U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Reports, Manuals, & Forms
  4. Reports
  5. Economic Impact Analyses of FDA Regulations
  6. Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products Regulatory Impact Analysis (Proposed Rule)
  1. Economic Impact Analyses of FDA Regulations

Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products Regulatory Impact Analysis (Proposed Rule)

This proposed rule, if finalized, would require an ACE filer to submit the Submission Tracking Number (STN) for tobacco products submitted for any entry containing Electronic Nicotine Delivery System (ENDS) tobacco product(s) at the time of entry in the Automated Commercial Environment (ACE) or any other electronic data interchange system authorized by U.S. Customs and Border Protection. Benefits of the rule would be cost savings for the federal government and industry from reducing FDA’s time spent on obtaining the STN of each ENDS product contained in the entry. We discuss these benefits qualitatively. We quantify costs to ACE filers of import entries containing ENDS products from reading and understanding the rule as well as obtaining and submitting the STN for these ENDS products. We estimate that the present value of costs of the rule over 10 years would range from $0.021 million to $0.061 million at a 2 percent discount rate, with a primary estimate of $0.041 million. The annualized costs would range from $0.002 million to $0.007 million, with a primary estimate of $0.005 million.

Regulatory Impact Analysis

Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products Regulatory Impact Analysis (Proposed Rule) (PDF 350 KB)

Federal Register: 89 FR 66647
Publication Date: 8/16/2024
Docket: FDA-2024-N-1111 

Back to Top