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# Biologic Reporting Info Collection Extesnsion
- URL: https://www.fdaweb.com/biologic-reporting-info-collection-extesnsion/
- Published: 2019-07-31T12:00:00.000Z
- Updated: 2026-09-15T01:41:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144662

*Federal Register* notice: FDA is seeking comments on an information collection extension for “Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A” (OMB Control Number 0910-0458). FDA requires a manufacturer who holds the biological product license, for other than human blood and blood components, and who had control over a distributed product when the deviation occurred, to report to CBER/CDER after acquiring information reasonably suggesting that a reportable event has occurred. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-07-31/pdf/2019-16243.pdf?ref=fdaweb.com).