# 2026-18946: FDA Wants Comments on Reporting Vaccine Goofs in Factories

2026-18946, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-09-16, effective Submit written comments (including recommendations) on the collection of information by October 16, 2026.; PRIA reads it as touching household money (as of 2026-09-23).

- Canonical: https://policyrisk.com/federal-register/2026-18946
- As of: 2026-09-23
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-18946
- Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 58682
- Published: 2026-09-16
- Effective: Submit written comments (including recommendations) on the collection of information by October 16, 2026.
- Comments close: 2026-10-16
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-09-23

## In one line

FDA Wants Comments on Reporting Vaccine Goofs in Factories

## Summary

The FDA is asking for public feedback on a plan to keep track of problems during the making of biological products like vaccines and human tissues. This helps make sure these products stay safe and effective for everyone. If you’re involved in making or selling these products, you’ll want to know about the new reporting rules and get your comments in by October 16, 2026.

## Abstract

The Food and Drug Administration (FDA, Agency, or we) 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

- 45-Day Deviation Reporting Requirement: cost, medium. If you manufacture biological products, human blood and blood components, operate a registered blood establishment, or run a transfusion service, you must report biological product deviations using Form FDA 3486. The rule requires reports to be submitted to CBER or CDER “as soon as possible” but no…
- Electronic Filing and Addendum Details: mixed, low. CBER accepts electronic submissions of Form FDA 3486 and has a web-based addendum (Form FDA 3486A) to collect extra recall-related details; CDER does not currently accept electronic filings. CBER estimates 5 percent of BPD reports to CBER need the addendum, and the addendum takes about 15 minutes (…
- Estimated Annual Reporting Burden Increased: cost, medium. FDA estimates total annual responses of 17,818 and total annual burden of 34,191 hours for Form FDA 3486/3486A reporting. FDA states this reflects an overall increase of approximately 2,642 responses and 4,612 hours compared to prior estimates, largely from Sec. 606.171 reports (16,277 responses; 3…

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## Sources
- [2026-18946 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/16/2026-18946/agency-information-collection-activities-submission-for-office-of-management-and-budget-review)
- [2026-18946 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-16/pdf/2026-18946.pdf)

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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-18946 (as of 2026-09-23).