> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Info Collection Extension on Biologic Safety Reporting
- URL: https://www.fdaweb.com/info-collection-extension-on-biologic-safety-reporting/
- Published: 2018-01-08T12:00:00.000Z
- Updated: 2026-09-14T23:11:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140440

*Federal Register* notice: FDA has submitted to OMB an information collection extension for “Adverse Experience Reporting (AER) for Licensed Biological Products; and General Records — 21 CFR Part 600; OMB Control Number 0910-0308.” Evaluation of these safety issues enables FDA to take focused regulatory action. Such action may include, but is not limited to, important changes to the product’s labeling (such as adding a new warning), coordination with manufacturers to ensure adequate corrective action is taken, and removal of a biological product from the market when necessary. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-01-08/pdf/2018-00095.pdf?ref=fdaweb.com).