MANUFACTURE OF ORAL AND TOPICAL DOSAGE FORMS RELEASE DATE: May 4, 2004 NOTICE: NOT-CA-04-016 National Cancer Institute (NCI) (http://www.nci.nih.gov/) The Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) conducts formulation of cancer therapeutic agents under the Developmental Therapeutics Program (DTP). Among the services that DTP provides are formulation and production of clinical dosage forms (i.e. tablets, enteric-coated tablets, capsules, soft gelatin capsules oral powders, oral solutions, gel, cream and ointment) of the agents selected by the DTP program. The clinical dosage forms are used in the NCI-sponsored and/or investigator-initiated clinical trials in humans. DCTD is soliciting proposals to provide the NCI with oral and topical dosage forms to be used in the NCI-sponsored clinical trials. The Contractor will be responsible for formulation studies, process optimization, manufacture of the clinical dosage forms, release testing, quality control, and quality assurance. Preformulation data may be provided to the Contractor by the NCI, but the Contractor may be requested to conduct preformulation studies. Data obtained from this contract(s) may be used to support Investigational New Drug Applications (IND) submitted to the US Food and Drug Administration (FDA). Batch sizes will range from small batches (e.g., several 100 units of tablets or capsules), to large size batches (e.g., 20-50,000 tablets or capsules) for phase I/II studies, to larger batches required for Phase II clinical trials (e.g., several thousand capsules or tablets). Data obtained from the contractors will be used to prepare IND applications to submit to the FDA. The Principal Investigator should have at least three years of experience in the development and manufacture of oral and topical dosage forms. Other personnel should possess suitable training and experience to insure satisfactory performance of the contract. The facilities and equipment must be adequate to formulate, to manufacture, and to provide quality controls of oral and topical dosage forms. The facilities should also have air- handling systems suitable for handling highly cytotoxic agents. The Government anticipates that a single, cost-reimbursement, incrementally funded contract will be awarded on or before November 30, 2004, for a base period of five (5) years. The NAICS code No.325412 has a size standard of 750 employees. The solicitation is scheduled for electronic release on or about April 23. 2004. An Offeror must meet the mandatory qualification criteria that requires that it be FDA-approved manufacturer of oral and topical dosage forms, that it have facilities to handle cytotoxic agents, and that it have manufacturing facilities that are in compliance with current good manufacturing practices (cGMP) set forth by the FDA. The incumbent is the University of Iowa (NCI Contract No. NO1-CM-07100). The RFP may be accessed via the Internet at http://rcb.nci.nih.gov/ . INQUIRIES For further information, contact: Kathleen E. Giuliano Contract Specialist National Cancer Institute Treatment, Biology and Science Section, RCB 6120 Executive Blvd., EPS Room 6052, MSC 7193 Bethesda, MD 20892-7193 Rockville, MD 20852 (express/courier service) Telephone: 301-435-3821 Fax: 301-402-6699 E-mail: giuliank@mail.nih.gov
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