[House Report 107-616]
[From the U.S. Government Publishing Office]
107th Congress Report
HOUSE OF REPRESENTATIVES
2d Session 107-616
======================================================================
WOMEN'S HEALTH OFFICE ACT OF 2002
_______
July 25, 2002.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Tauzin, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 1784]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 1784) to establish an Office on Women's Health
within the Department of Health and Human Services, and for
other purposes, having considered the same, report favorably
thereon with an amendment and recommend that the bill as
amended do pass.
CONTENTS
Page
Amendment........................................................ 1
Purpose and Summary.............................................. 6
Background and Need for Legislation.............................. 7
Hearings......................................................... 7
Committee Consideration.......................................... 7
Committee Votes.................................................. 7
Committee Oversight Findings..................................... 8
Statement of General Performance Goals and Objectives............ 8
New Budget Authority, Entitlement Authority, and Tax Expenditures 8
Committee Cost Estimate.......................................... 8
Congressional Budget Office Estimate............................. 8
Federal Mandates Statement....................................... 10
Advisory Committee Statement..................................... 10
Constitutional Authority Statement............................... 10
Applicability to Legislative Branch.............................. 11
Section-by-Section Analysis of the Legislation................... 11
Changes in Existing Law Made by the Bill, as Reported............ 13
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Women's Health Office Act of 2002''.
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:
``health and human services office on women's health
``Sec. 229. (a) Establishment of Office.--The Secretary shall
establish through the last date for which appropriations are authorized
under subsection (e), 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, 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 2003 through 2007.''.
(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
through the last date for which appropriations are authorized under
subsection (f), 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 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 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, 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 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.
``(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 2003 through 2007.''.
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, through the last date for
which appropriations are authorized under section 928(e), 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 Research
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, 2003, 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 2003 through
2007.''.
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 through
the last date for which appropriations are authorized under subsection
(f), 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 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 of the Administration.
``(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
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) 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 2003 through 2007.''.
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.--The Secretary shall establish through the last
date for which appropriations are authorized under subsection (e),
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 studies on 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, 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 2003 through 2007.''.
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.
Purpose and Summary
The purpose of H.R. 1784 is to formally establish an Office
on Women's Health at the Department of Health and Human
Services (HHS), the Centers for Disease Control and Prevention
(CDC), the Food and Drug Administration (FDA), and the Health
Resources and Services Administration (HRSA), and coordinate
women's health activities at the Agency for Healthcare Research
and Quality through its Office of Priority Populations.
Background and Need for Legislation
In 1991, President George H. Bush created the Office on
Women's Health at HHS to improve the health of American women.
The mission of the office is to direct, develop, coordinate,
and advance women's health research, health care services, and
public and health care professional education and training
across the agencies and offices of the public health services.
The office does this in conjunction with other government
agencies, public and private organizations, and consumer and
health care professional groups. The Office on Women's Health
also advises the Secretary, and the Assistant Secretary for
Health, on the scientific, medical, ethical, and policy issues
related to the advancement of women's health in the United
States and internationally.
In addition to the Office of Women's Health located in
Washington, D.C., the ten HHS Regional Offices also have a
women's health coordinator. The CDC, FDA, and HRSA also
maintain separate offices to focus on women's health. In 1992,
Congress mandated the establishment of an Associate
Administrator for Women's Services at the Substance Abuse and
Mental Health Services Administration (SAMSA) and, in 1993, an
Office of Research on Women's Health at the National Institutes
of Health (NIH).
Current statistical data show that certain health
conditions have a disproportionate impact on women. For
example, osteoporosis, asthma, diabetes, and lupus continue to
plague women at a higher rate than men. Similar to the purpose
of the Office on Women's Health, the National Women's Health
Information Center was created by HHS to help share information
with the public and medical community on new research
advancements and health initiatives focused primarily on
women's health.
The federal government currently spends almost $70 billion
on cross-cutting programs to address women's health.
Hearings
The Committee on Energy and Commerce has not held hearings
on the legislation.
Committee Consideration
On June 11, the Subcommittee on Health met in open markup
session and approved H.R. 1784 for Full Committee
consideration, as amended, by a voice vote. On June 13, the
Full Committee met in open markup session, and favorably
ordered reported H.R. 1784, as amended, by a voice vote.
Committee Votes
There were no record votes taken in connection with
ordering H.R. 1784 reported. A motion by Mr. Tauzin to order
H.R. 1784 reported to the House, as amended, was agreed to by a
voice vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
Statement of General Performance Goals and Objectives
The goal of this legislation is to establish an Office on
Women's Health at HHS, CDC, FDA, and HRSA.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
1784, the Women's Health Office Act of 2002, would result in no
new or increased budget authority, entitlement authority, or
tax expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
H.R. 1784--Women's Health Office Act of 2002
Summary: H.R. 1784 would provide explicit authorization for
offices of women's health in four federal agencies: the
Department of Health and Human Services (HHS); the Centers for
Disease Control and Prevention (CDC); the Health Resources and
Services Administration (HRSA); and the Food and Drug
Administration (FDA). In addition, the bill would designate an
individual within the existing Office of Priority Populations
within the Agency for Health Care Research and Quality (AHRQ)
to lead the agency's research on women's health.
H.R. 1784 also would establish coordinating committees
within the AHRQ and the CDC. Each of the agencies affected
currently engages in research on women's health and executes
many of the provisions of H.R. 1784, but those activities are
not specifically authorized under the Public Health Service
Act.
Assuming the appropriation of the necessary amounts, CBO
estimates that implementing H.R. 1784 would cost $27 million in
2003 and $144 million over the 2003-2007 period, assuming
annual adjustments for inflation for those activities without
specified authorization levels. The five-year total would be
$139 million if such inflation adjustments are not made. The
legislation would not affect direct spending or receipts;
therefore, pay-as-you-go procedures would not apply.
H.R. 1784 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA)
and would not affect the budgets of state, local, or tribal
governments.
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 1784 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By Fiscal Year, in Millions of Dollars--
-----------------------------------------------------------
2002 2003 2004 2005 2006 2007
----------------------------------------------------------------------------------------------------------------
SPENDING SUBJECT TO APPROPRIATION
Spending under Current Law for Offices of Women's
Health:
Estimated Budget Authority...................... 24 0 0 0 0 0
Estimated Outlays............................... 23 5 0 0 0 0
Proposed Changes:
Estimated Authorization Level \1\............... 0 29 30 30 31 32
Estimated Outlays............................... 0 27 26 30 31 31
Spending under H.R. 1784 for Offices of Women's
Health:
Estimated Authorization Level................... 24 29 30 30 31 32
Estimated Outlays............................... 23 27 26 30 31 31
----------------------------------------------------------------------------------------------------------------
\1\ The amounts shown reflect adjustments for anticipated inflation for those activities for which the bill
would authorize such sums as necessary. Without such inflation adjustments, the five-year changes in
authorization levels would total $142 million (instead of $151 million) and the changes in outlays would total
$139 million (instead of $144 million).
Note.--Numbers may not sum to totals due to rounding.
Basis of estimate: H.R. 1784 would require the Secretary of
HHS to establish an Office on Women's Health within the Office
of the Secretary and to transfer to that office all functions
and personnel of the current Office on Women's Health of the
Public Health Service. The office would be headed by the Deputy
Assistant Secretary for Women's Health, with the task of
establishing both short-range and long-range goals and
objectives regarding women's health at both the national and
local levels. The office would coordinate with and monitor the
activities of other women's health offices within HHS on issues
that relate to disease prevention, health promotion, service
delivery, research, and education of the public and health care
professionals on women's health issues.
In addition, the bill would establish the HHS Coordinating
Committee on Women's Health, which would be chaired by the
Deputy Assistant Secretary and senior-level representatives
from other agencies within the department. H.R. 1784 also would
establish a National Women's Health Information Center to
facilitate the exchange of women's health information and
provide technical assistance in analyzing women's health issues
and health problems. The bill would authorize the office to
make grants and cooperative agreements with public and private
entities, and would require the office to report progress
annually to the Congress. CBO estimates that these activities
would cost $18 million in 2003 and $94 million over the 2003-
2007 period if the necessary amounts are appropriated.
H.R. 1784 would authorize appropriations of such sums as
necessary for the CDC, HRSA, and the FDA to establish at each
agency an Office on Women's Health. Each would be responsible
for assessing the current level of agency activity in the area
of women's health, and for setting short-range and long-range
goals for women's health and for each agency's activities
related to prevention, research, education and training,
service delivery, and policy development. The bill would also
establish a Coordinating Committee on Research on Women's
Health within each agency. CBO estimates these activities would
cost $2 million in 2003 and $9 million over the 2003-2007
period for the CDC, $1 million in 2003 and $3 million over the
2003-2007 period for HRSA, and $6 million in 2003 and $37
million over the 2003-2007 period for the FDA, if the necessary
amounts are appropriated.
The bill would direct the director of AHRQ to designate an
individual within the Office of Priority Populations to report
to the director on the current level of activity within AHRQ on
women's health issues, establish short-term and long-term
research goals, identify opportunities for agency projects on
women's health, serve as AHRQ's main point of contact on
women's health issues for public and private stakeholders, and
serve as a member of HHS's Coordinating Committee on Women's
Health. In addition, H.R. 1784 would establish a Coordinating
Committee on Research on Women's Health within the AHRQ to
identify areas of research on women's health, estimate funds
needed to fund this research, identify areas where coordination
of research is needed, and make recommendations to the director
of AHRQ based on the findings of the committee. CBO estimates
these activities would cost less than $500,000 in 2003 and $2
million over the 2003-2007 period if the necessary amounts are
appropriated.
For this estimate, CBO assumes that the bill would have an
effective date of October 1, 2002, and that outlays would
follow historical spending rates for the relevant agencies for
the authorized activities. For most agencies, CBO based its
estimates on amounts spent in the past for similar activities
of the affected agencies. In the case of the FDA, CBO estimates
that based on information obtained from the agency, the FDA
would require an additional $4 million in appropriations over
the 2002 appropriations level to carry out the requirements of
the bill.
Pay-as-you-go considerations: None.
Intergovernmental and private-sector mandates: H.R. 1784
contains no intergovernmental or private-sector mandates as
defined in UMRA and would not affect the budgets of state,
local, or tribal governments.
Estimate prepared by: Federal Costs: Alexis Ahlstrom, Julia
Christenson, Jeanne De Sa, Hallie Torrell, and Christopher
Topoleski. Impact on state, local, and tribal governments: Leo
Lex. Impact on the private sector: Jennifer Bowman.
Estimate approved by: Robert A. Sunshine, Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 provides the short title of the bill, the
``Women's Health Office Act of 2002.''
Section 2. Health and Human Services Office on Women's Health
Section 2 requires the Secretary of HHS to establish,
within the Office of the Secretary, an Office on Women's
Health. A Deputy Assistant Secretary for Women's Health will
head the office. The duties of the office include (1)
establishing short-range and long-range goals and objectives
within HHS and the coordination of activities 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) providing expert
advice and consultation concerning scientific, legal, ethical,
and policy issues relating to women's health; (3) monitoring
the offices, agencies, and regional activities regarding
women's health and stimulate activities and facilitate
coordination of these activities; (4) establishing a
Coordinating Committee on Women's Health composed of senior
level representatives from each of the agencies and offices of
HHS; (5) establishing a National Women's Health Information
Center to facilitate the exchange of information; (6)
coordinating efforts to promote women's health programs and
policies with the private sector; and, (7) providing for the
exchange of information through publications and other means.
The Secretary may also make grants and enter into contracts and
interagency agreements with public and private entities,
agencies, and organizations. The Secretary must evaluate
projects, and submit a report to Congress describing the
activities carried out. This section also establishes the
Office on Women's Health for fiscal years 2003 through 2007 and
authorizes such sums as may be necessary for the same period.
Section 3. Centers for Disease Control and Prevention Office on Women's
Health
Section 3 requires the Secretary to establish an Office on
Women's Health within the Office of the Director of the CDC.
The purpose of the new office will be to (1) report to the
Director of the CDC on the current level of the Centers
activity regarding women's health conditions; (2) establish
short-range and long-range goals and objectives for issues of
particular concern to women; (3) identify projects in women's
health; (4) consult with health professionals, and other
individuals; and, (5) serve as a member of the HHS Coordinating
Committee on Women's Health. The office must also establish a
Coordinating Committee on Research on Women's Health. The
Director of the Office must report to Congress on the
activities of the office one year following enactment of the
legislation, and each second year thereafter. This section also
establishes the office for fiscal years 2003 through 2007 and
authorizes such sums as may be necessary for the same period.
Section 4. Agency for Healthcare Research and Quality Activities
Regarding Women's Health
Section 4 requires the Director of the Agency for
Healthcare Research and Quality to designate an official of the
Office of Priority Populations to report to the Director on the
current Agency level of activity regarding women's health. The
Official will (1) report to the Director on the current Agency
level of activity regarding women's health; (2) establish
short-range and long-range goals and objectives within the
Agency for research important to women's health; (3) identify
projects in women's health that should be conducted or
supported by the Agency; (4) consult with health professionals
and others on Agency policy with regard to women; and, (5)
serve as a member of the HHS Coordinating Committee on Women's
Health. The Official designated by this section must also
establish a Coordinating Committee on Research on Women's
Health, and report to Congress on the activities carried out by
the Office of Priority Populations one year following enactment
of the legislation, and each second year thereafter. This
section also establishes the office for fiscal years 2003
through 2007 and authorizes such sums as may be necessary for
the same period.
Section 5. Health Resources and Services Administration Office of
Women's Health
Section 5 requires the Secretary to establish an Office of
Women's Health within the Office of the Administrator of HRSA.
The Director of the Office will (1) report to the Administrator
on the current level of activity regarding women's health; (2)
establish short-range and long-range goals for issues of
particular concern to women; (3) identify projects in women's
health that should be conducted; (4) consult with health
professionals and others on Administration policy with regard
to women; and, (5) serve as a member of the HHS Coordinating
Committee on Women's Health. This section also requires that
the office establish a Coordinating Committee on Research on
Women's Health. The Director of the Office is required to
report to Congress on the activities of the office one year
following enactment of the legislation, and each second year
thereafter. There are authorized to be appropriated such sums
as may be necessary for fiscal years 2003 through 2007. This
section also establishes the office for fiscal years 2003
through 2007 and authorizes such sums as may be necessary for
the same period.
Section 6. Food and Drug Administration Office of Women's Health
Section 6 requires the Secretary to establish an Office of
Women's Health within the Office of the Commissioner at FDA.
The Director of the Office must (1) report to the FDA
Commissioner on current FDA levels of activities regarding
women's participation in clinical trials and the analysis of
data, by sex, in the testing of drugs, medical devices, and
biological products; (2) establish short-range and long-range
goals and objectives for issues of particular concern to
women's health; (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; and, (6) serve as a member
of the HHS Coordinating Committee on Women's Health. In
addition, the office must establish a Coordinating Committee on
Women's Health, and the Director must report to Congress on the
activities of the office one year following enactment of the
legislation, and each second year thereafter. This section also
establishes the office for fiscal years 2003 through 2007 and
authorizes such sums as may be necessary for the same period.
Section 7. No New Regulatory Authority
Section 7 states that nothing in this legislation may be
construed as establishing new regulatory authority or modifying
existing regulatory authority.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE II--ADMINISTRATION AND MISCELLANEOUS PROVISIONS
Part A--Administration
* * * * * * *
HEALTH AND HUMAN SERVICES OFFICE ON WOMEN'S HEALTH
Sec. 229. (a) Establishment of Office.--The Secretary shall
establish through the last date for which appropriations are
authorized under subsection (e), 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, 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 2003 through 2007.
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
Part A--Research and Investigation
* * * * * * *
CENTERS FOR DISEASE CONTROL AND PREVENTION OFFICE OF WOMEN'S HEALTH
Sec. 310A. (a) Establishment.--The Secretary shall establish
through the last date for which appropriations are authorized
under subsection (f), 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 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 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, 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 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.
(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 2003 through 2007.
* * * * * * *
TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY
* * * * * * *
PART C--GENERAL PROVISIONS
* * * * * * *
SEC. 927. ACTIVITIES REGARDING WOMEN'S HEALTH.
(a) Establishment.--The Director shall designate an official
of the Office of Priority Populations to carry out, through the
last date for which appropriations are authorized under section
928(e), 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 Research 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, 2003, 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.
SEC. [927.] 928. FUNDING.
(a) * * *
* * * * * * *
(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 2003 through 2007.
SEC. [928.] 929. DEFINITIONS.
In this title:
(1) * * *
* * * * * * *
----------
SOCIAL SECURITY ACT
* * * * * * *
TITLE VII--ADMINISTRATION
* * * * * * *
OFFICE OF WOMEN'S HEALTH
Sec. 713. (a) Establishment.--The Secretary shall establish
through the last date for which appropriations are authorized
under subsection (f), 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 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 of the
Administration.
(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 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) 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 2003 through 2007.
* * * * * * *
----------
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER IX--MISCELLANEOUS
* * * * * * *
SEC. 908. OFFICE OF WOMEN'S HEALTH.
(a) Establishment.--The Secretary shall establish through the
last date for which appropriations are authorized under
subsection (e), 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 studies on 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, 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 2003 through 2007.
* * * * * * *