FDA Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry(1)

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Draft — Not for Implementation 1   Assessing User Fees Under the Generic Drug User Fee 2   Amendments of 2017 1 3   Guidance for Industry 4   5   6   7   This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8  Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9   binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10  applicable statutes and regulations. To discuss an alternative approach, contact the FDA office 11  responsible for this guidance as listed on the title page. 12  13  14  I. INTRODUCTION 15  16  This guidance provides stakeholders information regarding FDA’s implementation of the 17  Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA 18   Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this 19  guidance serves to provide an explanation about the new fee structure and types of fees for 20  which entities are responsible. 21  22  This guidance describes the types of user fees authorized by GDUFA II, the process for 23  submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the 24  process for requesting a reconsideration of a user fee assessment. This guidance also describes 25   how FDA determines affiliation for purposes of assessing generic drug user fees. FDA will 26  issue separate guidance documents regarding GDUFA II non-user fee requirements and 27  processes. This guidance does not address how FDA determines and adjusts fees each fiscal 28  year; nor does it address FDA’s implementation of other user fee programs (e.g. Prescription 2

29   Drug User Fee Amendments, Biosimilar Biological User Fee Amendments). Throughout this 30  guidance, references to user fees or the user-fee program are to generic drug user fees collected 31   under section 744B of the Federal Food Drug and Cosmetic Act (FD&C Act). 32  33  In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 34  Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 35   as recommendations, unless specific regulatory or statutory requirements are cited. The use of 36  the word should in Agency guidances means that something is suggested or recommended, but 37  not required. 38                                                              

1 This guidance has been prepared by the Division of User Fee Management and Budget Formulation, Office of Management, in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

FDA will publish in the Federal Register the fee revenue and fee amounts for each fiscal year not later than 60 days before the start of each fiscal year. Section 744B(d)(1) of the FD&C Act. 1

 

 

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