Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, the Agency, us, or we) is issuing a final rule that sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.
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 Parts 1100, 1107 and 1114 [Docket No. FDA-2019-N-2854] RIN 0910-AH44 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, us, or we) is issuing a final rule that sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization. DATES: This rule is effective November 4, 2021. FOR FURTHER INFORMATION CONTACT: Paul Hart, Office of Regulations, Center for Tobacco Products (CTP), Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993, 877-287-1373, AskCTP@fda.hhs.gov . SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary A. Purpose of the Reg…
Other Federal Register documents from the same docket.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements
Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period
Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period
Premarket Tobacco Product Applications and Recordkeeping Requirements
Citation: 86 FR 55300
