103D CONGRESS

1ST SESSION S. 1

AN ACT

To amend the Public Health Service Act to revise

tutes of Health, and for other purposes.and extend the programs of the National Insti-
103D CONGRESS

1ST SESSION S. 1

AN ACT

To amend the Public Health Service Act to revise and extend

the programs of the National Institutes of Health, and

for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

5 ‘‘National Institutes of Health Revitalization Act of

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

2 this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I—GENERAL PROVISIONS REGARDING TITLE IV OF

PUBLIC HEALTH SERVICE ACT

Subtitle A—Research Freedom

PART I—REVIEW OF PROPOSALS FOR BIOMEDICAL AND BEHAVIORAL

RESEARCH

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

supported by National Institutes of Health.

PART II—RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

Sec. 111. Establishment of authorities.

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

as directed donation for use in transplantation.

Sec. 113. Report by General Accounting Office on adequacy of requirements.

PART III—MISCELLANEOUS REPEALS

Sec. 121. Repeals.

Subtitle B—Clinical Research Equity Regarding Women and Minorities

PART I—WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH

Sec. 131. Requirement of inclusion in research.

Sec. 132. Peer review.

Sec. 133. Applicability to current projects.

PART II—OFFICE OF RESEARCH ON WOMEN’S HEALTH

Sec. 141. Establishment.

PART III—OFFICE OF RESEARCH ON MINORITY HEALTH

Sec. 151. Establishment.

Subtitle C—Scientific Integrity

Sec. 161. Establishment of Office of Scientific Integrity.

Sec. 162. Commission on Scientific Integrity.

Sec. 163. Protection of whistleblowers.

Sec. 164. Requirement of regulations regarding protection against financial

conflicts of interest in certain projects of research.

Sec. 165. Effective dates.

TITLE II—NATIONAL INSTITUTES OF HEALTH IN GENERAL

Sec. 201. Health promotion research dissemination.

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

Sec. 203. Children’s vaccine initiative.
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Sec. 204. Plan for use of animals in research.

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

minorities in fields of biomedical and behavioral research.

Sec. 206. Requirements regarding surveys of sexual behavior.

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

Sec. 208. Miscellaneous provisions.

TITLE III—GENERAL PROVISIONS RESPECTING NATIONAL

RESEARCH INSTITUTES

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

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

bone disorders.

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

TITLE IV—NATIONAL CANCER INSTITUTE

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

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

Sec. 403. Authorization of appropriations.

TITLE V—NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

Sec. 501. Education and training.

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

Sec. 503. National Center on Sleep Disorders Research.

Sec. 504. Authorization of appropriations.

TITLE VI—NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE

AND KIDNEY DISEASES

Sec. 601. Provisions regarding nutritional disorders.

TITLE VII—NATIONAL INSTITUTE ON ARTHRITIS AND

MUSCULOSKELETAL AND SKIN DISEASES

Sec. 701. Juvenile arthritis.

TITLE VIII—NATIONAL INSTITUTE ON AGING

Sec. 801. Alzheimer’s disease registry.

Sec. 802. Aging processes regarding women.

Sec. 803. Authorization of appropriations.

Sec. 804. Conforming amendment.

TITLE IX—NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS

DISEASES

Sec. 901. Tropical diseases.

Sec. 902. Chronic fatigue syndrome.

TITLE X—NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN

DEVELOPMENT

Subtitle A—Research Centers With Respect to Contraception and Research

Centers With Respect to Infertility

Sec. 1001. Grants and contracts for research centers.
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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 and health services research on eye care and diabetes.

TITLE XII—NATIONAL INSTITUTE OF NEUROLOGICAL

DISORDERS AND STROKE

Sec. 1201. Research on multiple sclerosis.

TITLE XIII—NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH

SCIENCES

Sec. 1301. Applied Toxicological Research and Testing Program.

TITLE XIV—NATIONAL LIBRARY OF MEDICINE

Subtitle A—General Provisions

Sec. 1401. Additional authorities.

Sec. 1402. Authorization of appropriations.

Subtitle B—Financial Assistance

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

technologies.

Subtitle C—National Information Center on Health Services Research and

Health Care Technology

Sec. 1421. Establishment of Center.

Sec. 1422. Conforming provisions.

TITLE XV—OTHER AGENCIES OF NATIONAL INSTITUTES OF

HEALTH

Subtitle A—Division of Research Resources

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

Sec. 1502. Biomedical and behavioral research facilities.

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

Subtitle B—National Center for Nursing Research

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

Institute of Nursing Research.
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Sec. 1512. Study on adequacy of number of nurses.

Subtitle C—National Center for Human Genome Research

Sec. 1521. Purpose of Center.

TITLE XVI—AWARDS AND TRAINING

Subtitle A—National Research Service Awards

Sec. 1601. Requirement regarding women and individuals from disadvantaged

backgrounds.

Sec. 1602. Service payback requirements.

Subtitle B—Acquired Immune Deficiency Syndrome

Sec. 1611. Loan repayment program.

Subtitle C—Loan Repayment for Research Generally

Sec. 1621. Establishment of program.

Subtitle D—Scholarship and Loan Repayment Programs Regarding

Professional Skills Needed by Certain Agencies

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

Sec. 1632. Funding.

Subtitle E—Funding

Sec. 1641. Authorization of appropriations.

TITLE XVII—NATIONAL FOUNDATION FOR BIOMEDICAL

RESEARCH

Sec. 1701. National Foundation for Biomedical Research.

TITLE XVIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE

DEFICIENCY SYNDROME

Sec. 1801. Revision and extension of various programs.

TITLE XIX—STUDIES

Sec. 1901. Acquired immune deficiency syndrome.

Sec. 1902. Malnutrition in the elderly.

Sec. 1903. Research activities on chronic fatigue syndrome.

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

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

Sec. 1906. Procurement.

Sec. 1907. Report concerning leading causes of death.

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

Sec. 1909. Cost of care in last 6 months of life.

Sec. 1910. Reducing administrative health care costs.

Sec. 1911. Study concerning radioisotopes.

Sec. 1912. Medical technologies productivity study.

Sec. 1913. Sentinel disease concept study.

Sec. 1914. Congressional appropriation of federally supported disease research.
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TITLE XX—MISCELLANEOUS PROVISIONS

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

Silvio O. Conte, and limitation on number of members.

Sec. 2002. Technical corrections.

Sec. 2003. Technical corrections with respect to the Agency for Health Care

Policy and Research.

Sec. 2004. Technical corrections with respect to the Health Professions Education Extension Amendments of 1992.

Sec. 2005. Biennial report on carcinogens.

Sec. 2006. Master plan for physical infrastructure for research.

Sec. 2007. Transfer of provisions of title XXVII.

Sec. 2008. Certain authorization of appropriations.

Sec. 2009. Prohibition against SHARP adult sex survey and the American

teenage sex survey.

Sec. 2010. Support for bioengineering research.

Sec. 2011. Admission to the United States of aliens infected with the AIDS

virus.

Sec. 2012. Sense of the Congress regarding action on a request for certain

waivers under the medicaid program.

Sec. 2013. Authorization of appropriations.

Sec. 2014. Vaccine injury compensation program.

TITLE XXI—EFFECTIVE DATES

Sec. 2101. Effective dates.

1 TITLE I—GENERAL PROVISIONS

2 REGARDING TITLE IV OF PUB3 LIC HEALTH SERVICE ACT

4 Subtitle A—Research Freedom

5 PART I—REVIEW OF PROPOSALS FOR

6 BIOMEDICAL AND BEHAVIORAL RESEARCH

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

10 HEALTH.

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

12 (42 U.S.C. 289 et seq.) is amended by inserting after sec13 tion 492 the following new section:
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1 ‘‘CERTAIN PROVISIONS REGARDING REVIEW AND

2 APPROVAL OF PROPOSALS FOR RESEARCH

3 ‘‘SEC. 492A. (a) REVIEW AS PRECONDITION TO RE4 SEARCH.—

5 ‘‘(1) PROTECTION OF HUMAN RESEARCH SUB6 JECTS.—

7 ‘‘(A) In the case of any application submit8 ted to the Secretary for financial assistance to

9 conduct research, the Secretary may not ap10 prove or fund any application that is subject to

11 review under section 491(a) by an Institutional

12 Review Board unless the application has under13 gone review in accordance with such section and

14 has been recommended for approval by a major15 ity of the members of the Board conducting

16 such review.

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

18 to review under procedures established by the

19 Secretary for the protection of human subjects

20 in clinical research conducted by the National

21 Institutes of Health, the Secretary may not au22 thorize the conduct of the research unless the

23 research has, pursuant to such procedures, been

24 recommended for approval.
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1 ‘‘(2) PEER REVIEW.—In the case of any appli2 cation submitted to the Secretary for financial as3 sistance to conduct research, the Secretary may not

4 approve or fund any application that is subject to

5 technical and scientific peer review under section

6 492(a) unless the application has undergone peer re7 view in accordance with such section and has been

8 recommended for approval by a majority of the

9 members of the entity conducting such review.

10 ‘‘(b) ETHICAL REVIEW OF RESEARCH.—

11 ‘‘(1) PROCEDURES REGARDING WITHHOLDING

12 OF FUNDS.—If research has been recommended for

13 approval for purposes of subsection (a), the Sec14 retary may not withhold funding for the research on

15 ethical grounds unless—

16 ‘‘(A) the Secretary convenes an advisory

17 board in accordance with paragraph (4) to

18 study the ethical implications of the research;

19 and

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

21 recommends that, on ethical grounds, the Sec22 retary withhold funds for the research; or

23 ‘‘(ii) the majority of such board rec24 ommends that the Secretary not withhold funds

25 for the research on ethical grounds, but the
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1 Secretary finds, on the basis of the report sub2 mitted under paragraph (4)(B)(ii), that there is

3 a reasonable basis for overruling the board’s

4 recommendations.

5 ‘‘(2) APPLICABILITY.—The limitation estab6 lished in paragraph (1) regarding the authority to

7 withhold funds on ethical grounds shall apply with8 out regard to whether the withholding such funds is

9 characterized as a disapproval, a moratorium, a pro10 hibition, or other description.

11 ‘‘(3) PRELIMINARY MATTERS REGARDING USE

12 OF PROCEDURES.—

13 ‘‘(A) If the Secretary makes a determina14 tion that an advisory board should be convened

15 for purposes of paragraph (1), the Secretary

16 shall, through a statement published in the

17 Federal Register, announce the intention of the

18 Secretary to convene such a board.

19 ‘‘(B) A statement issued under subpara20 graph (A) shall include a request that inter21 ested individuals submit to the Secretary rec22 ommendations specifying the particular individ23 uals who should be appointed to the advisory

24 board involved. The President shall consider
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1 such recommendations in making appointments

2 to the board.

3 ‘‘(C) The President may not make appoint4 ments to an advisory board under paragraph

5 (1) until the expiration of the 30-day period be6 ginning on the date on which the statement re7 quired in subparagraph (A) is made with re8 spect to the board.

9 ‘‘(4) ETHICS ADVISORY BOARDS.—

10 ‘‘(A) Any advisory board convened for pur11 poses of paragraph (1) shall be known as an

12 ethics advisory board (hereafter in this para13 graph referred to as an ‘ethics board’).

14 ‘‘(B)(i) An ethics board shall advise, con15 sult with, and make recommendations to the

16 Secretary regarding the ethics of the project of

17 biomedical or behavioral research with respect

18 to which the board has been convened.

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

20 date on which the statement required in para21 graph (3)(A) is made with respect to an ethics

22 board, the board shall submit to the Secretary,

23 and to the Committee on Energy and Com24 merce of the House of Representatives and the

25 Committee on Labor and Human Resources of
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1 the Senate, a report describing the findings of

2 the board regarding the project of research in3 volved and making a recommendation under

4 clause (i) of whether the Secretary should or

5 should not withhold funds for the project. The

6 report shall include the information considered

7 in making the findings.

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

9 no fewer than 14, and no more than 20, indi10 viduals who are not officers or employees of the

11 United States. The President shall make ap12 pointments to the board from among individ13 uals with special qualifications and competence

14 to provide advice and recommendations regard15 ing ethical matters in biomedical and behavioral

16 research. Of the members of the board—

17 ‘‘(i) no fewer than 1 shall be an attor18 ney;

19 ‘‘(ii) no fewer than 1 shall be an

20 ethicist;

21 ‘‘(iii) no fewer than 1 shall be a prac22 ticing physician;

23 ‘‘(iv) no fewer than 1 shall be a theo24 logian; and
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1 ‘‘(v) no fewer than one-third, and no

2 more than one-half, shall be scientists with

3 substantial accomplishments in biomedical

4 or behavioral research.

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

6 an ethics board shall be for the life of the

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

8 term of such service, the individual appointed to

9 fill the resulting vacancy shall be appointed for

10 the remainder of the term of the predecessor of

11 the individual.

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

13 subject to removal from the board by the Presi14 dent for neglect of duty or malfeasance or for

15 other good cause shown.

16 ‘‘(F) The President shall designate an in17 dividual from among the members of an ethics

18 board to serve as the chair of the board.

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

20 with respect to a project of research, an ethics

21 board shall conduct inquiries and hold public

22 hearings.

23 ‘‘(H) With respect to information relevant

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

25 an ethics board shall have access to all such in-
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1 formation possessed by the Department of

2 Health and Human Services, or available to the

3 Secretary from other agencies.

4 ‘‘(I) Members of an ethics board shall re5 ceive compensation for each day engaged in car6 rying out the duties of the board, including

7 time engaged in traveling for purposes of such

8 duties. Such compensation may not be provided

9 in an amount in excess of the maximum rate of

10 basic pay payable for GS–18 of the General

11 Schedule.

12 ‘‘(J) The Secretary, acting through the Di13 rector of the National Institutes of Health,

14 shall provide to each ethics board such reason15 able staff and assistance as may be necessary to

16 carry out the duties of the board.

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

18 days after the date on which the report required

19 in subparagraph (B)(ii) is submitted to the Sec20 retary and the congressional committees speci21 fied in such subparagraph.’’.
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1 PART II—RESEARCH ON TRANSPLANTATION OF

2 FETAL TISSUE

3 SEC. 111. ESTABLISHMENT OF AUTHORITIES.

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

5 (42 U.S.C. 289 et seq.) is amended by inserting after sec6 tion 498 the following new section:

7 ‘‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

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

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

10 or support research on the transplantation of human

11 fetal tissue for therapeutic purposes.

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

13 may be used in research carried out under para14 graph (1) regardless of whether the tissue is ob15 tained pursuant to a spontaneous or induced abor16 tion or pursuant to a stillbirth.

17 ‘‘(b) INFORMED CONSENT OF DONOR.—

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

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

20 used only if the woman providing the tissue makes

21 a statement, made in writing and signed by the

22 woman, declaring that—

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

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

25 ‘‘(B) the donation is made without any re26 striction regarding the identity of individuals
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1 who may be the recipients of transplantations

2 of the tissue; and

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

4 the identity of any such individuals.

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

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

7 may be used only if the attending physician with re8 spect to obtaining the tissue from the woman in9 volved makes a statement, made in writing and

10 signed by the physician, declaring that—

11 ‘‘(A) in the case of tissue obtained pursu12 ant to an induced abortion—

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

14 abortion was obtained prior to requesting

15 or obtaining consent for the tissue to be

16 used in such research; and

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

18 method, or procedures used to terminate

19 the pregnancy was made solely for the pur20 poses of obtaining the tissue;

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

22 woman in accordance with paragraph (1); and

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

24 the woman with regard to—
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1 ‘‘(i) such physician’s interest, if any,

2 in the research to be conducted with the

3 tissue; and

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

5 woman or risks to her privacy that might

6 be associated with the donation of the tis7 sue and that are in addition to risks of

8 such type that are associated with the

9 woman’s medical care.

10 ‘‘(c) INFORMED CONSENT OF RESEARCHER AND

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

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

13 the principal responsibility for conducting the research in14 volved makes a statement, made in writing and signed by

15 the individual, declaring that the individual—

16 ‘‘(1) is aware that—

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

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

19 pursuant to a spontaneous or induced abortion

20 or subsequent to a stillbirth; and

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

22 purposes;

23 ‘‘(2) has provided such information to other in24 dividuals with responsibilities regarding the research;
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1 ‘‘(3) will require, prior to obtaining the consent

2 of an individual to be a recipient of a transplan3 tation of the tissue, written acknowledgment of re4 ceipt of such information by such recipient; and

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

6 timing, method, or procedures used to terminate the

7 pregnancy made solely for the purposes of the re8 search.

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

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

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

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

13 conducting the research involved certifies to the Sec14 retary that the statements required under sub15 sections (b)(1), (b)(2), and (c) will be available for

16 audit by the Secretary.

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

18 conducted by the Secretary pursuant to paragraph

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

20 protect the privacy rights of the individuals and enti21 ties involved in such research, including such indi22 viduals and entities involved in the donation, trans23 fer, receipt, or transplantation of human fetal tissue.

24 With respect to any material or information obtained

25 pursuant to such audit, the Secretary shall—
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1 ‘‘(A) use such material or information only

2 for the purposes of verifying compliance with

3 the requirements of this section;

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

5 or information, except where required by Fed6 eral law, in which case such material or infor7 mation shall be coded in a manner such that

8 the identities of such individuals and entities

9 are protected; and

10 ‘‘(C) not maintain such material or infor11 mation after completion of such audit, except

12 where necessary for the purposes of such audit.

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

14 ‘‘(1) RESEARCH CONDUCTED BY RECIPIENTS

15 OF ASSISTANCE.—The Secretary may not provide

16 support for research under subsection (a) unless the

17 applicant agrees to conduct the research in accord18 ance with applicable State and local law.

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

20 The Secretary may conduct research under sub21 section (a) only in accordance with applicable State

22 and local law.

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

24 term ‘human fetal tissue’ means tissue or cells obtained
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1 from a dead human embryo or fetus after a spontaneous

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

3 SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITA4 TION OR ACCEPTANCE OF TISSUE AS DI5 RECTED DONATION FOR USE IN TRANSPLAN6 TATION.

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

8 as amended by section 111 of this Act, is amended by in9 serting after section 498A the following new section:

10 ‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE

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

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

13 otherwise transfer any human fetal tissue for valuable con14 sideration if the transfer affects interstate commerce.

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

16 DIRECTED DONATION FOR USE IN TRANSPLANTATION.—

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

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

19 for the purpose of transplantation of such tissue into an20 other person if the donation affects interstate commerce,

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

22 abortion, and—

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

24 to a promise to the donating individual that the do25 nated tissue will be transplanted into a recipient

26 specified by such individual;
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1 ‘‘(2) the donated tissue will be transplanted

2 into a relative of the donating individual; or

3 ‘‘(3) the person who solicits or knowingly ac4 quires, receives, or accepts the donation has provided

5 valuable consideration for the costs associated with

6 such abortion.

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

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

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

10 with title 18, United States Code, subject to para11 graph (2), or imprisoned for not more than 10

12 years, or both.

13 ‘‘(2) PENALTIES APPLICABLE TO PERSONS RE14 CEIVING CONSIDERATION.—With respect to the im15 position of a fine under paragraph (1), if the person

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

17 be imposed in an amount not less than twice the

18 amount of the valuable consideration received.

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

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

21 meaning given such term in section 498A(e).

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

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

24 Federal Food, Drug, and Cosmetic Act.
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1 ‘‘(3) The term ‘valuable consideration’ does not

2 include reasonable payments associated with the

3 transportation, implantation, processing, preserva4 tion, quality control, or storage of human fetal tis5 sue.’’.

6 SEC. 113. REPORT BY GENERAL ACCOUNTING OFFICE ON

7 ADEQUACY OF REQUIREMENTS.

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

9 transplantation of human fetal tissue for therapeutic pur10 poses, the Comptroller General of the United States shall

11 conduct an audit for the purpose of determining—

12 (1) whether and to what extent such research

13 conducted or supported by the Secretary of Health

14 and Human Services has been conducted in accord15 ance with section 498A of the Public Health Service

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

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

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

19 section 112 of this Act).

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

21 Comptroller General of the United States shall complete

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

23 Committee on Energy and Commerce of the House of

24 Representatives, and to the Committee on Labor and
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1 Human Resources of the Senate, a report describing the

2 findings made pursuant to the audit.

3 PART III—MISCELLANEOUS REPEALS

4 SEC. 121. REPEALS.

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

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

7 is amended by striking part J.

8 (b) OTHER REPEALS.—Part G of title IV of the Pub9 lic Health Service Act (42 U.S.C. 289 et seq.) is amend10 ed—

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

12 and

13 (2) by striking section 499; and

14 (3) by redesignating section 499A as section

15 499.

16 (c) NULLIFICATION OF CERTAIN REGULATION.—The

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

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

19 not have any legal effect.
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1 Subtitle B—Clinical Research Eq2 uity Regarding Women and Mi3 norities

4 PART I—WOMEN AND MINORITIES AS SUBJECTS

5 IN CLINICAL RESEARCH

6 SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.

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

8 as amended by section 101 of this Act, is amended by in9 serting after section 492A the following new section:

10 ‘‘INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

11 RESEARCH

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

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

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

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

16 project of such research; and

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

18 as subjects in such research.

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

20 regarding women and members of minority groups shall

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

22 as subjects in the project, of women and members of mi23 nority groups, respectively—

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

25 of the subjects;
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1 ‘‘(2) is inappropriate with respect to the pur2 pose of the research; or

3 ‘‘(3) is inappropriate under such other cir4 cumstances as the Director of NIH may designate.

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

6 in which women or members of minority groups will under

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

8 Director of NIH shall ensure that the project is designed

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

10 valid analysis of whether the variables being tested in the

11 research affect women or members of minority groups, as

12 the case may be, differently than other subjects in the re13 search.

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

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

16 the Director of the Office of Research on Minority Health,

17 shall establish guidelines regarding—

18 ‘‘(A) the circumstances under which the inclu19 sion of women and minorities in projects of clinical

20 research is inappropriate for purposes of subsection

21 (b);

22 ‘‘(B) the manner in which such projects are re23 quired to be designed and carried out for purposes

24 of subsection (c), including a specification of the cir25 cumstances in which the requirement of such sub-
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1 section does not apply on the basis of impracticabil2 ity; and

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

4 recruitment of women and members of minority

5 groups as subjects in such research.

6 ‘‘(2) The guidelines established under paragraph

7 (1)—

8 ‘‘(A) may not provide that the cost of including

9 women and minorities in clinical research is a per10 missible consideration regarding the circumstances

11 described in subparagraph (A) of such paragraph;

12 and

13 ‘‘(B) may provide that such circumstances in14 clude circumstances in which there are scientific rea15 sons for believing that the variables proposed to be

16 studied do not affect women or minorities differently

17 than other subjects in the research.

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

19 be established and published in the Federal Register not

20 later than 180 days after the date of the enactment of

21 the National Institutes of Health Revitalization Act of

22 1993.

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

24 the Director of NIH may not provide funding for any

25 project of clinical research to be conducted or supported
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1 by any agency of the National Institutes of Health unless

2 the project specifies the manner in which the research will

3 comply with subsection (a).

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

5 institute shall annually submit to the Director of NIH and

6 the Director of the institute involved a report describing

7 the manner in which the agency has complied with sub8 section (a).’’.

9 SEC. 132. PEER REVIEW.

10 Section 492 of the Public Health Service Act (42

11 U.S.C. 289a) is amended by adding at the end the follow12 ing new subsection:

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

14 this section of proposals for clinical research, the consider15 ation of any such proposed project (including the initial

16 consideration) shall, except as provided in paragraph (2),

17 include an evaluation of the technical and scientific merit

18 of the proposed project regarding compliance with section

19 492B(a).

20 ‘‘(2) Paragraph (1) shall not apply to any proposed

21 project for clinical research that, pursuant to subsection

22 (b) of section 492B, is not subject to the requirement of

23 subsection (a) of such section regarding the inclusion of

24 women and members of minority groups as subjects in

25 clinical research.’’.
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1 SEC. 133. APPLICABILITY TO CURRENT PROJECTS.

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

3 added by section 131 of this Act, shall not apply with re4 spect to projects of clinical research for which initial fund5 ing was provided prior to the date of the enactment of

6 this Act. With respect to the inclusion of women and mi7 norities as subjects in clinical research conducted or sup8 ported by the National Institutes of Health, any policies

9 of the Secretary of Health and Human Services regarding

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

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

12 the projects referred to in the preceding sentence.

13 PART II—OFFICE OF RESEARCH ON WOMEN’S

14 HEALTH

15 SEC. 141. ESTABLISHMENT.

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

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

18 613, is amended—

19 (1) by redesignating section 486 as section

20 485A;

21 (2) by redesignating parts F through H as

22 parts G through I, respectively; and

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

24 part:
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1 ‘‘PART F—RESEARCH ON WOMEN’S HEALTH

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

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

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

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

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

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

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

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

10 health that should be conducted or supported by the

11 national research institutes;

12 ‘‘(2) identify multidisciplinary research relating

13 to research on women’s health that should be so con14 ducted or supported;

15 ‘‘(3) carry out paragraphs (1) and (2) with re16 spect to the aging process in women, with priority

17 given to menopause;

18 ‘‘(4) promote coordination and collaboration

19 among entities conducting research identified under

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

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

22 entities receiving funds from the national research

23 institutes;

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

25 supporting such research;
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1 ‘‘(7) promote the sufficient allocation of the re2 sources of the national research institutes for con3 ducting and supporting such research;

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

5 492B with respect to the inclusion of women as sub6 jects in clinical research; and

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

8 486B.

9 ‘‘(c) COORDINATING COMMITTEE.—

10 ‘‘(1) In carrying out subsection (b), the Direc11 tor of the Office shall establish a committee to be

12 known as the Coordinating Committee on Research

13 on Women’s Health (hereafter in this subsection re14 ferred to as the ‘Coordinating Committee’).

15 ‘‘(2) The Coordinating Committee shall be com16 posed of the Directors of the national research insti17 tutes (or the designees of the Directors) and other

18 appropriate entities.

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

20 the chair of the Coordinating Committee.

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

22 health, the Coordinating Committee shall assist the

23 Director of the Office in—

24 ‘‘(A) identifying the need for such re25 search, and making an estimate each fiscal year
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1 of the funds needed to adequately support the

2 research;

3 ‘‘(B) identifying needs regarding the co4 ordination of research activities, including in5 tramural and extramural multidisciplinary ac6 tivities;

7 ‘‘(C) supporting the development of meth8 odologies to determine the circumstances in

9 which obtaining data specific to women (includ10 ing data relating to the age of women and the

11 membership of women in ethnic or racial

12 groups) is an appropriate function of clinical

13 trials of treatments and therapies;

14 ‘‘(D) supporting the development and ex15 pansion of clinical trials of treatments and

16 therapies for which obtaining such data has

17 been determined to be an appropriate function;

18 and

19 ‘‘(E) encouraging the national research in20 stitutes to conduct and support such research,

21 including such clinical trials.

22 ‘‘(d) ADVISORY COMMITTEE.—

23 ‘‘(1) In carrying out subsection (b), the Direc24 tor of the Office shall establish an advisory commit25 tee to be known as the Advisory Committee on Re-
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1 search on Women’s Health (hereafter in this sub2 section referred to as the ‘Advisory Committee’).

3 ‘‘(2)(A) The Advisory Committee shall be com4 posed of no fewer than 12, and not more than 18

5 individuals, who are not officers or employees of the

6 Federal Government. The Director of the Office

7 shall make appointments to the Advisory Committee

8 from among physicians, practitioners, scientists, and

9 other health professionals, whose clinical practice,

10 research specialization, or professional expertise in11 cludes a significant focus on research on women’s

12 health. A majority of the members of the Advisory

13 Committee shall be women.

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

15 receive compensation for each day engaged in carry16 ing out the duties of the Committee, 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 pay

20 payable for GS–18 of the General Schedule.

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

22 the chair of the Advisory Committee.

23 ‘‘(4) The Advisory Committee shall—

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

25 appropriate research activities to be undertaken
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1 by the national research institutes with respect

2 to—

3 ‘‘(i) research on women’s health;

4 ‘‘(ii) research on gender differences in

5 clinical drug trials, including responses to

6 pharmacological drugs;

7 ‘‘(iii) research on gender differences

8 in disease etiology, course, and treatment;

9 ‘‘(iv) research on obstetrical and gyne10 cological health conditions, diseases, and

11 treatments; and

12 ‘‘(v) research on women’s health con13 ditions which require a multidisciplinary

14 approach;

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

16 on such research;

17 ‘‘(C) provide recommendations to such Di18 rector regarding activities of the Office (includ19 ing recommendations on the development of the

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

21 and recommendations on priorities in carrying

22 out research described in subparagraph (A));

23 and
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1 ‘‘(D) assist in monitoring compliance with

2 section 492B regarding the inclusion of women

3 in clinical research.

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

5 a biennial report describing the activities of the

6 Committee, including findings made by the Commit7 tee regarding—

8 ‘‘(i) compliance with section 492B;

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

10 research on women’s health by the agencies of

11 the National Institutes of Health; and

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

13 research.

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

15 shall be submitted to the Director of NIH for inclu16 sion in the report required in section 403.

17 ‘‘(e) REPRESENTATION OF WOMEN AMONG RE18 SEARCHERS.—The Secretary, acting through the Assist19 ant Secretary for Personnel and in collaboration with the

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

21 women are represented among senior physicians and sci22 entists of the national research institutes and among phy23 sicians and scientists conducting research with funds pro24 vided by such institutes, and as appropriate, carry out ac25 tivities to increase the extent of such representation.
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1 ‘‘(f) DEFINITIONS.—For purposes of this part:

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

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

4 groups, means all diseases, disorders, and conditions

5 (including with respect to mental health)—

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

7 prevalent in women;

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

9 or types of medical intervention are different

10 for women, or for which it is unknown whether

11 such factors or types are different for women;

12 or

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

14 insufficient clinical research involving women as

15 subjects or insufficient clinical data on women.

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

17 means research on women’s health conditions, in18 cluding research on preventing such conditions.

19 ‘‘SEC. 486A. NATIONAL DATA SYSTEM AND CLEARING20 HOUSE ON RESEARCH ON WOMEN’S HEALTH.

21 ‘‘(a) DATA SYSTEM.—

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

23 the Director of the Office, shall establish a data sys24 tem for the collection, storage, analysis, retrieval,

25 and dissemination of information regarding research
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1 on women’s health that is conducted or supported by

2 the national research institutes. Information from

3 the data system shall be available through informa4 tion systems available to health care professionals

5 and providers, researchers, and members of the

6 public.

7 ‘‘(2) The data system established under para8 graph (1) shall include a registry of clinical trials of

9 experimental treatments that have been developed

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

11 include information on subject eligibility criteria,

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

13 trial site or sites. Principal investigators of such

14 clinical trials shall provide this information to the

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

16 trial has been completed, the principal investigator

17 shall provide the registry with information pertain18 ing to the results, including potential toxicities or

19 adverse effects associated with the experimental

20 treatment or treatments evaluated.

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

22 consultation with the Director of the Office and with the

23 National Library of Medicine, shall establish, maintain,

24 and operate a program to provide information on research
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1 and prevention activities of the national research institutes

2 that relate to research on women’s health.

3 ‘‘SEC. 486B. BIENNIAL REPORT.

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

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

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

7 a report—

8 ‘‘(1) describing and evaluating the progress

9 made during the preceding 2 fiscal years in research

10 and treatment conducted or supported by the Na11 tional Institutes of Health;

12 ‘‘(2) describing and analyzing the professional

13 status of women physicians and scientists of such

14 Institutes, including the identification of problems

15 and barriers regarding advancements;

16 ‘‘(3) summarizing and analyzing expenditures

17 made by the agencies of such Institutes (and by

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

19 ‘‘(4) making such recommendations for legisla20 tive and administrative initiatives as the Director of

21 the Office determines to be appropriate.

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

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

24 report prepared under subsection (a) to the Director of
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1 NIH for inclusion in the report submitted to the President

2 and the Congress under section 403.’’.

3 (b) REQUIREMENT OF SUFFICIENT ALLOCATION OF

4 RESOURCES OF INSTITUTES.—Section 402(b) of the Pub5 lic 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 fol11 lowing new paragraph:

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

13 the Office of Research on Women’s Health, shall en14 sure that resources of the National Institutes of

15 Health are sufficiently allocated for projects of re16 search on women’s health that are identified under

17 section 486(b).’’.

18 PART III—OFFICE OF RESEARCH ON MINORITY

19 HEALTH

20 SEC. 151. ESTABLISHMENT.

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

22 (42 U.S.C. 281 et seq.) is amended by adding at the end

23 the following new section:

24 ‘‘OFFICE OF RESEARCH ON MINORITY HEALTH

25 ‘‘SEC. 403A. (a) ESTABLISHMENT.—There is estab26 lished within the Office of the Director of NIH an office
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1 to be known as the Office of Research on Minority Health

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

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

4 Director of NIH.

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

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

7 health that should be conducted or supported by the

8 national research institutes;

9 ‘‘(2) identify multidisciplinary research relating

10 to research on minority health that should be so con11 ducted or supported;

12 ‘‘(3) promote coordination and collaboration

13 among entities conducting research identified under

14 paragraph (1) or (2);

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

16 entities receiving funds from the national research

17 institutes;

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

19 supporting such research;

20 ‘‘(6) promote the sufficient allocation of the re21 sources of the national research institutes for con22 ducting and supporting such research; and

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

24 492B with respect to the inclusion of members of

25 minority groups as subjects in clinical research.’’.
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1 Subtitle C—Scientific Integrity

2 SEC. 161. ESTABLISHMENT OF OFFICE OF SCIENTIFIC IN3 TEGRITY.

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

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

7 ‘‘OFFICE OF SCIENTIFIC INTEGRITY

8 ‘‘SEC. 493. (a) ESTABLISHMENT.—

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

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

12 Office of Scientific Integrity (hereafter referred to in

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

15 of Health and Human Services.

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

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

18 be experienced and specially trained in the conduct

19 of research, and have experience in the conduct of

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

22 Director of the Office. The Director shall report to

23 the Secretary.

24 ‘‘(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS

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

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

3 Act for any project or program that involves the conduct

4 of biomedical or behavioral research submit in or with its

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

7 entity—

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

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

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

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

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

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

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

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

2 information from recipients of funds under this Act;

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

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

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

8 shall by regulation establish procedures for the Director

9 to monitor administrative processes and investigations

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

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

14 been or will be commenced prior to the promulgation of

15 final regulations under this section.’’.

16 (b) ESTABLISHMENT OF DEFINITION OF SCIENTIFIC

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

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

20 Secretary shall by regulation establish a definition for the

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

22 of the Public Health Service Act, as amended by sub23 section (a) of this section.
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1 SEC. 162. COMMISSION ON SCIENTIFIC INTEGRITY.

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

3 Human Services shall establish a commission to be known

4 as the Commission on Scientific Integrity (in this section

5 referred to as the ‘‘Commission’’).

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

8 Services on the administration of section 493 of the Public

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

10 of this Act).

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

13 of Health and Human Services from among individuals

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

15 Of the members appointed to the Commission—

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

18 (2) three shall be individuals with experience in

19 investigating allegations of misconduct with respect

20 to scientific research;

21 (3) three shall be representatives of institutions

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

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

2 whom shall be an ethicist.

3 (d) COMPENSATION.—Members of the Commission

4 shall receive compensation for each day engaged in carry5 ing out the duties of the Commission, including time en6 gaged in traveling for purposes of such duties. Such com7 pensation may not be provided in an amount in excess of

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

9 General Schedule.

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

11 of enactment of this section, the Commission shall prepare

12 and submit to the Secretary of Health and Human Serv13 ices, the Committee on Energy and Commerce of the

14 House of Representatives, and the Committee on Labor

15 and Human Resources of the Senate, a report containing

16 the recommendations developed under subsection (b).

17 SEC. 163. PROTECTION OF WHISTLEBLOWERS.

18 Section 493 of the Public Health Service Act, as

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

20 at the end the following new subsection:

21 ‘‘(f) PROTECTION OF WHISTLEBLOWERS.—

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

23 required to establish administrative processes under

24 subsection (b), the Secretary shall by regulation es25 tablish standards for preventing, and for responding
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1 to the occurrence of retaliation by such entity, its of2 ficials or agents, against an employee in the terms

3 and conditions of employment in response to the em4 ployee having in good faith—

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

6 officials or agents, has engaged in or failed to

7 adequately respond to an allegation of scientific

8 misconduct; or

9 ‘‘(B) cooperated with an investigation of

10 such an allegation.

11 ‘‘(2) MONITORING BY SECRETARY.—The Sec12 retary shall establish by regulation procedures for

13 the Director to monitor the implementation of the

14 standards established by an entity under paragraph

15 (1) for the purpose of determining whether the pro16 cedures have been established, and are being uti17 lized, in accordance with the standards established

18 under such paragraph.

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

20 regulation establish remedies for noncompliance by

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

22 in retaliation in violation of the standards estab23 lished under paragraph (1). Such remedies may in24 clude termination of funding provided by the Sec25 retary for such project or recovery of funding being
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1 provided by the Secretary for such project, or other

2 actions as appropriate.

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

4 Secretary shall issue a final rule for the regulations

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

6 after the date of the enactment of the National In7 stitutes of Health Revitalization Act of 1993.

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

9 year beginning after the date on which the regula10 tions required in paragraph (1) are issued, the Sec11 retary may not provide a grant, cooperative agree12 ment, or contract under this Act for biomedical or

13 behavioral research unless the entity seeking such fi14 nancial assistance agrees that the entity—

15 ‘‘(A) will maintain the procedures de16 scribed in the regulations; and

17 ‘‘(B) will otherwise be subject to the regu18 lations.’’.

19 SEC. 164. REQUIREMENT OF REGULATIONS REGARDING

20 PROTECTION AGAINST FINANCIAL CON21 FLICTS OF INTEREST IN CERTAIN PROJECTS

22 OF RESEARCH.

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

24 as redesignated by section 141(a)(2) of this Act, is amend25 ed by inserting after section 493 the following new section:
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1 ‘‘PROTECTION AGAINST FINANCIAL CONFLICTS OF

2 INTEREST IN CERTAIN PROJECTS OF RESEARCH

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

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

5 by regulation, the specific circumstances that con6 stitute the existence of a financial interest in a

7 project on the part of an entity or individual that

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

9 in favor of obtaining results in such project that are

10 consistent with such financial interest. Such defini11 tion shall apply uniformly to each entity or individ12 ual conducting a research project under this Act. In

13 the case of any entity or individual receiving assist14 ance from the Secretary for a project of research de15 scribed in paragraph (2), the Secretary shall by reg16 ulation establish standards for responding to, includ17 ing managing, reducing, or eliminating, the existence

18 of such a financial interest. The entity may adopt

19 individualized procedures for implementing the

20 standards.

21 ‘‘(2) RELEVANT PROJECTS.—A project of re22 search referred to in paragraph (1) is a project of

23 clinical research whose purpose is to evaluate the

24 safety or effectiveness of a drug, medical device, or
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1 treatment and for which such entity is receiving as2 sistance from the Secretary.

3 ‘‘(3) IDENTIFYING AND REPORTING TO THE DI4 RECTOR.—The Secretary shall ensure that the

5 standards established under paragraph (1) specify

6 that as a condition of receiving assistance from the

7 Secretary for the project involved, an entity de8 scribed in such subsection is required—

9 ‘‘(A) to have in effect at the time the en10 tity applies for the assistance and throughout

11 the period during which the assistance is re12 ceived, a process for identifying such financial

13 interests as defined in paragraph (1) that exist

14 regarding the project; and

15 ‘‘(B) to report to the Director such finan16 cial interest as defined in paragraph (1) identi17 fied by the entity and how any such financial

18 interest identified by the entity will be managed

19 or eliminated such that the project in question

20 will be protected from bias that may stem from

21 such financial interest.

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

23 shall monitor the establishment and conduct of the

24 process established by an entity pursuant to para25 graph (1).
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1 ‘‘(5) RESPONSE.—In any case in which the Sec2 retary determines that an entity has failed to comply

3 with paragraph (3) regarding a project of research

4 described in paragraph (1), the Secretary—

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

6 receiving assistance, the entity disclose the ex7 istence of a financial interest as defined in

8 paragraph (1) in each public presentation of the

9 results of such project; and

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

11 Secretary determines to be appropriate.

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

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

14 the receipt of consulting fees or honoraria and

15 the ownership of stock or equity.

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

17 conducting a project of research, means a

18 grant, contract, or cooperative agreement.

19 ‘‘(b) FINAL RULE FOR REGULATIONS.—The Sec20 retary shall issue a final rule for the regulations required

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

22 of the enactment of the National Institutes of Health Re23 vitalization Act of 1993.’’.
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1 SEC. 165. EFFECTIVE DATES.

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

3 subtitle shall become effective on the date that occurs 180

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

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

6 amended by sections 161 and 163, is published in the Fed7 eral Register.

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

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

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

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

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

13 research for which initial funding under the Public Health

14 Service Act was provided prior to the effective date de15 scribed in subsection (a).

16 TITLE II—NATIONAL INSTITUTES

17 OF HEALTH IN GENERAL

18 SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINA19 TION.

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

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

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

23 inserting ‘‘other public and private entities, including ele24 mentary, secondary, and post-secondary schools. The As25 sociate Director shall—
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1 ‘‘(1) annually review the efficacy of existing

2 policies and techniques used by the national research

3 institutes to disseminate the results of disease pre4 vention and behavioral research programs;

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

6 modification or reconstruction of such policies and

7 techniques to ensure maximum dissemination, using

8 advanced technologies to the maximum extent prac9 ticable, of research results to such entities; and

10 ‘‘(3) annually prepare and submit to the Direc11 tor of NIH a report concerning the prevention and

12 dissemination activities undertaken by the Associate

13 Director, including—

14 ‘‘(A) a summary of the Associate Direc15 tor’s review of existing dissemination policies

16 and techniques together with a detailed state17 ment concerning any modification or restructur18 ing, or recommendations for modification or re19 structuring, of such policies and techniques;

20 and

21 ‘‘(B) a detailed statement of the expendi22 tures made for the prevention and dissemina23 tion activities reported on and the personnel

24 used in connection with such activities.’’.
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1 SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARD2 ING CERTAIN STATES AND RESEARCHERS.

3 Section 402 of the Public Health Service Act (42

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

5 new subsection:

6 ‘‘(g)(1)(A) In the case of entities described in sub7 paragraph (B), the Director of NIH, acting through the

8 Director of the National Center for Research Resources,

9 shall establish a program to enhance the competitiveness

10 of such entities in obtaining funds from the national re11 search institutes for conducting biomedical and behavioral

12 research.

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

14 entities that conduct biomedical and behavioral research

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

16 rate for applications to the national research institutes for

17 assistance for such research by the entities in the State

18 has historically constituted a low success rate of obtaining

19 such funds, relative to such aggregate rate for such enti20 ties in other States.

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

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

23 carrying out the program established under such subpara24 graph, may—

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

26 involved, including technical assistance in the prepa-
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1 ration of applications for obtaining funds from the

2 national research institutes;

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

4 biomedical or behavioral research proposals; and

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

6 plan.

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

8 of supporting projects of biomedical or behavioral research

9 whose principal researchers are individuals who have not

10 previously served as the principal researchers of such

11 projects supported by the Director.’’.

12 SEC. 203. CHILDREN’S VACCINE INITIATIVE.

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

14 (42 U.S.C. 281 et seq.) is amended by adding at the end

15 the following new section:

16 ‘‘CHILDREN’S VACCINE INITIATIVE

17 ‘‘SEC. 404. (a) DEVELOPMENT OF NEW VAC18 CINES.—The Secretary, in consulation with the Director

19 of the National Vaccine Program under title XXI and act20 ing through the Directors of the National Institute for Al21 lergy and Infectious Diseases, the National Institute for

22 Child Health and Human Development, the National In23 stitute for Aging, and other public and private programs,

24 shall carry out activities, which shall be consistent with

25 the global Children’s Vaccine Initiative, to develop afford26 able new and improved vaccines to be used in the United
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1 States and in the developing world that will increase the

2 efficacy and efficiency of the prevention of infectious dis3 eases. In carrying out such activities, the Secretary shall,

4 to the extent practicable, develop and make available vac5 cines that require fewer contacts to deliver, that can be

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

7 that obviate refrigeration, needles and syringes, and that

8 protect against a larger number of diseases.

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

10 2104, the Secretary, acting through the Director of the

11 National Vaccine Program under title XXI, shall include

12 information with respect to activities and the progress

13 made in implementing the provisions of this section and

14 achieving its goals.

15 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—In ad16 dition to any other amounts authorized to be appropriated

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

18 are authorized to be appropriated to carry out this section

19 $20,000,000 for fiscal year 1994, and such sums as may

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

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

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

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

24 is amended by adding at the end the following new section:
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1 ‘‘PLAN FOR USE OF ANIMALS IN RESEARCH

2 ‘‘SEC. 404A. (a) The Director of NIH, after consulta3 tion with the committee established under subsection (e),

4 shall prepare a plan—

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

6 conduct or support research into—

7 ‘‘(A) methods of biomedical research and

8 experimentation that do not require the use of

9 animals;

10 ‘‘(B) methods of such research and experi11 mentation that reduce the number of animals

12 used in such research; and

13 ‘‘(C) methods of such research and experi14 mentation that produce less pain and distress in

15 such animals;

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

17 of the methods described in paragraph (1);

18 ‘‘(3) for encouraging the acceptance by the sci19 entific community of such methods that have been

20 found to be valid and reliable; and

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

22 methods that have been found to be valid and reli23 able.

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

25 of NIH shall submit to the Committee on Energy and
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1 Commerce of the House of Representatives, and to the

2 Committee on Labor and Human Resources of the Senate,

3 the plan required in subsection (a) and shall begin imple4 mentation of the plan.

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

6 and as appropriate, make revisions in the plan required

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

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

9 under section 403 that is submitted after the revision is

10 made.

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

12 may be appropriate to convey to scientists and others who

13 use animals in biomedical or behavioral research or experi14 mentation information respecting the methods found to be

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

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

17 the National Institutes of Health a committee to be known

18 as the Interagency Coordinating Committee on the Use

19 of Animals in Research (hereafter in this subsection re20 ferred to as the ‘Committee’).

21 ‘‘(2) The Committee shall provide advice to the Direc22 tor of NIH on the preparation of the plan required in sub23 section (a).

24 ‘‘(3) The Committee shall be composed of—
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1 ‘‘(A) the Directors of each of the national re2 search institutes and the Director of the Center for

3 Research Resources (or the designees of such Direc4 tors); and

5 ‘‘(B) representatives of the Environmental Pro6 tection Agency, the Food and Drug Administration,

7 the Consumer Product Safety Commission, the Na8 tional Science Foundation, and such additional agen9 cies as the Director of NIH determines to be appro10 priate.’’.

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

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

13 158; 99 Stat. 880) is repealed.

14 SEC. 205. INCREASED PARTICIPATION OF WOMEN AND

15 MEMBERS OF UNDERREPRESENTED MINORI16 TIES IN FIELDS OF BIOMEDICAL AND BEHAV17 IORAL RESEARCH.

18 Section 402 of the Public Health Service Act, as

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

20 at the end the following new subsection:

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

22 NIH and the Directors of the agencies of the National

23 Institutes of Health, may conduct and support programs

24 for research, research training, recruitment, and other ac25 tivities to provide for an increase in the number of women
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1 and members of underrepresented minority groups in the

2 fields of biomedical and behavioral research.’’.

3 SEC. 206. REQUIREMENTS REGARDING SURVEYS OF SEX4 UAL BEHAVIOR.

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

6 as amended by section 204 of this Act, is amended by add7 ing at the end the following new section:

8 ‘‘REQUIREMENTS REGARDING SURVEYS OF SEXUAL

9 BEHAVIOR

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

11 sexual behavior proposed to be conducted or supported

12 through the National Institutes of Health, the survey may

13 not be carried out unless—

14 ‘‘(1) the proposal has undergone review in ac15 cordance with any applicable requirements of sec16 tions 491 and 492; and

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

18 492A, makes a determination that the information

19 expected to be obtained through the survey will as20 sist—

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

22 transmitted diseases, the incidence of infection

23 with the human immunodeficiency virus, or the

24 incidence of any other infectious disease; or

25 ‘‘(B) in improving reproductive health or

26 other conditions of health.’’.
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1 SEC. 207. DISCRETIONARY FUND OF DIRECTOR OF NA2 TIONAL INSTITUTES OF HEALTH.

3 Section 402 of the Public Health Service Act, as

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

5 at the end the following new subsection:

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

7 amounts appropriated under paragraph (3) and made

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

9 carry out the activities authorized in this Act for the Na10 tional Institutes of Health. The purposes for which such

11 fund may be expended include—

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

13 have not received significant funding relative to

14 other matters, responding to new issues and sci15 entific emergencies, and acting on research opportu16 nities of high priority;

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

18 within the authority of any single agency of such In19 stitutes; and

20 ‘‘(C) purchasing or renting equipment and

21 quarters for activities of such Institutes.

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

23 the Secretary shall submit to the Committee on Energy

24 and Commerce of the House of Representatives, and to

25 the Committee on Labor and Human Resources of the

26 Senate, a report describing the activities undertaken and
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1 expenditures made under this section during the preceding

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

3 Secretary regarding this section as the Secretary deter4 mines to be appropriate.

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

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

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

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

9 SEC. 208. MISCELLANEOUS PROVISIONS.

10 (a) TERM OF OFFICE FOR MEMBERS OF ADVISORY

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

12 Act (42 U.S.C. 284a(c)) is amended in the second sen13 tence by striking ‘‘until a successor has been appointed’’

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

15 of such expiration’’.

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

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

18 amended—

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

20 end;

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

22 inserting ‘‘; and’’; and

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

24 new paragraph:
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1 ‘‘(5) ensure that, after January 1, 1994, at

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

3 and promotion materials developed or funded by the

4 National Institutes of Health is in a form that does

5 not exceed a level of functional literacy, as defined

6 in the National Literacy Act of 1991 (Public Law

7 102–73).’’.

8 (c) DAY CARE REGARDING CHILDREN OF EMPLOY9 EES.—Section 402 of the Public Health Service Act, as

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

11 at the end the following new subsection:

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

13 to provide day care service for the employees of the Na14 tional Institutes of Health similar to those services pro15 vided by other Federal agencies (including the availability

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

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

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

19 into consideration the income and needs of the employee.

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

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

22 purchase agreements.’’.
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1 TITLE III—GENERAL PROVI2 SIONS RESPECTING NA3 TIONAL RESEARCH INSTI4 TUTES

5 SEC. 301. APPOINTMENT AND AUTHORITY OF DIRECTORS

6 OF NATIONAL RESEARCH INSTITUTES.

7 (a) ESTABLISHMENT OF GENERAL AUTHORITY RE8 GARDING DIRECT FUNDING.—

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

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

11 amended—

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

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

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

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

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

17 subparagraph:

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

19 Office of Management and Budget directly all funds

20 appropriated by the Congress for obligation and ex21 penditure by the Institute.’’.

22 (2) CONFORMING AMENDMENT.—Section

23 413(b)(9) of the Public Health Service Act (42

24 U.S.C. 285a–2(b)(9)) is amended—

25 (A) by striking ‘‘(A)’’ after ‘‘(9)’’; and
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1 (B) by striking ‘‘advisory council;’’ and all

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

3 (b) APPOINTMENT AND DURATION OF TECHNICAL

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

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

6 amended—

7 (1) by amending paragraph (3) to read as fol8 lows:

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

10 council for the Institute and with the approval of the

11 Director of NIH—

12 ‘‘(A) establish technical and scientific peer

13 review groups in addition to those appointed

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

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

16 groups established under subparagraph (A);

17 and’’; and

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

19 the following:

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

21 the duration of a peer review group appointed under para22 graph (3).’’.
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1 SEC. 302. PROGRAM OF RESEARCH ON OSTEOPOROSIS,

2 PAGET’S DISEASE, AND RELATED BONE DIS3 ORDERS.

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

5 (42 U.S.C. 284 et seq.), as amended by section 121(b)

6 of Public Law 102–321 (106 Stat. 358), is amended by

7 adding at the end the following new section:

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

9 RELATED BONE DISORDERS

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

11 the National Institute of Arthritis and Musculoskeletal

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

13 National Institute of Diabetes, Digestive and Kidney Dis14 eases, and the National Institute of Dental Research, shall

15 expand and intensify the programs of such Institutes with

16 respect to research and related activities concerning

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

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

19 subsection (a) shall jointly coordinate the programs re20 ferred to in such subsection and consult with the Arthritis

21 and Musculoskeletal Diseases Interagency Coordinating

22 Committee and the Interagency Task Force on Aging Re23 search.

24 ‘‘(c) INFORMATION CLEARINGHOUSE.—

25 ‘‘(1) IN GENERAL.—In order to assist in carry26 ing out the purpose described in subsection (a), the
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1 Director of NIH shall provide for the establishment

2 of an information clearinghouse on osteoporosis and

3 related bone disorders to facilitate and enhance

4 knowledge and understanding on the part of health

5 professionals, patients, and the public through the

6 effective dissemination of information.

7 ‘‘(2) ESTABLISHMENT THROUGH GRANT OR

8 CONTRACT.—For the purpose of carrying out para9 graph (1), the Director of NIH shall enter into a

10 grant, cooperative agreement, or contract with a

11 nonprofit private entity involved in activities regard12 ing the prevention and control of osteoporosis and

13 related bone disorders.

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

15 purpose of carrying out this section, there are authorized

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

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

18 1995 and 1996.’’.

19 SEC. 303. ESTABLISHMENT OF INTERAGENCY PROGRAM

20 FOR TRAUMA RESEARCH.

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

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

23 at the end the following part:
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1 ‘‘PART E—INTERAGENCY PROGRAM FOR TRAUMA

2 RESEARCH

3 ‘‘SEC. 1251. ESTABLISHMENT OF PROGRAM.

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

5 the Director of the National Institutes of Health (here6 after in this section referred to as the ‘Director’), shall

7 establish a comprehensive program of conducting basic

8 and clinical research on trauma (hereafter in this section

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

10 research regarding the diagnosis, treatment, rehabilita11 tion, and general management of trauma.

12 (b) PLAN FOR PROGRAM.—

13 ‘‘(1) IN GENERAL.—The Director, in consulta14 tion with the Trauma Research Interagency Coordi15 nating Committee established under subsection (g),

16 shall establish and implement a plan for carrying

17 out the activities of the Program, including the ac18 tivities described in subsection (d). All such activities

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

20 plan shall be periodically reviewed, and revised as

21 appropriate.

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

23 than one year after the date of enactment of this

24 section, the Director shall submit the plan required

25 in paragraph (1) to the Committee on Energy and
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1 Commerce of the House of Representatives, and to

2 the Committee on Labor and Human Resources of

3 the Senate, together with an estimate of the funds

4 needed for each of the fiscal years 1994 through

5 1996 to implement the plan.

6 ‘‘(c) PARTICIPATING AGENCIES; COORDINATION AND

7 COLLABORATION.—The Director—

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

9 under the Program by the Directors of the agencies

10 of the National Institutes of Health involved in re11 search with respect to trauma;

12 ‘‘(2) shall ensure that the activities of the Pro13 gram are coordinated among such agencies; and

14 ‘‘(3) shall, as appropriate, provide for collabora15 tion among such agencies in carrying out such ac16 tivities.

17 ‘‘(d) CERTAIN ACTIVITIES OF PROGRAM.—The Pro18 gram shall include—

19 ‘‘(1) studies with respect to all phases of trau20 ma care, including prehospital, resuscitation, sur21 gical intervention, critical care, infection control,

22 wound healing, nutritional care and support, and

23 medical rehabilitation care;

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

25 response of the body to trauma and the acute treat-
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1 ment and medical rehabilitation of individuals who

2 are the victims of trauma; and

3 ‘‘(3) basic and clinical research regarding trau4 ma care for pediatric and geriatric patients.

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

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

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

8 to public and nonprofit entities, including designated trau9 ma centers.

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

11 availability of appropriate resources to carry out the Pro12 gram, including the plan established under subsection (b)

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

14 ‘‘(g) COORDINATING COMMITTEE.—

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

16 a Trauma Research Interagency Coordinating Com17 mittee (hereafter in this section referred to as the

18 ‘Coordinating Committee’).

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

20 shall make recommendations regarding—

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

22 carried out by each of the agencies represented

23 on the Committee and the amount of funds

24 needed by each of the agencies for such activi25 ties; and
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1 ‘‘(B) effective collaboration among the

2 agencies in carrying out the activities.

3 ‘‘(3) COMPOSITION.—The Coordinating Com4 mittee shall be composed of the Directors of each of

5 the agencies that, under subsection (c), have respon6 sibilities under the Program, and any other individ7 uals who are practitioners in the trauma field as

8 designated by the Director of the National Institutes

9 of Health.

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

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

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

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

14 the National Institutes of Health.

15 ‘‘(3) The term ‘trauma’ means any serious in16 jury that could result in loss of life or in significant

17 disability and that would meet pre-hospital triage

18 criteria for transport to a designated trauma cen19 ter.’’.

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

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

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

23 new subsection:
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1 ‘‘(k) The Director of NIH shall carry out the pro2 gram established in part E of title XII (relating to inter3 agency research on trauma).’’.

4 TITLE IV—NATIONAL CANCER

5 INSTITUTE

6 SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVI7 TIES REGARDING BREAST CANCER.

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

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

10 at the end the following new section:

11 ‘‘BREAST AND GYNECOLOGICAL CANCERS

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

13 ACTIVITIES.—The Director of the Institute, in consulta14 tion with the National Cancer Advisory Board, shall ex15 pand, intensify, and coordinate the activities of the Insti16 tute with respect to research on breast cancer, ovarian

17 cancer, and other cancers of the reproductive system of

18 women.

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

20 The Director of the Institute shall coordinate the activities

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

22 conducted by other national research institutes and agen23 cies of the National Institutes of Health to the extent that

24 such Institutes and agencies have responsibilities that are

25 related to breast cancer and other cancers of the reproduc26 tive system of women.
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1 ‘‘(c) PROGRAMS FOR BREAST CANCER.—

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

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

4 support research to expand the understanding of the

5 cause of, and to find a cure for, breast cancer. Ac6 tivities under such subsection shall provide for an

7 expansion and intensification of the conduct and

8 support of—

9 ‘‘(A) basic research concerning the etiology

10 and causes of breast cancer;

11 ‘‘(B) clinical research and related activities

12 concerning the causes, prevention, detection and

13 treatment of breast cancer;

14 ‘‘(C) control programs with respect to

15 breast cancer in accordance with section 412;

16 ‘‘(D) information and education programs

17 with respect to breast cancer in accordance with

18 section 413; and

19 ‘‘(E) research and demonstration centers

20 with respect to breast cancer in accordance with

21 section 414, including the development and op22 eration of centers for breast cancer research to

23 bring together basic and clinical, biomedical and

24 behavioral scientists to conduct basic, clinical,

25 epidemiological, psychosocial, prevention and
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1 treatment research and related activities on

2 breast cancer.

3 Not less than six centers shall be operated under

4 subparagraph (E). Activities of such centers should

5 include supporting new and innovative research and

6 training programs for new researchers. Such centers

7 shall give priority to expediting the transfer of re8 search advances to clinical applications.

9 ‘‘(2) IMPLEMENTATION OF PLAN FOR PRO10 GRAMS.—

11 ‘‘(A) The Director of the Institute shall en12 sure that the research programs described in

13 paragraph (1) are implemented in accordance

14 with a plan for the programs. Such plan shall

15 include comments and recommendations that

16 the Director of the Institute considers appro17 priate, with due consideration provided to the

18 professional judgment needs of the Institute as

19 expressed in the annual budget estimate pre20 pared in accordance with section 413(9). The

21 Director of the Institute, in consultation with

22 the National Cancer Advisory Board, shall peri23 odically review and revise such plan.

24 ‘‘(B) Not later than May 1, 1993, the Di25 rector of the Institute shall submit a copy of
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1 the plan to the President’s Cancer Panel, the

2 Secretary and the Director of NIH.

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

4 submit any revisions of the plan to the Presi5 dent’s Cancer Panel, the Secretary, and the Di6 rector of NIH.

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

8 the plan submitted under subparagraph (A),

9 and any revisions submitted under subpara10 graph (C), to the Committee on Energy and

11 Commerce of the House of Representatives and

12 the Committee on Labor and Human Resources

13 of the Senate.

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

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

16 research on ovarian cancer and other cancers of the repro17 ductive system of women. Activities under such subsection

18 shall provide for the conduct and support of—

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

20 causes of ovarian cancer and other cancers of the re21 productive system of women;

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

23 the causes, prevention, detection and treatment of

24 ovarian cancer and other cancers of the reproductive

25 system of women;
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1 ‘‘(3) control programs with respect to ovarian

2 cancer and other cancers of the reproductive system

3 of women in accordance with section 412;

4 ‘‘(4) information and education programs with

5 respect to ovarian cancer and other cancers of the

6 reproductive system of women in accordance with

7 section 413; and

8 ‘‘(5) research and demonstration centers with

9 respect to ovarian cancer and cancers of the repro10 ductive system in accordance with section 414.

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

12 prepare, for inclusion in the biennial report submitted

13 under section 407, a report that describes the activities

14 of the National Cancer Institute under the research pro15 grams referred to in subsection (a), that shall include—

16 ‘‘(1) a description of the research plan with re17 spect to breast cancer prepared under subsection (c);

18 ‘‘(2) an assessment of the development, revi19 sion, and implementation of such plan;

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

21 progress made, during the period for which such re22 port is prepared, in the research programs on breast

23 cancer and cancers of the reproductive system of

24 women;
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1 ‘‘(4) a summary and analysis of expenditures

2 made, during the period for which such report is

3 made, for activities with respect to breast cancer and

4 cancers of the reproductive system of women con5 ducted and supported by the National Institutes of

6 Health; and

7 ‘‘(5) such comments and recommendations as

8 the Director considers appropriate.’’.

9 SEC. 402. EXPANSION AND INTENSIFICATION OF ACTIVI10 TIES REGARDING PROSTATE CANCER.

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

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

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

14 ‘‘PROSTATE CANCER

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

16 OF ACTIVITIES.—The Director of the Institute, in con17 sultation with the National Cancer Advisory Board, shall

18 expand, intensify, and coordinate the activities of the In19 stitute with respect to research on prostate cancer.

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

21 The Director of the Institute shall coordinate the activities

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

23 conducted by other national research institutes and agen24 cies of the National Institutes of Health to the extent that

25 such Institutes and agencies have responsibilities that are

26 related to prostate cancer.
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1 ‘‘(c) PROGRAMS.—

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

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

4 support research to expand the understanding of the

5 cause of, and to find a cure for, prostate cancer. Ac6 tivities under such subsection shall provide for an

7 expansion and intensification of the conduct and

8 support of—

9 ‘‘(A) basic research concerning the etiology

10 and causes of prostate cancer;

11 ‘‘(B) clinical research and related activities

12 concerning the causes, prevention, detection and

13 treatment of prostate cancer;

14 ‘‘(C) prevention and control and early de15 tection programs with respect to prostate can16 cer in accordance with section 412, particularly

17 as it relates to intensifying research on the role

18 of prostate specific antigen for the screening

19 and early detection of prostate cancer;

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

21 the direction of the Director of the Institute, to

22 provide coordination between relevant National

23 Institutes of Health components of research ef24 forts on prostate cancer;
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1 ‘‘(E) control programs with respect to

2 prostate cancer in accordance with section 412;

3 ‘‘(F) information and education programs

4 with respect to prostate cancer in accordance

5 with section 413; and

6 ‘‘(G) research and demonstration centers

7 with respect to prostate cancer in accordance

8 with section 414, including the development and

9 operation of centers for prostate cancer re10 search to bring together basic and clinical, bio11 medical and behavioral scientists to conduct

12 basic, clinical, epidemiological, psychosocial,

13 prevention and treatment research and related

14 activities on prostate cancer.

15 Not less than six centers shall be operated under

16 subparagraph (G). Activities of such centers should

17 include supporting new and innovative research and

18 training programs for new researchers. Such centers

19 shall give priority to expediting the transfer of re20 search advances to clinical applications.

21 ‘‘(2) IMPLEMENTATION OF PLAN FOR PRO22 GRAMS.—

23 ‘‘(A) The Director of the Institute shall en24 sure that the research programs described in

25 paragraph (1) are implemented in accordance
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1 with a plan for the programs. Such plan shall

2 include comments and recommendations that

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

5 professional judgment needs of the Institute as

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

8 Director of the Institute, in consultation with

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

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

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

14 Secretary and the Director of NIH.

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

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

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

20 the plan submitted under subparagraph (A),

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

23 Commerce of the House of Representatives and

24 the Committee on Labor and Human Resources

25 of the Senate.’’.
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1 SEC. 403. AUTHORIZATION OF APPROPRIATIONS.

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

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

4 402 of this Act, is amended by adding at the end the fol5 lowing new section:

6 ‘‘AUTHORIZATION OF APPROPRIATIONS

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

8 purpose of carrying out this subpart, there are authorized

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

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

11 years 1995 and 1996.

12 ‘‘(b) BREAST CANCER AND GYNECOLOGICAL CAN13 CERS.—

14 ‘‘(1) BREAST CANCER.—

15 ‘‘(A) For the purpose of carrying out sub16 paragraph (A) of section 417(c)(1), there are

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

18 fiscal year 1994, and such sums as may be nec19 essary for each of the fiscal years 1995 and

20 1996. Such authorizations of appropriations are

21 in addition to the authorizations of appropria22 tions established in subsection (a) with respect

23 to such purpose.

24 ‘‘(B) For the purpose of carrying out sub25 paragraphs (B) through (E) of section

26 417(c)(1), there are authorized to be appro-
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1 priated $100,000,000 for fiscal year 1994, and

2 such sums as may be necessary for each of the

3 fiscal years 1995 and 1996. Such authoriza4 tions of appropriations are in addition to the

5 authorizations of appropriations established in

6 subsection (a) with respect to such purpose.

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

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

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

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

11 of the fiscal years 1995 and 1996. Such authoriza12 tions of appropriations are in addition to the author13 izations of appropriations established in subsection

14 (a) with respect to such purpose.

15 ‘‘(c) PROSTATE CANCER.—For the purpose of carry16 ing out section 417A, there are authorized to be appro17 priated $72,000,000 for fiscal year 1994, and such sums

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

19 1996. Such authorizations of appropriations are in addi20 tion to the authorizations of appropriations established in

21 subsection (a) with respect to such purpose.

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

23 Of the amounts appropriated for the National Cancer In24 stitute for a fiscal year, the Director of the Institute is

25 authorized to make available not less than 10 percent for
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1 carrying out the cancer control activities authorized in sec2 tion 412 and for which budget estimates are made under

3 section 413(b)(9) for the fiscal year.’’.

4 (b) CONFORMING AMENDMENTS.—

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

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

7 (A) by striking subsection (a);

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

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

12 (b); and

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

15 ‘‘CERTAIN USES OF FUNDS’’.

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

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

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

20 TITLE V—NATIONAL HEART,

21 LUNG, AND BLOOD INSTITUTE

22 SEC. 501. EDUCATION AND TRAINING.

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

24 U.S.C. 285b–3(b)) is amended—

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

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

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

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

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

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

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

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

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

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

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

15 the end;

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

17 and inserting ‘‘; and’’; and

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

19 new subparagraph:

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

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

2 cardiovascular diseases in children.’’.

3 SEC. 503. NATIONAL CENTER ON SLEEP DISORDERS RE4 SEARCH.

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

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

7 at the end the following new section:

8 ‘‘NATIONAL CENTER ON SLEEP DISORDERS RESEARCH

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

10 of the enactment of the National Institutes of Health Re11 vitalization Act of 1993, the Director of the Institute shall

12 establish the National Center on Sleep Disorders Research

13 (in this section referred to as the ‘Center’). The Center

14 shall be headed by a director, who shall be appointed by

15 the Director of the Institute.

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

17 ‘‘(1) the conduct and support of research, train18 ing, health information dissemination, and other ac19 tivities with respect to sleep disorders, including bio20 logical and circadian rhythm research, basic under21 standing of sleep, chronobiological and other sleep

22 related research; and

23 ‘‘(2) to coordinate the activities of the Center

24 with similar activities of other Federal agencies, in25 cluding the other agencies of the National Institutes
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1 of Health, and similar activities of other public enti2 ties and nonprofit entities.

3 ‘‘(c)(1) The Director of the National Institutes of

4 Health shall establish a committee to be known as the

5 Sleep Disorders Coordinating Committee (hereafter in this

6 section referred to as the ‘Coordinating Committee’).

7 ‘‘(2) The Coordinating Committee shall be composed

8 of the directors of the National Institutes of Health, the

9 National Institute on Aging, the National Institute of

10 Child Health and Human Development, the National

11 Heart, Lung and Blood Institute, the National Institute

12 of Neurological Disorders and Stroke, the National Insti13 tute of Mental Health, and of such other national research

14 institutes as the Director of the National Institutes of

15 Health determines to be appropriate, and shall include

16 representation from other Federal departments and agen17 cies whose programs involve sleep disorders.

18 ‘‘(3) The Director of the National Health, Lung, and

19 Blood Institute shall serve as the chairperson of the Co20 ordinating Committee.

21 ‘‘(4) The Coordinating Committee shall make rec22 ommendations to the Director of the National Institutes

23 of Health and the Director of the Center with respect to

24 the content of the plan required in subsection (e), with

25 respect to the activities of the Center that are carried out
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1 in conjunction with other agencies of the National Insti2 tutes of Health, and with respect to the activities of the

3 Center that are carried out in conjunction with other agen4 cies of the Federal Government.

5 ‘‘(d)(1) The Director of the National Institutes of

6 Health shall establish a board to be known as the Sleep

7 Disorders Research Advisory Board (hereafter in this sec8 tion referred to as the ‘Advisory Board’).

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

10 with, and make recommendations to the Director of the

11 National Institutes of Health, through the Director of the

12 Institute, and the Director of the Center concerning mat13 ters relating to the scientific activities carried out by and

14 through the Center and the policies respecting such activi15 ties, including recommendations with respect to the plan

16 required in subsection (c).

17 ‘‘(3)(A) The Director of the National Institutes of

18 Health shall appoint to the Advisory Board 12 appro19 priately qualified representatives of the public who are not

20 officers or employees of the Federal Government. Of such

21 members, eight shall be representatives of health and sci22 entific disciplines with respect to sleep disorders and four

23 shall be individuals representing the interests of individ24 uals with or undergoing treatment for sleep disorders.
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1 ‘‘(B) The following officials shall serve as ex officio

2 members of the Advisory Board:

3 ‘‘(i) The Director of the National Institutes of

4 Health.

5 ‘‘(ii) The Director of the Center.

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

7 and Blood Institute.

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

9 Mental Health.

10 ‘‘(v) The Director of the National Institute on

11 Aging.

12 ‘‘(vi) The Director of the National Institute of

13 Child Health and Human Development.

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

15 Neurological Disorders and Stroke.

16 ‘‘(viii) The Assistant Secretary for Health.

17 ‘‘(ix) The Assistant Secretary of Defense

18 (Health Affairs).

19 ‘‘(x) The Chief Medical Director of the Veter20 ans’ Administration.

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

22 among the members of the Advisory Board, designate an

23 individual to serve as the chairperson of the Advisory

24 Board.
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1 ‘‘(5) Except as inconsistent with, or inapplicable to,

2 this section, the provisions of section 406 shall apply to

3 the advisory board established under this section in the

4 same manner as such provisions apply to any advisory

5 council established under such section.

6 ‘‘(e)(1) After consultation with the Director of the

7 Center, the advisory board established under subsection

8 (d), and the coordinating committee established under

9 subsection (c), the Director of the National Institutes of

10 Health shall develop a comprehensive plan for the conduct

11 and support of sleep disorders research.

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

13 identify priorities with respect to such research and shall

14 provide for the coordination of such research conducted

15 or supported by the agencies of the National Institutes

16 of Health.

17 ‘‘(3) The Director of the National Institutes of

18 Health (after consultation with the Director of the Center,

19 the advisory board established under subsection (d), and

20 the coordinating committee established under subsection

21 (c)) shall revise the plan developed under paragraph (1)

22 as appropriate.

23 ‘‘(f) The Director of the Center, in cooperation with

24 the Centers for Disease Control, is authorized to coordi25 nate activities with the Department of Transportation, the
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1 Department of Defense, the Department of Education, the

2 Department of Labor, and the Department of Commerce

3 to collect data, conduct studies, and disseminate public in4 formation concerning the impact of sleep disorders and

5 sleep deprivation.’’.

6 SEC. 504. AUTHORIZATION OF APPROPRIATIONS.

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

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

9 amended by adding at the end the following section:

10 ‘‘AUTHORIZATION OF APPROPRIATIONS

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

12 subpart, there are authorized to be appropriated

13 $1,500,000,000 for fiscal year 1994, and such sums as

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

15 1996.

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

17 (1) for a fiscal year, the Director of the Institute is au18 thorized to make available not less than 10 percent for

19 carrying out community-based prevention and control ac20 tivities that include clinical investigations, clinical trials,

21 epidemiologic studies, and prevention demonstration and

22 education projects.’’.
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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 shall es11 tablish a program of conducting and supporting research,

12 training, health information dissemination, and other ac13 tivities with respect to nutritional disorders, including obe14 sity.

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. The Director of NIH shall ensure that, as appro19 priate, the other national research institutes and agencies

20 of the National Institutes of Health have responsibilities

21 regarding such activities.

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

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

24 activities to facilitate and enhance knowledge and under25 standing of nutritional disorders, including obesity, on the
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1 part of health professionals, patients, and the public

2 through the effective dissemination of information.’’.

3 (b) DEVELOPMENT AND EXPANSION OF RESEARCH

4 AND TRAINING CENTERS.—Section 431 of the Public

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

6 (1) by redesignating subsection (d) as sub7 section (e); and

8 (2) by inserting after subsection (c) the follow9 ing new subsection:

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

11 to the extent of amounts made available in appropriations

12 Acts, provide for the development or substantial expansion

13 of centers for research and training regarding nutritional

14 disorders, including obesity.

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

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

17 National Cancer Institute and with the Directors of such

18 other agencies of the National Institutes of Health as the

19 Director of NIH determines to be appropriate.

20 ‘‘(3) Each center developed or expanded under para21 graph (1) shall—

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

23 or be formed from a consortium of cooperating insti24 tutions, meeting such research and training quali25 fications as may be prescribed by the Director;
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1 ‘‘(B) conduct basic and clinical research into

2 the cause, diagnosis, early detection, prevention, con3 trol and treatment of nutritional disorders, including

4 obesity and the impact of nutrition and diet on child

5 development;

6 ‘‘(C) conduct training programs for physicians

7 and allied health professionals in current methods of

8 diagnosis and treatment of such diseases and com9 plications, and in research in such disorders; and

10 ‘‘(D) conduct information programs for physi11 cians and allied health professionals who provide pri12 mary care for patients with such disorders or com13 plications.’’.

14 TITLE VII—NATIONAL INSTI15 TUTE ON ARTHRITIS AND

16 MUSCULOSKELETAL AND

17 SKIN DISEASES

18 SEC. 701. JUVENILE ARTHRITIS.

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

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

21 other programs’’ and all that follows and inserting the fol22 lowing: ‘‘and other programs with respect to arthritis and

23 musculoskeletal and skin diseases (including sports-related

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

25 diseases on children.’’.
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1 (b) PROGRAMS.—Section 436 (42 U.S.C. 285d–1) is

2 amended—

3 (1) in subsection (a), by inserting after the sec4 ond sentence, the following: ‘‘The plan shall place

5 particular emphasis upon expanding research into

6 better understanding the causes and the develop7 ment of effective treatments for arthritis affecting

8 children.’’; and

9 (2) in subsection (b)—

10 (A) by striking ‘‘and’’ at the end of para11 graph (3);

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

13 paragraph (4) and inserting ‘‘; and’’; and

14 (C) by adding at the end thereof the fol15 lowing new paragraph:

16 ‘‘(5) research into the causes of arthritis affect17 ing children and the development, trial, and evalua18 tion of techniques, drugs and devices used in the di19 agnosis, treatment (including medical rehabilitation),

20 and prevention of arthritis in children.’’.

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

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

23 the end thereof the following new subsection:

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

25 shall establish a multipurpose arthritis and musculo-
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1 skeletal disease center for the purpose of expanding the

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

3 prevention, control, and treatment of, and rehabilitation

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

5 (d) ADVISORY BOARD.—

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

7 Health Service Act (42 U.S.C. 285d–7(a)) is amend8 ed by inserting after ‘‘Arthritis’’ the the first place

9 such term appears the following: ‘‘and Musculo10 skeletal and Skin Diseases’’.

11 (2) COMPOSITION.—Section 442(b) of the Pub12 lic Health Service Act (42 U.S.C. 285d–7(b)) is

13 amended—Section 442(b) of the Public Health Serv14 ice Act (42 U.S.C. 285d–7(b)) is amended—

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

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

17 and

18 (B) in paragraph (1)(B)—

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

20 ‘‘eight’’; and

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

22 that follows and inserting the following:

23 ‘‘including one member who is a person

24 who has such a disease, one person who is

25 the parent of an adult with such a disease,
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1 and two members who are parents of chil2 dren with arthritis.’’.

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

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

5 amended—

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

7 (3);

8 (2) by striking the period at the end of para9 graph (4) and inserting ‘‘; and’’; and

10 (3) by adding at the end the following para11 graph:

12 ‘‘(5) contains recommendations for expanding

13 the Institute’s funding of research directly applicable

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

15 control, and treatment of, and rehabilitation of chil16 dren with arthritis and musculoskeletal diseases.’’.

17 TITLE VIII—NATIONAL

18 INSTITUTE ON AGING

19 SEC. 801. ALZHEIMER’S DISEASE REGISTRY.

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

21 (99 Stat. 885) is—

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

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

24 et seq.);

25 (2) redesignated as section 445G; and
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1 (3) inserted after section 445F of such Act.

2 (b) TECHNICAL AND CONFORMING AMENDMENTS.—

3 Section 445G of the Public Health Service Act, as trans4 ferred and inserted by subsection (a) of this section, is

5 amended—

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

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

8 (a) and inserting the following:

9 ‘‘ALZHEIMER’S DISEASE REGISTRY

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

11 Institute may make a grant’’; and

12 (2) by striking subsection (c).

13 SEC. 802. AGING PROCESSES REGARDING WOMEN.

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

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

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

17 ‘‘AGING PROCESSES REGARDING WOMEN

18 ‘‘SEC. 445H. The Director of the Institute, in addi19 tion to other special functions specified in section 444 and

20 in cooperation with the Directors of the other national re21 search institutes and agencies of the National Institutes

22 of Health, shall conduct research into the aging processes

23 of women, with particular emphasis given to the effects

24 of menopause and the physiological and behavioral

25 changes occurring during the transition from pre- to post26 menopause, and into the diagnosis, disorders, and com-
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1 plications related to aging and loss of ovarian hormones

2 in women.’’.

3 SEC. 803. AUTHORIZATION OF APPROPRIATIONS.

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

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

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

7 ‘‘AUTHORIZATION OF APPROPRIATIONS

8 ‘‘SEC. 445I. For the purpose of carrying out this sub9 part, there are authorized to be appropriated

10 $500,000,000 for fiscal year 1994, and such sums as may

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

12 SEC. 804. CONFORMING AMENDMENT.

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

14 U.S.C. 285e–5(b)) is amended—

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

16 by inserting after ‘‘Council’’ the following: ‘‘on Alz17 heimer’s Disease (hereafter in this section referred

18 to as the ‘Council’)’’; and

19 (2) by adding at the end the following new sub20 section:

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

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

23 section 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

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

8 SEC. 902. CHRONIC FATIGUE SYNDROME.

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

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

11 is 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

15 consultation with the advisory council for the Institute,

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

17 or nonprofit private entities for the development and oper18 ation of centers to conduct basic and clinical research on

19 chronic 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

24 Institute.’’.
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1 (b) EXTRAMURAL STUDY SECTION.—Not later than

2 6 months after the date of enactment of this Act, the Sec3 retary of Health and Human Services shall establish an

4 extramural study section for chronic fatigue syndrome re5 search.

6 (c) REPRESENTATIVES.—The Secretary of Health

7 and Human Services, acting through the Director of the

8 National Institutes of Health, shall ensure that appro9 priate individuals with expertise in chronic fatigue syn10 drome or neuromuscular diseases and representative of a

11 variety of disciplines and fields within the research com12 munity are appointed to appropriate National Institutes

13 of Health advisory committees and boards.

14 TITLE X—NATIONAL INSTITUTE

15 OF CHILD HEALTH AND

16 HUMAN DEVELOPMENT

17 Subtitle A—Research Centers With

18 Respect to Contraception and

19 Research Centers With Respect

20 to Infertility

21 SEC. 1001. GRANTS AND CONTRACTS FOR RESEARCH CEN22 TERS.

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

24 Service Act, as amended by section 3 of Public Law 101–
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1 613, is amended by adding at the end the following new

2 section:

3 ‘‘RESEARCH CENTERS WITH RESPECT TO

4 CONTRACEPTION AND INFERTILITY

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

6 consultation with the advisory council for the Institute,

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

8 or nonprofit private entities for the development and oper9 ation of centers to conduct activities for the purpose of

10 improving methods of contraception and centers to con11 duct activities for the purpose of improving methods of

12 diagnosis and treatment of infertility.

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

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

15 available in appropriations Acts, provide for the establish16 ment of three centers with respect to contraception and

17 for two centers with respect to infertility.

18 ‘‘(c)(1) Each center assisted under this section shall,

19 in carrying out the purpose of the center involved—

20 ‘‘(A) conduct clinical and other applied re21 search, including—

22 ‘‘(i) for centers with respect to contracep23 tion, clinical trials of new or improved drugs

24 and devices for use by males and females (in25 cluding barrier methods); and
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1 ‘‘(ii) for centers with respect to infertility,

2 clinical trials of new or improved drugs and de3 vices for the diagnosis and treatment of infertil4 ity in males and females;

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

6 scientists, nurses, and other health and allied health

7 professionals;

8 ‘‘(C) conduct training programs for such indi9 viduals;

10 ‘‘(D) develop model continuing education pro11 grams for such professionals; and

12 ‘‘(E) disseminate information to such profes13 sionals and the public.

14 ‘‘(2) A center may use funds provided under sub15 section (a) to provide stipends for health and allied health

16 professionals enrolled in programs described in subpara17 graph (C) of paragraph (1), and to provide fees to individ18 uals serving as subjects in clinical trials conducted under

19 such paragraph.

20 ‘‘(d) The Director of the Institute shall, as appro21 priate, provide for the coordination of information among

22 the centers assisted under this section.

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

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

25 a consortium of cooperating institutions, meeting such re-
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1 quirements as may be prescribed by the Director of the

2 Institute.

3 ‘‘(f) Support of a center under subsection (a) may

4 be for a period not exceeding 5 years. Such period may

5 be extended for one or more additional periods not exceed6 ing 5 years if the operations of such center have been re7 viewed by an appropriate technical and scientific peer re8 view group established by the Director and if such group

9 has recommended to the Director that such period should

10 be extended.

11 ‘‘(g) For the purpose of carrying out this section,

12 there are authorized to be appropriated $30,000,000 for

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

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

15 SEC. 1002. LOAN REPAYMENT PROGRAM FOR RESEARCH

16 WITH RESPECT TO CONTRACEPTION AND IN17 FERTILITY.

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

19 as redesignated by section 141(a)(2) of this Act, is amend20 ed by inserting after section 487A the following section:

21 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH

22 RESPECT TO CONTRACEPTION AND INFERTILITY

23 ‘‘SEC. 487B. (a) The Secretary, in consultation with

24 the Director of the National Institute of Child Health and

25 Human Development, shall establish a program of enter26 ing into agreements with qualified health professionals (in-
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1 cluding graduate students) under which such health pro2 fessionals agree to conduct research with respect to con3 traception, or with respect to infertility, in consideration

4 of the Federal Government agreeing to repay, for each

5 year of such service, not more than $20,000 of the prin6 cipal and interest of the educational loans of such health

7 professionals.

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

9 338E shall apply to the program established in subsection

10 (a) to the same extent and in the same manner as such

11 provisions apply to the National Health Service Corps

12 Loan Repayment Program established in subpart III of

13 part D of title III.

14 ‘‘(c) Amounts appropriated for carrying out this sec15 tion shall remain available until the expiration of the sec16 ond fiscal year beginning after the fiscal year for which

17 the amounts were appropriated.’’.

18 Subtitle B—Program Regarding

19 Obstetrics and Gynecology

20 SEC. 1011. ESTABLISHMENT OF PROGRAM.

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

22 Service Act, as amended by section 1001 of this Act, is

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

24 ‘‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY

25 ‘‘SEC. 452B. The Director of the Institute shall es26 tablish and maintain within the Institute an intramural
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1 laboratory and clinical research program in obstetrics and

2 gynecology.’’.

3 Subtitle C—Child Health Research

4 Centers

5 SEC. 1021. ESTABLISHMENT OF CENTERS.

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

7 Service Act, as amended by section 1011 of this Act, is

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

9 ‘‘CHILD HEALTH RESEARCH CENTERS

10 ‘‘SEC. 452C. The Director of the Institute shall de11 velop and support centers for conducting research with re12 spect to child health. Such centers shall give priority to

13 the expeditious transfer of advances from basic science to

14 clinical applications and improving the care of infants and

15 children.’’.

16 Subtitle D—Study Regarding

17 Adolescent Health

18 SEC. 1031. PROSPECTIVE LONGITUDINAL STUDY.

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

20 Service Act, as amended by section 1021 of this Act, is

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

22 ‘‘PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT

23 HEALTH

24 ‘‘SEC. 452D. (a) IN GENERAL.—Not later than No25 vember 1, 1993, the Director of the Institute shall initiate

26 a 3-year study for the purpose of providing information
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1 on the general health and well-being of adolescents in the

2 United States, including, with respect to such adolescents,

3 information on—

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

5 behaviors that are detrimental to health; and

6 ‘‘(2) the influence on health of factors particu7 lar to the communities in which the adolescents

8 reside.

9 ‘‘(b) DESIGN OF STUDY.—

10 ‘‘(1) IN GENERAL.—The study required in sub11 section (a) shall be a longitudinal study in which a

12 substantial number of adolescents participate as sub13 jects. With respect to the purpose described in such

14 subsection, the study shall monitor the subjects

15 throughout the period of the study to determine the

16 health status of the subjects and any change in such

17 status over time.

18 ‘‘(2) POPULATION-SPECIFIC ANALYSES.—The

19 study required in subsection (a) shall be conducted

20 with respect to the population of adolescents who are

21 female, the population of adolescents who are male,

22 various socioeconomic populations of adolescents,

23 and various racial and ethnic populations of adoles24 cents. The study shall be designed and conducted in

25 a manner sufficient to provide for a valid analysis of
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1 whether there are significant differences among such

2 populations in health status and whether and to

3 what extent any such differences are due to factors

4 particular to the populations involved.

5 ‘‘(c) COORDINATION WITH WOMEN’S HEALTH INI6 TIATIVE.—With respect to the national study of women

7 being conducted by the Secretary and known as the Wom8 en’s Health Initiative, the Secretary shall ensure that such

9 study is coordinated with the component of the study re10 quired in subsection (a) that concerns adolescent females,

11 including coordination in the design of the 2 studies.’’.

12 TITLE XI—NATIONAL EYE

13 INSTITUTE

14 SEC. 1101. CLINICAL AND HEALTH SERVICES RESEARCH ON

15 EYE CARE AND DIABETES.

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

17 of the Public Health Service Act (42 U.S.C. 285i) is

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

19 ‘‘CLINICAL RESEARCH ON EYE CARE AND DIABETES

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

21 of the Institute, in consultation with the advisory council

22 for the Institute, may award research grants to one or

23 more Diabetes Eye Research Institutions for the support

24 of programs in clinical or health services aimed at—
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1 ‘‘(1) providing comprehensive eye care services

2 for people with diabetes, including a full complement

3 of preventive, diagnostic and treatment procedures;

4 ‘‘(2) developing new and improved techniques of

5 patient care through basic and clinical research;

6 ‘‘(3) assisting in translation of the latest re7 search advances into clinical practice; and

8 ‘‘(4) expanding the knowledge of the eye and

9 diabetes through further research.

10 ‘‘(b) USE OF FUNDS.—Amounts received under a

11 grant awarded under this section shall be used for the fol12 lowing:

13 ‘‘(1) Establishing the biochemical, cellular, and

14 genetic mechanisms associated with diabetic eye dis15 ease and the earlier detection of pending eye abnor16 malities. The focus of work under this paragraph

17 shall require that ophthalmologists have training in

18 the most up-to-date molecular and cell biological

19 methods.

20 ‘‘(2) Establishing new frontiers in technology,

21 such as video-based diagnostic and research re22 sources, to—

23 ‘‘(A) provide improved patient care;

24 ‘‘(B) provide for the evaluation of retinal

25 physiology and its affect on diabetes; and
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1 ‘‘(C) provide for the assessment of risks

2 for the development and progression of diabetic

3 eye disease and a more immediate evaluation of

4 various therapies aimed at preventing diabetic

5 eye disease.

6 Such technologies shall be designed to permit eval7 uations to be performed both in humans and in ani8 mal models.

9 ‘‘(3) The translation of the results of vision re10 search into the improved care of patients with dia11 betic eye disease. Such translation shall require the

12 application of institutional resources that encompass

13 patient care, clinical research and basic laboratory

14 research.

15 ‘‘(4) The conduct of research concerning the

16 outcomes of eye care treatments and eye health edu17 cation programs as they relate to patients with dia18 betic eye disease, including the evaluation of regional

19 approaches to such research.

20 ‘‘(c) AUTHORIZED EXPENDITURES.—The purposes

21 for which a grant under subsection (a) may be expended

22 include equipment for the research described in such sub23 section and the construction and modernization of facili24 ties for such research.’’.
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1 (b) CONFORMING AMENDMENT.—Section 455 of the

2 Public Health Service Act (42 U.S.C. 285i) is amended

3 in the second sentence by striking ‘‘The Director’’ and in4 serting ‘‘Subject to section 456, the Director’’.

5 TITLE XII—NATIONAL INSTI6 TUTE OF NEUROLOGICAL DIS7 ORDERS AND STROKE

8 SEC. 1201. RESEARCH ON MULTIPLE SCLEROSIS.

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

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

11 at the end the following new section:

12 ‘‘RESEARCH ON MULTIPLE SCLEROSIS

13 ‘‘SEC. 460. The Director of the Institute shall con14 duct and support research on multiple sclerosis, especially

15 research on effects of genetics and hormonal changes on

16 the progress of the disease.’’.

17 TITLE XIII—NATIONAL INSTI18 TUTE OF ENVIRONMENTAL

19 HEALTH SCIENCES

20 SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND

21 TESTING PROGRAM.

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

23 of the Public Health Service Act (42 U.S.C. 285l) is

24 amended by adding at the end the following new section:
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1 ‘‘APPLIED TOXICOLOGICAL RESEARCH AND TESTING

2 PROGRAM

3 ‘‘SEC. 463A. (a) There is established within the Insti4 tute a program for conducting applied research and test5 ing regarding toxicology, which program shall be known

6 as the Applied Toxicological Research and Testing Pro7 gram.

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

9 subsection (a), the Director of the Institute shall, with re10 spect to toxicology, carry out activities—

11 ‘‘(1) to expand knowledge of the health effects

12 of environmental agents;

13 ‘‘(2) to broaden the spectrum of toxicology in14 formation that is obtained on selected chemicals;

15 ‘‘(3) to develop and validate assays and proto16 cols, including alternative methods that can reduce

17 or eliminate the use of animals in acute or chronic

18 safety testing;

19 ‘‘(4) to establish criteria for the validation and

20 regulatory acceptance of alternative testing and to

21 recommend a process through which scientifically

22 validated alternative methods can be accepted for

23 regulatory use;
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1 ‘‘(5) to communicate the results of research to

2 government agencies, to medical, scientific, and reg3 ulatory communities, and to the public; and

4 ‘‘(6) to integrate related activities of the De5 partment of Health and Human Services.’’.

6 (b) TECHNICAL AMENDMENT.—Section 463 of the

7 Public Health Service Act (42 U.S.C. 285l) is amended

8 by inserting after ‘‘Sciences’’ the following: ‘‘(hereafter in

9 this subpart referred to as the ‘Institute’)’’.

10 TITLE XIV—NATIONAL LIBRARY

11 OF MEDICINE

12 Subtitle A—General Provisions

13 SEC. 1401. ADDITIONAL AUTHORITIES.

14 (a) IN GENERAL.—Section 465(b) of the Public

15 Health Service Act (42 U.S.C. 286(b)) is amended—

16 (1) by striking ‘‘and’’ after the semicolon at the

17 end of paragraph (5);

18 (2) by redesignating paragraph (6) as para19 graph (8); and

20 (3) by inserting after paragraph (5) the follow21 ing new paragraphs:

22 ‘‘(6) publicize the availability from the Library

23 of the products and services described in any of

24 paragraphs (1) through (5);
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1 ‘‘(7) promote the use of computers and tele2 communications by health professionals (including

3 health professionals in rural areas) for the purpose

4 of improving access to biomedical information for

5 health care delivery and medical research; and’’.

6 (b) LIMITATION REGARDING GRANTS.—Section

7 474(b)(2) of the Public Health Service Act (42 U.S.C.

8 286b–S(b)(2)) is amended by striking ‘‘$750,000’’ and in9 serting ‘‘$1,000,000’’.

10 (c) TECHNICAL AND CONFORMING AMENDMENTS.—

11 (1) REPEAL OF CERTAIN AUTHORITY.—Section

12 215 of the Department of Health and Human Serv13 ices Appropriations Act, 1988, as contained in sec14 tion 101(h) of Public Law 100–202 (101 Stat.

15 1329–275), is repealed.

16 (2) APPLICABILITY OF CERTAIN NEW AUTHOR17 ITY.—With respect to the authority established for

18 the National Library of Medicine in section

19 465(b)(6) of the Public Health Service Act, as added

20 by subsection (a) of this section, such authority shall

21 be effective as if the authority had been established

22 on December 22, 1987.

23 SEC. 1402. AUTHORIZATION OF APPROPRIATIONS.

24 (a) ESTABLISHMENT OF SINGLE AUTHORIZATION.—

25 Subpart 1 of part D of title IV of the Public Health Serv-
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1 ice Act (42 U.S.C. 286 et seq.) is amended by adding at

2 the end the following section:

3 ‘‘AUTHORIZATION OF APPROPRIATIONS

4 ‘‘SEC. 468. (a) For the purpose of carrying out this

5 part, there are authorized to be appropriated

6 $150,000,000 for fiscal year 1994, and such sums as may

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

8 ‘‘(b) Amounts appropriated under subsection (a) and

9 made available for grants or contracts under any of sec10 tions 472 through 476 shall remain available until the end

11 of the fiscal year following the fiscal year for which the

12 amounts were appropriated.’’.

13 (b) CONFORMING AMENDMENTS.—Part D of title IV

14 of the Public Health Service Act (42 U.S.C. 286 et seq.)

15 is amended by striking section 469 and section 478(c).

16 Subtitle B—Financial Assistance

17 SEC. 1411. ESTABLISHMENT OF PROGRAM OF GRANTS FOR

18 DEVELOPMENT OF EDUCATION TECH19 NOLOGIES.

20 Section 473 of the Public Health Service Act (42

21 U.S.C. 286b–4) is amended by adding at the end the fol22 lowing new subsection:

23 ‘‘(c)(1) The Secretary shall make grants to public or

24 nonprofit private institutions for the purpose of carrying

25 out projects of research on, and development and dem26 onstration of, new education technologies.
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1 ‘‘(2) The purposes for which a grant under paragraph

2 (1) may be made include projects concerning—

3 ‘‘(A) computer-assisted teaching and testing of

4 clinical competence at health professions and re5 search institutions;

6 ‘‘(B) the effective transfer of new information

7 from research laboratories to appropriate clinical ap8 plications;

9 ‘‘(C) the expansion of the laboratory and clini10 cal uses of computer-stored research databases; and

11 ‘‘(D) the testing of new technologies for train12 ing health care professionals.

13 ‘‘(3) The Secretary may not make a grant under

14 paragraph (1) unless the applicant for the grant agrees

15 to make the projects available with respect to—

16 ‘‘(A) assisting in the training of health profes17 sions students; and

18 ‘‘(B) enhancing and improving the capabilities

19 of health professionals regarding research and teach20 ing.’’.
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1 Subtitle C—National Information

2 Center on Health Services Re3 search and Health Care Tech4 nology

5 SEC. 1421. ESTABLISHMENT OF CENTER.

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

7 (42 U.S.C. 286 et seq.) is amended by adding at the end

8 the following new subpart:

9 ‘‘Subpart 4—National Information Center on Health

10 Services Research and Health Care Technology

11 ‘‘NATIONAL INFORMATION CENTER

12 ‘‘SEC. 478A. (a) There is established within the Li13 brary an entity to be known as the National Information

14 Center on Health Services Research and Health Care

15 Technology (in this section referred to as the ‘Center’).

16 ‘‘(b) The purpose of the Center is the collection, stor17 age, analysis, retrieval, and dissemination of information

18 on health services research, clinical practice guidelines,

19 and on health care technology, including the assessment

20 of such technology. Such purpose includes developing and

21 maintaining data bases and developing and implementing

22 methods of carrying out such purpose.

23 ‘‘(c) The Director of the Center shall ensure that in24 formation under subsection (b) concerning clinical practice

25 guidelines is collected and maintained electronically and
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1 in a convenient format. Such Director shall develop and

2 publish criteria for the inclusion of practice guidelines and

3 technology assessments in the information center

4 database.

5 ‘‘(d) The Secretary, acting through the Center, shall

6 coordinate the activities carried out under this section

7 through the Center with related activities of the Adminis8 trator for Health Care Policy and Research.’’.

9 SEC. 1422. CONFORMING PROVISIONS.

10 (a) IN GENERAL.—Section 903 of the Public Health

11 Service Act, as amended by section 3 of Public Law 102–

12 410 (106 Stat. 2094), is amended to read as follows:

13 ‘‘(e) REQUIRED INTERAGENCY AGREEMENT.—The

14 Administrator and the Director of the National Library

15 of Medicine shall enter into an agreement providing for

16 the implementation of section 478A.’’.

17 (b) RULE OF CONSTRUCTION.—The amendments

18 made by section 3 of Public Law 102–410 (106 Stat.

19 2094), by section 1421 of this Act, and by subsection (a)

20 of this section may not be construed as terminating the

21 information center on health care technologies and health

22 care technology assessment established under section 904

23 of the Public Health Service Act, as in effect on the day

24 before the date of the enactment of Public Law 102–410.

25 Such center shall be considered to be the center estab-
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1 lished in section 478A of the Public Health Service Act,

2 as added by section 1421 of this Act, and shall be subject

3 to the provisions of such section 478A.

4 TITLE XV—OTHER AGENCIES OF

5 NATIONAL INSTITUTES OF

6 HEALTH

7 Subtitle A—Division of Research

8 Resources

9 SEC. 1501. REDESIGNATION OF DIVISION AS NATIONAL

10 CENTER FOR RESEARCH RESOURCES.

11 Title IV of the Public Health Service Act (42 U.S.C.

12 281 et seq.) is amended—

13 (1) in section 401(b)(2)(B), by amending such

14 subparagraph to read as follows:

15 ‘‘(B) The National Center for Research Re16 sources.’’; and

17 (2) in part E—

18 (A) in the heading for subpart 1, by strik19 ing ‘‘Division of ’’ and inserting ‘‘National Cen20 ter for’’;

21 (B) in section 479, by striking ‘‘the Divi22 sion of Research Resources’’ and inserting the

23 following: ‘‘the National Center for Research

24 Resources (hereafter in this subpart referred to

25 as the ‘Center’)’’;
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1 (C) in sections 480 and 481, by striking

2 ‘‘the Division of Research Resources’’ each

3 place such term appears and inserting ‘‘the

4 Center’’; and

5 (D) in sections 480 and 481, as amended

6 by subparagraph (C), by striking ‘‘the Division’’

7 each place such term appears and inserting

8 ‘‘the Center’’.

9 SEC. 1502. BIOMEDICAL AND BEHAVIORAL RESEARCH FA10 CILITIES.

11 Subpart 1 of part E of title IV of the Public Health

12 Service Act (42 U.S.C. 287 et seq.) is amended by adding

13 at the end the following new section:

14 ‘‘BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES

15 ‘‘SEC. 481A. (a) MODERNIZATION AND CONSTRUC16 TION OF FACILITIES.—

17 ‘‘(1) IN GENERAL.—The Director of NIH, act18 ing through the Director of the Center, may make

19 grants to public and nonprofit private entities to ex20 pand, remodel, renovate, or alter existing research

21 facilities or construct new research facilities, subject

22 to the provisions of this section.

23 ‘‘(2) CONSTRUCTION AND COST OF CONSTRUC24 TION.—For purposes of this section, the terms ‘con25 struction’ and ‘cost of construction’ include the con26 struction of new buildings and the expansion, ren-
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1 ovation, remodeling, and alteration of existing build2 ings, including architects’ fees, but do not include

3 the cost of acquisition of land or off-site improve4 ments.

5 ‘‘(b) SCIENTIFIC AND TECHNICAL REVIEW BOARDS

6 FOR MERIT-BASED REVIEW OF PROPOSALS.—

7 ‘‘(1) IN GENERAL; APPROVAL AS PRECONDITION

8 TO GRANTS.—

9 ‘‘(A) There is established within the Center

10 a Scientific and Technical Review Board on

11 Biomedical and Behavioral Research Facilities

12 (hereafter referred to in this section as the

13 ‘Board’).

14 ‘‘(B) The Director of the Center may ap15 prove an application for a grant under sub16 section (a) only if—

17 ‘‘(i) the Board has under paragraph

18 (2) recommended the application for ap19 proval; or

20 ‘‘(ii) the Director makes a written de21 termination (setting forth in detail the Di22 rector’s reasons for rejecting the rec23 ommendations of the Board) to approve a

24 grant despite the adverse recommendation

25 of the Board.
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1 ‘‘(2) DUTIES.—

2 ‘‘(A) The Board shall provide advice to the

3 Director of the Center and the advisory council

4 established under section 480 (hereafter in this

5 section referred to as the ‘Advisory Council’) on

6 carrying out this section.

7 ‘‘(B) In carrying out subparagraph (A),

8 the Board shall make a determination of the

9 merit of each application submitted for a grant

10 under subsection (a), after consideration of the

11 requirements established in subsection (c), and

12 shall report the results of the determination to

13 the Director of the Center and the Advisory

14 Council. Such determinations shall be con15 ducted in a manner consistent with procedures

16 established under section 492.

17 ‘‘(C) In carrying out subparagraph (A),

18 the Board shall, in the case of applications rec19 ommended for approval, make recommendations

20 to the Director and the Advisory Council on the

21 amount that should be provided in the grant.

22 ‘‘(D) In carrying out subparagraph (A),

23 the Board shall prepare an annual report for

24 the Director of the Center and the Advisory

25 Council describing the activities of the Board in
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1 the fiscal year for which the report is made.

2 Each such report shall be available to the pub3 lic, and shall—

4 ‘‘(i) summarize and analyze expendi5 tures made under this section;

6 ‘‘(ii) provide a summary of the types,

7 numbers, and amounts of applications that

8 were recommended for grants under sub9 section (a) but that were not approved by

10 the Director of the Center; and

11 ‘‘(iii) contain the recommendations of

12 the Board for any changes in the adminis13 tration of this section.

14 ‘‘(3) MEMBERSHIP.—

15 ‘‘(A) Subject to subparagraph (B), the

16 Board shall be composed of not more than 9

17 members appointed by the Secretary, acting

18 through the Director of the National Institutes

19 of Health, and ex officio members as the Direc20 tor of the Center may determine.

21 ‘‘(B) Not more than 2 individuals who are

22 officers or employees of the Federal Govern23 ment may serve as members of the Board.

24 ‘‘(4) CERTAIN REQUIREMENTS REGARDING

25 MEMBERSHIP.—In selecting individuals for member-
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1 ship on the Board, the Secretary shall ensure that

2 the members are individuals who, by the virtue of

3 their training or experience, are eminently qualified

4 to perform peer review functions. In selecting such

5 individuals for such membership, the Secretary shall

6 ensure that the members of the Board collectively—

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 cen21 ters of excellence, as described in subsection

22 (c)(3).

23 ‘‘(5) CERTAIN AUTHORITIES.—

24 ‘‘(A) In carrying out paragraph (2), the

25 Board may establish subcommittees, convene
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1 workshops and conferences, and collect data as

2 the Board considers appropriate.

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 Secretary when

19 making the appointments)—

20 ‘‘(i) 3 shall hold office for a term of

21 3 years;

22 ‘‘(ii) 3 shall hold office for a term of

23 2 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

3 after the end of the most recent term of the

4 member.

5 ‘‘(7) COMPENSATION.—Members of board who

6 are not officers or employees of the United States

7 shall receive compensation for each day engaged in

8 carrying out the duties of the board, including time

9 engaged in traveling for purposes of such duties.

10 Such compensation may not be provided in an

11 amount in excess of the maximum rate of basic pay

12 payable for GS–18 of the General Schedule.

13 ‘‘(c) REQUIREMENTS FOR GRANTS.—

14 ‘‘(1) IN GENERAL.—The Director of the Center

15 may make a grant under subsection (a) only if the

16 applicant for the grant meets the following condi17 tions:

18 ‘‘(A) The applicant is determined by such

19 Director to be competent to engage in the type

20 of research for which the proposed facility is to

21 be constructed.

22 ‘‘(B) The applicant provides assurances

23 satisfactory to the Director that—

24 ‘‘(i) for not less than 20 years after

25 completion of the construction, the facility
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1 will be used for the purposes of research

2 for which it is to be constructed;

3 ‘‘(ii) sufficient funds will be available

4 to meet the non-Federal share of the cost

5 of constructing the facility;

6 ‘‘(iii) sufficient funds will be available,

7 when construction is completed, for the ef8 fective use of the facility for the research

9 for which it is being constructed; and

10 ‘‘(iv) the proposed construction will

11 expand the applicant’s capacity for re12 search, or is necessary to improve or main13 tain the quality of the applicant’s research.

14 ‘‘(C) The applicant meets reasonable quali15 fications established by the Director with re16 spect to—

17 ‘‘(i) the relative scientific and tech18 nical merit of the applications, and the rel19 ative effectiveness of the proposed facili20 ties, in expanding the capacity for bio21 medical or behavioral research and in im22 proving the quality of such research;

23 ‘‘(ii) the quality of the research or

24 training, or both, to be carried out in the

25 facilities involved;
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1 ‘‘(iii) the need of the applicant for

2 such facilities in order to maintain or ex3 pand the applicant’s research and training

4 mission;

5 ‘‘(iv) the congruence of the research

6 activities to be carried out within the facil7 ity with the research and investigator man8 power needs of the United States; and

9 ‘‘(v) the age and condition of existing

10 research facilities and equipment.

11 ‘‘(D) The applicant has demonstrated a

12 commitment to enhancing and expanding the

13 research productivity of the applicant.

14 ‘‘(2) CONSIDERATION OF CERTAIN FACTORS.—

15 In making grants under subsection (a), the Director

16 of the Center may, in addition to the requirements

17 established in paragraph (1), consider the following

18 factors:

19 ‘‘(A) To what extent the applicant has the

20 capacity to broaden the scope of research and

21 research training programs of the applicant by

22 promoting—

23 ‘‘(i) interdisciplinary research;

24 ‘‘(ii) research on emerging tech25 nologies, including those involving novel
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1 analytical techniques or computational

2 methods; or

3 ‘‘(iii) other novel research mechanisms

4 or programs.

5 ‘‘(B) To what extent the applicant has

6 broadened the scope of research and research

7 training programs of qualified institutions by

8 promoting genomic research with an emphasis

9 on interdisciplinary research, including research

10 related to pediatric investigations.

11 ‘‘(3) INSTITUTIONS OF EMERGING EXCEL12 LENCE.—Of the amounts appropriated under sub13 section (i) for a fiscal year, the Director of the Cen14 ter shall make available 25 percent for grants under

15 subsection (a) to applicants that, in addition to

16 meeting the requirements established in paragraph

17 (1), have demonstrated emerging excellence in bio18 medical or behavioral research, as follows:

19 ‘‘(A) The applicant has a plan for research

20 or training advancement and possesses the abil21 ity to carry out the plan.

22 ‘‘(B) The applicant carries out research

23 and research training programs that have a

24 special relevance to a problem, concern, or

25 unmet health need of the United States.
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1 ‘‘(C) The applicant has been productive in

2 research or research development and training.

3 ‘‘(D) The applicant—

4 ‘‘(i) has been designated as a center

5 of excellence under section 739;

6 ‘‘(ii) is located in a geographic area a

7 significant percentage of whose population

8 has a health-status deficit, and the appli9 cant provides health services to such popu10 lation; or

11 ‘‘(iii) is located in a geographic area

12 in which a deficit in health care tech13 nology, services, or research resources may

14 adversely affect health status of the popu15 lation of the area in the future, and the

16 applicant is carrying out activities with re17 spect to protecting the health status of

18 such population.

19 ‘‘(d) REQUIREMENT OF APPLICATION.—The Director

20 of the Center may make a grant under subsection (a) only

21 if an application for the grant is submitted to the Director

22 and the application is in such form, is made in such man23 ner, and contains such agreements, assurances, and infor24 mation as the Director determines to be necessary to carry

25 out this section.
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1 ‘‘(e) AMOUNT OF GRANT; PAYMENTS.—

2 ‘‘(1) AMOUNT.—The amount of any grant

3 awarded under subsection (a) shall be determined by

4 the Director of the Center, except that such amount

5 shall not exceed—

6 ‘‘(A) 50 percent of the necessary cost of

7 the construction of a proposed facility as deter8 mined by the Director; or

9 ‘‘(B) in the case of a multipurpose facility,

10 40 percent of that part of the necessary cost of

11 construction that the Director determines to be

12 proportionate to the contemplated use of the fa13 cility.

14 ‘‘(2) RESERVATION OF AMOUNTS.—On approval

15 of any application for a grant under subsection (a),

16 the Director of the Center shall reserve, from any

17 appropriation available therefore, the amount of

18 such grant, and shall pay such amount, in advance

19 or by way of reimbursement, and in such install20 ments consistent with the construction progress, as

21 the Director may determine appropriate. The res22 ervation of the Director of any amount by the Direc23 tor under this paragraph may be amended by the

24 Director, either on the approval of an amendment of
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1 the application or on the revision of the estimated

2 cost of construction of the facility.

3 ‘‘(3) EXCLUSION OF CERTAIN COSTS.—In deter4 mining the amount of any grant under this sub5 section (a), there shall be excluded from the cost of

6 construction an amount equal to the sum of—

7 ‘‘(A) the amount of any other Federal

8 grant that the applicant has obtained, or is as9 sured of obtaining, with respect to construction

10 that is to be financed in part by a grant author11 ized under this section; and

12 ‘‘(B) the amount of any non-Federal funds

13 required to be expended as a condition of such

14 other Federal grant.

15 ‘‘(4) WAIVER OF LIMITATIONS.—The limita16 tions imposed by paragraph (1) may be waived at

17 the discretion of the Director for applicants meeting

18 the conditions described in paragraphs (1) and (2)

19 of subsection (c).

20 ‘‘(f) RECAPTURE OF PAYMENTS.—If, not later than

21 20 years after the completion of construction for which

22 a grant has been awarded under subsection (a)—

23 ‘‘(1) the applicant or other owner of the facility

24 shall cease to be a public or nonprofit private entity;

25 or
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1 ‘‘(2) the facility shall cease to be used for the

2 research purposes for which it was constructed (un3 less the Director determines, in accordance with reg4 ulations, that there is good cause for releasing the

5 applicant or other owner from obligation to do so);

6 the United States shall be entitled to recover from the ap7 plicant or other owner of the facility the amount bearing

8 the same ratio to the current value (as determined by an

9 agreement between the parties or by action brought in the

10 United States District Court for the district in which such

11 facility is situated) of the facility as the amount of the

12 Federal participation bore to the cost of the construction

13 of such facility.

14 ‘‘(g) NONINTERFERENCE WITH ADMINISTRATION OF

15 ENTITIES.—Except as otherwise specifically provided in

16 this section, nothing contained in this part shall be con17 strued as authorizing any department, agency, officer, or

18 employee of the United States to exercise any direction,

19 supervision, or control over, or impose any requirement

20 or condition with respect to the administration of any en21 tity funded under this part.

22 ‘‘(h) GUIDELINES.—Not later than 6 months after

23 the date of the enactment of this section, the Director of

24 the Center, after consultation with the Advisory Council,
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1 shall issue guidelines with respect to grants under sub2 section (a).

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

4 purpose of carrying out this section and section 481B,

5 there are authorized to be appropriated $150,000,000 for

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

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

8 SEC. 1503. CONSTRUCTION PROGRAM FOR NATIONAL PRI9 MATE RESEARCH CENTER.

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

11 Service Act, as amended by section 1502 of this Act, is

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

13 ‘‘CONSTRUCTION OF REGIONAL CENTERS FOR RESEARCH

14 ON PRIMATES

15 ‘‘SEC. 481B. (a) The Director of the National Insti16 tutes of Health, acting through the Director of the Na17 tional Center for Research Resources, may award grants

18 and contracts to public or nonprofit private entities to con19 struct, renovate, or otherwise improve such regional cen20 ters.

21 ‘‘(b) The Director of NIH may not make a grant or

22 enter into a contract under subsection (a) unless the appli23 cant for such assistance agrees, with respect to the costs

24 to be incurred by the applicant in carrying out the purpose

25 described in such subsection, to make available (directly

26 or through donations from public or private entities) non-
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1 Federal contributions in cash toward such costs in an

2 amount equal to not less than $1 for each $4 of Federal

3 funds provided in such assistance.

4 ‘‘(c) The Secretary may reserve not more than

5 $7,000,000 of the amounts appropriated under section

6 481A(i) for each fiscal year to carry out this section.’’.

7 Subtitle B—National Center for

8 Nursing Research

9 SEC. 1511. REDESIGNATION OF NATIONAL CENTER FOR

10 NURSING RESEARCH AS NATIONAL INSTI11 TUTE OF NURSING RESEARCH.

12 (a) IN GENERAL.—Subpart 3 of part E of title IV

13 of the Public Health Service Act (42 U.S.C. 287c et seq.)

14 is amended—

15 (1) in section 483—

16 (A) in the heading for the section, by strik17 ing ‘‘CENTER’’ and inserting ‘‘INSTITUTE’’; and

18 (B) by striking ‘‘The general purpose’’ and

19 all that follows through ‘‘is’’ and inserting the

20 following: ‘‘The general purpose of the National

21 Institute of Nursing Research (hereafter in this

22 subpart referred to as the ‘Institute’) is’’;

23 (2) in section 484, by striking ‘‘Center’’ each

24 place such term appears and inserting ‘‘Institute’’;

25 (3) in section 485—
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1 (A) in subsection (a), in each of para2 graphs (1) through (3), by striking ‘‘Center’’

3 each place such term appears and inserting

4 ‘‘Institute’’;

5 (B) in subsection (b)—

6 (i) in paragraph (2)(A), by striking

7 ‘‘Center’’ and inserting ‘‘Institute’’; and

8 (ii) in paragraph (3)(A), in the first

9 sentence, by striking ‘‘Center’’ and insert10 ing ‘‘Institute’’; and

11 (C) in subsections (d) through (g), by

12 striking ‘‘Center’’ each place such term appears

13 and inserting ‘‘Institute’’; and

14 (4) in section 485A (as redesignated by section

15 141(a)(1) of this Act), by striking ‘‘Center’’ each

16 place such term appears and inserting ‘‘Institute’’.

17 (b) CONFORMING AMENDMENTS.—

18 (1) ORGANIZATION OF NATIONAL INSTITUTE OF

19 HEALTH.—Section 401(b) of the Public Health

20 Service Act (42 U.S.C. 281(b)) is amended—

21 (A) in paragraph (1), by adding at the end

22 the following new subparagraph:

23 ‘‘(Q) The National Institute of Nursing

24 Research.’’; and
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1 (B) in paragraph (2), by striking subpara2 graph (D).

3 (2) TRANSFER OF STATUTORY PROVISIONS.—

4 Sections 483 through 485A of the Public Health

5 Service Act, as amended by subsection (a) of this

6 section—

7 (A) are transferred to part C of title IV of

8 such Act;

9 (B) are redesignated as sections 464V

10 through 464Y of such part; and

11 (C) are inserted, in the appropriate se12 quence, at the end of such part.

13 (3) HEADING FOR NEW SUBPART.—Title IV of

14 the Public Health Service Act, as amended by the

15 preceding provisions of this section, is amended—

16 (A) in part C, by inserting before section

17 464V the following new heading:

18 ‘‘Subpart 17—National Institute of Nursing Research’’;

19 and

20 (B) by striking the heading for subpart 3

21 of part E.

22 (4) CROSS-REFERENCES.—Title IV of the Pub23 lic Health Service Act, as amended by the preceding

24 provisions of this section, is amended in subpart 17

25 of part C—
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1 (A) in section 464W, by striking ‘‘section

2 483’’ and inserting ‘‘section 464V’’;

3 (B) in section 464X(g), by striking ‘‘sec4 tion 486’’ and inserting ‘‘section 464Y’’; and

5 (C) in section 464Y, in the last sentence,

6 by striking ‘‘section 485(g)’’ and inserting ‘‘sec7 tion 464X(g)’’.

8 SEC. 1512. STUDY ON ADEQUACY OF NUMBER OF NURSES.

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

10 Human Services, acting through the Director of the Na11 tional Institute of Nursing Research and in collaboration

12 with the Division of Nursing of the Health Resources and

13 Services Administration, shall enter into a contract with

14 a public or nonprofit private entity to conduct a study for

15 the purpose of determining whether and to what extent

16 there is a need for an increase in the number of nurses

17 in hospitals and nursing homes in order to promote the

18 quality of patient care and reduce the incidence among

19 nurses of work-related injuries and stress.

20 (b) NATIONAL ACADEMY OF SCIENCES.—The Sec21 retary shall request the National Academy of Sciences to

22 enter into the contract under subsection (a) to conduct

23 the study described in such subsection. If such Institute

24 declines to conduct the study, the Secretary shall carry
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1 out such subsection through another public or nonprofit

2 private entity.

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

4 (1) The term ‘‘nurse’’ means a registered nurse,

5 a licensed practical nurse, a licensed vocational

6 nurse, and a nurse assistant.

7 (2) The term ‘‘Secretary’’ means the Secretary

8 of Health and Human Services.

9 (d) REPORTS.—The Secretary shall ensure that, not

10 later than 18 months after the date of enactment of this

11 Act, an interim report describing the preliminary findings

12 of the study conducted under this section will be issued,

13 and not later than 3 years after such date of enactment,

14 a final report shall be issued. Such reports shall be submit15 ted to the Committee on Energy and Commerce of the

16 House of Representatives, and to the Committee on Labor

17 and Human Resources of the Senate.

18 Subtitle C—National Center for

19 Human Genome Research

20 SEC. 1521. PURPOSE OF CENTER.

21 Title IV of the Public Health Service Act, as amended

22 by sections 141(a)(1) and 1611(b)(1)(B) of this Act, is

23 amended—

24 (1) in section 401(b)(2), by adding at the end

25 the following new subparagraph:
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1 ‘‘(D) The National Center for Human Genome

2 Research.’’; and

3 (2) in part E, by adding at the end the follow4 ing new subpart:

5 ‘‘Subpart 4—National Center for Human Genome

6 Research

7 ‘‘PURPOSE OF THE CENTER

8 ‘‘SEC. 485B. (a) The general purpose of the National

9 Center for Human Genome Research (hereafter in this

10 subpart referred to as the ‘Center’) is to characterize the

11 structure and function of the human genome, including

12 the mapping and sequencing of individual genes. Such

13 purpose includes—

14 ‘‘(1) planning and coordinating the research

15 goal of the genome project;

16 ‘‘(2) reviewing and funding research proposals;

17 ‘‘(3) developing training programs;

18 ‘‘(4) coordinating international genome re19 search;

20 ‘‘(5) communicating advances in genome science

21 to the public; and

22 ‘‘(6) reviewing and funding proposals to address

23 the ethical and legal issues associated with the ge24 nome project.
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1 ‘‘(b)(1) Except as provided in paragraph (2), of the

2 amounts appropriated to carry out subsection (a) for a

3 fiscal year, the Director of the Center is authorized to

4 make available not less than 5 percent for carrying out

5 paragraph (6) of such subsection.

6 ‘‘(2) With respect to providing funds under sub7 section (a)(6) for proposals to address the ethical and legal

8 issues, including the issuing of patents, associated with the

9 genome project, paragraph (1) shall not apply for a fiscal

10 year if the Director of the Center certifies to the Commit11 tee on Energy and Commerce of the House of Representa12 tives, and to the Committee on Labor and Human Re13 sources of the Senate, that the Director has determined

14 that an insufficient number of such proposals meet the

15 applicable requirements of sections 491 and 492.

16 ‘‘(3) In carrying out the provisions of paragraph (1),

17 the Director of the Center shall consider proposals from

18 qualified public and nonprofit academic or research facili19 ties.’’.
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1 TITLE XVI—AWARDS AND

2 TRAINING

3 Subtitle A—National Research

4 Service Awards

5 SEC. 1601. REQUIREMENT REGARDING WOMEN AND INDI6 VIDUALS FROM DISADVANTAGED BACK7 GROUNDS.

8 Section 487(a) of the Public Health Service Act (42

9 U.S.C. 288(a)(4)) is amended by adding at the end the

10 following paragraph:

11 ‘‘(4) The Secretary shall carry out paragraph (1) in

12 a manner that will result in the recruitment of women,

13 and members from underrepresented minority groups, into

14 fields of biomedical or behavioral research and in the pro15 vision of research training to women and such individ16 uals.’’.

17 SEC. 1602. SERVICE PAYBACK REQUIREMENTS.

18 Paragraph (2) of section 487(c) of the Public Health

19 Service Act (42 U.S.C. 288(c)(2)) is amended to read as

20 follows:

21 ‘‘(2)(A) For the initial year for which an individual

22 receives a National Research Service Award for the con23 duct of postdoctoral training or research, such individual

24 shall engage in one year of health research or teaching

25 or any combination thereof which is in accordance with
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1 the usual patterns of academic employment, or complete

2 a second year of training or research under such Award.

3 ‘‘(B) Service obligations for National Research Serv4 ice Awards that are less than 12 months may be satis5 fied—

6 ‘‘(i) by the conduct of health research or teach7 ing or any combination thereof which is in accord8 ance with the usual patterns of academic employ9 ment for a period of time equal to the amount of

10 time under the Award; or

11 ‘‘(ii) by reimbursing the Federal Government

12 for the amounts provided to such individual under

13 the Award.’’.

14 Subtitle B—Acquired Immune

15 Deficiency Syndrome

16 SEC. 1611. LOAN REPAYMENT PROGRAM.

17 Section 487A of the Public Health Service Act (42

18 U.S.C. 288–1) is amended to read as follows:

19 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH

20 RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME

21 ‘‘SEC. 487A. (a) IN GENERAL.—

22 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

23 paragraph (2), the Secretary shall carry out a pro24 gram of entering into agreements with appropriately

25 qualified health professionals under which such

26 health professionals agree to conduct, as employees
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1 of the National Institutes of Health, research with

2 respect to acquired immune deficiency syndrome in

3 consideration of the Federal Government agreeing to

4 repay, for each year of such service, not more than

5 $20,000 of the principal and interest of the edu6 cational loans of such health professionals.

7 ‘‘(2) LIMITATION.—The Secretary may not

8 enter into an agreement with a health professional

9 pursuant to paragraph (1) unless such profes10 sional—

11 ‘‘(A) has a substantial amount of edu12 cational loans relative to income; and

13 ‘‘(B)(i) was not employed at the National

14 Institutes of Health during the 1-year period

15 preceding the date of the enactment of the

16 Health Professions Reauthorization Act of

17 1988; or

18 ‘‘(ii) agrees to serve as an employee of

19 such Institutes for purposes of paragraph (1)

20 for a period of not less than 3 years.’’.

21 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—

22 With respect to the National Health Service Corps Loan

23 Repayment Program established in subpart III of part D

24 of title III, the provisions of such subpart shall, except

25 as inconsistent with subsection (a) of this section, apply
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1 to the program established in such subsection (a) in the

2 same manner and to the same extent as such provisions

3 apply to the National Health Service Corps Loan Repay4 ment Program established in such subpart.

5 ‘‘(c) FUNDING; REIMBURSABLE TRANSFERS.—

6 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—

7 For the purpose of carrying out this section, there

8 are authorized to be appropriated such sums as may

9 be necessary for each of the fiscal years 1994

10 through 1996.

11 ‘‘(2) TRANSFERS FOR RELATED PROGRAM.—

12 The Commissioner of Food and Drugs may carry

13 out for the Food and Drug Administration a pro14 gram similar to the program established in sub15 section (a), which program shall be carried out with

16 respect to the review of applications concerning ac17 quired immune deficiency syndrome that are submit18 ted to such Commissioner. From the amounts appro19 priated under paragraph (1) for a fiscal year, the

20 Secretary may transfer amounts to the Commis21 sioner for the purpose of carrying out such program.

22 The Commissioner shall provide a reimbursement to

23 the Secretary for the amount so transferred, and the

24 reimbursement shall be available only for the pro25 gram established in subsection (a). Any transfer and
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1 reimbursement made for purposes of this paragraph

2 for a fiscal year shall be completed by April 1 of

3 such year.’’.

4 Subtitle C—Loan Repayment for

5 Research Generally

6 SEC. 1621. ESTABLISHMENT OF PROGRAM.

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

8 as redesignated by section 141(a)(2) of this Act and as

9 amended by section 1002 of this Act, is amended by in10 serting after section 487B the following new section:

11 ‘‘LOAN REPAYMENT PROGRAM FOR RESEARCH

12 GENERALLY

13 ‘‘SEC. 487C. (a) IN GENERAL.—

14 ‘‘(1) AUTHORITY FOR PROGRAM.—Subject to

15 paragraph (2), the Secretary shall carry out a pro16 gram of entering into agreements with appropriately

17 qualified health professionals under which such

18 health professionals agree to conduct research, as

19 employees of the National Institutes of Health, in

20 consideration of the Federal Government agreeing to

21 repay, for each year of such service, not more than

22 $20,000 of the principal and interest of the edu23 cational loans of such health professionals.

24 ‘‘(2) LIMITATION.—The Secretary may not

25 enter into an agreement with a health professional
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1 pursuant to paragraph (1) unless such profes2 sional—

3 ‘‘(A) has a substantial amount of edu4 cational loans relative to income; and

5 ‘‘(B)(i) was not employed at the National

6 Institutes of Health during the 1-year period

7 preceding the date of the enactment of the

8 Health Professions Reauthorization Act of

9 1988; or

10 ‘‘(ii) agrees to serve as an employee of

11 such Institutes for purposes of paragraph (1)

12 for a period of not less than 3 years.’’.

13 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—

14 With respect to the National Health Service Corps Loan

15 Repayment Program established in subpart III of part D

16 of title III, the provisions of such subpart shall, except

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

18 to the program established in such subsection (a) in the

19 same manner and to the same extent as such provisions

20 apply to the National Health Service Corps Loan Repay21 ment Program established in such subpart.

22 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the

23 purpose of carrying out this section other than with re24 spect to acquired immune deficiency syndrome, there are
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1 authorized to be appropriated such sums as may be nec2 essary for each of the fiscal years 1994 through 1996.’’.

3 Subtitle D—Scholarship and Loan

4 Repayment Programs Regard5 ing Professional Skills Needed

6 by 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 in12 serting 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 Di19 rector of NIH, may carry out a program of entering

20 into contracts with individuals described in para21 graph (2) 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

10 BACKGROUNDS.—The individuals referred to in

11 paragraph (1) are individuals who—

12 ‘‘(A) are enrolled or accepted for enroll13 ment as full-time undergraduates at accredited

14 institutions of higher education; and

15 ‘‘(B) are from minority groups that are

16 underrepresented in the fields of biomedical or

17 behavioral research.

18 ‘‘(b) FACILITATION OF INTEREST OF STUDENTS IN

19 CAREERS AT NATIONAL INSTITUTES OF HEALTH.—In

20 providing employment to individuals pursuant to contracts

21 under subsection (a)(1), the Director of NIH shall carry

22 out activities to facilitate the interest of the individuals

23 in pursuing careers as employees of the National Insti24 tutes of Health.

25 ‘‘(c) PERIOD OF OBLIGATED SERVICE.—
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1 ‘‘(1) DURATION OF SERVICE.—For purposes of

2 subparagraph (B) of subsection (a)(1), the period of

3 service for which an individual is obligated to serve

4 as an employee of the National Institutes of Health

5 is 12 months for each academic year for which the

6 scholarship under such subsection is provided.

7 ‘‘(2) SCHEDULE FOR SERVICE.—

8 ‘‘(A) Subject to subparagraph (B), the Di9 rector of NIH may not provide a scholarship

10 under subsection (a) unless the individual ap11 plying for the scholarship agrees that—

12 ‘‘(i) the individual will serve as an em13 ployee of the National Institutes of Health

14 full-time for not less than 10 consecutive

15 weeks of each year during which the indi16 vidual is attending the educational institu17 tion involved and receiving such a scholar18 ship;

19 ‘‘(ii) the period of service as such an

20 employee that the individual is obligated to

21 provide under clause (i) is in addition to

22 the period of service as such an employee

23 that the individual is obligated to provide

24 under subsection (a)(1)(B); and
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1 ‘‘(iii) not later than 60 days after ob2 taining the educational degree involved, the

3 individual will begin serving full-time as

4 such an employee in satisfaction of the pe5 riod of service that the individual is obli6 gated to provide under subsection

7 (a)(1)(B).

8 ‘‘(B) The Director of NIH may defer the

9 obligation of an individual to provide a period

10 of service under subsection (a)(1)(B), if the Di11 rector determines that such a deferral is appro12 priate.

13 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS

14 RELATING TO APPOINTMENT AND COMPENSATION.—

15 For any period in which an individual provides serv16 ice as an employee of the National Institutes of

17 Health in satisfaction of the obligation of the indi18 vidual under subsection (a)(1)(B) or paragraph

19 (2)(A)(i), the individual may be appointed as such

20 an employee without regard to the provisions of title

21 5, United States Code, relating to appointment and

22 compensation.

23 ‘‘(d) PROVISIONS REGARDING SCHOLARSHIP.—
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1 ‘‘(1) APPROVAL OF ACADEMIC PROGRAM.—The

2 Director of NIH may not provide a scholarship

3 under subsection (a) for an academic year unless—

4 ‘‘(A) the individual applying for the schol5 arship has submitted to the Director a proposed

6 academic program for the year and the Director

7 has approved the program; and

8 ‘‘(B) the individual agrees that the pro9 gram will not be altered without the approval of

10 the Director.

11 ‘‘(2) ACADEMIC STANDING.—The Director of

12 NIH may not provide a scholarship under subsection

13 (a) for an academic year unless the individual apply14 ing for the scholarship agrees to maintain an accept15 able level of academic standing, as determined by

16 the educational institution involved in accordance

17 with regulations issued by the Secretary.

18 ‘‘(3) LIMITATION ON AMOUNT.—The Director

19 of NIH may not provide a scholarship under sub20 section (a) for an academic year in an amount ex21 ceeding $20,000.

22 ‘‘(4) AUTHORIZED USES.—A scholarship pro23 vided under subsection (a) may be expended only for

24 tuition expenses, other reasonable educational ex-
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1 penses, and reasonable living expenses incurred in

2 attending the school involved.

3 ‘‘(5) CONTRACT REGARDING DIRECT PAYMENTS

4 TO INSTITUTION.—In the case of an institution of

5 higher education with respect to which a scholarship

6 under subsection (a) is provided, the Director of

7 NIH may enter into a contract with the institution

8 under which the amounts provided in the scholarship

9 for tuition and other educational expenses are paid

10 directly to the institution. Payments to the institu11 tion under the contract may be made without regard

12 to section 3324 of title 31, United States Code.

13 ‘‘(e) PENALTIES FOR BREACH OF SCHOLARSHIP

14 CONTRACT.—The provisions of section 338E shall apply

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

16 extent and in the same manner as such provisions apply

17 to the National Health Service Corps Loan Repayment

18 Program established in section 338B.

19 ‘‘(f) REQUIREMENT OF APPLICATION.—The Director

20 of NIH may not provide a scholarship under subsection

21 (a) unless an application for the scholarship is submitted

22 to the Director and the application is in such form, is

23 made in such manner, and contains such agreements, as24 surances, and information as the Director determines to

25 be necessary to carry out this section.
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1 ‘‘(g) AVAILABILITY OF AUTHORIZATION OF APPRO2 PRIATIONS.—Amounts appropriated for a fiscal year for

3 scholarships under this section 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 ‘‘LOAN REPAYMENT PROGRAM REGARDING CLINICAL

7 RESEARCHERS FROM DISADVANTAGED BACKGROUNDS

8 ‘‘SEC. 487E. (a) IMPLEMENTATION OF PROGRAM.—

9 ‘‘(1) IN GENERAL.—Subject to section

10 487(a)(1)(C), the Secretary, acting through the Di11 rector of NIH may, subject to paragraph (2), carry

12 out a program of entering into contracts with appro13 priately qualified health professionals who are from

14 disadvantaged backgrounds under which such health

15 professionals agree to conduct clinical research as

16 employees of the National Institutes of Health in

17 consideration of the Federal Government agreeing to

18 pay, for each year of such service, not more than

19 $20,000 of the principal and interest of the edu20 cational loans of the health professionals.

21 ‘‘(2) LIMITATION.—The Director of NIH may

22 not enter into a contract with a health professional

23 pursuant to paragraph (1) unless such professional

24 has a substantial amount of education loans relative

25 to income.
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1 ‘‘(3) APPLICABILITY OF CERTAIN PROVISIONS

2 REGARDING OBLIGATED SERVICE.—Except to the ex3 tent inconsistent with this section, the provisions of

4 sections 338C and 338E shall apply to the program

5 established in paragraph (1) to the same extent and

6 in the same manner as such provisions apply to the

7 National Health Service Corps Loan Repayment

8 Program established in section 338B.

9 ‘‘(b) AVAILABILITY OF AUTHORIZATION OF APPRO10 PRIATIONS.—Amounts appropriated for a fiscal year for

11 contracts under subsection (a) shall remain available until

12 the expiration of the second fiscal year beginning after the

13 fiscal year for which the amounts were appropriated.’’.

14 SEC. 1632. FUNDING.

15 Section 487(a)(1) of the Public Health Service Act

16 (42 U.S.C. 288(a)(1)) is amended—

17 (1) in subparagraph (A), by striking ‘‘and’’

18 after the semicolon at the end;

19 (2) in subparagraph (B), by striking the period

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

21 (3) by adding at the end the following new sub22 paragraph:

23 ‘‘(C) provide contracts for scholarships and loan

24 repayments in accordance with sections 487D and

25 487E, subject to providing not more than an aggre-
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1 gate 50 such contracts during the fiscal years 1994

2 through 1996.’’.

3 Subtitle E—Funding

4 SEC. 1641. AUTHORIZATION OF APPROPRIATIONS.

5 Section 487(d) of the Public Health Service Act (42

6 U.S.C. 288(d)) is amended—

7 (1) in the first sentence, by amending the sen8 tence to read as follows: ‘‘For the purpose of carry9 ing out this section, there are authorized to be ap10 propriated $400,000,000 for fiscal year 1994, and

11 such sums as may be necessary for each of the fiscal

12 years 1995 and 1996.’’; and

13 (2) in paragraph (3)—

14 (A) by striking ‘‘one-half of one percent’’

15 each place such term appears and inserting ‘‘1

16 percent’’; and

17 (B) by striking ‘‘780, 784, or 786’’ and in18 serting ‘‘747, 748, or 749’’.

19 TITLE XVII—NATIONAL FOUNDA20 TION FOR BIOMEDICAL RE21 SEARCH

22 SEC. 1701. NATIONAL FOUNDATION FOR BIOMEDICAL RE23 SEARCH.

24 Section 499 of the Public Health Service Act, as re25 designated by section 121(b), is amended—
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1 (1) in subsection (a), by striking ‘‘, except for’’

2 and all that follows through ‘‘Transfer Act’’;

3 (2) by redesignating subsections (c), (d), (e),

4 (f), (g), (h), and (i) as subsections (d), (f), (g), (h),

5 (i), (j), and (m), respectively;

6 (3) by striking subsection (b) and inserting in

7 lieu thereof the following new subsections:

8 ‘‘(b) PURPOSE OF FOUNDATION.—The purpose of

9 the Foundation shall be to support the National Institutes

10 of Health in its mission, and to advance collaboration with

11 biomedical researchers from universities, industry, and

12 nonprofit organizations.

13 ‘‘(c) CERTAIN ACTIVITIES OF FOUNDATION.—

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

15 (b), the Foundation may solicit and accept gifts,

16 grants, and other donations, establish accounts, and

17 invest and expend funds in support of the following

18 activities with respect to the purpose described in

19 such subsection:

20 ‘‘(A) A program to provide and administer

21 endowed positions that are associated with the

22 research program of the National Institutes of

23 Health. Such endowments may be expended for

24 the compensation of individuals holding the po25 sitions, for staff, equipment, quarters, travel,
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1 and other expenditures that are appropriate in

2 supporting the endowed positions.

3 ‘‘(B) A program to provide and administer

4 fellowships and grants to research personnel in

5 order to work and study in association with the

6 National Institutes of Health. Such fellowships

7 and grants may include stipends, travel, health

8 insurance benefits and other appropriate ex9 penses. The recipients of fellowships shall be se10 lected by the donors and the Foundation upon

11 the recommendation of the National Institutes

12 of Health employees in the laboratory where the

13 fellow would serve, and shall be subject to the

14 agreement of the Director of the National Insti15 tutes of Health and the Executive Director of

16 the Foundation.

17 ‘‘(C) Supplementary programs to provide

18 for—

19 ‘‘(i) scientists of other countries to

20 serve in research capacities in the United

21 States in association with the National In22 stitutes of Health or elsewhere, or opportu23 nities for employees of the National Insti24 tutes of Health or other public health offi-
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1 cials in the United States to serve in such

2 capacities in other countries, or both;

3 ‘‘(ii) the conduct and support of stud4 ies, projects, and research, which may in5 clude stipends, travel and other support for

6 personnel in collaboration with national

7 and international non-profit and for-profit

8 organizations;

9 ‘‘(iii) the conduct and support of fo10 rums, meetings, conferences, courses, and

11 training workshops that may include un12 dergraduate, graduate, post-graduate, and

13 post-doctoral accredited courses and the

14 maintenance of accreditation of such

15 courses by the Foundation at the State

16 and national level for college or continuing

17 education credits or for degrees;

18 ‘‘(iv) programs to support and encour19 age teachers and students of science at all

20 levels of education and programs for the

21 general public which promote the under22 standing of science;

23 ‘‘(v) programs for writing, editing,

24 printing, publishing, and vending of books

25 and other materials; and
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1 ‘‘(vi) the conduct of other activities to

2 carry out and support the purpose de3 scribed in subsection (b).

4 ‘‘(2) FEES.—The Foundation may assess fees

5 for the provision of professional, administrative and

6 management services by the Foundation in amounts

7 determined reasonable and appropriate by the Exec8 utive Director.

9 ‘‘(3) AUTHORITY OF FOUNDATION.—The Foun10 dation shall be the sole entity responsible for carry11 ing out the activities described in this subsection.’’;

12 (4) in subsection (d) (as so redesignated)—

13 (A) in paragraph (1)—

14 (i) by striking ‘‘members of the Foun15 dation’’ in subparagraph (A) and inserting

16 ‘‘appointed members of the Board’’;

17 (ii) by striking ‘‘Council’’ in subpara18 graph (B) and inserting ‘‘Board’’;

19 (iii) by striking ‘‘Council’’ in subpara20 graph (C) and inserting ‘‘Board’’; and

21 (iv) by adding at the end thereof the

22 following new subparagraphs:

23 ‘‘(D)(i) Not later than 30 days after the

24 date of enactment of the National Institutes of

25 Health Revitalization Act of 1993, the Director
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1 of the National Institutes of Health shall con2 vene a meeting of the ex officio members of the

3 Board to—

4 ‘‘(I) incorporate the Foundation and

5 establish the general policies of the Foun6 dation for carrying out the purposes of

7 subsection (b), including the establishment

8 of the bylaws of the Foundation; and

9 ‘‘(II) appoint the members of the

10 Board in accordance with subparagraph

11 (C).

12 ‘‘(ii) Upon the appointment of the mem13 bers of the Board under clause (i)(II), the

14 terms of service of the ex officio members of the

15 Board as members of the Board shall termi16 nate.

17 ‘‘(E) The agreement of not less than three18 fifths of the members of the ex officio members

19 of the Board shall be required for the appoint20 ment of each member to the initial Board.

21 ‘‘(F) No employee of the National Insti22 tutes of Health shall be appointed as a member

23 of the Board.

24 ‘‘(G) The Board may, through amend25 ments to the bylaws of the Foundation, provide
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1 that the number of members of the Board shall

2 be greater than the number specified in sub3 paragraph (C).’’;

4 (B) in paragraph (2)—

5 (i) by inserting ‘‘(A)’’ before ‘‘The

6 ex’’;

7 (ii) by striking ‘‘an appointed member

8 of the Board to serve as the Chair’’ and in9 serting ‘‘an individual to serve as the ini10 tial Chairperson’’; and

11 (iii) by adding at the end thereof the

12 following new subparagraph:

13 ‘‘(B) Upon the termination of the term of serv14 ice of the initial Chairperson of the Board, the ap15 pointed members of the Board shall elect a member

16 of the Board to serve as the Chairperson of the

17 Board.’’;

18 (C) in paragraph (3)(A), by striking

19 ‘‘(2)(C)’’ and inserting ‘‘(1)(C)’’; and

20 (D) by adding at the end thereof the fol21 lowing new paragraphs:

22 ‘‘(5) MEETINGS AND QUORUM.—A majority of

23 the members of the Board shall constitute a quorum

24 for purposes of conducting the business of the

25 Board.
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1 ‘‘(6) CERTAIN BYLAWS.—

2 ‘‘(A) In establishing bylaws under this sub3 section, the Board shall ensure that the follow4 ing are provided for:

5 ‘‘(i) Policies for the selection of the

6 officers, employees, agents, and contractors

7 of the Foundation.

8 ‘‘(ii) Policies, including ethical stand9 ards, for the acceptance, solicitation, and

10 disposition of donations and grants to the

11 Foundation and for the disposition of the

12 assets of the Foundation. Policies with re13 spect to ethical standards shall ensure that

14 officers, employees and agents of the

15 Foundation (including members of the

16 Board) avoid encumbrances that would re17 sult in a conflict of interest, including a fi18 nancial conflict of interest or a divided al19 legiance. Such policies shall include re20 quirements for the provision of information

21 concerning any ownership or controlling in22 terest in entities related to the activities of

23 the Foundation by such officers, employees

24 and agents and their spouses and relatives.
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1 ‘‘(iii) Policies for the conduct of the

2 general operations of the Foundation.

3 ‘‘(iv) Policies for writing, editing,

4 printing, publishing, and vending of books

5 and other materials.

6 ‘‘(B) In establishing bylaws under this sub7 section, the Board shall ensure that such by8 laws (and activities carried out under the by9 laws) do not—

10 ‘‘(i) reflect unfavorably upon the abil11 ity of the Foundation or the National In12 stitutes of Health to carry out its respon13 sibilities or official duties in a fair and ob14 jective manner; or

15 ‘‘(ii) compromise, or appear to com16 promise, the integrity of any governmental

17 agency or program, or any officer or em18 ployee involved in such program.’’;

19 (5) in subsection (i) (as so redesignated)—

20 (A) by inserting ‘‘, and define the duties of

21 the officers and employees’’ before the semi22 colon in paragraph (4);

23 (B) by striking paragraph (5);
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1 (C) by redesignating paragraphs (6)

2 through (14), as paragraphs (5) through (13),

3 respectively;

4 (D) by striking paragraph (8) (as so redes5 ignated), and inserting the following new para6 graph:

7 ‘‘(8) establish a process for the selection of can8 didates for positions under subsection (c);’’

9 (E) by inserting ‘‘solicit’’ after the para10 graph designation in paragraph (11) (as so re11 designated);

12 (F) by striking ‘‘Executive’’ in paragraph

13 (12) (as so redesignated);

14 (G) by striking ‘‘and’’ at the end of para15 graph (13) (as so redesignate); and

16 (H) by inserting after paragraph (13) (as

17 so redesignated), the following new paragraph:

18 ‘‘(14) enter into such other contracts, leases,

19 cooperative agreements, and other transactions as

20 the Director considers appropriate to conduct the ac21 tivities of the Foundation; and’’;

22 (6) by inserting after subsection (j) (as so re23 designated), the following new subsections:

24 ‘‘(k) GENERAL PROVISIONS.—
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1 ‘‘(1) FOUNDATION INTEGRITY.—The members

2 of the Board shall be accountable for the integrity

3 of the operations of the Foundation and shall ensure

4 such integrity through the development and enforce5 ment of criteria and procedures relating to stand6 ards of conduct (including those developed under

7 subsection (d)(2)(B)(i)(II)), financial disclosure

8 statements, conflict of interest rules, recusal and

9 waiver rules, audits and other matter determined ap10 propriate by the Board.

11 ‘‘(2) FINANCIAL CONFLICTS OF INTEREST.—

12 Any individual who is an officer, employee, or mem13 ber of the Board of the Foundation may not (in ac14 cordance with policies and requirements developed

15 under subsection (d)(2)(B)(i)(II)) personally or sub16 stantially participate in the consideration or deter17 mination by the Foundation of any matter that

18 would directly or predictably affect any financial in19 terest of the individual or a relative (as such term

20 is defined in section 109(16) of the Ethics in Gov21 ernment Act of 1978) of the individual, of any busi22 ness organization or other entity, or of which the in23 dividual is an officer or employee, or is negotiating

24 for employment, or in which the individual has any

25 other financial interest.
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1 ‘‘(3) AUDITS; AVAILABILITY OF RECORDS.—The

2 Foundation shall—

3 ‘‘(A) provide for annual audits of the fi4 nancial condition of the Foundation; and

5 ‘‘(B) make such audits, and all other

6 records, documents, and other papers of the

7 Foundation, available to the Secretary and the

8 Comptroller General of the United States for

9 examination or audit.

10 ‘‘(4) REPORTS.—

11 ‘‘(A) Not later than 5 months following the

12 end of each fiscal year, the Foundation shall

13 publish a report describing the activities of the

14 Foundation during the preceding fiscal year.

15 Each such report shall include for the fiscal

16 year involved a comprehensive statement of the

17 operations, activities, financial condition, and

18 accomplishments of the Foundation.

19 ‘‘(B) With respect to the financial condi20 tion of the Foundation, each report under sub21 paragraph (A) shall include the source, and a

22 description of, all gifts or grants to the Founda23 tion of real or personal property, and the source

24 and amount of all gifts or grants to the Foun25 dation of money. Each such report shall include
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1 a specification of any restrictions on the pur2 poses for which gifts or grants to the Founda3 tion may be used.

4 ‘‘(C) The Foundation shall make copies of

5 each report submitted under subparagraph (A)

6 available for public inspection, and shall upon

7 request provide a copy of the report to any indi8 vidual for a charge not exceeding the cost of

9 providing the copy.

10 ‘‘(D) The Board shall annually hold a pub11 lic meeting to summarize the activities of the

12 Foundation and distribute written reports con13 cerning such activities and the scientific results

14 derived from such activities.

15 ‘‘(5) SERVICE OF FEDERAL EMPLOYEES.—Fed16 eral employees may serve on committees advisory to

17 the Foundation and otherwise cooperate with and

18 assist the Foundation in carrying out its function, so

19 long as the employees do not direct or control Foun20 dation activities.

21 ‘‘(6) RELATIONSHIP WITH EXISTING ENTI22 TIES.—The Foundation may, pursuant to appro23 priate agreements, merge with, acquire, or use the

24 resources of existing nonprofit private corporations

25 with missions similar to the purposes of the Founda-
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1 tion, such as the Foundation for Advanced Edu2 cation in the Sciences.

3 ‘‘(7) INTELLECTUAL PROPERTY RIGHTS.—The

4 Board shall adopt written standards with respect to

5 the ownership of any intellectual property rights de6 rived from the collaborative efforts of the Founda7 tion prior to the commencement of such efforts.

8 ‘‘(8) NATIONAL INSTITUTES OF HEALTH

9 AMENDMENTS OF 1990.—The activities conducted in

10 support of the National Institutes of Health Amend11 ments of 1990 (Public Law 101-613) and the

12 amendments made by such Act, shall not be nullified

13 by the enactment of this section.

14 ‘‘(9) LIMITATION OF ACTIVITIES.—The Foun15 dation shall exist solely as an entity to work in col16 laboration with the research programs of the Na17 tional Institutes of Health. The Foundation may not

18 undertake activities (such as the operation of inde19 pendent laboratories or competing for Federal re20 search funds) that are independent of those of the

21 National Institutes of Health research programs.

22 ‘‘(l) DUTIES OF THE DIRECTOR.—

23 ‘‘(1) APPLICABILITY OF CERTAIN STANDARDS

24 TO NON-FEDERAL EMPLOYEES.—In the case of any

25 individual who is not an employee of the Federal
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1 Government and who serves in association with the

2 National Institutes of Health, with respect to finan3 cial assistance received from the Foundation, the

4 Foundation may not provide the assistance of, or

5 otherwise permit the work at the National Institutes

6 of Health to begin until a memorandum of under7 standing between the individual and the Director of

8 the National Institutes of Health, or the designee of

9 such Director, has been executed specifying that the

10 individual shall be subject to such ethical and proce11 dural standards of conduct relating to duties per12 formed at the National Institutes of Health, as the

13 Director of the National Institutes of Health deter14 mines is appropriate.

15 ‘‘(2) SUPPORT SERVICES.—The Director of the

16 National Institutes of Health may provide facilities,

17 utilities and support services to the Foundation if it

18 is determined by the Director to be advantageous to

19 the research programs of the National Institutes of

20 Health.’’;

21 (7) in subsection (m) (as so redesignated)—

22 (A) by striking ‘‘$200,000’’ each place that

23 such appears and inserting ‘‘$500,000’’; and

24 (B) by striking ‘‘1995’’ in paragraph (1)

25 and inserting ‘‘1996’’; and
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1 (8) by adding at the end thereof the following

2 new subsections:

3 ‘‘(n) LIMITATION.—The Secretary shall ensure that

4 no extramural funds made available by the National Insti5 tutes of Health are provided to the Foundation or for ac6 tivities provided for under subparagraphs (A) and (B) of

7 subsection (c)(1).

8 ‘‘(o) REPORT ON ADEQUACY OF COMPLIANCE.—

9 ‘‘(1) IN GENERAL.—With respect to the mission

10 and function of the Foundation, the Comptroller

11 General of the United States shall conduct an audit

12 to determine—

13 ‘‘(A) whether the Foundation is in compli14 ance with the guidelines established under this

15 section; and

16 ‘‘(B) whether the procedures utilized under

17 this section are adequate to prevent conflicts of

18 interest involving the Foundation, the employ19 ees of the Foundation or members of the Board

20 of the Foundation.

21 ‘‘(2) REPORT.—Not later than 18 months after

22 the date on which the Foundation is incorporated,

23 the Comptroller General of the United States shall

24 complete the audit required under paragraph (1)

25 and prepare and submit to the Committee on En-
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1 ergy and Commerce of the House of Representatives

2 and the Committee on Labor and Human Resources

3 of the Senate, a report describing the findings made

4 with respect to such audit.’’.

5 TITLE XVIII—RESEARCH WITH

6 RESPECT TO ACQUIRED IM7 MUNE DEFICIENCY SYN8 DROME

9 SEC. 1801. REVISION AND EXTENSION OF VARIOUS PRO10 GRAMS.

11 (a) AMENDMENTS.—Title XXIII of the Public Health

12 Service Act (42 U.S.C. 300cc et seq.) is amended—

13 (1) in section 2304(c)(1)—

14 (A) in the matter preceding subparagraph

15 (A), by inserting after ‘‘Director of such Insti16 tute’’ the following: ‘‘(and may provide advice

17 to the Directors of other agencies of the Na18 tional Institutes of Health, as appropriate)’’;

19 and

20 (B) in subparagraph (A), by inserting be21 fore the semicolon the following: ‘‘, including

22 recommendations on the projects of research

23 with respect to diagnosing immune deficiency

24 and with respect to predicting, diagnosing, pre-
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1 venting, and treating cancers, opportunistic in2 fections, and infectious diseases’’;

3 (2) in section 2311(a)(1), by inserting before

4 the semicolon the following: ‘‘, including evaluations

5 of methods of diagnosing immune deficiency and

6 evaluations of methods of predicting, diagnosing,

7 preventing, and treating cancers, opportunistic infec8 tions, and infectious diseases’’;

9 (3) in section 2315(a)(2), by striking ‘‘inter10 national research’’ and all that follows and inserting

11 ‘‘international research and training concerning the

12 natural history and pathogenesis of the human

13 immunodeficiency virus and the development and

14 evaluation of vaccines and treatments for acquired

15 immune deficiency syndrome and opportunistic infec16 tions.’’;

17 (4) in section 2318—

18 (A) in subsection (a)(1)—

19 (i) by inserting after ‘‘The Secretary’’

20 the following: ‘‘, acting through the Direc21 tor of the National Institutes of Health

22 and after consultation with the Adminis23 trator for Health Care Policy and Re24 search,’’; and
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1 (ii) by striking ‘‘syndrome’’ and in2 serting ‘‘syndrome, including treatment

3 and prevention of HIV infection and relat4 ed conditions among women’’; and

5 (B) in subsection (e), by striking ‘‘1991.’’

6 and inserting the following: ‘‘1991, and such

7 sums as may be necessary for each of the fiscal

8 years 1994 through 1996.’’;

9 (5) in section 2320(b)(1)(A), by striking ‘‘syn10 drome’’ and inserting ‘‘syndrome and the natural

11 history of such infection’’;

12 (6) in the part heading for part D, by striking

13 ‘‘DIRECTOR OF THE NATIONAL INSTITUTES OF

14 HEALTH’’ and inserting ‘‘OFFICE OF AIDS RE15 SEARCH’’;

16 (7) in section 2351—

17 (A) by redesignating subsections (a), (b)

18 and (c) as subsections (c), (d) and (e), respec19 tively;

20 (B) by inserting after the section heading

21 the following new subsections:

22 ‘‘(a) IN GENERAL.—In carrying out research with re23 spect to acquired immune deficiency syndrome, the Sec24 retary, acting through the Director of the National Insti25 tutes of Health—
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1 ‘‘(1) shall establish an office to be known as the

2 Office of AIDS Research, which Office shall be

3 headed by a Director who shall—

4 ‘‘(A) be appointed by the Secretary;

5 ‘‘(B) be determined by the Secretary to be

6 an individual who is an outstanding scientist

7 and a highly skilled administrator;

8 ‘‘(C) report directly to the Director of the

9 National Institutes of Health; and

10 ‘‘(D) be the primary Federal official re11 sponsible for the conduct of AIDS-related re12 search at the National Institutes of Health; and

13 ‘‘(2) shall provide administrative support and

14 support services to the Director of such Office and

15 shall ensure that such support takes maximum ad16 vantage of existing administrative structures at the

17 institutes, centers and divisions of the National In18 stitutes of Health to the fullest extent practicable.

19 ‘‘(b) ACTIVITIES OF THE OFFICE OF AIDS RE20 SEARCH.—

21 ‘‘(1) IN GENERAL.—The Secretary, acting

22 through the director of the Office of AIDS Research,

23 shall ensure that AIDS research activities are co24 ordinated across and throughout the institutes, cen-
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1 ters, and divisions of the National Institutes of

2 Health.

3 ‘‘(2) GENERAL DUTIES.—The Director of the

4 Office of AIDS Research shall, based upon a strate5 gic plan as defined in paragraph (3), develop and

6 oversee the implementation of a scientifically justi7 fied budget for AIDS-related research at the Na8 tional Institutes of Health and coordinate all AIDS9 related research activities conducted at the insti10 tutes, centers, and divisions of the National Insti11 tutes of Health, and conduct evaluations on all such

12 programs.

13 ‘‘(3) STRATEGIC PLAN.—

14 ‘‘(A) DEVELOPMENT.—The Director of the

15 Office of AIDS Research shall, based on the ad16 vice of the directors of the institutes, centers,

17 and divisions of the National Institutes of

18 Health, and in consultation with the advisory

19 council established in paragraph (5) and the co20 ordinating groups established in subparagraph

21 (B), develop and oversee the implementation of

22 a comprehensive, long-range plan for the con23 duct and support of such research by the insti24 tutes, centers and divisions of the National In-
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1 stitutes of Health. Such plan shall be updated

2 annually, and shall—

3 ‘‘(i) determine the appropriate overall

4 balance between basic and applied research

5 and between intramural and extramural re6 search;

7 ‘‘(ii) determine and prioritize among

8 critical scientific AIDS-related questions;

9 ‘‘(iii) based upon such determinations,

10 specify the broad short and long range ob11 jectives to be achieved, and provide an esti12 mate of the resources needed to achieve

13 such objectives;

14 ‘‘(iv) evaluate the sufficiency of exist15 ing AIDS research programs to meet such

16 objectives, and establish evaluation criteria,

17 timelines and objectives for future program

18 evaluation activities; and

19 ‘‘(v) make recommendations for

20 changes and necessary resource allocation

21 in and among such programs.

22 ‘‘(B) COORDINATING GROUPS.—The Direc23 tor of the Office of AIDS Research shall estab24 lish AIDS coordinating groups for each re25 search discipline within the AIDS research pro-
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1 gram, composed of representatives of relevant

2 agencies of the National Institutes of Health

3 and qualified extramural scientists, to evaluate

4 and assess the efforts of the AIDS Research

5 Program at the National Institutes of Health,

6 to advise on the development of the strategic

7 plan described in subparagraph (A), and to de8 termine the extent to which such efforts are in

9 accordance with such strategic plan.

10 ‘‘(4) COORDINATION.—The Director of the Of11 fice of AIDS Research shall act as the primary Fed12 eral official with responsibility for overseeing all

13 AIDS-related research efforts undertaken by the Na14 tional Institutes of Health, and

15 ‘‘(A) shall serve to represent the National

16 Institutes of Health AIDS Research Program

17 at all relevant Executive branch task forces and

18 committees; and

19 ‘‘(B) shall maintain communications with

20 all relevant Public Health Service agencies and

21 with various other departments of the Federal

22 Government, to ensure the timely transmission

23 of information concerning advances in AIDS-re24 lated research and the clinical treatment of

25 AIDS and its related conditions, between these
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1 various agencies for dissemination to affected

2 communities and health care providers.

3 ‘‘(5) ADVISORY COUNCIL.—

4 ‘‘(A) ESTABLISHMENT.—The Secretary

5 shall, consistent with section 406, establish an

6 advisory council to be known as the Office of

7 AIDS Research Advisory Council (hereafter re8 ferred to as the ‘Council’), which shall serve to

9 replace the AIDS Program Advisory Committee

10 which is operating on the date of enactment of

11 this subsection.

12 ‘‘(B) COMPOSITION.—The Council shall be

13 composed of biomedical, behavioral, and social

14 scientists, and representatives of diverse HIV

15 affected communities, and shall be appointed by

16 the Secretary.

17 ‘‘(C) AUTHORITY.—The Council shall—

18 ‘‘(i) advise the Director of the Office

19 of AIDS Research and make recommenda20 tions concerning the development of the

21 AIDS-related research budget, and the de22 velopment and implementation of the stra23 tegic plan for AIDS-related research at the

24 National Institutes of Health;
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1 ‘‘(ii) provide the second level of peer

2 review for awards made directly from the

3 Office of AIDS Research from the discre4 tionary fund described in paragraph (7);

5 and

6 ‘‘(iii) carry out such other activities

7 determined appropriate by the Director of

8 the Office of AIDS Research.

9 ‘‘(6) BUDGETARY AUTHORITY.—The Director

10 of the Office of AIDS Research shall—

11 ‘‘(A) in accordance with the strategic plan

12 established under paragraph (3), in consultation

13 with the Council, and based on budget requests

14 and additional advice from the directors of the

15 institutes, centers and divisions of the National

16 Institutes of Health, prepare and submit di17 rectly to the President for review and transmit18 tal to Congress, an annual, scientifically justi19 fied budget estimate for AIDS-related research

20 conducted within the agencies of the National

21 Institutes of Health, after reasonable oppor22 tunity for comment (but without change) by the

23 Secretary and the Director of the National In24 stitutes of Health, which shall include the

25 amount of funds required (as requested by the
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1 directors of such institutes, centers and divi2 sions) for—

3 ‘‘(i) the continued funding of the com4 mitment base (ongoing program initiatives)

5 at the sole discretion of the directors of

6 such institutes, centers and divisions; and

7 ‘‘(ii) the funding of new and compet8 ing program initiatives through such insti9 tutes, centers and divisions, at the discre10 tion of the Director of the Office of AIDS

11 Research;

12 ‘‘(B) receive from the President and the

13 Office of Management and Budget directly all

14 AIDS-related research funds appropriated by

15 Congress for transfer to, and obligation and ex16 penditure by, the institutes, centers and divi17 sions of the National Institutes of Health in ac18 cordance with the budget delineated under

19 clauses (i) and (ii) of subparagraph (A); and

20 ‘‘(C) distribute AIDS research funding to

21 the various institutes, centers, and divisions of

22 the National Institutes of Health in accordance

23 with the budget delineated under clauses (i)

24 and (ii) of subparagraph (A).
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1 The provisions of this paragraph shall become effec2 tive in the fiscal year following the submission of the

3 consolidated AIDS budget.

4 ‘‘(7) DISCRETIONARY FUND.—

5 ‘‘(A) AVAILABILITY OF FUNDS.—The Sec6 retary shall ensure that not to exceed 25 per7 cent of the funds available in excess of the

8 amount of baseline AIDS research spending

9 during the previous fiscal year, be made avail10 able to the Director of the Office of AIDS Re11 search for the establishment of an AIDS re12 search discretionary fund.

13 ‘‘(B) USE.—The Director of the Office of

14 AIDS Research, in consultation with the advi15 sory council established under paragraph (5),

16 shall use amounts in the AIDS research discre17 tionary fund, either through the institutes, cen18 ters and divisions of the National Institutes of

19 Health or grants made directly by the Office of

20 AIDS Research, to—

21 ‘‘(i) fund emergency AIDS research

22 programs;

23 ‘‘(ii) fund programs for the conduct of

24 research aimed at filling gaps that exist in

25 existing research programs;
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1 ‘‘(iii) conduct conferences, convene

2 committees, hold meetings or carry out

3 other activities determined appropriate by

4 the Director.

5 ‘‘(C) REDUCTION IN ADMINISTRATIVE IM6 PEDIMENTS.—Notwithstanding any other provi7 sion of law relating to the number of individuals

8 who may be employed as full-time equivalent in9 dividuals, with respect to the number of full10 time equivalent individuals so employed, the Di11 rector of the Office of AIDS Research shall be

12 permitted to authorize the employment of such

13 full-time equivalent individuals to perform

14 AIDS-related research through the institutes,

15 centers and divisions of the National Institutes

16 of Health as described in clauses (i) and (ii) of

17 subparagraph (B) and subject to appropria18 tions.’’;

19 (C) in subsection (c) (as so redesig20 nated)—

21 (i) by striking the subsection designa22 tion and all that follows through paragraph

23 (1) and inserting the following:

24 ‘‘(c) OTHER DUTIES.—The director of the office—

25 ’’;
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1 (ii) by redesignating paragraphs (2)

2 through (8) as paragraphs (1) through (7),

3 respectively;

4 (iii) by striking ‘‘for the appropriate

5 national research institute of the National

6 Institutes of Health’’ in paragraph (4) (as

7 so redesignated); and

8 (iv) by inserting ‘‘cannot reasonably

9 be accomplished within the United States

10 and’’ after ‘‘if such research’’ in paragraph

11 (4)(A) (as so redesignated); and

12 (D) by adding at the end thereof the fol13 lowing new subsection:

14 ‘‘(f) EVALUATION AND REPORT.—

15 ‘‘(1) EVALUATION.—Not later than 5 years

16 after the date of enactment of this Act, the Sec17 retary shall conduct an evaluation to—

18 ‘‘(A) determine the effect of this section on

19 the planning and coordination of the AIDS re20 search programs at the institutes, centers and

21 divisions of the National Institutes of Health;

22 ‘‘(B) evaluate the extent to which this sec23 tion has eliminated the duplication of adminis24 trative resources among such institutes, centers

25 and divisions; and
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1 ‘‘(C) provide recommendations concerning

2 future alterations with respect to this section.

3 ‘‘(2) REPORT.—Not later than 1 year after the

4 date on which the evaluation is commenced under

5 paragraph (1), the Secretary shall prepare and sub6 mit to the Committee on Labor and Human Re7 sources of the Senate and the Committee on Energy

8 and Commerce of the House of Representatives, a

9 report concerning the results of such evaluation.’’;

10 (8) in section 2361, by striking ‘‘For purposes’’

11 and all that follows and inserting the following:

12 ‘‘For purposes of this title:

13 ‘‘(1) The term ‘infection’, with respect to the

14 etiologic agent for acquired immune deficiency syn15 drome, includes cancers, opportunistic infections,

16 and infectious diseases and any other conditions

17 arising from infection with such etiologic agent.

18 ‘‘(2) The term ‘treatment’, with respect to the

19 etiologic agent for acquired immune deficiency syn20 drome, includes primary and secondary prophy21 laxis.’’;

22 (9) in section 2315(f), by striking ‘‘there are

23 authorized’’ and all that follows and inserting ‘‘there

24 are authorized to be appropriated such sums as may

25 be necessary for each fiscal year.’’;
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1 (10) in section 2320(e)(1), by striking ‘‘there

2 are authorized’’ and all that follows and inserting

3 ‘‘there are authorized to be appropriated such sums

4 as may be necessary for each fiscal year.’’; and

5 (11) in section 2341(d), by striking ‘‘there are

6 authorized’’ and all that follows and inserting ‘‘there

7 are authorized to be appropriated such sums as may

8 be necessary for each fiscal year.’’.

9 TITLE XIX—STUDIES

10 SEC. 1901. ACQUIRED IMMUNE DEFICIENCY SYNDROME.

11 (a) CERTAIN DRUG-RELEASE MECHANISMS.—

12 (1) The Secretary of Health and Human Serv13 ices shall, subject to paragraph (2), enter into a con14 tract with a public or nonprofit private entity to con15 duct a study for the purpose of determining, with re16 spect to acquired immune deficiency syndrome, the

17 impact of parallel-track drug-release mechanisms on

18 public and private clinical research, and on the ac19 tivities of the Commissioner of Food and Drugs re20 garding the approval of drugs.

21 (2) The Secretary of Health and Human Serv22 ices shall request the Institute of Medicine of the

23 National Academy of Sciences to enter into the con24 tract under paragraph (1) to conduct the study de25 scribed in such paragraph. If such Institute declines
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1 to conduct the study, the Secretary shall carry out

2 paragraph (1) through another public or nonprofit

3 private entity.

4 (b) THIRD-PARTY PAYMENTS REGARDING CERTAIN

5 CLINICAL TRIALS.—The Secretary of Health and Human

6 Services 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 (c) ADVISORY COMMITTEES.—The Secretary of

16 Health and Human Services, acting through the Director

17 of the National Institutes of Health, shall conduct a study

18 for the purpose of determining—

19 (1) whether the activities of the various advi20 sory committees established in the National Insti21 tutes of Health regarding acquired immune defi22 ciency syndrome are being coordinated sufficiently;

23 and
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1 (2) whether the functions of any of such advi2 sory committees should be modified in order to

3 achieve greater efficiency.

4 (d) VACCINES FOR HUMAN IMMUNODEFICIENCY

5 VIRUS.—

6 (1) IN GENERAL.—The Secretary of Health and

7 Human Services, acting through the National Insti8 tutes of Health, shall develop a plan for the appro9 priate inclusion of HIV-infected women, including

10 pregnant women, HIV-infected infants, and HIV-in11 fected children in studies conducted by or through

12 the National Institutes of Health concerning the

13 safety and efficacy of HIV vaccines for the treat14 ment and prevention of HIV infection. Such plan

15 shall ensure the full participation of other Federal

16 agencies currently conducting HIV vaccine studies

17 and require that such studies conform fully to the

18 requirements of part 46 of title 45, Code of Federal

19 Regulations.

20 (2) REPORT.—Not later than 180 days after

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

22 of Health and Human Services shall prepare and

23 submit to the Committee on Energy and Commerce

24 of the House of Representatives, and the Committee

25 on Labor and Human Resources of the Senate, a re-
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1 port concerning the plan developed under paragraph

2 (1).

3 (3) IMPLEMENTATION.—Not later than 12

4 months after the date of the enactment of this Act,

5 the Secretary of Health and Human Services shall

6 implement the plan developed under paragraph (1),

7 including measures for the full participation of other

8 Federal agencies currently conducting HIV vaccine

9 studies.

10 (4) For the purpose of carrying out this sub11 section, there are authorized to be appropriated such

12 sums as may be necessary for each of the fiscal

13 years 1994 through 1996.

14 SEC. 1902. MALNUTRITION IN THE ELDERLY.

15 (a) STUDY.—

16 (1) IN GENERAL.—The Secretary of Health and

17 Human Services (referred to in this section as the

18 ‘‘Secretary’’), acting through the National Institute

19 on Aging, coordinating with the Agency for Health

20 Care Policy and Research and, to the degree pos21 sible, in consultation with the head of the National

22 Nutrition Monitoring System established under sec23 tion 1428 of the Food and Agriculture Act of 1977

24 (7 U.S.C. 3178), shall conduct a 3-year nutrition
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1 screening and intervention activities study of the el2 derly.

3 (2) EFFICACY AND COST-EFFECTIVENESS OF

4 NUTRITION SCREENING AND INTERVENTION ACTIVI5 TIES.—In conducting the study, the Secretary shall

6 determine the efficacy and cost-effectiveness of nu7 trition screening and intervention activities con8 ducted in the elderly health and long-term care con9 tinuum, and of a program that would institutionalize

10 nutrition screening and intervention activities. In

11 evaluating such a program, the Secretary shall de12 termine—

13 (A) if health or quality of life is measur14 ably improved for elderly individuals who re15 ceive routine nutritional screening and treat16 ment;

17 (B) if federally subsidized home or institu18 tional care is reduced because of increased inde19 pendence of elderly individuals resulting from

20 improved nutritional status;

21 (C) if a multidisciplinary approach to nu22 tritional care is effective in addressing the nu23 tritional needs of elderly individuals; and

24 (D) if reimbursement for nutrition screen25 ing and intervention activities is a cost-effective
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1 approach to improving the health status of el2 derly individuals.

3 (3) POPULATIONS.—The populations of elderly

4 individuals in which the study will be conducted

5 shall include populations of elderly individuals who

6 are—

7 (A) living independently, including—

8 (i) individuals who receive home and

9 community-based services or family sup10 port;

11 (ii) individuals who do not receive ad12 ditional services and support;

13 (iii) individuals with low incomes; and

14 (iv) individuals who are minorities;

15 (B) hospitalized, including individuals ad16 mitted from home and from institutions; and

17 (C) institutionalized in residential facilities

18 such as nursing homes and adult homes.

19 (b) MALNUTRITION STUDY.—The Secretary, acting

20 through the National Institute on Aging, shall conduct a

21 3-year study to determine the extent of malnutrition in

22 elderly individuals in hospitals and long-term care facili23 ties and in elderly individuals who are living independ24 ently.
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1 (c) REPORT.—The Secretary shall submit a report to

2 the Committee on Labor and Human Resources of the

3 Senate and the Committee on Energy and Commerce of

4 the House of Representatives containing the findings re5 sulting from the studies described in subsections (a) and

6 (b), including a determination regarding whether a pro7 gram that would institutionalize nutrition screening and

8 intervention activities should be adopted, and the rationale

9 for the determination.

10 (d) ADVISORY PANEL.—

11 (1) ESTABLISHMENT.—The Secretary, acting

12 through the Director of the National Institute on

13 Aging, shall establish an advisory panel that shall

14 oversee the design, implementation, and evaluation

15 of the studies described in subsections (a) and (b).

16 (2) COMPOSITION.—The advisory panel shall in17 clude representatives appointed for the life of the

18 panel by the Secretary from the Health Care Fi19 nancing Administration, the Social Security Admin20 istration, the National Center for Health Statistics,

21 the Administration on Aging, the National Council

22 on the Aging, the American Dietetic Association, the

23 American Academy of Family Physicians, and such

24 other agencies or organizations as the Secretary de25 termines to be appropriate.
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1 (3) COMPENSATION AND EXPENSES.—

2 (A) COMPENSATION.—Each member of the

3 advisory panel who is not an employee of the

4 Federal Government shall receive compensation

5 for each day engaged in carrying out the duties

6 of the panel, including time engaged in travel7 ing for purposes of such duties. Such com8 pensation may not be provided in an amount in

9 excess of the maximum rate of basic pay pay10 able for GS–18 of the General Schedule.

11 (B) TRAVEL EXPENSES.—Each member of

12 the advisory panel shall receive travel expenses,

13 including per diem in lieu of subsistence, at

14 rates authorized for employees of agencies

15 under subchapter I of chapter 57 of title 5,

16 United States Code, for each day the member

17 is engaged in the performance of duties away

18 from the home or regular place of business of

19 the member.

20 (4) DETAIL OF FEDERAL EMPLOYEES.—On the

21 request of the advisory panel, the head of any Fed22 eral agency shall detail, without reimbursement, any

23 of the personnel of the agency to the advisory panel

24 to assist the advisory panel in carrying out its du25 ties. Any detail shall not interrupt or otherwise af-
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1 fect the civil service status or privileges of the Fed2 eral employee.

3 (5) TECHNICAL ASSISTANCE.—On the request

4 of the advisory panel, the head of a Federal agency

5 shall provide such technical assistance to the advi6 sory panel as the advisory panel determines to be

7 necessary to carry out its duties.

8 (6) TERMINATION.—Notwithstanding section

9 15 of the Federal Advisory Committee Act (5 U.S.C.

10 App.), the advisory panel shall terminate 3 years

11 after the date of enactment of this Act.

12 SEC. 1903. RESEARCH ACTIVITIES ON CHRONIC FATIGUE

13 SYNDROME.

14 The Secretary of Health and Human Services shall,

15 not later than May 1, 1993, and annually thereafter for

16 the next 3 years, prepare and submit to the Committee

17 on Energy and Commerce of the House of Representatives

18 and the Committee on Labor and Human Resources of

19 the Senate, a report that summarizes the research activi20 ties conducted or supported by the National Institutes of

21 Health concerning chronic fatigue syndrome. Such report

22 should include information concerning grants made, coop23 erative agreements or contracts entered into, intramural

24 activities, research priorities and needs, and a plan to ad25 dress such priorities and needs.
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1 SEC. 1904. REPORT ON MEDICAL USES OF BIOLOGICAL

2 AGENTS IN DEVELOPMENT OF DEFENSES

3 AGAINST BIOLOGICAL WARFARE.

4 The Secretary of Health and Human Services, in con5 sultation with other appropriate executive agencies, shall

6 report to the House Energy and Commerce Committee

7 and the Senate Labor and Human Resources Committee

8 on the appropriateness and impact of the National Insti9 tutes of Health assuming responsibility for the conduct of

10 all Federal research, development, testing, and evaluation

11 functions relating to medical countermeasures against

12 biowarfare threat agents. In preparing the report, the Sec13 retary shall identify the extent to which such activities are

14 carried out by agencies other than the National Institutes

15 of Health, and assess the impact (positive and negative)

16 of the National Institutes of Health assuming responsibil17 ity for such activities, including the impact under the

18 Budget Enforcement Act and the Omnibus Budget Rec19 onciliation Act of 1990 on existing National Institutes of

20 Health research programs as well as other programs with21 in the category of domestic discretionary spending. The

22 Secretary shall submit the report not later than 12 months

23 after the date of the enactment of this Act.
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1 SEC. 1905. PERSONNEL STUDY OF RECRUITMENT, RETEN2 TION AND TURNOVER.

3 (a) STUDY OF PERSONNEL SYSTEM.—Not later than

4 1 year after the date of the enactment of this Act, the

5 Secretary of Health and Human Services, acting through

6 the Director of the National Institutes of Health, shall

7 conduct a study to review the retention, recruitment, va8 cancy and turnover rates of support staff, including fire9 fighters, law enforcement, procurement officers, techni10 cians, nurses and clerical employees, to ensure that the

11 National Institutes of Health is adequately supporting the

12 conduct of efficient, effective and high quality research for

13 the American public. The Director of NIH shall work in

14 conjunction with appropriate employee organizations and

15 representatives in developing such a study.

16 (b) SUBMISSION TO CONGRESS.—Not later than 1

17 year after the date of the enactment of this Act, the Sec18 retary of Health and Human Services shall prepare and

19 submit to the Committee on Energy and Commerce of the

20 House of Representatives, and to the Committee on Labor

21 and Human Resources of the Senate, a report containing

22 the study conducted under subsection (a) together with

23 the recommendations of the Secretary concerning the en24 actment of legislation to implement the results of such

25 study.
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1 SEC. 1906. PROCUREMENT.

2 (a) IN GENERAL.—The Director of the National In3 stitutes of Health and the Administrator of the General

4 Services Administration shall jointly conduct a study to

5 develop a streamlined procurement system for the Na6 tional Institutes of Health that complies with the require7 ments of Federal law.

8 (b) REPORT.—Not later than March 1, 1994, the of9 ficials specified in subsection (a) shall complete the study

10 required in such subsection and shall submit to the Com11 mittee on Energy and Commerce of the House of Rep12 resentatives, and the Committee on Labor and Human Re13 sources of the Senate, a report describing the findings

14 made as a result of the study.

15 SEC. 1907. REPORT CONCERNING LEADING CAUSES OF

16 DEATH.

17 (a) REPORT.—The Secretary of Health and Human

18 Services shall, not later than October 1, 1993, prepare a

19 report that lists—

20 (1) the 20 illnesses that, in terms of mortality,

21 number of years of expected life lost, and of number

22 of preventable years of life lost, are the leading

23 causes of death in the United States and the number

24 of deaths from each such cause, the age-specific and

25 age-adjusted death rates for each such cause, the

26 death rate per 100,000 population for each such
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1 cause, the percentage of change in cause specific

2 death rates for each age group, and the percentage

3 of total deaths for each such cause;

4 (2) the amount expended by the Department of

5 Health and Human Services for research, preven6 tion, and education with respect to each of the 20

7 illnesses described in paragraph (1) for the most re8 cent year for which the actual expenditures are

9 known;

10 (3) an estimate by the Secretary of the amount

11 to be expended on research, prevention, and edu12 cation with respect to each of the 20 illnesses de13 scribed in paragraph (1) for the year for which the

14 report is prepared; and

15 (4) with respect to the years specified in para16 graphs (2) and (3), the percentage of the total of

17 the annual expenditures for research, prevention,

18 and education on the 20 illnesses described in para19 graph (1) that are attributable to each illness.

20 (b) SUBMISSION TO CONGRESS.—The Secretary of

21 Health and Human Services shall submit the report re22 quired under subsection (a), together with relevant budget

23 information, to the Committee on Energy and Commerce

24 and the Committee on Appropriations of the House of

25 Representatives and the Committee on Labor and Human
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1 Resources and the Committee on Appropriations of the

2 Senate.

3 SEC. 1908. RELATIONSHIP BETWEEN THE CONSUMPTION

4 OF LEGAL AND ILLEGAL DRUGS.

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

6 Human Services, acting through the Commissioner of

7 Food and Drugs, shall review and consider all existing rel8 evant data and research concerning whether there is a re9 lationship between an individual’s receptivity to use or

10 consume legal drugs and the consumption or abuse by the

11 individual of illegal drugs. On the basis of such review,

12 the Secretary shall determine whether additional research

13 is necessary. If the Secretary determines additional re14 search is required, the Secretary shall conduct a study of

15 those subjects where the Secretary’s review indicates addi16 tional research is needed, including, if necessary, a review

17 of—

18 (1) the effect of advertising and marketing

19 campaigns that promote the use of legal drugs on

20 the public;

21 (2) the correlation of legal drug abuse with ille22 gal drug abuse; and

23 (3) other matters that the Secretary determines

24 appropriate.
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1 (b) REPORT.—Not later than 12 months after the

2 date of enactment of this Act, the Secretary shall prepare

3 and submit, to the Committee on Energy and Commerce

4 of the House of Representatives and Committee on Labor

5 and Human Resources of the Senate, a report containing

6 the results of the review conducted under subsection (b).

7 If the Secretary determines additional research is re8 quired, no later than 2 years after the date of enactment

9 of this Act, the Secretary shall prepare and submit, to the

10 Committee on Energy and Commerce of the House of

11 Representatives and Committee on Labor and Human Re12 sources of the Senate, a report containing the results of

13 the additional research conducted under subsection (b).

14 SEC. 1909. COST OF CARE IN LAST 6 MONTHS OF LIFE.

15 (a) STUDY.—

16 (1) IN GENERAL.—The Secretary of Health and

17 Human Services (referred to in this section as the

18 ‘‘Secretary’’), acting through the Agency for Health

19 Care Policy and Research and, to the degree pos20 sible, in consultation with the Health Care Financ21 ing Administration, shall conduct a study, using the

22 most recent National Medical Expenditure Survey

23 database, to estimate the average amount of health

24 care expenditures incurred during the last 6 months

25 of life and during the last 3 months of life by—
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1 (A) the population of individuals who are

2 65 years of age and older; and

3 (B) the total population, broken down

4 based on noninstitutionalized and institutional5 ized populations.

6 (2) ELEMENTS OF STUDY.—The study con7 ducted under paragraph (1) shall—

8 (A) be designed in a manner that will

9 produce estimates of health care costs expended

10 for health care provided to individuals during

11 the last 3 and 6 months of life;

12 (B) be designed to produce estimates of

13 such costs for the populations identified in sub14 paragraphs (A) and (B) of paragraph (1);

15 (C) include a calculation of the estimated

16 amount of total health care expenditures during

17 such periods of time; and

18 (D) include a calculation of the estimate

19 described in subparagraph (C)—

20 (i) as a percentage of the total na21 tional health care expenditures; and

22 (ii) for those age 65 years and over,

23 as a percentage of the total Medicare ex24 penditures for those age 65 years and over.
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1 (b) REPORT.—Not later than 6 months after the date

2 of enactment of this section, the Secretary shall prepare

3 and submit to the Committee on Labor and Human Re4 sources of the Senate and the Committee on Energy and

5 Commerce of the House of Representatives, a report con6 taining the findings resulting from the study described in

7 subsection (a).

8 (c) 1996 NATIONAL MEDICAL EXPENDITURE SUR9 VEY.—

10 (1) IN GENERAL.—The Secretary, acting

11 through the Agency for Health Care Policy and Re12 search, shall ensure that the 1996 National Medical

13 Expenditure Survey is designed in a manner that

14 will produce an estimate of the amount expended for

15 health care provided to individuals during the last 3

16 and 6 months of life.

17 (2) POPULATIONS.—In designing the Survey

18 under paragraph (1), the Secretary shall ensure that

19 such Survey produces the data required under such

20 paragraph for the population of individuals who are

21 65 years of age or older, broken down based on

22 noninstitutionalized and institutionalized popu23 lations.

24 (d) EXPENDITURE STUDY.—
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1 (1) IN GENERAL.—Not later than 6 months

2 after that date of enactment of this section, the Sec3 retary, acting through the Agency for Health Care

4 Policy and Research, shall design a study to produce

5 estimates of expenditures for health care provided to

6 children who are less than 1 year of age during the

7 last 3 and 6 months of life, and prepare and submit

8 to the Committee on Labor and Human Resources

9 of the Senate and the Committee on Energy and

10 Commerce of the House of Representatives, a report

11 concerning such design. The Secretary shall ensure

12 that such study is carried out not later than 2 years

13 after the date on which such study is designed.

14 (2) REPORT.—Not later than 30 months after

15 the date of enactment of this section, the Secretary

16 shall prepare and submit to the Committee on Labor

17 and Human Resources of the Senate and the Com18 mittee on Energy and Commerce of the House of

19 Representatives, a report concerning the study de20 scribed in paragraph (1).

21 (3) AUTHORIZATION OF APPROPRIATIONS.—

22 There are authorized to be appropriated such sums

23 as may be necessary to carry out this subsection.
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1 SEC. 1910. REDUCING ADMINISTRATIVE HEALTH CARE

2 COSTS.

3 The Secretary of Health and Human Services, acting

4 through the Agency for Health Care Policy and Research

5 and, to the extent possible, in consultation with the Health

6 Care Financing Administration, may fund research to de7 velop a text-based standardized billing process, through

8 the utilization of text-based information retrieval and nat9 ural language processing techniques applied to automatic

10 coding and analysis of textual patient discharge sum11 maries and other text-based electronic medical records,

12 within a parallel general purpose (shared memory) high

13 performance computing environment. The Secretary shall

14 determine whether such a standardized approach to medi15 cal billing, through the utilization of the text-based hos16 pital discharge summary as well as electronic patient

17 records can reduce the administrative billing costs of

18 health care delivery.

19 SEC. 1911. STUDY CONCERNING RADIOISOTOPES.

20 (a) STUDY.—The Secretary of Health and Human

21 Services, in collaboration with the Secretary of Energy,

22 shall, subject to the availability of funds, conduct a study

23 concerning the use and availability of radioisotopes in the

24 United States for medical (both diagnostic and thera25 peutic) uses in relationship to other uses.
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1 (b) SUBJECT OF STUDY.—In carrying out the study

2 under subsection (a), the Secretary shall—

3 (1) analyze the domestic isotope availability and

4 production in the United States as it relates to med5 ical (both diagnostic and therapeutic) needs;

6 (2) make recommendations concerning—

7 (A) isotope availability and production to

8 meet domestic demand; and

9 (B) the need for additional production ca10 pacity.

11 (c) REPORT.—Not later than 1 year after the date

12 of enactment of this Act, the Secretary of Health and

13 Human Services shall prepare and submit to the Commit14 tee on Energy and Natural Resources of the Senate and

15 the Committee on Energy and Commerce of the House

16 of Representatives, a report concerning the results of the

17 study conducted under this section together with the rec18 ommendations developed in such study.

19 SEC. 1912. MEDICAL TECHNOLOGIES PRODUCTIVITY

20 STUDY.

21 (a) FINDINGS.—Congress finds that—

22 (1)(A) the Congressional Budget Office, the

23 General Accounting Office, and the Office of Tech24 nology Assessment have cited health care technology

25 as a primary source of medical inflation; and
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1 (B) data from the Office of Technology Assess2 ment suggest that no more than one quarter of the

3 12 to 13 percent annual increase in health care ex4 penditures, or an estimated 3 percent increase in

5 such expenditures, is attributable to health care

6 technology;

7 (2)(A) the 3 percent increase represents the

8 maximum increase in such expenditures, because the

9 Office of Technology Assessment arrives at the esti10 mate by exclusion; and

11 (B) the increase attributable to health care

12 technology may nevertheless amount to a direct in13 crease of as much as $27,000,000,000 in health care

14 costs in 1993 and an even greater indirect increase

15 in such health care costs;

16 (3) one reason for the high increase in health

17 care costs attributable to health care technology is

18 that few incentives exist in the national research in19 stitutes of the National Institutes of Health to en20 courage the development of technology that improves

21 the productivity of health care delivery; and

22 (4) since the National Institutes of Health is a

23 major engine determining the direction of medical

24 technology as well as basic biomedical research, it is

25 appropriate, in the process of directing the medical
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1 research and development resources of the National

2 Institutes of Health, to provide incentives that en3 courage the development of technology to improve

4 the productivity of health care delivery.

5 (b) STUDY.—The Secretary of Health and Human

6 Services shall conduct a study concerning—

7 (1) methods by which to encourage the develop8 ment of medical technologies that improve the pro9 ductivity, and thereby reduce the cost, of health care

10 delivery through changes in the scientific peer review

11 process; and

12 (2) methods by which to reduce the costs of the

13 production of new medical technologies and increase

14 the availability of such technologies through changes

15 in the scientific peer review process.

16 (c) REPORT.—Not later than 1 year after the date

17 of enactment of this Act, the Secretary of Health and

18 Human Services shall prepare and submit to the Commit19 tee on Labor and Human Resources of the Senate and

20 the Committee on Energy and Commerce of the House

21 of Representatives, a report concerning the study con22 ducted under subsection (b). Such report shall contain the

23 findings of the Secretary with respect to the study and

24 the recommendations of the Secretary for the implementa25 tion of measures to encourage enhanced productivity of
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1 medical technologies and increase the availability of such

2 technologies through changes in the scientific peer review

3 process. Such report shall also contain the steps that the

4 Secretary proposes to implement the recommendations.

5 SEC. 1913. SENTINEL DISEASE CONCEPT STUDY.

6 (a) IN GENERAL.—The Director of the National In7 stitutes of Health, in cooperation with the Agency for

8 Toxic Substances and Disease Registry and the Centers

9 for Disease Control and Prevention, may design and im10 plement a pilot sentinel disease surveillance and follow11 up system.

12 (b) PURPOSE.—The purpose of the study conducted

13 under subsection (a) shall be to determine the applicability

14 of and the difficulties associated with the implementation

15 of the sentinel disease concept for identifying the relation16 ship between the occupation of household members and

17 the incidence of subsequent conditions or diseases in other

18 members of the household.

19 (c) REPORT.—Not later than 4 years after the date

20 of enactment of this Act, the Director of the National In21 stitutes of Health shall prepare and submit to the appro22 priate committees of Congress, a report concerning the re23 sults of the study conducted under subsection (a).
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1 SEC. 1914. CONGRESSIONAL APPROPRIATION OF FEDER2 ALLY SUPPORTED DISEASE RESEARCH.

3 (a) FINDINGS.—Congress finds that—

4 (1) it is in the public interest to support nec5 essary and valuable biomedical research on diseases

6 and conditions that harm or kill individuals and that

7 threaten public health;

8 (2) it is in the public interest to allocate scarce

9 Federal taxpayer money for research that is based

10 on scientific merit and cost-effectiveness; and

11 (3) it is in the public interest for Members of

12 Congress to have a criteria or methodologies to in13 form and assist them in the decision making process

14 when allocating Federal taxpayer money for specific

15 biomedical research.

16 (b) STUDY.—

17 (1) CONTRACT.—The Secretary of Health and

18 Human Services shall, subject to the availability of

19 appropriations and subject to paragraph (2), enter

20 into a contract with a public or nonprofit private en21 tity to develop criteria or methodologies which Mem22 bers of Congress may use to assist and inform them

23 during consideration of allocations for biomedical re24 search.

25 (2) INSTITUTE OF MEDICINE.—The Secretary

26 of Health and Human Services shall request the In-
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1 stitute of Medicine of the National Academy of

2 Sciences to enter into the contract under paragraph

3 (1) to conduct the study described in such para4 graph. If such Institute declines to conduct the

5 study, the Secretary shall carry out paragraph (1)

6 through another public or nonprofit private entity.

7 (3) ITEMS.—Items that may be considered in

8 the development of the criteria of methodologies may

9 include, but are not limited to, the following—

10 (A) the populations affected by, or poten11 tially affected by diseases and conditions that

12 are targets for research;

13 (B) the incidence and prevalence rates of

14 disease and conditions;

15 (C) mortality rates of the diseases and

16 conditions;

17 (D) rates of morbidity, impairment disabil18 ity, and health status and functional outcomes

19 of the diseases and conditions;

20 (E) the economic burden of the diseases

21 and conditions including past and projected ex22 penditures on diagnosis and treatment;

23 (F) other economic and social burdens;

24 and
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1 (G) potential for medical research on spe2 cific diseases to assist basic research efforts.

3 (c) SUBMISSION TO CONGRESS.—Not later than 1

4 year after the date on which the contract under subsection

5 (b)(1) is signed, the Institutes of Medicine of the National

6 Academy of Sciences shall prepare and submit to the Sec7 retary of Health and Human Services, and the appropriate

8 committees of Congress, a report that includes the rec9 ommendations developed under subsection (b). Not later

10 than 90 days after the receipt of such report, the Sec11 retary of Health and Human Services shall submit com12 ments on the recommendations to the appropriate commit13 tees of Congress.

14 (d) COSTS.—For the purpose of carrying out this sec15 tion, there are authorized to be appropriated such sums

16 as may be necessary for fiscal years 1994 and 1995.

17 TITLE XX—MISCELLANEOUS

18 PROVISIONS

19 SEC. 2001. DESIGNATION OF SENIOR BIOMEDICAL RE20 SEARCH SERVICE IN HONOR OF SILVIO O.

21 CONTE, AND LIMITATION ON NUMBER OF

22 MEMBERS.

23 (a) IN GENERAL.—Section 228(a) of the Public

24 Health Service Act (42 U.S.C. 237(a)), as added by sec-
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1 tion 304 of Public Law 101–509, is amended to read as

2 follows:

3 ‘‘(a)(1) There shall be in the Public Health Service

4 a Silvio O. Conte Senior Biomedical Research Service, not

5 to exceed 350 members.

6 ‘‘(2) The authority established in paragraph (1) re7 garding the number of members in the Silvio O. Conte

8 Senior Biomedical Research Service is in addition to any

9 authority established regarding the number of members

10 in the commissioned Regular Corps, in the Reserve Corps,

11 and in the Senior Executive Service. Such paragraph may

12 not be construed to require that the number of members

13 in the commissioned Regular Corps, in the Reserve Corps,

14 or in the Senior Executive Service be reduced to offset

15 the number of members serving in the Silvio O. Conte Sen16 ior Biomedical Research Service (hereafter in this section

17 referred to as the ‘Service’).’’.

18 (b) CONFORMING AMENDMENT.—Section 228 of the

19 Public Health Service Act (42 U.S.C. 237), as added by

20 section 304 of Public Law 101–509, is amended in the

21 heading for the section by amending the heading to read

22 as follows:
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1 ‘‘SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH

2 SERVICE’’.

3 SEC. 2002. TECHNICAL CORRECTIONS.

4 (a) TITLE III.—Subsection (c) of section 316 of the

5 Public Health Service Act (42 U.S.C. 247a(c)) is repealed.

6 (b) TITLE IV.—Title IV of the Public Health Service

7 Act (42 U.S.C. 281 et seq.) is amended—

8 (1) in section 406—

9 (A) in subsection (b)(2)(A), by striking

10 ‘‘Veterans’ Administration’’ each place such

11 term appears and inserting ‘‘Department of

12 Veterans Affairs’’; and

13 (B) in subsection (h)(2)(A)(v), by striking

14 ‘‘Veterans’ Administration’’ and inserting ‘‘De15 partment of Veterans Affairs’’;

16 (2) in section 408, in subsection (b) (as redesig17 nated by section 501(c)(1)(C) of this Act), by strik18 ing ‘‘Veterans’ Administration’’ and inserting ‘‘De19 partment of Veterans Affairs’’;

20 (3) in section 421(b)(1), by inserting a comma

21 after ‘‘may’’;

22 (4) in section 428(b), in the matter preceding

23 paragraph (1), by striking ‘‘the the’’ and inserting

24 ‘‘the’’;
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1 (5) in section 430(b)(2)(A)(i), by striking ‘‘Vet2 erans’ Administration’’ and inserting ‘‘Department

3 of Veterans Affairs’’;

4 (6) in section 439(b), by striking ‘‘Veterans’

5 Administration’’ and inserting ‘‘Department of Vet6 erans Affairs’’;

7 (7) in section 442(b)(2)(A), by striking ‘‘Veter8 ans’ Administration’’ and inserting ‘‘Department of

9 Veterans Affairs’’;

10 (8) in section 464D(b)(2)(A), by striking ‘‘Vet11 erans’ Administration’’ and inserting ‘‘Department

12 of Veterans Affairs’’;

13 (9) in section 464E—

14 (A) in subsection (d), in the first sentence,

15 by inserting ‘‘Coordinating’’ before ‘‘Commit16 tee’’; and

17 (B) in subsection (e), by inserting ‘‘Coordi18 nating’’ before ‘‘Committee’’ the first place

19 such term appears;

20 (10) in section 464P(b)(6) (as added by section

21 123 of Public Law 102-321 (106 Stat. 362)), by

22 striking ‘‘Administration’’ and inserting ‘‘Institute’’;

23 (11) in section 466(a)(1)(B), by striking ‘‘Vet24 erans’ Administration’’ and inserting ‘‘Department

25 of Veterans Affairs’’;
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1 (12) in section 480(b)(2)(A), by striking ‘‘Vet2 erans’ Administration’’ and inserting ‘‘Department

3 of Veterans Affairs’’;

4 (13) in section 485(b)(2)(A), by striking ‘‘Vet5 erans’ Administration’’ and inserting ‘‘Department

6 of Veterans Affairs’’;

7 (14) in section 487(d)(3), by striking ‘‘section

8 304(a)(3)’’ and inserting ‘‘section 304(a)’’; and

9 (15) in section 496(a), by striking ‘‘Such ap10 propriations,’’ and inserting the following: ‘‘Appro11 priations to carry out the purposes of this title,’’.

12 (c) TITLE XV.—Title XV of the Public Health Serv13 ice Act is amended—

14 (1) in section 1501(b) (42 U.S.C. 300k(b)), by

15 striking ‘‘nonprofit’’; and

16 (2) in section 1505(3) (42 U.S.C. 300n–1(3)),

17 by striking ‘‘nonprivate’’ and inserting ‘‘private’’.

18 (d) TITLE XXIII.—Part A of title XXIII of the Pub19 lic Health Service Act (42 U.S.C. 300cc et seq.) is amend20 ed—

21 (1) in section 2304—

22 (A) in the heading for the section, by strik23 ing ‘‘CLINICAL RESEARCH REVIEW COM24 MITTEE’’ and inserting ‘‘RESEARCH ADVI25 SORY COMMITTEE’’; and
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1 (B) in subsection (a), by striking ‘‘AIDS

2 Clinical Research Review Committee’’ and in3 serting ‘‘AIDS Research Advisory Committee’’;

4 (2) in section 2312(a)(2)(A), by striking ‘‘AIDS

5 Clinical Research Review Committee’’ and inserting

6 ‘‘AIDS Research Advisory Committee’’;

7 (3) in section 2314(a)(1), in the matter preced8 ing subparagraph (A), by striking ‘‘Clinical Research

9 Review Committee’’ and inserting ‘‘AIDS Research

10 Advisory Committee’’;

11 (4) in section 2317(d)(1), by striking ‘‘Clinical

12 Research Review Committee’’ and inserting ‘‘AIDS

13 Research Advisory Committee established under sec14 tion 2304’’; and

15 (5) in section 2318(b)(3), by striking ‘‘Clinical

16 Research Review Committee’’ and inserting ‘‘AIDS

17 Research Advisory Committee’’.

18 (e) SECRETARY.—Section 2(c) of the Public Health

19 Service Act (42 U.S.C. 201(c)) is amended by striking

20 ‘‘Health, Education, and Welfare’’ and inserting ‘‘Health

21 and Human Services’’.

22 (f) DEPARTMENT.—Section 201 of the Public Health

23 Service Act (42 U.S.C. 202) is amended—
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1 (1) by striking ‘‘Health, Education, and Wel2 fare’’ and inserting ‘‘Health and Human Services’’;

3 and

4 (2) by striking ‘‘Surgeon General’’ and insert5 ing ‘‘Assistant Secretary for Health’’.

6 (g) DEPARTMENT.—Section 202 of the Public Health

7 Service Act (42 U.S.C. 203) is amended—

8 (1) by striking ‘‘Surgeon General’’ the second

9 and subsequent times that such term appears and

10 inserting ‘‘Secretary’’; and

11 (2) by inserting ‘‘, and the Agency for Health

12 Care Policy and Research’’ before the first period.

13 (h) VOLUNTEER SERVICES.—Section 223 of the Pub14 lic Health Service Act (42 U.S.C. 217b) is amended by

15 striking ‘‘Health, Education, and Welfare’’ and inserting

16 ‘‘Health and Human Services’’.

17 SEC. 2003. TECHNICAL CORRECTIONS WITH RESPECT TO

18 THE AGENCY FOR HEALTH CARE POLICY AND

19 RESEARCH.

20 Title IX of the Public Health Service Act is amend21 ed—

22 (1) in section 904(d) (42 U.S.C. 299a-2(d))—

23 (A) by striking ‘‘IN GENERAL’’ in para24 graph (1) and inserting ‘‘ADDITIONAL ASSESS25 MENTS’’;
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1 (B) by redesignating paragraphs (1) and

2 (2) as paragraphs (3) and (4), respectively;

3 (C) by inserting after the subsection des4 ignation the following new paragraphs:

5 ‘‘(1) RECOMMENDATIONS WITH RESPECT TO

6 HEALTH CARE TECHNOLOGY.—The Administrator

7 shall make recommendations to the Secretary with

8 respect to whether specific health care technologies

9 should be reimbursable under federally financed

10 health programs, including recommendations with

11 respect to any conditions and requirements under

12 which any such reimbursements should be made.

13 ‘‘(2) CONSIDERATIONS OF CERTAIN FACTORS.—

14 In making recommendations respecting health care

15 technologies, the Administrator shall consider the

16 safety, efficacy, and effectiveness, and, as appro17 priate, the appropriate uses of such technologies.

18 The Administrator shall also consider the cost effec19 tiveness of such technologies where cost information

20 is available and reliable.’’; and

21 (D) by adding at the end thereof the fol22 lowing new paragraph:

23 ‘‘(5) CONSULTATIONS.—In carrying out this

24 subsection, the Administrator shall cooperate and

25 consult with the Director of the National Institutes
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1 of Health, the Commissioner of Food and Drugs,

2 and the heads of any other interested Federal de3 partment or agency.’’; and

4 (2) in section 914(a)(2)(C), by striking

5 ‘‘904(c)(2)’’ and inserting ‘‘904(d)(2)’’.

6 SEC. 2004. TECHNICAL CORRECTIONS WITH RESPECT TO

7 THE HEALTH PROFESSIONS EDUCATION EX8 TENSION AMENDMENTS OF 1992.

9 (a) ASSISTANCE IN COLLECTION OF LOANS.—Sub10 part I of part A of title VII of the Public Health Service

11 Act is amended—

12 (1) in section 705(a)(2)—

13 (A) by inserting ‘‘and’’ after the semicolon

14 at the end of subparagraph (G);

15 (B) by striking subparagraph (H); and

16 (C) by redesignating subparagraph (I) as

17 subparagraph (H); and

18 (2) by adding at the end of section 707 the fol19 lowing new subsection:

20 ‘‘(j) SCHOOL COLLECTION ASSISTANCE.—An institu21 tion or postgraduate training program attended by a bor22 rower may assist in the collection of any loan of that bor23 rower made under this subpart which becomes delinquent.

24 The institution or postgraduate training program will not

25 be subject to section 809 of the Fair Debt Collection Prac-
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1 tices Act for purposes of assisting in the collection of any

2 such loan.’’.

3 (b) FINANCIAL NEED REQUIREMENT.—Subsection

4 (b) of section 722 is amended—

5 (1) by inserting ‘‘and’’ after the semicolon at

6 the end of paragraph (1);

7 (2) by striking paragraph (2); and

8 (3) by redesignating paragraph (3) as para9 graph (2).

10 (c) CENTERS OF EXCELLENCE.—Section

11 739(i)(2)(C) is amended by adding after the period the

12 following new sentence: ‘‘Health professional schools de13 scribed in paragraph (2) of subsection (c) are eligible for

14 funding under this subsection.’’.

15 (d) TRAINEESHIPS FOR ADVANCED NURSE EDU16 CATION.—Subsection (a) of section 830 of the Public

17 Health Service Act is amended to read as follows:

18 ‘‘(a) IN GENERAL.—The Secretary may make grants

19 to public and nonprofit private entities to meet the cost

20 of—

21 ‘‘(1) traineeships for individuals in advanced22 degree programs in order to educate the individuals

23 to serve as nurse practitioners, nurse midwives,

24 nurse educators, or public health nurses, or in other
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1 clinical nursing specialities determined by the Sec2 retary to require advanced education; and

3 ‘‘(2) traineeships for nurses in certificate nurse

4 midwifery programs which conform to guidelines es5 tablished by the Secretary under section 822(b), to

6 educate the nurses to serve as nurse midwives.’’.

7 (e) CERTAIN GENERALLY APPLICABLE PROVI8 SIONS.—Subsection (d) of section 860 of the Public

9 Health Service Act is amended by striking ‘‘821, 822, 830,

10 and 831’’ and inserting in lieu thereof ‘‘821, 822, and

11 827’’.

12 SEC. 2005. BIENNIAL REPORT ON CARCINOGENS.

13 Section 301(b)(4) of the Public Health Service Act

14 (42 U.S.C. 241(b)(4)) is amended by striking ‘‘an annual’’

15 and inserting in lieu thereof ‘‘a biennial’’.

16 SEC. 2006. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE

17 FOR RESEARCH.

18 Not later than June 1, 1994, the Secretary of Health

19 and Human Services, acting through the Director of the

20 National Institutes of Health, shall present to the Con21 gress a master plan to provide for the replacement or re22 furbishment of less than adequate buildings, utility equip23 ment and distribution systems (including the resources

24 that provide electrical and other utilities, chilled water, air

25 handling, and other services that the Secretary, acting
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1 through the Director, deems necessary), roads, walkways,

2 parking areas, and grounds that underpin the laboratory

3 and clinical facilities of the National Institutes of Health.

4 Such plan may make recommendations for the undertak5 ing of new projects that are consistent with the objectives

6 of this section, such as encircling the National Institutes

7 of Health Federal enclave with an adequate chilled water

8 conduit.

9 SEC. 2007. TRANSFER OF PROVISIONS OF TITLE XXVII.

10 (a) IN GENERAL.—The Public Health Service Act

11 (42 U.S.C. 201 et seq.), as amended by section 101 of

12 Public Law 101–381 and section 304 of Public Law 101–

13 509, is amended—

14 (1) by transferring sections 2701 through 2714

15 to title II;

16 (2) by redesignating such sections as sections

17 231 through 244, respectively;

18 (3) by inserting such sections, in the appro19 priate sequence, after section 228;

20 (4) by inserting before section 201 the following

21 new heading:

22 ‘‘PART A—ADMINISTRATION’’; and

23 (5) by inserting before section 231 (as redesig24 nated by paragraph (2) of this subsection) the fol25 lowing new heading:
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1 ‘‘PART B—MISCELLANEOUS PROVISIONS’’.

2 (b) CONFORMING AMENDMENTS.—The Public

3 Health Service Act (42 U.S.C. 201 et seq.) is amended—

4 (1) in the heading for title II, by inserting

5 ‘‘AND MISCELLANEOUS PROVISIONS’’ after

6 ‘‘ADMINISTRATION’’;

7 (2) in section 406(a)(2), by striking ‘‘2701’’

8 and inserting ‘‘231’’;

9 (3) in section 465(f), by striking ‘‘2701’’ and

10 inserting ‘‘231’’;

11 (4) in section 480(a)(2), by striking ‘‘2701’’

12 and inserting ‘‘231’’;

13 (5) in section 485(a)(2), by striking ‘‘2701’’

14 and inserting ‘‘231’’;

15 (6) in section 497, by striking ‘‘2701’’ and in16 serting ‘‘231’’;

17 (7) in section 505(a)(2), by striking ‘‘2701’’

18 and inserting ‘‘231’’;

19 (8) in section 926(b), by striking ‘‘2711’’ each

20 place such term appears and inserting ‘‘241’’; and

21 (9) in title XXVII, by striking the heading for

22 such title.
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1 SEC. 2008. 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 1997.’’; 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 SEC. 2009. PROHIBITION AGAINST SHARP ADULT SEX SUR15 VEY AND THE AMERICAN TEENAGE SEX SUR16 VEY.

17 The Secretary of Health and Human Services may

18 not during fiscal year 1993 or any subsequent fiscal year

19 conduct or support the SHARP survey of adult sexual be20 havior or the American Teenage Study of adolescent sex21 ual behavior. This section becomes effective on the date

22 of enactment of this Act.

23 SEC. 2010. SUPPORT FOR BIOENGINEERING RESEARCH.

24 (a) STUDY.—The Secretary of Health and Human

25 Services, acting through the Director of the National In-
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1 stitutes of Health, shall conduct a study for the purpose

2 of—

3 (1) determining the sources and amounts of

4 public and private funding devoted to basic research

5 in bioengineering, including biomaterials sciences,

6 cellular bioprocessing, tissue and rehabilitation engi7 neering;

8 (2) evaluating whether that commitment is suf9 ficient to maintain the innovative edge that the

10 United States has in these technologies;

11 (3) evaluating the role of the National Insti12 tutes of Health or any other Federal agency to

13 achieve a greater commitment to innovation in

14 bioengineering; and

15 (4) evaluating the need for better coordination

16 and collaboration among Federal agencies and be17 tween the public and private sectors.

18 In conducting such study, the Director shall work in con19 junction with appropriate organizations and representa20 tives including academics, industry leaders, bioengineering

21 societies, and public agencies.

22 (b) REPORT.—Not later than 1 year after the date

23 of enactment of this Act, the Secretary of Health and

24 Human Services shall prepare and submit to the Commit25 tee on Labor and Human Resources of the Senate, and
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1 the Committee on Energy and Commerce of the House

2 of Representatives, a report containing the findings of the

3 study conducted under subsection (a) together with rec4 ommendations concerning the enactment of legislation to

5 implement the results of such study.

6 SEC. 2011. ADMISSION TO THE UNITED STATES OF ALIENS

7 INFECTED WITH THE AIDS VIRUS.

8 (a) ADMISSION.—Notwithstanding any other provi9 sion of law, regulations or directives concerning the exclu10 sion of aliens on health related grounds, infection with

11 HIV, the human immunodeficiency virus, shall constitute

12 a communicable disease of public health significance for

13 purposes of section 212(a)(1)(A)(i) of the Immigration

14 and Nationality Act (8 U.S.C. 1182(a)(1)(A)(i)).

15 (b) REPORT REQUIRED.—The President shall submit

16 a report by September 1, 1993, containing—

17 (1) an assessment of the anticipated costs of

18 the admission to the United States of persons with

19 HIV to public health care programs, including such

20 costs as will be borne by States and municipalities,

21 and private insurers and health care providers;

22 (2) an estimate of the number and origins of

23 persons infected with HIV likely to seek entry into

24 the United States before December 31, 2003;
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1 (3) an assessment of the effectiveness of the

2 Immigration and Nationality Act in preventing per3 sons entering the United States likely to become a

4 public charge, as well as the ability to enforce this

5 Act with regard to persons infected with potentially

6 costly health conditions including, but not limited to

7 HIV;

8 (4) the cost implications of refugees entering or

9 likely to enter the United States, who carry the HIV

10 virus;

11 (5) a comparison of the anticipated public and

12 private health care costs associated with aliens in13 fected with HIV with the costs attributable to the

14 entry of aliens suffering from other health condi15 tions.

16 (c) HIV TESTING.—Except as otherwise provided in

17 subsection (d) the Attorney General, in consultation with

18 the Secretary of Health and Human Services, shall pro19 vide for the testing of aliens for infection with HIV in ac20 cordance with the policy in effect on January 1, 1993.

21 (d) WAIVER AUTHORITY.—Subsection (c) may be

22 waived by the Attorney General, in consultation with the

23 Secretary of Health and Human Services for non-immi24 grants who, except for the provisions of this Act, would
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1 be admissible to the United States, and who seek admis2 sion for 30 days or less for the purpose of—

3 (1) attending educational or medical con4 ferences;

5 (2) receiving medical treatment;

6 (3) visiting close family members;

7 (4) conducting temporary business activities; or

8 (5) visiting for pleasure (tourism);

9 and in addition such non-immigrants may be admitted

10 without questions as to whether they are carriers of the

11 HIV virus, at the discretion of the Attorney General.

12 (e) RULE OF CONSTRUCTION.—Nothing in this sec13 tion shall be construed to limit the authority of the Sec14 retary of HHS to prescribe regulations concerning com15 municable diseases of public health significance, other

16 than infection with the human immunodeficiency virus in

17 accordance with section 212(a)(1)(A)(i) of the Immigra18 tion and Nationality Act (8 U.S.C. 1182(a)(1)(A)(i)).

19 SEC. 2012. SENSE OF THE CONGRESS REGARDING ACTION

20 ON A REQUEST FOR CERTAIN WAIVERS

21 UNDER THE MEDICAID PROGRAM.

22 It is the sense of the Congress that—

23 (1) the Secretary of Health and Human Serv24 ices should be commended for her commitment to ei25 ther approve or deny the application for waivers to
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1 conduct a demonstration project under section

2 1115(a) of the Social Security Act submitted by the

3 Oregon Department of Human Services on Novem4 ber 13, 1992, (hereafter referred to in this section

5 as the ‘‘application’’) by March 19, 1993, and

6 (2) because the application for waivers has been

7 pending for one and a half years and the Oregon

8 State legislature faces a biennium budget currently

9 under consideration, a decision must be reached by

10 March 19, 1993, in order for the legislature to ap11 propriate the funds necessary to implement the Or12 egon plan.

13 SEC. 2013. AUTHORIZATION OF APPROPRIATIONS.

14 Section 2602 of the Low-Income Home Energy As15 sistance Act of 1981 (42 U.S.C. 8621) is amended—

16 (1) in the first sentence of subsection (b), by

17 striking ‘‘1993 and 1994’’ and inserting ‘‘1993,

18 1994, and 1995’’; and

19 (2) in subsection (d), by striking ‘‘in each of

20 the fiscal years 1993 and 1994’’ and inserting ‘‘for

21 each of the fiscal years 1993, 1994, and 1995’’.

22 SEC. 2014. VACCINE INJURY COMPENSATION PROGRAM.

23 Section 2111(a) of the Public Health Service Act (42

24 U.S.C. 300aa-11(a)) is amended by adding at the end

25 thereof the following new paragraph:
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1 ‘‘(10) The Clerk of the United States Claims

2 Court is authorized to continue to receive, and for3 ward, petitions for compensation for a vaccine-relat4 ed injury or death associated with the administra5 tion of a vaccine on or after October 1, 1992.’’.

6 TITLE XXI—EFFECTIVE DATES

7 SEC. 2101. EFFECTIVE DATES.

8 Subject to section 155, this Act and the amendments

9 made by this Act take effect upon the date of the enact10 ment of this Act.

Passed the Senate February 18 (legislative day,

January 5), 1993.

Attest:

Secretary.
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