of all appropriate institutes and components of the Na-
tional Institutes of Health with respect to research and 
development of microbicides to prevent the transmission 
of the human immunodeficiency virus (‘HIV’) and other 
sexually transmitted diseases. 
‘‘(c) MICROBICIDE DEVELOPMENT UNIT.—In car-
rying out subsection (b), the Director of the National In-
stitute of Allergy and Infectious Diseases shall establish 
within the Division of AIDS in the Institute, a clearly de-
fined organizational unit charged with carrying out 
microbicide research and development. In establishing 
such unit, the Director shall ensure that there are a suffi-
cient number of employees dedicated to carrying out the 
mission of the unit. 
‘‘(d) MICROBICIDE CLINICAL TRIALS.—In carrying 
out subsection (c), the Director of the National Institute 
of Allergy and Infectious Diseases shall assign priority to 
ensuring adequate funding and support for the integration 
of basic science and clinical research, with particular em-
phasis on implementation of trials leading to product li-
censure. 
‘‘(e) REPORTS TO CONGRESS.— 
‘‘(1) IN GENERAL.—Not later than 6 months 
after the date of enactment of the Microbicide De-
velopment Act, and annually thereafter, the Director 
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of the Office of AIDS Research shall submit to the 
appropriate committees of Congress a report that 
describes the strategies being implemented by the 
Federal Government regarding microbicide research 
and development. 
‘‘(2) CONTENTS
OF
REPORTS.—Each report 
submitted under paragraph (1) shall include— 
‘‘(A) a description of activities with respect 
to microbicide research and development con-
ducted and supported by the Federal Govern-
ment; 
‘‘(B) a summary and analysis of the ex-
penditures made by the Director of the Office 
of AIDS Research during the preceding year 
for activities with respect to microbicide-specific 
research and development, including basic re-
search, preclinical product development, clinical 
trials, and process development and production; 
‘‘(C) a description and evaluation of the 
progress made, during the preceding year, to-
ward the development of effective and accept-
able microbicides; and 
‘‘(D) a review of scientific and pro-
grammatic obstacles to expediting the commer-
cial availability of microbicide products. 
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‘‘(3) APPROPRIATE COMMITTEES OF CONGRESS 
DEFINED.—In this subsection, the term ‘appropriate 
committees of Congress’ means the Committee on 
Health, Education, Labor, and Pensions and the 
Committee on Appropriations of the Senate and the 
Committee on Energy and Commerce and the Com-
mittee on Appropriations of the House of Represent-
atives. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary for each fiscal year to carry out this section.’’. 
TITLE 
II—MICROBICIDE 
RE-
SEARCH 
AT 
THE 
CENTERS 
FOR DISEASE CONTROL AND 
PREVENTION 
SEC. 201. MICROBICIDES FOR PREVENTING TRANSMISSION 
OF HIV AND OTHER 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 317S the following: 
‘‘SEC. 371T. MICROBICIDES FOR PREVENTING TRANS-
MISSION OF HIV AND OTHER DISEASES. 
‘‘(a) DEVELOPMENT AND IMPLEMENTATION OF THE 
MICROBICIDE AGENDA SUPPORTED
BY
THE CENTERS 
FOR DISEASE CONTROL AND PREVENTION.—The Direc-
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tor of the Centers for Disease Control and Prevention 
shall fully implement such Centers’ topical microbicide 
agenda to support microbicide research and development. 
Such an agenda shall include— 
‘‘(1) conducting laboratory research in prepara-
tion for, and support of, clinical microbicide trials; 
‘‘(2) conducting behavioral research in prepara-
tion for, and support of, clinical microbicide trials; 
‘‘(3) developing and characterizing domestic 
populations and international cohorts appropriate 
for Phases I, II, and III clinical trials of candidate 
topical microbicides; 
‘‘(4) conducting Phases I and II clinical trials 
to assess the safety and acceptability of candidate 
microbicides; 
‘‘(5) conducting Phase III clinical trials to as-
sess the efficacy of candidate microbicides; 
‘‘(6) providing technical assistance to, and con-
sulting with, a wide variety of domestic and inter-
national entities involved in developing and evalu-
ating topical microbicides, including health agencies, 
extramural researchers, industry, health advocates, 
and nonprofit organizations; and 
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