I

107TH CONGRESS

1ST SESSION H. R. 1784

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

and Human Services, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

MAY 9, 2001

Mrs. MORELLA (for herself, Mrs. MALONEY of New York, Mr. WAXMAN, Mr.

TOM DAVIS of Virginia, Ms. SLAUGHTER, Mr. MCNULTY, Mr. HONDA,

Ms. BROWN of Florida, Mrs. THURMAN, Ms. ESHOO, Mr. LANTOS, Ms.

LEE, Mr. WYNN, Mr. FROST, Ms. NORTON, Ms. MCCARTHY of Missouri,

Mr. HILLIARD, Mr. HORN, Ms. BALDWIN, Ms. MILLENDER-MCDONALD,

Mrs. CHRISTENSEN, Ms. DELAURO, Ms. JACKSON-LEE of Texas, Mr.

WEXLER, Ms. SOLIS, Mrs. ROUKEMA, Mr. KILDEE, Ms. KAPTUR, Ms.

HARMAN, Ms. SCHAKOWSKY, Mr. BENTSEN, and Mrs. JONES of Ohio) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To establish an Office on Women’s Health within the Department of Health and Human Services, 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 2001’’.
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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 (referred to in this section as the ‘Of11 fice’). The Office on Women’s Health shall be headed by

12 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 stimulate ac-
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1 tivities and facilitate coordination of such depart2 mental and agency 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 organizations,

21 provide for evaluations of projects carried out with

22 financial assistance provided under paragraph (1)

23 and for the dissemination of information developed

24 as a result of such projects.
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1 ‘‘(d) REPORTS.—Not later than January 31, 2003,

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 2002 through 2006.

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 Deputy Assist8 ant Secretary for Women’s Health or other authorized of9 ficial, a court of competent jurisdiction, or by operation

10 of law.’’.

11 SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVEN12 TION OFFICE OF WOMEN’S HEALTH.

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

14 (42 U.S.C. 241 et seq.) is amended by adding at the end

15 the following:

16 ‘‘CENTERS FOR DISEASE CONTROL AND PREVENTION

17 OFFICE OF WOMEN’S HEALTH

18 ‘‘SEC. 310A. (a) ESTABLISHMENT.—There is estab19 lished within the Office of the Director of the Centers for

20 Disease Control and Prevention an office to be known as

21 the Office of Women’s Health (referred to in this section

22 as the ‘Office’). The Office shall be headed by a director

23 who shall be appointed by the Director of such 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) serve as a member of the Department of

19 Health and Human Services Coordinating Com20 mittee on Women’s Health (established under sec21 tion 229(b)(4)).

22 ‘‘(c) COORDINATING COMMITTEE.—

23 ‘‘(1) ESTABLISHMENT.—In carrying out sub24 section (b), the Director of the Office shall establish

25 a committee to be known as the Coordinating Com-
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1 mittee on Research on Women’s Health (referred to

2 in this subsection as the ‘Coordinating Committee’).

3 ‘‘(2) COMPOSITION.—The Coordinating Com4 mittee shall be composed of the Directors of the Na5 tional Centers.

6 ‘‘(3) CHAIRPERSON.—The Director of the Of7 fice shall serve as the chairperson of the Coordi8 nating 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, 2003,

22 and January 31 of each second year thereafter, the Direc23 tor of the Office shall prepare and submit to the appro24 priate committees of Congress a report describing the ac-
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1 tivities carried out under this section during the period

2 for which the report is being prepared.

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

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

5 age, ethnic, and racial groups, means all diseases, dis6 orders, and conditions—

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

8 in women; and

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

10 type of medical intervention are different for women,

11 or for which it is unknown whether such factors or

12 types are different for women.

13 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the

14 purpose of carrying out this section, there are authorized

15 to be appropriated such sums as may be necessary for

16 each of the fiscal years 2002 through 2006.’’.

17 SEC. 4. AGENCY FOR HEALTHCARE RESEARCH AND QUAL18 ITY OFFICE OF WOMEN’S HEALTH.

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

20 (42 U.S.C. 299c et seq.) is amended—

21 (1) by redesignating section 928 as section 929;

22 and

23 (2) by inserting after section 927 the following:
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1 ‘‘SEC. 928. OFFICE OF WOMEN’S HEALTH.

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

3 the Office of the Director of the Agency for Healthcare

4 Research and Quality an office to be known as the Office

5 of Women’s Health (referred to in this section as the ‘Of6 fice’). The Office shall be headed by a director who shall

7 be appointed by the Director of the Agency.

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

9 ‘‘(1) determine the current Agency level of ac10 tivity regarding women’s health, across age, biologi11 cal, and sociocultural contexts, in all aspects of

12 Agency work, including development of evidence re13 ports and clinical practice protocols, and conducting

14 research into patient outcomes, delivery of health

15 care services, quality of care, and access to health

16 care;

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

18 and objectives for research important to women’s

19 health and coordinate all other activities within the

20 Agency that relate to health services and medical ef21 fectiveness research;

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

23 should be conducted or supported by the Agency;

24 ‘‘(4) consult with health professionals, non25 governmental organizations, consumer organizations,

26 women’s health professionals, and other individuals
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1 and groups, as appropriate, on Agency policy with

2 regard to women; and

3 ‘‘(5) serve as a member of the Department of

4 Health and Human Services Coordinating Com5 mittee on Women’s Health (established under sec6 tion 229(b)(4)).

7 ‘‘(c) COORDINATING COMMITTEE.—

8 ‘‘(1) ESTABLISHMENT.—In carrying out sub9 section (b), the Director of the Office shall establish

10 a committee to be known as the Coordinating Com11 mittee on Research on Women’s Health (referred to

12 in this subsection as the ‘Coordinating Committee’).

13 ‘‘(2) COMPOSITION.—The Coordinating Com14 mittee shall be composed of the Directors of the

15 Centers and Offices.

16 ‘‘(3) CHAIRPERSON.—The Director of the Of17 fice shall serve as the chairperson of the Coordi18 nating Committee.

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

20 women’s health, the Coordinating Committee shall

21 assist the Director of the Office in—

22 ‘‘(A) identifying the need for such re23 search, and making an estimate each fiscal year

24 of the funds needed to adequately support the

25 research;
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1 ‘‘(B) identifying needs regarding the co2 ordination of research activities, including in3 tramural and extramural multidisciplinary ac4 tivities; and

5 ‘‘(C) making recommendations to the Di6 rector of the Agency concerning findings made

7 under subparagraphs (A) and (B).

8 ‘‘(d) REPORTS.—Not later than January 31, 2003,

9 and January 31 of each second year thereafter, the Direc10 tor of the Office shall prepare and submit to the appro11 priate committees of Congress a report describing the ac12 tivities carried out under this section during the period

13 for which the report is being prepared.

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

15 purpose of carrying out this section, there are authorized

16 to be appropriated such sums as may be necessary for

17 each of the fiscal years 2002 through 2006.’’.

18 SEC. 5. HEALTH RESOURCES AND SERVICES ADMINISTRA19 TION OFFICE OF WOMEN’S HEALTH.

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

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

22 ‘‘OFFICE OF WOMEN’S HEALTH

23 ‘‘SEC. 713. (a) ESTABLISHMENT.—There is estab24 lished within the Office of the Administrator of the Health

25 Resources and Services Administration an office to be

26 known as the Office of Women’s Health (referred to in
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1 this section as the ‘Office’). The Office shall be headed

2 by a director who shall be appointed by the Administrator.

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;

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

8 and objectives for women’s health and coordinate all

9 other activities within the Agency that relate to

10 health care provider training, health service delivery,

11 research, and demonstration projects;

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

13 should be conducted or supported by the Bureaus;

14 ‘‘(4) consult with health professionals, non-gov15 ernmental organizations, consumer organizations,

16 women’s health professionals, and other individuals

17 and groups, as appropriate, on Agency policy with

18 regard to women; and

19 ‘‘(5) serve as a member of the Department of

20 Health and Human Services Coordinating Com21 mittee on Women’s Health (established under sec22 tion 229(b)(4) of the Public Health Service Act).

23 ‘‘(c) COORDINATING COMMITTEE.—

24 ‘‘(1) ESTABLISHMENT.—In carrying out sub25 section (b), the Director of the Office shall establish
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1 a committee to be known as the Coordinating Com2 mittee on Research on Women’s Health (referred to

3 in this subsection as the ‘Coordinating Committee’).

4 ‘‘(2) COMPOSITION.—The Coordinating Com5 mittee shall be composed of the Directors of the Bu6 reaus.

7 ‘‘(3) CHAIRPERSON.—The Director of the Of8 fice shall serve as the Chairperson of the Coordi9 nating Committee.

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

11 women’s health, the Coordinating Committee shall

12 assist the Director of the Office in—

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

14 activities that focus on women’s health;

15 ‘‘(B) identifying needs regarding the co16 ordination of activities, including intramural

17 and extramural multidisciplinary activities; and

18 ‘‘(C) making recommendations to the Ad19 ministrator of the Health Resources and Serv20 ices Administration concerning findings made

21 under subparagraphs (A) and (B).

22 ‘‘(d) REPORTS.—Not later than January 31, 2003,

23 and January 31 of each second year thereafter, the Direc24 tor of the Office shall prepare and submit to the appro25 priate committees of Congress a report describing the ac-
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1 tivities carried out under this section during the period

2 for which the report is being prepared.

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

4 purpose of carrying out this section, there are authorized

5 to be appropriated such sums as may be necessary for

6 each of the fiscal years 2002 through 2006.’’.

7 SEC. 6. FOOD AND DRUG ADMINISTRATION OFFICE OF

8 WOMEN’S HEALTH.

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

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

11 end the following:

12 ‘‘SEC. 908. OFFICE OF WOMEN’S HEALTH.

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

14 the Office of the Commissioner of the Food and Drug Ad15 ministration an office to be known as the Office of Wom16 en’s Health (referred to in this section as the ‘Office’).

17 The Office shall be headed by a director who shall be ap18 pointed by the Commissioner.

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

20 ‘‘(1) determine current Agency levels of activity

21 regarding women’s participation in clinical trials and

22 the analysis of data by sex in the testing of drugs,

23 medical devices, biological products, and foods across

24 age, sociocultural, and where deemed appropriate,

25 biological contexts;
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1 ‘‘(2) establish short-range and long-range goals

2 and objectives for all issues of women’s health within

3 the jurisdiction of the Food and Drug Administra4 tion, including adequate inclusion of women and

5 analysis of data by sex in all Agency protocols and

6 policies;

7 ‘‘(3) provide guidance or criteria for drug, bio8 logics, and device manufacturers to use in deter9 mining the extent and sufficiency of female rep10 resentation in clinical trials and provide information

11 to women and health care providers on those areas

12 in which differences between men and women exist;

13 ‘‘(4) consult with pharmaceutical manufactur14 ers, health professionals with expertise in women’s

15 issues, consumer organizations, and women’s health

16 professionals on Agency policy with regard to

17 women;

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

19 monitor clinical trials and analysis of data by sex in

20 accordance with needs that are identified; and

21 ‘‘(6) serve as a member of the Department of

22 Health and Human Services Coordinating Com23 mittee on Women’s Health (established under sec24 tion 229(b)(4) of the Public Health Service Act).

25 ‘‘(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 Women’s Health (referred to in this sub5 section as the ‘Coordinating Committee’).

6 ‘‘(2) COMPOSITION.—The Coordinating Com7 mittee shall be composed of the Directors of the

8 Food and Drug Administration Centers.

9 ‘‘(3) CHAIRPERSON.—The Director of the Of10 fice shall serve as the Chairperson of the Coordi11 nating Committee.

12 ‘‘(4) DUTIES.—With respect to studies on wom13 en’s health, the Coordinating Committee shall assist

14 the Director of the Office in—

15 ‘‘(A) identifying the need for further stud16 ies and issues in specific areas of women’s

17 health that fall within the mission of the Agen18 cy, and developing strategies to foster such

19 studies;

20 ‘‘(B) identifying needs regarding the co21 ordination of Agency activities, including inter22 nal and external activities;

23 ‘‘(C) maintaining the Agency’s focus in

24 areas of importance to women;
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1 ‘‘(D) supporting the development of meth2 odologies to determine how to obtain data spe3 cific to women (including data relating to the

4 age of women and the membership of women in

5 ethnic or racial groups);

6 ‘‘(E) supporting the development and ex7 pansion of clinical trials of treatments and

8 therapies for which obtaining such data has

9 been determined to be an appropriate function;

10 and

11 ‘‘(F) encouraging the Food and Drug Ad12 ministration Centers to conduct and support

13 such studies, including such clinical trials.

14 ‘‘(d) REPORTS.—Not later than January 31, 2003,

15 and January 31 of each second year thereafter, the Direc16 tor of the Office shall prepare and submit to the appro17 priate committees of Congress a report describing the ac18 tivities carried out under this section during the period

19 for which the report is being prepared.

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

21 purpose of carrying out this section, there are authorized

22 to be appropriated such sums as may be necessary for

23 each of the fiscal years 2002 through 2006.’’.

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