is amended by inserting after section 487B the

following section:

‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH GENERALLY

‘‘SEC. 487C. (a) IN GENERAL.—

‘‘(1) AUTHORITY FOR PROGRAM.—Subject to paragraph (2),

the Secretary shall carry out a program of entering into contracts with appropriately qualified health professionals under

which such health professionals agree to conduct research, as

employees of the National Institutes of Health, in consideration

of the Federal Government agreeing to repay, for each year

of such service, not more than $20,000 of the principal and

interest of the educational loans of such health professionals.

‘‘(2) LIMITATION.—The Secretary may not enter into an

agreement with a health professional pursuant to paragraph

(1) unless such professional—

‘‘(A) has a substantial amount of educational loans

relative to income; and
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‘‘(B) agrees to serve as an employee of the National

Institutes of Health for purposes of paragraph (1) for a

period of not less than 3 years.

‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to

the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III, the provisions of such

subpart shall, except as inconsistent with subsection (a) of this

section, apply to the program established in such subsection (a)

in the same manner and to the same extent as such provisions

apply to the National Health Service Corps Loan Repayment Program established in such subpart.’’.

Subtitle D—Scholarship and Loan Repayment Programs Regarding Professional

Skills Needed by Certain Agencies

SEC. 1631. ESTABLISHMENT OF PROGRAMS FOR NATIONAL

INSTITUTES OF HEALTH.

Part G of title IV of the Public Health Service Act, as redesignated by section 141(a)(2) of this Act and as amended by section

1621 of this Act, is amended by inserting after section 487C the

following sections:

‘‘UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS

NEEDED BY NATIONAL RESEARCH INSTITUTES

‘‘SEC. 487D. (a) ESTABLISHMENT OF PROGRAM.—

‘‘(1) IN GENERAL.—Subject to section 487(a)(1)(C), the Secretary, acting through the Director of NIH, may carry out

a program of entering into contracts with individuals described

in paragraph (2) under which—

‘‘(A) the Director of NIH agrees to provide to the

individuals scholarships for pursuing, as undergraduates

at accredited institutions of higher education, academic

programs appropriate for careers in professions needed by

the National Institutes of Health; and

‘‘(B) the individuals agree to serve as employees of

the National Institutes of Health, for the period described

in subsection (c), in positions that are needed by the

National Institutes of Health and for which the individuals

are qualified.

‘‘(2) INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS.—

The individuals referred to in paragraph (1) are individuals

who—

‘‘(A) are enrolled or accepted for enrollment as fulltime undergraduates at accredited institutions of higher

education; and

‘‘(B) are from disadvantaged backgrounds. ‘‘(b) FACILITATION OF INTEREST OF STUDENTS IN CAREERS AT

NATIONAL INSTITUTES OF HEALTH.—In providing employment to individuals pursuant to contracts under subsection (a)(1), the Director of NIH shall carry out activities to facilitate the interest of

the individuals in pursuing careers as employees of the National

Institutes of Health.

‘‘(c) PERIOD OF OBLIGATED SERVICE.—
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‘‘(1) DURATION OF SERVICE.—For purposes of subparagraph

(B) of subsection (a)(1), the period of service for which an

individual is obligated to serve as an employee of the National

Institutes of Health is, subject to paragraph (2)(A), 12 months

for each academic year for which the scholarship under such

subsection is provided.

‘‘(2) SCHEDULE FOR SERVICE.—

‘‘(A) Subject to subparagraph (B), the Director of NIH

may not provide a scholarship under subsection (a) unless

the individual applying for the scholarship agrees that—

‘‘(i) the individual will serve as an employee of

the National Institutes of Health full-time for not less

than 10 consecutive weeks of each year during which

the individual is attending the educational institution

involved and receiving such a scholarship;

‘‘(ii) the period of service as such an employee

that the individual is obligated to provide under clause

(i) is in addition to the period of service as such an

employee that the individual is obligated to provide

under subsection (a)(1)(B); and

‘‘(iii) not later than 60 days after obtaining the

educational degree involved, the individual will begin

serving full-time as such an employee in satisfaction

of the period of service that the individual is obligated

to provide under subsection (a)(1)(B).

‘‘(B) The Director of NIH may defer the obligation

of an individual to provide a period of service under subsection (a)(1)(B), if the Director determines that such a

deferral is appropriate.

‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS RELATING TO

APPOINTMENT AND COMPENSATION.—For any period in which

an individual provides service as an employee of the National

Institutes of Health in satisfaction of the obligation of the

individual under subsection (a)(1)(B) or paragraph (2)(A)(i), the

individual may be appointed as such an employee without

regard to the provisions of title 5, United States Code, relating

to appointment and compensation.

‘‘(d) PROVISIONS REGARDING SCHOLARSHIP.—

‘‘(1) APPROVAL OF ACADEMIC PROGRAM.—The Director of

NIH may not provide a scholarship under subsection (a) for

an academic year unless—

‘‘(A) the individual applying for the scholarship has

submitted to the Director a proposed academic program

for the year and the Director has approved the program;

and

‘‘(B) the individual agrees that the program will not

be altered without the approval of the Director.

‘‘(2) ACADEMIC STANDING.—The Director of NIH may not

provide a scholarship under subsection (a) for an academic

year unless the individual applying for the scholarship agrees

to maintain an acceptable level of academic standing, as determined by the educational institution involved in accordance

with regulations issued by the Secretary.

‘‘(3) LIMITATION ON AMOUNT.—The Director of NIH may

not provide a scholarship under subsection (a) for an academic

year in an amount exceeding $20,000.
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‘‘(4) AUTHORIZED USES.—A scholarship provided under sub- section (a) may be expended only for tuition expenses, other

reasonable educational expenses, and reasonable living

expenses incurred in attending the school involved. ‘‘(5) CONTRACT REGARDING DIRECT PAYMENTS TO INSTITUTION.—In the case of an institution of higher education with respect to which a scholarship under subsection (a) is provided,

the Director of NIH may enter into a contract with the institution under which the amounts provided in the scholarship

for tuition and other educational expenses are paid directly

to the institution.

‘‘(e) PENALTIES FOR BREACH OF SCHOLARSHIP CONTRACT.—The

provisions of section 338E shall apply to the program established

in subsection (a) to the same extent and in the same manner

as such provisions apply to the National Health Service Corps

Loan Repayment Program established in section 338B. ‘‘(f) REQUIREMENT OF APPLICATION.—The Director of NIH may not provide a scholarship under subsection (a) unless an application

for the scholarship is submitted to the Director and the application

is in such form, is made in such manner, and contains such agreements, assurances, and information as the Director determines

to be necessary to carry out this section. ‘‘(g) AVAILABILITY OF AUTHORIZATION OF APPROPRIATIONS.— Amounts appropriated for a fiscal year for scholarships under this

section shall remain available until the expiration of the second

fiscal year beginning after the fiscal year for which the amounts

were appropriated.

‘‘LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS

FROM DISADVANTAGED BACKGROUNDS

‘‘SEC. 487E. (a) IMPLEMENTATION OF PROGRAM.— ‘‘(1) IN GENERAL.—Subject to section 487(a)(1)(C), the Sec- retary, acting through the Director of NIH may, subject to

paragraph (2), carry out a program of entering into contracts

with appropriately qualified health professionals who are from

disadvantaged backgrounds under which such health professionals agree to conduct clinical research as employees of the

National Institutes of Health in consideration of the Federal

Government agreeing to pay, for each year of such service,

not more than $20,000 of the principal and interest of the

educational loans of the health professionals. ‘‘(2) LIMITATION.—The Director of NIH may not enter into a contract with a health professional pursuant to paragraph

(1) unless such professional has a substantial amount of education loans relative to income.

‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS REGARDING OBLIGATED SERVICE.—Except to the extent inconsistent with this

section, the provisions of sections 338C and 338E shall apply

to the program established in paragraph (1) to the same extent

and in the same manner as such provisions apply to the

National Health Service Corps Loan Repayment Program established in section 338B.

‘‘(b) AVAILABILITY OF AUTHORIZATION OF APPROPRIATIONS.— Amounts appropriated for a fiscal year for contracts under subsection (a) shall remain available until the expiration of the second

fiscal year beginning after the fiscal year for which the amounts

were appropriated.’’.
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SEC. 1632. FUNDING.

Section 487(a)(1) of the Public Health Service Act (42 U.S.C.

288(a)(1)) is amended—

(1) in subparagraph (A), by striking ‘‘and’’ after the semicolon at the end;

(2) in subparagraph (B), by striking the period at the

end and inserting ‘‘; and’’; and (3) by inserting after subparagraph (B) the following

subparagraph: ‘‘(C) provide contracts for scholarships and loan repayments

in accordance with sections 487D and 487E, subject to providing

not more than an aggregate 50 such contracts during the fiscal

years 1994 through 1996.’’.

Subtitle E—Funding

SEC. 1641. AUTHORIZATION OF APPROPRIATIONS.

Section 487(d) of the Public Health Service Act (42 U.S.C.

288(d)) is amended—

(1) in the first sentence, by amending the sentence to

read as follows: ‘‘For the purpose of carrying out this section,

there are authorized to be appropriated $400,000,000 for fiscal

year 1994, and such sums as may be necessary for each of

the fiscal years 1995 and 1996.’’; and

(2) in paragraph (3)—

(A) by striking ‘‘one-half of one percent’’ each place

such term appears and inserting ‘‘1 percent’’; and

(B) by striking ‘‘780, 784, or 786,’’ and inserting ‘‘747,

748, or 749,’’.

TITLE XVII—NATIONAL FOUNDATION

FOR BIOMEDICAL RESEARCH

SEC. 1701. NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH.

Section 499 of the Public Health Service Act, as redesignated by section 121(b)(3) of this Act, is amended— (1) in subsection (a)—

(A) by inserting ‘‘, acting through the Director of NIH,’’

after ‘‘Secretary shall’’; and (B) by striking ‘‘, except for’’ and all that follows

through ‘‘Transfer Act,’’;

(2) by redesignating subsections (c), (d), (e), (f), (g), (h),

and (i) as subsections (d), (f), (g), (h), (i), (j), and (m), respectively;

(3) by striking subsection (b) and inserting the following

subsections:

‘‘(b) PURPOSE OF FOUNDATION.—The purpose of the Foundation

shall be to support the National Institutes of Health in its mission,

and to advance collaboration with biomedical researchers from

universities, industry, and nonprofit organizations.

‘‘(c) CERTAIN ACTIVITIES OF FOUNDATION.—

‘‘(1) IN GENERAL.—In carrying out subsection (b), the

Foundation may solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in sup-
S. 1—66

port of the following activities with respect to the purpose

described in such subsection:

‘‘(A) A program to provide and administer endowed

positions that are associated with the research program

of the National Institutes of Health. Such endowments

may be expended for the compensation of individuals holding the positions, for staff, equipment, quarters, travel,

and other expenditures that are appropriate in supporting

the endowed positions.

‘‘(B) A program to provide and administer fellowships

and grants to research personnel in order to work and

study in association with the National Institutes of Health.

Such fellowships and grants may include stipends, travel,

health insurance benefits and other appropriate expenses.

The recipients of fellowships shall be selected by the donors

and the Foundation upon the recommendation of the

National Institutes of Health employees in the laboratory

where the fellow would serve, and shall be subject to the

agreement of the Director of the National Institutes of

Health and the Executive Director of the Foundation.

‘‘(C) Supplementary programs to provide for—

‘‘(i) scientists of other countries to serve in research

capacities in the United States in association with

the National Institutes of Health or elsewhere, or

opportunities for employees of the National Institutes

of Health or other public health officials in the United

States to serve in such capacities in other countries,

or both;

‘‘(ii) the conduct and support of studies, projects,

and research, which may include stipends, travel and

other support for personnel in collaboration with

national and international non-profit and for-profit

organizations; ‘‘(iii) the conduct and support of forums, meetings,

conferences, courses, and training workshops that may

include undergraduate, graduate, post-graduate, and

post-doctoral accredited courses and the maintenance

of accreditation of such courses by the Foundation at

the State and national level for college or continuing

education credits or for degrees; ‘‘(iv) programs to support and encourage teachers

and students of science at all levels of education and

programs for the general public which promote the

understanding of science; ‘‘(v) programs for writing, editing, printing,

publishing, and vending of books and other materials;

and

‘‘(vi) the conduct of other activities to carry out

and support the purpose described in subsection (b).

‘‘(2) FEES.—The Foundation may assess fees for the provision of professional, administrative and management services

by the Foundation in amounts determined reasonable and

appropriate by the Executive Director.

‘‘(3) AUTHORITY OF FOUNDATION.—The Foundation shall be

the sole entity responsible for carrying out the activities

described in this subsection.’’;

(4) in subsection (d) (as so redesignated)—
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(A) in paragraph (1)—

(i) by striking ‘‘members of the Foundation’’ in

subparagraph (A) and inserting ‘‘appointed members

of the Board’’;

(ii) by striking ‘‘Council’’ in subparagraph (B) and

inserting ‘‘Board’’;

(iii) by striking ‘‘Council’’ in subparagraph (C) and

inserting ‘‘Board’’; and

(iv) by adding at the end the following subparagraphs:

‘‘(D)(i) Not later than 30 days after the date of the

enactment of the National Institutes of Health Revitalization Act of 1993, the Director of the National Institutes

of Health shall convene a meeting of the ex officio members

of the Board to—

‘‘(I) incorporate the Foundation and establish the

general policies of the Foundation for carrying out

the purposes of subsection (b), including the establishment of the bylaws of the Foundation; and

‘‘(II) appoint the members of the Board in accordance with subparagraph (C).

‘‘(ii) Upon the appointment of the members of the Board

under clause (i)(II), the terms of service of the ex officio

members of the Board as members of the Board shall

terminate.

‘‘(E) The agreement of not less than three-fifths of

the members of the ex officio members of the Board shall

be required for the appointment of each member to the

initial Board.

‘‘(F) No employee of the National Institutes of Health

shall be appointed as a member of the Board.

‘‘(G) The Board may, through amendments to the

bylaws of the Foundation, provide that the number of members of the Board shall be greater than the number specified in subparagraph (C).’’; (B) in paragraph (2)— (i) by striking ‘‘The ex officio’’ and inserting the

following:

‘‘(A) The ex officio’’;

(ii) by striking ‘‘an appointed member of the Board

to serve as the Chair’’ and inserting ‘‘an individual

to serve as the initial Chair’’; and

(iii) by adding at the end the following subparagraph: ‘‘(B) Upon the termination of the term of service of the

initial Chair of the Board, the appointed members of the Board

shall elect a member of the Board to serve as the Chair of

the Board.’’;

(C) in paragraph (3)(A), by striking ‘‘(2)(C)’’ and inserting ‘‘(1)(C)’’; and

(D) by adding at the end the following paragraphs:

‘‘(5) MEETINGS AND QUORUM.—A majority of the members

of the Board shall constitute a quorum for purposes of conducting the business of the Board.

‘‘(6) CERTAIN BYLAWS.—

‘‘(A) In establishing bylaws under this subsection, the

Board shall ensure that the following are provided for:
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‘‘(i) Policies for the selection of the officers, employees, agents, and contractors of the Foundation.

‘‘(ii) Policies, including ethical standards, for the

acceptance, solicitation, and disposition of donations

and grants to the Foundation and for the disposition

of the assets of the Foundation. Policies with respect

to ethical standards shall ensure that officers, employees and agents of the Foundation (including members

of the Board) avoid encumbrances that would result

in a conflict of interest, including a financial conflict

of interest or a divided allegiance. Such policies shall

include requirements for the provision of information

concerning any ownership or controlling interest in

entities related to the activities of the Foundation by

such officers, employees and agents and their spouses

and relatives.

‘‘(iii) Policies for the conduct of the general operations of the Foundation.

‘‘(iv) Policies for writing, editing, printing, publishing, and vending of books and other materials.

‘‘(B) In establishing bylaws under this subsection, the

Board shall ensure that such bylaws (and activities carried

out under the bylaws) do not—

‘‘(i) reflect unfavorably upon the ability of the

Foundation or the National Institutes of Health to

carry out its responsibilities or official duties in a fair

and objective manner; or

‘‘(ii) compromise, or appear to compromise, the

integrity of any governmental agency or program, or

any officer or employee involved in such program.’’; (5) in subsection (i) (as so redesignated)— (A) in paragraph (4), by inserting ‘‘, and define the

duties of the officers and employees’’ before the semicolon

at the end;

(B) by striking paragraph (5);

(C) by redesignating paragraphs (6) through (14), as paragraphs (5) through (13), respectively; (D) in paragraph (7) (as so redesignated), by striking

‘‘this subtitle’’ and inserting ‘‘this part’’; (E) by striking paragraph (8) (as so redesignated), and

inserting the following paragraph:

‘‘(8) establish a process for the selection of candidates for

positions under subsection (c);’’

(F) by inserting ‘‘solicit’’ after the paragraph designa- tion in paragraph (11) (as so redesignated);

(G) by striking ‘‘and’’ at the end of paragraph (13)

(as so redesignated);

(H) by inserting after paragraph (13) (as so redesignated), the following paragraph:

‘‘(14) enter into such other contracts, leases, cooperative

agreements, and other transactions as the Executive Director

considers appropriate to conduct the activities of the Foundation; and’’; and

(I) in paragraph (15), by striking ‘‘this subtitle’’ and

inserting ‘‘this part’’;

(6) by inserting after subsection (j) (as so redesignated),

the following subsections:
S. 1—69

‘‘(k) GENERAL PROVISIONS.—

‘‘(1) FOUNDATION INTEGRITY.—The members of the Board

shall be accountable for the integrity of the operations of the

Foundation and shall ensure such integrity through the development and enforcement of criteria and procedures relating

to standards of conduct (including those developed under subsection (d)(2)(B)(i)(II)), financial disclosure statements, conflict

of interest rules, recusal and waiver rules, audits and other

matter determined appropriate by the Board.

‘‘(2) FINANCIAL CONFLICTS OF INTEREST.—Any individual

who is an officer, employee, or member of the Board of the

Foundation may not (in accordance with policies and requirements developed under subsection (d)(2)(B)(i)(II)) personally or

substantially participate in the consideration or determination

by the Foundation of any matter that would directly or predictably affect any financial interest of the individual or a relative

(as such term is defined in section 109(16) of the Ethics in

Government Act of 1978) of the individual, of any business

organization or other entity, or of which the individual is an

officer or employee, or is negotiating for employment, or in

which the individual has any other financial interest.

‘‘(3) AUDITS; AVAILABILITY OF RECORDS.—The Foundation

shall—

‘‘(A) provide for annual audits of the financial condition

of the Foundation; and

‘‘(B) make such audits, and all other records, documents, and other papers of the Foundation, available to

the Secretary and the Comptroller General of the United

States for examination or audit.

‘‘(4) REPORTS.— ‘‘(A) Not later than 5 months following the end of

each fiscal year, the Foundation shall publish a report

describing the activities of the Foundation during the

preceding fiscal year. Each such report shall include for

the fiscal year involved a comprehensive statement of the

operations, activities, financial condition, and accomplishments of the Foundation.

‘‘(B) With respect to the financial condition of the

Foundation, each report under subparagraph (A) shall

include the source, and a description of, all gifts or grants

to the Foundation of real or personal property, and the

source and amount of all gifts or grants to the Foundation

of money. Each such report shall include a specification

of any restrictions on the purposes for which gifts or grants

to the Foundation may be used.

‘‘(C) The Foundation shall make copies of each report

submitted under subparagraph (A) available for public

inspection, and shall upon request provide a copy of the

report to any individual for a charge not exceeding the

cost of providing the copy.

‘‘(D) The Board shall annually hold a public meeting

to summarize the activities of the Foundation and distribute written reports concerning such activities and the scientific results derived from such activities.

‘‘(5) SERVICE OF FEDERAL EMPLOYEES.—Federal employees

may serve on committees advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying
S. 1—70

out its function, so long as the employees do not direct or

control Foundation activities.

‘‘(6) RELATIONSHIP WITH EXISTING ENTITIES.—The Foundation may, pursuant to appropriate agreements, merge with,

acquire, or use the resources of existing nonprofit private corporations with missions similar to the purposes of the Foundation, such as the Foundation for Advanced Education in the

Sciences.

‘‘(7) INTELLECTUAL PROPERTY RIGHTS.—The Board shall

adopt written standards with respect to the ownership of any

intellectual property rights derived from the collaborative

efforts of the Foundation prior to the commencement of such

efforts.

‘‘(8) NATIONAL INSTITUTES OF HEALTH AMENDMENTS OF

1990.—The activities conducted in support of the National

Institutes of Health Amendments of 1990 (Public Law 101–

613), and the amendments made by such Act, shall not be

nullified by the enactment of this section.

‘‘(9) LIMITATION OF ACTIVITIES.—The Foundation shall exist

solely as an entity to work in collaboration with the research

programs of the National Institutes of Health. The Foundation

may not undertake activities (such as the operation of independent laboratories or competing for Federal research funds) that

are independent of those of the National Institutes of Health

research programs.

‘‘(10) TRANSFER OF FUNDS.—The Foundation may not transfer funds to the National Institutes of Health.

‘‘(l) DUTIES OF THE DIRECTOR.— ‘‘(1) APPLICABILITY OF CERTAIN STANDARDS TO NON-FEDERAL

EMPLOYEES.—In the case of any individual who is not an

employee of the Federal Government and who serves in association with the National Institutes of Health, with respect to

financial assistance received from the Foundation, the Foundation may not provide the assistance of, or otherwise permit

the work at the National Institutes of Health to begin until

a memorandum of understanding between the individual and

the Director of the National Institutes of Health, or the designee

of such Director, has been executed specifying that the individual shall be subject to such ethical and procedural standards

of conduct relating to duties performed at the National

Institutes of Health, as the Director of the National Institutes

of Health determines is appropriate.

‘‘(2) SUPPORT SERVICES.—The Director of the National

Institutes of Health may provide facilities, utilities and support

services to the Foundation if it is determined by the Director

to be advantageous to the research programs of the National

Institutes of Health.’’;

(7) in subsection (m) (as so redesignated), by amending

the subsection to read as follows:

‘‘(m) FUNDING.—

‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose

of carrying out this part, there is authorized to be appropriated

an aggregate $200,000 for the fiscal years 1994 and 1995.

‘‘(2) LIMITATION REGARDING OTHER FUNDS.—Amounts

appropriated under any provision of law other than paragraph

(1) may not be expended to establish or operate the Foundation.’’; and
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(8) by adding at the end the following subsection: ‘‘(n) REPORT ON ADEQUACY OF COMPLIANCE.— ‘‘(1) IN GENERAL.—With respect to the mission and function

of the Foundation, the Comptroller General of the United States

shall conduct an audit to determine—

‘‘(A) whether the Foundation is in compliance with

the guidelines established under this section; and ‘‘(B) whether the procedures utilized under this section

are adequate to prevent conflicts of interest involving the

Foundation, the employees of the Foundation or members

of the Board of the Foundation.

‘‘(2) REPORT.—Not later than 18 months after the date

on which the Foundation is incorporated, the Comptroller General of the United States shall complete the audit required

under paragraph (1) and prepare and submit to the Committee

on Energy and Commerce of the House of Representatives

and the Committee on Labor and Human Resources of the

Senate, a report describing the findings made with respect

to such audit.’’.

TITLE XVIII—RESEARCH WITH RESPECT

TO ACQUIRED IMMUNE DEFICIENCY

SYNDROME

Subtitle A—Office of AIDS Research

SEC. 1801. ESTABLISHMENT OF OFFICE.

(a) IN GENERAL.—Part D of title XXIII of the Public Health

Service Act (42 U.S.C. 300cc–41 et seq.) is amended— (1) by striking the part designation and the heading for the part; (2) by redesignating section 2351 as section 2354; and

(3) by inserting before section 2354 (as so redesignated) the following:

‘‘PART D—OFFICE OF AIDS RESEARCH

‘‘Subpart I—Interagency Coordination of Activities

‘‘SEC. 2351. ESTABLISHMENT OF OFFICE.

‘‘(a) IN GENERAL.—There is established within the National

Institutes of Health an office to be known as the Office of AIDS

Research. The Office shall be headed by a director, who shall

be appointed by the Secretary. ‘‘(b) DUTIES.—

‘‘(1) INTERAGENCY COORDINATION OF AIDS ACTIVITIES.—With

respect to acquired immune deficiency syndrome, the Director

of the Office shall plan, coordinate, and evaluate research and

other activities conducted or supported by the agencies of the

National Institutes of Health. In carrying out the preceding

sentence, the Director of the Office shall evaluate the AIDS

activities of each of such agencies and shall provide for the

periodic reevaluation of such activities.

‘‘(2) CONSULTATIONS.—The Director of the Office shall carry out this subpart (including developing and revising the plan
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required in section 2353) in consultation with the heads of

the agencies of the National Institutes of Health, with the

advisory councils of the agencies, and with the advisory council

established under section 2352.

‘‘(3) COORDINATION.—The Director of the Office shall act

as the primary Federal official with responsibility for overseeing

all AIDS research conducted or supported by the National

Institutes of Health, and

‘‘(A) shall serve to represent the National Institutes

of Health AIDS Research Program at all relevant Executive

branch task forces and committees; and

‘‘(B) shall maintain communications with all relevant

Public Health Service agencies and with various other

departments of the Federal Government, to ensure the

timely transmission of information concerning advances

in AIDS research and the clinical treatment of acquired

immune deficiency syndrome and its related conditions,

between these various agencies for dissemination to

affected communities and health care providers.

‘‘SEC. 2352. ADVISORY COUNCIL; COORDINATING COMMITTEES.

‘‘(a) ADVISORY COUNCIL.—

‘‘(1) IN GENERAL.—The Secretary shall establish an advisory

council for the purpose of providing advice to the Director

of the Office on carrying out this part. (Such council is referred

to in this subsection as the ‘Advisory Council’.)

‘‘(2) COMPOSITION, COMPENSATION, TERMS, CHAIR, ETC.—

Subsections (b) through (g) of section 406 apply to the Advisory

Council to the same extent and in the same manner as such

subsections apply to advisory councils for the national research

institutes, except that—

‘‘(A) in addition to the ex officio members specified

in section 406(b)(2), there shall serve as such members

of the Advisory Council a representative from the advisory

council of each of the National Cancer Institute and the

National Institute on Allergy and Infectious Diseases; and

‘‘(B) with respect to the other national research

institutes, there shall serve as ex officio members of such

Council, in addition to such members specified in subparagraph (A), a representative from the advisory council of

each of the 2 institutes that receive the greatest funding

for AIDS activities.

‘‘(b) INDIVIDUAL COORDINATING COMMITTEES REGARDING

RESEARCH DISCIPLINES.—

‘‘(1) IN GENERAL.—The Director of the Office shall establish,

for each research discipline in which any activity under the

plan required in section 2353 is carried out, a committee for

the purpose of providing advice to the Director of the Office

on carrying out this part with respect to such discipline. (Each

such committee is referred to in this subsection as a ‘coordinating committee’.)

‘‘(2) COMPOSITION.—Each coordinating committee shall be

composed of representatives of the agencies of the National

Institutes of Health with significant responsibilities regarding

the research discipline involved.
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‘‘SEC. 2353. COMPREHENSIVE PLAN FOR EXPENDITURE OF APPROPRIATIONS.

‘‘(a) IN GENERAL.—Subject to the provisions of this section and other applicable law, the Director of the Office, in carrying

out section 2351, shall—

‘‘(1) establish a comprehensive plan for the conduct and

support of all AIDS activities of the agencies of the National

Institutes of Health (which plan shall be first established under

this paragraph not later than 12 months after the date of

the enactment of the National Institutes of Health Revitalization Act of 1993);

‘‘(2) ensure that the Plan establishes priorities among the AIDS activities that such agencies are authorized to carry

out;

‘‘(3) ensure that the Plan establishes objectives regarding such activities, describes the means for achieving the objectives,

and designates the date by which the objectives are expected

to be achieved;

‘‘(4) ensure that all amounts appropriated for such activities

are expended in accordance with the Plan; ‘‘(5) review the Plan not less than annually, and revise

the Plan as appropriate; and

‘‘(6) ensure that the Plan serves as a broad, binding statement of policies regarding AIDS activities of the agencies, but

does not remove the responsibility of the heads of the agencies

for the approval of specific programs or projects, or for other

details of the daily administration of such activities, in accordance with the Plan.

‘‘(b) CERTAIN COMPONENTS OF PLAN.—With respect to AIDS

activities of the agencies of the National Institutes of Health, the

Director of the Office shall ensure that the Plan—

‘‘(1) provides for basic research;

‘‘(2) provides for applied research;

‘‘(3) provides for research that is conducted by the agencies;

‘‘(4) provides for research that is supported by the agencies;

‘‘(5) provides for proposals developed pursuant to solicitations by the agencies and for proposals developed independently

of such solicitations; and

‘‘(6) provides for behavioral research and social sciences

research.

‘‘(c) BUDGET ESTIMATES.—

‘‘(1) FULL-FUNDING BUDGET.—

‘‘(A) With respect to a fiscal year, the Director of the

Office shall prepare and submit directly to the President,

for review and transmittal to the Congress, a budget estimate for carrying out the Plan for the fiscal year, after

reasonable opportunity for comment (but without change)

by the Secretary, the Director of the National Institutes

of Health, and the advisory council established under section 2352. The budget estimate shall include an estimate

of the number and type of personnel needs for the Office. ‘‘(B) The budget estimate submitted under subpara- graph (A) shall estimate the amounts necessary for the

agencies of the National Institutes of Health to carry out

all AIDS activities determined by the Director of the Office

to be appropriate, without regard to the probability that

such amounts will be appropriated.
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‘‘(2) ALTERNATIVE BUDGETS.—

‘‘(A) With respect to a fiscal year, the Director of the

Office shall prepare and submit to the Secretary and the

Director of the National Institutes of Health the budget

estimates described in subparagraph (B) for carrying out

the Plan for the fiscal year. The Secretary and such Director shall consider each of such estimates in making recommendations to the President regarding a budget for the

Plan for such year.

‘‘(B) With respect to the fiscal year involved, the budget

estimates referred to in subparagraph (A) for the Plan

are as follows:

‘‘(i) The budget estimate submitted under paragraph (1).

‘‘(ii) A budget estimate developed on the assumption that the amounts appropriated will be sufficient

only for—

‘‘(I) continuing the conduct by the agencies

of the National Institutes of Health of existing

AIDS activities (if approved for continuation), and

continuing the support of such activities by the

agencies in the case of projects or programs for

which the agencies have made a commitment of

continued support; and

‘‘(II) carrying out, of activities that are in addition to activities specified in subclause (I), only

such activities for which the Director determines

there is the most substantial need.

‘‘(iii) Such other budget estimates as the Director

of the Office determines to be appropriate.

‘‘(d) FUNDING.— ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose

of carrying out AIDS activities under the Plan, there are authorized to be appropriated such sums as may be necessary for

each of the fiscal years 1994 through 1996. ‘‘(2) RECEIPT OF FUNDS.—For the first fiscal year beginning

after the date on which the Plan first established under section

2353(a)(1) has been in effect for 12 months, and for each subsequent fiscal year, the Director of the Office shall receive directly

from the President and the Director of the Office of Management and Budget all funds available for AIDS activities of

the National Institutes of Health.

‘‘(3) ALLOCATIONS FOR AGENCIES.— ‘‘(A) Each fiscal year the Director of the Office shall, from the amounts received under paragraph (2) for the

fiscal year, allocate to the agencies of the National

Institutes of Health (in accordance with the Plan) all

amounts available for such year for carrying out the AIDS

activities specified in subsection (c)(2)(B)(ii)(I) for such year.

Such allocation shall, to the extent practicable, be made

not later than 15 days after the date on which the Director

receives amounts under paragraph (2).

‘‘(B) Each fiscal year the Director of the Office shall,

from the amounts received under paragraph (2) for the

fiscal year, allocate to the agencies of the National

Institutes of Health (in accordance with the Plan) all

amounts available for such year for carrying out AIDS
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activities that are not referred to in subparagraph (A).

Such allocation shall, to the extent practicable, be made

not later than 30 days after the date on which the Director

receives amounts under paragraph (2).’’.

(b) CONFORMING AMENDMENTS.—Section 2354 of the Public

Health Service Act, as redesignated by subsection (a)(2) of this

section, is amended—

(1) in the heading for the section, by striking

‘‘ESTABLISHMENT OF’’ and inserting ‘‘ADDITIONAL’’;

(2) in subsection (a)—

(A) in the matter preceding paragraph (1), by striking

‘‘In carrying out’’ and all that follows and inserting the

following: ‘‘In carrying out AIDS research, the Director

of the Office—’’;

(B) by striking paragraphs (1) and (2) and redesignating paragraphs (3) through (8) as paragraphs (1) through

(6);

(C) in paragraph (3) (as so redesignated), by striking

‘‘may’’ and all that follows in the matter preceding subparagraph (A) and inserting the following: ‘‘may support—’’;

(D) in paragraph (5) (as so redesignated)—

(i) in subparagraph (A)—

‘‘(I) by striking ‘‘may’’ and all that follows

through ‘‘acquire,’’ and inserting ‘‘may acquire,’’;

and

‘‘(II) by striking ‘‘Director’’ and all that follows

through ‘‘determines’’ and inserting ‘‘Director of

the Office determines’’;

(ii) in subparagraph (B), by striking ‘‘may’’ and

all that follows through ‘‘make grants’’ and inserting

‘‘may make grants’’; and (iii) in subparagraph (C), by striking ‘‘may’’ and

all that follows through ‘‘acquire,’’ and inserting ‘‘may

acquire,’’; and

(E) in each of paragraphs (2), (3)(A), and (4) (as so redesignated), by striking ‘‘research relating to acquired

immune deficiency syndrome’’ and inserting ‘‘AIDS

research’’;

(3) in subsection (b), in the matter preceding paragraph (1), by striking ‘‘The Director’’ and all that follows through

‘‘shall’’ and inserting ‘‘The Director of the Office shall’’; and (4) in subsection (c), by striking ‘‘the Director’’ and all

that follows through ‘‘shall’’ and inserting ‘‘the Director of the

Office shall’’.

SEC. 1802. ESTABLISHMENT OF EMERGENCY DISCRETIONARY FUND.

Part D of title XXIII of the Public Health Service Act, as

amended by section 1801 of this Act, is amended by adding at

the end the following subpart:

‘‘Subpart II—Emergency Discretionary Fund

‘‘SEC. 2356. EMERGENCY DISCRETIONARY FUND.

‘‘(a) IN GENERAL.—

‘‘(1) ESTABLISHMENT.—There is established a fund consisting of such amounts as may be appropriated under subsection

(g). Subject to the provisions of this section, the Director of
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the Office, after consultation with the advisory council established under section 2352, may expend amounts in the Fund

for the purpose of conducting and supporting such AIDS activities, including projects of AIDS research, as may be authorized

in this Act for the National Institutes of Health.

‘‘(2) PRECONDITIONS TO USE OF FUND.—Amounts in the

Fund may be expended only if—

‘‘(A) the Director identifies the particular set of AIDS

activities for which such amounts are to be expended;

‘‘(B) the set of activities so identified constitutes either

a new project or additional AIDS activities for an existing

project;

‘‘(C) the Director of the Office has made a determination that there is a significant need for such set of activities;

and

‘‘(D) as of June 30 of the fiscal year preceding the

fiscal year in which the determination is made, such need

was not provided for in any appropriations Act passed

by the House of Representatives to make appropriations

for the Departments of Labor, Health and Human Services

(including the National Institutes of Health), Education,

and related agencies for the fiscal year in which the determination is made.

‘‘(3) TWO-YEAR USE OF FUND FOR PROJECT INVOLVED.—In

the case of an identified set of AIDS activities, obligations

of amounts in the Fund may not be made for such set of

activities after the expiration of the 2-year period beginning

on the date on which the initial obligation of such amounts

is made for such set.

‘‘(b) PEER REVIEW.—With respect to an identified set of AIDS

activities carried out with amounts in the Fund, this section may

not be construed as waiving applicable requirements for peer review. ‘‘(c) LIMITATIONS ON USE OF FUND.— ‘‘(1) CONSTRUCTION OF FACILITIES.—Amounts in the Fund

may not be used for the construction, renovation, or relocation

of facilities, or for the acquisition of land.

‘‘(2) CONGRESSIONAL DISAPPROVAL OF PROJECTS.— ‘‘(A) Amounts in the Fund may not be expended for

the fiscal year involved for an identified set of AIDS activities, or a category of AIDS activities, 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 available 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 NUMBER OF

EMPLOYEES.—The purposes for which amounts in the Fund may

be expended include the employment of individuals necessary to

carry out identified sets of AIDS activities approved under subsection (a). Any individual employed under the preceding sentence
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may not be included in any determination of the number of fulltime equivalent employees for the Department of Health and

Human Services for the purpose of any limitation on the number

of such employees established by law prior to, on, or after the

date of the enactment of the National Institutes of Health Revitalization Act of 1993.

‘‘(e) REPORT TO CONGRESS.—Not later than February 1 of each

fiscal year, the Director of the Office shall submit to the Committee

on Energy and Commerce of the House of Representatives, and

to the Committee on Labor and Human Resources of the Senate,

a report on the identified sets of AIDS activities carried out during

the preceding fiscal year with amounts in the Fund. The report

shall provide a description of each such set of activities and an

explanation of the reasons underlying the use of the Fund for

the set.

‘‘(f) DEFINITIONS.—For purposes of this section:

‘‘(1) The term ‘Fund’ means the fund established in subsection (a).

‘‘(2) The term ‘identified set of AIDS activities’ means a

particular set of AIDS activities identified under subsection

(a)(2)(A).

‘‘(g) FUNDING.—

‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose

of providing amounts for the Fund, there is authorized to

be appropriated $100,000,000 for each of the fiscal years 1994

through 1996.

‘‘(2) AVAILABILITY.—Amounts appropriated for the Fund

are available until expended.’’.

SEC. 1803. GENERAL PROVISIONS.

Part D of title XXIII of the Public Health Service Act, as

amended by section 1802 of this Act, is amended by adding at

the end the following subpart:

‘‘Subpart III—General Provisions

‘‘SEC. 2359. GENERAL PROVISIONS REGARDING THE OFFICE.

‘‘(a) ADMINISTRATIVE SUPPORT FOR OFFICE.—The Secretary, acting through the Director of the National Institutes of Health, shall

provide administrative support and support services to the Director

of the Office and shall ensure that such support takes maximum

advantage of existing administrative structures at the agencies

of the National Institutes of Health.

‘‘(b) EVALUATION AND REPORT.—

‘‘(1) EVALUATION.—Not later than 5 years after the date

of the enactment of National Institutes of Health Revitalization

Act of 1993, the Secretary shall conduct an evaluation to—

‘‘(A) determine the effect of this section on the planning

and coordination of the AIDS research programs at the

institutes, centers and divisions of the National Institutes

of Health;

‘‘(B) evaluate the extent to which this part has eliminated the duplication of administrative resources among

such Institutes, centers and divisions; and

‘‘(C) provide recommendations concerning future alterations with respect to this part.
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‘‘(2) REPORT.—Not later than 1 year after the date on

which the evaluation is commenced under paragraph (1), the

Secretary shall prepare and submit to the Committee on Labor

and Human Resources of the Senate, and the Committee on

Energy and Commerce of the House of Representatives, a report

concerning the results of such evaluation.

‘‘(c) DEFINITIONS.—For purposes of this part:

‘‘(1) The term ‘AIDS activities’ means AIDS research and

other activities that relate to acquired immune deficiency syndrome.

‘‘(2) The term ‘AIDS research’ means research with respect

to acquired immune deficiency syndrome.

‘‘(3) The term ‘Office’ means the Office of AIDS Research.

‘‘(4) The term ‘Plan’ means the plan required in section

2353(a)(1).’’.

Subtitle B—Certain Programs

SEC. 1811. REVISION AND EXTENSION OF CERTAIN PROGRAMS.

Title XXIII of the Public Health Service Act (42 U.S.C. 300cc

et seq.) is amended—

(1) in section 2304(c)(1)—

(A) in the matter preceding subparagraph (A), by

inserting after ‘‘Director of such Institute’’ the following:

‘‘(and may provide advice to the Directors of other agencies

of the National Institutes of Health, as appropriate)’’; and

(B) in subparagraph (A), by inserting before the semicolon the following: ‘‘, including recommendations on the

projects of research with respect to diagnosing immune

deficiency and with respect to predicting, diagnosing,

preventing, and treating opportunistic cancers and infectious diseases’’;

(2) in section 2311(a)(1), by inserting before the semicolon

the following: ‘‘, including evaluations of methods of diagnosing

immune deficiency and evaluations of methods of predicting,

diagnosing, preventing, and treating opportunistic cancers and

infectious diseases’’;

(3) in section 2315—

(A) in subsection (a)(2), by striking ‘‘international

research’’ and all that follows and inserting ‘‘international

research and training concerning the natural history and

pathogenesis of the human immunodeficiency virus and

the development and evaluation of vaccines and treatments

for acquired immune deficiency syndrome and opportunistic

infections.’’; and

(B) in subsection (f), by striking ‘‘there are authorized’’

and all that follows and inserting ‘‘there are authorized

to be appropriated such sums as may be necessary for

each fiscal year.’’;

(4) in section 2318—

(A) in subsection (a)(1)—

(i) by inserting after ‘‘The Secretary’’ the following:

‘‘, acting through the Director of the National Institutes

of Health and after consultation with the Administrator for Health Care Policy and Research,’’; and
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(ii) by striking ‘‘syndrome’’ and inserting ‘‘syndrome, including treatment and prevention of HIV

infection and related conditions among women’’; and

(B) in subsection (e), by striking ‘‘1991.’’ and inserting

the following: ‘‘1991, and such sums as may be necessary

for each of the fiscal years 1994 through 1996.’’;

(5) in section 2320(b)(1)(A), by striking ‘‘syndrome’’ and

inserting ‘‘syndrome and the natural history of such infection’’;

(6) in section 2320(e)(1), by striking ‘‘there are authorized’’

and all that follows and inserting ‘‘there are authorized to

be appropriated such sums as may be necessary for each fiscal

year.’’;

(7) in section 2341(d), by striking ‘‘there are authorized’’

and all that follows and inserting ‘‘there are authorized to

be appropriated such sums as may be necessary for each fiscal

year.’’; and

(8) in section 2361, by striking ‘‘For purposes’’ and all

that follows and inserting the following:

‘‘For purposes of this title:

‘‘(1) The term ‘infection’, with respect to the etiologic agent

for acquired immune deficiency syndrome, includes opportunistic cancers and infectious diseases and any other conditions

arising from infection with such etiologic agent.

‘‘(2) The term ‘treatment’, with respect to the etiologic

agent for acquired immune deficiency syndrome, includes primary and secondary prophylaxis.’’.

TITLE XIX—STUDIES

SEC. 1901. LIFE-THREATENING ILLNESSES.

(a) THIRD-PARTY PAYMENTS REGARDING CERTAIN CLINICAL

TRIALS AND CERTAIN LIFE-THREATENING ILLNESSES.—The Secretary

of Health and Human Services, acting through the Director of

the National Institutes of Health, shall conduct a study for the

purpose of—

(1) determining the policies of third-party payors regarding

the payment of the costs of appropriate health services that

are provided incident to the participation of individuals as

subjects in clinical trials conducted in the development of drugs

with respect to acquired immune deficiency syndrome, cancer,

and other life-threatening illnesses; and (2) developing recommendations regarding such policies. (b) VACCINES FOR HUMAN IMMUNODEFICIENCY VIRUS.— (1) IN GENERAL.—The Secretary of Health and Human

Services, acting through the National Institutes of Health, shall

develop a plan for the appropriate inclusion of HIV-infected

women, including pregnant women, HIV-infected infants, and

HIV-infected children in studies conducted by or through the

National Institutes of Health concerning the safety and efficacy

of HIV vaccines for the treatment and prevention of HIV infection. Such plan shall ensure the full participation of other

Federal agencies currently conducting HIV vaccine studies and

require that such studies conform fully to the requirements

of part 46 of title 45, Code of Federal Regulations.

(2) REPORT.—Not later than 180 days after the date of

the enactment of this Act, the Secretary of Health and Human
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Services shall prepare and submit to the Committee on Energy

and Commerce of the House of Representatives, and the

Committee on Labor and Human Resources of the Senate,

a report concerning the plan developed under paragraph (1).

(3) IMPLEMENTATION.—Not later than 12 months after the

date of the enactment of this Act, the Secretary of Health

and Human Services shall implement the plan developed under

paragraph (1), including measures for the full participation

of other Federal agencies currently conducting HIV vaccine

studies.

(4) AUTHORIZATION OF APPROPRIATIONS.—For the purpose

of carrying out this subsection, there are authorized to be

appropriated such sums as may be necessary for each of the

fiscal years 1994 through 1996.

SEC. 1902. MALNUTRITION IN THE ELDERLY.

(a) STUDY.—

(1) IN GENERAL.—The Secretary of Health and Human

Services (referred to in this section as the ‘‘Secretary’’), acting

through the National Institute on Aging, coordinating with

the Agency for Health Care Policy and Research and, to the

degree possible, in consultation with the head of the National

Nutrition Monitoring and Related Research Program established by section 5311(a) of Public Law 101–445 (7 U.S.C.

5301 et seq.), shall conduct a 3-year nutrition screening and

intervention activities study of the elderly.

(2) EFFICACY AND COST-EFFECTIVENESS OF NUTRITION

SCREENING AND INTERVENTION ACTIVITIES.—In conducting the

study, the Secretary shall determine the efficacy and costeffectiveness of nutrition screening and intervention activities

conducted in the elderly health and long-term care continuum,

and of a program that would institutionalize nutrition screening

and intervention activities. In evaluating such a program, the

Secretary shall determine—

(A) if health or quality of life is measurably improved

for elderly individuals who receive routine nutritional

screening and treatment;

(B) if federally subsidized home or institutional care

is reduced because of increased independence of elderly

individuals resulting from improved nutritional status;

(C) if a multidisciplinary approach to nutritional care

is effective in addressing the nutritional needs of elderly

individuals; and

(D) if reimbursement for nutrition screening and intervention activities is a cost-effective approach to improving

the health status of elderly individuals.

(3) POPULATIONS.—The populations of elderly individuals

in which the study will be conducted shall include populations

of elderly individuals who are—

(A) living independently, including—

(i) individuals who receive home and communitybased services or family support;

(ii) individuals who do not receive additional services and support;

(iii) individuals with low incomes; and

(iv) individuals who are minorities;
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(B) hospitalized, including individuals admitted from

home and from institutions; and

(C) institutionalized in residential facilities such as

nursing homes and adult homes.

(b) MALNUTRITION STUDY.—The Secretary, acting through the

National Institute on Aging, shall conduct a 3-year study to determine the extent of malnutrition in elderly individuals in hospitals

and long-term care facilities and in elderly individuals who are

living independently.

(c) REPORT.—The Secretary shall submit a report to the

Committee on Labor and Human Resources of the Senate and

the Committee on Energy and Commerce of the House of Representatives containing the findings resulting from the studies described

in subsections (a) and (b), including a determination regarding

whether a program that would institutionalize nutrition screening

and intervention activities should be adopted, and the rationale

for the determination.

(d) ADVISORY PANEL.—

(1) ESTABLISHMENT.—The Secretary, acting through the

Director of the National Institute on Aging, shall establish

an advisory panel that shall oversee the design, implementation, and evaluation of the studies described in subsections

(a) and (b).

(2) COMPOSITION.—The advisory panel shall include representatives appointed for the life of the panel by the Secretary

from the Health Care Financing Administration, the Social

Security Administration, the National Center for Health Statistics, the Administration on Aging, the National Council on

the Aging, the American Dietetic Association, the American

Academy of Family Physicians, and such other agencies or

organizations as the Secretary determines to be appropriate. (3) COMPENSATION AND EXPENSES.— (A) COMPENSATION.—Each member of the advisory

panel who is not an employee of the Federal Government

shall receive compensation for each day engaged in carrying

out the duties of the panel, including time engaged in

traveling for purposes of such duties. Such compensation

may not be provided in an amount in excess of the maximum rate of basic pay payable for GS–18 of the General

Schedule.

(B) TRAVEL EXPENSES.—Each member of the advisory

panel shall receive travel expenses, including per diem

in lieu of subsistence, at rates authorized for employees

of agencies under subchapter I of chapter 57 of title 5,

United States Code, for each day the member is engaged

in the performance of duties away from the home or regular

place of business of the member.

(4) DETAIL OF FEDERAL EMPLOYEES.—On the request of

the advisory panel, the head of any Federal agency shall detail,

without reimbursement, any of the personnel of the agency

to the advisory panel to assist the advisory panel in carrying

out its duties. Any detail shall not interrupt or otherwise affect

the civil service status or privileges of the Federal employee.

(5) TECHNICAL ASSISTANCE.—On the request of the advisory

panel, the head of a Federal agency shall provide such technical

assistance to the advisory panel as the advisory panel determines to be necessary to carry out its duties.
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(6) TERMINATION.—Notwithstanding section 15 of the Fed- eral Advisory Committee Act (5 U.S.C. App.), the advisory

panel shall terminate 3 years after the date of enactment

of this Act.

SEC. 1903. RESEARCH ACTIVITIES ON CHRONIC FATIGUE SYNDROME.

The Secretary of Health and Human Services shall, not later than October 1, 1993, and annually thereafter for the next 3 years,

prepare and submit to the Committee on Energy and Commerce

of the House of Representatives and the Committee on Labor and

Human Resources of the Senate, a report that summarizes the

research activities conducted or supported by the National Institutes

of Health concerning chronic fatigue syndrome. Such report should

include information concerning grants made, cooperative agreements or contracts entered into, intramural activities, research

priorities and needs, and a plan to address such priorities and

needs.

SEC. 1904. REPORT ON MEDICAL USES OF BIOLOGICAL AGENTS IN

DEVELOPMENT OF DEFENSES AGAINST BIOLOGICAL WARFARE.

The Secretary of Health and Human Services, in consultation

with the Secretary of Defense and with the heads of other appropriate executive agencies, shall report to the House Energy and

Commerce Committee and the Senate Labor and Human Resources

Committee on the appropriateness and impact of the National

Institutes of Health assuming responsibility for the conduct of all

Federal research, development, testing, and evaluation functions

relating to medical countermeasures against biowarfare threat

agents. In preparing the report, the Secretary of Health and Human

Services shall identify the extent to which such activities are carried

out by agencies other than the National Institutes of Health, and

assess the impact (positive and negative) of the National Institutes

of Health assuming responsibility for such activities, including the

impact under the Budget Enforcement Act and the Omnibus Budget

Reconciliation Act of 1990 on existing National Institutes of Health

research programs as well as other programs within the category

of domestic discretionary spending. Such Secretary shall submit

the report not later than 12 months after the date of the enactment

of this Act. The Secretary shall provide a copy of the report to

the House and Senate Committees on Armed Services.

SEC. 1905. PERSONNEL STUDY OF RECRUITMENT, RETENTION AND

TURNOVER.

(a) STUDY OF PERSONNEL SYSTEM.—Not later than 1 year after

the date of the enactment of this Act, the Secretary of Health

and Human Services, acting through the Director of the National

Institutes of Health, shall conduct a study to review the retention,

recruitment, vacancy and turnover rates of support staff, including

firefighters, law enforcement, procurement officers, technicians,

nurses and clerical employees, to ensure that the National Institutes

of Health is adequately supporting the conduct of efficient, effective

and high quality research for the American public. The Director

of NIH shall work in conjunction with appropriate employee

organizations and representatives in developing such a study.

(b) SUBMISSION TO CONGRESS.—Not later than 1 year after

the date of the enactment of this Act, the Secretary of Health

and Human Services shall prepare and submit to the Committee
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on Energy and Commerce of the House of Representatives, and

to the Committee on Labor and Human Resources of the Senate,

a report containing the study conducted under subsection (a)

together with the recommendations of the Secretary concerning

the enactment of legislation to implement the results of such study.

SEC. 1906. PROCUREMENT.

(a) IN GENERAL.—The Director of the National Institutes of

Health and the Administrator of the General Services Administration shall jointly conduct a study to develop a streamlined procurement system for the National Institutes of Health that complies

with the requirements of Federal law. (b) REPORT.—Not later than March 1, 1994, the officials speci- fied in subsection (a) shall complete the study required in such

subsection and shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on

Labor and Human Resources of the Senate, a report describing

the findings made as a result of the study.

SEC. 1907. CHRONIC PAIN CONDITIONS.

(a) IN GENERAL.—The Director of the National Institutes of

Health (in this section referred to as the ‘Director’), acting through

the Director of the National Institute of Dental Research and as

appropriate through the heads of other agencies of such Institutes,

shall conduct a study for the purpose of determining the incidence

in the United States of cases of chronic pain (including chronic

pain resulting from back injuries) and the effect of such cases

on the costs of health care in the United States.

(b) CERTAIN ELEMENTS OF STUDY.—The cases of chronic pain

with respect to which the study required in subsection (a) is conducted shall include reflex sympathetic dystrophy syndrome,

temporomandibular joint disorder, post-herpetic neuropathy, painful

diabetic neuropathy, phantom pain, and post-stroke pain.

(c) REPORT.—Not later than 2 years after the date of the enactment of this Act, the Director shall complete the study required

in subsection (a) and submit to the Committee on Energy and

Commerce of the House of Representatives, and to the Committee

on Labor and Human Resources of the Senate, a report describing

the findings made as a result of the study.

SEC. 1908. RELATIONSHIP BETWEEN THE CONSUMPTION OF LEGAL

AND ILLEGAL DRUGS.

(a) IN GENERAL.—The Secretary of Health and Human Services

shall review and consider all existing relevant data and research

concerning whether there is a relationship between an individual’s

receptivity to use or consume legal drugs and the consumption

or abuse by the individual of illegal drugs. On the basis of such

review, the Secretary shall determine whether additional research

is necessary. If the Secretary determines additional research is

required, the Secretary shall conduct a study of those subjects

where the Secretary’s review indicates additional research is

needed, including, if necessary, a review of—

(1) the effect of advertising and marketing campaigns that

promote the use of legal drugs on the public;

(2) the correlation of legal drug abuse with illegal drug

abuse; and

(3) other matters that the Secretary determines appropriate.
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(b) REPORT.—Not later than 12 months after the date of enactment of this Act, the Secretary shall prepare and submit, to the

Committee on Energy and Commerce of the House of Representatives and Committee on Labor and Human Resources of the Senate,

a report containing the results of the review conducted under subsection (b). If the Secretary determines additional research is

required, no later than 2 years after the date of enactment of

this Act, the Secretary shall prepare and submit, to the Committee

on Energy and Commerce of the House of Representatives and

Committee on Labor and Human Resources of the Senate, a report

containing the results of the additional research conducted under

subsection (b).

SEC. 1909. REDUCING ADMINISTRATIVE HEALTH CARE COSTS.

The Secretary of Health and Human Services, acting through

the Agency for Health Care Policy and Research and, to the extent

possible, in consultation with the Health Care Financing Administration, may fund research to develop a text-based standardized

billing process, through the utilization of text-based information

retrieval and natural language processing techniques applied to

automatic coding and analysis of textual patient discharge summaries and other text-based electronic medical records, within a

parallel general purpose (shared memory) high performance computing environment. The Secretary shall determine whether such a

standardized approach to medical billing, through the utilization

of the text-based hospital discharge summary as well as electronic

patient records can reduce the administrative billing costs of health

care delivery.

SEC. 1910. SENTINEL DISEASE CONCEPT STUDY.

(a) IN GENERAL.—The Secretary of Health and Human Services,

in cooperation with the Agency for Toxic Substances and Disease

Registry and the Centers for Disease Control and Prevention, shall

design and implement a pilot sentinel disease surveillance system,

and as appropriate, a follow-up system. (b) PURPOSE.—The purpose of the study conducted under sub- section (a) shall be to determine the applicability of and the difficulties associated with the implementation of the sentinel disease

concept for identifying the relationship between the occupation of

household members and the incidence of subsequent conditions

or diseases in other members of the household.

(c) REPORT.—Not later than 4 years after the date of enactment

of this Act, the Director of the National Institutes of Health shall

prepare and submit to the appropriate committees of Congress,

a report concerning the results of the study conducted under subsection (a).

SEC. 1911. POTENTIAL ENVIRONMENTAL AND OTHER RISKS CONTRIBUTING TO INCIDENCE OF BREAST CANCER.

(a) REQUIREMENT OF STUDY.—

(1) IN GENERAL.—The Director of the National Cancer

Institute (in this section referred to as the ‘‘Director’’), in

collaboration with the Director of the National Institute of

Environmental Health Sciences, shall conduct a case-control

study to assess biological markers of environmental and other

potential risk factors contributing to the incidence of breast

cancer in—
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(A) the Counties of Nassau and Suffolk, in the State

of New York; and

(B) the 2 counties in the northeastern United States

that, as identified in the report specified in paragraph

(2), had the highest age-adjusted mortality rate of such

cancer that reflected not less than 30 deaths during the

5-year period for which findings are made in the report.

(2) RELEVANT REPORT.—The report referred to in paragraph

(1)(B) is the report of the findings made in the study entitled

‘‘Survival, Epidemiology, and End Results’’, relating to cases

of cancer during the years 1983 through 1987.

(b) CERTAIN ELEMENTS OF STUDY.—Activities of the Director

in carrying out the study under subsection (a) shall include the

use of a geographic system to evaluate the current and past 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;

(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 30 months after the date of the

enactment of this Act, the Director shall complete the study required

in subsection (a) and submit to the Committee on Energy and

Commerce of the House of Representatives, and to the Committee

on Labor and Human Resources of the Senate, a report describing

the findings made as a result of the study. (d) FUNDING.—Of the amounts appropriated for fiscal years

1994 and 1995 for the National Institute of Environmental 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).

SEC. 1912. SUPPORT FOR BIOENGINEERING RESEARCH.

(a) STUDY.—The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall

conduct a study for the purpose of— (1) determining the sources and amounts of public and

private funding devoted to basic research in bioengineering,

including biomaterials sciences, cellular bioprocessing, tissue

and rehabilitation engineering; (2) evaluating whether that commitment is sufficient to

maintain the innovative edge that the United States has in

these technologies;

(3) evaluating the role of the National Institutes of Health

or any other Federal agency to achieve a greater commitment

to innovation in bioengineering; and

(4) evaluating the need for better coordination and

collaboration among Federal agencies and between the public

and private sectors.

In conducting such study, the Director shall work in conjunction

with appropriate organizations and representatives including academics, industry leaders, bioengineering societies, and public agencies.
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(b) REPORT.—Not later than 1 year after the date of enactment

of this Act, the Secretary of Health and Human Services shall

prepare and submit to the Committee on Labor and Human

Resources of the Senate, and the Committee on Energy and Commerce of the House of Representatives, a report containing the

findings of the study conducted under subsection (a) together with

recommendations concerning the enactment of legislation to implement the results of such study.

SEC. 1913. COST OF CARE IN LAST 6 MONTHS OF LIFE.

(a) STUDY.—

(1) IN GENERAL.—The Secretary of Health and Human

Services (in this section referred to as the ‘‘Secretary’’), acting

through the Agency for Health Care Policy and Research and,

to the degree possible, in consultation with the Health Care

Financing Administration, shall conduct a study, using the

most recent National Medical Expenditure Survey database,

to estimate the average amount of health care expenditures

incurred during the last 6 months of life by—

(A) the population of individuals who are 65 years

of age and older; and

(B) the total population, broken down based on

noninstitutionalized and institutionalized populations.

(2) ELEMENTS OF STUDY.—The study conducted under paragraph (1) shall—

(A) be designed in a manner that will produce estimates of health care costs expended for health care provided to individuals during the last 6 months of life; (B) be designed to produce estimates of such costs for the populations identified in subparagraphs (A) and

(B) of paragraph (1); (C) include a calculation of the estimated amount of

total health care expenditures during such periods of time;

and

(D) include a calculation of the estimate described in

subparagraph (C)— (i) as a percentage of the total national health

care expenditures; and

(ii) for those age 65 years and over, as a percentage

of the total Medicare expenditures for those age 65

years and over. (b) REPORT.—Not later than 6 months after the date of the

enactment of this Act, the Secretary shall prepare and submit

to the Committee on Labor and Human Resources of the Senate

and the Committee on Energy and Commerce of the House of

Representatives, a report containing the findings resulting from

the study described in subsection (a).

(c) 1996 NATIONAL MEDICAL EXPENDITURE SURVEY.—

(1) IN GENERAL.—The Secretary, acting through the Agency

for Health Care Policy and Research, shall ensure that the

1996 National Medical Expenditure Survey is designed in a

manner that will produce an estimate of the amount expended

for health care provided to individuals during the last 6 months

of life.

(2) POPULATIONS.—In designing the Survey under paragraph (1), the Secretary shall ensure that such Survey produces

the data required under such paragraph for the population
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of individuals who are 65 years of age or older, broken down

based on noninstitutionalized and institutionalized populations.

TITLE XX—MISCELLANEOUS

PROVISIONS

SEC. 2001. DESIGNATION OF SENIOR BIOMEDICAL RESEARCH SERVICE

IN HONOR OF SILVIO O. CONTE; LIMITATION ON NUMBER

OF MEMBERS.

(a) IN GENERAL.—Section 228(a) of the Public Health Service

Act (42 U.S.C. 237(a)), as added by section 304 of Public Law

101–509, is amended to read as follows:

‘‘(a)(1) There shall be in the Public Health Service a Silvio

O. Conte Senior Biomedical Research Service, not to exceed 500

members.

‘‘(2) The authority established in paragraph (1) regarding the

number of members in the Silvio O. Conte Senior Biomedical

Research Service is in addition to any authority established regarding the number of members in the commissioned Regular Corps,

in the Reserve Corps, and in the Senior Executive Service. Such

paragraph may not be construed to require that the number of

members in the commissioned Regular Corps, in the Reserve Corps,

or in the Senior Executive Service be reduced to offset the number

of members serving in the Silvio O. Conte Senior Biomedical

Research Service (in this section referred to as the ‘Service’).’’.

(b) CONFORMING AMENDMENT.—Section 228 of the Public

Health Service Act (42 U.S.C. 237), as added by section 304 of

Public Law 101–509, is amended in the heading for the section

by amending the heading to read as follows:

‘‘SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH SERVICE’’.

SEC. 2002. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE FOR

RESEARCH.

Not later than June 1, 1994, the Secretary of Health and

Human Services, acting through the Director of the National

Institutes of Health, shall present to the Congress a master plan

to provide for the replacement or refurbishment of less than adequate buildings, utility equipment and distribution systems (including the resources that provide electrical and other utilities, chilled

water, air handling, and other services that the Secretary, acting

through the Director, deems necessary), roads, walkways, parking

areas, and grounds that underpin the laboratory and clinical facilities of the National Institutes of Health. Such plan may make

recommendations for the undertaking of new projects that are

consistent with the objectives of this section, such as encircling

the National Institutes of Health Federal enclave with an adequate

chilled water conduit.

SEC. 2003. CERTAIN AUTHORIZATION OF APPROPRIATIONS.

Section 399L(a) of the Public Health Service Act (42 U.S.C.

280e–4(a)), as added by Public Law 102–515 (106 Stat. 3376),

is amended—

(1) in the first sentence, by striking ‘‘the Secretary’’ and

all that follows and inserting the following: ‘‘there are authorized to be appropriated $30,000,000 for fiscal year 1994, and
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such sums as may be necessary for each of the fiscal years

1995 through 1996.’’; and (2) in the second sentence, by striking ‘‘Out of any amounts used’’ and inserting ‘‘Of the amounts appropriated under the

preceding sentence’’.

SEC. 2004. BUY-AMERICAN PROVISIONS.

(a) COMPLIANCE WITH BUY AMERICAN ACT.—No funds appropriated pursuant to this Act for any of the fiscal years 1994 through

1996 may be expended by an entity unless the entity agrees that

in expending the assistance the entity will comply with sections

2 through 4 of the Act of March 3, 1933 (41 U.S.C. 10a–10c,

popularly known as the ‘‘Buy American Act’’). (b) SENSE OF CONGRESS; REQUIREMENT REGARDING NOTICE.— (1) PURCHASE OF AMERICAN-MADE EQUIPMENT AND PRODUCTS.—In the case of any equipment or product that may be authorized to be purchased with financial assistance provided pursuant to this Act for any of the fiscal years 1994

through 1996, it is the sense of the Congress that entities

receiving such assistance should, in expending the assistance,

purchase only American-made equipment and products. (2) NOTICE TO RECIPIENTS OF ASSISTANCE.—In providing

financial assistance pursuant to this Act, the Secretary of

Health and Human Services shall provide to each recipient

of the assistance a notice describing the statement made in

paragraph (1) by the Congress.

SEC. 2005. PROHIBITION AGAINST FURTHER FUNDING FOR PROJECT

ARIES.

For fiscal year 1994 and each subsequent fiscal year, the project

administered by the University of Washington at Seattle and known

as Project Aries may not receive any funding from any agency

of the National Institutes of Health (other than payments under

awards made for fiscal year 1993 or prior fiscal years) unless—

(1) the proposal for funding for the project has undergone

review in accordance with the applicable requirements of section 491 of the Public Health Service Act on restrictions regarding institutional review boards and ethics guidance;

(2) the proposal for funding for the project has undergone

review in accordance with the applicable requirements of section 492 of such Act on restrictions regarding peer review;

(3) the Secretary of Health and Human Services, in accordance with section 492A of such Act (as added by section 101

of this Act), makes a determination that the project will assist—

(A) in reducing the incidence of infection with the

human immunodeficiency virus;

(B) in reducing the incidence of sexually transmitted

diseases; or

(C) in reducing the incidence of tuberculosis; and

(4) the data to be collected through the project cannot

be obtained in any other manner.

SEC. 2006. LOAN REPAYMENT PROGRAM.

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 391 et seq.), as amended by Public Law 101–635, is

amended—

(1) by redesignating the second section 903 as section 904;

and
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(2) by adding at the end the following section:

‘‘SEC. 905. LOAN REPAYMENT PROGRAM.

‘‘(a) IN GENERAL.—

‘‘(1) AUTHORITY FOR PROGRAM.—Subject to paragraph (2),

the Secretary shall carry out a program of entering into contracts with appropriately qualified health professionals under

which such health professionals agree to conduct research, as

employees of the Food and Drug Administration, in consideration of the Federal Government agreeing to repay, for each

year of such service, not more than $20,000 of the principal

and interest of the educational loans of such health professionals.

‘‘(2) LIMITATION.—The Secretary may not enter into an

agreement with a health professional pursuant to paragraph

(1) unless such professional—

‘‘(A) has a substantial amount of educational loans

relative to income; and

‘‘(B) agrees to serve as an employee of the Food and

Drug Administration for purposes of paragraph (1) for a

period of not less than 3 years.

‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—With respect to

the National Health Service Corps Loan Repayment Program established in subpart III of part D of title III of the Public Health

Service Act, the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in such subsection in the same manner and to the same

extent as such provisions apply to the National Health Service

Corps Loan Repayment Program. ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of

carrying out this section, there are authorized to be appropriated

such sums as may be necessary for each of the fiscal years 1994

through 1996.’’.

SEC. 2007. EXCLUSION OF ALIENS INFECTED WITH THE AGENT FOR

ACQUIRED IMMUNE DEFICIENCY SYNDROME.

(a) EXCLUSION OF ALIENS ON HEALTH-RELATED GROUNDS.— Section 212(a)(1)(A)(i) of the Immigration and Nationality Act (8

U.S.C. 1182(a)(1)(A)(i)) is amended by adding at the end the following: ‘‘which shall include infection with the etiologic agent for

acquired immune deficiency syndrome,’’. (b) EFFECTIVE DATE.—The amendment made by subsection (a)

shall take effect 30 days after the date of the enactment of this

Act.

SEC. 2008. TECHNICAL CORRECTIONS.

(a) TITLE III.—Section 316 of the Public Health Service Act

(42 U.S.C. 247a(c)) is amended by striking subsection (c).

(b) TITLE IV.—Title IV of the Public Health Service Act (42

U.S.C. 281 et seq.) is amended—

(1) in section 406—

(A) in subsection (b)(2)(A), by striking ‘‘Veterans’

Administration’’ each place such term appears and inserting ‘‘Department of Veterans Affairs’’; and

(B) in subsection (h)(2)(A)(v), by striking ‘‘Veterans’

Administration’’ and inserting ‘‘Department of Veterans

Affairs’’;
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(2) in section 408, in subsection (b) (as redesignated by

section 501(c)(1)(C) of this Act), by striking ‘‘Veterans’ Administration’’ and inserting ‘‘Department of Veterans Affairs’’;

(3) in section 421(b)(1), by inserting a comma after ‘‘may’’;

(4) in section 428(b), in the matter preceding paragraph

(1), by striking ‘‘the the’’ and inserting ‘‘the’’;

(5) in section 430(b)(2)(A)(i), by striking ‘‘Veterans’

Administration’’ and inserting ‘‘Department of Veterans

Affairs’’;

(6) in section 439(b), by striking ‘‘Veterans’ Administration’’

and inserting ‘‘Department of Veterans Affairs’’;

(7) in section 442(b)(2)(A), by striking ‘‘Veterans’ Administration’’ and inserting ‘‘Department of Veterans Affairs’’;

(8) in section 464D(b)(2)(A), by striking ‘‘Veterans’ Administration’’ and inserting ‘‘Department of Veterans Affairs’’;

(9) in section 464E—

(A) in subsection (d), in the first sentence, by inserting

‘‘Coordinating’’ before ‘‘Committee’’; and

(B) in subsection (e), by inserting ‘‘Coordinating’’ before

‘‘Committee’’ the first place such term appears;

(10) in section 464P(b)(6) (as added by section 123 of Public

Law 102–321 (106 Stat. 362)), by striking ‘‘Administration’’

and inserting ‘‘Institute’’;

(11) in section 466(a)(1)(B), by striking ‘‘Veterans’ Administration’’ and inserting ‘‘Department of Veterans Affairs’’;

(12) in section 480(b)(2)(A), by striking ‘‘Veterans’ Administration’’ and inserting ‘‘Department of Veterans Affairs’’;

(13) in section 485(b)(2)(A), by striking ‘‘Veterans’ Administration’’ and inserting ‘‘Department of Veterans Affairs’’; (14) in section 487(d)(3), by striking ‘‘section 304(a)(3)’’ and inserting ‘‘section 304(a)’’; and (15) in section 496(a), by striking ‘‘Such appropriations,’’

and inserting the following: ‘‘Appropriations to carry out the

purposes of this title,’’.

(c) TITLE XV.—

(1) LIMITED AUTHORITY REGARDING FOR-PROFIT ENTITIES.— Section 1501(b) of the Public Health Service Act (42 U.S.C.

300k(b)) is amended—

(A) by striking ‘‘STATES.—A State’’ and all that follows

through ‘‘may expend’’ and inserting the following:

‘‘STATES.— ‘‘(1) IN GENERAL.—A State receiving a grant under sub- section (a) may, subject to paragraph (2), expend’’; and (B) by adding at the end the following paragraph: ‘‘(2) LIMITED AUTHORITY REGARDING OTHER ENTITIES.—In

addition to the authority established in paragraph (1) for a

State with respect to grants and contracts, the State may

provide for screenings under subsection (a)(1) through entering

into contracts with private entities. The amount paid by a

State to a private entity under the preceding sentence for

a screening procedure may not exceed the amount that would

be paid under part B of title XVIII of the Social Security

Act if payment were made under such part for furnishing

the procedure to a woman enrolled under such part.’’.

(2) CONFORMING AMENDMENT.—Section 1505(3) of the Public Health Service Act (42 U.S.C. 300n–1(3)) is amended by

inserting before the semicolon the following: ‘‘(and additionally,
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in the case of services and activities under section 1501(a)(1),

with any similar services or activities of private entities)’’.

(d) TITLE XXIII.—Part A of title XXIII of the Public Health

Service Act (42 U.S.C. 300cc et seq.) is amended—

(1) in section 2304—

(A) in the heading for the section, by striking ‘‘CLINICAL RESEARCH REVIEW COMMITTEE’’ and inserting

‘‘RESEARCH ADVISORY COMMITTEE’’; and

(B) in subsection (a), by striking ‘‘AIDS Clinical

Research Review Committee’’ and inserting ‘‘AIDS

Research Advisory Committee’’;

(2) in section 2312(a)(2)(A), by striking ‘‘AIDS Clinical

Research Review Committee’’ and inserting ‘‘AIDS Research

Advisory Committee’’;

(3) in section 2314(a)(1), in the matter preceding subparagraph (A), by striking ‘‘Clinical Research Review Committee’’

and inserting ‘‘AIDS Research Advisory Committee’’;

(4) in section 2317(d)(1), by striking ‘‘Clinical Research

Review Committee’’ and inserting ‘‘AIDS Research Advisory

Committee established under section 2304’’; and

(5) in section 2318(b)(3), by striking ‘‘Clinical Research

Review Committee’’ and inserting ‘‘AIDS Research Advisory

Committee’’.

(e) SECRETARY.—Section 2(c) of the Public Health Service Act

(42 U.S.C. 201(c)) is amended by striking ‘‘Health, Education, and

Welfare’’ and inserting ‘‘Health and Human Services’’.

(f) DEPARTMENT.—Section 201 of the Public Health Service

Act (42 U.S.C. 202) is amended—

(1) by striking ‘‘Health, Education, and Welfare’’ and inserting ‘‘Health and Human Services’’; and (2) by striking ‘‘Surgeon General’’ and inserting ‘‘Assistant

Secretary for Health’’.

(g) DEPARTMENT.—Section 202 of the Public Health Service

Act (42 U.S.C. 203) is amended—

(1) by striking ‘‘Surgeon General’’ the second and subsequent times that such term appears and inserting ‘‘Secretary’’;

and

(2) by inserting ‘‘, and the Agency for Health Care Policy

and Research’’ before the first period.

(h) VOLUNTEER SERVICES.—Section 223 of the Public Health

Service Act (42 U.S.C. 217b) is amended by striking ‘‘Health, Education, and Welfare’’ and inserting ‘‘Health and Human Services’’. (i) MISCELLANEOUS.— (1) AMENDATORY INSTRUCTIONS.— (A) Section 602(a) of Public Law 102–585 (106 Stat.

4967) is amended by striking ‘‘by adding the following

subpart’’ and inserting ‘‘by adding at the end the following

subpart’’.

(B) Public Law 102–531 is amended—

(i) in section 303(b) (106 Stat. 3488)—

(I) by striking ‘‘Part A of title III’’ and inserting

‘‘Part B of title III’’; and

(II) by striking ‘‘241 et seq.’’ and inserting

‘‘243 et seq.’’;

(ii) in section 304 (106 Stat. 3490)—

(I) by striking ‘‘Part A of title III’’ and inserting

‘‘Part B of title III’’; and
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(II) by striking ‘‘241 et seq.’’ and inserting

‘‘243 et seq.’’;

(iii) in section 306 (106 Stat. 3494), by striking

‘‘Part A of title III’’ and inserting ‘‘Part B of title

III’’; and

(iv) in section 308 (106 Stat. 3495), by striking

‘‘Part A of title III’’ and inserting ‘‘Part B of title

III’’;

(2) TITLE III OF PUBLIC HEALTH SERVICE ACT.—Title III

of the Public Health Service Act (42 U.S.C. 241 et seq.), as

amended by Public Law 102–321, Public Law 102–515, Public

Law 102–531, and Public Law 102–585, by section 121(a) of

this Act, and by paragraph (1) of this subsection, is amended—

(A) in part D—

(i) by transferring subpart VIII from the current

placement of the subpart and inserting the subpart

after subpart VII; and

(ii) by redesignating section 340B of subpart VIII

as section 340C; and

(B)(i) by redesignating parts K and L as parts J and

K, respectively; and

(ii) by redesignating the part M added by Public Law

102–321 as part L.

(3) TITLE VII OF PUBLIC HEALTH SERVICE ACT.—Section

746(i)(1) of the Public Health Service Act (42 U.S.C. 293j(i)(1)),

as added by section 102 of Public Law 102–408 (106 Stat.

1994) and amended by section 313(a)(2)(B) of Public Law 102–

531 (106 Stat. 3507), is amended to read as if the amendment

made by such section 313(a)(2)(B) had not been enacted.

SEC. 2009. BIENNIAL REPORT ON CARCINOGENS.

Section 301(b)(4) of the Public Health Service Act (42 U.S.C.

241(b)(4)) is amended by striking ‘‘an annual’’ and inserting ‘‘a

biennial’’.

SEC. 2010. TRANSFER OF PROVISIONS OF TITLE XXVII.

(a) IN GENERAL.—The Public Health Service Act (42 U.S.C.

201 et seq.), as amended by section 101 of Public Law 101–381

and section 304 of Public Law 101–509, is amended—

(1) by transferring sections 2701 through 2714 to title

II;

(2) by redesignating such sections as sections 231 through

244, respectively; (3) by inserting such sections, in the appropriate sequence,

after section 228;

(4) by inserting before section 201 the following heading:

‘‘PART A—ADMINISTRATION’’; and

(5) by inserting before section 231 (as redesignated by

paragraph (2) of this subsection) the following heading:

‘‘PART B—MISCELLANEOUS PROVISIONS’’.

(b) CONFORMING AMENDMENTS.—The Public Health Service Act

(42 U.S.C. 201 et seq.) is amended—

(1) in the heading for title II, by inserting ‘‘AND MISCELLANEOUS PROVISIONS’’ after ‘‘ADMINISTRATION’’;
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(2) in section 406(a)(2), by striking ‘‘2701’’ and inserting

‘‘231’’;

(3) in section 465(f), by striking ‘‘2701’’ and inserting ‘‘231’’;

(4) in section 480(a)(2), by striking ‘‘2701’’ and inserting

‘‘231’’;

(5) in section 485(a)(2), by striking ‘‘2701’’ and inserting

‘‘231’’;

(6) in section 497, by striking ‘‘2701’’ and inserting ‘‘231’’;

(7) in section 505(a)(2), by striking ‘‘2701’’ and inserting

‘‘231’’;

(8) in section 926(b), by striking ‘‘2711’’ each place such term appears and inserting ‘‘241’’; and (9) in title XXVII, by striking the heading for such title.

SEC. 2011. AUTHORIZATION OF APPROPRIATIONS.

Section 2602 of the Low-Income Home Energy Assistance Act of 1981 (42 U.S.C. 8621) is amended—

(1) in the first sentence of subsection (b), by striking ‘‘1993 and 1994’’ and inserting ‘‘1993, 1994, and 1995’’; and (2) in subsection (d), by striking ‘‘in each of the fiscal

years 1993 and 1994’’ and inserting ‘‘for each of the fiscal

years 1993, 1994, and 1995’’.

SEC. 2012. VACCINE INJURY COMPENSATION PROGRAM.

Section 2111(a) of the Public Health Service Act (42 U.S.C.

300aa–11(a)) is amended by adding at the end the following paragraph:

‘‘(10) The Clerk of the United States Claims Court is

authorized to continue to receive, and forward, petitions for

compensation for a vaccine-related injury or death associated

with the administration of a vaccine on or after October 1,

1992.’’.

SEC. 2013. TECHNICAL CORRECTIONS WITH RESPECT TO THE AGENCY

FOR HEALTH CARE POLICY AND RESEARCH.

Title IX of the Public Health Service Act is amended—

(1) in section 904(d) (42 U.S.C. 299a–2(d))—

(A) by striking ‘‘IN GENERAL’’ in paragraph (1) and

inserting ‘‘ADDITIONAL ASSESSMENTS’’;

(B) by redesignating paragraphs (1) and (2) as paragraphs (3) and (4), respectively;

(C) by inserting after the subsection designation the

following paragraphs:

‘‘(1) RECOMMENDATIONS WITH RESPECT TO HEALTH CARE

TECHNOLOGY.—The Administrator shall make recommendations

to the Secretary with respect to whether specific health care

technologies should be reimbursable under federally financed

health programs, including recommendations with respect to

any conditions and requirements under which any such

reimbursements should be made.

‘‘(2) CONSIDERATIONS OF CERTAIN FACTORS.—In making recommendations respecting health care technologies, the

Administrator shall consider the safety, efficacy, and effectiveness, and, as appropriate, the appropriate uses of such technologies. The Administrator shall also consider the cost

effectiveness of such technologies where cost information is

available and reliable.’’; and

(D) by adding at the end the following paragraph:
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‘‘(5) CONSULTATIONS.—In carrying out this subsection, the

Administrator shall cooperate and consult with the Director

of the National Institutes of Health, the Commissioner of Food

and Drugs, and the heads of any other interested Federal

department or agency.’’; and

(2) in section 914(a)(2)(C), by striking ‘‘904(c)(2)’’ and inserting ‘‘904(d)(2)’’.

SEC. 2014. TECHNICAL CORRECTIONS WITH RESPECT TO THE HEALTH

PROFESSIONS EDUCATION EXTENSION AMENDMENTS OF

1992.

(a) INSURED HEALTH EDUCATION ASSISTANCE LOANS TO GRADUATE STUDENTS.—Subpart I of part A of title VII of the Public

Health Service Act (42 U.S.C. 292 et seq.), as added by section

102 of Public Law 102–408 (106 Stat. 1994), is amended—

(1) in section 705(a)(2)—

(A) in subparagraph (G), by inserting ‘‘and’’ after the

semicolon at the end;

(B) by striking subparagraph (H); and

(C) by redesignating subparagraph (I) as subparagraph

(H); and

(2) in section 707—

(A) in subsection (g), by amending paragraph (1) to

read as follows:

‘‘(1) after the expiration of the seven-year period beginning

on the first date when repayment of such loan is required,

exclusive of any period after such date in which the obligation

to pay installments on the loan is suspended;’’; and (B) by adding at the end the following subsection: ‘‘(j) SCHOOL COLLECTION ASSISTANCE.—An institution or postgraduate training program attended by a borrower may assist in

the collection of any loan of that borrower made under this subpart

which becomes delinquent, including providing information concerning the borrower to the Secretary and to past and present lenders

and holders of the borrower’s loans, contacting the borrower in

order to encourage repayment, and withholding services in accordance with regulations issued by the Secretary under section

715(a)(7). The institution or postgraduate training program shall

not be subject to section 809 of the Fair Debt Collection Practices

Act for purposes of carrying out activities authorized by this section.’’.

(b) LOAN PROVISIONS.—Section 722 of the Public Health Service

Act (42 U.S.C. 292r), as added by section 102 of Public Law 102–

408 (106 Stat. 1994), is amended—

(1) in subsection (a), by amending the subsection to read

as follows:

‘‘(a) AMOUNT OF LOAN.—

‘‘(1) IN GENERAL.—Loans from a student loan fund (established under an agreement with a school under section 721)

may not, subject to paragraph (2), exceed for any student for

a school year (or its equivalent) the sum of—

‘‘(A) the cost of tuition for such year at such school,

and

‘‘(B) $2,500.

‘‘(2) THIRD AND FOURTH YEARS OF MEDICAL SCHOOL.—For

purposes of paragraph (1), the amount $2,500 may, in the

case of the third or fourth year of a student at school of
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medicine or osteopathic medicine, be increased to the extent

necessary (including such $2,500) to pay the balances of loans

that, from sources other than the student loan fund under

section 721, were made to the individual for attendance at

the school. The authority to make such an increase is subject

to the school and the student agreeing that such amount (as

increased) will be expended to pay such balances.’’; and

(2) in subsection (b)—

(A) in paragraph (1), by adding ‘‘and’’ after the semicolon at the end;

(B) by striking paragraph (2); and

(C) by redesignating paragraph (3) as paragraph (2).

(c) MEDICAL SCHOOLS AND PRIMARY HEALTH CARE.—

(1) REQUIREMENTS FOR STUDENTS.—Section 723(a) of the

Public Health Service Act (42 U.S.C. 292s(a)), as added by

section 102 of Public Law 102–408 (106 Stat. 1994), is amended

by adding at the end the following paragraph:

‘‘(4) WAIVERS.—

‘‘(A) With respect to the obligation of an individual

under an agreement made under paragraph (1) as a student, the Secretary shall provide for the partial or total

waiver or suspension of the obligation whenever compliance

by the individual is impossible, or would involve extreme

hardship to the individual, and if enforcement of the obligation with respect to the individual would be unconscionable.

‘‘(B) For purposes of subparagraph (A), the obligation

of an individual shall be waived if—

‘‘(i) the status of the individual as a student of

the school involved is terminated before graduation

from the school, whether voluntarily or involuntarily;

and

‘‘(ii) the individual does not, after such termination, resume attendance at the school or begin

attendance at any other school of medicine or osteopathic medicine.

‘‘(C) If an individual resumes or begins attendance for purposes of subparagraph (B), the obligation of the

individual under the agreement under paragraph (1) shall

be considered to have been suspended for the period in

which the individual was not in attendance.

‘‘(D) This paragraph may not be construed as authorizing the waiver or suspension of the obligation of a student

to repay, in accordance with section 722, loans from student

loan funds under section 721.’’.

(2) REQUIREMENTS FOR SCHOOLS.—Section 723(b) of the

Public Health Service Act (42 U.S.C. 292s(b)), as added by

section 102 of Public Law 102–408 (106 Stat. 1994), is

amended—

(A) in paragraph (1)—

(i) by striking ‘‘1994,’’ and inserting ‘‘1997;’’; and

(ii) by striking ‘‘4 years before’’ and inserting ‘‘3

years before’’;

(B) in paragraph (2)(B), by striking ‘‘15 percent’’ and

inserting ‘‘25 percent’’; and

(C) in paragraph (4)(B)—

(i) in clause (i), by striking ‘‘1994,’’ and inserting

‘‘1997,’’; and
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(ii) in clause (ii), by striking ‘‘1995,’’ and inserting

‘‘1998,’’.

(d) AUTHORIZATION OF APPROPRIATIONS REGARDING MEDICAL

SCHOOLS.—Section 735 of the Public Health Service Act (42 U.S.C.

292y), as added by section 102 of Public Law 102–408 (106 Stat.

1994), is amended by adding at the end the following subsection:

‘‘(f) FUNDING FOR CERTAIN MEDICAL SCHOOLS.—

‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—For the purpose

of making Federal capital contributions to student loan funds

established under section 721 by schools of medicine or osteopathic medicine, there is authorized to be appropriated

$10,000,000 for each of the fiscal years 1994 through 1996.

‘‘(2) MINIMUM REQUIREMENTS.—

‘‘(A) Subject to subparagraph (B), the Secretary may

make a Federal capital contribution pursuant to paragraph

(1) only if the school of medicine or osteopathic medicine

involved meets the conditions described in subparagraph

(A) of section 723(b)(2) or the conditions described in

subparagraph (C) of such section.

‘‘(B) For purposes of subparagraph (A), the conditions

referred to in such subparagraph shall be applied with

respect to graduates of the school involved whose date

of graduation occurred approximately 3 years before June

30 of the fiscal year preceding the fiscal year for which

the Federal capital contribution involved is made.

(e) PUBLIC HEALTH TRAINEESHIPS.—Section 761(b)(3) of the

Public Health Service Act (42 U.S.C. 294(b)(3)), as added by section

102 of Public Law 102–408 (106 Stat. 1994), is amended by striking

‘‘and nutrition’’ and inserting ‘‘nutrition, and maternal and child

health’’.

(f) TRAINEESHIPS FOR ADVANCED NURSE EDUCATION.—Section

830(a) of the Public Health Service Act, as added by section 206

of Public Law 102–408 (106 Stat. 2073), is amended—

(1) by striking ‘‘meet the cost of traineeships for individuals’’ and inserting the following: ‘‘meet the costs of—

‘‘(1) traineeships for individuals’’;

(2) by striking the period at the end and inserting ‘‘; and’’;

and

(3) by adding at the end the following paragraph:

‘‘(2) traineeships for participation in certificate nurse midwifery programs that conform to guidelines established by the

Secretary under section 822(b).’’.

(g) CERTAIN GENERALLY APPLICABLE PROVISIONS.—Section

860(d) of the Public Health Service Act (42 U.S.C. 298b–7(d)),

as added by section 209 of Public Law 102–408 (106 Stat. 2075),

is amended in the first sentence by striking ‘‘821, 822, 830, and

831’’ and inserting ‘‘821, 822, and 827’’.

SEC. 2015. PROHIBITION AGAINST SHARP ADULT SEX SURVEY AND

THE AMERICAN TEENAGE SEX SURVEY.

The Secretary of Health and Human Services may not during

fiscal year 1993 or any subsequent fiscal year conduct or support

the SHARP survey of adult sexual behavior or the American Teenage Study of adolescent sexual behavior. This section becomes effective on the date of the enactment of this Act.
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SEC. 2016. HEALTH SERVICES RESEARCH.

(a) DEFINITION.—Section 409 of the Public Health Service Act

(42 U.S.C. 284d), as added by section 121(b) of Public Law 102–

321 (106 Stat. 358), is amended by adding at the end the following

sentence: ‘‘Such term does not include research on the efficacy

of services to prevent, diagnose, or treat medical conditions.’’. (b) REQUIRED ALLOCATIONS.— (1) IN GENERAL.—With respect to the allocation for health

services research required in each of the provisions of law

specified in paragraph (2), the term ‘‘15 percent’’ appearing

in each of such provisions is, in the case of allocations for

fiscal year 1993, deemed to be 12 percent. (2) RELEVANT PROVISIONS OF LAW.—The provisions of law

referred to in paragraph (1) are— (A) section 464H(d)(2) of the Public Health Service

Act, as added by section 122 of Public Law 102–321 (106

Stat. 358);

(B) section 464L(d)(2) of the Public Health Service

Act, as added by section 123 of Public Law 102–321 (106

Stat. 360); and

(C) section 464R(f)(2) of the Public Health Service Act,

as added by section 124 of Public Law 102–321 (106 Stat.

364).

(c) REPORT.—Section 494A(b) of the Public Health Service Act

(42 U.S.C. 289c–1(b)), as added by section 125 of Public Law 102–

321 (106 Stat. 366), is amended by striking ‘‘May 3, 1993,’’ and

inserting ‘‘September 30, 1993,’’.

SEC. 2017. CHILDHOOD MENTAL HEALTH.

Part E of title V of the Public Health Service Act (42 U.S.C.

290ff et seq.), as added by section 119 of Public Law 102–321

(106 Stat. 349), is amended—

(1) in section 561—

(A) in subsection (a)(2), by striking ‘‘this subpart’’ and

inserting ‘‘this part’’; and

(B) in subsection (b)(1), by striking ‘‘is receiving such

payments’’ each place such term appears and inserting

‘‘is such a grantee’’; and

(2) in section 565—

(A) in subsection (c)(1), by striking ‘‘this subpart’’ and

inserting ‘‘this part’’;

(B) in subsection (d), by striking ‘‘this subpart’’ and

inserting ‘‘this part’’; and

(C) in subsection (f)—

(i) in paragraph (1), by striking ‘‘this subpart’’

and inserting ‘‘this part’’; and

(ii) by amending paragraph (2) to read as follows:

‘‘(2) LIMITATION REGARDING TECHNICAL ASSISTANCE.—Not more

than 10 percent of the amounts appropriated under paragraph

(1) for a fiscal year may be expended for carrying out subsection

(b).’’.

SEC. 2018. EXPENDITURES FROM CERTAIN ACCOUNT.

With respect to amounts appropriated in title II of Public

Law 102–394 for buildings and facilities of the National Institutes

of Health, the purposes for which such amounts may be expended

include repairing, improving, or constructing (or any combination
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thereof) roads on non-Federal property in close proximity to the

main campus of the National Institutes of Health in Bethesda,

Maryland, subject to the agreement of the appropriate officials

of Montgomery County, Maryland, or the appropriate officials of

the State of Maryland, or both, as the case may be. None of

such amounts may be used for the non-Federal share of the cost

of any project or activity under title 23, United States Code, the

Intermodal Surface Transportation Efficiency Act of 1991, or any

law amended by such Act.

TITLE XXI—EFFECTIVE DATES

SEC. 2101. EFFECTIVE DATES.

Subject to section 203(c), this Act and the amendments made

by this Act take effect upon the date of the enactment of this

Act.

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.