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GUIDANCE DOCUMENT

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry Guidance for Industry May 2018

Final

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2017-D-5913
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides stakeholders information regarding FDA’s implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) under Title I of the FDA Reauthorization Act of 2017. Because PDUFA VI created changes to the user fee program, this guidance explains the new fee structure created by the statute, and the types of fees for which entities are responsible.

This guidance describes the types of user fees authorized by PDUFA VI, the process for submitting payments to FDA, the consequences for failing to pay application fees or prescription drug program fees, and the process for requesting a reconsideration of a user fee assessment. The guidance also describes how FDA determines which products are subject to a fee and discusses certain changes to FDA’s policies under the new law. FDA has separate guidance documents about PDUFA VI waivers, refunds, and reductions. This guidance does not address how FDA determines and adjusts fees each fiscal year (FY); nor does it address FDA’s implementation of other user fee programs (e.g., Biosimilar User Fee Amendments, Generic Drug User Fee Amendments).2 Throughout this guidance, references to user fees or the user-fee program are to prescription drug user fees collected under section 736 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).


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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-2017-D-5913 .