National Cancer Institute, Research Contracts Branch, Executive Plaza South, Room 603, Bethesda, MD 20892

P -- SYNTHESIS OF BULK CHEMICALS & DRUGS FOR PRECLINICAL & CLINICAL STUDIES'' SOL NCI-CM-57238-30 DUE 071795 POC ELSA B CARLTON, CONTRACT SPECIALIST, (301) 496-8620 OR THERESE M DICK, CONTRACTING OFFICER, (301) 496-8620. The Pharmaceutical Resources Branch (PRB), Developmental Therapeutics Program (DTP), Division of Cancer Treatment, (DCT) National Cancer Institute (NCI) at the National Institutes of Health (NIH) anticipates making award (s) of cost-reimbursement, incrementally funded contracts, for a base period of three (3) years, with two (2), one year option years, beginning on or about April 1, 1996. The objective of this project is for the preparation of chemicals and bulk drugs needed by the program for preclinical and clinical studies. This contract will provide and operate a materials preparation laboratory for the synthesis of varying amounts of materials, not readily available from other sources in the quantity and/or quality needed by the NCI. The scale of the work to be performed under this soliciation requires a functional large-scale facility with at least one (20-100 gallons) glass-lined reactor, and several glass reaction vessels (50 and 100 Litres), with the necessary supporting equipment and laboratories. The project may be proposed on two (2) levels. Level I offerors shall provide 2.75 to 3 technical staff years, per year, with completion and deliveries of the targets of 8 to 12 assignments, excluding reports. Level II offerors shall provide 5.5 to 6 technical staff years, per year, with completion and deliveries of the targets of 15 to 25 assignments, excluding reports. The proposed Principal Investigator should be trained in organic or medicinal chemistry, preferably at the Ph.D. level, from an accredited University or possess equivalent experience, and have extensive experience in the conception and execution of chemical syntheses, scaleups and synthetic process development. The offeror shall be registered with the Food and Drug Administration (FDA) as a manufacturer of bulk drugs. Facilities shall met FDA standards in accordance with the Current Good Manufacturing Practicies (GMP), as well as be in compliance with all OSHA, DOT and EPA regulations, and those of similar state and local agencies. Non-compliance with the above requirements shall render the proposal technically unacceptable, without the consideration of award. The Standard Industrial Classification (SIC) Code is 8731. Offerors who qualify only as a small business are encouraged to submit proposals. The facilities of foreign offerors shall conform to all the standards of their equivalent national, state and local regulatory agencies. This is a recompetition of a group of contracts performing synthesis of bulk chemicals and drugs for preclinical and clinical studies. The Request for Proposal (RFP) will be available on or about May 25, 1995. Copies of the RFP may be obtained by written request to Elsa B. Carlton, Contract Specialist, Treatment Contracts Section, Research Cntracts Branch, National Cancer Institute, Executive Plaza South, Room 603, 6120 EXECUTIVE BLVD MSC 7220, BETHESDA MD 20892-7220. No collect calls will be accepted. (0100)

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