Loren Data's SAM Daily™

FBO DAILY ISSUE OF MARCH 27, 2004 FBO #0852
SOLICITATION NOTICE

B -- Prescription User Fee Act (PDUFA III) Implementation of a Quality System

Notice Date

3/25/2004
 

Notice Type

Solicitation Notice
 

NAICS

541614 — Process, Physical Distribution, and Logistics Consulting Services
 

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

223-04-8200
 

Response Due

5/31/2004
 

Archive Date

6/15/2004
 

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

The FDA is seeking qualified sources that have the interest and ability to provide FDA?s Office of Planning (OPL) with the services as follows. This synopsis seeks to identify the interest from prospective contractors to assist in the development and Implementation of a Quality System for the new drug review process for human drugs and biologics. The contractor will be required to develop and implement a customized quality system in a coordinated effort with drug reviewers and review managers to meet the FDA?s high review standards. Prospective contractors will be required to have a working knowledge of the FDA?s process for reviewing New Drug Applications (NDAs), Biologic License Applications (BLAs) and Investigational New Drug Applications (INDs) under PDUFA and experience with PDUFA programs within FDA-regulated industry. Proposals will primarily be evaluated based upon the contractor?s technical expertise to include type of personnel, organizational experience and technical approach. Preliminarily this requirement has been identified under NAICS Code 541614. THIS SYNOPSIS IS FOR INFORMATION AND PLANNING PURPOSES AND IS NOT TO BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP INFORMATION REQUESTS. The FDA anticipates the solicitation will be available on or about 12 April 2004. Interested parties shall have 10 days, to include solicitation 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
 

Place of Performance

Address: Dept. of Health and Human Services, Food & Drug Adminsitration, 5600 Fishers lane, Rockville, Maryland

Zip Code: 20857

Country: USA
 

Record

SN00554002-W 20040327/040325211814 (fbodaily.com)
 

Source

FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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