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GUIDANCE DOCUMENT

Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 June 2023

Download the Final Guidance Document
Final Level 2 Guidance
Docket Number:
FDA-2012-D-0880
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides information to stakeholders regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2022 (GDUFA III) under Title III of the FDA User Fee Reauthorization Act of 2022. Because GDUFA III created changes to the user fee structure, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.

 

This guidance describes the types of user fees authorized by GDUFA III, and the processes for submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the process for requesting a reconsideration of a user fee assessment previously developed under earlier GDUFA authorizations.  This guidance also describes how FDA determines affiliation for purposes of assessing generic drug user fees.  FDA will issue separate guidance documents regarding GDUFA III non-user fee requirements and processes.  This guidance does not address how FDA determines and adjusts fees for each fiscal year, nor does it address FDA’s implementation of other user fee programs (e.g., under the Prescription Drug User Fee Act (PDUFA) or Biosimilar User Fee Act (BsUFA)).  Throughout this guidance, references to user fees or the user fee program indicate generic drug user fees assessed and collected under section 744B of the Federal Food, Drug, and Cosmetic Act (the 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))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0880.

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