# 2025-20771: FDA Seeks Approval for Emergency Drug Authorization Forms 2025-20771, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-24, effective Submit written comments by December 24, 2025. (as of 2026-06-08). - Canonical: https://policyrisk.com/federal-register/2025-20771 - As of: 2026-06-08 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2025-20771 - Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products - Type: Notice - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 90 FR 52962 - Published: 2025-11-24 - Effective: Submit written comments by December 24, 2025. - Comments close: 2025-12-24 - Significant: no - Touches household money: no - Regulation identifier numbers: none - Last updated: 2026-06-08 ## In one line FDA Seeks Approval for Emergency Drug Authorization Forms ## 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! ## Abstract The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. ## Effects PRIA read - EUA Application Reporting Burden: cost, medium. 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… - Pre‑EUA Submission Time Burden: cost, low. 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 vo… - Recordkeeping Burden for EUA Holders: cost, high. 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 m… - Required Dissemination and Disclosure Burden: cost, medium. 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… - State/Local Public Health Authority Burdens: cost, low. 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 request… - Net Reduction in Paperwork Burden: benefit, medium. 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. ## Related documents - [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11 - [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13 - [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29 - [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25 - [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27 - [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09 ## Sources - [2025-20771 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/24/2025-20771/agency-information-collection-activities-submission-for-office-of-management-and-budget-review) - [2025-20771 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20771.pdf) ## Related - [Previous: 2025-20770, Submission for Office of Management and Budget Review; Trafficking Victim Assis…](https://policyrisk.com/federal-register/2025-20770) - [Next: 2025-20772, Agency Information Collection Activities; Submission for Office of Management a…](https://policyrisk.com/federal-register/2025-20772) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2025-20771 (as of 2026-06-08).