[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3176 Introduced in House (IH)]







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 programs of 
 research with respect to women and cases of infection with the human 
                        immunodeficiency virus.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Women and AIDS Research Initiative 
Amendments of 1996''.

SEC. 2. ESTABLISHMENT OF GENERAL PROGRAM OF RESEARCH 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 infection with the 
human immunodeficiency virus, the Secretary shall establish a program 
for the purpose of conducting 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 entities 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, including the relationship between 
        cases of infection with such virus and other cases of sexually 
        transmitted 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 research on the 
        following:
                    ``(A) The prevention of any sexually transmitted 
                disease that may facilitate the transmission of the 
                virus.
                    ``(B) Rapid, inexpensive, easy-to-use sexually 
                transmitted disease diagnostic tests for women.
                    ``(C) Inexpensive single dose therapy for treatable 
                sexually transmitted diseases.
                    ``(D) The development of methods of prevention 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 symptoms resulting 
        from infection with such virus, including 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 programs for such prevention.
            ``(6) Research leading to an understanding of social, 
        economic, and legal factors whose impact contributes to an 
        increased risk of such infection.
            ``(7) Research leading to an understanding of social, 
        economic, and legal factors whose impact contributes to--
                    ``(A) low levels of participation by women in 
                clinical trials; or
                    ``(B) inadequate access to health care services, or 
                inadequate utilization of such services.
    ``(c) Clinical Research.--
            ``(1) Gynecological evaluations.--In clinical 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, including evaluation of the 
                reproductive tract, and appropriate follow-up services 
                regarding such evaluations; 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 reproductive-tract 
                infections and diseases.
            ``(2) Standard treatments for gynecological conditions.--
        The Secretary shall conduct or support clinical trials under 
        subsection (a) to determine whether standard methods of 
        treating gynecological 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 subsection (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, medical and mental health 
services, treatment for drug abuse, social services (including services 
addressing domestic violence), and other support services.
                    ``(B) Services under subparagraph (A) shall include 
                services designed to respond to the particular needs of 
                women with respect to participation in the clinical 
                trials involved, including, 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 
                        research on topical microbicides that are not 
                        spermicides and that otherwise are methods that 
                        do not pose a threat to the ability of women to 
                        conceive and bear healthy children.
            ``(2) Epidemiological research.--The Secretary shall 
        conduct or support epidemiological research 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 
                contraceptive methods;
                    ``(B) the use of vaginal products, including 
                douches, tampons, and vaginal medications;
                    ``(C) the relationship between such infection and 
                other sexually transmitted diseases;
                    ``(D) the relationship between such infection and 
                various forms of substance abuse (including use of the 
                form of cocaine commonly known as crack); and
                    ``(E) the relationship between such infection 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 Secretary through various agencies of the Public Health 
Service for the purpose of monitoring the progression in women of 
infection with the human immunodeficiency virus, and determining 
whether such progression is different 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 currently included in the list of 
        conditions arising from such infection that, for surveillance 
        purposes, is maintained by the Director of the Centers for 
        Disease 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 available for the 
        following purposes:
                    ``(A) For the purpose of carrying out subsection 
                (c)(1), there are authorized to be appropriated 
                $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 subsection 
                (c)(2), there are authorized to be appropriated 
                $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 subsection 
                (c)(3), there are authorized to be appropriated 
                $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 subsection 
                (c)(4), there are authorized to be appropriated 
                $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 subsection 
                (d)(1), there are authorized to be appropriated 
                $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 subsection 
                (d)(2), there are authorized to be appropriated 
                $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 available 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.''.
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