[Federal Register Volume 74, Number 35 (Tuesday, February 24, 2009)]
[Notices]
[Pages 8260-8261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3865]


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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 and HCV

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 and hepatitis C virus (HCV). The Centers for 
Disease Control and Prevention (CDC), National Center for HIV/AIDS, 
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), has an opportunity 
for collaboration to evaluate diagnostic tests for HIV and HCV. These 
evaluations will include evaluation of the sensitivity and specificity 
of the tests, and the predictive value of algorithms using two or more 
different rapid tests in combination.

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    Specific tests are sought to meet one or more of the following 
purposes: (1) Laboratory-based or rapid point-of-care tests designed to 
detect both HIV antigen and antibody; (2) laboratory-based or rapid 
point-of-care tests that can distinguish persons with acute HIV 
infection from persons who have longer-standing HIV infection; (3) 
laboratory-based or rapid point-of-care tests that can be used as 
supplemental confirmatory tests to help diagnose HIV-1 or HIV-2 
infection, (4) rapid laboratory-based or rapid point-of-care tests 
designed to detect HCV antibody, antigen or both. Tests of interest 
include those that can detect HIV-\1/2\ and/or HCV antibody, antigen, 
RNA, or DNA when used on whole blood, serum, plasma, oral fluid or 
dried blood spots. Evaluations will include the sensitivity and 
specificity of the test when used in the intended application (e.g., 
for screening or confirmation).
SUMMARY: The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB 
Prevention (NCHHSTP) 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 are distributing rapid 
diagnostic tests for HIV or HCV and are interested in marketing the 
tests for use in the United States. The Division of HIV/AIDS Prevention 
and the Division of Viral Hepatitis are interested in evaluating such 
tests. The evaluation will include determination of sensitivity and 
specificity of the test, and may 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 screening and/or diagnosis for HIV or HCV in the 
United States, and to examine laboratory-based or rapid point-of-care 
tests. These tests require high sensitivity to detect persons with 
acute and longer-standing HIV infection; or high specificity to 
distinguish persons with acute infection from those with longer-
standing infection; or high specificity for tests that can be used as 
to confirm HIV-1 or HIV-2 infection. Acute HIV infection is defined as 
the early infection period associated with a transient symptomatic 
illness, high viral load, and expansive immunologic response. For HCV 
testing,

[[Page 8261]]

rapid tests to be used in the screening setting require high 
sensitivity and confirmatory tests with high specificity.
    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 30 calendar 
days after date of publication in the Federal Register.

ADDRESSES: Formal proposals should be submitted to Sal Butera, 
Associate Director for Laboratory Science, NCHHSTP, CDC, 1600 Clifton 
Road, NE., Mailstop E-07, Atlanta, GA 30333; Phone 404-639-6379; Fax 
404-639-3125; e-mail; [email protected].
    Scientific questions should be addressed to Bernard M. Branson, 
M.D., Division of HIV/AIDS Prevention, NCHSTP, CDC 1600 Clifton Road, 
NE., Mailstop D-21, Atlanta, GA 30333; Phone 404-639-6166, Fax 404-639-
0897; e-mail [email protected].

SUPPLEMENTARY INFORMATION: 

Technology Sought

    One goal of the National Center for HIV/AIDS, Viral Hepatitis, STD, 
and TB Prevention (NCHHSTP) is to develop new approaches to increase 
the number of persons infected with HIV and/or HCV who know their 
status and have access to effective treatment. These approaches might 
include increasing the use of more sensitive screening assays (such as 
antigen or nucleic acid amplification tests) that can identify persons 
with acute HIV infection; rapid tests that can identify resolved or 
ongoing HCV infection; and more sensitive and specific confirmatory 
assays that can be used at point-of-care to obviate the need for 
clients to return for confirmed test results. NCHHSTP is seeking rapid 
diagnostic tests that are suitable for commercial distribution and that 
are simple: preferably, tests that use direct, unprocessed specimens 
(e.g., whole blood); 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. Of particular interest are tests with high 
sensitivity for early stage HIV infection and tests that can 
distinguish persons with acute or recent HIV infection from persons 
with longer standing infections. NCHHSTP also seeks new methods that 
could serve to expedite confirmatory testing for HIV-1, HIV-2, and HCV 
either at the point-of-care or in the laboratory.

NCHHSTP and Collaborator Responsibilities

    The NCHHSTP role may include, but will not be limited to, the 
following:
    (1) Providing scientific and technical expertise needed for the 
evaluation project;
    (2) Planning and conducting evaluation studies of the diagnostic 
tests and interpreting results; and
    (3) Publishing evaluation results.
    The NCHHSTP anticipates that the role of the successful 
collaborator(s) will include the following:
    (1) Providing NCHHSTP access to data necessary to identify 
candidate tests for further evaluation; and
    (2) Providing tests that can be used in the evaluation.

Selection Criteria

    Proposals submitted for consideration will be evaluated according 
to selection criteria, and should address, as best as possible and to 
the extent relevant to the proposal, each of the following:
    (1) Information on the technology used for the test, including 
basic operating principals such as antigen or antibody components used 
for detection;
    (2) Data available on the performance characteristics of the tests 
in different populations;
    (3) Information on the time required to perform the test, whether 
the test is performed on oral fluid, whole blood, serum, plasma, or 
dried blood spots, 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;
    (6) Ability to provide to CDC approximately 8,000 tests and all 
related equipment to enable laboratory validation at CDC;
    (7) Documentation of production capacity to provide at least 
500,000 tests annually.

    Dated: February 13, 2009.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-3865 Filed 2-23-09; 8:45 am]
BILLING CODE 4163-18-M