{"abstract":"The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) entitled \"Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products\" that appeared in the Federal Register of July 1, 2015. In the ANPRM, FDA requested comments, data, research results, or other information, that may inform regulatory actions that FDA might take with respect to nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.","action":"Advance notice of proposed rulemaking; extension of comment period.","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/2015/08/24/2015-20759.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1100,"title":21},{"chapter":null,"citation_url":null,"part":1140,"title":21},{"chapter":null,"citation_url":null,"part":1143,"title":21}],"citation":"80 FR 51146","comment_url":null,"comments_close_on":"2015-09-30","correction_of":null,"corrections":[],"dates":"FDA is extending the comment period on the ANPRM published July 1, 2015 (80 FR 37555). Submit either electronic or written comments by September 30, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-1514"],"dockets":[{"supporting_documents":[{"title":"Attachment 5 Survey Responses ID902 - ID1087 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 185)","document_id":"FDA-2015-N-1514-0419"},{"title":"Attachment 4 Survey Responses ID701 - ID901 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 200)","document_id":"FDA-2015-N-1514-0418"},{"title":"Attachment 3 Survey Responses ID404 - ID699 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 295)","document_id":"FDA-2015-N-1514-0417"},{"title":"Attachment 2 Survey Responses ID202 - ID402 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 200)","document_id":"FDA-2015-N-1514-0416"},{"title":"Attachment 1 Survey Responses ID02 - ID201 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 199)","document_id":"FDA-2015-N-1514-0415"},{"title":"A Copy of the Final Regulatory Action as Published in the Federal Register (TAB C) re ANPRM Memo July 22, 2015","document_id":"FDA-2015-N-1514-0005"},{"title":"The Substantive Changes Between the draft Submitted to OIRA for Review and the Regulatory Action Subsequently Published are Shown in Track Changes text (TAB B) re ANPRM Memo July 22, 2015","document_id":"FDA-2015-N-1514-0004"},{"title":"Tab A Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Draft Advance Notice of Proposed Rulemaking","document_id":"FDA-2015-N-1514-0003"}],"agency_name":null,"documents":[{"comment_count":220,"comment_start_date":"2015-08-24","updated_at":"2023-03-01T00:01:17.901-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-1514-0090","allow_late_comments":null,"id":"FDA-2015-N-1514-0090","comment_end_date":"2015-10-01","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":8,"id":"FDA-2015-N-1514","title":"Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products"}],"document_number":"2015-20759","effective_on":null,"end_page":51147,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/08/24/2015-20759.xml","html_url":"https://www.federalregister.gov/documents/2015/08/24/2015-20759/nicotine-exposure-warnings-and-child-resistant-packaging-for-liquid-nicotine-nicotine-containing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-20759?publication_date=2015-08-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-08-24/2015-20759/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2596,"last_updated":"2026-09-21 20:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-08-24/pdf/2015-20759.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-20759.pdf?1440161133","publication_date":"2015-08-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/08/24/2015-20759.txt","regulation_id_number_info":{"0910-AH24":{"issue":"202110","html_url":"https://www.federalregister.gov/regulations/0910-AH24/nicotine-toxicity-warnings-","title":"Nicotine Toxicity Warnings ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202110&RIN=0910-AH24&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH24"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 5 Survey Responses ID902 - ID1087 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 185)","document_id":"FDA-2015-N-1514-0419"},{"title":"Attachment 4 Survey Responses ID701 - ID901 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 200)","document_id":"FDA-2015-N-1514-0418"},{"title":"Attachment 3 Survey Responses ID404 - ID699 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 295)","document_id":"FDA-2015-N-1514-0417"},{"title":"Attachment 2 Survey Responses ID202 - ID402 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 200)","document_id":"FDA-2015-N-1514-0416"},{"title":"Attachment 1 Survey Responses ID02 - ID201 re: Comment from Shiv Patel (Sai Shiva, LLC) (Multiple Submitters = 199)","document_id":"FDA-2015-N-1514-0415"},{"title":"A Copy of the Final Regulatory Action as Published in the Federal Register (TAB C) re ANPRM Memo July 22, 2015","document_id":"FDA-2015-N-1514-0005"},{"title":"The Substantive Changes Between the draft Submitted to OIRA for Review and the Regulatory Action Subsequently Published are Shown in Track Changes text (TAB B) re ANPRM Memo July 22, 2015","document_id":"FDA-2015-N-1514-0004"},{"title":"Tab A Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Draft Advance Notice of Proposed Rulemaking","document_id":"FDA-2015-N-1514-0003"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AH24/nicotine-toxicity-warnings-","title":"Nicotine Toxicity Warnings "},"comments_count":220,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-1514","supporting_documents_count":8,"docket_id":"FDA-2015-N-1514","document_id":"FDA-2015-N-1514-0090","regulation_id_number":"0910-AH24","title":"Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products","checked_regulationsdotgov_at":"2023-03-01T05:01:16Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":51146,"subtype":null,"title":"Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products; Request for Comments; Extension of Comment Period","toc_doc":"Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products","toc_subject":null,"topics":[],"type":"Proposed Rule","volume":80}