Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 1</CFR> <DEPDOC>[Docket No. FDA-2024-N-1111]</DEPDOC> <RIN>RIN 0910-AI64</RIN> <SUBJECT>Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration, with the Department of the Treasury's concurrence, proposes amending its regulations to require that the Submission Tracking Number for Electronic Nicotine Delivery System tobacco products that are being imported or offered for import be submitted in the Automated Commercial Environment or any other electronic data interchange system authorized by U.S. Customs and Border Protection, at the time of entry. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the proposed rule must be submitted by October 15, 2024. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by October 15, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 15, 2024. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2024-N-1111 for “Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Products.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents, the plain language summary of the proposed rule of not more than 100 words as required by the “Providing Accountability Through Transparency Act,” or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. Submit comments on information collection under the Paperwork Reduction Act of 1995 to the Office of Management and Budget (OMB) at <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E> Find this particular information collection by selecting “Currently Under Review—Open for Public Comments” or by using the search function. The title of this proposed collection is “Importer's Entry Notice—OMB Control Number 0910-0046—Revision.” <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">With regard to the proposed rule:</E> Ann M. Metayer, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4375, Silver Spring, MD 20993-0002, 301-796-3324. <E T="03">With regard to the information collection:</E> JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents </HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Proposed Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Proposed Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Table of Abbreviations/Commonly Used Acronyms in This Document</FP> <FP SOURCE="FP-2">III. Background</FP> <FP SOURCE="FP1-2">A. Introduction/History of This Rulemaking</FP> <FP SOURCE="FP1-2">B. Need for the Regulation</FP> <FP SOURCE="FP1-2">C. FDA's Current Regulatory Framework</FP> <FP SOURCE="FP-2">IV. Legal Authority</FP> <FP SOURCE="FP-2">V. Description of the Proposed Rule</FP> <FP SOURCE="FP-2">VI. Proposed Effective Date</FP> <FP SOURCE="FP-2">VII. Preliminary Economic Analysis of Impacts</FP> <FP SOURCE="FP-2">VIII. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">IX. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">X. Federalism</FP> <FP SOURCE="FP-2">XI. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-2">XII. Reference</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Proposed Rule</HD> The proposed rule would require that the Submission Tracking Number (STN) for tobacco products, as defined in 21 CFR 1114.3, be submitted for any entry containing an 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 (EDI) system authorized by U.S. Customs and Border Protection (CBP). The purpose of the rulemaking is to assist the Food and Drug Administration (FDA, the Agency, or we) in making decisions on admissibility for ENDS products by facilitating FDA's automated review process. The proposed rule, if finalized, would result in a more effective and efficient import admissibility review process by lowering instances of manual review by FDA of entries containing ENDS products, which will protect the public health by conserving Agency resources and more quickly identifying ENDS products that do not have marketing authorization and which may be associated with a greater public health risk. The automated review compares the STN submitted by the ACE filer, as defined in 21 CFR 1.71, to information in FDA's internal databases to determine if a “May Proceed” is appropriate. An automated “May Proceed” does not constitute a determination by FDA about the article's compliance status, and it does not preclude FDA action at a later time. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Proposed Rule</HD> FDA proposes to revise part 1, subpart D of 21 CFR chapter I (21 CFR part 1, subpart D), added by a final rule issued by the Agency on November 29, 2016 (81 FR 85854), which established requirements for the electronic filing of certain data elements for FDA-regulate ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 51k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━