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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All written comments should be identified with this document's docket number: 2019-22690 .