[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 920 Introduced in House (IH)]







105th CONGRESS
  1st Session
                                H. R. 920

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 4, 1997

Mrs. Morella (for herself, Mrs. Lowey, Mrs. Johnson of Connecticut, Ms. 
  Norton, Mr. Greenwood, Ms. Slaughter, Mr. Waxman, Mr. McHugh, Mrs. 
 Maloney of New York, Mr. Fazio of California, Ms. Sanchez, Mr. Romero-
Barcelo, Mrs. Carson, Mrs. Meek of Florida, Mr. Oberstar, Mr. Dellums, 
 Mr. Delahunt, Mr. Baldacci, Mr. Evans, Mr. Frost, Ms. Furse, and Mrs. 
    Kelly) introduced the following bill; which was referred to the 
                         Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
   To establish an Office on 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 1997''.

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 (hereafter 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 coordinate and stimulate activities 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 organization, 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, 1998, 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 1998 through 2001.
    ``(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 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 
(hereafter 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 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) coordinate agency activities on women's health with 
        the Office on Women's Health established under section 229.
    ``(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 
        (hereafter 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, 1998, and January 31 of 
each second year thereafter, the Director shall prepare and submit to 
the Director of the Office on Women's Health established under section 
229, a report describing the activities carried out under this section 
during the preceding 2 fiscal years.
    ``(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.''.

SEC. 4. AGENCY FOR HEALTH CARE POLICY AND RESEARCH 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 927 as section 928; and
            (2) by inserting after section 926 the following:

``SEC. 927. OFFICE OF WOMEN'S HEALTH.

    ``(a) Establishment.--There is established within the Office of the 
Director of the Agency for Health Care Policy and Research an office to 
be known as the Office of Women's Health (hereafter 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 drafting clinical practice guidelines, and conducting 
        research into patient outcomes, delivery of health care 
        services, 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) coordinate agency activities on women's health with 
        the Office of Women's Health established under section 310A.
    ``(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 
        (hereafter referred to in this subsection as the `Coordinating 
        Committee').
            ``(2) Composition.--The Coordinating Committee shall be 
        composed of the Directors of the 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 for Health Care Policy and Research concerning 
                findings made under subparagraphs (A) and (B).
    ``(d) Reports.--Not later than January 31, 1998, and January 31 of 
each second year thereafter, the Director shall prepare and submit to 
the Director of the Office on Women's Health established under section 
229, a report describing the activities carried out under this section 
during the preceding 2 fiscal years.''.

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 
(hereafter 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 Administration.
    ``(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) coordinate agency activities on women's health with 
        the Office of Women's Health established under section 310A 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 
        (hereafter 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 Director of the 
                Centers for Disease Control and Prevention concerning 
                findings made under subparagraphs (A) and (B).
    ``(d) Reports.--Not later than January 31, 1998, and January 31 of 
each second year thereafter, the Director of the Office shall prepare 
and submit to the Director of the Office on Women's Health established 
under section 229 of the Public Health Service Act, a report describing 
the activities carried out under this section during the preceding 2 
fiscal years.''.

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. 906. 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 (hereafter referred to in this section 
as the `Office'). The Office shall be headed by a Director who shall be 
appointed by the Commissioner of the Administration.
    ``(b) Purpose.--The Director of the Office shall--
            ``(1) determine current Commission levels of activity 
        regarding women's participation in clinical trials the study of 
        gender differences in the testing of drugs, medical devices, 
        and biological products, across, age, sociocultural, and, where 
        deemed appropriate, biological contexts;
            ``(2) establish short-range and long-range goals and 
        objectives for adequate inclusion of women in all Commission 
        protocols and policies;
            ``(3) provide guidance or criteria for drug and device 
        manufacturers to use in determining the extent and sufficiency 
        of female representation in clinical trials;
            ``(4) consult with pharmaceutical manufacturers, health 
        professionals with expertise in women's issues, consumer 
        organizations, and women's health professionals on Commission 
        policy with regard to women;
            ``(5) make annual estimates of funds needed to monitor 
        clinical trials in accordance with needs that are identified; 
        and
            ``(6) coordinate Commission activities on women's health 
        with the Office of Women's Health established under section 
        310A 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 (hereafter 
        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 in 
                specific areas of women's health that fall within the 
mission of the Commission, and developing strategies to foster such 
studies;
                    ``(B) identifying needs regarding the coordination 
                of Commission activities, including intramural and 
                extramural studies;
                    ``(C) maintaining the Commission's focus in areas 
                of importance to women;
                    ``(D) supporting the development of methodologies 
                to determine the circumstances in which obtaining data 
                specific to women (including data relating to the age 
                of women and the membership of women in ethnic or 
                racial groups) is an appropriate function of clinical 
                trials of treatments and therapies;
                    ``(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, 1998, and January 31 of 
each second year thereafter, the Director shall prepare and submit to 
the Director of the Office on Women's Health established under section 
229 of the Public Health Service Act, a report describing the 
activities carried out under this section during the preceding 2 fiscal 
years.''.
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