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

• 31 U.S.C. § 1502 – Apportionment of Appropriations (subjecting user-fee accounts to quarterly apportionment). • OMB Circular A-11 (Sections governing apportionment of user-fee accounts).

User-Fee Account Apportionment Constraints

Apportionment rules under 31 U.S.C. § 1502 and OMB Circular A-11 fragment FDA’s user-fee revenues across fiscal quarters, causing artificial pauses in hiring, contracting, and IT upgrades. Exempting user-fee accounts from apportionment restores multi-year obligation authority, ensuring stable funding for vital review and inspection activities.

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

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

Under the Antideficiency Act and Apportionment statutes (31 U.S.C. § 1502) — and as implemented in OMB Circular A-11 — all federal accounts, including user-fee revenues, are apportioned by quarter. FDA must therefore delay obligations when a quarter’s allotment is spent, even if unobligated balances exist.

Removing user-fee accounts from apportionment frees FDA to obligate collections immediately upon receipt, aligning resource deployment with workload rather than arbitrary quarterly ceilings—avoiding unnecessary hiring and contracting delays.

— 31 U.S.C. § 1502 amended to exclude FDA user-fee accounts from quarterly apportionment requirements. — OMB Circular A-11 revised to exempt PDUFA and MDUFA accounts from apportionment, allowing full-year carryforward and obligation. All other apportionment rules continue to apply to appropriated funds.

Robert F. Kennedy Jr.

Secretary of Health and Human Services