{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as \"essential uses\" under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is taking this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs.","action":"Direct final rule.","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/2016/10/26/2016-25851.html","cfr_references":[{"chapter":null,"citation_url":null,"part":2,"title":21}],"citation":"81 FR 74298","comment_url":null,"comments_close_on":"2016-12-27","correction_of":null,"corrections":[],"dates":"This direct final rule is effective February 23, 2017. Submit either electronic or written comments on the direct final rule by December 27, 2016. If FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-1355"],"dockets":[{"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"}],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2016-10-26","updated_at":"2023-02-28T15:55:12.904-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2015-N-1355-0003","allow_late_comments":null,"id":"FDA-2015-N-1355-0003","comment_end_date":"2016-12-28","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":11,"id":"FDA-2015-N-1355","title":"Use of Ozone-Depleting Substances"}],"document_number":"2016-25851","effective_on":"2017-02-23","end_page":74302,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/10/26/2016-25851.xml","html_url":"https://www.federalregister.gov/documents/2016/10/26/2016-25851/use-of-ozone-depleting-substances","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-25851?publication_date=2016-10-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-10-26/2016-25851/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":1310,"last_updated":"2026-08-23 18:15:06 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-10-26/pdf/2016-25851.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-25851.pdf?1477399589","publication_date":"2016-10-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/10/26/2016-25851.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_count":1,"agency_id":"FDA","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","document_id":"FDA-2015-N-1355-0003","regulation_id_number":null,"title":"Use of Ozone-Depleting Substances","checked_regulationsdotgov_at":"2023-02-28T20:55:11Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":74298,"subtype":null,"title":"Use of Ozone-Depleting Substances","toc_doc":"Use of Ozone-Depleting Substances","toc_subject":null,"topics":["Administrative practice and procedure","Cosmetics","Drugs","Foods"],"type":"Rule","volume":81}