[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 695 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 695

   To amend the Public Health Service Act to establish an Office of 
          Research on Women's Health, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 27, 1993

  Ms. Snowe introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Public Health Service Act to establish an Office of 
          Research on Women's 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.

    This Act may be cited as the ``Women's Health Research Act of 
1993''.

SEC. 2. ESTABLISHMENT OF OFFICE OF RESEARCH ON WOMEN'S HEALTH.

    (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) ensure that women are appropriately represented as 
        subjects in projects of clinical research conducted or 
        supported by the national research institutes; and
            ``(9) prepare the report required in section 486B.
    ``(c) Coordinating Committee.--
            ``(1) In carrying out subsection (b), the Director of the 
        Office shall establish a committee to be known as the 
        Coordinating Committee on Research on Women's Health (hereafter 
        in this subsection referred to as the `Coordinating 
        Committee').
            ``(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.
    ``(d) Advisory Committee.--
            ``(1) In carrying out subsection (b), the Director of the 
        Office shall establish an advisory committee to be known as the 
        Advisory Committee on Research on Women's Health (hereafter in 
        this subsection referred to as the `Advisory Committee').
            ``(2) 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.
            ``(3) The Director of the Office shall serve as the chair 
        of the Advisory Committee.
            ``(4) The Advisory Committee shall--
                    ``(A) advise the Director of the Office on 
                appropriate research activities to be undertaken by the 
                national research institutes with respect to--
                            ``(i) research on women's health;
                            ``(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 
                486(b)(8) 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--
                    ``(i) compliance with section 486(b)(8);
                    ``(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.

    ``(a) Data System.--
            ``(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.

``SEC. 486C. AUTHORIZATION OF APPROPRIATIONS.

    ``For the purpose of carrying out this part, 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.''.
    (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).''.

SEC. 3. OBSTETRICS AND GYNECOLOGY PROGRAM OF NATIONAL INSTITUTE OF 
              CHILD HEALTH AND HUMAN DEVELOPMENT.

    Subpart 7 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285g et seq.) is amended by adding at the end the following 
section:

             ``program regarding obstetrics and gynecology

    ``Sec. 452A. The Director of the Institute shall establish and 
maintain within the Institute an intramural laboratory and clinical 
research program in obstetrics and gynecology.''.

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