I
105TH CONGRESS
1ST SESSION
H. R. 920
To establish an Office on Women’s Health within the Department of Health
and Human Services.
IN THE HOUSE OF REPRESENTATIVES
MARCH 4, 1997
Mrs. MORELLA (for herself, Mrs. LOWEY, Mrs. JOHNSON of Connecticut, Ms.
NORTON, Mr. GREENWOOD, Ms. SLAUGHTER, Mr. WAXMAN, Mr.
MCHUGH, Mrs. MALONEY of New York, Mr. FAZIO of California, Ms.
SANCHEZ, Mr. ROMERO-BARCELO´, Mrs. CARSON, Mrs. MEEK of Florida,
Mr. OBERSTAR, Mr. DELLUMS, Mr. DELAHUNT, Mr. BALDACCI, Mr.
EVANS, Mr. FROST, Ms. FURSE, and Mrs. KELLY) introduced the follow-
ing bill; which was referred to the Committee on Commerce
A BILL
To establish an Office on Women’s Health within the
Department of Health and Human Services.
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 Office
Act of 1997’’.
SEC. 2. HEALTH AND HUMAN SERVICES OFFICE ON WOM-
EN’S HEALTH.
Part A of title II of the Public Health Service Act
(42 U.S.C. 202 et seq.) is amended by adding at the end
the following:
‘‘SEC. 229. HEALTH AND HUMAN SERVICES OFFICE ON
WOMEN’S HEALTH.
‘‘(a) ESTABLISHMENT OF OFFICE.—There is estab-
lished within the Office of the Secretary an Office on
Women’s Health (hereafter referred to in this section as
the ‘Office’). The Office on Women’s Health shall be head-
ed by a Deputy Assistant Secretary for Women’s Health.
‘‘(b) DUTIES.—The Office shall, with respect to the
health concerns of women—
‘‘(1) establish short-range and long-range goals
and objectives and coordinate all activities within the
Department of Health and Human Services that re-
late to disease prevention, health promotion, service
delivery, research, and public and health care profes-
sional education concerning women;
‘‘(2) provide expert advice and consultation to
the Secretary concerning scientific, legal ethical, and
policy issues relating to women’s health;
‘‘(3) monitor the Department of Health and
Human Services offices, agencies, and regional ac-
tivities regarding women’s health and coordinate and
stimulate activities of such departmental and agency
offices on women’s health;
‘‘(4) establish a Department of Health and
Human Services Coordinating Committee on Wom-
en’s Health to be chaired by the Deputy Assistant
Secretary for Women’s Health which shall be com-
posed of senior level representatives from each of the
agencies and offices of the Department of Health
and Human Services;
‘‘(5) establish a National Women’s Health In-
formation Center to—
‘‘(A) facilitate the exchange of information
regarding matters relating to health informa-
tion and health promotion, preventive health
services, research advances, and education in
the appropriate use of health care;
‘‘(B) facilitate access to such information;
‘‘(C) assist in the analysis of issues and
problems relating to the matters described in
this paragraph; and
‘‘(D) provide technical assistance with re-
spect to the exchange of information (including
facilitating the development of materials for
such technical assistance);
‘‘(6) coordinate efforts to promote women’s
health programs and policies in the private sector;
and
‘‘(7) through publications and any other means
appropriate, provide for the exchange of information
between the Office and recipients of grants, con-
tracts, and agreements under subsection (c), and be-
tween the Office and health professionals and the
general public.
‘‘(c) GRANTS
AND CONTRACTS REGARDING DU-
TIES.—
‘‘(1) AUTHORITY.—In carrying out subsection
(b), the Secretary, acting through the Office, may
make grants to, and enter into cooperative agree-
ments, contracts, and interagency agreements with
public and nonprofit private entities, agencies, and
organizations.
‘‘(2) EVALUATION AND DISSEMINATION.—The
Office shall directly or through contracts with public
and private entities, agencies, and organization, pro-
vide for evaluations of projects carried out with fi-
nancial assistance provided under paragraph (1) and
for the dissemination of information developed as a
result of such projects.
‘‘(d) REPORTS.—Not later than January 31, 1998,
and January 31 of each second year thereafter, the Sec-
retary shall prepare and submit to the appropriate com-
mittees of Congress a report describing the activities car-
ried 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 1998 through 2001.
‘‘(f) TRANSFER.—There are transferred to the Office,
all functions exercised by the Office on Women’s Health
of the Public Health Service prior to the date of enactment
of this section, including all personnel and compensation
authority, all delegation and assignment authority, and all
remaining appropriations. All orders, determinations,
rules, regulations, permits, agreements, grants, contracts,
certificates, licenses, registrations, privileges, and other
administrative actions—
‘‘(1) which have been issued, made, granted, or
allowed to become effective by the President, any
Federal agency or official thereof, or by a court of
competent jurisdiction, in the performance of func-
tions which are transferred under this subsection;
and
‘‘(2) which are in effect at the time this section
takes effect, or were final before the date of enact-
ment of this section and are to become effective on
or after such date;
shall continue in effect according to their terms until
modified, terminated, superseded, set aside, or revoked in
accordance with law by the President, the Assistant Sec-
retary for Women’s Health or other authorized official, a
court of competent jurisdiction, or by operation of law.’’.
SEC. 3. CENTERS FOR DISEASE CONTROL AND PREVEN-
TION OFFICE OF WOMEN’S HEALTH.
Part A of title III of the Public Health Service Act
(42 U.S.C. 241 et seq.) is amended by adding at the end
the following:
‘‘CENTERS FOR DISEASE CONTROL AND PREVENTION
OFFICE OF WOMEN’S HEALTH
‘‘SEC. 310A. (a) ESTABLISHMENT.—There is estab-
lished within the Office of the Director of the Centers for
Disease Control and Prevention an office to be known as
the Office of Women’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 Director of the
Centers.
‘‘(b) PURPOSE.—The Director of the Office shall—
‘‘(1) determine the current level of the Centers
activity regarding women’s health conditions, across
age, biological, and sociocultural contexts, in all as-
pects of the Centers work, including prevention pro-
grams, public and professional education, services,
and treatment;
‘‘(2) establish short-range and long-range goals
and objectives for women’s health and coordinate all
other activities within the Centers that relate to pre-
vention, research, education and training, service de-
livery, and policy development;
‘‘(3) identify projects in women’s health that
should be conducted or supported by the National
Centers;
‘‘(4) consult with health professionals, non-
governmental organizations, consumer organizations,
women’s health professionals, and other individuals
and groups, as appropriate, on the policy of the Cen-
ters with regard to women; and
‘‘(5) coordinate agency activities on women’s
health with the Office on Women’s Health estab-
lished under section 229.
‘‘(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
National Centers.
‘‘(3) CHAIRPERSON.—The Director of the Of-
fice shall serve as the chairperson of the Coordinat-
ing Committee.
‘‘(4) DUTIES.—With respect to 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, 1998,
and January 31 of each second year thereafter, the Direc-
tor shall prepare and submit to the Director of the Office
on Women’s Health established under section 229, a re-
port describing the activities carried out under this section
during the preceding 2 fiscal years.
‘‘(e) DEFINITION.—As used in this section the term
‘women’s health conditions’, with respect to women of all
age, ethnic, and racial groups, means all diseases, dis-
orders, and conditions—
‘‘(1) unique to, more serious, or more prevalent
in women; and
‘‘(2) for which the factors of medical risk or
type of medical intervention are different for women,
or for which it is unknown whether such factors or
types are different for women.’’.
SEC. 4. AGENCY FOR HEALTH CARE POLICY AND RE-
SEARCH OFFICE OF WOMEN’S HEALTH.
Part C of title IX of the Public Health Service Act
(42 U.S.C. 299c et seq.) is amended—
(1) by redesignating section 927 as section 928;
and
(2) by inserting after section 926 the following:
‘‘SEC. 927. OFFICE OF WOMEN’S HEALTH.
‘‘(a) ESTABLISHMENT.—There is established within
the Office of the Director of the Agency for Health Care
Policy and Research an office to be known as the Office
of Women’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 Director of the Agency.
‘‘(b) PURPOSE.—The Director of the Office shall—
‘‘(1) determine the current Agency level of ac-
tivity regarding women’s health, across age, biologi-
cal, and sociocultural contexts, in all aspects of
Agency work, including drafting clinical practice
guidelines, and conducting research into patient out-
comes, delivery of health care services, and access to
health care;
‘‘(2) establish short-range and long-range goals
and objectives for research important to women’s
health and coordinate all other activities within the
Agency that relate to health services and medical
effectiveness research;
‘‘(3) identify projects in women’s health that
should be conducted or supported by the Agency;
‘‘(4) consult with health professionals, non-
governmental 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 Office of Women’s Health estab-
lished under section 310A.
‘‘(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
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, 1998,
and January 31 of each second year thereafter, the Direc-
tor shall prepare and submit to the Director of the Office
on Women’s Health established under section 229, a re-
port describing 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.
Title VII of the Social Security Act (42 U.S.C. 901
et seq.) is amended by adding at the end the following:
‘‘OFFICE OF WOMEN’S HEALTH
‘‘SEC. 713. (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 Office of Women’s Health estab-
lished under section 310A of the Public Health Serv-
ice 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 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, 1998,
and January 31 of each second year thereafter, the Direc-
tor of the Office shall prepare and submit to the Director
of the Office on Women’s Health established under section
229 of the Public Health Service Act, a report describing
the activities carried out under this section during the pre-
ceding 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:
‘‘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 Office of Women’s Health estab-
lished under section 310A of the Public Health Serv-
ice 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.
‘‘(3) CHAIRPERSON.—The Director of the Of-
fice shall serve as the Chairperson of the Coordinat-
ing 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 in specific areas of women’s health that fall
within the mission of the Commission, and de-
veloping strategies to foster such studies;
‘‘(B) identifying needs regarding the co-
ordination of Commission activities, including
intramural and extramural studies;
‘‘(C) maintaining the Commission’s focus
in areas of importance to women;
‘‘(D) 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;
‘‘(E) supporting the development and ex-
pansion of clinical trials of treatments and
therapies for which obtaining such data has