[Federal Register: June 28, 2001 (Volume 66, Number 125)]
[Notices]
[Page 34453-34454]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn01-58]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Opportunity To Collaborate in the Evaluation of Topical
Microbicides To Reduce Heterosexual Transmission of Human
Immunodeficiency Virus (HIV)
AGENCY: Centers for Disease Control and Prevention, Department of
Health and Human Services.
ACTION: Opportunities for collaboration for evaluation of topical
microbicides.
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The Centers for Disease Control and Prevention (CDC), National
Center for HIV, STD, and TB Prevention (NCHSTP), Division of HIV/AIDS
Prevention-Surveillance and Epidemiology (DHAP-SE), Epidemiology Branch
(EpiBr), has an opportunity for collaboration to evaluate the safety
and preliminary efficacy of topical microbicides designed for vaginal
application to reduce HIV transmission. These evaluations will include
in-vitro assays, macaque studies, and phase I/phase II trials in
heterosexual women and men.
SUMMARY: The Division of HIV/AIDS Prevention-Surveillance and
Epidemiology (DHAP-SE) of the National Center of HIV, STD, and TB
Prevention (NCHSTP) at the Centers for Disease Control and Prevention
(CDC) of the Department of Health and Human Services (DHHS) seeks one
or more pharmaceutical, biotechnological, or other companies who hold a
proprietary position on microbicides that are ready for phase I/phase
II trials. The selected company and CDC will execute an ``Agreement''
to evaluate the company's microbicides for safety and preliminary
efficacy of topical microbicides designed for vaginal application to
reduce HIV transmission.
These evaluations will include in-vitro assays, macaque studies,
and phase I/phase II trials in heterosexual women and men. Each
collaboration would have an expected duration of two (2) to five (5)
years. The goals of the collaboration include the timely development of
data to further the identification and commercialization of effective
topical microbicides and the rapid publication of research findings to
increase the number of HIV prevention technologies proven effective and
available for use.
Confidential proposals, preferably 10 pages or less (excluding
appendices), are solicited from companies with patented or licensed
agents which have undergone sufficient preclinical testing to be either
(1) currently under an IND application approved by the Food and Drug
Administration (FDA) or (2) prepared to submit an IND application to
the FDA by December 31, 2001.
DATES: Formal proposals must be submitted no later than July 30, 2001.
ADDRESSES: Formal proposals should be submitted to Jeff Efird, MPA,
Epidemiology Branch, Division of HIV/AIDS Prevention--Surveillance and
Epidemiology, NCHSTP, CDC, 1600 Clifton Road, Mailstop E-45, Atlanta,
GA 30333; Phone: (direct) 404-639-6136, (office) 404-639-6130; Fax:
404-639-6127; e-mail: JLE1@cdc.gov. Scientific questions should be
addressed to Dawn K. Smith, MD., Epidemiology Branch, Division of HIV/
AIDS Prevention--Surveillance and Epidemiology, NCHSTP, CDC, 1600
Clifton Road, Mailstop E-45, Atlanta, GA 30333; Phone: (direct) 404-
639-6165, (office) 404-639-6146; Fax: 404-639-6127; e-mail:
Dsmith1@cdc.gov. Inquiries directed to ``Agreement'' documents related
to participation in this opportunity should be addressed to Thomas E.
O'Toole, MPH, Deputy Director, Technology Transfer Office, CDC, 1600
Clifton Road, Mailstop E-67, Atlanta, GA 30333; Phone: (direct) 404-
639-6270, (office) 404-639-6270; Fax: 404-639-6266; e-mail:
TEO1@cdc.gov.
SUPPLEMENTARY INFORMATION:
Technology Available
One mission of the Epidemiology Branch of DHAP-SE/NCHSTP is to
develop and evaluate biomedical interventions to reduce HIV
transmission. To this end, the EpiBr is establishing contracts to
conduct phase I and phase II trials of topical microbicides. EpiBr also
funds research in the Division of AIDS, STD, and TB Laboratory Research
(DASTLR) of the National Center for Infectious Diseases (NCID) at CDC
and with external laboratories to conduct macaque studies and in-vitro
studies in support of human microbicide trials. The goal of these
efforts is to provide scientific and technical expertise and key
resources for the evaluation of topical microbicides through late
preclinical, phase I, phase II, and proof-of-concept clinical trials.
Technology Sought
EpiBr now seeks potential collaborators having licensed or patented
agents for use as vaginal microbicides which:
(1) Have laboratory or animal model evidence of anti-HIV activity;
(2) Have been formulated for vaginal application;
(3) Are not entering phase III clinical trial in the next 12
months;
(4) Have an IND and are currently in phase I clinical trial or have
not yet submitted an IND application but have sufficient preclinical
data to do so by December 31, 2001; and
(5) Have manufacturing arrangements for production of clinical
trial-grade product (an applicator if necessary) under Good
Manufacturing Process (c-GMP) standards.
NCHSTP and Collaborator Responsibilities
The NCHSTP anticipates that its role may include, but not be
limited to, the following:
(1) Providing intellectual, scientific, and technical expertise and
experience to the research project;
(2) Planning and conducting preclinical (in-vitro and in-vivo)
research studies of the agent and interpreting results;
(3) Publishing research results;
(4) Depending on the results of these preclinical investigations,
NCHSTP may elect to conduct additional research with macaques to
evaluate safety and/or efficacy proof-of-concept; and
(5) Depending on the results of preclinical and/or macaque studies
and FDA approval, NCHSTP may elect to conduct phase I/II clinical
trials of the agent.
The NCHSTP anticipates that the role of the successful
collaborator(s) will include the following:
(1) Providing intellectual, scientific, and technical expertise and
experience to the research project;
(2) Participating in the planning of research studies,
interpretation of
[[Page 34454]]
research results and, as appropriate, joint publication of conclusions;
(3) Providing NCHSTP access to necessary proprietary technology
and/or data in support of the research activities; and
(4) Providing NCHSTP clinical grade (c-GMP) agent for use in
preclinical and clinical studies covered in this collaboration.
Other contributions may be necessary for particular proposals.
Selection Criteria
In addition to evidence of the ability to fulfill the roles
described above, proposals submitted for consideration should address,
as best as possible and to the extent relevant to the proposal, each of
the following:
(1) Data on the in-vitro anti-HIV activity of the agent;
(2) Animal and other data on the safety of the agent when applied
to mucosal surfaces;
(3) Data on the effects of the agent on vaginal commensal microbial
organisms; and
(4) Data on the in-vitro activity of the agent against other
sexually transmitted organisms.
Dated: June 22, 2001.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease
Control and Prevention.
[FR Doc. 01-16244 Filed 6-27-01; 8:45 am]
BILLING CODE 4163-18-P