{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.\" Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This draft guidance is intended to assist persons with their PMTA submissions for ENDS products.","action":"Notification of availability.","agencies":[{"raw_name":"DEPARTMENT OF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/2016/05/10/2016-10687.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":"81 FR 28781","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 11, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-2496"],"dockets":[],"document_number":"2016-10687","effective_on":null,"end_page":28783,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/05/10/2016-10687.xml","html_url":"https://www.federalregister.gov/documents/2016/05/10/2016-10687/premarket-tobacco-product-applications-for-electronic-nicotine-delivery-systems-draft-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-10687?publication_date=2016-05-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-05-10/2016-10687/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1912,"last_updated":"2026-10-25 08:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-05-10/pdf/2016-10687.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-10687.pdf?1462452413","publication_date":"2016-05-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/05/10/2016-10687.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Platforms Porfolio re Comment from Gregory Connolly, DMD, MPH","document_id":"FDA-2015-D-2496-0042"},{"title":"Philip Morris International Reduced Risk Products re Comment from Gregory Connolly, DMD, MPH","document_id":"FDA-2015-D-2496-0041"},{"title":"R.J. Reynolds Tobacco Company's VUSE Privacy Policy re Comment from Gregory Connolly, DMD, MPH","document_id":"FDA-2015-D-2496-0040"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-2496","supporting_documents_count":3,"docket_id":"FDA-2015-D-2496","regulation_id_number":null,"title":"Premarket Tobacco Product Application for Electronic Nicotine Delivery Systems","checked_regulationsdotgov_at":"2016-07-12T05:00:50Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28781,"subtype":null,"title":"Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request","toc_doc":"Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems","toc_subject":"Guidance:","topics":[],"type":"Proposed Rule","volume":81}