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GUIDANCE DOCUMENT

User Fee Waivers, Reductions, and Refunds for Drug and Biological Products September 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0108
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides recommendations to applicants regarding requests for waivers, refunds, and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (the Act) for drugs, including biological drug products. This guidance is a revision of the draft guidance entitled Draft Interim Guidance Document for Waivers of and Reductions in User Fees (1993 interim guidance), issued July 16, 1993.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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 written comments should be identified with this document's docket number: FDA-2011-D-0108.

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