{"abstract":"In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations Implementing NEPA (CEQ regulations), the Food and Drug Administration (FDA or the Agency) is issuing a final rule to revise its NEPA implementing regulations to provide categorical exclusions for certain actions related to substantial equivalence (SE) reports, SE exemption requests, and tobacco product applications, and the rescission (order withdrawing an order) or suspension of orders regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is also amending its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act.","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/2015/09/24/2015-24219.html","cfr_references":[{"chapter":null,"citation_url":null,"part":25,"title":21}],"citation":"80 FR 57531","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective October 26, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-N-1282"],"dockets":[],"document_number":"2015-24219","effective_on":"2015-10-26","end_page":57536,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/09/24/2015-24219.xml","html_url":"https://www.federalregister.gov/documents/2015/09/24/2015-24219/national-environmental-policy-act-environmental-assessments-for-tobacco-products-categorical","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-24219?publication_date=2015-09-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-09-24/2015-24219/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":3721,"last_updated":"2026-10-24 22:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-09-24/pdf/2015-24219.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-24219.pdf?1443012347","publication_date":"2015-09-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/09/24/2015-24219.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-N-1282","supporting_documents_count":null,"docket_id":"FDA-2013-N-1282","regulation_id_number":null,"title":"National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions","checked_regulationsdotgov_at":"2015-10-14T06:00:36Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":57531,"subtype":null,"title":"National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions","toc_doc":"National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions","toc_subject":null,"topics":["Environmental impact statements","Foreign relations","Reporting and recordkeeping requirements"],"type":"Rule","volume":80}