[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4354 Introduced in House (IH)]






108th CONGRESS
  2d Session
                                H. R. 4354

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 HOUSE OF REPRESENTATIVES

                              May 12, 2004

Mrs. Maloney (for herself, Ms. Pryce of Ohio, Mr. Waxman, Mr. Grijalva, 
 Mr. Serrano, Mrs. Jones of Ohio, Ms. Millender-McDonald, Ms. Baldwin, 
  Ms. Carson of Indiana, Mr. George Miller of California, Ms. Roybal-
    Allard, Ms. Norton, Mrs. McCarthy of New York, Ms. Berkley, Ms. 
   Lofgren, Mr. Frost, Mr. Gonzalez, Mr. Kildee, Ms. Slaughter, Ms. 
Schakowsky, Ms. DeLauro, Ms. Lee, Mr. Hinchey, Mr. Castle, Mr. Lantos, 
 Mr. Owens, Mrs. Capito, Ms. Linda T. Sanchez of California, Mr. Brady 
     of Pennsylvania, Mr. Van Hollen, Mr. Schiff, Mr. Crowley, Mr. 
 Nethercutt, Mr. Ford, Mr. Hastings of Florida, Ms. Eshoo, Mr. Stark, 
   Mr. Conyers, Ms. Waters, Mr. Towns, Ms. Bordallo, and Ms. Solis) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 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.

    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 2004''.

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, 2006, 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 2005 through 2009.''.
    (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, 2006, 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 2005 through 2009.''.

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, 2006, 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 2005 through 
2009.''.

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, 2006, 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 2005 through 2010.''.

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, 2006, 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 2005 through 2009.''.

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.
                                 <all>