{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing a roundtable discussion with small tobacco product manufacturers to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products. The topics to be discussed will include certain components of PMTAs such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk). The purpose of the roundtable is to provide manufacturers an opportunity to share their experience with, and other opinions about, the premarket application process. This notice provides information on meeting participation and selection. FDA is establishing a docket for public comments related to the roundtable meeting.","action":"Notice of roundtable discussion; establishment of a public docket; request for comments.","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/2025/12/29/2025-23851.html","cfr_references":[],"citation":"90 FR 60715","comment_url":null,"comments_close_on":"2025-12-29","correction_of":null,"corrections":[],"dates":"The roundtable meeting will be held on February 10, 2026, 9:00 a.m. to 5 p.m., Eastern Time. Electronic or written comments on the roundtable may be submitted beginning December 29, 2025. See the SUPPLEMENTARY INFORMATION section for registration date and information.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-7022"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":16,"comment_start_date":"2025-12-29","updated_at":"2026-03-13T01:56:10.090-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-7022-0001","allow_late_comments":false,"id":"FDA-2025-N-7022-0001","comment_end_date":"2026-03-13","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-N-7022","title":"Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments"}],"document_number":"2025-23851","effective_on":null,"end_page":60717,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/12/29/2025-23851.xml","html_url":"https://www.federalregister.gov/documents/2025/12/29/2025-23851/roundtable-on-premarket-tobacco-application-submissions-for-electronic-nicotine-delivery-systems","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-23851?publication_date=2025-12-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-12-29/2025-23851/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":682,"last_updated":"2026-06-27 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23851.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-23851.pdf?1766497516","publication_date":"2025-12-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/12/29/2025-23851.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":16,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-N-7022","supporting_documents_count":0,"docket_id":"FDA-2025-N-7022","document_id":"FDA-2025-N-7022-0001","regulation_id_number":null,"title":"Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments","checked_regulationsdotgov_at":"2026-03-14T08:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60715,"subtype":null,"title":"Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments","toc_doc":"Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products","toc_subject":"Hearings, Meetings, Proceedings, etc.","topics":[],"type":"Notice","volume":90}