{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled \"Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised).\" This is a revision to the guidance which describes, among other things, how FDA intends to prioritize its enforcement resources with regard to the marketing of ENDS products that do not have premarket authorization. FDA is revising this guidance to change the date required to submit premarket authorization applications to the Agency from May 12, 2020, to September 9, 2020.","action":"Notice 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/2020/04/30/2020-09164.html","cfr_references":[],"citation":"85 FR 23973","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on April 30, 2020.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-0661"],"dockets":[],"document_number":"2020-09164","effective_on":null,"end_page":23974,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/04/30/2020-09164.xml","html_url":"https://www.federalregister.gov/documents/2020/04/30/2020-09164/enforcement-priorities-for-electronic-nicotine-delivery-systems-and-other-deemed-products-on-the","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-09164?publication_date=2020-04-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-04-30/2020-09164/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":3118,"last_updated":"2026-10-23 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-04-30/pdf/2020-09164.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-09164.pdf?1588164341","publication_date":"2020-04-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/04/30/2020-09164.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-2019-D-0661","supporting_documents_count":0,"docket_id":"FDA-2019-D-0661","regulation_id_number":null,"title":"Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2020-05-04T02:00:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23973,"subtype":null,"title":"Enforcement Priorities for Electronic Nicotine Delivery Systems and Other Deemed Products on the Market Without Premarket Authorization (Revised); Guidance for Industry; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":85}