I
103D CONGRESS
1ST SESSION
H. R. 2394
To amend the Public Health Service Act to establish programs of research
with respect to women and cases of infection with the human
immunodeficiency virus.
IN THE HOUSE OF REPRESENTATIVES
JUNE 10, 1993
Mrs. MORELLA (for herself, Mr. BIELENSON, Mr. FRANK of Massachusetts,
Mr. FROST, Mr. GIBBONS, Mr. GILMAN, Mr. JEFFERSON, Ms. EDDIE
BERNICE JOHNSON of Texas, Mr. MATSUI, Mr. MCDERMOTT, Mrs.
MEEK, Mr. MILLER of California, Mrs. MINK, Ms. MOLINARI, Ms. NOR-
TON, Mr. PAYNE of New Jersey, Mr. SANDERS, Mrs. SCHROEDER, Ms.
SNOWE, Mr. STUDDS, Mr. TOWNS, Mrs. UNSOELD, Ms. WATERS, Mr.
WHEAT, Mr. WYDEN, and Mr. YATES) introduced the following bill;
which was referred to the Committee on Energy and Commerce
A BILL
To amend the Public Health Service Act to establish pro-
grams of research with respect to women and cases of
infection with the human immunodeficiency virus.
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 and AIDS Re-
search Initiative Amendments of 1993’’.
SEC. 2. 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
‘‘(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.’’.
Æ