DIRECTOR, USAMRAA, MCMR-AAA, BLDG 820, FORT DETRICK, FREDERICK MD 21702-5014

A -- SOURCES FOR DESIGN/DEVELOPMENT OF A DIAGNOSTIC KIT FOR BIOLOGICAL WARFARE AGENTS SOL CBD&&&-9605-0001 POC Contract Specialist Kathryn M. Dunn 301-619-7354 (Site Code DAMD17) The U.S. Army is surveying potential organizations that have the capability to design/develop a FDA approved medical diagnostic kit for biological warfare agents as well as design/develop a USDA approved ''veterinary-use'' label for diagnostic kit for biological warfare agents. The project is to be accomplished in two phases- Phase I will consist of (i) manufacture of a diagnostic device, which includes a colloidal gold chromatographic assay; (ii) preparation of the necessary antigens/antibodies and other clinical reagents under cGMPs - specifically anthrax, plague, staphylococcus enterotoxin B (SEB), and ricin; and (iii) assembly of diagnostic kits for human and veterinary use. Phase II will include (iv) design and conduct of animal studies; (v) preparation and filing of an Investigational Device Exemption (IDE), if necessary, for each of the four combinations of kits (anthrax, plague, SEB, and ricin); (vi) conduct of clinical trials on each of the four combinations; (vii) design and production of labeling and packaging for each kit combination, both human use and veterinary use; and (viii) preparation and filing of a 510(k) for each of the four combinations with the FDA. This announcement is not a Request For Proposal. The Government will not award a contract based on information received as a result of this announcement. All responses should be submitted by June 30, 1996. Interested parties should contact Kathryn M. Dunn, 301-619-7354.(0136)

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