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GUIDANCE DOCUMENT

Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act June 1999

Download the Final Guidance Document
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document is intended to provide guidance to industry on the procedures adopted by the Food and Drug Administration (FDA) to determine eligibility for waivers or refunds of user fees collected under the Prescription Drug User Fee Act (PDUFA), as amended, on the basis that fees paid exceed the costs the FDA incurred in reviewing submissions (21 U.S.C. 379h(d)(1)(C)). This guidance provides substantially the same information as that provided in FDA’s Supplement to Attachment G, Draft Interim Guidance Document for Waivers of and Reductions in User Fees (February 1, 1995), but it has been updated to reflect statutory changes effected by the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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