FDA Seeks Approval for Emergency Drug Authorization Forms
Published Date: 11/24/2025
Notice
Summary
The FDA is asking for public feedback on their paperwork for emergency use authorizations (EUAs) of medical products, like vaccines or treatments used during health emergencies. This helps keep the process smooth and up-to-date without adding extra costs or delays. Comments are open until December 24, 2025, so anyone involved in medical product development or emergency response should take note!
Analyzed Economic Effects
6 provisions identified: 1 benefits, 5 costs, 0 mixed.
Recordkeeping Burden for EUA Holders
EUA holders must keep records under conditions of authorization; FDA estimates annual recordkeeping of 35,200 hours for EUA holders. The tables in the notice also report an overall recordkeeping total shown as 59,403 hours (including state and local entries), reflecting the paperwork time tied to maintaining required records.
EUA Application Reporting Burden
If you apply for an Emergency Use Authorization (EUA) or a substantive amendment, FDA estimates a total annual reporting burden of 6,435 hours across respondents for those requests. The estimate covers submissions to CBER, CDER, and CDRH and reflects the paperwork time required to request an EUA or amend an existing EUA.
Required Dissemination and Disclosure Burden
EUA holders and authorized stakeholders must disseminate required information (fact sheets, advertising, promotional materials); FDA estimates an annual third‑party disclosure burden of 6,920 hours for these activities. The estimate covers preparing and distributing required fact sheets and related informational materials.
Net Reduction in Paperwork Burden
FDA reports the estimated information collection burden reflects an overall decrease of 7,087 hours and a decrease of 302,456 responses compared to prior estimates. That reduction lowers the total paperwork burden for respondents covered by this collection.
Pre‑EUA Submission Time Burden
If you submit a pre‑EUA package (information for FDA review before an EUA), FDA estimates a total annual burden of 1,292 hours across respondents for pre‑EUA submissions and amendments. This covers preparedness-focused reviews by the Centers (CBER, CDER, CDRH) and reflects the paperwork time for voluntary pre‑submission engagement.
State/Local Public Health Authority Burdens
State and local public health authorities have specified submission and recordkeeping tasks tied to EUAs: the notice lists 2 hours for certain submissions required under conditions of authorization, 2 hours for requests for Emergency Dispensing Orders, 20 hours for expiration date extension requests to CDER, and 3 hours for recordkeeping in one table entry. These items reflect time public health authorities may need to spend on EUA-related actions.
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