{"abstract":"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.","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2021/10/05/2021-21009.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"16","title":21},{"chapter":null,"citation_url":null,"part":"1107","title":21}],"citation":"86 FR 55224","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective November 4, 2021.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-3818"],"dockets":[],"document_number":"2021-21009","effective_on":"2021-11-04","end_page":55300,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/10/05/2021-21009.xml","html_url":"https://www.federalregister.gov/documents/2021/10/05/2021-21009/content-and-format-of-substantial-equivalence-reports-food-and-drug-administration-actions-on","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-21009?publication_date=2021-10-05","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-10-05/2021-21009/mods.xml","not_received_for_publication":null,"page_length":77,"page_views":{"count":13778,"last_updated":"2026-08-26 20:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-10-05/pdf/2021-21009.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-21009.pdf?1633351524","publication_date":"2021-10-05","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/10/05/2021-21009.txt","regulation_id_number_info":{"0910-AH89":{"issue":"202104","html_url":"https://www.federalregister.gov/regulations/0910-AH89/format-and-content-of-reports-intended-to-demonstrate-substantial-equivalence","title":"Format and Content of Reports Intended to Demonstrate Substantial Equivalence","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202104&RIN=0910-AH89&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH89"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 79 Nitrate Concentration Changes During Senescence and Air Curing of Burley Tobacco 1982 re: Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports","document_id":"FDA-2016-N-3818-0195"},{"title":"FRIA Ref 3 FDA Report to House Committee on Appropriations 2018 re: Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports","document_id":"FDA-2016-N-3818-0188"},{"title":"Reference 27. ISO 3308-2012. Routine analytical cigarette-smoking machine - Definitions and standard conditions re: Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports","document_id":"FDA-2016-N-3818-0180"},{"title":"Reference 15 Cigarette Yields and Human Exposure-A Comparison...Testing Regimens 2006 re: Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports","document_id":"FDA-2016-N-3818-0178"},{"title":"TAB C 2013-288 SE PRIA as Cleared by OMB re Memorandum to FDA DMS on SE NPRM","document_id":"FDA-2016-N-3818-0091"},{"title":"TAB B 2013-288 SE PRIA Track Changes re Memorandum to FDA DMS on SE NPRM","document_id":"FDA-2016-N-3818-0089"},{"title":"TAB A 2013-288 SE PRIA as Submitted to OMB re Memorandum to FDA DMS on SE NPRM","document_id":"FDA-2016-N-3818-0087"},{"title":"02 Reference 1 Application, function, and effects of menthol in cigarettes a survey of tobacco industry documents, Wayne, 2004","document_id":"FDA-2016-N-3818-0058"},{"title":"04 Reference 3 DRAFT FDA-3965","document_id":"FDA-2016-N-3818-0056"},{"title":"56 PRIA Ref 1 Memo_SEApril5","document_id":"FDA-2016-N-3818-0054"}],"comments_count":0,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-3818","supporting_documents_count":86,"docket_id":"FDA-2016-N-3818","document_id":"FDA-2016-N-3818-0176","regulation_id_number":null,"title":"Content and Format of Substantial Equivalence Applications; Food and Drug Administration Actions on Substantial Equivalence Reports","checked_regulationsdotgov_at":"2021-10-06T03:30:11Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":55224,"subtype":null,"title":"Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports","toc_doc":"Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports","toc_subject":null,"topics":["Administrative practice and procedure","Smoking","Tobacco"],"type":"Rule","volume":86}