[Federal Register Volume 66, Number 164 (Thursday, August 23, 2001)]
[Notices]
[Pages 44354-44355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21271]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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

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 syphilis. The Centers for Disease Control and 
Prevention (CDC), National Center for HIV, STD, and TB Prevention 
(NCHSTP), Division of STD Prevention, has an opportunity for 
collaboration to evaluate rapid diagnostic tests for syphilis. These 
evaluations will include evaluation of the sensitivity in primary, 
secondary and latent syphilis, and of the specificity of the test.

-----------------------------------------------------------------------

SUMMARY: The Division of STD 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 who have developed or are distributing a 
rapid diagnostic test for syphilis and are interested in marketing the 
test for use in the United States. The Division of STD Prevention is 
interested in evaluating such tests. The evaluation will include 
determination of the sensitivity in primary, secondary and latent 
syphilis and of the specificity of the test. 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

[[Page 44355]]

to be used to determine whether the test could be used in the diagnosis 
of syphilis and/or screening for syphilis 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 September 24, 
2001.

ADDRESSES: Formal proposals should be submitted to Candice Nowicki-
Lehnherr, Division of STD Prevention, NCHSTP, CDC, 1600 Clifton Road, 
Mailstop E-05 Atlanta, GA 30333; Phone 404-639-8264; Fax 404-639-8608; 
e-mail: [email protected]. Scientific questions should be addressed to 
Madeline Sutton, MD, Division of STD Prevention, NCHSTP, CDC, 1600 
Clifton Road, Mailstop E-05, Atlanta, GA 30333; Phone: 404-639-8368; 
Fax: 404-639-8610; e-mail [email protected].

SUPPLEMENTARY INFORMATION

Technology Sought

    One mission of the Division of STD Prevention/NCHSTP is to develop 
and evaluate biomedical interventions to reduce syphilis. To this end, 
the Surveillance and Epidemiology Branch is seeking rapid diagnostic 
tests for syphilis that are suitable for commercial distribution and 
that are simple, tests that can be performed in 30 minutes or less by 
persons with minimal training.

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 
stages of syphilis and in the absence of syphilis;
    (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; and
    (4) Interest by the company to seek FDA approval and market the 
test in the United States.

    Dated: August 17, 2001.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention.
[FR Doc. 01-21271 Filed 8-22-01; 8:45 am]
BILLING CODE 4163-18-P