DHHS/PHS/FDA/Office of Facilities, Acquisitions, and Services, Division of Contracts and Procurement Management, HFA-512, 5600 Fishers Lane, Park Bldg., Rm 3-32, Rockville, Maryland 20857

A -- TOPICAL TRENTINOIN: SKIN STRIPPING TECHNIQUE FOR BIOEQUIVALENCE ASSESSMENT SOL FDA 243807-95 DUE 092095 POC Contact: Patricia Wright, Contract Specialist, (301) 443-0424, M. Deborah Smith-Castle, Contracting Officer, (301) 443-0424 The Food and Drug Administration will issue a purchase order on a sole-source basis to Department of Dermatology, University of California San Francisco for research to validate the skin stripping technique for use in bioequivalence of topical tretinion drug products in humans. The study should provide information on intra and inter subject variability and dermatokinetics of tretinoin in humans. The elimination from stratum corneum, should provide a dose response study data and information about conductance of a bioequivalence study. No radioactivity should be used in the study and it should be carried out using marketed products. Any other persons desiring consideration are requested to fully identify their interest and capabilities which will be considered. (0256)

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