[Federal Register Volume 66, Number 125 (Thursday, June 28, 2001)]
[Notices]
[Pages 34452-34453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16243]


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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 Transmission of Human Immunodeficiency Virus 
(HIV) Among Men Who Have Sex With Men (MSM)

AGENCY: Centers for Disease Control and Prevention, 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 
(EpiB), has an opportunity for collaboration to evaluate the safety and 
preliminary efficacy of topical microbicides for rectal application to 
reduce HIV transmission. These evaluations will include in-vitro 
assays, macaque studies, and phase I/phase II trials in MSM.

SUMMARY: The Division of HIV/AIDS Prevention-Surveillance and 
Epidemiology (DHAP-SE) of the National Center for 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 developed for vaginal use that are 
ready for phase III trials. The selected company and CDC would execute 
an ``Agreement'' to evaluate the company's microbicides for safety and 
acceptability of topical microbicides designed for vaginal application 
to reduce HIV transmission when applied to the rectal mucosa. These 
evaluations will include in-vitro assays, macaque studies, and phase I/
phase II trials in MSM. 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 by MSM 
as well has heterosexual men and women.
    Confidential proposals, preferably 10 pages or less (excluding 
appendices), are solicited from companies with patented or licensed 
agents which have undergone sufficient clinical testing to be: (1) 
Currently under an IND approved by the Food and Drug Administration 
(FDA); (2) have completed at least one phase I and one phase II trial 
for vaginal application of the microbicide as of December 31, 2001; and 
(3) be planning to begin a phase III trial for vaginal use which is 
anticipated to begin enrollment prior to December 31, 2002.

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: [email protected]. 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: 
[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 E-67, Atlanta, GA 30333; Phone: (direct) 404-
639-6270, (office) 404-639-6270; Fax: 404-639-6266; e-mail: 
[email protected].

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 and:
    (1) Will have at least one phase I and one phase II trial for 
vaginal use completed by December 31, 2001;
    (2) Will have a phase III trial for vaginal use planned to begin 
enrollment prior to December 31, 2002;
    (3) Have manufacturing arrangements for production of clinical 
trial-grade product (and applicator if necessary) under Good 
Manufacturing Process (c-GMP) standards; and
    (4) Are willing to provide a formulation and dosage appropriate for 
rectal application.

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.

[[Page 34453]]

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, human, and in-vitro data on the safety of the agent 
when applied to mucosal surfaces;
    (3) Data on the effects of the agent on rectal mucosa (if 
available); 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. 01-16243 Filed 6-27-01; 8:45 am]
BILLING CODE 4163-18-P