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  1. User Fee Reports

User Fee Performance Reports

The various user fee acts require the HHS Secretary to submit annual performance reports to Congress for each fiscal year during which fees are collected. Annual performance reports document FDA performance in meeting goals agreed to by the HHS Secretary. FDA’s user fee act programs include:

  • Animal Drug User Fee Act (ADUFA) – Focuses on performance goals intended to improve the predictability and timeliness of the review of new animal drug applications (NADAs), supplemental NADAs, and investigational new animal drug (INAD) submissions.
  • Animal Generic Drug User Fee Act (AGDUFA) – Focuses on performance goals intended to improve the predictability and timeliness of the review of abbreviated new animal drug applications (ANADAs), supplemental ANADAs, and generic investigational new animal drug (JINAD) submissions.
  • Biosimilar User Fee Act (BsUFA) - Focuses on performance goals that strive to expedite the process for the review of biosimilar biological product submissions, including applications, supplements, notifications, responses, and meeting management.
  • Generic Drug User Fee Amendments of 2012 (GDUFA) - Focuses on performance goals to improve the predictability and timeliness to the review of human generic drugs.  FDA has also committed to achieve goals related to hiring and establishing parity between the number and rigor of domestic and foreign inspection of human generic drugs manufacturing facilities.
  • Medical Device User Fee and Modernization Act (MDUFMA)/Medical Device User Fee Amendments (MDUFA) - Focuses on performance goals intended to significantly improve the timeliness and predictability of FDA’s review of new medical devices.
  • Over-the-Counter Monograph Drug User Fee Act (OMUFA) – Focuses on performance goals aimed at improving the efficiency, timeliness, and predictability of FDA's regulatory activities with respect to OTC monograph drugs.
  • Prescription Drug User Fee Act (PDUFA) - Focuses on performance goals that apply to the review of original and resubmitted new prescription drug applications and efficacy and manufacturing supplements.  FDA has also committed to achieve certain procedure and processing goals aimed at facilitating and assuring quality in new drug development.



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