[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 427 Introduced in Senate (IS)]







104th CONGRESS
  1st Session
                                 S. 427

  To amend various Acts to establish offices of women's health within 
               certain agencies, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

             February 16 (legislative day January 30), 1995

   Ms. Snowe introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
  To amend various Acts to establish offices of women's health within 
               certain agencies, 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 1995''.

SEC. 2. PUBLIC HEALTH SERVICE 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 section:

            ``public health service office of women's health

    ``Sec. 310A. (a) Establishment of Office.--There is established an 
Office of Women's Health (hereafter referred to in this section as the 
`Office') within the Office of the Assistant Secretary for Health.
    ``(b) Assistant Secretary.--There shall be in the Department of 
Health and Human Services a Deputy Assistant Secretary for Women's 
Health, who shall be the head of the Office. The Secretary, acting 
through such Deputy Assistant Secretary, shall carry out this section.
    ``(c) Duties.--The Secretary, acting through the Office, shall, 
with respect to the health concerns of women--
            ``(1) establish short-range and long-range goals and 
        objectives and coordinate all other activities within the 
        Department of Health and Human Services that relate to disease 
        prevention, health promotion, service delivery, and research 
        concerning women;
            ``(2) advise the Assistant Secretary for Health concerning 
        scientific, legal, ethical, and policy issues relating to 
        women's health;
            ``(3) monitor Public Health Service agency and regional 
        activities regarding women's health, and coordinate activities 
        of such agency Offices of Women's Health;
            ``(4) establish a women's health resource center to 
        facilitate the exchange of information regarding matters 
        relating to health information and health promotion, preventive 
        health services, and education in the appropriate use of health 
        care, to facilitate access to such information, to assist in 
        the analysis of issues and problems relating to such matters, 
        and to provide technical assistance with respect to the 
        exchange of such information (including facilitating the 
        development of materials for such technical assistance); and
            ``(5) coordinate efforts to promote women's health programs 
        and policies in the voluntary and corporate sectors.
    ``(d) Reports.--Not later than January 31, 1996, 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 preceding 2 fiscal 
years.
    ``(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 1996 through 1998.''.

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.) (as amended by section 2) is further amended by adding at the 
end the following section:

 ``centers for disease control and prevention office of women's health

    ``Sec. 310B. (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, non-governmental 
        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 Public Health Service 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 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, 1996, and January 31 of 
each second year thereafter, the Director shall prepare and submit to 
the Director of the Public Health Service Office of Women's Health, 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 section:

``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, 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 Public Health Service 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, 1996, and January 31 of 
each second year thereafter, the Director shall prepare and submit to 
the Director of the Public Health Service Office of Women's Health, 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 section:

                       ``office of women's health

    ``Sec. 712. (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 Public Health Service 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, 1996, and January 31 of 
each second year thereafter, the Director of the Office shall prepare 
and submit to the Director of the Public Health Service Office of 
Women's Health, 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 section:

``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 Public Health Service 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, 1996, and January 31 of 
each second year thereafter, the Director shall prepare and submit to 
the Director of the Public Health Service Office of Women's Health, a 
report describing the activities carried out under this section during 
the preceding 2 fiscal years.''.
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