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GUIDANCE DOCUMENT

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry October 2019

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
2019-22690
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, 17 and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and 18 Cosmetic Act (the FD&C Act) for drugs, including biological products.2 This guidance is a 19 revision of the guidance for industry entitled User Fee Waivers, Reductions, and Refunds for 20 Drug and Biological Products, issued in September 2011.

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Submit Comments Online

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: 2019-22690 .

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