MODIFICATION
B -- Development and Production of Parenteral Dosage Forms for Clinical Studies
- Notice Date
- 11/8/2002
- Notice Type
- Modification
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N02-CM-37005-19
- Response Due
- 12/18/2002
- Archive Date
- 3/7/2003
- Point of Contact
- Diane Stalder, Contract Specialist, Phone (301) 435-3822, Fax (301) 402-6699, - MaryAnne Golling, Contracting Officer, Phone (301) 435-3819, Fax (301) 402-6699,
- E-Mail Address
-
ds88b@nih.gov, mg345x@nih.gov
- Description
- This modification changes the date for receipt of proposals to December 18, 2002. The Pharmaceutical Resources Branch (PRB), Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking to develop and produce pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer. Certain agents selected by the NCI, DCTD, Cancer Operating Committees will be assigned for development and production as parenteral products (primarily sterile freeze dried products). Batch sizes will range from small development batches (less than 500) to intermediate size batches to be used in Phase I and II trials; however, escalation to large batch size for Phase III trials is possible. The capability to develop and manufacture other pharmaceutical dosage forms (i.e., large volume parenteral, sterile emulsions, sterile micro-dispersions, liposomes, etc) is desirable but not essential. Data obtained from the contract(s) will: 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms, and 3) be provided to physicians, pharmacists, nurses, and other medical personnel handling these products in a clinical setting. An offeror must meet the following Mandatory Qualification Criteria at the time of proposal submission, in order for the proposal to be considered any further for award: The Contractor must be registered with the FDA as a pharmaceutical manufacturing facility for sterile products. The Contractor should show proof (FDA form 483) of routine FDA inspection(s) within the last two years. Moreover, the Contractor must be in compliance with FDA requirements during the course of the contract performance. All chemicals and drugs handled during the contact should be regarded as potentially toxic and should be handled accordingly. Offerors will be instructed to describe their safety program and their proposed approach for the handling of toxic agents. Proposals will be evaluated as to the adequacy of their facilities and their proposed method of handling these agents. It is anticipated that two (2) cost reimbursement completion type contracts will be awarded for a period of five (5) years. The proposed contract project represents a recompetition of Ben Venue Laboratories, Inc. Contract No. NO1-CM-77020. All responsible offerors will be considered. The solicitation is scheduled for electronic release approximately October 31, 2002. The proposals will be due approximately 30 days following the actual date of RFP issuance. The RFP may be accessed through the Research Contracts Branch Home Page by using the following internet address: http://rcb.nci.nih.gov It's the offeror's responsibility to monitor the above Internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITATION AND AMENDMENTS. Point of contact: Diane Stalder, Contract Specialist at e-mail: ds88b@nih.gov; FAX: 301-402-6699; Telephone: 301-435-3822. No collect calls will be accepted.
- Record
- SN00202311-W 20021110/021108213305 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |