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.
‘‘(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 of the Health Resources and Serv-
ices Administration 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) 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 2002 through 2006.’’.
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.—There is established within
the Office of the Commissioner of the Food and Drug Ad-
ministration an office to be known as the Office of Wom-
en’s Health (referred to in this section as the ‘Office’).
The Office shall be headed by a director who shall be ap-
pointed by the Commissioner.
‘‘(b) PURPOSE.—The Director of the Office shall—
‘‘(1) determine current Agency levels of activity
regarding women’s participation in clinical trials and
the analysis of data by sex in the testing of drugs,
medical devices, biological products, and foods across
age, sociocultural, and where deemed appropriate,
biological contexts;
‘‘(2) establish short-range and long-range goals
and objectives for all issues of women’s health within
the jurisdiction of the Food and Drug Administra-
tion, including adequate inclusion of women and
analysis of data by sex in all Agency protocols and
policies;
‘‘(3) provide guidance or criteria for drug, bio-
logics, and device manufacturers to use in deter-
mining the extent and sufficiency of female rep-
resentation in clinical trials and provide information
to women and health care providers on those areas
in which differences between men and women exist;
‘‘(4) consult with pharmaceutical manufactur-
ers, health professionals with expertise in women’s
issues, consumer organizations, and women’s health
professionals on Agency 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
Food and Drug Administration Centers.
‘‘(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 the need for further stud-
ies and issues in specific areas of women’s
health that fall within the mission of the Agen-
cy, and developing strategies to foster such
studies;
‘‘(B) identifying needs regarding the co-
ordination of Agency activities, including inter-
nal and external activities;
‘‘(C) maintaining the Agency’s focus in
areas of importance to women;
‘‘(D) 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);
‘‘(E) 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;
and
‘‘(F) encouraging the Food and Drug Ad-
ministration Centers to conduct and support
such studies, including such clinical trials.
‘‘(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 2002 through 2006.’’.
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