II 

109TH CONGRESS 

1ST SESSION S. 569 

To improve the health of women through the establishment of Offices of 

Women’s Health within the Department of Health and Human Services. 

IN THE SENATE OF THE UNITED STATES 

MARCH 8, 2005 

Ms. SNOWE (for herself, Ms. MIKULSKI, Mr. HARKIN, Mr. CORZINE, and Mrs. 

BOXER) introduced the following bill; which was read twice and referred 

to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To improve the health of women through the establishment 

of Offices of 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 2005’’. 
2 

•S 569 IS

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

3 (a) ESTABLISHMENT.—Part A of title II of the Pub4 lic Health Service Act (42 U.S.C. 202 et seq.) is amended 

5 by adding at the end the following: 

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

7 WOMEN’S HEALTH. 

8 ‘‘(a) ESTABLISHMENT OF OFFICE.—The Secretary 

9 shall establish within the Office of the Secretary, an Office 

10 on Women’s Health (referred to in this section as the ‘Of11 fice’). The Office shall be headed by a Deputy Assistant 

12 Secretary for Women’s Health. 

13 ‘‘(b) DUTIES.—The Secretary, acting through the Of14 fice, with respect to the health concerns of women, shall— 

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

16 and objectives within the Department of Health and 

17 Human Services and, as relevant and appropriate, 

18 coordinate with other appropriate offices on activi19 ties within the Department that relate to disease 

20 prevention, health promotion, service delivery, re21 search, and public and health care professional edu22 cation, for issues of particular concern to women; 

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

24 the Secretary concerning scientific, legal, ethical, 

25 and policy issues relating to women’s health; 
3 

•S 569 IS

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

2 Human Services’ offices, agencies, and regional ac3 tivities regarding women’s health and stimulate ac4 tivities and facilitate coordination of such depart5 mental and agency offices on women’s health; 

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

7 Human Services Coordinating Committee on Wom8 en’s Health, which shall be chaired by the Deputy 

9 Assistant Secretary for Women’s Health and com10 posed of senior level representatives from each of the 

11 agencies and offices of the Department of Health 

12 and Human Services; 

13 ‘‘(5) establish a National Women’s Health In14 formation Center to— 

15 ‘‘(A) facilitate the exchange of information 

16 regarding matters relating to health informa17 tion, health promotion, preventive health serv18 ices, research advances, and education in the 

19 appropriate use of health care; 

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

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

22 problems relating to the matters described in 

23 this paragraph; and 

24 ‘‘(D) provide technical assistance with re25 spect to the exchange of information (including 
4 

•S 569 IS

1 facilitating the development of materials for 

2 such technical assistance); 

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

4 health programs and policies with the private sector; 

5 and 

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

7 appropriate, provide for the exchange of information 

8 between the Office and recipients of grants, con9 tracts, and agreements under subsection (c), and be10 tween the Office and health professionals and the 

11 general public. 

12 ‘‘(c) GRANTS AND CONTRACTS REGARDING DU13 TIES.— 

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

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

16 into cooperative agreements, contracts, and inter17 agency agreements with, public and private entities, 

18 agencies, and organizations. 

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

20 Secretary shall directly or through contracts with 

21 public and private entities, agencies, and organiza22 tions, provide for evaluations of projects carried out 

23 with financial assistance provided under paragraph 

24 (1) and for the dissemination of information devel25 oped as a result of such projects. 
5 

•S 569 IS

1 ‘‘(d) REPORTS.—Not later than 1 year after the date 

2 of enactment of this section, and every second year there3 after, the Secretary shall prepare and submit to the appro4 priate committees of Congress a report describing the ac5 tivities carried out under this section during the period 

6 for which 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 2006 through 2010.’’. 

11 (b) TRANSFER OF FUNCTIONS.—There are trans12 ferred to the Office on Women’s Health (established under 

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

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

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

16 date of enactment of this section, including all personnel 

17 and compensation authority, all delegation and assign18 ment authority, and all remaining appropriations. All or19 ders, determinations, rules, regulations, permits, agree20 ments, grants, contracts, certificates, licenses, registra21 tions, privileges, and other administrative actions that— 

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

23 to become effective by the President, any Federal 

24 agency or official thereof, or by a court of competent 
6 

•S 569 IS

1 jurisdiction, in the performance of functions trans2 ferred under this subsection; and 

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

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

5 this section and are to become effective on or after 

6 such date; 

7 shall continue in effect according to their terms until 

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

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

10 other authorized official, a court of competent jurisdiction, 

11 or by operation of law. 

12 SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVEN13 TION OFFICE OF WOMEN’S HEALTH. 

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

15 (42 U.S.C. 241 et seq.) is amended by adding at the end 

16 the following: 

17 ‘‘SEC. 310A. CENTERS FOR DISEASE CONTROL AND PREVEN18 TION OFFICE OF WOMEN’S HEALTH. 

19 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab20 lish within the Office of the Director of the Centers for 

21 Disease Control and Prevention, an office to be known as 

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

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

24 who shall be appointed by the Director of such Centers. 

25 ‘‘(b) PURPOSE.—The Director of the Office shall— 
7 

•S 569 IS

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

2 Disease Control and Prevention on the current level 

3 of the Centers’ activity regarding women’s health 

4 conditions across, where appropriate, age, biological, 

5 and sociocultural contexts, in all aspects of the Cen6 ters’ work, including prevention programs, public 

7 and professional education, services, and treatment; 

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

9 and objectives within the Centers for women’s health 

10 and, as relevant and appropriate, coordinate with 

11 other appropriate offices on activities within the 

12 Centers that relate to prevention, research, edu13 cation and training, service delivery, and policy de14 velopment, for issues of particular concern to 

15 women; 

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

17 should be conducted or supported by the Centers; 

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 the policy of the Cen22 ters with regard to women; and 

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

24 Health and Human Services Coordinating Com-
8 

•S 569 IS

1 mittee on Women’s Health (established under sec2 tion 229(b)(4)). 

3 ‘‘(c) COORDINATING COMMITTEE.— 

4 ‘‘(1) ESTABLISHMENT.—In carrying out sub5 section (b), the Director of the Office shall establish 

6 a committee to be known as the Coordinating Com7 mittee on Women’s Health (referred to in this sub8 section as the ‘Coordinating Committee’). 

9 ‘‘(2) COMPOSITION.—The Coordinating Com10 mittee shall be composed of the directors of the na11 tional centers and other appropriate officials of the 

12 Centers for Disease Control and Prevention. 

13 ‘‘(3) CHAIRPERSON.—The Director of the Of14 fice shall serve as the Chairperson of the Coordi15 nating Committee. 

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

17 the Coordinating Committee shall assist the Director 

18 of the Office in— 

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

20 activities that focus on women’s health; 

21 ‘‘(B) identifying needs regarding the co22 ordination of activities, including intramural 

23 and extramural multidisciplinary activities; and 

24 ‘‘(C) making recommendations to the Di25 rector of the Centers for Disease Control and 
9 

•S 569 IS

1 Prevention concerning findings made under 

2 subparagraphs (A) and (B). 

3 ‘‘(d) REPORTS.—Not later than 1 year after the date 

4 of enactment of this section, and every second year there5 after, the Director of the Office shall prepare and submit 

6 to the appropriate committees of Congress a report de7 scribing the activities carried out under this section during 

8 the period for which the report is being prepared. 

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

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

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

12 and conditions— 

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

14 or significantly more prevalent in women; and 

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

16 type of medical intervention are different for women, 

17 or for which there is reasonable evidence that indi18 cates that such factors or types may be different for 

19 women. 

20 ‘‘(f) 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 2006 through 2010.’’. 
10 

•S 569 IS

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 the responsibilities described in this section for such 

13 official. 

14 ‘‘(b) PURPOSE.—The official designated under sub15 section (a) shall— 

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

17 Agency level of activity regarding women’s health, 

18 across, where appropriate, age, biological, and 

19 sociocultural contexts, in all aspects of Agency work, 

20 including the development of evidence reports and 

21 clinical practice protocols and the conduct of re22 search into patient outcomes, delivery of health care 

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

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

25 and objectives within the Agency for research impor26 tant to women’s health and, as relevant and appro-
11 

•S 569 IS

1 priate, coordinate with other appropriate offices on 

2 activities within the Agency that relate to health 

3 services and medical effectiveness research, for 

4 issues of particular concern to women; 

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

6 should be conducted or supported by the Agency; 

7 ‘‘(4) consult with health professionals, non8 governmental organizations, consumer organizations, 

9 women’s health professionals, and other individuals 

10 and groups, as appropriate, on Agency policy with 

11 regard to women; and 

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

13 Health and Human Services Coordinating Com14 mittee on Women’s Health (established under sec15 tion 229(b)(4)). 

16 ‘‘(c) COORDINATING COMMITTEE.— 

17 ‘‘(1) ESTABLISHMENT.—In carrying out sub18 section (b), the official designated under subsection 

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

20 Coordinating Committee on Women’s Health (re21 ferred to in this subsection as the ‘Coordinating 

22 Committee’). 

23 ‘‘(2) COMPOSITION.—The Coordinating Com24 mittee shall be composed of the official designated 
12 

•S 569 IS

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 1 year after the date 

22 of enactment of this section, and every second year there23 after, the official designated under subsection (a) shall 

24 prepare and submit to the appropriate committees of Con25 gress a report describing the activities carried out under 
13 

•S 569 IS

1 this section during the period for which the report is being 

2 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 2006 through 2010.’’. 

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

14 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab15 lish within the Office of the Administrator of the Health 

16 Resources and Services Administration, an office to be 

17 known as the Office of Women’s Health. The Office shall 

18 be headed by a director who shall be appointed by the Ad19 ministrator. 

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

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

22 Administration level of activity regarding women’s 

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

24 sociocultural contexts; 
14 

•S 569 IS

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-
15 

•S 569 IS

1 mittee on Women’s Health (referred to in this sub2 section 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 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 Ad18 ministrator concerning findings made under 

19 subparagraphs (A) and (B). 

20 ‘‘(d) REPORTS.—Not later than 1 year after the date 

21 of enactment of this section, and every second year there22 after, the Director of the Office shall prepare and submit 

23 to the appropriate committees of Congress a report de24 scribing the activities carried out under this section during 

25 the period for which the report is being prepared. 
16 

•S 569 IS

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 2006 through 2010.’’. 

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. 910. OFFICE OF WOMEN’S HEALTH. 

21 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab22 lish within the Office of the Commissioner, an office to 

23 be known as the Office of Women’s Health (referred to 

24 in this section as the ‘Office’). The Office shall be headed 
17 

•S 569 IS

1 by a director who shall be appointed by the Commissioner 

2 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, 
18 

•S 569 IS

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 women’s health, 

23 the Coordinating Committee shall assist the Director 

24 of the Office in— 
19 

•S 569 IS

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 1 year after the date 

22 of enactment of this section, and every second year there23 after, the Director of the Office shall prepare and submit 

24 to the appropriate committees of Congress a report de-
20 

•S 569 IS

1 scribing the activities carried out under this section during 

2 the period 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 2006 through 2010.’’. 

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. 

Æ