I

104TH CONGRESS

1ST SESSION H. R. 1736

To amend various Acts to establish offices of women’s health within certain

agencies, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

MAY 25, 1995

Mrs. MORELLA (for herself, Mrs. LOWEY, Mrs. JOHNSON of Connecticut, Ms.

NORTON, Ms. SLAUGHTER, Ms. EDDIE BERNICE JOHNSON of Texas,

Mrs. KENNELLY, Mrs. SCHROEDER, Mrs. MINK of Hawaii, Ms. PELOSI,

Ms. WOOLSEY, Mrs. MALONEY, Ms. MCKINNEY, Ms. LOFGREN, Ms.

VELA ́ZQUEZ, Ms. JACKSON-LEE, and Miss COLLINS of Michigan) introduced the following bill; which was referred to the Committee on Commerce

A BILL

To amend various Acts to establish offices of women’s health

within certain agencies, 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 Office

5 Act of 1995’’.
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1 SEC. 2. PUBLIC HEALTH SERVICE OFFICE ON WOMEN’S

2 HEALTH.

3 Title XVII of the Public Health Service Act (42

4 U.S.C. 300u et seq.) is amended by adding at the end

5 the following section:

6 ‘‘OFFICE ON WOMEN’S HEALTH

7 ‘‘SEC. 1710. (a) ESTABLISHMENT OF OFFICE.—

8 There is established an Office on Women’s Health (here9 after referred to in this section as the ‘Office’) within the

10 Office of the Assistant Secretary for Health.

11 ‘‘(b) ASSISTANT SECRETARY.—There shall be in the

12 Department of Health and Human Services a Deputy As13 sistant Secretary for Women’s Health, who shall be the

14 head of the Office. The Secretary, acting through such

15 Deputy Assistant Secretary, shall carry out this section.

16 ‘‘(c) DUTIES.—The Secretary, acting through the Of17 fice, shall, with respect to women’s health conditions—

18 ‘‘(1) advise the Assistant Secretary for Health

19 concerning scientific, legal, ethical, and policy issues

20 relating to women’s health;

21 ‘‘(2) establish short-range and long-range goals

22 and objectives and coordinate all other activities

23 within the Department of Health and Human Serv24 ices that relate to disease prevention, health pro25 motion, service delivery, and research concerning

26 women;
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1 ‘‘(3) enter into interagency agreements with

2 other agencies of the Service to increase the partici3 pation of women in health service and promotion

4 programs;

5 ‘‘(4) support research, demonstrations and eval6 uations to test new and innovative models, to in7 crease knowledge and understanding of health risk

8 factors, to develop mechanisms that support better

9 information dissemination, education, prevention,

10 and service delivery for women, and to support ini11 tiatives for the promotion of women with respect to

12 careers in the health professions and research;

13 ‘‘(5) monitor Public Health Service agency and

14 regional activities regarding women’s health, and co15 ordinate activities of such agency Offices of Wom16 en’s Health;

17 ‘‘(6) establish a women’s health resource center

18 to facilitate the exchange of information regarding

19 matters relating to health information and health

20 promotion, preventive health services, and education

21 in the appropriate use of health care, to facilitate ac22 cess to such information, to assist in the analysis of

23 issues and problems relating to such matters, and to

24 provide technical assistance with respect to the ex25 change of such information (including facilitating
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1 the development of materials for such technical as2 sistance); and

3 ‘‘(7) coordinate efforts to promote women’s

4 health programs and policies in the voluntary and

5 corporate sectors.

6 ‘‘(d) COORDINATING COMMITTEE.—The Secretary

7 shall provide for the operation of a committee composed

8 of the heads of the agencies of the Public Health Service

9 (or the designees of the agency heads), which committee

10 shall be chaired by the Deputy Assistant Secretary for

11 Women’s Health. With respect to women’s health condi12 tions, such committee shall assist the Deputy Assistant

13 Secretary in identifying the needs for programs regarding

14 the conditions, and in making an estimate each fiscal year

15 of the funds needed to adequately support the programs;

16 identifying needs regarding the coordination of programs;

17 and encouraging the agencies of the Public Health Service

18 to conduct and support programs.

19 ‘‘(e) ADVISORY COMMITTEE.—The Secretary shall

20 provide for the operation of an advisory committee regard21 ing the duties of the Office. Such committee shall be com22 posed of 15 voting members, appointed from among indi23 viduals who have expertise in women’s health and who are

24 not officers or employees of the Federal Government, and

25 the term of office for such members shall be four years.
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1 The membership of the committee shall include as

2 nonvoting members each of the individuals serving as

3 nonvoting members of the Coordinating Committee under

4 subsection (d), and shall include such other Federal offi5 cials or employees as the Secretary determines to be ap6 propriate. The committee shall be chaired by the Deputy

7 Assistant Secretary for Women’s Health, and shall meet

8 at the call of the Chair, but not less than once each fiscal

9 year.

10 ‘‘(f) REPORTS.—Not later than January 31, 1996,

11 and January 31 of each second year thereafter, the Sec12 retary shall prepare and submit to the appropriate com13 mittees of Congress a report describing the activities car14 ried out under this section during the preceding 2 fiscal

15 years.

16 ‘‘(g) DEFINITION.—For purposes of this section, the

17 term ‘women’s health conditions’, with respect to women

18 of all age, ethnic, and racial groups, means all diseases,

19 disorders, and conditions—

20 ‘‘(1) unique to, more serious, or more prevalent

21 in women; and

22 ‘‘(2) for which the factors of medical risk or

23 type of medical intervention are different for women,

24 or for which it is unknown whether such factors or

25 types are different for women.
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1 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the

2 purpose of carrying out this section, there are authorized

3 to be appropriated $6,000,000 for fiscal year 1996, and

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

5 1997 and 1998.’’.

6 SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVEN7 TION OFFICE OF WOMEN’S HEALTH.

8 Part B of title III of the Public Health Service Act

9 (42 U.S.C. 243 et seq.) is amended by inserting after sec10 tion 317F the following section:

11 ‘‘CENTERS FOR DISEASE CONTROL AND PREVENTION

12 OFFICE OF WOMEN’S HEALTH

13 ‘‘SEC. 317G. (a) ESTABLISHMENT.—There is estab14 lished within the Office of the Director of the Centers for

15 Disease Control and Prevention an office to be known as

16 the Office of Women’s Health (hereafter referred to in this

17 section as the ‘Office’). The Office shall be headed by a

18 director who shall be appointed by the Director of the

19 Centers.

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

21 ‘‘(1) determine the current level of the Centers

22 activity regarding women’s health conditions, across

23 age, biological, and sociocultural contexts, in all as24 pects of the Centers work, including prevention pro25 grams, public and professional education, services,

26 and treatment;
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1 ‘‘(2) establish short-range and long-range goals

2 and objectives for women’s health and coordinate all

3 other activities within the Centers that relate to pre4 vention, research, education and training, service de5 livery, and policy development;

6 ‘‘(3) identify projects in women’s health that

7 should be conducted or supported by the National

8 Centers;

9 ‘‘(4) consult with health professionals, non-gov10 ernmental organizations, consumer organizations,

11 women’s health professionals, and other individuals

12 and groups, as appropriate, on the policy of the Cen13 ters with regard to women; and

14 ‘‘(5) coordinate agency activities on women’s

15 health with the Public Health Service Office on

16 Women’s Health established under section 1710.

17 ‘‘(c) COORDINATING COMMITTEE.—

18 ‘‘(1) ESTABLISHMENT.—In carrying out sub19 section (b), the Director of the Office shall establish

20 a committee to be known as the Coordinating Com21 mittee on Research on Women’s Health (hereafter

22 referred to in this subsection as the ‘Coordinating

23 Committee’).
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1 ‘‘(2) COMPOSITION.—The Coordinating Com2 mittee shall be composed of the Directors of the

3 National Centers.

4 ‘‘(3) CHAIRPERSON.—The Director of the Of5 fice shall serve as the chairperson of the Coordinat6 ing Committee.

7 ‘‘(4) DUTIES.—With respect to women’s health,

8 the Coordinating Committee shall assist the Director

9 of the Office in—

10 ‘‘(A) identifying the need for programs and

11 activities that focus on women’s health;

12 ‘‘(B) identifying needs regarding the co13 ordination of activities, including intramural

14 and extramural multidisciplinary activities; and

15 ‘‘(C) making recommendations to the Di16 rector of the Centers for Disease Control and

17 Prevention concerning findings made under

18 subparagraphs (A) and (B).

19 ‘‘(d) REPORTS.—Not later than January 31, 1996,

20 and January 31 of each second year thereafter, the Direc21 tor shall prepare and submit to the Director of the Public

22 Health Service Office of Women’s Health, a report de23 scribing the activities carried out under this section during

24 the preceding 2 fiscal years.
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1 ‘‘(e) DEFINITION.—As used in this section the term

2 ‘women’s health conditions’, with respect to women of all

3 age, ethnic, and racial groups, means all diseases, dis4 orders, and conditions—

5 ‘‘(1) unique to, more serious, or more prevalent

6 in women; and

7 ‘‘(2) for which the factors of medical risk or

8 type of medical intervention are different for women,

9 or for which it is unknown whether such factors or

10 types are different for women.’’.

11 SEC. 4. AGENCY FOR HEALTH CARE POLICY AND RE12 SEARCH OFFICE OF WOMEN’S HEALTH.

13 Part C of title IX of the Public Health Service Act

14 (42 U.S.C. 299c et seq.) is amended—

15 (1) by redesignating section 927 as section 928;

16 and

17 (2) by inserting after section 926 the following

18 section:

19 ‘‘SEC. 927. OFFICE OF WOMEN’S HEALTH.

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

21 the Office of the Director of the Agency for Health Care

22 Policy and Research an office to be known as the Office

23 of Women’s Health (hereafter referred to in this section

24 as the ‘Office’). The Office shall be headed by a Director

25 who shall be appointed by the Director of the Agency.
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1 ‘‘(b) PURPOSE.—The Director of the Office shall—

2 ‘‘(1) determine the current Agency level of ac3 tivity regarding women’s health, across age, biologi4 cal, and sociocultural contexts, in all aspects of

5 Agency work, including drafting clinical practice

6 guidelines, and conducting research into patient out7 comes, delivery of health care services, and access to

8 health care;

9 ‘‘(2) establish short-range and long-range goals

10 and objectives for research important to women’s

11 health and coordinate all other activities within the

12 Agency that relate to health services and medical

13 effectiveness research;

14 ‘‘(3) identify projects in women’s health that

15 should be conducted or supported by the Agency;

16 ‘‘(4) consult with health professionals, non-gov17 ernmental organizations, consumer organizations,

18 women’s health professionals, and other individuals

19 and groups, as appropriate, on Agency policy with

20 regard to women; and

21 ‘‘(5) coordinate agency activities on women’s

22 health with the Public Health Service Office on

23 Women’s Health established under section 1710.

24 ‘‘(c) COORDINATING COMMITTEE.—
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1 ‘‘(1) ESTABLISHMENT.—In carrying out sub2 section (b), the Director of the Office shall establish

3 a committee to be known as the Coordinating Com4 mittee on Research on Women’s Health (hereafter

5 referred to in this subsection as the ‘Coordinating

6 Committee’).

7 ‘‘(2) COMPOSITION.—The Coordinating Com8 mittee shall be composed of the Directors of the

9 Offices.

10 ‘‘(3) CHAIRPERSON.—The Director of the Of11 fice shall serve as the chairperson of the Coordinat12 ing Committee.

13 ‘‘(4) DUTIES.—With respect to research on

14 women’s health, the Coordinating Committee shall

15 assist the Director of the Office in—

16 ‘‘(A) identifying the need for such re17 search, and making an estimate each fiscal year

18 of the funds needed to adequately support the

19 research;

20 ‘‘(B) identifying needs regarding the co21 ordination of research activities, including in22 tramural and extramural multidisciplinary ac23 tivities; and

24 ‘‘(C) making recommendations to the Di25 rector of the Agency for Health Care Policy and
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1 Research concerning findings made under sub2 paragraphs (A) and (B).

3 ‘‘(d) REPORTS.—Not later than January 31, 1996,

4 and January 31 of each second year thereafter, the Direc5 tor shall prepare and submit to the Director of the Public

6 Health Service Office of Women’s Health, a report de7 scribing the activities carried out under this section during

8 the preceding 2 fiscal years.’’.

9 SEC. 5. HEALTH RESOURCES AND SERVICES ADMINISTRA10 TION OFFICE OF WOMEN’S HEALTH.

11 Part D of title III of the Public Health Service Act

12 (42 U.S.C. 254b et seq.) is amended—

13 (1) by redesignating section 340D as section

14 340E; and

15 (2) by inserting before section 340E (as so re16 designated) the following:

17 ‘‘Subpart IX—Miscellaneous Provisions

18 ‘‘OFFICE OF WOMEN’S HEALTH

19 ‘‘SEC. 340D. (a) ESTABLISHMENT.—There is estab20 lished within the Office of the Administrator of the Health

21 Resources and Services Administration an office to be

22 known as the Office of Women’s Health (hereafter re23 ferred to in this section as the ‘Office’). The Office shall

24 be headed by a director who shall be appointed by the Di25 rector of the Administration.
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1 ‘‘(b) PURPOSE.—The Director of the Office shall—

2 ‘‘(1) determine the current agency level of activ3 ity regarding women’s health across age, biological,

4 and sociocultural contexts;

5 ‘‘(2) establish short-range and long-range goals

6 and objectives for women’s health and coordinate all

7 other activities within the agency that relate to

8 health care provider training, health service delivery,

9 research, and demonstration projects;

10 ‘‘(3) identify projects in women’s health that

11 should be conducted or supported by the Bureaus;

12 ‘‘(4) consult with health professionals, non-gov13 ernmental organizations, consumer organizations,

14 women’s health professionals, and other individuals

15 and groups, as appropriate, on agency policy with

16 regard to women; and

17 ‘‘(5) coordinate agency activities on women’s

18 health with the Public Health Service Office on

19 Women’s Health established under section 1710.

20 ‘‘(c) COORDINATING COMMITTEE.—

21 ‘‘(1) ESTABLISHMENT.—In carrying out sub22 section (b), the Director of the Office shall establish

23 a committee to be known as the Coordinating Com24 mittee on Research on Women’s Health (hereafter
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1 referred to in this subsection as the ‘Coordinating

2 Committee’).

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

5 Bureaus.

6 ‘‘(3) CHAIRPERSON.—The Director of the Of7 fice shall serve as the Chairperson of the Coordinat8 ing Committee.

9 ‘‘(4) DUTIES.—With respect to research on

10 women’s health, the Coordinating Committee shall

11 assist the Director of the Office in—

12 ‘‘(A) identifying the need for programs and

13 activities that focus on women’s health;

14 ‘‘(B) identifying needs regarding the co15 ordination of activities, including intramural

16 and extramural multidisciplinary activities; and

17 ‘‘(C) making recommendations to the Di18 rector of the Centers for Disease Control and

19 Prevention concerning findings made under

20 subparagraphs (A) and (B).

21 ‘‘(d) REPORTS.—Not later than January 31, 1996,

22 and January 31 of each second year thereafter, the Direc23 tor of the Office shall prepare and submit to the Director

24 of the Public Health Service Office of Women’s Health,
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1 a report describing the activities carried out under this

2 section during the preceding 2 fiscal years.’’.

3 SEC. 6. FOOD AND DRUG ADMINISTRATION OFFICE OF

4 WOMEN’S HEALTH.

5 Chapter IX of the Federal Food, Drug, and Cosmetic

6 Act (21 U.S.C. 391 et seq.) is amended by adding at the

7 end the following section:

8 ‘‘SEC. 906. OFFICE OF WOMEN’S HEALTH.

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

10 the Office of the Commissioner of the Food and Drug Ad11 ministration an office to be known as the Office of Wom12 en’s Health (hereafter referred to in this section as the

13 ‘Office’). The Office shall be headed by a Director who

14 shall be appointed by the Commissioner of the Administra15 tion.

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

17 ‘‘(1) determine current Commission levels of ac18 tivity regarding women’s participation in clinical

19 trials the study of gender differences in the testing

20 of drugs, medical devices, and biological products,

21 across, age, sociocultural, and, where deemed appro22 priate, biological contexts;

23 ‘‘(2) establish short-range and long-range goals

24 and objectives for adequate inclusion of women in all

25 Commission protocols and policies;
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1 ‘‘(3) provide guidance or criteria for drug and

2 device manufacturers to use in determining the ex3 tent and sufficiency of female representation in clini4 cal trials;

5 ‘‘(4) consult with pharmaceutical manufactur6 ers, health professionals with expertise in women’s

7 issues, consumer organizations, and women’s health

8 professionals on Commission policy with regard to

9 women;

10 ‘‘(5) make annual estimates of funds needed to

11 monitor clinical trials in accordance with needs that

12 are identified; and

13 ‘‘(6) coordinate Commission activities on wom14 en’s health with the Public Health Service Office on

15 Women’s Health established under section 1710 of

16 the Public Health Service Act.

17 ‘‘(c) COORDINATING COMMITTEE.—

18 ‘‘(1) ESTABLISHMENT.—In carrying out sub19 section (b), the Director of the Office shall establish

20 a committee to be known as the Coordinating Com21 mittee on Women’s Health (hereafter referred to in

22 this subsection as the ‘Coordinating Committee’).

23 ‘‘(2) COMPOSITION.—The Coordinating Com24 mittee shall be composed of the Directors of the

25 Food and Drug Administration Centers.
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1 ‘‘(3) CHAIRPERSON.—The Director of the Of2 fice shall serve as the Chairperson of the Coordinat3 ing Committee.

4 ‘‘(4) DUTIES.—With respect to studies on wom5 en’s health, the Coordinating Committee shall assist

6 the Director of the Office in—

7 ‘‘(A) identifying the need for further stud8 ies in specific areas of women’s health that fall

9 within the mission of the Commission, and de10 veloping strategies to foster such studies;

11 ‘‘(B) identifying needs regarding the co12 ordination of Commission activities, including

13 intramural and extramural studies;

14 ‘‘(C) maintaining the Commission’s focus

15 in areas of importance to women;

16 ‘‘(D) supporting the development of meth17 odologies to determine the circumstances in

18 which obtaining data specific to women (includ19 ing data relating to the age of women and the

20 membership of women in ethnic or racial

21 groups) is an appropriate function of clinical

22 trials of treatments and therapies;

23 ‘‘(E) supporting the development and ex24 pansion of clinical trials of treatments and

25 therapies for which obtaining such data has
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1 been determined to be an appropriate function;

2 and

3 ‘‘(F) encouraging the Food and Drug Ad4 ministration Centers to conduct and support

5 such studies, including such clinical trials.

6 ‘‘(d) REPORTS.—Not later than January 31, 1996,

7 and January 31 of each second year thereafter, the Direc8 tor shall prepare and submit to the Director of the Public

9 Health Service Office of Women’s Health, a report de10 scribing the activities carried out under this section during

11 the preceding 2 fiscal years.’’.

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