Union Calendar No. 12

103D CONGRESS

1ST SESSION H. R. 4

[Report No. 103–28]

A BILL

To amend the Public Health Service Act to revise

tutes of Health, and for other purposes.and extend the programs of the National InstiMARCH 9, 1993

Reported with an amendment, committed to the Commitordered to be printed tee of the Whole House on the State of the Union, and
IB

Union Calendar No. 12

103D CONGRESS

1ST SESSION H. R. 4

[Report No. 103–28]

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

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

IN THE HOUSE OF REPRESENTATIVES

JANUARY 5, 1993

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

COLLINS of Illinois, Ms. DANNER, Ms. ENGLISH, Mrs. JOHNSON of 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

MARCH 9, 1993

Additional sponsors: Miss COLLINS of Michigan, Mr. SWIFT, Ms. KAPTUR, Mr.

BOUCHER, Ms. FURSE, Ms. SHEPHERD, Mrs. BYRNE, Mr. SHAYS, Mr.

DIXON, and Mr. EDWARDS of California

MARCH 9, 1993

Reported with an amendment, committed to the Committee of the Whole

House on the State of the Union, and ordered to be printed

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

[For text of introduced bill, see copy of bill as introduced on January 5, 1993]
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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 ‘‘Na5 tional Institutes of Health Revitalization Act of 1993’’.

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

7 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.
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PART II—OFFICE OF RESEARCH ON WOMEN’S HEALTH

Sec. 141. Establishment.

PART III—OFFICE OF RESEARCH ON MINORITY HEALTH

Sec. 151. Establishment.

Subtitle C—Research Integrity

Sec. 161. Establishment of Office of Research Integrity.

Sec. 162. Commission on Research Integrity.

Sec. 163. Protection of whistleblowers.

Sec. 164. Requirement of regulations regarding protection against financial conflicts of interest in certain projects of research.

Sec. 165. Effective dates.

TITLE II—NATIONAL INSTITUTES OF HEALTH IN GENERAL

Sec. 201. Health promotion research dissemination.

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

Sec. 203. Establishment of Office of Behavioral Research.

Sec. 204. Children’s vaccine initiative.

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

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

fields of biomedical and behavioral research.

Sec. 207. Requirements regarding surveys of sexual behavior.

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

Sec. 209. Miscellaneous provisions.

TITLE III—GENERAL PROVISIONS RESPECTING NATIONAL

RESEARCH INSTITUTES

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

Sec. 302. Program of research on osteoporosis, Paget’s disease, and related 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.
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TITLE VII—NATIONAL INSTITUTE ON ARTHRITIS AND

MUSCULOSKELETAL AND SKIN DISEASES

Sec. 701. Juvenile arthritis.

TITLE VIII—NATIONAL INSTITUTE ON AGING

Sec. 801. Alzheimer’s disease registry.

Sec. 802. Aging processes regarding women.

Sec. 803. Authorization of appropriations.

Sec. 804. Conforming amendment.

TITLE IX—NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS

DISEASES

Sec. 901. Tropical diseases.

Sec. 902. Chronic fatigue syndrome.

TITLE X—NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN

DEVELOPMENT

Subtitle A—Research Centers With Respect to Contraception and Research

Centers With Respect to Infertility

Sec. 1001. Grants and contracts for research centers.

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

and infertility.

Subtitle B—Program Regarding Obstetrics and Gynecology

Sec. 1011. Establishment of program.

Subtitle C—Child Health Research Centers

Sec. 1021. Establishment of centers.

Subtitle D—Study Regarding Adolescent Health

Sec. 1031. Prospective longitudinal study.

TITLE XI—NATIONAL EYE INSTITUTE

Sec. 1101. Clinical research on diabetes eye care.

TITLE XII—NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS

AND STROKE

Sec. 1201. Research on multiple sclerosis.

TITLE XIII—NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH

SCIENCES

Sec. 1301. Applied Toxicological Research and Testing Program.

Sec. 1302. Study of environmental and other risks contributing to incidence of

breast and prostate cancer.
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TITLE XIV—NATIONAL LIBRARY OF MEDICINE

Subtitle A—General Provisions

Sec. 1401. Additional authorities.

Sec. 1402. Authorization of appropriations.

Subtitle B—Financial Assistance

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

Subtitle C—National Information Center on Health Services Research and

Health Care Technology

Sec. 1421. Establishment of Center.

Sec. 1422. Conforming provisions.

TITLE XV—OTHER AGENCIES OF NATIONAL INSTITUTES OF

HEALTH

Subtitle A—Division of Research Resources

Sec. 1501. Redesignation of Division as National Center for Research Resources.

Sec. 1502. Biomedical and behavioral research facilities.

Sec. 1503. Construction program for national primate research center.

Subtitle B—National Center for Nursing Research

Sec. 1511. Redesignation of National Center for Nursing Research as National

Institute of Nursing Research.

Sec. 1512. Study on adequacy of number of nurses.

Subtitle C—National Center for Human Genome Research

Sec. 1521. Purpose of Center.

TITLE XVI—AWARDS AND TRAINING

Subtitle A—National Research Service Awards

Sec. 1601. Requirement regarding women and individuals from disadvantaged

backgrounds.

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.
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TITLE XVII—NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH

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

Sec. 1702. Miscellaneous provisions.

TITLE XVIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE

DEFICIENCY SYNDROME

Subtitle A—Office of AIDS Research

Sec. 1801. Establishment of Office.

Sec. 1802. Establishment of emergency discretionary fund.

Sec. 1803. General provisions.

Subtitle B—Certain Programs

Sec. 1811. Revision and extension of certain programs.

TITLE XIX—STUDIES

Sec. 1901. Acquired immune deficiency syndrome.

Sec. 1902. Malnutrition in the elderly.

Sec. 1903. Research activities on chronic fatigue syndrome.

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

against biological warfare.

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

Sec. 1906. Procurement.

Sec. 1907. Chronic pain conditions.

TITLE XX—MISCELLANEOUS PROVISIONS

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

O. Conte; limitation on number of members.

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

Sec. 2003. Certain authorization of appropriations.

TITLE XXI—EFFECTIVE DATES

Sec. 2101. Effective dates.
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1 TITLE I—GENERAL PROVISIONS

2 REGARDING TITLE IV OF PUB3 LIC HEALTH SERVICE ACT

4 Subtitle A—Research Freedom

5 PART I—REVIEW OF PROPOSALS FOR

6 BIOMEDICAL AND BEHAVIORAL RESEARCH

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

10 HEALTH.

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

12 (42 U.S.C. 289 et seq.) is amended by inserting after section

13 492 the following new section:

14 ‘‘CERTAIN PROVISIONS REGARDING REVIEW AND APPROVAL

15 OF PROPOSALS FOR RESEARCH

16 ‘‘SEC. 492A. (a) REVIEW AS PRECONDITION TO RE17 SEARCH.—

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 approve

23 or fund any application that is subject to review

24 under section 491(a) by an Institutional Review

25 Board unless the application has undergone re-
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1 view in accordance with such section and has

2 been recommended for approval by a majority of

3 the members of the Board conducting such re4 view.

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 in

8 clinical research conducted by the National In9 stitutes of Health, the Secretary may not author10 ize the conduct of the research unless the research

11 has, pursuant to such procedures, been rec12 ommended for approval.

13 ‘‘(2) PEER REVIEW.—In the case of any applica14 tion submitted to the Secretary for financial assist15 ance to conduct research, the Secretary may not ap16 prove or fund any application that is subject to tech17 nical and scientific peer review under section 492(a)

18 unless the application has undergone peer review in

19 accordance with such section and has been rec20 ommended for approval by a majority of the members

21 of the entity conducting such review.

22 ‘‘(b) ETHICAL REVIEW OF RESEARCH.—

23 ‘‘(1) PROCEDURES REGARDING WITHHOLDING OF

24 FUNDS.—If research has been recommended for ap25 proval for purposes of subsection (a), the Secretary
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1 may not withhold funding for the research on ethical

2 grounds unless—

3 ‘‘(A) the Secretary convenes an advisory

4 board in accordance with paragraph (4) to study

5 the ethical implications of the research; and

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

7 recommends that, on ethical grounds, the Sec8 retary withhold funds for the research; or

9 (ii) the majority of such board recommends

10 that the Secretary not withhold funds for the re11 search on ethical grounds, but the Secretary

12 finds, on the basis of the report submitted under

13 paragraph (4)(B)(ii), that the recommendation

14 is arbitrary and capricious.

15 ‘‘(2) APPLICABILITY.—The limitation established

16 in paragraph (1) regarding the authority to withhold

17 funds on ethical grounds shall apply without regard

18 to whether the withholding of funds on such grounds

19 is characterized as a disapproval, a moratorium, a

20 prohibition, or other description.

21 ‘‘(3) PRELIMINARY MATTERS REGARDING USE OF

22 PROCEDURES.—

23 ‘‘(A) If the Secretary makes a determina24 tion that an advisory board should be convened

25 for purposes of paragraph (1), the Secretary
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1 shall, through a statement published in the Fed2 eral Register, announce the intention of the Sec3 retary to convene such a board.

4 ‘‘(B) A statement issued under subpara5 graph (A) shall include a request that interested

6 individuals submit to the Secretary recommenda7 tions specifying the particular individuals who

8 should be appointed to the advisory board in9 volved. The Secretary shall consider such rec10 ommendations in making appointments to the

11 board.

12 ‘‘(C) The Secretary may not make appoint13 ments to an advisory board under paragraph (1)

14 until the expiration of the 30-day period begin15 ning on the date on which the statement required

16 in subparagraph (A) is made with respect to the

17 board.

18 ‘‘(4) ETHICS ADVISORY BOARDS.—

19 ‘‘(A) Any advisory board convened for pur20 poses of paragraph (1) shall be known as an eth21 ics advisory board (hereafter in this paragraph

22 referred to as an ‘ethics board’).

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

24 with, and make recommendations to the Sec25 retary regarding the ethics of the project of bio-
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1 medical or behavioral research with respect to

2 which the board has been convened.

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

4 on which the statement required in paragraph

5 (3)(A) is made with respect to an ethics board,

6 the board shall submit to the Secretary, and to

7 the Committee on Energy and Commerce of the

8 House of Representatives and the Committee on

9 Labor and Human Resources of the Senate, a re10 port describing the findings of the board regard11 ing the project of research involved and making

12 a recommendation under clause (i) of whether

13 the Secretary should or should not withhold

14 funds for the project. The report shall include the

15 information considered in making the findings.

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

17 no fewer than 14, and no more than 20, individ18 uals who are not officers or employees of the

19 United States. The Secretary shall make ap20 pointments to the board from among individuals

21 with special qualifications and competence to

22 provide advice and recommendations regarding

23 ethical matters in biomedical and behavioral re24 search. Of the members of the board—
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1 ‘‘(i) no fewer than 1 shall be an attor2 ney;

3 ‘‘(ii) no fewer than 1 shall be an

4 ethicist;

5 ‘‘(iii) no fewer than 1 shall be a prac6 ticing physician;

7 ‘‘(iv) no fewer than 1 shall be a theolo8 gian; and

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

10 more than one-half, shall be scientists with

11 substantial accomplishments in biomedical

12 or behavioral research.

13 ‘‘(D) The term of service as a member of an

14 ethics board shall be for the life of the board. If

15 such a member does not serve the full term of

16 such service, the individual appointed to fill the

17 resulting vacancy shall be appointed for the re18 mainder of the term of the predecessor of the in19 dividual.

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

21 subject to removal from the board by the Sec22 retary for neglect of duty or malfeasance or for

23 other good cause shown.
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1 ‘‘(F) The Secretary shall designate an indi2 vidual from among the members of an ethics

3 board to serve as the chair of the board.

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

5 with respect to a project of research, an ethics

6 board shall conduct inquiries and hold public

7 hearings.

8 ‘‘(H) In carrying out subparagraph (B)(i)

9 with respect to a project of research, an ethics

10 board shall have access to all relevant informa11 tion possessed by the Department of Health and

12 Human Services, or available to the Secretary

13 from other agencies.

14 ‘‘(I) Members of an ethics board shall re15 ceive compensation for each day engaged in car16 rying out the duties of the board, including time

17 engaged in traveling for purposes of such duties.

18 Such compensation may not be provided in an

19 amount in excess of the maximum rate of basic

20 pay payable for GS–18 of the General Schedule.

21 ‘‘(J) The Secretary, acting through the Di22 rector of the National Institutes of Health, shall

23 provide to each ethics board reasonable staff and

24 assistance to carry out the duties of the board.
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1 ‘‘(K) An ethics board shall terminate 30

2 days after the date on which the report required

3 in subparagraph (B)(ii) is submitted to the Sec4 retary and the congressional committees specified

5 in such subparagraph.’’.

6 PART II—RESEARCH ON TRANSPLANTATION OF

7 FETAL TISSUE

8 SEC. 111. ESTABLISHMENT OF AUTHORITIES.

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

10 (42 U.S.C. 289 et seq.) is amended by inserting after section

11 498 the following new section:

12 ‘‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

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

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

15 or support research on the transplantation of human

16 fetal tissue for therapeutic purposes.

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

18 may be used in research carried out under paragraph

19 (1) regardless of whether the tissue is obtained pursu20 ant to a spontaneous or induced abortion or pursuant

21 to a stillbirth.

22 ‘‘(b) INFORMED CONSENT OF DONOR.—

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

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

25 only if the woman providing the tissue makes a state-
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1 ment, made in writing and signed by the woman, de2 claring that—

3 ‘‘(A) the woman donates the fetal tissue for

4 use in research described in subsection (a);

5 ‘‘(B) the donation is made without any re6 striction regarding the identity of individuals

7 who may be the recipients of transplantations of

8 the tissue; and

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

10 the identity of any such individuals.

11 ‘‘(2) ADDITIONAL STATEMENT.—In research car12 ried out under subsection (a), human fetal tissue may

13 be used only if the attending physician with respect

14 to obtaining the tissue from the woman involved

15 makes a statement, made in writing and signed by

16 the physician, declaring that—

17 ‘‘(A) in the case of tissue obtained pursuant

18 to an induced abortion—

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

20 abortion was obtained prior to requesting or

21 obtaining consent for the tissue to be used

22 in such research; and

23 ‘‘(ii) no alteration of the timing, meth24 od, or procedures used to terminate the
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1 pregnancy was made solely for the purposes

2 of obtaining the tissue;

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

4 woman in accordance with paragraph (1); and

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

6 woman with regard to—

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

8 in the research to be conducted with the tis9 sue; and

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

11 woman or risks to her privacy that might

12 be associated with the donation of the tissue

13 and that are in addition to risks of such

14 type that are associated with the woman’s

15 medical care.

16 ‘‘(c) INFORMED CONSENT OF RESEARCHER AND

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

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

19 the principal responsibility for conducting the research in20 volved makes a statement, made in writing and signed by

21 the individual, declaring that the individual—

22 ‘‘(1) is aware that—

23 ‘‘(A) the tissue is human fetal tissue;
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1 ‘‘(B) the tissue may have been obtained pur2 suant to a spontaneous or induced abortion or

3 subsequent to a stillbirth; and

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

5 purposes;

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

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

9 of an individual to be a recipient of a transplan10 tation of the tissue, written acknowledgment of receipt

11 of such information by such recipient; and

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

13 timing, method, or procedures used to terminate the

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

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

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

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

19 only if the head of the agency or other entity conduct20 ing the research involved certifies to the Secretary

21 that the statements required under subsections (b) (2)

22 and (c) will be available for audit by the Secretary.

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

24 conducted by the Secretary pursuant to paragraph (1)

25 shall be conducted in a confidential manner to protect
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1 the privacy rights of the individuals and entities in2 volved in such research, including such individuals

3 and entities involved in the donation, transfer, re4 ceipt, or transplantation of human fetal tissue. With

5 respect to any material or information obtained pur6 suant to such audit, the Secretary shall—

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

8 for the purposes of verifying compliance with the

9 requirements of this section;

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

11 or information, except where required by Federal

12 law, in which case such material or information

13 shall be coded in a manner such that the identi14 ties of such individuals and entities are pro15 tected; and

16 ‘‘(C) not maintain such material or infor17 mation after completion of such audit, except

18 where necessary for the purposes of such audit.

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

20 ‘‘(1) RESEARCH CONDUCTED BY RECIPIENTS OF

21 ASSISTANCE.—The Secretary may not provide sup22 port for research under subsection (a) unless the ap23 plicant for the financial assistance involved agrees to

24 conduct the research in accordance with applicable

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

2 The Secretary may conduct research under subsection

3 (a) only in accordance with applicable State and

4 local law.

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

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

7 from a dead human embryo or fetus after a spontaneous

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

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

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

14 as amended by section 111 of this Act, is amended by insert15 ing after section 498A the following new section:

16 ‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE

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

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

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

21 ‘‘(b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DI22 RECTED DONATION FOR USE IN TRANSPLANTATION.—It

23 shall be unlawful for any person to solicit or knowingly

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

25 for the purpose of transplantation of such tissue into an26 other person if the donation affects interstate commerce, the
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1 tissue will be or is obtained pursuant to an induced abor2 tion, and—

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

4 a promise to the donating individual that the donated

5 tissue will be transplanted into a recipient specified

6 by such individual;

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

8 a relative of the donating individual; or

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

11 valuable consideration for the costs associated with

12 such abortion.

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

14 ‘‘(1) IN GENERAL.—Any person who violates sub15 section (a) or (b) shall be fined in accordance with

16 title 18, United States Code, subject to paragraph (2),

17 or imprisoned for not more than 10 years, or both.

18 ‘‘(2) PENALTIES APPLICABLE TO PERSONS RE19 CEIVING CONSIDERATION.—With respect to the impo20 sition of a fine under paragraph (1), if the person in21 volved violates subsection (a) or (b)(3), a fine shall be

22 imposed in an amount not less than twice the amount

23 of the valuable consideration received.

24 ‘‘(d) DEFINITIONS.—For purposes of this section:
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1 ‘‘(1) The term ‘human fetal tissue’ has the mean2 ing given such term in section 498A(f).

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

4 meaning given such term in section 201(b) of the Fed5 eral Food, Drug, and Cosmetic Act.

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

7 include reasonable payments associated with the

8 transportation, implantation, processing, preserva9 tion, quality control, or storage of human fetal

10 tissue.’’.

11 SEC. 113. NULLIFICATION OF MORATORIUM.

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

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

14 that the Department of Health and Human Services is pro15 hibited from conducting or supporting any research on the

16 transplantation of human fetal tissue for therapeutic pur17 poses. Such research shall be carried out in accordance with

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

19 by section 111 of this Act), without regard to any such pol20 icy that may have been in effect prior to the date of the

21 enactment of this Act.

22 (b) PROHIBITION AGAINST WITHHOLDING OF FUNDS

23 IN CASES OF TECHNICAL AND SCIENTIFIC MERIT.—

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

25 for research on the transplantation of human fetal tis-
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1 sue for therapeutic purposes, the Secretary of Health

2 and Human Services may not withhold funds for the

3 research if—

4 (A) the research has been approved for pur5 poses of section 492A(a) of the Public Health

6 Service Act (as added by section 101 of this Act);

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

9 by section 111 of this Act); and

10 (C) there are reasonable assurances that the

11 research will not utilize any human fetal tissue

12 that has been obtained in violation of section

13 498B(a) of such Act (as added by section 112 of

14 this Act).

15 (2) STANDING APPROVAL REGARDING ETHICAL

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

17 the transplantation of human fetal tissue for thera18 peutic purposes, the issuance in December 1988 of the

19 Report of the Human Fetal Tissue Transplantation

20 Research Panel shall be deemed to be a report—

21 (A) issued by an ethics advisory board pur22 suant to section 492A(b)(4)(B)(ii) of the Public

23 Health Service Act (as added by section 101 of

24 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 RE5 SEARCH.—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 in

9 any of subparagraphs (A) through (C) of subsection (b)(1)

10 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 term

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

14 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 Comp5 troller General of the United States shall complete the audit

6 required in subsection (a) and submit to the Committee on

7 Energy and Commerce of the House of Representatives, and

8 to the Committee on Labor and Human Resources of the

9 Senate, a report describing the findings made pursuant to

10 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 Public

17 Health Service Act (42 U.S.C. 289 et seq.) is amended—

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

19 (2) by striking section 499; and

20 (3) by redesignating section 499A as section 499.

21 (c) NULLIFICATION OF CERTAIN PROVISIONS.—The

22 provisions of Executive Order 12806 (57 Fed. Reg. 21589

23 (May 21, 1992)) shall not have any legal effect. The provi24 sions of section 204(d) of part 46 of title 45 of the Code
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1 of Federal Regulations (45 CFR 46.204(d)) shall not have

2 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 insert11 ing after section 492A the following new section:

12 ‘‘INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

13 RESEARCH

14 ‘‘SEC. 492B. (a) REQUIREMENT OF INCLUSION.—

15 ‘‘(1) IN GENERAL.—In conducting or supporting

16 clinical research for purposes of this title, the Director

17 of NIH shall, subject to subsection (b), ensure that—

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

19 project of such research; and

20 ‘‘(B) members of minority groups are in21 cluded as subjects in such research.

22 ‘‘(2) OUTREACH REGARDING PARTICIPATION AS

23 SUBJECTS.—The Director of NIH, in consultation

24 with the Director of the Office of Research on Wom25 en’s Health and the Director of the Office of Research

26 on Minority Health, shall conduct or support out-
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1 reach programs for the recruitment of women and

2 members of minority groups as subjects in projects of

3 clinical research.

4 ‘‘(b) INAPPLICABILITY OF REQUIREMENT.—The re5 quirement established in subsection (a) regarding women

6 and members of minority groups shall not apply to a

7 project of clinical research if the inclusion, as subjects in

8 the project, of women and members of minority groups, re9 spectively—

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

11 of the subjects;

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

13 of the research; or

14 ‘‘(3) is inappropriate under such other cir15 cumstances as the Director of NIH may designate.

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

17 clinical trial in which women or members of minority

18 groups will under subsection (a) be included as subjects, the

19 Director of NIH shall ensure that the trial is designed and

20 carried out in a manner sufficient to provide for a valid

21 analysis of whether the variables being studied in the trial

22 affect women or members of minority groups, as the case

23 may be, differently than other subjects in the trial.

24 ‘‘(d) GUIDELINES.—
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1 ‘‘(1) IN GENERAL.—Subject to paragraph (2), the

2 Director of NIH, in consultation with the Director of

3 the Office of Research on Women’s Health and the Di4 rector of the Office of Research on Minority Health,

5 shall establish guidelines regarding the requirements

6 of this section. The guidelines shall include guidelines

7 regarding—

8 ‘‘(A) the circumstances under which the in9 clusion of women and minorities as subjects in

10 projects of clinical research is inappropriate for

11 purposes of subsection (b);

12 ‘‘(B) the manner in which clinical trials

13 are required to be designed and carried out for

14 purposes of subsection (c); and

15 ‘‘(C) the operation of outreach programs

16 under subsection (a).

17 ‘‘(2) CERTAIN PROVISIONS.—With respect to the

18 circumstances under which the inclusion of women or

19 members of minority groups (as the case may be) as

20 subjects in a project of clinical research is inappro21 priate for purposes of subsection (b), the following ap22 plies to guidelines under paragraph (1):

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

24 guidelines shall provide that the costs of such in25 clusion in the trial is not a permissible consider-
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1 ation in determining whether such inclusion is

2 inappropriate.

3 ‘‘(ii) In the case of other projects of clinical

4 research, the guidelines shall provide that the

5 costs of such inclusion in the project is not a per6 missible consideration in determining whether

7 such inclusion is inappropriate unless the data

8 regarding women or members of minority

9 groups, respectively, that would be obtained in

10 such project (in the event that such inclusion

11 were required) have been or will be obtained

12 through other means that provide data of com13 parable quality.

14 ‘‘(B) In the case of a clinical trial, the

15 guidelines may provide that such inclusion in

16 the trial is not required if there is substantial

17 scientific data demonstrating that there is no

18 significant difference between—

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

20 studied in the trial have on women or mem21 bers of minority groups, respectively; and

22 ‘‘(ii) the effects that the variables have

23 on the individuals who would serve as sub24 jects in the trial in the event that such in25 clusion were not required.
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1 ‘‘(e) DATE CERTAIN FOR GUIDELINES; APPLICABIL2 ITY.—

3 ‘‘(1) DATE CERTAIN.—The guidelines required in

4 subsection (d) shall be established and published in

5 the Federal Register not later than 180 days after the

6 date of the enactment of the National Institutes of

7 Health Revitalization Act of 1993.

8 ‘‘(2) APPLICABILITY.—For fiscal year 1995 and

9 subsequent fiscal years, the Director of NIH may not

10 approve any proposal of clinical research to be con11 ducted or supported by any agency of the National

12 Institutes of Health unless the proposal specifies the

13 manner in which the research will comply with this

14 section.

15 ‘‘(f) REPORTS BY ADVISORY COUNCILS.—The advisory

16 council of each national research institute shall annually

17 submit to the Director of NIH and the Director of the insti18 tute involved a report describing the manner in which the

19 agency has complied with this section.

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

21 ‘‘(1) The term ‘project of clinical research’ in22 cludes a clinical trial.

23 ‘‘(2) The term ‘minority group’ includes sub24 populations of minority groups. The Director of NIH

25 shall, through the guidelines established under sub-
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1 section (d), define the terms ‘minority group’ and

2 ‘subpopulation’ for purposes of the preceding sen3 tence.’’.

4 SEC. 132. PEER REVIEW.

5 Section 492 of the Public Health Service Act (42

6 U.S.C. 289a) is amended by adding at the end the following

7 new subsection:

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

9 this section of proposals for clinical research, the consider10 ation of any such proposal (including the initial consider11 ation) shall, except as provided in paragraph (2), include

12 an evaluation of the technical and scientific merit of the

13 proposal regarding compliance with section 492B.

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

15 for clinical research that, pursuant to subsection (b) of sec16 tion 492B, is not subject to the requirement of subsection

17 (a) of such section regarding the inclusion of women and

18 members of minority groups as subjects in clinical re19 search.’’.

20 SEC. 133. APPLICABILITY TO CURRENT PROJECTS.

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

22 added by section 131 of this Act, shall not apply with re23 spect to projects of clinical research for which initial fund24 ing was provided prior to the date of the enactment of this

25 Act. With respect to the inclusion of women and minorities
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1 as subjects in clinical research conducted or supported by

2 the National Institutes of Health, any policies of the Sec3 retary of Health and Human Services regarding such inclu4 sion that are in effect on the day before the date of the enact5 ment of this Act shall continue to apply to the projects re6 ferred to in the preceding sentence.

7 PART II—OFFICE OF RESEARCH ON WOMEN’S

8 HEALTH

9 SEC. 141. ESTABLISHMENT.

10 (a) IN GENERAL.—Title IV of the Public Health Serv11 ice Act, as amended by the preceding provisions of this title,

12 is amended—

13 (1) by redesignating section 486 as section 485A;

14 (2) by redesignating parts F through H as parts

15 G through I, respectively; and

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

17 part:

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

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

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

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

22 the Office of Research on Women’s Health (in this part re23 ferred to as the ‘Office’). The Office shall be headed by a

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

25 ‘‘(b) PURPOSE.—The Director of the Office shall—
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1 ‘‘(1) identify projects of research on women’s

2 health that should be conducted or supported by the

3 national research institutes;

4 ‘‘(2) identify multidisciplinary research relating

5 to research on women’s health that should be so con6 ducted or supported;

7 ‘‘(3) carry out paragraphs (1) and (2) with re8 spect to the aging process in women, with priority

9 given to menopause;

10 ‘‘(4) promote coordination and collaboration

11 among entities conducting research identified under

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

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

14 entities receiving funds from the national research in15 stitutes;

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

17 supporting such research;

18 ‘‘(7) promote the sufficient allocation of the re19 sources of the national research institutes for conduct20 ing and supporting such research;

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

22 with respect to the inclusion of women as subjects in

23 clinical research; and

24 ‘‘(9) prepare the report required in section 486B.

25 ‘‘(c) COORDINATING COMMITTEE.—
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1 ‘‘(1) In carrying out subsection (b), the Director

2 of the Office shall establish a committee to be known

3 as the Coordinating Committee on Research on Wom4 en’s Health (hereafter in this subsection referred to as

5 the ‘Coordinating Committee’).

6 ‘‘(2) The Coordinating Committee shall be com7 posed of the Directors of the national research insti8 tutes (or the designees of the Directors).

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

10 chair of the Coordinating Committee.

11 ‘‘(4) With respect to research on women’s health,

12 the Coordinating Committee shall assist the Director

13 of the Office in—

14 ‘‘(A) identifying the need for such research,

15 and making an estimate each fiscal year of the

16 funds needed to adequately support the research;

17 ‘‘(B) identifying needs regarding the coordi18 nation of research activities, including intra19 mural and extramural multidisciplinary activi20 ties;

21 ‘‘(C) supporting the development of meth22 odologies to determine the circumstances in

23 which obtaining data specific to women (includ24 ing data relating to the age of women and the

25 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 been

6 determined to be an appropriate function; and

7 ‘‘(E) encouraging the national research in8 stitutes to conduct and support such research, in9 cluding such clinical trials.

10 ‘‘(d) ADVISORY COMMITTEE.—

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

12 of the Office shall establish an advisory committee to

13 be known as the Advisory Committee on Research on

14 Women’s Health (hereafter in this subsection referred

15 to as the ‘Advisory Committee’).

16 ‘‘(2) The Advisory Committee shall be composed

17 of no fewer than 12, and not more than 18 individ18 uals, who are not officers or employees of the Federal

19 Government. The Director of the Office shall make ap20 pointments to the Advisory Committee from among

21 physicians, practitioners, scientists, and other health

22 professionals, whose clinical practice, research spe23 cialization, or professional expertise includes a sig24 nificant focus on research on women’s health. A ma-
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1 jority of the members of the Advisory Committee shall

2 be women.

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

4 chair of the Advisory Committee.

5 ‘‘(4) The Advisory Committee shall—

6 ‘‘(A) advise the Director of the Office on ap7 propriate research activities to be undertaken by

8 the national research institutes with respect to—

9 ‘‘(i) research on women’s health;

10 ‘‘(ii) research on gender differences in

11 clinical drug trials, including responses to

12 pharmacological drugs;

13 ‘‘(iii) research on gender differences in

14 disease etiology, course, and treatment;

15 ‘‘(iv) research on obstetrical and gyne16 cological health conditions, diseases, and

17 treatments; and

18 ‘‘(v) research on women’s health condi19 tions which require a multidisciplinary ap20 proach;

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

22 such research;

23 ‘‘(C) provide recommendations to such Di24 rector regarding activities of the Office (includ25 ing recommendations on the development of the
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1 methodologies described in subsection (c)(4)(C)

2 and recommendations on priorities in carrying

3 out research described in subparagraph (A)); and

4 ‘‘(D) assist in monitoring compliance with

5 section 492B regarding the inclusion of women

6 in clinical research.

7 ‘‘(5)(A) The Advisory Committee shall prepare a

8 biennial report describing the activities of the Com9 mittee, including findings made by the Committee re10 garding—

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

12 ‘‘(ii) the extent of expenditures made for re13 search on women’s health by the agencies of the

14 National Institutes of Health; and

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

16 research.

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

18 shall be submitted to the Director of NIH for inclu19 sion in the report required in section 403.

20 ‘‘(e) REPRESENTATION OF WOMEN AMONG RESEARCH21 ERS.—The Secretary, acting through the Assistant Sec22 retary for Personnel and in collaboration with the Director

23 of the Office, shall determine the extent to which women

24 are represented among senior physicians and scientists of

25 the national research institutes and among physicians and
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1 scientists conducting research with funds provided by such

2 institutes, and as appropriate, carry out activities to in3 crease the extent of such representation.

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

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

6 respect to women of all age, ethnic, and racial groups,

7 means all diseases, disorders, and conditions (includ8 ing with respect to mental health)—

9 ‘‘(A) unique to, more serious, or more prev10 alent in women;

11 ‘‘(B) for which the factors of medical risk or

12 types of medical intervention are different for

13 women, or for which it is unknown whether such

14 factors or types are different for women; or

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

16 insufficient clinical research involving women as

17 subjects or insufficient clinical data on women.

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

19 means research on women’s health conditions, includ20 ing research on preventing such conditions.

21 ‘‘SEC. 486A. NATIONAL DATA SYSTEM AND CLEARINGHOUSE

22 ON RESEARCH ON WOMEN’S HEALTH.

23 ‘‘(a) DATA SYSTEM.—

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

25 the Director of the Office and the Director of the Na-
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1 tional Library of Medicine, shall establish a data sys2 tem for the collection, storage, analysis, retrieval, and

3 dissemination of information regarding research on

4 women’s health that is conducted or supported by the

5 national research institutes. Information from the

6 data system shall be available through information

7 systems available to health care professionals and

8 providers, researchers, and members of the public.

9 ‘‘(2) The data system established under para10 graph (1) shall include a registry of clinical trials of

11 experimental treatments that have been developed for

12 research on women’s health. Such registry shall in13 clude information on subject eligibility criteria, sex,

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

15 or sites. Principal investigators of such clinical trials

16 shall provide this information to the registry within

17 30 days after it is available. Once a trial has been

18 completed, the principal investigator shall provide the

19 registry with information pertaining to the results,

20 including potential toxicities or adverse effects associ21 ated with the experimental treatment or treatments

22 evaluated.

23 ‘‘(b) CLEARINGHOUSE.—The Director of NIH, in con24 sultation with the Director of the Office and with the Na25 tional Library of Medicine, shall establish, maintain, and
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1 operate a program to provide information on research and

2 prevention activities of the national research institutes that

3 relate to research on women’s health.

4 ‘‘SEC. 486B. BIENNIAL REPORT.

5 ‘‘(a) IN GENERAL.—With respect to research on wom6 en’s health, the Director of the Office shall, not later than

7 February 1, 1994, and biennially thereafter, prepare a re8 port—

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

10 during the preceding 2 fiscal years in research and

11 treatment conducted or supported by the National In12 stitutes of Health;

13 ‘‘(2) describing and analyzing the professional

14 status of women physicians and scientists of such In15 stitutes, including the identification of problems and

16 barriers regarding advancements;

17 ‘‘(3) summarizing and analyzing expenditures

18 made by the agencies of such Institutes (and by such

19 Office) during the preceding 2 fiscal years; and

20 ‘‘(4) making such recommendations for legisla21 tive and administrative initiatives as the Director of

22 the Office determines to be appropriate.

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

24 OF NIH.—The Director of the Office shall submit each re25 port prepared under subsection (a) to the Director of NIH
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1 for inclusion in the report submitted to the President and

2 the Congress under section 403.’’.

3 (b) REQUIREMENT OF SUFFICIENT ALLOCATION OF

4 RESOURCES OF INSTITUTES.—Section 402(b) of the Public

5 Health Service Act (42 U.S.C. 282(b)) is amended—

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

7 the semicolon at the end;

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

9 the end and inserting ‘‘; and’’; and

10 (3) by inserting after paragraph (11) the follow11 ing new paragraph:

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

13 Office of Research on Women’s Health, shall ensure

14 that resources of the National Institutes of Health are

15 sufficiently allocated for projects of research on wom16 en’s health that are identified under section 486(b).’’.

17 PART III—OFFICE OF RESEARCH ON MINORITY

18 HEALTH

19 SEC. 151. ESTABLISHMENT.

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

21 (42 U.S.C. 281 et seq.) is amended by adding at the end

22 the following section:

23 ‘‘OFFICE OF RESEARCH ON MINORITY HEALTH

24 ‘‘SEC. 404. (a) ESTABLISHMENT.—There is established

25 within the Office of the Director of NIH an office to be

26 known as the Office of Research on Minority Health (in
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1 this section referred to as the ‘Office’). The Office shall be

2 headed by a director, who shall be appointed by the Director

3 of NIH.

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

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

6 health that should be conducted or supported by the

7 national research institutes;

8 ‘‘(2) identify multidisciplinary research relating

9 to research on minority health that should be so con10 ducted or supported;

11 ‘‘(3) promote coordination and collaboration

12 among entities conducting research identified under

13 paragraph (1) or (2);

14 ‘‘(4) encourage the conduct of such research by

15 entities receiving funds from the national research in16 stitutes;

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

18 supporting such research;

19 ‘‘(6) promote the sufficient allocation of the re20 sources of the national research institutes for conduct21 ing and supporting such research; and

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

23 with respect to the inclusion of members of minority

24 groups as subjects in clinical research.’’.
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1 Subtitle C—Research Integrity

2 SEC. 161. ESTABLISHMENT OF OFFICE OF RESEARCH 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 follows:

6 ‘‘OFFICE OF RESEARCH INTEGRITY

7 ‘‘SEC. 493. (a) ESTABLISHMENT.—

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

9 the date of enactment of this section, the Secretary

10 shall establish an office to be known as the Office of

11 Research Integrity (hereafter referred to in this sec12 tion as the ‘Office’), which shall be established as an

13 independent entity in the Department of Health and

14 Human Services.

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

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

17 be experienced and specially trained in the conduct of

18 research, and have experience in the conduct of inves19 tigations of research misconduct. The Secretary shall

20 carry out this section acting through the Director of

21 the Office. The Director shall report to the Secretary.

22 ‘‘(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS

23 CONDITION OF FUNDING FOR RESEARCH.—The Secretary

24 shall by regulation require that each entity that applies for

25 a grant, contract, or cooperative agreement under this Act
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1 for any project or program that involves the conduct of bio2 medical or behavioral research submit in or with its appli3 cation for such grant, contract, or cooperative agreement

4 assurances satisfactory to the Secretary that such entity—

5 ‘‘(1) has established (in accordance with regula6 tions which the Secretary shall prescribe) an adminis7 trative process to review reports of research mis8 conduct in connection with biomedical and behavioral

9 research conducted at or sponsored by such entity;

10 and

11 ‘‘(2) will report to the Director any investigation

12 of alleged research misconduct in connection with

13 projects for which funds have been made available

14 under this Act that appears substantial.

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

16 Secretary shall establish by regulation a process to be fol17 lowed by the Director for the prompt and appropriate—

18 ‘‘(1) response to information provided to the Di19 rector respecting research misconduct in connection

20 with projects for which funds have been made avail21 able under this Act;

22 ‘‘(2) receipt of reports by the Director of such in23 formation from recipients of funds under this Act;

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

25 and
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1 ‘‘(4) taking of other actions, including appro2 priate remedies, with respect to such misconduct.

3 ‘‘(d) MONITORING BY DIRECTOR.—The Secretary shall

4 by regulation establish procedures for the Director to mon5 itor administrative processes and investigations that have

6 been established or carried out under this section.

7 ‘‘(e) EFFECT ON PRESENT INVESTIGATIONS.—Nothing

8 in this section shall affect investigations which have been

9 or will be commenced prior to the promulgation of final

10 regulations under this section.’’.

11 (b) ESTABLISHMENT OF DEFINITION OF RESEARCH

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

13 which the report required under section 162(d) is submitted

14 to the Secretary of Health and Human Services, such Sec15 retary shall by regulation establish a definition for the term

16 ‘‘research misconduct’’ for purposes of section 493 of the

17 Public Health Service Act, as amended by subsection (a)

18 of this section.

19 SEC. 162. COMMISSION ON RESEARCH INTEGRITY.

20 (a) IN GENERAL.—Not later than 90 days after the

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

22 and Human Services shall establish a commission to be

23 known as the Commission on Research Integrity (in this

24 section referred to as the ‘‘Commission’’).
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1 (b) DUTIES.—The Commission shall develop rec2 ommendations for the Secretary of Health and Human

3 Services on the administration of section 493 of the Public

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

5 of this Act).

6 (c) COMPOSITION.—The Commission shall be composed

7 of 12 members to be appointed by the Secretary of Health

8 and Human Services. Not more than 3 members of the Com9 mission may be officers or employees of the United States.

10 Of the members of the Commission—

11 (1) three shall be scientists with substantial ac12 complishments in biomedical or behavioral research;

13 (2) three shall be individuals with experience in

14 investigating allegations of misconduct with respect to

15 research research;

16 (3) three shall be representatives of institutions

17 of higher education at which biomedical or behavioral

18 research is conducted; and

19 (4) three shall be individuals who are not de20 scribed in paragraphs (1), (2), or (3), at least one of

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

22 shall be an ethicist.

23 (d) COMPENSATION.—Members of the Commission

24 may not receive compensation for service on the Commis25 sion. Members may be reimbursed for travel, subsistence,
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1 and other necessary expenses incurred in carrying out the

2 duties of the Commission.

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

4 on which the Commission is established under subsection

5 (a), the Commission shall prepare and submit to the Sec6 retary of Health and Human Services, the Committee on

7 Energy and Commerce of the House of Representatives, and

8 the Committee on Labor and Human Resources of the Sen9 ate, a report containing the recommendations developed

10 under subsection (b).

11 SEC. 163. PROTECTION OF WHISTLEBLOWERS.

12 Section 493 of the Public Health Service Act, as

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

14 at the end the following new subsection:

15 ‘‘(f) PROTECTION OF WHISTLEBLOWERS.—

16 ‘‘(1) IN GENERAL.—In the case of any entity re17 quired to establish administrative processes under

18 subsection (b), the Secretary shall by regulation estab19 lish standards for preventing, and for responding to

20 the occurrence of retaliation by such entity, its offi21 cials or agents, against an employee in the terms and

22 conditions of employment in response to the employee

23 having in good faith—

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

25 officials or agents, has engaged in or failed to
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1 adequately respond to an allegation of research

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 the

7 Director to monitor the implementation of the stand8 ards established by an entity under paragraph (1) for

9 the purpose of determining whether the procedures

10 have been established, and are being utilized, in ac11 cordance with the standards established under such

12 paragraph.

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

14 regulation establish remedies for noncompliance by an

15 entity, its officials or agents, which has engaged in re16 taliation in violation of the standards established

17 under paragraph (1). Such remedies may include ter18 mination of funding provided by the Secretary for

19 such project or recovery of funding being provided by

20 the Secretary for such project, or other actions as ap21 propriate.

22 ‘‘(4) FINAL RULE FOR REGULATIONS.—The Sec23 retary shall issue a final rule for the regulations re24 quired in paragraph (1) not later than 180 days after
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1 the date of the enactment of the National Institutes of

2 Health Revitalization Act of 1993.

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

4 year beginning after the date on which the regulations

5 required in paragraph (1) are issued, the Secretary

6 may not provide a grant, cooperative agreement, or

7 contract under this Act for biomedical or behavioral

8 research unless the entity seeking such financial as9 sistance agrees that the entity—

10 ‘‘(A) will maintain the procedures described

11 in the regulations; and

12 ‘‘(B) will otherwise be subject to the regula13 tions.’’.

14 SEC. 164. 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 amended

20 by inserting after section 493 the following new section:

21 ‘‘PROTECTION AGAINST FINANCIAL CONFLICTS OF INTEREST

22 IN CERTAIN PROJECTS OF RESEARCH

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

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

25 regulation, the specific circumstances that constitute

26 the existence of a financial interest in a project on the
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1 part of an entity or individual that will, or may be

2 reasonably expected to, create a bias in favor of ob3 taining results in such project that are consistent

4 with such financial interest. Such definition shall

5 apply uniformly to each entity or individual conduct6 ing a research project under this Act. In the case of

7 any entity or individual receiving assistance from the

8 Secretary for a project of research described in para9 graph (2), the Secretary shall by regulation establish

10 standards for responding to, including managing, re11 ducing, or eliminating, the existence of such a finan12 cial interest. The entity may adopt individualized

13 procedures for implementing the standards.

14 ‘‘(2) RELEVANT PROJECTS.—A project of re15 search referred to in paragraph (1) is a project of

16 clinical research whose purpose is to evaluate the safe17 ty or effectiveness of a drug, medical device, or treat18 ment and for which such entity is receiving assistance

19 from the Secretary.

20 ‘‘(3) IDENTIFYING AND REPORTING TO THE DI21 RECTOR.—The Secretary shall ensure that the stand22 ards established under paragraph (1) specify that as

23 a condition of receiving assistance from the Secretary

24 for the project involved, an entity described in such

25 subsection is required—
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1 ‘‘(A) to have in effect at the time the entity

2 applies for the assistance and throughout the pe3 riod during which the assistance is received, a

4 process for identifying such financial interests as

5 defined in paragraph (1) that exist regarding the

6 project; and

7 ‘‘(B) to report to the Director such financial

8 interest as defined in paragraph (1) identified

9 by the entity and how any such financial inter10 est identified by the entity will be managed or

11 eliminated such that the project in question will

12 be protected from bias that may stem from such

13 financial interest.

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

15 shall monitor the establishment and conduct of the

16 process established by an entity pursuant to para17 graph (1).

18 ‘‘(5) RESPONSE.—In any case in which the Sec19 retary determines that an entity has failed to comply

20 with paragraph (3) regarding a project of research

21 described in paragraph (1), the Secretary—

22 ‘‘(A) shall require that, as a condition of re23 ceiving assistance, the entity disclose the exist24 ence of a financial interest as defined in para-
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1 graph (1) in each public presentation of the re2 sults of such project; and

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

4 Secretary determines to be appropriate.

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

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

7 the receipt of consulting fees or honoraria and

8 the ownership of stock or equity.

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

10 conducting a project of research, means a grant,

11 contract, or cooperative agreement.

12 ‘‘(b) FINAL RULE FOR REGULATIONS.—The Secretary

13 shall issue a final rule for the regulations required in sub14 section (a) not later than 180 days after the date of the

15 enactment of the National Institutes of Health Revitaliza16 tion Act of 1993.’’.

17 SEC. 165. EFFECTIVE DATES.

18 (a) IN GENERAL.—The amendments made by this sub19 title shall become effective on the date that occurs 180 days

20 after the date on which the final rule required under section

21 493(f)(4) of the Public Health Service Act, as amended by

22 sections 161 and 163, is published in the Federal Register.

23 (b) AGREEMENTS AS A CONDITION OF FUNDING.—The

24 requirements of subsection (f)(5) of section 493 of the Public

25 Health Service Act, as amended by sections 161 and 163,
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1 with respect to agreements as a condition of funding shall

2 not be effective in the case of projects of research for which

3 initial funding under the Public Health Service Act was

4 provided prior to the effective date described in subsection

5 (a).

6 TITLE II—NATIONAL INSTITUTES

7 OF HEALTH IN GENERAL

8 SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINATION.

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

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

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

12 inserting ‘‘other public and private entities, including ele13 mentary, secondary, and post-secondary schools. The Asso14 ciate Director shall—

15 ‘‘(1) annually review the efficacy of existing poli16 cies and techniques used by the national research in17 stitutes to disseminate the results of disease preven18 tion and behavioral research programs;

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

20 modification or reconstruction of such policies and

21 techniques to ensure maximum dissemination, using

22 advanced technologies to the maximum extent prac23 ticable, of research results to such entities; and

24 ‘‘(3) annually prepare and submit to the Direc25 tor of NIH a report concerning the prevention and
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1 dissemination activities undertaken by the Associate

2 Director, including—

3 ‘‘(A) a summary of the Associate Director’s

4 review of existing dissemination policies and

5 techniques together with a detailed statement

6 concerning any modification or restructuring, or

7 recommendations for modification or restructur8 ing, of such policies and techniques; and

9 ‘‘(B) a detailed statement of the expendi10 tures made for the prevention and dissemination

11 activities reported on and the personnel used in

12 connection with such activities.’’.

13 SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARD14 ING CERTAIN STATES AND RESEARCHERS.

15 Section 402 of the Public Health Service Act (42

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

17 new subsection:

18 ‘‘(g)(1)(A) In the case of entities described in subpara19 graph (B), the Director of NIH, acting through the Director

20 of the National Center for Research Resources, shall estab21 lish a program to enhance the competitiveness of such enti22 ties in obtaining funds from the national research institutes

23 for conducting biomedical and behavioral research.

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

25 entities that conduct biomedical and behavioral research
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1 and are located in a State in which the aggregate success

2 rate for applications to the national research institutes for

3 assistance for such research by the entities in the State has

4 historically constituted a low success rate of obtaining such

5 funds, relative to such aggregate rate for such entities in

6 other States.

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

8 purposes of subparagraph (A), the Director of NIH, in car9 rying out the program established under such subpara10 graph, may—

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

12 involved, including technical assistance in the prepa13 ration of applications for obtaining funds from the

14 national research institutes;

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

16 biomedical or behavioral research proposals; and

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

18 plan.

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

20 of supporting projects of biomedical or behavioral research

21 whose principal researchers are individuals who have not

22 previously served as the principal researchers of such

23 projects supported by the Director.’’.
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1 SEC. 203. ESTABLISHMENT OF OFFICE OF BEHAVIORAL RE2 SEARCH.

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

4 as amended by section 151 of this Act, is amended by add5 ing at the end the following new section:

6 ‘‘OFFICE OF BEHAVIORAL RESEARCH

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

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

9 of Behavioral Research (in this section referred to as the

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

11 be appointed by the Director of NIH.

12 ‘‘(b)(1) With respect to research on the relationship be13 tween human behavior and the development, treatment, and

14 prevention of medical conditions, the Director of the Office

15 shall coordinate research conducted or supported by the

16 agencies of the National Institutes of Health.

17 ‘‘(2) Research authorized under paragraph (1) in18 cludes research on teen pregnancy, infant mortality, violent

19 behavior, suicide, and homelessness.

20 ‘‘(3) The sole responsibility of the Director of the Office

21 shall be carrying out paragraph (1).’’.

22 SEC. 204. CHILDREN’S VACCINE INITIATIVE.

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

24 as amended by section 203 of this Act, is amended by add25 ing at the end the following new section:
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1 ‘‘CHILDREN’S VACCINE INITIATIVE

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

3 The Secretary, in consultation with the Director of the Na4 tional Vaccine Program under title XXI and acting through

5 the Directors of the National Institute for Allergy and Infec6 tious Diseases, the National Institute for Child Health and

7 Human Development, the National Institute for Aging, and

8 other public and private programs, shall carry out activi9 ties, which shall be consistent with the global Children’s

10 Vaccine Initiative, to develop affordable new and improved

11 vaccines to be used in the United States and in the develop12 ing world that will increase the efficacy and efficiency of

13 the prevention of infectious diseases. In carrying out such

14 activities, the Secretary shall, to the extent practicable, de15 velop and make available vaccines that require fewer con16 tacts to deliver, that can be given early in life, that provide

17 long lasting protection, that obviate refrigeration, needles

18 and syringes, and that protect against a larger number of

19 diseases.

20 ‘‘(b) REPORT.—In the report required in section 2104,

21 the Secretary, acting through the Director of the National

22 Vaccine Program under title XXI, shall include information

23 with respect to activities and the progress made in imple24 menting the provisions of this section and achieving its

25 goals.
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1 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—In addi2 tion to any other amounts authorized to be appropriated

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

4 authorized to be appropriated to carry out this section

5 $50,000,000 for fiscal year 1994, and such sums as may

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

7 SEC. 205. PLAN FOR USE OF ANIMALS IN RESEARCH.

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

9 Health Service Act, as amended by section 204 of this Act,

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

11 ‘‘PLAN FOR USE OF ANIMALS IN RESEARCH

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

14 shall prepare a plan—

15 ‘‘(1) for the National Institutes of Health to con16 duct or support research into—

17 ‘‘(A) methods of biomedical research and ex18 perimentation that do not require the use of ani19 mals;

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

22 used in such research;

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

25 such animals; and
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1 ‘‘(D) methods of such research and experi2 mentation that involve the use of marine life

3 (other than marine mammals);

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

5 of the methods described in paragraph (1);

6 ‘‘(3) for encouraging the acceptance by the sci7 entific community of such methods that have been

8 found to be valid and reliable; and

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

10 methods that have been found to be valid and reliable.

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

12 NIH shall submit to the Committee on Energy and Com13 merce of the House of Representatives, and to the Committee

14 on Labor and Human Resources of the Senate, the plan

15 required in subsection (a) and shall begin implementation

16 of the plan.

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

18 and as appropriate, make revisions in the plan required

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

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

21 under section 403 that is submitted after the revision is

22 made.

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

24 may be appropriate to convey to scientists and others who

25 use animals in biomedical or behavioral research or experi-
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1 mentation information respecting the methods found to be

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

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

4 National Institutes of Health a committee to be known as

5 the Interagency Coordinating Committee on the Use of Ani6 mals in Research (hereafter in this subsection referred to

7 as the ‘Committee’).

8 ‘‘(2) The Committee shall provide advice to the Direc9 tor of NIH on the preparation of the plan required in sub10 section (a).

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

12 ‘‘(A) the Directors of each of the national re13 search institutes and the Director of the Center for

14 Research Resources (or the designees of such Direc15 tors); and

16 ‘‘(B) representatives of the Environmental Pro17 tection Agency, the Food and Drug Administration,

18 the Consumer Product Safety Commission, the Na19 tional Science Foundation, and such additional agen20 cies as the Director of NIH determines to be appro21 priate.’’.

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

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

24 158; 99 Stat. 880) is repealed.
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1 SEC. 206. INCREASED PARTICIPATION OF WOMEN AND DIS2 ADVANTAGED INDIVIDUALS IN FIELDS OF

3 BIOMEDICAL AND BEHAVIORAL RESEARCH.

4 Section 402 of the Public Health Service Act, as

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

6 at the end the following new subsection:

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

8 and the Directors of the agencies of the National Institutes

9 of Health, may conduct and support programs for research,

10 research training, recruitment, and other activities to pro11 vide for an increase in the number of women and individ12 uals from disadvantaged backgrounds in the fields of bio13 medical and behavioral research.’’.

14 SEC. 207. REQUIREMENTS REGARDING SURVEYS OF SEXUAL

15 BEHAVIOR.

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

17 as amended by section 205 of this Act, is amended by add18 ing at the end the following new section:

19 ‘‘REQUIREMENTS REGARDING SURVEYS OF SEXUAL

20 BEHAVIOR

21 ‘‘SEC. 404D. With respect to any survey of human sex22 ual behavior proposed to be conducted or supported through

23 the National Institutes of Health, the survey may not be

24 carried out unless—
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1 ‘‘(1) the proposal has undergone review in ac2 cordance with any applicable requirements of sections

3 491 and 492; and

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

5 492A, makes a determination that the information ex6 pected to be obtained through the survey will assist—

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

8 transmitted diseases, the incidence of infection

9 with the human immunodeficiency virus, or the

10 incidence of any other infectious disease; or

11 ‘‘(B) in improving reproductive health or

12 other conditions of health.’’.

13 SEC. 208. DISCRETIONARY FUND OF DIRECTOR OF NA14 TIONAL INSTITUTES OF HEALTH.

15 Section 402 of the Public Health Service Act, as

16 amended by section 206 of this Act, is amended by adding

17 at the end the following new subsection:

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

19 amounts appropriated under paragraph (3) and made

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

21 carry out the activities authorized in this Act for the Na22 tional Institutes of Health. The purposes for which such

23 fund may be expended include—

24 ‘‘(A) providing for research on matters that have

25 not received significant funding relative to other mat-
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1 ters, responding to new issues and scientific emer2 gencies, and acting on research opportunities of high

3 priority;

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

5 within the authority of any single agency of such In6 stitutes; and

7 ‘‘(C) purchasing or renting equipment and quar8 ters for activities of such Institutes.

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

10 the Secretary shall submit to the Committee on Energy and

11 Commerce of the House of Representatives, and to the Com12 mittee on Labor and Human Resources of the Senate, a

13 report describing the activities undertaken and expenditures

14 made under this section during the preceding fiscal year.

15 The report may contain such comments of the Secretary re16 garding this section as the Secretary determines to be ap17 propriate.

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

19 there are authorized to be appropriated $25,000,000 for fis20 cal year 1994, and such sums as may be necessary for each

21 of the fiscal years 1995 and 1996.’’.

22 SEC. 209. MISCELLANEOUS PROVISIONS.

23 (a) TERM OF OFFICE FOR MEMBERS OF ADVISORY

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

25 Act (42 U.S.C. 284a(c)) is amended in the second sentence
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1 by striking ‘‘until a successor has taken office’’ and insert2 ing the following: ‘‘for 180 days after the date of such expi3 ration’’.

4 (b) LITERACY REQUIREMENTS.—Section 402(e) of the

5 Public Health Service Act (42 U.S.C. 282(e)) is amended—

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

7 end;

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

9 inserting ‘‘; and’’; and

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

11 new paragraph:

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

13 one-half of all new or revised health education and

14 promotion materials developed or funded by the Na15 tional Institutes of Health is in a form that does not

16 exceed a level of functional literacy, as defined in the

17 National Literacy Act of 1991 (Public Law 102–

18 73).’’.

19 (c) DAY CARE REGARDING CHILDREN OF EMPLOY20 EES.—Section 402 of the Public Health Service Act, as

21 amended by section 208 of this Act, is amended by adding

22 at the end the following new subsection:

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

24 to provide day care services for the employees of the Na25 tional Institutes of Health similar to those services provided
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1 by other Federal agencies (including the availability of day

2 care service on a 24-hour-a-day basis).

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

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

5 into consideration the income and needs of the employee.

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

7 services, the Director of NIH may enter into rental or lease

8 purchase agreements.’’.

9 TITLE III—GENERAL PROVI10 SIONS RESPECTING NA11 TIONAL RESEARCH INSTI12 TUTES

13 SEC. 301. APPOINTMENT AND AUTHORITY OF DIRECTORS

14 OF NATIONAL RESEARCH INSTITUTES.

15 (a) ESTABLISHMENT OF GENERAL AUTHORITY RE16 GARDING DIRECT FUNDING.—

17 (1) IN GENERAL.—Section 405(b)(2) of the Pub18 lic Health Service Act (42 U.S.C. 284(b)(2)) is

19 amended—

20 (A) in subparagraph (A), by striking ‘‘and’’

21 after the semicolon at the end;

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

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

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

25 subparagraph:
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1 ‘‘(C) shall receive from the President and the Of2 fice of Management and Budget directly all funds ap3 propriated by the Congress for obligation and expend4 iture by the Institute.’’.

5 (2) CONFORMING AMENDMENT.—Section

6 413(b)(9) of the Public Health Service Act (42 U.S.C.

7 285a–2(b)(9)) is amended—

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

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

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

11 (b) APPOINTMENT AND DURATION OF TECHNICAL AND

12 SCIENTIFIC PEER REVIEW GROUPS.—Section 405(c) of the

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

14 (1) by amending paragraph (3) to read as fol15 lows:

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

17 council for the Institute and with the approval of the

18 Director of NIH—

19 ‘‘(A) establish technical and scientific peer

20 review groups in addition to those appointed

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

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

23 groups established under subparagraph (A);

24 and’’; and
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1 (2) by adding after and below paragraph (4) the

2 following:

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

4 the duration of a peer review group appointed under para5 graph (3).’’.

6 SEC. 302. PROGRAM OF RESEARCH ON OSTEOPOROSIS,

7 PAGET’S DISEASE, AND RELATED BONE DIS8 ORDERS.

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

10 (42 U.S.C. 284 et seq.), as amended by section 121(b) of

11 Public Law 102–321 (106 Stat. 358), is amended by adding

12 at the end the following new section:

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

14 RELATED BONE DISORDERS

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

16 the National Institute of Arthritis and Musculoskeletal and

17 Skin Diseases, the National Institute on Aging, and the Na18 tional Institute of Diabetes, Digestive and Kidney Diseases,

19 shall expand and intensify the programs of such Institutes

20 with respect to research and related activities concerning

21 osteoporosis, Paget’s disease, and related bone disorders.

22 ‘‘(b) COORDINATION.—The Directors referred to in sub23 section (a) shall jointly coordinate the programs referred

24 to in such subsection and consult with the Arthritis and

25 Musculoskeletal Diseases Interagency Coordinating Com26 mittee and the Interagency Task Force on Aging Research.
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1 ‘‘(c) INFORMATION CLEARINGHOUSE.—

2 ‘‘(1) IN GENERAL.—In order to assist in carry3 ing out the purpose described in subsection (a), the

4 Director of NIH shall provide for the establishment of

5 an information clearinghouse on osteoporosis and re6 lated bone disorders to facilitate and enhance knowl7 edge and understanding on the part of health profes8 sionals, patients, and the public through the effective

9 dissemination of information.

10 ‘‘(2) ESTABLISHMENT THROUGH GRANT OR CON11 TRACT.—For the purpose of carrying out paragraph

12 (1), the Director of NIH shall enter into a grant, co13 operative agreement, or contract with a nonprofit pri14 vate entity involved in activities regarding the pre15 vention and control of osteoporosis and related bone

16 disorders.

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

18 purpose of carrying out this section, there are authorized

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

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

21 1995 and 1996.’’.

22 SEC. 303. ESTABLISHMENT OF INTERAGENCY PROGRAM

23 FOR TRAUMA RESEARCH.

24 (a) IN GENERAL.—Title XII of the Public Health Serv25 ice Act (42 U.S.C. 300d et seq.), as amended by title VI
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1 of Public Law 102–321 (106 Stat. 433) and section 304

2 of Public Law 102–408 (106 Stat. 2084), is amended by

3 adding at the end the following part:

4 ‘‘PART F—INTERAGENCY PROGRAM FOR TRAUMA

5 RESEARCH

6 ‘‘SEC. 1261. ESTABLISHMENT OF PROGRAM.

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

8 Director of the National Institutes of Health (hereafter in

9 this section referred to as the ‘Director’), shall establish a

10 comprehensive program of conducting basic and clinical re11 search on trauma (hereafter in this section referred to as

12 the ‘Program’). The Program shall include research regard13 ing the diagnosis, treatment, rehabilitation, and general

14 management of trauma.

15 ‘‘(b) PLAN FOR PROGRAM.—

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

17 with the Trauma Research Interagency Coordinating

18 Committee established under subsection (g), shall es19 tablish and implement a plan for carrying out the ac20 tivities of the Program, including the activities de21 scribed in subsection (d). All such activities shall be

22 carried out in accordance with the plan. The plan

23 shall be periodically reviewed, and revised as appro24 priate.
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1 ‘‘(2) SUBMISSION TO CONGRESS.—Not later than

2 June 1, 1993, the Director shall submit the plan re3 quired in paragraph (1) to the Committee on Energy

4 and Commerce of the House of Representatives, and

5 to the Committee on Labor and Human Resources of

6 the Senate, together with an estimate of the funds

7 needed for each of the fiscal years 1994 through 1996

8 to implement the plan.

9 ‘‘(c) PARTICIPATING AGENCIES; COORDINATION AND

10 COLLABORATION.—The Director—

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

12 under the Program by the Directors of the agencies of

13 the National Institutes of Health involved in research

14 with respect to trauma;

15 ‘‘(2) shall ensure that the activities of the Pro16 gram are coordinated among such agencies; and

17 ‘‘(3) shall, as appropriate, provide for collabora18 tion among such agencies in carrying out such activi19 ties.

20 ‘‘(d) CERTAIN ACTIVITIES OF PROGRAM.—The Pro21 gram shall include—

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

23 care, including prehospital, resuscitation, surgical

24 intervention, critical care, infection control, wound
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1 healing, nutritional care and support, and medical

2 rehabilitation care;

3 ‘‘(2) basic and clinical research regarding the re4 sponse of the body to trauma and the acute treatment

5 and medical rehabilitation of individuals who are the

6 victims of trauma; and

7 ‘‘(3) basic and clinical research regarding trau8 ma care for pediatric and geriatric patients.

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

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

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

12 to public and nonprofit entities, including designated trau13 ma centers.

14 ‘‘(f) RESOURCES.—The Director shall assure the avail15 ability of appropriate resources to carry out the Program,

16 including the plan established under subsection (b) (includ17 ing the activities described in subsection (d)).

18 ‘‘(g) COORDINATING COMMITTEE.—

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

20 Trauma Research Interagency Coordinating Commit21 tee (hereafter in this section referred to as the ‘Coordi22 nating Committee’).

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

24 shall make recommendations regarding—
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1 ‘‘(A) the activities of the Program to be car2 ried out by each of the agencies represented on

3 the Committee and the amount of funds needed

4 by each of the agencies for such activities; and

5 ‘‘(B) effective collaboration among the agen6 cies in carrying out the activities.

7 ‘‘(3) COMPOSITION.—The Coordinating Commit8 tee shall be composed of the Directors of each of the

9 agencies that, under subsection (c), have responsibil10 ities under the Program, and any other individuals

11 who are practitioners in the trauma field as des12 ignated by the Director of the National Institutes of

13 Health.

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

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

16 meaning given such term in section 1231(1).

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

18 the National Institutes of Health.

19 ‘‘(3) The term ‘trauma’ means any serious in20 jury that could result in loss of life or in significant

21 disability and that would meet pre-hospital triage

22 criteria for transport to a designated trauma center.’’.

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

24 Public Health Service Act, as amended by section 209(c)
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1 of this Act, is amended by adding at the end the following

2 new subsection:

3 ‘‘(k) The Director of NIH shall carry out the program

4 established in part E of title XII (relating to interagency

5 research on trauma).’’.

6 TITLE IV—NATIONAL CANCER

7 INSTITUTE

8 SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVI9 TIES REGARDING BREAST CANCER.

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

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

12 at the end the following new section:

13 ‘‘BREAST AND GYNECOLOGICAL CANCERS

14 ‘‘SEC. 417. (a) EXPANSION AND COORDINATION OF AC15 TIVITIES.—The Director of the Institute, in consultation

16 with the National Cancer Advisory Board, shall expand,

17 intensify, and coordinate the activities of the Institute with

18 respect to research on breast cancer, ovarian cancer, and

19 other cancers of the reproductive system of women.

20 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.—The

21 Director of the Institute shall coordinate the activities of

22 the Director under subsection (a) with similar activities

23 conducted by other national research institutes and agencies

24 of the National Institutes of Health to the extent that such

25 Institutes and agencies have responsibilities that are related
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1 to breast cancer and other cancers of the reproductive sys2 tem of women.

3 ‘‘(c) PROGRAMS FOR BREAST CANCER.—

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

5 (a), the Director of the Institute shall conduct or sup6 port research to expand the understanding of the

7 cause of, and to find a cure for, breast cancer. Activi8 ties under such subsection shall provide for an expan9 sion and intensification of the conduct and support

10 of—

11 ‘‘(A) basic research concerning the etiology

12 and causes of breast cancer;

13 ‘‘(B) clinical research and related activities

14 concerning the causes, prevention, detection and

15 treatment of breast cancer;

16 ‘‘(C) control programs with respect to breast

17 cancer in accordance with section 412, including

18 community-based programs designed to assist

19 women who are members of medically under20 served populations, low-income populations, or

21 minority groups;

22 ‘‘(D) information and education programs

23 with respect to breast cancer in accordance with

24 section 413; and
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1 ‘‘(E) research and demonstration centers

2 with respect to breast cancer in accordance with

3 section 414, including the development and oper4 ation of centers for breast cancer research to

5 bring together basic and clinical, biomedical and

6 behavioral scientists to conduct basic, clinical,

7 epidemiological, psychosocial, prevention and

8 treatment research and related activities on

9 breast cancer.

10 Not less than six centers shall be operated under sub11 paragraph (E). Activities of such centers should in12 clude supporting new and innovative research and

13 training programs for new researchers. Such centers

14 shall give priority to expediting the transfer of re15 search advances to clinical applications.

16 ‘‘(2) IMPLEMENTATION OF PLAN FOR PRO17 GRAMS.—

18 ‘‘(A) The Director of the Institute shall en19 sure that the research programs described in

20 paragraph (1) are implemented in accordance

21 with a plan for the programs. Such plan shall

22 include comments and recommendations that the

23 Director of the Institute considers appropriate,

24 with due consideration provided to the profes25 sional judgment needs of the Institute as ex-
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1 pressed in the annual budget estimate prepared

2 in accordance with section 413(9). The Director

3 of the Institute, in consultation with the Na4 tional Cancer Advisory Board, shall periodically

5 review and revise such plan.

6 ‘‘(B) Not later than May 1, 1993, the Direc7 tor of the Institute shall submit a copy of the

8 plan to the President’s Cancer Panel, the Sec9 retary and the Director of NIH.

10 ‘‘(C) The Director of the Institute shall sub11 mit any revisions of the plan to the President’s

12 Cancer Panel, the Secretary, and the Director of

13 NIH.

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

15 the plan submitted under subparagraph (A), and

16 any revisions submitted under subparagraph

17 (C), to the Committee on Energy and Commerce

18 of the House of Representatives and the Commit19 tee on Labor and Human Resources of the Sen20 ate.

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

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

23 research on ovarian cancer and other cancers of the repro24 ductive system of women. Activities under such subsection

25 shall provide for the conduct and support of—
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1 ‘‘(1) basic research concerning the etiology and

2 causes of ovarian cancer and other cancers of the re3 productive system of women;

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

5 the causes, prevention, detection and treatment of

6 ovarian cancer and other cancers of the reproductive

7 system of women;

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

9 cancer and other cancers of the reproductive system of

10 women in accordance with section 412;

11 ‘‘(4) information and education programs with

12 respect to ovarian cancer and other cancers of the re13 productive system of women in accordance with sec14 tion 413; and

15 ‘‘(5) research and demonstration centers with re16 spect to ovarian cancer and cancers of the reproduc17 tive system in accordance with section 414.

18 ‘‘(e) REPORT.—The Director of the Institute shall pre19 pare, for inclusion in the biennial report submitted under

20 section 407, a report that describes the activities of the Na21 tional Cancer Institute under the research programs re22 ferred to in subsection (a), that shall include—

23 ‘‘(1) a description of the research plan with re24 spect to breast cancer prepared under subsection (c);
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1 ‘‘(2) an assessment of the development, revision,

2 and implementation of such plan;

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

4 made, during the period for which such report is pre5 pared, in the research programs on breast cancer and

6 cancers of the reproductive system of women;

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

8 made, during the period for which such report is

9 made, for activities with respect to breast cancer and

10 cancers of the reproductive system of women con11 ducted and supported by the National Institutes of

12 Health; and

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

14 Director considers appropriate.’’.

15 SEC. 402. EXPANSION AND INTENSIFICATION OF ACTIVI16 TIES REGARDING PROSTATE CANCER.

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

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

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

20 ‘‘PROSTATE CANCER

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

22 ACTIVITIES.—The Director of the Institute, in consultation

23 with the National Cancer Advisory Board, shall expand,

24 intensify, and coordinate the activities of the Institute with

25 respect to research on prostate cancer.
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1 ‘‘(b) COORDINATION WITH OTHER INSTITUTES.—The

2 Director of the Institute shall coordinate the activities of

3 the Director under subsection (a) with similar activities

4 conducted by other national research institutes and agencies

5 of the National Institutes of Health to the extent that such

6 Institutes and agencies have responsibilities that are related

7 to prostate cancer.

8 ‘‘(c) PROGRAMS.—

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

10 (a), the Director of the Institute shall conduct or sup11 port research to expand the understanding of the

12 cause of, and to find a cure for, prostate cancer. Ac13 tivities under such subsection shall provide for an ex14 pansion and intensification of the conduct and sup15 port of—

16 ‘‘(A) basic research concerning the etiology

17 and causes of prostate cancer;

18 ‘‘(B) clinical research and related activities

19 concerning the causes, prevention, detection and

20 treatment of prostate cancer;

21 ‘‘(C) prevention and control and early de22 tection programs with respect to prostate cancer

23 in accordance with section 412, particularly as

24 it relates to intensifying research on the role of
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1 prostate specific antigen for the screening and

2 early detection of prostate cancer;

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

4 the direction of the Director of the Institute, to

5 provide coordination between relevant National

6 Institutes of Health components of research ef7 forts on prostate cancer;

8 ‘‘(E) control programs with respect to pros9 tate cancer in accordance with section 412;

10 ‘‘(F) information and education programs

11 with respect to prostate cancer in accordance

12 with section 413; and

13 ‘‘(G) research and demonstration centers

14 with respect to prostate cancer in accordance

15 with section 414, including the development and

16 operation of centers for prostate cancer research

17 to bring together basic and clinical, biomedical

18 and behavioral scientists to conduct basic, clini19 cal, epidemiological, psychosocial, prevention

20 and control, treatment, research, and related ac21 tivities on prostate cancer.

22 Not less than six centers shall be operated under sub23 paragraph (G). Activities of such centers should in24 clude supporting new and innovative research and

25 training programs for new researchers. Such centers
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1 shall give priority to expediting the transfer of re2 search advances to clinical applications.

3 ‘‘(2) IMPLEMENTATION OF PLAN FOR PRO4 GRAMS.—

5 ‘‘(A) The Director of the Institute shall en6 sure that the research programs described in

7 paragraph (1) are implemented in accordance

8 with a plan for the programs. Such plan shall

9 include comments and recommendations that the

10 Director of the Institute considers appropriate,

11 with due consideration provided to the profes12 sional judgment needs of the Institute as ex13 pressed in the annual budget estimate prepared

14 in accordance with section 413(9). The Director

15 of the Institute, in consultation with the Na16 tional Cancer Advisory Board, shall periodically

17 review and revise such plan.

18 ‘‘(B) Not later than May 1, 1993, the Direc19 tor of the Institute shall submit a copy of the

20 plan to the President’s Cancer Panel, the Sec21 retary and the Director of NIH.

22 ‘‘(C) The Director of the Institute shall sub23 mit any revisions of the plan to the President’s

24 Cancer Panel, the Secretary, and the Director of

25 NIH.
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1 ‘‘(D) The Secretary shall provide a copy of

2 the plan submitted under subparagraph (A), and

3 any revisions submitted under subparagraph

4 (C), to the Committee on Energy and Commerce

5 of the House of Representatives and the Commit6 tee on Labor and Human Resources of the Sen7 ate.’’.

8 SEC. 403. AUTHORIZATION OF APPROPRIATIONS.

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

10 the Public Health Service Act, as amended by section 402

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

12 new section:

13 ‘‘AUTHORIZATION OF APPROPRIATIONS

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

15 purpose of carrying out this subpart, there are authorized

16 to be appropriated $3,200,000,000 for fiscal year 1994, and

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

18 1995 and 1996.

19 ‘‘(b) BREAST CANCER AND GYNECOLOGICAL CAN20 CERS.—

21 ‘‘(1) BREAST CANCER.—

22 ‘‘(A) For the purpose of carrying out sub23 paragraph (A) of section 417(c)(1), there are au24 thorized to be appropriated $225,000,000 for fis25 cal year 1994, and such sums as may be nec26 essary for each of the fiscal years 1995 and 1996.
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1 Such authorizations of appropriations are in ad2 dition to the authorizations of appropriations es3 tablished in subsection (a) with respect to such

4 purpose.

5 ‘‘(B) For the purpose of carrying out sub6 paragraphs (B) through (E) of section 417(c)(1),

7 there are authorized to be appropriated

8 $100,000,000 for fiscal year 1994, and such sums

9 as may be necessary for each of the fiscal years

10 1995 and 1996. Such authorizations of appro11 priations are in addition to the authorizations of

12 appropriations established in subsection (a) with

13 respect to such purpose.

14 ‘‘(2) OTHER CANCERS.—For the purpose of car15 rying out subsection (d) of section 417, there are au16 thorized to be appropriated $75,000,000 for fiscal

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

18 of the fiscal years 1995 and 1996. Such authoriza19 tions of appropriations are in addition to the author20 izations of appropriations established in subsection

21 (a) with respect to such purpose.

22 ‘‘(c) PROSTATE CANCER.—For the purpose of carrying

23 out section 417A, there are authorized to be appropriated

24 $72,000,000 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 Such authorizations of appropriations are in addition to

2 the authorizations of appropriations established in sub3 section (a) with respect to such purpose.

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

5 ‘‘(1) IN GENERAL.—Of the amounts appro6 priated for the National Cancer Institute for a fiscal

7 year, the Director of the Institute shall make available

8 not less than the applicable percentage specified in

9 paragraph (2) for carrying out the cancer control ac10 tivities authorized in section 412 and for which budg11 et estimates are made under section 413(b)(9) for the

12 fiscal year.

13 ‘‘(2) APPLICABLE PERCENTAGE.—The percentage

14 referred to in paragraph (1) is—

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

16 1994;

17 ‘‘(B) 9 percent, in the case of fiscal year

18 1995; and

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

20 1996 and each subsequent fiscal year.’’.

21 (b) CONFORMING AMENDMENTS.—

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

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

24 (A) by striking subsection (a);
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1 (B) by redesignating subsection (b) as sub2 section (a);

3 (C) by redesignating paragraph (5) of sub4 section (a) (as so redesignated) as subsection (b);

5 and

6 (D) by amending the heading for the section

7 to read as follows:

8 ‘‘CERTAIN USES OF FUNDS’’.

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

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

11 amended by striking ‘‘section 408(b)(1)’’ and insert12 ing ‘‘section 408(a)(1)’’.

13 TITLE V—NATIONAL HEART,

14 LUNG, AND BLOOD INSTITUTE

15 SEC. 501. EDUCATION AND TRAINING.

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

17 U.S.C. 285b–3(b)) is amended—

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

19 semicolon at the end;

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

21 the end and inserting ‘‘; and’’; and

22 (3) by inserting after paragraph (4) the follow23 ing new paragraph:

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

25 council for the Institute, conduct appropriate intra26 mural training and education programs, including
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1 continuing education and laboratory and clinical re2 search training programs.’’.

3 SEC. 502. CENTERS FOR THE STUDY OF PEDIATRIC CARDIO4 VASCULAR DISEASES.

5 Section 422(a)(1) of the Public Health Service Act (42

6 U.S.C. 285b–4(a)(1)) is amended—

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

8 the end;

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

10 and inserting ‘‘; and’’; and

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

12 new subparagraph:

13 ‘‘(D) three centers for basic and clinical research

14 into, training in, and demonstration of, advanced di15 agnostic, prevention, and treatment (including genetic

16 studies, intrauterine environment studies, postnatal

17 studies, heart arrhythmias, and acquired heart dis18 ease and preventive cardiology) for cardiovascular

19 diseases in children.’’.

20 SEC. 503. NATIONAL CENTER ON SLEEP DISORDERS.

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

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

23 at the end the following new section:

24 ‘‘NATIONAL CENTER ON SLEEP DISORDERS

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

26 of the enactment of the National Institutes of Health Revi-
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1 talization Act of 1993, the Director of the Institute shall

2 establish the National Center on Sleep Disorders (in this

3 section referred to as the ‘Center’). The Center shall be head4 ed by a director, who shall be appointed by the Director

5 of the Institute.

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

7 and support of research, training, health information dis8 semination, and other activities with respect to sleep dis9 orders.

10 ‘‘(c) The Director of the Center may coordinate the ac11 tivities of the Center with similar activities of other agen12 cies of the Federal Government, including the other agencies

13 of the National Institutes of Health, and with similar ac14 tivities of other public entities and of private entities.’’.

15 SEC. 504. AUTHORIZATION OF APPROPRIATIONS.

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

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

18 amended by adding at the end the following section:

19 ‘‘AUTHORIZATION OF APPROPRIATIONS

20 ‘‘SEC. 425. For the purpose of carrying out this sub21 part, there are authorized to be appropriated

22 $1,500,000,000 for fiscal year 1994, and such sums as may

23 be necessary for each of the fiscal years 1995 and 1996.’’.
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1 TITLE VI—NATIONAL INSTITUTE

2 ON DIABETES AND DIGESTIVE

3 AND KIDNEY DISEASES

4 SEC. 601. PROVISIONS REGARDING NUTRITIONAL DIS5 ORDERS.

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

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

8 at the end the following new section:

9 ‘‘NUTRITIONAL DISORDERS PROGRAM

10 ‘‘SEC. 434. (a) The Director of the Institute, in con11 sultation with the Director of NIH, shall establish a pro12 gram of conducting and supporting research, training,

13 health information dissemination, and other activities with

14 respect to nutritional disorders, including obesity.

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

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

17 and support each of the activities described in such sub18 section.

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

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

21 activities to facilitate and enhance knowledge and under22 standing of nutritional disorders, including obesity, on the

23 part of health professionals, patients, and the public

24 through the effective dissemination of information.’’.
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1 (b) DEVELOPMENT AND EXPANSION OF RESEARCH

2 AND TRAINING CENTERS.—Section 431 of the Public Health

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

4 (1) by redesignating subsection (d) as subsection

5 (e); and

6 (2) by inserting after subsection (c) the following

7 new subsection:

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

9 the extent of amounts made available in appropriations

10 Acts, provide for the development or substantial expansion

11 of centers for research and training regarding nutritional

12 disorders, including obesity.

13 ‘‘(2) The Director of the Institute shall carry out para14 graph (1) in collaboration with the Director of the National

15 Cancer Institute and with the Directors of such other agen16 cies of the National Institutes of Health as the Director of

17 NIH determines to be appropriate.

18 ‘‘(3) Each center developed or expanded under para19 graph (1) shall—

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

21 or be formed from a consortium of cooperating insti22 tutions, meeting such research and training qualifica23 tions as may be prescribed by the Director;

24 ‘‘(B) conduct basic and clinical research into the

25 cause, diagnosis, early detection, prevention, control
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1 and treatment of nutritional disorders, including obe2 sity and the impact of nutrition and diet on child de3 velopment;

4 ‘‘(C) conduct training programs for physicians

5 and allied health professionals in current methods of

6 diagnosis and treatment of such diseases and com7 plications, and in research in such disorders; and

8 ‘‘(D) conduct information programs for physi9 cians and allied health professionals who provide pri10 mary care for patients with such disorders or com11 plications.’’.

12 TITLE VII—NATIONAL INSTI13 TUTE ON ARTHRITIS AND

14 MUSCULOSKELETAL AND

15 SKIN DISEASES

16 SEC. 701. JUVENILE ARTHRITIS.

17 (a) PURPOSE.—Section 435 of the Public Health Serv18 ice Act (42 U.S.C. 285d) is amended by striking ‘‘and other

19 programs’’ and all that follows and inserting the following:

20 ‘‘and other programs with respect to arthritis and musculo21 skeletal and skin diseases (including sports-related dis22 orders), with particular attention to the effect of these dis23 eases on children.’’.

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

25 amended—
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1 (1) in subsection (a), by inserting after the sec2 ond sentence, the following: ‘‘The plan shall place

3 particular emphasis upon expanding research into

4 better understanding the causes and the development

5 of effective treatments for arthritis affecting chil6 dren.’’; and

7 (2) in subsection (b)—

8 (A) by striking ‘‘and’’ at the end of para9 graph (3);

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

11 paragraph (4) and inserting ‘‘; and’’; and

12 (C) by adding at the end thereof the follow13 ing new paragraph:

14 ‘‘(5) research into the causes of arthritis affecting

15 children and the development, trial, and evaluation of

16 techniques, drugs and devices used in the diagnosis,

17 treatment (including medical rehabilitation), and

18 prevention of arthritis in children.’’.

19 (c) CENTERS.—Section 441 of the Public Health Serv20 ice Act (42 U.S.C. 286d–6) is amended by adding at the

21 end thereof the following new subsection:

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

23 establish a multipurpose arthritis and musculoskeletal dis24 ease center for the purpose of expanding the level of research

25 into the cause, diagnosis, early detection, prevention, con-
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1 trol, and treatment of, and rehabilitation of children with

2 arthritis and musculoskeletal diseases.’’.

3 (d) ADVISORY BOARD.—

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

5 Service Act (42 U.S.C. 285d–7(a)) is amended by in6 serting after ‘‘Arthritis’’ the following: ‘‘and Musculo7 skeletal and Skin Diseases’’.

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

9 Health Service Act (42 U.S.C. 285d–7(b)) is amend10 ed—

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

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

13 and

14 (B) in paragraph (1)(B)—

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

16 ‘‘eight’’; and

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

18 that follows and inserting the following:

19 ‘‘including one member who is a person who

20 has such a disease, one person who is the

21 parent of an adult with such a disease, and

22 two members who are parents of children

23 with arthritis.’’.
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1 (3) ANNUAL REPORT.—Section 442(j) of the Pub2 lic Health Service Act (42 U.S.C. 285d–7(j)) is

3 amended—

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

5 (3);

6 (2) by striking the period at the end of para7 graph (4) and inserting ‘‘; and’’; and

8 (3) by adding at the end the following para9 graph:

10 ‘‘(5) contains recommendations for expanding

11 the Institute’s funding of research directly applicable

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

13 control, and treatment of, and rehabilitation of chil14 dren with arthritis and musculoskeletal diseases.’’.

15 TITLE VIII—NATIONAL

16 INSTITUTE ON AGING

17 SEC. 801. ALZHEIMER’S DISEASE REGISTRY.

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

19 (99 Stat. 885) is—

20 (1) transferred to subpart 5 of part C of title IV

21 of the Public Health Service Act (42 U.S.C. 285e et

22 seq.);

23 (2) redesignated as section 445G; and

24 (3) inserted after section 445F of such Act.
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1 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

2 Section 445G of the Public Health Service Act, as trans3 ferred and inserted by subsection (a) of this section, is

4 amended—

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

6 follows through ‘‘may make a grant’’ in subsection (a)

7 and inserting the following:

8 ‘‘ALZHEIMER’S DISEASE REGISTRY

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

10 Institute may make a grant’’; and

11 (2) by striking subsection (c).

12 SEC. 802. AGING PROCESSES REGARDING WOMEN.

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

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

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

16 ‘‘AGING PROCESSES REGARDING WOMEN

17 ‘‘SEC. 445H. The Director of the Institute, in addition

18 to other special functions specified in section 444 and in

19 cooperation with the Directors of the other national research

20 institutes and agencies of the National Institutes of Health,

21 shall conduct research into the aging processes of women,

22 with particular emphasis given to the effects of menopause

23 and the physiological and behavioral changes occurring

24 during the transition from pre- to post-menopause, and into

25 the diagnosis, disorders, and complications related to aging

26 and loss of ovarian hormones in women.’’.
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1 SEC. 803. AUTHORIZATION OF APPROPRIATIONS.

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

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

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

5 ‘‘AUTHORIZATION OF APPROPRIATIONS

6 ‘‘SEC. 445I. For the purpose of carrying out this sub7 part, there are authorized to be appropriated $500,000,000

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

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

10 SEC. 804. CONFORMING AMENDMENT.

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

12 U.S.C. 285e–5), as amended by section 9 of Public Law

13 102-507 (106 Stat. 3287), is amended—

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

15 inserting after ‘‘Council’’ the following: ‘‘on Alz16 heimer’s Disease (hereafter in this section referred to

17 as the ‘Council’)’’; and

18 (2) by adding at the end the following new sub19 section:

20 ‘‘(e) For purposes of this section, the term ‘Council on

21 Alzheimer’s Disease’ means the council established in sec22 tion 911(a) of Public Law 99–660.’’.
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1 TITLE IX—NATIONAL INSTITUTE

2 OF ALLERGY AND INFEC3 TIOUS DISEASES

4 SEC. 901. TROPICAL DISEASES.

5 Section 446 of the Public Health Service Act (42

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

7 following: ‘‘, including tropical diseases’’.

8 SEC. 902. CHRONIC FATIGUE SYNDROME.

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

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

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

12 ‘‘RESEARCH CENTERS REGARDING CHRONIC FATIGUE

13 SYNDROME

14 ‘‘SEC. 447. (a) The Director of the Institute, after con15 sultation with the advisory council for the Institute, may

16 make grants to, or enter into contracts with, public or non17 profit private entities for the development and operation of

18 centers to conduct basic and clinical research on chronic

19 fatigue syndrome.

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

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

22 consortium of cooperating institutions, meeting such re23 quirements as may be prescribed by the Director of the In24 stitute.’’.
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1 (b) EXTRAMURAL STUDY SECTION.—Not later than 6

2 months after the date of enactment of this Act, the Secretary

3 of Health and Human Services shall establish an extra4 mural study section for chronic fatigue syndrome research.

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

6 Human Services, acting through the Director of the Na7 tional Institutes of Health, shall ensure that appropriate

8 individuals with expertise in chronic fatigue syndrome or

9 neuromuscular diseases and representative of a variety of

10 disciplines and fields within the research community are

11 appointed to appropriate National Institutes of Health ad12 visory committees and boards.

13 TITLE X—NATIONAL INSTITUTE

14 OF CHILD HEALTH AND

15 HUMAN DEVELOPMENT

16 Subtitle A—Research Centers With

17 Respect to Contraception and

18 Research Centers With Respect

19 to Infertility

20 SEC. 1001. GRANTS AND CONTRACTS FOR RESEARCH CEN21 TERS.

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

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

24 613, is amended by adding at the end the following new

25 section:
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1 ‘‘RESEARCH CENTERS WITH RESPECT TO CONTRACEPTION

2 AND INFERTILITY

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

4 consultation with the advisory council for the Institute,

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

6 or nonprofit private entities for the development and oper7 ation of centers to conduct activities for the purpose of im8 proving methods of contraception and centers to conduct ac9 tivities for the purpose of improving methods of diagnosis

10 and treatment of infertility.

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

12 Institute shall, subject to the extent of amounts made avail13 able in appropriations Acts, provide for the establishment

14 of three centers with respect to contraception and for two

15 centers with respect to infertility.

16 ‘‘(c)(1) Each center assisted under this section shall,

17 in carrying out the purpose of the center involved—

18 ‘‘(A) conduct clinical and other applied research,

19 including—

20 ‘‘(i) for centers with respect to contracep21 tion, clinical trials of new or improved drugs

22 and devices for use by males and females (in23 cluding barrier methods); and

24 ‘‘(ii) for centers with respect to infertility,

25 clinical trials of new or improved drugs and de-
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1 vices for the diagnosis and treatment of infertil2 ity in males and females;

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

4 scientists, nurses, and other health and allied health

5 professionals;

6 ‘‘(C) conduct training programs for such indi7 viduals;

8 ‘‘(D) develop model continuing education pro9 grams for such professionals; and

10 ‘‘(E) disseminate information to such profes11 sionals and the public.

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

13 (a) to provide stipends for health and allied health profes14 sionals enrolled in programs described in subparagraph (C)

15 of paragraph (1), and to provide fees to individuals serving

16 as subjects in clinical trials conducted under such para17 graph.

18 ‘‘(d) The Director of the Institute shall, as appropriate,

19 provide for the coordination of information among the cen20 ters assisted under this section.

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

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

23 consortium of cooperating institutions, meeting such re24 quirements as may be prescribed by the Director of the In25 stitute.
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1 ‘‘(f) Support of a center under subsection (a) may be

2 for a period not exceeding 5 years. Such period may be ex3 tended for one or more additional periods not exceeding 5

4 years if the operations of such center have been reviewed

5 by an appropriate technical and scientific peer review

6 group established by the Director and if such group has rec7 ommended to the Director that such period should be ex8 tended.

9 ‘‘(g) For the purpose of carrying out this section, there

10 are authorized to be appropriated $30,000,000 for fiscal

11 year 1994, and such sums as may be necessary for each

12 of the fiscal years 1995 and 1996.’’.

13 SEC. 1002. LOAN REPAYMENT PROGRAM FOR RESEARCH

14 WITH RESPECT TO CONTRACEPTION AND IN15 FERTILITY.

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

17 as redesignated by section 141(a)(2) of this Act, is amended

18 by inserting after section 487A the following section:

19 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH

20 RESPECT TO CONTRACEPTION AND INFERTILITY

21 ‘‘SEC. 487B. (a) The Secretary, in consultation with

22 the Director of the National Institute of Child Health and

23 Human Development, shall establish a program of entering

24 into agreements with qualified health professionals (includ25 ing graduate students) under which such health profes26 sionals agree to conduct research with respect to contracep-
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1 tion, or with respect to infertility, in consideration of the

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

3 service, not more than $20,000 of the principal and interest

4 of the educational loans of such health professionals.

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

6 shall apply to the program established in subsection (a) to

7 the same extent and in the same manner as such provisions

8 apply to the National Health Service Corps Loan Repay9 ment Program established in subpart III of part D of title

10 III.

11 ‘‘(c) Amounts appropriated for carrying out this sec12 tion shall remain available until the expiration of the sec13 ond fiscal year beginning after the fiscal year for which

14 the amounts were appropriated.’’.

15 Subtitle B—Program Regarding

16 Obstetrics and Gynecology

17 SEC. 1011. ESTABLISHMENT OF PROGRAM.

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

19 Service Act, as amended by section 1001 of this Act, is

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

21 ‘‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY

22 ‘‘SEC. 452B. The Director of the Institute shall estab23 lish and maintain within the Institute an intramural lab24 oratory and clinical research program in obstetrics and

25 gynecology.’’.
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1 Subtitle C—Child Health Research

2 Centers

3 SEC. 1021. ESTABLISHMENT OF CENTERS.

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

5 Service Act, as amended by section 1011 of this Act, is

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

7 ‘‘CHILD HEALTH RESEARCH CENTERS

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

9 and support centers for conducting research with respect to

10 child health. Such centers shall give priority to the expedi11 tious transfer of advances from basic science to clinical ap12 plications and improving the care of infants and children.’’.

13 Subtitle D—Study Regarding

14 Adolescent Health

15 SEC. 1031. PROSPECTIVE LONGITUDINAL STUDY.

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

17 Service Act, as amended by section 1021 of this Act, is

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

19 ‘‘PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT

20 HEALTH

21 ‘‘SEC. 452D. (a) IN GENERAL.—Not later than October

22 1, 1993, the Director of the Institute shall commence a study

23 for the purpose of providing information on the general

24 health and well-being of adolescents in the United States,
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1 including, with respect to such adolescents, information

2 on—

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

4 behaviors that are detrimental to health; and

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

6 to the communities in which the adolescents reside.

7 ‘‘(b) DESIGN OF STUDY.—

8 ‘‘(1) IN GENERAL.—The study required in sub9 section (a) shall be a longitudinal study in which a

10 substantial number of adolescents participate as sub11 jects. With respect to the purpose described in such

12 subsection, the study shall monitor the subjects

13 throughout the period of the study to determine the

14 health status of the subjects and any change in such

15 status over time.

16 ‘‘(2) POPULATION-SPECIFIC ANALYSES.—The

17 study required in subsection (a) shall be conducted

18 with respect to the population of adolescents who are

19 female, the population of adolescents who are male,

20 various socioeconomic populations of adolescents, and

21 various racial and ethnic populations of adolescents.

22 The study shall be designed and conducted in a man23 ner sufficient to provide for a valid analysis of wheth24 er there are significant differences among such popu25 lations in health status and whether and to what ex-
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1 tent any such differences are due to factors particular

2 to the populations involved.

3 ‘‘(c) COORDINATION WITH WOMEN’S HEALTH INITIA4 TIVE.—With respect to the national study of women being

5 conducted by the Secretary and known as the Women’s

6 Health Initiative, the Secretary shall ensure that such study

7 is coordinated with the component of the study required in

8 subsection (a) that concerns adolescent females, including

9 coordination in the design of the 2 studies.’’.

10 TITLE XI—NATIONAL EYE

11 INSTITUTE

12 SEC. 1101. CLINICAL RESEARCH ON DIABETES EYE CARE.

13 (a) IN GENERAL.—Subpart 9 of part C of title IV of

14 the Public Health Service Act (42 U.S.C. 285i) is amended

15 by adding at the end the following new section:

16 ‘‘CLINICAL RESEARCH ON EYE CARE AND DIABETES

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

18 of the Institute, in consultation with the advisory council

19 for the Institute, may award not more than three grants

20 for the establishment and support of centers for clinical re21 search on eye care for individuals with diabetes.

22 ‘‘(b) AUTHORIZED EXPENDITURES.—The purposes for

23 which a grant under subsection (a) may be expended in24 clude equipment for the research described in such sub25 section and the construction and modernization of facilities

26 for such research.’’.
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1 (b) CONFORMING AMENDMENT.—Section 455 of the

2 Public Health Service Act (42 U.S.C. 285i) is amended in

3 the second sentence by striking ‘‘The Director’’ and insert4 ing ‘‘Subject to section 456, the Director’’.

5 TITLE XII—NATIONAL INSTI6 TUTE OF NEUROLOGICAL DIS7 ORDERS AND STROKE

8 SEC. 1201. RESEARCH ON MULTIPLE SCLEROSIS.

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

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

11 at the end the following new section:

12 ‘‘RESEARCH ON MULTIPLE SCLEROSIS

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

14 and support research on multiple sclerosis, especially re15 search on effects of genetics and hormonal changes on the

16 progress of the disease.’’.

17 TITLE XIII—NATIONAL INSTI18 TUTE OF ENVIRONMENTAL

19 HEALTH SCIENCES

20 SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND TEST21 ING PROGRAM.

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

23 of the Public Health Service Act (42 U.S.C. 285l) is amend24 ed 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 testing

5 regarding toxicology, which program shall be known as the

6 Applied Toxicological Research and Testing Program.

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

8 subsection (a), the Director of the Institute shall, with re9 spect to toxicology, carry out activities—

10 ‘‘(1) to expand knowledge of the health effects of

11 environmental agents;

12 ‘‘(2) to broaden the spectrum of toxicology infor13 mation that is obtained on selected chemicals;

14 ‘‘(3) to develop and validate assays and proto15 cols, including alternative methods that can reduce or

16 eliminate the use of animals in acute or chronic safe17 ty testing;

18 ‘‘(4) to establish criteria for the validation and

19 regulatory acceptance of alternative testing and to

20 recommend a process through which scientifically

21 validated alternative methods can be accepted for reg22 ulatory use;

23 ‘‘(5) to communicate the results of research to

24 government agencies, to medical, scientific, and regu25 latory communities, and to the public; and
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1 ‘‘(6) to integrate related activities of the Depart2 ment of Health and Human Services.’’.

3 (b) TECHNICAL AMENDMENT.—Section 463 of the Pub4 lic Health Service Act (42 U.S.C. 285l) is amended by in5 serting after ‘‘Sciences’’ the following: ‘‘(hereafter in this

6 subpart referred to as the ‘Institute’)’’.

7 SEC. 1302. STUDY OF ENVIRONMENTAL AND OTHER RISKS

8 CONTRIBUTING TO INCIDENCE OF BREAST

9 AND PROSTATE CANCER.

10 (a) IN GENERAL.—The Director of the National Insti11 tute of Environmental Health Sciences (in this section re12 ferred to as the ‘‘Director’’), in collaboration with the Direc13 tor of the National Cancer Institute, shall conduct a case14 controlled study to assess biological markers of environ15 mental and other risk factors contributing to the incidence

16 of breast and prostate cancer in the Counties of Nassau and

17 Suffolk, in the State of New York.

18 (b) CERTAIN ELEMENTS OF STUDY.—Activities of the

19 Director in carrying out the study under subsection (a)

20 shall include the use of a geographic system to evaluate the

21 current and past exposure of individuals, including direct

22 monitoring and cumulative estimates of exposure, to—

23 (1) contaminated drinking water;

24 (2) sources of indoor and ambient air pollution,

25 including emissions from aircraft;
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1 (3) electromagnetic fields;

2 (4) pesticides and other toxic chemicals;

3 (5) hazardous and municipal waste; and

4 (6) such other factors as the Director determines

5 to be appropriate.

6 (c) REPORT.—Not later than 24 months after the date

7 of the enactment of this Act, the Director shall complete the

8 study required in subsection (a) and submit to the Commit9 tee on Energy and Commerce of the House of Representa10 tives, and to the Committee on Labor and Human Re11 sources of the Senate, a report describing the findings made

12 as a result of the study.

13 (d) FUNDING.—Of the amounts appropriated for fiscal

14 years 1994 and 1995 for the National Institute of Environ15 mental Health Sciences and the National Cancer Institute,

16 the Director of the National Institutes of Health shall make

17 available amounts for carrying out the study required in

18 subsection (a).

19 TITLE XIV—NATIONAL LIBRARY

20 OF MEDICINE

21 Subtitle A—General Provisions

22 SEC. 1401. ADDITIONAL AUTHORITIES.

23 (a) IN GENERAL.—Section 465(b) of the Public Health

24 Service Act (42 U.S.C. 286(b)) is amended—
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1 (1) by striking ‘‘and’’ after the semicolon at the

2 end of paragraph (5);

3 (2) by redesignating paragraph (6) as para4 graph (8); and

5 (3) by inserting after paragraph (5) the follow6 ing new paragraphs:

7 ‘‘(6) publicize the availability from the Library

8 of the products and services described in any of para9 graphs (1) through (5);

10 ‘‘(7) promote the use of computers and tele11 communications by health professionals (including

12 health professionals in rural areas) for the purpose of

13 improving access to biomedical information for health

14 care delivery and medical research; and’’.

15 (b) LIMITATION REGARDING GRANTS.—Section

16 474(b)(2) of the Public Health Service Act (42 U.S.C. 286b–

17 S(b)(2)) is amended by striking ‘‘$750,000’’ and inserting

18 ‘‘$1,000,000’’.

19 (c) TECHNICAL AND CONFORMING AMENDMENTS.—

20 (1) REPEAL OF CERTAIN AUTHORITY.—Section

21 215 of the Department of Health and Human Serv22 ices Appropriations Act, 1988, as contained in section

23 101(h) of Public Law 100–202 (101 Stat. 1329–275),

24 is repealed.
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1 (2) APPLICABILITY OF CERTAIN NEW AUTHOR2 ITY.—With respect to the authority established for the

3 National Library of Medicine in section 465(b)(6) of

4 the Public Health Service Act, as added by subsection

5 (a) of this section, such authority shall be effective as

6 if the authority had been established on December 22,

7 1987.

8 SEC. 1402. AUTHORIZATION OF APPROPRIATIONS.

9 (a) ESTABLISHMENT OF SINGLE AUTHORIZATION.—

10 Subpart 1 of part D of title IV of the Public Health Service

11 Act (42 U.S.C. 286 et seq.) is amended by adding at the

12 end the following section:

13 ‘‘AUTHORIZATION OF APPROPRIATIONS

14 ‘‘SEC. 468. (a) For the purpose of carrying out this

15 part, there are authorized to be appropriated $150,000,000

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

17 for each of the fiscal years 1995 and 1996.

18 ‘‘(b) Amounts appropriated under subsection (a) and

19 made available for grants or contracts under any of sections

20 472 through 476 shall remain available until the end of

21 the fiscal year following the fiscal year for which the

22 amounts were appropriated.’’.

23 (b) CONFORMING AMENDMENTS.—Part D of title IV

24 of the Public Health Service Act (42 U.S.C. 286 et seq.)

25 is amended by striking section 469 and section 478(c).
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1 Subtitle B—Financial Assistance

2 SEC. 1411. ESTABLISHMENT OF PROGRAM OF GRANTS FOR

3 DEVELOPMENT OF EDUCATION TECH4 NOLOGIES.

5 Section 473 of the Public Health Service Act (42

6 U.S.C. 286b–4) is amended by adding at the end the follow7 ing new subsection:

8 ‘‘(c)(1) The Secretary shall make grants to public or

9 nonprofit private institutions for the purpose of carrying

10 out projects of research on, and development and dem11 onstration of, new education technologies.

12 ‘‘(2) The purposes for which a grant under paragraph

13 (1) may be made include projects concerning—

14 ‘‘(A) computer-assisted teaching and testing of

15 clinical competence at health professions and research

16 institutions;

17 ‘‘(B) the effective transfer of new information

18 from research laboratories to appropriate clinical ap19 plications;

20 ‘‘(C) the expansion of the laboratory and clinical

21 uses of computer-stored research databases; and

22 ‘‘(D) the testing of new technologies for training

23 health care professionals.
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1 ‘‘(3) The Secretary may not make a grant under para2 graph (1) unless the applicant for the grant agrees to make

3 the projects available with respect to—

4 ‘‘(A) assisting in the training of health profes5 sions students; and

6 ‘‘(B) enhancing and improving the capabilities

7 of health professionals regarding research and teach8 ing.’’.

9 Subtitle C—National Information

10 Center on Health Services Re11 search and Health Care Tech12 nology

13 SEC. 1421. ESTABLISHMENT OF CENTER.

14 Part D of title IV of the Public Health Service Act

15 (42 U.S.C. 286 et seq.) is amended by adding at the end

16 the following new subpart:

17 ‘‘Subpart 4—National Information Center on Health

18 Services Research and Health Care Technology

19 ‘‘NATIONAL INFORMATION CENTER

20 ‘‘SEC. 478A. (a) There is established within the Li21 brary an entity to be known as the National Information

22 Center on Health Services Research and Health Care Tech23 nology (in this section referred to as the ‘Center’).

24 ‘‘(b) The purpose of the Center is the collection, storage,

25 analysis, retrieval, and dissemination of information on
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1 health services research, clinical practice guidelines, and on

2 health care technology, including the assessment of such

3 technology. Such purpose includes developing and main4 taining data bases and developing and implementing meth5 ods of carrying out such purpose.

6 ‘‘(c) The Director of the Center shall ensure that infor7 mation under subsection (b) concerning clinical practice

8 guidelines is collected and maintained electronically and in

9 a convenient format. Such Director shall develop and pub10 lish criteria for the inclusion of practice guidelines and

11 technology assessments in the information center database.

12 ‘‘(d) The Secretary, acting through the Center, shall

13 coordinate the activities carried out under this section

14 through the Center with related activities of the Adminis15 trator for Health Care Policy and Research.’’.

16 SEC. 1422. CONFORMING PROVISIONS.

17 (a) IN GENERAL.—Section 903 of the Public Health

18 Service Act, as amended by section 3 of Public Law 102–

19 410 (106 Stat. 2094), is amended by amending subsection

20 (e) to read as follows:

21 ‘‘(e) REQUIRED INTERAGENCY AGREEMENT.—The Ad22 ministrator and the Director of the National Library of

23 Medicine shall enter into an agreement providing for the

24 implementation of section 478A.’’.
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1 (b) RULE OF CONSTRUCTION.—The amendments made

2 by section 3 of Public Law 102–410 (106 Stat. 2094), by

3 section 1421 of this Act, and by subsection (a) of this section

4 may not be construed as terminating the information center

5 on health care technologies and health care technology as6 sessment established under section 904 of the Public Health

7 Service Act, as in effect on the day before the date of the

8 enactment of Public Law 102–410. Such center shall be con9 sidered to be the center established in section 478A of the

10 Public Health Service Act, as added by section 1421 of this

11 Act, and shall be subject to the provisions of such section

12 478A.

13 TITLE XV—OTHER AGENCIES OF

14 NATIONAL INSTITUTES OF

15 HEALTH

16 Subtitle A—Division of Research

17 Resources

18 SEC. 1501. REDESIGNATION OF DIVISION AS NATIONAL

19 CENTER FOR RESEARCH RESOURCES.

20 Title IV of the Public Health Service Act (42 U.S.C.

21 281 et seq.) is amended—

22 (1) in section 401(b)(2)(B), by amending such

23 subparagraph to read as follows:

24 ‘‘(B) The National Center for Research Re25 sources.’’; and
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1 (2) in part E—

2 (A) in the heading for subpart 1, by strik3 ing ‘‘Division of’’ and inserting ‘‘National Cen4 ter for’’;

5 (B) in section 479, by striking ‘‘the Divi6 sion of Research Resources’’ and inserting the

7 following: ‘‘the National Center for Research Re8 sources (hereafter in this subpart referred to as

9 the ‘Center’)’’;

10 (C) in sections 480 and 481, by striking

11 ‘‘the Division of Research Resources’’ each place

12 such term appears and inserting ‘‘the Center’’;

13 and

14 (D) in sections 480 and 481, as amended by

15 subparagraph (C), by striking ‘‘the Division’’

16 each place such term appears and inserting ‘‘the

17 Center’’.

18 SEC. 1502. BIOMEDICAL AND BEHAVIORAL RESEARCH FA19 CILITIES.

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

21 Service Act (42 U.S.C. 287 et seq.) is amended by adding

22 at the end the following new section:

23 ‘‘BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES

24 ‘‘SEC. 481A. (a) MODERNIZATION AND CONSTRUCTION

25 OF FACILITIES.—
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1 ‘‘(1) IN GENERAL.—The Director of NIH, acting

2 through the Director of the Center, may make grants

3 to public and nonprofit private entities to expand, re4 model, renovate, or alter existing research facilities or

5 construct new research facilities, subject to the provi6 sions of this section.

7 ‘‘(2) CONSTRUCTION AND COST OF CONSTRUC8 TION.—For purposes of this section, the terms

9 ‘construction’ and ‘cost of construction’ include the

10 construction of new buildings and the expansion, ren11 ovation, remodeling, and alteration of existing build12 ings, including architects’ fees, but do not include the

13 cost of acquisition of land or off-site improvements.

14 ‘‘(b) SCIENTIFIC AND TECHNICAL REVIEW BOARDS

15 FOR MERIT-BASED REVIEW OF PROPOSALS.—

16 ‘‘(1) IN GENERAL; APPROVAL AS PRECONDITION

17 TO GRANTS.—

18 ‘‘(A) There is established within the Center

19 a Scientific and Technical Review Board on

20 Biomedical and Behavioral Research Facilities

21 (hereafter referred to in this section as the

22 ‘Board’).

23 ‘‘(B) The Director of the Center may ap24 prove an application for a grant under

25 subsection (a) only if the Board has under para-
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1 graph (2) recommended the application for ap2 proval.

3 ‘‘(2) DUTIES.—

4 ‘‘(A) The Board shall provide advice to the

5 Director of the Center and the advisory council

6 established under section 480 (hereafter in this

7 section referred to as the ‘Advisory Council’) on

8 carrying out this section.

9 ‘‘(B) In carrying out subparagraph (A), the

10 Board shall make a determination of the merit

11 of each application submitted for a grant under

12 subsection (a), after consideration of the require13 ments established in subsection (c), and shall re14 port the results of the determination to the Direc15 tor of the Center and the Advisory Council. Such

16 determinations shall be conducted in a manner

17 consistent with procedures established under sec18 tion 492.

19 ‘‘(C) In carrying out subparagraph (A), the

20 Board shall, in the case of applications rec21 ommended for approval, make recommendations

22 to the Director and the Advisory Council on the

23 amount that should be provided in the grant.

24 ‘‘(D) In carrying out subparagraph (A), the

25 Board shall prepare an annual report for the Di-
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1 rector of the Center and the Advisory Council de2 scribing the activities of the Board in the fiscal

3 year for which the report is made. Each such re4 port shall be available to the public, and shall—

5 ‘‘(i) summarize and analyze expendi6 tures made under this section;

7 ‘‘(ii) provide a summary of the types,

8 numbers, and amounts of applications that

9 were recommended for grants under sub10 section (a) but that were not approved by

11 the Director of the Center; and

12 ‘‘(iii) contain the recommendations of

13 the Board for any changes in the adminis14 tration of this section.

15 ‘‘(3) MEMBERSHIP.—

16 ‘‘(A) Subject to subparagraph (B), the

17 Board shall be composed of 9 appointed mem18 bers, and such ex officio members as the Director

19 of the Center determines to be appropriate.

20 ‘‘(B) Not more than 3 individuals who are

21 officers or employees of the Federal Government

22 may serve as members of the Board.

23 ‘‘(4) CERTAIN REQUIREMENTS REGARDING MEM24 BERSHIP.—In selecting individuals for membership

25 on the Board, the Director of the Center shall ensure
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1 that the members are individuals who, by virtue of

2 their training or experience, are eminently qualified

3 to perform peer review functions. In selecting such in4 dividuals for such membership, the Director of the

5 Center shall ensure that the members of the Board col6 lectively—

7 ‘‘(A) are experienced in the planning, con8 struction, financing, and administration of enti9 ties that conduct biomedical or behavioral re10 search sciences;

11 ‘‘(B) are knowledgeable in making deter12 minations of the need of entities for biomedical

13 or behavioral research facilities, including such

14 facilities for the dentistry, nursing, pharmacy,

15 and allied health professions;

16 ‘‘(C) are knowledgeable in evaluating the

17 relative priorities for applications for grants

18 under subsection (a) in view of the overall re19 search needs of the United States; and

20 ‘‘(D) are experienced with emerging centers

21 of excellence, as described in subsection (c)(3).

22 ‘‘(5) CERTAIN AUTHORITIES.—

23 ‘‘(A) In carrying out paragraph (2), the

24 Board may convene workshops and conferences,
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1 and collect data as the Board considers appro2 priate.

3 ‘‘(B) In carrying out paragraph (2), the

4 Board may establish subcommittees within the

5 Board. Such subcommittees may hold meetings

6 as determined necessary to enable the sub7 committee to carry out its duties.

8 ‘‘(6) TERMS.—

9 ‘‘(A) Except as provided in subparagraph

10 (B), each appointed member of the Board shall

11 hold office for a term of 4 years. Any member

12 appointed to fill a vacancy occurring prior to

13 the expiration of the term for which such mem14 ber’s predecessor was appointed shall be ap15 pointed for the remainder of the term of the

16 predecessor.

17 ‘‘(B) Of the initial members appointed to

18 the Board (as specified by the Director of the

19 Center when making the appointments)—

20 ‘‘(i) 3 shall hold office for a term of 3

21 years;

22 ‘‘(ii) 3 shall hold office for a term of 2

23 years; and

24 ‘‘(iii) 3 shall hold office for a term of

25 1 year.
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1 ‘‘(C) No member is eligible for reappoint2 ment to the Board until 1 year has elapsed after

3 the end of the most recent term of the member.

4 ‘‘(7) COMPENSATION.—Members of the Board

5 who are not officers or employees of the United States

6 shall receive for each day the members are engaged in

7 the performance of the functions of the Board com8 pensation at the same rate received by members of

9 other national advisory councils established under

10 this title.

11 ‘‘(c) REQUIREMENTS FOR GRANTS.—

12 ‘‘(1) IN GENERAL.—The Director of the Center

13 may make a grant under subsection (a) only if the

14 applicant for the grant meets the following conditions:

15 ‘‘(A) The applicant is determined by such

16 Director to be competent to engage in the type of

17 research for which the proposed facility is to be

18 constructed.

19 ‘‘(B) The applicant provides assurances sat20 isfactory to the Director that—

21 ‘‘(i) for not less than 20 years after

22 completion of the construction, the facility

23 will be used for the purposes of research for

24 which it is to be constructed;
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1 ‘‘(ii) sufficient funds will be available

2 to meet the non-Federal share of the cost of

3 constructing the facility;

4 ‘‘(iii) sufficient funds will be available,

5 when construction is completed, for the ef6 fective use of the facility for the research for

7 which it is being constructed; and

8 ‘‘(iv) the proposed construction will ex9 pand the applicant’s capacity for research,

10 or is necessary to improve or maintain the

11 quality of the applicant’s research.

12 ‘‘(C) The applicant meets reasonable quali13 fications established by the Director with respect

14 to—

15 ‘‘(i) the relative scientific and technical

16 merit of the applications, and the relative

17 effectiveness of the proposed facilities, in ex18 panding the capacity for biomedical or be19 havioral research and in improving the

20 quality of such research;

21 ‘‘(ii) the quality of the research or

22 training, or both, to be carried out in the

23 facilities involved;

24 ‘‘(iii) the need of the applicant for such

25 facilities in order to maintain or expand
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1 the applicant’s research and training mis2 sion;

3 ‘‘(iv) the congruence of the research ac4 tivities to be carried out within the facility

5 with the research and investigator man6 power needs of the United States; and

7 ‘‘(v) the age and condition of existing

8 research facilities and equipment.

9 ‘‘(D) The applicant has demonstrated a

10 commitment to enhancing and expanding the re11 search productivity of the applicant.

12 ‘‘(2) CONSIDERATION OF CERTAIN FACTORS.—In

13 making grants under subsection (a), the Director of

14 the Center may, in addition to the requirements es15 tablished in paragraph (1), consider the following fac16 tors:

17 ‘‘(A) To what extent the applicant has the

18 capacity to broaden the scope of research and re19 search training programs of the applicant by

20 promoting—

21 ‘‘(i) interdisciplinary research;

22 ‘‘(ii) research on emerging technologies,

23 including those involving novel analytical

24 techniques or computational methods; or
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1 ‘‘(iii) other novel research mechanisms

2 or programs.

3 ‘‘(B) To what extent the applicant has

4 broadened the scope of research and research

5 training programs of qualified institutions by

6 promoting genomic research with an emphasis

7 on interdisciplinary research, including research

8 related to pediatric investigations.

9 ‘‘(3) INSTITUTIONS OF EMERGING EXCEL10 LENCE.—Of the amounts appropriated under sub11 section (h) for a fiscal year, the Director of the Center

12 shall make available 25 percent for grants under sub13 section (a) to applicants that, in addition to meeting

14 the requirements established in paragraph (1), have

15 demonstrated emerging excellence in biomedical or be16 havioral research, as follows:

17 ‘‘(A) The applicant has a plan for research

18 or training advancement and possesses the abil19 ity to carry out the plan.

20 ‘‘(B) The applicant carries out research and

21 research training programs that have a special

22 relevance to a problem, concern, or unmet health

23 need of the United States.

24 ‘‘(C) The applicant has been productive in

25 research or research development and training.
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1 ‘‘(D) The applicant—

2 ‘‘(i) has been designated as a center of

3 excellence under section 739;

4 ‘‘(ii) is located in a geographic area a

5 significant percentage of whose population

6 has a health-status deficit, and the appli7 cant provides health services to such popu8 lation; or

9 ‘‘(iii) is located in a geographic area

10 in which a deficit in health care technology,

11 services, or research resources may adversely

12 affect health status of the population of the

13 area in the future, and the applicant is car14 rying out activities with respect to protect15 ing the health status of such population.

16 ‘‘(d) REQUIREMENT OF APPLICATION.—The Director

17 of the Center may make a grant under subsection (a) only

18 if an application for the grant is submitted to the Director

19 and the application is in such form, is made in such man20 ner, and contains such agreements, assurances, and infor21 mation as the Director determines to be necessary to carry

22 out this section.

23 ‘‘(e) AMOUNT OF GRANT; PAYMENTS.—

24 ‘‘(1) AMOUNT.—The amount of any grant

25 awarded under subsection (a) shall be determined by
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1 the Director of the Center, except that such amount

2 shall not exceed—

3 ‘‘(A) 50 percent of the necessary cost of the

4 construction of a proposed facility as determined

5 by the Director; or

6 ‘‘(B) in the case of a multipurpose facility,

7 40 percent of that part of the necessary cost of

8 construction that the Director determines to be

9 proportionate to the contemplated use of the fa10 cility.

11 ‘‘(2) RESERVATION OF AMOUNTS.—On approval

12 of any application for a grant under subsection (a),

13 the Director of the Center shall reserve, from any ap14 propriation available therefore, the amount of such

15 grant, and shall pay such amount, in advance or by

16 way of reimbursement, and in such installments con17 sistent with the construction progress, as the Director

18 may determine appropriate. The reservation of the

19 Director of any amount by the Director under this

20 paragraph may be amended by the Director, either on

21 the approval of an amendment of the application or

22 on the revision of the estimated cost of construction

23 of the facility.

24 ‘‘(3) EXCLUSION OF CERTAIN COSTS.—In deter25 mining the amount of any grant under this sub-
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1 section (a), there shall be excluded from the cost of

2 construction an amount equal to the sum of—

3 ‘‘(A) the amount of any other Federal grant

4 that the applicant has obtained, or is assured of

5 obtaining, with respect to construction that is to

6 be financed in part by a grant authorized under

7 this section; and

8 ‘‘(B) the amount of any non-Federal funds

9 required to be expended as a condition of such

10 other Federal grant.

11 ‘‘(4) WAIVER OF LIMITATIONS.—The limitations

12 imposed by paragraph (1) may be waived at the dis13 cretion of the Director for applicants meeting the con14 ditions described in paragraphs (1) and (2) of sub15 section (c).

16 ‘‘(f) RECAPTURE OF PAYMENTS.—If, not later than 20

17 years after the completion of construction for which a grant

18 has been awarded under subsection (a)—

19 ‘‘(1) the applicant or other owner of the facility

20 shall cease to be a public or nonprofit private entity;

21 or

22 ‘‘(2) the facility shall cease to be used for the re23 search purposes for which it was constructed (unless

24 the Director determines, in accordance with regula-
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1 tions, that there is good cause for releasing the appli2 cant or other owner from obligation to do so);

3 the United States shall be entitled to recover from the appli4 cant or other owner of the facility the amount bearing the

5 same ratio to the current value (as determined by an agree6 ment between the parties or by action brought in the United

7 States District Court for the district in which such facility

8 is situated) of the facility as the amount of the Federal

9 participation bore to the cost of the construction of such

10 facility.

11 ‘‘(g) GUIDELINES.—Not later than 6 months after the

12 date of the enactment of this section, the Director of the

13 Center, after consultation with the Advisory Council, shall

14 issue guidelines with respect to grants under subsection (a).

15 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the

16 purpose of carrying out this section, there are authorized

17 to be appropriated $150,000,000 for fiscal year 1994, and

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

19 1995 and 1996.’’.

20 SEC. 1503. CONSTRUCTION PROGRAM FOR NATIONAL PRI21 MATE RESEARCH CENTER.

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

23 Service Act, as amended by section 1502 of this Act, is

24 amended by adding at the end the following new section:
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1 ‘‘CONSTRUCTION OF REGIONAL CENTERS FOR RESEARCH

2 ON PRIMATES

3 ‘‘SEC. 481B. (a) With respect to activities carried out

4 by the National Center for Research Resources to support

5 regional centers for research on primates, the Director of

6 NIH shall, for each of the fiscal years 1994 through 1996,

7 reserve from the amounts appropriated under section

8 481A(i) $5,000,000 for the purpose of making awards of

9 grants and contracts to public or nonprofit private entities

10 to construct, renovate, or otherwise improve such regional

11 centers. The reservation of such amounts for any fiscal year

12 is subject to the availability of qualified applicants for such

13 awards.

14 ‘‘(b) The Director of NIH may not make a grant or

15 enter into a contract under subsection (a) unless the appli16 cant for such assistance agrees, with respect to the costs to

17 be incurred by the applicant in carrying out the purpose

18 described in such subsection, to make available (directly or

19 through donations from public or private entities) non-Fed20 eral contributions in cash toward such costs in an amount

21 equal to not less than $1 for each $4 of Federal funds pro22 vided in such assistance.’’.
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1 Subtitle B—National Center for

2 Nursing Research

3 SEC. 1511. REDESIGNATION OF NATIONAL CENTER FOR

4 NURSING RESEARCH AS NATIONAL INSTI5 TUTE OF NURSING RESEARCH.

6 (a) IN GENERAL.—Subpart 3 of part E of title IV of

7 the Public Health Service Act (42 U.S.C. 287c et seq.) is

8 amended—

9 (1) in section 483—

10 (A) in the heading for the section, by strik11 ing ‘‘CENTER’’ and inserting ‘‘INSTITUTE’’; and

12 (B) by striking ‘‘The general purpose’’ and

13 all that follows through ‘‘is’’ and inserting the

14 following: ‘‘The general purpose of the National

15 Institute of Nursing Research (hereafter in this

16 subpart referred to as the ‘Institute’) is’’;

17 (2) in section 484, by striking ‘‘Center’’ each

18 place such term appears and inserting ‘‘Institute’’;

19 (3) in section 485—

20 (A) in subsection (a), in each of paragraphs

21 (1) through (3), by striking ‘‘Center’’ each place

22 such term appears and inserting ‘‘Institute’’;

23 (B) in subsection (b)—

24 (i) in paragraph (2)(A), by striking

25 ‘‘Center’’ and inserting ‘‘Institute’’; and
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1 (ii) in paragraph (3)(A), in the first

2 sentence, by striking ‘‘Center’’ and inserting

3 ‘‘Institute’’; and

4 (C) in subsections (d) through (g), by strik5 ing ‘‘Center’’ each place such term appears and

6 inserting ‘‘Institute’’; and

7 (4) in section 485A (as redesignated by section

8 141(a)(1) of this Act), by striking ‘‘Center’’ each place

9 such term appears and inserting ‘‘Institute’’.

10 (b) CONFORMING AMENDMENTS.—

11 (1) ORGANIZATION OF NATIONAL INSTITUTES OF

12 HEALTH.—Section 401(b) of the Public Health Serv13 ice Act (42 U.S.C. 281(b)) is amended—

14 (A) in paragraph (1), by adding at the end

15 the following new subparagraph:

16 ‘‘(Q) The National Institute of Nursing Re17 search.’’; and

18 (B) in paragraph (2), by striking subpara19 graph (D).

20 (2) TRANSFER OF STATUTORY PROVISIONS.—The

21 Public Health Service Act, as amended by subsection

22 (a) of this section and by section 124 of Public Law

23 102-321 (106 Stat. 364), is amended—

24 (A) by transferring sections 483 through

25 485A to part C of title IV;
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1 (B) by redesignating such sections as sec2 tions 464V through 464Y of such part; and

3 (C) by adding such sections, in the appro4 priate sequence, at the end of such part.

5 (3) HEADING FOR NEW SUBPART.—Title IV of

6 the Public Health Service Act, as amended by the pre7 ceding provisions of this section, is amended—

8 (A) in part C, by inserting before section

9 464V the following:

10 ‘‘Subpart 17—National Institute of Nursing Research’’;

11 and

12 (B) by striking the subpart designation and

13 heading for subpart 3 of part E.

14 (4) CROSS-REFERENCES.—Title IV of the Public

15 Health Service Act, as amended by the preceding pro16 visions of this section, is amended in subpart 17 of

17 part C—

18 (A) in section 464W, by striking ‘‘section

19 483’’ and inserting ‘‘section 464V’’;

20 (B) in section 464X(g), by striking ‘‘section

21 486’’ and inserting ‘‘section 464Y’’; and

22 (C) in section 464Y, in the last sentence, by

23 striking ‘‘section 485(g)’’ and inserting ‘‘section

24 464X(g)’’.
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1 SEC. 1512. STUDY ON ADEQUACY OF NUMBER OF NURSES.

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

3 Human Services, acting through the Director of the Na4 tional Institute of Nursing Research, shall enter into a con5 tract with a public or nonprofit private entity to conduct

6 a study for the purpose of determining whether and to what

7 extent there is a need for an increase in the number of

8 nurses in hospitals and nursing homes in order to promote

9 the quality of patient care and reduce the incidence among

10 nurses of work-related injuries and stress.

11 (b) NATIONAL ACADEMY OF SCIENCES.—The Secretary

12 shall request the Institute of Medicine of the National Acad13 emy of Sciences to enter into the contract under subsection

14 (a) to conduct the study described in such subsection. If such

15 Institute declines to conduct the study, the Secretary shall

16 carry out such subsection through another public or non17 profit private entity.

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

19 (1) The term ‘‘nurse’’ means a registered nurse,

20 a licensed practical nurse, a licensed vocational

21 nurse, and a nurse assistant.

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

23 Health and Human Services.

24 (d) REPORT.—The Secretary shall ensure that, not

25 later than October 1, 1994, the study required in subsection

26 (a) is completed and a report describing the findings made
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1 as a result of the study is submitted to the Committee on

2 Energy and Commerce of the House of Representatives, and

3 to the Committee on Labor and Human Resources of the

4 Senate.

5 Subtitle C—National Center for

6 Human Genome Research

7 SEC. 1521. PURPOSE OF CENTER.

8 Title IV of the Public Health Service Act, as amended

9 by section 141(a)(1) of this Act and by paragraphs (1)(B)

10 and (3)(B) of section 1511(b) of this Act, is amended—

11 (1) in section 401(b)(2), by adding at the end the

12 following new subparagraph:

13 ‘‘(D) The National Center for Human Genome

14 Research.’’; and

15 (2) in part E, by adding at the end the following

16 new subpart:

17 ‘‘Subpart 3—National Center for Human Genome

18 Research

19 ‘‘PURPOSE OF THE CENTER

20 ‘‘SEC. 485B. (a) The general purpose of the National

21 Center for Human Genome Research (hereafter in this sub22 part referred to as the ‘Center’) is to characterize the struc23 ture and function of the human genome, including the map24 ping and sequencing of individual genes. Such purpose in25 cludes—
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1 ‘‘(1) planning and coordinating the research goal

2 of the genome project;

3 ‘‘(2) reviewing and funding research proposals;

4 ‘‘(3) developing training programs;

5 ‘‘(4) coordinating international genome research;

6 ‘‘(5) communicating advances in genome science

7 to the public; and

8 ‘‘(6) reviewing and funding proposals to address

9 the ethical and legal issues associated with the genome

10 project.

11 ‘‘(b) The Director of the Center may conduct and sup12 port research training—

13 ‘‘(1) for which fellowship support is not provided

14 under section 487; and

15 ‘‘(2) that is not residency training of physicians

16 or other health professionals.

17 ‘‘(c)(1) Except as provided in paragraph (2), of the

18 amounts appropriated to carry out subsection (a) for a fis19 cal year, the Director of the Center shall make available

20 not less than 5 percent for carrying out paragraph (6) of

21 such subsection.

22 ‘‘(2) With respect to providing funds under subsection

23 (a)(6) for proposals to address the ethical issues associated

24 with the genome project, paragraph (1) shall not apply for

25 a fiscal year if the Director of the Center certifies to the
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1 Committee on Energy and Commerce of the House of Rep2 resentatives, and to the Committee on Labor and Human

3 Resources of the Senate, that the Director has determined

4 that an insufficient number of such proposals meet the ap5 plicable requirements of sections 491 and 492.’’.

6 TITLE XVI—AWARDS AND

7 TRAINING

8 Subtitle A—National Research

9 Service Awards

10 SEC. 1601. REQUIREMENT REGARDING WOMEN AND INDI11 VIDUALS FROM DISADVANTAGED BACK12 GROUNDS.

13 Section 487(a) of the Public Health Service Act (42

14 U.S.C. 288(a)(4)) is amended by adding at the end the fol15 lowing paragraph:

16 ‘‘(4) The Secretary shall carry out paragraph (1) in

17 a manner that will result in the recruitment of women, and

18 individuals from disadvantaged backgrounds, into fields of

19 biomedical or behavioral research and in the provision of

20 research training to women and such individuals.’’.

21 Subtitle B—Acquired Immune

22 Deficiency Syndrome

23 SEC. 1611. LOAN REPAYMENT PROGRAM.

24 Section 487A of the Public Health Service Act (42

25 U.S.C. 288–1) is amended to read as follows:
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1 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH

2 RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME

3 ‘‘SEC. 487A. (a) IN GENERAL.—

4 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

5 paragraph (2), the Secretary shall carry out a pro6 gram of entering into agreements with appropriately

7 qualified health professionals under which such health

8 professionals agree to conduct, as employees of the Na9 tional Institutes of Health, research with respect to

10 acquired immune deficiency syndrome in consider11 ation of the Federal Government agreeing to repay,

12 for each year of such service, not more than $20,000

13 of the principal and interest of the educational loans

14 of such health professionals.

15 ‘‘(2) LIMITATION.—The Secretary may not enter

16 into an agreement with a health professional pursu17 ant to paragraph (1) unless such professional—

18 ‘‘(A) has a substantial amount of edu19 cational loans relative to income; and

20 ‘‘(B) agrees to serve as an employee of the

21 National Institutes of Health for purposes of

22 paragraph (1) for a period of not less than 3

23 years.

24 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—With

25 respect to the National Health Service Corps Loan Repay-
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1 ment Program established in subpart III of part D of title

2 III, the provisions of such subpart shall, except as inconsist3 ent with subsection (a) of this section, apply to the program

4 established in such subsection (a) in the same manner and

5 to the same extent as such provisions apply to the National

6 Health Service Corps Loan Repayment Program established

7 in such subpart.

8 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the

9 purpose of carrying out this section, there are authorized

10 to be appropriated such sums as may be necessary for each

11 of the fiscal years 1994 through 1996.’’.

12 Subtitle C—Loan Repayment for

13 Research Generally

14 SEC. 1621. ESTABLISHMENT OF PROGRAM.

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

16 as redesignated by section 141(a)(2) of this Act and as

17 amended by section 1002 of this Act, is amended by insert18 ing after section 487B the following new section:

19 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH GENERALLY

20 ‘‘SEC. 487C. (a) IN GENERAL.—

21 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

22 paragraph (2), the Secretary shall carry out a pro23 gram of entering into agreements with appropriately

24 qualified health professionals under which such health

25 professionals agree to conduct research, as employees

26 of the National Institutes of Health, in consideration
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1 of the Federal Government agreeing to repay, for each

2 year of such service, not more than $20,000 of the

3 principal and interest of the educational loans of such

4 health professionals.

5 ‘‘(2) LIMITATION.—The Secretary may not enter

6 into an agreement with a health professional pursu7 ant to paragraph (1) unless such professional—

8 ‘‘(A) has a substantial amount of edu9 cational loans relative to income; and

10 ‘‘(B) agrees to serve as an employee of the

11 National Institutes of Health for purposes of

12 paragraph (1) for a period of not less than 3

13 years.

14 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—With

15 respect to the National Health Service Corps Loan Repay16 ment Program established in subpart III of part D of title

17 III, the provisions of such subpart shall, except as inconsist18 ent with subsection (a) of this section, apply to the program

19 established in such subsection (a) in the same manner and

20 to the same extent as such provisions apply to the National

21 Health Service Corps Loan Repayment Program established

22 in such subpart.

23 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the

24 purpose of carrying out this section other than with respect

25 to acquired immune deficiency syndrome, there are author-
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1 ized to be appropriated such sums as may be necessary for

2 each of the fiscal years 1994 through 1996.’’.

3 Subtitle D—Scholarship and Loan

4 Repayment Programs Regarding

5 Professional Skills Needed by

6 Certain Agencies

7 SEC. 1631. ESTABLISHMENT OF PROGRAMS FOR NATIONAL

8 INSTITUTES OF HEALTH.

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

10 as redesignated by section 141(a)(2) of this Act and as

11 amended by section 1621 of this Act, is amended by insert12 ing after section 487C the following new sections:

13 ‘‘UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING

14 PROFESSIONS NEEDED BY NATIONAL RESEARCH IN15 STITUTES

16 ‘‘SEC. 487D. (a) ESTABLISHMENT OF PROGRAM.—

17 ‘‘(1) IN GENERAL.—Subject to section

18 487(a)(1)(C), the Secretary, acting through the Direc19 tor of NIH, may carry out a program of entering into

20 contracts with individuals described in paragraph (2)

21 under which—

22 ‘‘(A) the Director of NIH agrees to provide

23 to the individuals scholarships for pursuing, as

24 undergraduates at accredited institutions of

25 higher education, academic programs appro-
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1 priate for careers in professions needed by the

2 National Institutes of Health; and

3 ‘‘(B) the individuals agree to serve as em4 ployees of the National Institutes of Health, for

5 the period described in subsection (c), in posi6 tions that are needed by the National Institutes

7 of Health and for which the individuals are

8 qualified.

9 ‘‘(2) INDIVIDUALS FROM DISADVANTAGED BACK10 GROUNDS.—The individuals referred to in paragraph

11 (1) are individuals who—

12 ‘‘(A) are enrolled or accepted for enrollment

13 as full-time undergraduates at accredited institu14 tions of higher education; and

15 ‘‘(B) are from disadvantaged backgrounds.

16 ‘‘(b) FACILITATION OF INTEREST OF STUDENTS IN CA17 REERS AT NATIONAL INSTITUTES OF HEALTH.—In provid18 ing employment to individuals pursuant to contracts under

19 subsection (a)(1), the Director of NIH shall carry out ac20 tivities to facilitate the interest of the individuals in pursu21 ing careers as employees of the National Institutes of

22 Health.

23 ‘‘(c) PERIOD OF OBLIGATED SERVICE.—

24 ‘‘(1) DURATION OF SERVICE.—For purposes of

25 subparagraph (B) of subsection (a)(1), the period of
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1 service for which an individual is obligated to serve

2 as an employee of the National Institutes of Health

3 is, subject to paragraph (2)(A), 12 months for each

4 academic year for which the scholarship under such

5 subsection is provided.

6 ‘‘(2) SCHEDULE FOR SERVICE.—

7 ‘‘(A) Subject to subparagraph (B), the Di8 rector of NIH may not provide a scholarship

9 under subsection (a) unless the individual apply10 ing for the scholarship agrees that—

11 ‘‘(i) the individual will serve as an em12 ployee of the National Institutes of Health

13 full-time for not less than 10 consecutive

14 weeks of each year during which the indi15 vidual is attending the educational institu16 tion involved and receiving such a scholar17 ship;

18 ‘‘(ii) the period of service as such an

19 employee that the individual is obligated to

20 provide under clause (i) is in addition to

21 the period of service as such an employee

22 that the individual is obligated to provide

23 under subsection (a)(1)(B); and

24 ‘‘(iii) not later than 60 days after ob25 taining the educational degree involved, the
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1 individual will begin serving full-time as

2 such an employee in satisfaction of the pe3 riod of service that the individual is obli4 gated to provide under subsection (a)(1)(B).

5 ‘‘(B) The Director of NIH may defer the ob6 ligation of an individual to provide a period of

7 service under subsection (a)(1)(B), if the Direc8 tor determines that such a deferral is appro9 priate.

10 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS RE11 LATING TO APPOINTMENT AND COMPENSATION.—For

12 any period in which an individual provides service as

13 an employee of the National Institutes of Health in

14 satisfaction of the obligation of the individual under

15 subsection (a)(1)(B) or paragraph (2)(A)(i), the indi16 vidual may be appointed as such an employee with17 out regard to the provisions of title 5, United States

18 Code, relating to appointment and compensation.

19 ‘‘(d) PROVISIONS REGARDING SCHOLARSHIP.—

20 ‘‘(1) APPROVAL OF ACADEMIC PROGRAM.—The

21 Director of NIH may not provide a scholarship under

22 subsection (a) for an academic year unless—

23 ‘‘(A) the individual applying for the schol24 arship has submitted to the Director a proposed
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1 academic program for the year and the Director

2 has approved the program; and

3 ‘‘(B) the individual agrees that the program

4 will not be altered without the approval of the

5 Director.

6 ‘‘(2) ACADEMIC STANDING.—The Director of

7 NIH may not provide a scholarship under subsection

8 (a) for an academic year unless the individual apply9 ing for the scholarship agrees to maintain an accept10 able level of academic standing, as determined by the

11 educational institution involved in accordance with

12 regulations issued by the Secretary.

13 ‘‘(3) LIMITATION ON AMOUNT.—The Director of

14 NIH may not provide a scholarship under subsection

15 (a) for an academic year in an amount exceeding

16 $20,000.

17 ‘‘(4) AUTHORIZED USES.—A scholarship pro18 vided under subsection (a) may be expended only for

19 tuition expenses, other reasonable educational ex20 penses, and reasonable living expenses incurred in at21 tending the school involved.

22 ‘‘(5) CONTRACT REGARDING DIRECT PAYMENTS

23 TO INSTITUTION.—In the case of an institution of

24 higher education with respect to which a scholarship

25 under subsection (a) is provided, the Director of NIH
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1 may enter into a contract with the institution under

2 which the amounts provided in the scholarship for

3 tuition and other educational expenses are paid di4 rectly to the institution.

5 ‘‘(e) PENALTIES FOR BREACH OF SCHOLARSHIP CON6 TRACT.—The provisions of section 338E shall apply to the

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

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

9 National Health Service Corps Loan Repayment Program

10 established in section 338B.

11 ‘‘(f) REQUIREMENT OF APPLICATION.—The Director of

12 NIH may not provide a scholarship under subsection (a)

13 unless an application for the scholarship is submitted to

14 the Director and the application is in such form, is made

15 in such manner, and contains such agreements, assurances,

16 and information as the Director determines to be necessary

17 to carry out this section.

18 ‘‘(g) AVAILABILITY OF AUTHORIZATION OF APPRO19 PRIATIONS.—Amounts appropriated for a fiscal year for

20 scholarships under this section shall remain available until

21 the expiration of the second fiscal year beginning after the

22 fiscal year for which the amounts were appropriated.

23 ‘‘LOAN REPAYMENT PROGRAM REGARDING CLINICAL

24 RESEARCHERS FROM DISADVANTAGED BACKGROUNDS

25 ‘‘SEC. 487E. (a) IMPLEMENTATION OF PROGRAM.—
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1 ‘‘(1) IN GENERAL.—Subject to section

2 487(a)(1)(C), the Secretary, acting through the Direc3 tor of NIH may, subject to paragraph (2), carry out

4 a program of entering into contracts with appro5 priately qualified health professionals who are from

6 disadvantaged backgrounds under which such health

7 professionals agree to conduct clinical research as em8 ployees of the National Institutes of Health in consid9 eration of the Federal Government agreeing to pay,

10 for each year of such service, not more than $20,000

11 of the principal and interest of the educational loans

12 of the health professionals.

13 ‘‘(2) LIMITATION.—The Director of NIH may

14 not enter into a contract with a health professional

15 pursuant to paragraph (1) unless such professional

16 has a substantial amount of education loans relative

17 to income.

18 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS RE19 GARDING OBLIGATED SERVICE.—Except to the extent

20 inconsistent with this section, the provisions of sec21 tions 338C and 338E shall apply to the program es22 tablished in paragraph (1) to the same extent and in

23 the same manner as such provisions apply to the Na24 tional Health Service Corps Loan Repayment Pro25 gram established in section 338B.
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1 ‘‘(b) AVAILABILITY OF AUTHORIZATION OF APPRO2 PRIATIONS.—Amounts appropriated for a fiscal year for

3 contracts under subsection (a) shall remain available until

4 the expiration of the second fiscal year beginning after the

5 fiscal year for which the amounts were appropriated.’’.

6 SEC. 1632. FUNDING.

7 Section 487(a)(1) of the Public Health Service Act (42

8 U.S.C. 288(a)(1)) is amended—

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

10 the semicolon at the end;

11 (2) in subparagraph (B), by striking the period

12 at the end and inserting ‘‘; and’’; and

13 (3) by inserting after subparagraph (B) the fol14 lowing new subparagraph:

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 E—Funding

21 SEC. 1641. AUTHORIZATION OF APPROPRIATIONS.

22 Section 487(d) of the Public Health Service Act (42

23 U.S.C. 288(d)) is amended—

24 (1) in the first sentence, by amending the sen25 tence to read as follows: ‘‘For the purpose of carrying
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1 out this section, there are authorized to be appro2 priated $400,000,000 for fiscal year 1994, and such

3 sums as may be necessary for each of the fiscal years

4 1995 and 1996.’’; and

5 (2) in paragraph (3)—

6 (A) by striking ‘‘one-half of one percent’’

7 each place such term appears and inserting ‘‘1

8 percent’’; and

9 (B) by striking ‘‘780, 784, or 786,’’ and in10 serting ‘‘747, 748, or 749,’’.

11 TITLE XVII—NATIONAL FOUNDA12 TION FOR BIOMEDICAL RE13 SEARCH

14 SEC. 1701. DATE CERTAIN FOR APPOINTMENT OF BOARD

15 MEMBERS.

16 Section 499 of the Public Health Service Act, as redes17 ignated by section 121(b)(3) of this Act, is amended in sub18 section (c)(1)(C) by inserting after and below clause (iii)

19 the following:

20 ‘‘Not later than April 1, 1993, the Secretary

21 shall convene a meeting of the ex officio members

22 of the Board for the purpose of making the ap23 pointments required in this subparagraph.’’.
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1 SEC. 1702. MISCELLANEOUS PROVISIONS.

2 Section 499 of the Public Health Service Act, as redes3 ignated 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 ‘‘the

9 purposes of’’ and all that follows through

10 ‘‘Transfer Act,’’ and inserting the following: ‘‘the

11 purposes of the Ethics in Government Act of

12 1978 and the Stevenson-Wydler Technology In13 novation Act of 1980,’’;

14 (2) in subsection (b)(2), by striking ‘‘Ethics’’

15 and all that follows and inserting the following: ‘‘Eth16 ics in Government Act of 1978, and the Stevenson17 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 officio

22 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 ‘‘para5 graph (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 Subtitle A—Office of AIDS Research

16 SEC. 1801. ESTABLISHMENT OF OFFICE.

17 (a) IN GENERAL.—Part D of title XXIII of the Public

18 Health Service Act (42 U.S.C. 300cc-41 et seq.) is amend19 ed—

20 (1) by striking the part designation and the

21 heading for the part;

22 (2) by redesignating section 2351 as section

23 2354; and

24 (3) by inserting before section 2354 (as so redes25 ignated) the following:
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1 ‘‘PART D—OFFICE OF AIDS RESEARCH

2 ‘‘Subpart I—Interagency Coordination of Activities

3 ‘‘SEC. 2351. ESTABLISHMENT OF OFFICE.

4 ‘‘(a) IN GENERAL.—There is established within the

5 National Institutes of Health an office to be known as the

6 Office of AIDS Research. The Office shall be headed by a

7 director, who shall be appointed by the Secretary.

8 ‘‘(b) DUTIES.—

9 ‘‘(1) INTERAGENCY COORDINATION OF AIDS AC10 TIVITIES.—With respect to acquired immune defi11 ciency syndrome, the Director of the Office shall plan,

12 coordinate, and evaluate research and other activities

13 conducted or supported by the agencies of the Na14 tional Institutes of Health.

15 ‘‘(2) CONSULTATIONS.—The Director of the Of16 fice shall carry out this subpart (including developing

17 and revising the plan required in section 2353) in

18 consultation with the heads of the agencies of the Na19 tional Institutes of Health, with the advisory councils

20 of the agencies, and with the advisory council estab21 lished under section 2352.

22 ‘‘SEC. 2352. ADVISORY COUNCIL.

23 ‘‘(a) IN GENERAL.—The Secretary shall establish an

24 advisory council for the purpose of providing advice to the
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1 Director of the Office on carrying out this part. (Such coun2 cil is referred to in this section as the ‘Advisory Council’.)

3 ‘‘(b) COMPOSITION, COMPENSATION, TERMS, CHAIR,

4 ETC.—Subsections (b) through (g) of section 406 apply to

5 the Advisory Council to the same extent and in the same

6 manner as such subsections apply to advisory councils for

7 the national research institutes, except that, in addition to

8 the ex officio members specified in section 406(b)(2), there

9 shall serve as ex officio members of the Advisory Council

10 the chairs of the advisory councils for each of the National

11 Cancer Institute, the National Institute on Allergy and In12 fectious Diseases, and the National Institute on Mental

13 Health.

14 ‘‘SEC. 2353. COMPREHENSIVE PLAN FOR EXPENDITURE OF

15 APPROPRIATIONS.

16 ‘‘(a) IN GENERAL.—Subject to the provisions of this

17 section and other applicable law, the Director of the Office,

18 in carrying out section 2351, shall—

19 ‘‘(1) establish a comprehensive plan for the con20 duct and support of all AIDS activities of the agen21 cies of the National Institutes of Health (which plan

22 shall be first established under this paragraph not

23 later than 12 months after the date of the enactment

24 of the National Institutes of Health Revitalization Act

25 of 1993);
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1 ‘‘(2) ensure that the Plan establishes priorities

2 among the AIDS activities that such agencies are au3 thorized to carry out;

4 ‘‘(3) ensure that the Plan establishes objectives

5 regarding such activities, describes the means for

6 achieving the objectives, and designates the date by

7 which the objectives are expected to be achieved;

8 ‘‘(4) ensure that all amounts appropriated for

9 such activities are expended in accordance with the

10 Plan;

11 ‘‘(5) review the Plan not less than annually, and

12 revise the Plan as appropriate; and

13 ‘‘(6) ensure that the Plan serves as a broad,

14 binding statement of policies regarding AIDS activi15 ties of the agencies, but does not remove the respon16 sibility of the heads of the agencies for the approval

17 of specific programs or projects, or for other details of

18 the daily administration of such activities, in accord19 ance with the Plan.

20 ‘‘(b) CERTAIN COMPONENTS OF PLAN.—With respect

21 to AIDS activities of the agencies of the National Institutes

22 of Health, the Director of the Office shall ensure that the

23 Plan—

24 ‘‘(1) provides for basic research;

25 ‘‘(2) provides for applied research;
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1 ‘‘(3) provides for research that is conducted by

2 the agencies;

3 ‘‘(4) provides for research that is supported by

4 the agencies;

5 ‘‘(5) provides for proposals developed pursuant to

6 solicitations by the agencies and for proposals devel7 oped independently of such solicitations; and

8 ‘‘(6) provides for behavioral research and social

9 sciences research.

10 ‘‘(c) BUDGET ESTIMATES.—

11 ‘‘(1) FULL-FUNDING BUDGET.—

12 ‘‘(A) With respect to a fiscal year, the Di13 rector of the Office shall prepare and submit di14 rectly to the President, for review and transmit15 tal to the Congress, a budget estimate for carry16 ing out the Plan for the fiscal year, after reason17 able opportunity for comment (but without

18 change) by the Secretary, the Director of the Na19 tional Institutes of Health, and the advisory

20 council established under section 2352. The budg21 et estimate shall include an estimate of the num22 ber and type of personnel needs for the Office.

23 ‘‘(B) The budget estimate submitted under

24 subparagraph (A) shall estimate the amounts

25 necessary for the agencies of the National Insti-
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1 tutes of Health to carry out all AIDS activities

2 determined by the Director of the Office to be ap3 propriate, without regard to the probability that

4 such amounts will be appropriated.

5 ‘‘(2) ALTERNATIVE BUDGETS.—

6 ‘‘(A) With respect to a fiscal year, the Di7 rector of the Office shall prepare and submit to

8 the Secretary and the Director of the National

9 Institutes of Health the budget estimates de10 scribed in subparagraph (B) for carrying out the

11 Plan for the fiscal year. The Secretary and such

12 Director shall consider each of such estimates in

13 making recommendations to the President re14 garding a budget for the Plan for such year.

15 ‘‘(B) With respect to the fiscal year in16 volved, the budget estimates referred to in sub17 paragraph (A) for the Plan are as follows:

18 ‘‘(i) The budget estimate submitted

19 under paragraph (1).

20 ‘‘(ii) A budget estimate developed on

21 the assumption that the amounts appro22 priated will be sufficient only for—

23 ‘‘(I) continuing the conduct by the

24 agencies of the National Institutes of

25 Health of existing AIDS activities (if
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1 approved for continuation), and con2 tinuing the support of such activities

3 by the agencies in the case of projects

4 or programs for which the agencies

5 have made a commitment of continued

6 support; and

7 ‘‘(II) carrying out, of activities

8 that are in addition to activities speci9 fied in subclause (I), only such activi10 ties for which the Director determines

11 there is the most substantial need.

12 ‘‘(iii) Such other budget estimates as

13 the Director of the Office determines to be

14 appropriate.

15 ‘‘(d) FUNDING.—

16 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—For

17 the purpose of carrying out AIDS activities under the

18 Plan, there are authorized to be appropriated such

19 sums as may be necessary for each of the fiscal years

20 1994 through 1996.

21 ‘‘(2) DIRECT RECEIPT BY DIRECTOR OF NA22 TIONAL INSTITUTES OF HEALTH.—For the first fiscal

23 year beginning after the date on which the Plan first

24 established under section 2353(a)(1) has been in effect

25 for 12 months, and for each subsequent fiscal year, the
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1 Director of the National Institutes of Health shall re2 ceive directly from the President and the Director of

3 the Office of Management and Budget all funds avail4 able for AIDS activities of the National Institutes of

5 Health.

6 ‘‘(3) DISBURSEMENT TO AGENCIES.—

7 ‘‘(A) With respect to the disbursement by

8 the Director of the National Institutes of Health

9 of amounts for carrying out AIDS activities

10 specified in subsection (c)(2)(B)(ii)(I) for the fis11 cal year involved, the Director shall, to the extent

12 practicable, disburse all of such amounts to the

13 agencies of such Institutes not later than 30 days

14 after the date on which the Director receives

15 amounts under paragraph (2).

16 ‘‘(B) With respect to the disbursement by

17 the Director of the National Institutes of Health

18 of amounts for carrying out AIDS activities of

19 the National Institutes of Health in addition to

20 the activities specified in subparagraph (A) for

21 the fiscal year, the Director shall, to the extent

22 practicable, disburse all of such amounts to the

23 agencies of the National Institutes of Health not

24 later than 90 days after the date on which the
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1 Director receives amounts under paragraph

2 (2).’’.

3 (b) CONFORMING AMENDMENTS.—Section 2354 of the

4 Public Health Service Act, as redesignated by subsection

5 (a)(2) of this section, is amended—

6 (1) in the heading for the section, by striking

7 ‘‘ESTABLISHMENT OF’’ and inserting ‘‘ADDI8 TIONAL’’;

9 (2) in subsection (a)—

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

11 by striking ‘‘In carrying out’’ and all that fol12 lows and inserting the following: ‘‘In carrying

13 out AIDS research, the Director of the Of14 fice—’’;

15 (B) by striking paragraphs (1) and (2) and

16 redesignating paragraphs (3) through (8) as

17 paragraphs (1) through (6);

18 (C) in paragraph (3) (as so redesignated),

19 by striking ‘‘may’’ and all that follows in the

20 matter preceding subparagraph (A) and insert21 ing the following: ‘‘may support—’’;

22 (D) in paragraph (5) (as so redesignated)—

23 (i) in subparagraph (A)—
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1 ‘‘(I) by striking ‘‘may’’ and all

2 that follows through ‘‘acquire,’’ and in3 serting ‘‘may acquire,’’; and

4 ‘‘(II) by striking ‘‘Director’’ and

5 all that follows through ‘‘determines’’

6 and inserting ‘‘Director of the Office

7 determines’’;

8 (ii) in subparagraph (B), by striking

9 ‘‘may’’ and all that follows through ‘‘make

10 grants’’ and inserting ‘‘may make grants’’;

11 and

12 (iii) in subparagraph (C), by striking

13 ‘‘may’’ and all that follows through ‘‘ac14 quire,’’ and inserting ‘‘may acquire,’’; and

15 (E) in each of paragraphs (2), (3)(A), and

16 (4) (as so redesignated), by striking ‘‘research re17 lating to acquired immune deficiency syndrome’’

18 and inserting ‘‘AIDS research’’;

19 (3) in subsection (b), in the matter preceding

20 paragraph (1), by striking ‘‘The Director’’ and all

21 that follows through ‘‘shall’’ and inserting ‘‘The Di22 rector of the Office shall’’; and

23 (4) in subsection (c), by striking ‘‘the Director’’

24 and all that follows through ‘‘shall’’ and inserting

25 ‘‘the Director of the Office shall’’.
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1 SEC. 1802. ESTABLISHMENT OF EMERGENCY DISCRE2 TIONARY FUND.

3 Part D of title XXIII of the Public Health Service Act,

4 as amended by section 1801 of this Act, is amended by add5 ing at the end the following subpart:

6 ‘‘Subpart II—Emergency Discretionary Fund

7 ‘‘SEC. 2356. EMERGENCY DISCRETIONARY FUND.

8 ‘‘(a) IN GENERAL.—

9 ‘‘(1) ESTABLISHMENT.—There is established a

10 fund consisting of such amounts as may be appro11 priated under subsection (g). Subject to the provisions

12 of this section, the Director of the Office, after con13 sultation with the advisory council established under

14 section 2352, may expend amounts in the Fund for

15 the purpose of conducting and supporting such

16 projects of AIDS research and other AIDS activities

17 as may be authorized in this Act for the National In18 stitutes Health.

19 ‘‘(2) PRECONDITIONS TO USE OF FUND.—

20 Amounts in the Fund may be expended for an AIDS

21 project only if—

22 ‘‘(A) the Director of the Office has made a

23 determination that there is a significant need for

24 the project; and

25 ‘‘(B) as of June 30 of the fiscal year preced26 ing the fiscal year in which the determination is
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1 made, such need was not provided for in any ap2 propriations Act passed by the House of Rep3 resentatives to make appropriations for the De4 partments of Labor, Health and Human Services

5 (including the National Institutes of Health),

6 Education, and related agencies for the fiscal

7 year in which the determination is made.

8 ‘‘(3) TWO-YEAR USE OF FUND FOR PROJECT IN9 VOLVED.—In the case of an AIDS project, obligations

10 of amounts in the Fund may not be made for the

11 project after the expiration of the 2-year period begin12 ning on the date on which the initial obligation of

13 such amounts is made for the project.

14 ‘‘(b) PEER REVIEW.—With respect to an AIDS project

15 carried out with amounts in the Fund, this section may

16 not be construed as waiving applicable requirements for

17 peer review.

18 ‘‘(c) LIMITATIONS ON USE OF FUND.—

19 ‘‘(1) CONSTRUCTION OF FACILITIES.—Amounts

20 in the Fund may not be used for the construction,

21 renovation, or relocation of facilities, or for the acqui22 sition of land.

23 ‘‘(2) CONGRESSIONAL DISAPPROVAL OF

24 PROJECTS.—
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1 ‘‘(A) Amounts in the Fund may not be ex2 pended for the fiscal year involved for an AIDS

3 project, or category of such projects, for which—

4 ‘‘(i)(I) amounts were made available

5 in an appropriations Act for the preceding

6 fiscal year; and

7 ‘‘(II) amounts are not made available

8 in any appropriations Act for the fiscal

9 year involved; or

10 ‘‘(ii) amounts are by law prohibited

11 from being expended.

12 ‘‘(B) A determination under subparagraph

13 (A)(i) of whether amounts have been made avail14 able in appropriations Acts for a fiscal year

15 shall be made without regard to whether such

16 Acts make available amounts for the Fund.

17 ‘‘(3) INVESTMENT OF FUND AMOUNTS.—Amounts

18 in the Fund may not be invested.

19 ‘‘(d) APPLICABILITY OF LIMITATION REGARDING NUM20 BER OF EMPLOYEES.—The purposes for which amounts in

21 the Fund may be expended include the employment of indi22 viduals necessary to carry out AIDS projects approved

23 under subsection (a). Any individual employed under the

24 preceding sentence may not be included in any determina25 tion of the number of full-time equivalent employees for the
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1 Department of Health and Human Services for the purpose

2 of any limitation on the number of such employees estab3 lished by law prior to, on, or after the date of the enactment

4 of the National Institutes of Health Revitalization Act of

5 1993.

6 ‘‘(e) REPORT TO CONGRESS.—Not later than February

7 1 of each fiscal year, the Director of the Office shall submit

8 to the Committee on Energy and Commerce of the House

9 of Representatives, and to the Committee on Labor and

10 Human Resources of the Senate, a report on the AIDS

11 projects carried out during the preceding fiscal year with

12 amounts in the Fund. The report shall provide a descrip13 tion of each such project and an explanation of the reasons

14 underlying the use of the Fund for the project.

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

16 ‘‘(1) The term ‘AIDS project’ means a project de17 scribed in subsection (a).

18 ‘‘(2) The term ‘Fund’ means the fund established

19 in subsection (a).

20 ‘‘(g) FUNDING.—

21 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—For

22 the purpose of providing amounts for the Fund, there

23 is authorized to be appropriated $100,000,000 for

24 each of the fiscal years 1994 through 1996.
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1 ‘‘(2) AVAILABILITY.—Amounts appropriated for

2 the Fund are available until expended.’’.

3 SEC. 1803. GENERAL PROVISIONS.

4 Part D of title XXIII of the Public Health Service Act,

5 as amended by section 1802 of this Act, is amended by add6 ing at the end the following subpart:

7 ‘‘Subpart III—General Provisions

8 ‘‘SEC. 2359. GENERAL PROVISIONS REGARDING THE OF9 FICE.

10 ‘‘(a) ADMINISTRATIVE SUPPORT FOR OFFICE.—The

11 Secretary, acting through the Director of the National Insti12 tutes of Health, shall provide administrative support and

13 support services to the Director of the Office.

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

15 ‘‘(1) The term ‘AIDS activities’ means AIDS re16 search and other activities that relate to acquired im17 mune deficiency syndrome.

18 ‘‘(2) The term ‘AIDS research’ means research

19 with respect to acquired immune deficiency syndrome.

20 ‘‘(3) The term ‘Office’ means the Office of AIDS

21 Research.

22 ‘‘(4) The term ‘Plan’ means the plan required in

23 section 2353(a)(1).’’.
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1 Subtitle B—Certain Programs

2 SEC. 1811. REVISION AND EXTENSION OF CERTAIN PRO3 GRAMS.

4 Title XXIII of the Public Health Service Act (42

5 U.S.C. 300cc et seq.) is amended—

6 (1) in section 2304(c)(1)—

7 (A) in the matter preceding subparagraph

8 (A), by inserting after ‘‘Director of such Insti9 tute’’ the following: ‘‘(and may provide advice to

10 the Directors of other agencies of the National

11 Institutes of Health, as appropriate)’’; and

12 (B) in subparagraph (A), by inserting be13 fore the semicolon the following: ‘‘, including rec14 ommendations on the projects of research with

15 respect to diagnosing immune deficiency and

16 with respect to predicting, diagnosing, prevent17 ing, and treating opportunistic cancers and in18 fectious diseases’’;

19 (2) in section 2311(a)(1), by inserting before the

20 semicolon the following: ‘‘, including evaluations of

21 methods of diagnosing immune deficiency and evalua22 tions of methods of predicting, diagnosing, preventing,

23 and treating opportunistic cancers and infectious

24 diseases’’;

25 (3) in section 2315—
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1 (A) in subsection (a)(2), by striking ‘‘inter2 national research’’ and all that follows and in3 serting ‘‘international research and training

4 concerning the natural history and pathogenesis

5 of the human immunodeficiency virus and the

6 development and evaluation of vaccines and

7 treatments for acquired immune deficiency syn8 drome and opportunistic infections.’’; and

9 (B) in subsection (f), by striking ‘‘there are

10 authorized’’ and all that follows and inserting

11 ‘‘there are authorized to be appropriated such

12 sums as may be necessary for each fiscal year.’’;

13 (4) in section 2318—

14 (A) in subsection (a)(1)—

15 (i) by inserting after ‘‘The Secretary’’

16 the following: ‘‘, acting through the Director

17 of the National Institutes of Health and

18 after consultation with the Administrator

19 for Health Care Policy and Research,’’; and

20 (ii) by striking ‘‘syndrome’’ and insert21 ing ‘‘syndrome, including treatment and

22 prevention of HIV infection and related

23 conditions among women’’; and

24 (B) in subsection (e), by striking ‘‘1991.’’

25 and inserting the following: ‘‘1991, and such
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1 sums as may be necessary for each of the fiscal

2 years 1994 through 1996.’’;

3 (5) in section 2320(b)(1)(A), by striking ‘‘syn4 drome’’ and inserting ‘‘syndrome and the natural his5 tory of such infection’’;

6 (6) in section 2320(e)(1), by striking ‘‘there are

7 authorized’’ and all that follows and inserting ‘‘there

8 are authorized to be appropriated such sums as may

9 be necessary for each fiscal year.’’;

10 (7) in section 2341(d), by striking ‘‘there are au11 thorized’’ and all that follows and inserting ‘‘there are

12 authorized to be appropriated such sums as may be

13 necessary for each fiscal year.’’; and

14 (8) in section 2361, by striking ‘‘For purposes’’

15 and all that follows and inserting the following:

16 ‘‘For purposes of this title:

17 ‘‘(1) The term ‘infection’, with respect to the etio18 logic agent for acquired immune deficiency syndrome,

19 includes opportunistic cancers and infectious diseases

20 and any other conditions arising from infection with

21 such etiologic agent.

22 ‘‘(2) The term ‘treatment’, with respect to the

23 etiologic agent for acquired immune deficiency syn24 drome, includes primary and secondary prophy25 laxis.’’;
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1 TITLE XIX—STUDIES

2 SEC. 1901. ACQUIRED IMMUNE DEFICIENCY SYNDROME.

3 (a) THIRD-PARTY PAYMENTS REGARDING CERTAIN

4 CLINICAL TRIALS.—The Secretary of Health and Human

5 Services, acting through the Director of the National Insti6 tutes of Health, shall conduct a study for the purpose of—

7 (1) determining the policies of third-party

8 payors regarding the payment of the costs of appro9 priate health services that are provided incident to

10 the participation of individuals as subjects in clinical

11 trials conducted in the development of drugs with re12 spect to acquired immune deficiency syndrome; and

13 (2) developing recommendations regarding such

14 policies.

15 (b) ADVISORY COMMITTEES.—The Secretary of Health

16 and Human Services, acting through the Director of the Na17 tional Institutes of Health, shall conduct a study for the

18 purpose of determining—

19 (1) whether the activities of the various advisory

20 committees established in the National Institutes of

21 Health regarding acquired immune deficiency syn22 drome are being coordinated sufficiently; and

23 (2) whether the functions of any of such advisory

24 committees should be modified in order to achieve

25 greater efficiency.
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1 (c) VACCINES FOR HUMAN IMMUNODEFICIENCY

2 VIRUS.—

3 (1) IN GENERAL.—The Secretary of Health and

4 Human Services, acting through the National Insti5 tutes of Health, shall develop a plan for the appro6 priate inclusion of HIV-infected women, including

7 pregnant women, HIV-infected infants, and HIV-in8 fected children in studies conducted by or through the

9 National Institutes of Health concerning the safety

10 and efficacy of HIV vaccines for the treatment and

11 prevention of HIV infection. Such plan shall ensure

12 the full participation of other Federal agencies cur13 rently conducting HIV vaccine studies and require

14 that such studies conform fully to the requirements of

15 part 46 of title 45, Code of Federal Regulations.

16 (2) REPORT.—Not later than 180 days after the

17 date of the enactment of this Act, the Secretary of

18 Health and Human Services shall prepare and sub19 mit to the Committee on Energy and Commerce of the

20 House of Representatives, and the Committee on

21 Labor and Human Resources of the Senate, a report

22 concerning the plan developed under paragraph (1).

23 (3) IMPLEMENTATION.—Not later than 12

24 months after the date of the enactment of this Act, the

25 Secretary of Health and Human Services shall imple-
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1 ment the plan developed under paragraph (1), includ2 ing measures for the full participation of other

3 Federal agencies currently conducting HIV vaccine

4 studies.

5 (4) For the purpose of carrying out this sub6 section, there are authorized to be appropriated such

7 sums as may be necessary for each of the fiscal years

8 1994 through 1996.

9 SEC. 1902. MALNUTRITION IN THE ELDERLY.

10 (a) STUDY.—

11 (1) IN GENERAL.—The Secretary of Health and

12 Human Services (referred to in this section as the

13 ‘‘Secretary’’), acting through the National Institute

14 on Aging, coordinating with the Agency for Health

15 Care Policy and Research and, to the degree possible,

16 in consultation with the head of the National Nutri17 tion Monitoring System established under section

18 1428 of the Food and Agriculture Act of 1977 (7

19 U.S.C. 3178), shall conduct a 3-year nutrition screen20 ing and intervention activities study of the elderly.

21 (2) EFFICACY AND COST-EFFECTIVENESS OF NU22 TRITION SCREENING AND INTERVENTION ACTIVI23 TIES.—In conducting the study, the Secretary shall

24 determine the efficacy and cost-effectiveness of nutri25 tion screening and intervention activities conducted
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1 in the elderly health and long-term care continuum,

2 and of a program that would institutionalize nutri3 tion screening and intervention activities. In evaluat4 ing such a program, the Secretary shall determine—

5 (A) if health or quality of life is measurably

6 improved for elderly individuals who receive rou7 tine nutritional screening and treatment;

8 (B) if federally subsidized home or institu9 tional care is reduced because of increased inde10 pendence of elderly individuals resulting from

11 improved nutritional status;

12 (C) if a multidisciplinary approach to nu13 tritional care is effective in addressing the nutri14 tional needs of elderly individuals; and

15 (D) if reimbursement for nutrition screen16 ing and intervention activities is a cost-effective

17 approach to improving the health status of elder18 ly individuals.

19 (3) POPULATIONS.—The populations of elderly

20 individuals in which the study will be conducted shall

21 include populations of elderly individuals who are—

22 (A) living independently, including—

23 (i) individuals who receive home and

24 community-based services or family sup25 port;
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1 (ii) individuals who do not receive ad2 ditional services and support;

3 (iii) individuals with low incomes; and

4 (iv) individuals who are minorities;

5 (B) hospitalized, including individuals ad6 mitted from home and from institutions; and

7 (C) institutionalized in residential facilities

8 such as nursing homes and adult homes.

9 (b) MALNUTRITION STUDY.—The Secretary, acting

10 through the National Institute on Aging, shall conduct a

11 3-year study to determine the extent of malnutrition in el12 derly individuals in hospitals and long-term care facilities

13 and in elderly individuals who are living independently.

14 (c) REPORT.—The Secretary shall submit a report to

15 the Committee on Labor and Human Resources of the Sen16 ate and the Committee on Energy and Commerce of the

17 House of Representatives containing the findings resulting

18 from the studies described in subsections (a) and (b), in19 cluding a determination regarding whether a program that

20 would institutionalize nutrition screening and intervention

21 activities should be adopted, and the rationale for the deter22 mination.

23 (d) ADVISORY PANEL.—

24 (1) ESTABLISHMENT.—The Secretary, acting

25 through the Director of the National Institute on
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1 Aging, shall establish an advisory panel that shall

2 oversee the design, implementation, and evaluation of

3 the studies described in subsections (a) and (b).

4 (2) COMPOSITION.—The advisory panel shall in5 clude representatives appointed for the life of the

6 panel by the Secretary from the Health Care Financ7 ing Administration, the Social Security Administra8 tion, the National Center for Health Statistics, the

9 Administration on Aging, the National Council on

10 the Aging, the American Dietetic Association, the

11 American Academy of Family Physicians, and such

12 other agencies or organizations as the Secretary deter13 mines to be appropriate.

14 (3) COMPENSATION AND EXPENSES.—

15 (A) COMPENSATION.—Each member of the

16 advisory panel who is not an employee of the

17 Federal Government shall receive compensation

18 at the daily equivalent of the rate specified for

19 level V of the Executive Schedule under section

20 5316 of title 5, United States Code, for each day

21 the member is engaged in the performance of du22 ties for the advisory panel, including attendance

23 at meetings and conferences of the panel, and

24 travel to conduct the duties of the panel.
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1 (B) TRAVEL EXPENSES.—Each member of

2 the advisory panel shall receive travel expenses,

3 including per diem in lieu of subsistence, at

4 rates authorized for employees of agencies under

5 subchapter I of chapter 57 of title 5, United

6 States Code, for each day the member is engaged

7 in the performance of duties away from the home

8 or regular place of business of the member.

9 (4) DETAIL OF FEDERAL EMPLOYEES.—On the

10 request of the advisory panel, the head of any Federal

11 agency shall detail, without reimbursement, any of

12 the personnel of the agency to the advisory panel to

13 assist the advisory panel in carrying out its duties.

14 Any detail shall not interrupt or otherwise affect the

15 civil service status or privileges of the Federal em16 ployee.

17 (5) TECHNICAL ASSISTANCE.—On the request of

18 the advisory panel, the head of a Federal agency shall

19 provide such technical assistance to the advisory

20 panel as the advisory panel determines to be nec21 essary to carry out its duties.

22 (6) TERMINATION.—Notwithstanding section 15

23 of the Federal Advisory Committee Act (5 U.S.C.

24 App.), the advisory panel shall terminate 3 years

25 after the date of enactment of this Act.
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1 SEC. 1903. RESEARCH ACTIVITIES ON CHRONIC FATIGUE

2 SYNDROME.

3 The Secretary of Health and Human Services shall,

4 not later than May 1, 1993, and annually thereafter for

5 the next 3 years, prepare and submit to the Committee on

6 Energy and Commerce of the House of Representatives and

7 the Committee on Labor and Human Resources of the Sen8 ate, a report that summarizes the research activities con9 ducted or supported by the National Institutes of Health

10 concerning chronic fatigue syndrome. Such report should

11 include information concerning grants made, cooperative

12 agreements or contracts entered into, intramural activities,

13 research priorities and needs, and a plan to address such

14 priorities and needs.

15 SEC. 1904. REPORT ON MEDICAL USES OF BIOLOGICAL

16 AGENTS IN DEVELOPMENT OF DEFENSES

17 AGAINST BIOLOGICAL WARFARE.

18 The Secretary of Health and Human Services, in con19 sultation with other appropriate executive agencies, shall

20 report to the House Energy and Commerce Committee and

21 the Senate Labor and Human Resources Committee on the

22 appropriateness and impact of the National Institutes of

23 Health assuming responsibility for the conduct of all Fed24 eral research, development, testing, and evaluation func25 tions relating to medical countermeasures against

26 biowarfare threat agents. In preparing the report, the Sec-
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1 retary shall identify the extent to which such activities are

2 carried out by agencies other than the National Institutes

3 of Health, and assess the impact (positive and negative) of

4 the National Institutes of Health assuming responsibility

5 for such activities, including the impact under the Budget

6 Enforcement Act and the Omnibus Budget Reconciliation

7 Act of 1990 on existing National Institutes of Health re8 search programs as well as other programs within the cat9 egory of domestic discretionary spending. The Secretary

10 shall submit the report not later than 12 months after the

11 date of the enactment of this Act.

12 SEC. 1905. PERSONNEL STUDY OF RECRUITMENT, RETEN13 TION AND TURNOVER.

14 (a) STUDY OF PERSONNEL SYSTEM.—Not later than

15 1 year after the date of the enactment of this Act, the Sec16 retary of Health and Human Services, acting through the

17 Director of the National Institutes of Health, shall conduct

18 a study to review the retention, recruitment, vacancy and

19 turnover rates of support staff, including firefighters, law

20 enforcement, procurement officers, technicians, nurses and

21 clerical employees, to ensure that the National Institutes of

22 Health is adequately supporting the conduct of efficient, ef23 fective and high quality research for the American public.

24 The Director of NIH shall work in conjunction with appro-
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1 priate employee organizations and representatives in devel2 oping such a study.

3 (b) SUBMISSION TO CONGRESS.—Not later than 1 year

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

5 of Health and Human Services shall prepare and submit

6 to the Committee on Energy and Commerce of the House

7 of Representatives, and to the Committee on Labor and

8 Human Resources of the Senate, a report containing the

9 study conducted under subsection (a) together with the rec10 ommendations of the Secretary concerning the enactment

11 of legislation to implement the results of such study.

12 SEC. 1906. PROCUREMENT.

13 (a) IN GENERAL.—The Director of the National Insti14 tutes of Health and the Administrator of the General Serv15 ices Administration shall jointly conduct a study to develop

16 a streamlined procurement system for the National Insti17 tutes of Health that complies with the requirements of Fed18 eral law.

19 (b) REPORT.—Not later than March 1, 1994, the offi20 cials specified in subsection (a) shall complete the study re21 quired in such subsection and shall submit to the Committee

22 on Energy and Commerce of the House of Representatives,

23 and the Committee on Labor and Human Resources of the

24 Senate, a report describing the findings made as a result

25 of the study.
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1 SEC. 1907. CHRONIC PAIN CONDITIONS.

2 (a) IN GENERAL.—The Director of the National Insti3 tutes of Health (in this section referred to as the ‘Director’),

4 acting through the Director of the National Institute of Den5 tal Research and as appropriate through the heads of other

6 agenices of such Institutes, shall conduct a study for the

7 purpose of determining the incidence in the United States

8 of cases of chronic pain and the effect of such cases on the

9 costs of health care in the United States.

10 (b) CERTAIN ELEMENTS OF STUDY.—The cases of

11 chronic pain with respect to which the study required in

12 subsection (a) is conducted shall include reflex sympathetic

13 dystrophy syndrome, temporomandibular joint disorder,

14 post-herpetic neuropathy, painful diabetic neuropathy,

15 phantom pain, and post-stroke pain.

16 (c) REPORT.—Not later than 2 years after the date of

17 the enactment of this Act, the Director shall complete the

18 study required in subsection (a) and submit to the the Com19 mittee on Energy and Commerce of the House of Represent20 atives, and to the Committee on Labor and Human Re21 sources of the Senate, a report describing the findings made

22 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; LIMITATION ON NUMBER OF MEM6 BERS.

7 (a) IN GENERAL.—Section 228(a) of the Public Health

8 Service Act (42 U.S.C. 237(a)), as added by section 304

9 of Public Law 101–509, is amended to read as follows:

10 ‘‘(a)(1) There shall be in the Public Health Service a

11 Silvio O. Conte Senior Biomedical Research Service, not

12 to exceed 750 members.

13 ‘‘(2) The authority established in paragraph (1) re14 garding the number of members in the Silvio O. Conte Sen15 ior Biomedical Research Service is in addition to any au16 thority established regarding the number of members in the

17 commissioned Regular Corps, in the Reserve Corps, and in

18 the Senior Executive Service. Such paragraph may not be

19 construed to require that the number of members in the com20 missioned Regular Corps, in the Reserve Corps, or in the

21 Senior Executive Service be reduced to offset the number

22 of members serving in the Silvio O. Conte Senior Bio23 medical Research Service (hereafter in this section referred

24 to as the ‘Service’).’’.
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1 (b) CONFORMING AMENDMENT.—Section 228 of the

2 Public Health Service Act (42 U.S.C. 237), as added by

3 section 304 of Public Law 101–509, is amended in the head4 ing for the section by amending the heading to read as fol5 lows:

6 ‘‘SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH

7 SERVICE’’.

8 SEC. 2002. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE

9 FOR RESEARCH.

10 Not later than 18 months after the date of the enact11 ment of this Act, the Secretary of Health and Human Serv12 ices, acting through the Director of the National Institutes

13 of Health, shall present to the Congress a master plan to

14 provide for the replacement or refurbishment of less than

15 adequate buildings, utility equipment and distribution sys16 tems (including the resources that provide electrical and

17 other utilities, chilled water, air handling, and other serv18 ices that the Secretary, acting through the Director, deems

19 necessary), roads, walkways, parking areas, and grounds

20 that underpin the laboratory and clinical facilities of the

21 National Institutes of Health. Such plan may make rec22 ommendations for the undertaking of new projects that are

23 consistent with the objectives of this section, such as encir24 cling the National Institutes of Health Federal enclave with

25 an adequate chilled water conduit.
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1 SEC. 2003. CERTAIN AUTHORIZATION OF APPROPRIATIONS.

2 Section 399L(a) of the Public Health Service Act (42

3 U.S.C. 280e–4(a)), as added by Public Law 102–515 (106

4 Stat. 3376), is amended—

5 (1) in the first sentence, by striking ‘‘the Sec6 retary’’ and all that follows and inserting the follow7 ing: ‘‘there are authorized to be appropriated

8 $30,000,000 for fiscal year 1994, and such sums as

9 may be necessary for each of the fiscal years 1995

10 through 1996.’’; and

11 (2) in the second sentence, by striking ‘‘Out of

12 any amounts used’’ and inserting ‘‘Of the amounts

13 appropriated under the preceding sentence’’.

14 TITLE XXI—EFFECTIVE DATES

15 SEC. 2101. EFFECTIVE DATES.

16 Subject to section 165, this Act and the amendments

17 made by this Act take effect upon the date of the enactment

18 of this Act.

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