PDUFA User‐Fee Operating‐Reserve Requirement

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Let the FDA Spend their money

AKA “FDA Efficiency Act”


Which agency/agencies promulgated the regulation? *
Department of Health & Human Services (HHS) / Food & Drug Administration (FDA)
Which title, parts, and/or sections of the Code of Federal Regulations (C.F.R.) should be rescinded? *
• 21 U.S.C. § 379h(c)(4) – the Prescription Drug User Fee Act (PDUFA) operating‐reserve requirement (10–14 week carryover of user‐fee balances).
What is your name?
—OPTIONAL--
Is your proposed rescission a notice of proposed rulemaking, final rule, direct final rule, interim final rule, or interpretive rule? *
Notice of Proposed Rulemaking
What is the name of the regulation being rescinded, if applicable? *
PDUFA User‐Fee Operating‐Reserve Requirement
Please provide a short summary of the justifications for the rescission. *
The mandatory 10–14 week operating reserve in 21 U.S.C. § 379h(c)(4) forces FDA to hold user-fee revenues in reserve, triggering end-of-year hiring freezes and resource shortfalls. Rescinding this requirement would allow carryforward of unobligated fee revenues, supporting continuous staffing, training, and critical infrastructure investments.
Please insert the address of the agency. [NPRM, DFR, and IFR only]
Department of Health & Human Services Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Please insert the contact information for the agency. *
492-4305 (410) 786-1524 (410) 786-8437
What is the background for the regulation being rescinded? *
When PDUFA was first authorized in 1992 (and reauthorized subsequently), Congress required FDA to maintain a 10–14 week operating reserve of user fees (21 U.S.C. § 379h(c)(4)). While intended to ensure liquidity, this floor leads to periodic freezes in hiring and contracting, reducing review capacity at precisely the moments when industry workloads surge.
Explain the reasons for the rescission. *
Striking § 379h(c)(4) removes the artificial floor on carryforward, allowing FDA to obligate fee revenues as needed across fiscal years—smoothing staffing levels, avoiding seasonal slowdowns, and ensuring reviewers, inspectors, and policy staff are onboard year-round.
Describe the text of the relevant C.F.R. provisions as it will exist after the rescission. *
— 21 U.S.C. § 379h(c)(4) deleted; no statutory operating-reserve requirement. FDA may carry forward and obligate user fees according to operational needs without a mandated balance floor. All other PDUFA provisions remain in effect.
Please insert the name of the current agency head. *
Robert F. Kennedy Jr.
Please insert the title of the agency head. *
Secretary of Health and Human Services

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