I
103D CONGRESS
1ST SESSION
H. R. 695
To amend the Public Health Service Act to establish an Office of Research
on Women’s Health, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 27, 1993
Ms. SNOWE introduced the following bill; which was referred to the Committee
on Energy and Commerce
A BILL
To amend the Public Health Service Act to establish an
Office of Research on Women’s Health, and for other
purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Women’s Health Re-
search Act of 1993’’.
SEC. 2. ESTABLISHMENT OF OFFICE OF RESEARCH ON
WOMEN’S HEALTH.
(a) IN GENERAL.—Title IV of the Public Health
Service Act, as amended by section 2 of Public Law 101–
613, is amended—
(1) by redesignating section 486 as section
485A;
(2) by redesignating parts F through H as
parts G through I, respectively; and
(3) by inserting after part E the following new
part:
‘‘PART F—RESEARCH ON WOMEN’S HEALTH
‘‘SEC. 486. OFFICE OF RESEARCH ON WOMEN’S HEALTH.
‘‘(a) ESTABLISHMENT.—There is established within
the Office of the Director of NIH an office to be known
as the Office of Research on Women’s Health (in this part
referred to as the ‘Office’). The Office shall be headed by
a director, who shall be appointed by the Director of NIH.
‘‘(b) PURPOSE.—The Director of the Office shall—
‘‘(1) identify projects of research on women’s
health that should be conducted or supported by the
national research institutes;
‘‘(2) identify multidisciplinary research relating
to research on women’s health that should be so con-
ducted or supported;
‘‘(3) carry out paragraphs (1) and (2) with re-
spect to the aging process in women, with priority
given to menopause;
‘‘(4) promote coordination and collaboration
among entities conducting research identified under
any of paragraphs (1) through (3);
‘‘(5) encourage the conduct of such research by
entities receiving funds from the national research
institutes;
‘‘(6) recommend an agenda for conducting and
supporting such research;
‘‘(7) promote the sufficient allocation of the re-
sources of the national research institutes for con-
ducting and supporting such research;
‘‘(8) ensure that women are appropriately rep-
resented as subjects in projects of clinical research
conducted or supported by the national research in-
stitutes; and
‘‘(9) prepare the report required in section
486B.
‘‘(c) COORDINATING COMMITTEE.—
‘‘(1) In carrying out subsection (b), the Direc-
tor of the Office shall establish a committee to be
known as the Coordinating Committee on Research
on Women’s Health (hereafter in this subsection re-
ferred to as the ‘Coordinating Committee’).
‘‘(2) The Coordinating Committee shall be com-
posed of the Directors of the national research insti-
tutes (or the designees of the Directors).
‘‘(3) The Director of the Office shall serve as
the chair of the Coordinating Committee.
‘‘(4) 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;
‘‘(C) supporting the development of meth-
odologies to determine the circumstances in
which obtaining data specific to women (includ-
ing data relating to the age of women and the
membership of women in ethnic or racial
groups) is an appropriate function of clinical
trials of treatments and therapies;
‘‘(D) 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
‘‘(E) encouraging the national research in-
stitutes to conduct and support such research,
including such clinical trials.
‘‘(d) ADVISORY COMMITTEE.—
‘‘(1) In carrying out subsection (b), the Direc-
tor of the Office shall establish an advisory commit-
tee to be known as the Advisory Committee on Re-
search on Women’s Health (hereafter in this sub-
section referred to as the ‘Advisory Committee’).
‘‘(2) The Advisory Committee shall be com-
posed of no fewer than 12, and not more than 18
individuals, who are not officers or employees of the
Federal Government. The Director of the Office
shall make appointments to the Advisory Committee
from among physicians, practitioners, scientists, and
other health professionals, whose clinical practice,
research specialization, or professional expertise in-
cludes a significant focus on research on women’s
health. A majority of the members of the Advisory
Committee shall be women.
‘‘(3) The Director of the Office shall serve as
the chair of the Advisory Committee.
‘‘(4) The Advisory Committee shall—
‘‘(A) advise the Director of the Office on
appropriate research activities to be undertaken
by the national research institutes with respect
to—
‘‘(i) research on women’s health;
‘‘(ii) research on gender differences in
clinical drug trials, including responses to
pharmacological drugs;
‘‘(iii) research on gender differences
in disease etiology, course, and treatment;
‘‘(iv) research on obstetrical and gyne-
cological health conditions, diseases, and
treatments; and
‘‘(v) research on women’s health con-
ditions which require a multidisciplinary
approach;
‘‘(B) report to the Director of the Office
on such research;
‘‘(C) provide recommendations to such Di-
rector regarding activities of the Office (includ-
ing recommendations on the development of the
methodologies described in subsection (c)(4)(C)
and recommendations on priorities in carrying
out research described in subparagraph (A));
and
‘‘(D) assist in monitoring compliance with
section 486(b)(8) regarding the inclusion of
women in clinical research.
‘‘(5)(A) The Advisory Committee shall prepare
a biennial report describing the activities of the
Committee, including findings made by the Commit-
tee regarding—
‘‘(i) compliance with section 486(b)(8);
‘‘(ii) the extent of expenditures made for
research on women’s health by the agencies of
the National Institutes of Health; and
‘‘(iii) the level of funding needed for such
research.
‘‘(B) The report required in subparagraph (A)
shall be submitted to the Director of NIH for inclu-
sion in the report required in section 403.
‘‘(e) REPRESENTATION
OF WOMEN AMONG RE-
SEARCHERS.—The Secretary, acting through the Assist-
ant Secretary for Personnel and in collaboration with the
Director of the Office, shall determine the extent to which
women are represented among senior physicians and sci-
entists of the national research institutes and among phy-
sicians and scientists conducting research with funds pro-
vided by such institutes, and as appropriate, carry out ac-
tivities to increase the extent of such representation.
‘‘(f) DEFINITIONS.—For purposes of this part:
‘‘(1) The term ‘women’s health conditions’, with
respect to women of all age, ethnic, and racial
groups, means all diseases, disorders, and conditions
(including with respect to mental health)—
‘‘(A) unique to, more serious, or more
prevalent in women;
‘‘(B) for which the factors of medical risk
or types of medical intervention are different
for women, or for which it is unknown whether
such factors or types are different for women;
or
‘‘(C) with respect to which there has been
insufficient clinical research involving women as
subjects or insufficient clinical data on women.
‘‘(2) The term ‘research on women’s health’
means research on women’s health conditions, in-
cluding research on preventing such conditions.
‘‘SEC. 486A. NATIONAL DATA SYSTEM AND CLEARINGHOUSE
ON RESEARCH ON WOMEN’S HEALTH.
‘‘(a) DATA SYSTEM.—
‘‘(1) The Director of NIH, in consultation with
the Director of the Office, shall establish a data sys-
tem for the collection, storage, analysis, retrieval,
and dissemination of information regarding research
on women’s health that is conducted or supported by
the national research institutes. Information from
the data system shall be available through informa-
tion systems available to health care professionals
and providers, researchers, and members of the
public.
‘‘(2) The data system established under para-
graph (1) shall include a registry of clinical trials of
experimental treatments that have been developed
for research on women’s health. Such registry shall
include information on subject eligibility criteria,
sex, age, ethnicity or race, and the location of the
trial site or sites. Principal investigators of such
clinical trials shall provide this information to the
registry within 30 days after it is available. Once a
trial has been completed, the principal investigator
shall provide the registry with information pertain-
ing to the results, including potential toxicities or
adverse effects associated with the experimental
treatment or treatments evaluated.
‘‘(b) CLEARINGHOUSE.—The Director of NIH, in
consultation with the Director of the Office and with the
National Library of Medicine, shall establish, maintain,
and operate a program to provide information on research
and prevention activities of the national research institutes
that relate to research on women’s health.
‘‘SEC. 486B. BIENNIAL REPORT.
‘‘(a) IN GENERAL.—With respect to research on
women’s health, the Director of the Office shall, not later
than February 1, 1994, and biennially thereafter, prepare
a report—
‘‘(1) describing and evaluating the progress
made during the preceding 2 fiscal years in research
and treatment conducted or supported by the Na-
tional Institutes of Health;
‘‘(2) describing and analyzing the professional
status of women physicians and scientists of such
Institutes, including the identification of problems
and barriers regarding advancements;
‘‘(3) summarizing and analyzing expenditures
made by the agencies of such Institutes (and by
such Office) during the preceding 2 fiscal years; and
‘‘(4) making such recommendations for legisla-
tive and administrative initiatives as the Director of
the Office determines to be appropriate.
‘‘(b) INCLUSION IN BIENNIAL REPORT OF DIRECTOR
OF NIH.—The Director of the Office shall submit each
report prepared under subsection (a) to the Director of
NIH for inclusion in the report submitted to the President
and the Congress under section 403.
‘‘SEC. 486C. AUTHORIZATION OF APPROPRIATIONS.
‘‘For the purpose of carrying out this part, there are
authorized to be appropriated $25,000,000 for fiscal year
1994, and such sums as may be necessary for each of the
fiscal years 1995 and 1996.’’.
(b) REQUIREMENT OF SUFFICIENT ALLOCATION OF
RESOURCES OF INSTITUTES.—Section 402(b) of the Pub-
lic Health Service Act (42 U.S.C. 282(b)) is amended—
(1) in paragraph (10), by striking ‘‘and’’ after
the semicolon at the end;
(2) in paragraph (11), by striking the period at
the end and inserting ‘‘; and’’; and
(3) by inserting after paragraph (11) the fol-
lowing new paragraph:
‘‘(12) after consultation with the Director of
the Office of Research on Women’s Health, shall en-
sure that resources of the National Institutes of
Health are sufficiently allocated for projects of re-
search on women’s health that are identified under
section 486(b).’’.
SEC. 3. OBSTETRICS AND GYNECOLOGY PROGRAM OF NA-
TIONAL INSTITUTE OF CHILD HEALTH AND
HUMAN DEVELOPMENT.
Subpart 7 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285g et seq.) is amended by adding
at the end the following section:
‘‘PROGRAM REGARDING OBSTETRICS AND GYNECOLOGY
‘‘SEC. 452A. The Director of the Institute shall es-
tablish and maintain within the Institute an intramural
laboratory and clinical research program in obstetrics and
gynecology.’’.
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