
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC287d]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
                   Part F--Research on Women's Health
 
Sec. 287d. 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 289a-2 of this title 
    with respect to the inclusion of women as subjects in clinical 
    research; and
        (9) prepare the report required in section 287d-2 of this title.

(c) Coordinating Committee

    (1) In carrying out subsection (b) of this section, the Director of 
the Office shall establish a committee to be known as the Coordinating 
Committee on Research on Women's Health (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) of this section, the Director of 
the Office shall establish an advisory committee to be known as the 
Advisory Committee on Research on Women's Health (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 NIH 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) 
    of this section and recommendations on priorities in carrying out 
    research described in subparagraph (A)); and
        (D) assist in monitoring compliance with section 289a-2 of this 
    title 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 289a-2 of this title;
        (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 283 
of this title.

(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.

(July 1, 1944, ch. 373, title IV, Sec. 486, as added Pub. L. 103-43, 
title I, Sec. 141(a)(3), June 10, 1993, 107 Stat. 136; amended Pub. L. 
105-340, title I, Sec. 106, Oct. 31, 1998, 112 Stat. 3193.)


                               Amendments

    1998--Subsec. (d)(2). Pub. L. 105-340 substituted ``NIH'' for ``the 
Office''.


                   Termination of Advisory Committees

    Advisory committees established after Jan. 5, 1973, to terminate not 
later than the expiration of the 2-year period beginning on the date of 
their establishment, unless, in the case of a committee established by 
the President or an officer of the Federal Government, such committee is 
renewed by appropriate action prior to the expiration of such 2-year 
period, or in the case of a committee established by Congress, its 
duration is otherwise provided for by law. See section 14 of Pub. L. 92-
463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title 5, 
Government Organization and Employees.
    Pub. L. 93-641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a 
note under section 217a of this title, provided that an advisory 
committee established pursuant to the Public Health Service Act shall 
terminate at such time as may be specifically prescribed by an Act of 
Congress enacted after Jan. 4, 1975.

                  Section Referred to in Other Sections

    This section is referred to in section 282 of this title.
