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FDA proposes to amend 21 CFR 1.79 to add a requirement that an import filer submit the FDA premarket application number at the time of entry in the Automated Commercial Environment (ACE), operated by U.S. Customs and Border Protection, for an Electronic Nicotine Delivery Systems (ENDS) product. This rule, if finalized, will allow FDA to more effectively and efficiently determine the marketing authorization status of ENDS products offered for import, and thereby enforce the premarket authorization requirements of chapter IX of the Federal Food, Drug, and Cosmetic Act. By reducing the time spent on import entry review, this rule, if finalized, will produce cost savings for FDA. Import filers of ENDS products will face costs to learn the rule and to retrieve pre-market application numbers and enter them into ACE.