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 trans-
mitted 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 Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Microbicides Develop-
ment 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, tricho-
moniasis, hepatitis B, herpes, human immuno-
deficiency virus (HIV), and human papilloma virus.
Of these, hepatitis B, herpes, HIV, and human pap-
illoma 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 dis-
eases (87 percent of all cases) are sexually trans-
mitted. 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, di-
minished quality of life, disability, and mortality. In
women, STDs other than HIV can produce infer-
tility, cancers, and numerous pregnancy-related com-
plications, including ectopic pregnancy, spontaneous
abortion, and stillbirth. Passed to a fetus or infant,
these infections can cause low birthweight, pneu-
monia, neurologic damage, and congenital abnor-
malities. These infections also substantially enhance
susceptibility to HIV infection.
(5) Individuals of every age and every geo-
graphic, 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, re-
sulting 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 ac-
counted 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 mor-
tality and disability. Only ‘‘maternal causes,’’ that
is, immediate complications of pregnancy and child-
birth, rank higher.
(10) AIDS is rapidly becoming a ‘‘women’s epi-
demic.’’ 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, includ-
section as the ‘Director’) shall expand, intensify, and co-
ordinate the activities of the Institute with respect to re-
search 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 subpara-
graph (c)(1) among all appropriate institutes and compo-
nents 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 co-
ordination with institute directors as described in sub-
section (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 pro-
grams. Such plan shall include the comments of the Direc-
tor and shall include, but not be limited to, the following
information for the five year period beginning upon enact-
ment of such section:
‘‘(1) Description of plan and objectives with re-
spect 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 mecha-
nisms available to facilitate microbicide research, in-
cluding grant and contract mechanisms, RFA’s,
SBIR/STTRs, support for preclinical product devel-
opment 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, op-
portunities 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 pre-
pare, 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 re-
spect to microbicide research prepared under sub-
section (d);
‘‘(2) an assessment of the development, revi-
sion, and implementation of such plan;
‘‘(3) a description and evaluation of the
progress made, during the period for which such re-
port 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 con-
ducted 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 trans-
mitted diseases and microbicides carried out at the Cen-
ters 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 
RE-
SEARCH 
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 sec-
tion 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 co-
ordinate the activities of such Centers with respect to re-
search on microbicides to prevent the transmission of sex-
ually 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.’’.
Æ