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:

• The 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.

• 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.

• Animal Drug User Fee Act (ADUFA) - Focuses on performance goals that strive to expedite the review of new animal drug applications (NADAs), supplemental NADAs, and investigational new animal drug (INAD) submissions.