Regulatory Counsel

0910-AI64 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products

This final rule would 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.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined No Deregulatory 21 CFR 1, subpart D 21 U.S.C. 371 21 U.S.C. 381 21 U.S.C. 387j No NPRM 08/16/2024 89 FR 66647 NPRM Comment Period End 10/15/2024 Final Rule 10/00/2025 No Businesses Federal No No No No Ann Metayer Marie Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3324 ann.metayer@fda.hhs.gov 10903 New Hampshire Avenue, Building 32, Room 4375, Silver Spring MD 20993