I
104TH CONGRESS
2D SESSION
H. R. 3176
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
MARCH 27, 1996
Mrs. MORELLA introduced the following bill; which was referred to the
Committee on 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 1996’’.
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 the following:
‘‘(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 the following:
‘‘(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.
‘‘(E) The development and dissemination
of prevention programs and materials whose
purpose 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.
‘‘(5) Behavioral research on the prevention of
such cases and research on model educational pro-
grams for such prevention.
‘‘(6) Research leading to an understanding of
social, economic, and legal factors whose impact con-
tributes to an increased risk of such infection.
‘‘(7) Research leading to an understanding of
social, economic, and legal factors whose impact con-
tributes to—
‘‘(A) low levels of participation by women
in clinical trials; or
‘‘(B) inadequate access to health care serv-
ices, or inadequate utilization of such services.
‘‘(c) CLINICAL RESEARCH.—
‘‘(1) GYNECOLOGICAL EVALUATIONS.—In clini-
cal trials regarding the human immunodeficiency
virus in which women participate as subjects, the
Secretary shall ensure—
‘‘(A) that the designs of the trials include
adequate evaluation of prospective subjects
prior to enrollment, and adequate evaluation of
subjects during the course of the trials, includ-
ing evaluation of the reproductive tract, and ap-
propriate follow-up services regarding such eval-
uations; and
‘‘(B) the conduct of studies related to the
propensity for cases of infection with such virus
to cause abnormalities in the reproductive tract,
or to alter the natural history of other repro-
ductive-tract infections and diseases.
‘‘(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 research under sub-
section (a) to determine the effectiveness, on such
cases in women, of approved treatment protocols.
‘‘(4) SUPPORT SERVICES.—
‘‘(A) In conducting or supporting clinical
trials regarding the human immunodeficiency
virus in which women participate as subjects,
the Secretary shall take into account factors
that can facilitate such participation, including
consideration of employment schedules and the
provision of support services. The Secretary
may provide such services accordingly, including
transportation services, child care services, med-
ical and mental health services, treatment for
drug abuse, social services (including services
addressing domestic violence), and other sup-
port services.
‘‘(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 and other sexually transmitted diseases,
the Secretary shall conduct or support research
under subsection (a) on topical microbicide and
physical barrier methods of prevention that
women can use without their sexual partner’s
cooperation or knowledge.
‘‘(B) In carrying out subparagraph (A),
the Secretary shall—
‘‘(i) give priority to carrying out the
topical microbicide research agenda of the
National Institutes of Health, including
agendas regarding basic research, product
development, and clinical evaluation of new
and existing products; and
‘‘(ii) give special consideration to re-
search on topical microbicides that are not
spermicides and that otherwise are meth-
ods that do not pose a threat to the ability
of women to conceive and bear healthy
children.
‘‘(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 spermicides and other con-
traceptive methods;
‘‘(B) the use of vaginal products, including
douches, tampons, and vaginal medications;
‘‘(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 March 1996, 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 2,500 women with such infection are included
in the study, and that the demographic variability of
the cohort is maintained.
‘‘(2) The Secretary shall ensure that the study
period is extended for a minimum of 5 years.
‘‘(3) With respect to markers of human
immunodeficiency virus disease progression and viral
activity (including the cells commonly known as CD4
cells and including quantitative viral load measures),
the Secretary shall ensure that the study adequately
addresses the relationship between such markers and
the development of serious illnesses in such women.
For purposes of the preceding sentence, the study
shall address gynecological conditions, and other
conditions particular to women, that are not cur-
rently 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 RESEARCH.—In addition to any
other authorizations of appropriations that are avail-
able for the following purposes:
‘‘(A) For the purpose of carrying out sub-
section (c)(1), there are authorized to be appro-
priated $20,000,000 for fiscal year 1997, and
such sums as may be necessary for each of the
fiscal years 1998 through 1999.
‘‘(B) For the purpose of carrying out sub-
section (c)(2), there are authorized to be appro-
priated $10,000,000 for fiscal year 1997, and
such sums as may be necessary for each of the
fiscal years 1998 through 1999.
‘‘(C) For the purpose of carrying out sub-
section (c)(3), there are authorized to be appro-
priated $10,000,000 for fiscal year 1997, and
such sums as may be necessary for each of the
fiscal years 1998 through 1999.
‘‘(D) For the purpose of carrying out sub-
section (c)(4), there are authorized to be appro-
priated $15,000,000 for fiscal year 1997, and
such sums as may be necessary for each of the
fiscal years 1998 and 1999.
‘‘(2) PREVENTION PROGRAMS.—In addition to
any other authorizations of appropriations that are
available for the following purposes:
‘‘(A) For the purpose of carrying out sub-
section (d)(1), there are authorized to be appro-
priated $10,000,000 for fiscal year 1997, and
such sums as may be necessary for each of the
fiscal years 1998 through 1999.
‘‘(B) For the purpose of carrying out sub-
section (d)(2), there are authorized to be appro-
priated $10,000,000 for fiscal year 1997, and
such sums as may be necessary for each of the
fiscal years 1998 through 1999.
‘‘(3) INTERAGENCY STUDY.—In addition to any
other authorizations of appropriations that are avail-
able for the purpose of carrying out subsection (e),
there are authorized to be appropriated for such
purpose $6,000,000 for fiscal year 1997, and such
sums as may be necessary for each of the fiscal
years 1998 through 1999.’’.
Æ