I
106TH CONGRESS
2D SESSION
H. R. 4483
To establish an Office on Women’s Health within the Department of Health
and Human Services, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 17, 2000
Mrs. MORELLA (for herself and Mrs. MALONEY of New York) introduced the
following bill; which was referred to the Committee on Commerce
A BILL
To establish an Office on Women’s Health within the Depart-
ment of Health and Human Services, and for other pur-
poses.
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 2000’’.
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 (referred to in this section as the ‘Of-
fice’). The Office on Women’s Health shall be headed 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 stimulate ac-
tivities and facilitate coordination of such depart-
mental 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-
‘‘(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 2001 through 2005.
‘‘(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 Deputy Assist-
ant Secretary for Women’s Health or other authorized of-
ficial, 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 (referred to in this section
as the ‘Office’). The Office shall be headed by a director
who shall be appointed by the Director of such 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) 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)).
‘‘(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 (referred to
in this subsection as the ‘Coordinating Committee’).
‘‘(2) COMPOSITION.—The Coordinating Com-
mittee shall be composed of the Directors of the Na-
tional Centers.
‘‘(3) CHAIRPERSON.—The Director of the Of-
fice shall serve as the chairperson of the Coordi-
nating 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, 2002,
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) 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.
‘‘(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 2001 through 2005.’’.
SEC. 4. AGENCY FOR HEALTHCARE RESEARCH AND QUAL-
ITY 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 928 as section 929;
and
(2) by inserting after section 927 the following:
‘‘SEC. 928. OFFICE OF WOMEN’S HEALTH.
‘‘(a) ESTABLISHMENT.—There is established within
the Office of the Director of the Agency for Healthcare
Research and Quality 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 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 development of evidence re-
ports and clinical practice protocols, and conducting
research into patient outcomes, delivery of health
care services, quality of care, 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 ef-
fectiveness 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) 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)).
‘‘(c) COORDINATING COMMITTEE.—
‘‘(d) REPORTS.—Not later than January 31, 2002,
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 2001 through 2005.’’.
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 (referred to in
this section as the ‘Office’). The Office shall be headed
by a director who shall be appointed by the Administrator.
‘‘(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;
‘‘(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) 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 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
Bureaus.
‘‘(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, 2002,
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 2001 through 2005.’’.
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
analyis 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, 2002,
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 2001 through 2005.’’.
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