{"abstract":"In accordance with a determination by the Director of the Office of Management and Budget (OMB) that the direct final rule (\"Use of Ozone Depleting Substances\") published on October 26, 2016, is excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled \"Regulatory Freeze Pending Review,\" this action confirms the effective date of February 23, 2017, for the direct final rule.","action":"Direct final rule; confirmation of effective date.","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/2017/02/28/2017-03866.html","cfr_references":[{"chapter":null,"citation_url":null,"part":2,"title":21}],"citation":"82 FR 12067","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The effective date of the direct final rule that published on October 26, 2016, at 81 FR 74298, is confirmed to be February 23, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-1355"],"dockets":[],"document_number":"2017-03866","effective_on":"2017-02-23","end_page":12068,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/02/28/2017-03866.xml","html_url":"https://www.federalregister.gov/documents/2017/02/28/2017-03866/use-of-ozone-depleting-substances","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-03866?publication_date=2017-02-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-02-28/2017-03866/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":438,"last_updated":"2026-07-28 02:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-02-28/pdf/2017-03866.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-03866.pdf?1488207859","publication_date":"2017-02-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/02/28/2017-03866.txt","regulation_id_number_info":{"0910-AH36":{"issue":"201610","html_url":"https://www.federalregister.gov/regulations/0910-AH36/use-of-ozone-depleting-substances","title":"Use of Ozone Depleting Substances","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201610&RIN=0910-AH36&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH36"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Exhibit F Current Laryng-0-Jet kit label from DailyMed database re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)","document_id":"FDA-2015-N-1355-0024"},{"title":"Exhibit E Current Cetacaine® Spray label from DailyMed database re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)","document_id":"FDA-2015-N-1355-0023"},{"title":"Exhibit D A Guidance on the Use of Topical Anesthetics for Naso/Oropharyngeal and Laryngotracheal Procedures Feb. 2006 www.pbm.va.gov re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)","document_id":"FDA-2015-N-1355-0022"},{"title":"Exhibit C Greenfield, Hittelman, and Glickman Evaluation of Anesthetic Agents on Human Mucous Membrane: AI Illustration Experimental Protocol Using Computers NYS Dental Journal (1986): 22-28. re: Comment from Keller and Heckman LLP (Cetylite Industries, I","document_id":"FDA-2015-N-1355-0021"},{"title":"Exhibit A Guidance for FDA Staff and Industry Marketed Unapproved Drugs Compliance Policy Guide Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs Sept 9, 2011 re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)","document_id":"FDA-2015-N-1355-0020"},{"title":"Attachment 4 Redacted List of Cetylite's communications with DAAAP re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)","document_id":"FDA-2015-N-1355-0019"},{"title":"Attachment 3 Redacted Information about Cetylite's business status re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)","document_id":"FDA-2015-N-1355-0018"},{"title":"Attachment 2 Redacted Cetylite adverse drug experience reports re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)","document_id":"FDA-2015-N-1355-0017"},{"title":"Attachment 1 Redacted History of Cetylite's DESI proceeding re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)","document_id":"FDA-2015-N-1355-0016"},{"title":"Reference 1 -More methemoglobin is produced by benzocaine treatment than lidocaine treatment in human in vitro systems","document_id":"FDA-2015-N-1355-0007"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-1355","supporting_documents_count":11,"docket_id":"FDA-2015-N-1355","regulation_id_number":null,"title":"Use of Ozone-Depleting Substances","checked_regulationsdotgov_at":"2017-03-20T06:00:19Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":12067,"subtype":null,"title":"Use of Ozone-Depleting Substances","toc_doc":"Use of Ozone-Depleting Substances","toc_subject":null,"topics":[],"type":"Rule","volume":82}