[Federal Register Volume 66, Number 173 (Thursday, September 6, 2001)]
[Notices]
[Pages 46639-46640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22431]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Opportunity To Collaborate in the Evaluation of Rapid Diagnostic 
Tests for HIV

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

ACTION: Opportunities for collaboration for evaluation of rapid 
diagnostic tests for HIV. The Centers for Disease Control and 
Prevention (CDC), National Center for HIV, STD, and TB Prevention 
(NCHSTP), Division of HIV/AIDS Prevention, has an opportunity for 
collaboration to evaluate rapid diagnostic tests for HIV. These 
evaluations will include evaluation of the sensitivity and specificity 
of the test, and the predictive value of algorithms using two or more 
different rapid tests in combination.

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SUMMARY: The Division of HIV/AIDS Prevention 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 companies that have developed or is 
distributing a rapid diagnostic test for HIV and is interested in 
marketing the test for use in the United States. The Division of HIV/
AIDS Prevention is interested in evaluating such tests. The evaluation 
will include determination of the sensitivity and specificity of the 
test, and also evaluate the predictive value of two or more different 
tests used in combination in populations of low prevalence. This 
collaboration will have an expected duration of two (2) to three (3) 
years. The goals of the collaboration include the timely development of 
data to be used to determine whether the test could be used in the 
diagnosis and/or screening for HIV in the United States.
    Confidential proposals, preferably six pages or less (excluding 
appendices), are solicited from companies who have a product that is 
suitable for commercial distribution.

DATES: Formal proposals must be submitted no later than October 9, 
2001.

ADDRESSES: Formal proposals should be submitted to Cassandra Walker, 
Division of HIV/AIDS Prevention, NCHSTP, CDC, 1600 Clifton Road, 
Mailstop E-46 Atlanta, GA 30333; Phone 404-639-6191; Fax 404-639-8640; 
e-mail:[email protected] . Scientific questions should be addressed to 
Bernard M. Branson, MD,

[[Page 46640]]

Division of HIV/AIDS Prevention, NCHSTP, CDC, 1600 Clifton Road, 
Mailstop E-46, Atlanta, GA 30333; Phone: 404-639-6166; Fax: 404-639-
8640; e-mail [email protected].

SUPPLEMENTARY INFORMATION:

Technology Sought

    One mission of the Division of HIV/AIDS Prevention/NCHSTP is to 
develop new alternatives to increase the number of persons who know 
their HIV infection status. The Prevention Services Research Branch is 
seeking rapid diagnostic tests for HIV that are suitable for commercial 
distribution and that are simple: preferably, tests that: use direct 
unprocessed specimens (e.g., whole blood or oral fluid); can be 
performed in 30 minutes or less by persons with minimal training; 
include all necessary reagents in the test kit; can be stored at 
temperatures between 25 and 39 deg.C; and have a minimum 1-year shelf 
life.
NCHSTP and Collaborator Responsibilities
    The NCHSTP role may include, but will not be limited to, the 
following:
    (1) Providing scientific, and technical expertise needed for the 
research project;
    (2) Planning and conducting research studies of the diagnostic 
tests and interpreting results; and
    (3) Publishing research results.
    The NCHSTP anticipates that the role of the successful 
collaborator(s) will include the following:
    (1) Providing tests that can be used in the evaluation; and
    (2) Providing NCHSTP access to necessary data in support of the 
research activities.

Selection Criteria

    Proposals submitted for consideration should address, as best as 
possible and to the extent relevant to the proposal, each of the 
following:
    (1) Data available on the performance of the tests in different 
populations;
    (2) Information on the technology used for the test;
    (3) Information on the time required to perform the test, whether 
the test is preformed on whole blood, sera, plasma or saliva, and the 
steps involved in performing the test;
    (4) Information on the storage requirements and stability of the 
test;
    (5) Interest by the company to seek FDA approval and market the 
test in the United States; and
    (6) Documentation of production capacity to provide at least 
500,000 tests annually, and the ability to deliver a minimum of 45,000 
tests within 90 days of order.

    Dated: August 29, 2001.
James D. Seligman,
Associate Director for Program Services, Centers for Disease Control 
and Prevention.
[FR Doc. 01-22431 Filed 9-5-01; 8:45 am]
BILLING CODE 4163-18-P