FDA to Bio-Makers: Tell Us About Your Oopsy-Daisies in Production
Published Date: 2/25/2026
Notice
Summary
The FDA wants to hear from companies that make biological products and human tissues about how they report mistakes during manufacturing. They’re asking for feedback on updating the forms and rules to keep things clear and safe. If you’re involved in making these products, you’ve got until April 27, 2026, to share your thoughts—no extra costs, just a chance to help improve the process!
Analyzed Economic Effects
4 provisions identified: 2 benefits, 1 costs, 1 mixed.
Mandatory 45‑Day Deviation Reporting
If you manufacture biological products, blood products, or regulated human cells and tissues, you must report product deviations using Form FDA 3486 as soon as possible but no later than 45 calendar days after learning of a reportable event. FDA estimates an average 2 hours to complete each deviation report; there are 17,818 total annual responses and a total estimated 43,246.25 annual burden hours (an increase of 13,602.95 hours and 2,383 responses based on FY2024 data).
Addendum and Partial Electronic Filing Rules
CBER offers an electronic report option and a web‑based addendum (Form FDA 3486A) for reports that may lead to a recall; FDA estimates 5% of CBER reports (about 825 annual addendum responses) and 15 minutes to complete each addendum. CDER currently does not accept electronic filings, so submissions to CDER must be made by non‑electronic methods.
Public Comment Opportunity by April 27, 2026
FDA is asking companies and stakeholders involved in biological product and HCT/P manufacturing to submit comments on the proposed information collection by April 27, 2026, via regulations.gov or by mail. The notice explains how to submit confidential information and that comments filed electronically will be posted publicly.
No Capital or O&M Costs Claimed
FDA states there are no capital costs or operating and maintenance (O&M) costs associated with this information collection for respondents. The burden estimate covers only reporting time, not equipment or other capital expenses.
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Key Dates
Department and Agencies
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