I

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.

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

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Women’s Health Re5 search Act of 1993’’.

6 SEC. 2. ESTABLISHMENT OF OFFICE OF RESEARCH ON

7 WOMEN’S HEALTH.

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

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

10 613, is amended—
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1 (1) by redesignating section 486 as section

2 485A;

3 (2) by redesignating parts F through H as

4 parts G through I, respectively; and

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

6 part:

7 ‘‘PART F—RESEARCH ON WOMEN’S HEALTH

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

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

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

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

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

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

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

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

16 health that should be conducted or supported by the

17 national research institutes;

18 ‘‘(2) identify multidisciplinary research relating

19 to research on women’s health that should be so con20 ducted or supported;

21 ‘‘(3) carry out paragraphs (1) and (2) with re22 spect to the aging process in women, with priority

23 given to menopause;
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1 ‘‘(4) promote coordination and collaboration

2 among entities conducting research identified under

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

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

5 entities receiving funds from the national research

6 institutes;

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

8 supporting such research;

9 ‘‘(7) promote the sufficient allocation of the re10 sources of the national research institutes for con11 ducting and supporting such research;

12 ‘‘(8) ensure that women are appropriately rep13 resented as subjects in projects of clinical research

14 conducted or supported by the national research in15 stitutes; and

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

17 486B.

18 ‘‘(c) COORDINATING COMMITTEE.—

19 ‘‘(1) In carrying out subsection (b), the Direc20 tor of the Office shall establish a committee to be

21 known as the Coordinating Committee on Research

22 on Women’s Health (hereafter in this subsection re23 ferred to as the ‘Coordinating Committee’).
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1 ‘‘(2) The Coordinating Committee shall be com2 posed of the Directors of the national research insti3 tutes (or the designees of the Directors).

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

5 the chair of the Coordinating Committee.

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

7 health, the Coordinating Committee shall assist the

8 Director of the Office in—

9 ‘‘(A) identifying the need for such re10 search, and making an estimate each fiscal year

11 of the funds needed to adequately support the

12 research;

13 ‘‘(B) identifying needs regarding the co14 ordination of research activities, including in15 tramural and extramural multidisciplinary ac16 tivities;

17 ‘‘(C) supporting the development of meth18 odologies to determine the circumstances in

19 which obtaining data specific to women (includ20 ing data relating to the age of women and the

21 membership of women in ethnic or racial

22 groups) is an appropriate function of clinical

23 trials of treatments and therapies;

24 ‘‘(D) supporting the development and ex25 pansion of clinical trials of treatments and
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1 therapies for which obtaining such data has

2 been determined to be an appropriate function;

3 and

4 ‘‘(E) encouraging the national research in5 stitutes to conduct and support such research,

6 including such clinical trials.

7 ‘‘(d) ADVISORY COMMITTEE.—

8 ‘‘(1) In carrying out subsection (b), the Direc9 tor of the Office shall establish an advisory commit10 tee to be known as the Advisory Committee on Re11 search on Women’s Health (hereafter in this sub12 section referred to as the ‘Advisory Committee’).

13 ‘‘(2) The Advisory Committee shall be com14 posed of no fewer than 12, and not more than 18

15 individuals, who are not officers or employees of the

16 Federal Government. The Director of the Office

17 shall make appointments to the Advisory Committee

18 from among physicians, practitioners, scientists, and

19 other health professionals, whose clinical practice,

20 research specialization, or professional expertise in21 cludes a significant focus on research on women’s

22 health. A majority of the members of the Advisory

23 Committee shall be women.

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

25 the chair of the Advisory Committee.
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1 ‘‘(4) The Advisory Committee shall—

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

3 appropriate research activities to be undertaken

4 by the national research institutes with respect

5 to—

6 ‘‘(i) research on women’s health;

7 ‘‘(ii) research on gender differences in

8 clinical drug trials, including responses to

9 pharmacological drugs;

10 ‘‘(iii) research on gender differences

11 in disease etiology, course, and treatment;

12 ‘‘(iv) research on obstetrical and gyne13 cological health conditions, diseases, and

14 treatments; and

15 ‘‘(v) research on women’s health con16 ditions which require a multidisciplinary

17 approach;

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

19 on such research;

20 ‘‘(C) provide recommendations to such Di21 rector regarding activities of the Office (includ22 ing recommendations on the development of the

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

24 and recommendations on priorities in carrying
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1 out research described in subparagraph (A));

2 and

3 ‘‘(D) assist in monitoring compliance with

4 section 486(b)(8) regarding the inclusion of

5 women in clinical research.

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

7 a biennial report describing the activities of the

8 Committee, including findings made by the Commit9 tee regarding—

10 ‘‘(i) compliance with section 486(b)(8);

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

12 research on women’s health by the agencies of

13 the National Institutes of Health; and

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

15 research.

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

17 shall be submitted to the Director of NIH for inclu18 sion in the report required in section 403.

19 ‘‘(e) REPRESENTATION OF WOMEN AMONG RE20 SEARCHERS.—The Secretary, acting through the Assist21 ant Secretary for Personnel and in collaboration with the

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

23 women are represented among senior physicians and sci24 entists of the national research institutes and among phy25 sicians and scientists conducting research with funds pro-
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1 vided by such institutes, and as appropriate, carry out ac2 tivities to increase the extent of such representation.

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

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

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

6 groups, means all diseases, disorders, and conditions

7 (including with respect to mental health)—

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

9 prevalent in women;

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

11 or types of medical intervention are different

12 for women, or for which it is unknown whether

13 such factors or types are different for women;

14 or

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

16 insufficient clinical research involving women as

17 subjects or insufficient clinical data on women.

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

19 means research on women’s health conditions, in20 cluding research on preventing such conditions.

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

22 ON RESEARCH ON WOMEN’S HEALTH.

23 ‘‘(a) DATA SYSTEM.—

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

25 the Director of the Office, shall establish a data sys-
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1 tem for the collection, storage, analysis, retrieval,

2 and dissemination of information regarding research

3 on women’s health that is conducted or supported by

4 the national research institutes. Information from

5 the data system shall be available through informa6 tion systems available to health care professionals

7 and providers, researchers, and members of the

8 public.

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

11 experimental treatments that have been developed

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

13 include information on subject eligibility criteria,

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

15 trial site or sites. Principal investigators of such

16 clinical trials shall provide this information to the

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

18 trial has been completed, the principal investigator

19 shall provide the registry with information pertain20 ing to the results, including potential toxicities or

21 adverse effects associated with the experimental

22 treatment or treatments evaluated.

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

24 consultation with the Director of the Office and with the

25 National Library of Medicine, shall establish, maintain,
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1 and operate a program to provide information on research

2 and prevention activities of the national research institutes

3 that relate to research on women’s health.

4 ‘‘SEC. 486B. BIENNIAL REPORT.

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

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

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

8 a report—

9 ‘‘(1) describing and evaluating the progress

10 made during the preceding 2 fiscal years in research

11 and treatment conducted or supported by the Na12 tional Institutes of Health;

13 ‘‘(2) describing and analyzing the professional

14 status of women physicians and scientists of such

15 Institutes, including the identification of problems

16 and barriers regarding advancements;

17 ‘‘(3) summarizing and analyzing expenditures

18 made by the agencies of such Institutes (and by

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

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

22 the Office determines to be appropriate.

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

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

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

2 and the Congress under section 403.

3 ‘‘SEC. 486C. AUTHORIZATION OF APPROPRIATIONS.

4 ‘‘For the purpose of carrying out this part, there are

5 authorized to be appropriated $25,000,000 for fiscal year

6 1994, and such sums as may be necessary for each of the

7 fiscal years 1995 and 1996.’’.

8 (b) REQUIREMENT OF SUFFICIENT ALLOCATION OF

9 RESOURCES OF INSTITUTES.—Section 402(b) of the Pub10 lic Health Service Act (42 U.S.C. 282(b)) is amended—

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

12 the semicolon at the end;

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

14 the end and inserting ‘‘; and’’; and

15 (3) by inserting after paragraph (11) the fol16 lowing new paragraph:

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

18 the Office of Research on Women’s Health, shall en19 sure that resources of the National Institutes of

20 Health are sufficiently allocated for projects of re21 search on women’s health that are identified under

22 section 486(b).’’.
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1 SEC. 3. OBSTETRICS AND GYNECOLOGY PROGRAM OF NA2 TIONAL INSTITUTE OF CHILD HEALTH AND

3 HUMAN DEVELOPMENT.

4 Subpart 7 of part C of title IV of the Public Health

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

6 at the end the following section:

7 ‘‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY

8 ‘‘SEC. 452A. The Director of the Institute shall es9 tablish and maintain within the Institute an intramural

10 laboratory and clinical research program in obstetrics and

11 gynecology.’’.

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