Annual FDA Staffing Cap

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)
Which title, parts, and/or sections of the Code of Federal Regulations (C.F.R.) should be rescinded? *
• 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).
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What is the name of the regulation being rescinded, if applicable? *
Annual FDA Staffing Cap
Please provide a short summary of the justifications for the rescission. *
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.
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. *
(888) 463-6332
What is the background for the regulation being rescinded? *
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.
Explain the reasons for the rescission. *
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.
Describe the text of the relevant C.F.R. provisions as it will exist after the rescission. *
— 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.
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