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 Of-
fice shall serve as the Chairperson of the Coordi-
nating 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 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, 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-
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 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-
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,
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—
‘‘(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-
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:
Clerk.