Requirements for Tobacco Product Manufacturing Practice

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 1120 [Docket No. FDA-2013-N-0227] RIN 0910-AH91 ( printed page 15174) AGENCY: Food and Drug Administration, Health and Human Services (HHS). ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is proposing to establish tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth the requirements with which finished and bulk tobacco product manufacturers must comply in the manufacture, preproduction design validation, packing, and storage of finished and bulk tobacco products, to assure that the public health is protected and that tobacco products are in compliance with chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: Either electronic or written comments on the proposed rule must be submitted by September 6, 2023. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by April 10, 2023 (see section “VI. Paperwork Reduction Act of 1995” of this document). See section V of this document for the proposed effective date of a final rule based on this proposed rule. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept commen…