[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 946 Introduced in Senate (IS)]
107th CONGRESS
1st Session
S. 946
To establish an Office on Women's Health within the Department of
Health and Human Services.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 24, 2001
Ms. Snowe (for herself, Ms. Mikulski, and Mr. Harkin) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
_______________________________________________________________________
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 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 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, 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:
``SEC. 310A. CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF
WOMEN'S HEALTH.
``(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 women's 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:
``SEC. 713. OFFICE OF WOMEN'S HEALTH.
``(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 .''.
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