This announcement constitutes a Sources Sought Synopsis. Responses to this publication are solicited to identify qualified sources. Qualified sources are limited to 8(a), Hubzone and small businesses to include veteran and women owned businesses. Those parties that have an interest and ability to provide FDA’s Office of Policy (OPL) with the services detailed below should SUBMIT CAPABILITY STATEMENTS ONLY. Supporting data, previous similar services performed or resumes, may be submitted that clearly illustrate/exhibit the contractors ability to perform the specified requirement no later than 20 February 2004. This IS NOT a request for proposals. 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 shall 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 process for reviewing New Drug Applications (NDAs), Biologic License Applications (BLAs) and Investigational New Drug Applications (INDs). 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. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP INFORMATION REQUESTS. RESPONDENTS WILL NOT BE NOTIFIED OF THE RESULTS OF THE EVALUATION. ALL INFORMATION SUBMITTED IN RESPONSE TO THIS ANNOUNCEMENT MUST ARRIVE ON OR BEFORE THE CLOSING DATE. THE CLOSING DATE FOR RESPONSES IS 20 FEBRUARY 2004. Submit CAPABILITY STATEMENTS 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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