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  1. FDA User Fee Programs

Generic Drug User Fee Amendments

On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2022. Congress first enacted GDUFA in 2012, following negotiations between the FDA and industry and with input from public stakeholders. Congress enacted GDUFA to ensure patients have access to safe, high-quality, and affordable generic drugs. GDUFA enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications.

This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information. More information about GDUFA II is available on the Generic Drug User Fee Amendments Implementation Activities page.

Latest News:

  • CDER’s Work to Meet User Fee Goals During the Pandemic: This webpage will provide periodic updates on key user fee metrics related to application review and the pre-approval process throughout the COVID-19 pandemic.
  • Starting in fiscal year (FY) 2021, FDA will no longer permit the transferring of GDUFA fee payments from a closed-out fiscal year (FY) cover sheet to a different FY cover sheet.  FDA’s FY begins on October 1 and ends on September 30, with the year being designated by the calendar year in which it ends (e.g., FY 2020 begins on October 1, 2019, and ends on September 30, 2020).  Beginning in FY 2021, payment transfer requests for cover sheets from a closed-out FY will not be processed.  Instead, payments from closed-out FY cover sheets will only be processed as refunds to the original payors.  Form FDA 3913 should be completed and submitted to CDERCollections@fda.hhs.gov for review and the fee paid will be refunded if appropriate.
    This does not affect requests for the transfer of payments within the same FY. For example, a request to transfer a payment from a FY 2020 cover sheet to another FY 2020 cover sheet within the same fee type (perhaps due to an incorrect FEI) will be processed, provided the request is made within 180 calendar days of the original payment date.
  • The GDUFA publicly available Arrears Lists for FY 2021 are available. To review our lists, please click here.
  • The GDUFA user fee rates for Fiscal Year (FY) 2021 was published in the Federal Register.  Please see the table below for the FY 2020 and FY 2021 rates.
  • IMPORTANT NOTICE REGARDING GENERIC DRUG USER FEE STAFF CONTACT INFORMATION: Due to the COVID-19 pandemic, and until further notice, electronic mail is the Generic Drug User Fee staff’s preferred method of receiving communication over postal mail.  If you have questions or documentation for the Generic Drug User Fee staff regarding GDUFA Fee requirements, please send them by electronic mail to CDERCollections@fda.hhs.gov.  Please continue to contact the User Fee Helpdesk at userfees@fda.gov for technical assistance with the User Fee System or GDUFA Cover Sheet and pay.gov.clev@clev.frb.org for questions about Pay.gov. 
  • NEW! Visit Points of Contact for Questions Related to Generic Drugs for information on topics related to the Generic Drugs Program and GDUFA.

GDUFA II User Fee Rates

User Fee Type FY 2020 FY 2021
ANDA $ 176,237 $ 196,868
DMF $ 57,795 $ 69,921
Program Large Size $ 1,661,684 $ 1,542,993
Medium Size $ 664,674 $ 617,197
Small Size $ 166,168 $ 154,299
Facility Domestic API $ 44,400 $ 41,671
Foreign API $ 59,400 $ 56,671
Domestic FDF $ 195,662 $ 184,022
Foreign FDF $ 210,662 $ 199,022
Domestic CMO $ 65,221 $ 61,341
Foreign CMO $ 80,221 $ 76,341
Backlog $ 17,434 $ 17,434

*The one-time backlog fee was set in FY 2013 only. Those who have not paid for the incurred backlog fee may email CDERCollections@fda.hhs.gov for further assistance.

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