1.
This Act may be cited as the
Women’s Health Office Act of
2005
.
2.
Health and human services Office on Women’s Health
(a)
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:
229.
Health and human services Office on Women’s Health
(a)
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)
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)
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)
Not later than 1 year after
the date of enactment of this section, and every 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 2006 through 2010.
.
(b)
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.
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:
310A.
Centers for Disease Control and Prevention Office of Women’s
Health
(a)
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)
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)
(1)
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)
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)
The Director of the Office
shall serve as the Chairperson of the Coordinating Committee.
(4)
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)
Not later than 1 year after
the date of enactment of this section, and every 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)
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 2006 through 2010.
.
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:
927.
Activities regarding Women’s Health
(a)
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)
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)
(1)
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)
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)
The official designated
under subsection (a) shall serve as the Chairperson of the Coordinating
Committee.
(4)
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)
Not later than 1 year after
the date of enactment of this section, and every 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)
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 2006
through 2010.
.
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:
713.
(a)
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)
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)
(1)
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)
The Coordinating Committee
shall be composed of the directors of the bureaus of the Administration.
(3)
The Director of the Office
shall serve as the Chairperson of the Coordinating Committee.
(4)
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)
Not later than 1 year after
the date of enactment of this section, and every 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)
For purposes of this
section:
(1)
The term
Administration means the Health Resources and Services
Administration.
(2)
The term
Administrator means the Administrator of the Health Resources and
Services Administration.
(3)
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 2006 through 2010.
.
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:
910.
(a)
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)
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)
(1)
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)
The Coordinating Committee
shall be composed of the directors of the centers of the Administration.
(3)
The Director of the Office
shall serve as the Chairperson of the Coordinating Committee.
(4)
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)
Not later than 1 year after
the date of enactment of this section, and every 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 2006 through 2010.
.
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.