SOURCES SOUGHT
B -- Prescription Drug User Fee Act (PDUFA III) Evaluations and Initiativess
- Notice Date
- 8/20/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 223-04-8100
- Response Due
- 9/5/2003
- Archive Date
- 9/20/2003
- Point of Contact
- John Speer, Contract Specialist, Phone (301) 827-7162, Fax (301) 827-7103, - Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
- E-Mail Address
-
jspeer@oc.fda.gov, hbrown@oc.fda.gov
- Description
- This announcement constitutes a Sources Sought Synopsis. Responses to this publication are solicited to identify qualified sources. Qualified sources are limited to 8(a) and small businesses to include veteran and women owned and hub-zone businesses. Those parties that have the interest and ability to provide FDA?s Office of Policy & Planning (OPPL) with the services detailed below should submit capability statements no later than 5 September 2003. This is not a request for a formal proposal. 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 collections 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 investingating systems that assist in the development and evaluation procedures of Good Review Management Principles (GRMPS). Submit Offers to the FDA/OAGS/Division of Contracts & Grants Management, Attn.: John D. Speer, HFA-530, 5630 Fishers Lane, Room 2129, Rockville, Maryland 20857-0001.
- Record
- SN00407256-W 20030822/030820213500 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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