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Remove Annual FDA FTE Cap
AKA “FDA workforce Efficiency Act”
Which agency/agencies promulgated the regulation? *
Congress — Labor, Health and Human Services, Education, and Related Agencies Appropriations Committees
Department of Health & Human Services (HHS) / Food & Drug Administration (FDA)
• The annual full-time equivalent (FTE) cap on FDA staffing contained in the Labor-HHS Appropriations Act for Fiscal Year 2025 (and similar provisions in prior years).
—OPTIONAL--
Notice of Proposed Rulemaking
Annual FDA Staffing Cap
Each year, Congress caps FDA’s total authorized FTE count in the Appropriations Act, forcing the agency to trade off critical hires (e.g., reviewers, inspectors, epidemiologists) against one another. Removing this cap permits FDA to scale staffing in line with scientific and safety needs, bolstering review speed, inspection coverage, and emerging‐risk responsiveness.
Department of Health & Human Services
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
(888) 463-6332
Since at least FY 2010, the annual Labor-HHS Appropriations Act has included language limiting FDA’s total FTE count (e.g., “Not to exceed 17,500 FTEs”). While intended to control federal headcount, this cap constrains FDA’s ability to expand critical workforce capacities in response to emerging modalities and public-health challenges.
Striking the FTE cap enables FDA to hire needed expertise—such as digital-health reviewers, AI/ML specialists, and laboratory inspectors—without arbitrary headcount ceilings, ensuring the agency can meet its expanding mission in drug, device, and food safety oversight.
— The “Not to exceed ___ FTEs” clause is removed from the fiscal‐year appropriations language.
— FDA’s authorized FTE ceiling defaults to the prior year’s actual staffing level plus any additions approved through PDUFA or other statutory authority, with no separate cap.
Robert F. Kennedy Jr.
Secretary of Health and Human Services