B -- Development and Production of Parenteral Dosage Forms

This modification changes the Sources Sought announcement as follows. The primary objective of this project is to develop and produce under cGMP Pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer. Certain agents selected by the NCI, DCTDC, Cancer operating committee will be assigned for development and production as parenteral products. Batch sizes will be small development batches, average 8 batches of up to 1000 vials each per year. The capability to develop and manufacture other pharmaceutical dosage forms (i.e. large volume parenteral, sterile emulsions, sterile micro-dispersions, etc) is desirable but not essential. Data obtained from the contract 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, and nurses and other medical personnel handling these products in a clinical setting. Please submit capability statements by 3:00 PM local time on September 30, 2002 to Diane Stalder at ds88b@nih.gov Limit 20 pages by e-mail.