IIB 

107TH CONGRESS 

2D SESSION H. R. 1784

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 18, 2002

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT

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,
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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Women’s Health Office 

3 Act of 2002’’. 

4 SEC. 2. HEALTH AND HUMAN SERVICES OFFICE ON WOM5 EN’S HEALTH. 

6 (a) ESTABLISHMENT.—Part A of title II of the Pub7 lic Health Service Act (42 U.S.C. 202 et seq.) is amended 

8 by adding at the end the following: 

9 ‘‘HEALTH AND HUMAN SERVICES OFFICE ON WOMEN’S

10 HEALTH

11 ‘‘SEC. 229. (a) ESTABLISHMENT OF OFFICE.—The 

12 Secretary shall establish through the last date for which 

13 appropriations are authorized under subsection (e), within 

14 the Office of the Secretary, an Office on Women’s Health 

15 (referred to in this section as the ‘Office’). The Office shall 

16 be headed by a Deputy Assistant Secretary for Women’s 

17 Health. 

18 ‘‘(b) DUTIES.—The Secretary, acting through the Of19 fice, with respect to the health concerns of women, shall—

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

21 and objectives within the Department of Health and 

22 Human Services and, as relevant and appropriate, 

23 coordinate with other appropriate offices on activi24 ties within the Department that relate to disease 

25 prevention, health promotion, service delivery, re-
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1 search, and public and health care professional edu2 cation, for issues of particular concern to women; 

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

4 the Secretary concerning scientific, legal, ethical, 

5 and policy issues relating to women’s health; 

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

7 Human Services’ offices, agencies, and regional ac8 tivities regarding women’s health and stimulate ac9 tivities and facilitate coordination of such depart10 mental and agency offices on women’s health; 

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

12 Human Services Coordinating Committee on Wom13 en’s Health, which shall be chaired by the Deputy 

14 Assistant Secretary for Women’s Health and com15 posed of senior level representatives from each of the 

16 agencies and offices of the Department of Health 

17 and Human Services; 

18 ‘‘(5) establish a National Women’s Health In19 formation Center to—

20 ‘‘(A) facilitate the exchange of information 

21 regarding matters relating to health informa22 tion, health promotion, preventive health serv23 ices, research advances, and education in the 

24 appropriate use of health care; 

25 ‘‘(B) facilitate access to such information; 
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1 ‘‘(C) assist in the analysis of issues and 

2 problems relating to the matters described in 

3 this paragraph; and 

4 ‘‘(D) provide technical assistance with re5 spect to the exchange of information (including 

6 facilitating the development of materials for 

7 such technical assistance); 

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

9 health programs and policies with the private sector; 

10 and 

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

12 appropriate, provide for the exchange of information 

13 between the Office and recipients of grants, con14 tracts, and agreements under subsection (c), and be15 tween the Office and health professionals and the 

16 general public. 

17 ‘‘(c) GRANTS AND CONTRACTS REGARDING DU18 TIES.—

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

20 (b), the Secretary may make grants to, and enter 

21 into cooperative agreements, contracts, and inter22 agency agreements with, public and private entities, 

23 agencies, and organizations. 

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

25 Secretary shall directly or through contracts with 
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1 public and private entities, agencies, and organiza2 tions, provide for evaluations of projects carried out 

3 with financial assistance provided under paragraph 

4 (1) and for the dissemination of information devel5 oped as a result of such projects. 

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

7 and January 31 of each second year thereafter, the Sec8 retary shall prepare and submit to the appropriate com9 mittees of Congress a report describing the activities car10 ried out under this section during the period for which 

11 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 2003 through 2007.’’. 

16 (b) TRANSFER OF FUNCTIONS.—There are trans17 ferred to the Office on Women’s Health (established under 

18 section 229 of the Public Health Service Act, as added 

19 by this section), all functions exercised by the Office on 

20 Women’s Health of the Public Health Service prior to the 

21 date of enactment of this section, including all personnel 

22 and compensation authority, all delegation and assign23 ment authority, and all remaining appropriations. All or24 ders, determinations, rules, regulations, permits, agree-
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1 ments, grants, contracts, certificates, licenses, registra2 tions, privileges, and other administrative actions that—

3 (1) have been issued, made, granted, or allowed 

4 to become effective by the President, any Federal 

5 agency or official thereof, or by a court of competent 

6 jurisdiction, in the performance of functions trans7 ferred under this subsection; and 

8 (2) are in effect at the time this section takes 

9 effect, or were final before the date of enactment of 

10 this section and are to become effective on or after 

11 such date; 

12 shall continue in effect according to their terms until 

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

14 accordance with law by the President, the Secretary, or 

15 other authorized official, a court of competent jurisdiction, 

16 or by operation of law. 

17 SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVEN18 TION OFFICE OF WOMEN’S HEALTH. 

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

20 (42 U.S.C. 241 et seq.) is amended by adding at the end 

21 the following: 

22 ‘‘CENTERS FOR DISEASE CONTROL AND PREVENTION

23 OFFICE OF WOMEN’S HEALTH

24 ‘‘SEC. 310A. (a) ESTABLISHMENT.—The Secretary 

25 shall establish through the last date for which appropria26 tions are authorized under subsection (f), within the Office 
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1 of the Director of the Centers for Disease Control and 

2 Prevention, an office to be known as the Office of Wom3 en’s Health (referred to in this section as the ‘Office’). 

4 The Office shall be headed by a director who shall be ap5 pointed by the Director of such Centers. 

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

7 ‘‘(1) report to the Director of the Centers for 

8 Disease Control and Prevention on the current level 

9 of the Centers’ activity regarding women’s health 

10 conditions across, where appropriate, age, biological, 

11 and sociocultural contexts, in all aspects of the Cen12 ters’ work, including prevention programs, public 

13 and professional education, services, and treatment; 

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

15 and objectives within the Centers for women’s health 

16 and, as relevant and appropriate, coordinate with 

17 other appropriate offices on activities within the 

18 Centers that relate to prevention, research, edu19 cation and training, service delivery, and policy de20 velopment, for issues of particular concern to 

21 women; 

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

23 should be conducted or supported by the Centers; 

24 ‘‘(4) consult with health professionals, non25 governmental organizations, consumer organizations, 
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1 women’s health professionals, and other individuals 

2 and groups, as appropriate, on the policy of the Cen3 ters with regard to women; and 

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

5 Health and Human Services Coordinating Com6 mittee on Women’s Health (established under sec7 tion 229(b)(4)). 

8 ‘‘(c) COORDINATING COMMITTEE.—

9 ‘‘(1) ESTABLISHMENT.—In carrying out sub10 section (b), the Director of the Office shall establish 

11 a committee to be known as the Coordinating Com12 mittee on Research on Women’s Health (referred to 

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

14 ‘‘(2) COMPOSITION.—The Coordinating Com15 mittee shall be composed of the directors of the na16 tional centers and other appropriate officials of the 

17 Centers for Disease Control and Prevention. 

18 ‘‘(3) CHAIRPERSON.—The Director of the Of19 fice shall serve as the Chairperson of the Coordi20 nating Committee. 

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

22 the Coordinating Committee shall assist the Director 

23 of the Office in—

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

25 activities that focus on women’s health; 
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1 ‘‘(B) identifying needs regarding the co2 ordination of activities, including intramural 

3 and extramural multidisciplinary activities; and 

4 ‘‘(C) making recommendations to the Di5 rector of the Centers for Disease Control and 

6 Prevention concerning findings made under 

7 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) DEFINITION.—As used in this section, the term 

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

16 age, ethnic, and racial groups, means diseases, disorders, 

17 and conditions—

18 ‘‘(1) unique to, significantly more serious for, 

19 or significantly more prevalent in women; and 

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

21 type of medical intervention are different for women. 

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

23 purpose of carrying out this section, there are authorized 

24 to be appropriated such sums as may be necessary for 

25 each of the fiscal years 2003 through 2007.’’. 
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1 SEC. 4. AGENCY FOR HEALTHCARE RESEARCH AND QUAL2 ITY ACTIVITIES REGARDING WOMEN’S 

3 HEALTH. 

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

5 (42 U.S.C. 299c et seq.) is amended—

6 (1) by redesignating sections 927 and 928 as 

7 sections 928 and 929, respectively; 

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

9 ‘‘SEC. 927. ACTIVITIES REGARDING WOMEN’S HEALTH. 

10 ‘‘(a) ESTABLISHMENT.—The Director shall designate 

11 an official of the Office of Priority Populations to carry 

12 out, through the last date for which appropriations are 

13 authorized under section 928(e), the responsibilities de14 scribed in this section for such official. 

15 ‘‘(b) PURPOSE.—The official designated under sub16 section (a) shall—

17 ‘‘(1) report to the Director on the current 

18 Agency level of activity regarding women’s health, 

19 across, where appropriate, age, biological, and 

20 sociocultural contexts, in all aspects of Agency work, 

21 including the development of evidence reports and 

22 clinical practice protocols and the conduct of re23 search into patient outcomes, delivery of health care 

24 services, quality of care, and access to health care; 

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

26 and objectives within the Agency for research impor-
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1 tant to women’s health and, as relevant and appro2 priate, coordinate with other appropriate offices on 

3 activities within the Agency that relate to health 

4 services and medical effectiveness research, for 

5 issues of particular concern to women; 

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

7 should be conducted or supported by the Agency; 

8 ‘‘(4) consult with health professionals, non9 governmental 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) serve as a member of the Department of 

14 Health and Human Services Coordinating Com15 mittee on Women’s Health (established under sec16 tion 229(b)(4)). 

17 ‘‘(c) COORDINATING COMMITTEE.—

18 ‘‘(1) ESTABLISHMENT.—In carrying out sub19 section (b), the official designated under subsection 

20 (a) shall establish a committee to be known as the 

21 Coordinating Committee on Research on Women’s 

22 Health (referred to in this subsection as the ‘Coordi23 nating Committee’). 

24 ‘‘(2) COMPOSITION.—The Coordinating Com25 mittee shall be composed of the official designated 
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1 under subsection (a) and the directors of the centers 

2 and offices of the Agency. 

3 ‘‘(3) CHAIRPERSON.—The official designated 

4 under subsection (a) shall serve as the Chairperson 

5 of the Coordinating Committee. 

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

7 women’s health, the Coordinating Committee shall 

8 assist the official designated under subsection (a) 

9 in—

10 ‘‘(A) identifying the need for such re11 search, and making an estimate each fiscal year 

12 of the funds needed to adequately support the 

13 research; 

14 ‘‘(B) identifying needs regarding the co15 ordination of research activities, including in16 tramural and extramural multidisciplinary ac17 tivities; and 

18 ‘‘(C) making recommendations to the Di19 rector of the Agency concerning findings made 

20 under subparagraphs (A) and (B). 

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

22 and January 31 of each second year thereafter, the official 

23 designated under subsection (a) shall prepare and submit 

24 to the appropriate committees of Congress a report de-
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1 scribing the activities carried out under this section during 

2 the period for which the report is being prepared.’’; and 

3 (3) by adding at the end of section 928 (as re4 designated by paragraph (1)) the following: 

5 ‘‘(e) WOMEN’S HEALTH.—For the purpose of car6 rying out section 927 regarding women’s health, there are 

7 authorized to be appropriated such sums as may be nec8 essary for each of the fiscal years 2003 through 2007.’’. 

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

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

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

13 ‘‘OFFICE OF WOMEN’S HEALTH

14 ‘‘SEC. 713. (a) ESTABLISHMENT.—The Secretary 

15 shall establish through the last date for which appropria16 tions are authorized under subsection (f), within the Office 

17 of the Administrator of the Health Resources and Services 

18 Administration, an office to be known as the Office of 

19 Women’s Health. The Office shall be headed by a director 

20 who shall be appointed by the Administrator. 

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

22 ‘‘(1) report to the Administrator on the current 

23 Administration level of activity regarding women’s 

24 health across, where appropriate, age, biological, and 

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

2 and objectives within the Health Resources and 

3 Services Administration for women’s health and, as 

4 relevant and appropriate, coordinate with other ap5 propriate offices on activities within the Administra6 tion that relate to health care provider training, 

7 health service delivery, research, and demonstration 

8 projects, for issues of particular concern to women; 

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

10 should be conducted or supported by the bureaus of 

11 the Administration; 

12 ‘‘(4) consult with health professionals, non13 governmental organizations, consumer organizations, 

14 women’s health professionals, and other individuals 

15 and groups, as appropriate, on Administration policy 

16 with regard to women; and 

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

18 Health and Human Services Coordinating Com19 mittee on Women’s Health (established under sec20 tion 229(b)(4) of the Public Health Service Act). 

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 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 bu5 reaus of the Administration. 

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 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 Ad18 ministrator concerning findings made under 

19 subparagraphs (A) and (B). 

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

21 and January 31 of each second year thereafter, the Direc22 tor of the Office shall prepare and submit to the appro23 priate committees of Congress a report describing the ac24 tivities carried out under this section during the period 

25 for which the report is being prepared. 
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1 ‘‘(e) DEFINITIONS.—For purposes of this section: 

2 ‘‘(1) ADMINISTRATION.—The term ‘Administra3 tion’ means the Health Resources and Services Ad4 ministration. 

5 ‘‘(2) ADMINISTRATOR.—The term ‘Adminis6 trator’ means the Administrator of the Health Re7 sources and Services Administration. 

8 ‘‘(3) OFFICE.—The term ‘Office’ means the Of9 fice of Women’s Health established under this sec10 tion in the Administration. 

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 2003 through 2007.’’. 

15 SEC. 6. FOOD AND DRUG ADMINISTRATION OFFICE OF 

16 WOMEN’S HEALTH. 

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

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

19 end the following: 

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

21 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab22 lish through the last date for which appropriations are au23 thorized under subsection (e), within the Office of the 

24 Commissioner, an office to be known as the Office of 

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

2 be appointed by the Commissioner of Food and Drugs. 

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

4 ‘‘(1) report to the Commissioner of Food and 

5 Drugs on current Food and Drug Administration 

6 (referred to in this section as the ‘Administration’) 

7 levels of activity regarding women’s participation in 

8 clinical trials and the analysis of data by sex in the 

9 testing of drugs, medical devices, and biological 

10 products across, where appropriate, age, biological, 

11 and sociocultural contexts; 

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

13 and objectives within the Administration for issues 

14 of particular concern to women’s health within the 

15 jurisdiction of the Administration, including, where 

16 relevant and appropriate, adequate inclusion of 

17 women and analysis of data by sex in Administration 

18 protocols and policies; 

19 ‘‘(3) provide information to women and health 

20 care providers on those areas in which differences 

21 between men and women exist; 

22 ‘‘(4) consult with pharmaceutical, biologics, and 

23 device manufacturers, health professionals with ex24 pertise in women’s issues, consumer organizations, 
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1 and women’s health professionals on Administration 

2 policy with regard to women; 

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

4 monitor clinical trials and analysis of data by sex in 

5 accordance with needs that are identified; and 

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

7 Health and Human Services Coordinating Com8 mittee on Women’s Health (established under sec9 tion 229(b)(4) of the Public Health Service Act). 

10 ‘‘(c) COORDINATING COMMITTEE.—

11 ‘‘(1) ESTABLISHMENT.—In carrying out sub12 section (b), the Director of the Office shall establish 

13 a committee to be known as the Coordinating Com14 mittee on Women’s Health (referred to in this sub15 section as the ‘Coordinating Committee’). 

16 ‘‘(2) COMPOSITION.—The Coordinating Com17 mittee shall be composed of the directors of the cen18 ters of the Administration. 

19 ‘‘(3) CHAIRPERSON.—The Director of the Of20 fice shall serve as the Chairperson of the Coordi21 nating Committee. 

22 ‘‘(4) DUTIES.—With respect to studies on wom23 en’s health, the Coordinating Committee shall assist 

24 the Director of the Office in—
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1 ‘‘(A) identifying whether there is a need 

2 for further studies and, if so, developing strate3 gies to foster such studies; 

4 ‘‘(B) identifying issues in specific areas of 

5 women’s health that fall within the mission of 

6 the Administration; 

7 ‘‘(C) identifying whether any need exists 

8 for the coordination of Administration activi9 ties, including internal and external activities; 

10 ‘‘(D) maintaining the Administration’s 

11 focus in areas of importance to women; 

12 ‘‘(E) supporting the development of meth13 odologies to determine how to obtain data spe14 cific to women (including data relating to the 

15 age of women and the membership of women in 

16 ethnic or racial groups); and 

17 ‘‘(F) supporting the development and ex18 pansion of clinical trials of treatments and 

19 therapies for which obtaining such data has 

20 been determined to be an appropriate function. 

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) 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 2003 through 2007.’’. 

7 SEC. 7. NO NEW REGULATORY AUTHORITY. 

8 Nothing in this Act and the amendments made by 

9 this Act may be construed as establishing regulatory au10 thority or modifying any existing regulatory authority.

Passed the House of Representatives September 17, 

2002. 

Attest: JEFF TRANDAHL, 

Clerk.