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# Info Collection Extension on Adverse Event Guide
- URL: https://www.fdaweb.com/info-collection-extension-on-adverse-event-guide/
- Published: 2018-08-15T12:00:00.000Z
- Updated: 2026-09-15T00:26:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142113

*Federal Register* notice: FDA is seeking comments on an information collection extension entitled “Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application” (OMB Control Number 0910–0636). Comments sought are related to estimates of annual submissions. The guidance discusses what should be included in a serious adverse drug event report. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-08-15/pdf/2018-17526.pdf?ref=fdaweb.com).