To establish an Office on Women's Health within the Department of Health and Human Services, and for other purposes.

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

To establish an Office on Women's Health within the Department of Health and Human Services, and for other purposes.

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 2001'.

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

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- There is established within the Office of the Secretary an Office on Women's Health (referred to in this section as the `Office'). The Office on Women's Health shall be headed by a Deputy Assistant Secretary for Women's Health.

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

`(1) establish short-range and long-range goals and objectives and coordinate all activities within the Department of Health and Human Services that relate to disease prevention, health promotion, service delivery, research, and public and health care professional education concerning 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 to be chaired by the Deputy Assistant Secretary for Women's Health which shall be 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 and 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 in 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, acting through the Office, may make grants to, and enter into cooperative agreements, contracts, and interagency agreements with public and nonprofit private entities, agencies, and organizations.

`(2) EVALUATION AND DISSEMINATION- The Office 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, 2003, 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 2002 through 2006.

`(f) TRANSFER- There are transferred to the Office, 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--

`(1) which 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 which are transferred under this subsection; and

`(2) which 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 Deputy Assistant Secretary for Women's Health 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- There is established 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) determine the current level of the Centers activity regarding women's health conditions, across 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 for women's health and coordinate all other activities within the Centers that relate to prevention, research, education and training, service delivery, and policy development;

`(3) identify projects in women's health that should be conducted or supported by the National 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 Research 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.

`(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, 2003, 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 all diseases, disorders, and conditions--

`(1) unique to, more serious, or 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 it is unknown whether such factors or types are 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 2002 through 2006.'.

SEC. 4. AGENCY FOR HEALTHCARE RESEARCH AND QUALITY OFFICE OF 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 section 928 as section 929; and

(2) by inserting after section 927 the following:

`SEC. 928. OFFICE OF WOMEN'S HEALTH.

`(a) ESTABLISHMENT- There is established within the Office of the Director of the Agency for Healthcare Research and Quality 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 the Agency.

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

`(1) determine the current Agency level of activity regarding women's health, across age, biological, and sociocultural contexts, in all aspects of Agency work, including development of evidence reports and clinical practice protocols, and conducting 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 for research important to women's health and coordinate all other activities within the Agency that relate to health services and medical effectiveness research;

`(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 Director of the Office shall establish

a committee to be known as the Coordinating Committee on Research 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 and Offices.

`(3) CHAIRPERSON- The Director of the Office 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 Director of the Office 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, 2003, 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 2002 through 2006.'.

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- There is established 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 (referred to in this section as the `Office'). The Office shall be headed by a director who shall be appointed by the Administrator.

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

`(1) determine the current Agency level of activity regarding women's health across age, biological, and sociocultural contexts;

`(2) establish short-range and long-range goals and objectives for women's health and coordinate all other activities within the Agency that relate to health care provider training, health service delivery, research, and demonstration projects;

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

`(4) consult with health professionals, non-governmental 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) 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 Research 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.

`(3) CHAIRPERSON- The Director of the Office 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 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 of the Health Resources and Services Administration concerning findings made under subparagraphs (A) and (B).

`(d) REPORTS- Not later than January 31, 2003, 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 2002 through 2006.'.

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. 908. OFFICE OF WOMEN'S HEALTH.

`(a) ESTABLISHMENT- There is established within the Office of the Commissioner of the Food and Drug Administration 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.

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

`(1) determine current Agency levels of activity regarding women's participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, biological products, and foods across age, sociocultural, and where deemed appropriate, biological contexts;

`(2) establish short-range and long-range goals and objectives for all issues of women's health within the jurisdiction of the Food and Drug Administration, including adequate inclusion of women and analysis of data by sex in all Agency protocols and policies;

`(3) provide guidance or criteria for drug, biologics, and device manufacturers to use in determining the extent and sufficiency of female representation in clinical trials and provide information to women and health care providers on those areas in which differences between men and women exist;

`(4) consult with pharmaceutical manufacturers, health professionals with expertise in women's issues, consumer organizations, and women's health professionals on Agency 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 Food and Drug Administration Centers.

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

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

`(A) identifying the need for further studies and issues in specific areas of women's health that fall within the mission of the Agency, and developing strategies to foster such studies;

`(B) identifying needs regarding the coordination of Agency activities, including internal and external activities;

`(C) maintaining the Agency's focus in areas of importance to women;

`(D) 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);

`(E) 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; and

`(F) encouraging the Food and Drug Administration Centers to conduct and support such studies, including such clinical trials.

`(d) REPORTS- Not later than January 31, 2003, 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 2002 through 2006.'.

END