U.S. ARMY MEDICAL RESEARCH, ACQUISITION ACTIVITY, ATTN MCMR-AAA-B BLDG 820 FORT DETRICK, FREDERICK MD 21702-5014

A -- NON-CLINICAL TOXICOLOGY FOR DRUGS, VACCINES AND TOXOIDS SOL DAMD17-96-R-0005 DUE 022096 POC Contract Specialist Juanita Bourne (301) 619-7426 Contracting Officer Patricia M. McAllister (301) 619-7360 (Site Code DAMD17) The U.S. Army Medical Research and Materiel Command is seeking organizations for the evaluation of non-clinical toxicology of Drugs Vaccines and Toxoids. Non-clinical toxicological evaluations are required for an ''Investigational New Drug Application'' (IND), a ''New Drug Application'' (NDA), and a ''New Drug Application, Human Use'' (PLA). In general, the toxicological investigations will be conducted in rodents or in other mammals and will include the following types of studies: Mutagenicity, acute, subacute, chronic, 2-year carcinogenicity, teratology (Segment II), and reproductive function (Segment I and III). For the vaccine-and toxoid related work, a BL-2-compliant facility may be required. Special studies, as required, will be conducted to define more completely the toxic potential of the candidate drug, vaccine, or toxoid. Drugs to be evaluated will be chemical and biological warfare antidotes and vaccines, antiparasitic drugs, and drugs effective against potential infections of military personnel. Vaccine-related work will involve vaccines (recombinant, inactivated or attenuated) containing chemical adjuvants and vaccines contained in a novel delivery system. Toxoid-related work will involve chemically treated and inactivated toxins containing chemical adjuvants and chemically treated and inactivated toxins in a novel delivery systems. The Army expects to award a five year contract with work assigned through individual task orders. RFP DAMD17-96-R-0005 to be issued in approximately two weeks from date of the announcement. Proposals will be due 60 days after issue date. This CBD announcement replaces the original announcement issued 15 November 1995. The original announcement included an error in the description of the research. The toxicological investigations, which included a 2-year carcinogenicity study, was incorrectly stated as a 20 year carcinogenicity study. Contractors who have requested copies of the RFP as a result of the 15 November 1995 announcement need not resubmit their requests. Only written requests will b accepted.(0349)

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