NOT-CA-04-016: MANUFACTURE OF ORAL AND TOPICAL DOSAGE FORMS

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®

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: [email protected]
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