I 
108TH CONGRESS 
2D SESSION 
H. R. 4354
To improve the health of women through the establishment of Offices of 
Women’s Health within the Department of Health and Human Services. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 12, 2004
Mrs. MALONEY (for herself, Ms. PRYCE of Ohio, Mr. WAXMAN, Mr. GRIJALVA, 
Mr. SERRANO, Mrs. JONES of Ohio, Ms. MILLENDER-MCDONALD, Ms. 
BALDWIN, Ms. CARSON of Indiana, Mr. GEORGE MILLER of California, 
Ms. ROYBAL-ALLARD, Ms. NORTON, Mrs. MCCARTHY of New York, Ms. 
BERKLEY, Ms. LOFGREN, Mr. FROST, Mr. GONZALEZ, Mr. KILDEE, Ms. 
SLAUGHTER, Ms. SCHAKOWSKY, Ms. DELAURO, Ms. LEE, Mr. HINCHEY, 
Mr. CASTLE, Mr. LANTOS, Mr. OWENS, Mrs. CAPITO, Ms. LINDA T. 
SA´NCHEZ of California, Mr. BRADY of Pennsylvania, Mr. VAN HOLLEN, 
Mr. SCHIFF, Mr. CROWLEY, Mr. NETHERCUTT, Mr. FORD, Mr. 
HASTINGS of Florida, Ms. ESHOO, Mr. STARK, Mr. CONYERS, Ms. WA-
TERS, Mr. TOWNS, Ms. BORDALLO, and Ms. SOLIS) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce 
A BILL 
To improve the health of women through the establishment 
of Offices of Women’s Health within the Department 
of Health and Human Services.
Be it enacted by the Senate and House of 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 2004’’. 
SEC. 2. HEALTH AND HUMAN SERVICES OFFICE ON WOM-
EN’S HEALTH. 
(a) ESTABLISHMENT.—Part A of title II of the Pub-
lic Health Service Act (42 U.S.C. 202 et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON 
WOMEN’S HEALTH. 
‘‘(a) ESTABLISHMENT OF OFFICE.—The Secretary 
shall establish within the Office of the Secretary, an Office 
on Women’s Health (referred to in this section as the ‘Of-
fice’). 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 activi-
ties within the Department that relate to disease 
prevention, health promotion, service delivery, re-
search, and public and health care professional edu-
cation, 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 
Assistant Secretary for Women’s Health and com-
posed 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 In-
formation Center to—
‘‘(A) facilitate the exchange of information 
regarding matters relating to health informa-
tion, health promotion, preventive health serv-
ices, 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 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, con-
tracts, and agreements under subsection (c), and be-
tween the Office and health professionals and the 
general public. 
‘‘(c) GRANTS
AND CONTRACTS REGARDING DU-
TIES.—
‘‘(1) AUTHORITY.—In carrying out subsection 
(b), the Secretary may make grants to, and enter 
into cooperative agreements, contracts, and inter-
agency 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, 2006, 
and January 31 of each second year thereafter, the Sec-
retary shall prepare and submit to the appropriate com-
mittees of Congress a report describing the activities car-
ried out under this section during the period for which 
the report is being prepared. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary for 
each of the fiscal years 2005 through 2009.’’. 
(b) TRANSFER OF FUNCTIONS.—There are trans-
ferred 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 assign-
ment authority, and all remaining appropriations. All or-
ders, determinations, rules, regulations, permits, agree-
ments, grants, contracts, certificates, licenses, registra-
tions, 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 
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 PREVEN-
TION OFFICE OF WOMEN’S HEALTH. 
Part A of title III of the Public Health Service Act 
(42 U.S.C. 241 et seq.) is amended by adding at the end 
the following: 
‘‘CENTERS FOR DISEASE CONTROL AND PREVENTION 
OFFICE OF WOMEN’S HEALTH 
‘‘SEC. 310A. (a) ESTABLISHMENT.—The Secretary 
shall establish within the Office of the Director of the Cen-
ters for Disease Control and Prevention, an office to be
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 Com-
mittee on Women’s Health (established under sec-
tion 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 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 na-
tional centers and other appropriate officials of the 
Centers for Disease Control and Prevention. 
‘‘(3) CHAIRPERSON.—The Director of the Of-
fice shall serve as the Chairperson of the Coordi-
nating 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 co-
ordination of activities, including intramural 
and extramural multidisciplinary activities; and 
‘‘(C) making recommendations to the Di-
rector of the Centers for Disease Control and 
Prevention concerning findings made under 
subparagraphs (A) and (B). 
‘‘(d) REPORTS.—Not later than January 31, 2006, 
and January 31 of each second year thereafter, the Direc-
tor of the Office shall prepare and submit to the appro-
priate committees of Congress a report describing the ac-
tivities carried out under this section during the period 
for which the report is being prepared. 
‘‘(e) DEFINITION.—As used in this section, the term 
‘women’s health conditions’, with respect to women of all 
age, ethnic, and racial groups, means diseases, disorders, 
and conditions—
‘‘(1) unique to, significantly more serious for, 
or significantly more prevalent in women; and 
‘‘(2) for which the factors of medical risk or 
type of medical intervention are different for women, 
or for which there is reasonable evidence that indi-
cates that such factors or types may be different for 
women.
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary for 
each of the fiscal years 2005 through 2009.’’. 
SEC. 4. AGENCY FOR HEALTHCARE RESEARCH AND 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 
sections 928 and 929, respectively; 
(2) by inserting after section 926 the following: 
‘‘SEC. 927. ACTIVITIES REGARDING WOMEN’S HEALTH. 
‘‘(a) ESTABLISHMENT.—The Director shall designate 
an official of the Office of Priority Populations to carry 
out the responsibilities described in this section for such 
official. 
‘‘(b) PURPOSE.—The official designated under 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 re-
search 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 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 
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, 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 Com-
mittee on Women’s Health (established under sec-
tion 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 
Coordinating Committee on Women’s Health (re-
ferred to in this subsection as the ‘Coordinating 
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 
women’s health, the Coordinating Committee shall 
assist the official designated under subsection (a) 
in—
‘‘(A) identifying the need for such re-
search, and making an estimate each fiscal year 
of the funds needed to adequately support the 
research; 
‘‘(B) identifying needs regarding the co-
ordination of research activities, including in-
tramural and extramural multidisciplinary ac-
tivities; and 
‘‘(C) making recommendations to the Di-
rector of the Agency concerning findings made 
under subparagraphs (A) and (B).
‘‘(d) REPORTS.—Not later than January 31, 2006, 
and January 31 of each second year thereafter, the official 
designated under subsection (a) shall prepare and submit 
to the appropriate committees of Congress a report de-
scribing 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 re-
designated by paragraph (1)) the following: 
‘‘(e) WOMEN’S HEALTH.—For the purpose of car-
rying out section 927 regarding women’s health, there are 
authorized to be appropriated such sums as may be nec-
essary for each of the fiscal years 2005 through 2009.’’. 
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 within the Office of the Administrator of 
the Health Resources and Services Administration, an of-
fice 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 ap-
propriate offices on activities within the Administra-
tion 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 Com-
mittee on Women’s Health (established under sec-
tion 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 bu-
reaus of the Administration. 
‘‘(3) CHAIRPERSON.—The Director of the Of-
fice shall serve as the Chairperson of the Coordi-
nating 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 co-
ordination of activities, including intramural 
and extramural multidisciplinary activities; and 
‘‘(C) making recommendations to the Ad-
ministrator concerning findings made under 
subparagraphs (A) and (B). 
‘‘(d) REPORTS.—Not later than January 31, 2006, 
and January 31 of each second year thereafter, the Direc-
tor of the Office shall prepare and submit to the appro-
priate committees of Congress a report describing the ac-
tivities 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 Of-
fice of Women’s Health established under this sec-
tion in the Administration. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary for 
each of the fiscal years 2005 through 2010.’’. 
SEC. 6. FOOD AND DRUG ADMINISTRATION OFFICE OF 
WOMEN’S HEALTH. 
Chapter IX of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 910. OFFICE OF WOMEN’S HEALTH. 
‘‘(a) ESTABLISHMENT.—The Secretary shall estab-
lish 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 ex-
pertise 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 Com-
mittee on Women’s Health (established under sec-
tion 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 cen-
ters of the Administration. 
‘‘(3) CHAIRPERSON.—The Director of the Of-
fice shall serve as the Chairperson of the Coordi-
nating Committee. 
‘‘(4) DUTIES.—With respect to women’s health, 
the Coordinating Committee shall assist the Director 
of the Office in—
‘‘(A) identifying whether there is a need 
for further studies and, if so, developing strate-
gies 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 activi-
ties, including 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, 2006, 
and January 31 of each second year thereafter, the Direc-
tor of the Office shall prepare and submit to the appro-
priate committees of Congress a report describing the ac-
tivities carried out under this section during the period 
for which the report is being prepared. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of carrying out this section, there are authorized 
to be appropriated such sums as may be necessary for 
each of the fiscal years 2005 through 2009.’’. 
SEC. 7. NO NEW REGULATORY AUTHORITY. 
Nothing in this Act and the amendments made by 
this Act may be construed as establishing regulatory au-
thority or modifying any existing regulatory authority.
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