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withdrawn,object_id FDA-1998-N-0880-2101,FDA,FDA-1998-N-0880,Attachment 1 International Smart Tan Network Tanning Industry Calls For Meeting with Dermatology Industry Leaders re: Comment from Suntanning Association for Education,Supporting & Related Material,Background Material,2016-12-14T05:00:00Z,2016,12,,,2018-04-09T19:30:35Z,,0,0,0900006482409491 FDA-1998-N-0880-2102,FDA,FDA-1998-N-0880,Attachment 3 Rees The melanoma epidemic: reality and artefact: Warrants a reappraisal of the relation between histology and clinical behaviour re: Comment from Suntanning Association for Education,Supporting & Related Material,Background Material,2016-12-14T05:00:00Z,2016,12,,,2016-12-14T20:05:52Z,,0,0,09000064824094e2 FDA-1998-N-0880-2077,FDA,FDA-1998-N-0880,Section 5 Exposure Schedule Background Information re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:13:42Z,,0,0,09000064823e6ac3 FDA-1998-N-0880-2086,FDA,FDA-1998-N-0880,Section 14 The Greatest Good for the Greatest Number re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:16:18Z,,0,0,09000064823e6acc FDA-1998-N-0880-2088,FDA,FDA-1998-N-0880,Section 16 Self- Regulation by the Indoor Tanning Industry re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:16:42Z,,0,0,09000064823e6ace FDA-1998-N-0880-2085,FDA,FDA-1998-N-0880,Section 13 New Information of Importance re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:16:04Z,,0,0,09000064823e6acb FDA-1998-N-0880-2089,FDA,FDA-1998-N-0880,Section 17 Sunbed Re-Certification re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:16:54Z,,0,0,09000064823e6acf FDA-1998-N-0880-2092,FDA,FDA-1998-N-0880,Section 20 the ANPRM Should Have Considered These Matters re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:17:41Z,,0,0,09000064823e6ad2 FDA-1998-N-0880-2094,FDA,FDA-1998-N-0880,Section 22 Demographics of Indoor Tanning Industry re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:18:03Z,,0,0,09000064823e6ad4 FDA-1998-N-0880-2082,FDA,FDA-1998-N-0880,Section 10 Photoimmunosuppression Photoimmunoprotection re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:15:26Z,,0,0,09000064823e6ac8 FDA-1998-N-0880-2087,FDA,FDA-1998-N-0880,Section 15 The Truth about Tanning re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:16:31Z,,0,0,09000064823e6acd FDA-1998-N-0880-2093,FDA,FDA-1998-N-0880,"Section 21 False, Deceptive, and Misleading re: Comment from Donald L. Smith",Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:17:52Z,,0,0,09000064823e6ad3 FDA-1998-N-0880-2096,FDA,FDA-1998-N-0880,Section 24 Articles by Donald L. Smith re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:18:32Z,,0,0,09000064823e6ad6 FDA-1998-N-0880-2091,FDA,FDA-1998-N-0880,Section 19 TUVR/SUVR and the Correct Use of Sunscreen re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:17:28Z,,0,0,09000064823e6ad1 FDA-1998-N-0880-2095,FDA,FDA-1998-N-0880,Section 23 Definition of Acronyms and Terms Used Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:18:16Z,,0,0,09000064823e6ad5 FDA-1998-N-0880-2081,FDA,FDA-1998-N-0880,Section 9 Beneficial Effects of Ultraviolet Radiation re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:15:11Z,,0,0,09000064823e6ac7 FDA-1998-N-0880-2075,FDA,FDA-1998-N-0880,Section 3 Recommended Decision Tree re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:13:12Z,,0,0,09000064823e7283 FDA-1998-N-0880-2076,FDA,FDA-1998-N-0880,Section 4 Melanoma Warning is Not Warranted re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:13:25Z,,0,0,09000064823e7284 FDA-1998-N-0880-2090,FDA,FDA-1998-N-0880,Section 18 TUVR/SUVR and the Ultraviolet Index re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:17:05Z,,0,0,09000064823e6ad0 FDA-1998-N-0880-2074,FDA,FDA-1998-N-0880,Section 2 Executive Summary re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:12:52Z,,0,0,09000064823e7282 FDA-1998-N-0880-2078,FDA,FDA-1998-N-0880,Section 6 Recommended Universal Biological Efficacy Rating Scale re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:13:55Z,,0,0,09000064823e6ac4 FDA-1998-N-0880-2084,FDA,FDA-1998-N-0880,Section 12 Skin Cancer Incidence vs Mortality re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:15:51Z,,0,0,09000064823e6aca FDA-1998-N-0880-2097,FDA,FDA-1998-N-0880,Section 25 Other Articles and Information re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:18:47Z,,0,0,09000064823e6ad7 FDA-1998-N-0880-2072,FDA,FDA-1998-N-0880,Table of Contents re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:14:10Z,,0,0,09000064823e7280 FDA-1998-N-0880-2080,FDA,FDA-1998-N-0880,Section 8 Recommended Exposure Schedule Parameters re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:14:51Z,,0,0,09000064823e6ac6 FDA-1998-N-0880-2073,FDA,FDA-1998-N-0880,Section 1 Empowerment re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:12:31Z,,0,0,09000064823e7281 FDA-1998-N-0880-2079,FDA,FDA-1998-N-0880,Section 7 Recommended Phototyping/Subtyping System re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:14:37Z,,0,0,09000064823e6ac5 FDA-1998-N-0880-2083,FDA,FDA-1998-N-0880,Section 11 Carcinogens and Cocarcinogens re: Comment from Donald L. Smith,Supporting & Related Material,Background Material,2016-12-07T05:00:00Z,2016,12,,,2018-04-09T19:15:38Z,,0,0,09000064823e6ac9 FDA-1998-N-0880-1919,FDA,FDA-1998-N-0880,Attachment 1 Answer from FDA CDRH to International Smart Tan Network Question/Request #1 re: Letter from FDA CDRH to International Smart Tan Network,Supporting & Related Material,Background Material,2016-12-05T05:00:00Z,2016,12,,,2018-04-09T18:40:04Z,,0,0,09000064823e09cf FDA-1998-N-0880-1922,FDA,FDA-1998-N-0880,Attachment 1 Cited Non-Copyrighted Articles re: Comment from Kerry M. Hanson,Supporting & Related Material,Background Material,2016-12-05T05:00:00Z,2016,12,,,2018-04-09T18:59:53Z,,0,0,09000064823e0ea9 FDA-1998-N-0880-1931,FDA,FDA-1998-N-0880,"Attachment 1 The Kinetics of the Tanning Response to Tanning Bed Exposures Michael Caswell, Ph.D. Thomas J. Stephens & Associates, Inc. re: Comment from Michael Caswell",Supporting & Related Material,Background Material,2016-12-05T05:00:00Z,2016,12,,,2018-04-09T19:04:07Z,,0,0,09000064823e0eb1 FDA-1998-N-0880-1916,FDA,FDA-1998-N-0880,"Attachment 1 The Kinetics of the Tanning Response to Tanning Bed Exposures Michael Caswell, Ph.D. Thomas J. Stephens & Associates, Inc re: Comment from Michael Caswell",Supporting & Related Material,Background Material,2016-12-05T05:00:00Z,2016,12,,,2018-04-09T18:26:30Z,,0,0,09000064823e037c FDA-1998-N-0880-1918,FDA,FDA-1998-N-0880,Letter from FDA CDRH to International Smart Tan Network,Other,Letter(s),2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,,2018-04-09T18:37:13Z,,0,0,09000064805a1a22 FDA-1998-N-0880-1879,FDA,FDA-1998-N-0880,Request to Extend Comment Period from International Smart Tan Network,Other,Request for Extension,2016-12-05T05:00:00Z,2016,12,2016-12-05T05:00:00Z,,2018-04-09T18:05:37Z,,0,0,09000064805a1a1b FDA-1998-N-0880-1914,FDA,FDA-1998-N-0880,Medical Devices; Sunlamp Products Performance Standard; Request for Comments and Information; Extension of Comment Period,Proposed Rule,Extension of Comment Period,2016-12-05T05:00:00Z,2016,12,1999-05-04T04:00:00Z,1999-07-10T03:59:59Z,2018-04-09T18:16:37Z,99–11121,0,0,09000064805a1a1f FDA-1998-N-0880-0015,FDA,FDA-1998-N-0880,Reference 14 - Photobiology of Melanin Pigmentation,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:51:56Z,,0,0,0900006481d69ef6 FDA-1998-N-0880-0005,FDA,FDA-1998-N-0880,List of References,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:49:39Z,,0,0,0900006481d699dd FDA-1998-N-0880-0010,FDA,FDA-1998-N-0880,Reference 07 - Laser Products - Conformance with IEC standards,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:50:45Z,,0,0,0900006481d69c5f FDA-1998-N-0880-0007,FDA,FDA-1998-N-0880,Reference 02 - FDA Policy on Warning Label Required on Sunlamp Products,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:50:06Z,,0,0,0900006481d69b75 FDA-1998-N-0880-0011,FDA,FDA-1998-N-0880,Reference 10 - FDA-Sunlamp Recommended Maximum Timer Interval and Exposure Schedule,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:51:00Z,,0,0,0900006481d69e88 FDA-1998-N-0880-0012,FDA,FDA-1998-N-0880,Reference 11 - Sun Exposure Predicts Risk of Ocular Melanoma in Australia,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:51:14Z,,0,0,0900006481d69e89 FDA-1998-N-0880-0006,FDA,FDA-1998-N-0880,Reference 01 - Cutaneous Melanoma Attributable to Sunbed Use,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:49:51Z,,0,0,0900006481d699de FDA-1998-N-0880-0016,FDA,FDA-1998-N-0880,Reference 15 - Evidence for a New Paradigm for UV Exposure,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:52:07Z,,0,0,0900006481d69ef7 FDA-1998-N-0880-0004,FDA,FDA-1998-N-0880,Sunlamp Products; Proposed Amendment to Performance Standard,Proposed Rule,Amendment,2015-12-22T05:00:00Z,2015,12,2015-12-22T05:00:00Z,2016-03-22T03:59:59Z,2016-12-16T02:00:42Z,2015-32023,0,0,0900006481dc147f FDA-1998-N-0880-0013,FDA,FDA-1998-N-0880,Reference 12 - Report to Congress - Labeling information on the relationship between indoor tanning devices and skin cancer or damage,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:51:31Z,,0,0,0900006481d69e8a FDA-1998-N-0880-0017,FDA,FDA-1998-N-0880,"Reference 16 - Sunlamp Products; Proposed Amendment to Performance Standard Preliminary Regulatory Impact Analysis",Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:52:18Z,,0,0,0900006481dc605d FDA-1998-N-0880-0014,FDA,FDA-1998-N-0880,Reference 13 - Validity and Practicality of Sun-Reactive Skin Types I Through VI,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:51:44Z,,0,0,0900006481d69e8b FDA-1998-N-0880-0009,FDA,FDA-1998-N-0880,Reference 04 - FDA Policy on Lamp Compatibility,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:50:33Z,,0,0,0900006481d69b77 FDA-1998-N-0880-0008,FDA,FDA-1998-N-0880,Reference 03 - FDA Policy on Maximum Timer Intervals and Exposure Schedules for Sunlamps,Supporting & Related Material,Background Material,2015-12-22T05:00:00Z,2015,12,,,2015-12-23T16:50:19Z,,0,0,0900006481d69b76 FDA-1998-N-0880-0002,FDA,FDA-1998-N-0880,Medical Devices; Sunlamp Products Performance Standard; Request for Comments and Information See FDA-1998-N-0880-0001 (Pre_FDMS-1),Proposed Rule,Advance Notice of Proposed Rulemaking (ANPRM),2010-10-21T04:00:00Z,2010,10,2010-10-21T04:00:00Z,1999-05-11T03:59:59Z,2018-04-09T19:50:47Z,,0,0,0900006480b6f5da FDA-1998-N-0880-0001,FDA,FDA-1998-N-0880,Medical Devices; Sunlamp Products Performance Standard; Request for Comments and Information,Proposed Rule,Advance Notice of Proposed Rulemaking (ANPRM),2010-10-14T04:00:00Z,2010,10,1999-02-09T05:00:00Z,1999-05-11T03:59:59Z,2018-04-09T18:01:24Z,99–3109,0,0,09000064805a1a18