[Federal Register Volume 68, Number 243 (Thursday, December 18, 2003)]
[Notices]
[Pages 70511-70512]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31186]


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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 Sexual Transmission of Human Immunodeficiency 
Virus (HIV)

AGENCY: Centers for Disease Control and Prevention, Department of 
Health and Human Services (DHHS).

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), announces an opportunity for collaboration to evaluate the 
safety and preliminary efficacy of topical microbicides designed for 
vaginal and/or rectal application to reduce HIV transmission. These 
evaluations will include in-vitro assays, macaque studies, and phase I/
phase II trials in 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, biotechnical, or other companies that hold a 
proprietary position on agents which may be useful as microbicides to 
prevent sexual transmission of HIV infection. The selected company and 
CDC will execute an Agreement under which the company will provide a 
product for CDC to study the product's safety and preliminary efficacy 
as a topical microbicide. Initial studies will include in-vitro assays 
and may include macaque studies. Agents will be selected for phase I 
and phase II trials in women and men based upon data obtained in the 
CDC studies as well as other available published and unpublished safety 
and efficacy data. Each collaboration would have an expected duration 
of one (1) 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 
prepared to submit an Investigational New Drug (IND) application to the 
FDA within six months of submitting the proposal.

DATES: This Notice will be open indefinitely.

ADDRESSES: Formal proposals should be submitted to Carmen Villar, 
Epidemiology Branch, Division of HIV/AIDS Prevention--Surveillance and 
Epidemiology, NCHSTP, CDC, 1600 Clifton Road, Mailstop E-45, Atlanta, 
GA 30333; Phone: (direct) 404-639-5259, (office) 404-639-6130; Fax: 
404-639-6127; e-mail: [email protected]. Scientific questions should be 
addressed to Lisa A. Grohskopf, MD, MPH, Epidemiology Branch, Division 
of HIV/AIDS Prevention--Surveillance and Epidemiology, NCHSTP, CDC, 
1600 Clifton Road, Mailstop E-45, Atlanta, GA 30333; Phone: (direct) 
404-639-6116, (office) 404-639-6146; Fax: 404-639-6127; e-mail: 
[email protected]. 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 K-79, Atlanta, GA 30333; Phone: (direct) 770-
488-8611, (office) 770-488-8607; Fax: 770-488-8615; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Technology Available

    One mission of the Epidemiology Branch (EpiBr) 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

[[Page 70512]]

for the evaluation of topical microbicides through late preclinical, 
phase I and phase II safety and phase II efficacy clinical trials.

Technology Sought

    EpiBr now seeks potential collaborators having licensed or patented 
agents for use as vaginal and/or rectal microbicides which:
    (1) Have laboratory or animal model evidence of anti-HIV activity;
    (2) Have been formulated for vaginal or rectal application;
    (3) Are not entering phase III clinical trial in the next 12 
months;
    (4) Have sufficient preclinical data to submit an IND application 
within approximately six months following submission of proposal; and
    (5) Have manufacturing arrangements for production of clinical 
trial-grade product (and 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 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 and/or rectal 
commensal microbial organisms; and
    (4) Data on the in-vitro activity of the agent against other 
sexually transmitted organisms.

    Dated: December 11, 2003.
Joseph R. Carter,
Deputy Chief Operating Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 03-31186 Filed 12-17-03; 8:45 am]
BILLING CODE 4163-18-P