Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Adverse Event and Product Experience Reporting Program
Published Date: 1/17/2025
Notice
Summary
The FDA wants your thoughts on how it collects reports about problems with medicines and products. This affects anyone who reports issues with FDA-regulated products, like doctors, companies, and consumers. You’ve got until March 18, 2025, to share your comments, and the FDA is making sure this process stays smooth without extra costs or delays.
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Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
New Cosmetic Reporting Requirements
If you are the responsible person or manufacturer for a cosmetic product, FDA’s proposed Form FDA 3500A instructions ask you to include a copy of the product label and other identifying information (such as FEI # if available) when submitting serious adverse event reports. For cosmetics, FDA says the manufacturer/responsible person report number should uniquely identify the report and that the submission will not be considered complete without this information; FDA gives an email contact and a mailing address for cosmetics reports.
Pet Food Early Warning Reporting
FDA’s Safety Reporting Portal includes a Pet Food Early Warning System questionnaire for voluntary reports about pet and livestock food adverse events. The information collected is used to help identify adulteration or outbreaks and to remove affected pet or livestock food from the market quickly.
Dietary Supplement/Food Reports Move Online
FDA proposes removing dietary supplements and food/medical food from the Form FDA 3500 product-type selections and directs reporters to submit adverse experiences for these products through the Safety Reporting Portal (SRP) at https://www.safetyreporting.fda.gov/. This change applies to voluntary consumer reports and to electronic reporting routes for dietary supplement manufacturers.
CBD/Hemp Products Added to Forms
FDA proposes adding 'Cannabinoid Hemp Products (such as products containing CBD)' as an explicit product-type option on Form FDA 3500 (and related forms). This lets consumers and manufacturers identify hemp/CBD products directly when reporting adverse events.
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