National Heart, Lung, and Blood Institute, BDR Contracts Section, Contracts Operations Branch, Federal Building, Room 610, National Institutes of Health, Bethesda, MD 20892

A -- REFINEMENT OF NEW ASSAYS FOR DIRECT DETECTION OF VIRAL NUCLEIC ACIDS IN DONATED BLOOD, ORGANS, AND TISSUES SOL NHLBI-HB-95-03 POC Lynda A. Bindseil, Contracting Officer, (301) 496-3513. The National Heart, Lung, and Blood Institute intends to negotiate with the State University of New York Health Research Center at Syracuse for a five-year follow-on contract. Phase I of the contract requires refinement and testing of newly developed gene-based tests for screening biologicals (including the capability of detecting HIV during the seronegative window), in blood for transfusion and organs for transplantation. The contract requires the refinement and pre-clinical testing to be completed within twenty-four months, including the exemption for an Investigational New Drug from the FDA. Phase II requires the appropriate clinical trials to validate the new tests in support of a product license application for each. The applicable statutory authority is 41 USC 253(c)(1) as set forth in FAR 6.302-1(b)(1). The incumbent has the unique capability to provide the required services to the NHLBI without substantial duplication of cost and unacceptable delays. See Note 22. (0067)

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