National Cancer Institute, Research Contracts Branch, ESS, Executive Plaza South, Rm. 620, 6120 Executive Blvd., MSC 7224, Bethesda, MD 20892-7224

A -- DEVELOPMENT AND MANUFACTURE OF ORAL DOSAGE FORMS SOL N01-CM-97016-30 DUE 110298 POC Elsa B. Carlton, Contract Specialist, (301)435-3811 WEB: Acquisition Management Branch Homepage, http://amb.nci.nih.gov/RFP.htm. E-MAIL: Elsa B. Carlton, ec39g@nih.gov. THIS IS RFP N01-CM-97016-30. THIS IS AN ELECTRONIC RFP. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. The Pharmaceutical Resources Branch (PRB), of the Developmental Therapeutics Program (DTP), of the National Cancer Institute (NCI)'s Division of Cancer Treatment and Diagnosis (DCTD) is seeking a contractor to develop and manufacture oral dosage forms of anti-cancer agents in support of NCI sponsored clinical trials for anti-cancer drugs. These dosage forms include tablets, capsules, and solutions to be ingested orally. The Contractor will be responsible for formulation development and optimization of the dosage forms and production of clinical oral product batches for the NCI, as well as provide a complete quality control evaluation of the products. Pre-formulation data may be provided to the Contractor by NCI, however, the Contractor may be requested to conduct limited pre-formulation studies. Sizes of runs will range from very small batches required for toxicology studies, to larger lots required for phase II clinical trials. The Principal Investigator should have at least three years experience in the development and manufacturing of oral dosage forms. Other personnel should possess suitable training and experience to insure satisfactory performance of all phases of work under their purview. The facilities and equipment must be adequate to develop, manufacture, and quality control test oral dosage forms. The offeror should have facilities and procedures for handling highly toxic drugs at the time of Final Proposal Revisions (FPR). The offeror must be an U.S. Food and Drug Administration (FDA) approved manufacturer of oral dosage forms at the time of contract award. It is anticipated that a single cost-reimbursement, completion award will be made, for a five year period of performance, with incremental funding each year. Offerors will be invited to submit proposals for approximately 2,800 direct labor hours per year. The direct labor hours areprovided for estimating purposes only. This is a recompetition of contract NO1-CM-47014 currently being performed by The University of Iowa. The solicitation is scheduled for electronic release on or about September 16, 1998. The RFP may be accessed through the Acquisition Management Branch Home Page by using the following Internet address: http://amb.nci.nih.gov/RFP.htm It is the offerors responsibility to monitor the above Internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. No collect calls will be accepted. Posted 08/14/98 (W-SN237199). (0226)

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