Calendar No. 2

103D CONGRESS

1ST SESSION S. 1

[Report No. 103–2]

A BILL

To amend the Public Health Service Act to revise

tutes of Health, and for other purposes.and extend the programs of the National InstiJANUARY 27 (legislative day, JANUARY 5), 1993

Reported with an amendment
II

Calendar No. 2

103D CONGRESS

1ST SESSION S. 1

[Report No. 103–2]

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

of the National Institutes of Health, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JANUARY 21 (legislative day, JANUARY 5), 1993

Mr. KENNEDY (for himself, Mrs. BOXER, Mr. WELLSTONE, Mr. DODD, Mr.

LAUTENBERG, Ms. MIKULSKI, Mr. PELL, Mr. SIMON, Mr. WOFFORD,

Mr. INOUYE, Mr. SARBANES, Ms. MOSELEY-BRAUN, Mr. LEAHY, Mr.

RIEGLE, Mr. DURENBERGER, Mr. METZENBAUM, and Mr. LEVIN) introduced the following bill; which was read twice and referred to the Committee on Labor and Human Resources

JANUARY 27 (legislative day, JANUARY 5), 1993

Reported by Mr. KENNEDY, with an amendment

[Strike out all after the enacting clause and insert the part printed in italic]

A BILL

To amend the Public Health Service Act to revise and extend

the programs of the National Institutes of Health, and

for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

3 ‘‘National Institutes of Health Revitalization Act of

4 1993’’.

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

6 this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I—GENERAL PROVISIONS REGARDING TITLE IV OF

PUBLIC HEALTH SERVICE ACT

Subtitle A—Research Freedom

PART I—REVIEW OF PROPOSALS FOR BIOMEDICAL AND BEHAVIORAL

RESEARCH

Sec. 101. Establishment of certain provisions regarding research conducted or

supported by National Institutes of Health.

PART II—RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

Sec. 111. Establishment of authorities.

Sec. 112. Purchase of human fetal tissue; solicitation or acceptance of tissue

as directed donation for use in transplantation.

Sec. 113. Nullification of moratorium.

Sec. 114. Report by General Accounting Office on adequacy of requirements.

PART III—MISCELLANEOUS REPEALS

Sec. 121. Repeals.

Subtitle B—Clinical Research Equity Regarding Women and Minorities

PART I—WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH

Sec. 131. Requirement of inclusion in research.

Sec. 132. Peer review.

Sec. 133. Applicability to current projects.

PART II—OFFICE OF RESEARCH ON WOMEN’S HEALTH

Sec. 141. Establishment.

PART III—OFFICE OF RESEARCH ON MINORITY HEALTH

Sec. 151. Establishment.

Subtitle C—Scientific Integrity

Sec. 161. Establishment of Office of Scientific Integrity.

Sec. 162. Commission on Scientific Integrity.

Sec. 163. Protection of whistleblowers.
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Sec. 164. Requirement of regulations regarding protection against financial

conflicts of interest in certain projects of research.

Sec. 165. Effective dates.

TITLE II—NATIONAL INSTITUTES OF HEALTH IN GENERAL

Sec. 201. Health promotion research dissemination.

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

Sec. 203. Children’s vaccine initiative.

Sec. 204. Plan for use of animals in research.

Sec. 205. Increased participation of women and members of underrepresented

minorities in fields of biomedical and behavioral research.

Sec. 206. Requirements regarding surveys of sexual behavior.

Sec. 207. Discretionary fund of Director of National Institutes of Health.

Sec. 208. 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 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.

Sec. 504. Authorization of appropriations.

TITLE VI—NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE

AND KIDNEY DISEASES

Sec. 601. Provisions regarding nutritional disorders.

TITLE VII—NATIONAL INSTITUTE ON ARTHRITIS AND

MUSCULOSKELETAL AND SKIN DISEASES

Sec. 701. Juvenile arthritis.

TITLE VIII—NATIONAL INSTITUTE ON AGING

Sec. 801. Alzheimer’s disease registry.

Sec. 802. Aging processes regarding women.

Sec. 803. Authorization of appropriations.

Sec. 804. Conforming amendment.

TITLE IX—NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS

DISEASES
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Sec. 901. Tropical diseases.

Sec. 902. Chronic fatigue syndrome.

TITLE X—NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN

DEVELOPMENT

Subtitle A—Research Centers With Respect to Contraception and Research

Centers With Respect to Infertility

Sec. 1001. Grants and contracts for research centers.

Sec. 1002. Loan repayment program for research with respect to contraception

and infertility.

Subtitle B—Program Regarding Obstetrics and Gynecology

Sec. 1011. Establishment of program.

Subtitle C—Child Health Research Centers

Sec. 1021. Establishment of centers.

Subtitle D—Study Regarding Adolescent Health

Sec. 1031. Prospective longitudinal study.

TITLE XI—NATIONAL EYE INSTITUTE

Sec. 1101. Clinical research on diabetes eye care.

TITLE XII—NATIONAL INSTITUTE OF NEUROLOGICAL

DISORDERS AND STROKE

Sec. 1201. Research on multiple sclerosis.

TITLE XIII—NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH

SCIENCES

Sec. 1301. Applied Toxicological Research and Testing Program.

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
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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 National Institutes of Health

Sec. 1631. Establishment of programs.

Sec. 1632. Funding.

Subtitle E—Funding for Awards and Training Generally

Sec. 1641. Authorization of appropriations.

TITLE XVII—NATIONAL FOUNDATION FOR BIOMEDICAL

RESEARCH

Sec. 1701. Establishment of Foundation.

TITLE XVIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE

DEFICIENCY SYNDROME

Sec. 1801. Revision and extension of various programs.

TITLE XIX—STUDIES

Sec. 1901. Acquired immune deficiency syndrome.

Sec. 1902. Malnutrition in the elderly.

Sec. 1903. Research activities on chronic fatigue syndrome.

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

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

Sec. 1906. Procurement.
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Sec. 1907. Report concerning leading causes of death.

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

TITLE XX—MISCELLANEOUS PROVISIONS

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

Silvio Conte, and limitation on number of members.

Sec. 2002. Technical corrections.

Sec. 2003. Biennial report on carcinogens.

Sec. 2004. Master plan for physical infrastructure for research.

Sec. 2005. Transfer of provisions of title xxvii.

Sec. 2006. Certain authorization of appropriations.

Sec. 2007. Prohibition against SHARP adult sex survey and the American

teenage sex survey.

Sec. 2008. Support for bioengineering research.

TITLE XXI—EFFECTIVE DATES

Sec. 2101. Effective dates.

1 TITLE I—GENERAL PROVISIONS

2 REGARDING TITLE IV OF PUB3 LIC HEALTH SERVICE ACT

4 Subtitle A—Research Freedom

5 PART I—REVIEW OF PROPOSALS FOR

6 BIOMEDICAL AND BEHAVIORAL RESEARCH

7 SEC. 101. ESTABLISHMENT OF CERTAIN PROVISIONS RE8 GARDING RESEARCH CONDUCTED OR SUP9 PORTED BY NATIONAL INSTITUTES OF

10 HEALTH.

11 Part G of title IV of the Public Health Service Act

12 (42 U.S.C. 289 et seq.) is amended by inserting after sec13 tion 492 the following new section:

14 ‘‘CERTAIN PROVISIONS REGARDING REVIEW AND

15 APPROVAL OF PROPOSALS FOR RESEARCH

16 ‘‘SEC. 492A. (a) REVIEW AS PRECONDITION TO RE17 SEARCH.—
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1 ‘‘(1) PROTECTION OF HUMAN RESEARCH SUB2 JECTS.—

3 ‘‘(A) In the case of any application submit4 ted to the Secretary for financial assistance to

5 conduct research, the Secretary may not ap6 prove or fund any application that is subject to

7 review under section 491(a) by an Institutional

8 Review Board unless the application has under9 gone review in accordance with such section and

10 has been recommended for approval by a major11 ity of the members of the Board conducting

12 such review.

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

14 to review under procedures established by the

15 Secretary for the protection of human subjects

16 in clinical research conducted by the National

17 Institutes of Health, the Secretary may not au18 thorize the conduct of the research unless the

19 research has, pursuant to such procedures, been

20 recommended for approval.

21 ‘‘(2) PEER REVIEW.—In the case of any appli22 cation submitted to the Secretary for financial as23 sistance to conduct research, the Secretary may not

24 approve or fund any application that is subject to

25 technical and scientific peer review under section
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1 492(a) unless the application has undergone peer re2 view in accordance with such section and has been

3 recommended for approval by a majority of the

4 members of the entity conducting such review.

5 ‘‘(b) ETHICAL REVIEW OF RESEARCH.—

6 ‘‘(1) PROCEDURES REGARDING WITHHOLDING

7 OF FUNDS.—If research has been recommended for

8 approval for purposes of subsection (a), the Sec9 retary may not withhold funding for the research on

10 ethical grounds unless—

11 ‘‘(A) the Secretary convenes an advisory

12 board in accordance with paragraph (4) to

13 study the ethical implications of the research;

14 and

15 ‘‘(B) the majority of the advisory board

16 recommends that, on ethical grounds, the Sec17 retary withhold funds for the research.

18 ‘‘(2) APPLICABILITY.—The limitation estab19 lished in paragraph (1) regarding the authority to

20 withhold funds on ethical grounds shall apply with21 out regard to whether the withholding of funds is

22 characterized as a disapproval, a moratorium, a pro23 hibition, or other description.

24 ‘‘(3) PRELIMINARY MATTERS REGARDING USE

25 OF PROCEDURES.—
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1 ‘‘(A) If the Secretary makes a determina2 tion that an advisory board should be convened

3 for purposes of paragraph (1), the Secretary

4 shall, through a statement published in the

5 Federal Register, announce the intention of the

6 Secretary to convene such a board.

7 ‘‘(B) A statement issued under subpara8 graph (A) shall include a request that inter9 ested individuals submit to the Secretary rec10 ommendations specifying the particular individ11 uals who should be appointed to the advisory

12 board involved. The Secretary shall consider

13 such recommendations in making appointments

14 to the board.

15 ‘‘(C) The Secretary may not make appoint16 ments to an advisory board under paragraph

17 (1) until the expiration of the 30-day period be18 ginning on the date on which the statement re19 quired in subparagraph (A) is made with re20 spect to the board.

21 ‘‘(4) ETHICS ADVISORY BOARDS.—

22 ‘‘(A) Any advisory board convened for pur23 poses of paragraph (1) shall be known as an

24 ethics advisory board (hereafter in this para25 graph referred to as an ‘ethics board’).
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1 ‘‘(B)(i) An ethics board shall advise, con2 sult with, and make recommendations to the

3 Secretary regarding the ethics of the project of

4 biomedical or behavioral research with respect

5 to which the board has been convened.

6 ‘‘(ii) Not later than 180 days after the

7 date on which the statement required in para8 graph (3)(A) is made with respect to an ethics

9 board, the board shall submit to the Secretary,

10 and to the Committee on Energy and Com11 merce of the House of Representatives and the

12 Committee on Labor and Human Resources of

13 the Senate, a report describing the findings of

14 the board regarding the project of research in15 volved and making a recommendation under

16 clause (i) of whether the Secretary should or

17 should not withhold funds for the project. The

18 report shall include the information considered

19 in making the findings.

20 ‘‘(C) An ethics board shall be composed of

21 no fewer than 14, and no more than 20, indi22 viduals who are not officers or employees of the

23 United States. The Secretary shall make ap24 pointments to the board from among individ25 uals with special qualifications and competence
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1 to provide advice and recommendations regard2 ing ethical matters in biomedical and behavioral

3 research. Of the members of the board—

4 ‘‘(i) no fewer than 1 shall be an attor5 ney;

6 ‘‘(ii) no fewer than 1 shall be an

7 ethicist;

8 ‘‘(iii) no fewer than 1 shall be a prac9 ticing physician;

10 ‘‘(iv) no fewer than 1 shall be a theo11 logian; and

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

13 more than one-half, shall be scientists with

14 substantial accomplishments in biomedical

15 or behavioral research.

16 ‘‘(D) The term of service as a member of

17 an ethics board shall be for the life of the

18 board. If such a member does not serve the full

19 term of such service, the individual appointed to

20 fill the resulting vacancy shall be appointed for

21 the remainder of the term of the predecessor of

22 the individual.

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

24 subject to removal from the board by the Sec-
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1 retary for neglect of duty or malfeasance or for

2 other good cause shown.

3 ‘‘(F) The Secretary shall designate an indi4 vidual from among the members of an ethics

5 board to serve as the chair of the board.

6 ‘‘(G) In carrying out subparagraph (B)(i)

7 with respect to a project of research, an ethics

8 board shall conduct inquiries and hold public

9 hearings.

10 ‘‘(H) With respect to information relevant

11 to the duties described in subparagraph (B)(i),

12 an ethics board shall have access to all such in13 formation possessed by the Department of

14 Health and Human Services, or available to the

15 Secretary from other agencies.

16 ‘‘(I) Members of an ethics board shall re17 ceive compensation for each day engaged in car18 rying out the duties of the board, including

19 time engaged in traveling for purposes of such

20 duties. Such compensation may not be provided

21 in an amount in excess of the maximum rate of

22 basic pay payable for GS–18 of the General

23 Schedule.

24 ‘‘(J) The Secretary, acting through the Di25 rector of the National Institutes of Health,
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1 shall provide to each ethics board such staff

2 and other assistance as may be necessary to

3 carry out the duties of the board.

4 ‘‘(K) An ethics board shall terminate 30

5 days after the date on which the report required

6 in subparagraph (B)(ii) is submitted to the Sec7 retary and the congressional committees speci8 fied in such subparagraph.’’.

9 PART II—RESEARCH ON TRANSPLANTATION OF

10 FETAL TISSUE

11 SEC. 111. ESTABLISHMENT OF AUTHORITIES.

12 Part G of title IV of the Public Health Service Act

13 (42 U.S.C. 289 et seq.) is amended by inserting after sec14 tion 498 the following new section:

15 ‘‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

16 ‘‘SEC. 498A. (a) ESTABLISHMENT OF PROGRAM.—

17 ‘‘(1) IN GENERAL.—The Secretary may conduct

18 or support research on the transplantation of human

19 fetal tissue for therapeutic purposes.

20 ‘‘(2) SOURCE OF TISSUE.—Human fetal tissue

21 may be used in research carried out under para22 graph (1) regardless of whether the tissue is ob23 tained pursuant to a spontaneous or induced abor24 tion or pursuant to a stillbirth.

25 ‘‘(b) INFORMED CONSENT OF DONOR.—
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1 ‘‘(1) IN GENERAL.—In research carried out

2 under subsection (a), human fetal tissue may be

3 used only if the woman providing the tissue makes

4 a statement, made in writing and signed by the

5 woman, declaring that—

6 ‘‘(A) the woman donates the fetal tissue

7 for use in research described in subsection (a);

8 ‘‘(B) the donation is made without any re9 striction regarding the identity of individuals

10 who may be the recipients of transplantations

11 of the tissue; and

12 ‘‘(C) the woman has not been informed of

13 the identity of any such individuals.

14 ‘‘(2) ADDITIONAL STATEMENT.—In research

15 carried out under subsection (a), human fetal tissue

16 may be used only if the attending physician with re17 spect to obtaining the tissue from the woman in18 volved makes a statement, made in writing and

19 signed by the physician, declaring that—

20 ‘‘(A) in the case of tissue obtained pursu21 ant to an induced abortion—

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

23 abortion was obtained prior to requesting

24 or obtaining consent for the tissue to be

25 used in such research; and
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1 ‘‘(ii) no alteration of the timing,

2 method, or procedures used to terminate

3 the pregnancy was made solely for the pur4 poses of obtaining the tissue;

5 ‘‘(B) the tissue has been donated by the

6 woman in accordance with paragraph (1); and

7 ‘‘(C) full disclosure has been provided to

8 the woman with regard to—

9 ‘‘(i) such physician’s interest, if any,

10 in the research to be conducted with the

11 tissue; and

12 ‘‘(ii) any known medical risks to the

13 woman or risks to her privacy that might

14 be associated with the donation of the tis15 sue and that are in addition to risks of

16 such type that are associated with the

17 woman’s medical care.

18 ‘‘(c) INFORMED CONSENT OF RESEARCHER AND

19 DONEE.—In research carried out under subsection (a),

20 human fetal tissue may be used only if the individual with

21 the principal responsibility for conducting the research in22 volved makes a statement, made in writing and signed by

23 the individual, declaring that the individual—

24 ‘‘(1) is aware that—

25 ‘‘(A) the tissue is human fetal tissue;
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1 ‘‘(B) the tissue may have been obtained

2 pursuant to a spontaneous or induced abortion

3 or subsequent to a stillbirth; and

4 ‘‘(C) the tissue was donated for research

5 purposes;

6 ‘‘(2) has provided such information to other in7 dividuals with responsibilities regarding the research;

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

9 of an individual to be a recipient of a transplan10 tation of the tissue, written acknowledgment of re11 ceipt of such information by such recipient; and

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

13 timing, method, or procedures used to terminate the

14 pregnancy made solely for the purposes of the re15 search.

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

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

18 under subsection (a), human fetal tissue may be

19 used only if the head of the agency or other entity

20 conducting the research involved certifies to the Sec21 retary that the statements required under sub22 sections (a)(3), (b)(2), and (c) will be available for

23 audit by the Secretary.

24 ‘‘(2) CONFIDENTIALITY OF AUDIT.—Any audit

25 conducted by the Secretary pursuant to paragraph
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1 (1) shall be conducted in a confidential manner to

2 protect the privacy rights of the individuals and enti3 ties involved in such research, including such indi4 viduals and entities involved in the donation, trans5 fer, receipt, or transplantation of human fetal tissue.

6 With respect to any material or information obtained

7 pursuant to such audit, the Secretary shall—

8 ‘‘(A) use such material or information only

9 for the purposes of verifying compliance with

10 the requirements of this section;

11 ‘‘(B) not disclose or publish such material

12 or information, except where required by Fed13 eral law, in which case such material or infor14 mation shall be coded in a manner such that

15 the identities of such individuals and entities

16 are protected; and

17 ‘‘(C) not maintain such material or infor18 mation after completion of such audit, except

19 where necessary for the purposes of such audit.

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

21 ‘‘(1) RESEARCH CONDUCTED BY RECIPIENTS

22 OF ASSISTANCE.—The Secretary may not provide

23 support for research under subsection (a) conduct

24 the research in accordance with applicable State and

25 local law.
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1 ‘‘(2) RESEARCH CONDUCTED BY SECRETARY.—

2 The Secretary may conduct research under sub3 section (a) only in accordance with applicable State

4 and local law.

5 ‘‘(f) DEFINITION.—For purposes of this section, the

6 term ‘human fetal tissue’ means tissue or cells obtained

7 from a dead human embryo or fetus after a spontaneous

8 or induced abortion, or after a stillbirth.’’.

9 SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITA10 TION OR ACCEPTANCE OF TISSUE AS DI11 RECTED DONATION FOR USE IN TRANSPLAN12 TATION.

13 Part G of title IV of the Public Health Service Act,

14 as amended by section 111 of this Act, is amended by in15 serting after section 498A the following new section:

16 ‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE

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

18 unlawful for any person to knowingly acquire, receive, or

19 otherwise transfer any human fetal tissue for valuable con20 sideration if the transfer affects interstate commerce.

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

22 DIRECTED DONATION FOR USE IN TRANSPLANTATION.—

23 It shall be unlawful for any person to solicit or knowingly

24 acquire, receive, or accept a donation of human fetal tissue

25 for the purpose of transplantation of such tissue into an26 other person if the donation affects interstate commerce,
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1 the tissue will be or is obtained pursuant to an induced

2 abortion, and—

3 ‘‘(1) the donation will be or is made pursuant

4 to a promise to the donating individual that the do5 nated tissue will be transplanted into a recipient

6 specified by such individual;

7 ‘‘(2) the donated tissue will be transplanted

8 into a relative of the donating individual; or

9 ‘‘(3) the person who solicits or knowingly ac10 quires, receives, or accepts the donation has provided

11 valuable consideration for the costs associated with

12 such abortion.

13 ‘‘(c) CRIMINAL PENALTIES FOR VIOLATIONS.—

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

15 subsection (a) or (b) shall be fined in accordance

16 with title 18, United States Code, subject to para17 graph (2), or imprisoned for not more than 10

18 years, or both.

19 ‘‘(2) PENALTIES APPLICABLE TO PERSONS RE20 CEIVING CONSIDERATION.—With respect to the im21 position of a fine under paragraph (1), if the person

22 involved violates subsection (a) or (b)(3), a fine shall

23 be imposed in an amount not less than twice the

24 amount of the valuable consideration received.

25 ‘‘(d) DEFINITIONS.—For purposes of this section:
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1 ‘‘(1) The term ‘human fetal tissue’ has the

2 meaning given such term in section 498A(f).

3 ‘‘(2) The term ‘interstate commerce’ has the

4 meaning given such term in section 201(b) of the

5 Federal Food, Drug, and Cosmetic Act.

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

7 include reasonable payments associated with the

8 transportation, implantation, processing, preserva9 tion, quality control, or storage of human fetal tis10 sue.’’.

11 SEC. 113. NULLIFICATION OF MORATORIUM.

12 (a) IN GENERAL.—Except as provided in subsection

13 (c), no official of the executive branch may impose a policy

14 that the Department of Health and Human Services is

15 prohibited from conducting or supporting any research on

16 the transplantation of human fetal tissue for therapeutic

17 purposes. Such research shall be carried out in accordance

18 with section 498A of the Public Health Service Act (as

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

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

21 of the enactment of this Act.

22 (b) PROHIBITION AGAINST WITHHOLDING OF FUNDS

23 IN CASES OF TECHNICAL AND SCIENTIFIC MERIT.—

24 (1) IN GENERAL.—In the case of any proposal

25 for research on the transplantation of human fetal
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1 tissue for therapeutic purposes, the Secretary of

2 Health and Human Services may not withhold funds

3 for the research if—

4 (A) the research has been approved for

5 purposes of section 492A(a) of the Public

6 Health Service Act (as added by section 101 of

7 this Act);

8 (B) the research will be carried out in ac9 cordance with section 498A of such Act (as

10 added by section 111 of this Act); and

11 (C) there are reasonable assurances that

12 the research will not utilize any human fetal tis13 sue that has been obtained in violation of sec14 tion 498B(a) of such Act (as added by section

15 112 of this Act).

16 (2) STANDING APPROVAL REGARDING ETHICAL

17 STATUS.—In the case of any proposal for research

18 on the transplantation of human fetal tissue for

19 therapeutic purposes, the issuance in December

20 1988 of the Report of the Human Fetal Tissue

21 Transplantation Research Panel shall be deemed to

22 be a report—

23 (A) issued by an ethics advisory board pur24 suant to section 492A(b)(4)(B)(ii) of the Public
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1 Health Service Act (as added by section 101 of

2 this Act); and

3 (B) finding, on a basis that is neither arbi4 trary nor capricious, that there are no ethical

5 grounds for withholding funds for the research.

6 (c) AUTHORITY FOR WITHHOLDING FUNDS FROM

7 RESEARCH.—In the case of any research on the transplan8 tation of human fetal tissue for therapeutic purposes, the

9 Secretary of Health and Human Services may withhold

10 funds for the research if any of the conditions specified

11 in any of subparagraphs (A) through (C) of subsection

12 (b)(1) are not met with respect to the research.

13 (d) DEFINITION.—For purposes of this section, the

14 term ‘‘human fetal tissue’’ has the meaning given such

15 term in section 498A(f) of the Public Health Service Act

16 (as added by section 111 of this Act).

17 SEC. 114. REPORT BY GENERAL ACCOUNTING OFFICE ON

18 ADEQUACY OF REQUIREMENTS.

19 (a) IN GENERAL.—With respect to research on the

20 transplantation of human fetal tissue for therapeutic pur21 poses, the Comptroller General of the United States shall

22 conduct an audit for the purpose of determining—

23 (1) whether and to what extent such research

24 conducted or supported by the Secretary of Health

25 and Human Services has been conducted in accord-
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1 ance with section 498A of the Public Health Service

2 Act (as added by section 111 of this Act); and

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

4 violations of section 498B of such Act (as added by

5 section 112 of this Act).

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

7 Comptroller General of the United States shall complete

8 the audit required in subsection (a) and submit to the

9 Committee on Energy and Commerce of the House of

10 Representatives, and to the Committee on Labor and

11 Human Resources of the Senate, a report describing the

12 findings made pursuant to the audit.

13 PART III—MISCELLANEOUS REPEALS

14 SEC. 121. REPEALS.

15 (a) CERTAIN BIOMEDICAL ETHICS BOARD.—Title III

16 of the Public Health Service Act (42 U.S.C. 241 et seq.)

17 is amended by striking part J.

18 (b) OTHER REPEALS.—Part G of title IV of the Pub19 lic Health Service Act (42 U.S.C. 289 et seq.) is amend20 ed—

21 (1) in section 498, by striking subsection (c);

22 and

23 (2) by striking section 499; and

24 (3) by redesignating section 499A as section

25 499.
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1 (c) NULLIFICATION OF CERTAIN REGULATION.—The

2 provisions of section 204(d) of part 46 of title 45 of the

3 Code of Federal Regulations (45 CFR 46.204(d)) shall

4 not have any legal effect.

5 Subtitle B—Clinical Research Eq6 uity Regarding Women and Mi7 norities

8 PART I—WOMEN AND MINORITIES AS SUBJECTS

9 IN CLINICAL RESEARCH

10 SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.

11 Part G of title IV of the Public Health Service Act,

12 as amended by section 101 of this Act, is amended by in13 serting after section 492A the following new section:

14 ‘‘INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

15 RESEARCH

16 ‘‘SEC. 492B. (a) In conducting or supporting clinical

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

18 shall, subject to subsection (b), ensure that—

19 ‘‘(1) women are included as subjects in each

20 project of such research; and

21 ‘‘(2) members of minority groups are included

22 as subjects in such research.

23 ‘‘(b) The requirement established in subsection (a)

24 regarding women and members of minority groups shall

25 not apply to a project of clinical research if the inclusion,
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1 as subjects in the project, of women and members of mi2 nority groups, respectively—

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

4 of the subjects;

5 ‘‘(2) is inappropriate with respect to the pur6 pose of the research; or

7 ‘‘(3) is inappropriate under such other cir8 cumstances as the Director of NIH may designate.

9 ‘‘(c) In the case of any project of clinical research

10 in which women or members of minority groups will under

11 subsection (a) be included as subjects in the research, the

12 Director of NIH shall ensure that the project is designed

13 and carried out in a manner sufficient to provide for a

14 valid analysis of whether the variables being tested in the

15 research affect women or members of minority groups, as

16 the case may be, differently than other subjects in the re17 search.

18 ‘‘(d)(1) The Director of NIH, in consultation with the

19 Director of the Office of Research on Women’s Health,

20 shall establish guidelines regarding—

21 ‘‘(A) the circumstances under which the inclu22 sion of women and minorities in projects of clinical

23 research is inappropriate for purposes of subsection

24 (b);
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1 ‘‘(B) the manner in which such projects are re2 quired to be designed and carried out for purposes

3 of subsection (c), including a specification of the cir4 cumstances in which the requirement of such sub5 section does not apply on the basis of impracticabil6 ity; and

7 ‘‘(C) the conduct of outreach programs for the

8 recruitment of women and members of minority

9 groups as subjects in such research.

10 ‘‘(2) With respect to the circumstances under which

11 the inclusion of women or members of minority groups (as

12 the case may be) as subjects in clinical research is inap13 propriate for purposes of subsection (b), the guidelines es14 tablished under paragraph (1)(A)—

15 ‘‘(A) shall provide that the costs of such inclu16 sion in a project of clinical research is not a permis17 sible consideration in determining whether such in18 clusion is inappropriate unless the data of com19 parable quality regarding women or members of mi20 nority groups, respectively, that would be obtained in

21 such project in the event that such inclusion were re22 quired will be obtained through other means; and

23 ‘‘(B) may provide that such inclusion in a

24 project of clinical research is not required if there is
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1 substantial scientific data demonstrating that there

2 is no significant difference between—

3 ‘‘(i) the effects that the variables to be

4 studied in the project have on women or mem5 bers of minority groups, respectively; and

6 ‘‘(ii) the effects that the variables have on

7 the individuals who would serve as subjects in

8 the project in the event that such inclusion were

9 not required.

10 ‘‘(3) The guidelines required in paragraph (1) shall

11 be established and published in the Federal Register not

12 later than 120 days after the date of the enactment of

13 the National Institutes of Health Revitalization Act of

14 1993.

15 ‘‘(4) For fiscal year 1994 and subsequent fiscal years,

16 the Director of NIH may not approve any proposal of clin17 ical research to be conducted or supported by any agency

18 of the National Institutes of Health unless the proposal

19 specifies the manner in which the research will comply

20 with subsection (a).

21 ‘‘(e) The advisory council of each national research

22 institute shall annually submit to the Director of NIH and

23 the Director of the institute involved a report describing

24 the manner in which the agency has complied with sub25 section (a).’’.
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1 SEC. 132. PEER REVIEW.

2 Section 492 of the Public Health Service Act (42

3 U.S.C. 289a) is amended by adding at the end the follow4 ing new subsection:

5 ‘‘(c)(1) In technical and scientific peer review under

6 this section of proposals for clinical research, the consider7 ation of any such proposal (including the initial consider8 ation) shall, except as provided in paragraph (2), include

9 an evaluation of the technical and scientific merit of the

10 proposal regarding compliance with section 492B(a).

11 ‘‘(2) Paragraph (1) shall not apply to any proposal

12 for clinical research that, pursuant to subsection (b) of

13 section 492B, is not subject to the requirement of sub14 section (a) of such section regarding the inclusion of

15 women and members of minority groups as subjects in

16 clinical research.’’.

17 SEC. 133. APPLICABILITY TO CURRENT PROJECTS.

18 Section 492B of the Public Health Service Act, as

19 added by section 131 of this Act, shall not apply with re20 spect to projects of clinical research for which initial fund21 ing was provided prior to the date of the enactment of

22 this Act. With respect to the inclusion of women and mi23 norities as subjects in clinical research conducted or sup24 ported by the National Institutes of Health, any policies

25 of the Secretary of Health and Human Services regarding

26 such inclusion that are in effect on the day before the date
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1 of the enactment of this Act shall continue to apply to

2 the projects referred to in the preceding sentence.

3 PART II—OFFICE OF RESEARCH ON WOMEN’S

4 HEALTH

5 SEC. 141. ESTABLISHMENT.

6 (a) IN GENERAL.—Title IV of the Public Health

7 Service Act, as amended by section 2 of Public Law 101–

8 613, is amended—

9 (1) by redesignating section 486 as section

10 485A;

11 (2) by redesignating parts F through H as

12 parts G through I, respectively; and

13 (3) by inserting after part E the following new

14 part:

15 ‘‘PART F—RESEARCH ON WOMEN’S HEALTH

16 ‘‘SEC. 486. OFFICE OF RESEARCH ON WOMEN’S HEALTH.

17 ‘‘(a) ESTABLISHMENT.—There is established within

18 the Office of the Director of NIH an office to be known

19 as the Office of Research on Women’s Health (in this part

20 referred to as the ‘Office’). The Office shall be headed by

21 a director, who shall be appointed by the Director of NIH.

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

23 ‘‘(1) identify projects of research on women’s

24 health that should be conducted or supported by the

25 national research institutes;
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1 ‘‘(2) identify multidisciplinary research relating

2 to research on women’s health that should be so con3 ducted or supported;

4 ‘‘(3) carry out paragraphs (1) and (2) with re5 spect to the aging process in women, with priority

6 given to menopause;

7 ‘‘(4) promote coordination and collaboration

8 among entities conducting research identified under

9 any of paragraphs (1) through (3);

10 ‘‘(5) encourage the conduct of such research by

11 entities receiving funds from the national research

12 institutes;

13 ‘‘(6) recommend an agenda for conducting and

14 supporting such research;

15 ‘‘(7) promote the sufficient allocation of the re16 sources of the national research institutes for con17 ducting and supporting such research;

18 ‘‘(8) assist in the administration of section

19 492B with respect to the inclusion of women as sub20 jects in clinical research; and

21 ‘‘(9) prepare the report required in section

22 486B.

23 ‘‘(c) COORDINATING COMMITTEE.—

24 ‘‘(1) In carrying out subsection (b), the Direc25 tor of the Office shall establish a committee to be
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1 known as the Coordinating Committee on Research

2 on Women’s Health (hereafter in this subsection re3 ferred to as the ‘Coordinating Committee’).

4 ‘‘(2) The Coordinating Committee shall be com5 posed of the Directors of the national research insti6 tutes (or the designees of the Directors).

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

8 the chair of the Coordinating Committee.

9 ‘‘(4) With respect to research on women’s

10 health, the Coordinating Committee shall assist the

11 Director of the Office in—

12 ‘‘(A) identifying the need for such re13 search, and making an estimate each fiscal year

14 of the funds needed to adequately support the

15 research;

16 ‘‘(B) identifying needs regarding the co17 ordination of research activities, including in18 tramural and extramural multidisciplinary ac19 tivities;

20 ‘‘(C) supporting the development of meth21 odologies to determine the circumstances in

22 which obtaining data specific to women (includ23 ing data relating to the age of women and the

24 membership of women in ethnic or racial
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1 groups) is an appropriate function of clinical

2 trials of treatments and therapies;

3 ‘‘(D) supporting the development and ex4 pansion of clinical trials of treatments and

5 therapies for which obtaining such data has

6 been determined to be an appropriate function;

7 and

8 ‘‘(E) encouraging the national research in9 stitutes to conduct and support such research,

10 including such clinical trials.

11 ‘‘(d) ADVISORY COMMITTEE.—

12 ‘‘(1) In carrying out subsection (b), the Direc13 tor of the Office shall establish an advisory commit14 tee to be known as the Advisory Committee on Re15 search on Women’s Health (hereafter in this sub16 section referred to as the ‘Advisory Committee’).

17 ‘‘(2)(A) The Advisory Committee shall be com18 posed of no fewer than 12, and not more than 18

19 individuals, who are not officers or employees of the

20 Federal Government. The Director of the Office

21 shall make appointments to the Advisory Committee

22 from among physicians, practitioners, scientists, and

23 other health professionals, whose clinical practice,

24 research specialization, or professional expertise in25 cludes a significant focus on research on women’s
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1 health. A majority of the members of the Advisory

2 Committee shall be women.

3 ‘‘(B) Members of the Advisory Committee shall

4 receive compensation for each day engaged in carry5 ing out the duties of the Committee, including time

6 engaged in traveling for purposes of such duties.

7 Such compensation may not be provided in an

8 amount in excess of the maximum rate of basic pay

9 payable for GS–18 of the General Schedule.

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

11 the chair of the Advisory Committee.

12 ‘‘(4) The Advisory Committee shall—

13 ‘‘(A) advise the Director of the Office on

14 appropriate research activities to be undertaken

15 by the national research institutes with respect

16 to—

17 ‘‘(i) research on women’s health;

18 ‘‘(ii) research on gender differences in

19 clinical drug trials, including responses to

20 pharmacological drugs;

21 ‘‘(iii) research on gender differences

22 in disease etiology, course, and treatment;

23 ‘‘(iv) research on obstetrical and gyne24 cological health conditions, diseases, and

25 treatments; and
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1 ‘‘(v) research on women’s health con2 ditions which require a multidisciplinary

3 approach;

4 ‘‘(B) report to the Director of the Office

5 on such research;

6 ‘‘(C) provide recommendations to such Di7 rector regarding activities of the Office (includ8 ing recommendations on the development of the

9 methodologies described in subsection (c)(4)(C)

10 and recommendations on priorities in carrying

11 out research described in subparagraph (A));

12 and

13 ‘‘(D) assist in monitoring compliance with

14 section 492B regarding the inclusion of women

15 in clinical research.

16 ‘‘(5)(A) The Advisory Committee shall prepare

17 a biennial report describing the activities of the

18 Committee, including findings made by the Commit19 tee regarding—

20 ‘‘(i) compliance with section 492B;

21 ‘‘(ii) the extent of expenditures made for

22 research on women’s health by the agencies of

23 the National Institutes of Health; and

24 ‘‘(iii) the level of funding needed for such

25 research.
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1 ‘‘(B) The report required in subparagraph (A)

2 shall be submitted to the Director of NIH for inclu3 sion in the report required in section 403.

4 ‘‘(e) REPRESENTATION OF WOMEN AMONG RE5 SEARCHERS.—The Secretary, acting through the Assist6 ant Secretary for Personnel and in collaboration with the

7 Director of the Office, shall determine the extent to which

8 women are represented among senior physicians and sci9 entists of the national research institutes and among phy10 sicians and scientists conducting research with funds pro11 vided by such institutes, and as appropriate, carry out ac12 tivities to increase the extent of such representation.

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

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

15 respect to women of all age, ethnic, and racial

16 groups, means all diseases, disorders, and conditions

17 (including with respect to mental health)—

18 ‘‘(A) unique to, more serious, or more

19 prevalent in women;

20 ‘‘(B) for which the factors of medical risk

21 or types of medical intervention are different

22 for women, or for which it is unknown whether

23 such factors or types are different for women;

24 or
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1 ‘‘(C) with respect to which there has been

2 insufficient clinical research involving women as

3 subjects or insufficient clinical data on women.

4 ‘‘(2) The term ‘research on women’s health’

5 means research on women’s health conditions, in6 cluding research on preventing such conditions.

7 ‘‘SEC. 486A. NATIONAL DATA SYSTEM AND CLEARING8 HOUSE ON RESEARCH ON WOMEN’S HEALTH.

9 ‘‘(a) DATA SYSTEM.—

10 ‘‘(1) The Director of NIH, in consultation with

11 the Director of the Office, shall establish a data sys12 tem for the collection, storage, analysis, retrieval,

13 and dissemination of information regarding research

14 on women’s health that is conducted or supported by

15 the national research institutes. Information from

16 the data system shall be available through informa17 tion systems available to health care professionals

18 and providers, researchers, and members of the

19 public.

20 ‘‘(2) The data system established under para21 graph (1) shall include a registry of clinical trials of

22 experimental treatments that have been developed

23 for research on women’s health. Such registry shall

24 include information on subject eligibility criteria,

25 sex, age, ethnicity or race, and the location of the
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1 trial site or sites. Principal investigators of such

2 clinical trials shall provide this information to the

3 registry within 30 days after it is available. Once a

4 trial has been completed, the principal investigator

5 shall provide the registry with information pertain6 ing to the results, including potential toxicities or

7 adverse effects associated with the experimental

8 treatment or treatments evaluated.

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

10 consultation with the Director of the Office and with the

11 National Library of Medicine, shall establish, maintain,

12 and operate a program to provide information on research

13 and prevention activities of the national research institutes

14 that relate to research on women’s health.

15 ‘‘SEC. 486B. BIENNIAL REPORT.

16 ‘‘(a) IN GENERAL.—With respect to research on

17 women’s health, the Director of the Office shall, not later

18 than February 1, 1994, and biennially thereafter, prepare

19 a report—

20 ‘‘(1) describing and evaluating the progress

21 made during the preceding 2 fiscal years in research

22 and treatment conducted or supported by the Na23 tional Institutes of Health;

24 ‘‘(2) describing and analyzing the professional

25 status of women physicians and scientists of such
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1 Institutes, including the identification of problems

2 and barriers regarding advancements;

3 ‘‘(3) summarizing and analyzing expenditures

4 made by the agencies of such Institutes (and by

5 such Office) during the preceding 2 fiscal years; and

6 ‘‘(4) making such recommendations for legisla7 tive and administrative initiatives as the Director of

8 the Office determines to be appropriate.

9 ‘‘(b) INCLUSION IN BIENNIAL REPORT OF DIRECTOR

10 OF NIH.—The Director of the Office shall submit each

11 report prepared under subsection (a) to the Director of

12 NIH for inclusion in the report submitted to the President

13 and the Congress under section 403.’’.

14 (b) REQUIREMENT OF SUFFICIENT ALLOCATION OF

15 RESOURCES OF INSTITUTES.—Section 402(b) of the Pub16 lic Health Service Act (42 U.S.C. 282(b)) is amended—

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

18 the semicolon at the end;

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

20 the end and inserting ‘‘; and’’; and

21 (3) by inserting after paragraph (11) the fol22 lowing new paragraph:

23 ‘‘(12) after consultation with the Director of

24 the Office of Research on Women’s Health, shall en25 sure that resources of the National Institutes of
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1 Health are sufficiently allocated for projects of re2 search on women’s health that are identified under

3 section 486(b).’’.

4 PART III—OFFICE OF RESEARCH ON MINORITY

5 HEALTH

6 SEC. 151. ESTABLISHMENT.

7 Part A of title IV of the Public Health Service Act

8 (42 U.S.C. 281 et seq.) is amended by adding at the end

9 the following new section:

10 ‘‘OFFICE OF RESEARCH ON MINORITY HEALTH

11 ‘‘SEC. 403A. (a) ESTABLISHMENT.—There is estab12 lished within the Office of the Director of NIH an office

13 to be known as the Office of Research on Minority Health

14 (in this section referred to as the ‘Office’). The Office shall

15 be headed by a director, who shall be appointed by the

16 Director of NIH.

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

18 ‘‘(1) identify projects of research on minority

19 health that should be conducted or supported by the

20 national research institutes;

21 ‘‘(2) identify multidisciplinary research relating

22 to research on minority health that should be so con23 ducted or supported;

24 ‘‘(3) promote coordination and collaboration

25 among entities conducting research identified under

26 paragraph (1) or (2);
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1 ‘‘(4) encourage the conduct of such research by

2 entities receiving funds from the national research

3 institutes;

4 ‘‘(5) recommend an agenda for conducting and

5 supporting such research;

6 ‘‘(6) promote the sufficient allocation of the re7 sources of the national research institutes for con8 ducting and supporting such research; and

9 ‘‘(7) assist in the administration of section

10 492B with respect to the inclusion of members of

11 minority groups as subjects in clinical research.’’.

12 Subtitle C—Scientific Integrity

13 SEC. 161. ESTABLISHMENT OF OFFICE OF SCIENTIFIC IN14 TEGRITY.

15 (a) IN GENERAL.—Section 493 of the Public Health

16 Service Act (42 U.S.C. 289b) is amended to read as fol17 lows:

18 ‘‘OFFICE OF SCIENTIFIC INTEGRITY

19 ‘‘SEC. 493. (a) ESTABLISHMENT.—

20 ‘‘(1) IN GENERAL.—Not later than 90 days

21 after the date of enactment of this section, the Sec22 retary shall establish an office to be known as the

23 Office of Scientific Integrity (hereafter referred to in

24 this section as the ‘Office’), which shall be estab25 lished as an independent entity in the Department

26 of Health and Human Services.
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1 ‘‘(2) DIRECTOR.—The Office shall be headed by

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

3 be experienced and specially trained in the conduct

4 of research, and have experience in the conduct of

5 investigations of scientific misconduct. The Sec6 retary shall carry out this section acting through the

7 Director of the Office. The Director shall report to

8 the Secretary.

9 ‘‘(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS

10 CONDITION OF FUNDING FOR RESEARCH.—The Secretary

11 shall by regulation require that each entity that applies

12 for a grant, contract, or cooperative agreement under this

13 Act for any project or program that involves the conduct

14 of biomedical or behavioral research submit in or with its

15 application for such grant, contract, or cooperative agree16 ment assurances satisfactory to the Secretary that such

17 entity—

18 ‘‘(1) has established (in accordance with regula19 tions which the Secretary shall prescribe) an admin20 istrative process to review reports of scientific mis21 conduct in connection with biomedical and behav22 ioral research conducted at or sponsored by such en23 tity; and

24 ‘‘(2) will report to the Director any investiga25 tion of alleged scientific misconduct in connection
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1 with projects for which funds have been made avail2 able under this Act that appears substantial.

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

4 Secretary shall establish by regulation a process to be fol5 lowed by the Director for the prompt and appropriate—

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

7 Director respecting scientific misconduct in connec8 tion with projects for which funds have been made

9 available under this Act;

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

11 information from recipients of funds under this Act;

12 ‘‘(3) conduct of investigations, when appro13 priate; and

14 ‘‘(4) taking of other actions, including appro15 priate remedies, with respect to such misconduct.

16 ‘‘(d) MONITORING BY DIRECTOR.—The Secretary

17 shall by regulation establish procedures for the Director

18 to monitor administrative processes and investigations

19 that have been established or carried out under this sec20 tion.

21 ‘‘(e) EFFECT ON PRESENT INVESTIGATIONS.—Noth22 ing in this section shall affect investigations which have

23 been or will be commenced prior to the promulgation of

24 final regulations under this section.’’.
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1 (b) ESTABLISHMENT OF DEFINITION OF SCIENTIFIC

2 MISCONDUCT.—Not later than 90 days after the date on

3 which the report required under section 152(d) is submit4 ted to the Secretary of Health and Human Services, such

5 Secretary shall by regulation establish a definition for the

6 term ‘‘scientific misconduct’’ for purposes of section 493

7 of the Public Health Service Act, as amended by sub8 section (a) of this section.

9 SEC. 162. COMMISSION ON SCIENTIFIC INTEGRITY.

10 (a) IN GENERAL.—The Secretary of Health and

11 Human Services shall establish a commission to be known

12 as the Commission on Scientific Integrity (in this section

13 referred to as the ‘‘Commission’’).

14 (b) DUTIES.—The Commission shall develop rec15 ommendations for the Secretary of Health and Human

16 Services on the administration of section 493 of the Public

17 Health Service Act (as amended and added by section 161

18 of this Act).

19 (c) COMPOSITION.—The Commission shall be com20 posed of 12 members to be appointed by the Secretary

21 of Health and Human Services from among individuals

22 who are not officers or employees of the United States.

23 Of the members appointed to the Commission—

24 (1) three shall be scientists with substantial ac25 complishments in biomedical or behavioral research;
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1 (2) three shall be individuals with experience in

2 investigating allegations of misconduct with respect

3 to scientific research;

4 (3) three shall be representatives of institutions

5 of higher education at which biomedical or behav6 ioral research is conducted; and

7 (4) three shall be individuals who are not de8 scribed in paragraphs (1), (2), or (3), at least one

9 of whom shall be an attorney and at least one of

10 whom shall be an ethicist.

11 (d) COMPENSATION.—Members of the Commission

12 shall receive compensation for each day engaged in carry13 ing out the duties of the Commission, including time en14 gaged in traveling for purposes of such duties. Such com15 pensation may not be provided in an amount in excess of

16 the maximum rate of basic pay payable for GS–18 of the

17 General Schedule.

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

19 of enactment of this section, the Commission shall prepare

20 and submit to the Secretary of Health and Human Serv21 ices, the Committee on Energy and Commerce of the

22 House of Representatives, and the Committee on Labor

23 and Human Resources of the Senate, a report containing

24 the recommendations developed under subsection (b).
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1 SEC. 163. PROTECTION OF WHISTLEBLOWERS.

2 Section 493 of the Public Health Service Act, as

3 amended by section 161 of this Act, is amended by adding

4 at the end the following new subsection:

5 ‘‘(f) PROTECTION OF WHISTLEBLOWERS.—

6 ‘‘(1) IN GENERAL.—In the case of any entity

7 required to establish administrative processes under

8 subsection (b), the Secretary shall by regulation es9 tablish standards for preventing, and for responding

10 to the occurrence of retaliation by such entity, its of11 ficials or agents, against an employee in the terms

12 and conditions of employment in response to the em13 ployee having in good faith—

14 ‘‘(A) made an allegation that the entity, its

15 officials or agents, has engaged in or failed to

16 adequately respond to an allegation of scientific

17 misconduct; or

18 ‘‘(B) cooperated with an investigation of

19 such an allegation.

20 ‘‘(2) MONITORING BY SECRETARY.—The Sec21 retary shall establish by regulation procedures for

22 the Director to monitor the implementation of the

23 standards established by an entity under paragraph

24 (1) for the purpose of determining whether the pro25 cedures have been established, and are being uti-
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1 lized, in accordance with the standards established

2 under such paragraph.

3 ‘‘(3) NONCOMPLIANCE.—The Secretary shall by

4 regulation establish remedies for noncompliance by

5 an entity, its officials or agents, which has engaged

6 in retaliation in violation of the standards estab7 lished under paragraph (1). Such remedies may in8 clude termination of funding provided by the Sec9 retary for such project or recovery of funding being

10 provided by the Secretary for such project, or other

11 actions as appropriate.

12 ‘‘(4) FINAL RULE FOR REGULATIONS.—The

13 Secretary shall issue a final rule for the regulations

14 required in paragraph (1) not later than 180 days

15 after the date of the enactment of the National In16 stitutes of Health Revitalization Act of 1993.

17 ‘‘(5) REQUIRED AGREEMENTS.—For any fiscal

18 year beginning after the date on which the regula19 tions required in paragraph (1) are issued, the Sec20 retary may not provide a grant, cooperative agree21 ment, or contract under this Act for biomedical or

22 behavioral research unless the entity seeking such fi23 nancial assistance agrees that the entity—

24 ‘‘(A) will maintain the procedures de25 scribed in the regulations; and
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1 ‘‘(B) will otherwise be subject to the regu2 lations.’’.

3 SEC. 164. REQUIREMENT OF REGULATIONS REGARDING

4 PROTECTION AGAINST FINANCIAL CON5 FLICTS OF INTEREST IN CERTAIN PROJECTS

6 OF RESEARCH.

7 Part H of title IV of the Public Health Service Act,

8 as redesignated by section 141(a)(2) of this Act, is amend9 ed by inserting after section 493 the following new section:

10 ‘‘PROTECTION AGAINST FINANCIAL CONFLICTS OF

11 INTEREST IN CERTAIN PROJECTS OF RESEARCH

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

13 ‘‘(1) IN GENERAL.—The Secretary shall define

14 by regulation, the specific circumstances that con15 stitute the existence of a financial interest in a

16 project on the part of an entity or individual that

17 will, or may be reasonably expected to, create a bias

18 in favor of obtaining results in such project that are

19 consistent with such financial interest. Such defini20 tion shall apply uniformly to each entity or individ21 ual conducting a research project under this Act. In

22 the case of any entity or individual receiving assist23 ance from the Secretary for a project of research de24 scribed in paragraph (2), the Secretary shall by reg25 ulation establish standards for responding to, includ26 ing managing, reducing, or eliminating, the existence
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1 of such a financial interest. The entity may adopt

2 individualized procedures for implementing the

3 standards.

4 ‘‘(2) RELEVANT PROJECTS.—A project of re5 search referred to in paragraph (1) is a project of

6 clinical research whose purpose is to evaluate the

7 safety or effectiveness of a drug, medical device, or

8 treatment and for which such entity is receiving as9 sistance from the Secretary.

10 ‘‘(3) IDENTIFYING AND REPORTING TO THE DI11 RECTOR.—The Secretary shall ensure that the

12 standards established under paragraph (1) specify

13 that as a condition of receiving assistance from the

14 Secretary for the project involved, an entity de15 scribed in such subsection is required—

16 ‘‘(A) to have in effect at the time the en17 tity applies for the assistance and throughout

18 the period during which the assistance is re19 ceived, a process for identifying such financial

20 interests as defined in paragraph (1) that exist

21 regarding the project; and

22 ‘‘(B) to report to the Director such finan23 cial interest as defined in paragraph (1) identi24 fied by the entity and how any such financial

25 interest identified by the entity will be managed
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1 or eliminated such that the project in question

2 will be protected from bias that may stem from

3 such financial interest.

4 ‘‘(4) MONITORING OF PROCESS.—The Secretary

5 shall monitor the establishment and conduct of the

6 process established by an entity pursuant to para7 graph (1).

8 ‘‘(5) RESPONSE.—In any case in which the Sec9 retary determines that an entity has failed to comply

10 with paragraph (3) regarding a project of research

11 described in paragraph (1), the Secretary—

12 ‘‘(A) shall require that, as a condition of

13 receiving assistance, the entity disclose the ex14 istence of a financial interest as defined in

15 paragraph (1) in each public presentation of the

16 results of such project; and

17 ‘‘(B) may take such other actions as the

18 Secretary determines to be appropriate.

19 ‘‘(6) DEFINITION.—As used in this section:

20 ‘‘(A) The term ‘financial interest’ includes

21 the receipt of consulting fees or honoraria and

22 the ownership of stock or equity.

23 ‘‘(B) The term ‘assistance’, with respect to

24 conducting a project of research, means a

25 grant, contract, or cooperative agreement.
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1 ‘‘(b) FINAL RULE FOR REGULATIONS.—The Sec2 retary shall issue a final rule for the regulations required

3 in subsection (a) not later than 180 days after the date

4 of the enactment of the National Institutes of Health Re5 vitalization Act of 1993.’’.

6 SEC. 165. EFFECTIVE DATES.

7 (a) IN GENERAL.—The amendments made by this

8 subtitle shall become effective on the date that occurs 180

9 days after the date on which the final rule required under

10 section 493(f)(4) of the Public Health Service Act, as

11 amended by sections 161 and 163, is published in the Fed12 eral Register.

13 (b) AGREEMENTS AS A CONDITION OF FUNDING.—

14 The requirements of subsection (f)(5) of section 493 of

15 the Public Health Service Act, as amended by sections 161

16 and 163, with respect to agreements as a condition of

17 funding shall not be effective in the case of projects of

18 research for which initial funding under the Public Health

19 Service Act was provided prior to the effective date de20 scribed in subsection (a).
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1 TITLE II—NATIONAL INSTITUTES

2 OF HEALTH IN GENERAL

3 SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINA4 TION.

5 Section 402(f) of the Public Health Service Act (42

6 U.S.C. 282(f)) is amended by striking ‘‘other public and

7 private entities.’’ and all that follows through the end and

8 inserting ‘‘other public and private entities, including ele9 mentary, secondary, and post-secondary schools. The As10 sociate Director shall—

11 ‘‘(1) annually review the efficacy of existing

12 policies and techniques used by the national research

13 institutes to disseminate the results of disease pre14 vention and behavioral research programs;

15 ‘‘(2) recommend, coordinate, and oversee the

16 modification or reconstruction of such policies and

17 techniques to ensure maximum dissemination, using

18 advanced technologies to the maximum extent prac19 ticable, of research results to such entities; and

20 ‘‘(3) annually prepare and submit to the Direc21 tor of NIH a report concerning the prevention and

22 dissemination activities undertaken by the Associate

23 Director, including—

24 ‘‘(A) a summary of the Associate Direc25 tor’s review of existing dissemination policies
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1 and techniques together with a detailed state2 ment concerning any modification or restructur3 ing, or recommendations for modification or re4 structuring, of such policies and techniques;

5 and

6 ‘‘(B) a detailed statement of the expendi7 tures made for the prevention and dissemina8 tion activities reported on and the personnel

9 used in connection with such activities.’’.

10 SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARD11 ING CERTAIN STATES AND RESEARCHERS.

12 Section 402 of the Public Health Service Act (42

13 U.S.C. 282) is amended by adding at the end the following

14 new subsection:

15 ‘‘(g)(1)(A) In the case of entities described in sub16 paragraph (B), the Director of NIH, acting through the

17 Director of the National Center for Research Resources,

18 shall establish a program to enhance the competitiveness

19 of such entities in obtaining funds from the national re20 search institutes for conducting biomedical and behavioral

21 research.

22 ‘‘(B) The entities referred to in subparagraph (A) are

23 entities that conduct biomedical and behavioral research

24 and are located in a State in which the aggregate success

25 rate for applications to the national research institutes for
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1 assistance for such research by the entities in the State

2 has historically constituted a low success rate of obtaining

3 such funds, relative to such aggregate rate for such enti4 ties in other States.

5 ‘‘(C) With respect to enhancing competitiveness for

6 purposes of subparagraph (A), the Director of NIH, in

7 carrying out the program established under such subpara8 graph, may—

9 ‘‘(i) provide technical assistance to the entities

10 involved, including technical assistance in the prepa11 ration of applications for obtaining funds from the

12 national research institutes;

13 ‘‘(ii) assist the entities in developing a plan for

14 biomedical or behavioral research proposals; and

15 ‘‘(iii) assist the entities in implementing such

16 plan.

17 ‘‘(2) The Director of NIH shall establish a program

18 of supporting projects of biomedical or behavioral research

19 whose principal researchers are individuals who have not

20 previously served as the principal researchers of such

21 projects supported by the Director.’’.

22 SEC. 203. CHILDREN’S VACCINE INITIATIVE.

23 Part A of title IV of the Public Health Service Act

24 (42 U.S.C. 281 et seq.) is amended by adding at the end

25 the following new section:
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1 ‘‘CHILDREN’S VACCINE INITIATIVE

2 ‘‘SEC. 404. (a) DEVELOPMENT OF NEW VAC3 CINES.—The Secretary, in consulation with the Director

4 of the National Vaccine Program under title XXI and act5 ing through the Directors of the National Institute for Al6 lergy and Infectious Diseases, the National Institute for

7 Child Health and Human Development, the National In8 stitute for Aging, and other public and private programs,

9 shall carry out activities, which shall be consistent with

10 the global Children’s Vaccine Initiative, to develop afford11 able new and improved vaccines to be used in the United

12 States and in the developing world that will increase the

13 efficacy and efficiency of the prevention of infectious dis14 eases. In carrying out such activities, the Secretary shall,

15 to the extent practicable, develop and make available vac16 cines that require fewer contacts to deliver, that can be

17 given early in life, that provide long lasting protection,

18 that obviate refrigeration, needles and syringes, and that

19 protect against a larger number of diseases.

20 ‘‘(b) REPORT.—In the report required in section

21 2104, the Secretary, acting through the Director of the

22 National Vaccine Program under title XXI, shall include

23 information with respect to activities and the progress

24 made in implementing the provisions of this section and

25 achieving its goals.
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1 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—In ad2 dition to any other amounts authorized to be appropriated

3 for activities of the type described in this section, there

4 are authorized to be appropriated to carry out this section

5 $20,000,000 for fiscal year 1994, and such sums as may

6 be necessary for each of the fiscal years 1995 and 1996.’’.

7 SEC. 204. PLAN FOR USE OF ANIMALS IN RESEARCH.

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

9 Health Service Act, as amended by section 203 of this Act,

10 is amended by adding at the end the following new section:

11 ‘‘PLAN FOR USE OF ANIMALS IN RESEARCH

12 ‘‘SEC. 404A. (a) The Director of NIH, after consulta13 tion with the committee established under subsection (e),

14 shall prepare a plan—

15 ‘‘(1) for the National Institutes of Health to

16 conduct or support research into—

17 ‘‘(A) methods of biomedical research and

18 experimentation that do not require the use of

19 animals;

20 ‘‘(B) methods of such research and experi21 mentation that reduce the number of animals

22 used in such research; and

23 ‘‘(C) methods of such research and experi24 mentation that produce less pain and distress in

25 such animals;
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1 ‘‘(2) for establishing the validity and reliability

2 of the methods described in paragraph (1);

3 ‘‘(3) for encouraging the acceptance by the sci4 entific community of such methods that have been

5 found to be valid and reliable; and

6 ‘‘(4) for training scientists in the use of such

7 methods that have been found to be valid and reli8 able.

9 ‘‘(b) Not later than October 1, 1993, the Director

10 of NIH shall submit to the Committee on Energy and

11 Commerce of the House of Representatives, and to the

12 Committee on Labor and Human Resources of the Senate,

13 the plan required in subsection (a) and shall begin imple14 mentation of the plan.

15 ‘‘(c) The Director of NIH shall periodically review,

16 and as appropriate, make revisions in the plan required

17 under subsection (a). A description of any revision made

18 in the plan shall be included in the first biennial report

19 under section 403 that is submitted after the revision is

20 made.

21 ‘‘(d) The Director of NIH shall take such actions as

22 may be appropriate to convey to scientists and others who

23 use animals in biomedical or behavioral research or experi24 mentation information respecting the methods found to be

25 valid and reliable under subsection (a)(2).
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1 ‘‘(e)(1) The Director of NIH shall establish within

2 the National Institutes of Health a committee to be known

3 as the Interagency Coordinating Committee on the Use

4 of Animals in Research (hereafter in this subsection re5 ferred to as the ‘Committee’).

6 ‘‘(2) The Committee shall provide advice to the Direc7 tor of NIH on the preparation of the plan required in sub8 section (a).

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

10 ‘‘(A) the Directors of each of the national re11 search institutes and the Director of the Center for

12 Research Resources (or the designees of such Direc13 tors); and

14 ‘‘(B) representatives of the Environmental Pro15 tection Agency, the Food and Drug Administration,

16 the Consumer Product Safety Commission, the Na17 tional Science Foundation, and such additional agen18 cies as the Director of NIH determines to be appro19 priate.’’.

20 (b) CONFORMING AMENDMENT.—Section 4 of the

21 Health Research Extension Act of 1985 (Public Law 99–

22 158; 99 Stat. 880) is repealed.
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1 SEC. 205. INCREASED PARTICIPATION OF WOMEN AND

2 MEMBERS OF UNDERREPRESENTED MINORI3 TIES IN FIELDS OF BIOMEDICAL AND BEHAV4 IORAL RESEARCH.

5 Section 402 of the Public Health Service Act, as

6 amended by section 202 of this Act, is amended by adding

7 at the end the following new subsection:

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

9 NIH and the Directors of the agencies of the National

10 Institutes of Health, may conduct and support programs

11 for research, research training, recruitment, and other ac12 tivities to provide for an increase in the number of women

13 and members of underrepresented minority groups in the

14 fields of biomedical and behavioral research.’’.

15 SEC. 206. REQUIREMENTS REGARDING SURVEYS OF SEX16 UAL BEHAVIOR.

17 Part A of title IV of the Public Health Service Act,

18 as amended by section 204 of this Act, is amended by add19 ing at the end the following new section:

20 ‘‘REQUIREMENTS REGARDING SURVEYS OF SEXUAL

21 BEHAVIOR

22 ‘‘SEC. 404B. With respect to any survey of human

23 sexual behavior proposed to be conducted or supported

24 through the National Institutes of Health, the survey may

25 not be carried out unless—
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1 ‘‘(1) the proposal has undergone review in ac2 cordance with any applicable requirements of sec3 tions 491 and 492; and

4 ‘‘(2) the Secretary, in accordance with section

5 492A, makes a determination that the information

6 expected to be obtained through the survey will as7 sist—

8 ‘‘(A) in reducing the incidence of sexually

9 transmitted diseases, the incidence of infection

10 with the human immunodeficiency virus, or the

11 incidence of any other infectious disease; or

12 ‘‘(B) in improving reproductive health or

13 other conditions of health.’’.

14 SEC. 207. DISCRETIONARY FUND OF DIRECTOR OF NA15 TIONAL INSTITUTES OF HEALTH.

16 Section 402 of the Public Health Service Act, as

17 amended by section 205 of this Act, is amended by adding

18 at the end the following new subsection:

19 ‘‘(i)(1) There is established a fund, consisting of

20 amounts appropriated under paragraph (3) and made

21 available for the fund, for use by the Director of NIH to

22 carry out the activities authorized in this Act for the Na23 tional Institutes of Health. The purposes for which such

24 fund may be expended include—
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1 ‘‘(A) providing for research on matters that

2 have not received significant funding relative to

3 other matters, responding to new issues and sci4 entific emergencies, and acting on research opportu5 nities of high priority;

6 ‘‘(B) supporting research that is not exclusively

7 within the authority of any single agency of such In8 stitutes; and

9 ‘‘(C) purchasing or renting equipment and

10 quarters for activities of such Institutes.

11 ‘‘(2) Not later than February 10 of each fiscal year,

12 the Secretary shall submit to the Committee on Energy

13 and Commerce of the House of Representatives, and to

14 the Committee on Labor and Human Resources of the

15 Senate, a report describing the activities undertaken and

16 expenditures made under this section during the preceding

17 fiscal year. The report may contain such comments of the

18 Secretary regarding this section as the Secretary deter19 mines to be appropriate.

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

21 there are authorized to be appropriated $25,000,000 for

22 fiscal year 1994, and such sums as may be necessary for

23 each of the fiscal years 1995 and 1996.’’.
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1 SEC. 208. MISCELLANEOUS PROVISIONS.

2 (a) TERM OF OFFICE FOR MEMBERS OF ADVISORY

3 COUNCILS.—Section 406(c) of the Public Health Service

4 Act (42 U.S.C. 284a(c)) is amended in the second sen5 tence by striking ‘‘until a successor has been appointed’’

6 and inserting the following: ‘‘for 180 days after the date

7 of such expiration’’.

8 (b) LITERACY REQUIREMENTS.—Section 402(e) of

9 the Public Health Service Act (42 U.S.C. 282(e)) is

10 amended—

11 (1) in paragraph (3), by striking ‘‘and’’ at the

12 end;

13 (2) in paragraph (4), by striking the period and

14 inserting ‘‘; and’’; and

15 (3) by adding at the end thereof the following

16 new paragraph:

17 ‘‘(5) ensure that, after January 1, 1994, at

18 least one-half of all new or revised health education

19 and promotion materials developed or funded by the

20 National Institutes of Health is in a form that does

21 not exceed a level of functional literacy, as defined

22 in the National Literacy Act of 1991 (Public Law

23 102–73).’’.

24 (c) DAY CARE REGARDING CHILDREN OF EMPLOY25 EES.—Section 402 of the Public Health Service Act, as
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1 amended by section 207 of this Act, is amended by adding

2 at the end the following new subsection:

3 ‘‘(i)(1) The Director of NIH may establish a program

4 to provide day care service for the employees of the Na5 tional Institutes of Health similar to those services pro6 vided by other Federal agencies (including the availability

7 of day care service on a 24-hour-a-day basis).

8 ‘‘(2) Any day care provider at the National Institutes

9 of Health shall establish a sliding scale of fees that takes

10 into consideration the income and needs of the employee.

11 ‘‘(3) For purposes regarding the provision of day care

12 service, the Director of NIH may enter into rental or lease

13 purchase agreements.’’.

14 TITLE III—GENERAL PROVI15 SIONS RESPECTING NA16 TIONAL RESEARCH INSTI17 TUTES

18 SEC. 301. APPOINTMENT AND AUTHORITY OF DIRECTORS

19 OF NATIONAL RESEARCH INSTITUTES.

20 (a) ESTABLISHMENT OF GENERAL AUTHORITY RE21 GARDING DIRECT FUNDING.—

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

23 Public Health Service Act (42 U.S.C. 284(b)(2)) is

24 amended—
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1 (A) in subparagraph (A), by striking

2 ‘‘and’’ after the semicolon at the end;

3 (B) in subparagraph (B), by striking the

4 period at the end and inserting ‘‘; and’’; and

5 (C) by adding at the end the following new

6 subparagraph:

7 ‘‘(C) shall receive from the President and the

8 Office of Management and Budget directly all funds

9 appropriated by the Congress for obligation and ex10 penditure by the Institute.’’.

11 (2) CONFORMING AMENDMENT.—Section

12 413(b)(9) of the Public Health Service Act (42

13 U.S.C. 285a–2(b)(9)) is amended—

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

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

16 that follows and inserting ‘‘advisory council.’’.

17 (b) APPOINTMENT AND DURATION OF TECHNICAL

18 AND SCIENTIFIC PEER REVIEW GROUPS.—Section 405(c)

19 of the Public Health Service Act (42 U.S.C. 284(c)) is

20 amended—

21 (1) by amending paragraph (3) to read as fol22 lows:

23 ‘‘(3) may, in consultation with the advisory

24 council for the Institute and with the approval of the

25 Director of NIH—
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1 ‘‘(A) establish technical and scientific peer

2 review groups in addition to those appointed

3 under section 402(b)(6); and

4 ‘‘(B) appoint the members of peer review

5 groups established under subparagraph (A);

6 and’’; and

7 (2) by adding after and below paragraph (4)

8 the following:

9 ‘‘The Federal Advisory Committee Act shall not apply to

10 the duration of a peer review group appointed under para11 graph (3).’’.

12 SEC. 302. PROGRAM OF RESEARCH ON OSTEOPOROSIS,

13 PAGET’S DISEASE, AND RELATED BONE DIS14 ORDERS.

15 Part B of title IV of the Public Health Service Act

16 (42 U.S.C. 284 et seq.), as amended by section 121(b)

17 of Public Law 102-321 (106 Stat. 358), is amended by

18 adding at the end the following new section:

19 ‘‘RESEARCH ON OSTEOPOROSIS, PAGET’S DISEASE, AND

20 RELATED BONE DISORDERS

21 ‘‘SEC. 410. (a) ESTABLISHMENT.—The Directors of

22 the National Institute of Arthritis and Musculoskeletal

23 and Skin Diseases, the National Institute on Aging, and

24 the National Institute of Diabetes, Digestive and Kidney

25 Diseases, shall expand and intensify the programs of such

26 Institutes with respect to research and related activities
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1 concerning osteoporosis, Paget’s disease, and related bone

2 disorders.

3 ‘‘(b) COORDINATION.—The Directors referred to in

4 subsection (a) shall jointly coordinate the programs re5 ferred to in such subsection and consult with the Arthritis

6 and Musculoskeletal Diseases Interagency Coordinating

7 Committee and the Interagency Task Force on Aging Re8 search.

9 ‘‘(c) INFORMATION CLEARINGHOUSE.—

10 ‘‘(1) IN GENERAL.—In order to assist in carry11 ing out the purpose described in subsection (a), the

12 Director of NIH shall provide for the establishment

13 of an information clearinghouse on osteoporosis and

14 related bone disorders to facilitate and enhance

15 knowledge and understanding on the part of health

16 professionals, patients, and the public through the

17 effective dissemination of information.

18 ‘‘(2) ESTABLISHMENT THROUGH GRANT OR

19 CONTRACT.—For the purpose of carrying out para20 graph (1), the Director of NIH shall enter into a

21 grant, cooperative agreement, or contract with a

22 nonprofit private entity involved in activities regard23 ing the prevention and control of osteoporosis and

24 related bone disorders.
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1 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the

2 purpose of carrying out this section, there are authorized

3 to be appropriated $40,000,000 for fiscal year 1994, and

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

5 1995 and 1996.’’.

6 SEC. 303. ESTABLISHMENT OF INTERAGENCY PROGRAM

7 FOR TRAUMA RESEARCH.

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

9 Service Act (42 U.S.C. 300d et seq.) is amended by adding

10 at the end the following part:

11 ‘‘PART E—INTERAGENCY PROGRAM FOR TRAUMA

12 RESEARCH

13 ‘‘SEC. 1251. ESTABLISHMENT OF PROGRAM.

14 ‘‘(a) IN GENERAL.—The Secretary, acting through

15 the Director of the National Institutes of Health (here16 after in this section referred to as the ‘Director’), shall

17 establish a comprehensive program of conducting basic

18 and clinical research on trauma (hereafter in this section

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

20 research regarding the diagnosis, treatment, rehabilita21 tion, and general management of trauma.

22 (b) PLAN FOR PROGRAM.—

23 ‘‘(1) IN GENERAL.—The Director, in consulta24 tion with the Trauma Research Interagency Coordi25 nating Committee established under subsection (g),
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1 shall establish and implement a plan for carrying

2 out the activities of the Program, including the ac3 tivities described in subsection (d). All such activities

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

5 plan shall be periodically reviewed, and revised as

6 appropriate.

7 ‘‘(2) SUBMISSION TO CONGRESS.—Not later

8 than June 1, 1993, the Director shall submit the

9 plan required in paragraph (1) to the Committee on

10 Energy and Commerce of the House of Representa11 tives, and to the Committee on Labor and Human

12 Resources of the Senate, together with an estimate

13 of the funds needed for each of the fiscal years 1994

14 through 1996 to implement the plan.

15 ‘‘(c) PARTICIPATING AGENCIES; COORDINATION AND

16 COLLABORATION.—The Director—

17 ‘‘(1) shall provide for the conduct of activities

18 under the Program by the Directors of the agencies

19 of the National Institutes of Health involved in re20 search with respect to trauma;

21 ‘‘(2) shall ensure that the activities of the Pro22 gram are coordinated among such agencies; and

23 ‘‘(3) shall, as appropriate, provide for collabora24 tion among such agencies in carrying out such ac25 tivities.
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1 ‘‘(d) CERTAIN ACTIVITIES OF PROGRAM.—The Pro2 gram shall include—

3 ‘‘(1) studies with respect to all phases of trau4 ma care, including prehospital, resuscitation, sur5 gical intervention, critical care, infection control,

6 wound healing, nutritional care and support, and

7 medical rehabilitation care;

8 ‘‘(2) basic and clinical research regarding the

9 response of the body to trauma and the acute treat10 ment and medical rehabilitation of individuals who

11 are the victims of trauma; and

12 ‘‘(3) basic and clinical research regarding trau13 ma care for pediatric and geriatric patients.

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

15 Program, the Director, acting through the Directors of the

16 agencies referred to in subsection (c)(1), may make grants

17 to public and nonprofit entities, including designated trau18 ma centers.

19 ‘‘(f) RESOURCES.—The Director shall assure the

20 availability of appropriate resources to carry out the Pro21 gram, including the plan established under subsection (b)

22 (including the activities described in subsection (d)).

23 ‘‘(g) COORDINATING COMMITTEE.—

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

25 a Trauma Research Interagency Coordinating Com-
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1 mittee (hereafter in this section referred to as the

2 ‘Coordinating Committee’).

3 ‘‘(2) DUTIES.—The Coordinating Committee

4 shall make recommendations regarding—

5 ‘‘(A) the activities of the Program to be

6 carried out by each of the agencies represented

7 on the Committee and the amount of funds

8 needed by each of the agencies for such activi9 ties; and

10 ‘‘(B) effective collaboration among the

11 agencies in carrying out the activities.

12 ‘‘(3) COMPOSITION.—The Coordinating Com13 mittee shall be composed of the Directors of each of

14 the agencies that, under subsection (c), have respon15 sibilities under the Program, and any other individ16 uals who are practitioners in the trauma field as

17 designated by the Director of the National Institutes

18 of Health.

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

20 ‘‘(1) The term ‘designated trauma center’ has

21 the meaning given such term in section 1231(1).

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

23 the National Institutes of Health.

24 ‘‘(3) The term ‘trauma’ means any serious in25 jury that could result in loss of life or in significant
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1 disability and that would meet pre-hospital triage

2 criteria for transport to a designated trauma cen3 ter.’’.

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

5 Public Health Service Act, as amended by section 208(c)

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

7 new subsection:

8 ‘‘(k) The Director of NIH shall carry out the pro9 gram established in part E of title XII (relating to inter10 agency research on trauma).’’.

11 TITLE IV—NATIONAL CANCER

12 INSTITUTE

13 SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVI14 TIES REGARDING BREAST CANCER.

15 Subpart 1 of part C of title IV of the Public Health

16 Service Act (42 U.S.C. 285 et seq.) is amended by adding

17 at the end the following new section:

18 ‘‘BREAST AND GYNECOLOGICAL CANCERS

19 ‘‘SEC. 417. (a) EXPANSION AND COORDINATION OF

20 ACTIVITIES.—The Director of the Institute, in consulta21 tion with the National Cancer Advisory Board, shall ex22 pand, intensify, and coordinate the activities of the Insti23 tute with respect to research on breast cancer, ovarian

24 cancer, and other cancers of the reproductive system of

25 women.
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1 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.—

2 The Director of the Institute shall coordinate the activities

3 of the Director under subsection (a) with similar activities

4 conducted by other national research institutes and agen5 cies of the National Institutes of Health to the extent that

6 such Institutes and agencies have responsibilities that are

7 related to breast cancer and other cancers of the reproduc8 tive system of women.

9 ‘‘(c) PROGRAMS FOR BREAST CANCER.—

10 ‘‘(1) IN GENERAL.—In carrying out subsection

11 (a), the Director of the Institute shall conduct or

12 support research to expand the understanding of the

13 cause of, and to find a cure for, breast cancer. Ac14 tivities under such subsection shall provide for an

15 expansion and intensification of the conduct and

16 support of—

17 ‘‘(A) basic research concerning the etiology

18 and causes of breast cancer;

19 ‘‘(B) clinical research and related activities

20 concerning the causes, prevention, detection and

21 treatment of breast cancer;

22 ‘‘(C) control programs with respect to

23 breast cancer in accordance with section 412;
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1 ‘‘(D) information and education programs

2 with respect to breast cancer in accordance with

3 section 413; and

4 ‘‘(E) research and demonstration centers

5 with respect to breast cancer in accordance with

6 section 414, including the development and op7 eration of centers for breast cancer research to

8 bring together basic and clinical, biomedical and

9 behavioral scientists to conduct basic, clinical,

10 epidemiological, psychosocial, prevention and

11 treatment research and related activities on

12 breast cancer.

13 Not less than six centers shall be operated under

14 subparagraph (E). Activities of such centers should

15 include supporting new and innovative research and

16 training programs for new researchers. Such centers

17 shall give priority to expediting the transfer of re18 search advances to clinical applications.

19 ‘‘(2) IMPLEMENTATION OF PLAN FOR PRO20 GRAMS.—

21 ‘‘(A) The Director of the Institute shall en22 sure that the research programs described in

23 paragraph (1) are implemented in accordance

24 with a plan for the programs. Such plan shall

25 include comments and recommendations that
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1 the Director of the Institute considers appro2 priate, with due consideration provided to the

3 professional judgment needs of the Institute as

4 expressed in the annual budget estimate pre5 pared in accordance with section 413(9). The

6 Director of the Institute, in consultation with

7 the National Cancer Advisory Board, shall peri8 odically review and revise such plan.

9 ‘‘(B) Not later than May 1, 1993, the Di10 rector of the Institute shall submit a copy of

11 the plan to the President’s Cancer Panel, the

12 Secretary and the Director of NIH.

13 ‘‘(C) The Director of the Institute shall

14 submit any revisions of the plan to the Presi15 dent’s Cancer Panel, the Secretary, and the Di16 rector of NIH.

17 ‘‘(D) The Secretary shall provide a copy of

18 the plan submitted under subparagraph (A),

19 and any revisions submitted under subpara20 graph (C), to the Committee on Energy and

21 Commerce of the House of Representatives and

22 the Committee on Labor and Human Resources

23 of the Senate.

24 ‘‘(d) OTHER CANCERS.—In carrying out subsection

25 (a), the Director of the Institute shall conduct or support
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1 research on ovarian cancer and other cancers of the repro2 ductive system of women. Activities under such subsection

3 shall provide for the conduct and support of—

4 ‘‘(1) basic research concerning the etiology and

5 causes of ovarian cancer and other cancers of the re6 productive system of women;

7 ‘‘(2) clinical research and related activities into

8 the causes, prevention, detection and treatment of

9 ovarian cancer and other cancers of the reproductive

10 system of women;

11 ‘‘(3) control programs with respect to ovarian

12 cancer and other cancers of the reproductive system

13 of women in accordance with section 412;

14 ‘‘(4) information and education programs with

15 respect to ovarian cancer and other cancers of the

16 reproductive system of women in accordance with

17 section 413; and

18 ‘‘(5) research and demonstration centers with

19 respect to ovarian cancer and cancers of the repro20 ductive system in accordance with section 414.

21 ‘‘(e) REPORT.—The Director of the Institute shall

22 prepare, for inclusion in the biennial report submitted

23 under section 407, a report that describes the activities

24 of the National Cancer Institute under the research pro25 grams referred to in subsection (a), that shall include—
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1 ‘‘(1) a description of the research plan with re2 spect to breast cancer prepared under subsection (c);

3 ‘‘(2) an assessment of the development, revi4 sion, and implementation of such plan;

5 ‘‘(3) a description and evaluation of the

6 progress made, during the period for which such re7 port is prepared, in the research programs on breast

8 cancer and cancers of the reproductive system of

9 women;

10 ‘‘(4) a summary and analysis of expenditures

11 made, during the period for which such report is

12 made, for activities with respect to breast cancer and

13 cancers of the reproductive system of women con14 ducted and supported by the National Institutes of

15 Health; and

16 ‘‘(5) such comments and recommendations as

17 the Director considers appropriate.’’.

18 SEC. 402. EXPANSION AND INTENSIFICATION OF ACTIVI19 TIES REGARDING PROSTATE CANCER.

20 Subpart 1 of part C of title IV of the Public Health

21 Service Act, as amended by section 401 of this Act, is

22 amended by adding at the end the following new section:

23 ‘‘PROSTATE CANCER

24 ‘‘SEC. 417A. (a) EXPANSION AND COORDINATION

25 OF ACTIVITIES.—The Director of the Institute, in con26 sultation with the National Cancer Advisory Board, shall
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1 expand, intensify, and coordinate the activities of the In2 stitute with respect to research on prostate cancer.

3 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.—

4 The Director of the Institute shall coordinate the activities

5 of the Director under subsection (a) with similar activities

6 conducted by other national research institutes and agen7 cies of the National Institutes of Health to the extent that

8 such Institutes and agencies have responsibilities that are

9 related to prostate cancer.

10 ‘‘(c) PROGRAMS.—

11 ‘‘(1) IN GENERAL.—In carryinf out subsection

12 (a), the Director of the Institute shall conduct or

13 support research to expand the understanding of the

14 cause of, and to find a cure for, prostate cancer. Ac15 tivities under such subsection shall provide for an

16 expansion and intensification of the conduct and

17 support of—

18 ‘‘(A) basic research concerning the etiology

19 and causes of prostate cancer;

20 ‘‘(B) clinical research and related activities

21 concerning the causes, prevention, detection and

22 treatment of prostate cancer;

23 ‘‘(C) prevention and control and early de24 tection programs with respect to prostate can25 cer in accordance with section 412, particularly
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1 as it relates to intensifying research on the role

2 of prostate specific antigen for the screening

3 and early detection of prostate cancer;

4 ‘‘(D) an Inter-Institute Task Force, under

5 the direction of the Director of the Institute, to

6 provide coordination between relevant National

7 Institutes of Health components of research ef8 forts on prostate cancer;

9 ‘‘(E) control programs with respect to

10 prostate cancer in accordance with section 412;

11 ‘‘(F) information and education programs

12 with respect to prostate cancer in accordance

13 with section 413; and

14 ‘‘(G) research and demonstration centers

15 with respect to prostate cancer in accordance

16 with section 414, including the development and

17 operation of centers for prostate cancer re18 search to bring together basic and clinical, bio19 medical and behavioral scientists to conduct

20 basic, clinical, epidemiological, psychosocial,

21 prevention and treatment research and related

22 activities on prostate cancer.

23 Not less than six centers shall be operated under

24 subparagraph (G). Activities of such centers should

25 include supporting new and innovative research and
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1 training programs for new researchers. Such centers

2 shall give priority to expediting the transfer of re3 search advances to clinical applications.

4 ‘‘(2) IMPLEMENTATION OF PLAN FOR PRO5 GRAMS.—

6 ‘‘(A) The Director of the Institute shall en7 sure that the research programs described in

8 paragraph (1) are implemented in accordance

9 with a plan for the programs. Such plan shall

10 include comments and recommendations that

11 the Director of the Institute considers appro12 priate, with due consideration provided to the

13 professional judgment needs of the Institute as

14 expressed in the annual budget estimate pre15 pared in accordance with section 413(9). The

16 Director of the Institute, in consultation with

17 the National Cancer Advisory Board, shall peri18 odically review and revise such plan.

19 ‘‘(B) Not later than May 1, 1993, the Di20 rector of the Institute shall submit a copy of

21 the plan to the President’s Cancer Panel, the

22 Secretary, and the Director of NIH.

23 ‘‘(C) The Director of the Institute shall

24 submit any revisions of the plan to the Presi-
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1 dent’s Cancer Panel, the Secretary, and the Di2 rector of NIH.

3 ‘‘(D) The Secretary shall provide a copy of

4 the plan submitted under subparagraph (A),

5 and any revisions submitted under subpara6 graph (C), to the Committee on Energy and

7 Commerce of the House of Representatives and

8 the Committee on Labor and Human Resources

9 of the Senate.’’.

10 SEC. 403. AUTHORIZATION OF APPROPRIATIONS.

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

12 of the Public Health Service Act, as amended by section

13 402 of this Act, is amended by adding at the end the fol14 lowing new section:

15 ‘‘AUTHORIZATION OF APPROPRIATIONS

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

17 purpose of carrying out this subpart, there are authorized

18 to be appropriated $2,200,000,000 for fiscal year 1994,

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

20 years 1995 and 1996.

21 ‘‘(b) BREAST CANCER AND GYNECOLOGICAL CAN22 CERS.—

23 ‘‘(1) BREAST CANCER.—

24 ‘‘(A) For the purpose of carrying out sub25 paragraph (A) of section 417(c)(1), there are

26 authorized to be appropriated $225,000,000 for
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1 fiscal year 1994, and such sums as may be nec2 essary for each of the fiscal years 1995 and

3 1996. Such authorizations of appropriations are

4 in addition to the authorizations of appropria5 tions established in subsection (a) with respect

6 to such purpose.

7 ‘‘(B) For the purpose of carrying out sub8 paragraphs (B) through (E) of section

9 417(c)(1), there are authorized to be appro10 priated $100,000,000 for fiscal year 1994, and

11 such sums as may be necessary for each of the

12 fiscal years 1995 and 1996. Such authoriza13 tions of appropriations are in addition to the

14 authorizations of appropriations established in

15 subsection (a) with respect to such purpose.

16 ‘‘(2) OTHER CANCERS.—For the purpose of

17 carrying out subsection (d) of section 417, there are

18 authorized to be appropriated $75,000,000 for fiscal

19 year 1994, and such sums as are necessary for each

20 of the fiscal years 1995 and 1996. Such authoriza21 tions of appropriations are in addition to the author22 izations of appropriations established in subsection

23 (a) with respect to such purpose.

24 ‘‘(c) PROSTATE CANCER.—For the purpose of carry25 ing out section 417A, there are authorized to be appro-
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1 priated $72,000,000 for fiscal year 1994, and such sums

2 as may be necessary for each of the fiscal years 1995 and

3 1996. Such authorizations of appropriations are in addi4 tion to the authorizations of appropriations established in

5 subsection (a) with respect to such purpose.

6 ‘‘(d) ALLOCATION REGARDING CANCER CONTROL.—

7 Of the amounts appropriated for the National Cancer In8 stitute for a fiscal year, the Director of the Institute shall

9 make available not less than 10 percent for carrying out

10 the cancer control activities authorized in section 412 and

11 for which budget estimates are made under section

12 413(b)(9) for the fiscal year.’’.

13 (b) SPECIAL RULE REGARDING FUNDS FOR SECTION

14 412 FOR FISCAL YEAR 1994.—Notwithstanding section

15 417B(d) of the Public Health Service Act, as added by

16 subsection (a) of this section, the amount made available

17 under such section for fiscal year 1994 for carrying out

18 section 412 of such Act shall be an amount not less than

19 an amount equal to 75 percent of the amount specified

20 for activities under such section 412 in the budget esti21 mate made under section 413(b)(9) of such Act for such

22 fiscal year.

23 (c) CONFORMING AMENDMENTS.—

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

25 Health Service Act (42 U.S.C. 284c) is amended—
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1 (A) by striking subsection (a);

2 (B) by redesignating subsection (b) as sub3 section (a);

4 (C) by redesignating paragraph (5) of sub5 section (a) (as so redesignated) as subsection

6 (b); and

7 (D) by amending the heading for the sec8 tion to read as follows:

9 ‘‘CERTAIN USES OF FUNDS’’.

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

11 Public Health Service Act (42 U.S.C. 285m–6) is

12 amended by striking ‘‘section 408(b)(1)’’ and insert13 ing ‘‘section 408(a)(1)’’.

14 TITLE V—NATIONAL HEART,

15 LUNG, AND BLOOD INSTITUTE

16 SEC. 501. EDUCATION AND TRAINING.

17 Section 421(b) of the Public Health Service Act (42

18 U.S.C. 285b–3(b)) is amended—

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

20 the semicolon at the end;

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

22 the end and inserting ‘‘; and’’; and

23 (3) by inserting after paragraph (4) the follow24 ing new paragraph:

25 ‘‘(5) shall, in consultation with the advisory

26 council for the Institute, conduct appropriate intra-
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1 mural training and education programs, including

2 continuing education and laboratory and clinical re3 search training programs.’’.

4 SEC. 502. CENTERS FOR THE STUDY OF PEDIATRIC CAR5 DIOVASCULAR DISEASES.

6 Section 422(a)(1) of the Public Health Service Act

7 (42 U.S.C. 285b–4(a)(1)) is amended—

8 (1) in subparagraph (B), by striking ‘‘and’’ at

9 the end;

10 (2) in subparagraph (C), by striking the period

11 and inserting ‘‘; and’’; and

12 (3) by adding at the end thereof the following

13 new subparagraph:

14 ‘‘(D) three centers for basic and clinical re15 search into, training in, and demonstration of, ad16 vanced diagnostic, prevention, and treatment (in17 cluding genetic studies, intrauterine environment

18 studies, postnatal studies, heart arrhythmias, and

19 acquired heart disease and preventive cardiology) for

20 cardiovascular diseases in children.’’.

21 SEC. 503. NATIONAL CENTER ON SLEEP DISORDERS.

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

23 Service Act (42 U.S.C. 285b et seq.) is amended by adding

24 at the end the following new section:
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1 ‘‘NATIONAL CENTER ON SLEEP DISORDERS

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

3 of the enactment of the National Institutes of Health Re4 vitalization Act of 1993, the Director of the Institute shall

5 establish the National Center on Sleep Disorders (in this

6 section referred to as the ‘Center’). The Center shall head7 ed by a director, who shall be appointed by the Director

8 of the Institute.

9 ‘‘(b) The general purpose of the Center is the conduct

10 and support of research, training, health information dis11 semination, and other activities with respect to sleep dis12 orders.’’.

13 SEC. 504. AUTHORIZATION OF APPROPRIATIONS.

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

15 Service Act, as amended by section 503 of this Act, is

16 amended by adding at the end the following section:

17 ‘‘AUTHORIZATION OF APPROPRIATIONS

18 ‘‘SEC. 425. (a) For the purpose of carrying out this

19 subpart, there are authorized to be appropriated

20 $1,500,000,000 for fiscal year 1994, and such sums as

21 may be necessary for each of the fiscal years 1995 and

22 1996.

23 ‘‘(b) Of the amounts appropriated under paragraph

24 (1) for a fiscal year, the Director of the Institute shall

25 make available not less than 10 percent for carrying out

26 community-based prevention and control activities that in-
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1 clude clinical investigations, clinical trials, epidemiologic

2 studies, and prevention demonstration and education

3 projects.’’.

4 TITLE VI—NATIONAL INSTITUTE

5 ON DIABETES AND DIGESTIVE

6 AND KIDNEY DISEASES

7 SEC. 601. PROVISIONS REGARDING NUTRITIONAL DIS8 ORDERS.

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

10 Service Act (42 U.S.C. 285c et seq.) is amended by adding

11 at the end the following new section:

12 ‘‘NUTRITIONAL DISORDERS PROGRAM

13 ‘‘SEC. 434. (a) The Director of the Institute shall es14 tablish a program of conducting and supporting research,

15 training, health information dissemination, and other ac16 tivities with respect to nutritional disorders, including obe17 sity.

18 ‘‘(b) In carrying out the program established under

19 subsection (a), the Director of the Institute shall conduct

20 and support each of the activities described in such sub21 section. The Director of NIH shall ensure that, as appro22 priate, the other national research institutes and agencies

23 of the National Institutes of Health have responsibilities

24 regarding such activities.

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

26 subsection (a), the Director of the Institute shall carry out
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1 activities to facilitate and enhance knowledge and under2 standing of nutritional disorders, including obesity, on the

3 part of health professionals, patients, and the public

4 through the effective dissemination of information.’’.

5 (b) DEVELOPMENT AND EXPANSION OF RESEARCH

6 AND TRAINING CENTERS.—Section 431 of the Public

7 Health Service Act (42 U.S.C. 285c–5) is amended—

8 (1) by redesignating subsection (d) as sub9 section (e); and

10 (2) by inserting after subsection (c) the follow11 ing new subsection:

12 ‘‘(d)(1) The Director of the Institute shall, subject

13 to the extent of amounts made available in appropriations

14 Acts, provide for the development or substantial expansion

15 of centers for research and training regarding nutritional

16 disorders, including obesity.

17 ‘‘(2) The Director of the Institute shall carry out

18 paragraph (1) in collaboration with the Director of the

19 National Cancer Institute and with the Directors of such

20 other agencies of the National Institutes of Health as the

21 Director of NIH determines to be appropriate.

22 ‘‘(3) Each center developed or expanded under para23 graph (1) shall—

24 ‘‘(A) utilize the facilities of a single institution,

25 or be formed from a consortium of cooperating insti-
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1 tutions, meeting such research and training quali2 fications as may be prescribed by the Director;

3 ‘‘(B) conduct basic and clinical research into

4 the cause, diagnosis, early detection, prevention, con5 trol and treatment of nutritional disorders, including

6 obesity and the impact of nutrition and diet on child

7 development;

8 ‘‘(C) conduct training programs for physicians

9 and allied health professionals in current methods of

10 diagnosis and treatment of such diseases and com11 plications, and in research in such disorders; and

12 ‘‘(D) conduct information programs for physi13 cians and allied health professionals who provide pri14 mary care for patients with such disorders or com15 plications.’’.

16 TITLE VII—NATIONAL INSTI17 TUTE ON ARTHRITIS AND

18 MUSCULOSKELETAL AND

19 SKIN DISEASES

20 SEC. 701. JUVENILE ARTHRITIS.

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

22 Service Act (42 U.S.C. 285d) is amended by striking ‘‘and

23 other programs’’ and all that follows and inserting the fol24 lowing: ‘‘and other programs with respect to arthritis and

25 musculoskeletal and skin diseases (including sports-related
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1 disorders), with particular attention to the effect of these

2 diseases on children.’’.

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

4 amended—

5 (1) in subsection (a), by inserting after the sec6 ond sentence, the following: ‘‘The plan shall place

7 particular emphasis upon expanding research into

8 better understanding the causes and the develop9 ment of effective treatments for arthritis affecting

10 children.’’; and

11 (2) in subsection (b)—

12 (A) by striking ‘‘and’’ at the end of para13 graph (3);

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

15 paragraph (4) and inserting ‘‘; and’’; and

16 (C) by adding at the end thereof the fol17 lowing new paragraph:

18 ‘‘(5) research into the causes of arthritis affect19 ing children and the development, trial, and evalua20 tion of techniques, drugs and devices used in the di21 agnosis, treatment (including medical rehabilitation),

22 and prevention of arthritis in children.’’.

23 (c) CENTERS.—Section 441 of the Public Health

24 Service Act (42 U.S.C. 286d–6) is amended by adding at

25 the end thereof the following new subsection:
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1 ‘‘(f) Not later than October 1, 1994, the Director

2 shall establish a multipurpose arthritis and musculo3 skeletal disease center for the purpose of expanding the

4 level of research into the cause, diagnosis, early detection,

5 prevention, control, and treatment of, and rehabilitation

6 of children with arthritis and musculoskeletal diseases.’’.

7 (d) ADVISORY BOARD.—

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

9 Health Service Act (42 U.S.C. 285d–7(a)) is amend10 ed by inserting after ‘‘Arthritis’’ the first place such

11 term appears the following: ‘‘and Musculoskeletal

12 and Skin Diseases’’.

13 (2) COMPOSITION.—Section 442(b) of the Pub14 lic Health Service Act (42 U.S.C. 285d–7(b)) is

15 amended—Section 442(b) of the Public Health Serv16 ice Act (42 U.S.C. 285d–7(b)) is amended—

17 (A) in the matter preceding paragraph (1),

18 by striking ‘‘eighteen’’ and inserting ‘‘twenty’’;

19 and

20 (B) in paragraph (1)(B)—

21 (i) by striking ‘‘six’’ and inserting

22 ‘‘eight’’; and

23 (ii) by striking ‘‘including’’ and all

24 that follows and inserting the following:

25 ‘‘including one member who is a person
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1 who has such a disease, one person who is

2 the parent of an adult with such a disease,

3 and two members who are parents of chil4 dren with arthritis.’’.

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

6 Public Health Service Act (42 U.S.C. 285d–7(j)) is

7 amended—

8 (1) by striking ‘‘and’’ at the end of paragraph

9 (3);

10 (2) by striking the period at the end of para11 graph (4) and inserting ‘‘; and’’; and

12 (3) by adding at the end the following para13 graph:

14 ‘‘(5) contains recommendations for expanding

15 the Institute’s funding of research directly applicable

16 to the cause, diagnosis, early detection, prevention,

17 control, and treatment of, and rehabilitation of chil18 dren with arthritis and musculoskeletal diseases.’’.

19 TITLE VIII—NATIONAL

20 INSTITUTE ON AGING

21 SEC. 801. ALZHEIMER’S DISEASE REGISTRY.

22 (a) IN GENERAL.—Section 12 of Public Law 99–158

23 (99 Stat. 885) is—
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1 (1) transferred to subpart 5 of part C of title

2 IV of the Public Health Service Act (42 U.S.C. 285e

3 et seq.);

4 (2) redesignated as section 445G; and

5 (3) inserted after section 445F of such Act.

6 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

7 Section 445G of the Public Health Service Act, as trans8 ferred and inserted by subsection (a) of this section, is

9 amended—

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

11 follows through ‘‘may make a grant’’ in subsection

12 (a) and inserting the following:

13 ‘‘ALZHEIMER’S DISEASE REGISTRY

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

15 Institute may make a grant’’; and

16 (2) by striking subsection (c).

17 SEC. 802. AGING PROCESSES REGARDING WOMEN.

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

19 Service Act, as amended by section 801 of this Act, is

20 amended by adding at the end the following new section:

21 ‘‘AGING PROCESSES REGARDING WOMEN

22 ‘‘SEC. 445H. The Director of the Institute, in addi23 tion to other special functions specified in section 444 and

24 in cooperation with the Directors of the other national re25 search institutes and agencies of the National Institutes

26 of Health, shall conduct research into the aging processes
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1 of women, with particular emphasis given to the effects

2 of menopause and the physiological and behavioral

3 changes occurring during the transition from pre- to post4 menopause, and into the diagnosis, disorders, and com5 plications related to aging and loss of ovarian hormones

6 in women.’’.

7 SEC. 803. AUTHORIZATION OF APPROPRIATIONS.

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

9 Service Act, as amended by section 802 of this Act, is

10 amended by adding at the end the following new section:

11 ‘‘AUTHORIZATION OF APPROPRIATIONS

12 ‘‘SEC. 445I. For the purpose of carrying out this sub13 part, there are authorized to be appropriated

14 $500,000,000 for fiscal year 1994, and such sums as may

15 be necessary for each of the fiscal years 1995 and 1996.’’.

16 SEC. 804. CONFORMING AMENDMENT.

17 Section 445C of the Public Health Service Act (42

18 U.S.C. 285e–5(b)) is amended—

19 (1) in subsection (b)(1), in the first sentence,

20 by inserting after ‘‘Council’’ the following: ‘‘on Alz21 heimer’s Disease (hereafter in this section referred

22 to as the ‘Council’)’’; and

23 (2) by adding at the end the following new sub24 section:
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1 ‘‘(d) For purposes of this section, the term ‘Council

2 on Alzheimer’s Disease’ means the council established in

3 section 911(a) of Public Law 99–660.’’.

4 TITLE IX—NATIONAL INSTITUTE

5 OF ALLERGY AND INFEC6 TIOUS DISEASES

7 SEC. 901. TROPICAL DISEASES.

8 Section 446 of the Public Health Service Act (42

9 U.S.C. 285f) is amended by inserting before the period

10 the following: ‘‘, including tropical diseases’’.

11 SEC. 902. CHRONIC FATIGUE SYNDROME.

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

13 title IV of the Public Health Service Act (42 U.S.C. 285f)

14 is amended by adding at the end the following new section:

15 ‘‘RESEARCH CENTERS REGARDING CHRONIC FATIGUE

16 SYNDROME

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

18 consultation with the advisory council for the Institute,

19 may make grants to, or enter into contracts with, public

20 or nonprofit private entities for the development and oper21 ation of centers to conduct basic and clinical research on

22 chronic fatigue syndrome.

23 ‘‘(b) Each center assisted under this section shall use

24 the facilities of a single institution, or be formed from a

25 consortium of cooperating institutions, meeting such re-
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1 quirements as may be prescribed by the Director of the

2 Institute.’’.

3 (b) EXTRAMURAL STUDY SECTION.—Not later than

4 6 months after the date of enactment of this Act, the Sec5 retary of Health and Human Services shall establish an

6 extramural study section for chronic fatigue syndrome re7 search.

8 (c) REPRESENTATIVES.—The Secretary of Health

9 and Human Services, acting through the Director of the

10 National Institutes of Health, shall ensure that appro11 priate individuals with expertise in chronic fatigue syn12 drome or neuromuscular diseases and representative of a

13 variety of disciplines and fields within the research com14 munity are appointed to appropriate National Institutes

15 of Health advisory committees and boards.
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1 TITLE X—NATIONAL INSTITUTE

2 OF CHILD HEALTH AND

3 HUMAN DEVELOPMENT

4 Subtitle A—Research Centers With

5 Respect to Contraception and

6 Research Centers With Respect

7 to Infertility

8 SEC. 1001. GRANTS AND CONTRACTS FOR RESEARCH CEN9 TERS.

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

11 Service Act, as amended by section 3 of Public Law 101–

12 613, is amended by adding at the end the following new

13 section:

14 ‘‘RESEARCH CENTERS WITH RESPECT TO

15 CONTRACEPTION AND INFERTILITY

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

17 consultation with the advisory council for the Institute,

18 shall make grants to, or enter into contracts with, public

19 or nonprofit private entities for the development and oper20 ation of centers to conduct activities for the purpose of

21 improving methods of contraception and centers to con22 duct activities for the purpose of improving methods of

23 diagnosis and treatment of infertility.

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

25 the Institute shall, subject to the extent of amounts made
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1 available in appropriations Acts, provide for the establish2 ment of three centers with respect to contraception and

3 for two centers with respect to infertility.

4 ‘‘(c)(1) Each center assisted under this section shall,

5 in carrying out the purpose of the center involved—

6 ‘‘(A) conduct clinical and other applied re7 search, including—

8 ‘‘(i) for centers with respect to contracep9 tion, clinical trials of new or improved drugs

10 and devices for use by males and females (in11 cluding barrier methods); and

12 ‘‘(ii) for centers with respect to infertility,

13 clinical trials of new or improved drugs and de14 vices for the diagnosis and treatment of infertil15 ity in males and females;

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

17 scientists, nurses, and other health and allied health

18 professionals;

19 ‘‘(C) conduct training programs for such indi20 viduals;

21 ‘‘(D) develop model continuing education pro22 grams for such professionals; and

23 ‘‘(E) disseminate information to such profes24 sionals and the public.
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1 ‘‘(2) A center may use funds provided under sub2 section (a) to provide stipends for health and allied health

3 professionals enrolled in programs described in subpara4 graph (C) of paragraph (1), and to provide fees to individ5 uals serving as subjects in clinical trials conducted under

6 such paragraph.

7 ‘‘(d) The Director of the Institute shall, as appro8 priate, provide for the coordination of information among

9 the centers assisted under this section.

10 ‘‘(e) Each center assisted under subsection (a) shall

11 use the facilities of a single institution, or be formed from

12 a consortium of cooperating institutions, meeting such re13 quirements as may be prescribed by the Director of the

14 Institute.

15 ‘‘(f) Support of a center under subsection (a) may

16 be for a period not exceeding 5 years. Such period may

17 be extended for one or more additional periods not exceed18 ing 5 years if the operations of such center have been re19 viewed by an appropriate technical and scientific peer re20 view group established by the Director and if such group

21 has recommended to the Director that such period should

22 be extended.

23 ‘‘(g) For the purpose of carrying out this section,

24 there are authorized to be appropriated $30,000,000 for
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1 fiscal year 1994, and such sums as may be necessary for

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

3 SEC. 1002. LOAN REPAYMENT PROGRAM FOR RESEARCH

4 WITH RESPECT TO CONTRACEPTION AND IN5 FERTILITY.

6 Part G of title IV of the Public Health Service Act,

7 as redesignated by section 141(a)(2) of this Act, is amend8 ed by inserting after section 487A the following section:

9 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH

10 RESPECT TO CONTRACEPTION AND INFERTILITY

11 ‘‘SEC. 487B. (a) The Secretary, in consultation with

12 the Director of the National Institute of Child Health and

13 Human Development, shall establish a program of enter14 ing into agreements with qualified health professionals (in15 cluding graduate students) under which such health pro16 fessionals agree to conduct research with respect to con17 traception, or with respect to infertility, in consideration

18 of the Federal Government agreeing to repay, for each

19 year of such service, not more than $20,000 of the prin20 cipal and interest of the educational loans of such health

21 professionals.

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

23 338E shall apply to the program established in subsection

24 (a) to the same extent and in the same manner as such

25 provisions apply to the National Health Service Corps
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1 Loan Repayment Program established in subpart III of

2 part D of title III.

3 ‘‘(c) Amounts appropriated for carrying out this sec4 tion shall remain available until the expiration of the sec5 ond fiscal year beginning after the fiscal year for which

6 the amounts were appropriated.’’.

7 Subtitle B—Program Regarding

8 Obstetrics and Gynecology

9 SEC. 1011. ESTABLISHMENT OF PROGRAM.

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

11 Service Act, as amended by section 1001 of this Act, is

12 amended by adding at the end the following new section:

13 ‘‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY

14 ‘‘SEC. 452B. The Director of the Institute shall es15 tablish and maintain within the Institute an intramural

16 laboratory and clinical research program in obstetrics and

17 gynecology.’’.

18 Subtitle C—Child Health Research

19 Centers

20 SEC. 1021. ESTABLISHMENT OF CENTERS.

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

22 Service Act, as amended by section 1011 of this Act, is

23 amended by adding at the end the following new section:

24 ‘‘CHILD HEALTH RESEARCH CENTERS

25 ‘‘SEC. 452C. The Director of the Institute shall de26 velop and support centers for conducting research with re-
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1 spect to child health. Such centers shall give priority to

2 the expeditious transfer of advances from basic science to

3 clinical applications and improving the care of infants and

4 children.’’.

5 Subtitle D—Study Regarding

6 Adolescent Health

7 SEC. 1031. PROSPECTIVE LONGITUDINAL STUDY.

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

9 Service Act, as amended by section 1021 of this Act, is

10 amended by adding at the end the following new section:

11 ‘‘PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT

12 HEALTH

13 ‘‘SEC. 452D. (a) IN GENERAL.—The Director of the

14 Institute shall conduct a study for the purpose of provid15 ing information on the general health and well-being of

16 adolescents in the United States, including, with respect

17 to such adolescents, information on—

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

19 behaviors that are detrimental to health; and

20 ‘‘(2) the influence on health of factors particu21 lar to the communities in which the adolescents

22 reside.

23 ‘‘(b) DESIGN OF STUDY.—

24 ‘‘(1) IN GENERAL.—The study required in sub25 section (a) shall be a longitudinal study in which a

26 substantial number of adolescents participate as sub-
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1 jects. With respect to the purpose described in such

2 subsection, the study shall monitor the subjects

3 throughout the period of the study to determine the

4 health status of the subjects and any change in such

5 status over time.

6 ‘‘(2) POPULATION-SPECIFIC ANALYSES.—The

7 study required in subsection (a) shall be conducted

8 with respect to the population of adolescents who are

9 female, the population of adolescents who are male,

10 various socioeconomic populations of adolescents,

11 and various racial and ethnic populations of adoles12 cents. The study shall be designed and conducted in

13 a manner sufficient to provide for a valid analysis of

14 whether there are significant differences among such

15 populations in health status and whether and to

16 what extent any such differences are due to factors

17 particular to the populations involved.

18 ‘‘(c) COORDINATION WITH WOMEN’S HEALTH INI19 TIATIVE.—With respect to the national study of women

20 being conducted by the Secretary and known as the Wom21 en’s Health Initiative, the Secretary shall ensure that such

22 study is coordinated with the component of the study re23 quired in subsection (a) that concerns adolescent females,

24 including coordination in the design of the 2 studies.
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1 ‘‘(d) ALLOCATION OF FUNDS FOR STUDY.—Of the

2 amounts appropriated for each of the fiscal years 1994

3 through 1996 for the National Institute of Child Health

4 and Human Development, the Secretary of Health and

5 Human Services, acting through the Director of such In6 stitute, shall reserve $3,000,000 to conduct the study re7 quired in subsection (a). The amounts so reserved shall

8 remain available until expended.’’.

9 TITLE XI—NATIONAL EYE

10 INSTITUTE

11 SEC. 1101. CLINICAL RESEARCH ON DIABETES EYE CARE.

12 (a) IN GENERAL.—Subpart 9 of part C of title IV

13 of the Public Health Service Act (42 U.S.C. 285i) is

14 amended by adding at the end the following new section:

15 ‘‘CLINICAL RESEARCH ON EYE CARE AND DIABETES

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

17 of the Institute, in consultation with the advisory council

18 for the Institute, may award not more than three grants

19 for the establishment and support of centers for clinical

20 research on eye care for individuals with diabetes.

21 ‘‘(b) AUTHORIZED EXPENDITURES.—The purposes

22 for which a grant under subsection (a) may be expended

23 include equipment for the research described in such sub24 section and the construction and modernization of facili25 ties for such research.’’.
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1 (b) CONFORMING AMENDMENT.—Section 455 of the

2 Public Health Service Act (42 U.S.C. 285i) is amended

3 in the second sentence by striking ‘‘The Director’’ and in4 serting ‘‘Subject to section 456, the Director’’.

5 TITLE XII—NATIONAL INSTI6 TUTE OF NEUROLOGICAL DIS7 ORDERS AND STROKE

8 SEC. 1201. RESEARCH ON MULTIPLE SCLEROSIS.

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

10 Service Act (42 U.S.C. 285j et seq.) is amended by adding

11 at the end the following new section:

12 ‘‘RESEARCH ON MULTIPLE SCLEROSIS

13 ‘‘SEC. 460. The Director of the Institute shall con14 duct and support research on multiple sclerosis, especially

15 research on effects of genetics and hormonal changes on

16 the progress of the disease.’’.

17 TITLE XIII—NATIONAL INSTI18 TUTE OF ENVIRONMENTAL

19 HEALTH SCIENCES

20 SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND

21 TESTING PROGRAM.

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

23 of the Public Health Service Act (42 U.S.C. 285l) is

24 amended by adding at the end the following new section:
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1 ‘‘APPLIED TOXICOLOGICAL RESEARCH AND TESTING

2 PROGRAM

3 ‘‘SEC. 463A. (a) There is established within the Insti4 tute a program for conducting applied research and test5 ing regarding toxicology, which program shall be known

6 as the Applied Toxicological Research and Testing Pro7 gram.

8 ‘‘(b) In carrying out the program established under

9 subsection (a), the Director of the Institute shall, with re10 spect to toxicology, carry out activities—

11 ‘‘(1) to expand knowledge of the health effects

12 of environmental agents;

13 ‘‘(2) to broaden the spectrum of toxicology in14 formation that is obtained on selected chemicals;

15 ‘‘(3) to develop and validate assays and proto16 cols, including alternative methods that can reduce

17 or eliminate the use of animals in acute or chronic

18 safety testing;

19 ‘‘(4) to establish criteria for the validation and

20 regulatory acceptance of alternative testing and to

21 recommend a process through which scientifically

22 validated alternative methods can be accepted for

23 regulatory use;
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1 ‘‘(5) to communicate the results of research to

2 government agencies, to medical, scientific, and reg3 ulatory communities, and to the public; and

4 ‘‘(6) to integrate related activities of the De5 partment of Health and Human Services.’’.

6 (b) TECHNICAL AMENDMENT.—Section 463 of the

7 Public Health Service Act (42 U.S.C. 285l) is amended

8 by inserting after ‘‘Sciences’’ the following: ‘‘(hereafter in

9 this subpart referred to as the ‘Institute’)’’.

10 TITLE XIV—NATIONAL LIBRARY

11 OF MEDICINE

12 Subtitle A—General Provisions

13 SEC. 1401. ADDITIONAL AUTHORITIES.

14 (a) IN GENERAL.—Section 465(b) of the Public

15 Health Service Act (42 U.S.C. 286(b)) is amended—

16 (1) by striking ‘‘and’’ after the semicolon at the

17 end of paragraph (5);

18 (2) by redesignating paragraph (6) as para19 graph (8); and

20 (3) by inserting after paragraph (5) the follow21 ing new paragraphs:

22 ‘‘(6) publicize the availability from the Library

23 of the products and services described in any of

24 paragraphs (1) through (5);
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1 ‘‘(7) promote the use of computers and tele2 communications by health professionals (including

3 health professionals in rural areas) for the purpose

4 of improving access to biomedical information for

5 health care delivery and medical research; and’’.

6 (b) LIMITATION REGARDING GRANTS.—Section

7 474(b)(2) of the Public Health Service Act (42 U.S.C.

8 286b–S(b)(2)) is amended by striking ‘‘$750,000’’ and in9 serting ‘‘$1,000,000’’.

10 (c) TECHNICAL AND CONFORMING AMENDMENTS.—

11 (1) REPEAL OF CERTAIN AUTHORITY.—Section

12 215 of the Department of Health and Human Serv13 ices Appropriations Act, 1988, as contained in sec14 tion 101(h) of Public Law 100–202 (101 Stat.

15 1329–275), is repealed.

16 (2) APPLICABILITY OF CERTAIN NEW AUTHOR17 ITY.—With respect to the authority established for

18 the National Library of Medicine in section

19 465(b)(6) of the Public Health Service Act, as added

20 by subsection (a) of this section, such authority shall

21 be effective as if the authority had been established

22 on December 22, 1987.

23 SEC. 1402. AUTHORIZATION OF APPROPRIATIONS.

24 (a) ESTABLISHMENT OF SINGLE AUTHORIZATION.—

25 Subpart 1 of part D of title IV of the Public Health Serv-
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1 ice Act (42 U.S.C. 286 et seq.) is amended by adding at

2 the end the following section:

3 ‘‘AUTHORIZATION OF APPROPRIATIONS

4 ‘‘SEC. 468. (a) For the purpose of carrying out this

5 part, there are authorized to be appropriated

6 $150,000,000 for fiscal year 1994, and such sums as may

7 be necessary for each of the fiscal years 1995 and 1996.

8 ‘‘(b) Amounts appropriated under subsection (a) and

9 made available for grants or contracts under any of sec10 tions 472 through 476 shall remain available until the end

11 of the fiscal year following the fiscal year for which the

12 amounts were appropriated.’’.

13 (b) CONFORMING AMENDMENTS.—Part D of title IV

14 of the Public Health Service Act (42 U.S.C. 286 et seq.)

15 is amended by striking section 469 and section 478(c).

16 Subtitle B—Financial Assistance

17 SEC. 1411. ESTABLISHMENT OF PROGRAM OF GRANTS FOR

18 DEVELOPMENT OF EDUCATION TECH19 NOLOGIES.

20 Section 473 of the Public Health Service Act (42

21 U.S.C. 286b–4) is amended by adding at the end the fol22 lowing new subsection:

23 ‘‘(c)(1) The Secretary shall make grants to public or

24 nonprofit private institutions for the purpose of carrying

25 out projects of research on, and development and dem26 onstration of, new education technologies.
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1 ‘‘(2) The purposes for which a grant under paragraph

2 (1) may be made include projects concerning—

3 ‘‘(A) computer-assisted teaching and testing of

4 clinical competence at health professions and re5 search institutions;

6 ‘‘(B) the effective transfer of new information

7 from research laboratories to appropriate clinical ap8 plications;

9 ‘‘(C) the expansion of the laboratory and clini10 cal uses of computer-stored research databases; and

11 ‘‘(D) the testing of new technologies for train12 ing health care professionals.

13 ‘‘(3) The Secretary may not make a grant under

14 paragraph (1) unless the applicant for the grant agrees

15 to make the projects available with respect to—

16 ‘‘(A) assisting in the training of health profes17 sions students; and

18 ‘‘(B) enhancing and improving the capabilities

19 of health professionals regarding research and teach20 ing.’’.
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1 Subtitle C—National Information

2 Center on Health Services Re3 search and Health Care Tech4 nology

5 SEC. 1421. ESTABLISHMENT OF CENTER.

6 Part D of title IV of the Public Health Service Act

7 (42 U.S.C. 286 et seq.) is amended by adding at the end

8 the following new subpart:

9 ‘‘Subpart 4—National Information Center on Health

10 Services Research and Health Care Technology

11 ‘‘NATIONAL INFORMATION CENTER

12 ‘‘SEC. 478A. (a) There is established within the Li13 brary an entity to be known as the National Information

14 Center on Health Services Research and Health Care

15 Technology (in this section referred to as the ‘Center’).

16 ‘‘(b) The purpose of the Center is the collection, stor17 age, analysis, retrieval, and dissemination of information

18 on health services research, clinical practice guidelines,

19 and on health care technology, including the assessment

20 of such technology. Such purpose includes developing and

21 maintaining data bases and developing and implementing

22 methods of carrying out such purpose.

23 ‘‘(c) The Director of the Center shall ensure that in24 formation under subsection (b) concerning clinical practice

25 guidelines is collected and maintained electronically and
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1 in a convenient format. Such Director shall develop and

2 publish criteria for the inclusion of practice guidelines and

3 technology assessments in the information center

4 database.

5 ‘‘(d) The Secretary, acting through the Center, shall

6 coordinate the activities carried out under this section

7 through the Center with related activities of the Adminis8 trator for Health Care Policy and Research.’’.

9 SEC. 1422. CONFORMING PROVISIONS.

10 (a) IN GENERAL.—Section 903 of the Public Health

11 Service Act, as amended by section 3 of Public Law 102-

12 410 (106 Stat. 2094), is amended to read as follows:

13 ‘‘(e) REQUIRED INTERAGENCY AGREEMENT.—The

14 Administrator and the Director of the National Library

15 of Medicine shall enter into an agreement providing for

16 the implementation of section 478A.’’.

17 (b) RULE OF CONSTRUCTION.—The amendments

18 made by section 3 of Public Law 102-410 (106 Stat.

19 2094), by section 1421 of this Act, and by subsection (a)

20 of this section may not be construed as terminating the

21 information center on health care technologies and health

22 care technology assessment established under section 904

23 of the Public Health Service Act, as in effect on the day

24 before the date of the enactment of Public Law 102-410.

25 Such center shall be considered to be the center estab-
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1 lished in section 478A of the Public Health Service Act,

2 as added by section 1421 of this Act, and shall be subject

3 to the provisions of such section 478A.

4 TITLE XV—OTHER AGENCIES OF

5 NATIONAL INSTITUTES OF

6 HEALTH

7 Subtitle A—Division of Research

8 Resources

9 SEC. 1501. REDESIGNATION OF DIVISION AS NATIONAL

10 CENTER FOR RESEARCH RESOURCES.

11 Title IV of the Public Health Service Act (42 U.S.C.

12 281 et seq.) is amended—

13 (1) in section 401(b)(2)(B), by amending such

14 subparagraph to read as follows:

15 ‘‘(B) The National Center for Research Re16 sources.’’; and

17 (2) in part E—

18 (A) in the heading for subpart 1, by strik19 ing ‘‘Division of’’ and inserting ‘‘National Cen20 ter for’’;

21 (B) in section 479, by striking ‘‘the Divi22 sion of Research Resources’’ and inserting the

23 following: ‘‘the National Center for Research

24 Resources (hereafter in this subpart referred to

25 as the ‘Center’)’’;
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1 (C) in sections 480 and 481, by striking

2 ‘‘the Division of Research Resources’’ each

3 place such term appears and inserting ‘‘the

4 Center’’; and

5 (D) in sections 480 and 481, as amended

6 by subparagraph (C), by striking ‘‘the Division’’

7 each place such term appears and inserting

8 ‘‘the Center’’.

9 SEC. 1502. BIOMEDICAL AND BEHAVIORAL RESEARCH FA10 CILITIES.

11 Subpart 1 of part E of title IV of the Public Health

12 Service Act (42 U.S.C. 287 et seq.) is amended by adding

13 at the end the following new section:

14 ‘‘BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES

15 ‘‘SEC. 481A. (a) MODERNIZATION AND CONSTRUC16 TION OF FACILITIES.—

17 ‘‘(1) IN GENERAL.—The Director of NIH, act18 ing through the Director of the Center, may make

19 grants to public and nonprofit private entities to ex20 pand, remodel, renovate, or alter existing research

21 facilities or construct new research facilities, subject

22 to the provisions of this section.

23 ‘‘(2) CONSTRUCTION AND COST OF CONSTRUC24 TION.—For purposes of this section, the terms ‘con25 struction’ and ‘cost of construction’ include the con26 struction of new buildings and the expansion, ren-
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1 ovation, remodeling, and alteration of existing build2 ings, including architects’ fees, but do not include

3 the cost of acquisition of land or off-site improve4 ments.

5 ‘‘(b) SCIENTIFIC AND TECHNICAL REVIEW BOARDS

6 FOR MERIT-BASED REVIEW OF PROPOSALS.—

7 ‘‘(1) IN GENERAL; APPROVAL AS PRECONDITION

8 TO GRANTS.—

9 ‘‘(A) There is established within the Center

10 a Scientific and Technical Review Board on

11 Biomedical and Behavioral Research Facilities

12 (hereafter referred to in this section as the

13 ‘Board’).

14 ‘‘(B) The Director of the Center may ap15 prove an application for a grant under sub16 section (a) only if the Board has under para17 graph (2) recommended the application for ap18 proval.

19 ‘‘(2) DUTIES.—

20 ‘‘(A) The Board shall provide advice to the

21 Director of the Center and the advisory council

22 established under section 480 (hereafter in this

23 section referred to as the ‘Advisory Council’) on

24 carrying out this section.
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1 ‘‘(B) In carrying out subparagraph (A),

2 the Board shall make a determination of the

3 merit of each application submitted for a grant

4 under subsection (a), after consideration of the

5 requirements established in subsection (c), and

6 shall report the results of the determination to

7 the Director of the Center and the Advisory

8 Council. Such determinations shall be con9 ducted in a manner consistent with procedures

10 established under section 492.

11 ‘‘(C) In carrying out subparagraph (A),

12 the Board shall, in the case of applications rec13 ommended for approval, make recommendations

14 to the Director and the Advisory Council on the

15 amount that should be provided in the grant.

16 ‘‘(D) In carrying out subparagraph (A),

17 the Board shall prepare an annual report for

18 the Director of the Center and the Advisory

19 Council describing the activities of the Board in

20 the fiscal year for which the report is made.

21 Each such report shall be available to the pub22 lic, and shall—

23 ‘‘(i) summarize and analyze expendi24 tures made under this section;
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1 ‘‘(ii) provide a summary of the types,

2 numbers, and amounts of applications that

3 were recommended for grants under sub4 section (a) but that were not approved by

5 the Director of the Center; and

6 ‘‘(iii) contain the recommendations of

7 the Board for any changes in the adminis8 tration of this section.

9 ‘‘(3) MEMBERSHIP.—

10 ‘‘(A) Subject to subparagraph (B), the

11 Board shall be composed of such appointed and

12 ex officio members as the Director of the Cen13 ter may determine.

14 ‘‘(B) Not more than 3 individuals who are

15 officers or employees of the Federal Govern16 ment may serve as members of the Board.

17 ‘‘(C) Of the members of the Board—

18 ‘‘(i) 12 shall be appointed by the Di19 rector of the Center (without regard to the

20 civil service laws); and

21 ‘‘(ii) 1 shall be an official of the Na22 tional Science Foundation designated by

23 the National Science Board.

24 ‘‘(4) CERTAIN REQUIREMENTS REGARDING

25 MEMBERSHIP.—In selecting individuals for member-
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1 ship on the Board, the Director of the Center shall

2 ensure that the members are individuals who, by the

3 virtue of their training or experience, are eminently

4 qualified to perform peer review functions. In select5 ing such individuals for such membership, the Direc6 tor of the Center shall ensure that the members of

7 the Board collectively—

8 ‘‘(A) are experienced in the planning, con9 struction, financing, and administration of enti10 ties that conduct biomedical or behavioral re11 search sciences;

12 ‘‘(B) are knowledgeable in making deter13 minations of the need of entities for biomedical

14 or behavioral research facilities, including such

15 facilities for the dentistry, nursing, pharmacy,

16 and allied health professions;

17 ‘‘(C) are knowledgeable in evaluating the

18 relative priorities for applications for grants

19 under subsection (a) in view of the overall re20 search needs of the United States; and

21 ‘‘(D) are experienced with emerging cen22 ters of excellence, as described in subsection

23 (c)(3).

24 ‘‘(5) CERTAIN AUTHORITIES.—
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1 ‘‘(A) In carrying out paragraph (2), the

2 Board may establish subcommittees, convene

3 workshops and conferences, and collect data as

4 the Board considers appropriate.

5 ‘‘(B) In carrying out paragraph (2), the

6 Board may establish subcommittees within the

7 Board. Such subcommittees may hold meetings

8 as determined necessary to enable the sub9 committee to carry out its duties.

10 ‘‘(6) TERMS.—

11 ‘‘(A) Except as provided in subparagraph

12 (B), each appointed member of the Board shall

13 hold office for a term of 4 years. Any member

14 appointed to fill a vacancy occurring prior to

15 the expiration of the term for which such mem16 ber’s predecessor was appointed shall be ap17 pointed for the remainder of the term of the

18 predecessor.

19 ‘‘(B) Of the initial members appointed to

20 the Board (as specified by the Director of the

21 Center when making the appointments)—

22 ‘‘(i) 3 shall hold office for a term of

23 3 years;

24 ‘‘(ii) 3 shall hold office for a term of

25 2 years; and
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1 ‘‘(iii) 3 shall hold office for a term of

2 1 year.

3 ‘‘(C) No member is eligible for reappoint4 ment to the Board until 1 year has elapsed

5 after the end of the most recent term of the

6 member.

7 ‘‘(7) COMPENSATION.—Members of board who

8 are not officers or employees of the United States

9 shall receive compensation for each day engaged in

10 carrying out the duties of the board, including time

11 engaged in traveling for purposes of such duties.

12 Such compensation may not be provided in an

13 amount in excess of the maximum rate of basic pay

14 payable for GS–18 of the General Schedule.

15 ‘‘(c) REQUIREMENTS FOR GRANTS.—

16 ‘‘(1) IN GENERAL.—The Director of the Center

17 may make a grant under subsection (a) only if the

18 applicant for the grant meets the following condi19 tions:

20 ‘‘(A) The applicant is determined by such

21 Director to be competent to engage in the type

22 of research for which the proposed facility is to

23 be constructed.

24 ‘‘(B) The applicant provides assurances

25 satisfactory to the Director that—
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1 ‘‘(i) for not less than 20 years after

2 completion of the construction, the facility

3 will be used for the purposes of research

4 for which it is to be constructed;

5 ‘‘(ii) sufficient funds will be available

6 to meet the non-Federal share of the cost

7 of constructing the facility;

8 ‘‘(iii) sufficient funds will be available,

9 when construction is completed, for the ef10 fective use of the facility for the research

11 for which it is being constructed; and

12 ‘‘(iv) the proposed construction will

13 expand the applicant’s capacity for re14 search, or is necessary to improve or main15 tain the quality of the applicant’s research.

16 ‘‘(C) The applicant meets reasonable quali17 fications established by the Director with re18 spect to—

19 ‘‘(i) the relative scientific and tech20 nical merit of the applications, and the rel21 ative effectiveness of the proposed facili22 ties, in expanding the capacity for bio23 medical or behavioral research and in im24 proving the quality of such research;
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1 ‘‘(ii) the quality of the research or

2 training, or both, to be carried out in the

3 facilities involved;

4 ‘‘(iii) the need of the applicant for

5 such facilities in order to maintain or ex6 pand the applicant’s research and training

7 mission;

8 ‘‘(iv) the congruence of the research

9 activities to be carried out within the facil10 ity with the research and investigator man11 power needs of the United States; and

12 ‘‘(v) the age and condition of existing

13 research facilities and equipment.

14 ‘‘(D) The applicant has demonstrated a

15 commitment to enhancing and expanding the

16 research productivity of the applicant.

17 ‘‘(2) CONSIDERATION OF CERTAIN FACTORS.—

18 In making grants under subsection (a), the Director

19 of the Center may, in addition to the requirements

20 established in paragraph (1), consider the following

21 factors:

22 ‘‘(A) To what extent the applicant has the

23 capacity to broaden the scope of research and

24 research training programs of the applicant by

25 promoting—
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1 ‘‘(i) interdisciplinary research;

2 ‘‘(ii) research on emerging tech3 nologies, including those involving novel

4 analytical techniques or computational

5 methods; or

6 ‘‘(iii) other novel research mechanisms

7 or programs.

8 ‘‘(B) To what extent the applicant has

9 broadened the scope of research and research

10 training programs of qualified institutions by

11 promoting genomic research with an emphasis

12 on interdisciplinary research, including research

13 related to pediatric investigations.

14 ‘‘(3) INSTITUTIONS OF EMERGING EXCEL15 LENCE.—Of the amounts appropriated under sub16 section (i) for a fiscal year, the Director of the Cen17 ter shall make available 25 percent for grants under

18 subsection (a) to applicants that, in addition to

19 meeting the requirements established in paragraph

20 (1), have demonstrated emerging excellence in bio21 medical or behavioral research, as follows:

22 ‘‘(A) The applicant has a plan for research

23 or training advancement and possesses the abil24 ity to carry out the plan.
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1 ‘‘(B) The applicant carries out research

2 and research training programs that have a

3 special relevance to a problem, concern, or

4 unmet health need of the United States.

5 ‘‘(C) The applicant has been productive in

6 research or research development and training.

7 ‘‘(D) The applicant—

8 ‘‘(i) has been designated as a center

9 of excellence under section 739;

10 ‘‘(ii) is located in a geographic area a

11 significant percentage of whose population

12 has a health-status deficit, and the appli13 cant provides health services to such popu14 lation; or

15 ‘‘(iii) is located in a geographic area

16 in which a deficit in health care tech17 nology, services, or research resources may

18 adversely affect health status of the popu19 lation of the area in the future, and the

20 applicant is carrying out activities with re21 spect to protecting the health status of

22 such population.

23 ‘‘(d) REQUIREMENT OF APPLICATION.—The Director

24 of the Center may make a grant under subsection (a) only

25 if an application for the grant is submitted to the Director
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1 and the application is in such form, is made in such man2 ner, and contains such agreements, assurances, and infor3 mation as the Director determines to be necessary to carry

4 out this section.

5 ‘‘(e) AMOUNT OF GRANT; PAYMENTS.—

6 ‘‘(1) AMOUNT.—The amount of any grant

7 awarded under subsection (a) shall be determined by

8 the Director of the Center, except that such amount

9 shall not exceed—

10 ‘‘(A) 50 percent of the necessary cost of

11 the construction of a proposed facility as deter12 mined by the Director; or

13 ‘‘(B) in the case of a multipurpose facility,

14 40 percent of that part of the necessary cost of

15 construction that the Director determines to be

16 proportionate to the contemplated use of the fa17 cility.

18 ‘‘(2) RESERVATION OF AMOUNTS.—On approval

19 of any application for a grant under subsection (a),

20 the Director of the Center shall reserve, from any

21 appropriation available therefore, the amount of

22 such grant, and shall pay such amount, in advance

23 or by way of reimbursement, and in such install24 ments consistent with the construction progress, as

25 the Director may determine appropriate. The res-
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1 ervation of the Director of any amount by the Direc2 tor under this paragraph may be amended by the

3 Director, either on the approval of an amendment of

4 the application or on the revision of the estimated

5 cost of construction of the facility.

6 ‘‘(3) EXCLUSION OF CERTAIN COSTS.—In deter7 mining the amount of any grant under this sub8 section (a), there shall be excluded from the cost of

9 construction an amount equal to the sum of—

10 ‘‘(A) the amount of any other Federal

11 grant that the applicant has obtained, or is as12 sured of obtaining, with respect to construction

13 that is to be financed in part by a grant author14 ized under this section; and

15 ‘‘(B) the amount of any non-Federal funds

16 required to be expended as a condition of such

17 other Federal grant.

18 ‘‘(4) WAIVER OF LIMITATIONS.—The limita19 tions imposed by paragraph (1) may be waived at

20 the discretion of the Director for applicants meeting

21 the conditions described in paragraphs (1) and (2)

22 of subsection (c).

23 ‘‘(f) RECAPTURE OF PAYMENTS.—If, not later than

24 20 years after the completion of construction for which

25 a grant has been awarded under subsection (a)—
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1 ‘‘(1) the applicant or other owner of the facility

2 shall cease to be a public or nonprofit private entity;

3 or

4 ‘‘(2) the facility shall cease to be used for the

5 research purposes for which it was constructed (un6 less the Director determines, in accordance with reg7 ulations, that there is good cause for releasing the

8 applicant or other owner from obligation to do so);

9 the United States shall be entitled to recover from the ap10 plicant or other owner of the facility the amount bearing

11 the same ratio to the current value (as determined by an

12 agreement between the parties or by action brought in the

13 United States District Court for the district in which such

14 facility is situated) of the facility as the amount of the

15 Federal participation bore to the cost of the construction

16 of such facility.

17 ‘‘(g) NONINTERFERENCE WITH ADMINISTRATION OF

18 ENTITIES.—Except as otherwise specifically provided in

19 this section, nothing contained in this part shall be con20 strued as authorizing any department, agency, officer, or

21 employee of the United States to exercise any direction,

22 supervision, or control over, or impose any requirement

23 or condition with respect to the administration of any en24 tity funded under this part.
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1 ‘‘(h) GUIDELINES.—Not later than 6 months after

2 the date of the enactment of this section, the Director of

3 the Center, after consultation with the Advisory Council,

4 shall issue guidelines with respect to grants under sub5 section (a).

6 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—For the

7 purpose of carrying out this section, there are authorized

8 to be appropriated $150,000,000 for fiscal year 1994, and

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

10 1995 and 1996.’’.

11 SEC. 1503. CONSTRUCTION PROGRAM FOR NATIONAL PRI12 MATE RESEARCH CENTER.

13 Subpart 1 of part E of title IV of the Public Health

14 Service Act, as amended by section 1502 of this Act, is

15 amended by adding at the end the following new section:

16 ‘‘CONSTRUCTION OF REGIONAL CENTERS FOR RESEARCH

17 ON PRIMATES

18 ‘‘SEC. 481B. (a) With respect to activities carried out

19 by the National Center for Research Resources to support

20 regional centers for research on primates, the Director of

21 NIH shall, for each of the fiscal years 1994 through 1996,

22 reserve from the amounts appropriated under section

23 481A(i) $7,000,000 for the purpose of making awards of

24 grants and contracts to public or nonprofit private entities

25 to construct, renovate, or otherwise improve such regional

26 centers. The reservation of such amounts for any fiscal
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1 year is subject to the availability of qualified applicants

2 for such awards.

3 ‘‘(b) The Director of NIH may not make a grant or

4 enter into a contract under subsection (a) unless the appli5 cant for such assistance agrees, with respect to the costs

6 to be incurred by the applicant in carrying out the purpose

7 described in such subsection, to make available (directly

8 or through donations from public or private entities) non9 Federal contributions in cash toward such costs in an

10 amount equal to not less than $1 for each $4 of Federal

11 funds provided in such assistance.’’.

12 Subtitle B—National Center for

13 Nursing Research

14 SEC. 1511. REDESIGNATION OF NATIONAL CENTER FOR

15 NURSING RESEARCH AS NATIONAL INSTI16 TUTE OF NURSING RESEARCH.

17 (a) IN GENERAL.—Subpart 3 of part E of title IV

18 of the Public Health Service Act (42 U.S.C. 287c et seq.)

19 is amended—

20 (1) in section 483—

21 (A) in the heading for the section, by strik22 ing ‘‘CENTER’’ and inserting ‘‘INSTITUTE’’; and

23 (B) by striking ‘‘The general purpose’’ and

24 all that follows through ‘‘is’’ and inserting the

25 following: ‘‘The general purpose of the National
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1 Institute of Nursing Research (hereafter in this

2 subpart referred to as the ‘Institute’) is’’;

3 (2) in section 484, by striking ‘‘Center’’ each

4 place such term appears and inserting ‘‘Institute’’;

5 (3) in section 485—

6 (A) in subsection (a), in each of para7 graphs (1) through (3), by striking ‘‘Center’’

8 each place such term appears and inserting

9 ‘‘Institute’’;

10 (B) in subsection (b)—

11 (i) in paragraph (2)(A), by striking

12 ‘‘Center’’ and inserting ‘‘Institute’’; and

13 (ii) in paragraph (3)(A), in the first

14 sentence, by striking ‘‘Center’’ and insert15 ing ‘‘Institute’’; and

16 (C) in subsections (d) through (g), by

17 striking ‘‘Center’’ each place such term appears

18 and inserting ‘‘Institute’’; and

19 (4) in section 485A (as redesignated by section

20 141(a)(1) of this Act), by striking ‘‘Center’’ each

21 place such term appears and inserting ‘‘Institute’’.

22 (b) CONFORMING AMENDMENTS.—

23 (1) ORGANIZATION OF NATIONAL INSTITUTE OF

24 HEALTH.—Section 401(b) of the Public Health

25 Service Act (42 U.S.C. 281(b)) is amended—
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1 (A) in paragraph (1), by adding at the end

2 the following new subparagraph:

3 ‘‘(Q) The National Institute of Nursing

4 Research.’’; and

5 (B) in paragraph (2), by striking subpara6 graph (D).

7 (2) TRANSFER OF STATUTORY PROVISIONS.—

8 Sections 483 through 485A of the Public Health

9 Service Act, as amended by subsection (a) of this

10 section—

11 (A) are transferred to part C of title IV of

12 such Act;

13 (B) are redesignated as sections 464V

14 through 464Y of such part; and

15 (C) are inserted, in the appropriate se16 quence, at the end of such part.

17 (3) HEADING FOR NEW SUBPART.—Title IV of

18 the Public Health Service Act, as amended by the

19 preceding provisions of this section, is amended—

20 (A) in part C, by inserting before section

21 464V the following new heading:

22 ‘‘Subpart 17—National Institute of Nursing Research’’;

23 and

24 (B) by striking the heading for subpart 3

25 of part E.
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1 (4) CROSS-REFERENCES.—Title IV of the Pub2 lic Health Service Act, as amended by the preceding

3 provisions of this section, is amended in subpart 17

4 of part C—

5 (A) in section 464W, by striking ‘‘section

6 483’’ and inserting ‘‘section 464V’’;

7 (B) in section 464X(g), by striking ‘‘sec8 tion 486’’ and inserting ‘‘section 464Y’’; and

9 (C) in section 464Y, in the last sentence,

10 by striking ‘‘section 485(g)’’ and inserting ‘‘sec11 tion 464X(g)’’.

12 SEC. 1512. STUDY ON ADEQUACY OF NUMBER OF NURSES.

13 (a) IN GENERAL.—The Secretary of Health and

14 Human Services, acting through the Director of the Na15 tional Institute of Nursing Research, shall enter into a

16 contract with a public or nonprofit private entity to con17 duct a study for the purpose of determining whether and

18 to what extent there is a need for an increase in the num19 ber of nurses in hospitals and nursing homes in order to

20 promote the quality of patient care and reduce the inci21 dence among nurses of work-related injuries and stress.

22 (b) NATIONAL ACADEMY OF SCIENCES.—The Sec23 retary shall request the National Academy of Sciences to

24 enter into the contract under subsection (a) to conduct

25 the study described in such subsection. If such Institute
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1 declines to conduct the study, the Secretary shall carry

2 out such subsection through another public or nonprofit

3 private entity.

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

5 (1) The term ‘‘nurse’’ means a registered nurse,

6 a licensed practical nurse, a licensed vocational

7 nurse, and a nurse assistant.

8 (2) The term ‘‘Secretary’’ means the Secretary

9 of Health and Human Services.

10 (d) REPORT.—The Secretary shall ensure that, not

11 later than October 1, 1994, the study required in sub12 section (a) is completed and a report describing the find13 ings made as a result of the study is submitted to the

14 Committee on Energy and Commerce of the House of

15 Representatives, and to the Committee on Labor and

16 Human Resources of the Senate.

17 Subtitle C—National Center for

18 Human Genome Research

19 SEC. 1521. PURPOSE OF CENTER.

20 Title IV of the Public Health Service Act, as amended

21 by sections 141(a)(1) and 1611(b)(1)(B) of this Act, is

22 amended—

23 (1) in section 401(b)(2), by adding at the end

24 the following new subparagraph:
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1 ‘‘(D) The National Center for Human Genome

2 Research.’’; and

3 (2) in part E, by adding at the end the follow4 ing new subpart:

5 ‘‘Subpart 4—National Center for Human Genome

6 Research

7 ‘‘PURPOSE OF THE CENTER

8 ‘‘SEC. 485B. (a) The general purpose of the National

9 Center for Human Genome Research (hereafter in this

10 subpart referred to as the ‘Center’) is to characterize the

11 structure and function of the human genome, including

12 the mapping and sequencing of individual genes. Such

13 purpose includes—

14 ‘‘(1) planning and coordinating the research

15 goal of the genome project;

16 ‘‘(2) reviewing and funding research proposals;

17 ‘‘(3) developing training programs;

18 ‘‘(4) coordinating international genome re19 search;

20 ‘‘(5) communicating advances in genome science

21 to the public; and

22 ‘‘(6) reviewing and funding proposals to address

23 the ethical issues associated with the genome

24 project.
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1 ‘‘(b)(1) Except as provided in paragraph (2), of the

2 amounts appropriated to carry out subsection (a) for a

3 fiscal year, the Director of the Center shall make available

4 not less than 5 percent for carrying out paragraph (6)

5 of such subsection.

6 ‘‘(2) With respect to providing funds under sub7 section (a)(6) for proposals to address the ethical issues

8 associated with the genome project, paragraph (1) shall

9 not apply for a fiscal year if the Director of the Center

10 certifies to the Committee on Energy and Commerce of

11 the House of Representatives, and to the Committee on

12 Labor and Human Resources of the Senate, that the Di13 rector has determined that an insufficient number of such

14 proposals meet the applicable requirements of sections 491

15 and 492.’’.

16 TITLE XVI—AWARDS AND

17 TRAINING

18 Subtitle A—National Research

19 Service Awards

20 SEC. 1601. REQUIREMENT REGARDING WOMEN AND INDI21 VIDUALS FROM DISADVANTAGED BACK22 GROUNDS.

23 Section 487(a) of the Public Health Service Act (42

24 U.S.C. 288(a)(4)) is amended by adding at the end the

25 following paragraph:
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1 ‘‘(4) The Secretary shall carry out paragraph (1) in

2 a manner that will result in the recruitment of women,

3 and members from underrepresented minority groups, into

4 fields of biomedical or behavioral research and in the pro5 vision of research training to women and such individ6 uals.’’.

7 SEC. 1602. SERVICE PAYBACK REQUIREMENTS.

8 Paragraph (2) of section 487(c) of the Public Health

9 Service Act (42 U.S.C. 288(c)(2)) is amended to read as

10 follows:

11 ‘‘(2)(A) For the initial year for which an individual

12 receives a National Research Service Award for the con13 duct of postdoctoral training or research, such individual

14 shall engage in one year of health research or teaching

15 or any combination thereof which is in accordance with

16 the usual patterns of academic employment, or complete

17 a second year of training or research under such Award.

18 ‘‘(B) Service obligations for National Research Serv19 ice Awards that are less than 12 months may be satis20 fied—

21 ‘‘(i) by the conduct of health research or teach22 ing or any combination thereof which is in accord23 ance with the usual patterns of academic employ24 ment for a period of time equal to the amount of

25 time under the Award; or
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1 ‘‘(ii) by reimbursing the Federal Government

2 for the amounts provided to such individual under

3 the Award.

4 Subtitle B—Acquired Immune

5 Deficiency Syndrome

6 SEC. 1611. LOAN REPAYMENT PROGRAM.

7 Section 487A of the Public Health Service Act (42

8 U.S.C. 288–1) is amended to read as follows:

9 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH

10 RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME

11 ‘‘SEC. 487A. (a) IN GENERAL.—

12 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

13 paragraph (2), the Secretary shall carry out a pro14 gram of entering into agreements with appropriately

15 qualified health professionals under which such

16 health professionals agree to conduct, as employees

17 of the National Institutes of Health, research with

18 respect to acquired immune deficiency syndrome in

19 consideration of the Federal Government agreeing to

20 repay, for each year of such service, not more than

21 $20,000 of the principal and interest of the edu22 cational loans of such health professionals.

23 ‘‘(2) LIMITATION.—The Secretary may not

24 enter into an agreement with a health professional

25 pursuant to paragraph (1) unless such profes26 sional—
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1 ‘‘(A) has a substantial amount of edu2 cational loans relative to income; and

3 ‘‘(B)(i) was not employed at the National

4 Institutes of Health during the 1-year period

5 preceding the date of the enactment of the

6 Health Professions Reauthorization Act of

7 1988; or

8 ‘‘(ii) agrees to serve as an employee of

9 such Institutes for purposes of paragraph (1)

10 for a period of not less than 3 years.’’.

11 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—

12 With respect to the National Health Service Corps Loan

13 Repayment Program established in subpart III of part D

14 of title III, the provisions of such subpart shall, except

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

16 to the program established in such subsection (a) in the

17 same manner and to the same extent as such provisions

18 apply to the National Health Service Corps Loan Repay19 ment Program established in such subpart.

20 ‘‘(c) FUNDING; REIMBURSABLE TRANSFERS.—

21 ‘‘(1) AUTHORIZATIONDOF APPROPRIATIONS.—

22 For the purpose of carrying out this section, there

23 are authorized to be appropriated such sums as may

24 be necessary for each of the fiscal years 1994

25 through 1996.
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1 ‘‘(2) TRANSFERS FOR RELATED PROGRAM.—

2 The Commissioner of Food and Drugs may carry

3 out for the Food and Drug Administration a pro4 gram similar to the program established in sub5 section (a), which program shall be carried out with

6 respect to the review of applications concerning ac7 quired immune deficiency syndrome that are submit8 ted to such Commissioner. From the amounts appro9 priated under paragraph (1) for a fiscal year, the

10 Secretary may transfer amounts to the Commis11 sioner for the purpose of carrying out such program.

12 The Commissioner shall provide a reimbursement to

13 the Secretary for the amount so transferred, and the

14 reimbursement shall be available only for the pro15 gram established in subsection (a). Any transfer and

16 reimbursement made for purposes of this paragraph

17 for a fiscal year shall be completed by April 1 of

18 such year.’’.

19 Subtitle C—Loan Repayment for

20 Research Generally

21 SEC. 1621. ESTABLISHMENT OF PROGRAM.

22 Part G of title IV of the Public Health Service Act,

23 as redesignated by section 141(a)(2) of this Act and as

24 amended by section 1002 of this Act, is amended by in25 serting after section 487B the following new section:
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1 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH

2 GENERALLY

3 ‘‘SEC. 487C. (a) IN GENERAL.—

4 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

5 paragraph (2), the Secretary shall carry out a pro6 gram of entering into agreements with appropriately

7 qualified health professionals under which such

8 health professionals agree to conduct research, as

9 employees of the National Institutes of Health, in

10 consideration of the Federal Government agreeing to

11 repay, for each year of such service, not more than

12 $20,000 of the principal and interest of the edu13 cational loans of such health professionals.

14 ‘‘(2) LIMITATION.—The Secretary may not

15 enter into an agreement with a health professional

16 pursuant to paragraph (1) unless such profes17 sional—

18 ‘‘(A) has a substantial amount of edu19 cational loans relative to income; and

20 ‘‘(B)(i) was not employed at the National

21 Institutes of Health during the 1-year period

22 preceding the date of the enactment of the

23 Health Professions Reauthorization Act of

24 1988; or
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1 ‘‘(ii) agrees to serve as an employee of

2 such Institutes for purposes of paragraph (1)

3 for a period of not less than 3 years.’’.

4 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—

5 With respect to the National Health Service Corps Loan

6 Repayment Program established in subpart III of part D

7 of title III, the provisions of such subpart shall, except

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

9 to the program established in such subsection (a) in the

10 same manner and to the same extent as such provisions

11 apply to the National Health Service Corps Loan Repay12 ment Program established in such subpart.

13 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the

14 purpose of carrying out this section other than with re15 spect to acquired immune deficiency syndrome, there are

16 authorized to be appropriated such sums as may be nec17 essary for each of the fiscal years 1994 through 1996.’’.

18 Subtitle D—Scholarship and Loan

19 Repayment Programs Regard20 ing Professional Skills Needed

21 by Certain Agencies

22 SEC. 1631. ESTABLISHMENT OF PROGRAMS FOR NATIONAL

23 INSTITUTES OF HEALTH.

24 Part G of title IV of the Public Health Service Act,

25 as redesignated by section 141(a)(2) of this Act and as
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1 amended by section 1621 of this Act, is amended by in2 serting after section 487C the following new sections:

3 ‘‘UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING

4 PROFESSIONS NEEDED BY NATIONAL RESEARCH IN5 STITUTES

6 ‘‘SEC. 487D. (a) ESTABLISHMENT OF PROGRAM.—

7 ‘‘(1) IN GENERAL.—Subject to section

8 487(a)(1)(C), the Secretary, acting through the Di9 rector of NIH, may carry out a program of entering

10 into contracts with individuals described in para11 graph (2) under which—

12 ‘‘(A) the Director of NIH agrees to provide

13 to the individuals scholarships for pursuing, as

14 undergraduates at accredited institutions of

15 higher education, academic programs appro16 priate for careers in professions needed by the

17 National Institutes of Health; and

18 ‘‘(B) the individuals agree to serve as em19 ployees of the National Institutes of Health, for

20 the period described in subsection (c), in posi21 tions that are needed by the National Institutes

22 of Health and for which the individuals are

23 qualified.

24 ‘‘(2) INDIVIDUALS FROM DISADVANTAGED

25 BACKGROUNDS.—The individuals referred to in

26 paragraph (1) are individuals who—
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1 ‘‘(A) are enrolled or accepted for enroll2 ment as full-time undergraduates at accredited

3 institutions of higher education; and

4 ‘‘(B) are from minority groups that are

5 underrepresented in the fields of biomedical or

6 behavioral research.

7 ‘‘(b) FACILITATION OF INTEREST OF STUDENTS IN

8 CAREERS AT NATIONAL INSTITUTES OF HEALTH.—In

9 providing employment to individuals pursuant to contracts

10 under subsection (a)(1), the Director of NIH shall carry

11 out activities to facilitate the interest of the individuals

12 in pursuing careers as employees of the National Insti13 tutes of Health.

14 ‘‘(c) PERIOD OF OBLIGATED SERVICE.—

15 ‘‘(1) DURATION OF SERVICE.—For purposes of

16 subparagraph (B) of subsection (a)(1), the period of

17 service for which an individual is obligated to serve

18 as an employee of the National Institutes of Health

19 is 12 months for each academic year for which the

20 scholarship under such subsection is provided.

21 ‘‘(2) SCHEDULE FOR SERVICE.—

22 ‘‘(A) Subject to subparagraph (B), the Di23 rector of NIH may not provide a scholarship

24 under subsection (a) unless the individual ap25 plying for the scholarship agrees that—
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1 ‘‘(i) the individual will serve as an em2 ployee of the National Institutes of Health

3 full-time for not less than 10 consecutive

4 weeks of each year during which the indi5 vidual is attending the educational institu6 tion involved and receiving such a scholar7 ship;

8 ‘‘(ii) the period of service as such an

9 employee that the individual is obligated to

10 provide under clause (i) is in addition to

11 the period of service as such an employee

12 that the individual is obligated to provide

13 under subsection (a)(1)(B); and

14 ‘‘(iii) not later than 60 days after ob15 taining the educational degree involved, the

16 individual will begin serving full-time as

17 such an employee in satisfaction of the pe18 riod of service that the individual is obli19 gated to provide under subsection

20 (a)(1)(B).

21 ‘‘(B) The Director of NIH may defer the

22 obligation of an individual to provide a period

23 of service under subsection (a)(1)(B), if the Di24 rector determines that such a deferral is appro25 priate.
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1 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS

2 RELATING TO APPOINTMENT AND COMPENSATION.—

3 For any period in which an individual provides serv4 ice as an employee of the National Institutes of

5 Health in satisfaction of the obligation of the indi6 vidual under subsection (a)(1)(B) or paragraph

7 (2)(A)(i), the individual may be appointed as such

8 an employee without regard to the provisions of title

9 5, United States Code, relating to appointment and

10 compensation.

11 ‘‘(d) PROVISIONS REGARDING SCHOLARSHIP.—

12 ‘‘(1) APPROVAL OF ACADEMIC PROGRAM.—The

13 Director of NIH may not provide a scholarship

14 under subsection (a) for an academic year unless—

15 ‘‘(A) the individual applying for the schol16 arship has submitted to the Director a proposed

17 academic program for the year and the Director

18 has approved the program; and

19 ‘‘(B) the individual agrees that the pro20 gram will not be altered without the approval of

21 the Director.

22 ‘‘(2) ACADEMIC STANDING.—The Director of

23 NIH may not provide a scholarship under subsection

24 (a) for an academic year unless the individual apply25 ing for the scholarship agrees to maintain an accept-
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1 able level of academic standing, as determined by

2 the educational institution involved in accordance

3 with regulations issued by the Secretary.

4 ‘‘(3) LIMITATION ON AMOUNT.—The Director

5 of NIH may not provide a scholarship under sub6 section (a) for an academic year in an amount ex7 ceeding $20,000.

8 ‘‘(4) AUTHORIZED USES.—A scholarship pro9 vided under subsection (a) may be expended only for

10 tuition expenses, other reasonable educational ex11 penses, and reasonable living expenses incurred in

12 attending the school involved.

13 ‘‘(5) CONTRACT REGARDING DIRECT PAYMENTS

14 TO INSTITUTION.—In the case of an institution of

15 higher education with respect to which a scholarship

16 under subsection (a) is provided, the Director of

17 NIH may enter into a contract with the institution

18 under which the amounts provided in the scholarship

19 for tuition and other educational expenses are paid

20 directly to the institution. Payments to the institu21 tion under the contract may be made without regard

22 to section 3324 of title 31, United States Code.

23 ‘‘(e) PENALTIES FOR BREACH OF SCHOLARSHIP

24 CONTRACT.—The provisions of section 338E shall apply

25 to the program established in subsection (a) to the same
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1 extent and in the same manner as such provisions apply

2 to the National Health Service Corps Loan Repayment

3 Program established in section 338B.

4 ‘‘(f) REQUIREMENT OF APPLICATION.—The Director

5 of NIH may not provide a scholarship under subsection

6 (a) unless an application for the scholarship is submitted

7 to the Director and the application is in such form, is

8 made in such manner, and contains such agreements, as9 surances, and information as the Director determines to

10 be necessary to carry out this section.

11 ‘‘(g) AVAILABILITY OF AUTHORIZATION OF APPRO12 PRIATIONS.—Amounts appropriated for a fiscal year for

13 scholarships under this section shall remain available until

14 the expiration of the second fiscal year beginning after the

15 fiscal year for which the amounts were appropriated.

16 ‘‘LOAN REPAYMENT PROGRAM REGARDING CLINICAL

17 RESEARCHERS FROM DISADVANTAGED BACKGROUNDS

18 ‘‘SEC. 487E. (a) IMPLEMENTATION OF PROGRAM.—

19 ‘‘(1) IN GENERAL.—Subject to section

20 487(a)(1)(C), the Secretary, acting through the Di21 rector of NIH may, subject to paragraph (2), carry

22 out a program of entering into contracts with appro23 priately qualified health professionals who are from

24 disadvantaged backgrounds under which such health

25 professionals agree to conduct clinical research as

26 employees of the National Institutes of Health in
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1 consideration of the Federal Government agreeing to

2 pay, for each year of such service, not more than

3 $20,000 of the principal and interest of the edu4 cational loans of the health professionals.

5 ‘‘(2) LIMITATION.—The Director of NIH may

6 not enter into a contract with a health professional

7 pursuant to paragraph (1) unless such professional

8 has a substantial amount of education loans relative

9 to income.

10 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS

11 REGARDING OBLIGATED SERVICE.—Except to the ex12 tent inconsistent with this section, the provisions of

13 sections 338C and 338E shall apply to the program

14 established in paragraph (1) to the same extent and

15 in the same manner as such provisions apply to the

16 National Health Service Corps Loan Repayment

17 Program established in section 338B.

18 ‘‘(b) AVAILABILITY OF AUTHORIZATION OF APPRO19 PRIATIONS.—Amounts appropriated for a fiscal year for

20 contracts under subsection (a) shall remain available until

21 the expiration of the second fiscal year beginning after the

22 fiscal year for which the amounts were appropriated.’’.

23 SEC. 1632. FUNDING.

24 Section 487(a)(1) of the Public Health Service Act

25 (42 U.S.C. 288(a)(1)) is amended—
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1 (1) in subparagraph (A), by striking ‘‘and’’

2 after the semicolon at the end;

3 (2) in subparagraph (B), by striking the period

4 at the end and inserting ‘‘; and’’; and

5 (3) by adding at the end the following new sub6 paragraph:

7 ‘‘(C) provide contracts for scholarships and loan

8 repayments in accordance with sections 487D and

9 487E, subject to providing not more than an aggre10 gate 50 such contracts during the fiscal years 1994

11 through 1996.’’.

12 Subtitle D—Funding

13 SEC. 1641. AUTHORIZATION OF APPROPRIATIONS.

14 Section 487(d) of the Public Health Service Act (42

15 U.S.C. 288(d)) is amended—

16 (1) in the first sentence, by amending the sen17 tence to read as follows: ‘‘For the purpose of carry18 ing out this section, there are authorized to be ap19 propriated $400,000,000 for fiscal year 1994, and

20 such sums as may be necessary for each of the fiscal

21 years 1995 and 1996.’’; and

22 (2) in paragraph (3)—

23 (A) by striking ‘‘one-half of one percent’’

24 each place such term appears and inserting ‘‘1

25 percent’’; and
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1 (B) by striking ‘‘780, 784, or 786’’ and in2 serting ‘‘747, 748, or 749’’.

3 TITLE XVII—NATIONAL FOUNDA4 TION FOR BIOMEDICAL RE5 SEARCH

6 SEC. 1701. ESTABLISHMENT OF FOUNDATION.

7 Section 499 of the Public Health Service Act, as re8 designated by section 121(b), is amended to read as fol9 lows:

10 ‘‘SEC. 499A. ESTABLISHMENT AND DUTIES OF FOUNDATION.

11 ‘‘(a) IN GENERAL.—The Secretary shall establish a

12 nonprofit corporation to be known as the National Foun13 dation for Biomedical Research (hereafter in this section

14 referred to as the ‘Foundation’). The Foundation shall

15 not, except for the purposes of the Ethics in Government

16 Act and the Technology Transfer Act, be an agency or

17 instrumentality of the United States Government.

18 ‘‘(b) PURPOSE OF FOUNDATION.—The purpose of

19 the Foundation shall be to conduct and support research

20 with respect to any particular disease or groups of diseases

21 or any other aspect of human health.

22 ‘‘(c) ENDOWMENT FUND.—

23 ‘‘(1) IN GENERAL.—In carrying out subsection

24 (b), the Foundation shall establish a fund whose pri25 mary purpose shall be to provide endowments for po-
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1 sitions at the National Institutes of Health to con2 duct biomedical research, and dedicated to the pur3 pose described in such subsection. Such positions

4 may be held by scientists without regard to whether

5 the scientists are employees of the Federal Govern6 ment. Subject to subsection (g)(1)(B), the fund shall

7 consist of such donations as may be provided by

8 non-Federal entities and such non-Federal assets of

9 the Foundation (including earnings of the Founda10 tion and the fund) as the Foundation may elect to

11 transfer to the fund.

12 ‘‘(2) AUTHORIZED EXPENDITURES OF FUND.—

13 The provision of endowments under paragraph (1)

14 shall be the primary function of the fund established

15 under such paragraph. Such endowments may be ex16 pended only for the compensation of individuals

17 holding the positions, for staff, equipment, quarters,

18 travel, and other expenditures that are appropriate

19 in supporting the positions, and for recruiting indi20 viduals to hold the positions endowed by the fund.

21 ‘‘(d) CERTAIN ACTIVITIES OF FOUNDATION.—In car22 rying out subsection (b), and subject to subsection (c), the

23 Foundation may provide for the following with respect to

24 the purpose described in such subsection:
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1 ‘‘(1) Endowed chairs for distinguished senior

2 investigators.

3 ‘‘(2) Positions for support of visiting scientists

4 in mid-career who participate in the National Insti5 tutes of Health Scholars program.

6 ‘‘(3) Studies, projects, and research conducted

7 by scientists under paragraphs (1) and (2).

8 ‘‘(4) Forums for the exchange of information

9 between scientists. Participants in such forums may

10 include institutions of higher education and appro11 priate private and public organizations.

12 ‘‘(5) Meetings, conferences, courses, and train13 ing workshops.

14 ‘‘(6) Programs to improve the collection and

15 analysis of data.

16 ‘‘(7) Programs for writing, editing, printing,

17 and publishing of books and other materials.

18 ‘‘(8) Other activities to carry out the purpose

19 described in subsection (b).

20 ‘‘(e) POWERS.—In carrying out subsection (b), the

21 Foundation shall—

22 ‘‘(1) operate under the direction of its Board;

23 ‘‘(2) adopt, alter, and use a corporate seal,

24 which shall be judicially noticed;
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1 ‘‘(3) provide for 1 or more officers, employees,

2 and agents, as may be necessary, define their duties,

3 and require surety bonds or make other provisions

4 against losses occasioned by acts of such persons;

5 ‘‘(4) hire, promote, compensate, and discharge

6 officers and employees of the Foundation;

7 ‘‘(5) prescribe by its Board its bylaws, as de8 scribed in subsection (g)(1)(A);

9 ‘‘(6) with the consent of any executive depart10 ment or independent agency, use the information,

11 services, staff, and facilities of such in carrying out

12 this section;

13 ‘‘(7) sue and be sued in its corporate name, and

14 complain and defend in courts of competent jurisdic15 tion;

16 ‘‘(8) modify or consent to the modification of

17 any contract or agreement to which it is a party or

18 in which it has an interest under this subtitle;

19 ‘‘(9) establish a mechanism for the selection of

20 candidates, subject to the approval of the Director of

21 the National Institutes of Health for the endowed

22 scientific positions within the organizational struc23 ture of the intramural research programs of the Na24 tional Institutes of Health and candidates for par-
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1 ticipation in the National Institutes of Health Schol2 ars program;

3 ‘‘(10) enter into contracts with public and pri4 vate organizations for the writing, editing, printing,

5 and publishing of books and other material;

6 ‘‘(11) take such action as may be necessary to

7 obtain patents and licenses for devices and proce8 dures developed by the Foundation and its employ9 ees;

10 ‘‘(12) accept, hold, administer, invest, and

11 spend any gift, devise, or bequest of real or personal

12 property made to the Foundation;

13 ‘‘(13) enter into such other contracts, leases,

14 cooperative agreements, and other transactions as

15 the Executive Director considers appropriate to con16 duct the activities of the Foundation;

17 ‘‘(14) appoint other groups of advisors as may

18 be determined necessary from time to time to carry

19 out the functions of the Foundation; and

20 ‘‘(15) exercise other powers as set forth in this

21 section, and such other incidental powers as are nec22 essary to carry out its powers, duties, and functions

23 in accordance with this subtitle.

24 ‘‘(f) GENERAL STRUCTURE OF FOUNDATION; NON25 PROFIT STATUS.—
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1 ‘‘(1) BOARD OF DIRECTORS.—The Foundation

2 shall have a board of directors (in this part referred

3 to as the ‘Board’), which shall be established and

4 conducted in accordance with subsection (g). The

5 Board shall establish the general policies of the

6 Foundation for carrying out subsection (b), includ7 ing the establishment of the bylaws of the Founda8 tion.

9 ‘‘(2) EXECUTIVE DIRECTOR.—The Foundation

10 shall have an executive director (in this part referred

11 to as the ‘Director’), who shall be appointed by the

12 Board, who shall serve at the pleasure of the Board,

13 and for whom the Board shall establish the rate of

14 compensation. Subject to compliance with the poli15 cies and bylaws established by the Board pursuant

16 to paragraph (1), the Director shall be responsible

17 for the daily operations of the Foundation in carry18 ing out subsection (b).

19 ‘‘(3) NONPROFIT STATUS.—In carrying out

20 subsection (b), the Board shall establish such poli21 cies and bylaws under paragraph (1), and the Direc22 tor shall carry out such activities under paragraph

23 (2), as may be necessary to ensure that the Founda24 tion maintains status as an organization that—
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1 ‘‘(A) is described in subsection (c)(3) of

2 section 501 of the Internal Revenue Code of

3 1986; and

4 ‘‘(B) is, under subsection (a) of such sec5 tion, exempt from taxation.

6 ‘‘(4) LIAISON.—The Director of the National

7 Institutes of Health shall serve as the liaison rep8 resentative of the National Institutes of Health to

9 the Board and the Foundation.

10 ‘‘(g) BOARD OF DIRECTORS.—

11 ‘‘(1) CERTAIN BYLAWS.—

12 ‘‘(A) In establishing bylaws under sub13 section (f)(1), the Board shall ensure that the

14 bylaws of the Foundation include bylaws for the

15 following:

16 ‘‘(i) Policies for the selection of the

17 officers, employees, agents, and contractors

18 of the Foundation.

19 ‘‘(ii) Policies for the acquisition, hold20 ing, and transfer of property.

21 ‘‘(iii) Policies, including ethical stand22 ards, for the acceptance and disposition of

23 donations to the Foundation and for the

24 disposition of the assets of the Foundation.
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1 ‘‘(iv) Policies for the conduct of the

2 general operations of the Foundation.

3 ‘‘(v) Policies for writing, editing,

4 printing, and publishing of books and other

5 materials, and the acquisition of patents

6 and licenses for devices and procedures de7 veloped by the Foundation.

8 ‘‘(B) In establishing bylaws under sub9 section (f)(1), the Board shall ensure that the

10 bylaws of the Foundation (and activities carried

11 out under the bylaws) do not—

12 ‘‘(i) reflect unfavorably upon the abil13 ity of the Foundation, or the National In14 stitutes of Health, to carry out its respon15 sibilities or official duties in a fair and ob16 jective manner; or

17 ‘‘(ii) compromise, or appear to com18 promise, the integrity of any governmental

19 program or any officer or employee in20 volved in such program.

21 ‘‘(2) COMPOSITION.—

22 ‘‘(A) The Foundation shall have a Board

23 of Directors (hereafter referred to in this sec24 tion as the ‘Board’), which shall initially be

25 composed of ex officio and appointed members
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1 in accordance with this subsection until such

2 time as all the appointed members, including

3 the Chairperson, are fully appointed by the

4 Board under paragraph (4).

5 ‘‘(B) The ex officio members of the Coun6 cil shall be—

7 ‘‘(i) the Chairperson and ranking mi8 nority member of the Subcommittee on

9 Health and the Environment (Committee

10 on Energy and Commerce) or their des11 ignees, in the case of the House of Rep12 resentatives;

13 ‘‘(ii) the Chairperson and ranking mi14 nority member of the Committee on Labor

15 and Human Resources or their designees,

16 in the case of the Senate; and

17 ‘‘(iii) the Director of the National In18 stitutes of Health.

19 ‘‘(C) The ex officio members of the Board

20 under subparagraph (B) shall appoint to the

21 Council 9 individuals. Of such appointed mem22 bers—

23 ‘‘(i) 2 shall be representatives of the

24 general biomedical field;
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1 ‘‘(ii) 2 shall be representatives of the

2 general biobehavorial field; and

3 ‘‘(iii) 3 shall be representatives of the

4 general public.

5 ‘‘(3) CHAIRPERSON.—The ex officio members of

6 the Board under paragraph (2)(B) shall designate

7 an appointed member of the Board to serve as the

8 first Chairperson of the Board. Subsequently, the

9 Chairperson of the Board shall be chosen by the

10 Board according to its bylaws.

11 ‘‘(4) APPOINTMENTS, VACANCIES, AND

12 TERMS.—The following shall apply to the Board:

13 ‘‘(A) Any vacancy in the membership of

14 the Board shall be filled by appointment by the

15 Board, after consideration of suggestions made

16 by the Chairperson and the Director regarding

17 the appointments. Any such vacancy shall be

18 filled not later than the expiration of the 180-

19 day period beginning on the date on which the

20 vacancy occurs.

21 ‘‘(B) The term of office of each member of

22 the Board appointed under subparagraph (A)

23 shall be 5 years, except that the terms of office

24 for the initial appointed members of the Board

25 shall expire as determined by the Chairperson
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1 of the Board, in consultation with the Director

2 of the National Institutes of Health.

3 ‘‘(C) A vacancy in the membership of the

4 Board shall not affect the power of the Board

5 to carry out the duties of the Board. If a mem6 ber of the Board does not serve the full term

7 applicable under subparagraph (B), the individ8 ual appointed to fill the resulting vacancy shall

9 be appointed for the remainder of the term of

10 the predecessor of the individual.

11 ‘‘(5) COMPENSATION.—Members of the Board

12 may not receive compensation for service on the

13 Board. Such members may be reimbursed for travel,

14 subsistence, and other necessary expenses incurred

15 in carrying out the duties of the Board, as set forth

16 in the bylaws issued by the Board.

17 ‘‘(h) INCORPORATION.—The initial members of the

18 Board shall serve as incorporators and shall take whatever

19 actions necessary to incorporate the Foundation.

20 ‘‘(i) GENERAL PROVISIONS.—

21 ‘‘(1) ADMINISTRATIVE CONTROL.—No officer,

22 employee, or member of the Board of the Founda23 tion may exercise any administrative or managerial

24 control over any Federal employee.
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1 ‘‘(2) APPLICABILITY OF CERTAIN STANDARDS

2 TO NON-FEDERAL EMPLOYEES.—In the case of any

3 individual who is not an employee of the Federal

4 Government and who serves with financial support

5 from the Foundation, the Foundation shall negotiate

6 a memorandum of understanding with the individual

7 and the Director of the National Institutes of Health

8 specifying that the individual—

9 ‘‘(A) shall be subject to the ethical and

10 procedural standards regulating Federal em11 ployment, scientific investigation, and research

12 findings (including publications and patents)

13 that are required of individuals employed by the

14 National Institutes of Health, including stand15 ards under this Act, the Ethics in Government

16 Act, and the Technology Transfer Act; and

17 ‘‘(B) shall be subject to such ethical and

18 procedural standards under chapter 11 of title

19 18, United States Code (relating to conflicts of

20 interest), as the Director of the National Insti21 tutes of Health determines is appropriate, ex22 cept such memorandum may not provide that

23 the individual shall be subject to the standards

24 of section 209 of such chapter.
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1 ‘‘(3) FINANCIAL CONFLICTS OF INTEREST.—

2 Any individual who is an officer, employee, or mem3 ber of the Board of the Foundation may not directly

4 or indirectly participate in the consideration or de5 termination by the Foundation of any question af6 fecting—

7 ‘‘(A) any direct or indirect financial inter8 est of the individual; or

9 ‘‘(B) any direct or indirect financial inter10 est of any business organization or other entity

11 of which the individual is an officer or employee

12 or in which the individual has a direct or indi13 rect financial interest.

14 ‘‘(4) AUDITS; AVAILABILITY OF RECORDS.—The

15 Foundation shall—

16 ‘‘(A) provide for biennial audits of the fi17 nancial condition of the Foundation; and

18 ‘‘(B) make such audits, and all other

19 records, documents, and other papers of the

20 Foundation, available to the Secretary and the

21 Comptroller General of the United States for

22 examination or audit.

23 ‘‘(5) REPORTS.—

24 ‘‘(A) Not later than February 1 of each

25 fiscal year, the Foundation shall publish a re-
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1 port describing the activities of the Foundation

2 during the preceding fiscal year. Each such re3 port shall include for the fiscal year involved a

4 comprehensive statement of the operations, ac5 tivities, financial condition, and accomplish6 ments of the Foundation.

7 ‘‘(B) With respect to the financial condi8 tion of the Foundation, each report under sub9 paragraph (A) shall include the source, and a

10 description of, all gifts to the Foundation of

11 real or personal property, and the source and

12 amount of all gifts to the Foundation of money.

13 Each such report shall include a specification of

14 any restrictions on the purposes for which gifts

15 to the Foundation may be used.

16 ‘‘(C) The Foundation shall make copies of

17 each report submitted under subparagraph (A)

18 available for public inspection, and shall upon

19 request provide a copy of the report to any indi20 vidual for a charge not exceeding the cost of

21 providing the copy.

22 ‘‘(j) FEDERAL FUNDING.—

23 ‘‘(1) AUTHORITY FOR ANNUAL GRANTS.—

24 ‘‘(A) The Secretary, acting through the Di25 rector of the National Institutes of Health,
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1 shall for each of the fiscal years 1994 through

2 1996, make a grant to the Foundation.

3 ‘‘(B) A grant under subparagraph (A) may

4 be expended only for the purpose of the admin5 istrative expenses of the Foundation.

6 ‘‘(C) A grant under subparagraph (A) may

7 not be expended to provide amounts for the

8 fund established under subsection (c).

9 ‘‘(2) FUNDING FOR GRANTS.—

10 ‘‘(A) For the purpose of grants under

11 paragraph (1), there is authorized to be appro12 priated $500,000 for each of the fiscal years

13 1994 through 1996.

14 ‘‘(B) For the purpose of grants under

15 paragraph (1), the Secretary may for each fis16 cal year make available not more than

17 $500,000 from the amounts appropriated for

18 the fiscal year for the programs of the National

19 Institutes of Health. Such amounts may be

20 made available without regard to whether

21 amounts have been appropriated under sub22 paragraph (A).’’.
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1 TITLE XVIII—RESEARCH WITH

2 RESPECT TO ACQUIRED IM3 MUNE DEFICIENCY SYN4 DROME

5 SEC. 1801. REVISION AND EXTENSION OF VARIOUS PRO6 GRAMS.

7 Title XXIII of the Public Health Service Act (42

8 U.S.C. 300cc et seq.) is amended—

9 (1) in section 2304(c)(1)—

10 (A) in the matter preceding subparagraph

11 (A), by inserting after ‘‘Director of such Insti12 tute’’ the following: ‘‘(and may provide advice

13 to the Directors of other agencies of the Na14 tional Institutes of Health, as appropriate)’’;

15 and

16 (B) in subparagraph (A), by inserting be17 fore the semicolon the following: ‘‘, including

18 recommendations on the projects of research

19 with respect to diagnosing immune deficiency

20 and with respect to predicting, diagnosing, pre21 venting, and treating opportunistic cancers and

22 infectious diseases’’;

23 (2) in section 2311(a)(1), by inserting before

24 the semicolon the following: ‘‘, including evaluations

25 of methods of diagnosing immune deficiency and
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1 evaluations of methods of predicting, diagnosing,

2 preventing, and treating opportunistic cancers and

3 infectious diseases’’;

4 (3) in section 2315—

5 (A) in subsection (a)(2), by striking ‘‘inter6 national research’’ and all that follows and in7 serting ‘‘international research and training

8 concerning the natural history and pathogenesis

9 of the human immunodeficiency virus and the

10 development and evaluation of vaccines and

11 treatments for acquired immune deficiency syn12 drome and opportunistic infections.’’; and

13 (B) in subsection (f), by striking ‘‘and

14 1991’’ and inserting ‘‘through 1996’’;

15 (4) in section 2318—

16 (A) in subsection (a)(1)—

17 (i) by inserting after ‘‘The Secretary’’

18 the following: ‘‘, acting through the Direc19 tor of the National Institutes of Health

20 and after consultation with the Adminis21 trator for Health Care Policy and Re22 search,’’; and

23 (ii) by striking ‘‘syndrome’’ and in24 serting ‘‘syndrome, including treatment
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1 and prevention of HIV infection and relat2 ed conditions among women’’; and

3 (B) in subsection (e), by striking ‘‘1991.’’

4 and inserting the following: ‘‘1991, and such

5 sums as may be necessary for each of the fiscal

6 years 1994 through 1996.’’;

7 (5) in section 2320(b)(1)(A), by striking ‘‘syn8 drome’’ and inserting ‘‘syndrome and the natural

9 history of such infection’’;

10 (6) in the part heading for part D, by striking

11 ‘‘DIRECTOR OF THE NATIONAL INSTITUTES OF

12 HEALTH’’ and inserting ‘‘OFFICE OF AIDS RE13 SEARCH’’;

14 (7) in section 2351—

15 (A) by redesignating subsections (a), (b)

16 and (c) as subsections (b), (d) and (e), respec17 tively;

18 (B) by striking subsection (a) and insert19 ing the following new subsection:

20 ‘‘(a) IN GENERAL.—In carrying out research with re21 spect to acquired immune deficiency syndrome, the Sec22 retary, acting through the Director of the National Insti23 tutes of Health—
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1 ‘‘(1) shall establish an office to be known as the

2 Office of AIDS Research, which Office shall be

3 headed by a Director who shall be—

4 ‘‘(A) appointed by the Secretary;

5 ‘‘(B) determined by the Secretary to be an

6 individual who is an outstanding scientist and a

7 highly skilled administrator; and

8 ‘‘(C) the primary Federal official respon9 sible for the conduct of AIDS-related research

10 at the National Institutes of Health; and

11 ‘‘(2) shall provide administrative support and

12 support services to the Director of such Office.’’;

13 (C) in subsection (b) (as so redesig14 nated)—

15 (i) by striking the subsection designa16 tion and all that follows through paragraph

17 (1) and inserting in lieu thereof the follow18 ing:

19 ‘‘(b) ACTIVITIES OF THE OFFICE OF AIDS RE20 SEARCH.—

21 ‘‘(1) IN GENERAL.—The Secretary, acting

22 through the director of the Office of AIDS Research,

23 shall ensure that AIDS research activities are co24 ordinated across and throughout the institutes, cen-
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1 ters, and divisions of the National Institutes of

2 Health.

3 ‘‘(2) GENERAL DUTIES.—The Director of the

4 Office of AIDS Research shall, based upon a strate5 gic plan as defined in paragraph (3), develop and

6 implement a budget for AIDS-related research at

7 the National Institutes of Health and coordinate all

8 AIDS-related research activities conducted at the in9 stitutes, centers, and divisions of the National Insti10 tutes of Health, and conduct evaluations on all such

11 programs.

12 ‘‘(3) STRATEGIC PLAN.—

13 ‘‘(A) DEVELOPMENT.—The Director of the

14 Office of AIDS Research shall, with the advice

15 of the directors of the institutes, centers, and

16 divisions of the National Institutes of Health,

17 and in consultation with the advisory council es18 tablished in paragraph (5) and the coordinating

19 groups established in subparagraph (B), de20 velop and implement a comprehensive, long21 range plan for the conduct and support of such

22 research by the National Institutes of Health.

23 Such plan shall be updated annually, and

24 shall—
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1 ‘‘(i) determine and prioritize among

2 critical scientific AIDS-related questions;

3 ‘‘(ii) based upon such determinations,

4 specify the range of objectives to be

5 achieved, the date the objectives are ex6 pected to be achieved, and provide an esti7 mate of the resources needed to achieve

8 the objectives by such date;

9 ‘‘(iii) evaluate the sufficiency of exist10 ing AIDS research programs to meet such

11 objectives, and establish standard evalua12 tion criteria, timelines and objectives for

13 future program evaluation activities; and

14 ‘‘(iv) make recommendations for

15 changes and necessary resource allocation

16 in and among such programs.

17 ‘‘(B) COORDINATING GROUPS.—The Direc18 tor of the Office of AIDS Research shall estab19 lish AIDS coordinating groups for each re20 search discipline within the AIDS research pro21 gram, composed of representatives of relevant

22 agencies of the National Institutes of Health

23 and qualified extramural scientists, to evaluate

24 and assess the efforts of the AIDS Research

25 Program at the National Institutes of Health,
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1 to advise on the development of the strategic

2 plan described in subparagraph (A), and to de3 termine the extent to which such efforts are in

4 accordance with such strategic plan.

5 ‘‘(4) COORDINATION.—The Director of the Of6 fice of AIDS Research shall act as the primary Fed7 eral official with responsibility for overseeing all

8 AIDS-related research efforts undertaken by the Na9 tional Institutes of Health, and

10 ‘‘(A) shall serve to represent the National

11 Institutes of Health AIDS Research Program

12 at all relevant Executive branch task forces and

13 committees; and

14 ‘‘(B) shall maintain communications with

15 all relevant Public Health Service agencies and

16 with various other departments of the Federal

17 Government, to ensure the timely transmission

18 of information concerning advances in AIDS-re19 lated research and the clinical treatment of

20 AIDS and its related conditions, to these var21 ious agencies for dissemination to affected com22 munities and health care providers.

23 ‘‘(5) ADVISORY COUNCIL.—

24 ‘‘(A) ESTABLISHMENT.—The Director of

25 the Office of AIDS Research shall establish an
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1 advisory council to be known as the Office of

2 AIDS Research Advisory Council (hereafter re3 ferred to as the ‘‘Council’’), which shall serve to

4 replace the AIDS Program Advisory Committee

5 which is operating on the date of enactment of

6 this subsection.

7 ‘‘(B) COMPOSITION.—The Council shall be

8 composed of biomedical, behavioral, and social

9 scientists, and representatives of diverse HIV

10 affected communities, and shall be appointed by

11 the Director.

12 ‘‘(C) AUTHORITY.—The Council shall, con13 sistent with section 406—

14 ‘‘(i) advise the Director of the Office

15 of AIDS Research and make recommenda16 tions concerning the development of the

17 AIDS-related research budget, and the de18 velopment and implementation of the stra19 tegic plan for AIDS-related research at the

20 National Institutes of Health;

21 ‘‘(ii) provide the second level of peer

22 review for awards made directly to the Of23 fice of AIDS Research from the discre24 tionary fund described in paragraph (7);

25 and
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1 ‘‘(iii) carry out such other activities

2 determined appropriate by the Director of

3 the Office of AIDS Research.

4 ‘‘(6) BUDGETARY AUTHORITY.—The Director

5 of the Office of AIDS Research shall—

6 ‘‘(A) in consultation with the advisory

7 council established under paragraph (5) and

8 based upon budget requests and additional ad9 vice from the directors of the institutes, centers,

10 and divisions of the National Institutes of

11 Health, prepare and submit, directly to the

12 President for review and transmittal to Con13 gress, an annual budget estimate for the AIDS14 related research program conducted within the

15 agencies of the National Institutes of Health,

16 after reasonable opportunity for comment (but

17 without change) by the Secretary and the Di18 rector of the National Institutes of Health;

19 ‘‘(B) receive from the President and the

20 Office of Management and Budget directly all

21 AIDS-related research funds appropriated by

22 Congress for obligation and expenditure by the

23 agencies of the National Institutes of Health in

24 accordance with the strategic plan developed

25 under paragraph (3)(A); and
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1 ‘‘(C) distribute AIDS research funding to

2 the various institutes, centers, and divisions of

3 the National Institutes of Health in accordance

4 with the strategic plan.

5 ‘‘(7) DISCRETIONARY FUND.—

6 ‘‘(A) AVAILABILITY OF FUNDS.—The Sec7 retary shall ensure that not to exceed 25 per8 cent of the funds available in excess of the

9 amount of baseline AIDS research spending

10 during the previous fiscal year, but in no event

11 less than $50,000,000 each fiscal year, be made

12 available to the Director of the Office of AIDS

13 Research for the establishment of an AIDS re14 search discretionary fund.

15 ‘‘(B) USE.—The Director of the Office of

16 AIDS Research, in consultation with the advi17 sory council established under paragraph (5),

18 shall use amounts in the AIDS research discre19 tionary fund to—

20 ‘‘(i) fund emergency AIDS research

21 programs;

22 ‘‘(ii) fund programs for the conduct of

23 research aimed at filling gaps that exist in

24 existing research programs;
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1 ‘‘(iii) conduct conferences, convene

2 committees, hold meetings or carry out

3 other activities determined appropriate by

4 the Director.

5 ‘‘(C) REDUCTION IN ADMINISTRATIVE IM6 PEDIMENTS.—Notwithstanding any other provi7 sion of law, with respect to the number of full8 time equivalent individuals employed, the Direc9 tor of the Office of AIDS Research shall be per10 mitted to authorize the employment of such

11 full-time equivalent individuals to perform

12 AIDS-related research through the agencies of

13 the National Institutes of Health.

14 ‘‘(c) OTHER DUTIES.—The director of the office—

15 ’’; and

16 (ii) by redesignating paragraphs (2)

17 through (8) (as such paragraphs existed

18 one day prior to the date of enactment of

19 this Act) as paragraphs (1) through (7),

20 respectively; and

21 (C) in subsection (c) (as added by the

22 amendment made by subparagraph (B)) by

23 striking ‘‘for the appropriate national research

24 institute of the National Institutes of Health’’
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1 in paragraph (4) (as so designated by the

2 amendments made by subparagraph (B));

3 (8) in section 2361, by striking ‘‘For purposes’’

4 and all that follows and inserting the following:

5 ‘‘For purposes of this title:

6 ‘‘(1) The term ‘infection’, with respect to the

7 etiologic agent for acquired immune deficiency syn8 drome, includes opportunistic cancers and infectious

9 diseases and any other conditions arising from infec10 tion with such etiologic agent.

11 ‘‘(2) The term ‘treatment’, with respect to the

12 etiologic agent for acquired immune deficiency syn13 drome, includes primary and secondary prophy14 laxis.’’;

15 (9) in section 2315(f), by striking ‘‘there are

16 authorized’’ and all that follows and inserting ‘‘there

17 are authorized to be appropriated such sums as may

18 be necessary for each fiscal year.’’;

19 (10) in section 2320(e)(1), by striking ‘‘there

20 are authorized’’ and all that follows and inserting

21 ‘‘there are authorized to be appropriated such sums

22 as may be necessary for each fiscal year.’’; and

23 (11) in section 2341(d), by striking ‘‘there are

24 authorized’’ and all that follows and inserting ‘‘there
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1 are authorized to be appropriated such sums as may

2 be necessary for each fiscal year.’’.

3 TITLE XIX—STUDIES

4 SEC. 1901. ACQUIRED IMMUNE DEFICIENCY SYNDROME.

5 (a) CERTAIN DRUG-RELEASE MECHANISMS.—

6 (1) The Secretary of Health and Human Serv7 ices shall, subject to paragraph (2), enter into a con8 tract with a public or nonprofit private entity to con9 duct a study for the purpose of determining, with re10 spect to acquired immune deficiency syndrome, the

11 impact of parallel-track drug-release mechanisms on

12 public and private clinical research, and on the ac13 tivities of the Commissioner of Food and Drugs re14 garding the approval of drugs.

15 (2) The Secretary of Health and Human Serv16 ices shall request the Institute of Medicine of the

17 National Academy of Sciences to enter into the con18 tract under paragraph (1) to conduct the study de19 scribed in such paragraph. If such Institute declines

20 to conduct the study, the Secretary shall carry out

21 paragraph (1) through another public or nonprofit

22 private entity.

23 (b) THIRD-PARTY PAYMENTS REGARDING CERTAIN

24 CLINICAL TRIALS.—The Secretary of Health and Human

25 Services shall conduct a study for the purpose of—
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1 (1) determining the policies of third-party

2 payors regarding the payment of the costs of appro3 priate health services that are provided incident to

4 the participation of individuals as subjects in clinical

5 trials conducted in the development of drugs with re6 spect to acquired immune deficiency syndrome; and

7 (2) developing recommendations regarding such

8 policies.

9 (c) ADVISORY COMMITTEES.—The Secretary of

10 Health and Human Services, acting through the Director

11 of the National Institutes of Health, shall conduct a study

12 for the purpose of determining—

13 (1) whether the activities of the various advi14 sory committees established in the National Insti15 tutes of Health regarding acquired immune defi16 ciency syndrome are being coordinated sufficiently;

17 and

18 (2) whether the functions of any of such advi19 sory committees should be modified in order to

20 achieve greater efficiency.

21 (d) VACCINES FOR HUMAN IMMUNODEFICIENCY

22 VIRUS.—

23 (1) IN GENERAL.—The Secretary of Health and

24 Human Services, acting through the National Insti25 tutes of Health, shall develop a plan for the appro-
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1 priate inclusion of HIV-infected women, including

2 pregnant women, HIV-infected infants, and HIV-in3 fected children in studies conducted by or through

4 the National Institutes of Health concerning the

5 safety and efficacy of HIV vaccines for the treat6 ment and prevention of HIV infection. Such plan

7 shall ensure the full participation of other Federal

8 agencies currently conducting HIV vaccine studies

9 and require that such studies conform fully to the

10 requirements of part 46 of title 45, Code of Federal

11 Regulations.

12 (2) REPORT.—Not later than 180 days after

13 the date of the enactment of this Act, the Secretary

14 of Health and Human Services shall prepare and

15 submit to the Committee on Energy and Commerce

16 of the House of Representatives, and the Committee

17 on Labor and Human Resources of the Senate, a re18 port concerning the plan developed under paragraph

19 (1).

20 (3) IMPLEMENTATION.—Not later than 12

21 months after the date of the enactment of this Act,

22 the Secretary of Health and Human Services shall

23 implement the plan developed under paragraph (1),

24 including measures for the full participation of other
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1 Federal agencies currently conducting HIV vaccine

2 studies.

3 (4) For the purpose of carrying out this sub4 section, there are authorized to be appropriated such

5 sums as may be necessary for each of the fiscal

6 years 1994 through 1996.

7 SEC. 1902. MALNUTRITION IN THE ELDERLY.

8 (a) STUDY.—

9 (1) IN GENERAL.—The Secretary of Health and

10 Human Services (referred to in this section as the

11 ‘‘Secretary’’), acting through the National Institute

12 on Aging, coordinating with the Agency for Health

13 Care Policy and Research and, to the degree pos14 sible, in consultation with the head of the National

15 Nutrition Monitoring System established under sec16 tion 1428 of the Food and Agriculture Act of 1977

17 (7 U.S.C. 3178), shall conduct a 3-year nutrition

18 screening and intervention activities study of the el19 derly.

20 (2) EFFICACY AND COST-EFFECTIVENESS OF

21 NUTRITION SCREENING AND INTERVENTION ACTIVI22 TIES.—In conducting the study, the Secretary shall

23 determine the efficacy and cost-effectiveness of nu24 trition screening and intervention activities con25 ducted in the elderly health and long-term care con-
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1 tinuum, and of a program that would institutionalize

2 nutrition screening and intervention activities. In

3 evaluating such a program, the Secretary shall de4 termine—

5 (A) if health or quality of life is measur6 ably improved for elderly individuals who re7 ceive routine nutritional screening and treat8 ment;

9 (B) if federally subsidized home or institu10 tional care is reduced because of increased inde11 pendence of elderly individuals resulting from

12 improved nutritional status;

13 (C) if a multidisciplinary approach to nu14 tritional care is effective in addressing the nu15 tritional needs of elderly individuals; and

16 (D) if reimbursement for nutrition screen17 ing and intervention activities is a cost-effective

18 approach to improving the health status of el19 derly individuals.

20 (3) POPULATIONS.—The populations of elderly

21 individuals in which the study will be conducted

22 shall include populations of elderly individuals who

23 are—

24 (A) living independently, including—
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1 (i) individuals who receive home and

2 community-based services or family sup3 port;

4 (ii) individuals who do not receive ad5 ditional services and support;

6 (iii) individuals with low incomes; and

7 (iv) individuals who are minorities;

8 (B) hospitalized, including individuals ad9 mitted from home and from institutions; and

10 (C) institutionalized in residential facilities

11 such as nursing homes and adult homes.

12 (b) MALNUTRITION STUDY.—The Secretary, acting

13 through the National Institute on Aging, shall conduct a

14 3-year study to determine the extent of malnutrition in

15 elderly individuals in hospitals and long-term care facili16 ties and in elderly individuals who are living independ17 ently.

18 (c) REPORT.—The Secretary shall submit a report to

19 the Committee on Labor and Human Resources of the

20 Senate and the Committee on Energy and Commerce of

21 the House of Representatives containing the findings re22 sulting from the studies described in subsections (a) and

23 (b), including a determination regarding whether a pro24 gram that would institutionalize nutrition screening and
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1 intervention activities should be adopted, and the rationale

2 for the determination.

3 (d) ADVISORY PANEL.—

4 (1) ESTABLISHMENT.—The Secretary, acting

5 through the Director of the National Institute on

6 Aging, shall establish an advisory panel that shall

7 oversee the design, implementation, and evaluation

8 of the studies described in subsections (a) and (b).

9 (2) COMPOSITION.—The advisory panel shall in10 clude representatives appointed for the life of the

11 panel by the Secretary from the Health Care Fi12 nancing Administration, the Social Security Admin13 istration, the National Center for Health Statistics,

14 the Administration on Aging, the National Council

15 on the Aging, the American Dietetic Association, the

16 American Academy of Family Physicians, and such

17 other agencies or organizations as the Secretary de18 termines to be appropriate.

19 (3) COMPENSATION AND EXPENSES.—

20 (A) COMPENSATION.—Each member of the

21 advisory panel who is not an employee of the

22 Federal Government shall receive compensation

23 for each day engaged in carrying out the duties

24 of the panel, including time engaged in travel25 ing for purposes of such duties. Such com-
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1 pensation may not be provided in an amount in

2 excess of the maximum rate of basic pay pay3 able for GS–18 of the General Schedule.

4 (B) TRAVEL EXPENSES.—Each member of

5 the advisory panel shall receive travel expenses,

6 including per diem in lieu of subsistence, at

7 rates authorized for employees of agencies

8 under subchapter I of chapter 57 of title 5,

9 United States Code, for each day the member

10 is engaged in the performance of duties away

11 from the home or regular place of business of

12 the member.

13 (4) DETAIL OF FEDERAL EMPLOYEES.—On the

14 request of the advisory panel, the head of any Fed15 eral agency shall detail, without reimbursement, any

16 of the personnel of the agency to the advisory panel

17 to assist the advisory panel in carrying out its du18 ties. Any detail shall not interrupt or otherwise af19 fect the civil service status or privileges of the Fed20 eral employee.

21 (5) TECHNICAL ASSISTANCE.—On the request

22 of the advisory panel, the head of a Federal agency

23 shall provide such technical assistance to the advi24 sory panel as the advisory panel determines to be

25 necessary to carry out its duties.
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1 (6) TERMINATION.—Notwithstanding section

2 15 of the Federal Advisory Committee Act (5 U.S.C.

3 App.), the advisory panel shall terminate 3 years

4 after the date of enactment of this Act.

5 SEC. 1903. RESEARCH ACTIVITIES ON CHRONIC FATIGUE

6 SYNDROME.

7 The Secretary of Health and Human Services shall,

8 not later than May 1, 1993, and annually thereafter for

9 the next 3 years, prepare and submit to the Committee

10 on Energy and Commerce of the House of Representatives

11 and the Committee on Labor and Human Resources of

12 the Senate, a report that summarizes the research activi13 ties conducted or supported by the National Institutes of

14 Health concerning chronic fatigue syndrome. Such report

15 should include information concerning grants made, coop16 erative agreements or contracts entered into, intramural

17 activities, research priorities and needs, and a plan to ad18 dress such priorities and needs.

19 SEC. 1904. REPORT ON MEDICAL USES OF BIOLOGICAL

20 AGENTS IN DEVELOPMENT OF DEFENSES

21 AGAINST BIOLOGICAL WARFARE.

22 The Secretary of Health and Human Services, in con23 sultation with other appropriate executive agencies, shall

24 report to the House Energy and Commerce Committee

25 and the Senate Labor and Human Resources Committee
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1 on the appropriateness and impact of the National Insti2 tutes of Health assuming responsibility for the conduct of

3 all Federal research, development, testing, and evaluation

4 functions relating to medical countermeasures against

5 biowarfare threat agents. In preparing the report, the Sec6 retary shall identify the extent to which such activities are

7 carried out by agencies other than the National Institutes

8 of Health, and assess the impact (positive and negative)

9 of the National Institutes of Health assuming responsibil10 ity for such activities, including the impact under the

11 Budget Enforcement Act and the Omnibus Budget Rec12 onciliation Act of 1990 on existing National Institutes of

13 Health research programs as well as other programs with14 in the category of domestic discretionary spending. The

15 Secretary shall submit the report not later than 12 months

16 after the date of the enactment of this Act.

17 SEC. 1905. PERSONNEL STUDY OF RECRUITMENT, RETEN18 TION AND TURNOVER.

19 (a) STUDY OF PERSONNEL SYSTEM.—Not later than

20 1 year after the date of the enactment of this Act, the

21 Secretary of Health and Human Services, acting through

22 the Director of the National Institutes of Health, shall

23 conduct a study to review the retention, recruitment, va24 cancy and turnover rates of support staff, including fire25 fighters, law enforcement, procurement officers, techni-
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1 cians, nurses and clerical employees, to ensure that the

2 National Institutes of Health is adequately supporting the

3 conduct of efficient, effective and high quality research for

4 the American public. The Director of NIH shall work in

5 conjunction with appropriate employee organizations and

6 representatives in developing such a study.

7 (b) SUBMISSION TO CONGRESS.—Not later than 1

8 year after the date of the enactment of this Act, the Sec9 retary of Health and Human Services shall prepare and

10 submit to the Committee on Energy and Commerce of the

11 House of Representatives, and to the Committee on Labor

12 and Human Resources of the Senate, a report containing

13 the study conducted under subsection (a) together with

14 the recommendations of the Secretary concerning the en15 actment of legislation to implement the results of such

16 study.

17 SEC. 1906. PROCUREMENT.

18 (a) IN GENERAL.—The Director of the National In19 stitutes of Health and the Administrator of the General

20 Services Administration shall jointly conduct a study to

21 develop a streamlined procurement system for the Na22 tional Institutes of Health that complies with the require23 ments of Federal law.

24 (b) REPORT.—Not later than March 1, 1994, the of25 ficials specified in subsection (a) shall complete the study
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1 required in such subsection and shall submit to the Com2 mittee on Energy and Commerce of the House of Rep3 resentatives, and the Committee on Labor and Human Re4 sources of the Senate, a report describing the findings

5 made as a result of the study.

6 SEC. 1907. REPORT CONCERNING LEADING CAUSES OF

7 DEATH.

8 (a) REPORT.—The Secretary of Health and Human

9 Services shall, not later than February 1, 1993, prepare

10 a report that lists—

11 (1) the 20 illnesses that, in terms of mortality,

12 number of years of expected life lost, and of number

13 of preventable years of life lost, are the leading

14 causes of death in the United States and the number

15 of deaths from each such cause, the age-specific and

16 age-adjusted death rates for each such cause, the

17 death rate per 100,000 population for each such

18 cause, the percentage of change in cause specific

19 death rates for each age group, and the percentage

20 of total deaths for each such cause;

21 (2) the amount expended by the Department of

22 Health and Human Services for research, preven23 tion, and education with respect to each of the 20

24 illnesses described in paragraph (1) for the most re-
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1 cent year for which the actual expenditures are

2 known;

3 (3) an estimate by the Secretary of the amount

4 to be expended on research, prevention, and edu5 cation with respect to each of the 20 illnesses de6 scribed in paragraph (1) for the year for which the

7 report is prepared; and

8 (4) with respect to the years specified in para9 graphs (2) and (3), the percentage of the total of

10 the annual expenditures for research, prevention,

11 and education on the 20 illnesses described in para12 graph (1) that are attributable to each illness.

13 (b) SUBMISSION TO CONGRESS.—The Secretary of

14 Health and Human Services shall submit the report re15 quired under subsection (a), together with relevant budget

16 information, to the Committee on Energy and Commerce

17 and the Committee on Appropriations of the House of

18 Representatives and the Committee on Labor and Human

19 Resources and the Committee on Appropriations of the

20 Senate.

21 SEC. 1908. RELATIONSHIP BETWEEN THE CONSUMPTION

22 OF LEGAL AND ILLEGAL DRUGS.

23 (a) IN GENERAL.—The Secretary of Health and

24 Human Services, acting through the Commissioner of

25 Food and Drugs, shall review and consider all existing rel-
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1 evant data and research concerning whether there is a re2 lationship between an individual’s receptivity to use or

3 consume legal drugs and the consumption or abuse by the

4 individual of illegal drugs. On the basis of such review,

5 the Secretary shall determine whether additional research

6 is necessary. If the Secretary determines additional re7 search is required, the Secretary shall conduct a study of

8 those subjects where the Secretary’s review indicates addi9 tional research is needed, including, if necessary, a review

10 of—

11 (1) the effect of advertising and marketing

12 campaigns that promote the use of legal drugs on

13 the public;

14 (2) the correlation of legal drug abuse with ille15 gal drug abuse; and

16 (3) other matters that the Secretary determines

17 appropriate.

18 (b) REPORT.—Not later than 12 months after the

19 date of enactment of this Act, the Secretary shall prepare

20 and submit, to the Committee on Energy and Commerce

21 of the House of Representatives and Committee on Labor

22 and Human Resources of the Senate, a report containing

23 the results of the review conducted under subsection (b).

24 If the Secretary determines additional research is re25 quired, no later than 2 years after the date of enactment
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1 of this Act, the Secretary shall prepare and submit, to the

2 Committee on Energy and Commerce of the House of

3 Representatives and Committee on Labor and Human Re4 sources of the Senate, a report containing the results of

5 the additional research conducted under subsection (b).

6 TITLE XX—MISCELLANEOUS

7 PROVISIONS

8 SEC. 2001. DESIGNATION OF SENIOR BIOMEDICAL RE9 SEARCH SERVICE IN HONOR OF SILVIO O.

10 CONTE, AND LIMITATION ON NUMBER OF

11 MEMBERS.

12 (a) IN GENERAL.—Section 228(a) of the Public

13 Health Service Act (42 U.S.C. 237(a)), as added by sec14 tion 304 of Public Law 101–509, is amended to read as

15 follows:

16 ‘‘(a)(1) There shall be in the Public Health Service

17 a Silvio O. Conte Senior Biomedical Research Service, not

18 to exceed 750 members.

19 ‘‘(2) The authority established in paragraph (1) re20 garding the number of members in the Silvio O. Conte

21 Senior Biomedical Research Service is in addition to any

22 authority established regarding the number of members

23 in the commissioned Regular Corps, in the Reserve Corps,

24 and in the Senior Executive Service. Such paragraph may

25 not be construed to require that the number of members
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1 in the commissioned Regular Corps, in the Reserve Corps,

2 or in the Senior Executive Service be reduced to offset

3 the number of members serving in the Silvio O. Conte Sen4 ior Biomedical Research Service (hereafter in this section

5 referred to as the ‘Service’).’’.

6 (b) CONFORMING AMENDMENT.—Section 228 of the

7 Public Health Service Act (42 U.S.C. 237), as added by

8 section 304 of Public Law 101–509, is amended in the

9 heading for the section by amending the heading to read

10 as follows:

11 ‘‘SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH

12 SERVICE’’.

13 SEC. 2002. TECHNICAL CORRECTIONS.

14 (a) TITLE III.—Subsection (c) of section 316 of the

15 Public Health Service Act (42 U.S.C. 247a(c)) is repealed.

16 (b) TITLE IV.—Title IV of the Public Health Service

17 Act (42 U.S.C. 281 et seq.) is amended—

18 (1) in section 406—

19 (A) in subsection (b)(2)(A), by striking

20 ‘‘Veterans’ Administration’’ each place such

21 term appears and inserting ‘‘Department of

22 Veterans Affairs’’; and

23 (B) in subsection (h)(2)(A)(v), by striking

24 ‘‘Veterans’ Administration’’ and inserting ‘‘De25 partment of Veterans Affairs’’;
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1 (2) in section 408, in subsection (b) (as redesig2 nated by section 501(c)(1)(C) of this Act), by strik3 ing ‘‘Veterans’ Administration’’ and inserting ‘‘De4 partment of Veterans Affairs’’;

5 (3) in section 421(b)(1), by inserting a comma

6 after ‘‘may’’;

7 (4) in section 428(b), in the matter preceding

8 paragraph (1), by striking ‘‘the the’’ and inserting

9 ‘‘the’’;

10 (5) in section 430(b)(2)(A)(i), by striking ‘‘Vet11 erans’ Administration’’ and inserting ‘‘Department

12 of Veterans Affairs’’;

13 (6) in section 439(b), by striking ‘‘Veterans’

14 Administration’’ and inserting ‘‘Department of Vet15 erans Affairs’’;

16 (7) in section 442(b)(2)(A), by striking ‘‘Veter17 ans’ Administration’’ and inserting ‘‘Department of

18 Veterans Affairs’’;

19 (8) in section 464D(b)(2)(A), by striking ‘‘Vet20 erans’ Administration’’ and inserting ‘‘Department

21 of Veterans Affairs’’;

22 (9) in section 464E—

23 (A) in subsection (d), in the first sentence,

24 by inserting ‘‘Coordinating’’ before ‘‘Commit25 tee’’; and
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1 (B) in subsection (e), by inserting ‘‘Coordi2 nating’’ before ‘‘Committee’’ the first place

3 such term appears;

4 (10) in section 464P(b)(6) (as added by section

5 123 of Public Law 102-321 (106 Stat. 362)), by

6 striking ‘‘Administration’’ and inserting ‘‘Institute’’;

7 (11) in section 466(a)(1)(B), by striking ‘‘Vet8 erans’ Administration’’ and inserting ‘‘Department

9 of Veterans Affairs’’;

10 (12) in section 480(b)(2)(A), by striking ‘‘Vet11 erans’ Administration’’ and inserting ‘‘Department

12 of Veterans Affairs’’;

13 (13) in section 485(b)(2)(A), by striking ‘‘Vet14 erans’ Administration’’ and inserting ‘‘Department

15 of Veterans Affairs’’;

16 (14) in section 487(d)(3), by striking ‘‘section

17 304(a)(3)’’ and inserting ‘‘section 304(a)’’; and

18 (15) in section 496(a), by striking ‘‘Such ap19 propriations,’’ and inserting the following: ‘‘Appro20 priations to carry out the purposes of this title,’’.

21 (c) TITLE XXIII.—Part A of title XXIII of the Pub22 lic Health Service Act (42 U.S.C. 300cc et seq.) is amend23 ed—

24 (1) in section 2304—
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1 (A) in the heading for the section, by strik2 ing ‘‘CLINICAL RESEARCH REVIEW COM3 MITTEE’’ and inserting ‘‘RESEARCH ADVI4 SORY COMMITTEE’’; and

5 (B) in subsection (a), by striking ‘‘AIDS

6 Clinical Research Review Committee’’ and in7 serting ‘‘AIDS Research Advisory Committee’’;

8 (2) in section 2312(a)(2)(A), by striking ‘‘AIDS

9 Clinical Research Review Committee’’ and inserting

10 ‘‘AIDS Research Advisory Committee’’;

11 (3) in section 2314(a)(1), in the matter preced12 ing subparagraph (A), by striking ‘‘Clinical Research

13 Review Committee’’ and inserting ‘‘AIDS Research

14 Advisory Committee’’;

15 (4) in section 2317(d)(1), by striking ‘‘Clinical

16 Research Review Committee’’ and inserting ‘‘AIDS

17 Research Advisory Committee established under sec18 tion 2304’’; and

19 (5) in section 2318(b)(3), by striking ‘‘Clinical

20 Research Review Committee’’ and inserting ‘‘AIDS

21 Research Advisory Committee’’.

22 (d) SECRETARY.—Section 2(c) of the Public Health

23 Service Act (42 U.S.C. 201(c)) is amended by striking

24 ‘‘Health, Education, and Welfare’’ and inserting ‘‘Health

25 and Human Services’’.
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1 (e) DEPARTMENT.—Section 201 of the Public Health

2 Service Act (42 U.S.C. 202) is amended—

3 (1) by striking ‘‘Health, Education, and Wel4 fare’’ and inserting ‘‘Health and Human Services’’;

5 and

6 (2) by striking ‘‘Surgeon General’’ and insert7 ing ‘‘Assistant Secretary for Health’’.

8 (f) DEPARTMENT.—Section 202 of the Public Health

9 Service Act (42 U.S.C. 203) is amended—

10 (1) by striking ‘‘Health, Education, and Wel11 fare’’ and inserting ‘‘Health and Human Services’’;

12 (2) by striking ‘‘Surgeon General’’ the second

13 and subsequent times that such term appears and

14 inserting ‘‘Secretary’’; and

15 (3) by inserting ‘‘, and the Agency for Health

16 Care Policy and Research’’ before the first period.

17 (g) VOLUNTEER SERVICES.—Section 223 of the Pub18 lic Health Service Act (42 U.S.C. 217b) is amended by

19 striking ‘‘Health, Education, and Welfare’’ and inserting

20 ‘‘Health and Human Services’’.

21 SEC. 2003. BIENNIAL REPORT ON CARCINOGENS.

22 Section 301(b)(4) of the Public Health Service Act

23 (42 U.S.C. 241(b)(4)) is amended by striking ‘‘an annual’’

24 and inserting in lieu thereof ‘‘a biennial’’.
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1 SEC. 2004. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE

2 FOR RESEARCH.

3 Not later than 90 days after the date of the enact4 ment of this Act, the Secretary of Health and Human

5 Services, acting through the Director of the National In6 stitutes of Health, shall present to the Congress a master

7 plan to provide for the replacement or refurbishment of

8 less than adequate buildings, utility equipment and dis9 tribution systems (including the resources that provide

10 electrical and other utilities, chilled water, air handling,

11 and other services that the Secretary, acting through the

12 Director, deems necessary), roads, walkways, parking

13 areas, and grounds that underpin the laboratory and clini14 cal facilities of the National Institutes of Health. Such

15 plan may make recommendations for the undertaking of

16 new projects that are consistent with the objectives of this

17 section, such as encircling the National Institutes of

18 Health Federal enclave with an adequate chilled water

19 conduit.

20 SEC. 2005. TRANSFER OF PROVISIONS OF TITLE XXVII.

21 (a) IN GENERAL.—The Public Health Service Act

22 (42 U.S.C. 201 et seq.), as amended by section 101 of

23 Public Law 101–381 and section 304 of Public Law 101–

24 509, is amended—

25 (1) by transferring sections 2701 through 2714

26 to title II;
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1 (2) by redesignating such sections as sections

2 231 through 244, respectively;

3 (3) by inserting such sections, in the appro4 priate sequence, after section 228;

5 (4) by inserting before section 201 the following

6 new heading:

7 ‘‘PART A—ADMINISTRATION’’; and

8 (5) by inserting before section 231 (as redesig9 nated by paragraph (2) of this subsection) the fol10 lowing new heading:

11 ‘‘Part B—Miscellaneous Provisions’’.

12 (b) CONFORMING AMENDMENTS.—The Public

13 Health Service Act (42 U.S.C. 201 et seq.) is amended—

14 (1) in the heading for title II, by inserting

15 ‘‘AND MISCELLANEOUS PROVISIONS’’ after

16 ‘‘ADMINISTRATION’’;

17 (2) in section 406(a)(2), by striking ‘‘2701’’

18 and inserting ‘‘231’’;

19 (3) in section 465(f), by striking ‘‘2701’’ and

20 inserting ‘‘231’’;

21 (4) in section 480(a)(2), by striking ‘‘2701’’

22 and inserting ‘‘231’’;

23 (5) in section 485(a)(2), by striking ‘‘2701’’

24 and inserting ‘‘231’’;
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1 (6) in section 497, by striking ‘‘2701’’ and in2 serting ‘‘231’’;

3 (7) in section 505(a)(2), by striking ‘‘2701’’

4 and inserting ‘‘231’’;

5 (8) in section 926(b), by striking ‘‘2711’’ each

6 place such term appears and inserting ‘‘241’’; and

7 (9) in title XXVII, by striking the heading for

8 such title.

9 SEC. 2006. CERTAIN AUTHORIZATION OF APPROPRIATIONS.

10 Section 399L(a) of the Public Health Service Act (42

11 U.S.C. 280e–4(a)), as added by Public Law 102-515 (106

12 Stat. 3376), is amended—

13 (1) in the first sentence, by striking ‘‘the Sec14 retary’’ and all that follows and inserting the follow15 ing: ‘‘there are authorized to be appropriated

16 $30,000,000 for fiscal year 1994, and such sums as

17 may be necessary for each of the fiscal years 1995

18 through 1997.’’; and

19 (2) in the second sentence, by striking ‘‘Out of

20 any amounts used’’ and inserting ‘‘Of the amounts

21 appropriated under the preceding sentence’’.
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1 SEC. 2007. PROHIBITION AGAINST SHARP ADULT SEX SUR2 VEY AND THE AMERICAN TEENAGE SEX SUR3 VEY.

4 The Secretary of Health and Human Services may

5 not during fiscal year 1993 or any subsequent fiscal year

6 conduct or support the SHARP survey of adult sexual be7 havior or the American Teenage Study of adolescent sex8 ual behavior. This section becomes effective April 15,

9 1993.

10 SEC. 2008. SUPPORT FOR BIOENGINEERING RESEARCH.

11 (a) STUDY.—The Secretary of Health and Human

12 Services, acting through the Director of the National In13 stitutes of Health, shall conduct a study for the purpose

14 of—

15 (1) determining the sources and amounts of

16 public and private funding devoted to basic research

17 in bioengineering and biomaterials sciences;

18 (2) evaluating whether that commitment is suf19 ficient to maintain the innovative edge that the

20 United States has in these technologies; and

21 (3) evaluating the need to modify the structure

22 of the National Institutes of Health or any other

23 Federal agency to achieve a greater commitment to

24 innovation in bioengineering, and evaluating the

25 need for better coordination and collaboration among
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1 Federal agencies and between the public and private

2 sectors.

3 In conducting such study, the Director shall work in con4 junction with appropriate organizations and representa5 tives including academics, industry leaders, bioengineering

6 societies, and public agencies (such as the National

7 Science Foundation, Veterans Administration, Depart8 ment of Defense, National Aeronautics and Space Admin9 istration, and the White House Office of Science and

10 Technology Policy).

11 (b) REPORT.—Not later than 1 year after the date

12 of enactment of this Act, the Secretary of Health and

13 Human Services shall prepare and submit to the Commit14 tee on Labor and Human Resources of the Senate, and

15 the Committee on Energy and Commerce of the House

16 of Representatives, a report containing the findings of the

17 study conducted under subsection (a) together with rec18 ommendations concerning the enactment of legislation to

19 implement the results of such study.

20 TITLE XXI—EFFECTIVE DATES

21 SEC. 2101. EFFECTIVE DATES.

22 Subject to section 155, this Act and the amendments

23 made by this Act take effect upon the date of the enact24 ment of this Act.
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

2 (a) SHORT TITLE.—This Act may be cited as the ‘‘Na3 tional Institutes of Health Revitalization Act of 1993’’.

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

5 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. Report by General Accounting Office on adequacy of requirements.

PART III—MISCELLANEOUS REPEALS

Sec. 121. Repeals.

Subtitle B—Clinical Research Equity Regarding Women and Minorities

PART I—WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH

Sec. 131. Requirement of inclusion in research.

Sec. 132. Peer review.

Sec. 133. Applicability to current projects.

PART II—OFFICE OF RESEARCH ON WOMEN’S HEALTH

Sec. 141. Establishment.

PART III—OFFICE OF RESEARCH ON MINORITY HEALTH

Sec. 151. Establishment.

Subtitle C—Scientific Integrity

Sec. 161. Establishment of Office of Scientific Integrity.

Sec. 162. Commission on Scientific 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. Effective dates.
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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. Children’s vaccine initiative.

Sec. 204. Plan for use of animals in research.

Sec. 205. Increased participation of women and members of underrepresented minorities in fields of biomedical and behavioral research.

Sec. 206. Requirements regarding surveys of sexual behavior.

Sec. 207. Discretionary fund of Director of National Institutes of Health.

Sec. 208. 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 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.

Sec. 504. Authorization of appropriations.

TITLE VI—NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE

AND KIDNEY DISEASES

Sec. 601. Provisions regarding nutritional disorders.

TITLE VII—NATIONAL INSTITUTE ON ARTHRITIS AND

MUSCULOSKELETAL AND SKIN DISEASES

Sec. 701. Juvenile arthritis.

TITLE VIII—NATIONAL INSTITUTE ON AGING

Sec. 801. Alzheimer’s disease registry.

Sec. 802. Aging processes regarding women.

Sec. 803. Authorization of appropriations.

Sec. 804. Conforming amendment.

TITLE IX—NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS

DISEASES

Sec. 901. Tropical diseases.

Sec. 902. Chronic fatigue syndrome.
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TITLE X—NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN

DEVELOPMENT

Subtitle A—Research Centers With Respect to Contraception and Research

Centers With Respect to Infertility

Sec. 1001. Grants and contracts for research centers.

Sec. 1002. Loan repayment program for research with respect to contraception

and infertility.

Subtitle B—Program Regarding Obstetrics and Gynecology

Sec. 1011. Establishment of program.

Subtitle C—Child Health Research Centers

Sec. 1021. Establishment of centers.

Subtitle D—Study Regarding Adolescent Health.

Sec. 1031. Prospective longitudinal study.

TITLE XI—NATIONAL EYE INSTITUTE

Sec. 1101. Clinical research on diabetes eye care.

TITLE XII—NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS

AND STROKE

Sec. 1201. Research on multiple sclerosis.

TITLE XIII—NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH

SCIENCES

Sec. 1301. Applied Toxicological Research and Testing Program.

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.
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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 National Institutes of Health

Sec. 1631. Establishment of programs.

Sec. 1632. Funding.

Subtitle E—Funding for Awards and Training Generally

Sec. 1641. Authorization of appropriations.

TITLE XVII—NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH

Sec. 1701. Establishment of Foundation.

TITLE XVIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE

DEFICIENCY SYNDROME

Sec. 1801. Revision and extension of various programs.

TITLE XIX—STUDIES

Sec. 1901. Acquired immune deficiency syndrome.

Sec. 1902. Malnutrition in the elderly.

Sec. 1903. Research activities on chronic fatigue syndrome.

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

against biological warfare.

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

Sec. 1906. Procurement.

Sec. 1907. Report concerning leading causes of death.

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

Sec. 1909. Cost of care in last 6 months of life.
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TITLE XX—MISCELLANEOUS PROVISIONS

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

Conte, and limitation on number of members.

Sec. 2002. Technical corrections.

Sec. 2003. Biennial report on carcinogens.

Sec. 2004. Master plan for physical infrastructure for research.

Sec. 2005. Transfer of provisions of title xxvii.

Sec. 2006. Certain authorization of appropriations.

Sec. 2007. Prohibition against SHARP adult sex survey and the American teenage sex survey.

Sec. 2008. Support for bioengineering research.

TITLE XXI—EFFECTIVE DATES

Sec. 2101. Effective dates.

1 TITLE I—GENERAL PROVISIONS

2 REGARDING TITLE IV OF PUB3 LIC HEALTH SERVICE ACT

4 Subtitle A—Research Freedom

5 PART I—REVIEW OF PROPOSALS FOR

6 BIOMEDICAL AND BEHAVIORAL RESEARCH

7 SEC. 101. ESTABLISHMENT OF CERTAIN PROVISIONS RE8 GARDING RESEARCH CONDUCTED OR SUP9 PORTED BY NATIONAL INSTITUTES OF

10 HEALTH.

11 Part G of title IV of the Public Health Service Act

12 (42 U.S.C. 289 et seq.) is amended by inserting after section

13 492 the following new section:

14 ‘‘CERTAIN PROVISIONS REGARDING REVIEW AND APPROVAL

15 OF PROPOSALS FOR RESEARCH

16 ‘‘SEC. 492A. (a) REVIEW AS PRECONDITION TO RE17 SEARCH.—
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1 ‘‘(1) PROTECTION OF HUMAN RESEARCH SUB2 JECTS.—

3 ‘‘(A) In the case of any application submit4 ted to the Secretary for financial assistance to

5 conduct research, the Secretary may not approve

6 or fund any application that is subject to review

7 under section 491(a) by an Institutional Review

8 Board unless the application has undergone re9 view in accordance with such section and has

10 been recommended for approval by a majority of

11 the members of the Board conducting such re12 view.

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

14 to review under procedures established by the

15 Secretary for the protection of human subjects in

16 clinical research conducted by the National In17 stitutes of Health, the Secretary may not author18 ize the conduct of the research unless the research

19 has, pursuant to such procedures, been rec20 ommended for approval.

21 ‘‘(2) PEER REVIEW.—In the case of any applica22 tion submitted to the Secretary for financial assist23 ance to conduct research, the Secretary may not ap24 prove or fund any application that is subject to tech25 nical and scientific peer review under section 492(a)
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1 unless the application has undergone peer review in

2 accordance with such section and has been rec3 ommended for approval by a majority of the members

4 of the entity conducting such review.

5 ‘‘(b) ETHICAL REVIEW OF RESEARCH.—

6 ‘‘(1) PROCEDURES REGARDING WITHHOLDING OF

7 FUNDS.—If research has been recommended for ap8 proval for purposes of subsection (a), the Secretary

9 may not withhold funding for the research on ethical

10 grounds unless—

11 ‘‘(A) the Secretary convenes an advisory

12 board in accordance with paragraph (4) to study

13 the ethical implications of the research; and

14 ‘‘(B) the majority of the advisory board rec15 ommends that, on ethical grounds, the Secretary

16 withhold funds for the research.

17 ‘‘(2) APPLICABILITY.—The limitation established

18 in paragraph (1) regarding the authority to withhold

19 funds on ethical grounds shall apply without regard

20 to whether the withholding of funds is characterized

21 as a disapproval, a moratorium, a prohibition, or

22 other description.

23 ‘‘(3) PRELIMINARY MATTERS REGARDING USE OF

24 PROCEDURES.—
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1 ‘‘(A) If the Secretary makes a determina2 tion that an advisory board should be convened

3 for purposes of paragraph (1), the Secretary

4 shall, through a statement published in the Fed5 eral Register, announce the intention of the Sec6 retary to convene such a board.

7 ‘‘(B) A statement issued under subpara8 graph (A) shall include a request that interested

9 individuals submit to the Secretary recommenda10 tions specifying the particular individuals who

11 should be appointed to the advisory board in12 volved. The Secretary shall consider such rec13 ommendations in making appointments to the

14 board.

15 ‘‘(C) The Secretary may not make appoint16 ments to an advisory board under paragraph (1)

17 until the expiration of the 30-day period begin18 ning on the date on which the statement required

19 in subparagraph (A) is made with respect to the

20 board.

21 ‘‘(4) ETHICS ADVISORY BOARDS.—

22 ‘‘(A) Any advisory board convened for pur23 poses of paragraph (1) shall be known as an eth24 ics advisory board (hereafter in this paragraph

25 referred to as an ‘ethics board’).
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1 ‘‘(B)(i) An ethics board shall advise, consult

2 with, and make recommendations to the Sec3 retary regarding the ethics of the project of bio4 medical or behavioral research with respect to

5 which the board has been convened.

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

7 on which the statement required in paragraph

8 (3)(A) is made with respect to an ethics board,

9 the board shall submit to the Secretary, and to

10 the Committee on Energy and Commerce of the

11 House of Representatives and the Committee on

12 Labor and Human Resources of the Senate, a re13 port describing the findings of the board regard14 ing the project of research involved and making

15 a recommendation under clause (i) of whether

16 the Secretary should or should not withhold

17 funds for the project. The report shall include the

18 information considered in making the findings.

19 ‘‘(C) An ethics board shall be composed of

20 no fewer than 14, and no more than 20, individ21 uals who are not officers or employees of the

22 United States. The Secretary shall make ap23 pointments to the board from among individuals

24 with special qualifications and competence to

25 provide advice and recommendations regarding
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1 ethical matters in biomedical and behavioral re2 search. Of the members of the board—

3 ‘‘(i) no fewer than 1 shall be an attor4 ney;

5 ‘‘(ii) no fewer than 1 shall be an

6 ethicist;

7 ‘‘(iii) no fewer than 1 shall be a prac8 ticing physician;

9 ‘‘(iv) no fewer than 1 shall be a theolo10 gian; and

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

12 more than one-half, shall be scientists with

13 substantial accomplishments in biomedical

14 or behavioral research.

15 ‘‘(D) The term of service as a member of an

16 ethics board shall be for the life of the board. If

17 such a member does not serve the full term of

18 such service, the individual appointed to fill the

19 resulting vacancy shall be appointed for the re20 mainder of the term of the predecessor of the in21 dividual.

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

23 subject to removal from the board by the Sec24 retary for neglect of duty or malfeasance or for

25 other good cause shown.
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1 ‘‘(F) The Secretary shall designate an indi2 vidual from among the members of an ethics

3 board to serve as the chair of the board.

4 ‘‘(G) In carrying out subparagraph (B)(i)

5 with respect to a project of research, an ethics

6 board shall conduct inquiries and hold public

7 hearings.

8 ‘‘(H) With respect to information relevant

9 to the duties described in subparagraph (B)(i),

10 an ethics board shall have access to all such in11 formation possessed by the Department of Health

12 and Human Services, or available to the Sec13 retary from other agencies.

14 ‘‘(I) Members of an ethics board shall re15 ceive compensation for each day engaged in car16 rying out the duties of the board, including time

17 engaged in traveling for purposes of such duties.

18 Such compensation may not be provided in an

19 amount in excess of the maximum rate of basic

20 pay payable for GS–18 of the General Schedule.

21 ‘‘(J) The Secretary, acting through the Di22 rector of the National Institutes of Health, shall

23 provide to each ethics board such staff and other

24 assistance as may be necessary to carry out the

25 duties of the board.
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1 ‘‘(K) An ethics board shall terminate 30

2 days after the date on which the report required

3 in subparagraph (B)(ii) is submitted to the Sec4 retary and the congressional committees specified

5 in such subparagraph.’’.

6 PART II—RESEARCH ON TRANSPLANTATION OF

7 FETAL TISSUE

8 SEC. 111. ESTABLISHMENT OF AUTHORITIES.

9 Part G of title IV of the Public Health Service Act

10 (42 U.S.C. 289 et seq.) is amended by inserting after section

11 498 the following new section:

12 ‘‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

13 ‘‘SEC. 498A. (a) ESTABLISHMENT OF PROGRAM.—

14 ‘‘(1) IN GENERAL.—The Secretary may conduct

15 or support research on the transplantation of human

16 fetal tissue for therapeutic purposes.

17 ‘‘(2) SOURCE OF TISSUE.—Human fetal tissue

18 may be used in research carried out under paragraph

19 (1) regardless of whether the tissue is obtained pursu20 ant to a spontaneous or induced abortion or pursuant

21 to a stillbirth.

22 ‘‘(b) INFORMED CONSENT OF DONOR.—

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

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

25 only if the woman providing the tissue makes a state-
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1 ment, made in writing and signed by the woman, de2 claring that—

3 ‘‘(A) the woman donates the fetal tissue for

4 use in research described in subsection (a);

5 ‘‘(B) the donation is made without any re6 striction regarding the identity of individuals

7 who may be the recipients of transplantations of

8 the tissue; and

9 ‘‘(C) the woman has not been informed of

10 the identity of any such individuals.

11 ‘‘(2) ADDITIONAL STATEMENT.—In research car12 ried out under subsection (a), human fetal tissue may

13 be used only if the attending physician with respect

14 to obtaining the tissue from the woman involved

15 makes a statement, made in writing and signed by

16 the physician, declaring that—

17 ‘‘(A) in the case of tissue obtained pursuant

18 to an induced abortion—

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

20 abortion was obtained prior to requesting or

21 obtaining consent for the tissue to be used

22 in such research; and

23 ‘‘(ii) no alteration of the timing, meth24 od, or procedures used to terminate the
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1 pregnancy was made solely for the purposes

2 of obtaining the tissue;

3 ‘‘(B) the tissue has been donated by the

4 woman in accordance with paragraph (1); and

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

6 woman with regard to—

7 ‘‘(i) such physician’s interest, if any,

8 in the research to be conducted with the tis9 sue; and

10 ‘‘(ii) any known medical risks to the

11 woman or risks to her privacy that might

12 be associated with the donation of the tissue

13 and that are in addition to risks of such

14 type that are associated with the woman’s

15 medical care.

16 ‘‘(c) INFORMED CONSENT OF RESEARCHER AND

17 DONEE.—In research carried out under subsection (a),

18 human fetal tissue may be used only if the individual with

19 the principal responsibility for conducting the research in20 volved makes a statement, made in writing and signed by

21 the individual, declaring that the individual—

22 ‘‘(1) is aware that—

23 ‘‘(A) the tissue is human fetal tissue;
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1 ‘‘(B) the tissue may have been obtained pur2 suant to a spontaneous or induced abortion or

3 subsequent to a stillbirth; and

4 ‘‘(C) the tissue was donated for research

5 purposes;

6 ‘‘(2) has provided such information to other in7 dividuals with responsibilities regarding the research;

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

9 of an individual to be a recipient of a transplan10 tation of the tissue, written acknowledgment of receipt

11 of such information by such recipient; and

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

13 timing, method, or procedures used to terminate the

14 pregnancy made solely for the purposes of the re15 search.

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

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

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

19 only if the head of the agency or other entity conduct20 ing the research involved certifies to the Secretary

21 that the statements required under subsections (a)(3),

22 (b)(2), and (c) will be available for audit by the Sec23 retary.

24 ‘‘(2) CONFIDENTIALITY OF AUDIT.—Any audit

25 conducted by the Secretary pursuant to paragraph (1)
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1 shall be conducted in a confidential manner to protect

2 the privacy rights of the individuals and entities in3 volved in such research, including such individuals

4 and entities involved in the donation, transfer, re5 ceipt, or transplantation of human fetal tissue. With

6 respect to any material or information obtained pur7 suant to such audit, the Secretary shall—

8 ‘‘(A) use such material or information only

9 for the purposes of verifying compliance with the

10 requirements of this section;

11 ‘‘(B) not disclose or publish such material

12 or information, except where required by Federal

13 law, in which case such material or information

14 shall be coded in a manner such that the identi15 ties of such individuals and entities are pro16 tected; and

17 ‘‘(C) not maintain such material or infor18 mation after completion of such audit, except

19 where necessary for the purposes of such audit.

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

21 ‘‘(1) RESEARCH CONDUCTED BY RECIPIENTS OF

22 ASSISTANCE.—The Secretary may not provide sup23 port for research under subsection (a) unless the ap24 plicant agrees to conduct the research in accordance

25 with applicable State and local law.
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1 ‘‘(2) RESEARCH CONDUCTED BY SECRETARY.—

2 The Secretary may conduct research under subsection

3 (a) only in accordance with applicable State and

4 local law.

5 ‘‘(f) DEFINITION.—For purposes of this section, the

6 term ‘human fetal tissue’ means tissue or cells obtained

7 from a dead human embryo or fetus after a spontaneous

8 or induced abortion, or after a stillbirth.’’.

9 SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITA10 TION OR ACCEPTANCE OF TISSUE AS DI11 RECTED DONATION FOR USE IN TRANSPLAN12 TATION.

13 Part G of title IV of the Public Health Service Act,

14 as amended by section 111 of this Act, is amended by insert15 ing after section 498A the following new section:

16 ‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE

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

18 unlawful for any person to knowingly acquire, receive, or

19 otherwise transfer any human fetal tissue for valuable con20 sideration if the transfer affects interstate commerce.

21 ‘‘(b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DI22 RECTED DONATION FOR USE IN TRANSPLANTATION.—It

23 shall be unlawful for any person to solicit or knowingly

24 acquire, receive, or accept a donation of human fetal tissue

25 for the purpose of transplantation of such tissue into an26 other person if the donation affects interstate commerce, the
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1 tissue will be or is obtained pursuant to an induced abor2 tion, and—

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

4 a promise to the donating individual that the donated

5 tissue will be transplanted into a recipient specified

6 by such individual;

7 ‘‘(2) the donated tissue will be transplanted into

8 a relative of the donating individual; or

9 ‘‘(3) the person who solicits or knowingly ac10 quires, receives, or accepts the donation has provided

11 valuable consideration for the costs associated with

12 such abortion.

13 ‘‘(c) CRIMINAL PENALTIES FOR VIOLATIONS.—

14 ‘‘(1) IN GENERAL.—Any person who violates sub15 section (a) or (b) shall be fined in accordance with

16 title 18, United States Code, subject to paragraph (2),

17 or imprisoned for not more than 10 years, or both.

18 ‘‘(2) PENALTIES APPLICABLE TO PERSONS RE19 CEIVING CONSIDERATION.—With respect to the impo20 sition of a fine under paragraph (1), if the person in21 volved violates subsection (a) or (b)(3), a fine shall be

22 imposed in an amount not less than twice the amount

23 of the valuable consideration received.

24 ‘‘(d) DEFINITIONS.—For purposes of this section:
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1 ‘‘(1) The term ‘human fetal tissue’ has the mean2 ing given such term in section 498A(e).

3 ‘‘(2) The term ‘interstate commerce’ has the

4 meaning given such term in section 201(b) of the Fed5 eral Food, Drug, and Cosmetic Act.

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

7 include reasonable payments associated with the

8 transportation, implantation, processing, preserva9 tion, quality control, or storage of human fetal tis10 sue.’’.

11 SEC. 113. REPORT BY GENERAL ACCOUNTING OFFICE ON

12 ADEQUACY OF REQUIREMENTS.

13 (a) IN GENERAL.—With respect to research on the

14 transplantation of human fetal tissue for therapeutic pur15 poses, the Comptroller General of the United States shall

16 conduct an audit for the purpose of determining—

17 (1) whether and to what extent such research

18 conducted or supported by the Secretary of Health

19 and Human Services has been conducted in accord20 ance with section 498A of the Public Health Service

21 Act (as added by section 111 of this Act); and

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

23 violations of section 498B of such Act (as added by

24 section 112 of this Act).
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1 (b) REPORT.—Not later than May 19, 1995, the Comp2 troller General of the United States shall complete the audit

3 required in subsection (a) and submit to the Committee on

4 Energy and Commerce of the House of Representatives, and

5 to the Committee on Labor and Human Resources of the

6 Senate, a report describing the findings made pursuant to

7 the audit.

8 PART III—MISCELLANEOUS REPEALS

9 SEC. 121. REPEALS.

10 (a) CERTAIN BIOMEDICAL ETHICS BOARD.—Title III

11 of the Public Health Service Act (42 U.S.C. 241 et seq.)

12 is amended by striking part J.

13 (b) OTHER REPEALS.—Part G of title IV of the Public

14 Health Service Act (42 U.S.C. 289 et seq.) is amended—

15 (1) in section 498, by striking subsection (c); and

16 (2) by striking section 499; and

17 (3) by redesignating section 499A as section 499.

18 (c) NULLIFICATION OF CERTAIN REGULATION.—The

19 provisions of section 204(d) of part 46 of title 45 of the

20 Code of Federal Regulations (45 CFR 46.204(d)) shall not

21 have any legal effect.
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1 Subtitle B—Clinical Research Eq2 uity Regarding Women and Mi3 norities

4 PART I—WOMEN AND MINORITIES AS SUBJECTS

5 IN CLINICAL RESEARCH

6 SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.

7 Part G of title IV of the Public Health Service Act,

8 as amended by section 101 of this Act, is amended by insert9 ing after section 492A the following new section:

10 ‘‘INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

11 RESEARCH

12 ‘‘SEC. 492B. (a) In conducting or supporting clinical

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

14 subject to subsection (b), ensure that—

15 ‘‘(1) women are included as subjects in each

16 project of such research; and

17 ‘‘(2) members of minority groups are included as

18 subjects in such research.

19 ‘‘(b) The requirement established in subsection (a) re20 garding women and members of minority groups shall not

21 apply to a project of clinical research if the inclusion, as

22 subjects in the project, of women and members of minority

23 groups, respectively—

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

25 of the subjects;
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1 ‘‘(2) is inappropriate with respect to the purpose

2 of the research; or

3 ‘‘(3) is inappropriate under such other cir4 cumstances as the Director of NIH may designate.

5 ‘‘(c) In the case of any project of clinical research in

6 which women or members of minority groups will under

7 subsection (a) be included as subjects in the research, the

8 Director of NIH shall ensure that the project is designed

9 and carried out in a manner sufficient to provide for a

10 valid analysis of whether the variables being tested in the

11 research affect women or members of minority groups, as

12 the case may be, differently than other subjects in the re13 search.

14 ‘‘(d)(1) The Director of NIH, in consultation with the

15 Director of the Office of Research on Women’s Health, shall

16 establish guidelines regarding—

17 ‘‘(A) the circumstances under which the inclu18 sion of women and minorities in projects of clinical

19 research is inappropriate for purposes of subsection

20 (b);

21 ‘‘(B) the manner in which such projects are re22 quired to be designed and carried out for purposes of

23 subsection (c), including a specification of the cir24 cumstances in which the requirement of such sub-
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1 section does not apply on the basis of impracticabil2 ity; and

3 ‘‘(C) the conduct of outreach programs for the re4 cruitment of women and members of minority groups

5 as subjects in such research.

6 ‘‘(2) The guidelines established under paragraph (1)—

7 ‘‘(A) may not provide that the cost of including

8 women and minorities in clinical research are a per9 missible consideration regarding the circumstances

10 described in subparagraph (A) of such paragraph;

11 and

12 ‘‘(B) may provide that such circumstances in13 clude circumstances in which there are scientific rea14 sons for believing that the variables proposed to be

15 studied do not affect women or minorities differently

16 than other subjects in the research.

17 ‘‘(3) The guidelines required in paragraph (1) shall

18 be established and published in the Federal Register not

19 later than 120 days after the date of the enactment of the

20 National Institutes of Health Revitalization Act of 1993.

21 ‘‘(4) For fiscal year 1994 and subsequent fiscal years,

22 the Director of NIH may not approve any proposal of clini23 cal research to be conducted or supported by any agency

24 of the National Institutes of Health unless the proposal
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1 specifies the manner in which the research will comply with

2 subsection (a).

3 ‘‘(e) The advisory council of each national research in4 stitute shall annually submit to the Director of NIH and

5 the Director of the institute involved a report describing the

6 manner in which the agency has complied with subsection

7 (a).’’.

8 SEC. 132. PEER REVIEW.

9 Section 492 of the Public Health Service Act (42

10 U.S.C. 289a) is amended by adding at the end the following

11 new subsection:

12 ‘‘(c)(1) In technical and scientific peer review under

13 this section of proposals for clinical research, the consider14 ation of any such proposal (including the initial consider15 ation) shall, except as provided in paragraph (2), include

16 an evaluation of the technical and scientific merit of the

17 proposal regarding compliance with section 492B(a).

18 ‘‘(2) Paragraph (1) shall not apply to any proposal

19 for clinical research that, pursuant to subsection (b) of sec20 tion 492B, is not subject to the requirement of subsection

21 (a) of such section regarding the inclusion of women and

22 members of minority groups as subjects in clinical re23 search.’’.
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1 SEC. 133. APPLICABILITY TO CURRENT PROJECTS.

2 Section 492B of the Public Health Service Act, as

3 added by section 131 of this Act, shall not apply with re4 spect to projects of clinical research for which initial fund5 ing was provided prior to the date of the enactment of this

6 Act. With respect to the inclusion of women and minorities

7 as subjects in clinical research conducted or supported by

8 the National Institutes of Health, any policies of the Sec9 retary of Health and Human Services regarding such inclu10 sion that are in effect on the day before the date of the enact11 ment of this Act shall continue to apply to the projects re12 ferred to in the preceding sentence.

13 PART II—OFFICE OF RESEARCH ON WOMEN’S

14 HEALTH

15 SEC. 141. ESTABLISHMENT.

16 (a) IN GENERAL.—Title IV of the Public Health Serv17 ice Act, as amended by section 2 of Public Law 101–613,

18 is amended—

19 (1) by redesignating section 486 as section 485A;

20 (2) by redesignating parts F through H as parts

21 G through I, respectively; and

22 (3) by inserting after part E the following new

23 part:
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1 ‘‘PART F—RESEARCH ON WOMEN’S HEALTH

2 ‘‘SEC. 486. OFFICE OF RESEARCH ON WOMEN’S HEALTH.

3 ‘‘(a) ESTABLISHMENT.—There is established within

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

5 the Office of Research on Women’s Health (in this part re6 ferred to as the ‘Office’). The Office shall be headed by a

7 director, who shall be appointed by the Director of NIH.

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

9 ‘‘(1) identify projects of research on women’s

10 health that should be conducted or supported by the

11 national research institutes;

12 ‘‘(2) identify multidisciplinary research relating

13 to research on women’s health that should be so con14 ducted or supported;

15 ‘‘(3) carry out paragraphs (1) and (2) with re16 spect to the aging process in women, with priority

17 given to menopause;

18 ‘‘(4) promote coordination and collaboration

19 among entities conducting research identified under

20 any of paragraphs (1) through (3);

21 ‘‘(5) encourage the conduct of such research by

22 entities receiving funds from the national research in23 stitutes;

24 ‘‘(6) recommend an agenda for conducting and

25 supporting such research;
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1 ‘‘(7) promote the sufficient allocation of the re2 sources of the national research institutes for conduct3 ing and supporting such research;

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

5 with respect to the inclusion of women as subjects in

6 clinical research; and

7 ‘‘(9) prepare the report required in section 486B.

8 ‘‘(c) COORDINATING COMMITTEE.—

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

10 of the Office shall establish a committee to be known

11 as the Coordinating Committee on Research on Wom12 en’s Health (hereafter in this subsection referred to as

13 the ‘Coordinating Committee’).

14 ‘‘(2) The Coordinating Committee shall be com15 posed of the Directors of the national research insti16 tutes (or the designees of the Directors).

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

18 chair of the Coordinating Committee.

19 ‘‘(4) With respect to research on women’s health,

20 the Coordinating Committee shall assist the Director

21 of the Office in—

22 ‘‘(A) identifying the need for such research,

23 and making an estimate each fiscal year of the

24 funds needed to adequately support the research;
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1 ‘‘(B) identifying needs regarding the coordi2 nation of research activities, including intra3 mural and extramural multidisciplinary activi4 ties;

5 ‘‘(C) supporting the development of meth6 odologies to determine the circumstances in

7 which obtaining data specific to women (includ8 ing data relating to the age of women and the

9 membership of women in ethnic or racial

10 groups) is an appropriate function of clinical

11 trials of treatments and therapies;

12 ‘‘(D) supporting the development and ex13 pansion of clinical trials of treatments and

14 therapies for which obtaining such data has been

15 determined to be an appropriate function; and

16 ‘‘(E) encouraging the national research in17 stitutes to conduct and support such research, in18 cluding such clinical trials.

19 ‘‘(d) ADVISORY COMMITTEE.—

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

21 of the Office shall establish an advisory committee to

22 be known as the Advisory Committee on Research on

23 Women’s Health (hereafter in this subsection referred

24 to as the ‘Advisory Committee’).
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1 ‘‘(2)(A) The Advisory Committee shall be com2 posed of no fewer than 12, and not more than 18 in3 dividuals, who are not officers or employees of the

4 Federal Government. The Director of the Office shall

5 make appointments to the Advisory Committee from

6 among physicians, practitioners, scientists, and other

7 health professionals, whose clinical practice, research

8 specialization, or professional expertise includes a sig9 nificant focus on research on women’s health. A ma10 jority of the members of the Advisory Committee shall

11 be women.

12 ‘‘(B) Members of the Advisory Committee shall

13 receive compensation for each day engaged in carry14 ing out the duties of the Committee, including time

15 engaged in traveling for purposes of such duties. Such

16 compensation may not be provided in an amount in

17 excess of the maximum rate of basic pay payable for

18 GS–18 of the General Schedule.

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

20 chair of the Advisory Committee.

21 ‘‘(4) The Advisory Committee shall—

22 ‘‘(A) advise the Director of the Office on ap23 propriate research activities to be undertaken by

24 the national research institutes with respect to—

25 ‘‘(i) research on women’s health;
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1 ‘‘(ii) research on gender differences in

2 clinical drug trials, including responses to

3 pharmacological drugs;

4 ‘‘(iii) research on gender differences in

5 disease etiology, course, and treatment;

6 ‘‘(iv) research on obstetrical and gyne7 cological health conditions, diseases, and

8 treatments; and

9 ‘‘(v) research on women’s health condi10 tions which require a multidisciplinary ap11 proach;

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

13 such research;

14 ‘‘(C) provide recommendations to such Di15 rector regarding activities of the Office (includ16 ing recommendations on the development of the

17 methodologies described in subsection (c)(4)(C)

18 and recommendations on priorities in carrying

19 out research described in subparagraph (A)); and

20 ‘‘(D) assist in monitoring compliance with

21 section 492B regarding the inclusion of women

22 in clinical research.

23 ‘‘(5)(A) The Advisory Committee shall prepare a

24 biennial report describing the activities of the Com-
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1 mittee, including findings made by the Committee re2 garding—

3 ‘‘(i) compliance with section 492B;

4 ‘‘(ii) the extent of expenditures made for re5 search on women’s health by the agencies of the

6 National Institutes of Health; and

7 ‘‘(iii) the level of funding needed for such

8 research.

9 ‘‘(B) The report required in subparagraph (A)

10 shall be submitted to the Director of NIH for inclu11 sion in the report required in section 403.

12 ‘‘(e) REPRESENTATION OF WOMEN AMONG RESEARCH13 ERS.—The Secretary, acting through the Assistant Sec14 retary for Personnel and in collaboration with the Director

15 of the Office, shall determine the extent to which women

16 are represented among senior physicians and scientists of

17 the national research institutes and among physicians and

18 scientists conducting research with funds provided by such

19 institutes, and as appropriate, carry out activities to in20 crease the extent of such representation.

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

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

23 respect to women of all age, ethnic, and racial groups,

24 means all diseases, disorders, and conditions (includ25 ing with respect to mental health)—
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1 ‘‘(A) unique to, more serious, or more prev2 alent in women;

3 ‘‘(B) for which the factors of medical risk or

4 types of medical intervention are different for

5 women, or for which it is unknown whether such

6 factors or types are different for women; or

7 ‘‘(C) with respect to which there has been

8 insufficient clinical research involving women as

9 subjects or insufficient clinical data on women.

10 ‘‘(2) The term ‘research on women’s health’

11 means research on women’s health conditions, includ12 ing research on preventing such conditions.

13 ‘‘SEC. 486A. NATIONAL DATA SYSTEM AND CLEARING14 HOUSE ON RESEARCH ON WOMEN’S HEALTH.

15 ‘‘(a) DATA SYSTEM.—

16 ‘‘(1) The Director of NIH, in consultation with

17 the Director of the Office, shall establish a data sys18 tem for the collection, storage, analysis, retrieval, and

19 dissemination of information regarding research on

20 women’s health that is conducted or supported by the

21 national research institutes. Information from the

22 data system shall be available through information

23 systems available to health care professionals and

24 providers, researchers, and members of the public.
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1 ‘‘(2) The data system established under para2 graph (1) shall include a registry of clinical trials of

3 experimental treatments that have been developed for

4 research on women’s health. Such registry shall in5 clude information on subject eligibility criteria, sex,

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

7 or sites. Principal investigators of such clinical trials

8 shall provide this information to the registry within

9 30 days after it is available. Once a trial has been

10 completed, the principal investigator shall provide the

11 registry with information pertaining to the results,

12 including potential toxicities or adverse effects associ13 ated with the experimental treatment or treatments

14 evaluated.

15 ‘‘(b) CLEARINGHOUSE.—The Director of NIH, in con16 sultation with the Director of the Office and with the Na17 tional Library of Medicine, shall establish, maintain, and

18 operate a program to provide information on research and

19 prevention activities of the national research institutes that

20 relate to research on women’s health.

21 ‘‘SEC. 486B. BIENNIAL REPORT.

22 ‘‘(a) IN GENERAL.—With respect to research on wom23 en’s health, the Director of the Office shall, not later than

24 February 1, 1994, and biennially thereafter, prepare a re25 port—
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1 ‘‘(1) describing and evaluating the progress made

2 during the preceding 2 fiscal years in research and

3 treatment conducted or supported by the National In4 stitutes of Health;

5 ‘‘(2) describing and analyzing the professional

6 status of women physicians and scientists of such In7 stitutes, including the identification of problems and

8 barriers regarding advancements;

9 ‘‘(3) summarizing and analyzing expenditures

10 made by the agencies of such Institutes (and by such

11 Office) during the preceding 2 fiscal years; and

12 ‘‘(4) making such recommendations for legisla13 tive and administrative initiatives as the Director of

14 the Office determines to be appropriate.

15 ‘‘(b) INCLUSION IN BIENNIAL REPORT OF DIRECTOR

16 OF NIH.—The Director of the Office shall submit each re17 port prepared under subsection (a) to the Director of NIH

18 for inclusion in the report submitted to the President and

19 the Congress under section 403.’’.

20 (b) REQUIREMENT OF SUFFICIENT ALLOCATION OF

21 RESOURCES OF INSTITUTES.—Section 402(b) of the Public

22 Health Service Act (42 U.S.C. 282(b)) is amended—

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

24 the semicolon at the end;
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1 (2) in paragraph (11), by striking the period at

2 the end and inserting ‘‘; and’’; and

3 (3) by inserting after paragraph (11) the follow4 ing new paragraph:

5 ‘‘(12) after consultation with the Director of the

6 Office of Research on Women’s Health, shall ensure

7 that resources of the National Institutes of Health are

8 sufficiently allocated for projects of research on wom9 en’s health that are identified under section 486(b).’’.

10 PART III—OFFICE OF RESEARCH ON MINORITY

11 HEALTH

12 SEC. 151. ESTABLISHMENT.

13 Part A of title IV of the Public Health Service Act

14 (42 U.S.C. 281 et seq.) is amended by adding at the end

15 the following new section:

16 ‘‘OFFICE OF RESEARCH ON MINORITY HEALTH

17 ‘‘SEC. 403A. (a) ESTABLISHMENT.—There is estab18 lished within the Office of the Director of NIH an office

19 to be known as the Office of Research on Minority Health

20 (in this section referred to as the ‘Office’). The Office shall

21 be headed by a director, who shall be appointed by the Di22 rector of NIH.

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

24 ‘‘(1) identify projects of research on minority

25 health that should be conducted or supported by the

26 national research institutes;
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1 ‘‘(2) identify multidisciplinary research relating

2 to research on minority health that should be so con3 ducted or supported;

4 ‘‘(3) promote coordination and collaboration

5 among entities conducting research identified under

6 paragraph (1) or (2);

7 ‘‘(4) encourage the conduct of such research by

8 entities receiving funds from the national research in9 stitutes;

10 ‘‘(5) recommend an agenda for conducting and

11 supporting such research;

12 ‘‘(6) promote the sufficient allocation of the re13 sources of the national research institutes for conduct14 ing and supporting such research; and

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

16 with respect to the inclusion of members of minority

17 groups as subjects in clinical research.’’.

18 Subtitle C—Scientific Integrity

19 SEC. 161. ESTABLISHMENT OF OFFICE OF SCIENTIFIC IN20 TEGRITY.

21 (a) IN GENERAL.—Section 493 of the Public Health

22 Service Act (42 U.S.C. 289b) is amended to read as follows:

23 ‘‘OFFICE OF SCIENTIFIC INTEGRITY

24 ‘‘SEC. 493. (a) ESTABLISHMENT.—

25 ‘‘(1) IN GENERAL.—Not later than 90 days after

26 the date of enactment of this section, the Secretary
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1 shall establish an office to be known as the Office of

2 Scientific Integrity (hereafter referred to in this sec3 tion as the ‘Office’), which shall be established as an

4 independent entity in the Department of Health and

5 Human Services.

6 ‘‘(2) DIRECTOR.—The Office shall be headed by

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

8 be experienced and specially trained in the conduct of

9 research, and have experience in the conduct of inves10 tigations of scientific misconduct. The Secretary shall

11 carry out this section acting through the Director of

12 the Office. The Director shall report to the Secretary.

13 ‘‘(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS

14 CONDITION OF FUNDING FOR RESEARCH.—The Secretary

15 shall by regulation require that each entity that applies for

16 a grant, contract, or cooperative agreement under this Act

17 for any project or program that involves the conduct of bio18 medical or behavioral research submit in or with its appli19 cation for such grant, contract, or cooperative agreement

20 assurances satisfactory to the Secretary that such entity—

21 ‘‘(1) has established (in accordance with regula22 tions which the Secretary shall prescribe) an adminis23 trative process to review reports of scientific mis24 conduct in connection with biomedical and behavioral
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1 research conducted at or sponsored by such entity;

2 and

3 ‘‘(2) will report to the Director any investigation

4 of alleged scientific misconduct in connection with

5 projects for which funds have been made available

6 under this Act that appears substantial.

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

8 Secretary shall establish by regulation a process to be fol9 lowed by the Director for the prompt and appropriate—

10 ‘‘(1) response to information provided to the Di11 rector respecting scientific misconduct in connection

12 with projects for which funds have been made avail13 able under this Act;

14 ‘‘(2) receipt of reports by the Director of such in15 formation from recipients of funds under this Act;

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

17 and

18 ‘‘(4) taking of other actions, including appro19 priate remedies, with respect to such misconduct.

20 ‘‘(d) MONITORING BY DIRECTOR.—The Secretary shall

21 by regulation establish procedures for the Director to mon22 itor administrative processes and investigations that have

23 been established or carried out under this section.

24 ‘‘(e) EFFECT ON PRESENT INVESTIGATIONS.—Nothing

25 in this section shall affect investigations which have been
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1 or will be commenced prior to the promulgation of final

2 regulations under this section.’’.

3 (b) ESTABLISHMENT OF DEFINITION OF SCIENTIFIC

4 MISCONDUCT.—Not later than 90 days after the date on

5 which the report required under section 152(d) is submitted

6 to the Secretary of Health and Human Services, such Sec7 retary shall by regulation establish a definition for the term

8 ‘‘scientific misconduct’’ for purposes of section 493 of the

9 Public Health Service Act, as amended by subsection (a)

10 of this section.

11 SEC. 162. COMMISSION ON SCIENTIFIC INTEGRITY.

12 (a) IN GENERAL.—The Secretary of Health and

13 Human Services shall establish a commission to be known

14 as the Commission on Scientific Integrity (in this section

15 referred to as the ‘‘Commission’’).

16 (b) DUTIES.—The Commission shall develop rec17 ommendations for the Secretary of Health and Human

18 Services on the administration of section 493 of the Public

19 Health Service Act (as amended and added by section 161

20 of this Act).

21 (c) COMPOSITION.—The Commission shall be composed

22 of 12 members to be appointed by the Secretary of Health

23 and Human Services from among individuals who are not

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

25 appointed to the Commission—
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1 (1) three shall be scientists with substantial ac2 complishments in biomedical or behavioral research;

3 (2) three shall be individuals with experience in

4 investigating allegations of misconduct with respect to

5 scientific research;

6 (3) three shall be representatives of institutions

7 of higher education at which biomedical or behavioral

8 research is conducted; and

9 (4) three shall be individuals who are not de10 scribed in paragraphs (1), (2), or (3), at least one of

11 whom shall be an attorney and at least one of whom

12 shall be an ethicist.

13 (d) COMPENSATION.—Members of the Commission

14 shall receive compensation for each day engaged in carrying

15 out the duties of the Commission, including time engaged

16 in traveling for purposes of such duties. Such compensation

17 may not be provided in an amount in excess of the maxi18 mum rate of basic pay payable for GS–18 of the General

19 Schedule.

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

21 of enactment of this section, the Commission shall prepare

22 and submit to the Secretary of Health and Human Services,

23 the Committee on Energy and Commerce of the House of

24 Representatives, and the Committee on Labor and Human
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1 Resources of the Senate, a report containing the rec2 ommendations developed under subsection (b).

3 SEC. 163. PROTECTION OF WHISTLEBLOWERS.

4 Section 493 of the Public Health Service Act, as

5 amended by section 161 of this Act, is amended by adding

6 at the end the following new subsection:

7 ‘‘(f) PROTECTION OF WHISTLEBLOWERS.—

8 ‘‘(1) IN GENERAL.—In the case of any entity re9 quired to establish administrative processes under

10 subsection (b), the Secretary shall by regulation estab11 lish standards for preventing, and for responding to

12 the occurrence of retaliation by such entity, its offi13 cials or agents, against an employee in the terms and

14 conditions of employment in response to the employee

15 having in good faith—

16 ‘‘(A) made an allegation that the entity, its

17 officials or agents, has engaged in or failed to

18 adequately respond to an allegation of scientific

19 misconduct; or

20 ‘‘(B) cooperated with an investigation of

21 such an allegation.

22 ‘‘(2) MONITORING BY SECRETARY.—The Sec23 retary shall establish by regulation procedures for the

24 Director to monitor the implementation of the stand25 ards established by an entity under paragraph (1) for
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1 the purpose of determining whether the procedures

2 have been established, and are being utilized, in ac3 cordance with the standards established under such

4 paragraph.

5 ‘‘(3) NONCOMPLIANCE.—The Secretary shall by

6 regulation establish remedies for noncompliance by an

7 entity, its officials or agents, which has engaged in re8 taliation in violation of the standards established

9 under paragraph (1). Such remedies may include ter10 mination of funding provided by the Secretary for

11 such project or recovery of funding being provided by

12 the Secretary for such project, or other actions as ap13 propriate.

14 ‘‘(4) FINAL RULE FOR REGULATIONS.—The Sec15 retary shall issue a final rule for the regulations re16 quired in paragraph (1) not later than 180 days after

17 the date of the enactment of the National Institutes of

18 Health Revitalization Act of 1993.

19 ‘‘(5) REQUIRED AGREEMENTS.—For any fiscal

20 year beginning after the date on which the regulations

21 required in paragraph (1) are issued, the Secretary

22 may not provide a grant, cooperative agreement, or

23 contract under this Act for biomedical or behavioral

24 research unless the entity seeking such financial as25 sistance agrees that the entity—
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1 ‘‘(A) will maintain the procedures described

2 in the regulations; and

3 ‘‘(B) will otherwise be subject to the regula4 tions.’’.

5 SEC. 164. REQUIREMENT OF REGULATIONS REGARDING

6 PROTECTION AGAINST FINANCIAL CON7 FLICTS OF INTEREST IN CERTAIN PROJECTS

8 OF RESEARCH.

9 Part H of title IV of the Public Health Service Act,

10 as redesignated by section 141(a)(2) of this Act, is amended

11 by inserting after section 493 the following new section:

12 ‘‘PROTECTION AGAINST FINANCIAL CONFLICTS OF INTEREST

13 IN CERTAIN PROJECTS OF RESEARCH

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

15 ‘‘(1) IN GENERAL.—The Secretary shall define by

16 regulation, the specific circumstances that constitute

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

18 part of an entity or individual that will, or may be

19 reasonably expected to, create a bias in favor of ob20 taining results in such project that are consistent

21 with such financial interest. Such definition shall

22 apply uniformly to each entity or individual conduct23 ing a research project under this Act. In the case of

24 any entity or individual receiving assistance from the

25 Secretary for a project of research described in para26 graph (2), the Secretary shall by regulation establish
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1 standards for responding to, including managing, re2 ducing, or eliminating, the existence of such a finan3 cial interest. The entity may adopt individualized

4 procedures for implementing the standards.

5 ‘‘(2) RELEVANT PROJECTS.—A project of re6 search referred to in paragraph (1) is a project of

7 clinical research whose purpose is to evaluate the safe8 ty or effectiveness of a drug, medical device, or treat9 ment and for which such entity is receiving assistance

10 from the Secretary.

11 ‘‘(3) IDENTIFYING AND REPORTING TO THE DI12 RECTOR.—The Secretary shall ensure that the stand13 ards established under paragraph (1) specify that as

14 a condition of receiving assistance from the Secretary

15 for the project involved, an entity described in such

16 subsection is required—

17 ‘‘(A) to have in effect at the time the entity

18 applies for the assistance and throughout the pe19 riod during which the assistance is received, a

20 process for identifying such financial interests as

21 defined in paragraph (1) that exist regarding the

22 project; and

23 ‘‘(B) to report to the Director such financial

24 interest as defined in paragraph (1) identified

25 by the entity and how any such financial inter-
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1 est identified by the entity will be managed or

2 eliminated such that the project in question will

3 be protected from bias that may stem from such

4 financial interest.

5 ‘‘(4) MONITORING OF PROCESS.—The Secretary

6 shall monitor the establishment and conduct of the

7 process established by an entity pursuant to para8 graph (1).

9 ‘‘(5) RESPONSE.—In any case in which the Sec10 retary determines that an entity has failed to comply

11 with paragraph (3) regarding a project of research

12 described in paragraph (1), the Secretary—

13 ‘‘(A) shall require that, as a condition of re14 ceiving assistance, the entity disclose the exist15 ence of a financial interest as defined in para16 graph (1) in each public presentation of the re17 sults of such project; and

18 ‘‘(B) may take such other actions as the

19 Secretary determines to be appropriate.

20 ‘‘(6) DEFINITION.—As used in this section:

21 ‘‘(A) The term ‘financial interest’ includes

22 the receipt of consulting fees or honoraria and

23 the ownership of stock or equity.
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1 ‘‘(B) The term ‘assistance’, with respect to

2 conducting a project of research, means a grant,

3 contract, or cooperative agreement.

4 ‘‘(b) FINAL RULE FOR REGULATIONS.—The Secretary

5 shall issue a final rule for the regulations required in sub6 section (a) not later than 180 days after the date of the

7 enactment of the National Institutes of Health Revitaliza8 tion Act of 1993.’’.

9 SEC. 165. EFFECTIVE DATES.

10 (a) IN GENERAL.—The amendments made by this sub11 title shall become effective on the date that occurs 180 days

12 after the date on which the final rule required under section

13 493(f)(4) of the Public Health Service Act, as amended by

14 sections 161 and 163, is published in the Federal Register.

15 (b) AGREEMENTS AS A CONDITION OF FUNDING.—The

16 requirements of subsection (f)(5) of section 493 of the Public

17 Health Service Act, as amended by sections 161 and 163,

18 with respect to agreements as a condition of funding shall

19 not be effective in the case of projects of research for which

20 initial funding under the Public Health Service Act was

21 provided prior to the effective date described in subsection

22 (a).
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1 TITLE II—NATIONAL INSTITUTES

2 OF HEALTH IN GENERAL

3 SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINA4 TION.

5 Section 402(f) of the Public Health Service Act (42

6 U.S.C. 282(f)) is amended by striking ‘‘other public and

7 private entities.’’ and all that follows through the end and

8 inserting ‘‘other public and private entities, including ele9 mentary, secondary, and post-secondary schools. The Asso10 ciate Director shall—

11 ‘‘(1) annually review the efficacy of existing poli12 cies and techniques used by the national research in13 stitutes to disseminate the results of disease preven14 tion and behavioral research programs;

15 ‘‘(2) recommend, coordinate, and oversee the

16 modification or reconstruction of such policies and

17 techniques to ensure maximum dissemination, using

18 advanced technologies to the maximum extent prac19 ticable, of research results to such entities; and

20 ‘‘(3) annually prepare and submit to the Direc21 tor of NIH a report concerning the prevention and

22 dissemination activities undertaken by the Associate

23 Director, including—

24 ‘‘(A) a summary of the Associate Director’s

25 review of existing dissemination policies and
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1 techniques together with a detailed statement

2 concerning any modification or restructuring, or

3 recommendations for modification or restructur4 ing, of such policies and techniques; and

5 ‘‘(B) a detailed statement of the expendi6 tures made for the prevention and dissemination

7 activities reported on and the personnel used in

8 connection with such activities.’’.

9 SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARD10 ING CERTAIN STATES AND RESEARCHERS.

11 Section 402 of the Public Health Service Act (42

12 U.S.C. 282) is amended by adding at the end the following

13 new subsection:

14 ‘‘(g)(1)(A) In the case of entities described in subpara15 graph (B), the Director of NIH, acting through the Director

16 of the National Center for Research Resources, shall estab17 lish a program to enhance the competitiveness of such enti18 ties in obtaining funds from the national research institutes

19 for conducting biomedical and behavioral research.

20 ‘‘(B) The entities referred to in subparagraph (A) are

21 entities that conduct biomedical and behavioral research

22 and are located in a State in which the aggregate success

23 rate for applications to the national research institutes for

24 assistance for such research by the entities in the State has

25 historically constituted a low success rate of obtaining such
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1 funds, relative to such aggregate rate for such entities in

2 other States.

3 ‘‘(C) With respect to enhancing competitiveness for

4 purposes of subparagraph (A), the Director of NIH, in car5 rying out the program established under such subpara6 graph, may—

7 ‘‘(i) provide technical assistance to the entities

8 involved, including technical assistance in the prepa9 ration of applications for obtaining funds from the

10 national research institutes;

11 ‘‘(ii) assist the entities in developing a plan for

12 biomedical or behavioral research proposals; and

13 ‘‘(iii) assist the entities in implementing such

14 plan.

15 ‘‘(2) The Director of NIH shall establish a program

16 of supporting projects of biomedical or behavioral research

17 whose principal researchers are individuals who have not

18 previously served as the principal researchers of such

19 projects supported by the Director.’’.

20 SEC. 203. CHILDREN’S VACCINE INITIATIVE.

21 Part A of title IV of the Public Health Service Act

22 (42 U.S.C. 281 et seq.) is amended by adding at the end

23 the following new section:

24 ‘‘CHILDREN’S VACCINE INITIATIVE

25 ‘‘SEC. 404. (a) DEVELOPMENT OF NEW VACCINES.—

26 The Secretary, in consulation with the Director of the Na-
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1 tional Vaccine Program under title XXI and acting through

2 the Directors of the National Institute for Allergy and Infec3 tious Diseases, the National Institute for Child Health and

4 Human Development, the National Institute for Aging, and

5 other public and private programs, shall carry out activi6 ties, which shall be consistent with the global Children’s

7 Vaccine Initiative, to develop affordable new and improved

8 vaccines to be used in the United States and in the develop9 ing world that will increase the efficacy and efficiency of

10 the prevention of infectious diseases. In carrying out such

11 activities, the Secretary shall, to the extent practicable, de12 velop and make available vaccines that require fewer con13 tacts to deliver, that can be given early in life, that provide

14 long lasting protection, that obviate refrigeration, needles

15 and syringes, and that protect against a larger number of

16 diseases.

17 ‘‘(b) REPORT.—In the report required in section 2104,

18 the Secretary, acting through the Director of the National

19 Vaccine Program under title XXI, shall include information

20 with respect to activities and the progress made in imple21 menting the provisions of this section and achieving its

22 goals.

23 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—In addi24 tion to any other amounts authorized to be appropriated

25 for activities of the type described in this section, there are
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1 authorized to be appropriated to carry out this section

2 $20,000,000 for fiscal year 1994, and such sums as may

3 be necessary for each of the fiscal years 1995 and 1996.’’.

4 SEC. 204. PLAN FOR USE OF ANIMALS IN RESEARCH.

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

6 Health Service Act, as amended by section 203 of this Act,

7 is amended by adding at the end the following new section:

8 ‘‘PLAN FOR USE OF ANIMALS IN RESEARCH

9 ‘‘SEC. 404A. (a) The Director of NIH, after consulta10 tion with the committee established under subsection (e),

11 shall prepare a plan—

12 ‘‘(1) for the National Institutes of Health to con13 duct or support research into—

14 ‘‘(A) methods of biomedical research and ex15 perimentation that do not require the use of ani16 mals;

17 ‘‘(B) methods of such research and experi18 mentation that reduce the number of animals

19 used in such research; and

20 ‘‘(C) methods of such research and experi21 mentation that produce less pain and distress in

22 such animals;

23 ‘‘(2) for establishing the validity and reliability

24 of the methods described in paragraph (1);
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1 ‘‘(3) for encouraging the acceptance by the sci2 entific community of such methods that have been

3 found to be valid and reliable; and

4 ‘‘(4) for training scientists in the use of such

5 methods that have been found to be valid and reliable.

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

7 NIH shall submit to the Committee on Energy and Com8 merce of the House of Representatives, and to the Committee

9 on Labor and Human Resources of the Senate, the plan

10 required in subsection (a) and shall begin implementation

11 of the plan.

12 ‘‘(c) The Director of NIH shall periodically review,

13 and as appropriate, make revisions in the plan required

14 under subsection (a). A description of any revision made

15 in the plan shall be included in the first biennial report

16 under section 403 that is submitted after the revision is

17 made.

18 ‘‘(d) The Director of NIH shall take such actions as

19 may be appropriate to convey to scientists and others who

20 use animals in biomedical or behavioral research or experi21 mentation information respecting the methods found to be

22 valid and reliable under subsection (a)(2).

23 ‘‘(e)(1) The Director of NIH shall establish within the

24 National Institutes of Health a committee to be known as

25 the Interagency Coordinating Committee on the Use of Ani-
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1 mals in Research (hereafter in this subsection referred to

2 as the ‘Committee’).

3 ‘‘(2) The Committee shall provide advice to the Direc4 tor of NIH on the preparation of the plan required in sub5 section (a).

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

7 ‘‘(A) the Directors of each of the national re8 search institutes and the Director of the Center for

9 Research Resources (or the designees of such Direc10 tors); and

11 ‘‘(B) representatives of the Environmental Pro12 tection Agency, the Food and Drug Administration,

13 the Consumer Product Safety Commission, the Na14 tional Science Foundation, and such additional agen15 cies as the Director of NIH determines to be appro16 priate.’’.

17 (b) CONFORMING AMENDMENT.—Section 4 of the

18 Health Research Extension Act of 1985 (Public Law 99–

19 158; 99 Stat. 880) is repealed.
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1 SEC. 205. INCREASED PARTICIPATION OF WOMEN AND MEM2 BERS OF UNDERREPRESENTED MINORITIES

3 IN FIELDS OF BIOMEDICAL AND BEHAVIORAL

4 RESEARCH.

5 Section 402 of the Public Health Service Act, as

6 amended by section 202 of this Act, is amended by adding

7 at the end the following new subsection:

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

9 and the Directors of the agencies of the National Institutes

10 of Health, may conduct and support programs for research,

11 research training, recruitment, and other activities to pro12 vide for an increase in the number of women and members

13 of underrepresented minority groups in the fields of bio14 medical and behavioral research.’’.

15 SEC. 206. REQUIREMENTS REGARDING SURVEYS OF SEX16 UAL BEHAVIOR.

17 Part A of title IV of the Public Health Service Act,

18 as amended by section 204 of this Act, is amended by add19 ing at the end the following new section:

20 ‘‘REQUIREMENTS REGARDING SURVEYS OF SEXUAL

21 BEHAVIOR

22 ‘‘SEC. 404B. With respect to any survey of human

23 sexual behavior proposed to be conducted or supported

24 through the National Institutes of Health, the survey may

25 not be carried out unless—
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1 ‘‘(1) the proposal has undergone review in ac2 cordance with any applicable requirements of sections

3 491 and 492; and

4 ‘‘(2) the Secretary, in accordance with section

5 492A, makes a determination that the information ex6 pected to be obtained through the survey will assist—

7 ‘‘(A) in reducing the incidence of sexually

8 transmitted diseases, the incidence of infection

9 with the human immunodeficiency virus, or the

10 incidence of any other infectious disease; or

11 ‘‘(B) in improving reproductive health or

12 other conditions of health.’’.

13 SEC. 207. DISCRETIONARY FUND OF DIRECTOR OF NA14 TIONAL INSTITUTES OF HEALTH.

15 Section 402 of the Public Health Service Act, as

16 amended by section 205 of this Act, is amended by adding

17 at the end the following new subsection:

18 ‘‘(i)(1) There is established a fund, consisting of

19 amounts appropriated under paragraph (3) and made

20 available for the fund, for use by the Director of NIH to

21 carry out the activities authorized in this Act for the Na22 tional Institutes of Health. The purposes for which such

23 fund may be expended include—

24 ‘‘(A) providing for research on matters that have

25 not received significant funding relative to other mat-
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1 ters, responding to new issues and scientific emer2 gencies, and acting on research opportunities of high

3 priority;

4 ‘‘(B) supporting research that is not exclusively

5 within the authority of any single agency of such In6 stitutes; and

7 ‘‘(C) purchasing or renting equipment and quar8 ters for activities of such Institutes.

9 ‘‘(2) Not later than February 10 of each fiscal year,

10 the Secretary shall submit to the Committee on Energy and

11 Commerce of the House of Representatives, and to the Com12 mittee on Labor and Human Resources of the Senate, a

13 report describing the activities undertaken and expenditures

14 made under this section during the preceding fiscal year.

15 The report may contain such comments of the Secretary re16 garding this section as the Secretary determines to be ap17 propriate.

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

19 there are authorized to be appropriated $25,000,000 for fis20 cal year 1994, and such sums as may be necessary for each

21 of the fiscal years 1995 and 1996.’’.

22 SEC. 208. MISCELLANEOUS PROVISIONS.

23 (a) TERM OF OFFICE FOR MEMBERS OF ADVISORY

24 COUNCILS.—Section 406(c) of the Public Health Service

25 Act (42 U.S.C. 284a(c)) is amended in the second sentence
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1 by striking ‘‘until a successor has been appointed’’ and in2 serting the following: ‘‘for 180 days after the date of such

3 expiration’’.

4 (b) LITERACY REQUIREMENTS.—Section 402(e) of the

5 Public Health Service Act (42 U.S.C. 282(e)) is amended—

6 (1) in paragraph (3), by striking ‘‘and’’ at the

7 end;

8 (2) in paragraph (4), by striking the period and

9 inserting ‘‘; and’’; and

10 (3) by adding at the end thereof the following

11 new paragraph:

12 ‘‘(5) ensure that, after January 1, 1994, at least

13 one-half of all new or revised health education and

14 promotion materials developed or funded by the Na15 tional Institutes of Health is in a form that does not

16 exceed a level of functional literacy, as defined in the

17 National Literacy Act of 1991 (Public Law 102–

18 73).’’.

19 (c) DAY CARE REGARDING CHILDREN OF EMPLOY20 EES.—Section 402 of the Public Health Service Act, as

21 amended by section 207 of this Act, is amended by adding

22 at the end the following new subsection:

23 ‘‘(i)(1) The Director of NIH may establish a program

24 to provide day care service for the employees of the National

25 Institutes of Health similar to those services provided by
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1 other Federal agencies (including the availability of day

2 care service on a 24-hour-a-day basis).

3 ‘‘(2) Any day care provider at the National Institutes

4 of Health shall establish a sliding scale of fees that takes

5 into consideration the income and needs of the employee.

6 ‘‘(3) For purposes regarding the provision of day care

7 service, the Director of NIH may enter into rental or lease

8 purchase agreements.’’.

9 TITLE III—GENERAL PROVI10 SIONS RESPECTING NA11 TIONAL RESEARCH INSTI12 TUTES

13 SEC. 301. APPOINTMENT AND AUTHORITY OF DIRECTORS

14 OF NATIONAL RESEARCH INSTITUTES.

15 (a) ESTABLISHMENT OF GENERAL AUTHORITY RE16 GARDING DIRECT FUNDING.—

17 (1) IN GENERAL.—Section 405(b)(2) of the Pub18 lic Health Service Act (42 U.S.C. 284(b)(2)) is

19 amended—

20 (A) in subparagraph (A), by striking ‘‘and’’

21 after the semicolon at the end;

22 (B) in subparagraph (B), by striking the

23 period at the end and inserting ‘‘; and’’; and

24 (C) by adding at the end the following new

25 subparagraph:
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1 ‘‘(C) shall receive from the President and the Of2 fice of Management and Budget directly all funds ap3 propriated by the Congress for obligation and expend4 iture by the Institute.’’.

5 (2) CONFORMING AMENDMENT.—Section

6 413(b)(9) of the Public Health Service Act (42 U.S.C.

7 285a–2(b)(9)) is amended—

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

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

10 that follows and inserting ‘‘advisory council.’’.

11 (b) APPOINTMENT AND DURATION OF TECHNICAL AND

12 SCIENTIFIC PEER REVIEW GROUPS.—Section 405(c) of the

13 Public Health Service Act (42 U.S.C. 284(c)) is amended—

14 (1) by amending paragraph (3) to read as fol15 lows:

16 ‘‘(3) may, in consultation with the advisory

17 council for the Institute and with the approval of the

18 Director of NIH—

19 ‘‘(A) establish technical and scientific peer

20 review groups in addition to those appointed

21 under section 402(b)(6); and

22 ‘‘(B) appoint the members of peer review

23 groups established under subparagraph (A);

24 and’’; and
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1 (2) by adding after and below paragraph (4) the

2 following:

3 ‘‘The Federal Advisory Committee Act shall not apply to

4 the duration of a peer review group appointed under para5 graph (3).’’.

6 SEC. 302. PROGRAM OF RESEARCH ON OSTEOPOROSIS,

7 PAGET’S DISEASE, AND RELATED BONE DIS8 ORDERS.

9 Part B of title IV of the Public Health Service Act

10 (42 U.S.C. 284 et seq.), as amended by section 121(b) of

11 Public Law 102–321 (106 Stat. 358), is amended by adding

12 at the end the following new section:

13 ‘‘RESEARCH ON OSTEOPOROSIS, PAGET’S DISEASE, AND

14 RELATED BONE DISORDERS

15 ‘‘SEC. 410. (a) ESTABLISHMENT.—The Directors of the

16 National Institute of Arthritis and Musculoskeletal and

17 Skin Diseases, the National Institute on Aging, and the Na18 tional Institute of Diabetes, Digestive and Kidney Diseases,

19 shall expand and intensify the programs of such Institutes

20 with respect to research and related activities concerning

21 osteoporosis, Paget’s disease, and related bone disorders.

22 ‘‘(b) COORDINATION.—The Directors referred to in sub23 section (a) shall jointly coordinate the programs referred

24 to in such subsection and consult with the Arthritis and

25 Musculoskeletal Diseases Interagency Coordinating Com26 mittee and the Interagency Task Force on Aging Research.
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1 ‘‘(c) INFORMATION CLEARINGHOUSE.—

2 ‘‘(1) IN GENERAL.—In order to assist in carry3 ing out the purpose described in subsection (a), the

4 Director of NIH shall provide for the establishment of

5 an information clearinghouse on osteoporosis and re6 lated bone disorders to facilitate and enhance knowl7 edge and understanding on the part of health profes8 sionals, patients, and the public through the effective

9 dissemination of information.

10 ‘‘(2) ESTABLISHMENT THROUGH GRANT OR CON11 TRACT.—For the purpose of carrying out paragraph

12 (1), the Director of NIH shall enter into a grant, co13 operative agreement, or contract with a nonprofit pri14 vate entity involved in activities regarding the pre15 vention and control of osteoporosis and related bone

16 disorders.

17 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the

18 purpose of carrying out this section, there are authorized

19 to be appropriated $40,000,000 for fiscal year 1994, and

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

21 1995 and 1996.’’.
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1 SEC. 303. ESTABLISHMENT OF INTERAGENCY PROGRAM

2 FOR TRAUMA RESEARCH.

3 (a) IN GENERAL.—Title XII of the Public Health Serv4 ice Act (42 U.S.C. 300d et seq.) is amended by adding at

5 the end the following part:

6 ‘‘PART E—INTERAGENCY PROGRAM FOR TRAUMA

7 RESEARCH

8 ‘‘SEC. 1251. ESTABLISHMENT OF PROGRAM.

9 ‘‘(a) IN GENERAL.—The Secretary, acting through the

10 Director of the National Institutes of Health (hereafter in

11 this section referred to as the ‘Director’), shall establish a

12 comprehensive program of conducting basic and clinical re13 search on trauma (hereafter in this section referred to as

14 the ‘Program’). The Program shall include research regard15 ing the diagnosis, treatment, rehabilitation, and general

16 management of trauma.

17 (b) PLAN FOR PROGRAM.—

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

19 with the Trauma Research Interagency Coordinating

20 Committee established under subsection (g), shall es21 tablish and implement a plan for carrying out the ac22 tivities of the Program, including the activities de23 scribed in subsection (d). All such activities shall be

24 carried out in accordance with the plan. The plan

25 shall be periodically reviewed, and revised as appro26 priate.
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1 ‘‘(2) SUBMISSION TO CONGRESS.—Not later than

2 June 1, 1993, the Director shall submit the plan re3 quired in paragraph (1) to the Committee on Energy

4 and Commerce of the House of Representatives, and

5 to the Committee on Labor and Human Resources of

6 the Senate, together with an estimate of the funds

7 needed for each of the fiscal years 1994 through 1996

8 to implement the plan.

9 ‘‘(c) PARTICIPATING AGENCIES; COORDINATION AND

10 COLLABORATION.—The Director—

11 ‘‘(1) shall provide for the conduct of activities

12 under the Program by the Directors of the agencies of

13 the National Institutes of Health involved in research

14 with respect to trauma;

15 ‘‘(2) shall ensure that the activities of the Pro16 gram are coordinated among such agencies; and

17 ‘‘(3) shall, as appropriate, provide for collabora18 tion among such agencies in carrying out such activi19 ties.

20 ‘‘(d) CERTAIN ACTIVITIES OF PROGRAM.—The Pro21 gram shall include—

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

23 care, including prehospital, resuscitation, surgical

24 intervention, critical care, infection control, wound
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1 healing, nutritional care and support, and medical

2 rehabilitation care;

3 ‘‘(2) basic and clinical research regarding the re4 sponse of the body to trauma and the acute treatment

5 and medical rehabilitation of individuals who are the

6 victims of trauma; and

7 ‘‘(3) basic and clinical research regarding trau8 ma care for pediatric and geriatric patients.

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

10 Program, the Director, acting through the Directors of the

11 agencies referred to in subsection (c)(1), may make grants

12 to public and nonprofit entities, including designated trau13 ma centers.

14 ‘‘(f) RESOURCES.—The Director shall assure the avail15 ability of appropriate resources to carry out the Program,

16 including the plan established under subsection (b) (includ17 ing the activities described in subsection (d)).

18 ‘‘(g) COORDINATING COMMITTEE.—

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

20 Trauma Research Interagency Coordinating Commit21 tee (hereafter in this section referred to as the ‘Coordi22 nating Committee’).

23 ‘‘(2) DUTIES.—The Coordinating Committee

24 shall make recommendations regarding—
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1 ‘‘(A) the activities of the Program to be car2 ried out by each of the agencies represented on

3 the Committee and the amount of funds needed

4 by each of the agencies for such activities; and

5 ‘‘(B) effective collaboration among the agen6 cies in carrying out the activities.

7 ‘‘(3) COMPOSITION.—The Coordinating Commit8 tee shall be composed of the Directors of each of the

9 agencies that, under subsection (c), have responsibil10 ities under the Program, and any other individuals

11 who are practitioners in the trauma field as des12 ignated by the Director of the National Institutes of

13 Health.

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

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

16 meaning given such term in section 1231(1).

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

18 the National Institutes of Health.

19 ‘‘(3) The term ‘trauma’ means any serious in20 jury that could result in loss of life or in significant

21 disability and that would meet pre-hospital triage

22 criteria for transport to a designated trauma center.’’.

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

24 Public Health Service Act, as amended by section 208(c)
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1 of this Act, is amended by adding at the end the following

2 new subsection:

3 ‘‘(k) The Director of NIH shall carry out the program

4 established in part E of title XII (relating to interagency

5 research on trauma).’’.

6 TITLE IV—NATIONAL CANCER

7 INSTITUTE

8 SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVI9 TIES REGARDING BREAST CANCER.

10 Subpart 1 of part C of title IV of the Public Health

11 Service Act (42 U.S.C. 285 et seq.) is amended by adding

12 at the end the following new section:

13 ‘‘BREAST AND GYNECOLOGICAL CANCERS

14 ‘‘SEC. 417. (a) EXPANSION AND COORDINATION OF

15 ACTIVITIES.—The Director of the Institute, in consultation

16 with the National Cancer Advisory Board, shall expand,

17 intensify, and coordinate the activities of the Institute with

18 respect to research on breast cancer, ovarian cancer, and

19 other cancers of the reproductive system of women.

20 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.—The

21 Director of the Institute shall coordinate the activities of

22 the Director under subsection (a) with similar activities

23 conducted by other national research institutes and agencies

24 of the National Institutes of Health to the extent that such

25 Institutes and agencies have responsibilities that are related
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1 to breast cancer and other cancers of the reproductive sys2 tem of women.

3 ‘‘(c) PROGRAMS FOR BREAST CANCER.—

4 ‘‘(1) IN GENERAL.—In carrying out subsection

5 (a), the Director of the Institute shall conduct or sup6 port research to expand the understanding of the

7 cause of, and to find a cure for, breast cancer. Activi8 ties under such subsection shall provide for an expan9 sion and intensification of the conduct and support

10 of—

11 ‘‘(A) basic research concerning the etiology

12 and causes of breast cancer;

13 ‘‘(B) clinical research and related activities

14 concerning the causes, prevention, detection and

15 treatment of breast cancer;

16 ‘‘(C) control programs with respect to breast

17 cancer in accordance with section 412;

18 ‘‘(D) information and education programs

19 with respect to breast cancer in accordance with

20 section 413; and

21 ‘‘(E) research and demonstration centers

22 with respect to breast cancer in accordance with

23 section 414, including the development and oper24 ation of centers for breast cancer research to

25 bring together basic and clinical, biomedical and
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1 behavioral scientists to conduct basic, clinical,

2 epidemiological, psychosocial, prevention and

3 treatment research and related activities on

4 breast cancer.

5 Not less than six centers shall be operated under sub6 paragraph (E). Activities of such centers should in7 clude supporting new and innovative research and

8 training programs for new researchers. Such centers

9 shall give priority to expediting the transfer of re10 search advances to clinical applications.

11 ‘‘(2) IMPLEMENTATION OF PLAN FOR PRO12 GRAMS.—

13 ‘‘(A) The Director of the Institute shall en14 sure that the research programs described in

15 paragraph (1) are implemented in accordance

16 with a plan for the programs. Such plan shall

17 include comments and recommendations that the

18 Director of the Institute considers appropriate,

19 with due consideration provided to the profes20 sional judgment needs of the Institute as ex21 pressed in the annual budget estimate prepared

22 in accordance with section 413(9). The Director

23 of the Institute, in consultation with the Na24 tional Cancer Advisory Board, shall periodically

25 review and revise such plan.
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1 ‘‘(B) Not later than May 1, 1993, the Direc2 tor of the Institute shall submit a copy of the

3 plan to the President’s Cancer Panel, the Sec4 retary and the Director of NIH.

5 ‘‘(C) The Director of the Institute shall sub6 mit any revisions of the plan to the President’s

7 Cancer Panel, the Secretary, and the Director of

8 NIH.

9 ‘‘(D) The Secretary shall provide a copy of

10 the plan submitted under subparagraph (A), and

11 any revisions submitted under subparagraph

12 (C), to the Committee on Energy and Commerce

13 of the House of Representatives and the Commit14 tee on Labor and Human Resources of the Sen15 ate.

16 ‘‘(d) OTHER CANCERS.—In carrying out subsection

17 (a), the Director of the Institute shall conduct or support

18 research on ovarian cancer and other cancers of the repro19 ductive system of women. Activities under such subsection

20 shall provide for the conduct and support of—

21 ‘‘(1) basic research concerning the etiology and

22 causes of ovarian cancer and other cancers of the re23 productive system of women;

24 ‘‘(2) clinical research and related activities into

25 the causes, prevention, detection and treatment of
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1 ovarian cancer and other cancers of the reproductive

2 system of women;

3 ‘‘(3) control programs with respect to ovarian

4 cancer and other cancers of the reproductive system of

5 women in accordance with section 412;

6 ‘‘(4) information and education programs with

7 respect to ovarian cancer and other cancers of the re8 productive system of women in accordance with sec9 tion 413; and

10 ‘‘(5) research and demonstration centers with re11 spect to ovarian cancer and cancers of the reproduc12 tive system in accordance with section 414.

13 ‘‘(e) REPORT.—The Director of the Institute shall pre14 pare, for inclusion in the biennial report submitted under

15 section 407, a report that describes the activities of the Na16 tional Cancer Institute under the research programs re17 ferred to in subsection (a), that shall include—

18 ‘‘(1) a description of the research plan with re19 spect to breast cancer prepared under subsection (c);

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

21 and implementation of such plan;

22 ‘‘(3) a description and evaluation of the progress

23 made, during the period for which such report is pre24 pared, in the research programs on breast cancer and

25 cancers of the reproductive system of women;
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1 ‘‘(4) a summary and analysis of expenditures

2 made, during the period for which such report is

3 made, for activities with respect to breast cancer and

4 cancers of the reproductive system of women con5 ducted and supported by the National Institutes of

6 Health; and

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

8 Director considers appropriate.’’.

9 SEC. 402. EXPANSION AND INTENSIFICATION OF ACTIVI10 TIES REGARDING PROSTATE CANCER.

11 Subpart 1 of part C of title IV of the Public Health

12 Service Act, as amended by section 401 of this Act, is

13 amended by adding at the end the following new section:

14 ‘‘PROSTATE CANCER

15 ‘‘SEC. 417A. (a) EXPANSION AND COORDINATION OF

16 ACTIVITIES.—The Director of the Institute, in consultation

17 with the National Cancer Advisory Board, shall expand,

18 intensify, and coordinate the activities of the Institute with

19 respect to research on prostate cancer.

20 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.—The

21 Director of the Institute shall coordinate the activities of

22 the Director under subsection (a) with similar activities

23 conducted by other national research institutes and agencies

24 of the National Institutes of Health to the extent that such

25 Institutes and agencies have responsibilities that are related

26 to prostate cancer.
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1 ‘‘(c) PROGRAMS.—

2 ‘‘(1) IN GENERAL.—In carrying out subsection

3 (a), the Director of the Institute shall conduct or sup4 port research to expand the understanding of the

5 cause of, and to find a cure for, prostate cancer. Ac6 tivities under such subsection shall provide for an ex7 pansion and intensification of the conduct and sup8 port of—

9 ‘‘(A) basic research concerning the etiology

10 and causes of prostate cancer;

11 ‘‘(B) clinical research and related activities

12 concerning the causes, prevention, detection and

13 treatment of prostate cancer;

14 ‘‘(C) prevention and control and early de15 tection programs with respect to prostate cancer

16 in accordance with section 412, particularly as

17 it relates to intensifying research on the role of

18 prostate specific antigen for the screening and

19 early detection of prostate cancer;

20 ‘‘(D) an Inter-Institute Task Force, under

21 the direction of the Director of the Institute, to

22 provide coordination between relevant National

23 Institutes of Health components of research ef24 forts on prostate cancer;
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1 ‘‘(E) control programs with respect to pros2 tate cancer in accordance with section 412;

3 ‘‘(F) information and education programs

4 with respect to prostate cancer in accordance

5 with section 413; and

6 ‘‘(G) research and demonstration centers

7 with respect to prostate cancer in accordance

8 with section 414, including the development and

9 operation of centers for prostate cancer research

10 to bring together basic and clinical, biomedical

11 and behavioral scientists to conduct basic, clini12 cal, epidemiological, psychosocial, prevention

13 and treatment research and related activities on

14 prostate cancer.

15 Not less than six centers shall be operated under sub16 paragraph (G). Activities of such centers should in17 clude supporting new and innovative research and

18 training programs for new researchers. Such centers

19 shall give priority to expediting the transfer of re20 search advances to clinical applications.

21 ‘‘(2) IMPLEMENTATION OF PLAN FOR PRO22 GRAMS.—

23 ‘‘(A) The Director of the Institute shall en24 sure that the research programs described in

25 paragraph (1) are implemented in accordance
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1 with a plan for the programs. Such plan shall

2 include comments and recommendations that the

3 Director of the Institute considers appropriate,

4 with due consideration provided to the profes5 sional judgment needs of the Institute as ex6 pressed in the annual budget estimate prepared

7 in accordance with section 413(9). The Director

8 of the Institute, in consultation with the Na9 tional Cancer Advisory Board, shall periodically

10 review and revise such plan.

11 ‘‘(B) Not later than May 1, 1993, the Direc12 tor of the Institute shall submit a copy of the

13 plan to the President’s Cancer Panel, the Sec14 retary and the Director of NIH.

15 ‘‘(C) The Director of the Institute shall sub16 mit any revisions of the plan to the President’s

17 Cancer Panel, the Secretary, and the Director of

18 NIH.

19 ‘‘(D) The Secretary shall provide a copy of

20 the plan submitted under subparagraph (A), and

21 any revisions submitted under subparagraph

22 (C), to the Committee on Energy and Commerce

23 of the House of Representatives and the Commit24 tee on Labor and Human Resources of the Sen25 ate.’’.
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1 SEC. 403. AUTHORIZATION OF APPROPRIATIONS.

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

3 the Public Health Service Act, as amended by section 402

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

5 new section:

6 ‘‘AUTHORIZATION OF APPROPRIATIONS

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

8 purpose of carrying out this subpart, there are authorized

9 to be appropriated $2,200,000,000 for fiscal year 1994, and

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

11 1995 and 1996.

12 ‘‘(b) BREAST CANCER AND GYNECOLOGICAL CAN13 CERS.—

14 ‘‘(1) BREAST CANCER.—

15 ‘‘(A) For the purpose of carrying out sub16 paragraph (A) of section 417(c)(1), there are au17 thorized to be appropriated $225,000,000 for fis18 cal year 1994, and such sums as may be nec19 essary for each of the fiscal years 1995 and 1996.

20 Such authorizations of appropriations are in ad21 dition to the authorizations of appropriations es22 tablished in subsection (a) with respect to such

23 purpose.

24 ‘‘(B) For the purpose of carrying out sub25 paragraphs (B) through (E) of section 417(c)(1),

26 there are authorized to be appropriated
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1 $100,000,000 for fiscal year 1994, and such sums

2 as may be necessary for each of the fiscal years

3 1995 and 1996. Such authorizations of appro4 priations are in addition to the authorizations of

5 appropriations established in subsection (a) with

6 respect to such purpose.

7 ‘‘(2) OTHER CANCERS.—For the purpose of car8 rying out subsection (d) of section 417, there are au9 thorized to be appropriated $75,000,000 for fiscal

10 year 1994, and such sums as are necessary for each

11 of the fiscal years 1995 and 1996. Such authoriza12 tions of appropriations are in addition to the author13 izations of appropriations established in subsection

14 (a) with respect to such purpose.

15 ‘‘(c) PROSTATE CANCER.—For the purpose of carrying

16 out section 417A, there are authorized to be appropriated

17 $72,000,000 for fiscal year 1994, and such sums as may

18 be necessary for each of the fiscal years 1995 and 1996.

19 Such authorizations of appropriations are in addition to

20 the authorizations of appropriations established in sub21 section (a) with respect to such purpose.

22 ‘‘(d) ALLOCATION REGARDING CANCER CONTROL.—Of

23 the amounts appropriated for the National Cancer Institute

24 for a fiscal year, the Director of the Institute shall make

25 available not less than 10 percent for carrying out the can-
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1 cer control activities authorized in section 412 and for

2 which budget estimates are made under section 413(b)(9)

3 for the fiscal year.’’.

4 (b) SPECIAL RULE REGARDING FUNDS FOR SECTION

5 412 FOR FISCAL YEAR 1994.—Notwithstanding section

6 417B(d) of the Public Health Service Act, as added by sub7 section (a) of this section, the amount made available under

8 such section for fiscal year 1994 for carrying out section

9 412 of such Act shall be an amount not less than an amount

10 equal to 75 percent of the amount specified for activities

11 under such section 412 in the budget estimate made under

12 section 413(b)(9) of such Act for such fiscal year.

13 (c) CONFORMING AMENDMENTS.—

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

15 Health Service Act (42 U.S.C. 284c) is amended—

16 (A) by striking subsection (a);

17 (B) by redesignating subsection (b) as sub18 section (a);

19 (C) by redesignating paragraph (5) of sub20 section (a) (as so redesignated) as subsection (b);

21 and

22 (D) by amending the heading for the section

23 to read as follows:

24 ‘‘CERTAIN USES OF FUNDS’’.

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

26 Public Health Service Act (42 U.S.C. 285m–6) is
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1 amended by striking ‘‘section 408(b)(1)’’ and insert2 ing ‘‘section 408(a)(1)’’.

3 TITLE V—NATIONAL HEART,

4 LUNG, AND BLOOD INSTITUTE

5 SEC. 501. EDUCATION AND TRAINING.

6 Section 421(b) of the Public Health Service Act (42

7 U.S.C. 285b–3(b)) is amended—

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

9 semicolon at the end;

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

11 the end and inserting ‘‘; and’’; and

12 (3) by inserting after paragraph (4) the follow13 ing new paragraph:

14 ‘‘(5) shall, in consultation with the advisory

15 council for the Institute, conduct appropriate intra16 mural training and education programs, including

17 continuing education and laboratory and clinical re18 search training programs.’’.

19 SEC. 502. CENTERS FOR THE STUDY OF PEDIATRIC CARDIO20 VASCULAR DISEASES.

21 Section 422(a)(1) of the Public Health Service Act (42

22 U.S.C. 285b–4(a)(1)) is amended—

23 (1) in subparagraph (B), by striking ‘‘and’’ at

24 the end;
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1 (2) in subparagraph (C), by striking the period

2 and inserting ‘‘; and’’; and

3 (3) by adding at the end thereof the following

4 new subparagraph:

5 ‘‘(D) three centers for basic and clinical research

6 into, training in, and demonstration of, advanced di7 agnostic, prevention, and treatment (including genetic

8 studies, intrauterine environment studies, postnatal

9 studies, heart arrhythmias, and acquired heart dis10 ease and preventive cardiology) for cardiovascular

11 diseases in children.’’.

12 SEC. 503. NATIONAL CENTER ON SLEEP DISORDERS.

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

14 Service Act (42 U.S.C. 285b et seq.) is amended by adding

15 at the end the following new section:

16 ‘‘NATIONAL CENTER ON SLEEP DISORDERS

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

18 of the enactment of the National Institutes of Health Revi19 talization Act of 1993, the Director of the Institute shall

20 establish the National Center on Sleep Disorders (in this

21 section referred to as the ‘Center’). The Center shall be head22 ed by a director, who shall be appointed by the Director

23 of the Institute.

24 ‘‘(b) The general purpose of the Center is the conduct

25 and support of research, training, health information dis-
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1 semination, and other activities with respect to sleep dis2 orders.’’.

3 SEC. 504. AUTHORIZATION OF APPROPRIATIONS.

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

5 Service Act, as amended by section 503 of this Act, is

6 amended by adding at the end the following section:

7 ‘‘AUTHORIZATION OF APPROPRIATIONS

8 ‘‘SEC. 425. (a) For the purpose of carrying out this

9 subpart, there are authorized to be appropriated

10 $1,500,000,000 for fiscal year 1994, and such sums as may

11 be necessary for each of the fiscal years 1995 and 1996.

12 ‘‘(b) Of the amounts appropriated under paragraph

13 (1) for a fiscal year, the Director of the Institute shall make

14 available not less than 10 percent for carrying out commu15 nity-based prevention and control activities that include

16 clinical investigations, clinical trials, epidemiologic studies,

17 and prevention demonstration and education projects.’’.

18 TITLE VI—NATIONAL INSTITUTE

19 ON DIABETES AND DIGESTIVE

20 AND KIDNEY DISEASES

21 SEC. 601. PROVISIONS REGARDING NUTRITIONAL DIS22 ORDERS.

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

24 Service Act (42 U.S.C. 285c et seq.) is amended by adding

25 at the end the following new section:
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1 ‘‘NUTRITIONAL DISORDERS PROGRAM

2 ‘‘SEC. 434. (a) The Director of the Institute shall estab3 lish a program of conducting and supporting research,

4 training, health information dissemination, and other ac5 tivities with respect to nutritional disorders, including obe6 sity.

7 ‘‘(b) In carrying out the program established under

8 subsection (a), the Director of the Institute shall conduct

9 and support each of the activities described in such sub10 section. The Director of NIH shall ensure that, as appro11 priate, the other national research institutes and agencies

12 of the National Institutes of Health have responsibilities re13 garding such activities.

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

15 subsection (a), the Director of the Institute shall carry out

16 activities to facilitate and enhance knowledge and under17 standing of nutritional disorders, including obesity, on the

18 part of health professionals, patients, and the public

19 through the effective dissemination of information.’’.

20 (b) DEVELOPMENT AND EXPANSION OF RESEARCH

21 AND TRAINING CENTERS.—Section 431 of the Public Health

22 Service Act (42 U.S.C. 285c–5) is amended—

23 (1) by redesignating subsection (d) as subsection

24 (e); and
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1 (2) by inserting after subsection (c) the following

2 new subsection:

3 ‘‘(d)(1) The Director of the Institute shall, subject to

4 the extent of amounts made available in appropriations

5 Acts, provide for the development or substantial expansion

6 of centers for research and training regarding nutritional

7 disorders, including obesity.

8 ‘‘(2) The Director of the Institute shall carry out para9 graph (1) in collaboration with the Director of the National

10 Cancer Institute and with the Directors of such other agen11 cies of the National Institutes of Health as the Director of

12 NIH determines to be appropriate.

13 ‘‘(3) Each center developed or expanded under para14 graph (1) shall—

15 ‘‘(A) utilize the facilities of a single institution,

16 or be formed from a consortium of cooperating insti17 tutions, meeting such research and training qualifica18 tions as may be prescribed by the Director;

19 ‘‘(B) conduct basic and clinical research into the

20 cause, diagnosis, early detection, prevention, control

21 and treatment of nutritional disorders, including obe22 sity and the impact of nutrition and diet on child de23 velopment;

24 ‘‘(C) conduct training programs for physicians

25 and allied health professionals in current methods of
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1 diagnosis and treatment of such diseases and com2 plications, and in research in such disorders; and

3 ‘‘(D) conduct information programs for physi4 cians and allied health professionals who provide pri5 mary care for patients with such disorders or com6 plications.’’.

7 TITLE VII—NATIONAL INSTI8 TUTE ON ARTHRITIS AND

9 MUSCULOSKELETAL AND

10 SKIN DISEASES

11 SEC. 701. JUVENILE ARTHRITIS.

12 (a) PURPOSE.—Section 435 of the Public Health Serv13 ice Act (42 U.S.C. 285d) is amended by striking ‘‘and other

14 programs’’ and all that follows and inserting the following:

15 ‘‘and other programs with respect to arthritis and musculo16 skeletal and skin diseases (including sports-related dis17 orders), with particular attention to the effect of these dis18 eases on children.’’.

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

20 amended—

21 (1) in subsection (a), by inserting after the sec22 ond sentence, the following: ‘‘The plan shall place

23 particular emphasis upon expanding research into

24 better understanding the causes and the development
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1 of effective treatments for arthritis affecting chil2 dren.’’; and

3 (2) in subsection (b)—

4 (A) by striking ‘‘and’’ at the end of para5 graph (3);

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

7 paragraph (4) and inserting ‘‘; and’’; and

8 (C) by adding at the end thereof the follow9 ing new paragraph:

10 ‘‘(5) research into the causes of arthritis affecting

11 children and the development, trial, and evaluation of

12 techniques, drugs and devices used in the diagnosis,

13 treatment (including medical rehabilitation), and

14 prevention of arthritis in children.’’.

15 (c) CENTERS.—Section 441 of the Public Health Serv16 ice Act (42 U.S.C. 286d–6) is amended by adding at the

17 end thereof the following new subsection:

18 ‘‘(f) Not later than October 1, 1994, the Director shall

19 establish a multipurpose arthritis and musculoskeletal dis20 ease center for the purpose of expanding the level of research

21 into the cause, diagnosis, early detection, prevention, con22 trol, and treatment of, and rehabilitation of children with

23 arthritis and musculoskeletal diseases.’’.

24 (d) ADVISORY BOARD.—
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1 (1) TITLE.—Section 442(a) of the Public Health

2 Service Act (42 U.S.C. 285d–7(a)) is amended by in3 serting after ‘‘Arthritis’’ the the first place such term

4 appears the following: ‘‘and Musculoskeletal and Skin

5 Diseases’’.

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

7 Health Service Act (42 U.S.C. 285d–7(b)) is amend8 ed—Section 442(b) of the Public Health Service Act

9 (42 U.S.C. 285d–7(b)) is amended—

10 (A) in the matter preceding paragraph (1),

11 by striking ‘‘eighteen’’ and inserting ‘‘twenty’’;

12 and

13 (B) in paragraph (1)(B)—

14 (i) by striking ‘‘six’’ and inserting

15 ‘‘eight’’; and

16 (ii) by striking ‘‘including’’ and all

17 that follows and inserting the following:

18 ‘‘including one member who is a person who

19 has such a disease, one person who is the

20 parent of an adult with such a disease, and

21 two members who are parents of children

22 with arthritis.’’.

23 (3) ANNUAL REPORT.—Section 442(j) of the Pub24 lic Health Service Act (42 U.S.C. 285d–7(j)) is

25 amended—
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1 (1) by striking ‘‘and’’ at the end of paragraph

2 (3);

3 (2) by striking the period at the end of para4 graph (4) and inserting ‘‘; and’’; and

5 (3) by adding at the end the following para6 graph:

7 ‘‘(5) contains recommendations for expanding

8 the Institute’s funding of research directly applicable

9 to the cause, diagnosis, early detection, prevention,

10 control, and treatment of, and rehabilitation of chil11 dren with arthritis and musculoskeletal diseases.’’.

12 TITLE VIII—NATIONAL

13 INSTITUTE ON AGING

14 SEC. 801. ALZHEIMER’S DISEASE REGISTRY.

15 (a) IN GENERAL.—Section 12 of Public Law 99–158

16 (99 Stat. 885) is—

17 (1) transferred to subpart 5 of part C of title IV

18 of the Public Health Service Act (42 U.S.C. 285e et

19 seq.);

20 (2) redesignated as section 445G; and

21 (3) inserted after section 445F of such Act.

22 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

23 Section 445G of the Public Health Service Act, as trans24 ferred and inserted by subsection (a) of this section, is

25 amended—
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1 (1) by striking the section heading and all that

2 follows through ‘‘may make a grant’’ in subsection (a)

3 and inserting the following:

4 ‘‘ALZHEIMER’S DISEASE REGISTRY

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

6 Institute may make a grant’’; and

7 (2) by striking subsection (c).

8 SEC. 802. AGING PROCESSES REGARDING WOMEN.

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

10 Service Act, as amended by section 801 of this Act, is

11 amended by adding at the end the following new section:

12 ‘‘AGING PROCESSES REGARDING WOMEN

13 ‘‘SEC. 445H. The Director of the Institute, in addition

14 to other special functions specified in section 444 and in

15 cooperation with the Directors of the other national research

16 institutes and agencies of the National Institutes of Health,

17 shall conduct research into the aging processes of women,

18 with particular emphasis given to the effects of menopause

19 and the physiological and behavioral changes occurring

20 during the transition from pre- to post-menopause, and into

21 the diagnosis, disorders, and complications related to aging

22 and loss of ovarian hormones in women.’’.

23 SEC. 803. AUTHORIZATION OF APPROPRIATIONS.

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

25 Service Act, as amended by section 802 of this Act, is

26 amended by adding at the end the following new section:
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1 ‘‘AUTHORIZATION OF APPROPRIATIONS

2 ‘‘SEC. 445I. For the purpose of carrying out this sub3 part, there are authorized to be appropriated $500,000,000

4 for fiscal year 1994, and such sums as may be necessary

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

6 SEC. 804. CONFORMING AMENDMENT.

7 Section 445C of the Public Health Service Act (42

8 U.S.C. 285e–5(b)) is amended—

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

10 inserting after ‘‘Council’’ the following: ‘‘on Alz11 heimer’s Disease (hereafter in this section referred to

12 as the ‘Council’)’’; and

13 (2) by adding at the end the following new sub14 section:

15 ‘‘(d) For purposes of this section, the term ‘Council on

16 Alzheimer’s Disease’ means the council established in sec17 tion 911(a) of Public Law 99–660.’’.

18 TITLE IX—NATIONAL INSTITUTE

19 OF ALLERGY AND INFEC20 TIOUS DISEASES

21 SEC. 901. TROPICAL DISEASES.

22 Section 446 of the Public Health Service Act (42

23 U.S.C. 285f) is amended by inserting before the period the

24 following: ‘‘, including tropical diseases’’.
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1 SEC. 902. CHRONIC FATIGUE SYNDROME.

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

3 IV of the Public Health Service Act (42 U.S.C. 285f) is

4 amended by adding at the end the following new section:

5 ‘‘RESEARCH CENTERS REGARDING CHRONIC FATIGUE

6 SYNDROME

7 ‘‘SEC. 447. (a) The Director of the Institute, after con8 sultation with the advisory council for the Institute, may

9 make grants to, or enter into contracts with, public or non10 profit private entities for the development and operation of

11 centers to conduct basic and clinical research on chronic

12 fatigue syndrome.

13 ‘‘(b) Each center assisted under this section shall use

14 the facilities of a single institution, or be formed from a

15 consortium of cooperating institutions, meeting such re16 quirements as may be prescribed by the Director of the In17 stitute.’’.

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

19 months after the date of enactment of this Act, the Secretary

20 of Health and Human Services shall establish an extra21 mural study section for chronic fatigue syndrome research.

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

23 Human Services, acting through the Director of the Na24 tional Institutes of Health, shall ensure that appropriate

25 individuals with expertise in chronic fatigue syndrome or

26 neuromuscular diseases and representative of a variety of
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1 disciplines and fields within the research community are

2 appointed to appropriate National Institutes of Health ad3 visory committees and boards.

4 TITLE X—NATIONAL INSTITUTE

5 OF CHILD HEALTH AND

6 HUMAN DEVELOPMENT

7 Subtitle A—Research Centers With

8 Respect to Contraception and

9 Research Centers With Respect

10 to Infertility

11 SEC. 1001. GRANTS AND CONTRACTS FOR RESEARCH CEN12 TERS.

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

14 Service Act, as amended by section 3 of Public Law 101–

15 613, is amended by adding at the end the following new

16 section:

17 ‘‘RESEARCH CENTERS WITH RESPECT TO CONTRACEPTION

18 AND INFERTILITY

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

20 consultation with the advisory council for the Institute,

21 shall make grants to, or enter into contracts with, public

22 or nonprofit private entities for the development and oper23 ation of centers to conduct activities for the purpose of im24 proving methods of contraception and centers to conduct ac25 tivities for the purpose of improving methods of diagnosis

26 and treatment of infertility.
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1 ‘‘(b) In carrying out subsection (a), the Director of the

2 Institute shall, subject to the extent of amounts made avail3 able in appropriations Acts, provide for the establishment

4 of three centers with respect to contraception and for two

5 centers with respect to infertility.

6 ‘‘(c)(1) Each center assisted under this section shall,

7 in carrying out the purpose of the center involved—

8 ‘‘(A) conduct clinical and other applied research,

9 including—

10 ‘‘(i) for centers with respect to contracep11 tion, clinical trials of new or improved drugs

12 and devices for use by males and females (in13 cluding barrier methods); and

14 ‘‘(ii) for centers with respect to infertility,

15 clinical trials of new or improved drugs and de16 vices for the diagnosis and treatment of infertil17 ity in males and females;

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

19 scientists, nurses, and other health and allied health

20 professionals;

21 ‘‘(C) conduct training programs for such indi22 viduals;

23 ‘‘(D) develop model continuing education pro24 grams for such professionals; and
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1 ‘‘(E) disseminate information to such profes2 sionals and the public.

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

4 (a) to provide stipends for health and allied health profes5 sionals enrolled in programs described in subparagraph (C)

6 of paragraph (1), and to provide fees to individuals serving

7 as subjects in clinical trials conducted under such para8 graph.

9 ‘‘(d) The Director of the Institute shall, as appropriate,

10 provide for the coordination of information among the cen11 ters assisted under this section.

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

13 the facilities of a single institution, or be formed from a

14 consortium of cooperating institutions, meeting such re15 quirements as may be prescribed by the Director of the In16 stitute.

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

18 for a period not exceeding 5 years. Such period may be ex19 tended for one or more additional periods not exceeding 5

20 years if the operations of such center have been reviewed

21 by an appropriate technical and scientific peer review

22 group established by the Director and if such group has rec23 ommended to the Director that such period should be ex24 tended.
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1 ‘‘(g) For the purpose of carrying out this section, there

2 are authorized to be appropriated $30,000,000 for fiscal

3 year 1994, and such sums as may be necessary for each

4 of the fiscal years 1995 and 1996.’’.

5 SEC. 1002. LOAN REPAYMENT PROGRAM FOR RESEARCH

6 WITH RESPECT TO CONTRACEPTION AND IN7 FERTILITY.

8 Part G of title IV of the Public Health Service Act,

9 as redesignated by section 141(a)(2) of this Act, is amended

10 by inserting after section 487A the following section:

11 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH

12 RESPECT TO CONTRACEPTION AND INFERTILITY

13 ‘‘SEC. 487B. (a) The Secretary, in consultation with

14 the Director of the National Institute of Child Health and

15 Human Development, shall establish a program of entering

16 into agreements with qualified health professionals (includ17 ing graduate students) under which such health profes18 sionals agree to conduct research with respect to contracep19 tion, or with respect to infertility, in consideration of the

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

21 service, not more than $20,000 of the principal and interest

22 of the educational loans of such health professionals.

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

24 shall apply to the program established in subsection (a) to

25 the same extent and in the same manner as such provisions

26 apply to the National Health Service Corps Loan Repay-
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1 ment Program established in subpart III of part D of title

2 III.

3 ‘‘(c) Amounts appropriated for carrying out this sec4 tion shall remain available until the expiration of the sec5 ond fiscal year beginning after the fiscal year for which

6 the amounts were appropriated.’’.

7 Subtitle B—Program Regarding

8 Obstetrics and Gynecology

9 SEC. 1011. ESTABLISHMENT OF PROGRAM.

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

11 Service Act, as amended by section 1001 of this Act, is

12 amended by adding at the end the following new section:

13 ‘‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY

14 ‘‘SEC. 452B. The Director of the Institute shall estab15 lish and maintain within the Institute an intramural lab16 oratory and clinical research program in obstetrics and

17 gynecology.’’.

18 Subtitle C—Child Health Research

19 Centers

20 SEC. 1021. ESTABLISHMENT OF CENTERS.

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

22 Service Act, as amended by section 1011 of this Act, is

23 amended by adding at the end the following new section:

24 ‘‘CHILD HEALTH RESEARCH CENTERS

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

26 and support centers for conducting research with respect to
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1 child health. Such centers shall give priority to the expedi2 tious transfer of advances from basic science to clinical ap3 plications and improving the care of infants and children.’’.

4 Subtitle D—Study Regarding

5 Adolescent Health

6 SEC. 1031. PROSPECTIVE LONGITUDINAL STUDY.

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

8 Service Act, as amended by section 1021 of this Act, is

9 amended by adding at the end the following new section:

10 ‘‘PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT

11 HEALTH

12 ‘‘SEC. 452D. (a) IN GENERAL.—The Director of the

13 Institute shall conduct a study for the purpose of providing

14 information on the general health and well-being of adoles15 cents in the United States, including, with respect to such

16 adolescents, information on—

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

18 behaviors that are detrimental to health; and

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

20 to the communities in which the adolescents reside.

21 ‘‘(b) DESIGN OF STUDY.—

22 ‘‘(1) IN GENERAL.—The study required in sub23 section (a) shall be a longitudinal study in which a

24 substantial number of adolescents participate as sub25 jects. With respect to the purpose described in such

26 subsection, the study shall monitor the subjects
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1 throughout the period of the study to determine the

2 health status of the subjects and any change in such

3 status over time.

4 ‘‘(2) POPULATION-SPECIFIC ANALYSES.—The

5 study required in subsection (a) shall be conducted

6 with respect to the population of adolescents who are

7 female, the population of adolescents who are male,

8 various socioeconomic populations of adolescents, and

9 various racial and ethnic populations of adolescents.

10 The study shall be designed and conducted in a man11 ner sufficient to provide for a valid analysis of wheth12 er there are significant differences among such popu13 lations in health status and whether and to what ex14 tent any such differences are due to factors particular

15 to the populations involved.

16 ‘‘(c) COORDINATION WITH WOMEN’S HEALTH INITIA17 TIVE.—With respect to the national study of women being

18 conducted by the Secretary and known as the Women’s

19 Health Initiative, the Secretary shall ensure that such study

20 is coordinated with the component of the study required in

21 subsection (a) that concerns adolescent females, including

22 coordination in the design of the 2 studies.

23 ‘‘(d) ALLOCATION OF FUNDS FOR STUDY.—Of the

24 amounts appropriated for each of the fiscal years 1994

25 through 1996 for the National Institute of Child Health and
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1 Human Development, the Secretary of Health and Human

2 Services, acting through the Director of such Institute, shall

3 reserve $3,000,000 to conduct the study required in sub4 section (a). The amounts so reserved shall remain available

5 until expended.’’.

6 TITLE XI—NATIONAL EYE

7 INSTITUTE

8 SEC. 1101. CLINICAL RESEARCH ON DIABETES EYE CARE.

9 (a) IN GENERAL.—Subpart 9 of part C of title IV of

10 the Public Health Service Act (42 U.S.C. 285i) is amended

11 by adding at the end the following new section:

12 ‘‘CLINICAL RESEARCH ON EYE CARE AND DIABETES

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

14 of the Institute, in consultation with the advisory council

15 for the Institute, may award not more than three grants

16 for the establishment and support of centers for clinical re17 search on eye care for individuals with diabetes.

18 ‘‘(b) AUTHORIZED EXPENDITURES.—The purposes for

19 which a grant under subsection (a) may be expended in20 clude equipment for the research described in such sub21 section and the construction and modernization of facilities

22 for such research.’’.

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

24 Public Health Service Act (42 U.S.C. 285i) is amended in

25 the second sentence by striking ‘‘The Director’’ and insert26 ing ‘‘Subject to section 456, the Director’’.
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1 TITLE XII—NATIONAL INSTI2 TUTE OF NEUROLOGICAL DIS3 ORDERS AND STROKE

4 SEC. 1201. RESEARCH ON MULTIPLE SCLEROSIS.

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

6 Service Act (42 U.S.C. 285j et seq.) is amended by adding

7 at the end the following new section:

8 ‘‘RESEARCH ON MULTIPLE SCLEROSIS

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

10 and support research on multiple sclerosis, especially re11 search on effects of genetics and hormonal changes on the

12 progress of the disease.’’.

13 TITLE XIII—NATIONAL INSTI14 TUTE OF ENVIRONMENTAL

15 HEALTH SCIENCES

16 SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND TEST17 ING PROGRAM.

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

19 of the Public Health Service Act (42 U.S.C. 285l) is amend20 ed by adding at the end the following new section:

21 ‘‘APPLIED TOXICOLOGICAL RESEARCH AND TESTING

22 PROGRAM

23 ‘‘SEC. 463A. (a) There is established within the Insti24 tute a program for conducting applied research and testing
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1 regarding toxicology, which program shall be known as the

2 Applied Toxicological Research and Testing Program.

3 ‘‘(b) In carrying out the program established under

4 subsection (a), the Director of the Institute shall, with re5 spect to toxicology, carry out activities—

6 ‘‘(1) to expand knowledge of the health effects of

7 environmental agents;

8 ‘‘(2) to broaden the spectrum of toxicology infor9 mation that is obtained on selected chemicals;

10 ‘‘(3) to develop and validate assays and proto11 cols, including alternative methods that can reduce or

12 eliminate the use of animals in acute or chronic safe13 ty testing;

14 ‘‘(4) to establish criteria for the validation and

15 regulatory acceptance of alternative testing and to

16 recommend a process through which scientifically

17 validated alternative methods can be accepted for reg18 ulatory use;

19 ‘‘(5) to communicate the results of research to

20 government agencies, to medical, scientific, and regu21 latory communities, and to the public; and

22 ‘‘(6) to integrate related activities of the Depart23 ment of Health and Human Services.’’.

24 (b) TECHNICAL AMENDMENT.—Section 463 of the Pub25 lic Health Service Act (42 U.S.C. 285l) is amended by in-
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1 serting after ‘‘Sciences’’ the following: ‘‘(hereafter in this

2 subpart referred to as the ‘Institute’)’’.

3 TITLE XIV—NATIONAL LIBRARY

4 OF MEDICINE

5 Subtitle A—General Provisions

6 SEC. 1401. ADDITIONAL AUTHORITIES.

7 (a) IN GENERAL.—Section 465(b) of the Public Health

8 Service Act (42 U.S.C. 286(b)) is amended—

9 (1) by striking ‘‘and’’ after the semicolon at the

10 end of paragraph (5);

11 (2) by redesignating paragraph (6) as para12 graph (8); and

13 (3) by inserting after paragraph (5) the follow14 ing new paragraphs:

15 ‘‘(6) publicize the availability from the Library

16 of the products and services described in any of para17 graphs (1) through (5);

18 ‘‘(7) promote the use of computers and tele19 communications by health professionals (including

20 health professionals in rural areas) for the purpose of

21 improving access to biomedical information for health

22 care delivery and medical research; and’’.

23 (b) LIMITATION REGARDING GRANTS.—Section

24 474(b)(2) of the Public Health Service Act (42 U.S.C. 286b–
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1 S(b)(2)) is amended by striking ‘‘$750,000’’ and inserting

2 ‘‘$1,000,000’’.

3 (c) TECHNICAL AND CONFORMING AMENDMENTS.—

4 (1) REPEAL OF CERTAIN AUTHORITY.—Section

5 215 of the Department of Health and Human Serv6 ices Appropriations Act, 1988, as contained in section

7 101(h) of Public Law 100–202 (101 Stat. 1329–275),

8 is repealed.

9 (2) APPLICABILITY OF CERTAIN NEW AUTHOR10 ITY.—With respect to the authority established for the

11 National Library of Medicine in section 465(b)(6) of

12 the Public Health Service Act, as added by subsection

13 (a) of this section, such authority shall be effective as

14 if the authority had been established on December 22,

15 1987.

16 SEC. 1402. AUTHORIZATION OF APPROPRIATIONS.

17 (a) ESTABLISHMENT OF SINGLE AUTHORIZATION.—

18 Subpart 1 of part D of title IV of the Public Health Service

19 Act (42 U.S.C. 286 et seq.) is amended by adding at the

20 end the following section:

21 ‘‘AUTHORIZATION OF APPROPRIATIONS

22 ‘‘SEC. 468. (a) For the purpose of carrying out this

23 part, there are authorized to be appropriated $150,000,000

24 for fiscal year 1994, and such sums as may be necessary

25 for each of the fiscal years 1995 and 1996.
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1 ‘‘(b) Amounts appropriated under subsection (a) and

2 made available for grants or contracts under any of sections

3 472 through 476 shall remain available until the end of

4 the fiscal year following the fiscal year for which the

5 amounts were appropriated.’’.

6 (b) CONFORMING AMENDMENTS.—Part D of title IV

7 of the Public Health Service Act (42 U.S.C. 286 et seq.)

8 is amended by striking section 469 and section 478(c).

9 Subtitle B—Financial Assistance

10 SEC. 1411. ESTABLISHMENT OF PROGRAM OF GRANTS FOR

11 DEVELOPMENT OF EDUCATION TECH12 NOLOGIES.

13 Section 473 of the Public Health Service Act (42

14 U.S.C. 286b–4) is amended by adding at the end the follow15 ing new subsection:

16 ‘‘(c)(1) The Secretary shall make grants to public or

17 nonprofit private institutions for the purpose of carrying

18 out projects of research on, and development and dem19 onstration of, new education technologies.

20 ‘‘(2) The purposes for which a grant under paragraph

21 (1) may be made include projects concerning—

22 ‘‘(A) computer-assisted teaching and testing of

23 clinical competence at health professions and research

24 institutions;
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1 ‘‘(B) the effective transfer of new information

2 from research laboratories to appropriate clinical ap3 plications;

4 ‘‘(C) the expansion of the laboratory and clinical

5 uses of computer-stored research databases; and

6 ‘‘(D) the testing of new technologies for training

7 health care professionals.

8 ‘‘(3) The Secretary may not make a grant under para9 graph (1) unless the applicant for the grant agrees to make

10 the projects available with respect to—

11 ‘‘(A) assisting in the training of health profes12 sions students; and

13 ‘‘(B) enhancing and improving the capabilities

14 of health professionals regarding research and teach15 ing.’’.

16 Subtitle C—National Information

17 Center on Health Services Re18 search and Health Care Tech19 nology

20 SEC. 1421. ESTABLISHMENT OF CENTER.

21 Part D of title IV of the Public Health Service Act

22 (42 U.S.C. 286 et seq.) is amended by adding at the end

23 the following new subpart:
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1 ‘‘Subpart 4—National Information Center on Health

2 Services Research and Health Care Technology

3 ‘‘NATIONAL INFORMATION CENTER

4 ‘‘SEC. 478A. (a) There is established within the Li5 brary an entity to be known as the National Information

6 Center on Health Services Research and Health Care Tech7 nology (in this section referred to as the ‘Center’).

8 ‘‘(b) The purpose of the Center is the collection, storage,

9 analysis, retrieval, and dissemination of information on

10 health services research, clinical practice guidelines, and on

11 health care technology, including the assessment of such

12 technology. Such purpose includes developing and main13 taining data bases and developing and implementing meth14 ods of carrying out such purpose.

15 ‘‘(c) The Director of the Center shall ensure that infor16 mation under subsection (b) concerning clinical practice

17 guidelines is collected and maintained electronically and in

18 a convenient format. Such Director shall develop and pub19 lish criteria for the inclusion of practice guidelines and

20 technology assessments in the information center database.

21 ‘‘(d) The Secretary, acting through the Center, shall

22 coordinate the activities carried out under this section

23 through the Center with related activities of the Adminis24 trator for Health Care Policy and Research.’’.
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1 SEC. 1422. CONFORMING PROVISIONS.

2 (a) IN GENERAL.—Section 903 of the Public Health

3 Service Act, as amended by section 3 of Public Law 102–

4 410 (106 Stat. 2094), is amended to read as follows:

5 ‘‘(e) REQUIRED INTERAGENCY AGREEMENT.—The Ad6 ministrator and the Director of the National Library of

7 Medicine shall enter into an agreement providing for the

8 implementation of section 478A.’’.

9 (b) RULE OF CONSTRUCTION.—The amendments made

10 by section 3 of Public Law 102–410 (106 Stat. 2094), by

11 section 1421 of this Act, and by subsection (a) of this section

12 may not be construed as terminating the information center

13 on health care technologies and health care technology as14 sessment established under section 904 of the Public Health

15 Service Act, as in effect on the day before the date of the

16 enactment of Public Law 102–410. Such center shall be con17 sidered to be the center established in section 478A of the

18 Public Health Service Act, as added by section 1421 of this

19 Act, and shall be subject to the provisions of such section

20 478A.
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1 TITLE XV—OTHER AGENCIES OF

2 NATIONAL INSTITUTES OF

3 HEALTH

4 Subtitle A—Division of Research

5 Resources

6 SEC. 1501. REDESIGNATION OF DIVISION AS NATIONAL

7 CENTER FOR RESEARCH RESOURCES.

8 Title IV of the Public Health Service Act (42 U.S.C.

9 281 et seq.) is amended—

10 (1) in section 401(b)(2)(B), by amending such

11 subparagraph to read as follows:

12 ‘‘(B) The National Center for Research Re13 sources.’’; and

14 (2) in part E—

15 (A) in the heading for subpart 1, by strik16 ing ‘‘Division of ’’ and inserting ‘‘National Cen17 ter for’’;

18 (B) in section 479, by striking ‘‘the Divi19 sion of Research Resources’’ and inserting the

20 following: ‘‘the National Center for Research Re21 sources (hereafter in this subpart referred to as

22 the ‘Center’)’’;

23 (C) in sections 480 and 481, by striking

24 ‘‘the Division of Research Resources’’ each place
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1 such term appears and inserting ‘‘the Center’’;

2 and

3 (D) in sections 480 and 481, as amended by

4 subparagraph (C), by striking ‘‘the Division’’

5 each place such term appears and inserting ‘‘the

6 Center’’.

7 SEC. 1502. BIOMEDICAL AND BEHAVIORAL RESEARCH FA8 CILITIES.

9 Subpart 1 of part E of title IV of the Public Health

10 Service Act (42 U.S.C. 287 et seq.) is amended by adding

11 at the end the following new section:

12 ‘‘BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES

13 ‘‘SEC. 481A. (a) MODERNIZATION AND CONSTRUCTION

14 OF FACILITIES.—

15 ‘‘(1) IN GENERAL.—The Director of NIH, acting

16 through the Director of the Center, may make grants

17 to public and nonprofit private entities to expand, re18 model, renovate, or alter existing research facilities or

19 construct new research facilities, subject to the provi20 sions of this section.

21 ‘‘(2) CONSTRUCTION AND COST OF CONSTRUC22 TION.—For purposes of this section, the terms ‘con23 struction’ and ‘cost of construction’ include the con24 struction of new buildings and the expansion, renova25 tion, remodeling, and alteration of existing buildings,
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1 including architects’ fees, but do not include the cost

2 of acquisition of land or off-site improvements.

3 ‘‘(b) SCIENTIFIC AND TECHNICAL REVIEW BOARDS

4 FOR MERIT-BASED REVIEW OF PROPOSALS.—

5 ‘‘(1) IN GENERAL; APPROVAL AS PRECONDITION

6 TO GRANTS.—

7 ‘‘(A) There is established within the Center

8 a Scientific and Technical Review Board on

9 Biomedical and Behavioral Research Facilities

10 (hereafter referred to in this section as the

11 ‘Board’).

12 ‘‘(B) The Director of the Center may ap13 prove an application for a grant under sub14 section (a) only if the Board has under para15 graph (2) recommended the application for ap16 proval.

17 ‘‘(2) DUTIES.—

18 ‘‘(A) The Board shall provide advice to the

19 Director of the Center and the advisory council

20 established under section 480 (hereafter in this

21 section referred to as the ‘Advisory Council’) on

22 carrying out this section.

23 ‘‘(B) In carrying out subparagraph (A), the

24 Board shall make a determination of the merit

25 of each application submitted for a grant under
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1 subsection (a), after consideration of the require2 ments established in subsection (c), and shall re3 port the results of the determination to the Direc4 tor of the Center and the Advisory Council. Such

5 determinations shall be conducted in a manner

6 consistent with procedures established under sec7 tion 492.

8 ‘‘(C) In carrying out subparagraph (A), the

9 Board shall, in the case of applications rec10 ommended for approval, make recommendations

11 to the Director and the Advisory Council on the

12 amount that should be provided in the grant.

13 ‘‘(D) In carrying out subparagraph (A), the

14 Board shall prepare an annual report for the Di15 rector of the Center and the Advisory Council de16 scribing the activities of the Board in the fiscal

17 year for which the report is made. Each such re18 port shall be available to the public, and shall—

19 ‘‘(i) summarize and analyze expendi20 tures made under this section;

21 ‘‘(ii) provide a summary of the types,

22 numbers, and amounts of applications that

23 were recommended for grants under sub24 section (a) but that were not approved by

25 the Director of the Center; and
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1 ‘‘(iii) contain the recommendations of

2 the Board for any changes in the adminis3 tration of this section.

4 ‘‘(3) MEMBERSHIP.—

5 ‘‘(A) Subject to subparagraph (B), the

6 Board shall be composed of such appointed and

7 ex officio members as the Director of the Center

8 may determine.

9 ‘‘(B) Not more than 3 individuals who are

10 officers or employees of the Federal Government

11 may serve as members of the Board.

12 ‘‘(C) Of the members of the Board—

13 ‘‘(i) 12 shall be appointed by the Di14 rector of the Center (without regard to the

15 civil service laws); and

16 ‘‘(ii) 1 shall be an official of the Na17 tional Science Foundation designated by the

18 National Science Board.

19 ‘‘(4) CERTAIN REQUIREMENTS REGARDING MEM20 BERSHIP.—In selecting individuals for membership

21 on the Board, the Director of the Center shall ensure

22 that the members are individuals who, by the virtue

23 of their training or experience, are eminently quali24 fied to perform peer review functions. In selecting

25 such individuals for such membership, the Director of
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1 the Center shall ensure that the members of the Board

2 collectively—

3 ‘‘(A) are experienced in the planning, con4 struction, financing, and administration of enti5 ties that conduct biomedical or behavioral re6 search sciences;

7 ‘‘(B) are knowledgeable in making deter8 minations of the need of entities for biomedical

9 or behavioral research facilities, including such

10 facilities for the dentistry, nursing, pharmacy,

11 and allied health professions;

12 ‘‘(C) are knowledgeable in evaluating the

13 relative priorities for applications for grants

14 under subsection (a) in view of the overall re15 search needs of the United States; and

16 ‘‘(D) are experienced with emerging centers

17 of excellence, as described in subsection (c)(3).

18 ‘‘(5) CERTAIN AUTHORITIES.—

19 ‘‘(A) In carrying out paragraph (2), the

20 Board may establish subcommittees, convene

21 workshops and conferences, and collect data as

22 the Board considers appropriate.

23 ‘‘(B) In carrying out paragraph (2), the

24 Board may establish subcommittees within the

25 Board. Such subcommittees may hold meetings
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1 as determined necessary to enable the sub2 committee to carry out its duties.

3 ‘‘(6) TERMS.—

4 ‘‘(A) Except as provided in subparagraph

5 (B), each appointed member of the Board shall

6 hold office for a term of 4 years. Any member

7 appointed to fill a vacancy occurring prior to

8 the expiration of the term for which such mem9 ber’s predecessor was appointed shall be ap10 pointed for the remainder of the term of the

11 predecessor.

12 ‘‘(B) Of the initial members appointed to

13 the Board (as specified by the Director of the

14 Center when making the appointments)—

15 ‘‘(i) 3 shall hold office for a term of 3

16 years;

17 ‘‘(ii) 3 shall hold office for a term of 2

18 years; and

19 ‘‘(iii) 3 shall hold office for a term of

20 1 year.

21 ‘‘(C) No member is eligible for reappoint22 ment to the Board until 1 year has elapsed after

23 the end of the most recent term of the member.

24 ‘‘(7) COMPENSATION.—Members of board who

25 are not officers or employees of the United States
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1 shall receive compensation for each day engaged in

2 carrying out the duties of the board, including time

3 engaged in traveling for purposes of such duties. Such

4 compensation may not be provided in an amount in

5 excess of the maximum rate of basic pay payable for

6 GS–18 of the General Schedule.

7 ‘‘(c) REQUIREMENTS FOR GRANTS.—

8 ‘‘(1) IN GENERAL.—The Director of the Center

9 may make a grant under subsection (a) only if the

10 applicant for the grant meets the following conditions:

11 ‘‘(A) The applicant is determined by such

12 Director to be competent to engage in the type of

13 research for which the proposed facility is to be

14 constructed.

15 ‘‘(B) The applicant provides assurances sat16 isfactory to the Director that—

17 ‘‘(i) for not less than 20 years after

18 completion of the construction, the facility

19 will be used for the purposes of research for

20 which it is to be constructed;

21 ‘‘(ii) sufficient funds will be available

22 to meet the non-Federal share of the cost of

23 constructing the facility;

24 ‘‘(iii) sufficient funds will be available,

25 when construction is completed, for the ef-
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1 fective use of the facility for the research for

2 which it is being constructed; and

3 ‘‘(iv) the proposed construction will ex4 pand the applicant’s capacity for research,

5 or is necessary to improve or maintain the

6 quality of the applicant’s research.

7 ‘‘(C) The applicant meets reasonable quali8 fications established by the Director with respect

9 to—

10 ‘‘(i) the relative scientific and technical

11 merit of the applications, and the relative

12 effectiveness of the proposed facilities, in ex13 panding the capacity for biomedical or be14 havioral research and in improving the

15 quality of such research;

16 ‘‘(ii) the quality of the research or

17 training, or both, to be carried out in the

18 facilities involved;

19 ‘‘(iii) the need of the applicant for such

20 facilities in order to maintain or expand

21 the applicant’s research and training mis22 sion;

23 ‘‘(iv) the congruence of the research ac24 tivities to be carried out within the facility
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1 with the research and investigator man2 power needs of the United States; and

3 ‘‘(v) the age and condition of existing

4 research facilities and equipment.

5 ‘‘(D) The applicant has demonstrated a

6 commitment to enhancing and expanding the re7 search productivity of the applicant.

8 ‘‘(2) CONSIDERATION OF CERTAIN FACTORS.—In

9 making grants under subsection (a), the Director of

10 the Center may, in addition to the requirements es11 tablished in paragraph (1), consider the following fac12 tors:

13 ‘‘(A) To what extent the applicant has the

14 capacity to broaden the scope of research and re15 search training programs of the applicant by

16 promoting—

17 ‘‘(i) interdisciplinary research;

18 ‘‘(ii) research on emerging technologies,

19 including those involving novel analytical

20 techniques or computational methods; or

21 ‘‘(iii) other novel research mechanisms

22 or programs.

23 ‘‘(B) To what extent the applicant has

24 broadened the scope of research and research

25 training programs of qualified institutions by
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1 promoting genomic research with an emphasis

2 on interdisciplinary research, including research

3 related to pediatric investigations.

4 ‘‘(3) INSTITUTIONS OF EMERGING EXCEL5 LENCE.—Of the amounts appropriated under sub6 section (i) for a fiscal year, the Director of the Center

7 shall make available 25 percent for grants under sub8 section (a) to applicants that, in addition to meeting

9 the requirements established in paragraph (1), have

10 demonstrated emerging excellence in biomedical or be11 havioral research, as follows:

12 ‘‘(A) The applicant has a plan for research

13 or training advancement and possesses the abil14 ity to carry out the plan.

15 ‘‘(B) The applicant carries out research and

16 research training programs that have a special

17 relevance to a problem, concern, or unmet health

18 need of the United States.

19 ‘‘(C) The applicant has been productive in

20 research or research development and training.

21 ‘‘(D) The applicant—

22 ‘‘(i) has been designated as a center of

23 excellence under section 739;

24 ‘‘(ii) is located in a geographic area a

25 significant percentage of whose population
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1 has a health-status deficit, and the appli2 cant provides health services to such popu3 lation; or

4 ‘‘(iii) is located in a geographic area

5 in which a deficit in health care technology,

6 services, or research resources may adversely

7 affect health status of the population of the

8 area in the future, and the applicant is car9 rying out activities with respect to protect10 ing the health status of such population.

11 ‘‘(d) REQUIREMENT OF APPLICATION.—The Director

12 of the Center may make a grant under subsection (a) only

13 if an application for the grant is submitted to the Director

14 and the application is in such form, is made in such man15 ner, and contains such agreements, assurances, and infor16 mation as the Director determines to be necessary to carry

17 out this section.

18 ‘‘(e) AMOUNT OF GRANT; PAYMENTS.—

19 ‘‘(1) AMOUNT.—The amount of any grant

20 awarded under subsection (a) shall be determined by

21 the Director of the Center, except that such amount

22 shall not exceed—

23 ‘‘(A) 50 percent of the necessary cost of the

24 construction of a proposed facility as determined

25 by the Director; or
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1 ‘‘(B) in the case of a multipurpose facility,

2 40 percent of that part of the necessary cost of

3 construction that the Director determines to be

4 proportionate to the contemplated use of the fa5 cility.

6 ‘‘(2) RESERVATION OF AMOUNTS.—On approval

7 of any application for a grant under subsection (a),

8 the Director of the Center shall reserve, from any ap9 propriation available therefore, the amount of such

10 grant, and shall pay such amount, in advance or by

11 way of reimbursement, and in such installments con12 sistent with the construction progress, as the Director

13 may determine appropriate. The reservation of the

14 Director of any amount by the Director under this

15 paragraph may be amended by the Director, either on

16 the approval of an amendment of the application or

17 on the revision of the estimated cost of construction

18 of the facility.

19 ‘‘(3) EXCLUSION OF CERTAIN COSTS.—In deter20 mining the amount of any grant under this sub21 section (a), there shall be excluded from the cost of

22 construction an amount equal to the sum of—

23 ‘‘(A) the amount of any other Federal grant

24 that the applicant has obtained, or is assured of

25 obtaining, with respect to construction that is to
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1 be financed in part by a grant authorized under

2 this section; and

3 ‘‘(B) the amount of any non-Federal funds

4 required to be expended as a condition of such

5 other Federal grant.

6 ‘‘(4) WAIVER OF LIMITATIONS.—The limitations

7 imposed by paragraph (1) may be waived at the dis8 cretion of the Director for applicants meeting the con9 ditions described in paragraphs (1) and (2) of sub10 section (c).

11 ‘‘(f) RECAPTURE OF PAYMENTS.—If, not later than 20

12 years after the completion of construction for which a grant

13 has been awarded under subsection (a)—

14 ‘‘(1) the applicant or other owner of the facility

15 shall cease to be a public or nonprofit private entity;

16 or

17 ‘‘(2) the facility shall cease to be used for the re18 search purposes for which it was constructed (unless

19 the Director determines, in accordance with regula20 tions, that there is good cause for releasing the appli21 cant or other owner from obligation to do so);

22 the United States shall be entitled to recover from the appli23 cant or other owner of the facility the amount bearing the

24 same ratio to the current value (as determined by an agree25 ment between the parties or by action brought in the United
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1 States District Court for the district in which such facility

2 is situated) of the facility as the amount of the Federal par3 ticipation bore to the cost of the construction of such

4 facility.

5 ‘‘(g) NONINTERFERENCE WITH ADMINISTRATION OF

6 ENTITIES.—Except as otherwise specifically provided in

7 this section, nothing contained in this part shall be con8 strued as authorizing any department, agency, officer, or

9 employee of the United States to exercise any direction, su10 pervision, or control over, or impose any requirement or

11 condition with respect to the administration of any entity

12 funded under this part.

13 ‘‘(h) GUIDELINES.—Not later than 6 months after the

14 date of the enactment of this section, the Director of the

15 Center, after consultation with the Advisory Council, shall

16 issue guidelines with respect to grants under subsection (a).

17 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—For the

18 purpose of carrying out this section, there are authorized

19 to be appropriated $150,000,000 for fiscal year 1994, and

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

21 1995 and 1996.’’.
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1 SEC. 1503. CONSTRUCTION PROGRAM FOR NATIONAL PRI2 MATE RESEARCH CENTER.

3 Subpart 1 of part E of title IV of the Public Health

4 Service Act, as amended by section 1502 of this Act, is

5 amended by adding at the end the following new section:

6 ‘‘CONSTRUCTION OF REGIONAL CENTERS FOR RESEARCH

7 ON PRIMATES

8 ‘‘SEC. 481B. (a) With respect to activities carried out

9 by the National Center for Research Resources to support

10 regional centers for research on primates, the Director of

11 NIH shall, for each of the fiscal years 1994 through 1996,

12 reserve from the amounts appropriated under section

13 481A(i) $7,000,000 for the purpose of making awards of

14 grants and contracts to public or nonprofit private entities

15 to construct, renovate, or otherwise improve such regional

16 centers. The reservation of such amounts for any fiscal year

17 is subject to the availability of qualified applicants for such

18 awards.

19 ‘‘(b) The Director of NIH may not make a grant or

20 enter into a contract under subsection (a) unless the appli21 cant for such assistance agrees, with respect to the costs to

22 be incurred by the applicant in carrying out the purpose

23 described in such subsection, to make available (directly or

24 through donations from public or private entities) non-Fed25 eral contributions in cash toward such costs in an amount
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1 equal to not less than $1 for each $4 of Federal funds pro2 vided in such assistance.’’.

3 Subtitle B—National Center for

4 Nursing Research

5 SEC. 1511. REDESIGNATION OF NATIONAL CENTER FOR

6 NURSING RESEARCH AS NATIONAL INSTI7 TUTE OF NURSING RESEARCH.

8 (a) IN GENERAL.—Subpart 3 of part E of title IV of

9 the Public Health Service Act (42 U.S.C. 287c et seq.) is

10 amended—

11 (1) in section 483—

12 (A) in the heading for the section, by strik13 ing ‘‘CENTER’’ and inserting ‘‘INSTITUTE’’; and

14 (B) by striking ‘‘The general purpose’’ and

15 all that follows through ‘‘is’’ and inserting the

16 following: ‘‘The general purpose of the National

17 Institute of Nursing Research (hereafter in this

18 subpart referred to as the ‘Institute’) is’’;

19 (2) in section 484, by striking ‘‘Center’’ each

20 place such term appears and inserting ‘‘Institute’’;

21 (3) in section 485—

22 (A) in subsection (a), in each of paragraphs

23 (1) through (3), by striking ‘‘Center’’ each place

24 such term appears and inserting ‘‘Institute’’;

25 (B) in subsection (b)—
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1 (i) in paragraph (2)(A), by striking

2 ‘‘Center’’ and inserting ‘‘Institute’’; and

3 (ii) in paragraph (3)(A), in the first

4 sentence, by striking ‘‘Center’’ and inserting

5 ‘‘Institute’’; and

6 (C) in subsections (d) through (g), by strik7 ing ‘‘Center’’ each place such term appears and

8 inserting ‘‘Institute’’; and

9 (4) in section 485A (as redesignated by section

10 141(a)(1) of this Act), by striking ‘‘Center’’ each place

11 such term appears and inserting ‘‘Institute’’.

12 (b) CONFORMING AMENDMENTS.—

13 (1) ORGANIZATION OF NATIONAL INSTITUTE OF

14 HEALTH.—Section 401(b) of the Public Health Serv15 ice Act (42 U.S.C. 281(b)) is amended—

16 (A) in paragraph (1), by adding at the end

17 the following new subparagraph:

18 ‘‘(Q) The National Institute of Nursing Re19 search.’’; and

20 (B) in paragraph (2), by striking subpara21 graph (D).

22 (2) TRANSFER OF STATUTORY PROVISIONS.—Sec23 tions 483 through 485A of the Public Health Service

24 Act, as amended by subsection (a) of this section—
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1 (A) are transferred to part C of title IV of

2 such Act;

3 (B) are redesignated as sections 464V

4 through 464Y of such part; and

5 (C) are inserted, in the appropriate se6 quence, at the end of such part.

7 (3) HEADING FOR NEW SUBPART.—Title IV of

8 the Public Health Service Act, as amended by the pre9 ceding provisions of this section, is amended—

10 (A) in part C, by inserting before section

11 464V the following new heading:

12 ‘‘Subpart 17—National Institute of Nursing Research’’;

13 and

14 (B) by striking the heading for subpart 3 of

15 part E.

16 (4) CROSS-REFERENCES.—Title IV of the Public

17 Health Service Act, as amended by the preceding pro18 visions of this section, is amended in subpart 17 of

19 part C—

20 (A) in section 464W, by striking ‘‘section

21 483’’ and inserting ‘‘section 464V’’;

22 (B) in section 464X(g), by striking ‘‘section

23 486’’ and inserting ‘‘section 464Y’’; and
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1 (C) in section 464Y, in the last sentence, by

2 striking ‘‘section 485(g)’’ and inserting ‘‘section

3 464X(g)’’.

4 SEC. 1512. STUDY ON ADEQUACY OF NUMBER OF NURSES.

5 (a) IN GENERAL.—The Secretary of Health and

6 Human Services, acting through the Director of the Na7 tional Institute of Nursing Research, shall enter into a con8 tract with a public or nonprofit private entity to conduct

9 a study for the purpose of determining whether and to what

10 extent there is a need for an increase in the number of

11 nurses in hospitals and nursing homes in order to promote

12 the quality of patient care and reduce the incidence among

13 nurses of work-related injuries and stress.

14 (b) NATIONAL ACADEMY OF SCIENCES.—The Secretary

15 shall request the National Academy of Sciences to enter into

16 the contract under subsection (a) to conduct the study de17 scribed in such subsection. If such Institute declines to con18 duct the study, the Secretary shall carry out such subsection

19 through another public or nonprofit private entity.

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

21 (1) The term ‘‘nurse’’ means a registered nurse,

22 a licensed practical nurse, a licensed vocational

23 nurse, and a nurse assistant.

24 (2) The term ‘‘Secretary’’ means the Secretary of

25 Health and Human Services.
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1 (d) REPORT.—The Secretary shall ensure that, not

2 later than October 1, 1994, the study required in subsection

3 (a) is completed and a report describing the findings made

4 as a result of the study is submitted to the Committee on

5 Energy and Commerce of the House of Representatives, and

6 to the Committee on Labor and Human Resources of the

7 Senate.

8 Subtitle C—National Center for

9 Human Genome Research

10 SEC. 1521. PURPOSE OF CENTER.

11 Title IV of the Public Health Service Act, as amended

12 by sections 141(a)(1) and 1611(b)(1)(B) of this Act, is

13 amended—

14 (1) in section 401(b)(2), by adding at the end the

15 following new subparagraph:

16 ‘‘(D) The National Center for Human Genome

17 Research.’’; and

18 (2) in part E, by adding at the end the following

19 new subpart:

20 ‘‘Subpart 4—National Center for Human Genome

21 Research

22 ‘‘PURPOSE OF THE CENTER

23 ‘‘SEC. 485B. (a) The general purpose of the National

24 Center for Human Genome Research (hereafter in this sub25 part referred to as the ‘Center’) is to characterize the struc-
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1 ture and function of the human genome, including the map2 ping and sequencing of individual genes. Such purpose in3 cludes—

4 ‘‘(1) planning and coordinating the research goal

5 of the genome project;

6 ‘‘(2) reviewing and funding research proposals;

7 ‘‘(3) developing training programs;

8 ‘‘(4) coordinating international genome research;

9 ‘‘(5) communicating advances in genome science

10 to the public; and

11 ‘‘(6) reviewing and funding proposals to address

12 the ethical issues associated with the genome project.

13 ‘‘(b)(1) Except as provided in paragraph (2), of the

14 amounts appropriated to carry out subsection (a) for a fis15 cal year, the Director of the Center shall make available

16 not less than 5 percent for carrying out paragraph (6) of

17 such subsection.

18 ‘‘(2) With respect to providing funds under subsection

19 (a)(6) for proposals to address the ethical issues associated

20 with the genome project, paragraph (1) shall not apply for

21 a fiscal year if the Director of the Center certifies to the

22 Committee on Energy and Commerce of the House of Rep23 resentatives, and to the Committee on Labor and Human

24 Resources of the Senate, that the Director has determined
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1 that an insufficient number of such proposals meet the ap2 plicable requirements of sections 491 and 492.’’.

3 TITLE XVI—AWARDS AND

4 TRAINING

5 Subtitle A—National Research

6 Service Awards

7 SEC. 1601. REQUIREMENT REGARDING WOMEN AND INDI8 VIDUALS FROM DISADVANTAGED BACK9 GROUNDS.

10 Section 487(a) of the Public Health Service Act (42

11 U.S.C. 288(a)(4)) is amended by adding at the end the fol12 lowing paragraph:

13 ‘‘(4) The Secretary shall carry out paragraph (1) in

14 a manner that will result in the recruitment of women, and

15 members from underrepresented minority groups, into fields

16 of biomedical or behavioral research and in the provision

17 of research training to women and such individuals.’’.

18 SEC. 1602. SERVICE PAYBACK REQUIREMENTS.

19 Paragraph (2) of section 487(c) of the Public Health

20 Service Act (42 U.S.C. 288(c)(2)) is amended to read as

21 follows:

22 ‘‘(2)(A) For the initial year for which an individual

23 receives a National Research Service Award for the conduct

24 of postdoctoral training or research, such individual shall

25 engage in one year of health research or teaching or any
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1 combination thereof which is in accordance with the usual

2 patterns of academic employment, or complete a second

3 year of training or research under such Award.

4 ‘‘(B) Service obligations for National Research Service

5 Awards that are less than 12 months may be satisfied—

6 ‘‘(i) by the conduct of health research or teaching

7 or any combination thereof which is in accordance

8 with the usual patterns of academic employment for

9 a period of time equal to the amount of time under

10 the Award; or

11 ‘‘(ii) by reimbursing the Federal Government for

12 the amounts provided to such individual under the

13 Award.’’.

14 Subtitle B—Acquired Immune

15 Deficiency Syndrome

16 SEC. 1611. LOAN REPAYMENT PROGRAM.

17 Section 487A of the Public Health Service Act (42

18 U.S.C. 288–1) is amended to read as follows:

19 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH

20 RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME

21 ‘‘SEC. 487A. (a) IN GENERAL.—

22 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

23 paragraph (2), the Secretary shall carry out a pro24 gram of entering into agreements with appropriately

25 qualified health professionals under which such health

26 professionals agree to conduct, as employees of the Na-
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1 tional Institutes of Health, research with respect to

2 acquired immune deficiency syndrome in consider3 ation of the Federal Government agreeing to repay,

4 for each year of such service, not more than $20,000

5 of the principal and interest of the educational loans

6 of such health professionals.

7 ‘‘(2) LIMITATION.—The Secretary may not enter

8 into an agreement with a health professional pursu9 ant to paragraph (1) unless such professional—

10 ‘‘(A) has a substantial amount of edu11 cational loans relative to income; and

12 ‘‘(B)(i) was not employed at the National

13 Institutes of Health during the 1-year period

14 preceding the date of the enactment of the Health

15 Professions Reauthorization Act of 1988; or

16 ‘‘(ii) agrees to serve as an employee of such

17 Institutes for purposes of paragraph (1) for a pe18 riod of not less than 3 years.’’.

19 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—With

20 respect to the National Health Service Corps Loan Repay21 ment Program established in subpart III of part D of title

22 III, the provisions of such subpart shall, except as inconsist23 ent with subsection (a) of this section, apply to the program

24 established in such subsection (a) in the same manner and

25 to the same extent as such provisions apply to the National
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1 Health Service Corps Loan Repayment Program established

2 in such subpart.

3 ‘‘(c) FUNDING; REIMBURSABLE TRANSFERS.—

4 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—For

5 the purpose of carrying out this section, there are au6 thorized to be appropriated such sums as may be nec7 essary for each of the fiscal years 1994 through 1996.

8 ‘‘(2) TRANSFERS FOR RELATED PROGRAM.—The

9 Commissioner of Food and Drugs may carry out for

10 the Food and Drug Administration a program simi11 lar to the program established in subsection (a),

12 which program shall be carried out with respect to the

13 review of applications concerning acquired immune

14 deficiency syndrome that are submitted to such Com15 missioner. From the amounts appropriated under

16 paragraph (1) for a fiscal year, the Secretary may

17 transfer amounts to the Commissioner for the purpose

18 of carrying out such program. The Commissioner

19 shall provide a reimbursement to the Secretary for the

20 amount so transferred, and the reimbursement shall

21 be available only for the program established in sub22 section (a). Any transfer and reimbursement made for

23 purposes of this paragraph for a fiscal year shall be

24 completed by April 1 of such year.’’.
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1 Subtitle C—Loan Repayment for

2 Research Generally

3 SEC. 1621. ESTABLISHMENT OF PROGRAM.

4 Part G of title IV of the Public Health Service Act,

5 as redesignated by section 141(a)(2) of this Act and as

6 amended by section 1002 of this Act, is amended by insert7 ing after section 487B the following new section:

8 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH GENERALLY

9 ‘‘SEC. 487C. (a) IN GENERAL.—

10 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

11 paragraph (2), the Secretary shall carry out a pro12 gram of entering into agreements with appropriately

13 qualified health professionals under which such health

14 professionals agree to conduct research, as employees

15 of the National Institutes of Health, in consideration

16 of the Federal Government agreeing to repay, for each

17 year of such service, not more than $20,000 of the

18 principal and interest of the educational loans of such

19 health professionals.

20 ‘‘(2) LIMITATION.—The Secretary may not enter

21 into an agreement with a health professional pursu22 ant to paragraph (1) unless such professional—

23 ‘‘(A) has a substantial amount of edu24 cational loans relative to income; and
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1 ‘‘(B)(i) was not employed at the National

2 Institutes of Health during the 1-year period

3 preceding the date of the enactment of the Health

4 Professions Reauthorization Act of 1988; or

5 ‘‘(ii) agrees to serve as an employee of such

6 Institutes for purposes of paragraph (1) for a pe7 riod of not less than 3 years.’’.

8 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—With

9 respect to the National Health Service Corps Loan Repay10 ment Program established in subpart III of part D of title

11 III, the provisions of such subpart shall, except as inconsist12 ent with subsection (a) of this section, apply to the program

13 established in such subsection (a) in the same manner and

14 to the same extent as such provisions apply to the National

15 Health Service Corps Loan Repayment Program established

16 in such subpart.

17 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the

18 purpose of carrying out this section other than with respect

19 to acquired immune deficiency syndrome, there are author20 ized to be appropriated such sums as may be necessary for

21 each of the fiscal years 1994 through 1996.’’.
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1 Subtitle D—Scholarship and Loan

2 Repayment Programs Regarding

3 Professional Skills Needed by

4 Certain Agencies

5 SEC. 1631. ESTABLISHMENT OF PROGRAMS FOR NATIONAL

6 INSTITUTES OF HEALTH.

7 Part G of title IV of the Public Health Service Act,

8 as redesignated by section 141(a)(2) of this Act and as

9 amended by section 1621 of this Act, is amended by insert10 ing after section 487C the following new sections:

11 ‘‘UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING

12 PROFESSIONS NEEDED BY NATIONAL RESEARCH IN13 STITUTES

14 ‘‘SEC. 487D. (a) ESTABLISHMENT OF PROGRAM.—

15 ‘‘(1) IN GENERAL.—Subject to section

16 487(a)(1)(C), the Secretary, acting through the Direc17 tor of NIH, may carry out a program of entering into

18 contracts with individuals described in paragraph (2)

19 under which—

20 ‘‘(A) the Director of NIH agrees to provide

21 to the individuals scholarships for pursuing, as

22 undergraduates at accredited institutions of

23 higher education, academic programs appro24 priate for careers in professions needed by the

25 National Institutes of Health; and
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1 ‘‘(B) the individuals agree to serve as em2 ployees of the National Institutes of Health, for

3 the period described in subsection (c), in posi4 tions that are needed by the National Institutes

5 of Health and for which the individuals are

6 qualified.

7 ‘‘(2) INDIVIDUALS FROM DISADVANTAGED BACK8 GROUNDS.—The individuals referred to in paragraph

9 (1) are individuals who—

10 ‘‘(A) are enrolled or accepted for enrollment

11 as full-time undergraduates at accredited institu12 tions of higher education; and

13 ‘‘(B) are from minority groups that are

14 underrepresented in the fields of biomedical or

15 behavioral research.

16 ‘‘(b) FACILITATION OF INTEREST OF STUDENTS IN CA17 REERS AT NATIONAL INSTITUTES OF HEALTH.—In provid18 ing employment to individuals pursuant to contracts under

19 subsection (a)(1), the Director of NIH shall carry out ac20 tivities to facilitate the interest of the individuals in pursu21 ing careers as employees of the National Institutes of

22 Health.

23 ‘‘(c) PERIOD OF OBLIGATED SERVICE.—

24 ‘‘(1) DURATION OF SERVICE.—For purposes of

25 subparagraph (B) of subsection (a)(1), the period of
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1 service for which an individual is obligated to serve

2 as an employee of the National Institutes of Health

3 is 12 months for each academic year for which the

4 scholarship under such subsection is provided.

5 ‘‘(2) SCHEDULE FOR SERVICE.—

6 ‘‘(A) Subject to subparagraph (B), the Di7 rector of NIH may not provide a scholarship

8 under subsection (a) unless the individual apply9 ing for the scholarship agrees that—

10 ‘‘(i) the individual will serve as an em11 ployee of the National Institutes of Health

12 full-time for not less than 10 consecutive

13 weeks of each year during which the indi14 vidual is attending the educational institu15 tion involved and receiving such a scholar16 ship;

17 ‘‘(ii) the period of service as such an

18 employee that the individual is obligated to

19 provide under clause (i) is in addition to

20 the period of service as such an employee

21 that the individual is obligated to provide

22 under subsection (a)(1)(B); and

23 ‘‘(iii) not later than 60 days after ob24 taining the educational degree involved, the

25 individual will begin serving full-time as
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1 such an employee in satisfaction of the pe2 riod of service that the individual is obli3 gated to provide under subsection (a)(1)(B).

4 ‘‘(B) The Director of NIH may defer the ob5 ligation of an individual to provide a period of

6 service under subsection (a)(1)(B), if the Direc7 tor determines that such a deferral is appro8 priate.

9 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS RE10 LATING TO APPOINTMENT AND COMPENSATION.—For

11 any period in which an individual provides service as

12 an employee of the National Institutes of Health in

13 satisfaction of the obligation of the individual under

14 subsection (a)(1)(B) or paragraph (2)(A)(i), the indi15 vidual may be appointed as such an employee with16 out regard to the provisions of title 5, United States

17 Code, relating to appointment and compensation.

18 ‘‘(d) PROVISIONS REGARDING SCHOLARSHIP.—

19 ‘‘(1) APPROVAL OF ACADEMIC PROGRAM.—The

20 Director of NIH may not provide a scholarship under

21 subsection (a) for an academic year unless—

22 ‘‘(A) the individual applying for the schol23 arship has submitted to the Director a proposed

24 academic program for the year and the Director

25 has approved the program; and
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1 ‘‘(B) the individual agrees that the program

2 will not be altered without the approval of the

3 Director.

4 ‘‘(2) ACADEMIC STANDING.—The Director of

5 NIH may not provide a scholarship under subsection

6 (a) for an academic year unless the individual apply7 ing for the scholarship agrees to maintain an accept8 able level of academic standing, as determined by the

9 educational institution involved in accordance with

10 regulations issued by the Secretary.

11 ‘‘(3) LIMITATION ON AMOUNT.—The Director of

12 NIH may not provide a scholarship under subsection

13 (a) for an academic year in an amount exceeding

14 $20,000.

15 ‘‘(4) AUTHORIZED USES.—A scholarship pro16 vided under subsection (a) may be expended only for

17 tuition expenses, other reasonable educational ex18 penses, and reasonable living expenses incurred in at19 tending the school involved.

20 ‘‘(5) CONTRACT REGARDING DIRECT PAYMENTS

21 TO INSTITUTION.—In the case of an institution of

22 higher education with respect to which a scholarship

23 under subsection (a) is provided, the Director of NIH

24 may enter into a contract with the institution under

25 which the amounts provided in the scholarship for
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1 tuition and other educational expenses are paid di2 rectly to the institution. Payments to the institution

3 under the contract may be made without regard to

4 section 3324 of title 31, United States Code.

5 ‘‘(e) PENALTIES FOR BREACH OF SCHOLARSHIP CON6 TRACT.—The provisions of section 338E shall apply to the

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

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

9 National Health Service Corps Loan Repayment Program

10 established in section 338B.

11 ‘‘(f) REQUIREMENT OF APPLICATION.—The Director of

12 NIH may not provide a scholarship under subsection (a)

13 unless an application for the scholarship is submitted to

14 the Director and the application is in such form, is made

15 in such manner, and contains such agreements, assurances,

16 and information as the Director determines to be necessary

17 to carry out this section.

18 ‘‘(g) AVAILABILITY OF AUTHORIZATION OF APPRO19 PRIATIONS.—Amounts appropriated for a fiscal year for

20 scholarships under this section shall remain available until

21 the expiration of the second fiscal year beginning after the

22 fiscal year for which the amounts were appropriated.

23 ‘‘LOAN REPAYMENT PROGRAM REGARDING CLINICAL

24 RESEARCHERS FROM DISADVANTAGED BACKGROUNDS

25 ‘‘SEC. 487E. (a) IMPLEMENTATION OF PROGRAM.—
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1 ‘‘(1) IN GENERAL.—Subject to section

2 487(a)(1)(C), the Secretary, acting through the Direc3 tor of NIH may, subject to paragraph (2), carry out

4 a program of entering into contracts with appro5 priately qualified health professionals who are from

6 disadvantaged backgrounds under which such health

7 professionals agree to conduct clinical research as em8 ployees of the National Institutes of Health in consid9 eration of the Federal Government agreeing to pay,

10 for each year of such service, not more than $20,000

11 of the principal and interest of the educational loans

12 of the health professionals.

13 ‘‘(2) LIMITATION.—The Director of NIH may

14 not enter into a contract with a health professional

15 pursuant to paragraph (1) unless such professional

16 has a substantial amount of education loans relative

17 to income.

18 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS RE19 GARDING OBLIGATED SERVICE.—Except to the extent

20 inconsistent with this section, the provisions of sec21 tions 338C and 338E shall apply to the program es22 tablished in paragraph (1) to the same extent and in

23 the same manner as such provisions apply to the Na24 tional Health Service Corps Loan Repayment Pro25 gram established in section 338B.
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1 ‘‘(b) AVAILABILITY OF AUTHORIZATION OF APPRO2 PRIATIONS.—Amounts appropriated for a fiscal year for

3 contracts under subsection (a) shall remain available until

4 the expiration of the second fiscal year beginning after the

5 fiscal year for which the amounts were appropriated.’’.

6 SEC. 1632. FUNDING.

7 Section 487(a)(1) of the Public Health Service Act (42

8 U.S.C. 288(a)(1)) is amended—

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

10 the semicolon at the end;

11 (2) in subparagraph (B), by striking the period

12 at the end and inserting ‘‘; and’’; and

13 (3) by adding at the end the following new sub14 paragraph:

15 ‘‘(C) provide contracts for scholarships and loan

16 repayments in accordance with sections 487D and

17 487E, subject to providing not more than an aggre18 gate 50 such contracts during the fiscal years 1994

19 through 1996.’’.

20 Subtitle D—Funding

21 SEC. 1641. AUTHORIZATION OF APPROPRIATIONS.

22 Section 487(d) of the Public Health Service Act (42

23 U.S.C. 288(d)) is amended—

24 (1) in the first sentence, by amending the sen25 tence to read as follows: ‘‘For the purpose of carrying
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1 out this section, there are authorized to be appro2 priated $400,000,000 for fiscal year 1994, and such

3 sums as may be necessary for each of the fiscal years

4 1995 and 1996.’’; and

5 (2) in paragraph (3)—

6 (A) by striking ‘‘one-half of one percent’’

7 each place such term appears and inserting ‘‘1

8 percent’’; and

9 (B) by striking ‘‘780, 784, or 786’’ and in10 serting ‘‘747, 748, or 749’’.

11 TITLE XVII—NATIONAL FOUNDA12 TION FOR BIOMEDICAL RE13 SEARCH

14 SEC. 1701. ESTABLISHMENT OF FOUNDATION.

15 Section 499 of the Public Health Service Act, as redes16 ignated by section 121(b), is amended to read as follows:

17 ‘‘SEC. 499A. ESTABLISHMENT AND DUTIES OF FOUNDATION.

18 ‘‘(a) IN GENERAL.—The Secretary shall establish a

19 nonprofit corporation to be known as the National Founda20 tion for Biomedical Research (hereafter in this section re21 ferred to as the ‘Foundation’). The Foundation shall not,

22 except for the purposes of the Ethics in Government Act

23 and the Technology Transfer Act, be an agency or instru24 mentality of the United States Government.
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1 ‘‘(b) PURPOSE OF FOUNDATION.—The purpose of the

2 Foundation shall be to conduct and support research with

3 respect to any particular disease or groups of diseases or

4 any other aspect of human health.

5 ‘‘(c) ENDOWMENT FUND.—

6 ‘‘(1) IN GENERAL.—In carrying out subsection

7 (b), the Foundation shall establish a fund whose pri8 mary purpose shall be to provide endowments for po9 sitions at the National Institutes of Health to conduct

10 biomedical research, and dedicated to the purpose de11 scribed in such subsection. Such positions may be held

12 by scientists without regard to whether the scientists

13 are employees of the Federal Government. Subject to

14 subsection (g)(1)(B), the fund shall consist of such do15 nations as may be provided by non-Federal entities

16 and such non-Federal assets of the Foundation (in17 cluding earnings of the Foundation and the fund) as

18 the Foundation may elect to transfer to the fund.

19 ‘‘(2) AUTHORIZED EXPENDITURES OF FUND.—

20 The provision of endowments under paragraph (1)

21 shall be the primary function of the fund established

22 under such paragraph. Such endowments may be ex23 pended only for the compensation of individuals hold24 ing the positions, for staff, equipment, quarters, trav25 el, and other expenditures that are appropriate in
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1 supporting the positions, and for recruiting individ2 uals to hold the positions endowed by the fund.

3 ‘‘(d) CERTAIN ACTIVITIES OF FOUNDATION.—In car4 rying out subsection (b), and subject to subsection (c), the

5 Foundation may provide for the following with respect to

6 the purpose described in such subsection:

7 ‘‘(1) Endowed chairs for distinguished senior in8 vestigators.

9 ‘‘(2) Positions for support of visiting scientists

10 in mid-career who participate in the National Insti11 tutes of Health Scholars program.

12 ‘‘(3) Studies, projects, and research conducted by

13 scientists under paragraphs (1) and (2).

14 ‘‘(4) Forums for the exchange of information be15 tween scientists. Participants in such forums may in16 clude institutions of higher education and appro17 priate private and public organizations.

18 ‘‘(5) Meetings, conferences, courses, and training

19 workshops.

20 ‘‘(6) Programs to improve the collection and

21 analysis of data.

22 ‘‘(7) Programs for writing, editing, printing,

23 and publishing of books and other materials.

24 ‘‘(8) Other activities to carry out the purpose de25 scribed in subsection (b).
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1 ‘‘(e) POWERS.—In carrying out subsection (b), the

2 Foundation shall—

3 ‘‘(1) operate under the direction of its Board;

4 ‘‘(2) adopt, alter, and use a corporate seal, which

5 shall be judicially noticed;

6 ‘‘(3) provide for 1 or more officers, employees,

7 and agents, as may be necessary, define their duties,

8 and require surety bonds or make other provisions

9 against losses occasioned by acts of such persons;

10 ‘‘(4) hire, promote, compensate, and discharge of11 ficers and employees of the Foundation;

12 ‘‘(5) prescribe by its Board its bylaws, as de13 scribed in subsection (g)(1)(A);

14 ‘‘(6) with the consent of any executive depart15 ment or independent agency, use the information,

16 services, staff, and facilities of such in carrying out

17 this section;

18 ‘‘(7) sue and be sued in its corporate name, and

19 complain and defend in courts of competent

20 jurisdiction;

21 ‘‘(8) modify or consent to the modification of

22 any contract or agreement to which it is a party or

23 in which it has an interest under this subtitle;

24 ‘‘(9) establish a mechanism for the selection of

25 candidates, subject to the approval of the Director of
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1 the National Institutes of Health for the endowed sci2 entific positions within the organizational structure

3 of the intramural research programs of the National

4 Institutes of Health and candidates for participation

5 in the National Institutes of Health Scholars

6 program;

7 ‘‘(10) enter into contracts with public and pri8 vate organizations for the writing, editing, printing,

9 and publishing of books and other material;

10 ‘‘(11) take such action as may be necessary to

11 obtain patents and licenses for devices and procedures

12 developed by the Foundation and its employees;

13 ‘‘(12) accept, hold, administer, invest, and spend

14 any gift, devise, or bequest of real or personal prop15 erty made to the Foundation;

16 ‘‘(13) enter into such other contracts, leases, co17 operative agreements, and other transactions as the

18 Executive Director considers appropriate to conduct

19 the activities of the Foundation;

20 ‘‘(14) appoint other groups of advisors as may be

21 determined necessary from time to time to carry out

22 the functions of the Foundation; and

23 ‘‘(15) exercise other powers as set forth in this

24 section, and such other incidental powers as are nec-
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1 essary to carry out its powers, duties, and functions

2 in accordance with this subtitle.

3 ‘‘(f) GENERAL STRUCTURE OF FOUNDATION; NON4 PROFIT STATUS.—

5 ‘‘(1) BOARD OF DIRECTORS.—The Foundation

6 shall have a board of directors (in this part referred

7 to as the ‘Board’), which shall be established and con8 ducted in accordance with subsection (g). The Board

9 shall establish the general policies of the Foundation

10 for carrying out subsection (b), including the estab11 lishment of the bylaws of the Foundation.

12 ‘‘(2) EXECUTIVE DIRECTOR.—The Foundation

13 shall have an executive director (in this part referred

14 to as the ‘Director’), who shall be appointed by the

15 Board, who shall serve at the pleasure of the Board,

16 and for whom the Board shall establish the rate of

17 compensation. Subject to compliance with the policies

18 and bylaws established by the Board pursuant to

19 paragraph (1), the Director shall be responsible for

20 the daily operations of the Foundation in carrying

21 out subsection (b).

22 ‘‘(3) NONPROFIT STATUS.—In carrying out sub23 section (b), the Board shall establish such policies and

24 bylaws under paragraph (1), and the Director shall

25 carry out such activities under paragraph (2), as
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1 may be necessary to ensure that the Foundation

2 maintains status as an organization that—

3 ‘‘(A) is described in subsection (c)(3) of sec4 tion 501 of the Internal Revenue Code of 1986;

5 and

6 ‘‘(B) is, under subsection (a) of such section,

7 exempt from taxation.

8 ‘‘(4) LIAISON.—The Director of the National In9 stitutes of Health shall serve as the liaison representa10 tive of the National Institutes of Health to the Board

11 and the Foundation.

12 ‘‘(g) BOARD OF DIRECTORS.—

13 ‘‘(1) CERTAIN BYLAWS.—

14 ‘‘(A) In establishing bylaws under sub15 section (f)(1), the Board shall ensure that the by16 laws of the Foundation include bylaws for the

17 following:

18 ‘‘(i) Policies for the selection of the offi19 cers, employees, agents, and contractors of

20 the Foundation.

21 ‘‘(ii) Policies for the acquisition, hold22 ing, and transfer of property.

23 ‘‘(iii) Policies, including ethical stand24 ards, for the acceptance and disposition of
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1 donations to the Foundation and for the

2 disposition of the assets of the Foundation.

3 ‘‘(iv) Policies for the conduct of the

4 general operations of the Foundation.

5 ‘‘(v) Policies for writing, editing,

6 printing, and publishing of books and other

7 materials, and the acquisition of patents

8 and licenses for devices and procedures de9 veloped by the Foundation.

10 ‘‘(B) In establishing bylaws under sub11 section (f)(1), the Board shall ensure that the by12 laws of the Foundation (and activities carried

13 out under the bylaws) do not—

14 ‘‘(i) reflect unfavorably upon the abil15 ity of the Foundation, or the National In16 stitutes of Health, to carry out its respon17 sibilities or official duties in a fair and ob18 jective manner; or

19 ‘‘(ii) compromise, or appear to com20 promise, the integrity of any governmental

21 program or any officer or employee involved

22 in such program.

23 ‘‘(2) COMPOSITION.—

24 ‘‘(A) The Foundation shall have a Board of

25 Directors (hereafter referred to in this section as
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1 the ‘Board’), which shall initially be composed of

2 ex officio and appointed members in accordance

3 with this subsection until such time as all the

4 appointed members, including the Chairperson,

5 are fully appointed by the Board under para6 graph (4).

7 ‘‘(B) The ex officio members of the Council

8 shall be—

9 ‘‘(i) the Chairperson and ranking mi10 nority member of the Subcommittee on

11 Health and the Environment (Committee on

12 Energy and Commerce) or their designees,

13 in the case of the House of Representatives;

14 ‘‘(ii) the Chairperson and ranking mi15 nority member of the Committee on Labor

16 and Human Resources or their designees, in

17 the case of the Senate; and

18 ‘‘(iii) the Director of the National In19 stitutes of Health.

20 ‘‘(C) The ex officio members of the Board

21 under subparagraph (B) shall appoint to the

22 Council 9 individuals. Of such appointed mem23 bers—

24 ‘‘(i) 4 shall be representative of the

25 general biomedical field;
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1 ‘‘(ii) 2 shall be representatives of the

2 general biobehavorial field; and

3 ‘‘(iii) 3 shall be representatives of the

4 general public.

5 ‘‘(3) CHAIRPERSON.—The ex officio members of

6 the Board under paragraph (2)(B) shall designate an

7 appointed member of the Board to serve as the first

8 Chairperson of the Board. Subsequently, the Chair9 person of the Board shall be chosen by the Board ac10 cording to its bylaws.

11 ‘‘(4) APPOINTMENTS, VACANCIES, AND TERMS.—

12 The following shall apply to the Board:

13 ‘‘(A) Any vacancy in the membership of the

14 Board shall be filled by appointment by the

15 Board, after consideration of suggestions made

16 by the Chairperson and the Director regarding

17 the appointments. Any such vacancy shall be

18 filled not later than the expiration of the 180-

19 day period beginning on the date on which the

20 vacancy occurs.

21 ‘‘(B) The term of office of each member of

22 the Board appointed under subparagraph (A)

23 shall be 5 years, except that the terms of office

24 for the initial appointed members of the Board

25 shall expire as determined by the Chairperson of
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1 the Board, in consultation with the Director of

2 the National Institutes of Health.

3 ‘‘(C) A vacancy in the membership of the

4 Board shall not affect the power of the Board to

5 carry out the duties of the Board. If a member

6 of the Board does not serve the full term applica7 ble under subparagraph (B), the individual ap8 pointed to fill the resulting vacancy shall be ap9 pointed for the remainder of the term of the

10 predecessor of the individual.

11 ‘‘(5) COMPENSATION.—Members of the Board

12 may not receive compensation for service on the

13 Board. Such members may be reimbursed for travel,

14 subsistence, and other necessary expenses incurred in

15 carrying out the duties of the Board, as set forth in

16 the bylaws issued by the Board.

17 ‘‘(h) INCORPORATION.—The initial members of the

18 Board shall serve as incorporators and shall take whatever

19 actions necessary to incorporate the Foundation.

20 ‘‘(i) GENERAL PROVISIONS.—

21 ‘‘(1) ADMINISTRATIVE CONTROL.—No officer, em22 ployee, or member of the Board of the Foundation

23 may exercise any administrative or managerial con24 trol over any Federal employee.
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1 ‘‘(2) APPLICABILITY OF CERTAIN STANDARDS TO

2 NON-FEDERAL EMPLOYEES.—In the case of any indi3 vidual who is not an employee of the Federal Govern4 ment and who serves with financial support from the

5 Foundation, the Foundation shall negotiate a memo6 randum of understanding with the individual and the

7 Director of the National Institutes of Health specify8 ing that the individual—

9 ‘‘(A) shall be subject to the ethical and pro10 cedural standards regulating Federal employ11 ment, scientific investigation, and research find12 ings (including publications and patents) that

13 are required of individuals employed by the Na14 tional Institutes of Health, including standards

15 under this Act, the Ethics in Government Act,

16 and the Technology Transfer Act; and

17 ‘‘(B) shall be subject to such ethical and

18 procedural standards under chapter 11 of title

19 18, United States Code (relating to conflicts of

20 interest), as the Director of the National Insti21 tutes of Health determines is appropriate, except

22 such memorandum may not provide that the in23 dividual shall be subject to the standards of sec24 tion 209 of such chapter.
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1 ‘‘(3) FINANCIAL CONFLICTS OF INTEREST.—Any

2 individual who is an officer, employee, or member of

3 the Board of the Foundation may not directly or in4 directly participate in the consideration or deter5 mination by the Foundation of any question affect6 ing—

7 ‘‘(A) any direct or indirect financial inter8 est of the individual; or

9 ‘‘(B) any direct or indirect financial inter10 est of any business organization or other entity

11 of which the individual is an officer or employee

12 or in which the individual has a direct or indi13 rect financial interest.

14 ‘‘(4) AUDITS; AVAILABILITY OF RECORDS.—The

15 Foundation shall—

16 ‘‘(A) provide for biennial audits of the fi17 nancial condition of the Foundation; and

18 ‘‘(B) make such audits, and all other

19 records, documents, and other papers of the

20 Foundation, available to the Secretary and the

21 Comptroller General of the United States for ex22 amination or audit.

23 ‘‘(5) REPORTS.—

24 ‘‘(A) Not later than February 1 of each fis25 cal year, the Foundation shall publish a report
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1 describing the activities of the Foundation dur2 ing the preceding fiscal year. Each such report

3 shall include for the fiscal year involved a com4 prehensive statement of the operations, activities,

5 financial condition, and accomplishments of the

6 Foundation.

7 ‘‘(B) With respect to the financial condition

8 of the Foundation, each report under subpara9 graph (A) shall include the source, and a de10 scription of, all gifts to the Foundation of real

11 or personal property, and the source and amount

12 of all gifts to the Foundation of money. Each

13 such report shall include a specification of any

14 restrictions on the purposes for which gifts to the

15 Foundation may be used.

16 ‘‘(C) The Foundation shall make copies of

17 each report submitted under subparagraph (A)

18 available for public inspection, and shall upon

19 request provide a copy of the report to any indi20 vidual for a charge not exceeding the cost of pro21 viding the copy.

22 ‘‘(j) FEDERAL FUNDING.—

23 ‘‘(1) AUTHORITY FOR ANNUAL GRANTS.—

24 ‘‘(A) The Secretary, acting through the Di25 rector of the National Institutes of Health, shall
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1 for each of the fiscal years 1994 through 1996,

2 make a grant to the Foundation.

3 ‘‘(B) A grant under subparagraph (A) may

4 be expended only for the purpose of the adminis5 trative expenses of the Foundation.

6 ‘‘(C) A grant under subparagraph (A) may

7 not be expended to provide amounts for the fund

8 established under subsection (c).

9 ‘‘(2) FUNDING FOR GRANTS.—

10 ‘‘(A) For the purpose of grants under para11 graph (1), there is authorized to be appropriated

12 $500,000 for each of the fiscal years 1994

13 through 1996.

14 ‘‘(B) For the purpose of grants under para15 graph (1), the Secretary may for each fiscal year

16 make available not more than $500,000 from the

17 amounts appropriated for the fiscal year for the

18 programs of the National Institutes of Health.

19 Such amounts may be made available without

20 regard to whether amounts have been appro21 priated under subparagraph (A).’’.
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1 TITLE XVIII—RESEARCH WITH

2 RESPECT TO ACQUIRED IM3 MUNE DEFICIENCY SYN4 DROME

5 SEC. 1801. REVISION AND EXTENSION OF VARIOUS PRO6 GRAMS.

7 (a) AMENDMENTS.—Title XXIII of the Public Health

8 Service Act (42 U.S.C. 300cc et seq.) is amended—

9 (1) in section 2304(c)(1)—

10 (A) in the matter preceding subparagraph

11 (A), by inserting after ‘‘Director of such Insti12 tute’’ the following: ‘‘(and may provide advice to

13 the Directors of other agencies of the National

14 Institutes of Health, as appropriate)’’; and

15 (B) in subparagraph (A), by inserting be16 fore the semicolon the following: ‘‘, including rec17 ommendations on the projects of research with

18 respect to diagnosing immune deficiency and

19 with respect to predicting, diagnosing, prevent20 ing, and treating cancers, opportunistic infec21 tions, and infectious diseases’’;

22 (2) in section 2311(a)(1), by inserting before the

23 semicolon the following: ‘‘, including evaluations of

24 methods of diagnosing immune deficiency and evalua25 tions of methods of predicting, diagnosing, preventing,
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1 and treating cancers, opportunistic infections, and

2 infectious diseases’’;

3 (3) in section 2315(a)(2), by striking ‘‘inter4 national research’’ and all that follows and inserting

5 ‘‘international research and training concerning the

6 natural history and pathogenesis of the human

7 immunodeficiency virus and the development and

8 evaluation of vaccines and treatments for acquired

9 immune deficiency syndrome and opportunistic infec10 tions.’’;

11 (4) in section 2318—

12 (A) in subsection (a)(1)—

13 (i) by inserting after ‘‘The Secretary’’

14 the following: ‘‘, acting through the Director

15 of the National Institutes of Health and

16 after consultation with the Administrator

17 for Health Care Policy and Research,’’; and

18 (ii) by striking ‘‘syndrome’’ and insert19 ing ‘‘syndrome, including treatment and

20 prevention of HIV infection and related

21 conditions among women’’; and

22 (B) in subsection (e), by striking ‘‘1991.’’

23 and inserting the following: ‘‘1991, and such

24 sums as may be necessary for each of the fiscal

25 years 1994 through 1996.’’;
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1 (5) in section 2320(b)(1)(A), by striking ‘‘syn2 drome’’ and inserting ‘‘syndrome and the natural his3 tory of such infection’’;

4 (6) in the part heading for part D, by striking

5 ‘‘DIRECTOR OF THE NATIONAL INSTITUTES OF

6 HEALTH’’ and inserting ‘‘OFFICE OF AIDS RE7 SEARCH’’;

8 (7) in section 2351—

9 (A) by redesignating subsections (a), (b)

10 and (c) as subsections (c), (d) and (e), respec11 tively;

12 (B) by inserting after the section heading

13 the following new subsections:

14 ‘‘(a) IN GENERAL.—In carrying out research with re15 spect to acquired immune deficiency syndrome, the Sec16 retary, acting through the Director of the National Insti17 tutes of Health—

18 ‘‘(1) shall establish an office to be known as the

19 Office of AIDS Research, which Office shall be headed

20 by a Director who shall—

21 ‘‘(A) be appointed by the Secretary;

22 ‘‘(B) be determined by the Secretary to be

23 an individual who is an outstanding scientist

24 and a highly skilled administrator;
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1 ‘‘(C) report directly to the Director of the

2 National Institutes of Health; and

3 ‘‘(D) be the primary Federal official respon4 sible for the conduct of AIDS-related research at

5 the National Institutes of Health; and

6 ‘‘(2) shall provide administrative support and

7 support services to the Director of such Office and

8 shall ensure that such support takes maximum advan9 tage of existing administrative structures at the insti10 tutes, centers and divisions of the National Institutes

11 of Health to the fullest extent practicable.

12 ‘‘(b) ACTIVITIES OF THE OFFICE OF AIDS RE13 SEARCH.—

14 ‘‘(1) IN GENERAL.—The Secretary, acting

15 through the director of the Office of AIDS Research,

16 shall ensure that AIDS research activities are coordi17 nated across and throughout the institutes, centers,

18 and divisions of the National Institutes of Health.

19 ‘‘(2) GENERAL DUTIES.—The Director of the Of20 fice of AIDS Research shall, based upon a strategic

21 plan as defined in paragraph (3), develop and oversee

22 the implementation of a scientifically justified budget

23 for AIDS-related research at the National Institutes

24 of Health and coordinate all AIDS-related research

25 activities conducted at the institutes, centers, and di-
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1 visions of the National Institutes of Health, and con2 duct evaluations on all such programs.

3 ‘‘(3) STRATEGIC PLAN.—

4 ‘‘(A) DEVELOPMENT.—The Director of the

5 Office of AIDS Research shall, based on the ad6 vice of the directors of the institutes, centers, and

7 divisions of the National Institutes of Health,

8 and in consultation with the advisory council es9 tablished in paragraph (5) and the coordinating

10 groups established in subparagraph (B), develop

11 and oversee the implementation of a comprehen12 sive, long-range plan for the conduct and support

13 of such research by the institutes, centers and di14 visions of the National Institutes of Health. Such

15 plan shall be updated annually, and shall—

16 ‘‘(i) determine the appropriate overall

17 balance between basic and applied research

18 and between intramural and extramural re19 search;

20 ‘‘(ii) determine and prioritize among

21 critical scientific AIDS-related questions;

22 ‘‘(iii) based upon such determinations,

23 specify the broad short and long range ob24 jectives to be achieved, and provide an esti-
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1 mate of the resources needed to achieve such

2 objectives;

3 ‘‘(iv) evaluate the sufficiency of exist4 ing AIDS research programs to meet such

5 objectives, and establish evaluation criteria,

6 timelines and objectives for future program

7 evaluation activities; and

8 ‘‘(v) make recommendations for

9 changes and necessary resource allocation in

10 and among such programs.

11 ‘‘(B) COORDINATING GROUPS.—The Direc12 tor of the Office of AIDS Research shall establish

13 AIDS coordinating groups for each research dis14 cipline within the AIDS research program, com15 posed of representatives of relevant agencies of

16 the National Institutes of Health and qualified

17 extramural scientists, to evaluate and assess the

18 efforts of the AIDS Research Program at the Na19 tional Institutes of Health, to advise on the de20 velopment of the strategic plan described in sub21 paragraph (A), and to determine the extent to

22 which such efforts are in accordance with such

23 strategic plan.

24 ‘‘(4) COORDINATION.—The Director of the Office

25 of AIDS Research shall act as the primary Federal
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1 official with responsibility for overseeing all AIDS-re2 lated research efforts undertaken by the National In3 stitutes of Health, and

4 ‘‘(A) shall serve to represent the National

5 Institutes of Health AIDS Research Program at

6 all relevant Executive branch task forces and

7 committees; and

8 ‘‘(B) shall maintain communications with

9 all relevant Public Health Service agencies and

10 with various other departments of the Federal

11 Government, to ensure the timely transmission of

12 information concerning advances in AIDS-relat13 ed research and the clinical treatment of AIDS

14 and its related conditions, between these various

15 agencies for dissemination to affected commu16 nities and health care providers.

17 ‘‘(5) ADVISORY COUNCIL.—

18 ‘‘(A) ESTABLISHMENT.—The Secretary

19 shall, consistent with section 406, establish an

20 advisory council to be known as the Office of

21 AIDS Research Advisory Council (hereafter re22 ferred to as the ‘Council’), which shall serve to

23 replace the AIDS Program Advisory Committee

24 which is operating on the date of enactment of

25 this subsection.
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1 ‘‘(B) COMPOSITION.—The Council shall be

2 composed of biomedical, behavioral, and social

3 scientists, and representatives of diverse HIV af4 fected communities, and shall be appointed by

5 the Secretary.

6 ‘‘(C) AUTHORITY.—The Council shall—

7 ‘‘(i) advise the Director of the Office of

8 AIDS Research and make recommendations

9 concerning the development of the AIDS-re10 lated research budget, and the development

11 and implementation of the strategic plan

12 for AIDS-related research at the National

13 Institutes of Health;

14 ‘‘(ii) provide the second level of peer re15 view for awards made directly from the Of16 fice of AIDS Research from the discre17 tionary fund described in paragraph (7);

18 and

19 ‘‘(iii) carry out such other activities

20 determined appropriate by the Director of

21 the Office of AIDS Research.

22 ‘‘(6) BUDGETARY AUTHORITY.—The Director of

23 the Office of AIDS Research shall—

24 ‘‘(A) in accordance with the strategic plan

25 established under paragraph (3), in consultation
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1 with the Council, and based on budget requests

2 and additional advice from the directors of the

3 institutes, centers and divisions of the National

4 Institutes of Health, prepare and submit directly

5 to the President for review and transmittal to

6 Congress, an annual, scientifically justified

7 budget estimate for AIDS-related research con8 ducted within the agencies of the National Insti9 tutes of Health, after reasonable opportunity for

10 comment (but without change) by the Secretary

11 and the Director of the National Institutes of

12 Health, which shall include the amount of funds

13 required (as requested by the directors of such in14 stitutes, centers and divisions) for—

15 ‘‘(i) the continued funding of the com16 mitment base (ongoing program initiatives)

17 at the sole discretion of the directors of such

18 institutes, centers and divisions; and

19 ‘‘(ii) the funding of new and competing

20 program initiatives through such institutes,

21 centers and divisions, at the discretion of

22 the Director of the Office of AIDS Research;

23 ‘‘(B) receive from the President and the Of24 fice of Management and Budget directly all

25 AIDS-related research funds appropriated by
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1 Congress for transfer to, and obligation and ex2 penditure by, the institutes, centers and divisions

3 of the National Institutes of Health in accord4 ance with the budget delineated under clauses (i)

5 and (ii) of subparagraph (A); and

6 ‘‘(C) distribute AIDS research funding to

7 the various institutes, centers, and divisions of

8 the National Institutes of Health in accordance

9 with the budget delineated under clauses (i) and

10 (ii) of subparagraph (A).

11 The provisions of this paragraph shall become effec12 tive in the fiscal year following the submission of the

13 consolidated AIDS budget.

14 ‘‘(7) DISCRETIONARY FUND.—

15 ‘‘(A) AVAILABILITY OF FUNDS.—The Sec16 retary shall ensure that not to exceed 25 percent

17 of the funds available in excess of the amount of

18 baseline AIDS research spending during the pre19 vious fiscal year, be made available to the Direc20 tor of the Office of AIDS Research for the estab21 lishment of an AIDS research discretionary

22 fund.

23 ‘‘(B) USE.—The Director of the Office of

24 AIDS Research, in consultation with the advi25 sory council established under paragraph (5),
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1 shall use amounts in the AIDS research discre2 tionary fund, either through the institutes, cen3 ters and divisions of the National Institutes of

4 Health or grants made directly by the Office of

5 AIDS Research, to—

6 ‘‘(i) fund emergency AIDS research

7 programs;

8 ‘‘(ii) fund programs for the conduct of

9 research aimed at filling gaps that exist in

10 existing research programs;

11 ‘‘(iii) conduct conferences, convene

12 committees, hold meetings or carry out

13 other activities determined appropriate by

14 the Director.

15 ‘‘(C) REDUCTION IN ADMINISTRATIVE IM16 PEDIMENTS.—Notwithstanding any other provi17 sion of law relating to the number of individuals

18 who may be employed as full-time equivalent in19 dividuals, with respect to the number of full-time

20 equivalent individuals so employed, the Director

21 of the Office of AIDS Research shall be permitted

22 to authorize the employment of such full-time

23 equivalent individuals to perform AIDS-related

24 research through the institutes, centers and divi25 sions of the National Institutes of Health as de-
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1 scribed in clauses (i) and (ii) of subparagraph

2 (B) and subject to appropriations.’’;

3 (C) in subsection (c) (as so redesignated)—

4 (i) by striking the subsection designa5 tion and all that follows through paragraph

6 (1) and inserting the following:

7 ‘‘(c) OTHER DUTIES.—The director of the office—’’;

8 (ii) by redesignating paragraphs (2)

9 through (8) as paragraphs (1) through (7),

10 respectively;

11 (iii) by striking ‘‘for the appropriate

12 national research institute of the National

13 Institutes of Health’’ in paragraph (4) (as

14 so redesignated); and

15 (iv) by inserting ‘‘cannot reasonably be

16 accomplished within the United States and’’

17 after ‘‘if such research’’ in paragraph (4)(A)

18 (as so redesignated); and

19 (D) by adding at the end thereof the follow20 ing new subsection:

21 ‘‘(f) EVALUATION AND REPORT.—

22 ‘‘(1) EVALUATION.—Not later than 5 years after

23 the date of enactment of this Act, the Secretary shall

24 conduct an evaluation to—
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1 ‘‘(A) determine the effect of this section on

2 the planning and coordination of the AIDS re3 search programs at the institutes, centers and di4 visions of the National Institutes of Health;

5 ‘‘(B) evaluate the extent to which this sec6 tion has eliminated the duplication of adminis7 trative resources among such institutes, centers

8 and divisions; and

9 ‘‘(C) provide recommendations concerning

10 future alterations with respect to this section.

11 ‘‘(2) REPORT.—Not later than 1 year after the

12 date on which the evaluation is commenced under

13 paragraph (1), the Secretary shall prepare and sub14 mit to the Committee on Labor and Human Re15 sources of the Senate and the Committee on Energy

16 and Commerce of the House of Representatives, a re17 port concerning the results of such evaluation.’’;

18 (8) in section 2361, by striking ‘‘For purposes’’

19 and all that follows and inserting the following:

20 ‘‘For purposes of this title:

21 ‘‘(1) The term ‘infection’, with respect to the etio22 logic agent for acquired immune deficiency syndrome,

23 includes cancers, opportunistic infections, and infec24 tious diseases and any other conditions arising from

25 infection with such etiologic agent.
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1 ‘‘(2) The term ‘treatment’, with respect to the

2 etiologic agent for acquired immune deficiency syn3 drome, includes primary and secondary prophy4 laxis.’’;

5 (9) in section 2315(f), by striking ‘‘there are au6 thorized’’ and all that follows and inserting ‘‘there are

7 authorized to be appropriated such sums as may be

8 necessary for each fiscal year.’’;

9 (10) in section 2320(e)(1), by striking ‘‘there are

10 authorized’’ and all that follows and inserting ‘‘there

11 are authorized to be appropriated such sums as may

12 be necessary for each fiscal year.’’; and

13 (11) in section 2341(d), by striking ‘‘there are

14 authorized’’ and all that follows and inserting ‘‘there

15 are authorized to be appropriated such sums as may

16 be necessary for each fiscal year.’’.

17 TITLE XIX—STUDIES

18 SEC. 1901. ACQUIRED IMMUNE DEFICIENCY SYNDROME.

19 (a) CERTAIN DRUG-RELEASE MECHANISMS.—

20 (1) The Secretary of Health and Human Serv21 ices shall, subject to paragraph (2), enter into a con22 tract with a public or nonprofit private entity to con23 duct a study for the purpose of determining, with re24 spect to acquired immune deficiency syndrome, the

25 impact of parallel-track drug-release mechanisms on
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1 public and private clinical research, and on the ac2 tivities of the Commissioner of Food and Drugs re3 garding the approval of drugs.

4 (2) The Secretary of Health and Human Serv5 ices shall request the Institute of Medicine of the Na6 tional Academy of Sciences to enter into the contract

7 under paragraph (1) to conduct the study described

8 in such paragraph. If such Institute declines to con9 duct the study, the Secretary shall carry out para10 graph (1) through another public or nonprofit private

11 entity.

12 (b) THIRD-PARTY PAYMENTS REGARDING CERTAIN

13 CLINICAL TRIALS.—The Secretary of Health and Human

14 Services shall conduct a study for the purpose of—

15 (1) determining the policies of third-party

16 payors regarding the payment of the costs of appro17 priate health services that are provided incident to

18 the participation of individuals as subjects in clinical

19 trials conducted in the development of drugs with re20 spect to acquired immune deficiency syndrome; and

21 (2) developing recommendations regarding such

22 policies.
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1 (c) ADVISORY COMMITTEES.—The Secretary of Health

2 and Human Services, acting through the Director of the Na3 tional Institutes of Health, shall conduct a study for the

4 purpose of determining—

5 (1) whether the activities of the various advisory

6 committees established in the National Institutes of

7 Health regarding acquired immune deficiency syn8 drome are being coordinated sufficiently; and

9 (2) whether the functions of any of such advisory

10 committees should be modified in order to achieve

11 greater efficiency.

12 (d) VACCINES FOR HUMAN IMMUNODEFICIENCY

13 VIRUS.—

14 (1) IN GENERAL.—The Secretary of Health and

15 Human Services, acting through the National Insti16 tutes of Health, shall develop a plan for the appro17 priate inclusion of HIV-infected women, including

18 pregnant women, HIV-infected infants, and HIV-in19 fected children in studies conducted by or through the

20 National Institutes of Health concerning the safety

21 and efficacy of HIV vaccines for the treatment and

22 prevention of HIV infection. Such plan shall ensure

23 the full participation of other Federal agencies cur24 rently conducting HIV vaccine studies and require
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1 that such studies conform fully to the requirements of

2 part 46 of title 45, Code of Federal Regulations.

3 (2) REPORT.—Not later than 180 days after the

4 date of the enactment of this Act, the Secretary of

5 Health and Human Services shall prepare and sub6 mit to the Committee on Energy and Commerce of the

7 House of Representatives, and the Committee on

8 Labor and Human Resources of the Senate, a report

9 concerning the plan developed under paragraph (1).

10 (3) IMPLEMENTATION.—Not later than 12

11 months after the date of the enactment of this Act, the

12 Secretary of Health and Human Services shall imple13 ment the plan developed under paragraph (1), includ14 ing measures for the full participation of other Fed15 eral agencies currently conducting HIV vaccine

16 studies.

17 (4) For the purpose of carrying out this sub18 section, there are authorized to be appropriated such

19 sums as may be necessary for each of the fiscal years

20 1994 through 1996.

21 SEC. 1902. MALNUTRITION IN THE ELDERLY.

22 (a) STUDY.—

23 (1) IN GENERAL.—The Secretary of Health and

24 Human Services (referred to in this section as the

25 ‘‘Secretary’’), acting through the National Institute
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1 on Aging, coordinating with the Agency for Health

2 Care Policy and Research and, to the degree possible,

3 in consultation with the head of the National Nutri4 tion Monitoring System established under section

5 1428 of the Food and Agriculture Act of 1977 (7

6 U.S.C. 3178), shall conduct a 3-year nutrition screen7 ing and intervention activities study of the elderly.

8 (2) EFFICACY AND COST-EFFECTIVENESS OF NU9 TRITION SCREENING AND INTERVENTION ACTIVI10 TIES.—In conducting the study, the Secretary shall

11 determine the efficacy and cost-effectiveness of nutri12 tion screening and intervention activities conducted

13 in the elderly health and long-term care continuum,

14 and of a program that would institutionalize nutri15 tion screening and intervention activities. In evaluat16 ing such a program, the Secretary shall determine—

17 (A) if health or quality of life is measurably

18 improved for elderly individuals who receive rou19 tine nutritional screening and treatment;

20 (B) if federally subsidized home or institu21 tional care is reduced because of increased inde22 pendence of elderly individuals resulting from

23 improved nutritional status;
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1 (C) if a multidisciplinary approach to nu2 tritional care is effective in addressing the nutri3 tional needs of elderly individuals; and

4 (D) if reimbursement for nutrition screen5 ing and intervention activities is a cost-effective

6 approach to improving the health status of elder7 ly individuals.

8 (3) POPULATIONS.—The populations of elderly

9 individuals in which the study will be conducted shall

10 include populations of elderly individuals who are—

11 (A) living independently, including—

12 (i) individuals who receive home and

13 community-based services or family sup14 port;

15 (ii) individuals who do not receive ad16 ditional services and support;

17 (iii) individuals with low incomes; and

18 (iv) individuals who are minorities;

19 (B) hospitalized, including individuals ad20 mitted from home and from institutions; and

21 (C) institutionalized in residential facilities

22 such as nursing homes and adult homes.

23 (b) MALNUTRITION STUDY.—The Secretary, acting

24 through the National Institute on Aging, shall conduct a

25 3-year study to determine the extent of malnutrition in el-
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1 derly individuals in hospitals and long-term care facilities

2 and in elderly individuals who are living independently.

3 (c) REPORT.—The Secretary shall submit a report to

4 the Committee on Labor and Human Resources of the Sen5 ate and the Committee on Energy and Commerce of the

6 House of Representatives containing the findings resulting

7 from the studies described in subsections (a) and (b), in8 cluding a determination regarding whether a program that

9 would institutionalize nutrition screening and intervention

10 activities should be adopted, and the rationale for the deter11 mination.

12 (d) ADVISORY PANEL.—

13 (1) ESTABLISHMENT.—The Secretary, acting

14 through the Director of the National Institute on

15 Aging, shall establish an advisory panel that shall

16 oversee the design, implementation, and evaluation of

17 the studies described in subsections (a) and (b).

18 (2) COMPOSITION.—The advisory panel shall in19 clude representatives appointed for the life of the

20 panel by the Secretary from the Health Care Financ21 ing Administration, the Social Security Administra22 tion, the National Center for Health Statistics, the

23 Administration on Aging, the National Council on

24 the Aging, the American Dietetic Association, the

25 American Academy of Family Physicians, and such
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1 other agencies or organizations as the Secretary deter2 mines to be appropriate.

3 (3) COMPENSATION AND EXPENSES.—

4 (A) COMPENSATION.—Each member of the

5 advisory panel who is not an employee of the

6 Federal Government shall receive compensation

7 for each day engaged in carrying out the duties

8 of the panel, including time engaged in traveling

9 for purposes of such duties. Such compensation

10 may not be provided in an amount in excess of

11 the maximum rate of basic pay payable for GS–

12 18 of the General Schedule.

13 (B) TRAVEL EXPENSES.—Each member of

14 the advisory panel shall receive travel expenses,

15 including per diem in lieu of subsistence, at

16 rates authorized for employees of agencies under

17 subchapter I of chapter 57 of title 5, United

18 States Code, for each day the member is engaged

19 in the performance of duties away from the home

20 or regular place of business of the member.

21 (4) DETAIL OF FEDERAL EMPLOYEES.—On the

22 request of the advisory panel, the head of any Federal

23 agency shall detail, without reimbursement, any of

24 the personnel of the agency to the advisory panel to

25 assist the advisory panel in carrying out its duties.
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1 Any detail shall not interrupt or otherwise affect the

2 civil service status or privileges of the Federal em3 ployee.

4 (5) TECHNICAL ASSISTANCE.—On the request of

5 the advisory panel, the head of a Federal agency shall

6 provide such technical assistance to the advisory

7 panel as the advisory panel determines to be nec8 essary to carry out its duties.

9 (6) TERMINATION.—Notwithstanding section 15

10 of the Federal Advisory Committee Act (5 U.S.C.

11 App.), the advisory panel shall terminate 3 years

12 after the date of enactment of this Act.

13 SEC. 1903. RESEARCH ACTIVITIES ON CHRONIC FATIGUE

14 SYNDROME.

15 The Secretary of Health and Human Services shall,

16 not later than May 1, 1993, and annually thereafter for

17 the next 3 years, prepare and submit to the Committee on

18 Energy and Commerce of the House of Representatives and

19 the Committee on Labor and Human Resources of the Sen20 ate, a report that summarizes the research activities con21 ducted or supported by the National Institutes of Health

22 concerning chronic fatigue syndrome. Such report should

23 include information concerning grants made, cooperative

24 agreements or contracts entered into, intramural activities,
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1 research priorities and needs, and a plan to address such

2 priorities and needs.

3 SEC. 1904. REPORT ON MEDICAL USES OF BIOLOGICAL

4 AGENTS IN DEVELOPMENT OF DEFENSES

5 AGAINST BIOLOGICAL WARFARE.

6 The Secretary of Health and Human Services, in con7 sultation with other appropriate executive agencies, shall

8 report to the House Energy and Commerce Committee and

9 the Senate Labor and Human Resources Committee on the

10 appropriateness and impact of the National Institutes of

11 Health assuming responsibility for the conduct of all Fed12 eral research, development, testing, and evaluation func13 tions relating to medical countermeasures against

14 biowarfare threat agents. In preparing the report, the Sec15 retary shall identify the extent to which such activities are

16 carried out by agencies other than the National Institutes

17 of Health, and assess the impact (positive and negative) of

18 the National Institutes of Health assuming responsibility

19 for such activities, including the impact under the Budget

20 Enforcement Act and the Omnibus Budget Reconciliation

21 Act of 1990 on existing National Institutes of Health re22 search programs as well as other programs within the cat23 egory of domestic discretionary spending. The Secretary

24 shall submit the report not later than 12 months after the

25 date of the enactment of this Act.
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1 SEC. 1905. PERSONNEL STUDY OF RECRUITMENT, RETEN2 TION AND TURNOVER.

3 (a) STUDY OF PERSONNEL SYSTEM.—Not later than

4 1 year after the date of the enactment of this Act, the Sec5 retary of Health and Human Services, acting through the

6 Director of the National Institutes of Health, shall conduct

7 a study to review the retention, recruitment, vacancy and

8 turnover rates of support staff, including firefighters, law

9 enforcement, procurement officers, technicians, nurses and

10 clerical employees, to ensure that the National Institutes of

11 Health is adequately supporting the conduct of efficient, ef12 fective and high quality research for the American public.

13 The Director of NIH shall work in conjunction with appro14 priate employee organizations and representatives in devel15 oping such a study.

16 (b) SUBMISSION TO CONGRESS.—Not later than 1 year

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

18 of Health and Human Services shall prepare and submit

19 to the Committee on Energy and Commerce of the House

20 of Representatives, and to the Committee on Labor and

21 Human Resources of the Senate, a report containing the

22 study conducted under subsection (a) together with the rec23 ommendations of the Secretary concerning the enactment

24 of legislation to implement the results of such study.
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1 SEC. 1906. PROCUREMENT.

2 (a) IN GENERAL.—The Director of the National Insti3 tutes of Health and the Administrator of the General Serv4 ices Administration shall jointly conduct a study to develop

5 a streamlined procurement system for the National Insti6 tutes of Health that complies with the requirements of Fed7 eral law.

8 (b) REPORT.—Not later than March 1, 1994, the offi9 cials specified in subsection (a) shall complete the study re10 quired in such subsection and shall submit to the Committee

11 on Energy and Commerce of the House of Representatives,

12 and the Committee on Labor and Human Resources of the

13 Senate, a report describing the findings made as a result

14 of the study.

15 SEC. 1907. REPORT CONCERNING LEADING CAUSES OF

16 DEATH.

17 (a) REPORT.—The Secretary of Health and Human

18 Services shall, not later than October 1, 1993, prepare a

19 report that lists—

20 (1) the 20 illnesses that, in terms of mortality,

21 number of years of expected life lost, and of number

22 of preventable years of life lost, are the leading causes

23 of death in the United States and the number of

24 deaths from each such cause, the age-specific and age25 adjusted death rates for each such cause, the death

26 rate per 100,000 population for each such cause, the
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1 percentage of change in cause specific death rates for

2 each age group, and the percentage of total deaths for

3 each such cause;

4 (2) the amount expended by the Department of

5 Health and Human Services for research, prevention,

6 and education with respect to each of the 20 illnesses

7 described in paragraph (1) for the most recent year

8 for which the actual expenditures are known;

9 (3) an estimate by the Secretary of the amount

10 to be expended on research, prevention, and education

11 with respect to each of the 20 illnesses described in

12 paragraph (1) for the year for which the report is

13 prepared; and

14 (4) with respect to the years specified in para15 graphs (2) and (3), the percentage of the total of the

16 annual expenditures for research, prevention, and

17 education on the 20 illnesses described in paragraph

18 (1) that are attributable to each illness.

19 (b) SUBMISSION TO CONGRESS.—The Secretary of

20 Health and Human Services shall submit the report re21 quired under subsection (a), together with relevant budget

22 information, to the Committee on Energy and Commerce

23 and the Committee on Appropriations of the House of Rep24 resentatives and the Committee on Labor and Human Re25 sources and the Committee on Appropriations of the Senate.
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1 SEC. 1908. RELATIONSHIP BETWEEN THE CONSUMPTION OF

2 LEGAL AND ILLEGAL DRUGS.

3 (a) IN GENERAL.—The Secretary of Health and

4 Human Services, acting through the Commissioner of Food

5 and Drugs, shall review and consider all existing relevant

6 data and research concerning whether there is a relation7 ship between an individual’s receptivity to use or consume

8 legal drugs and the consumption or abuse by the individual

9 of illegal drugs. On the basis of such review, the Secretary

10 shall determine whether additional research is necessary. If

11 the Secretary determines additional research is required,

12 the Secretary shall conduct a study of those subjects where

13 the Secretary’s review indicates additional research is need14 ed, including, if necessary, a review of—

15 (1) the effect of advertising and marketing cam16 paigns that promote the use of legal dvugs on the

17 public;

18 (2) the correlation of legal drug abuse with ille19 gal drug abuse; and

20 (3) other matters that the Secretary determines

21 appropriate.

22 (b) REPORT.—Not later than 12 months after the date

23 of enactment of this Act, the Secretary shall prepare and

24 submit, to the Committee on Energy and Commerce of the

25 House of Representatives and Committee on Labor and

26 Human Resources of the Senate, a report containing the
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1 results of the review conducted under subsection (b). If the

2 Secretary determines additional research is required, no

3 later than 2 years after the date of enactment of this Act,

4 the Secretary shall prepare and submit, to the Committee

5 on Energy and Commerce of the House of Representatives

6 and Committee on Labor and Human Resources of the Sen7 ate, a report containing the results of the additional re8 search conducted under subsection (b).

9 SEC. 1909. COST OF CARE IN LAST 6 MONTHS OF LIFE.

10 (a) STUDY.—

11 (1) IN GENERAL.—The Secretary of Health and

12 Human Services (referred to in this section as the

13 ‘‘Secretary’’), acting through the Agency for Health

14 Care Policy and Research and, to the degree possible,

15 in consultation with the Health Care Financing Ad16 ministration, shall conduct a study, using the most

17 recent National Medical Expenditure Survey

18 database, to estimate the average amount of health

19 care expenditures incurred during the last 6 months

20 of life and during the last 3 months of life by—

21 (A) the population of individuals who are

22 65 years of age and older; and

23 (B) the total population, broken down based

24 on noninstitutionalized and institutionalized

25 populations.
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1 (2) ELEMENTS OF STUDY.—The study conducted

2 under paragraph (1) shall—

3 (A) be designed in a manner that will

4 produce estimates of health care costs expended

5 for health care provided to individuals during

6 the last 3 and 6 months of life;

7 (B) be designed to produce estimates of such

8 costs for the populations identified in subpara9 graphs (A) and (B) of paragraph (1);

10 (C) include a calculation of the estimated

11 amount of total health care expenditures during

12 such periods of time; and

13 (D) include a calculation of the estimate de14 scribed in subparagraph (C)—

15 (i) as a percentage of the total national

16 health care expenditures; and

17 (ii) for those age 65 years and over, as

18 a percentage of the total Medicare expendi19 tures for those age 65 years and over.

20 (b) REPORT.—Not later than 6 months after the date

21 of enactment of this section, the Secretary shall prepare and

22 submit to the Committee on Labor and Human Resources

23 of the Senate and the Committee on Energy and Commerce

24 of the House of Representatives, a report containing the
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1 findings resulting from the study described in subsection

2 (a).

3 (c) 1996 NATIONAL MEDICAL EXPENDITURE SUR4 VEY.—

5 (1) IN GENERAL.—The Secretary, acting through

6 the Agency for Health Care Policy and Research,

7 shall ensure that the 1996 National Medical Expendi8 ture Survey is designed in a manner that will

9 produce an estimate of the amount expended for

10 health care provided to individuals during the last 3

11 and 6 months of life.

12 (2) POPULATIONS.—In designing the Survey

13 under paragraph (1), the Secretary shall ensure that

14 such Survey produces the data required under such

15 paragraph for—

16 (A) the population of individuals who are

17 65 years of age and older; and

18 (B) the population of individuals who are 1

19 year of age and younger;

20 broken down based on noninstitutionalized and insti21 tutionalized populations.
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1 TITLE XX—MISCELLANEOUS

2 PROVISIONS

3 SEC. 2001. DESIGNATION OF SENIOR BIOMEDICAL RE4 SEARCH SERVICE IN HONOR OF SILVIO O.

5 CONTE, AND LIMITATION ON NUMBER OF

6 MEMBERS.

7 (a) IN GENERAL.—Section 228(a) of the Public Health

8 Service Act (42 U.S.C. 237(a)), as added by section 304

9 of Public Law 101–509, is amended to read as follows:

10 ‘‘(a)(1) There shall be in the Public Health Service a

11 Silvio O. Conte Senior Biomedical Research Service, not

12 to exceed 750 members.

13 ‘‘(2) The authority established in paragraph (1) re14 garding the number of members in the Silvio O. Conte Sen15 ior Biomedical Research Service is in addition to any au16 thority established regarding the number of members in the

17 commissioned Regular Corps, in the Reserve Corps, and in

18 the Senior Executive Service. Such paragraph may not be

19 construed to require that the number of members in the com20 missioned Regular Corps, in the Reserve Corps, or in the

21 Senior Executive Service be reduced to offset the number

22 of members serving in the Silvio O. Conte Senior Bio23 medical Research Service (hereafter in this section referred

24 to as the ‘Service’).’’.
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1 (b) CONFORMING AMENDMENT.—Section 228 of the

2 Public Health Service Act (42 U.S.C. 237), as added by

3 section 304 of Public Law 101–509, is amended in the head4 ing for the section by amending the heading to read as fol5 lows:

6 ‘‘SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH

7 SERVICE’’.

8 SEC. 2002. TECHNICAL CORRECTIONS.

9 (a) TITLE III.—Subsection (c) of section 316 of the

10 Public Health Service Act (42 U.S.C. 247a(c)) is repealed.

11 (b) TITLE IV.—Title IV of the Public Health Service

12 Act (42 U.S.C. 281 et seq.) is amended—

13 (1) in section 406—

14 (A) in subsection (b)(2)(A), by striking

15 ‘‘Veterans’ Administration’’ each place such term

16 appears and inserting ‘‘Department of Veterans

17 Affairs’’; and

18 (B) in subsection (h)(2)(A)(v), by striking

19 ‘‘Veterans’ Administration’’ and inserting ‘‘De20 partment of Veterans Affairs’’;

21 (2) in section 408, in subsection (b) (as redesig22 nated by section 501(c)(1)(C) of this Act), by striking

23 ‘‘Veterans’ Administration’’ and inserting ‘‘Depart24 ment of Veterans Affairs’’;

25 (3) in section 421(b)(1), by inserting a comma

26 after ‘‘may’’;
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1 (4) in section 428(b), in the matter preceding

2 paragraph (1), by striking ‘‘the the’’ and inserting

3 ‘‘the’’;

4 (5) in section 430(b)(2)(A)(i), by striking ‘‘Veter5 ans’ Administration’’ and inserting ‘‘Department of

6 Veterans Affairs’’;

7 (6) in section 439(b), by striking ‘‘Veterans’ Ad8 ministration’’ and inserting ‘‘Department of Veterans

9 Affairs’’;

10 (7) in section 442(b)(2)(A), by striking ‘‘Veter11 ans’ Administration’’ and inserting ‘‘Department of

12 Veterans Affairs’’;

13 (8) in section 464D(b)(2)(A), by striking ‘‘Veter14 ans’ Administration’’ and inserting ‘‘Department of

15 Veterans Affairs’’;

16 (9) in section 464E—

17 (A) in subsection (d), in the first sentence,

18 by inserting ‘‘Coordinating’’ before ‘‘Committee’’;

19 and

20 (B) in subsection (e), by inserting ‘‘Coordi21 nating’’ before ‘‘Committee’’ the first place such

22 term appears;

23 (10) in section 464P(b)(6) (as added by section

24 123 of Public Law 102-321 (106 Stat. 362)), by strik25 ing ‘‘Administration’’ and inserting ‘‘Institute’’;
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1 (11) in section 466(a)(1)(B), by striking ‘‘Veter2 ans’ Administration’’ and inserting ‘‘Department of

3 Veterans Affairs’’;

4 (12) in section 480(b)(2)(A), by striking ‘‘Veter5 ans’ Administration’’ and inserting ‘‘Department of

6 Veterans Affairs’’;

7 (13) in section 485(b)(2)(A), by striking ‘‘Veter8 ans’ Administration’’ and inserting ‘‘Department of

9 Veterans Affairs’’;

10 (14) in section 487(d)(3), by striking ‘‘section

11 304(a)(3)’’ and inserting ‘‘section 304(a)’’; and

12 (15) in section 496(a), by striking ‘‘Such appro13 priations,’’ and inserting the following: ‘‘Appropria14 tions to carry out the purposes of this title,’’.

15 (c) TITLE XV.—Title XV of the Public Health Service

16 Act is amended—

17 (1) in section 1501(b) (42 U.S.C. 300k(b)), by

18 striking ‘‘nonprofit’’; and

19 (2) in section 1505(3) (42 U.S.C. 300n–1(3)), by

20 striking ‘‘nonprivate’’ and inserting ‘‘private’’.

21 (d) TITLE XXIII.—Part A of title XXIII of the Public

22 Health Service Act (42 U.S.C. 300cc et seq.) is amended—

23 (1) in section 2304—

24 (A) in the heading for the section, by strik25 ing ‘‘CLINICAL RESEARCH REVIEW COMMIT-
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1 TEE’’ and inserting ‘‘RESEARCH ADVISORY

2 COMMITTEE’’; and

3 (B) in subsection (a), by striking ‘‘AIDS

4 Clinical Research Review Committee’’ and in5 serting ‘‘AIDS Research Advisory Committee’’;

6 (2) in section 2312(a)(2)(A), by striking ‘‘AIDS

7 Clinical Research Review Committee’’ and inserting

8 ‘‘AIDS Research Advisory Committee’’;

9 (3) in section 2314(a)(1), in the matter preced10 ing subparagraph (A), by striking ‘‘Clinical Research

11 Review Committee’’ and inserting ‘‘AIDS Research

12 Advisory Committee’’;

13 (4) in section 2317(d)(1), by striking ‘‘Clinical

14 Research Review Committee’’ and inserting ‘‘AIDS

15 Research Advisory Committee established under sec16 tion 2304’’; and

17 (5) in section 2318(b)(3), by striking ‘‘Clinical

18 Research Review Committee’’ and inserting ‘‘AIDS

19 Research Advisory Committee’’.

20 (e) SECRETARY.—Section 2(c) of the Public Health

21 Service Act (42 U.S.C. 201(c)) is amended by striking

22 ‘‘Health, Education, and Welfare’’ and inserting ‘‘Health

23 and Human Services’’.

24 (f) DEPARTMENT.—Section 201 of the Public Health

25 Service Act (42 U.S.C. 202) is amended—
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1 (1) by striking ‘‘Health, Education, and Wel2 fare’’ and inserting ‘‘Health and Human Services’’;

3 and

4 (2) by striking ‘‘Surgeon General’’ and inserting

5 ‘‘Assistant Secretary for Health’’.

6 (g) DEPARTMENT.—Section 202 of the Public Health

7 Service Act (42 U.S.C. 203) is amended—

8 (1) by striking ‘‘Surgeon General’’ the second

9 and subsequent times that such term appears and in10 serting ‘‘Secretary’’; and

11 (2) by inserting ‘‘, and the Agency for Health

12 Care Policy and Research’’ before the first period.

13 (h) VOLUNTEER SERVICES.—Section 223 of the Public

14 Health Service Act (42 U.S.C. 217b) is amended by striking

15 ‘‘Health, Education, and Welfare’’ and inserting ‘‘Health

16 and Human Services’’.

17 SEC. 2003. BIENNIAL REPORT ON CARCINOGENS.

18 Section 301(b)(4) of the Public Health Service Act (42

19 U.S.C. 241(b)(4)) is amended by striking ‘‘an annual’’ and

20 inserting in lieu thereof ‘‘a biennial’’.

21 SEC. 2004. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE

22 FOR RESEARCH.

23 Not later than 90 days after the date of the enactment

24 of this Act, the Secretary of Health and Human Services,

25 acting through the Director of the National Institutes of
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1 Health, shall present to the Congress a master plan to pro2 vide for the replacement or refurbishment of less than ade3 quate buildings, utility equipment and distribution systems

4 (including the resources that provide electrical and other

5 utilities, chilled water, air handling, and other services that

6 the Secretary, acting through the Director, deems nec7 essary), roads, walkways, parking areas, and grounds that

8 underpin the laboratory and clinical facilities of the Na9 tional Institutes of Health. Such plan may make rec10 ommendations for the undertaking of new projects that are

11 consistent with the objectives of this section, such as encir12 cling the National Institutes of Health Federal enclave with

13 an adequate chilled water conduit.

14 SEC. 2005. TRANSFER OF PROVISIONS OF TITLE XXVII.

15 (a) IN GENERAL.—The Public Health Service Act (42

16 U.S.C. 201 et seq.), as amended by section 101 of Public

17 Law 101–381 and section 304 of Public Law 101–509, is

18 amended—

19 (1) by transferring sections 2701 through 2714 to

20 title II;

21 (2) by redesignating such sections as sections 231

22 through 244, respectively;

23 (3) by inserting such sections, in the appropriate

24 sequence, after section 228;
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1 (4) by inserting before section 201 the following

2 new heading:

3 ‘‘PART A—ADMINISTRATION’’; and

4 (5) by inserting before section 231 (as redesig5 nated by paragraph (2) of this subsection) the follow6 ing new heading:

7 ‘‘PART B—MISCELLANEOUS PROVISIONS’’.

8 (b) CONFORMING AMENDMENTS.—The Public Health

9 Service Act (42 U.S.C. 201 et seq.) is amended—

10 (1) in the heading for title II, by inserting

11 ‘‘AND MISCELLANEOUS PROVISIONS’’ after

12 ‘‘ADMINISTRATION’’;

13 (2) in section 406(a)(2), by striking ‘‘2701’’ and

14 inserting ‘‘231’’;

15 (3) in section 465(f), by striking ‘‘2701’’ and in16 serting ‘‘231’’;

17 (4) in section 480(a)(2), by striking ‘‘2701’’ and

18 inserting ‘‘231’’;

19 (5) in section 485(a)(2), by striking ‘‘2701’’ and

20 inserting ‘‘231’’;

21 (6) in section 497, by striking ‘‘2701’’ and in22 serting ‘‘231’’;

23 (7) in section 505(a)(2), by striking ‘‘2701’’ and

24 inserting ‘‘231’’;
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1 (8) in section 926(b), by striking ‘‘2711’’ each

2 place such term appears and inserting ‘‘241’’; and

3 (9) in title XXVII, by striking the heading for

4 such title.

5 SEC. 2006. CERTAIN AUTHORIZATION OF APPROPRIATIONS.

6 Section 399L(a) of the Public Health Service Act (42

7 U.S.C. 280e-4(a)), as added by Public Law 102-515 (106

8 Stat. 3376), is amended—

9 (1) in the first sentence, by striking ‘‘the Sec10 retary’’ and all that follows and inserting the follow11 ing: ‘‘there are authorized to be appropriated

12 $30,000,000 for fiscal year 1994, and such sums as

13 may be necessary for each of the fiscal years 1995

14 through 1997.’’; and

15 (2) in the second sentence, by striking ‘‘Out of

16 any amounts used’’ and inserting ‘‘Of the amounts

17 appropriated under the preceding sentence’’.

18 SEC. 2007. PROHIBITION AGAINST SHARP ADULT SEX SUR19 VEY AND THE AMERICAN TEENAGE SEX SUR20 VEY.

21 The Secretary of Health and Human Services may not

22 during fiscal year 1993 or any subsequent fiscal year con23 duct or support the SHARP survey of adult sexual behavior

24 or the American Teenage Study of adolescent sexual behav-
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1 ior. This section becomes effective on the date of enactment

2 of this Act.

3 SEC. 2008. SUPPORT FOR BIOENGINEERING RESEARCH.

4 (a) STUDY.—The Secretary of Health and Human

5 Services, acting through the Director of the National Insti6 tutes of Health, shall conduct a study for the purpose of—

7 (1) determining the sources and amounts of pub8 lic and private funding devoted to basic research in

9 bioengineering and biomaterials sciences;

10 (2) evaluating whether that commitment is suffi11 cient to maintain the innovative edge that the United

12 States has in these technologies; and

13 (3) evaluating the need to modify the structure

14 of the National Institutes of Health or any other Fed15 eral agency to achieve a greater commitment to inno16 vation in bioengineering, and evaluating the need for

17 better coordination and collaboration among Federal

18 agencies and between the public and private sectors.

19 In conducting such study, the Director shall work in con20 junction with appropriate organizations and representa21 tives including academics, industry leaders, bioengineering

22 societies, and public agencies (such as the National Science

23 Foundation, Veterans Administration, Department of De24 fense, National Aeronautics and Space Administration, and

25 the White House Office of Science and Technology Policy).
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1 (b) REPORT.—Not later than 1 year after the date of

2 enactment of this Act, the Secretary of Health and Human

3 Services shall prepare and submit to the Committee on

4 Labor and Human Resources of the Senate, and the Com5 mittee on Energy and Commerce of the House of Represent6 atives, a report containing the findings of the study con7 ducted under subsection (a) together with recommendations

8 concerning the enactment of legislation to implement the

9 results of such study.

10 TITLE XXI—EFFECTIVE DATES

11 SEC. 2101. EFFECTIVE DATES.

12 Subject to section 155, this Act and the amendments

13 made by this Act take effect upon the date of the enactment

14 of this Act.

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