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# Adverse Event Reporting Info Collection Revised
- URL: https://www.fdaweb.com/adverse-event-reporting-info-collection-revised/
- Published: 2024-09-20T12:00:00.000Z
- Updated: 2026-09-14T14:41:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157826

*Federal Register* notice: FDA is seeking comments on an information collection revision entitled “Postmarketing Adverse Experience Reporting.” The collection was revised in response to the Covid-19 public health emergencyto provide recommendations for recordkeeping applicable to any pandemic, not just influenza, including recommendations for planning, notification, and documentation for continuity of operations for firms that report postmarketing adverse events during any pandemic. It is also revised to include the two guidances regarding submission of adverse event reports (“Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic” and “Providing Submissions in Electronic Format--Postmarketing Safety Reports”). To view the notice, click [here](https://public-inspection.federalregister.gov/2024-21675.pdf?ref=fdaweb.com).