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‘‘(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 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 estab-
lish through the last date for which appropriations are au-
thorized 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 ‘Of-
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fice’). 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,
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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 studies on wom-
en’s health, the Coordinating Committee shall assist 
the Director of the Office in—
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‘‘(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, 2003, 
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-
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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 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 au-
thority or modifying any existing regulatory authority.
Passed the House of Representatives September 17, 
2002. 
Attest: 
JEFF TRANDAHL, 
Clerk.