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HHS/FDA RIN: 0910-AI64 Publication ID: Fall 2023 
Title: Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products 

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.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 1, subpart D     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 371    21 U.S.C. 381    21 U.S.C. 387j   
Legal Deadline:  None
Action Date FR Cite
NPRM  01/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Ann Marie Metayer
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 32, Room 4375,
Silver Spring, MD 20993
Phone:301 796-3324