Women's Health Office Act of 2004 - Amends the Public Health Service Act, the Social Security Act, and the Federal Food, Drug, and Cosmetic Act to require the establishment of separate Offices on Women's Health within the Office of the Secretary of Health and Human Services, the Office of the Director of the Centers for Disease Control and Prevention, the Office of the Administrator of the Health Resources and Services Administration, and the Office of the Commissioner of the Food and Drug Administration to carry out specified activities relating to the health of women. Directs the lead officers of each Office of Women's Health to establish goals, provide information, serve as a consultant, and establish a Coordinating Committee on Women's Health within their respective agencies.
Requires the Director of the Agency of Healthcare Research and Quality to designate an official of the Office of Priority Populations to carry out similar responsibilities relating to women's health.
Requires the Secretary, acting through the Office of Women's Health, to establish a National Women's Health Information Center to facilitate the exchange of information, access to such information, and the analysis of issues and problems relating to women's health.
Transfers the functions of the Office on Women's Health of the Public Health Service to the Office of Women's Health within the Department of Health and Human Services.
[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>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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