FDA Wants Feedback on Vaccine Maker Paperwork—Snore Fest
Published Date: 10/9/2026
Notice
Summary
The FDA is asking for feedback on the paperwork rules for companies that make biological products, like vaccines. This helps keep everything safe and legal under health laws. If you’re a biologics manufacturer, you’ve got until November 9, 2026, to share your thoughts—no extra costs, just a chance to help shape the process!
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Paperwork burden totals and recent increase
FDA estimates the collection generates 17,818 total annual responses and 34,191 total annual burden hours. Reporting under 21 CFR 606.171 alone accounts for 16,277 annual responses and 32,554 hours. FDA states its estimated burden increased by approximately 2,642 responses and 4,612 hours, attributed to increased product-deviation reporting (FY 2024) under Sec. 606.171.
Public comment deadline: November 9, 2026
If you manufacture biologics or otherwise respond to this FDA information collection, you can submit written comments to the Office of Management and Budget by November 9, 2026. Use https://www.reginfo.gov and include OMB control number 0910-0338 and the FDA docket number FDA-2026-N-6667 when you comment.
Required FDA forms and ESG account
Licensed biologics applicants must use specified FDA forms (including Form FDA 356h, 2252, 2253, and 3674) for submissions. Form FDA 356h and Form FDA 3674 may be submitted through FDA’s Electronic Submission Gateway (ESG), for which respondents must create and maintain a user account.
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Key Dates
Department and Agencies
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