Release Date:  September 4, 1998



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

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

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 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

No collect calls will be accepted.

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