[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3891 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 3891

To amend the Public Health Service Act with respect to facilitating the 
  development of microbicides to prevent the transmission of sexually 
                         transmitted diseases.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 9, 2000

Mrs. Morella (for herself, Ms. Pelosi, Mrs. Kelly, Mrs. Maloney of New 
 York, Mr. Boehlert, and Mr. Greenwood) introduced the following bill; 
            which was referred to the Committee on Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act with respect to facilitating the 
  development of microbicides to prevent the transmission of sexually 
                         transmitted diseases.

    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 ``Microbicides Development Act of 
2000''.

 SEC. 2. FINDINGS.

    (a) In General.--The Congress finds as follows:
            (1) Annually at least 1 billion people worldwide contracted 
        one of eight sexually transmitted diseases (``STDs'')--
        chlamydia, gonorrhea, syphilis, trichomoniasis, hepatitis B, 
        herpes, human immunodeficiency virus (HIV), and human papilloma 
        virus. Of these, hepatitis B, herpes, HIV, and human papilloma 
        virus are incurable and represented two-thirds of the new 
        infections.
            (2) In 1999, 15.4 million people in the United States 
        acquired at least one of these eight diseases, the highest rate 
        in the industrialized world. Five of the top 10 most frequently 
        reported infectious diseases (87 percent of all cases) are 
        sexually transmitted. At least 66 million Americans, over 1 in 
        3 adults aged 15-65, are now living with an incurable viral 
        STD.
            (3) The total costs to the U.S. economy of STDs, excluding 
        HIV infection, were approximately $16 billion. When the costs 
        of sexually-transmitted HIV infection are included, that total 
        rises to $23 billion.
            (4) STDs impose high human costs in pain, diminished 
        quality of life, disability, and mortality. In women, STDs 
        other than HIV can produce infertility, cancers, and numerous 
        pregnancy-related complications, including ectopic pregnancy, 
        spontaneous abortion, and stillbirth. Passed to a fetus or 
        infant, these infections can cause low birthweight, pneumonia, 
        neurologic damage, and congenital abnormalities. These 
        infections also substantially enhance susceptibility to HIV 
        infection.
            (5) Individuals of every age and every geographic, racial, 
        cultural, socioeconomic, and religious background are affected 
        by STDs. Some infections are so prevalent that almost everyone 
        is at risk, with many perhaps unaware of their infected status.
            (6) Biologically and socially, women are more vulnerable to 
        STDs than men. Many STDs are transmitted more easily from a man 
        to a woman and are more likely to remain undetected in women, 
        resulting in delayed diagnosis and treatment, and more severe 
        complications.
            (7) In the United States, HIV morbidity and mortality 
        remain highest among African Americans, who make up 13% of the 
        U.S. population but accounted for almost half of AIDS deaths 
        and new AIDS cases in 1998. For African American women between 
        the ages 25 and 44 in the United States, AIDS now occupies 
        second place as the cause of death.
            (8) In the United States as well as globally, adolescents 
        and young adults are at highest risk of acquiring a sexually-
        transmitted infection. At least a quarter of all new cases of 
        STDs occur in teens, two-thirds in people ages 15-24, so that 
        by age 24, at least 1 in 3 sexually-active Americans will have 
        contracted an STD. Teenage girls are at particular risk, 
        behaviorally and physiologically.
            (9) The social, health, and economic burdens of STDs are 
        especially severe for developing countries. Among women ages 
        15-49 in developing countries, STDs represent the second 
        largest burdens of mortality and disability. Only ``maternal 
        causes,'' that is, immediate complications of pregnancy and 
        childbirth, rank higher.
            (10) AIDS is rapidly becoming a ``women's epidemic.'' In 
        the United States, women now constitute the fastest growing 
        group of those newly infected with HIV and in Africa, more 
        women are becoming infected with HIV than are men. Worldwide, 
        almost half of the approximately 14,000 adults infected daily 
        with HIV in 1998 were women, of whom 9 out of 10 live in 
        developing countries.
    (b) Microbicides.--The Congress finds as follows:
            (1) Since the early 1990s, ``topical microbicides'' have 
        attracted scientific attention as a possible new technology for 
        preventing STDs, including HIV. Like today's spermicides, 
        microbicides would be used vaginally by women to help protect 
        themselves, their partners, and their infants from the sexual 
        transmission of HIV and other STD pathogens. These compounds 
        could be formulated in a number of ways--as a gel, film, sponge 
        or time released-capsule--and could be used in addition to 
        condoms or as an alternative when condom use is not possible.
            (2) For individuals needing to use them without partner 
        knowledge or consent, safe, effective, acceptable, and 
        affordable topical microbicides could be formulated to be 
        undetectable.

   TITLE I--MICROBICIDE RESEARCH AT THE NATIONAL INSTITUTES OF HEALTH

 SEC. 101. PROGRAM REGARDING MICROBICIDES FOR PREVENTING TRANSMISSION 
              OF SEXUALLY TRANSMITTED DISEASES.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is amended by adding at the end following section:

  ``microbicides for preventing transmission of sexually transmitted 
                                diseases

    ``Sec. 409B. (a) Expansion and Coordination of Activities.--The 
Director of NIH (referred to in this section as the `Director') shall 
expand, intensify, and coordinate the activities of the Institute with 
respect to research on the development of microbicides to prevent the 
transmission of sexually transmitted diseases, including HIV (in this 
section referred to as `microbicide research').
    ``(b) Coordination.--The Director shall coordinate the activities 
under subsection (a) as outlined in subparagraph (c)(1) among all 
appropriate institutes and components of the National Institutes of 
Health to the extent such institutes and components have 
responsibilities that are related to the development of microbicides.
    ``(c) Program for Microbicide Development.--In carrying out 
subsection (a), the Institute shall establish a program to support 
research to develop microbicides that can substantially reduce 
transmission of sexually transmitted infections. Activities under such 
subsection shall provide for an expansion and intensification of the 
conduct and support of--
            ``(1) basic research on the initial mechanisms of infection 
        by sexually transmitted pathogens;
            ``(2) development of appropriate animal models for 
        evaluating safety and efficacy of microbicides;
            ``(3) development of mucosal delivery systems;
            ``(4) research on approaches to the design of contraceptive 
        and non-contraceptive microbicides;
            ``(5) clinical trials; and
            ``(6) behavioral research on use, acceptability and 
        compliance with microbicides.
    ``(d) Implementation Plan.--The Director, in coordination with 
institute directors as described in subsection (b), shall develop and 
implement a plan to ensure that the research programs described in 
paragraph (c)(1) are implemented in accordance with a plan for such 
programs. Such plan shall include the comments of the Director and 
shall include, but not be limited to, the following information for the 
five year period beginning upon enactment of such section:
            ``(1) Description of plan and objectives with respect to 
        microbicide research.
            ``(2) Description of the institutes involved and their role 
        in microbicide research.
            ``(3) Capacity of such institutes to conduct microbicide 
        research as described in (c)(1).
            ``(4) Description of grant and contract mechanisms 
        available to facilitate microbicide research, including grant 
        and contract mechanisms, RFA's, SBIR/STTRs, support for 
        preclinical product development and clinical trial capacity.
            ``(5) Description of the plan for increasing number of 
        investigators in this area of research.
    ``(e) Public Comment.--The Director shall develop a mechanism to 
provide the public, including non-profit private entities concerned 
with microbicide research, opportunities to submit comments on the 
plan, including provisions relating to the selection of products for 
clinical evaluations and to the SBIR and STTR program referred to in 
subparagraph (d)(4).
    ``(f) Report to Congress.--The Director shall prepare, and the 
Secretary shall submit, not later than 1 year after the date on 
enactment, and annually thereafter, a report that describes the 
activities of the Institute, under the research programs referred to in 
subsection (c), that shall include--
            ``(1) a description of the research plan with respect to 
        microbicide research prepared under subsection (d);
            ``(2) an assessment of the development, revision, and 
        implementation of such plan;
            ``(3) a description and evaluation of the progress made, 
        during the period for which such report is prepared, in the 
        research on microbicides;
            ``(4) a summary and analysis of expenditures made, during 
        the period for which the report is made, for activities with 
        respect to microbicides conducted and supported by the National 
        Institutes of Health; and
            ``(5) such comments and recommendations as the Director 
        considers appropriate.
    ``(g) Coordination.--The Director, to the extent practicable, shall 
consult with the Director for the Centers for Disease Control and 
Prevention and the United States Agency for International Development, 
in developing the plan under subparagraph (d) for research on 
microbicides that takes into consideration research on sexually 
transmitted diseases and microbicides carried out at the Centers for 
Disease Control and Prevention and the United States Agency for 
International Development.
    ``(h) Authorization of Appropriations.--For the purposes of 
carrying out this section, there are authorized to be appropriated 
$50,000,000 for fiscal year 2001, $75,000,000 for fiscal year 2002, 
$100,000,000 for fiscal year 2003, and such sums as may be necessary 
for each of the fiscal years 2004 and 2005.''.

 TITLE II--MICROBICIDE RESEARCH AT THE CENTERS FOR DISEASE CONTROL AND 
                               PREVENTION

SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION OF SEXUALLY 
              TRANSMITTED DISEASES.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317G the following 
section:

  ``microbicides for preventing transmission of sexually transmitted 
                                diseases

    ``Sec. 317H. (a) Expansion and Coordination of Microbicide Research 
Activities.--The Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall expand, intensify, and 
coordinate the activities of such Centers with respect to research on 
microbicides to prevent the transmission of sexually transmitted 
diseases, including HIV.
    ``(b) Authorization of Appropriations.--For the purposes of 
carrying out this section, there are authorized to be appropriated 
$7,000,000 for fiscal year 2001, $11,000,000 for fiscal year 2002, 
$15,000,000 for fiscal year 2003, and such sums as may be necessary for 
each of the fiscal years 2004 and 2005.''.
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