[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4483 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 4483

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 17, 2000

Mrs. Morella (for herself and Mrs. Maloney of New York) 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, 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 2000''.

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 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, 2002, 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 2001 through 2005.
    ``(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, 2002, 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 2001 through 2005.''.

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, 2002, 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 2001 through 2005.''.

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, 2002, 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 2001 through 2005.''.

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 analyis 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, 2002, 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 2001 through 2005.''.
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