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).
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.