TREATMENT AND BIOLOGY SECTION Release Date: September 4, 1998 RFP AVAILABLE: NCI-CM-97016-30 P.T. National Cancer Institute The Pharmaceutical Resources Branch (PRB), of the Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), 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 a U.S. Food and Drug Administration (FDA) approved manufacturer of oral dosage forms at the time of contract award. It is anticipated that one cost-reimbursement, completion contract will be awarded for a period of five years. Request for Proposal (RFP) NCI-CM-97016-30 may be accessed electronically through the Acquisition Management Branch Home Page at the following Internet address: http://amb.nci.nih.gov/appl/rfp/rfps_published.jsp Responses to this RFP will be due on November 2, 1998. Any responsible offerors may submit a proposal that will be considered by the Government. This advertisement does not commit the Government to award a contract. INQUIRIES Inquiries may be directed to: Elsa B. Carlton Acquisition Management Branch National Cancer Institute 6120 Executive Boulevard, Suite 603, MSC 7220 Bethesda, MD 20892-7220 Telephone: (301) 435-3811 FAX: (301) 402-6699 Email: ec39g@nih.gov No collect calls will be accepted.
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