Director, USAMRAA, 820 Chandler St, Fort Detrick, MD 21702-5014

A -- TICK-BORNE ENCEPHALITIS (TBE) SOL CBD-TBE-0599 DUE 060499 POC Craig D. Lebo, 301-619-2036 Request for information/Interest: The U.S. Army Medical Research and Materiel Command (USAMRMC) requires a U.S. Food and Drug Administration (FDA) approved (i.e., U.S. licensed) vaccine for protection of personnel against naturally acquired tick-borne encephalitis (TBE). The vaccine must protect against both Central European and Far Eastern TBE strains of virus. The USAMRMC is seeking manufacturers whose vaccines are currently licensed and marketed in two or more countries. This is not a request for proposals. The intent of this announcement is for the USAMRMC to enter into Cooperative Research and Development Agreements (CRDAs)-not contracts- with interested, qualified manufacturers of TBE vaccine with the goal of obtaining FDA licensure for the vaccine. The companies must be willing to assemble appropriate read-ahead packages for the FDA and subsequently present two briefings to the FDA. Personnel from USAMRMC will assist/confer in the preparation of read-ahead packages and presentations. The two presentations will summarize in moderate detail: a) information relating to the safety and efficacy of the vaccine, including any post-marketing experience; and b) information relating to the manufacturing process and the manufacturing facilities. After the FDA indicates whether additional information and/or clinical trials will be needed for U.S. licensure, a decision will be made as to the feasibility and cost effectiveness of any additional required clinical trials by USAMRMC. Interested companies should submit their name to the Craig D. Lebo, Contract Specialist via fax (301-619-2937), e-mail (craig.lebo@amedd.army.mil) or letter NLT 4 Jun 99. Tentative Schedule: Questions and pertinent comments must be submitted to the Contract specialist by 18 Jun 99. CRDA must be signed by both parties by 12 Jul 99. Read ahead packages must be received at the FDA by 17 Sep 99. Presentations at the FDA will occur in Oct 99. Posted 05/26/99 (W-SN335978). (0146)

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