‘‘(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 Research on Women’s Health (hereafter
referred to in this subsection as the ‘Coordinating
Committee’).
‘‘(2) COMPOSITION.—The Coordinating Com-
mittee shall be composed of the Directors of the
Offices.
‘‘(3) CHAIRPERSON.—The Director of the Of-
fice shall serve as the chairperson of the Coordinat-
ing 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 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 for Health Care Policy and
Research concerning findings made under sub-
paragraphs (A) and (B).
‘‘(d) REPORTS.—Not later than January 31, 1996,
and January 31 of each second year thereafter, the Direc-
tor shall prepare and submit to the Director of the Public
Health Service Office of Women’s Health, a report de-
scribing the activities carried out under this section during
the preceding 2 fiscal years.’’.
SEC. 5. HEALTH RESOURCES AND SERVICES ADMINISTRA-
TION OFFICE OF WOMEN’S HEALTH.
Part D of title III of the Public Health Service Act
(42 U.S.C. 254b et seq.) is amended—
(1) by redesignating section 340D as section
340E; and
(2) by inserting before section 340E (as so re-
designated) the following:
‘‘Subpart IX—Miscellaneous Provisions
‘‘OFFICE OF WOMEN’S HEALTH
‘‘SEC. 340D. (a) ESTABLISHMENT.—There is estab-
lished within the Office of the Administrator of the Health
Resources and Services Administration an office to be
known as the Office of Women’s Health (hereafter re-
ferred to in this section as the ‘Office’). The Office shall
be headed by a director who shall be appointed by the Di-
rector of the Administration.
‘‘(b) PURPOSE.—The Director of the Office shall—
‘‘(1) determine the current agency level of activ-
ity regarding women’s health across age, biological,
and sociocultural contexts;
‘‘(2) establish short-range and long-range goals
and objectives for women’s health and coordinate all
other activities within the agency that relate to
health care provider training, health service delivery,
research, and demonstration projects;
‘‘(3) identify projects in women’s health that
should be conducted or supported by the Bureaus;
‘‘(4) consult with health professionals, non-gov-
ernmental organizations, consumer organizations,
women’s health professionals, and other individuals
and groups, as appropriate, on agency policy with
regard to women; and
‘‘(5) coordinate agency activities on women’s
health with the Public Health Service Office on
Women’s Health established under section 1710.
‘‘(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 Research on Women’s Health (hereafter
referred to in this subsection as the ‘Coordinating
Committee’).
‘‘(2) COMPOSITION.—The Coordinating Com-
mittee shall be composed of the Directors of the
Bureaus.
‘‘(3) CHAIRPERSON.—The Director of the Of-
fice shall serve as the Chairperson of the Coordinat-
ing 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 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, 1996,
and January 31 of each second year thereafter, the Direc-
tor of the Office shall prepare and submit to the Director
of the Public Health Service Office of Women’s Health,
a report describing the activities carried out under this
section during the preceding 2 fiscal years.’’.
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 section:
‘‘SEC. 906. 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 (hereafter referred to in this section as the
‘Office’). The Office shall be headed by a Director who
shall be appointed by the Commissioner of the Administra-
tion.
‘‘(b) PURPOSE.—The Director of the Office shall—
‘‘(1) determine current Commission levels of ac-
tivity regarding women’s participation in clinical
trials the study of gender differences in the testing
of drugs, medical devices, and biological products,
across, age, sociocultural, and, where deemed appro-
priate, biological contexts;
‘‘(2) establish short-range and long-range goals
and objectives for adequate inclusion of women in all
Commission protocols and policies;
‘‘(3) provide guidance or criteria for drug and
device manufacturers to use in determining the ex-
tent and sufficiency of female representation in clini-
cal trials;
‘‘(4) consult with pharmaceutical manufactur-
ers, health professionals with expertise in women’s
issues, consumer organizations, and women’s health
professionals on Commission policy with regard to
women;
‘‘(5) make annual estimates of funds needed to
monitor clinical trials in accordance with needs that
are identified; and
‘‘(6) coordinate Commission activities on wom-
en’s health with the Public Health Service Office on
Women’s Health established under section 1710 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 (hereafter referred to in
this subsection as the ‘Coordinating Committee’).
‘‘(2) COMPOSITION.—The Coordinating Com-
mittee shall be composed of the Directors of the
Food and Drug Administration Centers.
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, 1996,
and January 31 of each second year thereafter, the Direc-
tor shall prepare and submit to the Director of the Public
Health Service Office of Women’s Health, a report de-
scribing the activities carried out under this section during
the preceding 2 fiscal years.’’.
Æ
HR 1736 IH——2