DHHS/PHS/FDA/Office of Facilities, Acquisition and Central Services, Contracts Operations Branch, HFA-512, 5600 Fishers Lane, Park Building, Room 3-32, Rockville, MD 20857

A -- USE OF HUMAN FLORA-ASSOCIATED RODENTS TO STUDY THE EFFECT OF LOW DOSES OF ANTIMICROBIALS SOL 223-96-7093 DUE 091895 POC Harriet Lilienfeld, Contract Specialist, (301) 443-4420, M. Deborah Smith-Castle, Contracting Officer, (301) 443-0424 The Center for Veterinary Medicine of the Food and Drug Administration has a requirement for a 3-year study to determine the concentration of selected antimicrobials (ampicillin, neomycin, and tetracycline) that produces no adverse effect in the human flora-associated rodent model. Adverse effects to be evaluated are: 1) changes in metabolic activity of fecal flora relating to metabolism of endogenous and exogenous compounds; 2) development of antimicrobial resistant strains; 3) disruption of colonization resistance to pathogenic microorganisms; and 4) counts of target organisms. The fecal suspension used to inoculate the rodents will originate from healthy volunteer(s) not treated with antibiotics for at least 3 months. (0212)

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