I
103D CONGRESS
1ST SESSION
H. R. 3075
To promote greater equity in the delivery of health care services to American
women through expanded research on women’s health issues and through
improved access to health care services, including preventive health serv-
ices.
IN THE HOUSE OF REPRESENTATIVES
SEPTEMBER 14, 1993
Mrs. SCHROEDER (for herself, Ms. SNOWE, Ms. SLAUGHTER, Ms. BROWN of
Florida, Ms. BYRNE, Mrs. CLAYTON, Mrs. COLLINS of Illinois, Ms.
DELAURO, Ms. ESHOO, Mrs. JOHNSON of Connecticut, Mrs. LLOYD, Mrs.
LOWEY, Mrs. KENNELLY, Ms. MCKINNEY, Mrs. MALONEY, Mrs. MEEK,
Mrs. MINK, Ms. MOLINARI, Mrs. MORELLA, Ms. PELOSI, Ms. ROYBAL-
ALLARD, Ms. SCHENK, Mr. THURMAN, Mrs. UNSOELD, Ms. VELA´ZQUEZ,
Ms. WATERS, Ms. WOOLSEY, Mr. ABERCROMBIE, Mr. BERMAN, Mr.
BROWN of California, Mr. EVANS, Mr. FRANK of Massachusetts, Mr.
HOCHBRUECKNER, Mr. LANTOS, Mr. MARTINEZ, Mr. MCDERMOTT, Mr.
NADLER, Mr. SANDERS, Mr. WHEAT, and Mr. YATES) introduced the fol-
lowing bill; which was referred jointly to the Committees on Energy and
Commerce, Ways and Means, Armed Services, Education and Labor,
Foreign Affairs, the Judiciary, and Veterans’ Affairs
A BILL
To promote greater equity in the delivery of health care
services to American women through expanded research
on women’s health issues and through improved access
to health care services, including preventive health serv-
ices.
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
Equity Act of 1993’’.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I—RESEARCH ON WOMEN’S HEALTH
Subtitle A—NIH Women Scientists Employment Opportunities Act
Sec. 101. Short title.
Sec. 102. Women’s scientific employment.
Subtitle B—Women and AIDS Research Initiative Amendments of 1993
Sec. 106. Short title.
Sec. 107. Establishment of general program of research regarding women and
Acquired Immune Deficiency Syndrome.
Subtitle C—Women and Alcohol Research Equity Act of 1993
Sec. 111. Short title.
Sec. 112. Findings.
Sec. 113. Provisions regarding increase in amount of funds expended for re-
search on alcohol abuse and alcoholism among women.
Subtitle D—National Breast Cancer Strategy Act of 1993
Sec. 116. Short title.
PART I—ESTABLISHMENT OF OFFICE OF BREAST CANCER AND NATIONAL
BREAST CANCER COMMISSION
Sec. 117. Office of breast cancer.
Sec. 118. Establishment of national breast cancer commission.
PART II—DUTIES OF DIRECTOR OF THE NATIONAL CANCER INSTITUTE
RELATING TO BREAST CANCER
Sec. 119. Provisions for full funding for National Cancer Institute with respect
to research on breast cancer.
Sec. 120. Duties of Director.
Sec. 121. Specialized programs of research excellence with respect to breast,
lung, and prostate cancer.
Subtitle E—Lupus Research Amendments of 1993
Sec. 126. Short title.
Sec. 127. Findings.
Sec. 128. Expansion and intensification of activities regarding lupus.
Subtitle F—Women’s Midlife Health Research Act
Sec. 131. Short title.
Sec. 132. Establishment of program for research centers on women’s midlife
health care, including menopause and menopausal health condi-
tions.
Subtitle G—Osteoporosis and Related Bone Disorders Research Education,
and Health Services Act of 1993
Sec. 136. Short title.
Sec. 137. Findings.
Sec. 138. Osteoporosis research.
Subtitle H—Ovarian Cancer Research and Information Amendments of 1993
Sec. 141. Short title.
Sec. 142. Funding for research on ovarian cancer.
Sec. 143. Public information and education on ovarian cancer.
Subtitle I—Antiprogestin Testing Act of 1993
Sec. 146. Short title.
Sec. 147. Research.
Sec. 148. Report.
Subtitle J—Women’s Health Environmental Factors Research Act of 1993
Sec. 151. Short title.
Sec. 152. Research on effect of environmental factors on women’s health.
Subtitle K—Federal Risk Assessment in Women’s Health Act of 1993
Sec. 156. Short title.
Sec. 157. Interagency review.
Sec. 158. Study of research needs.
Subtitle L—Pharmaceutical Interactions Safety Act
Sec. 161. Short title.
Sec. 162. Clinical investigations.
Sec. 163. Biological products clinical investigations.
Subtitle M—Pharmaceutical Testing Fairness Act
Sec. 166. Short title.
Sec. 167. New drug clinical investigations.
Sec. 168. Device clinical investigations.
Sec. 169. Biological products clinical investigations.
Subtitle N—Tobacco Advertising and Promotion Studies Act of 1993
Sec. 171. Short title.
Sec. 172. Findings.
Sec. 173. Tobacco advertising studies.
TITLE II—SERVICES REGARDING WOMEN’S HEALTH
Subtitle A—Equity in Health Professions Education Act
Sec. 201. Short title.
Sec. 202. Study regarding curricula of health professions schools and women’s
health conditions.
Subtitle B—Women’s Health Office Act of 1993
Sec. 206. Short title.
Sec. 207. Public Health Service Office of Women’s Health.
Sec. 208. Centers for Disease Control and Prevention Office of Women’s
Health.
Sec. 209. Agency for Health Care Policy and Research Office of Women’s
Health.
Sec. 210. Health Resources and Services Administration Office of Women’s
Health.
Sec. 210A. Food and Drug Administration Office of Women’s Health.
Subtitle C—Women’s Health Information Act of 1993
Sec. 211. Short title.
Sec. 212. Findings.
Sec. 213. Interagency Committee on Health Communications.
Sec. 214. Dissemination efforts of women’s health information within public
health service.
Sec. 215. Study on effectiveness of health communications.
Subtitle D—Breast and Cervical Cancer Amendments of 1993
Sec. 216. Short title.
Sec. 217. Revisions in program of State grants regarding breast and cervical
cancer.
Sec. 218. Funding.
Subtitle E—Women’s Preventive Health Amendments of 1993
Sec. 221. Short title.
Sec. 222. Establishment of demonstration program of grants for additional pre-
ventive health services for women.
Sec. 223. Funding.
Subtitle F—Postreproductive Health Care Act
Sec. 226. Short title.
Sec. 227. Establishment of program for postreproductive health care.
Subtitle G—Medicare Bone Mass Measurement Coverage Act of 1993
Sec. 231. Short title.
Sec. 232. Medicare coverage of bone mass measurements.
Subtitle H—Mickey Leland Adolescent Pregnancy Prevention and Parenthood
Act of 1993
Sec. 236. Short title.
Sec. 237. Adolescent pregnancy prevention, care, and research grants.
Subtitle I—Adolescent Health Demonstrations Projects Act of 1993
Sec. 241. Short title.
Sec. 242. Establishment or support of demonstration projects.
Sec. 243. Project requirements.
Sec. 244. Areas to be served.
Sec. 245. Abortion restriction.
Sec. 245A. Report.
Subtitle J—Eating Disorders Information and Education Act of 1993
Sec. 246. Short title.
Sec. 247. Findings.
Sec. 248. Public information and education on eating disorders.
Subtitle K—Women and HIV Outreach and Prevention Act
Sec. 251. Short title.
Sec. 252. Preventive 
health 
programs 
regarding 
women 
and 
human
immunodeficiency virus.
Sec. 253. Treatment of women for substance abuse.
Sec. 254. Early intervention services for women.
Subtitle L—Standby Guardianship Act
Sec. 256. Short title.
Sec. 257. States required to have standby guardianship law as a condition of
eligibility for Federal funds for foster care and adoption assist-
ance.
Subtitle M—Federal Prohibition of Female Genital Mutilation Act of 1993
Sec. 261. Short title.
Sec. 262. Title 18 amendment.
Sec. 263. Education and outreach.
Sec. 264. Effective dates.
Subtitle N—Smoking Prevention and Cessation in WIC Clinics Act
Sec. 266. Short title.
Sec. 267. Smoking cessation demonstration programs for WIC participants.
Subtitle O—Family and Medical Leave Health Care Reform Resolution of
1993
Sec. 271. Short title.
Sec. 272. Findings.
Sec. 273. Sense of Congress.
Subtitle P—Veteran Women’s Health Improvement Act of 1993
Sec. 276. Short title.
Sec. 277. Women’s health services.
Sec. 278. Expansion of research relating to women veterans.
Sec. 279. Mammography quality standards.
Subtitle Q—Defense Women’s Health Improvement Act of 1993
Sec. 281. Short title.
PART I—WOMEN’S HEALTH CARE
Sec. 282. Primary and preventive health-care services for women.
Sec. 283. Report on the provision of health-care services to women.
PART II—WOMEN’S HEALTH RESEARCH
Sec. 284. Defense women’s health research center.
Sec. 285. Continuation of Army breast cancer research program.
Sec. 286. Inclusion of women and minorities in clinical research projects.
Sec. 287. Report on research relating to female members of the uniformed serv-
ices and female covered beneficiaries.
PART III—WOMEN’S HEALTH EDUCATION
Sec. 288. Women’s health curriculum advisory committee.
Subtitle R—International Population Stabilization and Reproductive Health
Act
Sec. 291. Short title.
Sec. 292. Authorities relating to United States population assistance.
Sec. 293. Authorizations of appropriations.
Sec. 294. Economic and social development initiatives to stabilize world popu-
lation.
Sec. 295. AIDS prevention and control fund.
Sec. 296. Oversight of multilateral development banks.
Sec. 297. Commission on world population stabilization and reproductive
health.
Sec. 298. Support for United Nations forward looking strategies for the ad-
vancement of women.
Sec. 299. Support for the Convention on the Elimination of All Forms of Dis-
crimination Against Women.
TITLE I—RESEARCH ON
WOMEN’S HEALTH
Subtitle A—NIH Women Scientists
Employment Opportunites Act
SEC. 101. SHORT TITLE.
This subtitle may be cited as the ‘‘NIH Women Sci-
entists Employment Opportunity Act’’.
SEC. 102. WOMEN’S SCIENTIFIC EMPLOYMENT.
Subpart A of title IV of the Public Health Service
Act (42 U.S.C. 281 et seq.), as amended by section 209
of Public Law 103–43 (107 Stat. 149), is amended by
adding at the end the following section:
‘‘WOMEN’S SCIENTIFIC EMPLOYMENT
‘‘SEC. 404F. (a) IN GENERAL.—The Director of
NIH shall—
‘‘(1) establish policies for the National Insti-
tutes of Health on matters relating to the employ-
ment by the National Institutes of Health of women
as scientists; and
‘‘(2) monitor the extent of compliance with such
policies and take appropriate action in cases in
which the Director determines that the policies have
been violated.
‘‘(b) CERTAIN FUNCTIONS.—In carrying out sub-
section (a), the Director of NIH shall provide for the fol-
lowing:
‘‘(1) Implementing the recommendations of the
group known as the Task Force on the Status of
NIH Intramural Women Scientists.
‘‘(2) Determining the concerns of intramural
women scientists.
‘‘(3) Developing a policy defining the standard
tenure process for employment at the National Insti-
tutes of Health.
‘‘(4) Determining the reason for departure from
such Institutes by interviewing women and men sci-
entists as they leave.
‘‘(5) Distributing yearly to all employees of
such Institutes the policy of such Institutes on flexi-
ble family leave.
‘‘(6) Monitoring the number of women, includ-
ing minority women, included on the committees,
panels, and other working groups (and in meetings)
of such Institutes.
‘‘(7) Making efforts to recruit minority women,
based on the small numbers of tenured minority
women scientists.
‘‘(8) Developing additional goals related to
women and minority women scientists at such Insti-
tutes.
‘‘(c) INCLUSION OF WOMEN ON INTRAMURAL AND
EXTRAMURAL CONFERENCES AND OTHER GROUPS.—
‘‘(1) IN GENERAL.—The Director of NIH shall
establish a policy at the National Institutes of
Health of requiring inclusion of women scientists in
greater numbers on or in intramural and extramural
conferences, workshops, meetings, international con-
gresses, and other groups funded or sponsored by
such Institutes. Such policy shall provide for the in-
clusion of not less than one woman scientist in each
such group, except as provided in paragraph (2).
‘‘(2) EXCLUSION; WRITTEN
EXPLANATION.—
The policy established in paragraph (1) may provide
that no woman scientist will be included in a group
for purposes of such paragraph if the Director of
NIH provides a waiver of the requirement. The Di-
rector may grant such a waiver only if—
‘‘(A) the individual with the chief respon-
sibility for the group involved submits to the
Director a written request for the waiver and
the request provides an explanation of the rea-
sons underlying the need for the waiver; and
‘‘(B) the Director makes a determination
that extraordinary circumstances justify provid-
ing the waiver.
‘‘(d) STUDY ON PAY EQUITY.—
‘‘(1) IN GENERAL.—The Director of NIH shall
provide for study to identify any pay differences
among men and women scientists employed by the
National Institutes of Health, both tenured and
untenured. The study shall include recommendations
on measures to adjust any disparities or inequities,
and shall identify a program to communicate infor-
mation on salary ranges to all employees.
‘‘(2) REPORT.—Not later than 240 days after
the date of the enactment of the NIH Women Sci-
entist Employment Opportunity Act, the Director of
NIH shall complete the study required in paragraph
(1) and submit to the Committee on Energy and
Commerce of the House of Representatives, and to
the Committee on Labor and Human Resources of
the Senate, a report describing the findings made as
a result of the study.
‘‘(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.’’.
Subtitle B—Women and AIDS Re-
search Initiative Amendments
of 1993
SEC. 106. SHORT TITLE.
This subtitle may be cited as the ‘‘Women and AIDS
Research Initiative Amendments of 1993’’.
SEC. 107. ESTABLISHMENT OF GENERAL PROGRAM OF RE-
SEARCH REGARDING WOMEN AND ACQUIRED
IMMUNE DEFICIENCY SYNDROME.
Part B of title XXIII of the Public Health Service
Act (42 U.S.C. 300cc–11 et seq.) is amended by adding
at the end the following section:
‘‘SEC. 2321. RESEARCH REGARDING WOMEN.
‘‘(a) IN GENERAL.—With respect to cases of infec-
tion with the human immunodeficiency virus, the Sec-
retary shall establish a program for the purpose of con-
ducting biomedical and behavioral research on such cases
in women, including research on the prevention of such
cases. The Secretary may conduct such research directly,
and may make grants to public and nonprofit private enti-
ties for the conduct of the research.
‘‘(b) CERTAIN FORMS OF RESEARCH.—In carrying
out subsection (a), the Secretary shall provide for research
on—
‘‘(1) 
the 
manner 
in 
which 
the 
human
immunodeficiency virus is transmitted to women, in-
cluding the relationship between cases of infection
with such virus and other cases of sexually transmit-
ted diseases, including clinical trials which examine
the question of how much human immunodeficiency
virus infection can be prevented by finding and
treating sexually transmitted diseases in women;
‘‘(2) measures for the prevention of exposure to
and the transmission of such virus, including re-
search on—
‘‘(A) the prevention of any sexually trans-
mitted disease that may facilitate the trans-
mission of the virus;
‘‘(B) rapid, inexpensive, easy-to-use sexu-
ally transmitted disease diagnostic tests for
women;
‘‘(C) inexpensive single dose therapy for
treatable sexually transmitted diseases;
‘‘(D) the development of methods of pre-
vention for use by women; and
‘‘(E) the development and dissemination of
prevention programs and materials whose pur-
pose is to reduce the incidence of substance
abuse among women;
‘‘(3) the development and progression of symp-
toms resulting from infection with such virus, in-
cluding research regarding gynecological infections
as well as breast changes, hormonal changes, and
menses and menopause changes, whose occurrence
becomes probable as a result of the deterioration of
the immune system;
‘‘(4) the treatment of cases of such infection,
including clinical research; and
‘‘(5) behavioral research on the prevention of
such cases and research on model educational pro-
grams for such prevention.
‘‘(c) CLINICAL TRIALS.—
‘‘(1) GYNECOLOGICAL EVALUATIONS.—In clini-
cal trials regarding the human immunodeficiency
virus in which women participate as subjects, the
Secretary shall ensure that—
‘‘(A) each female subject who is infected
with the human immunodeficiency virus—
‘‘(i) undergoes a gynecological exam-
ination as part of the evaluation of the
medical status of the woman prior to par-
ticipation in the trial; and
‘‘(ii) receives appropriate follow-up
services regarding such examination; and
‘‘(B) the results of the gynecological ex-
aminations are analyzed to determine the rela-
tionship between gynecological conditions and
the infection with such virus.
‘‘(2) STANDARD
TREATMENTS
FOR
GYNECO-
LOGICAL CONDITIONS.—The Secretary shall conduct
or support clinical trials under subsection (a) to de-
termine whether standard methods of treating gyne-
cological conditions are effective in the case of such
conditions that arise as a result of infection with the
human immunodeficiency virus.
‘‘(3) EFFECTIVENESS OF CERTAIN TREATMENT
PROTOCOLS.—With respect to cases of infection with
the human immunodeficiency virus, the Secretary
shall conduct or support clinical trials under sub-
section (a) to determine whether treatment protocols
approved for men with such cases are effective for
women with such cases.
‘‘(4) SUPPORT SERVICES.—
‘‘(A) In conducting or supporting clinical
trials regarding the human immunodeficiency
virus in which women participate as subjects,
the Secretary shall provide the women with
such transportation, child care, and other sup-
port services (including medical and mental
health services, treatment for drug abuse, and
social services, including services addressing do-
mestic violence) as may be necessary to enable
the women to participate as such subjects.
‘‘(B) Services under subparagraph (A)
shall include services designed to respond to the
particular needs of women with respect to par-
ticipation in the clinical trials involved, includ-
ing, as appropriate, training of the individuals
who conduct the trials.
‘‘(d) PREVENTION PROGRAMS.—
‘‘(1) SEXUAL TRANSMISSION.—
‘‘(A) With respect to preventing the sexual
transmission of the human immunodeficiency
virus, the Secretary shall conduct or support re-
search under subsection (a) on barrier methods
for prevention of sexually transmitted diseases,
including human immunodeficiency virus dis-
ease, that women can use without their sexual
partner’s cooperation or knowledge.
‘‘(B) In carrying out subparagraph (A),
the Secretary shall give priority to identified re-
search needs and opportunities identified at the
National Institutes of Health sponsored meet-
ing on Development of Topical Microbicides
held in May 1993, including research on—
‘‘(i) the early steps in infectious proc-
esses;
‘‘(ii) identification, formulation, and
preclinical evaluation of new preparations;
‘‘(iii) clinical testing for safety and ef-
ficacy; and
‘‘(iv) studies on acceptability and com-
pliance of safe, effective microbicides.
‘‘(2) EPIDEMIOLOGICAL RESEARCH.—The Sec-
retary shall conduct or support epidemiological re-
search under subsection (a) to determine the factors
of risk regarding infection with the human
immunodeficiency virus that are particular to
women, including research regarding—
‘‘(A) the use of various contraceptive meth-
ods;
‘‘(B) the use of tampons;
‘‘(C) the relationship between such infec-
tion and other sexually transmitted diseases;
‘‘(D) the relationship between such infec-
tion and various forms of substance abuse (in-
cluding use of the form of cocaine commonly
known as crack); and
‘‘(E) the relationship between such infec-
tion and noncoital forms of sexual activity.
‘‘(e) INTERAGENCY STUDY.—With respect to the
study (known as the Women’s Interagency HIV Study)
that, as of June 1993, is being carried out by the Sec-
retary through various agencies of the Public Health Serv-
ice for the purpose of monitoring the progression in
women of infection with the human immunodeficiency
virus, and determining whether such progression is dif-
ferent in women than in men, the following applies:
‘‘(1) The Secretary shall ensure that not less
than 5,000 women with such infection are included
in the study.
‘‘(2) The Secretary shall provide for an increase
in the number of sites at which the study is to be
conducted.
‘‘(3) The Secretary shall ensure that the study
period is for a minimum of 8 years.
‘‘(4) With respect to markers of human
immunodeficiency virus disease progression and viral
activity, including the cells commonly known as CD4
cells, the Secretary shall ensure that the study ade-
quately addresses the relationship between such
markers and the development of serious illnesses in
such women, including the relationship between the
number of such cells and the development of such
illnesses. For purposes of the preceding sentence,
the study shall address gynecological conditions, and
other conditions particular to women, that are not
currently included in the list of conditions arising
from such infection that, for surveillance purposes,
is maintained by the Director of the Centers for Dis-
ease Control and Prevention.
‘‘(f) DEFINITIONS.—For purposes of this section, the
term ‘human immunodeficiency virus’ means the etiologic
agent for acquired immune deficiency syndrome.
‘‘(g) AUTHORIZATIONS OF APPROPRIATIONS.—
‘‘(1) CLINICAL TRIALS.—
‘‘(A) For the purpose of carrying out sub-
section (c)(1), there are authorized to be appro-
priated $20,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the
fiscal years 1995 through 1996.
‘‘(B) For the purpose of carrying out sub-
section (c)(2), there are authorized to be appro-
priated $10,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the
fiscal years 1995 through 1996.
‘‘(C) For the purpose of carrying out sub-
section (c)(3), there are authorized to be appro-
priated $10,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the
fiscal years 1995 through 1996.
‘‘(D) For the purpose of carrying out sub-
section (c)(4), there are authorized to be appro-
priated $15,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the
fiscal years 1995 and 1996.
‘‘(2) PREVENTION PROGRAMS.—
‘‘(A) For the purpose of carrying out sub-
section (d)(1), there are authorized to be appro-
priated $30,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the
fiscal years 1995 through 1996.
‘‘(B) For the purpose of carrying out sub-
section (d)(2), there are authorized to be appro-
priated $10,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the
fiscal years 1995 through 1996.
‘‘(3) INTERAGENCY STUDY.—For the purpose
of carrying out subsection (e), there are authorized
to be appropriated $15,000,000 for fiscal year 1994,
and such sums as may be necessary for each of the
fiscal years 1995 through 1996.’’.
Subtitle C—Women and Alcohol
Research Equity Act of 1993
SEC. 111. SHORT TITLE.
This subtitle may be cited as the ‘‘Women and Alco-
hol Research Equity Act of 1993’’.
SEC. 112. FINDINGS.
The Congress finds as follows with respect to the
United States:
(1) One of every 3 alcoholics receiving treat-
ment is a woman.
(2) In fiscal year 1992, the National Institute
on Alcohol Abuse and Alcoholism had a total re-
search 
budget 
of 
$169,000,000, 
and 
only
$14,200,000 of the budget (approximately 8 per-
cent) was available for research on alcohol abuse and
alcoholism among women. Research on this topic is
critical because alcoholism has long been known to
be a gender-specific disease.
(3) Women continue to be underrepresented in
treatment programs. Women make up less than 25
percent of all publicly funded alcohol treatment ad-
missions and about 30 percent of treatment admis-
sions for other drug dependencies although women
make up an estimated 50 percent of the total alcohol
and drug dependent population.
(4) Alcohol use by pregnant women is the lead-
ing known cause of mental retardation in newborns.
Fetal alcohol syndrome, which is marked by dysfunc-
tion of the central nervous system and by prenatal
and postnatal growth deficiency and facial mal-
formations, strikes 1 to 3 out of every 1,000
newborns, or 3,600 to 10,000 babies a year. The in-
cidence of less severe fetal alcohol effects is at least
3 times that of fetal alcohol syndrome. Research is
also needed on the male contribution to birth abnor-
malities related to alcohol and other drug use.
(5) Most treatment programs do not provide
child care or adequate alternatives for women enter-
ing treatment.
(6) The death rate of female alcoholics is 50 to
100 percent higher than for male alcoholics.
(7) More alcoholic women die of cirrhosis of the
liver than do alcoholic men.
(8) Combined effects of estrogen and alcohol
augment liver damage.
(9) Women experience greater physiological
damage from consumption of alcohol than do their
male counterparts. The interval between the onset of
drinking and entry into treatment appears to be
shorter for women than men.
(10) Negative effects of drinking show up ear-
lier in women than men, even when they consume
less alcohol than men. This disease process is ‘‘tele-
scoped’’ or accelerated in women.
(11) Women become intoxicated faster than
men. This is due to a different enzyme activity than
men and hormonal fluctuations in women.
(12) Chronic, heavy drinking contributes to
menstrual disorders, fertility problems, and pre-
mature menopause.
(13) Alcohol use may be associated with an in-
creased risk of breast cancer. Research indicates
that the incidence of breast cancer increases when a
woman consumes 1 ounce or more of absolute alco-
hol daily.
(14) The National Institute on Alcohol Abuse
and Alcoholism has identified areas for future re-
search on alcohol abuse and alcoholism among
women. These areas were identified by the Institute
more than a decade ago, yet a sufficient number of
research projects regarding such areas has yet to be
conducted.
SEC. 113. PROVISIONS REGARDING INCREASE IN AMOUNT
OF FUNDS EXPENDED FOR RESEARCH ON AL-
COHOL ABUSE AND ALCOHOLISM AMONG
WOMEN.
Section 464H(d)(1) of the Public Health Service Act
(42 U.S.C. 285n(d)(1)), as added by section 122 of Public
Law 102–321 (106 Stat. 358), is amended by adding at
the end the following new sentence: ‘‘For fiscal year 1994,
of the first $131,606,000 appropriated under the preced-
ing sentence, the Director of the Institute shall obligate
not less than $14,200,000 for the purpose of carrying out
under this subpart projects of research on alcohol abuse
and alcoholism among women, and of the amounts appro-
priated under such sentence in excess of $131,606,000,
the Director shall obligate for such purpose not less than
$23,250,000.’’.
Subtitle D—National Breast Cancer
Strategy Act of 1993
SEC. 116. SHORT TITLE.
This subtitle may be cited as the ‘‘National Breast
Cancer Strategy Act of 1993’’.
PART I—ESTABLISHMENT OF OFFICE OF BREAST
CANCER AND NATIONAL BREAST CANCER
COMMISSION
SEC. 117. OFFICE OF BREAST CANCER.
Title XVII of the Public Health Service Act (42
U.S.C. 300uu et seq.) is amended by adding at the end
the following new section:
‘‘SEC. 1709. ESTABLISHMENT OF OFFICE OF BREAST CAN-
CER.
‘‘(a) IN GENERAL.—There is established an Office of
Breast Cancer within the Office of the Assistant Secretary
for Health. The Office shall have a Director who shall be
appointed by the Secretary. The Secretary, acting through
the Director, shall carry out this section.
‘‘(b) DUTIES.—The Secretary shall coordinate, in
conjunction with the Director of the National Cancer In-
stitute, the activities of the Institute relating to breast
cancer with similar activities of other agencies of the Fed-
eral Government, including the other agencies of the Na-
tional Institutes of Health, and with similar activities of
other public entities and of private entities.’’.
SEC. 118. ESTABLISHMENT OF NATIONAL BREAST CANCER
COMMISSION.
Title XVII of the Public Health Service Act (42
U.S.C. 300uu et seq.), as amended by section 117, is
amended by adding at the end the following new section:
‘‘SEC. 1710. NATIONAL BREAST CANCER COMMISSION.
‘‘(a) ESTABLISHMENT.—There is established a com-
mission to be known as the ‘National Breast Cancer Com-
mission’ (in this section referred to as the ‘Commission’).
‘‘(b) STUDY.—The Commission shall conduct a study
on current efforts in both the public and private sectors
relating to the prevention, early detection, treatment, edu-
cation, and research relating to breast cancer.
‘‘(c) REPORT.—Not later than 1 year after the date
on which the initial appointments of the members have
been completed under subsection (d), the Commission
shall submit to the President and the Congress a report
containing—
‘‘(1) the results of the study conducted under
subsection (b); and
‘‘(2) recommendations relating to such study.
‘‘(d) NUMBER AND APPOINTMENT.—
‘‘(1) APPOINTMENT.—The Commission shall be
composed of 15 members as follows:
‘‘(A) 5 members shall be appointed by the
President—
‘‘(i) 3 of whom shall be—
‘‘(I) the Secretary of Health and
Human Services;
‘‘(II) the Secretary of Veterans
Affairs; and
‘‘(III) the Secretary of Defense;
who shall be nonvoting members, except
that, in the case of a tie vote by the Com-
mission, the Secretary of Health and
Human Services shall be a voting member;
and
‘‘(ii) 2 of whom shall be selected from
the general public on the basis of such in-
dividuals being specially qualified to serve
on the Commission by reason of their edu-
cation, training, or experience.
‘‘(B) 5 members shall be appointed by the
Speaker of the House of Representatives on the
joint recommendation of the Majority and Mi-
nority Leaders of the House of Representatives.
‘‘(C) 5 members shall be appointed by the
President pro tempore of the Senate on the
joint recommendation of the Majority and Mi-
nority Leaders of the Senate.
‘‘(2) 
CONGRESSIONAL
COMMITTEE
REC-
OMMENDATIONS.—In making appointments under
subparagraphs (B) and (C) of paragraph (1), the
Majority and Minority leaders of the House of Rep-
resentatives and the Senate shall duly consider the
recommendations of the Chairmen and Ranking Mi-
nority Members of committees with jurisdiction over
laws contained in chapter 17 of title 38, United
States Code (relating to veterans’ health care), title
XIX of the Social Security Act (42 U.S.C. 1901 et
seq.) (relating to Medicaid), and the Public Health
Service Act (42 U.S.C. 201 et seq.) (relating to the
Public Health Service).
‘‘(3) REQUIREMENTS OF APPOINTMENTS.—The
Majority and Minority leaders of the Senate and the
House of Representatives shall—
‘‘(A) select individuals who are specially
qualified to serve on the Commission by reason
of their education, training, or experience; and
‘‘(B) engage in consultations for the pur-
pose of ensuring that the expertise of the 10
members appointed by the Speaker of the
House of Representatives and the President pro
tempore of the Senate shall provide as much of
a balance as possible and, to the greatest extent
possible, cover the fields of medicine, science,
law, ethics, health-care and social services.
‘‘(4) TERM
OF
MEMBERS.—Members of the
Commission (other than members appointed under
paragraph (1)(A)(i)) shall serve for the life of the
Commission.
‘‘(5) VACANCY.—A vacancy on the Commission
shall be filled in the manner in which the original
appointment was made.
‘‘(e) CHAIRMAN.—Not later than 15 days after the
members of the Commission are appointed, such members
shall select a Chairman from among the members of the
Commission.
‘‘(f) QUORUM.—7 members of the Commission shall
constitute a quorum, but a lesser number may be author-
ized by the Commission to conduct hearings.
‘‘(g) MEETINGS.—The Commission shall hold its 1st
meeting on a date specified by the Chairman. After the
initial meeting, the Commission shall meet at the call of
the Chairman or a majority of its members, but shall meet
at least 3 times each year during the life of the Commis-
sion.
‘‘(h) PAY.—Members of the Commission who are offi-
cers or employees or elected officials of a government en-
tity shall receive no additional compensation by reason of
their service on the Commission.
‘‘(i) PER DIEM.—While away from their homes or
regular places of business in the performance of duties for
the Commission, members of the Commission shall be al-
lowed travel expenses, including per diem in lieu of sub-
sistence, at rates authorized for employees of agencies
under sections 5702 and 5703 of title 5, United States
Code.
‘‘(j) DEADLINE FOR APPOINTMENT.—The members
of the Commission shall be appointed not later than 60
days after the date of the enactment of this section.
‘‘(k) TERMINATION.—The Commission shall cease to
exist 60 days after the date on which its final report is
submitted under subsection (c).’’.
PART II—DUTIES OF DIRECTOR OF THE NA-
TIONAL CANCER INSTITUTE RELATING TO
BREAST CANCER
SEC. 119. PROVISIONS FOR FULL FUNDING FOR NATIONAL
CANCER INSTITUTE WITH RESPECT TO RE-
SEARCH ON BREAST CANCER.
Section 408(a)(1) of the Public Health Service Act
(42 U.S.C. 284c(a)(1)) is amended by adding at the end
the following subparagraph:
‘‘(C) For the purpose of conducting and sup-
porting research on breast cancer through the Na-
tional Cancer Institute, there is authorized to be ap-
propriated for fiscal year 1994 an amount equal to
the sum of $300,000,000 and the amount obligated
by such Institute for such research for fiscal year
1993. For such purpose, there are authorized to be
appropriated such sums as may be necessary for
each of the fiscal years 1995 and 1996.’’.
SEC. 120. DUTIES OF DIRECTOR.
Subpart 1 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285 et seq.) is amended by adding
at the end the following new section:
‘‘SEC. 417. DUTIES OF DIRECTOR OF THE INSTITUTE RELAT-
ING TO BREAST CANCER RESEARCH.
‘‘(a) The Director of the Institute shall conduct and
support biomedical and behavioral research and research
training, the dissemination of health information, and
other programs with respect to breast cancer.
‘‘(b) In carrying out subsection (a), the Director of
the Institute shall conduct or support multidisciplinary
clinical research on breast cancer, including research on
assisting individuals with such cancers (and the families
of such individuals) and with responding to psychological
and social problems that arise as the result of the cancer.
‘‘(c)(1) The Director of the Institute shall establish
the Rose Kushner Scholarship Program for the purpose
of entering into contracts with individuals under which—
‘‘(A) the Director of the Institute agrees to pro-
vide to the individuals scholarships for attendance at
accredited health professions schools; and
‘‘(B) the individuals agree—
‘‘(i) to complete the programs of education
for which the scholarships are provided;
‘‘(ii) to complete a program of post-
graduate clinical training in oncology; and
‘‘(iii) after completing a program of such
training, to serve as employees of the National
Institutes of Health, for the period described in
paragraph (2), in positions that are needed by
such Institutes in carrying out programs with
respect to breast cancer.
‘‘(2)(A) For purposes of paragraph (1)(B)(iii), the
period of service for which an individual is obligated to
serve as an employee of the National Institutes of Health
is 12 months for each academic year for which the scholar-
ship under such subsection is provided.
‘‘(B) The Director of the Institute may defer the obli-
gation of an individual to provide a period of service under
paragraph (1)(B)(iii), if the Director determines that such
a deferral is appropriate.
‘‘(C) For any period in which an individual provides
service as an employee of the National Institutes of Health
in satisfaction of the obligation of the individual under
paragraph (1)(B)(iii), the individual may be appointed as
such an employee without regard to the provisions of title
5, United States Code, relating to appointment and com-
pensation.
‘‘(3)(A) The Director of the Institute may not provide
a scholarship under paragraph (1) for an academic year
unless—
‘‘(i) the individual applying for the scholarship
has submitted to the Director a proposed academic
program for the year and the Director has approved
the program; and
‘‘(ii) the individual agrees that the program will
not be altered without the approval of the Director.
the National Health Service Corps Loan Repayment Pro-
gram established in section 338B.
‘‘(6) The Director of the Institute may not provide
a scholarship under paragraph (1) unless an application
for the scholarship is submitted to the Director and the
application is in such form, is made in such manner, and
contains such agreements, assurances, and information as
the Director determines to be necessary to carry out this
section.
‘‘(d)(1) The Director of the Institute shall, subject
to paragraph (2), carry out a program of entering into
contracts with appropriately qualified health professionals
under which the professionals agree to carry out activities
with respect to breast cancer as employees of the National
Institutes of Health in consideration of the Federal Gov-
ernment agreeing to pay, for each year of such service,
not more than $20,000 of the principal and interest of
the educational loans of the professionals.
‘‘(2) The Director of the Institute may not enter into
a contract with a health professional pursuant to para-
graph (1) unless the professional has a substantial amount
of educational loans relative to income.
‘‘(3) Except to the extent inconsistent with this sec-
tion, 338E shall apply to the program established in para-
graph (1) to the same extent and in the same manner as
such section applies to the National Health Service Corps
Loan Repayment Program established in section 338B.’’.
SEC. 121. SPECIALIZED PROGRAMS OF RESEARCH EXCEL-
LENCE WITH RESPECT TO BREAST, LUNG,
AND PROSTATE CANCER.
Section 408(a)(1) of the Public Health Service Act,
as amended by section 119, is amended by adding at the
end the following subparagraph:
‘‘(D)(i) For the purpose of carrying out not less
than 10 programs for research on breast cancer,
lung cancer, or prostate cancer under the programs
designated by the Director of the National Cancer
Institute as the Specialized Programs of Research
Excellence, there is authorized to be appropriated
such sums as may be necessary for each of the fiscal
years 1994 through 1996.
‘‘(ii) With respect to the purpose described in
clause (i), the authorizations of appropriations es-
tablished in such clause may not be construed as
terminating the availability for such purpose of any
other authorization of appropriations (including the
authorization established in subparagraph (A).’’.
Subtitle E—Lupus Research
Amendments of 1993
SEC. 126. SHORT TITLE.
This subtitle may be cited as the ‘‘Lupus Research
Amendments of 1993’’.
SEC. 127. FINDINGS.
The Congress finds that—
(1) lupus is a serious, complex, inflammatory,
autoimmune disease of particular concern to women;
(2) lupus affects women 9 times more often
than men;
(3) there are 3 main types of lupus: systemic
lupus, a serious form of the disease that affects
many parts of the body; discoid lupus, a form of the
disease that affects mainly the skin; and drug-in-
duced lupus caused by certain medications;
(4) lupus can be fatal if not detected and
treated early;
(5) the disease can simultaneously affect var-
ious areas of the body, such as the skin, joints, kid-
neys, and brain, and can be difficult to diagnose be-
cause the symptoms of lupus are similar to those of
many other diseases;
(6) lupus disproportionately affects African-
American women, as the prevalence of the disease
among such women is 3 times the prevalence among
white women, and an estimated 1 in 250 African-
American women between the ages of 15 and 65 de-
velops the disease;
(7) it has been estimated that over 500,000
Americans have been diagnosed with the disease,
and that many more have undiagnosed cases;
(8) current treatments for the disease can be
effective, but may lead to damaging side effects; and
(9) many victims of the disease suffer debilitat-
ing pain and fatigue, making it difficult to maintain
employment and lead normal lives.
SEC. 128. EXPANSION AND INTENSIFICATION OF ACTIVI-
TIES REGARDING LUPUS.
Subpart 4 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285d et seq.) is amended by insert-
ing after section 441 the following section:
‘‘LUPUS
‘‘SEC. 441A. (a) IN GENERAL.—The Director of the
Institute shall expand and intensify research and related
activities of the Institute with respect to lupus.
‘‘(b) COORDINATION WITH OTHER INSTITUTES.—
The Director of the Institute shall coordinate the activities
of the Director under subsection (a) with similar activities
conducted by the other national research institutes and
agencies of the National Institutes of Health to the extent
that such Institutes and agencies have responsibilities that
are related to lupus.
‘‘(c) PROGRAMS FOR LUPUS.—In carrying out sub-
section (a), the Director of the Institute shall conduct or
support research to expand the understanding of the
causes of, and to find a cure for, lupus. Activities under
such subsection shall include research to determine the
reasons underlying the elevated prevalence of the disease
among African-American and other women. Activities
under such subsection shall provide for an expansion and
intensification of the conduct and support of—
‘‘(1) basic research concerning the etiology and
causes of lupus;
‘‘(2) epidemiological studies to address the fre-
quency and natural history of the disease and the
differences among the sexes and among racial and
ethnic groups with respect to the disease;
‘‘(3) the development of improved screening
techniques;
‘‘(4) clinical research for the development and
evaluation of new treatments, including new biologi-
cal agents; and
‘‘(5) information and education programs for
health care professionals and the public.
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated $20,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the fiscal years
1994 through 1996. The authorization of appropriations
established in the preceding sentence is in addition to any
other authorization of appropriations that is available for
such purpose.’’.
Subtitle F—Women’s Midlife Health
Research Act
SEC. 131. SHORT TITLE.
This subtitle may be cited as the ‘‘Women’s Midlife
Health Research Act’’.
SEC. 132. ESTABLISHMENT OF PROGRAM FOR RESEARCH
CENTERS ON WOMEN’S MIDLIFE HEALTH
CARE, INCLUDING MENOPAUSE AND MENO-
PAUSAL HEALTH CONDITIONS.
Subpart 5 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285e et seq.) is amended by adding
at the end the following section:
‘‘RESEARCH CENTERS ON MENOPAUSE AND MENOPAUSAL
HEALTH CONDITIONS
‘‘SEC. 445G. (a) The Director of the Institute, after
consultation with the advisory council for the Institute,
shall provide for the development or expansion of not less
than 5 centers for research on—
‘‘(1) the process by which the functioning of the
ovaries diminishes or ceases completely (in this sec-
tion referred to as ‘menopause’); and
‘‘(2) conditions arising from the diminished or
complete cessation of the functioning of the ovaries,
whether occurring naturally or otherwise (in this
section referred to as ‘menopausal health condi-
tions’).
‘‘(b) Each center assisted under this section shall—
‘‘(1)(A) use the facilities of a single institution
or a consortium of cooperating institutions; and
‘‘(B) meet such qualifications as may be pre-
scribed by the Secretary;
‘‘(2) conduct basic and clinical research into the
natural history of menopause in order to improve
the state of medical knowledge or methods regarding
the cause, diagnosis, early detection, prevention, con-
trol, and treatment of menopausal health conditions;
‘‘(3) develop multidisciplinary models of health
care regarding menopause and menopausal health
conditions;
‘‘(4) conduct educational and training programs
on menopause and menopausal health conditions for
physicians, scientists, and other health and allied
health professionals;
‘‘(5) conduct information and continuing edu-
cation programs for physicians and other health and
allied health professionals who provide care for pa-
tients with such conditions; and
‘‘(6) conduct programs for the dissemination to
the general public of information on menopause and
menopausal health conditions.
‘‘(c) In carrying out subsection (b)(2), the Director
of the Institute shall ensure that centers assisted under
this section—
‘‘(1) conduct research on hormonal treatments
for menopausal health conditions, research on
nonhormonal treatments of symptoms arising from
such conditions, and research on the relationship be-
tween such conditions and cardiovascular disease,
osteoporosis, bone fractures, bladder conditions,
breast and uterine cancers, and other conditions that
research indicates may be relevant; and
‘‘(2) conduct research to determine whether and
to what extent differences may exist, with respect to
menopause 
and 
menopausal 
health 
conditions,
among various socioeconomic groups, ethnic groups,
and racial groups.
‘‘(d) In carrying out subsection (a), the Director of
the Institute, in consultation with the Director of NIH
and the Administrator for Health Care Policy and Re-
search, shall establish a program to develop protocols for
the prevention and treatment of menopausal health condi-
tions and other conditions regarding women’s midlife
health.
‘‘(e) A center may use funds provided under sub-
section (a) to provide stipends for health professionals en-
rolled in educational or training programs described in
subsection (b)(4).
‘‘(f) The Director shall ensure that the activities of
centers assisted under this section are coordinated among
the centers.
‘‘(g) The Director of the Institute shall, to the extent
practicable, provide for an equitable geographical distribu-
tion of centers assisted under this section.
‘‘(h) Support of a center under this section may be
for a period of not to exceed five years. Such period may
be extended by the Director of the Institute for one or
more additional periods of not more than five years if the
operations of such center have been reviewed by an appro-
priate technical and scientific peer review group estab-
lished by the Director and if such group has recommended
to the Director that such period should be extended.’’.
Subtitle G—Osteoporosis and Re-
lated Bone Disorders Research
Education, and Health Services
Act of 1993
SEC. 136. SHORT TITLE.
This subtitle may be cited as the ‘‘Osteoporosis and
Related Bone Disorders Research, Education, and Health
Services Act of 1993’’.
SEC. 137. FINDINGS.
The Congress finds that—
(1) osteoporosis, or porous bone, is a condition
characterized by an excessive loss of bone tissue and
an increased susceptibility to fractures of the hip,
spine, and wrist;
(2) an estimated 25,000,000 Americans have
osteoporosis, with many cases undiagnosed because
the condition develops without symptoms until a
strain, bump, or fall causes a fracture;
(3) between 3 and 4 million Americans have
Paget’s disease, Osteogenesis Imperfecta, and other
related metabolic bone disorders;
(4) osteoporosis is responsible for 1,300,000
bone fractures annually, including more than
250,000 hip fractures, 500,000 vertebral fractures,
200,000 fractures of the wrist, and the remaining
fractures at other limb sites;
(5) osteoporosis affects one-third to one-half of
all postmenopausal women and nearly half of all
people over age 75;
(6) direct medical costs of osteoporosis reached
an estimated $10,000,000,000 in 1988 for the Unit-
ed States, not including the costs of family care and
lost work for caregivers;
(7) direct medical costs of osteoporosis are ex-
pected to increase precipitously because the propor-
tion of the population comprised of older persons is
expanding and each generation of older persons
tends to have a higher incidence of osteoporosis than
preceding generations;
(8) technology now exists, and new technology
is developing, that will permit early diagnosis and
prevention of osteoporosis as well as management of
the condition once it has developed;
(9) funding for research on osteoporosis and re-
lated bone disorders is severely constrained at key
research institutes, including the National Institute
of Arthritis and Musculoskeletal and Skin Diseases,
the National Institute on Aging, and the National
Institute of Diabetes and Digestive and Kidney Dis-
eases;
(10) further research is needed to improve med-
ical knowledge concerning—
(A) cellular mechanisms related to the
processes of bone resorption and bone forma-
tion, and the effect of different agents on bone
remodeling;
(B) risk factors for osteoporosis, including
newly discovered risk factors, risk factors relat-
ed to groups not ordinarily studied, such as
men and minorities, and the relationship of
aging 
processes 
to 
the 
development 
of
osteoporosis;
(C) bone mass measurement technology,
including techniques for making faster and
more precise measurements and for interpreting
measurements;
(D) calcium, including bioavailability, in-
take requirements, and the role of calcium in
building heavier and denser skeletons;
(E) prevention and treatment, including
the efficacy of current therapies, alternative
drug therapies for prevention and treatment,
and the role of exercise; and
(F) rehabilitation; and
(11) further educational efforts are needed to
increase public and professional knowledge of the
causes of, methods for avoiding, and treatment of
osteoporosis.
SEC. 138. OSTEOPOROSIS RESEARCH.
Subpart 4 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285d et seq.) is amended—
(1) by inserting after the subpart designation
and heading the following:
‘‘DIVISION A—ARTHRITIS’’;
and
(2) by adding at the end the following:
‘‘DIVISION B—OSTEOPOROSIS
‘‘SEC. 442A. DEFINITIONS.
‘‘As used in this division:
‘‘(1) ADVISORY
PANEL.—The term ‘Advisory
Panel’ means the Advisory Panel on Osteoporosis
and Related Disorders, established in section 442D.
‘‘(2) COUNCIL.—The term ‘Council’ means the
Interagency Council on Osteoporosis and Related
Disorders, established in section 442C.
‘‘(3) DEPARTMENT.—The term ‘Department’
means the Department of Health and Human Serv-
ices.
‘‘(4) RELATED DISORDERS.—The term ‘related
bone disorders’ includes—
‘‘(A) Paget’s disease, a bone disease char-
acterized by enlargement and loss of density
with bowing and deformity of the bones;
‘‘(B) Osteogenesis Imperfecta, a familial
disease marked by extreme brittleness of the
long bones;
‘‘(C) hyperparathyroidism, a condition
characterized by the presence of excess para-
thormone in the body resulting in disturbance
of calcium metabolism with loss of calcium from
bone and renal damage;
‘‘(D) 
hypoparathyroidism, 
a 
condition
characterized by the absence of parathormone
resulting in disturbances of calcium metabolism;
‘‘(E) renal bone disease, a disease charac-
terized by metabolic disturbances from dialysis,
renal transplants, or other renal disturbances;
‘‘(F) 
primary 
or 
postmenopausal
osteoporosis and secondary osteoporosis, such
as that induced by corticosteroids; and
‘‘(G) other general disorders of bone and
mineral metabolism including abnormalities of
vitamin D.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated to carry out this section
$36,000,000 for the National Institute of Arthritis and
Musculoskeletal and Skin Diseases, $24,000,000 for the
National Institute on Aging, and $2,000,000 for the Na-
tional Institute of Diabetes and Digestive and Kidney Dis-
eases for each of the fiscal years 1994 through 1996, and
such sums as may be necessary for subsequent fiscal
years. These funds are in addition to amounts authorized
to be appropriated for biomedical research relating to
osteoporosis and related bone disorders under any other
provision of law.
‘‘SEC. 442C. INTERAGENCY COUNCIL ON OSTEOPOROSIS
AND RELATED BONE DISORDERS.
‘‘(a) ESTABLISHMENT.—There is established in the
Department an Interagency Council on Osteoporosis and
Related Disorders. The Council shall be composed of—
‘‘(1) the Assistant Secretary for Health;
‘‘(2) the Surgeon General of the United States;
‘‘(3) the Assistant Secretary for Planning and
Evaluation of the Department;
‘‘(4) the Director of the National Institute of
Arthritis and Musculoskeletal and Skin Diseases;
‘‘(5) the Director of the National Institute on
Aging;
‘‘(6) the Director of the National Institute of
Diabetes, Digestive, and Kidney Diseases;
‘‘(7) the Director of the National Institute of
Mental Health;
‘‘(8) the Director of the National Institute of
Child Health and Human Development;
‘‘(9) the Administrator of the Health Care Fi-
nancing Administration;
‘‘(10) the Administrator for Health Care Policy
and Research;
‘‘(11) the Director of the Bureau of Child and
Maternal Health;
‘‘(12) the Commissioner of Food and Drugs;
‘‘(13) the Director of the National Institute of
Dental Research;
‘‘(14) the Commissioner on Aging;
‘‘(15) the Director of the Office of Disease Pre-
vention and Health Promotion; and
‘‘(16) such additional members as the Secretary
considers appropriate.
‘‘(b) FUNCTIONS.—The Council shall—
‘‘(1) coordinate research conducted by or
through the Department on osteoporosis and related
bone disorders;
‘‘(2) establish a mechanism for sharing infor-
mation on osteoporosis and related bone disorders
among all officers and employees of the Department
involved in carrying out programs serving older per-
sons, midlife women, and young persons, in order to
provide for full communication and exchange of in-
formation;
‘‘(3) review and coordinate the most promising
areas of research concerning osteoporosis and relat-
ed bone disorders;
‘‘(4) assist the National Institute of Arthritis
and Musculoskeletal and Skin Diseases, the National
Institute on Aging, the National Institute of Diabe-
tes, Digestive and Kidney Disease, the National In-
stitute on Dental Research, and other institutes in
developing and coordinating plans for research on
osteoporosis and related bone disorders;
‘‘(5) assist the Office of Disease Prevention and
Health Promotion and the Administration on Aging
and other offices in developing and coordinating
plans for education and health promotion on
osteoporosis and related bone disorders; and
‘‘(6) establish mechanisms to use the results of
research concerning osteoporosis and related bone
disorders in the development of policies, programs,
and other measures to improve the quality of life for
older Americans.
‘‘(c) CHAIRPERSON.—The Secretary shall select a
Chairperson or co-Chairpersons for the Council from
among its members.
‘‘(d) QUORUM.—A majority of the members of the
Council shall constitute a quorum, but a lesser number
may hold hearings.
‘‘(e) MEETINGS.—The Council shall meet periodically
at the call of the Chairperson, but not less often than twice
each year.
‘‘(f) EXECUTIVE SECRETARY.—The Secretary shall
appoint an Executive Secretary for the Council.
‘‘(g) ADMINISTRATIVE STAFF AND SUPPORT.—The
Secretary shall provide the Council with such additional
administrative staff and support as may be necessary to
enable the Council to carry out its functions.
‘‘(h) REPORTS.—
‘‘(1) INITIAL REPORT.—
‘‘(A) PREPARATION.—Not later than 9
months after the date of enactment of this divi-
sion, the Executive Secretary of the Council
shall prepare a report detailing the research
plans referred to in paragraphs (4) and (5) of
subsection (b). The report shall describe the ac-
tivities to be carried out under the research
plans during each of the fiscal years 1994
through 1996.
‘‘(B) OTHER
FEDERAL
PROGRAMS.—To
the maximum extent feasible, the report shall
ensure that activities carried out under the re-
search plans are coordinated with, and use the
resources of, other Federal programs concern-
ing osteoporosis and related bone disorders, in-
cluding—
‘‘(i) centers supported by the National
Institute of Arthritis and Musculoskeletal
and Skin Diseases, the National Institute
on Aging, and the National Institute of Di-
abetes, Digestive and Kidney Disease;
‘‘(ii) other centers supported by Fed-
eral 
funds 
involved 
in 
research 
on
osteoporosis and related bone disorders;
and
‘‘(iii) 
other 
programs 
concerning
osteoporosis and related bone disorders
that are planned or conducted by Federal
agencies such as the Administration on
Aging and the Office of Disease Prevention
and Health Promotion, Federal agencies
outside the Department, State or local
agencies, community organizations, or pri-
vate foundations.
‘‘(C) DISTRIBUTION.—The Executive Sec-
retary of the Council shall—
‘‘(i) transmit the report to Congress;
and
‘‘(ii) make the report available to the
public and to the Advisory Panel.
‘‘(2) SUBSEQUENT REPORTS.—Not later than
12 months after the date on which the report re-
quired by paragraph (1) is transmitted to Congress,
and annually thereafter, the Executive Secretary of
the Council shall—
‘‘(A) prepare a report that—
‘‘(i) describes research and edu-
cational initiatives sponsored by the Fed-
eral Government on osteoporosis and relat-
ed bone disorders; and
‘‘(ii) makes recommendations for new
research and educational initiatives on
osteoporosis and related bone disorders;
and
‘‘(B) transmit the report to Congress and
make the report available to the public.
‘‘SEC. 442D. ADVISORY PANEL ON OSTEOPOROSIS AND RE-
LATED DISORDERS.
‘‘(a) ESTABLISHMENT.—There is established in the
Department an Advisory Panel on Osteoporosis and Relat-
ed Disorders. The Advisory Panel shall be composed of
the following 15 voting members and additional nonvoting,
ex officio members:
‘‘(1) VOTING MEMBERS.—The Director of the
Office of Technology Assessment shall appoint to the
Advisory Panel—
‘‘(A) 5 members who are biomedical re-
search scientists with demonstrated achieve-
ment in biomedical research on osteoporosis and
related bone disorders, including at least 1 re-
searcher at a specialized center for research in
osteoporosis;
‘‘(B) 
members 
with 
demonstrated
achievements in research on community-based
and family services covering osteoporosis and
related bone disorders;
‘‘(C) 1 member who is knowledgeable in
health promotion and disease prevention pro-
grams concerning osteoporosis and related bone
disorders;
‘‘(D) 2 members who are associated with
specialized bone programs affiliated with aca-
demic health centers;
‘‘(E) 2 members who are experts in private
health care insurance and long-term care fi-
nancing; and
‘‘(F) 3 members who are representatives of
national voluntary organizations that are con-
cerned with the problems of individuals with
osteoporosis and related bone disorders and
their families.
‘‘(2) NONVOTING, EX OFFICIO MEMBERS.—The
Advisory Panel shall include as nonvoting, ex officio
members—
‘‘(A) the Chairperson of the Council;
‘‘(B) the Director of National Institute of
Arthritis and Musculoskeletal and Skin Dis-
eases;
‘‘(C) the Director of the National Institute
on Aging;
‘‘(D) the Director of the National Institute
of Diabetes and Digestive and Kidney Diseases;
and
‘‘(E) such other members as the Secretary
may appoint.
‘‘(3) APPOINTMENT.—The Director of the Of-
fice of Technology Assessment shall appoint mem-
bers to the Advisory Panel within 90 days after the
date of enactment of this division. The Director shall
not appoint to the Advisory Panel individuals who
are officers or employees of the Federal Government.
‘‘(b) FUNCTIONS.—The Advisory Panel shall advise
the Secretary and Council with respect to the identifica-
tion of—
‘‘(1) 
research 
priorities 
for 
projects 
on
osteoporosis, related bone disorders, and the care of
individuals with osteoporosis or related bone dis-
orders;
‘‘(2) emerging issues in and promising areas of
biomedical, clinical, and behavioral research on
osteoporosis and related bone disorders;
‘‘(3) emerging issues in research on health serv-
ices for individuals, and the families of individuals,
with osteoporosis or related bone disorders;
‘‘(4) emerging issues in home-based and com-
munity-based services and systems of services for in-
dividuals, and the families of individuals, with
osteoporosis or related bone disorders;
‘‘(5) emerging issues in financing health care
services and social services for individuals, and the
families of individuals, with osteoporosis and related
bone disorders;
‘‘(6) emerging issues in health promotion pro-
grams concerning osteoporosis; and
‘‘(7) emerging issues in professional and public
education concerning osteoporosis.
‘‘(c) CHAIRPERSON.—The Secretary shall appoint a
Chairperson of the Advisory Panel from among the mem-
bers appointed.
‘‘(d) TERM OF OFFICE.—The term of a member of
the Advisory Panel shall be for the life of the Advisory
Panel. A vacancy on the Advisory Panel shall be filled in
the same manner as the original appointment was made.
A vacancy on the Advisory Panel shall not affect its
powers.
‘‘(e) QUORUM.—A majority of the members of the
Advisory Panel appointed shall constitute a quorum, but
a lesser number may hold hearings. The Advisory Panel
may establish such subcommittees as the Advisory Panel
considers appropriate.
‘‘(f) MEETINGS.—The Advisory Panel shall meet at
the call of the Chairperson, but not less often than twice
per year.
‘‘(g) EXECUTIVE SECRETARY.—The Executive Sec-
retary of the Council shall serve as Executive Secretary
of the Advisory Panel.
‘‘(h) STAFF AND SUPPORT.—The Secretary shall pro-
vide the Advisory Panel with such additional administra-
tive staff and support as may be necessary to enable the
Advisory Panel to carry out its functions.
‘‘(i) COMPENSATION AND TRAVEL EXPENSES.—
‘‘(1) COMPENSATION.—Subject to paragraph
(2), no member of the Advisory Panel shall receive
compensation for service on the Advisory Panel.
‘‘(2) TRAVEL EXPENSES.—Each member of the
Advisory Panel shall receive reimbursement for trav-
el, subsistence, and other necessary expenses in-
curred in the performance of duties of the Advisory
Panel.
‘‘(j) REPORT.—The Advisory Panel shall—
‘‘(1) prepare an annual report, which shall con-
tain recommendations for administrative and legisla-
tive actions to—
‘‘(A) improve services, education, and in-
formation for individuals, and families of indi-
viduals, with osteoporosis and related bone dis-
orders;
‘‘(B) improve professional education; and
‘‘(C) provide for promising biomedical re-
search related to osteoporosis and related bone
disorders; and
‘‘(2) transmit the annual report to the Con-
gress, the Secretary, and the Council and make it
available to the public.
‘‘(k) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated to carry out this section
$200,000 for each of fiscal years 1994 through 1996.
‘‘SEC. 442E. RESOURCE CENTER ON OSTEOPOROSIS AND
RELATED DISORDERS.
‘‘(a) ESTABLISHMENT.—The Director of the Na-
tional Institute of Arthritis and Musculoskeletal and Skin
Diseases shall make grants or enter into contracts with
eligible organizations to establish a Resource Center on
Osteoporosis and Related Disorders.
‘‘(b) PURPOSE.—The purpose of the Resource Center
shall be to facilitate and enhance knowledge and under-
standing of osteoporosis and related bone disorders by dis-
seminating information about research results, services
and educational materials, to health professionals, pa-
tients, and the public.
‘‘(c) FUNCTIONS.—An organization receiving a grant
or contract under this section shall—
‘‘(1) compile, archive, and disseminate informa-
tion concerning research, demonstration, evaluation,
and training programs and projects concerning
osteoporosis and related bone disorders;
‘‘(2) annually publish a summary of the infor-
mation compiled under paragraph (1) during the
preceding 12-month period, and make the informa-
tion available on request to appropriate individuals
and entities, including educational institutions, re-
search entities, and Federal and public agencies;
‘‘(3) provide information and assistance in
accessing community services to patients and the
public;
‘‘(4) coordinate regional training programs for
the development of health professional resource net-
works on osteoporosis and related bone disorders;
and
‘‘(5) maintain a resource library on osteoporosis
and related bone disorders.
‘‘(d) INFORMATION
SYSTEM
AND
TELEPHONE
LINE.—
‘‘(1) INFORMATION SYSTEM.—An organization
receiving a grant or contract under this section shall
establish a central computerized information system
to—
‘‘(A) compile and disseminate information
concerning initiatives by State and local govern-
ments and private entities to provide programs
and services for individuals with osteoporosis;
and
‘‘(B) translate scientific and technical in-
formation concerning the initiatives into infor-
mation readily understandable by the general
public, and make the information available on
request.
‘‘(2) TELEPHONE LINE.—An organization re-
ceiving a grant or contract under this section shall
establish a national toll-free telephone line to make
available the information described in paragraph (1)
and information concerning Federal programs, serv-
ices, and benefits for individuals with osteoporosis
and their families.
‘‘(e) FEES.—In accordance with regulations issued by
the Secretary, the organization receiving a grant or con-
tract under this section shall charge appropriate fees for
providing information through the Research Center as
specified in subsections (c) or (d). The organization may
make exceptions to the fees for individuals and organiza-
tions who are not financially able to pay the fees. The or-
ganization shall transfer the sums obtained from payment
of the fees to the Secretary, who shall use the sums to
carry out this section.
‘‘(f) APPLICATION OR PROPOSAL.—In order to re-
ceive a grant or enter into a contract under this section,
an organization shall submit an application or proposal
to the Director of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases. The application or
proposal shall contain—
‘‘(1) information demonstrating that the organi-
zation has a network of contacts that will enable the
organization to receive information necessary to op-
erate the central computerized information system
described in subsection (d)(1); and
‘‘(2) such other information as the Director
may prescribe.
‘‘(g) ELIGIBLE ORGANIZATIONS.—Organizations eli-
gible to receive grants under this section shall include pub-
lic and private nonprofit organizations that are knowledge-
able about osteoporosis and related bone disorders. The
Secretary shall establish additional eligibility criteria for
organizations to receive grants or enter into contracts
under this section.
‘‘(h) RESEARCH SUMMARIES.—The Director of the
National Institute of Arthritis and Musculoskeletal and
Skin Diseases, the National Institute on Aging, the Na-
tional Institute of Diabetes, Digestive, and Kidney Dis-
eases, the National Institute on Dental Research, and
other agencies specified by the Secretary shall provide to
the Resource Center summaries of the findings of research
conducted on osteoporosis, related bone disorders, or rel-
evant treatments for osteoporosis or related bone dis-
orders.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There
are authorized to be appropriated to carry out this section
$500,000 for fiscal year 1994, and such sums as may be
necessary for fiscal years 1995 and 1996.’’.
Subtitle H—Ovarian Cancer Re-
search and Information Amend-
ments of 1993
SEC. 141. SHORT TITLE.
This subtitle may be cited as the ‘‘Ovarian Cancer
Research and Information Amendments of 1993’’.
SEC. 142. FUNDING FOR RESEARCH ON OVARIAN CANCER.
Section 417B(b)(2) of the Public Health Service Act,
as added by section 403 of Public Law 103–43, is amend-
ed—
(1) by striking ‘‘CANCERS.—For the purpose
of’’ and all that follows through ‘‘417,’’ and insert-
ing the following: ‘‘CANCERS.—
‘‘(A) For the purpose of carrying out sec-
tion 417(d),’’; and
(2) by adding at the end the following subpara-
graph:
‘‘(B)(i) For the purpose of carrying out re-
search under section 417(d) on ovarian cancer,
there 
are 
authorized 
to 
be 
appropriated
$90,000,000 for fiscal year 1994, and such
sums as may be necessary for each of the fiscal
years 1995 and 1996. With respect to such pur-
pose, such authorizations of appropriations are
in addition to the authorizations of appropria-
tions established in subparagraph (A) and in
subsection (a).
‘‘(ii) Of the amounts appropriated under
clause (i), the Director of the Institute shall re-
serve 50 percent for research described in such
clause that does not involve treatment or clini-
cal trials, and 50 percent for research described
in such clause that does involve treatment and
clinical trials.
‘‘(iii) In expending the amounts reserved
under clause (ii), the Director of the Institute
shall ensure that 1 or more programs of re-
search on ovarian cancer are carried out under
the programs designated by the Director as the
Specialized Programs of Research Excellence.’’.
SEC. 143. PUBLIC INFORMATION AND EDUCATION ON
OVARIAN CANCER.
Section 417(d)(4) of the Public Health Service Act,
as added by section 401 of Public Law 103–43, is amend-
ed by striking ‘‘section 413; and’’ and inserting the follow-
ing: ‘‘section 413, which programs shall include programs
on ovarian cancer that (subject to changes in the applica-
ble facts) provide information and education regarding—
‘‘(A) screening procedures for such cancer,
including the fact that there is not a procedure
that reliably provides for the early detection of
such cancer;
‘‘(B) the fact that there may be a genetic
basis to such cancer;
‘‘(C) factors indicating a substantial risk
of such cancer; and
‘‘(D) the various treatments for such can-
cer and the extent to which the treatments are
effective; and’’.
Subtitle I—Antiprogestin Testing
Act of 1993
SEC. 146. SHORT TITLE.
This subtitle may be cited as the ‘‘Antiprogestin
Testing Act of 1993’’.
SEC. 147. RESEARCH.
(a) IN GENERAL.—The Secretary of Health and
Human Services, acting through the Director of the Na-
tional Institutes of Health, may conduct and support re-
search (including clinical trials) on antiprogestin drugs for
their safety and efficacy for any potential use, including
termination of pregnancy and contraception, and when
used therapeutically for cancer, endocrine disorders, and
endometriosis.
(b) INSTITUTIONAL REVIEW BOARDS AND PEER RE-
VIEW.—Research conducted or supported under sub-
section (a) shall be subject to sections 491 and 492 of
the Public Health Service Act (42 U.S.C. 289, 289a).
(c) PRIORITIES.—In determining priorities for re-
search under subsection (a), the Secretary shall consider
data from previous research.
SEC. 148. REPORT.
The Secretary of Health and Human Services shall
report to Congress the results of research conducted or
supported under section 2(a) on January 1, 1994, and
annually thereafter.
Subtitle J—Women’s Health Envi-
ronmental Factors Research Act
of 1993
SEC. 151. SHORT TITLE.
This subtitle may be cited as the ‘‘Women’s Health
Environmental Factors Research Act of 1993’’.
SEC. 152. RESEARCH ON EFFECT OF ENVIRONMENTAL FAC-
TORS ON WOMEN’S HEALTH.
Subpart 12 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285), as amended by section 1301
of Public Law 103–43 (107 Stat. 169), is amended by
adding at the end the following section:
‘‘EFFECT OF ENVIRONMENTAL FACTORS ON WOMEN’S
HEALTH
‘‘SEC. 463B. (a) The Director of the Institute shall
carry out research on the effects that environmental fac-
tors have on women’s health conditions (as defined in sec-
tion 486), including the effect of such factors on breast
cancer, immune disfunction, and estrogen-like compounds
(and related compounds).
‘‘(b) For the purpose of carrying out subsection (a),
there are authorized to be appropriated $30,000,000 for
fiscal year 1994, and such sums as may be necessary for
each of the fiscal years 1995 and 1996. Such authoriza-
tion is in addition to any other authorization of appropria-
tions that is established with respect to such purpose.’’.
Subtitle K—Federal Risk Assess-
ment in Women’s Health Act of
1993
SEC. 156. SHORT TITLE.
This subtitle may be cited as the ‘‘Federal Risk As-
sessment in Women’s Health Act of 1993’’.
SEC. 157. INTERAGENCY REVIEW.
The Office of Science and Technology Policy, through
the Federal Coordinating Council for Science, Engineer-
ing, and Technology, and in consultation with the Office
of Research on Women’s Health of the National Institutes
of Health, shall conduct a review of all Federal programs
that assess or mitigate the risks to women’s health from
environmental exposures, including programs setting
standards for exposure to various pollutants, toxic sub-
stances, pesticide use, and pesticide residues. The results
of such review, including recommendations for ensuring
that women’s health needs are addressed by Federal pro-
grams and policies, shall be transmitted to the Congress
within 6 months after the date of enactment of this Act.
SEC. 158. STUDY OF RESEARCH NEEDS.
The National Institute of Environmental Health
Sciences shall enter into a contract with the National Re-
search Council of the National Academy of Sciences for
the carrying out by such Council, in consultation with the
Office of Research on Women’s Health of the National
Institutes of Health, for a study to determine the status
of the science base and needs of the Federal Government
for research relating to the risks to women’s health from
environmental exposures, for the purpose of assessing and
mitigating such risks. The results of such study shall be
transmitted to the Congress within one year after the date
of enactment of this Act.
Subtitle L—Pharmaceutical
Interactions Safety Act
SEC. 161. SHORT TITLE.
This subtitle may be cited as the ‘‘Pharmaceutical
Interactions Safety Act’’.
SEC. 162. CLINICAL INVESTIGATIONS.
Section 505(b) of the Federal Food, Drug, and Cos-
metic Act is amended by adding at the end the following:
‘‘(4) Clinical investigations to be submitted as part
of an application in accordance with paragraph (1)(A)
shall include investigations of the possible interaction of
the drug with relevant female or male hormones or related
substances unless there is substantial evidence that there
are no significant interactions between the drug under in-
vestigation and such substances or the inclusion of such
investigations is otherwise inappropriate under guidelines
established by the Secretary by rule.’’.
SEC. 163. BIOLOGICAL PRODUCTS CLINICAL INVESTIGA-
TIONS.
Section 351(c) of the Public Health Service Act (42
U.S.C. 262(c)) is amended by adding at the end the fol-
lowing:
‘‘(3) Clinical investigations submitted as part of an
application for a biological product in accordance with
paragraph (1) shall include investigations of the possible
interaction of the biological product with relevant female
or male hormones or related substances unless there is
substantial evidence that there are no significant inter-
actions between the biological product under investigation
and such substances or the inclusion of such investigations
is otherwise inappropriate under guidelines established by
the Secretary by rule.’’.
Subtitle M—Pharmaceutical
Testing Fairness Act
SEC. 166. SHORT TITLE.
This subtitle may be cited as the ‘‘Pharmaceutical
Testing Fairness Act’’.
SEC. 167. NEW DRUG CLINICAL INVESTIGATIONS.
Section 505(b) of the Federal Food, Drug, and Cos-
metic Act is amended by adding at the end the following:
‘‘(4)(A) Clinical investigations submitted as part of
an application in accordance with paragraph (1)(A) shall
include women and members of minority groups as sub-
jects of such investigations unless the inclusion of women
and minority groups is inappropriate with respect to the
drug under investigation or is otherwise inappropriate
under such guidelines as the Secretary shall by rule estab-
lish in accordance with subparagraph (B).
‘‘(B) The guidelines of the Secretary respecting the
inclusion of women and members of minority groups in
clinical investigations—
‘‘(i) shall provide that the costs of such inclu-
sion is not a permissible consideration in determin-
ing whether such inclusion is inappropriate,
‘‘(ii) shall provide that women or minority
groups are not required to be included if women or
minority groups will not be using the drug under in-
vestigation, and
‘‘(iii) may provide that such inclusion is not re-
quired if there is substantial scientific data dem-
onstrating that there is no significant difference be-
tween the effects that the variables to be studied in
the investigation have on women or members of mi-
nority groups, respectively, and on the other individ-
uals who would serve as subjects in the investigation
in the event that the inclusion of women and mem-
bers of minority groups was not required.
‘‘(C) Phase three clinical investigations which are
submitted as part of an application in accordance with
paragraph (1)(A) shall be designed so that there is a valid
analysis of whether the drug under investigation affects
women or members of minority groups differently than
other users of the drug. If the Secretary determines that
it would be appropriate for other phases of such investiga-
tions to be so designed, such other phases shall be so de-
signed.’’.
SEC. 168. DEVICE CLINICAL INVESTIGATIONS.
Section 515(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360e(c)) is amended by adding at
the end the following:
‘‘(3)(A) Clinical investigations submitted as part of
an application in accordance with paragraph (1) shall in-
clude women and members of minority groups as subjects
of such investigations unless the inclusion of women and
minority groups is inappropriate with respect to the device
under investigation or is otherwise inappropriate under
such guidelines as the Secretary shall by rule establish in
accordance with subparagraph (B).
‘‘(B) The guidelines of the Secretary respecting the
inclusion of women and members of minority groups in
clinical investigations—
‘‘(i) shall provide that the costs of such inclu-
sion is not a permissible consideration in determin-
ing whether such inclusion is inappropriate,
‘‘(ii) shall provide that women or minority
groups are not required to be included if women or
minority groups will not be using the device under
investigation, and
‘‘(iii) may provide that such inclusion is not re-
quired if there is substantial scientific data dem-
onstrating that there is no significant difference be-
tween the effects that the variables to be studied in
the investigation have on women or members of mi-
nority groups, respectively, and on the other individ-
uals who would serve as subjects in the investigation
in the event that the inclusion of women and mem-
bers of minority groups was not required.
‘‘(C)(i) Clinical investigations designated by the Sec-
retary under clause (ii) which are submitted as part of
an application in accordance with paragraph (1) shall be
designed so that there is a valid analysis of whether the
device under investigation affects women or members of
minority groups differently than other users of the device.
‘‘(ii) The Secretary shall designate which of the clini-
cal investigations submitted as part of an application
under paragraph (1) shall be subject to the requirement
of clause (i).’’.
SEC. 169. BIOLOGICAL PRODUCTS CLINICAL INVESTIGA-
TIONS.
Section 351(c) of the Public Health Service Act (42
U.S.C. 262(c)) is amended by adding at the end the fol-
lowing:
‘‘(3)(A) Clinical investigations submitted as part of
an application in accordance with paragraph (1) shall in-
clude women and members of minority groups as subjects
of such investigations unless the inclusion of women and
minority groups is inappropriate with respect to the bio-
logical product under investigation or is otherwise inap-
propriate under such guidelines as the Secretary shall by
rule establish in accordance with subparagraph (B).
‘‘(B) The guidelines of the Secretary respecting the
inclusion of women and members of minority groups in
clinical investigations—
‘‘(i) shall provide that the costs of such inclu-
sion is not a permissible consideration in determin-
ing whether such inclusion is inappropriate,
‘‘(ii) shall provide that women or minority
groups are not required to be included if women or
Subtitle N—Tobacco Advertising
and Promotion Studies Act of 1993
SEC. 171. SHORT TITLE.
This subtitle may be cited as the ‘‘Tobacco Advertis-
ing and Promotion Studies Act of 1993’’.
SEC. 172. FINDINGS.
(a) WOMEN.—The Congress makes the following
findings respecting women and tobacco:
(1) The fastest growing sector of smokers in
the United States are women under the age of 23.
Approximately 2,000 women smoke their first ciga-
rette every day.
(2) It is expected that between the years 2005
and 2010, the number of women dying from smok-
ing related diseases will exceed the number of men
so dying.
(3) Each year tobacco kills more than 147,000
women in the United States, mostly through ciga-
rette smoking induced heart disease, lung cancer,
and other lung diseases.
(4) As smoking by women has increased, lung
cancer in women has skyrocketed. In 1987 lung can-
cer surpassed breast cancer as the leading cancer
killer of women.
(5) Women who smoke as little as one to 4
cigarettes each day increase their risk of heart at-
tack by 2 to 3 times.
(6) Once women start to smoke they find it
more difficult to quit than do men.
(7) Women who smoke cigarettes during preg-
nancy increase the risk for low birth weight and pre-
mature infants, miscarriage, stillbirths, sudden in-
fant death syndrome, and infant mortality.
(8) Pregnant women who smoke deliver babies
an average of one-half inch shorter and 7 ounces
lighter than the babies of nonsmoking mothers.
There is a 25 to 50 percent higher rate of fetal and
infant death among women who smoke during preg-
nancy compared with those who do not smoke. It is
estimated that 4,000 infants die each year because
of their mother’s smoking.
(9) Approximately 44 percent of all women who
currently smoke have attempted to quit smoking in
the past year.
(10) Cigarette smoking increases women’s risk
of contracting cervical cancer.
(b) MINORITIES.—The Congress makes the following
findings respecting minorities and tobacco:
(1) Tobacco use by African-Americans is re-
sponsible for nearly 48,000 deaths each year in the
United States.
(2) Tobacco companies aggressively target
members of the African-American community and
the growing Hispanic population, particularly in the
urban, inner-city environment.
(3) As of 1991, 29.2 percent of African-Amer-
ican adults (aged 18 and older) smoked cigarettes,
including 35.1 percent of African-American men and
24.4 percent of African-American women.
(4) As of 1991, 16 percent of Asian/Pacific Is-
lander adults (aged 18 and older) smoke cigarettes,
including 24.2 percent of Asian/Pacific Islander men
and 7.5 percent of Asian/Pacific Islander women.
(5) As of 1991, 31.4 percent of American In-
dian/Alaskan Natives adults (aged 18 and older)
smoked cigarettes, including 27.9 percent of Amer-
ican Indian/Alaskan Natives men and 35.2 percent
of American Indian/Alaskan Natives women.
(6) As of 1991, 20.2 percent of Hispanic adults
(aged 18 and older) smoked cigarettes, including
25.2 percent of Hispanic men and 15.5 percent His-
panic women.
(7) African Americans suffer from tobacco-re-
lated disease at a higher rate than whites, including
a higher incidence of respiratory system, esophagus,
and oral cavity cancers.
(8) Lung cancer is increasing among Hispanic
men.
SEC. 173. TOBACCO ADVERTISING STUDIES.
(a) STUDIES.—The Federal Trade Commission shall
conduct the following studies which should be based on
existing studies and on significant original market re-
search:
(1) WOMEN AND MINORITIES.—A study of cur-
rent tobacco advertising to determine—
(A) if and in what forms such advertising
is designed and disseminated in such a way as
to appeal specifically to (i) girls and women and
(ii) minorities to promote their use of tobacco,
and
(B) whether targeting girls, women, and
minorities increases tobacco use.
In connection with such study, advertising of alco-
holic beverages shall be reviewed to determine the
extent to which such advertising targets girls and
women and minorities.
(2) WEIGHT LOSS AND MAINTENANCE.—
(A) IN GENERAL.—A study of current cig-
arette advertising to investigate the targeting of
girls and women in cigarette advertising and to-
bacco companies’ use of messages in their ad-
vertising concerning weight loss and weight
maintenance, the wording and overall imagery
used in such advertising and its impact on girls
and women, and the perception of girls and
women, including smokers and non-smokers, of
the relation between the use of tobacco and
weight control and maintenance.
(B) TERMS AND IMAGERY.—In conducting
the study under subparagraph (A), the Federal
Trade Commission shall examine—
(i) whether women interpret the use
of the terms ‘‘slim’’, ‘‘light’’, ‘‘thin’’,
‘‘superslim’’, and related terms and the
shape of cigarettes employing such terms
as implying that cigarette smoking results
in weight loss or weight maintenance,
(ii) whether girl’s and women’s inter-
pretation of such terms and imagery accu-
rately reflects the actual effect of cigarette
smoking on weight,
(iii) the relative impact of cigarette
smoking on the health of girls and women,
and
(iv) what action should be taken by
the Federal Trade Commission with re-
spect to advertising using such terms and
imagery.
(3) DEMOGRAPHICS.—A study of the demo-
graphics of cigarette advertising and promotions
which are targeted at girls, women, and minorities,
including the age, gender, race, ethnicity, and socio-
economic groups of the girls, women, and minorities
and, in the case of minorities, the demographics of
such advertising and promotions for smokeless to-
bacco products. Such study shall include an exam-
ination of the expenditures for advertising and pro-
motions for each of the aspects of girls, women, and
minorities referred to in the preceding sentence.
(b) REPORT.—The Federal Trade Commission shall
complete each of the studies identified in subsection (a)
not later than 9 months after the date of the enactment
of this Act and shall, not later than 12 months after such
date, report to the Congress—
(1) the results of such studies, and
(2) any actions the Commission proposes to
take on the basis of such findings.
TITLE II—SERVICES REGARDING
WOMEN’S HEALTH
Subtitle A—Equity in Health
Professions Education Act
SEC. 201. SHORT TITLE.
This subtitle may be cited as the ‘‘Equity in Health
Professions Education Act’’.
SEC. 202. STUDY REGARDING CURRICULA OF HEALTH PRO-
FESSIONS SCHOOLS AND WOMEN’S HEALTH
CONDITIONS.
(a) IN GENERAL.—The Secretary of Health and
Human Services, acting through the Administrator of the
Health Resources and Services Administration, shall con-
duct a study for the purpose of determining the extent
to which health professions schools provide adequate edu-
cation to students on women’s health conditions. The Sec-
retary shall give priority in the study to schools of medi-
cine and osteopathic medicine.
(b) CONSULTATIONS.—The Secretary shall carry out
subsection (a) in consultation with the Director of the Of-
fice of Research on Women’s Health and the Director of
the Office of Women’s Health.
(c) CERTAIN ELEMENTS OF STUDY.—In conducting
the study under subsection (a), the Secretary—
(1) shall assess the content of the educational
programs of health professions schools with respect
to women’s health conditions, including the content
of programs providing clinical training; and
(2) shall, if the Secretary determines that the
extent of education on such conditions is inadequate,
determine the extent to which such inadequacy is af-
fecting the health of women.
(d) COMMENTS AND RECOMMENDATIONS OF PUBLIC
AND PRIVATE ENTITIES.—In carrying out subsection (a),
the Secretary shall consider the comments and rec-
ommendations of public and private entities regarding the
study under such subsection, including representatives of
health professions schools and representatives of organiza-
tions concerned with women’s health conditions.
(e) REPORT.—Not later than April 1, 1995, the Sec-
retary shall complete the study required in subsection (a)
and submit to the Committee on Energy and Commerce
and the Committee on Appropriations of the House of
Representatives, and to the Committee on Labor and
Human Resources and the Committee on Appropriations
of the Senate, a report describing the findings made as
a result of the study and containing any recommendations
of the Secretary regarding such findings, including rec-
ommendations regarding the accreditation of health pro-
fessions schools and the licensure of health professionals.
(f) DEFINITIONS.—For purposes of this section:
(1) The term ‘‘health professions schools’’
means—
(A) the schools and programs defined in
section 799(1) of the Public Health Service Act
(other than schools of veterinary medicine); and
(B) schools of nursing, as defined in sec-
tion 853 of such Act.
(2) The term ‘‘Office of Research on Women’s
Health’’ means the Office of Research on Women’s
Health established within the Office of the Director
of the National Institutes of Health.
(3) The term ‘‘Office of Women’s Health’’
means the Office of Women’s Health established
within the Office of the Assistant Secretary for
Health.
(4) The term ‘‘Secretary’’ means the Secretary
of Health and Human Services.
(5) The term ‘‘women’s health conditions’’ has
the meaning given such term in section 486 of the
Public Health Service Act.
Subtitle B—Women’s Health Office
Act of 1993
SEC. 206. SHORT TITLE.
This subtitle may be cited as the ‘‘Women’s Health
Office Act of 1993’’.
SEC. 207. 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
thereof the following new 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 co-
ordinate activities of such agency Offices of Wom-
en’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. 208. 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 thereof the following
new 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 Cen-
ters.
‘‘(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 Na-
tional 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. 209. 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
new 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 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-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 Of-
fices.
‘‘(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. 210. HEALTH RESOURCES AND SERVICES ADMINIS-
TRATION 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 thereof the fol-
lowing new 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 Bu-
reaus.
‘‘(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. 210A. 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 thereof the following new 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.’’.
Subtitle C—Women’s Health
Information Act of 1993
SEC. 211. SHORT TITLE.
This subtitle may be cited as the ‘‘Women’s Health
Information Act of 1993’’.
SEC. 212. FINDINGS.
The Congress finds as follows:
(1) A report by the General Accounting Office
indicates that the Department of Health and
Human Services, which is responsible for providing
health information to the public, lacks an overall
strategy for providing such information to women.
100
(2) Such Department has no overall strategy to
ensure that the most needed and useful health infor-
mation is distributed to the public.
(3) Health information activities of the Depart-
ment are left to the discretion of the agencies of the
Public Health Service, each of which largely plans
the production and dissemination of information
independently of the other agencies of the Service.
(4) Even when health information for the public
is produced and disseminated by the Department, it
is not always easily accessible to the public.
(5) With respect to health information, the
agencies of such Department cannot determine
whether the efforts of the agencies are appropriately
targeted to raise women’s awareness and increase
their knowledge about conditions that confront them.
SEC. 213. INTERAGENCY COMMITTEE ON HEALTH COMMU-
NICATIONS.
(a) IN GENERAL.—The Secretary of Health and
Human Services shall establish an Interagency Committee
on Health Communications (in this section referred to as
the ‘‘Committee’’).
(b) DUTIES.—
(1) IN GENERAL.—The Committee shall provide
advice to the Secretary of Health of Human Services
101
on developing, overseeing, and coordinating Federal
promotion and education activities, including such
activities within the Public Health Service.
(2) WOMEN’S HEALTH.—In carrying out para-
graph (1), the Committee shall give priority to car-
rying activities regarding women’s health.
(c) CHAIR.—The Committee shall be chaired by the
Assistant Secretary for Health.
(d) COMPOSITION.—
(1) IN GENERAL.—Subject to paragraph (2),
the Committee shall be composed of one representa-
tive from each agency with authority to speak for
the agency, in order to address activities and goal-
setting with regard to communications specific to
women’s health. Decisions shall be implemented ei-
ther individually or collectively as required.
(2) WOMEN’S HEALTH.—The Director of the
Office of Women’s Health at the Public Health
Service shall serve as a member of the Committee to
ensure that the efforts of the Committee and the
Public Health Service reflect pertinent recommenda-
tions and objectives to improve women’s health.
(e) MEETINGS.—
(1) IN GENERAL.—The Committee shall, as ap-
propriate, meet not fewer than 4 times a year in
102
order to promote collaboration, enhance cooperation,
and develop effective strategies in this effort.
(2) ANNUAL FORUM.—The Assistant Secretary
for Health shall convene a forum once a year to hear
testimony by interested public and private individ-
uals and organizations regarding priorities for areas
of women’s health, and shall respond to the testi-
mony and make recommendations regarding the tes-
timony.
(f) REPORT.—The Assistant Secretary of Health
shall issue a yearly report on the progress of the Commit-
tee’s efforts to establish a coordinated strategy of health
promotion and disease prevention activities at the Public
Health Service.
SEC. 214. DISSEMINATION EFFORTS OF WOMEN’S HEALTH
INFORMATION 
WITHIN 
PUBLIC 
HEALTH
SERVICE.
(a) CLEARINGHOUSE ON WOMEN’S HEALTH.—The
Assistant Secretary for Health shall establish the Clear-
inghouse on Women’s Health to compile, archive, and dis-
seminate information concerning women’s health and to
publish a yearly summary of such materials to be made
available upon request.
(b) OTHER ACTIVITIES.—
103
(1) IN GENERAL.—The Secretary of Health and
Human Services may make a grant, or enter into a
contract with one or more organizations representing
women—
(A) to make available information concern-
ing Federal programs, services, informational
resources, and benefits related to women’s
health;
(B) establish a toll-free hotline; and
(C) assess demand for publications and
costs on an annual basis, and develop publica-
tions as needed.
(2) FEES REGARDING TOLL-FREE HOTLINE.—
The Clearinghouse may, as necessary, charge an ap-
propriate fee for information provided by the toll-
free hotline. Exceptions shall be made for individuals
or organizations that are financially unable to pay
such fees.
(c) ADVERTISING
CAMPAIGN.—The Secretary of
Health and Human Services shall conduct an outreach
and advertising campaign to women and health profes-
sionals regarding the existence of the clearinghouse and
the toll-free number.
(d) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
104
to be appropriated such sums as may be necessary for
each of the fiscal years 1994 through 1999.
SEC. 215. STUDY ON EFFECTIVENESS OF HEALTH COMMU-
NICATIONS.
The Secretary of Health and Human Services shall
convene a study of the Agency for Health Care Policy and
Research to evaluate the overall effectiveness of health
communications, including the efficacy of existing policies
and techniques utilized by the Public Health Service to
develop and disseminate such information. The study shall
involve evaluation of effort, mode, use of toll-free numbers,
and assessment of organization and competency. The
study shall also include an analysis of efforts regarding
reaching underserved populations. The Agency for Health
Care Policy and Research shall make recommendations to
the Assistant Secretary for Health on the most effective
strategy for reaching the public and presenting health
communications.
Subtitle D—Breast and Cervical
Cancer Amendments of 1993
SEC. 216. SHORT TITLE.
This subtitle may be cited as the ‘‘Breast and Cer-
vical Cancer Amendments of 1993’’.
105
SEC. 217. REVISIONS IN PROGRAM OF STATE GRANTS RE-
GARDING BREAST AND CERVICAL CANCER.
(a) LIMITED AUTHORITY REGARDING FOR-PROFIT
ENTITIES.—
(1) IN GENERAL.—Section 1501(b) of the Pub-
lic Health Service Act (42 U.S.C. 300k(b)) is
amended—
(A) by striking ‘‘STATES.—A State’’ and
all that follows through ‘‘may expend’’ and in-
serting the following: ‘‘STATES.—
‘‘(1) IN GENERAL.—A State receiving a grant
under subsection (a) may, subject to paragraph (2),
expend’’; and
(B) by adding at the end the following
paragraph:
‘‘(2) LIMITED AUTHORITY REGARDING OTHER
ENTITIES.—In addition to the authority established
in paragraph (1) for a State with respect to grants
and contracts, the State may provide for screenings
under subsection (a)(1) through entering into con-
tracts with private entities. The amount paid by a
State to a private entity under the preceding sen-
tence for a screening procedure may not exceed the
amount that would be paid under part B of title
XVIII of the Social Security Act if payment were
106
made under such part for furnishing the procedure
to a woman enrolled under such part.’’.
(2) 
CONFORMING
AMENDMENT.—Section
1505(3) of the Public Health Service Act (42 U.S.C.
300n–1(3)) is amended by inserting before the semi-
colon the following: ‘‘(and additionally, in the case of
services and activities under section 1501(a)(1), with
any similar services or activities of private entities)’’.
(b) QUALITY ASSURANCE REGARDING SCREENING
PROCEDURES.—
(1) IN GENERAL.—Section 1503 of the Public
Health Service Act (42 U.S.C. 300m) is amended by
striking subsections (c) through (e) and inserting
the following:
‘‘(c) QUALITY ASSURANCE REGARDING SCREENING
PROCEDURES.—The Secretary may not make a grant
under section 1501 unless the State involved agrees that
the State will, in accordance with applicable law, assure
the quality of screening procedures conducted pursuant to
such section.’’.
(2) 
TRANSITION
RULE
REGARDING
MAMMOGRAPHIES.—With respect to the screening
procedure for breast cancer known as a mammog-
raphy, the requirements in effect on the day before
the date of the enactment of this subtitle under sec-
107
tion 1503(c) of the Public Health Service Act re-
main in effect (for an individual or facility conduct-
ing such procedures pursuant to a grant to a State
under section 1501 of such Act) until there is in ef-
fect for the facility a certificate (or provisional cer-
tificate) issued under section 354 of such Act.
(c) STATEWIDE PROVISION OF SERVICES.—Section
1504(c) of the Public Health Service Act (42 U.S.C.
300n(c)) is amended by adding at the end the following
paragraph:
‘‘(3) GRANTS TO TRIBES AND TRIBAL ORGANI-
ZATIONS.—
‘‘(A) The Secretary, acting through the Di-
rector of the Centers for Disease Control and
Prevention, may make grants to tribes and trib-
al organizations (as such terms are used in
paragraph (1)) for the purpose of carrying out
programs described in section 1501(a). This
title (other than section 1501(c)) applies to
such a grant (in relation to the jurisdiction of
the tribe or organization) to the same extent
and in the same manner as such title applies to
grants to States under section 1501 (in relation
to the jurisdiction of the States).
108
‘‘(B) If a tribe or tribal organization is re-
ceiving a grant under subparagraph (A) and the
State in which the tribe or organization is lo-
cated is receiving a grant under section 1501,
the requirement established in paragraph (1)
for the State regarding the tribe or organiza-
tion is deemed to have been waived under para-
graph (2).’’.
(d) EVALUATIONS AND REPORTS.—Section 1508 of
the Public Health Service Act (42 U.S.C. 300n–4) is
amended—
(1) in subsection (a), by adding at the end the
following sentence: ‘‘Such evaluations shall include
evaluations of the extent to which States carrying
out such programs are in compliance with section
1501(a)(2) and with section 1504(c).’’; and
(2) in subsection (b), by inserting before the pe-
riod the following: ‘‘, including recommendations re-
garding compliance by the States with section
1501(a)(2) and with section 1504(c)’’.
(e) ESTABLISHMENT
OF COORDINATING COMMIT-
TEE.—Section 1501 of the Public Health Service Act (42
U.S.C. 300k) is amended by adding at the end the follow-
ing subsection:
109
‘‘(c) COORDINATING COMMITTEE REGARDING YEAR
2000 HEALTH
OBJECTIVES.—The Secretary, acting
through the Director of the Centers for Disease Control
and Prevention, shall establish a committee to coordinate
the activities of the agencies of the Public Health Service
(and other appropriate Federal agencies) that are carried
out toward achieving the objectives established by the Sec-
retary for reductions in the incidence of breast and cer-
vical cancer in the United States by the year 2000. Such
committee shall be comprised of Federal officers or em-
ployees designated by the heads of the agencies involved
to serve on the committee as representatives of the agen-
cies, and such representatives from other public or private
entities as the Secretary determines to be appropriate.’’.
(f) TECHNICAL CORRECTIONS.—Title XV of the Pub-
lic Health Service Act (42 U.S.C. 300k et seq.) is amend-
ed—
(1) in section 1501(a), in the matter preceding
paragraph (1), by striking ‘‘Control,’’ and inserting
‘‘Control and Prevention,’’; and
(2) in section 1505(4), by inserting ‘‘will’’ be-
fore ‘‘be used’’.
SEC. 218. FUNDING.
Section 1509(a) of the Public Health Service Act (42
U.S.C. 300n–5(a)) is amended—
110
(1) by striking ‘‘and’’ after ‘‘1991,’’; and
(2) by inserting before the period the following:
‘‘, $100,000,000 for fiscal year 1994, and such sums
as may be necessary for each of the fiscal years
1995 through 1998’’.
Subtitle E—Women’s Preventive
Health Amendments of 1993
SEC. 221. SHORT TITLE.
This subtitle may be cited as the ‘‘Women’s Preven-
tive Health Amendments of 1993’’.
SEC. 222. ESTABLISHMENT OF DEMONSTRATION PROGRAM
OF GRANTS FOR ADDITIONAL PREVENTIVE
HEALTH SERVICES FOR WOMEN.
Title XV of the Public Health Service Act (42 U.S.C.
300k et seq.) is amended—
(1) by redesignating section 1509 as section
1510; and
(2) by inserting after section 1508 the following
section:
‘‘SEC. 1509. SUPPLEMENTAL GRANTS FOR ADDITIONAL
PREVENTIVE HEALTH SERVICES.
‘‘(a) DEMONSTRATION PROJECTS.—In the case of
States receiving grants under section 1501, the Secretary,
acting through the Director of the Centers for Disease
Control and Prevention, may make grants to not more
111
than 3 such States to carry out demonstration projects
for the purpose of—
‘‘(1) providing to women preventive health serv-
ices, and health promotion services, in addition to
the services authorized in such section;
‘‘(2) providing appropriate referrals for medical
treatment of women receiving services pursuant to
paragraph (1) and ensuring, to the extent prac-
ticable, the provision of appropriate follow-up serv-
ices; and
‘‘(3) evaluating activities conducted under para-
graphs (1) and (2) through appropriate surveillance
or program-monitoring activities.
‘‘(b) STATUS AS PARTICIPANT IN PROGRAM REGARD-
ING BREAST
AND CERVICAL CANCER.—The Secretary
may not make a grant under subsection (a) unless the
State involved agrees that services under the grant will
be provided only through entities that are screening
women for breast or cervical cancer pursuant to a grant
under section 1501.
‘‘(c) REQUIREMENTS REGARDING MATCHING FUNDS,
FEES FOR SERVICES, AND CERTAIN OTHER MATTERS.—
The Secretary may not make a grant under subsection (a)
unless the State involved agrees that section 1502, and
sections 1504 through 1506, apply to a grant under sub-
112
section (a) to the same extent and in the same manner
as such sections apply to a grant under section 1501.
‘‘(d) TECHNICAL ASSISTANCE; SUPPLIES AND SERV-
ICES IN LIEU OF GRANT FUNDS.—Section 1507 applies
to a grant under subsection (a) to the same extent and
in the same manner as such section applies to a grant
under section 1501.
‘‘(e) EVALUATIONS
AND REPORTS.—Section 1508
applies to a grant under subsection (a) to the same extent
and in the same manner as such section applies to a grant
under section 1501.’’.
SEC. 223. FUNDING.
Section 1510 of the Public Health Service Act, as re-
designated by section 222 of this Act, is amended to read
as follows:
‘‘SEC. 1510. FUNDING.
‘‘(a) PROGRAM REGARDING BREAST AND CERVICAL
CANCER.—
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.—
For the purpose of carrying out this title other than
section 1509, there are authorized to be appro-
priated such sums as may be necessary for fiscal
year 1994.
‘‘(2) SET-ASIDE
FOR
TECHNICAL
ASSISTANCE
AND PROVISION OF SUPPLIES AND SERVICES.—Of
113
the amounts appropriated under paragraph (1) for
a fiscal year, the Secretary shall reserve not more
than 20 percent for carrying out section 1507.
‘‘(b) PROGRAM REGARDING ADDITIONAL PREVEN-
TIVE HEALTH SERVICES.—
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.—
Subject to paragraph (2), for the purpose of carry-
ing out section 1509, there are authorized to be ap-
propriated such sums as may be necessary for each
of the fiscal years 1994 through 1996.
‘‘(2) LIMITATION
REGARDING
FUNDING
WITH
RESPECT TO BREAST AND CERVICAL CANCER.—The
authorization of appropriations established in para-
graph (1) is not effective for a fiscal year unless the
amount appropriated under subsection (a)(1) for the
fiscal year equals or exceeds the amount appro-
priated under such subsection for the preceding fis-
cal year.’’.
Subtitle F—Postreproductive
Health Care Act
SEC. 226. SHORT TITLE.
This subtitle may be cited as the ‘‘Postreproductive
Health Care Act’’.
114
SEC. 
227. 
ESTABLISHMENT 
OF 
PROGRAM 
FOR
POSTREPRODUCTIVE HEALTH CARE.
Part D of title III of the Public Health Service Act
(42 U.S.C. 254b et seq.) is amended by adding at the end
the following new subpart:
‘‘Subpart IX—Postreproductive Health Care
‘‘POSTREPRODUCTIVE HEALTH CARE
‘‘SEC. 340D. (a) IN GENERAL.—The Secretary shall
make grants for the purpose of providing the services de-
scribed in subsection (b) to women who are of menopausal
age or older. Such grants may be made only to public or
nonprofit private entities that provide health services to
a significant number of low-income women.
‘‘(b) AUTHORIZED SERVICES.—The services referred
to in subsection (a) are as follows:
‘‘(1) The prevention and outpatient treatment
of health conditions—
‘‘(A) unique to, more serious, or more
prevalent for eligible women; or
‘‘(B) for which, in the case of such women,
the factors of medical risk or types of medical
intervention are different.
‘‘(2) Counseling on the conditions described in
paragraph (1).
‘‘(3) The education and training of health pro-
fessionals (including allied health professionals) on
115
the prevention and treatment of such conditions and
on the provision of such counseling.
‘‘(c) PRIORITY IN PROVISION OF SERVICES.—The
Secretary may make a grant under subsection (a) only if
the applicant involved agrees that, in expending the grant
to provide authorized services to eligible women, the appli-
cant will give priority to providing the services for meno-
pausal health conditions.
‘‘(d) OUTREACH.—The Secretary may make a grant
under subsection (a) only if the applicant involved
agrees—
‘‘(1) to conduct outreach services to inform
women in the community involved of the fact that
authorized services are available from the applicant;
and
‘‘(2) to give priority to providing the outreach
services to low-income women.
‘‘(e) LIMITATION
ON IMPOSITION
OF FEES
FOR
SERVICES.—The Secretary may make a grant under sub-
section (a) only if the applicant involved agrees that, if
a charge is imposed for the provision of services or activi-
ties under the grant, such charge—
‘‘(1) will be made according to a schedule of
charges that is made available to the public;
116
‘‘(2) will be adjusted to reflect the income of
the woman involved; and
‘‘(3) will not be imposed on any woman with an
income equal to or less than 100 percent of the offi-
cial poverty line, as established by the Director of
the Office of Management and Budget and revised
by the Secretary in accordance with section 673(2)
of the Omnibus Budget Reconciliation Act of 1981.
‘‘(f) REPORTS TO SECRETARY.—The Secretary may
make a grant under subsection (a) only if the applicant
involved agrees to submit to the Secretary, for each fiscal
year for which such a grant is made to the applicant, a
report describing the purposes for which the grant has
been expended.
‘‘(g) REQUIREMENT
OF APPLICATION.—The Sec-
retary may make a grant under subsection (a) only if the
applicant involved makes an agreement that the grant will
not be expended for any purpose other than the purpose
described in such subsection and for compliance with any
other agreements required in this section. Such a grant
may be made only if an application for the grant is sub-
mitted to the Secretary containing such agreements, and
the application is in such form, is made in such manner,
and contains such other agreements, and such assurances
117
and information, as the Secretary determines to be nec-
essary to carry out this section.
‘‘(h) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘authorized services’ means the
services described in subsection (b).
‘‘(2) The term ‘eligible women’ means women
described in subsection (a).
‘‘(3) The term ‘health conditions’ includes dis-
eases and disorders.
‘‘(4) The term ‘health’ includes mental health.
‘‘(5) The term ‘menopausal age’, with respect
to a woman, includes the age at which the woman
is nearing menopause and includes any age at which
the woman experiences menopausal health condi-
tions.
‘‘(6) The term ‘menopausal health conditions’
means conditions arising from the diminished or
complete cessation of the functioning of the ovaries,
whether occurring naturally or otherwise.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, 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.’’.
118
Subtitle G—Medicare Bone Mass
Measurement Coverage Act of 1993
SEC. 231. SHORT TITLE.
This subtitle may be cited as the ‘‘Medicare Bone
Mass Measurement Coverage Act of 1993’’.
SEC. 232. MEDICARE COVERAGE OF BONE MASS MEASURE-
MENTS.
(a) IN GENERAL.—Section 1861 of the Social Secu-
rity Act (42 U.S.C. 1395x) is amended—
(1) in subsection (s)—
(A) in paragraph (12)(C), by striking
‘‘and’’ at the end,
(B) by striking the period at the end of
paragraph (14) and inserting ‘‘; and’’,
(C) by redesignating paragraphs (15) and
(16) as paragraphs (16) and (17), and
(D) by inserting after paragraph (14) the
following new paragraph:
‘‘(15) bone mass measurement (as defined in
subsection (oo));’’; and
(2) by inserting after subsection (nn) the fol-
lowing new subsection:
‘‘Bone Mass Measurement
‘‘(oo)(1) The term ‘bone mass measurement’ means
a radiologic or radioisotopic procedure performed on a
119
qualified individual (as defined in paragraph (2)) for the
purpose of detecting bone loss through the use of single
and dual photon absorptiometry, dual energy X-ray
absorptiometry or similar dual energy techniques, or quan-
titative computed tomography, and includes a physician’s
interpretation of the results of the procedure.
‘‘(2) For purposes of paragraph (1), the term ‘quali-
fied individual’ means (in accordance with regulations pre-
scribed by the Secretary)—
‘‘(A) an estrogen-deficient woman at clinical
risk for osteoporosis;
‘‘(B) an individual with vertebral abnormalities;
‘‘(C) 
an 
individual 
receiving 
long-term
glucocorticoid steroid therapy; or
‘‘(D) 
an 
individual 
with 
primary
hyperparathyroidism.’’.
(b) CONFORMING AMENDMENTS.—The Social Secu-
rity Act is amended by striking ‘‘paragraphs (15) and
(16)’’ each place it appears in sections 1864(a), 1865(a),
1902(a)(9)(C), and 1915(a)(1)(B)(ii)(I) and inserting
‘‘paragraphs (16) and (17)’’.
(c) EFFECTIVE DATE.—The amendments made by
this section shall apply to bone mass measurements per-
formed on or after January 1, 1994.
120
Subtitle H—Mickey Leland Adoles-
cent Pregnancy Prevention and
Parenthood Act of 1993
SEC. 236. SHORT TITLE.
This subtitle may be cited as the ‘‘Mickey Leland Ad-
olescent Pregnancy Prevention and Parenthood Act of
1993’’.
SEC. 237. ADOLESCENT PREGNANCY PREVENTION, CARE,
AND RESEARCH GRANTS.
Title XX of the Public Health Service Act (42 U.S.C.
300z et seq.) is amended to read as follows:
‘‘TITLE XX—ADOLESCENT PREG-
NANCY PREVENTION, CARE,
AND RESEARCH GRANTS
‘‘SEC. 2001. FINDINGS AND PURPOSES.
‘‘(a) FINDINGS.— The Congress finds that—
‘‘(1) adolescents are at a high risk of unwanted
pregnancy;
‘‘(2) in 1988, more than 1,000,000 teenagers
became pregnant, and nearly 500,000 teenagers car-
ried their pregnancies to term, of which more than
6 out of 10 births were out of wedlock;
‘‘(3) the birthrate for adolescents between the
ages of 15 and 17 increased 23 percent between
1986 and 1989;
121
‘‘(4) in a high proportion of cases, the pregnant
adolescent is herself the product of an unmarried
parenthood during adolescence and is continuing the
pattern in her own lifestyle;
‘‘(5) pregnancy and childbirth among unmar-
ried adolescents, particularly young adolescents,
often results in severe adverse health, social, and
economic consequences, including—
‘‘(A) higher percentage of pregnancy and
childbirth complications;
‘‘(B) higher incidence of low birth weight
babies;
‘‘(C) higher infant mortality and morbid-
ity;
‘‘(D) greater likelihood that an adolescent
marriage will end in divorce;
‘‘(E) decreased likelihood of completing
schooling; and
‘‘(F) higher risks of unemployment and
welfare dependency; and
therefore, education, training, and job research serv-
ices are important for adolescent parents; and
‘‘(6) an adolescent who becomes pregnant once
is likely to experience rapid repeat pregnancies and
childbearing, with increased risks;
122
‘‘(7) research has shown that in cases in which
there is a family involvement in comprehensive val-
ues-based projects and services—
‘‘(A) low birth weight is significantly re-
duced;
‘‘(B) delays in initiating sexual activity
occur;
‘‘(C) there are significant reductions in re-
peat pregnancy, welfare costs, and child abuse;
and
‘‘(D) teens are more likely to return and
complete their high school education; and
therefore, the family should become a partner in the
development of curriculum and programs that reflect
the values of the community;
‘‘(8) the problems of adolescent pregnancy and
parenthood are multiple and complex and are best
approached through a variety of integrated and es-
sential services, particularly those that allow the
pregnant adolescent and adolescent parent to stay in
school;
‘‘(9) such services, including a wide array of
educational and supportive services, often are not
available to the adolescents who need them, or are
available but fragmented and thus of limited effec-
123
tiveness in preventing pregnancies and future wel-
fare dependency; and
‘‘(10) Federal policy therefore should encourage
the development of appropriate health, educational,
and social services where they are now lacking or in-
adequate, and the better coordination of existing
services where they are available in order to prevent
unwanted early and repeat pregnancies and to help
adolescents become productive, independent contrib-
utors to family and community life.
‘‘(b) PURPOSES.—It is the purpose of this title—
‘‘(1) to establish better coordination, integra-
tion, and linkages among existing programs in order
to expand and improve the availability of, and access
to, needed comprehensive community services that
assist in preventing unwanted initial and repeat
pregnancies among adolescents, enable pregnant
adolescents to obtain proper care and assist preg-
nant adolescents, their male partners, and adoles-
cent parents to become productive independent con-
tributors to family and community life, with primary
emphasis on services to adolescents who are 17 years
of age and under;
‘‘(2) to expand the availability of such services
that are essential to that objective;
124
‘‘(3) to promote innovative, comprehensive, and
integrated approaches to the delivery of such serv-
ices;
‘‘(4) to encourage and support research pro-
grams concerning the societal causes and con-
sequences of pregnancy, childbearing, and child
rearing for adolescent females and males;
‘‘(5) to support evaluative research to identify
effective services that reduce adolescent pregnancy
rates and that improve the outcome of adolescent
childbearing for the parents, the child, and their
families; and
‘‘(6) to encourage and provide for the dissemi-
nation of results, findings, and information from
programs and research projects relating to adoles-
cent pregnancy and parenthood.
‘‘SEC. 2002. DEFINITIONS.
‘‘For the purposes of this title:
‘‘(1) ADOLESCENT.—The term ‘adolescent’
means an individual under the age of 21.
‘‘(2) CARE SERVICES.—The term ‘care services’
means all services for the provision of care to adoles-
cents, both male and female, pregnant adolescents
and their male partners, and adolescent parents.
Such term shall include all core services and may in-
126
ually transmitted diseases, including acquired
immunodeficiency syndrome;
‘‘(H) referral to appropriate pediatric care;
‘‘(I) educational services relating to sexual-
ity and family life, including—
‘‘(i) education on responsible decision-
making regarding sexual activity;
‘‘(ii) education on the responsibilities
of parenting;
‘‘(iii) education on a full range of
means for delaying becoming pregnant, in-
cluding abstinence, natural family plan-
ning, and contraception;
‘‘(iv) education on the prevention of
sexually transmitted diseases, including ac-
quired immunodeficiency syndrome; and
‘‘(v) assistance to parents, schools,
youth agencies, and health care providers
to educate adolescents and pre-adolescents
concerning self-discipline and responsibility
in human sexuality;
‘‘(J) referral to appropriate educational,
employment, employment training, and voca-
tional services;
127
‘‘(K) mental health services and referral to
mental health services and to other appropriate
physical health and social services; and
‘‘(L) encouragement of parent and family
involvement in each of the core services de-
scribed in subparagraphs (A) through (K).
‘‘(4) ELIGIBLE GRANT RECIPIENT.—The term
‘eligible grant recipient’ means a public or nonprofit
private organization or agency that demonstrates, to
the satisfaction of the Secretary—
‘‘(A) in the case of an organization that
will provide care services, the capability of pro-
viding all care services in a single setting or the
capability of creating a network through which
all care services would be provided; or
‘‘(B) in the case of an organization that
will provide prevention services, the capability
of providing such services.
‘‘(5) ELIGIBLE
PERSON.—The term ‘eligible
person’ means—
‘‘(A) with regard to the provision of pre-
vention services and referral to such other serv-
ices as may be appropriate, any adolescent; or
128
‘‘(B) with regard to the provision of care
services, adolescent parents and (when appro-
priate) adolescents who are not parents.
‘‘(6) PREVENTION SERVICES.—The term ‘pre-
vention services’ means services described in sub-
paragraphs (B) and (I) of paragraph (3) and refer-
rals to such other services as may be appropriate, in-
cluding services to be offered in schools at local dis-
cretion.
‘‘(7) SECRETARY.—The term ‘Secretary’ means
the Secretary of Health and Human Services.
‘‘(8) SUPPLEMENTAL
SERVICES.—The term
‘supplemental services’ means those services that
may be provided by a grantee, as determined by the
Secretary by regulation, which may include—
‘‘(A) child care sufficient to enable the ad-
olescent parent to continue education or to
enter into employment, including services to be
provided within secondary schools at local dis-
cretion;
‘‘(B) 
consumer 
education 
and 
home-
making;
‘‘(C) counseling for the immediate and ex-
tended family members of the eligible person;
‘‘(D) transportation;
129
‘‘(E) referral to licensed residential care or
maternity home services;
‘‘(F) referral to licensed adoption agencies
for adoption placement services;
‘‘(G) employability training and counseling;
and
‘‘(H) such other services as are consistent
with this title as the Secretary may approve in
accordance with regulations promulgated by the
Secretary.
‘‘SEC. 2003. AUTHORITY TO MAKE GRANTS FOR SERVICES.
‘‘The Secretary may make grants to provide preven-
tion and care services to pregnant adolescents and their
male partners, adolescent parents, and nonpregnant ado-
lescents. Grants shall be used to provide, supplement, or
improve the quality of such services.
‘‘SEC. 2004. USE OF GRANTS FOR SERVICES.
‘‘(a) USES.—A grant made under this title may be
used to—
‘‘(1) provide eligible persons—
‘‘(A) prevention services;
‘‘(B) care services; or
‘‘(C) any combination of prevention and
care services;
130
‘‘(2) coordinate, integrate, and provide linkages
among providers of prevention, care, and other serv-
ices for eligible persons in furtherance of the pur-
poses of this title;
‘‘(3) provide supplemental services where such
services are not adequate or not available to eligible
persons in the community and that are essential to
the care of eligible persons and to the prevention of
adolescent pregnancy;
‘‘(4) plan, for a period of not more than 1 year,
for the administration and coordination of preg-
nancy prevention services and programs of care for
eligible persons that will further the objectives of
this title; and
‘‘(5) fulfill assurances required for grant ap-
proval by section 2006.
‘‘(b) FEES.—Grantees shall charge fees for services
only pursuant to a fee schedule, approved by the Secretary
as a part of the application described in section 2006, that
bases fees charged by the grantee on the income of the
eligible person and takes into account the difficulty adoles-
cents face in obtaining resources to pay for services. In
no case may a grantee discriminate with regard to the pro-
vision of services to any individual because of that individ-
ual’s inability to provide payment for such services.
131
‘‘SEC. 2005. PRIORITIES, AMOUNTS, AND DURATION OF
GRANTS FOR SERVICES.
‘‘(a) PRIORITIES.—In approving applications for
grants for services under this title, the Secretary shall give
priority to applicants who—
‘‘(1) serve an area where there is a high inci-
dence of adolescent pregnancy;
‘‘(2) serve an area with a high proportion of
low-income families and where the availability of
programs of prevention and care for eligible persons
is low;
‘‘(3) show evidence—
‘‘(A) in the case of an applicant who will
provide prevention services, of having the ability
to provide prevention services for adolescents
and their families that are appropriate for the
target population and the geographic area to be
served, including the special needs of rural
areas; or
‘‘(B) in the case of an applicant who will
provide care services, of having the ability to
bring together a wide range of needed core serv-
ices and, as appropriate, supplemental services
in comprehensive single-site programs, or to es-
tablish a well-integrated network of such serv-
ices (appropriate for the target population and
132
geographic area to be served including the spe-
cial needs of rural areas) for eligible persons;
‘‘(4) will utilize to the maximum extent feasible
existing available programs and facilities such as
community health centers, child welfare agencies,
children and youth centers, maternal and infant
health centers, regional rural health facilities, li-
censed adoption agencies, maternity homes, school
and other educational programs, family planning
clinics, mental health programs, nutrition programs,
recreation programs, and other ongoing pregnancy
prevention and pregnancy-related services;
‘‘(5) make use, to the maximum extent feasible,
of other Federal, State, and local funds, programs,
contributions, and other third-party reimbursements;
‘‘(6) can demonstrate a community commitment
to the program by making available to the program
non-Federal funds, personnel, and facilities;
‘‘(7) have involved the community to be served,
including public and nonprofit private agencies, ado-
lescents, and families, in the planning and imple-
mentation of the program; and
‘‘(8) will demonstrate innovative and effective
approaches in addressing the problems of adolescent
pregnancy or parenthood, including outreach to ado-
133
lescent males and approaches for providing pregnant
adolescents with adequate information about adop-
tion.
‘‘(b) AMOUNTS.—
‘‘(1) IN GENERAL.—The amount of a grant for
a program for services under this title shall be deter-
mined by the Secretary, based on factors such as the
incidence of adolescent pregnancy in the geographic
area to be served, and the adequacy of pregnancy
prevention services and programs of care for eligible
persons in such area.
‘‘(2) RURAL
AREAS.—In making grants for
services under this title, the Secretary shall consider
the special needs of rural areas and, to the maxi-
mum extent practicable, shall distribute funds taking
into consideration the relative number of adolescents
in such areas in need of such services.
‘‘(c) FEDERAL SHARE.—
‘‘(1) IN GENERAL.—Subject to paragraph (3), a
grant for services under this title may not exceed 75
percent of the costs of the program for any year.
‘‘(2) 
FORM
OF
NON-FEDERAL
CONTRIBU-
TIONS.—Non-Federal 
contributions 
required 
by
paragraph (1) may be in cash or in kind, fairly eval-
uated, including plant, equipment, or services.
134
‘‘(3) WAIVER.—The Secretary may waive the
limitation specified in paragraph (1) for any year in
accordance with criteria established by regulation.
‘‘SEC. 
2006. 
REQUIREMENTS 
FOR 
APPLICATIONS 
FOR
GRANTS FOR SERVICES.
‘‘(a) IN GENERAL.—An application for a grant for
services under this title shall be in such form and contain
such information as the Secretary may require, and shall
include—
‘‘(1) an identification of the incidence of adoles-
cent pregnancy and related problems;
‘‘(2) a description of the economic conditions
and income levels in the geographic area to be
served;
‘‘(3) a description of existing pregnancy preven-
tion services and programs of care for eligible per-
sons (including adoption services), and including
where, how, by whom, and to which population
groups such services are provided, and the extent to
which they are coordinated in the geographic area to
be served;
‘‘(4) a description of the major unmet needs for
services for adolescents at risk of initial or recurrent
pregnancies and an estimate of the number of ado-
lescents not being served in the area;
135
‘‘(5)(A) in the case of an applicant who will
provide prevention services, a description of the nec-
essary services to be provided and how the applicant
will provide such services; or
‘‘(B) in the case of an applicant who will pro-
vide care services, a description of how all core serv-
ices will be provided in the program using funds
under this title or will otherwise be provided by the
grantee in the area to be served, the population to
which such services will be provided, how such serv-
ices will be coordinated, integrated, and linked with
other related programs and services and the source
or sources of funding of such core services in the
public and private sectors; or
‘‘(6) a description of the manner in which ado-
lescents needing services other than the services pro-
vided directly by the applicant will be identified and
how access and appropriate referral to such other
services (such as but not limited to medicaid; li-
censed adoption agencies; maternity home services;
public assistance; employment services; child care
services for adolescent parents; and other city, coun-
ty, and State programs related to adolescent preg-
nancy) will be provided, including a description of a
136
plan to coordinate such other services with the serv-
ices supported under this title;
‘‘(7) a description of the results expected from
the provision of services, and the procedures to be
used for evaluating those results;
‘‘(8) assurances that the applicant will have an
ongoing quality assurance program;
‘‘(9) assurances that the applicant shall have a
system for maintaining the confidentiality of patient
records in accordance with regulations prescribed by
the Secretary;
‘‘(10) assurances that the applicant will dem-
onstrate its financial responsibility by the use of
such accounting procedures and other requirements
as may be prescribed by the Secretary;
‘‘(11) assurances that the applicant will make
maximum use of other sources of Federal and State
funding;
‘‘(12)(A) a description of—
‘‘(i) the schedule of fees to be used in the
provision of services, which shall comply with
section 2004(c); and
‘‘(ii) a corresponding schedule of discounts
to be applied to the payment of such fees, which
shall—
137
‘‘(I) comply with section 2004(b);
‘‘(II) be adjusted on the basis of the
ability of the eligible person to pay; and
‘‘(III) provide that no fee will be im-
posed on any eligible individual with an in-
come of less than 100 percent of the offi-
cial poverty line;
‘‘(B) assurances that the applicant has made
and will continue to make every reasonable effort—
‘‘(i) to secure from eligible persons pay-
ment for services in accordance with such
schedules;
‘‘(ii) to collect reimbursement for health or
other services provided to persons who are enti-
tled to have payment made on their behalf for
such services under any Federal or other gov-
ernment program or private insurance program;
and
‘‘(iii) to seek such reimbursement on the
basis of the full amount of fees for services
without application of any discount; and
‘‘(C) assurances that the applicant has submit-
ted or will submit to the Secretary such reports as
the Secretary may require to determine compliance
with this paragraph;
138
‘‘(13) assurances that the applicant will make
maximum use of funds available under title X;
‘‘(14) assurances that the acceptance by any in-
dividual of family planning services or family plan-
ning information (including educational materials)
provided through financial assistance under this title
shall be voluntary and shall not be a prerequisite to
eligibility for or receipt of any other service fur-
nished by the applicant;
‘‘(15) assurances that fees collected by the ap-
plicant for services rendered in accordance with this
title shall be used by the applicant to further the
purposes of this title;
‘‘(16) assurances that the applicant, if provid-
ing both prevention and care services, will not ex-
clude or discriminate against any adolescent who re-
ceives prevention services and subsequently requires
care services as a pregnant adolescent;
‘‘(17) a description of how the applicant will as-
certain whether services for which adolescents have
been referred have actually been obtained and de-
velop a plan to ensure that needed services actually
are received;
‘‘(18) assurances that unemancipated minors
requesting services from the applicant will be en-
139
couraged to consult with their parents with respect
to such services and that services shall not be denied
to unemancipated minors who decide not to consult
their parents;
‘‘(19) assurances that all pregnant adolescents
receiving services will be informed of the availability
of counseling (either by the entity providing core
services or through a referral agreement with such
other entity that provides such counseling) on all op-
tions, regarding the pregnancy;
‘‘(20) assurances that primary emphasis for
services supported under this title shall be given to
adolescents 17 and under who are not able to obtain
needed assistance through other means;
‘‘(21) assurances that funds received under this
title shall not supplant funds received from any
other Federal, State, or local program or any private
sources of funds; and
‘‘(22) a plan for the conduct of, and assurances
that the applicant will conduct, evaluations of the ef-
fectiveness of the services supported under this title
in accordance with subsection (b).
‘‘(b) EVALUATIONS.—
‘‘(1) IN GENERAL.—Each grantee that receives
funds for a grant for services under this title shall
140
expend at least 3 percent but not in excess of 10
percent of the amounts received under this title for
the conduct of evaluations of the services supported
under this title. The Secretary may, for a particular
grantee on good cause shown, waive the preceding
sentence with respect to the amounts to be expended
on evaluations, but may not waive the requirement
that such evaluations be conducted.
‘‘(2) INDEPENDENT EVALUATION.—Evaluations
required by paragraph (1) shall be conducted by an
organization or entity that is independent of the
grantee providing services supported under this title.
‘‘(c) REPORTS.—
‘‘(1) IN GENERAL.—Each grantee that partici-
pates in the program established by this title shall
make such reports concerning its use of Federal
funds as the Secretary may require, including re-
ports on prevention programs and care programs.
‘‘(2) CONTENTS OF REPORTS ON PREVENTION
PROGRAMS.—Reports on prevention programs shall
be in a standard format as prescribed by the Sec-
retary and shall include a description of—
‘‘(A) the characteristics, educational at-
tainments, and economic status of clients;
141
‘‘(B) the clients’ previous exposure in
home, school, or other locations to educational
efforts regarding sexuality and family life;
‘‘(C) the types of interventions employed in
the prevention program;
‘‘(D) the before and after outcome meas-
urements on variables appropriate to the inter-
vention;
‘‘(E) to the extent possible and where ap-
propriate to program goals, the pregnancy and
sexually transmitted disease rates subsequent to
intervention; and
‘‘(F) the extent of parent or family involve-
ment in the program.
‘‘(3) CONTENTS
OF
REPORTS
ON
CARE
PRO-
GRAMS.—Reports on care programs shall be in
standard format as prescribed by the Secretary and
shall include a description of—
‘‘(A) the characteristics, health history,
educational attainments, and economic status of
clients at the time of entry;
‘‘(B) the client prenatal care and preg-
nancy outcome, complications of pregnancy and
delivery, and infant birth outcomes;
142
‘‘(C) the characteristics, educational at-
tainments, and economic status of clients at
time of follow-up and infant follow-up informa-
tion;
‘‘(D) the types of services provided to cli-
ents; and
‘‘(E) the extent of parent or family involve-
ment in the services provided.
‘‘(4) COMPARISON DATA.—Reports on preven-
tion programs and care programs shall include con-
trol group data or other appropriate comparison
data to provide comparisons with project data and to
indicate program impact or effectiveness.
‘‘(5) FOLLOW-UP DATA.—Reports on prevention
programs and care programs shall include, to the ex-
tent possible, follow-up data on a random sample of
program graduates and dropouts.
‘‘(d) TIMING OF SERVICES.—No application submit-
ted for a grant for a program for care services under this
title may be approved unless the Secretary is satisfied that
core services shall be available through the applicant with-
in a reasonable time after such grant is received.
143
‘‘SEC. 2007. COORDINATION OF FEDERAL AND STATE PRO-
GRAMS.
‘‘(a) FEDERAL PROGRAMS.—The Secretary shall co-
ordinate Federal policies and programs providing services
relating to the prevention of initial and recurrent adoles-
cent pregnancies and providing care services for eligible
persons. In achieving such coordination, the Secretary
shall—
‘‘(1) require grantees who receive grants for
services under this title to report periodically to the
Secretary concerning Federal, State, and local poli-
cies and programs that interfere with the delivery of
and coordination of pregnancy prevention services
and other programs of care for pregnant adolescents
and adolescent parents;
‘‘(2) provide technical assistance to facilitate
coordination by State and local recipients of Federal
assistance;
‘‘(3) give priority in the provision of funds,
where appropriate, to applicants using single or co-
ordinated grant applications for multiple programs;
and
‘‘(4) give priority, where appropriate, to the
provision of funds under Federal programs adminis-
tered by the Secretary (other than the program es-
tablished by this title) to programs providing com-
144
prehensive prevention services and comprehensive
programs of care for eligible persons.
‘‘(b) OTHER RECIPIENTS.—Any recipient of a grant
for services under this title shall coordinate its activities
with any other recipient of such a grant that is located
in the same locality.
‘‘SEC. 2008. GRANTS FOR RESEARCH.
‘‘(a) IN GENERAL.—
‘‘(1) AUTHORIZATION.—The Secretary may
make grants to public agencies or nonprofit private
organizations or institutions of higher education to
support the research and dissemination activities de-
scribed in paragraphs (4), (5), and (6) of section
2001(b).
‘‘(2) DURATION.—The Secretary may make
grants or enter into contracts under this section for
a period of 1 year. A grant or contract under this
section for a program may be renewed for 4 addi-
tional 1-year periods, which need not be consecutive.
‘‘(3) AMOUNT
LIMITATION.—A grant or con-
tract for any 1-year period under this section may
not exceed $100,000 for the direct costs of conduct-
ing research or dissemination activities under this
section and may include such additional amounts for
the indirect costs of conducting such activities as the
145
Secretary determines appropriate. The Secretary
may waive the preceding sentence with respect to a
specific program if the Secretary determines that—
‘‘(A) exceptional circumstances warrant
such waiver and that the program will have na-
tional impact;
‘‘(B) additional amounts are necessary for
the direct costs of conducting limited programs
for the provision of necessary services in order
to provide data for research carried out under
this title; or
‘‘(C) several grantees together require
more than $100,000 to evaluate the effective-
ness of different combinations of services, and
if such grantees demonstrate evidence of rea-
sonable progress in the first year, such
multisite evaluation studies shall receive pref-
erence for funding renewal.
‘‘(4) CARRYOVER FOR REPORT.—The amount
of any grant or contract made under this section
may remain available for obligation or expenditure
after the close of the 1-year period for which such
grant or contract is made in order to assist the re-
cipient in preparing the report required by sub-
section (f)(1).
146
‘‘(b) USE OF FUNDS.—
‘‘(1) IN
GENERAL.—Funds provided for re-
search under this section may be used for descriptive
or explanatory surveys, evaluation studies, longitu-
dinal studies, or limited programs for services that
are for the purpose of increasing knowledge and un-
derstanding of the matters described in paragraphs
(4) and (5) of section 2001(b).
‘‘(2) LIMITATIONS.—Funds provided under this
section may not be used for the purchase or im-
provement of land, or the purchase, construction, or
permanent improvement (other than minor remodel-
ing) of any building or facility.
‘‘(c) PREREQUISITES.—The Secretary may not make
any grant or enter into any contract to support research
or dissemination activities under this section unless—
‘‘(1) the Secretary has received an application
for such grant or contract that is in such form and
that contains such information as the Secretary may
by regulation require;
‘‘(2) the applicant has demonstrated that the
applicant is capable of conducting one or more of
the types of research or dissemination activities de-
scribed in paragraph (4), (5), or (6) of section
2001(b); and
147
‘‘(3) in the case of an application for a research
program, the panel established by subsection (e)(2)
has determined that the program is of scientific
merit.
‘‘(d) COORDINATION.—The Secretary shall coordi-
nate research and dissemination activities carried out
under this section with research and dissemination activi-
ties carried out by the National Institutes of Health.
‘‘(e) REVIEW OF APPLICATIONS.—
‘‘(1) SYSTEM.—The Secretary shall establish a
system for the review of applications for grants and
contracts under this section. Such system shall be
substantially similar to the system for scientific peer
review of the National Institutes of Health and shall
meet the requirements of paragraphs (2) and (3).
‘‘(2) PANEL.—
‘‘(A) ESTABLISHMENT.—In establishing
the system required by paragraph (1), the Sec-
retary shall establish a panel to review applica-
tions under this section.
‘‘(B) EXPERTISE.—Panel members should
have expertise in research and evaluation and
should represent disciplines relevant to the
study of adolescent pregnancy and parenting.
148
‘‘(C) LIMIT
ON
PHYSICIANS.—Not more
than 25 percent of the members of the panel
shall be physicians.
‘‘(D) MEETINGS.—The panel shall meet as
often as may be necessary to facilitate the expe-
ditious review of applications under this section,
but not less than once each year.
‘‘(E) REVIEW.—The panel shall review
each program for which an application is made
under this section, evaluate the scientific merit
of the program, determine whether the program
is of scientific merit, and make recommenda-
tions to the Secretary concerning whether the
application for the program should be approved.
‘‘(3) GRANT DETERMINATION.—The Secretary
shall make grants under this section from among the
programs that the panel established by paragraph
(2) has determined to be of scientific merit and may
only approve an application for a program if the
panel has made such determination with respect to
such a program. The Secretary shall make a deter-
mination with respect to an application within 1
month after receiving the determinations and rec-
ommendations of such panel with respect to the ap-
plication.
149
‘‘(f) REPORTS.—
‘‘(1) RESEARCH REPORTS.—
‘‘(A) IN
GENERAL.—The recipient of a
grant or contract for a research program under
this section shall prepare and transmit to the
Secretary a report describing the results and
conclusions of such research. Except as pro-
vided in subparagraph (B), such report shall be
transmitted to the Secretary not later than 12
months after the end of the year for which
funds are provided under this section. The re-
cipient may utilize reprints of articles published
or accepted for publication in professional jour-
nals to supplement or replace such report if the
research contained in such articles was sup-
ported under this section during the year for
which the report is required.
‘‘(B) MULTIYEAR PROGRAMS.—In the case
of any research program for which assistance is
provided under this section for 2 or more con-
secutive 1-year periods, the recipient of such as-
sistance shall prepare and transmit the report
required by subparagraph (A) to the Secretary
not later than 12 months after the end of each
150
1-year period for which such funding is pro-
vided.
‘‘(2) OTHER
REPORTS.—Recipients of grants
and contracts for dissemination under this section
shall submit to the Secretary such reports as the
Secretary determines appropriate.
‘‘SEC. 2009. EVALUATION.
‘‘Of the funds appropriated under this title, the Sec-
retary shall reserve not less than 1 percent and not more
than 3 percent for the evaluation of activities carried out
under this title. The Secretary shall submit to the appro-
priate committees of Congress a summary of each evalua-
tion conducted under this section and a summary of the
data reported by grantees under section 2006(c).
‘‘SEC. 2010. AUTHORIZATION OF APPROPRIATIONS.
‘‘(a) IN GENERAL.—For the purpose of carrying out
this title, there are authorized to be appropriated
$60,000,000 for each of the fiscal years 1995 through
1997.
‘‘(b) GRANTS FOR SERVICES.—At least two-thirds of
the amounts appropriated to carry out this title shall be
used to make grants for services.
‘‘(c) PREVENTION SERVICES.—Two-thirds of the
amounts specified under subsection (b) for use for grants
151
for services shall be used for grants for prevention serv-
ices.
‘‘SEC. 2011. FUND RESTRICTION.
‘‘No funds for grants made under this title may be
used for payment for the performance of an abortion.’’.
Subtitle I—Adolescent Health Dem-
onstrations Projects Act of 1993
SEC. 241. SHORT TITLE.
This subtitle may be cited as the ‘‘Adolescent Health
Demonstrations Projects Act of 1993’’.
SEC. 242. ESTABLISHMENT OR SUPPORT OF DEMONSTRA-
TION PROJECTS.
The Secretary of Health and Human Services (here-
inafter in this subtitle referred to as the ‘‘Secretary’’) shall
make grants in fiscal years 1994 through 1998 to public
and nonprofit private entities to establish or support ado-
lescent health demonstration projects in secondary schools
or entities associated with secondary schools for the pur-
pose of demonstrating how such projects may be estab-
lished throughout the United States.
SEC. 243. PROJECT REQUIREMENTS.
An adolescent health demonstration project estab-
lished or supported under section 242 shall (1) provide
nutrition and hygiene counseling, health care related to
sports, family planning information and services, prenatal
152
and postpartum care, family life and parenting counseling,
and alcohol and drug abuse education and treatment, (2)
serve adolescents before their graduation from high school,
(3) encourage family participation, to the extent practical,
(4) obtain the approval of the school board in the locality
to be served by the project before the project is imple-
mented, (5) furnish such reports and data as the Sec-
retary may require, including, at a minimum, the number
and characteristics of individuals served, the services pro-
vided, and the results achieved, and (6) establish a com-
munity advisory committee to oversee the establishment
and implementation of such project. Such community ad-
visory committee shall include students, parents, school
personnel, physicians, religious and business leaders, and
other community representatives and shall establish poli-
cies for the project with respect to the services to be pro-
vided under the project, the populations to be served, the
personnel who will provide services, fees to be charged, and
other policy issues.
SEC. 244. AREAS TO BE SERVED.
In making grants under section 242, the Secretary
shall give priority to applications for projects which will
serve areas with low-income residents or minority popu-
lations.
153
SEC. 245. ABORTION RESTRICTION.
None of the funds provided under a grant under sec-
tion 242 may be used to perform or pay for abortions.
SEC. 245A. REPORT.
The Secretary shall, in each fiscal year, set aside not
more than 5 percent of the amount appropriated for
grants under section 242 to evaluate the operations of the
projects for which grants were made under such section.
Not later than December 1, 1999, the Secretary shall re-
port to the Congress the result of such evaluation together
with such recommendations as the Secretary may have re-
specting the extension of the grant authority under section
242 or the establishment of a continuing service program.
Subtitle J—Eating Disorders Infor-
mation and Education Act of
1993
SEC. 246. SHORT TITLE.
This subtitle may be cited as the ‘‘Eating Disorders
Information and Education Act of 1993’’.
SEC. 247. FINDINGS.
The Congress finds the following:
(1) Eating disorders include anorexia nervosa
and bulimia nervosa, as well as eating disorders not
otherwise defined.
(2) Anorexia nervosa and bulimia each can re-
sult in death, cardiac impairments, depression, sub-
154
stance abuse, osteoporosis, infertility, amenorrhea,
anemia, and other medical conditions.
(3) Medical authorities are uncertain to what
extent eating disorders are caused by physiological
factors, by psychosocial factors, or by both.
(4) Such disorders primarily affect women. As
many as 6 percent of women may be experiencing
eating disorders, and the rate of new cases is in-
creasing. As many as 30 percent of women in insti-
tutions of higher education may be displaying symp-
toms of eating disorders.
(5) There are effective treatments for some eat-
ing disorders.
SEC. 248. PUBLIC INFORMATION AND EDUCATION ON EAT-
ING DISORDERS.
Subpart 3 of part B of title V of the Public Health
Service Act (42 U.S.C. 290bb-31 et seq.), as added by sec-
tion 115 of Public Law 102–321 (106 Stat. 346), is
amended by adding at the end the following section:
‘‘EATING DISORDERS
‘‘SEC. 520C. (a) INFORMATION AND EDUCATION.—
The Secretary, acting through the Director of the Center
for Mental Health Services, shall carry out a program to
provide information and education to the public on the
prevention and treatment of eating disorders.
155
‘‘(b) TOLL-FREE TELEPHONE COMMUNICATIONS.—
In carrying out subsection (a), the Secretary shall provide
for the operation of toll-free telephone communications to
provide information to the public on eating disorders, in-
cluding referrals for services for the prevention and treat-
ment of such disorders. Such communications shall be
available on a 24-hour, 7-day basis.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated $2,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the fiscal years
1994 through 1996.’’.
Subtitle K—Women and HIV
Outreach and Prevention Act
SEC. 251. SHORT TITLE.
This subtitle may be cited as the ‘‘Women and HIV
Outreach and Prevention Act’’.
SEC. 252. PREVENTIVE HEALTH PROGRAMS REGARDING
WOMEN AND HUMAN IMMUNODEFICIENCY
VIRUS.
Title XXV of the Public Health Service Act (42
U.S.C. 300ee et seq.) is amended by adding at the end
the following part:
156
‘‘PART C—PROGRAMS FOR WOMEN
‘‘SEC. 2531. PREVENTIVE HEALTH SERVICES.
‘‘(a) IN GENERAL.—The Secretary may make grants
for the following purposes:
‘‘(1) Providing to women preventive health serv-
ices that are related to acquired immune deficiency
syndrome, including—
‘‘(A) counseling on the prevention of infec-
tion with, and the transmission of, the etiologic
agent for such syndrome; and
‘‘(B) screening women for infection with
such agent.
‘‘(2) Providing appropriate referrals regarding
the provision of other services to women who are re-
ceiving services pursuant to paragraph (1), includ-
ing, as appropriate, referrals for treatment for such
infection, referrals for treatment for substance
abuse, referrals for mental health services, referrals
regarding pregnancy, childbirth, and pediatric care,
and referrals for housing services.
‘‘(3) Providing follow-up services regarding
such referrals, to the extent practicable.
‘‘(4) Improving referral arrangements for pur-
poses of paragraph (2).
157
‘‘(5) In the case of a woman receiving services
pursuant to any of paragraphs (1) through (3), pro-
viding to the partner of the woman the services de-
scribed in such paragraphs, as appropriate.
‘‘(6) With respect to the services specified in
paragraphs (1) through (5)—
‘‘(A) providing outreach services to inform
women of the availability of such services; and
‘‘(B) providing training regarding the ef-
fective provision of such services.
‘‘(b) MINIMUM QUALIFICATIONS
OF GRANTEES.—
The Secretary may make a grant under subsection (a)
only if the applicant for the grant is a grantee under sec-
tion 329, section 330, or section 1001, or is another public
or nonprofit private entity that provides health or vol-
untary family planning services to a significant number
of low-income women in a culturally sensitive and lan-
guage-appropriate manner.
‘‘(c) CONFIDENTIALITY.—The Secretary may make a
grant under subsection (a) only if the applicant for the
grant agrees to maintain the confidentiality of information
on individuals regarding screenings pursuant to subsection
(a), subject to complying with applicable law.
‘‘(d) APPLICATION FOR GRANT.—The Secretary may
make a grant under subsection (a) only if an application
158
for the grant is submitted to the Secretary and the appli-
cation is in such form, is made in such manner, and con-
tains such agreements, assurances, and information as the
Secretary determines to be necessary to carry out such
subsection.
‘‘(e) EVALUATIONS AND REPORTS.—
‘‘(1) EVALUATIONS.—The Secretary shall, di-
rectly or through contracts with public or private en-
tities, provide for evaluations of projects carried out
pursuant to subsection (a).
‘‘(2) REPORTS.—Not later than 1 year after the
date on which amounts are first appropriated under
subsection (f), and annually thereafter, the Sec-
retary shall submit to the Congress a report summa-
rizing evaluations carried out under paragraph (1)
during the preceding fiscal year.
‘‘(f) AUTHORIZATIONS OF APPROPRIATIONS.—
‘‘(1) TITLE
X
CLINICS.—For the purpose of
making grants under subsection (a) to entities that
are grantees under section 1001, and for the pur-
pose of otherwise carrying out this section with re-
spect to such grants, there are authorized to be ap-
propriated $30,000,000 for fiscal year 1994, and
such sums as may be necessary for each of the fiscal
years 1995 and 1996.
159
‘‘(2) COMMUNITY AND MIGRANT HEALTH CEN-
TERS; OTHER PROVIDERS.—For the purpose of mak-
ing grants under subsection (a) to entities that are
grantees under section 329 or 330, and to other en-
tities described in subsection (b) that are not grant-
ees under section 1001, and for the purpose of oth-
erwise carrying out this section with respect to such
grants, there are authorized to be appropriated
$20,000,000 for fiscal year 1994, and such sums as
may be necessary for each of the fiscal years 1995
and 1996.
‘‘SEC. 2532. PUBLIC EDUCATION.
‘‘(a) IN GENERAL.—The Secretary may make grants
for the purpose of developing and carrying out programs
to educate women on the prevention of infection with, and
the transmission of, the etiologic agent for acquired im-
mune deficiency syndrome.
‘‘(b) MINIMUM QUALIFICATIONS
OF GRANTEES.—
The Secretary may make a grant under subsection (a)
only if the applicant involved is a public or nonprofit pri-
vate entity that is experienced in carrying out health-relat-
ed activities for women, with a priority given to such enti-
ties that have successfully targeted women of color.
‘‘(c) APPLICATION FOR GRANT.—The Secretary may
make a grant under subsection (a) only if an application
160
for the grant is submitted to the Secretary and the appli-
cation is in such form, is made in such manner, and con-
tains such agreements, assurances, and information as the
Secretary determines to be necessary to carry out such
subsection.
‘‘(d) EVALUATIONS AND REPORTS.—
‘‘(1) EVALUATIONS.—The Secretary shall, di-
rectly or through contracts with public or private en-
tities, provide for evaluations of projects carried out
pursuant to subsection (a).
‘‘(2) REPORTS.—Not later than 1 year after the
date on which amounts are first appropriated under
subsection (e), and annually thereafter, the Sec-
retary shall submit to the Congress a report summa-
rizing evaluations carried out under paragraph (1)
during the preceding fiscal year.
‘‘(e) AUTHORIZATIONS
OF APPROPRIATIONS.—For
the purpose of carrying out this section, there are author-
ized to be appropriated $30,000,000 for fiscal year 1994,
and such sums as may be necessary for each of the fiscal
years 1995 and 1996.’’.
SEC. 253. TREATMENT OF WOMEN FOR SUBSTANCE ABUSE.
Subpart 1 of part B of title V of the Public Health
Service Act (42 U.S.C. 290bb et seq.), as amended by sec-
tion 108 of Public Law 102–321 (106 Stat. 336), is
161
amended by inserting after section 509 the following sec-
tion:
‘‘TREATMENT OF WOMEN FOR SUBSTANCE ABUSE
‘‘SEC. 509A. (a) IN GENERAL.—The Director of the
Center for Substance Abuse Treatment may make awards
of grants, cooperative agreements, and contracts for the
purpose of carrying out programs—
‘‘(1) to provide treatment for substance abuse
to women, including but not limited to, women with
dependent children;
‘‘(2) to provide to women who engage in such
abuse counseling on the prevention of infection with,
and the transmission of, the etiologic agent for ac-
quired immune deficiency syndrome; and
‘‘(3) to provide such counseling to women who
are the partners of individuals who engage in such
abuse.
‘‘(b) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out subsection (a), there are author-
ized to be appropriated $20,000,000 for fiscal year 1994,
and such sums as may be necessary for each of the fiscal
years 1995 and 1996.’’.
SEC. 254. EARLY INTERVENTION SERVICES FOR WOMEN.
Section 2655 of the Public Health Service Act (42
U.S.C. 300ff–55) is amended—
162
(1) by striking ‘‘For the purpose of’’ and insert-
ing ‘‘(a) IN GENERAL.—For the purpose of’’; and
(2) by adding at the end the following sub-
section:
‘‘(b) PROGRAMS FOR WOMEN.—For the purpose of
making grants under section 2651 to provide to women
early intervention services described in such section, and
for the purpose of providing technical assistance under
section 2654(b) with respect to such grants, there are au-
thorized to be appropriated $20,000,000 for fiscal year
1994, and such sums as may be necessary for each of the
fiscal years 1995 and 1996.’’.
Subtitle L—Standby Guardianship
Act
SEC. 256. SHORT TITLE.
This subtitle may be cited as the ‘‘Standby Guardian-
ship Act’’.
SEC. 257. STATES REQUIRED TO HAVE STANDBY GUARD-
IANSHIP LAW AS A CONDITION OF ELIGI-
BILITY FOR FEDERAL FUNDS FOR FOSTER
CARE AND ADOPTION ASSISTANCE.
(a) IN GENERAL.—Part E of title IV of the Social
Security Act (42 U.S.C. 670–679) is amended by inserting
after section 477 the following: