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FDA Assessing User Fees Under the Generic Drug User Fee Amendments of 2017

蒋千琴 10/26/2021 浏览 148 FDA 美国

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Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 [附网盘链接]是于之前发布的FDA标准，适用于美国。

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Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 [附网盘链接]
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 [附网盘链接](截图)

 

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标准部分原文

Draft – Not for Implementation 1 Assessing User Fees Under the Generic Drug User Fee 2 Amendments of 2017 1

3 Guidance for Industry 4 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic.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 9 and is not binding on FDA or the public. You can use an alternative approach if it satisfies the 10 requirements of the applicable statutes and regulations. To discuss an alternative approach, 11 contact the FDA office responsible for this guidance as listed on the title page. 12 13 14 15 16 I. INTRODUCTION 17 18 This guidance provides stakeholders information regarding FDA’s implementation of the 19 Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA 2

20 Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this 21 guidance serves to provide an explanation about the new fee structure and types of fees for 22 which entities are responsible. 23 24 This guidance describes the types of user fees authorized by GDUFA II, the process for 25 submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the 26 process for requesting a reconsideration of a user fee assessment. This guidance also describes 27 how FDA determines affiliation for purposes of assessing generic drug user fees. FDA will 28 issue separate guidance documents regarding GDUFA II non-user fee requirements and 29 processes. This guidance does not address how FDA determines and adjusts fees each fiscal 30 year, nor does it address FDA’s implementation of other user fee programs (e.g., Prescription 3

31 Drug User Fee Amendments, Biosimilar Biological User Fee Amendments). Throughout this 32 guidance, references to user fees or the user-fee program indicate generic drug user fees 33 collected under section 744B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This 34 guidance revises and replaces FDA’s draft guidance for industry Assessing User Fees Under the 35 Generic Drug User Fee Amendments of 2017, published in October 2017. 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 Reauthorization Act of 2017 (Public Law 115-52). 3

FDA will publish in the Federal Register the fee revenue and fee amounts for each fiscal year not more than 60 days before the start of each fiscal year (section 744B(d)(1) of the FD&C Act (21 U.S.C 379j-42)). On August 29, 2017, FDA published FY 2018 rates for GDUFA fees (82 FR 41026 (Aug. 29, 2017)). On July 27, 2018, FDA published FY 2019 rates for GDUFA fees (83 FR 35649 (July 27, 2018). 1

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