‘‘(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 2010 through 2014. 
‘‘(g) LIMITATION ON TERMINATION OF OFFICE.— 
Notwithstanding any other provision of law, the Office es-
tablished under this section may not be terminated, reor-
ganized, or have any of its powers or duties transferred 
unless such termination, reorganization, or transfer is ap-
proved through the adoption of a joint resolution of ap-
proval.’’. 
SEC. 8. 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. 911. OFFICE OF WOMEN’S HEALTH. 
‘‘(a) ESTABLISHMENT.—There is established within 
the Office of the Commissioner, an office to be known as 
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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-
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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— 
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