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withdrawn,object_id FDA-1978-N-0023-0166,FDA,FDA-1978-N-0023,Report from Nonprescription Drug Manufacturers Association,Other,Report,2012-12-24T05:00:00Z,2012,12,2012-12-24T05:00:00Z,,2019-09-25T19:25:17Z,,0,0,090000648055f19c FDA-1978-N-0023-0167,FDA,FDA-1978-N-0023,Acknowledgment Letter from FDA DDM to Michael T. Benson,Other,Acknowledgement Letter/Receipt,2012-12-24T05:00:00Z,2012,12,,,2019-09-13T15:31:17Z,,0,0,0900006480a3d7cf FDA-1978-N-0023-0168,FDA,FDA-1978-N-0023,"Supplement from Paul A. Lehman, M.Sc. and Thomas J. Franz, M.D.",Other,Supplement (SUP),2012-12-24T05:00:00Z,2012,12,2012-12-24T05:00:00Z,,2019-09-16T13:33:03Z,,0,0,090000648055fd10 FDA-1978-N-0023-0161,FDA,FDA-1978-N-0023,Reference 1 Minutes of Open Public Meeting Carcinogenicity Assessment Committe December 4 1996 re FDA-1978-N-0023-0160,Supporting & Related Material,Citizen Petition,2009-10-06T04:00:00Z,2009,10,,,2012-12-24T19:59:54Z,,0,0,0900006480a33acc FDA-1978-N-0023-0164,FDA,FDA-1978-N-0023,"Reference 7 International Agency for Research on Cancer (IARC) - Summaries and Evaluation, HYDROQUINOLONE, (Group 3) re FDA-1978-N-0023-0160",Supporting & Related Material,Citizen Petition,2009-10-06T04:00:00Z,2009,10,,,2012-12-24T20:00:21Z,,0,0,0900006480a33ad2 FDA-1978-N-0023-0160,FDA,FDA-1978-N-0023,Citizen Petition from Michael T. Benson,Other,Citizen Petition,2009-10-06T04:00:00Z,2009,10,2009-10-06T04:00:00Z,,2024-11-07T22:04:39Z,,1,0,0900006480a3d615 FDA-1978-N-0023-0163,FDA,FDA-1978-N-0023,Reference 6 The Covalent Bond re FDA-1978-N-0023-0160,Supporting & Related Material,Citizen Petition,2009-10-06T04:00:00Z,2009,10,,,2012-12-24T20:00:11Z,,0,0,0900006480a33ad1 FDA-1978-N-0023-0165,FDA,FDA-1978-N-0023,"Reference 8 Nordlund, The Safety of Hydroquinone re FDA-1978-N-0023-0160",Supporting & Related Material,Citizen Petition,2009-10-06T04:00:00Z,2009,10,,,2012-12-24T20:00:31Z,,0,0,0900006480a33ad3 FDA-1978-N-0023-0162,FDA,FDA-1978-N-0023,Reference 5 -Glucuronide (Wikipedia) re FDA-1978-N-0023-0160,Supporting & Related Material,Citizen Petition,2009-10-06T04:00:00Z,2009,10,,,2012-12-24T20:00:02Z,,0,0,0900006480a33ad0 FDA-1978-N-0023-0081,FDA,FDA-1978-N-0023,"Answer from FDA/CDER to Joan A. Kuriansky ,Older Women's League",Other,Answer,2008-10-06T04:00:00Z,2008,10,2008-10-06T04:00:00Z,1979-02-02T04:59:59Z,2019-11-01T20:17:14Z,,0,0,090000648055f147 FDA-1978-N-0023-0047,FDA,FDA-1978-N-0023,"Letter from FDA/CDER to Dr. John Kennedy, Jr.",Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-25T19:34:22Z,,0,0,090000648055f1b8 FDA-1978-N-0023-0043,FDA,FDA-1978-N-0023,"Correction Letter from Hunter, Maclean, Exley & Dunn, P.C. On Behalf Of Carson Products Company to FDA DDM",Other,Correction(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-30T13:12:32Z,,0,0,090000648055f024 FDA-1978-N-0023-0060,FDA,FDA-1978-N-0023,"Tab Reference 1: Kari, F. W., ""NTP Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies),"" NTP TR366, NTP Publication No. 89-2821, 1989. (Page 101-200) re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets",Supporting & Related Material,Background Material,2008-10-03T04:00:00Z,2008,10,,,2019-10-02T17:48:55Z,,0,0,090000648055f20c FDA-1978-N-0023-0046,FDA,FDA-1978-N-0023,Letter from FDA/CDER to University of Pennsylvania,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-25T19:28:44Z,,0,0,090000648055f1b4 FDA-1978-N-0023-0039,FDA,FDA-1978-N-0023,Enclosure 2: Salient Observations from the Published Literature on Exogenous Ochronosis Reportedly Associated with Skin Discoloration Fade Products re: Letter from the Nonprescription Drug Manufacturers Association to FDA/CDER,Supporting & Related Material,Background Material,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-27T17:26:10Z,,0,0,090000648055f0b2 FDA-1978-N-0023-0031,FDA,FDA-1978-N-0023,"Request For Extension From Rogers Hoge & Hills On Behalf Of Browne Drug Co., Inc.",Other,Request for Extension,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,1979-02-02T04:59:59Z,2019-09-24T13:20:48Z,,0,0,090000648055eff9 FDA-1978-N-0023-0057,FDA,FDA-1978-N-0023,"Tab Reference 1: Kari, F. W., ""NTP Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies),"" NTP TR366, NTP Publication No. 89-2821, 1989. (Page 1-100) re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets",Supporting & Related Material,Background Material,2008-10-03T04:00:00Z,2008,10,,,2019-10-02T17:49:27Z,,0,0,090000648055f1ec FDA-1978-N-0023-0040,FDA,FDA-1978-N-0023,Enclosure 1: Chronic Health Effects Testing for Hydroquinone re: Letter from the Nonprescription Drug Manufacturers Association to FDA/CDER,Supporting & Related Material,Background Material,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-27T17:25:50Z,,0,0,090000648055f0c4 FDA-1978-N-0023-0050,FDA,FDA-1978-N-0023,Letter from FDA/CDER to National Medical Association,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-25T19:57:30Z,,0,0,090000648055f1c3 FDA-1978-N-0023-0030,FDA,FDA-1978-N-0023,"Report from the National Toxicology Program, Toxicology and Carcinogenesis Studies of Hydroquinone (CAS No. 123-31-9) in F344/N Rats and B6C3F Mice (Gavage Studies)",Other,Report,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-10-29T14:53:24Z,,0,0,090000648055f02b FDA-1978-N-0023-0035,FDA,FDA-1978-N-0023,A Report By The City of New York Department of Consumer Affairs; A Study In Hype And Risk: The Marketing Of Skin Bleaches,Other,Report,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-30T13:03:09Z,,0,0,090000648055f070 FDA-1978-N-0023-0054,FDA,FDA-1978-N-0023,"Ref. 1: Memorandum of Meeting between FDA CDER, NDMA and Carcinogenicity Assessment Committee",Other,Memorandum,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-10-10T18:59:54Z,,0,0,090000648055f1d3 FDA-1978-N-0023-0053,FDA,FDA-1978-N-0023,Memorandum of Meeting between Nonprescription Drug Manufacturers Association et. al. and FDA,Other,Memorandum,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-26T12:01:08Z,,0,0,090000648055f1d0 FDA-1978-N-0023-0058,FDA,FDA-1978-N-0023,"Tab Reference 6: Bio/dynamics Inc., ""A Developmental Toxicity Study in Rabbits With Hydroquinone,"" Project No. 87-3Z20, 1989, in OTC Vol. 16ATFM2. re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets Management (HFA-350) August 17 2006",Supporting & Related Material,Background Material,2008-10-03T04:00:00Z,2008,10,,,2019-10-02T17:48:18Z,,0,0,090000648055f206 FDA-1978-N-0023-0052,FDA,FDA-1978-N-0023,Letter from FDA/CDER to Lilly A. Jackson,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-26T11:48:24Z,,0,0,090000648055f1cc FDA-1978-N-0023-0037,FDA,FDA-1978-N-0023,Letter From FDA/CDER to Nonprescription Drug Manufacturers Association,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-26T16:44:48Z,,0,0,090000648055f099 FDA-1978-N-0023-0041,FDA,FDA-1978-N-0023,Letter from the Nonprescription Drug Manufacturers Association to FDA/CDER,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-27T17:24:43Z,,0,0,090000648055f0ed FDA-1978-N-0023-0051,FDA,FDA-1978-N-0023,Letter from FDA/CDER to King-Drew Medical Center,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-26T11:45:27Z,,0,0,090000648055f1c8 FDA-1978-N-0023-0048,FDA,FDA-1978-N-0023,Letter from FDA/CDER to Dr. Harold Minus,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-25T19:39:09Z,,0,0,090000648055f1bb FDA-1978-N-0023-0044,FDA,FDA-1978-N-0023,Letter From Nonprescription Drug Manufacturers Association to FDA/CDER,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-27T18:08:12Z,,0,0,090000648055f149 FDA-1978-N-0023-0055,FDA,FDA-1978-N-0023,Letter from FDA/CDER to Nonprescription Drug Manufacturers Association,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-26T12:34:55Z,,0,0,090000648055f1d6 FDA-1978-N-0023-0045,FDA,FDA-1978-N-0023,Report from Nonprescription Drug Manufacturers Association,Other,Report,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-25T19:10:40Z,,0,0,090000648055f14b FDA-1978-N-0023-0056,FDA,FDA-1978-N-0023,"Tab Reference 1: Kari, F. W., ""NTP Technical Report of the Toxicology and Carcinogenesis Studies of Hydroquinone in F344/N Rats and B6C3F1 Mice (Gavage Studies),"" NTP TR366, NTP Publication No. 89-2821, 1989. (Page 201-253) re: Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets",Supporting & Related Material,Background Material,2008-10-03T04:00:00Z,2008,10,,,2019-10-02T17:49:41Z,,0,0,090000648055f1e3 FDA-1978-N-0023-0029,FDA,FDA-1978-N-0023,Reference List From The Proprietary Association,Other,Background Material,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-30T13:27:15Z,,0,0,090000648055f020 FDA-1978-N-0023-0033,FDA,FDA-1978-N-0023,Letter From Nonprescription Drug Manufacturers Association to FDA/CDER,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-30T13:06:41Z,,0,0,090000648055f06b FDA-1978-N-0023-0034,FDA,FDA-1978-N-0023,Letter From Nonprescription Drug Manufacturers Association to FDA/Office of the Commissioner,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-30T13:04:47Z,,0,0,090000648055f06d FDA-1978-N-0023-0038,FDA,FDA-1978-N-0023,Letter From Nonprescription Drug Manufacturers Association to FDA CDER,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-30T12:42:04Z,,0,0,090000648055f0b0 FDA-1978-N-0023-0042,FDA,FDA-1978-N-0023,Memorandum Of Meeting Between FDA/CDER And Nonprescription Drug Manufacturers Association Hydroquinone Task Force Representatives,Other,Memorandum,2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-30T12:35:15Z,,0,0,090000648055f127 FDA-1978-N-0023-0049,FDA,FDA-1978-N-0023,Letter from FDA/CDER to Dr. Rebat Halder,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-25T19:54:27Z,,0,0,090000648055f1bf FDA-1978-N-0023-0032,FDA,FDA-1978-N-0023,Letter From New York City Department of Consumer Affairs to FDA,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-30T13:09:08Z,,0,0,090000648055f065 FDA-1978-N-0023-0036,FDA,FDA-1978-N-0023,Letter From FDA/CDER to New York City Department of Consumer Affairs,Other,Letter(s),2008-10-03T04:00:00Z,2008,10,2008-10-03T04:00:00Z,,2019-09-27T18:46:56Z,,0,0,090000648055f076 FDA-1978-N-0023-0059,FDA,FDA-1978-N-0023,"Internal Memorandum from Susan S. Johnson, Acting Director Division of Nonprescription Regulation Development Office of Nonprescription Products to Division of Dockets Management (HFA-350) August 17 2006",Supporting & Related Material,Background Material,2008-10-03T04:00:00Z,2008,10,,,2019-09-11T19:06:13Z,,0,0,090000648055f208 FDA-1978-N-0023-0020,FDA,FDA-1978-N-0023,"Memorandum of Telephone Conversation between FDA/CDER and Venable, LLP",Other,Memorandum,2006-12-21T05:00:00Z,2006,12,,,2019-09-16T13:06:41Z,,0,0,090000648055fba3 FDA-1978-N-0023-0008,FDA,FDA-1978-N-0023,"Internal Memo from Jeffery Shuren, FDA/Office of the Commissioner, to FDA/DDM (HFA-305) dated December 19, 2006",Other,Memorandum,2006-12-20T05:00:00Z,2006,12,,,2019-10-11T16:36:58Z,,0,0,090000648055f84b FDA-1978-N-0023-0006,FDA,FDA-1978-N-0023,Letter from FDA to Colleague,Other,Letter(s),2006-09-08T04:00:00Z,2006,9,,,2019-09-27T13:06:58Z,,0,0,090000648055f272 FDA-1978-N-0023-0005,FDA,FDA-1978-N-0023,Skin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2006-08-29T04:00:00Z,2006,8,2006-08-28T04:00:00Z,2006-12-28T04:59:59Z,2019-09-26T13:15:35Z,E6-14263,0,0,090000648055f1de