The FDA is seeking qualified sources that have the interest and ability to provide FDA’s Office of Policy & Planning (OPPL) with the services as follows. This synopsis seeks to identify the interest from prospective contractors to assist and conduct evaluations of Prescription Drug User Fee Act of 1992 (PDUFA as amended) initiatives such as First Cycle Review and Continuous Marketing Application programs. The contractor will be required to develop an evaluation study design using both retrospective and prospective analyses, develop data collection plans, analyze program parameters, evaluate effectiveness of training programs and evaluate the system impact of changes. Prospective contractors will be required to have a working knowledge of the process for reviewing New Drug Applications (NDAs), Biologic License Applications (BLAs) and Investigational New Drug Applications (INDs) and investigating systems that assist in the development and evaluation procedures of Good Review Management Principles (GRMPS). The FDA anticipates the solicitation will be available on or about 10 October 2003. Interested parties shall have 10 days, to include release date, to submit any questions. Submit Offers to the FDA/OAGS/Division of Contracts & Grants Management, Attn.: John D. Speer, HFA-531, 5630 Fishers Lane, Room 2129, Rockville, Maryland 20857-0001.

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