To improve the health of women through the establishment of Offices of Women's Health within the Department of Health and Human Services.

June 20, 2003

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

To improve the health of women through the establishment of Offices of Women's Health within the Department of Health and Human Services.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the `Women's Health Office Act of 2003'.

SEC. 2. HEALTH AND HUMAN SERVICES OFFICE ON WOMEN'S HEALTH.

(a) ESTABLISHMENT- Part A of title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended by adding at the end the following:

`SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON WOMEN'S HEALTH.

`(a) ESTABLISHMENT OF OFFICE- The Secretary shall establish within the Office of the Secretary, an Office on Women's Health (referred to in this section as the `Office'). The Office shall be headed by a Deputy Assistant Secretary for Women's Health.

`(b) DUTIES- The Secretary, acting through the Office, with respect to the health concerns of women, shall--

`(1) establish short-range and long-range goals and objectives within the Department of Health and Human Services and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Department that relate to disease prevention, health promotion, service delivery, research, and public and health care professional education, for issues of particular concern to women;

`(2) provide expert advice and consultation to the Secretary concerning scientific, legal, ethical, and policy issues relating to women's health;

`(3) monitor the Department of Health and Human Services' offices, agencies, and regional activities regarding women's health and stimulate activities and facilitate coordination of such departmental and agency offices on women's health;

`(4) establish a Department of Health and Human Services Coordinating Committee on Women's Health, which shall be chaired by the Deputy Assistant Secretary for Women's Health and composed of senior level representatives from each of the agencies and offices of the Department of Health and Human Services;

`(5) establish a National Women's Health Information Center to--

`(A) facilitate the exchange of information regarding matters relating to health information, health promotion, preventive health services, research advances, and education in the appropriate use of health care;

`(B) facilitate access to such information;

`(C) assist in the analysis of issues and problems relating to the matters described in this paragraph; and

`(D) provide technical assistance with respect to the exchange of information (including facilitating the development of materials for such technical assistance);

`(6) coordinate efforts to promote women's health programs and policies with the private sector; and

`(7) through publications and any other means appropriate, provide for the exchange of information between the Office and recipients of grants, contracts, and agreements under subsection (c), and between the Office and health professionals and the general public.

`(c) GRANTS AND CONTRACTS REGARDING DUTIES-

`(1) AUTHORITY- In carrying out subsection (b), the Secretary may make grants to, and enter into cooperative agreements, contracts, and interagency agreements with, public and private entities, agencies, and organizations.

`(2) EVALUATION AND DISSEMINATION- The Secretary shall directly or through contracts with public and private entities, agencies, and organizations, provide for evaluations of projects carried out with financial assistance provided under paragraph (1) and for the dissemination of information developed as a result of such projects.

`(d) REPORTS- Not later than January 31, 2005, and January 31 of each second year thereafter, the Secretary shall prepare and submit to the appropriate committees of Congress a report describing the activities carried out under this section during the period for which the report is being prepared.

`(e) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2004 through 2008.'.

(b) TRANSFER OF FUNCTIONS- There are transferred to the Office on Women's Health (established under section 229 of the Public Health Service Act, as added by this section), all functions exercised by the Office on Women's Health of the Public Health Service prior to the date of enactment of this section, including all personnel and compensation authority, all delegation and assignment authority, and all remaining appropriations. All orders, determinations, rules, regulations, permits, agreements, grants, contracts, certificates, licenses, registrations, privileges, and other administrative actions that--

(1) have been issued, made, granted, or allowed to become effective by the President, any Federal agency or official thereof, or by a court of competent jurisdiction, in the performance of functions transferred under this subsection; and

(2) are in effect at the time this section takes effect, or were final before the date of enactment of this section and are to become effective on or after such date;

shall continue in effect according to their terms until modified, terminated, superseded, set aside, or revoked in accordance with law by the President, the Secretary, or other authorized official, a court of competent jurisdiction, or by operation of law.

SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF WOMEN'S HEALTH.

Part A of title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following:

`CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF WOMEN'S HEALTH

`SEC. 310A. (a) ESTABLISHMENT- The Secretary shall establish within the Office of the Director of the Centers for Disease Control and Prevention, an office to be known as the Office of Women's Health (referred to in this section as the `Office'). The Office shall be headed by a director who shall be appointed by the Director of such Centers.

`(b) PURPOSE- The Director of the Office shall--

`(1) report to the Director of the Centers for Disease Control and Prevention on the current level of the Centers' activity regarding women's health conditions across, where appropriate, age, biological, and sociocultural contexts, in all aspects of the Centers' work, including prevention programs, public and professional education, services, and treatment;

`(2) establish short-range and long-range goals and objectives within the Centers for women's health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Centers that relate to prevention, research, education and training, service delivery, and policy development, for issues of particular concern to women;

`(3) identify projects in women's health that should be conducted or supported by the Centers;

`(4) consult with health professionals, nongovernmental organizations, consumer organizations, women's health professionals, and other individuals and groups, as appropriate, on the policy of the Centers with regard to women; and

`(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 229(b)(4)).

`(c) COORDINATING COMMITTEE-

`(1) ESTABLISHMENT- In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the Coordinating Committee on Women's Health (referred to in this subsection as the `Coordinating Committee').

`(2) COMPOSITION- The Coordinating Committee shall be composed of the directors of the national centers and other appropriate officials of the Centers for Disease Control and Prevention.

`(3) CHAIRPERSON- The Director of the Office shall serve as the Chairperson of the Coordinating Committee.

`(4) DUTIES- With respect to women's health, the Coordinating Committee shall assist the Director of the Office in--

`(A) identifying the need for programs and activities that focus on women's health;

`(B) identifying needs regarding the coordination of activities, including intramural and extramural multidisciplinary activities; and

`(C) making recommendations to the Director of the Centers for Disease Control and Prevention concerning findings made under subparagraphs (A) and (B).

`(d) REPORTS- Not later than January 31, 2005, and January 31 of each second year thereafter, the Director of the Office shall prepare and submit to the appropriate committees of Congress a report describing the activities carried out under this section during the period for which the report is being prepared.

`(e) DEFINITION- As used in this section, the term `women's health conditions', with respect to women of all age, ethnic, and racial groups, means diseases, disorders, and conditions--

`(1) unique to, significantly more serious for, or significantly more prevalent in women; and

`(2) for which the factors of medical risk or type of medical intervention are different for women, or for which there is reasonable evidence that indicates that such factors or types may be different for women.

`(f) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2004 through 2008.'.

SEC. 4. AGENCY FOR HEALTHCARE RESEARCH AND QUALITY ACTIVITIES REGARDING WOMEN'S HEALTH.

Part C of title IX of the Public Health Service Act (42 U.S.C. 299c et seq.) is amended--

(1) by redesignating sections 927 and 928 as sections 928 and 929, respectively;

(2) by inserting after section 926 the following:

`SEC. 927. ACTIVITIES REGARDING WOMEN'S HEALTH.

`(a) ESTABLISHMENT- The Director shall designate an official of the Office of Priority Populations to carry out the responsibilities described in this section for such official.

`(b) PURPOSE- The official designated under subsection (a) shall--

`(1) report to the Director on the current Agency level of activity regarding women's health, across, where appropriate, age, biological, and sociocultural contexts, in all aspects of Agency work, including the development of evidence reports and clinical practice protocols and the conduct of research into patient outcomes, delivery of health care services, quality of care, and access to health care;

`(2) establish short-range and long-range goals and objectives within the Agency for research important to women's health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Agency that relate to health services and medical effectiveness research, for issues of particular concern to women;

`(3) identify projects in women's health that should be conducted or supported by the Agency;

`(4) consult with health professionals, nongovernmental organizations, consumer organizations, women's health professionals, and other individuals and groups, as appropriate, on Agency policy with regard to women; and

`(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 229(b)(4)).

`(c) COORDINATING COMMITTEE-

`(1) ESTABLISHMENT- In carrying out subsection (b), the official designated under subsection (a) shall establish a committee to be known as the Coordinating Committee on Women's Health (referred to in this subsection as the `Coordinating Committee').

`(2) COMPOSITION- The Coordinating Committee shall be composed of the official designated under subsection (a) and the directors of the centers and offices of the Agency.

`(3) CHAIRPERSON- The official designated under subsection (a) shall serve as the Chairperson of the Coordinating Committee.

`(4) DUTIES- With respect to research on women's health, the Coordinating Committee shall assist the official designated under subsection (a) in--

`(A) identifying the need for such research, and making an estimate each fiscal year of the funds needed to adequately support the research;

`(B) identifying needs regarding the coordination of research activities, including intramural and extramural multidisciplinary activities; and

`(C) making recommendations to the Director of the Agency concerning findings made under subparagraphs (A) and (B).

`(d) REPORTS- Not later than January 31, 2005, and January 31 of each second year thereafter, the official designated under subsection (a) shall prepare and submit to the appropriate committees of Congress a report describing the activities carried out under this section during the period for which the report is being prepared.'; and

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

`(e) WOMEN'S HEALTH- For the purpose of carrying out section 927 regarding women's health, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2004 through 2008.'.

SEC. 5. HEALTH RESOURCES AND SERVICES ADMINISTRATION OFFICE OF WOMEN'S HEALTH.

Title VII of the Social Security Act (42 U.S.C. 901 et seq.) is amended by adding at the end the following:

`OFFICE OF WOMEN'S HEALTH

`SEC. 713. (a) ESTABLISHMENT- The Secretary shall establish within the Office of the Administrator of the

Health Resources and Services Administration, an office to be known as the Office of Women's Health. The Office shall be headed by a director who shall be appointed by the Administrator.

`(b) PURPOSE- The Director of the Office shall--

`(1) report to the Administrator on the current Administration level of activity regarding women's health across, where appropriate, age, biological, and sociocultural contexts;

`(2) establish short-range and long-range goals and objectives within the Health Resources and Services Administration for women's health and, as relevant and appropriate, coordinate with other appropriate offices on activities within the Administration that relate to health care provider training, health service delivery, research, and demonstration projects, for issues of particular concern to women;

`(3) identify projects in women's health that should be conducted or supported by the bureaus of the Administration;

`(4) consult with health professionals, nongovernmental organizations, consumer organizations, women's health professionals, and other individuals and groups, as appropriate, on Administration policy with regard to women; and

`(5) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 229(b)(4) of the Public Health Service Act).

`(c) COORDINATING COMMITTEE-

`(1) ESTABLISHMENT- In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the Coordinating Committee on Women's Health (referred to in this subsection as the `Coordinating Committee').

`(2) COMPOSITION- The Coordinating Committee shall be composed of the directors of the bureaus of the Administration.

`(3) CHAIRPERSON- The Director of the Office shall serve as the Chairperson of the Coordinating Committee.

`(4) DUTIES- With respect to women's health, the Coordinating Committee shall assist the Director of the Office in--

`(A) identifying the need for programs and activities that focus on women's health;

`(B) identifying needs regarding the coordination of activities, including intramural and extramural multidisciplinary activities; and

`(C) making recommendations to the Administrator concerning findings made under subparagraphs (A) and (B).

`(d) REPORTS- Not later than January 31, 2005, and January 31 of each second year thereafter, the Director of the Office shall prepare and submit to the appropriate committees of Congress a report describing the activities carried out under this section during the period for which the report is being prepared.

`(e) DEFINITIONS- For purposes of this section:

`(1) ADMINISTRATION- The term `Administration' means the Health Resources and Services Administration.

`(2) ADMINISTRATOR- The term `Administrator' means the Administrator of the Health Resources and Services Administration.

`(3) OFFICE- The term `Office' means the Office of Women's Health established under this section in the Administration.

`(f) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2004 through 2009.'.

SEC. 6. FOOD AND DRUG ADMINISTRATION OFFICE OF WOMEN'S HEALTH.

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following:

`SEC. 910. OFFICE OF WOMEN'S HEALTH.

`(a) ESTABLISHMENT- The Secretary shall establish within the Office of the Commissioner, an office to be known as the Office of Women's Health (referred to in this section as the `Office'). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.

`(b) PURPOSE- The Director of the Office shall--

`(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the `Administration') levels of activity regarding women's participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;

`(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women's health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women

and analysis of data by sex in Administration protocols and policies;

`(3) provide information to women and health care providers on those areas in which differences between men and women exist;

`(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women's issues, consumer organizations, and women's health professionals on Administration policy with regard to women;

`(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and

`(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women's Health (established under section 229(b)(4) of the Public Health Service Act).

`(c) COORDINATING COMMITTEE-

`(1) ESTABLISHMENT- In carrying out subsection (b), the Director of the Office shall establish a committee to be known as the Coordinating Committee on Women's Health (referred to in this subsection as the `Coordinating Committee').

`(2) COMPOSITION- The Coordinating Committee shall be composed of the directors of the centers of the Administration.

`(3) CHAIRPERSON- The Director of the Office shall serve as the Chairperson of the Coordinating Committee.

`(4) DUTIES- With respect to women's health, the Coordinating Committee shall assist the Director of the Office in--

`(A) identifying whether there is a need for further studies and, if so, developing strategies to foster such studies;

`(B) identifying issues in specific areas of women's health that fall within the mission of the Administration;

`(C) identifying whether any need exists for the coordination of Administration activities, including internal and external activities;

`(D) maintaining the Administration's focus in areas of importance to women;

`(E) supporting the development of methodologies to determine how to obtain data specific to women (including data relating to the age of women and the membership of women in ethnic or racial groups); and

`(F) supporting the development and expansion of clinical trials of treatments and therapies for which obtaining such data has been determined to be an appropriate function.

`(d) REPORTS- Not later than January 31, 2005, and January 31 of each second year thereafter, the Director of the Office shall prepare and submit to the appropriate committees of Congress a report describing the activities carried out under this section during the period for which the report is being prepared.

`(e) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2004 through 2008.'.

SEC. 7. NO NEW REGULATORY AUTHORITY.

Nothing in this Act and the amendments made by this Act may be construed as establishing regulatory authority or modifying any existing regulatory authority.

END