National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

65 -- SOFT GELATIN CAPSULES SOL RFQ80171-NS DUE 073098 POC Patricia Haun (301) 402-4509 The National Cancer Institute (NCI), Pharmaceutical Management Branch (PMB), Division of Cancer Treatment and Diagnosis (DCTD) proposes to procure from Banner Gelatin Product Corporation, 4125 Premier Drive, High Point, NC 27261-2210 the manufacture of 400,000- 250 mg soft gelatin capsules of perillyl alcohol. Background: The Pharmaceutical Management Branch is responsible for the authorization and distribution of all Investigational New Drug (IND) agents for NCI sponsored cancer therapeutic trials. In addition, the PMB provides drug forecasting, drug acquisition, and inventory management of all IND agents distributed by the NCI for clinical trials. The capsules are needed for the ongoing and planned clinical trials to treat patients with cancer. The patients on these trials have failed other standard treatments and are enrolled in DCTD-sponsored clinical studies designed to determine the efficacy of perillyl alcohol to stabilize or cure their cancers. Since the DCTD studies are ongoing and have previously utilized Banner manufactured capsules, the integrity of clinical data (due to varying absorption rates between products) may be affected if the capsules are not produced and purchased from Banner Gelatin Product Corporation. Requirement: The Contractor shall: 1) manufacture the soft gelatin capsules within a containment facility designed to handle cytotoxic anticancer drugs; 2) produce 400,000- 250mg gelatincapsules in a single production batch ; 3) produce the capsules under FDA Good Manufacturing Practices (cGMP) within a GMP facility; 4) meet all state and federal regulatory requirements;and 5) ship F.O.B. Destination the manufactured capsules to the NCI designated packaging and labeling contractor within 90 days of the contract to the following address: Pharmaceutical Service, College of Pharmacy, The University of Iowa, G20 Pharmacy Building, Iowa City, Iowa 52242. This notice is a combined synopsis/solicitation and NCI does not intend to issue a separate solicitation. This solicitation, RFQ80171-NS, is not set-aside for small business; however, the Standard Industrial Classification Code is 2834. Since changing the manufacturer in the middle of ongoing clinical trials may result in different absorption or toxicity characteristics of the perillyl alcohol, the integrity of the study data could be affected. Therefore, Banner Gelatin Products Corporation is the only source known to NCI that can meet these requirements. However, if any interested party believes it can meet the above specifications, it may submit offers. Offers must be submitted on an SF-18 with a completed "Schedule of Offered Supplies/Services" and Representations and Certifications. Information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Offers must be received in the contracting office by 3:00 p.m. EST, on July 30, 1998. Full text copies of the Representations and Certifications, the SF-18, and the Terms and Conditions applicable to the anticipated Purchase Order may be obtained from Patricia Haun on (301)-402- 4509. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Posted 07/16/98 (W-SN224437). (0197)

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