- Docket Number:
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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
This guidance provides information to stakeholders regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2022 (BsUFA III) under Title IV of the FDA User Fee Reauthorization Act of 2022.
This guidance describes the types of user fees authorized by BsUFA III, how FDA determines which products are subject to a fee, and FDA’s policies regarding exceptions and waivers. This guidance also describes the process for submitting payments to FDA and the consequences for failing to pay BsUFA fees, and the process for requesting reconsideration if FDA denies a request for a waiver or return of user fees.
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:
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-2017-D-6209.