II

106TH CONGRESS

2D SESSION S. 2675

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

and Human Services.

IN THE SENATE OF THE UNITED STATES

JUNE 6, 2000

Ms. SNOWE (for herself and Ms. MIKULSKI) introduced the following bill;

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

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 2000’’.

6 SEC. 2. HEALTH AND HUMAN SERVICES OFFICE ON WOM7 EN’S HEALTH.

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

9 (42 U.S.C. 202 et seq.) is amended by adding at the end

10 the following:
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1 ‘‘SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON

2 WOMEN’S HEALTH.

3 ‘‘(a) ESTABLISHMENT OF OFFICE.—There is estab4 lished within the Office of the Secretary an Office on

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

7 a Deputy Assistant Secretary for Women’s Health.

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

9 health concerns of women—

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

11 and objectives and coordinate all activities within the

12 Department of Health and Human Services that re13 late to disease prevention, health promotion, service

14 delivery, research, and public and health care profes15 sional education concerning women;

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

17 the Secretary concerning scientific, legal ethical, and

18 policy issues relating to women’s health;

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

20 Human Services offices, agencies, and regional ac21 tivities regarding women’s health and stimulate ac22 tivities and facilitate coordination of such depart23 mental and agency offices on women’s health;

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

25 Human Services Coordinating Committee on Wom26 en’s Health to be chaired by the Deputy Assistant
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1 Secretary for Women’s Health which shall be com2 posed of senior level representatives from each of the

3 agencies and offices of the Department of Health

4 and Human Services;

5 ‘‘(5) establish a National Women’s Health In6 formation Center to—

7 ‘‘(A) facilitate the exchange of information

8 regarding matters relating to health informa9 tion and health promotion, preventive health

10 services, research advances, and education in

11 the appropriate use of health care;

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

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

14 problems relating to the matters described in

15 this paragraph; and

16 ‘‘(D) provide technical assistance with re17 spect to the exchange of information (including

18 facilitating the development of materials for

19 such technical assistance);

20 ‘‘(6) coordinate efforts to promote women’s

21 health programs and policies in the private sector;

22 and

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

24 appropriate, provide for the exchange of information

25 between the Office and recipients of grants, con-
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1 tracts, and agreements under subsection (c), and be2 tween the Office and health professionals and the

3 general public.

4 ‘‘(c) GRANTS AND CONTRACTS REGARDING DU5 TIES.—

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

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

8 make grants to, and enter into cooperative agree9 ments, contracts, and interagency agreements with

10 public and nonprofit private entities, agencies, and

11 organizations.

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

13 Office shall directly or through contracts with public

14 and private entities, agencies, and organization, pro15 vide for evaluations of projects carried out with fi16 nancial assistance provided under paragraph (1) and

17 for the dissemination of information developed as a

18 result of such projects.

19 ‘‘(d) REPORTS.—Not later than January 31, 2002,

20 and January 31 of each second year thereafter, the Sec21 retary shall prepare and submit to the appropriate com22 mittees of Congress a report describing the activities car23 ried out under this section during the period for which

24 the report is being prepared.
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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the

2 purpose of carrying out this section, there are authorized

3 to be appropriated such sums as may be necessary for

4 each of the fiscal years 2001 through 2005 .

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

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

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

8 of this section, including all personnel and compensation

9 authority, all delegation and assignment authority, and all

10 remaining appropriations. All orders, determinations,

11 rules, regulations, permits, agreements, grants, contracts,

12 certificates, licenses, registrations, privileges, and other

13 administrative actions—

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

15 allowed to become effective by the President, any

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

17 competent jurisdiction, in the performance of func18 tions which are transferred under this subsection;

19 and

20 ‘‘(2) which are in effect at the time this section

21 takes effect, or were final before the date of enact22 ment of this section and are to become effective on

23 or after such date;

24 shall continue in effect according to their terms until

25 modified, terminated, superseded, set aside, or revoked in
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1 accordance with law by the President, the Deputy Assist2 ant Secretary for Women’s Health or other authorized of3 ficial, a court of competent jurisdiction, or by operation

4 of law.’’.

5 SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVEN6 TION OFFICE OF WOMEN’S HEALTH.

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

8 (42 U.S.C. 241 et seq.) is amended by adding at the end

9 the following:

10 ‘‘SEC. 310A. CENTERS FOR DISEASE CONTROL AND PREVEN11 TION OFFICE OF WOMEN’S HEALTH.

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

13 the Office of the Director of the Centers for Disease Con14 trol and Prevention an office to be known as the Office

15 of Women’s Health (referred to in this section as the ‘Of16 fice’). The Office shall be headed by a director who shall

17 be appointed by the Director of such Centers.

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

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

20 activity regarding women’s health conditions, across

21 age, biological, and sociocultural contexts, in all as22 pects of the Centers work, including prevention pro23 grams, public and professional education, services,

24 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, non10 governmental 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) serve as a member of the Department of

15 Health and Human Services Coordinating Com16 mittee on Women’s Health (established under sec17 tion 229(b)(4)).

18 ‘‘(c) COORDINATING COMMITTEE.—

19 ‘‘(1) ESTABLISHMENT.—In carrying out sub20 section (b), the Director of the Office shall establish

21 a committee to be known as the Coordinating Com22 mittee on Research on Women’s Health (referred to

23 in this subsection as the ‘Coordinating Committee’).
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1 ‘‘(2) COMPOSITION.—The Coordinating Com2 mittee shall be composed of the Directors of the Na3 tional Centers.

4 ‘‘(3) CHAIRPERSON.—The Director of the Of5 fice shall serve as the chairperson of the Coordi6 nating 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, 2002,

20 and January 31 of each second year thereafter, the Direc21 tor of the Office shall prepare and submit to the appro22 priate committees of Congress a report describing the ac23 tivities carried out under this section during the period

24 for which the report is being prepared.
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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 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the

12 purpose of carrying out this section, there are authorized

13 to be appropriated such sums as may be necessary for

14 each of the fiscal years 2001 through 2005 .’’.

15 SEC. 4. AGENCY FOR HEALTHCARE RESEARCH AND QUAL16 ITY OFFICE OF WOMEN’S HEALTH.

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

18 (42 U.S.C. 299c et seq.) is amended—

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

20 and

21 (2) by inserting after section 927 the following:

22 ‘‘SEC. 928. OFFICE OF WOMEN’S HEALTH.

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

24 the Office of the Director of the Agency for Healthcare

25 Research and Quality an office to be known as the Office
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1 of Women’s Health (referred to in this section as the ‘Of2 fice’). The Office shall be headed by a director who shall

3 be appointed by the Director of the Agency.

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

5 ‘‘(1) determine the current Agency level of ac6 tivity regarding women’s health, across age, biologi7 cal, and sociocultural contexts, in all aspects of

8 Agency work, including development of evidence re9 ports and clinical practice protocols, and conducting

10 research into patient outcomes, delivery of health

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

12 care;

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

14 and objectives for research important to women’s

15 health and coordinate all other activities within the

16 Agency that relate to health services and medical ef17 fectiveness research;

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

19 should be conducted or supported by the Agency;

20 ‘‘(4) consult with health professionals, non21 governmental organizations, consumer organizations,

22 women’s health professionals, and other individuals

23 and groups, as appropriate, on Agency policy with

24 regard to women; and
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1 ‘‘(5) serve as a member of the Department of

2 Health and Human Services Coordinating Com3 mittee on Women’s Health (established under sec4 tion 229(b)(4)).

5 ‘‘(c) COORDINATING COMMITTEE.—

6 ‘‘(1) ESTABLISHMENT.—In carrying out sub7 section (b), the Director of the Office shall establish

8 a committee to be known as the Coordinating Com9 mittee on Research on Women’s Health (referred to

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

11 ‘‘(2) COMPOSITION.—The Coordinating Com12 mittee shall be composed of the Directors of the

13 Centers and Offices.

14 ‘‘(3) CHAIRPERSON.—The Director of the Of15 fice shall serve as the chairperson of the Coordi16 nating Committee.

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

18 women’s health, the Coordinating Committee shall

19 assist the Director of the Office in—

20 ‘‘(A) identifying the need for such re21 search, and making an estimate each fiscal year

22 of the funds needed to adequately support the

23 research;

24 ‘‘(B) identifying needs regarding the co25 ordination of research activities, including in-
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1 tramural and extramural multidisciplinary ac2 tivities; and

3 ‘‘(C) making recommendations to the Di4 rector of the Agency concerning findings made

5 under subparagraphs (A) and (B).

6 ‘‘(d) REPORTS.—Not later than January 31, 2002,

7 and January 31 of each second year thereafter, the Direc8 tor of the Office shall prepare and submit to the appro9 priate committees of Congress a report describing the ac10 tivities carried out under this section during the period

11 for which the report is being prepared.

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

13 purpose of carrying out this section, there are authorized

14 to be appropriated such sums as may be necessary for

15 each of the fiscal years 2001 through 2005 .’’.

16 SEC. 5. HEALTH RESOURCES AND SERVICES ADMINISTRA17 TION OFFICE OF WOMEN’S HEALTH.

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

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

20 ‘‘SEC. 713. OFFICE OF WOMEN’S HEALTH.

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

22 the Office of the Administrator of the Health Resources

23 and Services Administration an office to be known as the

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

2 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

6 Bureaus.

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, 2002,

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 2001 through 2005 .’’.

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,

22 and the analysis of data by sex in the testing of

23 drugs, medical devices, biological products, and

24 foods, across age, sociocultural, and where deemed

25 appropriate, 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, 2002,

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 2001 through 2005 .’’.

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