Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final rule also establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. The final rule will provide applicants with more certainty and clarity related to preparing and submitting SE Reports.
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 16 and 1107 [Docket No. FDA-2016-N-3818] RIN 0910-AH89 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final rule also establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. The final rule will provide applicants with more certainty and clarity related to preparing and submitting SE Reports. DATES: This rule is effective November 4, 2021. ADDRESSES: For access to the docket to read background documents or comments received, go to https://www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-5700. FOR FURTHER INFORMATION CONTACT: Daniel Gittleson or Nathan Mease, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, AskCTP@fda.hhs.gov . SUPPLEM…
Other Federal Register documents from the same docket.
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Extension of Comment Period
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
Citation: 86 FR 55224
