I
103D CONGRESS
2D SESSION
H. R. 3874
To amend various Acts to establish offices of women’s health within certain
agencies.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 22, 1994
Ms. SNOWE introduced the following bill; which was referred jointly to the
Committees on Energy and Commerce and Ways and Means
A BILL
To amend various Acts to establish offices of women’s health
within certain agencies.
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 1994’’.
SEC. 2. PUBLIC HEALTH SERVICE 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 section:
‘‘PUBLIC HEALTH SERVICE OFFICE OF WOMEN’S HEALTH
‘‘SEC. 310A. (a) ESTABLISHMENT
OF OFFICE.—
There is established an Office of Women’s Health (here-
after referred to in this section as the ‘Office’) within the
Office of the Assistant Secretary for Health.
‘‘(b) ASSISTANT SECRETARY.—There shall be in the
Department of Health and Human Services a Deputy As-
sistant Secretary for Women’s Health, who shall be the
head of the Office. The Secretary, acting through such
Deputy Assistant Secretary, shall carry out this section.
‘‘(c) DUTIES.—The Secretary, acting through the Of-
fice, shall, with respect to the health concerns of women—
‘‘(1) establish short-range and long-range goals
and objectives and coordinate all other activities
within the Department of Health and Human Serv-
ices that relate to disease prevention, health pro-
motion, service delivery, and research concerning
women;
‘‘(2) advise the Assistant Secretary for Health
concerning scientific, legal, ethical, and policy issues
relating to women’s health;
‘‘(3) monitor Public Health Service agency and
regional activities regarding women’s health, and
coordinate activities of such agency Offices of
Women’s Health;
‘‘(4) establish a women’s health resource center
to facilitate the exchange of information regarding
matters relating to health information and health
promotion, preventive health services, and education
in the appropriate use of health care, to facilitate ac-
cess to such information, to assist in the analysis of
issues and problems relating to such matters, and to
provide technical assistance with respect to the ex-
change of such information (including facilitating
the development of materials for such technical as-
sistance); and
‘‘(5) coordinate efforts to promote women’s
health programs and policies in the voluntary and
corporate sectors.
‘‘(d) REPORTS.—Not later than January 31, 1995,
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 preceding 2 fiscal
years.
‘‘(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 1994 through 1996.’’.
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.) (as amended by section 2) is fur-
ther amended by adding at the end the following section:
‘‘CENTERS FOR DISEASE CONTROL AND PREVENTION
OFFICE OF WOMEN’S HEALTH
‘‘SEC. 310B. (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-gov-
ernmental 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 Public Health Service Office of
Women’s Health established 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
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, 1995,
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.
‘‘(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
section:
‘‘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-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 of
Women’s Health established 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, 1995,
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.
Title VII of the Social Security Act (42 U.S.C. 901
et seq.) is amended by adding at the end the following
section:
‘‘OFFICE OF WOMEN’S HEALTH
‘‘SEC. 712. (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 of
Women’s Health established under section 310A 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 (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, 1995,
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 of
Women’s Health established under section 310A 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.
‘‘(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
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, 1995,
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.’’.
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