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# Info Collection on FDA Adverse Event Reporting
- URL: https://www.fdaweb.com/info-collection-on-fda-adverse-event-reporting/
- Published: 2019-05-28T12:00:00.000Z
- Updated: 2026-09-15T01:29:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144195

*Federal Register* notice: FDA has submitted to OMB an information collection extension entitled “FDA Adverse Event Reports; Electronic Submissions — 21 CFR 310.305, 314.80, 314.98, 314.540,329.100,514.80, 600.80, 1271.350, and Part 803” (OMB Control Number 0910-0645). FDA requires that product sponsors use its Safety Reporting Portal and Electronic Submission Gateway for submitting and processing adverse event reports, product problem reports, and other safety information for FDA-regulated products. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-11074.pdf?ref=fdaweb.com).