I

105TH CONGRESS

1ST SESSION H. R. 920

To establish an Office on Women’s Health within the Department of Health

and Human Services.

IN THE HOUSE OF REPRESENTATIVES

MARCH 4, 1997

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

NORTON, Mr. GREENWOOD, Ms. SLAUGHTER, Mr. WAXMAN, Mr.

MCHUGH, Mrs. MALONEY of New York, Mr. FAZIO of California, Ms.

SANCHEZ, Mr. ROMERO-BARCELO ́, Mrs. CARSON, Mrs. MEEK of Florida,

Mr. OBERSTAR, Mr. DELLUMS, Mr. DELAHUNT, Mr. BALDACCI, Mr.

EVANS, Mr. FROST, Ms. FURSE, and Mrs. KELLY) introduced the following bill; which was referred to the Committee on Commerce

A BILL

To establish an Office on Women’s Health within the

Department of Health and Human Services.

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 1997’’.
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1 SEC. 2. HEALTH AND HUMAN SERVICES OFFICE ON WOM2 EN’S HEALTH.

3 Part A of title II of the Public Health Service Act

4 (42 U.S.C. 202 et seq.) is amended by adding at the end

5 the following:

6 ‘‘SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON

7 WOMEN’S HEALTH.

8 ‘‘(a) ESTABLISHMENT OF OFFICE.—There is estab9 lished within the Office of the Secretary an Office on

10 Women’s Health (hereafter referred to in this section as

11 the ‘Office’). The Office on Women’s Health shall be head12 ed by a Deputy Assistant Secretary for Women’s Health.

13 ‘‘(b) DUTIES.—The Office shall, with respect to the

14 health concerns of women—

15 ‘‘(1) establish short-range and long-range goals

16 and objectives and coordinate all activities within the

17 Department of Health and Human Services that re18 late to disease prevention, health promotion, service

19 delivery, research, and public and health care profes20 sional education concerning women;

21 ‘‘(2) provide expert advice and consultation to

22 the Secretary concerning scientific, legal ethical, and

23 policy issues relating to women’s health;

24 ‘‘(3) monitor the Department of Health and

25 Human Services offices, agencies, and regional ac26 tivities regarding women’s health and coordinate and
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1 stimulate activities of such departmental and agency

2 offices on women’s health;

3 ‘‘(4) establish a Department of Health and

4 Human Services Coordinating Committee on Wom5 en’s Health to be chaired by the Deputy Assistant

6 Secretary for Women’s Health which shall be com7 posed of senior level representatives from each of the

8 agencies and offices of the Department of Health

9 and Human Services;

10 ‘‘(5) establish a National Women’s Health In11 formation Center to—

12 ‘‘(A) facilitate the exchange of information

13 regarding matters relating to health informa14 tion and health promotion, preventive health

15 services, research advances, and education in

16 the appropriate use of health care;

17 ‘‘(B) facilitate access to such information;

18 ‘‘(C) assist in the analysis of issues and

19 problems relating to the matters described in

20 this paragraph; and

21 ‘‘(D) provide technical assistance with re22 spect to the exchange of information (including

23 facilitating the development of materials for

24 such technical assistance);
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1 ‘‘(6) coordinate efforts to promote women’s

2 health programs and policies in the private sector;

3 and

4 ‘‘(7) through publications and any other means

5 appropriate, provide for the exchange of information

6 between the Office and recipients of grants, con7 tracts, and agreements under subsection (c), and be8 tween the Office and health professionals and the

9 general public.

10 ‘‘(c) GRANTS AND CONTRACTS REGARDING DU11 TIES.—

12 ‘‘(1) AUTHORITY.—In carrying out subsection

13 (b), the Secretary, acting through the Office, may

14 make grants to, and enter into cooperative agree15 ments, contracts, and interagency agreements with

16 public and nonprofit private entities, agencies, and

17 organizations.

18 ‘‘(2) EVALUATION AND DISSEMINATION.—The

19 Office shall directly or through contracts with public

20 and private entities, agencies, and organization, pro21 vide for evaluations of projects carried out with fi22 nancial assistance provided under paragraph (1) and

23 for the dissemination of information developed as a

24 result of such projects.
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1 ‘‘(d) REPORTS.—Not later than January 31, 1998,

2 and January 31 of each second year thereafter, the Sec3 retary shall prepare and submit to the appropriate com4 mittees of Congress a report describing the activities car5 ried out under this section during the period for which

6 the report is being prepared.

7 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the

8 purpose of carrying out this section, there are authorized

9 to be appropriated such sums as may be necessary for

10 each of the fiscal years 1998 through 2001.

11 ‘‘(f) TRANSFER.—There are transferred to the Office,

12 all functions exercised by the Office on Women’s Health

13 of the Public Health Service prior to the date of enactment

14 of this section, including all personnel and compensation

15 authority, all delegation and assignment authority, and all

16 remaining appropriations. All orders, determinations,

17 rules, regulations, permits, agreements, grants, contracts,

18 certificates, licenses, registrations, privileges, and other

19 administrative actions—

20 ‘‘(1) which have been issued, made, granted, or

21 allowed to become effective by the President, any

22 Federal agency or official thereof, or by a court of

23 competent jurisdiction, in the performance of func24 tions which are transferred under this subsection;

25 and
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1 ‘‘(2) which are in effect at the time this section

2 takes effect, or were final before the date of enact3 ment of this section and are to become effective on

4 or after such date;

5 shall continue in effect according to their terms until

6 modified, terminated, superseded, set aside, or revoked in

7 accordance with law by the President, the Assistant Sec8 retary for Women’s Health or other authorized official, a

9 court of competent jurisdiction, or by operation of law.’’.

10 SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVEN11 TION OFFICE OF WOMEN’S HEALTH.

12 Part A of title III of the Public Health Service Act

13 (42 U.S.C. 241 et seq.) is amended by adding at the end

14 the following:

15 ‘‘CENTERS FOR DISEASE CONTROL AND PREVENTION

16 OFFICE OF WOMEN’S HEALTH

17 ‘‘SEC. 310A. (a) ESTABLISHMENT.—There is estab18 lished within the Office of the Director of the Centers for

19 Disease Control and Prevention an office to be known as

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

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

22 director who shall be appointed by the Director of the

23 Centers.

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

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

26 activity regarding women’s health conditions, across
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1 age, biological, and sociocultural contexts, in all as2 pects of the Centers work, including prevention pro3 grams, public and professional education, services,

4 and treatment;

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

6 and objectives for women’s health and coordinate all

7 other activities within the Centers that relate to pre8 vention, research, education and training, service de9 livery, and policy development;

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

11 should be conducted or supported by the National

12 Centers;

13 ‘‘(4) consult with health professionals, non14 governmental organizations, consumer organizations,

15 women’s health professionals, and other individuals

16 and groups, as appropriate, on the policy of the Cen17 ters with regard to women; and

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

19 health with the Office on Women’s Health estab20 lished under section 229.

21 ‘‘(c) COORDINATING COMMITTEE.—

22 ‘‘(1) ESTABLISHMENT.—In carrying out sub23 section (b), the Director of the Office shall establish

24 a committee to be known as the Coordinating Com25 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 National Centers.

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 women’s health,

10 the Coordinating Committee shall assist the Director

11 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, 1998,

22 and January 31 of each second year thereafter, the Direc23 tor shall prepare and submit to the Director of the Office
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1 on Women’s Health established under section 229, a re2 port describing the activities carried out under this section

3 during the preceding 2 fiscal years.

4 ‘‘(e) DEFINITION.—As used in this section the term

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

6 age, ethnic, and racial groups, means all diseases, dis7 orders, and conditions—

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

9 in women; and

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

11 type of medical intervention are different for women,

12 or for which it is unknown whether such factors or

13 types are different for women.’’.

14 SEC. 4. AGENCY FOR HEALTH CARE POLICY AND RE15 SEARCH OFFICE OF WOMEN’S HEALTH.

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

17 (42 U.S.C. 299c et seq.) is amended—

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

19 and

20 (2) by inserting after section 926 the following:

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

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

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

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

25 of Women’s Health (hereafter referred to in this section
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1 as the ‘Office’). The Office shall be headed by a Director

2 who shall be appointed by the Director of the Agency.

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

4 ‘‘(1) determine the current Agency level of ac5 tivity regarding women’s health, across age, biologi6 cal, and sociocultural contexts, in all aspects of

7 Agency work, including drafting clinical practice

8 guidelines, and conducting research into patient out9 comes, delivery of health care services, and access to

10 health care;

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

12 and objectives for research important to women’s

13 health and coordinate all other activities within the

14 Agency that relate to health services and medical

15 effectiveness research;

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

17 should be conducted or supported by the Agency;

18 ‘‘(4) consult with health professionals, non19 governmental organizations, consumer organizations,

20 women’s health professionals, and other individuals

21 and groups, as appropriate, on Agency policy with

22 regard to women; and

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

24 health with the Office of Women’s Health estab25 lished under section 310A.
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1 ‘‘(c) COORDINATING COMMITTEE.—

2 ‘‘(1) ESTABLISHMENT.—In carrying out sub3 section (b), the Director of the Office shall establish

4 a committee to be known as the Coordinating Com5 mittee on Research on Women’s Health (hereafter

6 referred to in this subsection as the ‘Coordinating

7 Committee’).

8 ‘‘(2) COMPOSITION.—The Coordinating Com9 mittee shall be composed of the Directors of the

10 Offices.

11 ‘‘(3) CHAIRPERSON.—The Director of the Of12 fice shall serve as the chairperson of the Coordinat13 ing Committee.

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

15 women’s health, the Coordinating Committee shall

16 assist the Director of the Office in—

17 ‘‘(A) identifying the need for such re18 search, and making an estimate each fiscal year

19 of the funds needed to adequately support the

20 research;

21 ‘‘(B) identifying needs regarding the co22 ordination of research activities, including in23 tramural and extramural multidisciplinary ac24 tivities; and
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1 ‘‘(C) making recommendations to the Di2 rector of the Agency for Health Care Policy and

3 Research concerning findings made under sub4 paragraphs (A) and (B).

5 ‘‘(d) REPORTS.—Not later than January 31, 1998,

6 and January 31 of each second year thereafter, the Direc7 tor shall prepare and submit to the Director of the Office

8 on Women’s Health established under section 229, a re9 port describing the activities carried out under this section

10 during the preceding 2 fiscal years.’’.

11 SEC. 5. HEALTH RESOURCES AND SERVICES ADMINISTRA12 TION OFFICE OF WOMEN’S HEALTH.

13 Title VII of the Social Security Act (42 U.S.C. 901

14 et seq.) is amended by adding at the end the following:

15 ‘‘OFFICE OF WOMEN’S HEALTH

16 ‘‘SEC. 713. (a) ESTABLISHMENT.—There is estab17 lished within the Office of the Administrator of the Health

18 Resources and Services Administration an office to be

19 known as the Office of Women’s Health (hereafter re20 ferred to in this section as the ‘Office’). The Office shall

21 be headed by a director who shall be appointed by the Di22 rector of the Administration.

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

24 ‘‘(1) determine the current agency level of activ25 ity regarding women’s health across age, biological,

26 and sociocultural contexts;
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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 agency that relate to

4 health care provider training, health service delivery,

5 research, and demonstration projects;

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

7 should be conducted or supported by the Bureaus;

8 ‘‘(4) consult with health professionals, non-gov9 ernmental organizations, consumer organizations,

10 women’s health professionals, and other individuals

11 and groups, as appropriate, on agency policy with

12 regard to women; and

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

14 health with the Office of Women’s Health estab15 lished under section 310A of the Public Health Serv16 ice 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 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 Bureaus.

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 research on

8 women’s health, the Coordinating Committee shall

9 assist the Director 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, 1998,

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

22 of the Office on Women’s Health established under section

23 229 of the Public Health Service Act, a report describing

24 the activities carried out under this section during the pre25 ceding 2 fiscal years.’’.
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1 SEC. 6. FOOD AND DRUG ADMINISTRATION OFFICE OF

2 WOMEN’S HEALTH.

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

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

5 end the following:

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

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

8 the Office of the Commissioner of the Food and Drug Ad9 ministration an office to be known as the Office of Wom10 en’s Health (hereafter referred to in this section as the

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

12 shall be appointed by the Commissioner of the Administra13 tion.

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

15 ‘‘(1) determine current Commission levels of ac16 tivity regarding women’s participation in clinical

17 trials the study of gender differences in the testing

18 of drugs, medical devices, and biological products,

19 across, age, sociocultural, and, where deemed appro20 priate, biological contexts;

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

22 and objectives for adequate inclusion of women in all

23 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 Office of Women’s Health estab15 lished under section 310A of the Public Health Serv16 ice 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, 1998,

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

9 on Women’s Health established under section 229 of the

10 Public Health Service Act, a report describing the activi11 ties carried out under this section during the preceding

12 2 fiscal years.’’.

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