I

103D CONGRESS

1ST SESSION H. R. 4

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

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

IN THE HOUSE OF REPRESENTATIVES

JANUARY 5, 1993

Mr. WAXMAN (for himself, Mr. UPTON, Mrs. SCHROEDER, Ms. SNOWE, Mrs.

COLLINS of Illinois, Ms. DANNER, Ms. ENGLISH, Mrs. JOHNSON of Connecticut, Mrs. KENNELLY, Ms. LAMBERT, Mr. LEHMAN, Mrs. LOWEY of

New York, Mrs. LLOYD, Mr. MARKEY, Mrs. MINK, Mrs. MORELLA, Ms.

MOLINARI, Ms. NORTON, Mr. RICHARDSON, Ms. PELOSI, Mr. SANDERS,

Ms. SCHENK, Mr. SHARP, Ms. SLAUGHTER, Mr. STUDDS, Mr. SYNAR,

Mr. TOWNS, Mrs. UNSOELD, Ms. WATERS, Ms. WOOLSEY, and Mr.

WYDEN) introduced the following bill; which was referred to the Committee on Energy and Commerce

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,

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

5 ‘‘National Institutes of Health Revitalization Act of

6 1993’’.
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1 (b) TABLE OF CONTENTS.—The table of contents for

2 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.

Subtitle C—Scientific Integrity

Sec. 151. Establishment of Office of Scientific Integrity.

Sec. 152. Commission on Scientific Integrity.

Sec. 153. Protection of whistleblowers.

Sec. 154. Requirement of regulations regarding protection against financial

conflicts of interest in certain projects of research.

Sec. 155. 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 disadvantaged individuals in

fields of biomedical and behavioral research.
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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.

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.
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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.

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
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Sec. 1521. Purpose of Center.

TITLE XVI—AWARDS AND TRAINING

Subtitle A—National Research Service Awards

Sec. 1601. Requirement regarding women and individuals from disadvantaged

backgrounds.

Subtitle B—Acquired Immune Deficiency Syndrome

Sec. 1611. Loan repayment program.

Subtitle C—Loan Repayment for Research Generally

Sec. 1621. Establishment of program.

Subtitle D—Scholarship and Loan Repayment Programs Regarding

Professional Skills Needed by National Institutes of Health

Sec. 1631. Establishment of programs.

Sec. 1632. Funding.

Subtitle E—Funding for Awards and Training Generally

Sec. 1641. Authorization of appropriations.

TITLE XVII—NATIONAL FOUNDATION FOR BIOMEDICAL

RESEARCH

Sec. 1701. Date certain for appointment of Board members.

Sec. 1702. Miscellaneous provisions.

TITLE XVIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE

DEFICIENCY SYNDROME

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.

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.

TITLE XXI—EFFECTIVE DATES
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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.—

18 ‘‘(1) PROTECTION OF HUMAN RESEARCH SUB19 JECTS.—

20 ‘‘(A) In the case of any application submit21 ted to the Secretary for financial assistance to

22 conduct research, the Secretary may not ap23 prove or fund any application that is subject to

24 review under section 491(a) by an Institutional

25 Review Board unless the application has under-
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1 gone review in accordance with such section and

2 has been recommended for approval by a major3 ity of the members of the Board conducting

4 such review.

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

6 to review under procedures established by the

7 Secretary for the protection of human subjects

8 in clinical research conducted by the National

9 Institutes of Health, the Secretary may not au10 thorize the conduct of the research unless the

11 research has, pursuant to such procedures, been

12 recommended for approval.

13 ‘‘(2) PEER REVIEW.—In the case of any appli14 cation submitted to the Secretary for financial as15 sistance to conduct research, the Secretary may not

16 approve or fund any application that is subject to

17 technical and scientific peer review under section

18 492(a) unless the application has undergone peer re19 view in accordance with such section and has been

20 recommended for approval by a majority of the

21 members of the entity conducting such review.

22 ‘‘(b) ETHICAL REVIEW OF RESEARCH.—

23 ‘‘(1) PROCEDURES REGARDING WITHHOLDING

24 OF FUNDS.—If research has been recommended for

25 approval for purposes of subsection (a), the Sec-
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1 retary may not withhold funding for the research on

2 ethical grounds unless—

3 ‘‘(A) the Secretary convenes an advisory

4 board in accordance with paragraph (4) to

5 study the ethical implications of the research;

6 and

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

8 recommends that, on ethical grounds, the Sec9 retary withhold funds for the research.

10 ‘‘(2) APPLICABILITY.—The limitation estab11 lished in paragraph (1) regarding the authority to

12 withhold funds on ethical grounds shall apply with13 out regard to whether the withholding of funds is

14 characterized as a disapproval, a moratorium, a pro15 hibition, or other description.

16 ‘‘(3) PRELIMINARY MATTERS REGARDING USE

17 OF PROCEDURES.—

18 ‘‘(A) If the Secretary makes a determina19 tion that an advisory board should be convened

20 for purposes of paragraph (1), the Secretary

21 shall, through a statement published in the

22 Federal Register, announce the intention of the

23 Secretary to convene such a board.

24 ‘‘(B) A statement issued under subpara25 graph (A) shall include a request that inter-
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1 ested individuals submit to the Secretary rec2 ommendations specifying the particular individ3 uals who should be appointed to the advisory

4 board involved. The Secretary shall consider

5 such recommendations in making appointments

6 to the board.

7 ‘‘(C) The Secretary may not make appoint8 ments to an advisory board under paragraph

9 (1) until the expiration of the 30-day period be10 ginning on the date on which the statement re11 quired in subparagraph (A) is made with re12 spect to the board.

13 ‘‘(4) ETHICS ADVISORY BOARDS.—

14 ‘‘(A) Any advisory board convened for pur15 poses of paragraph (1) shall be known as an

16 ethics advisory board (hereafter in this para17 graph referred to as an ‘ethics board’).

18 ‘‘(B)(i) An ethics board shall advise, con19 sult with, and make recommendations to the

20 Secretary regarding the ethics of the project of

21 biomedical or behavioral research with respect

22 to which the board has been convened.

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

24 date on which the statement required in para25 graph (3)(A) is made with respect to an ethics
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1 board, the board shall submit to the Secretary,

2 and to the Committee on Energy and Com3 merce of the House of Representatives and the

4 Committee on Labor and Human Resources of

5 the Senate, a report describing the findings of

6 the board regarding the project of research in7 volved and making a recommendation under

8 clause (i) of whether the Secretary should or

9 should not withhold funds for the project. The

10 report shall include the information considered

11 in making the findings.

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

13 no fewer than 14, and no more than 20, indi14 viduals who are not officers or employees of the

15 United States. The Secretary shall make ap16 pointments to the board from among individ17 uals with special qualifications and competence

18 to provide advice and recommendations regard19 ing ethical matters in biomedical and behavioral

20 research. Of the members of the board—

21 ‘‘(i) no fewer than 1 shall be an attor22 ney;

23 ‘‘(ii) no fewer than 1 shall be an

24 ethicist;
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1 ‘‘(iii) no fewer than 1 shall be a prac2 ticing physician;

3 ‘‘(iv) no fewer than 1 shall be a theo4 logian; and

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

6 more than one-half, shall be scientists with

7 substantial accomplishments in biomedical

8 or behavioral research.

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

10 an ethics board shall be for the life of the

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

12 term of such service, the individual appointed to

13 fill the resulting vacancy shall be appointed for

14 the remainder of the term of the predecessor of

15 the individual.

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

17 subject to removal from the board by the Sec18 retary for neglect of duty or malfeasance or for

19 other good cause shown.

20 ‘‘(F) The Secretary shall designate an indi21 vidual from among the members of an ethics

22 board to serve as the chair of the board.

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

24 with respect to a project of research, an ethics
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1 board shall conduct inquiries and hold public

2 hearings.

3 ‘‘(H) With respect to information relevant

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

5 an ethics board shall have access to all such in6 formation possessed by the Department of

7 Health and Human Services, or available to the

8 Secretary from other agencies.

9 ‘‘(I) Members of an ethics board shall re10 ceive compensation for each day engaged in car11 rying out the duties of the board, including

12 time engaged in traveling for purposes of such

13 duties. Such compensation may not be provided

14 in an amount in excess of the maximum rate of

15 basic pay payable for GS–18 of the General

16 Schedule.

17 ‘‘(J) The Secretary, acting through the Di18 rector of the National Institutes of Health,

19 shall provide to each ethics board such staff

20 and other assistance as may be necessary to

21 carry out the duties of the board.

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

23 days after the date on which the report required

24 in subparagraph (B)(ii) is submitted to the Sec-
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1 retary and the congressional committees speci2 fied in such subparagraph.’’.

3 PART II—RESEARCH ON TRANSPLANTATION OF

4 FETAL TISSUE

5 SEC. 111. ESTABLISHMENT OF AUTHORITIES.

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

7 (42 U.S.C. 289 et seq.) is amended by inserting after sec8 tion 498 the following new section:

9 ‘‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

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

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

12 or support research on the transplantation of human

13 fetal tissue for therapeutic purposes.

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

15 may be used in research carried out under para16 graph (1) regardless of whether the tissue is ob17 tained pursuant to a spontaneous or induced abor18 tion or pursuant to a stillbirth.

19 ‘‘(b) INFORMED CONSENT OF DONOR.—

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

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

22 used only if the woman providing the tissue makes

23 a statement, made in writing and signed by the

24 woman, declaring that—

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

26 for use in research described in subsection (a);
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1 ‘‘(B) the donation is made without any re2 striction regarding the identity of individuals

3 who may be the recipients of transplantations

4 of the tissue; and

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

6 the identity of any such individuals.

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

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

9 may be used only if the attending physician with re10 spect to obtaining the tissue from the woman in11 volved makes a statement, made in writing and

12 signed by the physician, declaring that—

13 ‘‘(A) in the case of tissue obtained pursu14 ant to an induced abortion—

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

16 abortion was obtained prior to requesting

17 or obtaining consent for the tissue to be

18 used in such research; and

19 ‘‘(ii) no alteration of the timing,

20 method, or procedures used to terminate

21 the pregnancy was made solely for the pur22 poses of obtaining the tissue;

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

24 woman in accordance with paragraph (1); and
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1 ‘‘(C) full disclosure has been provided to

2 the woman with regard to—

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

4 in the research to be conducted with the

5 tissue; and

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

7 woman or risks to her privacy that might

8 be associated with the donation of the tis9 sue and that are in addition to risks of

10 such type that are associated with the

11 woman’s medical care.

12 ‘‘(c) INFORMED CONSENT OF RESEARCHER AND

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

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

15 the principal responsibility for conducting the research in16 volved makes a statement, made in writing and signed by

17 the individual, declaring that the individual—

18 ‘‘(1) is aware that—

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

20 ‘‘(B) the tissue may have been obtained

21 pursuant to a spontaneous or induced abortion

22 or subsequent to a stillbirth; and

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

24 purposes;
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1 ‘‘(2) has provided such information to other in2 dividuals with responsibilities regarding the research;

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

4 of an individual to be a recipient of a transplan5 tation of the tissue, written acknowledgment of re6 ceipt of such information by such recipient; and

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

8 timing, method, or procedures used to terminate the

9 pregnancy made solely for the purposes of the re10 search.

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

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

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

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

15 conducting the research involved certifies to the Sec16 retary that the statements required under sub17 sections (a)(3), (b)(2), and (c) will be available for

18 audit by the Secretary.

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

20 conducted by the Secretary pursuant to paragraph

21 (1) shall be conducted in a confidential manner to

22 protect the privacy rights of the individuals and enti23 ties involved in such research, including such indi24 viduals and entities involved in the donation, trans25 fer, receipt, or transplantation of human fetal tissue.
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1 With respect to any material or information obtained

2 pursuant to such audit, the Secretary shall—

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

4 for the purposes of verifying compliance with

5 the requirements of this section;

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

7 or information, except where required by Fed8 eral law, in which case such material or infor9 mation shall be coded in a manner such that

10 the identities of such individuals and entities

11 are protected; and

12 ‘‘(C) not maintain such material or infor13 mation after completion of such audit, except

14 where necessary for the purposes of such audit.

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

16 ‘‘(1) RESEARCH CONDUCTED BY RECIPIENTS

17 OF ASSISTANCE.—The Secretary may not provide

18 support for research under subsection (a) to conduct

19 the research in accordance with applicable State and

20 local law.

21 ‘‘(2) RESEARCH CONDUCTED BY SECRETARY.—

22 The Secretary may conduct research under sub23 section (a) only in accordance with applicable State

24 and local law.
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1 ‘‘(f) DEFINITION.—For purposes of this section, the

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

3 from a dead human embryo or fetus after a spontaneous

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

5 SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITA6 TION OR ACCEPTANCE OF TISSUE AS DI7 RECTED DONATION FOR USE IN TRANSPLAN8 TATION.

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

10 as amended by section 111 of this Act, is amended by in11 serting after section 498A the following new section:

12 ‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE

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

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

15 otherwise transfer any human fetal tissue for valuable con16 sideration if the transfer affects interstate commerce.

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

18 DIRECTED DONATION FOR USE IN TRANSPLANTATION.—

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

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

21 for the purpose of transplantation of such tissue into an22 other person if the donation affects interstate commerce,

23 the tissue will be or is obtained pursuant to an induced

24 abortion, and—

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

26 to a promise to the donating individual that the do-
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1 nated tissue will be transplanted into a recipient

2 specified by such individual;

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

4 into a relative of the donating individual; or

5 ‘‘(3) the person who solicits or knowingly ac6 quires, receives, or accepts the donation has provided

7 valuable consideration for the costs associated with

8 such abortion.

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

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

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

12 with title 18, United States Code, subject to para13 graph (2), or imprisoned for not more than 10

14 years, or both.

15 ‘‘(2) PENALTIES APPLICABLE TO PERSONS RE16 CEIVING CONSIDERATION.—With respect to the im17 position of a fine under paragraph (1), if the person

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

19 be imposed in an amount not less than twice the

20 amount of the valuable consideration received.

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

22 ‘‘(1) The term ‘human fetal tissue’ has the

23 meaning given such term in section 498A(f).
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1 ‘‘(2) The term ‘interstate commerce’ has the

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

3 Federal Food, Drug, and Cosmetic Act.

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

5 include reasonable payments associated with the

6 transportation, implantation, processing, preserva7 tion, quality control, or storage of human fetal

8 tissue.’’.

9 SEC. 113. NULLIFICATION OF MORATORIUM.

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

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

12 that the Department of Health and Human Services is

13 prohibited from conducting or supporting any research on

14 the transplantation of human fetal tissue for therapeutic

15 purposes. Such research shall be carried out in accordance

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

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

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

19 of the enactment of this Act.

20 (b) PROHIBITION AGAINST WITHHOLDING OF FUNDS

21 IN CASES OF TECHNICAL AND SCIENTIFIC MERIT.—

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

23 for research on the transplantation of human fetal

24 tissue for therapeutic purposes, the Secretary of
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1 Health and Human Services may not withhold funds

2 for the research if—

3 (A) the research has been approved for

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

5 Health Service Act (as added by section 101 of

6 this Act);

7 (B) the research will be carried out in ac8 cordance with section 498A of such Act (as

9 added by section 111 of this Act); and

10 (C) there are reasonable assurances that

11 the research will not utilize any human fetal tis12 sue that has been obtained in violation of sec13 tion 498B(a) of such Act (as added by section

14 112 of this Act).

15 (2) STANDING APPROVAL REGARDING ETHICAL

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

17 on the transplantation of human fetal tissue for

18 therapeutic purposes, the issuance in December

19 1988 of the Report of the Human Fetal Tissue

20 Transplantation Research Panel shall be deemed to

21 be a report—

22 (A) issued by an ethics advisory board pur23 suant to section 492A(b)(4)(B)(ii) of the Public

24 Health Service Act (as added by section 101 of

25 this Act); and
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1 (B) finding, on a basis that is neither arbi2 trary nor capricious, that there are no ethical

3 grounds for withholding funds for the research.

4 (c) AUTHORITY FOR WITHHOLDING FUNDS FROM

5 RESEARCH.—In the case of any research on the transplan6 tation of human fetal tissue for therapeutic purposes, the

7 Secretary of Health and Human Services may withhold

8 funds for the research if any of the conditions specified

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

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

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

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

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

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

15 SEC. 114. REPORT BY GENERAL ACCOUNTING OFFICE ON

16 ADEQUACY OF REQUIREMENTS.

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

18 transplantation of human fetal tissue for therapeutic pur19 poses, the Comptroller General of the United States shall

20 conduct an audit for the purpose of determining—

21 (1) whether and to what extent such research

22 conducted or supported by the Secretary of Health

23 and Human Services has been conducted in accord24 ance with section 498A of the Public Health Service

25 Act (as added by section 111 of this Act); and
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1 (2) whether and to what extent there have been

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

3 section 112 of this Act).

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

5 Comptroller General of the United States shall complete

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

7 Committee on Energy and Commerce of the House of

8 Representatives, and to the Committee on Labor and

9 Human Resources of the Senate, a report describing the

10 findings made pursuant to the audit.

11 PART III—MISCELLANEOUS REPEALS

12 SEC. 121. REPEALS.

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

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

15 is amended by striking part J.

16 (b) OTHER REPEALS.—Part G of title IV of the Pub17 lic Health Service Act (42 U.S.C. 289 et seq.) is amend18 ed—

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

20 and

21 (2) by striking section 499; and

22 (3) by redesignating section 499A as section

23 499.

24 (c) NULLIFICATION OF CERTAIN REGULATION.—The

25 provisions of section 204(d) of part 46 of title 45 of the
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1 Code of Federal Regulations (45 CFR 46.204(d)) shall

2 not have any legal effect.

3 Subtitle B—Clinical Research Eq4 uity Regarding Women and Mi5 norities

6 PART I—WOMEN AND MINORITIES AS SUBJECTS

7 IN CLINICAL RESEARCH

8 SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.

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

10 as amended by section 101 of this Act, is amended by in11 serting after section 492A the following new section:

12 ‘‘INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

13 RESEARCH

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

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

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

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

18 project of such research; and

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

20 as subjects in such research.

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

22 regarding women and members of minority groups shall

23 not apply to a project of clinical research if the inclusion,

24 as subjects in the project, of women and members of mi25 nority groups, respectively—
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1 ‘‘(1) is inappropriate with respect to the health

2 of the subjects;

3 ‘‘(2) is inappropriate with respect to the pur4 pose of the research; or

5 ‘‘(3) is inappropriate under such other cir6 cumstances as the Director of NIH may designate.

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

8 in which women or members of minority groups will under

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

10 Director of NIH shall ensure that the project is designed

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

12 valid analysis of whether the variables being tested in the

13 research affect women or members of minority groups, as

14 the case may be, differently than other subjects in the

15 research.

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

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

18 shall establish guidelines regarding—

19 ‘‘(A) the circumstances under which the inclu20 sion of women and minorities in projects of clinical

21 research is inappropriate for purposes of subsection

22 (b);

23 ‘‘(B) the manner in which such projects are re24 quired to be designed and carried out for purposes

25 of subsection (c), including a specification of the cir-
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1 cumstances in which the requirement of such sub2 section does not apply on the basis of impracticabil3 ity; and

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

5 recruitment of women and members of minority

6 groups as subjects in such research.

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

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

9 the case may be) as subjects in clinical research is inap10 propriate for purposes of subsection (b), the guidelines es11 tablished under paragraph (1)(A)—

12 ‘‘(A) shall provide that the costs of such inclu13 sion in a project of clinical research is not a permis14 sible consideration in determining whether such in15 clusion is inappropriate unless the data of com16 parable quality regarding women or members of mi17 nority groups, respectively, that would be obtained in

18 such project in the event that such inclusion were re19 quired will be obtained through other means; and

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

21 project of clinical research is not required if there is

22 substantial scientific data demonstrating that there

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

2 studied in the project have on women or mem3 bers of minority groups, respectively; and

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

5 the individuals who would serve as subjects in

6 the project in the event that such inclusion were

7 not required.

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

9 be established and published in the Federal Register not

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

11 the National Institutes of Health Revitalization Act of

12 1993.

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

14 the Director of NIH may not approve any proposal of clin15 ical research to be conducted or supported by any agency

16 of the National Institutes of Health unless the proposal

17 specifies the manner in which the research will comply

18 with subsection (a).

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

20 institute shall annually submit to the Director of NIH and

21 the Director of the institute involved a report describing

22 the manner in which the agency has complied with sub23 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) 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 ‘‘(3) The Director of the Office shall serve as

4 the chair of the Advisory Committee.

5 ‘‘(4) The Advisory Committee shall—

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

7 appropriate research activities to be undertaken

8 by the national research institutes with respect

9 to—

10 ‘‘(i) research on women’s health;

11 ‘‘(ii) research on gender differences in

12 clinical drug trials, including responses to

13 pharmacological drugs;

14 ‘‘(iii) research on gender differences

15 in disease etiology, course, and treatment;

16 ‘‘(iv) research on obstetrical and gyne17 cological health conditions, diseases, and

18 treatments; and

19 ‘‘(v) research on women’s health con20 ditions which require a multidisciplinary

21 approach;

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

23 on such research;

24 ‘‘(C) provide recommendations to such Di25 rector regarding activities of the Office (includ-
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1 ing recommendations on the development of the

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

3 and recommendations on priorities in carrying

4 out research described in subparagraph (A));

5 and

6 ‘‘(D) assist in monitoring compliance with

7 section 492B regarding the inclusion of women

8 in clinical research.

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

10 a biennial report describing the activities of the

11 Committee, including findings made by the Commit12 tee regarding—

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

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

15 research on women’s health by the agencies of

16 the National Institutes of Health; and

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

18 research.

19 ‘‘(B) The report required in subparagraph (A)

20 shall be submitted to the Director of NIH for inclu21 sion in the report required in section 403.

22 ‘‘(e) REPRESENTATION OF WOMEN AMONG RE23 SEARCHERS.—The Secretary, acting through the Assist24 ant Secretary for Personnel and in collaboration with the

25 Director of the Office, shall determine the extent to which
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1 women are represented among senior physicians and sci2 entists of the national research institutes and among phy3 sicians and scientists conducting research with funds pro4 vided by such institutes, and as appropriate, carry out ac5 tivities to increase the extent of such representation.

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

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

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

9 groups, means all diseases, disorders, and conditions

10 (including with respect to mental health)—

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

12 prevalent in women;

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

14 or types of medical intervention are different

15 for women, or for which it is unknown whether

16 such factors or types are different for women;

17 or

18 ‘‘(C) with respect to which there has been

19 insufficient clinical research involving women as

20 subjects or insufficient clinical data on women.

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

22 means research on women’s health conditions, in23 cluding research on preventing such conditions.
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1 ‘‘SEC. 486A. NATIONAL DATA SYSTEM AND CLEARINGHOUSE

2 ON RESEARCH ON WOMEN’S HEALTH.

3 ‘‘(a) DATA SYSTEM.—

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

5 the Director of the Office, shall establish a data sys6 tem for the collection, storage, analysis, retrieval,

7 and dissemination of information regarding research

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

9 the national research institutes. Information from

10 the data system shall be available through informa11 tion systems available to health care professionals

12 and providers, researchers, and members of the

13 public.

14 ‘‘(2) The data system established under para15 graph (1) shall include a registry of clinical trials of

16 experimental treatments that have been developed

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

18 include information on subject eligibility criteria,

19 sex, age, ethnicity or race, and the location of the

20 trial site or sites. Principal investigators of such

21 clinical trials shall provide this information to the

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

23 trial has been completed, the principal investigator

24 shall provide the registry with information pertain25 ing to the results, including potential toxicities or
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1 adverse effects associated with the experimental

2 treatment or treatments evaluated.

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

4 consultation with the Director of the Office and with the

5 National Library of Medicine, shall establish, maintain,

6 and operate a program to provide information on research

7 and prevention activities of the national research institutes

8 that relate to research on women’s health.

9 ‘‘SEC. 486B. BIENNIAL REPORT.

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

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

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

13 a report—

14 ‘‘(1) describing and evaluating the progress

15 made during the preceding 2 fiscal years in research

16 and treatment conducted or supported by the Na17 tional Institutes of Health;

18 ‘‘(2) describing and analyzing the professional

19 status of women physicians and scientists of such

20 Institutes, including the identification of problems

21 and barriers regarding advancements;

22 ‘‘(3) summarizing and analyzing expenditures

23 made by the agencies of such Institutes (and by

24 such Office) during the preceding 2 fiscal years; and
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1 ‘‘(4) making such recommendations for legisla2 tive and administrative initiatives as the Director of

3 the Office determines to be appropriate.

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

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

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

7 NIH for inclusion in the report submitted to the President

8 and the Congress under section 403.’’.

9 (b) REQUIREMENT OF SUFFICIENT ALLOCATION OF

10 RESOURCES OF INSTITUTES.—Section 402(b) of the Pub11 lic Health Service Act (42 U.S.C. 282(b)) is amended—

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

13 the semicolon at the end;

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

15 the end and inserting ‘‘; and’’; and

16 (3) by inserting after paragraph (11) the fol17 lowing new paragraph:

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

19 the Office of Research on Women’s Health, shall en20 sure that resources of the National Institutes of

21 Health are sufficiently allocated for projects of re22 search on women’s health that are identified under

23 section 486(b).’’.
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1 Subtitle C—Scientific Integrity

2 SEC. 151. ESTABLISHMENT OF OFFICE OF SCIENTIFIC IN3 TEGRITY.

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

5 Service Act (42 U.S.C. 289b) is amended to read as fol6 lows:

7 ‘‘OFFICE OF SCIENTIFIC INTEGRITY

8 ‘‘SEC. 493. (a) ESTABLISHMENT.—

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

10 after the date of enactment of this section, the Sec11 retary shall establish an office to be known as the

12 Office of Scientific Integrity (hereafter referred to in

13 this section as the ‘Office’), which shall be estab14 lished as an independent entity in the Department

15 of Health and Human Services.

16 ‘‘(2) DIRECTOR.—The Office shall be headed by

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

18 be experienced and specially trained in the conduct

19 of research, and have experience in the conduct of

20 investigations of scientific misconduct. The Sec21 retary shall carry out this section acting through the

22 Director of the Office. The Director shall report to

23 the Secretary.

24 ‘‘(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS

25 CONDITION OF FUNDING FOR RESEARCH.—The Secretary
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1 shall by regulation require that each entity that applies

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

3 Act for any project or program that involves the conduct

4 of biomedical or behavioral research submit in or with its

5 application for such grant, contract, or cooperative agree6 ment assurances satisfactory to the Secretary that such

7 entity—

8 ‘‘(1) has established (in accordance with regula9 tions which the Secretary shall prescribe) an admin10 istrative process to review reports of scientific mis11 conduct in connection with biomedical and behav12 ioral research conducted at or sponsored by such en13 tity; and

14 ‘‘(2) will report to the Director any investiga15 tion of alleged scientific misconduct in connection

16 with projects for which funds have been made avail17 able under this Act that appears substantial.

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

19 Secretary shall establish by regulation a process to be fol20 lowed by the Director for the prompt and appropriate—

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

22 Director respecting scientific misconduct in connec23 tion with projects for which funds have been made

24 available under this Act;
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1 ‘‘(2) receipt of reports by the Director of such

2 information from recipients of funds under this Act;

3 ‘‘(3) conduct of investigations, when appro4 priate; and

5 ‘‘(4) taking of other actions, including appro6 priate remedies, with respect to such misconduct.

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

8 shall by regulation establish procedures for the Director

9 to monitor administrative processes and investigations

10 that have been established or carried out under this sec11 tion.

12 ‘‘(e) EFFECT ON PRESENT INVESTIGATIONS.—Noth13 ing in this section shall affect investigations which have

14 been or will be commenced prior to the promulgation of

15 final regulations under this section.’’.

16 (b) ESTABLISHMENT OF DEFINITION OF SCIENTIFIC

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

18 which the report required under section 152(d) is submit19 ted to the Secretary of Health and Human Services, such

20 Secretary shall by regulation establish a definition for the

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

22 of the Public Health Service Act, as amended by sub23 section (a) of this section.
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1 SEC. 152. COMMISSION ON SCIENTIFIC INTEGRITY.

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

3 Human Services shall establish a commission to be known

4 as the Commission on Scientific Integrity (in this section

5 referred to as the ‘‘Commission’’).

6 (b) DUTIES.—The Commission shall develop rec7 ommendations for the Secretary of Health and Human

8 Services on the administration of section 493 of the Public

9 Health Service Act (as amended and added by section 151

10 of this Act).

11 (c) COMPOSITION.—The Commission shall be com12 posed of 12 members to be appointed by the Secretary

13 of Health and Human Services from among individuals

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

15 Of the members appointed to the Commission—

16 (1) three shall be scientists with substantial ac17 complishments in biomedical or behavioral research;

18 (2) three shall be individuals with experience in

19 investigating allegations of misconduct with respect

20 to scientific research;

21 (3) three shall be representatives of institutions

22 of higher education at which biomedical or behav23 ioral research is conducted; and

24 (4) three shall be individuals who are not de25 scribed in paragraphs (1), (2), or (3), at least one
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1 of whom shall be an attorney and at least one of

2 whom shall be an ethicist.

3 (d) REPORT.—Not later than 120 days after the date

4 of enactment of this section, the Commission shall prepare

5 and submit to the Secretary of Health and Human Serv6 ices, the Committee on Energy and Commerce of the

7 House of Representatives, and the Committee on Labor

8 and Human Resources of the Senate, a report containing

9 the recommendations developed under subsection (b).

10 SEC. 153. PROTECTION OF WHISTLEBLOWERS.

11 Section 493 of the Public Health Service Act, as

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

13 at the end the following new subsection:

14 ‘‘(f) PROTECTION OF WHISTLEBLOWERS.—

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

16 required to establish administrative processes under

17 subsection (b), the Secretary shall by regulation es18 tablish standards for preventing, and for responding

19 to the occurrence of retaliation by such entity, its of20 ficials or agents, against an employee in the terms

21 and conditions of employment in response to the em22 ployee having in good faith—

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

24 officials or agents, has engaged in or failed to
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1 adequately respond to an allegation of scientific

2 misconduct; or

3 ‘‘(B) cooperated with an investigation of

4 such an allegation.

5 ‘‘(2) MONITORING BY SECRETARY.—The Sec6 retary shall establish by regulation procedures for

7 the Director to monitor the implementation of the

8 standards established by an entity under paragraph

9 (1) for the purpose of determining whether the pro10 cedures have been established, and are being uti11 lized, in accordance with the standards established

12 under such paragraph.

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

14 regulation establish remedies for noncompliance by

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

16 in retaliation in violation of the standards estab17 lished under paragraph (1). Such remedies may in18 clude termination of funding provided by the Sec19 retary for such project or recovery of funding being

20 provided by the Secretary for such project, or other

21 actions as appropriate.

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

23 Secretary shall issue a final rule for the regulations

24 required in paragraph (1) not later than 180 days
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1 after the date of the enactment of the National In2 stitutes of Health Revitalization Act of 1993.

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

4 year beginning after the date on which the regula5 tions required in paragraph (1) are issued, the Sec6 retary may not provide a grant, cooperative agree7 ment, or contract under this Act for biomedical or

8 behavioral research unless the entity seeking such fi9 nancial assistance agrees that the entity—

10 ‘‘(A) will maintain the procedures de11 scribed in the regulations; and

12 ‘‘(B) will otherwise be subject to the regu13 lations.’’.

14 SEC. 154. REQUIREMENT OF REGULATIONS REGARDING

15 PROTECTION AGAINST FINANCIAL CON16 FLICTS OF INTEREST IN CERTAIN PROJECTS

17 OF RESEARCH.

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

19 as redesignated by section 141(a)(2) of this Act, is amend20 ed by inserting after section 493 the following new section:

21 ‘‘PROTECTION AGAINST FINANCIAL CONFLICTS OF

22 INTEREST IN CERTAIN PROJECTS OF RESEARCH

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

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

25 by regulation, the specific circumstances that con26 stitute the existence of a financial interest in a
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1 project on the part of an entity or individual that

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

3 in favor of obtaining results in such project that are

4 consistent with such financial interest. Such defini5 tion shall apply uniformly to each entity or individ6 ual conducting a research project under this Act. In

7 the case of any entity or individual receiving assist8 ance from the Secretary for a project of research de9 scribed in paragraph (2), the Secretary shall by reg10 ulation establish standards for responding to, includ11 ing managing, reducing, or eliminating, the existence

12 of such a financial interest. The entity may adopt

13 individualized procedures for implementing the

14 standards.

15 ‘‘(2) RELEVANT PROJECTS.—A project of re16 search referred to in paragraph (1) is a project of

17 clinical research whose purpose is to evaluate the

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

19 treatment and for which such entity is receiving as20 sistance from the Secretary.

21 ‘‘(3) IDENTIFYING AND REPORTING TO THE DI22 RECTOR.—The Secretary shall ensure that the

23 standards established under paragraph (1) specify

24 that as a condition of receiving assistance from the
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1 Secretary for the project involved, an entity de2 scribed in such subsection is required—

3 ‘‘(A) to have in effect at the time the en4 tity applies for the assistance and throughout

5 the period during which the assistance is re6 ceived, a process for identifying such financial

7 interests as defined in paragraph (1) that exist

8 regarding the project; and

9 ‘‘(B) to report to the Director such finan10 cial interest as defined in paragraph (1) identi11 fied by the entity and how any such financial

12 interest identified by the entity will be managed

13 or eliminated such that the project in question

14 will be protected from bias that may stem from

15 such financial interest.

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

17 shall monitor the establishment and conduct of the

18 process established by an entity pursuant to para19 graph (1).

20 ‘‘(5) RESPONSE.—In any case in which the Sec21 retary determines that an entity has failed to comply

22 with paragraph (3) regarding a project of research

23 described in paragraph (1), the Secretary—

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

25 receiving assistance, the entity disclose the ex-
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1 istence of a financial interest as defined in

2 paragraph (1) in each public presentation of the

3 results of such project; and

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

5 Secretary determines to be appropriate.

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

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

8 the receipt of consulting fees or honoraria and

9 the ownership of stock or equity.

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

11 conducting a project of research, means a

12 grant, contract, or cooperative agreement.

13 ‘‘(b) FINAL RULE FOR REGULATIONS.—The Sec14 retary shall issue a final rule for the regulations required

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

16 of the enactment of the National Institutes of Health Re17 vitalization Act of 1993.’’.

18 SEC. 155. EFFECTIVE DATES.

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

20 subtitle shall become effective on the date that occurs 180

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

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

23 amended by sections 151 and 153, is published in the Fed24 eral Register.
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1 (b) AGREEMENTS AS A CONDITION OF FUNDING.—

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

3 the Public Health Service Act, as amended by sections 151

4 and 153, with respect to agreements as a condition of

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

6 research for which initial funding under the Public Health

7 Service Act was provided prior to the effective date de8 scribed in subsection (a).

9 TITLE II—NATIONAL INSTITUTES

10 OF HEALTH IN GENERAL

11 SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINA12 TION.

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

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

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

16 inserting ‘‘other public and private entities, including ele17 mentary, secondary, and post-secondary schools. The As18 sociate Director shall—

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

20 policies and techniques used by the national research

21 institutes to disseminate the results of disease pre22 vention and behavioral research programs;

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

24 modification or reconstruction of such policies and

25 techniques to ensure maximum dissemination, using
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1 advanced technologies to the maximum extent prac2 ticable, of research results to such entities; and

3 ‘‘(3) annually prepare and submit to the Direc4 tor of NIH a report concerning the prevention and

5 dissemination activities undertaken by the Associate

6 Director, including—

7 ‘‘(A) a summary of the Associate Direc8 tor’s review of existing dissemination policies

9 and techniques together with a detailed state10 ment concerning any modification or restructur11 ing, or recommendations for modification or re12 structuring, of such policies and techniques;

13 and

14 ‘‘(B) a detailed statement of the expendi15 tures made for the prevention and dissemina16 tion activities reported on and the personnel

17 used in connection with such activities.’’.

18 SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARD19 ING CERTAIN STATES AND RESEARCHERS.

20 Section 402 of the Public Health Service Act (42

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

22 new subsection:

23 ‘‘(g)(1)(A) In the case of entities described in sub24 paragraph (B), the Director of NIH, acting through the

25 Director of the National Center for Research Resources,
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1 shall establish a program to enhance the competitiveness

2 of such entities in obtaining funds from the national re3 search institutes for conducting biomedical and behavioral

4 research.

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

6 entities that conduct biomedical and behavioral research

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

8 rate for applications to the national research institutes for

9 assistance for such research by the entities in the State

10 has historically constituted a low success rate of obtaining

11 such funds, relative to such aggregate rate for such enti12 ties in other States.

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

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

15 carrying out the program established under such subpara16 graph, may—

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

18 involved, including technical assistance in the prepa19 ration of applications for obtaining funds from the

20 national research institutes;

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

22 biomedical or behavioral research proposals; and

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

24 plan.
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1 ‘‘(2) The Director of NIH shall establish a program

2 of supporting projects of biomedical or behavioral research

3 whose principal researchers are individuals who have not

4 previously served as the principal researchers of such

5 projects supported by the Director.’’.

6 SEC. 203. CHILDREN’S VACCINE INITIATIVE.

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 ‘‘CHILDREN’S VACCINE INITIATIVE

11 ‘‘SEC. 404. (a) DEVELOPMENT OF NEW VACCINES.—

12 The Secretary, in consultation with the Director of the

13 National Vaccine Program under title XXI and acting

14 through the Directors of the National Institute for Allergy

15 and Infectious Diseases, the National Institute for Child

16 Health and Human Development, the National Institute

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

18 carry out activities, which shall be consistent with the

19 global Children’s Vaccine Initiative, to develop affordable

20 new and improved vaccines to be used in the United States

21 and in the developing world that will increase the efficacy

22 and efficiency of the prevention of infectious diseases. In

23 carrying out such activities, the Secretary shall, to the ex24 tent practicable, develop and make available vaccines that

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

26 in life, that provide long lasting protection, that obviate
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1 refrigeration, needles and syringes, and that protect

2 against a larger number of diseases.

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

4 2104, the Secretary, acting through the Director of the

5 National Vaccine Program under title XXI, shall include

6 information with respect to activities and the progress

7 made in implementing the provisions of this section and

8 achieving its goals.

9 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—In ad10 dition to any other amounts authorized to be appropriated

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

12 are authorized to be appropriated to carry out this section

13 $50,000,000 for fiscal year 1994, and such sums as may

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

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

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

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

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

19 ‘‘PLAN FOR USE OF ANIMALS IN RESEARCH

20 ‘‘SEC. 404A. (a) The Director of NIH, after consulta21 tion with the committee established under subsection (e),

22 shall prepare a plan—

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

24 conduct or support research into—
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1 ‘‘(A) methods of biomedical research and

2 experimentation that do not require the use of

3 animals;

4 ‘‘(B) methods of such research and experi5 mentation that reduce the number of animals

6 used in such research; and

7 ‘‘(C) methods of such research and experi8 mentation that produce less pain and distress in

9 such animals;

10 ‘‘(2) for establishing the validity and reliability

11 of the methods described in paragraph (1);

12 ‘‘(3) for encouraging the acceptance by the sci13 entific community of such methods that have been

14 found to be valid and reliable; and

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

16 methods that have been found to be valid and reli17 able.

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

19 of NIH shall submit to the Committee on Energy and

20 Commerce of the House of Representatives, and to the

21 Committee on Labor and Human Resources of the Senate,

22 the plan required in subsection (a) and shall begin imple23 mentation of the plan.

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

25 and as appropriate, make revisions in the plan required
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1 under subsection (a). A description of any revision made

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

3 under section 403 that is submitted after the revision is

4 made.

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

6 may be appropriate to convey to scientists and others who

7 use animals in biomedical or behavioral research or experi8 mentation information respecting the methods found to be

9 valid and reliable under subsection (a)(2).

10 ‘‘(e)(1) The Director of NIH shall establish within

11 the National Institutes of Health a committee to be known

12 as the Interagency Coordinating Committee on the Use

13 of Animals in Research (hereafter in this subsection re14 ferred to as the ‘Committee’).

15 ‘‘(2) The Committee shall provide advice to the Direc16 tor of NIH on the preparation of the plan required in sub17 section (a).

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

19 ‘‘(A) the Directors of each of the national re20 search institutes and the Director of the Center for

21 Research Resources (or the designees of such Direc22 tors); and

23 ‘‘(B) representatives of the Environmental Pro24 tection Agency, the Food and Drug Administration,

25 the Consumer Product Safety Commission, the Na-
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1 tional Science Foundation, and such additional agen2 cies as the Director of NIH determines to be appro3 priate.’’.

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

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

6 158; 99 Stat. 880) is repealed.

7 SEC. 205. INCREASED PARTICIPATION OF WOMEN AND DIS8 ADVANTAGED INDIVIDUALS IN FIELDS OF

9 BIOMEDICAL AND BEHAVIORAL RESEARCH.

10 Section 402 of the Public Health Service Act, as

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

12 at the end the following new subsection:

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

14 NIH and the Directors of the agencies of the National

15 Institutes of Health, may conduct and support programs

16 for research, research training, recruitment, and other ac17 tivities to provide for an increase in the number of women

18 and individuals from disadvantaged backgrounds in the

19 fields of biomedical and behavioral research.’’.

20 SEC. 206. REQUIREMENTS REGARDING SURVEYS OF SEX21 UAL BEHAVIOR.

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

23 as amended by section 204 of this Act, is amended by add24 ing at the end the following new section:
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1 ‘‘REQUIREMENTS REGARDING SURVEYS OF SEXUAL

2 BEHAVIOR

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

4 sexual behavior proposed to be conducted or supported

5 through the National Institutes of Health, the survey may

6 not be carried out unless—

7 ‘‘(1) the proposal has undergone review in ac8 cordance with any applicable requirements of sec9 tions 491 and 492; and

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

11 492A, makes a determination that the information

12 expected to be obtained through the survey will as13 sist—

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

15 transmitted diseases, the incidence of infection

16 with the human immunodeficiency virus, or the

17 incidence of any other infectious disease; or

18 ‘‘(B) in improving reproductive health or

19 other conditions of health.’’.

20 SEC. 207. DISCRETIONARY FUND OF DIRECTOR OF NA21 TIONAL INSTITUTES OF HEALTH.

22 Section 402 of the Public Health Service Act, as

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

24 at the end the following new subsection:
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1 ‘‘(i)(1) There is established a fund, consisting of

2 amounts appropriated under paragraph (3) and made

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

4 carry out the activities authorized in this Act for the Na5 tional Institutes of Health. The purposes for which such

6 fund may be expended include—

7 ‘‘(A) providing for research on matters that

8 have not received significant funding relative to

9 other matters, responding to new issues and sci10 entific emergencies, and acting on research opportu11 nities of high priority;

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

13 within the authority of any single agency of such In14 stitutes; and

15 ‘‘(C) purchasing or renting equipment and

16 quarters for activities of such Institutes.

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

18 the Secretary shall submit to the Committee on Energy

19 and Commerce of the House of Representatives, and to

20 the Committee on Labor and Human Resources of the

21 Senate, a report describing the activities undertaken and

22 expenditures made under this section during the preceding

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

24 Secretary regarding this section as the Secretary deter25 mines to be appropriate.
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1 ‘‘(3) For the purpose of carrying out this subsection,

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

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

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

5 SEC. 208. MISCELLANEOUS PROVISIONS.

6 (a) TERM OF OFFICE FOR MEMBERS OF ADVISORY

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

8 Act (42 U.S.C. 284a(c)) is amended in the second sen9 tence by striking ‘‘until a successor has been appointed’’

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

11 of such expiration’’.

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

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

14 amended—

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

16 end;

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

18 inserting ‘‘; and’’; and

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

20 new paragraph:

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

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

23 and promotion materials developed or funded by the

24 National Institutes of Health is in a form that does

25 not exceed a level of functional literacy, as defined
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1 in the National Literacy Act of 1991 (Public Law

2 102–73).’’.

3 (c) DAY CARE REGARDING CHILDREN OF EMPLOY4 EES.—Section 402 of the Public Health Service Act, as

5 amended by section 207 of this Act, is amended by adding

6 at the end the following new subsection:

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

8 to provide day care service for the employees of the Na9 tional Institutes of Health similar to those services pro10 vided by other Federal agencies (including the availability

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

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

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

14 into consideration the income and needs of the employee.

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

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

17 purchase agreements.’’.

18 TITLE III—GENERAL PROVI19 SIONS RESPECTING NA20 TIONAL RESEARCH INSTI21 TUTES

22 SEC. 301. APPOINTMENT AND AUTHORITY OF DIRECTORS

23 OF NATIONAL RESEARCH INSTITUTES.

24 (a) ESTABLISHMENT OF GENERAL AUTHORITY RE25 GARDING DIRECT FUNDING.—
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1 (1) IN GENERAL.—Section 405(b)(2) of the

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

3 amended—

4 (A) in subparagraph (A), by striking

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

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

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

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

9 subparagraph:

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

11 Office of Management and Budget directly all funds

12 appropriated by the Congress for obligation and ex13 penditure by the Institute.’’.

14 (2) CONFORMING AMENDMENT.—Section

15 413(b)(9) of the Public Health Service Act (42

16 U.S.C. 285a–2(b)(9)) is amended—

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

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

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

20 (b) APPOINTMENT AND DURATION OF TECHNICAL

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

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

23 amended—

24 (1) by amending paragraph (3) to read as fol25 lows:
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1 ‘‘(3) may, in consultation with the advisory

2 council for the Institute and with the approval of the

3 Director of NIH—

4 ‘‘(A) establish technical and scientific peer

5 review groups in addition to those appointed

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

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

8 groups established under subparagraph (A);

9 and’’; and

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

11 the following:

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

13 the duration of a peer review group appointed under para14 graph (3).’’.

15 SEC. 302. PROGRAM OF RESEARCH ON OSTEOPOROSIS,

16 PAGET’S DISEASE, AND RELATED BONE DIS17 ORDERS.

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

19 (42 U.S.C. 284 et seq.), as amended by section 121(b)

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

21 adding at the end the following new section:

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

23 RELATED BONE DISORDERS

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

25 the National Institute of Arthritis and Musculoskeletal

26 and Skin Diseases, the National Institute on Aging, and
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1 the National Institute of Diabetes, Digestive and Kidney

2 Diseases, shall expand and intensify the programs of such

3 Institutes with respect to research and related activities

4 concerning osteoporosis, Paget’s disease, and related bone

5 disorders.

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

7 subsection (a) shall jointly coordinate the programs re8 ferred to in such subsection and consult with the Arthritis

9 and Musculoskeletal Diseases Interagency Coordinating

10 Committee and the Interagency Task Force on Aging Re11 search.

12 ‘‘(c) INFORMATION CLEARINGHOUSE.—

13 ‘‘(1) IN GENERAL.—In order to assist in carry14 ing out the purpose described in subsection (a), the

15 Director of NIH shall provide for the establishment

16 of an information clearinghouse on osteoporosis and

17 related bone disorders to facilitate and enhance

18 knowledge and understanding on the part of health

19 professionals, patients, and the public through the

20 effective dissemination of information.

21 ‘‘(2) ESTABLISHMENT THROUGH GRANT OR

22 CONTRACT.—For the purpose of carrying out para23 graph (1), the Director of NIH shall enter into a

24 grant, cooperative agreement, or contract with a

25 nonprofit private entity involved in activities regard-
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1 ing the prevention and control of osteoporosis and

2 related bone disorders.

3 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the

4 purpose of carrying out this section, there are authorized

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

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

7 1995 and 1996.’’.

8 SEC. 303. ESTABLISHMENT OF INTERAGENCY PROGRAM

9 FOR TRAUMA RESEARCH.

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

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

12 at the end the following part:

13 ‘‘PART E—INTERAGENCY PROGRAM FOR TRAUMA

14 RESEARCH

15 ‘‘SEC. 1251. ESTABLISHMENT OF PROGRAM.

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

17 the Director of the National Institutes of Health (here18 after in this section referred to as the ‘Director’), shall

19 establish a comprehensive program of conducting basic

20 and clinical research on trauma (hereafter in this section

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

22 research regarding the diagnosis, treatment, rehabilita23 tion, and general management of trauma.

24 (b) PLAN FOR PROGRAM.—
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1 ‘‘(1) IN GENERAL.—The Director, in consulta2 tion with the Trauma Research Interagency Coordi3 nating Committee established under subsection (g),

4 shall establish and implement a plan for carrying

5 out the activities of the Program, including the ac6 tivities described in subsection (d). All such activities

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

8 plan shall be periodically reviewed, and revised as

9 appropriate.

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

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

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

13 Energy and Commerce of the House of Representa14 tives, and to the Committee on Labor and Human

15 Resources of the Senate, together with an estimate

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

17 through 1996 to implement the plan.

18 ‘‘(c) PARTICIPATING AGENCIES; COORDINATION AND

19 COLLABORATION.—The Director—

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

21 under the Program by the Directors of the agencies

22 of the National Institutes of Health involved in re23 search with respect to trauma;

24 ‘‘(2) shall ensure that the activities of the Pro25 gram are coordinated among such agencies; and
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1 ‘‘(3) shall, as appropriate, provide for collabora2 tion among such agencies in carrying out such ac3 tivities.

4 ‘‘(d) CERTAIN ACTIVITIES OF PROGRAM.—The Pro5 gram shall include—

6 ‘‘(1) studies with respect to all phases of trau7 ma care, including prehospital, resuscitation, sur8 gical intervention, critical care, infection control,

9 wound healing, nutritional care and support, and

10 medical rehabilitation care;

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

12 response of the body to trauma and the acute treat13 ment and medical rehabilitation of individuals who

14 are the victims of trauma; and

15 ‘‘(3) basic and clinical research regarding trau16 ma care for pediatric and geriatric patients.

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

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

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

20 to public and nonprofit entities, including designated trau21 ma centers.

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

23 availability of appropriate resources to carry out the Pro24 gram, including the plan established under subsection (b)

25 (including the activities described in subsection (d)).
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1 ‘‘(g) COORDINATING COMMITTEE.—

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

3 a Trauma Research Interagency Coordinating Com4 mittee (hereafter in this section referred to as the

5 ‘Coordinating Committee’).

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

7 shall make recommendations regarding—

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

9 carried out by each of the agencies represented

10 on the Committee and the amount of funds

11 needed by each of the agencies for such activi12 ties; and

13 ‘‘(B) effective collaboration among the

14 agencies in carrying out the activities.

15 ‘‘(3) COMPOSITION.—The Coordinating Com16 mittee shall be composed of the Directors of each of

17 the agencies that, under subsection (c), have respon18 sibilities under the Program, and any other individ19 uals who are practitioners in the trauma field as

20 designated by the Director of the National Institutes

21 of Health.

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

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

24 the meaning given such term in section 1231(1).
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1 ‘‘(2) The term ‘Director’ means the Director of

2 the National Institutes of Health.

3 ‘‘(3) The term ‘trauma’ means any serious in4 jury that could result in loss of life or in significant

5 disability and that would meet pre-hospital triage

6 criteria for transport to a designated trauma cen7 ter.’’.

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

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

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

11 new subsection:

12 ‘‘(k) The Director of NIH shall carry out the pro13 gram established in part E of title XII (relating to inter14 agency research on trauma).’’.

15 TITLE IV—NATIONAL CANCER

16 INSTITUTE

17 SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVI18 TIES REGARDING BREAST CANCER.

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

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

21 at the end the following new section:

22 ‘‘BREAST AND GYNECOLOGICAL CANCERS

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

24 ACTIVITIES.—The Director of the Institute, in consulta25 tion with the National Cancer Advisory Board, shall ex26 pand, intensify, and coordinate the activities of the Insti-
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1 tute with respect to research on breast cancer, ovarian

2 cancer, and other cancers of the reproductive system of

3 women.

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

5 The Director of the Institute shall coordinate the activities

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

7 conducted by other national research institutes and agen8 cies of the National Institutes of Health to the extent that

9 such Institutes and agencies have responsibilities that are

10 related to breast cancer and other cancers of the reproduc11 tive system of women.

12 ‘‘(c) PROGRAMS FOR BREAST CANCER.—

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

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

15 support research to expand the understanding of the

16 cause of, and to find a cure for, breast cancer. Ac17 tivities under such subsection shall provide for an

18 expansion and intensification of the conduct and

19 support of—

20 ‘‘(A) basic research concerning the etiology

21 and causes of breast cancer;

22 ‘‘(B) clinical research and related activities

23 concerning the causes, prevention, detection and

24 treatment of breast cancer;
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1 ‘‘(C) control programs with respect to

2 breast cancer in accordance with section 412;

3 ‘‘(D) information and education programs

4 with respect to breast cancer in accordance with

5 section 413; and

6 ‘‘(E) research and demonstration centers

7 with respect to breast cancer in accordance with

8 section 414, including the development and op9 eration of centers for breast cancer research to

10 bring together basic and clinical, biomedical and

11 behavioral scientists to conduct basic, clinical,

12 epidemiological, psychosocial, prevention and

13 treatment research and related activities on

14 breast cancer.

15 Not less than six centers shall be operated under

16 subparagraph (E). Activities of such centers should

17 include 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

3 the Director of the Institute considers appro4 priate, with due consideration provided to the

5 professional judgment needs of the Institute as

6 expressed in the annual budget estimate pre7 pared in accordance with section 413(9). The

8 Director of the Institute, in consultation with

9 the National Cancer Advisory Board, shall peri10 odically review and revise such plan.

11 ‘‘(B) Not later than May 1, 1993, the Di12 rector of the Institute shall submit a copy of

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

14 Secretary and the Director of NIH.

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

16 submit any revisions of the plan to the Presi17 dent’s Cancer Panel, the Secretary, and the Di18 rector of NIH.

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

20 the plan submitted under subparagraph (A),

21 and any revisions submitted under subpara22 graph (C), to the Committee on Energy and

23 Commerce of the House of Representatives and

24 the Committee on Labor and Human Resources

25 of the Senate.
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1 ‘‘(d) OTHER CANCERS.—In carrying out subsection

2 (a), the Director of the Institute shall conduct or support

3 research on ovarian cancer and other cancers of the repro4 ductive system of women. Activities under such subsection

5 shall provide for the conduct and support of—

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

7 causes of ovarian cancer and other cancers of the re8 productive system of women;

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

10 the causes, prevention, detection and treatment of

11 ovarian cancer and other cancers of the reproductive

12 system of women;

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

14 cancer and other cancers of the reproductive system

15 of women in accordance with section 412;

16 ‘‘(4) information and education programs with

17 respect to ovarian cancer and other cancers of the

18 reproductive system of women in accordance with

19 section 413; and

20 ‘‘(5) research and demonstration centers with

21 respect to ovarian cancer and cancers of the repro22 ductive system in accordance with section 414.

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

24 prepare, for inclusion in the biennial report submitted

25 under section 407, a report that describes the activities
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1 of the National Cancer Institute under the research pro2 grams referred to in subsection (a), that shall include—

3 ‘‘(1) a description of the research plan with re4 spect to breast cancer prepared under subsection (c);

5 ‘‘(2) an assessment of the development, revi6 sion, and implementation of such plan;

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

8 progress made, during the period for which such re9 port is prepared, in the research programs on breast

10 cancer and cancers of the reproductive system of

11 women;

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

13 made, during the period for which such report is

14 made, for activities with respect to breast cancer and

15 cancers of the reproductive system of women con16 ducted and supported by the National Institutes of

17 Health; and

18 ‘‘(5) such comments and recommendations as

19 the Director considers appropriate.’’.

20 SEC. 402. EXPANSION AND INTENSIFICATION OF ACTIVI21 TIES REGARDING PROSTATE CANCER.

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

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

24 amended by adding at the end the following new section:
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1 ‘‘PROSTATE CANCER

2 ‘‘SEC. 417A. (a) EXPANSION AND COORDINATION OF

3 ACTIVITIES.—The Director of the Institute, in consulta4 tion with the National Cancer Advisory Board, shall ex5 pand, intensify, and coordinate the activities of the Insti6 tute with respect to research on prostate cancer.

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

8 The Director of the Institute shall coordinate the activities

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

10 conducted by other national research institutes and agen11 cies of the National Institutes of Health to the extent that

12 such Institutes and agencies have responsibilities that are

13 related to prostate cancer.

14 ‘‘(c) PROGRAMS.—

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

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

17 support research to expand the understanding of the

18 cause of, and to find a cure for, prostate cancer. Ac19 tivities under such subsection shall provide for an

20 expansion and intensification of the conduct and

21 support of—

22 ‘‘(A) basic research concerning the etiology

23 and causes of prostate cancer;
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1 ‘‘(B) clinical research and related activities

2 concerning the causes, prevention, detection and

3 treatment of prostate cancer;

4 ‘‘(C) prevention and control and early de5 tection programs with respect to prostate can6 cer in accordance with section 412, particularly

7 as it relates to intensifying research on the role

8 of prostate specific antigen for the screening

9 and early detection of prostate cancer;

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

11 the direction of the Director of the Institute, to

12 provide coordination between relevant National

13 Institutes of Health components of research ef14 forts on prostate cancer;

15 ‘‘(E) control programs with respect to

16 prostate cancer in accordance with section 412;

17 ‘‘(F) information and education programs

18 with respect to prostate cancer in accordance

19 with section 413; and

20 ‘‘(G) research and demonstration centers

21 with respect to prostate cancer in accordance

22 with section 414, including the development and

23 operation of centers for prostate cancer re24 search to bring together basic and clinical, bio25 medical and behavioral scientists to conduct
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1 basic, clinical, epidemiological, psychosocial,

2 prevention and treatment research and related

3 activities on prostate cancer.

4 Not less than six centers shall be operated under

5 subparagraph (G). Activities of such centers should

6 include supporting new and innovative research and

7 training programs for new researchers. Such centers

8 shall give priority to expediting the transfer of re9 search advances to clinical applications.

10 ‘‘(2) IMPLEMENTATION OF PLAN FOR PRO11 GRAMS.—

12 ‘‘(A) The Director of the Institute shall en13 sure that the research programs described in

14 paragraph (1) are implemented in accordance

15 with a plan for the programs. Such plan shall

16 include comments and recommendations that

17 the Director of the Institute considers appro18 priate, with due consideration provided to the

19 professional judgment needs of the Institute as

20 expressed in the annual budget estimate pre21 pared in accordance with section 413(9). The

22 Director of the Institute, in consultation with

23 the National Cancer Advisory Board, shall peri24 odically review and revise such plan.
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1 ‘‘(B) Not later than May 1, 1993, the Di2 rector of the Institute shall submit a copy of

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

4 Secretary and the Director of NIH.

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

6 submit any revisions of the plan to the Presi7 dent’s Cancer Panel, the Secretary, and the Di8 rector of NIH.

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

10 the plan submitted under subparagraph (A),

11 and any revisions submitted under subpara12 graph (C), to the Committee on Energy and

13 Commerce of the House of Representatives and

14 the Committee on Labor and Human Resources

15 of the Senate.’’.

16 SEC. 403. AUTHORIZATION OF APPROPRIATIONS.

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

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

19 402 of this Act, is amended by adding at the end the fol20 lowing new section:

21 ‘‘AUTHORIZATION OF APPROPRIATIONS

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

23 purpose of carrying out this subpart, there are authorized

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

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

26 years 1995 and 1996.
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1 ‘‘(b) BREAST CANCER AND GYNECOLOGICAL CAN2 CERS.—

3 ‘‘(1) BREAST CANCER.—

4 ‘‘(A) For the purpose of carrying out sub5 paragraph (A) of section 417(c)(1), there are

6 authorized to be appropriated $225,000,000 for

7 fiscal year 1994, and such sums as may be nec8 essary for each of the fiscal years 1995 and

9 1996. Such authorizations of appropriations are

10 in addition to the authorizations of appropria11 tions established in subsection (a) with respect

12 to such purpose.

13 ‘‘(B) For the purpose of carrying out sub14 paragraphs (B) through (E) of section

15 417(c)(1), there are authorized to be appro16 priated $100,000,000 for fiscal year 1994, and

17 such sums as may be necessary for each of the

18 fiscal years 1995 and 1996. Such authoriza19 tions of appropriations are in addition to the

20 authorizations of appropriations established in

21 subsection (a) with respect to such purpose.

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

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

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

25 year 1994, and such sums as are necessary for each
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1 of the fiscal years 1995 and 1996. Such authoriza2 tions of appropriations are in addition to the author3 izations of appropriations established in subsection

4 (a) with respect to such purpose.

5 ‘‘(c) PROSTATE CANCER.—For the purpose of carry6 ing out section 417A, there are authorized to be appro7 priated $72,000,000 for fiscal year 1994, and such sums

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

9 1996. Such authorizations of appropriations are in addi10 tion to the authorizations of appropriations established in

11 subsection (a) with respect to such purpose.

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

13 Of the amounts appropriated for the National Cancer In14 stitute for a fiscal year, the Director of the Institute shall

15 make available not less than 10 percent for carrying out

16 the cancer control activities authorized in section 412 and

17 for which budget estimates are made under section

18 413(b)(9) for the fiscal year.’’.

19 (b) SPECIAL RULE REGARDING FUNDS FOR SECTION

20 412 FOR FISCAL YEAR 1994.—Notwithstanding section

21 417B(d) of the Public Health Service Act, as added by

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

23 under such section for fiscal year 1994 for carrying out

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

25 an amount equal to 75 percent of the amount specified
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1 for activities under such section 412 in the budget esti2 mate made under section 413(b)(9) of such Act for such

3 fiscal year.

4 (c) CONFORMING AMENDMENTS.—

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

6 Health Service Act (42 U.S.C. 284c) is amended—

7 (A) by striking subsection (a);

8 (B) by redesignating subsection (b) as sub9 section (a);

10 (C) by redesignating paragraph (5) of sub11 section (a) (as so redesignated) as subsection

12 (b); and

13 (D) by amending the heading for the sec14 tion to read as follows:

15 ‘‘CERTAIN USES OF FUNDS’’.

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

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

18 amended by striking ‘‘section 408(b)(1)’’ and insert19 ing ‘‘section 408(a)(1)’’.

20 TITLE V—NATIONAL HEART,

21 LUNG, AND BLOOD INSTITUTE

22 SEC. 501. EDUCATION AND TRAINING.

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

24 U.S.C. 285b–3(b)) is amended—

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

26 the semicolon at the end;
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1 (2) in paragraph (4), by striking the period at

2 the end and inserting ‘‘; and’’; and

3 (3) by inserting after paragraph (4) the follow4 ing new paragraph:

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

6 council for the Institute, conduct appropriate intra7 mural training and education programs, including

8 continuing education and laboratory and clinical re9 search training programs.’’.

10 SEC. 502. CENTERS FOR THE STUDY OF PEDIATRIC CAR11 DIOVASCULAR DISEASES.

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

13 (42 U.S.C. 285b–4(a)(1)) is amended—

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

15 the end;

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

17 and inserting ‘‘; and’’; and

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

19 new subparagraph:

20 ‘‘(D) three centers for basic and clinical re21 search into, training in, and demonstration of, ad22 vanced diagnostic, prevention, and treatment (in23 cluding genetic studies, intrauterine environment

24 studies, postnatal studies, heart arrhythmias, and
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1 acquired heart disease and preventive cardiology) for

2 cardiovascular diseases in children.’’.

3 SEC. 503. NATIONAL CENTER ON SLEEP DISORDERS.

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

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

6 at the end the following new section:

7 ‘‘NATIONAL CENTER ON SLEEP DISORDERS

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

9 of the enactment of the National Institutes of Health Re10 vitalization Act of 1993, the Director of the Institute shall

11 establish the National Center on Sleep Disorders (in this

12 section referred to as the ‘Center’). The Center shall head13 ed by a director, who shall be appointed by the Director

14 of the Institute.

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

16 and support of research, training, health information dis17 semination, and other activities with respect to sleep dis18 orders.’’.

19 SEC. 504. AUTHORIZATION OF APPROPRIATIONS.

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

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

22 amended by adding at the end the following section:

23 ‘‘AUTHORIZATION OF APPROPRIATIONS

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

25 subpart, there are authorized to be appropriated

26 $1,500,000,000 for fiscal year 1994, and such sums as
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1 may be necessary for each of the fiscal years 1995 and

2 1996.

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

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

5 make available not less than 10 percent for carrying out

6 prevention and control activities authorized in section

7 419.’’.

8 TITLE VI—NATIONAL INSTITUTE

9 ON DIABETES AND DIGESTIVE

10 AND KIDNEY DISEASES

11 SEC. 601. PROVISIONS REGARDING NUTRITIONAL DIS12 ORDERS.

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

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

15 at the end the following new section:

16 ‘‘NUTRITIONAL DISORDERS PROGRAM

17 ‘‘SEC. 434. (a) The Director of the Institute shall es18 tablish a program of conducting and supporting research,

19 training, health information dissemination, and other

20 activities with respect to nutritional disorders, including

21 obesity.

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

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

24 and support each of the activities described in such sub25 section. The Director of NIH shall ensure that, as appro26 priate, the other national research institutes and agencies
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1 of the National Institutes of Health have responsibilities

2 regarding such activities.

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

4 subsection (a), the Director of the Institute shall carry out

5 activities to facilitate and enhance knowledge and under6 standing of nutritional disorders, including obesity, on the

7 part of health professionals, patients, and the public

8 through the effective dissemination of information.’’.

9 (b) DEVELOPMENT AND EXPANSION OF RESEARCH

10 AND TRAINING CENTERS.—Section 431 of the Public

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

12 (1) by redesignating subsection (d) as sub13 section (e); and

14 (2) by inserting after subsection (c) the follow15 ing new subsection:

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

17 to the extent of amounts made available in appropriations

18 Acts, provide for the development or substantial expansion

19 of centers for research and training regarding nutritional

20 disorders, including obesity.

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

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

23 National Cancer Institute and with the Directors of such

24 other agencies of the National Institutes of Health as the

25 Director of NIH determines to be appropriate.
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1 ‘‘(3) Each center developed or expanded under para2 graph (1) shall—

3 ‘‘(A) utilize the facilities of a single institution,

4 or be formed from a consortium of cooperating insti5 tutions, meeting such research and training quali6 fications as may be prescribed by the Director;

7 ‘‘(B) conduct basic and clinical research into

8 the cause, diagnosis, early detection, prevention, con9 trol and treatment of nutritional disorders, including

10 obesity and the impact of nutrition and diet on child

11 development;

12 ‘‘(C) conduct training programs for physicians

13 and allied health professionals in current methods of

14 diagnosis and treatment of such diseases and com15 plications, and in research in such disorders; and

16 ‘‘(D) conduct information programs for physi17 cians and allied health professionals who provide pri18 mary care for patients with such disorders or com19 plications.’’.
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1 TITLE VII—NATIONAL INSTI2 TUTE ON ARTHRITIS AND

3 MUSCULOSKELETAL AND

4 SKIN DISEASES

5 SEC. 701. JUVENILE ARTHRITIS.

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

7 Service Act (42 U.S.C. 285d) is amended by striking ‘‘and

8 other programs’’ and all that follows and inserting the fol9 lowing: ‘‘and other programs with respect to arthritis and

10 musculoskeletal and skin diseases (including sports-related

11 disorders), with particular attention to the effect of these

12 diseases on children.’’.

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

14 amended—

15 (1) in subsection (a), by inserting after the sec16 ond sentence, the following: ‘‘The plan shall place

17 particular emphasis upon expanding research into

18 better understanding the causes and the develop19 ment of effective treatments for arthritis affecting

20 children.’’; and

21 (2) in subsection (b)—

22 (A) by striking ‘‘and’’ at the end of para23 graph (3);

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

25 paragraph (4) and inserting ‘‘; and’’; and
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1 (C) by adding at the end thereof the fol2 lowing new paragraph:

3 ‘‘(5) research into the causes of arthritis affect4 ing children and the development, trial, and evalua5 tion of techniques, drugs and devices used in the di6 agnosis, treatment (including medical rehabilitation),

7 and prevention of arthritis in children.’’.

8 (c) CENTERS.—Section 441 of the Public Health

9 Service Act (42 U.S.C. 286d–6) is amended by adding at

10 the end thereof the following new subsection:

11 ‘‘(f) Not later than October 1, 1994, the Director

12 shall establish a multipurpose arthritis and musculo13 skeletal disease center for the purpose of expanding the

14 level of research into the cause, diagnosis, early detection,

15 prevention, control, and treatment of, and rehabilitation

16 of children with arthritis and musculoskeletal diseases.’’.

17 (d) ADVISORY BOARD.—

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

19 Health Service Act (42 U.S.C. 285d–7(a)) is amend20 ed by inserting after ‘‘Arthritis’’ the the first place

21 such term appears the following: ‘‘and Musculo22 skeletal and Skin Diseases’’.

23 (2) COMPOSITION.—Section 442(b) of the Pub24 lic Health Service Act (42 U.S.C. 285d–7(b)) is
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1 amended—Section 442(b) of the Public Health Serv2 ice Act (42 U.S.C. 285d–7(b)) is amended—

3 (A) in the matter preceding paragraph (1),

4 by striking ‘‘eighteen’’ and inserting ‘‘twenty’’;

5 and

6 (B) in paragraph (1)(B)—

7 (i) by striking ‘‘six’’ and inserting

8 ‘‘eight’’; and

9 (ii) by striking ‘‘including’’ and all

10 that follows and inserting the following:

11 ‘‘including one member who is a person

12 who has such a disease, one person who is

13 the parent of an adult with such a disease,

14 and two members who are parents of chil15 dren with arthritis.’’.

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

17 Public Health Service Act (42 U.S.C. 285d–7(j)) is

18 amended—

19 (1) by striking ‘‘and’’ at the end of paragraph

20 (3);

21 (2) by striking the period at the end of para22 graph (4) and inserting ‘‘; and’’; and

23 (3) by adding at the end the following para24 graph:
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1 ‘‘(5) contains recommendations for expanding

2 the Institute’s funding of research directly applicable

3 to the cause, diagnosis, early detection, prevention,

4 control, and treatment of, and rehabilitation of chil5 dren with arthritis and musculoskeletal diseases.’’.

6 TITLE VIII—NATIONAL

7 INSTITUTE ON AGING

8 SEC. 801. ALZHEIMER’S DISEASE REGISTRY.

9 (a) IN GENERAL.—Section 12 of Public Law 99–158

10 (99 Stat. 885) is—

11 (1) transferred to subpart 5 of part C of title

12 IV of the Public Health Service Act (42 U.S.C. 285e

13 et seq.);

14 (2) redesignated as section 445G; and

15 (3) inserted after section 445F of such Act.

16 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

17 Section 445G of the Public Health Service Act, as trans18 ferred and inserted by subsection (a) of this section, is

19 amended—

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

21 follows through ‘‘may make a grant’’ in subsection

22 (a) and inserting the following:

23 ‘‘ALZHEIMER’S DISEASE REGISTRY

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

25 Institute may make a grant’’; and

26 (2) by striking subsection (c).
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1 SEC. 802. AGING PROCESSES REGARDING WOMEN.

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

3 Service Act, as amended by section 801 of this Act, is

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

5 ‘‘AGING PROCESSES REGARDING WOMEN

6 ‘‘SEC. 445H. The Director of the Institute, in addi7 tion to other special functions specified in section 444 and

8 in cooperation with the Directors of the other national re9 search institutes and agencies of the National Institutes

10 of Health, shall conduct research into the aging processes

11 of women, with particular emphasis given to the effects

12 of menopause and the physiological and behavioral

13 changes occurring during the transition from pre- to post14 menopause, and into the diagnosis, disorders, and com15 plications related to aging and loss of ovarian hormones

16 in women.’’.

17 SEC. 803. AUTHORIZATION OF APPROPRIATIONS.

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

19 Service Act, as amended by section 802 of this Act, is

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

21 ‘‘AUTHORIZATION OF APPROPRIATIONS

22 ‘‘SEC. 445I. For the purpose of carrying out this sub23 part, there are authorized to be appropriated

24 $500,000,000 for fiscal year 1994, and such sums as may

25 be necessary for each of the fiscal years 1995 and 1996.’’.
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1 SEC. 804. CONFORMING AMENDMENT.

2 Section 445C of the Public Health Service Act (42

3 U.S.C. 285e–5(b)) is amended—

4 (1) in subsection (b)(1), in the first sentence,

5 by inserting after ‘‘Council’’ the following: ‘‘on Alz6 heimer’s Disease (hereafter in this section referred

7 to as the ‘Council’)’’; and

8 (2) by adding at the end the following new sub9 section:

10 ‘‘(d) For purposes of this section, the term ‘Council

11 on Alzheimer’s Disease’ means the council established in

12 section 911(a) of Public Law 99–660.’’.

13 TITLE IX—NATIONAL INSTITUTE

14 OF ALLERGY AND INFEC15 TIOUS DISEASES

16 SEC. 901. TROPICAL DISEASES.

17 Section 446 of the Public Health Service Act (42

18 U.S.C. 285f) is amended by inserting before the period

19 the following: ‘‘, including tropical diseases’’.

20 SEC. 902. CHRONIC FATIGUE SYNDROME.

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

22 title IV of the Public Health Service Act (42 U.S.C. 285f)

23 is amended by adding at the end the following new section:
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1 ‘‘RESEARCH CENTERS REGARDING CHRONIC FATIGUE

2 SYNDROME

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

4 consultation with the advisory council for the Institute,

5 may make grants to, or enter into contracts with, public

6 or nonprofit private entities for the development and oper7 ation of centers to conduct basic and clinical research on

8 chronic fatigue syndrome.

9 ‘‘(b) Each center assisted under this section shall use

10 the facilities of a single institution, or be formed from a

11 consortium of cooperating institutions, meeting such re12 quirements as may be prescribed by the Director of the

13 Institute.’’.

14 (b) EXTRAMURAL STUDY SECTION.—Not later than

15 6 months after the date of enactment of this Act, the Sec16 retary of Health and Human Services shall establish an

17 extramural study section for chronic fatigue syndrome re18 search.

19 (c) REPRESENTATIVES.—The Secretary of Health

20 and Human Services, acting through the Director of the

21 National Institutes of Health, shall ensure that appro22 priate individuals with expertise in chronic fatigue syn23 drome or neuromuscular diseases and representative of a

24 variety of disciplines and fields within the research com-
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1 munity are appointed to appropriate National Institutes

2 of Health advisory committees and boards.

3 TITLE X—NATIONAL INSTITUTE

4 OF CHILD HEALTH AND

5 HUMAN DEVELOPMENT

6 Subtitle A—Research Centers With

7 Respect to Contraception and

8 Research Centers With Respect

9 to Infertility

10 SEC. 1001. GRANTS AND CONTRACTS FOR RESEARCH CEN11 TERS.

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

13 Service Act, as amended by section 3 of Public Law 101–

14 613, is amended by adding at the end the following new

15 section:

16 ‘‘RESEARCH CENTERS WITH RESPECT TO

17 CONTRACEPTION AND INFERTILITY

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

19 consultation with the advisory council for the Institute,

20 shall make grants to, or enter into contracts with, public

21 or nonprofit private entities for the development and oper22 ation of centers to conduct activities for the purpose of

23 improving methods of contraception and centers to con24 duct activities for the purpose of improving methods of

25 diagnosis and treatment of infertility.
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1 ‘‘(b) In carrying out subsection (a), the Director of

2 the Institute shall, subject to the extent of amounts made

3 available in appropriations Acts, provide for the establish4 ment of three centers with respect to contraception and

5 for two 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 re9 search, 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 sub4 section (a) to provide stipends for health and allied health

5 professionals enrolled in programs described in subpara6 graph (C) of paragraph (1), and to provide fees to individ7 uals serving as subjects in clinical trials conducted under

8 such paragraph.

9 ‘‘(d) The Director of the Institute shall, as appro10 priate, provide for the coordination of information among

11 the centers assisted under this section.

12 ‘‘(e) Each center assisted under subsection (a) shall

13 use the facilities of a single institution, or be formed from

14 a consortium of cooperating institutions, meeting such re15 quirements as may be prescribed by the Director of the

16 Institute.

17 ‘‘(f) Support of a center under subsection (a) may

18 be for a period not exceeding 5 years. Such period may

19 be extended for one or more additional periods not exceed20 ing 5 years if the operations of such center have been re21 viewed by an appropriate technical and scientific peer re22 view group established by the Director and if such group

23 has recommended to the Director that such period should

24 be extended.
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1 ‘‘(g) For the purpose of carrying out this section,

2 there are authorized to be appropriated $30,000,000 for

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

4 each 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 amend10 ed 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 enter16 ing into agreements with qualified health professionals (in17 cluding graduate students) under which such health pro18 fessionals agree to conduct research with respect to con19 traception, or with respect to infertility, in consideration

20 of the Federal Government agreeing to repay, for each

21 year of such service, not more than $20,000 of the prin22 cipal and interest of the educational loans of such health

23 professionals.

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

25 338E shall apply to the program established in subsection

26 (a) to the same extent and in the same manner as such
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1 provisions apply to the National Health Service Corps

2 Loan Repayment Program established in subpart III of

3 part D of title III.

4 ‘‘(c) Amounts appropriated for carrying out this sec5 tion shall remain available until the expiration of the sec6 ond fiscal year beginning after the fiscal year for which

7 the amounts were appropriated.’’.

8 Subtitle B—Program Regarding

9 Obstetrics and Gynecology

10 SEC. 1011. ESTABLISHMENT OF PROGRAM.

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

12 Service Act, as amended by section 1001 of this Act, is

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

14 ‘‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY

15 ‘‘SEC. 452B. The Director of the Institute shall es16 tablish and maintain within the Institute an intramural

17 laboratory and clinical research program in obstetrics and

18 gynecology.’’.

19 Subtitle C—Child Health Research

20 Centers

21 SEC. 1021. ESTABLISHMENT OF CENTERS.

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

23 Service Act, as amended by section 1011 of this Act, is

24 amended by adding at the end the following new section:
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1 ‘‘CHILD HEALTH RESEARCH CENTERS

2 ‘‘SEC. 452C. The Director of the Institute shall de3 velop and support centers for conducting research with re4 spect to child health. Such centers shall give priority to

5 the expeditious transfer of advances from basic science to

6 clinical applications and improving the care of infants and

7 children.’’.

8 Subtitle D—Study Regarding

9 Adolescent Health

10 SEC. 1031. PROSPECTIVE LONGITUDINAL STUDY.

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

12 Service Act, as amended by section 1021 of this Act, is

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

14 ‘‘PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT

15 HEALTH

16 ‘‘SEC. 452D. (a) IN GENERAL.—The Director of the

17 Institute shall conduct a study for the purpose of provid18 ing information on the general health and well-being of

19 adolescents in the United States, including, with respect

20 to such adolescents, information on—

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

22 behaviors that are detrimental to health; and

23 ‘‘(2) the influence on health of factors particu24 lar to the communities in which the adolescents

25 reside.

26 ‘‘(b) DESIGN OF STUDY.—
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1 ‘‘(1) IN GENERAL.—The study required in sub2 section (a) shall be a longitudinal study in which a

3 substantial number of adolescents participate as sub4 jects. With respect to the purpose described in such

5 subsection, the study shall monitor the subjects

6 throughout the period of the study to determine the

7 health status of the subjects and any change in such

8 status over time.

9 ‘‘(2) POPULATION-SPECIFIC ANALYSES.—The

10 study required in subsection (a) shall be conducted

11 with respect to the population of adolescents who are

12 female, the population of adolescents who are male,

13 various socioeconomic populations of adolescents,

14 and various racial and ethnic populations of adoles15 cents. The study shall be designed and conducted in

16 a manner sufficient to provide for a valid analysis of

17 whether there are significant differences among such

18 populations in health status and whether and to

19 what extent any such differences are due to factors

20 particular to the populations involved.

21 ‘‘(c) COORDINATION WITH WOMEN’S HEALTH INI22 TIATIVE.—With respect to the national study of women

23 being conducted by the Secretary and known as the Wom24 en’s Health Initiative, the Secretary shall ensure that such

25 study is coordinated with the component of the study re-
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1 quired in subsection (a) that concerns adolescent females,

2 including coordination in the design of the 2 studies.

3 ‘‘(d) ALLOCATION OF FUNDS FOR STUDY.—Of the

4 amounts appropriated for each of the fiscal years 1994

5 through 1996 for the National Institute of Child Health

6 and Human Development, the Secretary of Health and

7 Human Services, acting through the Director of such In8 stitute, shall reserve $3,000,000 to conduct the study re9 quired in subsection (a). The amounts so reserved shall

10 remain available until expended.’’.

11 TITLE XI—NATIONAL EYE

12 INSTITUTE

13 SEC. 1101. CLINICAL RESEARCH ON DIABETES EYE CARE.

14 (a) IN GENERAL.—Subpart 9 of part C of title IV

15 of the Public Health Service Act (42 U.S.C. 285i) is

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

17 ‘‘CLINICAL RESEARCH ON EYE CARE AND DIABETES

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

19 of the Institute, in consultation with the advisory council

20 for the Institute, may award not more than three grants

21 for the establishment and support of centers for clinical

22 research on eye care for individuals with diabetes.

23 ‘‘(b) AUTHORIZED EXPENDITURES.—The purposes

24 for which a grant under subsection (a) may be expended

25 include equipment for the research described in such sub-
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1 section and the construction and modernization of facili2 ties for such research.’’.

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

4 Public Health Service Act (42 U.S.C. 285i) is amended

5 in the second sentence by striking ‘‘The Director’’ and in6 serting ‘‘Subject to section 456, the Director’’.

7 TITLE XII—NATIONAL INSTI8 TUTE OF NEUROLOGICAL DIS9 ORDERS AND STROKE

10 SEC. 1201. RESEARCH ON MULTIPLE SCLEROSIS.

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

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

13 at the end the following new section:

14 ‘‘RESEARCH ON MULTIPLE SCLEROSIS

15 ‘‘SEC. 460. The Director of the Institute shall con16 duct and support research on multiple sclerosis, especially

17 research on effects of genetics and hormonal changes on

18 the progress of the disease.’’.

19 TITLE XIII—NATIONAL INSTI20 TUTE OF ENVIRONMENTAL

21 HEALTH SCIENCES

22 SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND TEST23 ING PROGRAM.

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

25 of the Public Health Service Act (42 U.S.C. 285l) is

26 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

25 ‘construction’ and ‘cost of construction’ include the

26 construction of new buildings and the expansion,
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1 renovation, remodeling, and alteration of existing

2 buildings, including architects’ fees, but do not in3 clude the cost of acquisition of land or off-site im4 provements.

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

16 subsection (a) only if the Board has under

17 paragraph (2) recommended the application for

18 approval.

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 the Board

8 who are not officers or employees of the United

9 States shall receive for each day the members are

10 engaged in the performance of the functions of the

11 Board compensation at the same rate received by

12 members of other national advisory councils estab13 lished under this title.

14 ‘‘(c) REQUIREMENTS FOR GRANTS.—

15 ‘‘(1) IN GENERAL.—The Director of the Center

16 may make a grant under subsection (a) only if the

17 applicant for the grant meets the following condi18 tions:

19 ‘‘(A) The applicant is determined by such

20 Director to be competent to engage in the type

21 of research for which the proposed facility is to

22 be constructed.

23 ‘‘(B) The applicant provides assurances

24 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 individuals from disadvantaged backgrounds, into

4 fields of biomedical or behavioral research and in the pro5 vision of research training to women and such individ6 uals.’’.

7 Subtitle B—Acquired Immune

8 Deficiency Syndrome

9 SEC. 1611. LOAN REPAYMENT PROGRAM.

10 Section 487A of the Public Health Service Act (42

11 U.S.C. 288–1) is amended to read as follows:

12 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH

13 RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME

14 ‘‘SEC. 487A. (a) IN GENERAL.—

15 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

16 paragraph (2), the Secretary shall carry out a pro17 gram of entering into agreements with appropriately

18 qualified health professionals under which such

19 health professionals agree to conduct, as employees

20 of the National Institutes of Health, research with

21 respect to acquired immune deficiency syndrome in

22 consideration of the Federal Government agreeing to

23 repay, for each year of such service, not more than

24 $20,000 of the principal and interest of the edu25 cational loans of such health professionals.
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1 ‘‘(2) LIMITATION.—The Secretary may not

2 enter into an agreement with a health professional

3 pursuant to paragraph (1) unless such profes4 sional—

5 ‘‘(A) has a substantial amount of edu6 cational loans relative to income; and

7 ‘‘(B)(i) was not employed at the National

8 Institutes of Health during the 1-year period

9 preceding the date of the enactment of the

10 Health Professions Reauthorization Act of

11 1988; or

12 ‘‘(ii) agrees to serve as an employee of

13 such Institutes for purposes of paragraph (1)

14 for a period of not less than 3 years.’’.

15 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—

16 With respect to the National Health Service Corps Loan

17 Repayment Program established in subpart III of part D

18 of title III, the provisions of such subpart shall, except

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

20 to the program established in such subsection (a) in the

21 same manner and to the same extent as such provisions

22 apply to the National Health Service Corps Loan Repay23 ment Program established in such subpart.

24 ‘‘(c) FUNDING; REIMBURSABLE TRANSFERS.—
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1 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—

2 For the purpose of carrying out this section, there

3 are authorized to be appropriated such sums as may

4 be necessary for each of the fiscal years 1994

5 through 1996.

6 ‘‘(2) TRANSFERS FOR RELATED PROGRAM.—

7 The Commissioner of Food and Drugs may carry

8 out for the Food and Drug Administration a pro9 gram similar to the program established in sub10 section (a), which program shall be carried out with

11 respect to the review of applications concerning ac12 quired immune deficiency syndrome that are submit13 ted to such Commissioner. From the amounts appro14 priated under paragraph (1) for a fiscal year, the

15 Secretary may transfer amounts to the Commis16 sioner for the purpose of carrying out such program.

17 The Commissioner shall provide a reimbursement to

18 the Secretary for the amount so transferred, and the

19 reimbursement shall be available only for the pro20 gram established in subsection (a). Any transfer and

21 reimbursement made for purposes of this paragraph

22 for a fiscal year shall be completed by April 1 of

23 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 in7 serting after section 487B the following new section:

8 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH

9 GENERALLY

10 ‘‘SEC. 487C. (a) IN GENERAL.—

11 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

12 paragraph (2), the Secretary shall carry out a pro13 gram of entering into agreements with appropriately

14 qualified health professionals under which such

15 health professionals agree to conduct research, as

16 employees of the National Institutes of Health, in

17 consideration of the Federal Government agreeing to

18 repay, for each year of such service, not more than

19 $20,000 of the principal and interest of the edu20 cational loans of such health professionals.

21 ‘‘(2) LIMITATION.—The Secretary may not

22 enter into an agreement with a health professional

23 pursuant to paragraph (1) unless such profes24 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) AUTHORIZATION OF APPROPRIATIONS.—For the

21 purpose of carrying out this section other than with re22 spect to acquired immune deficiency syndrome, there are

23 authorized to be appropriated such sums as may be nec24 essary for each of the fiscal years 1994 through 1996.’’.
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1 Subtitle D—Scholarship and Loan

2 Repayment Programs Regard3 ing Professional Skills Needed

4 by 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 in10 serting 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 Di17 rector of NIH, may carry out a program of entering

18 into contracts with individuals described in para19 graph (2) 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

8 BACKGROUNDS.—The individuals referred to in

9 paragraph (1) are individuals who—

10 ‘‘(A) are enrolled or accepted for enroll11 ment as full-time undergraduates at accredited

12 institutions of higher education; and

13 ‘‘(B) are from disadvantaged backgrounds.

14 ‘‘(b) FACILITATION OF INTEREST OF STUDENTS IN

15 CAREERS AT NATIONAL INSTITUTES OF HEALTH.—In

16 providing employment to individuals pursuant to contracts

17 under subsection (a)(1), the Director of NIH shall carry

18 out activities to facilitate the interest of the individuals

19 in pursuing careers as employees of the National Insti20 tutes of Health.

21 ‘‘(c) PERIOD OF OBLIGATED SERVICE.—

22 ‘‘(1) DURATION OF SERVICE.—For purposes of

23 subparagraph (B) of subsection (a)(1), the period of

24 service for which an individual is obligated to serve

25 as an employee of the National Institutes of Health
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1 is 12 months for each academic year for which the

2 scholarship under such subsection is provided.

3 ‘‘(2) SCHEDULE FOR SERVICE.—

4 ‘‘(A) Subject to subparagraph (B), the Di5 rector of NIH may not provide a scholarship

6 under subsection (a) unless the individual ap7 plying for the scholarship agrees that—

8 ‘‘(i) the individual will serve as an em9 ployee of the National Institutes of Health

10 full-time for not less than 10 consecutive

11 weeks of each year during which the indi12 vidual is attending the educational institu13 tion involved and receiving such a scholar14 ship;

15 ‘‘(ii) the period of service as such an

16 employee that the individual is obligated to

17 provide under clause (i) is in addition to

18 the period of service as such an employee

19 that the individual is obligated to provide

20 under subsection (a)(1)(B); and

21 ‘‘(iii) not later than 60 days after ob22 taining the educational degree involved, the

23 individual will begin serving full-time as

24 such an employee in satisfaction of the pe25 riod of service that the individual is obli-
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1 gated to provide under subsection

2 (a)(1)(B).

3 ‘‘(B) The Director of NIH may defer the

4 obligation of an individual to provide a period

5 of service under subsection (a)(1)(B), if the Di6 rector determines that such a deferral is appro7 priate.

8 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS

9 RELATING TO APPOINTMENT AND COMPENSATION.—

10 For any period in which an individual provides serv11 ice as an employee of the National Institutes of

12 Health in satisfaction of the obligation of the indi13 vidual under subsection (a)(1)(B) or paragraph

14 (2)(A)(i), the individual may be appointed as such

15 an employee without regard to the provisions of title

16 5, United States Code, relating to appointment and

17 compensation.

18 ‘‘(d) PROVISIONS REGARDING SCHOLARSHIP.—

19 ‘‘(1) APPROVAL OF ACADEMIC PROGRAM.—The

20 Director of NIH may not provide a scholarship

21 under 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 pro2 gram will not be altered without the approval of

3 the 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

9 the educational institution involved in accordance

10 with regulations issued by the Secretary.

11 ‘‘(3) LIMITATION ON AMOUNT.—The Director

12 of NIH may not provide a scholarship under sub13 section (a) for an academic year in an amount ex14 ceeding $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

19 attending 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

24 NIH may enter into a contract with the institution

25 under which the amounts provided in the scholarship
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1 for tuition and other educational expenses are paid

2 directly to the institution. Payments to the institu3 tion under the contract may be made without regard

4 to section 3324 of title 31, United States Code.

5 ‘‘(e) PENALTIES FOR BREACH OF SCHOLARSHIP

6 CONTRACT.—The provisions of section 338E shall apply

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

8 extent and in the same manner as such provisions apply

9 to the National Health Service Corps Loan Repayment

10 Program established in section 338B.

11 ‘‘(f) REQUIREMENT OF APPLICATION.—The Director

12 of NIH may not provide a scholarship under subsection

13 (a) unless an application for the scholarship is submitted

14 to the Director and the application is in such form, is

15 made in such manner, and contains such agreements, as16 surances, and information as the Director determines to

17 be necessary 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 Di3 rector of NIH may, subject to paragraph (2), carry

4 out 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

8 employees of the National Institutes of Health in

9 consideration of the Federal Government agreeing to

10 pay, for each year of such service, not more than

11 $20,000 of the principal and interest of the edu12 cational loans 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

19 REGARDING OBLIGATED SERVICE.—Except to the ex20 tent inconsistent with this section, the provisions of

21 sections 338C and 338E shall apply to the program

22 established in paragraph (1) to the same extent and

23 in the same manner as such provisions apply to the

24 National Health Service Corps Loan Repayment

25 Program 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

8 (42 U.S.C. 288(a)(1)) is amended—

9 (1) in subparagraph (A), by striking ‘‘and’’

10 after 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 carry-
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1 ing out this section, there are authorized to be ap2 propriated $400,000,000 for fiscal year 1994, and

3 such sums as may be necessary for each of the fiscal

4 years 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 inserting ‘‘785,’’ after ‘‘784,’’.

10 TITLE XVII—NATIONAL FOUNDA11 TION FOR BIOMEDICAL RE12 SEARCH

13 SEC. 1701. DATE CERTAIN FOR APPOINTMENT OF BOARD

14 MEMBERS.

15 Section 499 of the Public Health Service Act, as re16 designated by section 121(b)(3) of this Act, is amended

17 in subsection (c)(1)(C) by inserting after and below clause

18 (iii) the following:

19 ‘‘Not later than March 1, 1993, the Secretary

20 shall convene a meeting of the ex officio mem21 bers of the Board for the purpose of making

22 the appointments required in this subpara23 graph.’’.
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1 SEC. 1702. MISCELLANEOUS PROVISIONS.

2 Section 499 of the Public Health Service Act, as re3 designated by section 121(b)(3) of this Act, is amended—

4 (1) in subsection (a)—

5 (A) in the first sentence, by inserting after

6 ‘‘Secretary’’ the following: ‘‘, acting through the

7 Director of NIH,’’; and

8 (B) in the second sentence, by striking

9 ‘‘the purposes of’’ and all that follows through

10 ‘‘Transfer Act,’’ and inserting the following:

11 ‘‘the purposes of the Ethics in Government Act

12 of 1978 and the Stevenson-Wydler Technology

13 Innovation Act of 1980,’’;

14 (2) in subsection (b)(2), by striking ‘‘Ethics’’

15 and all that follows and inserting the following:

16 ‘‘Ethics in Government Act of 1978, and the Steven17 son-Wydler Technology Innovation Act of 1980.’’;

18 (3) in subsection (c)—

19 (A) in paragraph (1)—

20 (i) in subparagraph (A), in the second

21 sentence, by inserting ‘‘, except the ex

22 officio members,’’ after ‘‘Foundation’’;

23 (ii) in subparagraph (B), in the mat24 ter preceding clause (i), by striking ‘‘Coun25 cil’’ and inserting ‘‘Board’’; and
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1 (iii) in subparagraph (C), in the first

2 sentence, by striking ‘‘Council’’ and insert3 ing ‘‘Board’’; and

4 (B) in paragraph (3)(A), by striking

5 ‘‘paragraph (2)(C)’’ and inserting ‘‘paragraph

6 (1)(C)’’;

7 (4) in subsection (g)(8), by striking ‘‘subtitle’’

8 and inserting ‘‘part’’; and

9 (5) in subsection (i)(1), by striking ‘‘1995’’ and

10 inserting ‘‘1996’’.

11 TITLE XVIII—RESEARCH WITH

12 RESPECT TO ACQUIRED IM13 MUNE DEFICIENCY SYN14 DROME

15 SEC. 1801. REVISION AND EXTENSION OF VARIOUS PRO16 GRAMS.

17 Title XXIII of the Public Health Service Act (42

18 U.S.C. 300cc et seq.) is amended—

19 (1) in section 2304(c)(1)—

20 (A) in the matter preceding subparagraph

21 (A), by inserting after ‘‘Director of such Insti22 tute’’ the following: ‘‘(and may provide advice

23 to the Directors of other agencies of the Na24 tional Institutes of Health, as appropriate)’’;

25 and
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1 (B) in subparagraph (A), by inserting be2 fore the semicolon the following: ‘‘, including

3 recommendations on the projects of research

4 with respect to diagnosing immune deficiency

5 and with respect to predicting, diagnosing, pre6 venting, and treating opportunistic cancers and

7 infectious diseases’’;

8 (2) in section 2311(a)(1), by inserting before

9 the semicolon the following: ‘‘, including evaluations

10 of methods of diagnosing immune deficiency and

11 evaluations of methods of predicting, diagnosing,

12 preventing, and treating opportunistic cancers and

13 infectious diseases’’;

14 (3) in section 2315—

15 (A) in subsection (a)(2), by striking ‘‘inter16 national research’’ and all that follows and in17 serting ‘‘international research and training

18 concerning the natural history and pathogenesis

19 of the human immunodeficiency virus and the

20 development and evaluation of vaccines and

21 treatments for acquired immune deficiency syn22 drome and opportunistic infections.’’; and

23 (B) in subsection (f), by striking ‘‘and

24 1991’’ and inserting ‘‘through 1996’’;

25 (4) in section 2318—
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1 (A) in subsection (a)(1)—

2 (i) by inserting after ‘‘The Secretary’’

3 the following: ‘‘, acting through the Direc4 tor of the National Institutes of Health

5 and after consultation with the Adminis6 trator for Health Care Policy and Re7 search,’’; and

8 (ii) by striking ‘‘syndrome’’ and in9 serting ‘‘syndrome, including treatment

10 and prevention of HIV infection and relat11 ed conditions among women’’; and

12 (B) in subsection (e), by striking ‘‘1991.’’

13 and inserting the following: ‘‘1991, and such

14 sums as may be necessary for each of the fiscal

15 years 1994 through 1996.’’;

16 (5) in section 2320(b)(1)(A), by striking ‘‘syn17 drome’’ and inserting ‘‘syndrome and the natural

18 history of such infection’’;

19 (6)(A) in section 2351(a)—

20 (i) by redesignating paragraphs (2)

21 through (8) as paragraphs (3) through (9); and

22 (ii) by inserting after paragraph (1) the

23 following new paragraph:

24 ‘‘(2)(A) shall develop and implement a com25 prehensive plan for the conduct and support of such
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1 research by the agencies of the National Institutes

2 of Health, which plan shall specify the objectives to

3 be achieved, the date by which the objectives are ex4 pected to be achieved, and an estimate of the re5 sources needed to achieve the objectives by such

6 date; and

7 ‘‘(B) shall develop and implement a plan for

8 evaluating the sufficiency of the plan developed

9 under subparagraph (A) and for evaluating the ex10 tent to which activities of the National Institutes of

11 Health have been in accordance with the plan;’’; and

12 (B) in section 2301(b)(6), by inserting before

13 the semicolon the following: ‘‘, including evaluations

14 conducted under section 2351(a)(2)(B)’’;

15 (7) in section 2361, by striking ‘‘For purposes’’

16 and all that follows and inserting the following:

17 ‘‘For purposes of this title:

18 ‘‘(1) The term ‘infection’, with respect to the

19 etiologic agent for acquired immune deficiency syn20 drome, includes opportunistic cancers and infectious

21 diseases and any other conditions arising from infec22 tion with such etiologic agent.

23 ‘‘(2) The term ‘treatment’, with respect to the

24 etiologic agent for acquired immune deficiency syn-
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1 drome, includes primary and secondary prophy2 laxis.’’;

3 (8) in section 2315(f), by striking ‘‘there are

4 authorized’’ and all that follows and inserting ‘‘there

5 are authorized to be appropriated such sums as may

6 be necessary for each fiscal year.’’;

7 (9) in section 2320(e)(1), by striking ‘‘there are

8 authorized’’ and all that follows and inserting ‘‘there

9 are authorized to be appropriated such sums as may

10 be necessary for each fiscal year.’’; and

11 (10) in section 2341(d), by striking ‘‘there are

12 authorized’’ and all that follows and inserting ‘‘there

13 are authorized to be appropriated such sums as may

14 be necessary for each fiscal year.’’.

15 TITLE XIX—STUDIES

16 SEC. 1901. ACQUIRED IMMUNE DEFICIENCY SYNDROME.

17 (a) CERTAIN DRUG-RELEASE MECHANISMS.—

18 (1) The Secretary of Health and Human Serv19 ices shall, subject to paragraph (2), enter into a con20 tract with a public or nonprofit private entity to con21 duct a study for the purpose of determining, with re22 spect to acquired immune deficiency syndrome, the

23 impact of parallel-track drug-release mechanisms on

24 public and private clinical research, and on the ac-
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1 tivities of the Commissioner of Food and Drugs re2 garding the approval of drugs.

3 (2) The Secretary of Health and Human Serv4 ices shall request the Institute of Medicine of the

5 National Academy of Sciences to enter into the con6 tract under paragraph (1) to conduct the study de7 scribed in such paragraph. If such Institute declines

8 to conduct the study, the Secretary shall carry out

9 paragraph (1) through another public or nonprofit

10 private entity.

11 (b) THIRD-PARTY PAYMENTS REGARDING CERTAIN

12 CLINICAL TRIALS.—The Secretary of Health and Human

13 Services, acting through the Director of the National In14 stitutes of Health, shall conduct a study for the purpose

15 of—

16 (1) determining the policies of third-party

17 payors regarding the payment of the costs of appro18 priate health services that are provided incident to

19 the participation of individuals as subjects in clinical

20 trials conducted in the development of drugs with re21 spect to acquired immune deficiency syndrome; and

22 (2) developing recommendations regarding such

23 policies.

24 (c) ADVISORY COMMITTEES.—The Secretary of

25 Health and Human Services, acting through the Director
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1 of the National Institutes of Health, shall conduct a study

2 for the purpose of determining—

3 (1) whether the activities of the various advi4 sory committees established in the National Insti5 tutes of Health regarding acquired immune defi6 ciency syndrome are being coordinated sufficiently;

7 and

8 (2) whether the functions of any of such advi9 sory committees should be modified in order to

10 achieve greater efficiency.

11 (d) VACCINES FOR HUMAN IMMUNODEFICIENCY

12 VIRUS.—

13 (1) IN GENERAL.—The Secretary of Health and

14 Human Services, acting through the National Insti15 tutes of Health, shall develop a plan for the appro16 priate inclusion of HIV-infected women, including

17 pregnant women, HIV-infected infants, and HIV-in18 fected children in studies conducted by or through

19 the National Institutes of Health concerning the

20 safety and efficacy of HIV vaccines for the treat21 ment and prevention of HIV infection. Such plan

22 shall ensure the full participation of other Federal

23 agencies currently conducting HIV vaccine studies

24 and require that such studies conform fully to the
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1 requirements of part 46 of title 45, Code of Federal

2 Regulations.

3 (2) REPORT.—Not later than 180 days after

4 the date of the enactment of this Act, the Secretary

5 of Health and Human Services shall prepare and

6 submit to the Committee on Energy and Commerce

7 of the House of Representatives, and the Committee

8 on Labor and Human Resources of the Senate, a re9 port concerning the plan developed under paragraph

10 (1).

11 (3) IMPLEMENTATION.—Not later than 12

12 months after the date of the enactment of this Act,

13 the Secretary of Health and Human Services shall

14 implement the plan developed under paragraph (1),

15 including measures for the full participation of other

16 Federal agencies currently conducting HIV vaccine

17 studies.

18 (4) For the purpose of carrying out this sub19 section, there are authorized to be appropriated such

20 sums as may be necessary for each of the fiscal

21 years 1994 through 1996.

22 SEC. 1902. MALNUTRITION IN THE ELDERLY.

23 (a) STUDY.—

24 (1) IN GENERAL.—The Secretary of Health and

25 Human Services (referred to in this section as the
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1 ‘‘Secretary’’), acting through the National Institute

2 on Aging, coordinating with the Agency for Health

3 Care Policy and Research and, to the degree pos4 sible, in consultation with the head of the National

5 Nutrition Monitoring System established under sec6 tion 1428 of the Food and Agriculture Act of 1977

7 (7 U.S.C. 3178), shall conduct a 3-year nutrition

8 screening and intervention activities study of the el9 derly.

10 (2) EFFICACY AND COST-EFFECTIVENESS OF

11 NUTRITION SCREENING AND INTERVENTION ACTIVI12 TIES.—In conducting the study, the Secretary shall

13 determine the efficacy and cost-effectiveness of nu14 trition screening and intervention activities con15 ducted in the elderly health and long-term care con16 tinuum, and of a program that would institutionalize

17 nutrition screening and intervention activities. In

18 evaluating such a program, the Secretary shall de19 termine—

20 (A) if health or quality of life is measur21 ably improved for elderly individuals who re22 ceive routine nutritional screening and treat23 ment;

24 (B) if federally subsidized home or institu25 tional care is reduced because of increased inde-
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1 pendence of elderly individuals resulting from

2 improved nutritional status;

3 (C) if a multidisciplinary approach to nu4 tritional care is effective in addressing the nu5 tritional needs of elderly individuals; and

6 (D) if reimbursement for nutrition screen7 ing and intervention activities is a cost-effective

8 approach to improving the health status of el9 derly individuals.

10 (3) POPULATIONS.—The populations of elderly

11 individuals in which the study will be conducted

12 shall include populations of elderly individuals who

13 are—

14 (A) living independently, including—

15 (i) individuals who receive home and

16 community-based services or family sup17 port;

18 (ii) individuals who do not receive ad19 ditional services and support;

20 (iii) individuals with low incomes; and

21 (iv) individuals who are minorities;

22 (B) hospitalized, including individuals ad23 mitted from home and from institutions; and

24 (C) institutionalized in residential facilities

25 such as nursing homes and adult homes.
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1 (b) MALNUTRITION STUDY.—The Secretary, acting

2 through the National Institute on Aging, shall conduct a

3 3-year study to determine the extent of malnutrition in

4 elderly individuals in hospitals and long-term care facili5 ties and in elderly individuals who are living independ6 ently.

7 (c) REPORT.—The Secretary shall submit a report to

8 the Committee on Labor and Human Resources of the

9 Senate and the Committee on Energy and Commerce of

10 the House of Representatives containing the findings re11 sulting from the studies described in subsections (a) and

12 (b), including a determination regarding whether a pro13 gram that would institutionalize nutrition screening and

14 intervention activities should be adopted, and the rationale

15 for the determination.

16 (d) ADVISORY PANEL.—

17 (1) ESTABLISHMENT.—The Secretary, acting

18 through the Director of the National Institute on

19 Aging, shall establish an advisory panel that shall

20 oversee the design, implementation, and evaluation

21 of the studies described in subsections (a) and (b).

22 (2) COMPOSITION.—The advisory panel shall in23 clude representatives appointed for the life of the

24 panel by the Secretary from the Health Care Fi25 nancing Administration, the Social Security Admin-
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1 istration, the National Center for Health Statistics,

2 the Administration on Aging, the National Council

3 on the Aging, the American Dietetic Association, the

4 American Academy of Family Physicians, and such

5 other agencies or organizations as the Secretary de6 termines to be appropriate.

7 (3) COMPENSATION AND EXPENSES.—

8 (A) COMPENSATION.—Each member of the

9 advisory panel who is not an employee of the

10 Federal Government shall receive compensation

11 at the daily equivalent of the rate specified for

12 level V of the Executive Schedule under section

13 5316 of title 5, United States Code, for each

14 day the member is engaged in the performance

15 of duties for the advisory panel, including at16 tendance at meetings and conferences of the

17 panel, and travel to conduct the duties of the

18 panel.

19 (B) TRAVEL EXPENSES.—Each member of

20 the advisory panel shall receive travel expenses,

21 including per diem in lieu of subsistence, at

22 rates authorized for employees of agencies

23 under subchapter I of chapter 57 of title 5,

24 United States Code, for each day the member

25 is engaged in the performance of duties away
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1 from the home or regular place of business of

2 the member.

3 (4) DETAIL OF FEDERAL EMPLOYEES.—On the

4 request of the advisory panel, the head of any Fed5 eral agency shall detail, without reimbursement, any

6 of the personnel of the agency to the advisory panel

7 to assist the advisory panel in carrying out its du8 ties. Any detail shall not interrupt or otherwise af9 fect the civil service status or privileges of the Fed10 eral employee.

11 (5) TECHNICAL ASSISTANCE.—On the request

12 of the advisory panel, the head of a Federal agency

13 shall provide such technical assistance to the advi14 sory panel as the advisory panel determines to be

15 necessary to carry out its duties.

16 (6) TERMINATION.—Notwithstanding section

17 15 of the Federal Advisory Committee Act (5 U.S.C.

18 App.), the advisory panel shall terminate 3 years

19 after the date of enactment of this Act.

20 SEC. 1903. RESEARCH ACTIVITIES ON CHRONIC FATIGUE

21 SYNDROME.

22 The Secretary of Health and Human Services shall,

23 not later than May 1, 1993, and annually thereafter for

24 the next 3 years, prepare and submit to the Committee

25 on Energy and Commerce of the House of Representatives
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1 and the Committee on Labor and Human Resources of

2 the Senate, a report that summarizes the research activi3 ties conducted or supported by the National Institutes of

4 Health concerning chronic fatigue syndrome. Such report

5 should include information concerning grants made, coop6 erative agreements or contracts entered into, intramural

7 activities, research priorities and needs, and a plan to ad8 dress such priorities and needs.

9 SEC. 1904. REPORT ON MEDICAL USES OF BIOLOGICAL

10 AGENTS IN DEVELOPMENT OF DEFENSES

11 AGAINST BIOLOGICAL WARFARE.

12 The Secretary of Health and Human Services, in con13 sultation with other appropriate executive agencies, shall

14 report to the House Energy and Commerce Committee

15 and the Senate Labor and Human Resources Committee

16 on the appropriateness and impact of the National Insti17 tutes of Health assuming responsibility for the conduct of

18 all Federal research, development, testing, and evaluation

19 functions relating to medical countermeasures against

20 biowarfare threat agents. In preparing the report, the Sec21 retary shall identify the extent to which such activities are

22 carried out by agencies other than the National Institutes

23 of Health, and assess the impact (positive and negative)

24 of the National Institutes of Health assuming responsibil25 ity for such activities, including the impact under the
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1 Budget Enforcement Act and the Omnibus Budget Rec2 onciliation Act of 1990 on existing National Institutes of

3 Health research programs as well as other programs with4 in the category of domestic discretionary spending. The

5 Secretary shall submit the report not later than 12 months

6 after the date of the enactment of this Act.

7 SEC. 1905. PERSONNEL STUDY OF RECRUITMENT, RETEN8 TION AND TURNOVER.

9 (a) STUDY OF PERSONNEL SYSTEM.—Not later than

10 1 year after the date of the enactment of this Act, the

11 Secretary of Health and Human Services, acting through

12 the Director of the National Institutes of Health, shall

13 conduct a study to review the retention, recruitment, va14 cancy and turnover rates of support staff, including fire15 fighters, law enforcement, procurement officers, techni16 cians, nurses and clerical employees, to ensure that the

17 National Institutes of Health is adequately supporting the

18 conduct of efficient, effective and high quality research for

19 the American public. The Director of NIH shall work in

20 conjunction with appropriate employee organizations and

21 representatives in developing such a study.

22 (b) SUBMISSION TO CONGRESS.—Not later than 1

23 year after the date of the enactment of this Act, the Sec24 retary of Health and Human Services shall prepare and

25 submit to the Committee on Energy and Commerce of the
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1 House of Representatives, and to the Committee on Labor

2 and Human Resources of the Senate, a report containing

3 the study conducted under subsection (a) together with

4 the recommendations of the Secretary concerning the en5 actment of legislation to implement the results of such

6 study.

7 SEC. 1906. PROCUREMENT.

8 (a) IN GENERAL.—The Director of the National In9 stitutes of Health and the Administrator of the General

10 Services Administration shall jointly conduct a study to

11 develop a streamlined procurement system for the Na12 tional Institutes of Health that complies with the require13 ments of Federal law.

14 (b) REPORT.—Not later than March 1, 1994, the of15 ficials specified in subsection (a) shall complete the study

16 required in such subsection and shall submit to the Com17 mittee on Energy and Commerce of the House of Rep18 resentatives, and the Committee on Labor and Human Re19 sources of the Senate, a report describing the findings

20 made as a result of the study.
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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

8 Health Service Act (42 U.S.C. 237(a)), as added by sec9 tion 304 of Public Law 101–509, is amended to read as

10 follows:

11 ‘‘(a)(1) There shall be in the Public Health Service

12 a Silvio O. Conte Senior Biomedical Research Service, not

13 to exceed 750 members.

14 ‘‘(2) The authority established in paragraph (1) re15 garding the number of members in the Silvio O. Conte

16 Senior Biomedical Research Service is in addition to any

17 authority established regarding the number of members

18 in the commissioned Regular Corps, in the Reserve Corps,

19 and in the Senior Executive Service. Such paragraph may

20 not be construed to require that the number of members

21 in the commissioned Regular Corps, in the Reserve Corps,

22 or in the Senior Executive Service be reduced to offset

23 the number of members serving in the Silvio O. Conte Sen24 ior Biomedical Research Service (hereafter in this section

25 referred 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

4 heading for the section by amending the heading to read

5 as follows:

6 ‘‘SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH

7 SERVICE’’.

8 SEC. 2002. TECHNICAL CORRECTIONS.

9 (a) TITLE IV.—Title IV of the Public Health Service

10 Act (42 U.S.C. 281 et seq.) is amended—

11 (1) in section 406—

12 (A) in subsection (b)(2)(A), by striking

13 ‘‘Veterans’ Administration’’ each place such

14 term appears and inserting ‘‘Department of

15 Veterans Affairs’’; and

16 (B) in subsection (h)(2)(A)(v), by striking

17 ‘‘Veterans’ Administration’’ and inserting ‘‘De18 partment of Veterans Affairs’’;

19 (2) in section 408, in subsection (b) (as redesig20 nated by section 501(c)(1)(C) of this Act), by strik21 ing ‘‘Veterans’ Administration’’ and inserting ‘‘De22 partment of Veterans Affairs’’;

23 (3) in section 421(b)(1), by inserting a comma

24 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 ‘‘Vet5 erans’ Administration’’ and inserting ‘‘Department

6 of Veterans Affairs’’;

7 (6) in section 439(b), by striking ‘‘Veterans’

8 Administration’’ and inserting ‘‘Department of Vet9 erans 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 ‘‘Vet14 erans’ Administration’’ and inserting ‘‘Department

15 of Veterans Affairs’’;

16 (9) in section 464E—

17 (A) in subsection (d), in the first sentence,

18 by inserting ‘‘Coordinating’’ before ‘‘Commit19 tee’’; and

20 (B) in subsection (e), by inserting ‘‘Coordi21 nating’’ before ‘‘Committee’’ the first place

22 such term appears;

23 (10) in section 464P(b)(6) (as added by section

24 123 of Public Law 102–321 (106 Stat. 362)), by

25 striking ‘‘Administration’’ and inserting ‘‘Institute’’;
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1 (11) in section 466(a)(1)(B), by striking ‘‘Vet2 erans’ Administration’’ and inserting ‘‘Department

3 of Veterans Affairs’’;

4 (12) in section 480(b)(2)(A), by striking ‘‘Vet5 erans’ Administration’’ and inserting ‘‘Department

6 of Veterans Affairs’’;

7 (13) in section 485(b)(2)(A), by striking ‘‘Vet8 erans’ Administration’’ and inserting ‘‘Department

9 of 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 ap13 propriations,’’ and inserting the following: ‘‘Appro14 priations to carry out the purposes of this title,’’.

15 (b) TITLE XXIII.—Part A of title XXIII of the Pub16 lic Health Service Act (42 U.S.C. 300cc et seq.) is amend17 ed—

18 (1) in section 2304—

19 (A) in the heading for the section, by strik20 ing ‘‘CLINICAL RESEARCH REVIEW COM21 MITTEE’’ and inserting ‘‘RESEARCH ADVI22 SORY COMMITTEE’’; and

23 (B) in subsection (a), by striking ‘‘AIDS

24 Clinical Research Review Committee’’ and in25 serting ‘‘AIDS Research Advisory Committee’’;
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1 (2) in section 2312(a)(2)(A), by striking ‘‘AIDS

2 Clinical Research Review Committee’’ and inserting

3 ‘‘AIDS Research Advisory Committee’’;

4 (3) in section 2314(a)(1), in the matter preced5 ing subparagraph (A), by striking ‘‘Clinical Research

6 Review Committee’’ and inserting ‘‘AIDS Research

7 Advisory Committee’’;

8 (4) in section 2317(d)(1), by striking ‘‘Clinical

9 Research Review Committee’’ and inserting ‘‘AIDS

10 Research Advisory Committee established under sec11 tion 2304’’; and

12 (5) in section 2318(b)(3), by striking ‘‘Clinical

13 Research Review Committee’’ and inserting ‘‘AIDS

14 Research Advisory Committee’’.

15 SEC. 2003. BIENNIAL REPORT ON CARCINOGENS.

16 Section 301(b)(4) of the Public Health Service Act

17 (42 U.S.C. 241(b)(4)) is amended by striking ‘‘an annual’’

18 and inserting in lieu thereof ‘‘a biennial’’.

19 SEC. 2004. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE

20 FOR RESEARCH.

21 Not later than 90 days after the date of the enact22 ment of this Act, the Secretary of Health and Human

23 Services, acting through the Director of the National In24 stitutes of Health, shall present to the Congress a master

25 plan to provide for the replacement or refurbishment of
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1 less than adequate buildings, utility equipment and dis2 tribution systems (including the resources that provide

3 electrical and other utilities, chilled water, air handling,

4 and other services that the Secretary, acting through the

5 Director, deems necessary), roads, walkways, parking

6 areas, and grounds that underpin the laboratory and clini7 cal facilities of the National Institutes of Health. Such

8 plan may make recommendations for the undertaking of

9 new projects that are consistent with the objectives of this

10 section, such as encircling the National Institutes of

11 Health Federal enclave with an adequate chilled water

12 conduit.

13 SEC. 2005. TRANSFER OF PROVISIONS OF TITLE XXVII.

14 (a) IN GENERAL.—The Public Health Service Act

15 (42 U.S.C. 201 et seq.), as amended by section 101 of

16 Public Law 101–381 and section 304 of Public Law 101–

17 509, is amended—

18 (1) by transferring sections 2701 through 2714

19 to title II;

20 (2) by redesignating such sections as sections

21 231 through 244, respectively;

22 (3) by inserting such sections, in the appro23 priate sequence, after section 228;

24 (4) by inserting before section 201 the following

25 new heading:
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1 ‘‘PART A—ADMINISTRATION’’; and

2 (5) by inserting before section 231 (as redesig3 nated by paragraph (2) of this subsection) the fol4 lowing new heading:

5 ‘‘Part B—Miscellaneous Provisions’’.

6 (b) CONFORMING AMENDMENTS.—The Public

7 Health Service Act (42 U.S.C. 201 et seq.) is amended—

8 (1) in the heading for title II, by inserting

9 ‘‘AND MISCELLANEOUS PROVISIONS’’ after

10 ‘‘ADMINISTRATION’’;

11 (2) in section 406(a)(2), by striking ‘‘2701’’

12 and inserting ‘‘231’’;

13 (3) in section 465(f), by striking ‘‘2701’’ and

14 inserting ‘‘231’’;

15 (4) in section 480(a)(2), by striking ‘‘2701’’

16 and inserting ‘‘231’’;

17 (5) in section 485(a)(2), by striking ‘‘2701’’

18 and inserting ‘‘231’’;

19 (6) in section 497, by striking ‘‘2701’’ and in20 serting ‘‘231’’;

21 (7) in section 505(a)(2), by striking ‘‘2701’’

22 and inserting ‘‘231’’;

23 (8) in section 926(b), by striking ‘‘2711’’ each

24 place such term appears and inserting ‘‘241’’; and
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1 (9) in title XXVII, by striking the heading for

2 such title.

3 SEC. 2006. CERTAIN AUTHORIZATION OF APPROPRIATIONS.

4 Section 399L(a) of the Public Health Service Act (42

5 U.S.C. 280e–4(a)), as added by Public Law 102–515 (106

6 Stat. 3376), is amended—

7 (1) in the first sentence, by striking ‘‘the Sec8 retary’’ and all that follows and inserting the follow9 ing: ‘‘there are authorized to be appropriated

10 $30,000,000 for fiscal year 1994, and such sums as

11 may be necessary for each of the fiscal years 1995

12 through 1997.’’; and

13 (2) in the second sentence, by striking ‘‘Out of

14 any amounts used’’ and inserting ‘‘Of the amounts

15 appropriated under the preceding sentence’’.

16 TITLE XXI—EFFECTIVE DATES

17 SEC. 2101. EFFECTIVE DATES.

18 Subject to section 155, this Act and the amendments

19 made by this Act take effect upon the date of the enact20 ment of this Act.

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