S. 1 (103 rd ): National Institutes of Health Revitalization Act of 1993

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To amend the Public Health Service Act to revise and extend the programs of the National Institutes of Health, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JANUARY 21 (legislative day, JANUARY 5), 1993

Mr. KENNEDY (for himself, Mrs. BOXER, Mr. WELLSTONE, Mr. DODD, Mr. LAUTENBERG, Ms. MIKULSKI, Mr. PELL, Mr. SIMON, Mr. WOFFORD, Mr. INOUYE, Mr. SARBANES, Ms. MOSELEY-BRAUN, Mr. LEAHY, Mr. RIEGLE, Mr. DURENBERGER, and Mr. METZENBAUM) introduced the following bill; which was read twice and referred to the Committee on Labor and Human Resources

To amend the Public Health Service Act to revise and extend the programs of the National Institutes of Health, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) SHORT TITLE- This Act may be cited as the ‘National Institutes of Health Revitalization Act of 1993’.

(b) TABLE OF CONTENTS- The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

TITLE I--GENERAL PROVISIONS REGARDING TITLE IV OF PUBLIC HEALTH SERVICE ACT

Subtitle A--Research Freedom

Part I--Review of Proposals for Biomedical and Behavioral Research

Sec. 101. Establishment of certain provisions regarding research conducted or supported by National Institutes of Health.

Part II--Research on Transplantation of Fetal Tissue

Sec. 111. Establishment of authorities.

Sec. 112. Purchase of human fetal tissue; solicitation or acceptance of tissue as directed donation for use in transplantation.

Sec. 113. Nullification of moratorium.

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

Part III--Miscellaneous Repeals

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.

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

Sec. 205. Increased participation of women and members of underrepresented minorities in fields of biomedical and behavioral research.

Sec. 206. Requirements regarding surveys of sexual behavior.

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

Sec. 208. Miscellaneous provisions.

TITLE III--GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES

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

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

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

TITLE IV--NATIONAL CANCER INSTITUTE

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

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

Sec. 403. Authorization of appropriations.

TITLE V--NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

Sec. 501. Education and training.

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

Sec. 503. National Center on Sleep Disorders.

Sec. 504. Authorization of appropriations.

TITLE VI--NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE AND KIDNEY DISEASES

Sec. 601. Provisions regarding nutritional disorders.

TITLE VII--NATIONAL INSTITUTE ON ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES

Sec. 701. Juvenile arthritis.

TITLE VIII--NATIONAL INSTITUTE ON AGING

Sec. 801. Alzheimer’s disease registry.

Sec. 802. Aging processes regarding women.

Sec. 803. Authorization of appropriations.

Sec. 804. Conforming amendment.

TITLE IX--NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

Sec. 901. Tropical diseases.

Sec. 902. Chronic fatigue syndrome.

TITLE X--NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

Subtitle A--Research Centers With Respect to Contraception and Research Centers With Respect to Infertility

Sec. 1001. Grants and contracts for research centers.

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

Subtitle B--Program Regarding Obstetrics and Gynecology

Sec. 1011. Establishment of program.

Subtitle C--Child Health Research Centers

Sec. 1021. Establishment of centers.

Subtitle D--Study Regarding Adolescent Health

Sec. 1031. Prospective longitudinal study.

TITLE XI--NATIONAL EYE INSTITUTE

Sec. 1101. Clinical research on diabetes eye care.

TITLE XII--NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

Sec. 1201. Research on multiple sclerosis.

TITLE XIII--NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

Sec. 1301. Applied Toxicological Research and Testing Program.

TITLE XIV--NATIONAL LIBRARY OF MEDICINE

Subtitle A--General Provisions

Sec. 1401. Additional authorities.

Sec. 1402. Authorization of appropriations.

Subtitle B--Financial Assistance

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

Subtitle C--National Information Center on Health Services Research and Health Care Technology

Sec. 1421. Establishment of Center.

Sec. 1422. Conforming provisions.

TITLE XV--OTHER AGENCIES OF NATIONAL INSTITUTES OF HEALTH

Subtitle A--Division of Research Resources

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

Sec. 1502. Biomedical and behavioral research facilities.

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

Subtitle B--National Center for Nursing Research

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

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

Subtitle C--National Center for Human Genome Research

Sec. 1521. Purpose of Center.

TITLE XVI--AWARDS AND TRAINING

Subtitle A--National Research Service Awards

Sec. 1601. Requirement regarding women and individuals from disadvantaged backgrounds.

Sec. 1602. Service payback requirements.

Subtitle B--Acquired Immune Deficiency Syndrome

Sec. 1611. Loan repayment program.

Subtitle C--Loan Repayment for Research Generally

Sec. 1621. Establishment of program.

Subtitle D--Scholarship and Loan Repayment Programs Regarding Professional Skills Needed by National Institutes of Health

Sec. 1631. Establishment of programs.

Subtitle E--Funding for Awards and Training Generally

Sec. 1641. Authorization of appropriations.

TITLE XVII--NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH

Sec. 1701. Establishment of Foundation.

TITLE XVIII--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME

Sec. 1801. Revision and extension of various programs.

TITLE XIX--STUDIES

Sec. 1901. Acquired immune deficiency syndrome.

Sec. 1902. Malnutrition in the elderly.

Sec. 1903. Research activities on chronic fatigue syndrome.

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

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

Sec. 1906. Procurement.

Sec. 1907. Report concerning leading causes of death.

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

TITLE XX--MISCELLANEOUS PROVISIONS

Sec. 2001. Designation of Senior Biomedical Research Service in honor of Silvio Conte, and limitation on number of members.

Sec. 2002. Technical corrections.

Sec. 2003. Biennial report on carcinogens.

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

Sec. 2005. Transfer of provisions of title xxvii.

Sec. 2006. Certain authorization of appropriations.

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

Sec. 2008. Support for bioengineering research.

TITLE XXI--EFFECTIVE DATES

Sec. 2101. Effective dates.

TITLE I--GENERAL PROVISIONS REGARDING TITLE IV OF PUBLIC HEALTH SERVICE ACT

Subtitle A--Research Freedom

PART I--REVIEW OF PROPOSALS FOR BIOMEDICAL AND BEHAVIORAL RESEARCH

SEC. 101. ESTABLISHMENT OF CERTAIN PROVISIONS REGARDING RESEARCH CONDUCTED OR SUPPORTED BY NATIONAL INSTITUTES OF HEALTH.

Part G of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by inserting after section 492 the following new section:

‘CERTAIN PROVISIONS REGARDING REVIEW AND APPROVAL OF PROPOSALS FOR RESEARCH

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

‘(1) PROTECTION OF HUMAN RESEARCH SUBJECTS-

‘(A) In the case of any application submitted to the Secretary for financial assistance to conduct research, the Secretary may not approve or fund any application that is subject to review under section 491(a) by an Institutional Review Board unless the application has undergone review in accordance with such section and has been recommended for approval by a majority of the members of the Board conducting such review.

‘(B) In the case of research that is subject to review under procedures established by the Secretary for the protection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary may not authorize the conduct of the research unless the research has, pursuant to such procedures, been recommended for approval.

‘(2) PEER REVIEW- In the case of any application submitted to the Secretary for financial assistance to conduct research, the Secretary may not approve or fund any application that is subject to technical and scientific peer review under section 492(a) unless the application has undergone peer review in accordance with such section and has been recommended for approval by a majority of the members of the entity conducting such review.

‘(b) ETHICAL REVIEW OF RESEARCH-

‘(1) PROCEDURES REGARDING WITHHOLDING OF FUNDS- If research has been recommended for approval for purposes of subsection (a), the Secretary may not withhold funding for the research on ethical grounds unless--

‘(A) the Secretary convenes an advisory board in accordance with paragraph (4) to study the ethical implications of the research; and

‘(B) the majority of the advisory board recommends that, on ethical grounds, the Secretary withhold funds for the research.

‘(2) APPLICABILITY- The limitation established in paragraph (1) regarding the authority to withhold funds on ethical grounds shall apply without regard to whether the withholding of funds is characterized as a disapproval, a moratorium, a prohibition, or other description.

‘(3) PRELIMINARY MATTERS REGARDING USE OF PROCEDURES-

‘(A) If the Secretary makes a determination that an advisory board should be convened for purposes of paragraph (1), the Secretary shall, through a statement published in the Federal Register, announce the intention of the Secretary to convene such a board.

‘(B) A statement issued under subparagraph (A) shall include a request that interested individuals submit to the Secretary recommendations specifying the particular individuals who should be appointed to the advisory board involved. The Secretary shall consider such recommendations in making appointments to the board.

‘(C) The Secretary may not make appointments to an advisory board under paragraph (1) until the expiration of the 30-day period beginning on the date on which the statement required in subparagraph (A) is made with respect to the board.

hereafter in this

‘(B)(i) An ethics board shall advise, consult with, and make recommendations to the Secretary regarding the ethics of the project of biomedical or behavioral research with respect to which the board has been convened.

‘(ii) Not later than 180 days after the date on which the statement required in paragraph (3)(A) is made with respect to an ethics board, the board shall submit to the Secretary, and to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report describing the findings of the board regarding the project of research involved and making a recommendation under clause (i) of whether the Secretary should or should not withhold funds for the project. The report shall include the information considered in making the findings.

‘(C) An ethics board shall be composed of no fewer than 14, and no more than 20, individuals who are not officers or employees of the United States. The Secretary shall make appointments to the board from among individuals with special qualifications and competence to provide advice and recommendations regarding ethical matters in biomedical and behavioral research. Of the members of the board--

‘(v) no fewer than one-third, and no more than one-half, shall be scientists with substantial accomplishments in biomedical or behavioral research.

‘(D) The term of service as a member of an ethics board shall be for the life of the board. If such a member does not serve the full term of such service, the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.

‘(E) A member of an ethics board shall be subject to removal from the board by the Secretary for neglect of duty or malfeasance or for other good cause shown.

‘(F) The Secretary shall designate an individual from among the members of an ethics board to serve as the chair of the board.

‘(G) In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall conduct inquiries and hold public hearings.

Department of Health

‘(I) Members of an ethics board shall receive compensation for each day engaged in carrying out the duties of the board, including time engaged in traveling for purposes of such duties. Such compensation may not be provided in an amount in excess of the maximum rate of basic pay payable for GS-18 of the General Schedule.

‘(J) The Secretary, acting through the Director of the National Institutes of Health, shall provide to each ethics board such staff and other assistance as may be necessary to carry out the duties of the board.

‘(K) An ethics board shall terminate 30 days after the date on which the report required in subparagraph (B)(ii) is submitted to the Secretary and the congressional committees specified in such subparagraph.’.

PART II--RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

SEC. 111. ESTABLISHMENT OF AUTHORITIES.

Part G of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by inserting after section 498 the following new section:

‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

‘SEC. 498A. (a) ESTABLISHMENT OF PROGRAM-

‘(1) IN GENERAL- The Secretary may conduct or support research on the transplantation of human fetal tissue for therapeutic purposes.

‘(2) SOURCE OF TISSUE- Human fetal tissue may be used in research carried out under paragraph (1) regardless of whether the tissue is obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth.

‘(1) IN GENERAL- In research carried out under subsection (a), human fetal tissue may be used only if the woman providing the tissue makes a statement, made in writing and signed by the woman, declaring that--

‘(A) the woman donates the fetal tissue for use in research described in subsection (a);

‘(B) the donation is made without any restriction regarding the identity of individuals who may be the recipients of transplantations of the tissue; and

‘(C) the woman has not been informed of the identity of any such individuals.

‘(2) ADDITIONAL STATEMENT- In research carried out under subsection (a), human fetal tissue may be used only if the attending physician with respect to obtaining the tissue from the woman involved makes a statement, made in writing and signed by the physician, declaring that--

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

‘(i) the consent of the woman for the abortion was obtained prior to requesting or obtaining consent for the tissue to be used in such research; and

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

‘(B) the tissue has been donated by the woman in accordance with paragraph (1); and

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

‘(i) such physician’s interest, if any, in the research to be conducted with the tissue; and

‘(ii) any known medical risks to the woman or risks to her privacy that might be associated with the donation of the tissue and that are in addition to risks of such type that are associated with the woman’s medical care.

‘(c) INFORMED CONSENT OF RESEARCHER AND DONEE- In research carried out under subsection (a), human fetal tissue may be used only if the individual with the principal responsibility for conducting the research involved makes a statement, made in writing and signed by the individual, declaring that the individual--

‘(B) the tissue may have been obtained pursuant to a spontaneous or induced abortion or subsequent to a stillbirth; and

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

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

‘(3) will require, prior to obtaining the consent of an individual to be a recipient of a transplantation of the tissue, written acknowledgment of receipt of such information by such recipient; and

‘(4) has had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research.

‘(d) AVAILABILITY OF STATEMENTS FOR AUDIT-

‘(1) IN GENERAL- In research carried out under subsection (a), human fetal tissue may be used only if the head of the agency or other entity conducting the research involved certifies to the Secretary that the statements required under subsections (a)(3), (b)(2), and (c) will be available for audit by the Secretary.

‘(2) CONFIDENTIALITY OF AUDIT- Any audit conducted by the Secretary pursuant to paragraph (1) shall be conducted in a confidential manner to protect the privacy rights of the individuals and entities involved in such research, including such individuals and entities involved in the donation, transfer, receipt, or transplantation of human fetal tissue. With respect to any material or information obtained pursuant to such audit, the Secretary shall--

‘(A) use such material or information only for the purposes of verifying compliance with the requirements of this section;

‘(B) not disclose or publish such material or information, except where required by Federal law, in which case such material or information shall be coded in a manner such that the identities of such individuals and entities are protected; and

‘(C) not maintain such material or information after completion of such audit, except where necessary for the purposes of such audit.

‘(e) APPLICABILITY OF STATE AND LOCAL LAW-

‘(1) RESEARCH CONDUCTED BY RECIPIENTS OF ASSISTANCE- The Secretary may not provide support for research under subsection (a) conduct the research in accordance with applicable State and local law.

‘(2) RESEARCH CONDUCTED BY SECRETARY- The Secretary may conduct research under subsection (a) only in accordance with applicable State and local law.

‘(f) DEFINITION- For purposes of this section, the term ‘human fetal tissue’ means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.’.

SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DONATION FOR USE IN TRANSPLANTATION.

Part G of title IV of the Public Health Service Act, as amended by section 111 of this Act, is amended by inserting after section 498A the following new section:

‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE

‘SEC. 498B. (a) PURCHASE OF TISSUE- It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.

‘(b) SOLICITATION OR ACCEPTANCE OF TISSUE AS DIRECTED DONATION FOR USE IN TRANSPLANTATION- It shall be unlawful for any person to solicit or knowingly acquire, receive, or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the donation affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and--

‘(1) the donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual;

‘(2) the donated tissue will be transplanted into a relative of the donating individual; or

‘(3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.

‘(c) CRIMINAL PENALTIES FOR VIOLATIONS-

‘(1) IN GENERAL- Any person who violates subsection (a) or (b) shall be fined in accordance with title 18, United States Code, subject to paragraph (2), or imprisoned for not more than 10 years, or both.

‘(2) PENALTIES APPLICABLE TO PERSONS RECEIVING CONSIDERATION- With respect to the imposition of a fine under paragraph (1), if the person involved violates subsection (a) or (b)(3), a fine shall be imposed in an amount not less than twice the amount of the valuable consideration received.

‘(d) DEFINITIONS- For purposes of this section:

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

‘(2) The term ‘interstate commerce’ has the meaning given such term in section 201(b) of the Federal Food, Drug, and Cosmetic Act.

‘(3) The term ‘valuable consideration’ does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.’.

SEC. 113. NULLIFICATION OF MORATORIUM.

Department of Health

as added by

(b) Prohibition Against Withholding of Funds in Cases of Technical and Scientific Merit-

(1) IN GENERAL- In the case of any proposal for research on the transplantation of human fetal tissue for therapeutic purposes, the Secretary of Health and Human Services may not withhold funds for the research if--

as added by

(2) STANDING APPROVAL REGARDING ETHICAL STATUS- In the case of any proposal for research on the transplantation of human fetal tissue for therapeutic purposes, the issuance in December 1988 of the Report of the Human Fetal Tissue Transplantation Research Panel shall be deemed to be a report--

as added by

(B) finding, on a basis that is neither arbitrary nor capricious, that there are no ethical grounds for withholding funds for the research.

(c) AUTHORITY FOR WITHHOLDING FUNDS FROM RESEARCH- In the case of any research on the transplantation of human fetal tissue for therapeutic purposes, the Secretary of Health and Human Services may withhold funds for the research if any of the conditions specified in any of subparagraphs (A) through (C) of subsection (b)(1) are not met with respect to the research.

as added by

SEC. 114. REPORT BY GENERAL ACCOUNTING OFFICE ON ADEQUACY OF REQUIREMENTS.

(a) IN GENERAL- With respect to research on the transplantation of human fetal tissue for therapeutic purposes, the Comptroller General of the United States shall conduct an audit for the purpose of determining--

as added by

(b) REPORT- Not later than May 19, 1995, the Comptroller General of the United States shall complete the audit required in subsection (a) and submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the findings made pursuant to the audit.

PART III--MISCELLANEOUS REPEALS

SEC. 121. REPEALS.

(a) CERTAIN BIOMEDICAL ETHICS BOARD- Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by striking part J.

(b) OTHER REPEALS- Part G of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended--

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

(2) by striking section 499; and

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

(c) NULLIFICATION OF CERTAIN REGULATION- The provisions of section 204(d) of part 46 of title 45 of the Code of Federal Regulations (45 CFR 46.204(d)) shall not have any legal effect.

Subtitle B--Clinical Research Equity Regarding Women and Minorities

PART I--WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH

SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.

Part G of title IV of the Public Health Service Act, as amended by section 101 of this Act, is amended by inserting after section 492A the following new section:

‘INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH

‘SEC. 492B. (a) In conducting or supporting clinical research for purposes of this title, the Director of NIH shall, subject to subsection (b), ensure that--

‘(1) women are included as subjects in each project of such research; and

‘(2) members of minority groups are included as subjects in such research.

‘(b) The requirement established in subsection (a) regarding women and members of minority groups shall not apply to a project of clinical research if the inclusion, as subjects in the project, of women and members of minority groups, respectively--

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

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

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

‘(c) In the case of any project of clinical research in which women or members of minority groups will under subsection (a) be included as subjects in the research, the Director of NIH shall ensure that the project is designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being tested in the research affect women or members of minority groups, as the case may be, differently than other subjects in the research.

‘(d)(1) The Director of NIH, in consultation with the Director of the Office of Research on Women’s Health, shall establish guidelines regarding--

‘(A) the circumstances under which the inclusion of women and minorities in projects of clinical research is inappropriate for purposes of subsection (b);

‘(B) the manner in which such projects are required to be designed and carried out for purposes of subsection (c), including a specification of the circumstances in which the requirement of such subsection does not apply on the basis of impracticability; and

‘(C) the conduct of outreach programs for the recruitment of women and members of minority groups as subjects in such research.

‘(2) With respect to the circumstances under which the inclusion of women or members of minority groups (as the case may be) as subjects in clinical research is inappropriate for purposes of subsection (b), the guidelines established under paragraph (1)(A)--

‘(A) shall provide that the costs of such inclusion in a project of clinical research is not a permissible consideration in determining whether such inclusion is inappropriate unless the data of comparable quality regarding women or members of minority groups, respectively, that would be obtained in such project in the event that such inclusion were required will be obtained through other means; and

‘(B) may provide that such inclusion in a project of clinical research is not required if there is substantial scientific data demonstrating that there is no significant difference between--

‘(i) the effects that the variables to be studied in the project have on women or members of minority groups, respectively; and

‘(ii) the effects that the variables have on the individuals who would serve as subjects in the project in the event that such inclusion were not required.

‘(3) The guidelines required in paragraph (1) shall be established and published in the Federal Register not later than 120 days after the date of the enactment of the National Institutes of Health Revitalization Act of 1993.

‘(4) For fiscal year 1994 and subsequent fiscal years, the Director of NIH may not approve any proposal of clinical research to be conducted or supported by any agency of the National Institutes of Health unless the proposal specifies the manner in which the research will comply with subsection (a).

‘(e) The advisory council of each national research institute shall annually submit to the Director of NIH and the Director of the institute involved a report describing the manner in which the agency has complied with subsection (a).’.

SEC. 132. PEER REVIEW.

Section 492 of the Public Health Service Act (42 U.S.C. 289a) is amended by adding at the end the following new subsection:

‘(c)(1) In technical and scientific peer review under this section of proposals for clinical research, the consideration of any such proposal (including the initial consideration) shall, except as provided in paragraph (2), include an evaluation of the technical and scientific merit of the proposal regarding compliance with section 492B(a).

‘(2) Paragraph (1) shall not apply to any proposal for clinical research that, pursuant to subsection (b) of section 492B, is not subject to the requirement of subsection (a) of such section regarding the inclusion of women and members of minority groups as subjects in clinical research.’.

SEC. 133. APPLICABILITY TO CURRENT PROJECTS.

as added by

PART II--OFFICE OF RESEARCH ON WOMEN’S HEALTH

SEC. 141. ESTABLISHMENT.

(a) IN GENERAL- Title IV of the Public Health Service Act, as amended by section 2 of Public Law 101-613, is amended--

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

(2) by redesignating parts F through H as parts G through I, respectively; and

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

‘Part F--Research on Women’s Health

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

‘(a) ESTABLISHMENT- There is established within the Office of the Director of NIH an office to be known as the Office of Research on Women’s Health (in this part referred to as the ‘Office’). The Office shall be headed by a director, who shall be appointed by the Director of NIH.

‘(b) PURPOSE- The Director of the Office shall--

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

‘(2) identify multidisciplinary research relating to research on women’s health that should be so conducted or supported;

‘(3) carry out paragraphs (1) and (2) with respect to the aging process in women, with priority given to menopause;

‘(4) promote coordination and collaboration among entities conducting research identified under any of paragraphs (1) through (3);

‘(5) encourage the conduct of such research by entities receiving funds from the national research institutes;

‘(6) recommend an agenda for conducting and supporting such research;

‘(7) promote the sufficient allocation of the resources of the national research institutes for conducting and supporting such research;

‘(8) assist in the administration of section 492B with respect to the inclusion of women as subjects in clinical research; and

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

hereafter in this

‘(2) The Coordinating Committee shall be composed of the Directors of the national research institutes (or the designees of the Directors).

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

‘(4) With respect to research on women’s health, the Coordinating Committee shall assist the Director of the Office in--

‘(A) identifying the need for such research, and making an estimate each fiscal year of the funds needed to adequately support the research;

‘(B) identifying needs regarding the coordination of research activities, including intramural and extramural multidisciplinary activities;

‘(C) supporting the development of methodologies to determine the circumstances in which obtaining data specific to women (including data relating to the age of women and the membership of women in ethnic or racial groups) is an appropriate function of clinical trials of treatments and therapies;

‘(D) supporting the development and expansion of clinical trials of treatments and therapies for which obtaining such data has been determined to be an appropriate function; and

‘(E) encouraging the national research institutes to conduct and support such research, including such clinical trials.

hereafter in this

‘(2)(A) The Advisory Committee shall be composed of no fewer than 12, and not more than 18 individuals, who are not officers or employees of the Federal Government. The Director of the Office shall make appointments to the Advisory Committee from among physicians, practitioners, scientists, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on research on women’s health. A majority of the members of the Advisory Committee shall be women.

‘(B) Members of the Advisory Committee shall receive compensation for each day engaged in carrying out the duties of the Committee, including time engaged in traveling for purposes of such duties. Such compensation may not be provided in an amount in excess of the maximum rate of basic pay payable for GS-18 of the General Schedule.

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

‘(A) advise the Director of the Office on appropriate research activities to be undertaken by the national research institutes with respect to--

‘(ii) research on gender differences in clinical drug trials, including responses to pharmacological drugs;

‘(iii) research on gender differences in disease etiology, course, and treatment;

‘(iv) research on obstetrical and gynecological health conditions, diseases, and treatments; and

‘(v) research on women’s health conditions which require a multidisciplinary approach;

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

‘(C) provide recommendations to such Director regarding activities of the Office (including recommendations on the development of the methodologies described in subsection (c)(4)(C) and recommendations on priorities in carrying out research described in subparagraph (A)); and

‘(D) assist in monitoring compliance with section 492B regarding the inclusion of women in clinical research.

‘(5)(A) The Advisory Committee shall prepare a biennial report describing the activities of the Committee, including findings made by the Committee regarding--

‘(ii) the extent of expenditures made for research on women’s health by the agencies of the National Institutes of Health; and

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

‘(B) The report required in subparagraph (A) shall be submitted to the Director of NIH for inclusion in the report required in section 403.

‘(e) REPRESENTATION OF WOMEN AMONG RESEARCHERS- The Secretary, acting through the Assistant Secretary for Personnel and in collaboration with the Director of the Office, shall determine the extent to which women are represented among senior physicians and scientists of the national research institutes and among physicians and scientists conducting research with funds provided by such institutes, and as appropriate, carry out activities to increase the extent of such representation.

‘(f) DEFINITIONS- For purposes of this part:

‘(1) The term ‘women’s health conditions’, with respect to women of all age, ethnic, and racial groups, means all diseases, disorders, and conditions (including with respect to mental health)--

‘(A) unique to, more serious, or more prevalent in women;

‘(B) for which the factors of medical risk or types of medical intervention are different for women, or for which it is unknown whether such factors or types are different for women; or

‘(C) with respect to which there has been insufficient clinical research involving women as subjects or insufficient clinical data on women.

‘(2) The term ‘research on women’s health’ means research on women’s health conditions, including research on preventing such conditions.

‘SEC. 486A. NATIONAL DATA SYSTEM AND CLEARINGHOUSE ON RESEARCH ON WOMEN’S HEALTH.

‘(1) The Director of NIH, in consultation with the Director of the Office, shall establish a data system for the collection, storage, analysis, retrieval, and dissemination of information regarding research on women’s health that is conducted or supported by the national research institutes. Information from the data system shall be available through information systems available to health care professionals and providers, researchers, and members of the public.

‘(2) The data system established under paragraph (1) shall include a registry of clinical trials of experimental treatments that have been developed for research on women’s health. Such registry shall include information on subject eligibility criteria, sex, age, ethnicity or race, and the location of the trial site or sites. Principal investigators of such clinical trials shall provide this information to the registry within 30 days after it is available. Once a trial has been completed, the principal investigator shall provide the registry with information pertaining to the results, including potential toxicities or adverse effects associated with the experimental treatment or treatments evaluated.

‘(b) CLEARINGHOUSE- The Director of NIH, in consultation with the Director of the Office and with the National Library of Medicine, shall establish, maintain, and operate a program to provide information on research and prevention activities of the national research institutes that relate to research on women’s health.

‘SEC. 486B. BIENNIAL REPORT.

‘(a) IN GENERAL- With respect to research on women’s health, the Director of the Office shall, not later than February 1, 1994, and biennially thereafter, prepare a report--

‘(1) describing and evaluating the progress made during the preceding 2 fiscal years in research and treatment conducted or supported by the National Institutes of Health;

‘(2) describing and analyzing the professional status of women physicians and scientists of such Institutes, including the identification of problems and barriers regarding advancements;

‘(3) summarizing and analyzing expenditures made by the agencies of such Institutes (and by such Office) during the preceding 2 fiscal years; and

‘(4) making such recommendations for legislative and administrative initiatives as the Director of the Office determines to be appropriate.

‘(b) INCLUSION IN BIENNIAL REPORT OF DIRECTOR OF NIH- The Director of the Office shall submit each report prepared under subsection (a) to the Director of NIH for inclusion in the report submitted to the President and the Congress under section 403.’.

(b) REQUIREMENT OF SUFFICIENT ALLOCATION OF RESOURCES OF INSTITUTES- Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended--

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

(2) in paragraph (11), by striking the period at the end and inserting ‘; and’; and

(3) by inserting after paragraph (11) the following new paragraph:

‘(12) after consultation with the Director of the Office of Research on Women’s Health, shall ensure that resources of the National Institutes of Health are sufficiently allocated for projects of research on women’s health that are identified under section 486(b).’.

PART III--OFFICE OF RESEARCH ON MINORITY HEALTH

SEC. 151. ESTABLISHMENT.

Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following new section:

‘OFFICE OF RESEARCH ON MINORITY HEALTH

‘SEC. 403A. (a) ESTABLISHMENT- There is established within the Office of the Director of NIH an office to be known as the Office of Research on Minority Health (in this section referred to as the ‘Office’). The Office shall be headed by a director, who shall be appointed by the Director of NIH.

‘(b) PURPOSE- The Director of the Office shall--

‘(1) identify projects of research on minority health that should be conducted or supported by the national research institutes;

‘(2) identify multidisciplinary research relating to research on minority health that should be so conducted or supported;

‘(3) promote coordination and collaboration among entities conducting research identified under paragraph (1) or (2);

‘(4) encourage the conduct of such research by entities receiving funds from the national research institutes;

‘(5) recommend an agenda for conducting and supporting such research;

‘(6) promote the sufficient allocation of the resources of the national research institutes for conducting and supporting such research; and

‘(7) assist in the administration of section 492B with respect to the inclusion of members of minority groups as subjects in clinical research.’.

Subtitle C--Scientific Integrity

SEC. 161. ESTABLISHMENT OF OFFICE OF SCIENTIFIC INTEGRITY.

(a) IN GENERAL- Section 493 of the Public Health Service Act (42 U.S.C. 289b) is amended to read as follows:

‘OFFICE OF SCIENTIFIC INTEGRITY

Department of Health

‘(2) DIRECTOR- The Office shall be headed by a Director, who shall be appointed by the Secretary, be experienced and specially trained in the conduct of research, and have experience in the conduct of investigations of scientific misconduct. The Secretary shall carry out this section acting through the Director of the Office. The Director shall report to the Secretary.

‘(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS CONDITION OF FUNDING FOR RESEARCH- The Secretary shall by regulation require that each entity that applies for a grant, contract, or cooperative agreement under this Act for any project or program that involves the conduct of biomedical or behavioral research submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that such entity--

‘(1) has established (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of scientific misconduct in connection with biomedical and behavioral research conducted at or sponsored by such entity; and

‘(2) will report to the Director any investigation of alleged scientific misconduct in connection with projects for which funds have been made available under this Act that appears substantial.

‘(c) PROCESS FOR RESPONSE OF DIRECTOR- The Secretary shall establish by regulation a process to be followed by the Director for the prompt and appropriate--

‘(1) response to information provided to the Director respecting scientific misconduct in connection with projects for which funds have been made available under this Act;

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

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

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

‘(d) MONITORING BY DIRECTOR- The Secretary shall by regulation establish procedures for the Director to monitor administrative processes and investigations that have been established or carried out under this section.

‘(e) EFFECT ON PRESENT INVESTIGATIONS- Nothing in this section shall affect investigations which have been or will be commenced prior to the promulgation of final regulations under this section.’.

(b) ESTABLISHMENT OF DEFINITION OF SCIENTIFIC MISCONDUCT- Not later than 90 days after the date on which the report required under section 152(d) is submitted to the Secretary of Health and Human Services, such Secretary shall by regulation establish a definition for the term ‘scientific misconduct’ for purposes of section 493 of the Public Health Service Act, as amended by subsection (a) of this section.

SEC. 162. COMMISSION ON SCIENTIFIC INTEGRITY.

(a) IN GENERAL- The Secretary of Health and Human Services shall establish a commission to be known as the Commission on Scientific Integrity (in this section referred to as the ‘Commission’).

(b) DUTIES- The Commission shall develop recommendations for the Secretary of Health and Human Services on the administration of section 493 of the Public Health Service Act (as amended and added by section 161 of this Act).

(c) COMPOSITION- The Commission shall be composed of 12 members to be appointed by the Secretary of Health and Human Services from among individuals who are not officers or employees of the United States. Of the members appointed to the Commission--

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

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

(3) three shall be representatives of institutions of higher education at which biomedical or behavioral research is conducted; and

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

(d) COMPENSATION- Members of the Commission shall receive compensation for each day engaged in carrying out the duties of the Commission, including time engaged in traveling for purposes of such duties. Such compensation may not be provided in an amount in excess of the maximum rate of basic pay payable for GS-18 of the General Schedule.

(e) REPORT- Not later than 120 days after the date of enactment of this section, the Commission shall prepare and submit to the Secretary of Health and Human Services, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate, a report containing the recommendations developed under subsection (b).

SEC. 163. PROTECTION OF WHISTLEBLOWERS.

Section 493 of the Public Health Service Act, as amended by section 161 of this Act, is amended by adding at the end the following new subsection:

‘(f) PROTECTION OF WHISTLEBLOWERS-

‘(1) IN GENERAL- In the case of any entity required to establish administrative processes under subsection (b), the Secretary shall by regulation establish standards for preventing, and for responding to the occurrence of retaliation by such entity, its officials or agents, against an employee in the terms and conditions of employment in response to the employee having in good faith--

‘(A) made an allegation that the entity, its officials or agents, has engaged in or failed to adequately respond to an allegation of scientific misconduct; or

‘(B) cooperated with an investigation of such an allegation.

‘(2) MONITORING BY SECRETARY- The Secretary shall establish by regulation procedures for the Director to monitor the implementation of the standards established by an entity under paragraph (1) for the purpose of determining whether the procedures have been established, and are being utilized, in accordance with the standards established under such paragraph.

‘(3) NONCOMPLIANCE- The Secretary shall by regulation establish remedies for noncompliance by an entity, its officials or agents, which has engaged in retaliation in violation of the standards established under paragraph (1). Such remedies may include termination of funding provided by the Secretary for such project or recovery of funding being provided by the Secretary for such project, or other actions as appropriate.

‘(4) FINAL RULE FOR REGULATIONS- The Secretary shall issue a final rule for the regulations required in paragraph (1) not later than 180 days after the date of the enactment of the National Institutes of Health Revitalization Act of 1993.

‘(5) REQUIRED AGREEMENTS- For any fiscal year beginning after the date on which the regulations required in paragraph (1) are issued, the Secretary may not provide a grant, cooperative agreement, or contract under this Act for biomedical or behavioral research unless the entity seeking such financial assistance agrees that the entity--

‘(A) will maintain the procedures described in the regulations; and

‘(B) will otherwise be subject to the regulations.’.

SEC. 164. REQUIREMENT OF REGULATIONS REGARDING PROTECTION AGAINST FINANCIAL CONFLICTS OF INTEREST IN CERTAIN PROJECTS OF RESEARCH.

Part H of title IV of the Public Health Service Act, as redesignated by section 141(a)(2) of this Act, is amended by inserting after section 493 the following new section:

‘PROTECTION AGAINST FINANCIAL CONFLICTS OF INTEREST IN CERTAIN PROJECTS OF RESEARCH

‘SEC. 493A. (a) ISSUANCE OF REGULATIONS-

‘(1) IN GENERAL- The Secretary shall define by regulation, the specific circumstances that constitute the existence of a financial interest in a project on the part of an entity or individual that will, or may be reasonably expected to, create a bias in favor of obtaining results in such project that are consistent with such financial interest. Such definition shall apply uniformly to each entity or individual conducting a research project under this Act. In the case of any entity or individual receiving assistance from the Secretary for a project of research described in paragraph (2), the Secretary shall by regulation establish standards for responding to, including managing, reducing, or eliminating, the existence of such a financial interest. The entity may adopt individualized procedures for implementing the standards.

‘(2) RELEVANT PROJECTS- A project of research referred to in paragraph (1) is a project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment and for which such entity is receiving assistance from the Secretary.

‘(3) IDENTIFYING AND REPORTING TO THE DIRECTOR- The Secretary shall ensure that the standards established under paragraph (1) specify that as a condition of receiving assistance from the Secretary for the project involved, an entity described in such subsection is required--

‘(A) to have in effect at the time the entity applies for the assistance and throughout the period during which the assistance is received, a process for identifying such financial interests as defined in paragraph (1) that exist regarding the project; and

‘(B) to report to the Director such financial interest as defined in paragraph (1) identified by the entity and how any such financial interest identified by the entity will be managed or eliminated such that the project in question will be protected from bias that may stem from such financial interest.

‘(4) MONITORING OF PROCESS- The Secretary shall monitor the establishment and conduct of the process established by an entity pursuant to paragraph (1).

‘(5) RESPONSE- In any case in which the Secretary determines that an entity has failed to comply with paragraph (3) regarding a project of research described in paragraph (1), the Secretary--

‘(A) shall require that, as a condition of receiving assistance, the entity disclose the existence of a financial interest as defined in paragraph (1) in each public presentation of the results of such project; and

‘(B) may take such other actions as the Secretary determines to be appropriate.

‘(6) DEFINITION- As used in this section:

‘(A) The term ‘financial interest’ includes the receipt of consulting fees or honoraria and the ownership of stock or equity.

‘(B) The term ‘assistance’, with respect to conducting a project of research, means a grant, contract, or cooperative agreement.

‘(b) FINAL RULE FOR REGULATIONS- The Secretary shall issue a final rule for the regulations required in subsection (a) not later than 180 days after the date of the enactment of the National Institutes of Health Revitalization Act of 1993.’.

SEC. 165. EFFECTIVE DATES.

(a) IN GENERAL- The amendments made by this subtitle shall become effective on the date that occurs 180 days after the date on which the final rule required under section 493(f)(4) of the Public Health Service Act, as amended by sections 161 and 163, is published in the Federal Register.

(b) AGREEMENTS AS A CONDITION OF FUNDING- The requirements of subsection (f)(5) of section 493 of the Public Health Service Act, as amended by sections 161 and 163, with respect to agreements as a condition of funding shall not be effective in the case of projects of research for which initial funding under the Public Health Service Act was provided prior to the effective date described in subsection (a).

TITLE II--NATIONAL INSTITUTES OF HEALTH IN GENERAL

SEC. 201. HEALTH PROMOTION RESEARCH DISSEMINATION.

Section 402(f) of the Public Health Service Act (42 U.S.C. 282(f)) is amended by striking ‘other public and private entities.’ and all that follows through the end and inserting ‘other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall--

‘(1) annually review the efficacy of existing policies and techniques used by the national research institutes to disseminate the results of disease prevention and behavioral research programs;

‘(2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to ensure maximum dissemination, using advanced technologies to the maximum extent practicable, of research results to such entities; and

‘(3) annually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including--

‘(A) a summary of the Associate Director’s review of existing dissemination policies and techniques together with a detailed statement concerning any modification or restructuring, or recommendations for modification or restructuring, of such policies and techniques; and

‘(B) a detailed statement of the expenditures made for the prevention and dissemination activities reported on and the personnel used in connection with such activities.’.

SEC. 202. PROGRAMS FOR INCREASED SUPPORT REGARDING CERTAIN STATES AND RESEARCHERS.

Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended by adding at the end the following new subsection:

‘(g)(1)(A) In the case of entities described in subparagraph (B), the Director of NIH, acting through the Director of the National Center for Research Resources, shall establish a program to enhance the competitiveness of such entities in obtaining funds from the national research institutes for conducting biomedical and behavioral research.

‘(B) The entities referred to in subparagraph (A) are entities that conduct biomedical and behavioral research and are located in a State in which the aggregate success rate for applications to the national research institutes for assistance for such research by the entities in the State has historically constituted a low success rate of obtaining such funds, relative to such aggregate rate for such entities in other States.

‘(C) With respect to enhancing competitiveness for purposes of subparagraph (A), the Director of NIH, in carrying out the program established under such subparagraph, may--

‘(i) provide technical assistance to the entities involved, including technical assistance in the preparation of applications for obtaining funds from the national research institutes;

‘(ii) assist the entities in developing a plan for biomedical or behavioral research proposals; and

‘(iii) assist the entities in implementing such plan.

‘(2) The Director of NIH shall establish a program of supporting projects of biomedical or behavioral research whose principal researchers are individuals who have not previously served as the principal researchers of such projects supported by the Director.’.

SEC. 203. CHILDREN’S VACCINE INITIATIVE.

Part A of title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by adding at the end the following new section:

‘CHILDREN’S VACCINE INITIATIVE

‘SEC. 404. (a) DEVELOPMENT OF NEW VACCINES- The Secretary, in consulation with the Director of the National Vaccine Program under title XXI and acting through the Directors of the National Institute for Allergy and Infectious Diseases, the National Institute for Child Health and Human Development, the National Institute for Aging, and other public and private programs, shall carry out activities, which shall be consistent with the global Children’s Vaccine Initiative, to develop affordable new and improved vaccines to be used in the United States and in the developing world that will increase the efficacy and efficiency of the prevention of infectious diseases. In carrying out such activities, the Secretary shall, to the extent practicable, develop and make available vaccines that require fewer contacts to deliver, that can be given early in life, that provide long lasting protection, that obviate refrigeration, needles and syringes, and that protect against a larger number of diseases.

‘(b) REPORT- In the report required in section 2104, the Secretary, acting through the Director of the National Vaccine Program under title XXI, shall include information with respect to activities and the progress made in implementing the provisions of this section and achieving its goals.

‘(c) AUTHORIZATION OF APPROPRIATIONS- In addition to any other amounts authorized to be appropriated for activities of the type described in this section, there are authorized to be appropriated to carry out this section $20,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.’.

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

(a) IN GENERAL- Part A of title IV of the Public Health Service Act, as amended by section 203 of this Act, is amended by adding at the end the following new section:

‘PLAN FOR USE OF ANIMALS IN RESEARCH

‘SEC. 404A. (a) The Director of NIH, after consultation with the committee established under subsection (e), shall prepare a plan--

‘(1) for the National Institutes of Health to conduct or support research into--

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

‘(B) methods of such research and experimentation that reduce the number of animals used in such research; and

‘(C) methods of such research and experimentation that produce less pain and distress in such animals;

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

‘(3) for encouraging the acceptance by the scientific community of such methods that have been found to be valid and reliable; and

‘(4) for training scientists in the use of such methods that have been found to be valid and reliable.

‘(b) Not later than October 1, 1993, the Director of NIH shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, the plan required in subsection (a) and shall begin implementation of the plan.

‘(c) The Director of NIH shall periodically review, and as appropriate, make revisions in the plan required under subsection (a). A description of any revision made in the plan shall be included in the first biennial report under section 403 that is submitted after the revision is made.

‘(d) The Director of NIH shall take such actions as may be appropriate to convey to scientists and others who use animals in biomedical or behavioral research or experimentation information respecting the methods found to be valid and reliable under subsection (a)(2).

hereafter in this

‘(2) The Committee shall provide advice to the Director of NIH on the preparation of the plan required in subsection (a).

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

‘(A) the Directors of each of the national research institutes and the Director of the Center for Research Resources (or the designees of such Directors); and

‘(B) representatives of the Environmental Protection Agency, the Food and Drug Administration, the Consumer Product Safety Commission, the National Science Foundation, and such additional agencies as the Director of NIH determines to be appropriate.’.

(b) CONFORMING AMENDMENT- Section 4 of the Health Research Extension Act of 1985 (Public Law 99-158; 99 Stat. 880) is repealed.

SEC. 205. INCREASED PARTICIPATION OF WOMEN AND MEMBERS OF UNDERREPRESENTED MINORITIES IN FIELDS OF BIOMEDICAL AND BEHAVIORAL RESEARCH.

Section 402 of the Public Health Service Act, as amended by section 202 of this Act, is amended by adding at the end the following new subsection:

‘(h) The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, may conduct and support programs for research, research training, recruitment, and other activities to provide for an increase in the number of women and members of underrepresented minority groups in the fields of biomedical and behavioral research.’.

SEC. 206. REQUIREMENTS REGARDING SURVEYS OF SEXUAL BEHAVIOR.

Part A of title IV of the Public Health Service Act, as amended by section 204 of this Act, is amended by adding at the end the following new section:

‘REQUIREMENTS REGARDING SURVEYS OF SEXUAL BEHAVIOR

‘SEC. 404B. With respect to any survey of human sexual behavior proposed to be conducted or supported through the National Institutes of Health, the survey may not be carried out unless--

‘(1) the proposal has undergone review in accordance with any applicable requirements of sections 491 and 492; and

‘(2) the Secretary, in accordance with section 492A, makes a determination that the information expected to be obtained through the survey will assist--

‘(A) in reducing the incidence of sexually transmitted diseases, the incidence of infection with the human immunodeficiency virus, or the incidence of any other infectious disease; or

‘(B) in improving reproductive health or other conditions of health.’.

SEC. 207. DISCRETIONARY FUND OF DIRECTOR OF NATIONAL INSTITUTES OF HEALTH.

Section 402 of the Public Health Service Act, as amended by section 205 of this Act, is amended by adding at the end the following new subsection:

‘(i)(1) There is established a fund, consisting of amounts appropriated under paragraph (3) and made available for the fund, for use by the Director of NIH to carry out the activities authorized in this Act for the National Institutes of Health. The purposes for which such fund may be expended include--

‘(A) providing for research on matters that have not received significant funding relative to other matters, responding to new issues and scientific emergencies, and acting on research opportunities of high priority;

‘(B) supporting research that is not exclusively within the authority of any single agency of such Institutes; and

‘(C) purchasing or renting equipment and quarters for activities of such Institutes.

‘(2) Not later than February 10 of each fiscal year, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the activities undertaken and expenditures made under this section during the preceding fiscal year. The report may contain such comments of the Secretary regarding this section as the Secretary determines to be appropriate.

‘(3) For the purpose of carrying out this subsection, there are authorized to be appropriated $25,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.’.

SEC. 208. MISCELLANEOUS PROVISIONS.

(a) TERM OF OFFICE FOR MEMBERS OF ADVISORY COUNCILS- Section 406(c) of the Public Health Service Act (42 U.S.C. 284a(c)) is amended in the second sentence by striking ‘until a successor has been appointed’ and inserting the following: ‘for 180 days after the date of such expiration’.

(b) LITERACY REQUIREMENTS- Section 402(e) of the Public Health Service Act (42 U.S.C. 282(e)) is amended--

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

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

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

‘(5) ensure that, after January 1, 1994, at least one-half of all new or revised health education and promotion materials developed or funded by the National Institutes of Health is in a form that does not exceed a level of functional literacy, as defined in the National Literacy Act of 1991 (Public Law 102-73).’.

(c) DAY CARE REGARDING CHILDREN OF EMPLOYEES- Section 402 of the Public Health Service Act, as amended by section 207 of this Act, is amended by adding at the end the following new subsection:

‘(i)(1) The Director of NIH may establish a program to provide day care service for the employees of the National Institutes of Health similar to those services provided by other Federal agencies (including the availability of day care service on a 24-hour-a-day basis).

‘(2) Any day care provider at the National Institutes of Health shall establish a sliding scale of fees that takes into consideration the income and needs of the employee.

‘(3) For purposes regarding the provision of day care service, the Director of NIH may enter into rental or lease purchase agreements.’.

TITLE III--GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES

SEC. 301. APPOINTMENT AND AUTHORITY OF DIRECTORS OF NATIONAL RESEARCH INSTITUTES.

(a) ESTABLISHMENT OF GENERAL AUTHORITY REGARDING DIRECT FUNDING-

(1) IN GENERAL- Section 405(b)(2) of the Public Health Service Act (42 U.S.C. 284(b)(2)) is amended--

(A) in subparagraph (A), by striking ‘and’ after the semicolon at the end;

(B) in subparagraph (B), by striking the period at the end and inserting ‘; and’; and

‘(C) shall receive from the President and the Office of Management and Budget directly all funds appropriated by the Congress for obligation and expenditure by the Institute.’.

(2) CONFORMING AMENDMENT- Section 413(b)(9) of the Public Health Service Act (42 U.S.C. 285a-2(b)(9)) is amended--

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

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

(b) APPOINTMENT AND DURATION OF TECHNICAL AND SCIENTIFIC PEER REVIEW GROUPS- Section 405(c) of the Public Health Service Act (42 U.S.C. 284(c)) is amended--

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

‘(3) may, in consultation with the advisory council for the Institute and with the approval of the Director of NIH--

‘(A) establish technical and scientific peer review groups in addition to those appointed under section 402(b)(6); and

‘(B) appoint the members of peer review groups established under subparagraph (A); and’; and

(2) by adding after and below paragraph (4) the following:

‘The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under paragraph (3).’.

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

Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.), as amended by section 121(b) of Public Law 102-321 (106 Stat. 358), is amended by adding at the end the following new section:

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

‘SEC. 410. (a) ESTABLISHMENT- The Directors of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, and the National Institute of Diabetes, Digestive and Kidney Diseases, shall expand and intensify the programs of such Institutes with respect to research and related activities concerning osteoporosis, Paget’s disease, and related bone disorders.

‘(b) COORDINATION- The Directors referred to in subsection (a) shall jointly coordinate the programs referred to in such subsection and consult with the Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee and the Interagency Task Force on Aging Research.

‘(1) IN GENERAL- In order to assist in carrying out the purpose described in subsection (a), the Director of NIH shall provide for the establishment of an information clearinghouse on osteoporosis and related bone disorders to facilitate and enhance knowledge and understanding on the part of health professionals, patients, and the public through the effective dissemination of information.

‘(2) ESTABLISHMENT THROUGH GRANT OR CONTRACT- For the purpose of carrying out paragraph (1), the Director of NIH shall enter into a grant, cooperative agreement, or contract with a nonprofit private entity involved in activities regarding the prevention and control of osteoporosis and related bone disorders.

‘(d) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.’.

SEC. 303. ESTABLISHMENT OF INTERAGENCY PROGRAM FOR TRAUMA RESEARCH.

(a) IN GENERAL- Title XII of the Public Health Service Act (42 U.S.C. 300d et seq.) is amended by adding at the end the following part:

‘Part E--Interagency Program for Trauma Research

‘SEC. 1251. ESTABLISHMENT OF PROGRAM.

hereafter in this

(b) PLAN FOR PROGRAM-

‘(1) IN GENERAL- The Director, in consultation with the Trauma Research Interagency Coordinating Committee established under subsection (g), shall establish and implement a plan for carrying out the activities of the Program, including the activities described in subsection (d). All such activities shall be carried out in accordance with the plan. The plan shall be periodically reviewed, and revised as appropriate.

‘(2) SUBMISSION TO CONGRESS- Not later than June 1, 1993, the Director shall submit the plan required in paragraph (1) to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, together with an estimate of the funds needed for each of the fiscal years 1994 through 1996 to implement the plan.

‘(c) PARTICIPATING AGENCIES; COORDINATION AND COLLABORATION- The Director--

TITLE IV--NATIONAL CANCER INSTITUTE

SEC. 401. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING BREAST CANCER.

‘BREAST AND GYNECOLOGICAL CANCERS

SEC. 402. EXPANSION AND INTENSIFICATION OF ACTIVITIES REGARDING PROSTATE CANCER.

‘PROSTATE CANCER

SEC. 403. AUTHORIZATION OF APPROPRIATIONS.

‘AUTHORIZATION OF APPROPRIATIONS

‘CERTAIN USES OF FUNDS’.

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.

‘NATIONAL CENTER ON SLEEP DISORDERS

SEC. 504. AUTHORIZATION OF APPROPRIATIONS.

‘AUTHORIZATION OF APPROPRIATIONS

TITLE VI--NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE AND KIDNEY DISEASES

SEC. 601. PROVISIONS REGARDING NUTRITIONAL DISORDERS.

‘NUTRITIONAL DISORDERS PROGRAM

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.

‘ALZHEIMER’S DISEASE REGISTRY

SEC. 802. AGING PROCESSES REGARDING WOMEN.

‘AGING PROCESSES REGARDING WOMEN

SEC. 803. AUTHORIZATION OF APPROPRIATIONS.

‘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.

‘RESEARCH CENTERS REGARDING 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.

‘RESEARCH CENTERS WITH RESPECT TO CONTRACEPTION AND INFERTILITY

SEC. 1002. LOAN REPAYMENT PROGRAM FOR RESEARCH WITH RESPECT TO CONTRACEPTION AND INFERTILITY.

‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH RESPECT TO CONTRACEPTION AND INFERTILITY

Subtitle B--Program Regarding Obstetrics and Gynecology

SEC. 1011. ESTABLISHMENT OF PROGRAM.

‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY

Subtitle C--Child Health Research Centers

SEC. 1021. ESTABLISHMENT OF CENTERS.

‘CHILD HEALTH RESEARCH CENTERS

Subtitle D--Study Regarding Adolescent Health

SEC. 1031. PROSPECTIVE LONGITUDINAL STUDY.

‘PROSPECTIVE LONGITUDINAL STUDY ON ADOLESCENT HEALTH

TITLE XI--NATIONAL EYE INSTITUTE

SEC. 1101. CLINICAL RESEARCH ON DIABETES EYE CARE.

‘CLINICAL RESEARCH ON EYE CARE AND DIABETES

TITLE XII--NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

SEC. 1201. RESEARCH ON MULTIPLE SCLEROSIS.

‘RESEARCH ON MULTIPLE SCLEROSIS

TITLE XIII--NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES

SEC. 1301. APPLIED TOXICOLOGICAL RESEARCH AND TESTING PROGRAM.

‘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.

‘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.

‘Subpart 4--National Information Center on Health Services Research and Health Care Technology

‘NATIONAL INFORMATION 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.

‘BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES

SEC. 1503. CONSTRUCTION PROGRAM FOR NATIONAL PRIMATE RESEARCH CENTER.

‘CONSTRUCTION OF REGIONAL CENTERS FOR RESEARCH ON PRIMATES

Subtitle B--National Center for Nursing Research

SEC. 1511. REDESIGNATION OF NATIONAL CENTER FOR NURSING RESEARCH AS NATIONAL INSTITUTE OF NURSING RESEARCH.

‘Subpart 17--National Institute of Nursing Research’;

SEC. 1512. STUDY ON ADEQUACY OF NUMBER OF NURSES.

Subtitle C--National Center for Human Genome Research

SEC. 1521. PURPOSE OF CENTER.

‘Subpart 4--National Center for Human Genome Research

‘PURPOSE OF THE 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.

‘LOAN REPAYMENT PROGRAM FOR RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME

Subtitle C--Loan Repayment for Research Generally

SEC. 1621. ESTABLISHMENT OF PROGRAM.

‘LOAN REPAYMENT PROGRAM FOR RESEARCH GENERALLY

Subtitle D--Scholarship and Loan Repayment Programs Regarding Professional Skills Needed by Certain Agencies

SEC. 1631. ESTABLISHMENT OF PROGRAMS FOR NATIONAL INSTITUTES OF HEALTH.

‘UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY NATIONAL RESEARCH INSTITUTES

‘LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS FROM DISADVANTAGED BACKGROUNDS

SEC. 1632. FUNDING.

SEC. 1641. AUTHORIZATION OF APPROPRIATIONS.

TITLE XVII--NATIONAL FOUNDATION FOR BIOMEDICAL RESEARCH

SEC. 1701. ESTABLISHMENT OF FOUNDATION.

‘SEC. 499A. ESTABLISHMENT AND DUTIES OF FOUNDATION.

TITLE XVIII--RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME

SEC. 1801. REVISION AND EXTENSION OF VARIOUS PROGRAMS.

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.

TITLE XX--MISCELLANEOUS PROVISIONS

SEC. 2001. DESIGNATION OF SENIOR BIOMEDICAL RESEARCH SERVICE IN HONOR OF SILVIO O. CONTE, AND LIMITATION ON NUMBER OF MEMBERS.

‘SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH SERVICE’.

SEC. 2002. TECHNICAL CORRECTIONS.

SEC. 2003. BIENNIAL REPORT ON CARCINOGENS.

SEC. 2004. MASTER PLAN FOR PHYSICAL INFRASTRUCTURE FOR RESEARCH.

SEC. 2005. TRANSFER OF PROVISIONS OF TITLE XXVII.

‘PART A--ADMINISTRATION’; and

‘Part B--Miscellaneous Provisions’.

SEC. 2006. CERTAIN AUTHORIZATION OF APPROPRIATIONS.

SEC. 2007. PROHIBITION AGAINST SHARP ADULT SEX SURVEY AND THE AMERICAN TEENAGE SEX SURVEY.

SEC. 2008. SUPPORT FOR BIOENGINEERING RESEARCH.

TITLE XXI--EFFECTIVE DATES