Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Establishment Registration and Listing
Published Date: 1/17/2025
Notice
Summary
The FDA wants to hear from tobacco businesses about updating their registration and product listing info. If you make or sell tobacco products, you need to check out these changes and share your thoughts by March 18, 2025. This helps the FDA keep track of tobacco products and make sure everything’s up to date without adding extra costs or hassle.
Analyzed Economic Effects
5 provisions identified: 1 benefits, 3 costs, 1 mixed.
New combined Form FDA 3741 and 3741b spreadsheet
FDA proposes merging Form FDA 3741a into Form FDA 3741 to create an updated comprehensive Form FDA 3741 and adding a new product listing spreadsheet, Form FDA 3741b. FDA says the updated Form FDA 3741 and Form FDA 3741b will replace Forms FDA 3741 and 3741a upon implementation.
Ingredient listing and premarket notice timing rules
Manufacturers must submit ingredient listings under section 904(a)(1) and follow premarket timing in section 904(c): provide ingredient listings at least 90 days before introducing a product not on the market as of enactment, notify FDA at least 90 days before adding or increasing an additive (unless FDA has designated the additive as not harmful), and notify FDA at least 60 days before eliminating or decreasing an additive or adding/increasing an additive that FDA has designated as not harmful.
Updated FDA burden estimates and respondent counts
FDA updated its estimated annual reporting burden: it estimates 75 new establishment initial registrations, 1,003 renewals, and a total industry burden of 1,617 hours. FDA reports an overall increase of 655 hours and a decrease of 616 responses compared to prior estimates, and estimates obtaining a DUNS number will take 0.5 hour for up to 100 establishments.
Annual registration due December 31
If you own or operate a tobacco product establishment, you must complete an annual registration each year under section 905 of the FD&C Act. The statute requires that registration be completed by December 31 of each year.
Electronic portal encouraged; paper option kept
FDA collects registration and product listing information through the Tobacco Registration and Product Listing Module Next Generation (TRLM NG) electronic portal and strongly encourages electronic submission. Paper forms (Forms FDA 3741, 3741a, and FDA 3742) will remain available for those unable to submit electronically.
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