id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2015-N-1355-0026,FDA,FDA-2015-N-1355,Use of Ozone-Depleting Substances,Rule,Direct Final Rule,2017-02-28T05:00:00Z,2017,2,2017-02-28T05:00:00Z,,2017-02-28T14:41:22Z,2017-03866,0,0,09000064824e0d15 FDA-2015-N-1355-0017,FDA,FDA-2015-N-1355,"Attachment 2 Redacted Cetylite adverse drug experience reports re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)",Supporting & Related Material,Background Material,2016-12-27T05:00:00Z,2016,12,,,2017-01-13T17:09:39Z,,0,0,090000648243807b FDA-2015-N-1355-0016,FDA,FDA-2015-N-1355,"Attachment 1 Redacted History of Cetylite's DESI proceeding re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)",Supporting & Related Material,Background Material,2016-12-27T05:00:00Z,2016,12,,,2017-01-13T17:06:29Z,,0,0,090000648243807a FDA-2015-N-1355-0022,FDA,FDA-2015-N-1355,"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.)",Supporting & Related Material,Background Material,2016-12-27T05:00:00Z,2016,12,,,2016-12-27T18:21:59Z,,0,0,09000064824380ec FDA-2015-N-1355-0023,FDA,FDA-2015-N-1355,"Exhibit E Current Cetacaine® Spray label from DailyMed database re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)",Supporting & Related Material,Background Material,2016-12-27T05:00:00Z,2016,12,,,2016-12-27T18:24:02Z,,0,0,09000064824380ed FDA-2015-N-1355-0024,FDA,FDA-2015-N-1355,"Exhibit F Current Laryng-0-Jet kit label from DailyMed database re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)",Supporting & Related Material,Background Material,2016-12-27T05:00:00Z,2016,12,,,2016-12-27T18:27:37Z,,0,0,09000064824380ee FDA-2015-N-1355-0018,FDA,FDA-2015-N-1355,"Attachment 3 Redacted Information about Cetylite's business status re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)",Supporting & Related Material,Background Material,2016-12-27T05:00:00Z,2016,12,,,2017-01-13T17:12:15Z,,0,0,09000064824380e7 FDA-2015-N-1355-0020,FDA,FDA-2015-N-1355,"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.)",Supporting & Related Material,Background Material,2016-12-27T05:00:00Z,2016,12,,,2016-12-27T19:41:10Z,,0,0,09000064824380e9 FDA-2015-N-1355-0019,FDA,FDA-2015-N-1355,"Attachment 4 Redacted List of Cetylite's communications with DAAAP re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)",Supporting & Related Material,Background Material,2016-12-27T05:00:00Z,2016,12,,,2017-01-13T17:14:30Z,,0,0,09000064824380e8 FDA-2015-N-1355-0021,FDA,FDA-2015-N-1355,"Exhibit C Greenfield, Hittelman, and Glickman Evaluation of Anesthetic Agents on Human Mucous Membrane: An Illustration Experimental Protocol Using Computers NYS Dental Journal (1986): 22-28. re: Comment from Keller and Heckman LLP (Cetylite Industries, Inc.)",Supporting & Related Material,Background Material,2016-12-27T05:00:00Z,2016,12,,,2017-01-13T16:51:34Z,,0,0,09000064824380eb FDA-2015-N-1355-0003,FDA,FDA-2015-N-1355,Use of Ozone-Depleting Substances,Rule,Direct Final Rule,2016-10-26T04:00:00Z,2016,10,2016-10-26T04:00:00Z,2016-12-28T04:59:59Z,2016-12-28T02:02:24Z,2016-25851,0,0,090000648234d51a FDA-2015-N-1355-0007,FDA,FDA-2015-N-1355,Reference 1 -More methemoglobin is produced by benzocaine treatment than lidocaine treatment in human in vitro systems,Supporting & Related Material,Background Material,2016-10-26T04:00:00Z,2016,10,,,2016-10-26T20:08:17Z,,0,0,09000064823547dd FDA-2015-N-1355-0004,FDA,FDA-2015-N-1355,Use of Ozone-Depleting Substances,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-10-26T04:00:00Z,2016,10,2016-10-26T04:00:00Z,2016-12-28T04:59:59Z,2016-12-01T14:00:46Z,2016-25850,0,0,090000648234d577 FDA-2015-N-1355-0005,FDA,FDA-2015-N-1355,Use of Ozone-Depleting Substances,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-10-26T04:00:00Z,2016,10,2016-10-26T04:00:00Z,2016-12-28T04:59:59Z,2017-01-31T02:02:25Z,2016-25852,0,0,090000648234d5d1 FDA-2015-N-1355-0006,FDA,FDA-2015-N-1355,Reference 1 - Bryan Corporation (httplistings.findthecompany.coml12165972Bryan-Corporation-in-Woburn-MA,Supporting & Related Material,Background Material,2016-10-26T04:00:00Z,2016,10,,,2016-10-26T20:06:21Z,,0,0,09000064823547dc FDA-2015-N-1355-0001,FDA,FDA-2015-N-1355,"Use of Ozone-Depleting Substances; Request for Comment Concerning Essential-Use Designations",Proposed Rule,Notice of Proposed Rulemaking (NPRM),2015-06-29T04:00:00Z,2015,6,2015-06-29T04:00:00Z,2015-08-29T03:59:59Z,2015-08-22T01:30:54Z,2015-15902,0,0,0900006481b5acc4