[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.

           *       *       *       *       *       *       *


                                
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