SOLICITATION NOTICE
B -- Development and Production of Parenteral Dosage Forms for Clinical Trials
- Notice Date
- 4/30/2008
- Notice Type
- Modification/Amendment
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES
- ZIP Code
- 20852
- Solicitation Number
- N02-CM-77021-39
- Response Due
- 5/13/2008 3:00:00 PM
- Point of Contact
- Theresa H. Shroff,, Phone: (301) 228-4223, MaryAnne - Golling,, Phone: (301) 228-4215
- E-Mail Address
-
ts144t@nih.gov, mg345x@nih.gov
- Description
- ELECTRONIC RFP ANNOUNCEMENT The Pharmaceutical Research Branch (PRB), Developmental Therapeutics Program (DTP) of the Division of Cancer Treatment and Diagnosis (DCTD) of the National Cancer Institute (NCI)is seeking a contractor to provide services for developing and producing 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 batches (less than 100 units) to intermediate size batches to be used in Phase I and II trials; however, escalation to large batch sizes (1 - 10,000 or more units) for advanced Phase II/III trials is also possible. The capability to develop and manufacture other pharmaceutical dosage forms (i.e. large volume parenterals, sterile emulsions, liposomes and sterile micro-dispersions) is desirable but not essential. Data obtained from any contract that may be awarded will: 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration as well as foreign agencies, 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. Offerers must meet the following Mandatory Evaluation Criteria in order to be considered for an 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. This requirement shall be met at the time of proposal submission. Moreover, the Contractor must be in compliance with FDA requirements during the course of the contract performance. All chemicals and drugs handled during the contract should be regarded as potentially toxic and should be handled accordingly. Offerors will be instructed to descibe their safety program and proposed approach to handling toxic agents. Proposals will be evaluated as to the adequacy of the facilites and the proposed methods for handling these agents. It is anticipated that one (1) cost reimbursement, completion-type, options contract will be awarded for a base period of five (5) years plus two (2) option years for a potential period of performance of seven (7) years. The North American Industry Classification System (NAICS) code is 541711. The proposed solicitation represents a recompetition of Ben Venue Laboratories, Inc., contract N02-CM-37005. The solicitation will be released ELECTRONICALLY approximately March 15, 2008. The RFP will only be available electronically and may be accessed through the National Cancer Institute, Office of Acquisitions homepage at: http//rcb.nci.nih.gov/ Once at the Office of Acquisition homepage select Current Requests for Proposals. All information required for the preparation and submission of a proposal will be contained in the electronic RFP package. POTENTIAL OFFERORS ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE RFP AND ANY AMENDMENTS. FURTHER, ALL QUESTIONS REGARDING THE RFP SHALL BE SUBMITTED ELECTRONCIALLY TO CONTRACTING OFFICER THERESA H. SHROFF AT ts144t@nih.gov. This announcement does not commit the Government to award a contract.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=1f53b1f59bd99a60118ba542193cdd36&tab=core&_cview=1)
- Record
- SN01564295-W 20080502/080430222113-1f53b1f59bd99a60118ba542193cdd36 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |