IB
Union Calendar No. 371
107TH CONGRESS
2D SESSION
H. R. 1784
[Report No. 107–616]
To establish an Office on Women’s Health within the Department of Health
and Human Services, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 9, 2001
Mrs. MORELLA (for herself, Mrs. MALONEY of New York, Mr. WAXMAN, Mr.
TOM DAVIS of Virginia, Ms. SLAUGHTER, Mr. MCNULTY, Mr. HONDA,
Ms. BROWN of Florida, Mrs. THURMAN, Ms. ESHOO, Mr. LANTOS, Ms.
LEE, Mr. WYNN, Mr. FROST, Ms. NORTON, Ms. MCCARTHY of Missouri,
Mr. HILLIARD, Mr. HORN, Ms. BALDWIN, Ms. MILLENDER-MCDONALD,
Mrs. CHRISTENSEN, Ms. DELAURO, Ms. JACKSON-LEE of Texas, Mr.
WEXLER, Ms. SOLIS, Mrs. ROUKEMA, Mr. KILDEE, Ms. KAPTUR, Ms.
HARMAN, Ms. SCHAKOWSKY, Mr. BENTSEN, and Mrs. JONES of Ohio) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce
JULY 25, 2002
Additional sponsors: Mr. BONIOR, Ms. PELOSI, Mr. JACKSON of Illinois, Ms.
MCCOLLUM, Mr. MCINTYRE, Ms. RIVERS, Mr. JEFFERSON, Mr. MCGOV-
ERN, Mr. NADLER, Mrs. DAVIS of California, Mrs. CLAYTON, Mrs.
LOWEY, Mr. SANDERS, Mr. PAYNE, Mr. REYES, Mr. CUNNINGHAM, Mr.
BERMAN, Mrs. CAPPS, Mr. FILNER, Mr. LAHOOD, Mr. NETHERCUTT,
Mr. GREENWOOD, Mr. BLAGOJEVICH, Mr. CUMMINGS, Mr. RANGEL, Ms.
ROYBAL-ALLARD, Mr. PRICE of North Carolina, Mr. GEORGE MILLER of
California, Mr. OLVER, Mr. FARR of California, Mrs. NAPOLITANO, Mr.
GUTIERREZ, Ms. HOOLEY of Oregon, Mr. ISRAEL, Mr. RUSH, Mr.
DOYLE, Ms. LOFGREN, Mr. BORSKI, Mr. GANSKE, Mr. BRADY of Penn-
sylvania, Mr. BLUMENAUER, Ms. CARSON of Indiana, Mr. PALLONE, Mr.
HOLT, Mr. ANDREWS, Mrs. MINK of Hawaii, Mr. STARK, Mr. BALDACCI,
Mr. OWENS, Ms. WOOLSEY, Ms. WATSON, Mr. DEFAZIO, Mr. BOUCHER,
Mr. DINGELL, Mr. FOLEY, Mr. BISHOP, Mr. SHERMAN, Mr.
MCDERMOTT, Mr. CASTLE, Mr. WHITFIELD, Mr. STRICKLAND, Mr.
TOWNS, Mr. WALDEN of Oregon, Mr. BROWN of Ohio, and Mr. DAVIS
of Illinois
JULY 25, 2002
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed in italic]
[For text of introduced bill, see copy of bill as introduced on May 9, 2001]
A BILL
To establish an Office on Women’s Health within the Depart-
ment of Health and Human Services, and for other pur-
poses.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Women’s Health Office
Act of 2002’’.
SEC. 2. HEALTH AND HUMAN SERVICES OFFICE ON WOM-
EN’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 ap-
propriations are authorized under subsection (e), within the
Office of the Secretary, an Office on Women’s Health (re-
ferred 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 Of-
fice, 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 preven-
tion, 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 ac-
tivities regarding women’s health and stimulate ac-
tivities and facilitate coordination of such depart-
mental and agency offices on women’s health;
‘‘(4) establish a Department of Health and
Human Services Coordinating Committee on Wom-
en’s Health, which shall be chaired by the Deputy As-
sistant Secretary for Women’s Health and composed
of senior level representatives from each of the agen-
cies and offices of the Department of Health and
Human Services;
‘‘(5) establish a National Women’s Health Infor-
mation Center to—
‘‘(A) facilitate the exchange of information
regarding matters relating to health information,
health promotion, preventive health services, re-
search advances, and education in the appro-
priate 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 re-
spect 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 organiza-
tions, provide for evaluations of projects carried out
with financial assistance provided under paragraph
(1) and for the dissemination of information devel-
oped as a result of such projects.
‘‘(d) REPORTS.—Not later than January 31, 2003,
and January 31 of each second year thereafter, the Sec-
retary shall prepare and submit to the appropriate commit-
tees 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 sec-
tion), 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 com-
pensation authority, all delegation and assignment author-
ity, and all remaining appropriations. All orders, deter-
minations, 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 trans-
ferred under this subsection; and
(2) are in effect at the time this section takes ef-
fect, 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 modi-
fied, terminated, superseded, set aside, or revoked in accord-
ance with law by the President, the Secretary, or other au-
thorized 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 appropria-
tions are authorized under subsection (f), within the Office
of the Director of the Centers for Disease Control and Pre-
vention, 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 Dis-
ease Control and Prevention on the current level of
the Centers’ activity regarding women’s health condi-
tions across, where appropriate, age, biological, and
sociocultural contexts, in all aspects of the Centers’
work, including prevention programs, public and pro-
fessional 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 Cen-
ters 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, non-
governmental organizations, consumer organizations,
women’s health professionals, and other individuals
and groups, as appropriate, on the policy of the Cen-
ters 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 sub-
section (b), the Director of the Office shall establish a
committee to be known as the Coordinating Com-
mittee on Research on Women’s Health (referred to in
this subsection as the ‘Coordinating Committee’).
‘‘(2) COMPOSITION.—The Coordinating Com-
mittee shall be composed of the directors of the na-
tional 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 coordi-
nation of activities, including intramural and
extramural multidisciplinary activities; and
‘‘(C) making recommendations to the Direc-
tor of the Centers for Disease Control and Pre-
vention concerning findings made under sub-
paragraphs (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 QUAL-
ITY 
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 sec-
tions 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 au-
thorized under section 928(e), the responsibilities described
in this section for such official.
‘‘(b) PURPOSE.—The official designated under sub-
section (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 out-
comes, 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 impor-
tant to women’s health and, as relevant and appro-
priate, coordinate with other appropriate offices on
activities within the Agency that relate to health serv-
ices 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, non-
governmental organizations, consumer organizations,
women’s health professionals, and other individuals
and groups, as appropriate, on Agency policy with
regard to women; and
‘‘(5) serve as a member of the Department of
Health and Human Services Coordinating Committee
on Women’s Health (established under section
229(b)(4)).
‘‘(c) COORDINATING COMMITTEE.—
‘‘(1) ESTABLISHMENT.—In carrying out sub-
section (b), the official designated under subsection
(a) shall establish a committee to be known as the Co-
ordinating Committee on Research on Women’s
Health (referred to in this subsection as the ‘Coordi-
nating Committee’).
‘‘(2) COMPOSITION.—The Coordinating Com-
mittee 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 wom-
en’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 coordi-
nation of research activities, including intra-
mural and extramural multidisciplinary activi-
ties; and
‘‘(C) making recommendations to the Direc-
tor 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 describ-
ing 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 redes-
ignated by paragraph (1)) the following:
‘‘(e) WOMEN’S HEALTH.—For the purpose of carrying
out section 927 regarding women’s health, there are author-
ized to be appropriated such sums as may be necessary for
each of the fiscal years 2003 through 2007.’’.
SEC. 5. HEALTH RESOURCES AND SERVICES ADMINISTRA-
TION 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 Ad-
ministrator of the Health Resources and Services Adminis-
tration, 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 Serv-
ices Administration for women’s health and, as rel-
evant and appropriate, coordinate with other appro-
priate 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, non-
governmental 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 sub-
section (b), the Director of the Office shall establish a
committee to be known as the Coordinating Com-
mittee on Research on Women’s Health (referred to in
this subsection as the ‘Coordinating Committee’).
‘‘(2) COMPOSITION.—The Coordinating Com-
mittee shall be composed of the directors of the bu-
reaus 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 wom-
en’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 coordi-
nation of activities, including intramural and
extramural multidisciplinary activities; and
‘‘(C) making recommendations to the Ad-
ministrator concerning findings made under sub-
paragraphs (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 ‘Administra-
tion’ means the Health Resources and Services Ad-
ministration.
‘‘(2) 
ADMINISTRATOR.—The 
term 
‘Adminis-
trator’ means the Administrator of the Health Re-
sources 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 author-
ized under subsection (e), within the Office of the Commis-
sioner, 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 (re-
ferred to in this section as the ‘Administration’) levels
of activity regarding women’s participation in clin-
ical trials and the analysis of data by sex in the test-
ing 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 juris-
diction of the Administration, including, where rel-
evant and appropriate, adequate inclusion of women
and analysis of data by sex in Administration proto-
cols and policies;
‘‘(3) provide information to women and health
care providers on those areas in which differences be-
tween men and women exist;
‘‘(4) consult with pharmaceutical, biologics, and
device manufacturers, health professionals with exper-
tise in women’s issues, consumer organizations, and
women’s health professionals on Administration pol-
icy 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 sub-
section (b), the Director of the Office shall establish a
committee to be known as the Coordinating Com-
mittee on Women’s Health (referred to in this sub-
section as the ‘Coordinating Committee’).
‘‘(2) COMPOSITION.—The Coordinating Com-
mittee 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 wom-
en’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, in-
cluding internal and external activities;
‘‘(D) maintaining the Administration’s
focus in areas of importance to women;
‘‘(E) supporting the development of meth-
odologies to determine how to obtain data spe-
cific 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 ex-
pansion 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.