U.S. Department of Health & Human Services (HHS) / Food & Drug Administration (FDA) Office of Management and Budget (OMB)

• 21 C.F.R. Part 312, Subpart I (Expanded Access/Emergency Use of Unapproved Drugs and Biologics). • 21 U.S.C. § 379h(c)(4) (PDUFA operating-reserve requirement mandating a 10–14 week user-fee carryover).

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Notice of Proposed Rulemaking

“Budgetary Caps & EUA Loopholes Undermining FDA Oversight”

FDA’s capacity to hire, train, and retain critical review staff is hampered by the PDUFA operating-reserve mandate in 21 U.S.C. § 379h(c)(4), which requires a rigid year-end carryover and effectively forces hiring and procurement freezes. Meanwhile, 21 C.F.R. Part 312, Subpart I establishes a separate, expedited “emergency use” pathway that circumvents the agency’s standard safety-and-efficacy review processes. Rescinding these provisions would free FDA to deploy both appropriated and user-fee funds flexibly for full staffing and infrastructure, and ensure that any emergency access authorization meets the same transparent data and review standards as routine approvals.

Department of Health & Human Services Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

(301) 492-4305 (410) 786-1524 (410) 786-8437

Under PDUFA (1992, reauthorized periodically), Congress created user-fee revenue to fund FDA review staff but also imposed, in 21 U.S.C. § 379h(c)(4), a statutory requirement that FDA maintain a 10–14 week operating reserve, which agencies interpret as capping carryover and triggering hiring freezes. Separately, in 2007 FDA codified emergency-use authority—first created by statute at 21 U.S.C. § 360bbb–3—into Part 312, Subpart I, enabling broad access to unapproved medical products without the full data transparency and multi-phase review typical of NDA/BLA pathways.

Removing the PDUFA reserve requirement (§ 379h(c)(4)) allows FDA to carry forward user fees and appropriations into the next fiscal year, smoothing staffing cycles, avoiding end-of-year freezes, and supporting continuous evaluation capacity. Deleting Part 312 Subpart I ensures that any emergency access authorization follows the same minimum evidentiary and procedural safeguards as full IND and BLA reviews, reinforcing public trust and preventing loophole-driven rollouts.

— 21 U.S.C. § 379h(c)(4) would be struck, eliminating the statutory operating-reserve floor so that FDA may obligate user-fee funds in alignment with its scientific and staffing needs. — 21 C.F.R. Part 312, Subpart I would be deleted; emergency or expanded-access uses of unapproved drugs and biologics must proceed under the standard IND/BLA framework, with full safety, efficacy, and transparency requirements. All other FDA review, labeling, and post-market surveillance provisions remain in force.

Robert F. Kennedy Jr.

Secretary of Health and Human Services