# Federal Register #2026-18946

FDA requests public comment on information collection for reporting biological product and HCT/P manufacturing deviations

**Buyer:** Food and Drug Administration
**Posted:** September 16, 2026
**Respond By:** October 16, 2026
**Identifier:** 2026-18946

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is requesting public comment on its proposed information collection for reporting deviations in the manufacturing of biological products and human cells, tissues, and cellular and tissue-based products (HCT/Ps).
- Government Buyer:
  - Food and Drug Administration (FDA)
  - Department of Health and Human Services
- Scope of Request:
  - Notice pertains to regulatory reporting requirements, not procurement
  - Applies to licensed manufacturers of biological products, unlicensed registered blood establishments, transfusion services, and establishments manufacturing non-reproductive HCT/Ps
- Reporting Mechanism:
  - Utilizes FDA Forms 3486 and 3486A for deviation and addendum reporting
- No OEMs or vendors are mentioned
- No products or services are being procured
- Unique Requirement:
  - Solicitation is for public comment on regulatory compliance, not for goods or services

### Description

This notice announces 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. The collection involves reporting of biological product deviations and human cells, tissues, and cellular and tissue-based product deviations in manufacturing. The reporting is required from licensed manufacturers of biological products, blood and blood components, unlicensed registered blood establishments, transfusion services, and establishments manufacturing non-reproductive HCT/Ps. Comments on the information collection are due by October 16, 2026.

[View original listing](https://www.federalregister.gov/documents/2026/09/16/2026-18946/agency-information-collection-activities-submission-for-office-of-management-and-budget-review)