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NOT-AI-08-054: RFP ANNOUNCEMENT: Tuberculosis Clinical Diagnostics Research Consortium (CDRC) RFP-NIAID-DMID-NIHAI2008026 RFP ANNOUNCEMENT: Tuberculosis Clinical Diagnostics Research Consortium (CDRC) RFP-NIAID-DMID-NIHAI2008026

Notice Number: NOT-AI-08-054

Key Dates
Release Date:  August 4, 2008

Issued by
National Institutes of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

Description

The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of Microbiology and Infectious Diseases, has a requirement for a Tuberculosis Clinical Diagnostics Research Consortium (CDRC) to assess the performance of novel, early stage TB diagnostics.

This contract shall establish the Tuberculosis Clinical Diagnostics Research Consortium (CDRC), a consortium of clinical study sites in TB-endemic countries to assess the performance of novel, early stage TB diagnostics in the context of existing clinical diagnostic algorithms. Diagnostic devices, technologies and assays eligible for evaluation under this contract must have demonstrated preliminary specificity and sensitivity against the target organism(s) and must be available as at least a quality assured prototype diagnostic device, assay or test. CDRC clinical studies shall be designed to determine how new diagnostics can most effectively contribute to diagnostic fidelity and/or speed in comparison to, or in concert with, currently utilized diagnostics, and to ready diagnostic tests for further development by commercial and/or other non-governmental sponsors. The CDRC shall also serve as a resource to the research community to provide support and advice for the early stage development of TB diagnostics in the clinical setting and contribute to the overall scheme for moving diagnostics into clinical validation.

The goal of the Tuberculosis Clinical Diagnostics Research Consortium (CDRC) is to determine, early in the development process, where investigational diagnostics can be most appropriately positioned to improve speed and accuracy of TB diagnosis and/or the determination of drug resistance. The CDRC will evaluate experimental diagnostics not solely in comparison to stand alone “gold standard” diagnostics tests, but will also enable evaluation of how these diagnostics perform within a clinical algorithm. This is particularly important since the “gold standard” currently used for TB diagnosis (the acid fast stain) is an antiquated test with limited specificity and sensitivity. Through evaluation of new diagnostic tests in combination with a clinical algorithm, it is expected that the CDRC will demonstrate that even diagnostic tests with limited sensitivity and specificity may nevertheless show great utility when evaluated in the context of a diagnostic process.

It is anticipated that advanced preclinical development of diagnostic tests initially evaluated by the CDRC will be carried out by commercial sponsors, non-governmental organizations, and other government agencies, such as the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), other NIH funding sources, and other components of the Department of Health and Human Services (DHHS). Note: The CDRC is not intended to replace or compete with existing programs for clinical evaluation and implementation of new diagnostic tests but rather to assure, early in the development process, that new diagnostics indeed have the potential to contribute in a positive manner to existing diagnostic strategies. This approach is built on the premise of bringing together clinicians in the U.S. and TB-endemic countries with diagnostic developers at the earliest possible stage in the creation of new and improved tests.

Initially, the Contractor shall provide up to two diagnostic tests for assessment by the CDRC; additional diagnostics may be identified by either the Contractor or by the research community. This project will NOT support: the development of new clinical research facilities and laboratories for testing new diagnostics; the development of new diagnostics and new assays; interventional clinical trials; studies to collect data to support a 510(k) application with the FDA; the establishment or maintenance of a publicly accessible specimen repository; or any development and testing of investigational drugs and vaccines for the treatment or prevention of TB.

In summary, the contractor shall be required to: (1) establish and maintain the Tuberculosis Clinical Diagnostics Research Consortium, including clinical study sites and a CDRC data management center; (2) adhere to objectives and requirements for CDRC clinical studies, including study design and evaluation of diagnostic tests; (3) solicit, review, prioritize and recommend additional diagnostic candidates from the community; (4) develop clinical study plans and protocols for diagnostics; (5) provide protocol implementation, management, oversight, reporting and analysis; (6) establish an external scientific advisory group; and (7) develop and maintain the CDRC website.

It is anticipated that one cost-reimbursement, completion type contract will be awarded for a seven-year period of performance beginning on or about June 30, 2009. It is estimated that the provision of FTEs will be approximately as follows: 20.95 FTE per year. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about July 23, 2008, and may be accessed through FedBizOpps http://www.fbo.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or e-mail transmissions will be accepted.

Inquiries

For questions or further information, contact:

Andrew Q. Cherry
Contract Specialist
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-402-2443
Fax 301-402-0972
Email cherryan@niaid.nih.gov

 

Karen M. Gamble
Contracting Officer
Office of Acquisitions, Division of Extramural Activities, NIAID, NIH, DHHS
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612 (Express mail:  Use Zip Code 20817-7612)
Phone 301-402-2334
Fax 301-402-0972
Email gamblek@niaid.nih.gov


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