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withdrawn,object_id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-1975-N-0012-0636,FDA,FDA-1975-N-0012,Supplement from American Cleaning Institue (ACI),Other,Supplement (SUP),2015-11-20T05:00:00Z,2015,11,2015-11-20T05:00:00Z,,2016-03-10T21:51:30Z,,0,0,0900006481d5fde2
FDA-1975-N-0012-0634,FDA,FDA-1975-N-0012,"Memorandum of Meeting Minutes from FDA CDER to Lonza America, Inc.",Other,Minutes,2015-10-23T04:00:00Z,2015,10,2015-10-23T04:00:00Z,,2015-10-23T15:08:58Z,,0,0,0900006481ce5bc0
FDA-1975-N-0012-0635,FDA,FDA-1975-N-0012,Advice Letter from FDA CDER to Lewis & Harrison,Other,Letter(s),2015-10-23T04:00:00Z,2015,10,2015-10-23T04:00:00Z,,2015-10-23T15:12:31Z,,0,0,0900006481ce5bc1
FDA-1975-N-0012-0630,FDA,FDA-1975-N-0012,"Study 8 Volume 2 of 3 Gill, M.W., et al. Chronic Dietary Toxicity Oncogenicity Study with ADBAC in Rats re Comment from the ADBAC Steering Committee Lewis and Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:16:48Z,,0,0,09000064818c25ed
FDA-1975-N-0012-0622,FDA,FDA-1975-N-0012,"Study 1 Neeper Bradley, T.L. and Kubena, M.F. Developmental Toxicity Evaluation of ADBAC Administered by Gavage to New Zealand Rabbits re Comment from the ADBAC Steering Committee Lewis & Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:14:11Z,,0,0,09000064818c02c3
FDA-1975-N-0012-0632,FDA,FDA-1975-N-0012,"Study 9 Volume 1 of 2 Gill, M.W., et al. Chronic Dietary Oncogenicity Study with ADBAC in Mice re Comment from the ADBAC Steering Committee Lewis and Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:17:20Z,,0,0,09000064818c28cb
FDA-1975-N-0012-0627,FDA,FDA-1975-N-0012,"Study 6 Selim, Sami Absorption, Distribution, Metabolism and Excretion Studies of ADBAC in the Rat re Comment from the ADBAC Steering Committee Lewis and Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:15:32Z,,0,0,09000064818c222d
FDA-1975-N-0012-0624,FDA,FDA-1975-N-0012,Study 3 Neeper Bradley T.L. Developmental Toxicity Evaluation II of ADBAC Administered by Gavage to CD Rats re Comment from the ADBAC Steering Committee Lewis & Harrison,Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:14:32Z,,0,0,09000064818c1c56
FDA-1975-N-0012-0628,FDA,FDA-1975-N-0012,"Study 7 Neeper Bradley, Theresa L Two Generation Reproduction Study in Sprague Dawley Rats with ADBAC Administered in the Diet re Comment from the ADBAC Steering Committee Lewis and Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:15:50Z,,0,0,09000064818c2427
FDA-1975-N-0012-0629,FDA,FDA-1975-N-0012,"Study 8 Volume 1 of 3 Gill, M.W., et al. Chronic Dietary Toxicity Oncogenicity Study with ADBAC in Rats re Comment from the ADBAC Steering Committee Lewis and Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:16:37Z,,0,0,09000064818c25eb
FDA-1975-N-0012-0625,FDA,FDA-1975-N-0012,"Study 4 Gill, M.W. and Wagner C.L. Ninety Day Subchronic Dermal Toxicity Study with ADBAC in Rats re Comment from the ADBAC Steering Committee Lewis & Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:14:44Z,,0,0,09000064818c20a2
FDA-1975-N-0012-0626,FDA,FDA-1975-N-0012,"Study 5 Goldenthal, Edwin I. Evaluation of ADBAC in a One Year Chronic Dietary Toxicity Study in Dogs re Comment from the ADBAC Steering Committee Lewis & Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:14:52Z,,0,0,09000064818c2227
FDA-1975-N-0012-0631,FDA,FDA-1975-N-0012,"Study 8 Volume 3 of 3 Gill, M.W., et al. Chronic Dietary Toxicity Oncogenicity Study with ADBAC in Rats re Comment from the ADBAC Steering Committee Lewis and Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:17:06Z,,0,0,09000064818c25f3
FDA-1975-N-0012-0623,FDA,FDA-1975-N-0012,"Study 2 Van Miller, J.P. and Weaver, E.V. Ninety Day Dietary Toxicity Study with ADBAC in Rats re Comment from the ADBAC Steering Committee Lewis & Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:14:21Z,,0,0,09000064818c1c53
FDA-1975-N-0012-0633,FDA,FDA-1975-N-0012,"Study 9 Volume 2 of 2 Gill, M.W., et al. Chronic Dietary Oncogenicity Study with ADBAC in Mice re Comment from the ADBAC Steering Committee Lewis and Harrison",Supporting & Related Material,Background Material,2015-10-21T04:00:00Z,2015,10,,,2016-03-22T19:17:27Z,,0,0,09000064818c28cd
FDA-1975-N-0012-0543,FDA,FDA-1975-N-0012,"Memorandum of Meeting Minutes Between FDA CDER and American Cleaning Institute on April 24, 2015",Other,Memorandum,2015-07-07T04:00:00Z,2015,7,2015-07-07T04:00:00Z,,2015-07-07T19:12:21Z,,0,0,0900006481b6f792
FDA-1975-N-0012-0542,FDA,FDA-1975-N-0012,Letter from FDA CDER to American Cleaning Institute,Other,Letter(s),2015-07-07T04:00:00Z,2015,7,2015-07-07T04:00:00Z,,2015-07-07T19:12:15Z,,0,0,0900006481b6f78f
FDA-1975-N-0012-0541,FDA,FDA-1975-N-0012,Memorandum of Meeting Minutes Between FDA CDER and American Cleaning Institute,Other,Memorandum,2015-07-07T04:00:00Z,2015,7,2015-07-07T04:00:00Z,,2015-07-07T19:11:58Z,,0,0,0900006481b6f397
FDA-1975-N-0012-0537,FDA,FDA-1975-N-0012,"Letter from Lonza, Inc. (Lewis and Harrison)",Other,Letter(s),2015-05-20T04:00:00Z,2015,5,2015-05-20T04:00:00Z,,2015-05-20T18:57:40Z,,0,0,0900006481aec6de
FDA-1975-N-0012-0538,FDA,FDA-1975-N-0012,Attachment 1 Draft Protocol for Uterotrophic re Letter from Lonza Inc Lewis and Harrison,Supporting & Related Material,Background Material,2015-05-20T04:00:00Z,2015,5,,,2015-05-20T20:21:30Z,,0,0,0900006481aec0ee
FDA-1975-N-0012-0539,FDA,FDA-1975-N-0012,Attachment 2 FDA-QSAR for Benzethonium Chloride and Alkyl Dimetylbenzylammonium Chloride re Letter from Lonza Inc Lewis and Harrison,Supporting & Related Material,Background Material,2015-05-20T04:00:00Z,2015,5,,,2015-05-20T20:21:37Z,,0,0,0900006481aec0ef
FDA-1975-N-0012-0540,FDA,FDA-1975-N-0012,Attachment 4 Draft Protocol for Hershberger Bioassay of Benzethonium Chloride USP by Oral in Male Rats re Letter from Lonza Inc Lewis and Harrison,Supporting & Related Material,Background Material,2015-05-20T04:00:00Z,2015,5,,,2015-05-20T20:21:46Z,,0,0,0900006481aece32
FDA-1975-N-0012-0536,FDA,FDA-1975-N-0012,Letter from FDA CDER to Lonza America Inc. Granting Meeting Request regarding Potential Endocrine Effects of Benzethonium Chloride and Benzalkonium Chloride,Other,Letter(s),2015-04-24T04:00:00Z,2015,4,2015-04-24T04:00:00Z,,2015-04-24T19:44:06Z,,0,0,0900006481ab9bdc
FDA-1975-N-0012-0535,FDA,FDA-1975-N-0012,Letter from FDA CDER to American Cleaning Institute Granting Meeting Request Regarding Chloroxylenol,Other,Letter(s),2015-04-15T04:00:00Z,2015,4,2015-04-15T04:00:00Z,,2015-04-16T14:07:15Z,,0,0,0900006481aa7b59
FDA-1975-N-0012-0524,FDA,FDA-1975-N-0012,Supplementary Material Weight of Evidence Framework for EDSP Re: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:30:33Z,,0,0,0900006481a95398
FDA-1975-N-0012-0532,FDA,FDA-1975-N-0012,"Appendix F: Assessment of the Percutaneous Absorption of Chloroxylenol, and Effects of Formulation Re: Briefing Document from American Cleaning Institute",Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T16:21:32Z,,0,0,0900006481a970c6
FDA-1975-N-0012-0515,FDA,FDA-1975-N-0012,Appendix 1 Coalition Melon Ball Disease Transmission Model Re: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2020-02-07T19:33:21Z,,0,0,0900006481a95723
FDA-1975-N-0012-0518,FDA,FDA-1975-N-0012,"Appendix 4 Comments Submitted by the American Cleaning Institute and Personal Care Products Council on FDA Proposed Rule for Safety and Effectiveness of Consumer Antiseptics (78 FR 76444-76478; December 17, 2013), Appendix B Re: Briefing Document from American Cleaning Institute",Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:28:05Z,,0,0,0900006481a95726
FDA-1975-N-0012-0529,FDA,FDA-1975-N-0012,Appendix C: Assessment of the Hormonal Effects Database for Chloroxylenol Re: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:59:59Z,,0,0,0900006481a970c3
FDA-1975-N-0012-0531,FDA,FDA-1975-N-0012,Appendix E: Assessment of the Pharmacokinetics (ADME) Database for Chloroxylenol Summary of Re: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T16:15:31Z,,0,0,0900006481a970c5
FDA-1975-N-0012-0516,FDA,FDA-1975-N-0012,Appendix 2 Excerpts from Henkel Submission Re: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:27:13Z,,0,0,0900006481a95724
FDA-1975-N-0012-0520,FDA,FDA-1975-N-0012,"Appendix 6 Comments Submitted by the American Cleaning Institute and Personal Care Products Council on FDA proposed rule for Safety and Effectiveness of Consumer Antiseptics (78 FR 76444-76478; December 17, 2013), Appendix C Re: Briefing Document from American Cleaning Institute",Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:29:14Z,,0,0,0900006481a95728
FDA-1975-N-0012-0519,FDA,FDA-1975-N-0012,"Appendix 5 Schaffner, DW et al. 2014. Quantitative Microbial Risk Assessment of Antibacterial Hand Hygiene Products on the Risk of Shigellosis. Journal of Food Protection. 77(4): 574 - 582 Re: Briefing Document from American Cleaning Institute",Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2020-02-07T17:27:39Z,,0,0,0900006481a95727
FDA-1975-N-0012-0521,FDA,FDA-1975-N-0012,Appendix 7 Final Report Summary BIOHYPO (Confronting the clinical relevance of biocide induced antibiotic resistance) http://cordis.europa.eu/result/rcn/56830 en.html Re: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:29:33Z,,0,0,0900006481a95729
FDA-1975-N-0012-0528,FDA,FDA-1975-N-0012,"Appendix B: Assessment of the Developmental and 
Reproductive (DART) Database for Chloroxylenol Re: Briefing Document from American Cleaning Institute",Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:52:04Z,,0,0,0900006481a970c2
FDA-1975-N-0012-0523,FDA,FDA-1975-N-0012,"Appendix 9 Borgert, C. J., Mihaich, E. M., Ortego, L. S., Bentley, K. S., Holmes, C. M., Levine, S. L. and Becker, R. A. 2011. Hypothesis-driven Weight of Evidence Framework for Evaluating Data within the US EPA's Endocrine Disruptor Screening Program. Regul Toxicol Pharmacal, 61: 185-91 Re: Briefing Document from American Cleaning Institute",Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:30:13Z,,0,0,0900006481a95397
FDA-1975-N-0012-0527,FDA,FDA-1975-N-0012,Appendix A: Chloroxylenol Antimicrobial Efficacy and ResistanceRe: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:43:08Z,,0,0,0900006481a970c1
FDA-1975-N-0012-0522,FDA,FDA-1975-N-0012,"Appendix 8 Oggioni. M.R., L. Furi, J.R. Coelho, J-Y. Maillard, J.L. Martinez. 2013. Recent Advances in the Potential Interconnection between Antimicrobial Resistance to Biocides and Antibiotics. Expert Rev Anti Infect Ther. 11(4):363-6 Re: Briefing Document from American Cleaning Institute",Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:29:52Z,,0,0,0900006481a9572a
FDA-1975-N-0012-0525,FDA,FDA-1975-N-0012,Briefing Document from American Cleaning Institute,Other,Brief,2015-04-09T04:00:00Z,2015,4,2015-04-09T04:00:00Z,,2015-04-09T15:25:57Z,,0,0,0900006481a970be
FDA-1975-N-0012-0526,FDA,FDA-1975-N-0012,Appendix 1 Exponent FDA Consumer Antiseptics Rule: FDA Request for Data on Safety and Efficacy of ChloroxylenolRe: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:39:47Z,,0,0,0900006481a970c0
FDA-1975-N-0012-0530,FDA,FDA-1975-N-0012,Appendix D: Assessment of the Mutagenic and Carcinogenic Effects for Chloroxylenol Re: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T16:06:07Z,,0,0,0900006481a970c4
FDA-1975-N-0012-0517,FDA,FDA-1975-N-0012,"Appendix 3 Boyce, J.M et al. 2012. An Expert Panel Report of a Proposed Scientific Model Demonstrating the Effectiveness of Antibacterial Handwash Products. American Journal of Infection Control, 40: 742-9 Re: Briefing Document from American Cleaning Institute",Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T15:27:37Z,,0,0,0900006481a95725
FDA-1975-N-0012-0534,FDA,FDA-1975-N-0012,"APPENDIX 3 Sanderson H, Counts JL, Stanton KL, Sedlak Rl. 2006. Exposure and Prioritization-Human Screening Data and Methods for High Production Volume Chemicals in Consumer Products: Amine
oxides, A Case Study Risk Analysis 26:1637-1657 Re: Briefing Document from American Cleaning Institute",Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T16:33:36Z,,0,0,0900006481a9710b
FDA-1975-N-0012-0533,FDA,FDA-1975-N-0012,Appendix 2 Risk Assessment of Chloroxylenol in Liquid Hand Soap Used by Consumers and Health-Care Providers Re: Briefing Document from American Cleaning Institute,Supporting & Related Material,Background Material,2015-04-09T04:00:00Z,2015,4,,,2015-04-09T16:27:58Z,,0,0,0900006481a970c7
FDA-1975-N-0012-0514,FDA,FDA-1975-N-0012,Briefing Document from American Cleaning Institute,Other,Brief,2015-04-08T04:00:00Z,2015,4,2015-04-08T04:00:00Z,,2015-04-08T18:34:17Z,,0,0,0900006481a95600
FDA-1975-N-0012-0513,FDA,FDA-1975-N-0012,Letter from FDA/CDER to Personal Care Products Council and American Cleaning Institute Granting Meeting Request,Other,Letter(s),2015-03-09T04:00:00Z,2015,3,2015-03-09T04:00:00Z,,2015-03-09T14:35:15Z,,0,0,0900006481a33f3d
FDA-1975-N-0012-0512,FDA,FDA-1975-N-0012,Interim Response Letter from FDA CDER to the American Cleaning Institute and Personal Care Products Council,Other,Letter(s),2015-02-27T05:00:00Z,2015,2,2015-02-27T05:00:00Z,,2015-05-20T18:41:10Z,,0,0,0900006481a1e054
FDA-1975-N-0012-0511,FDA,FDA-1975-N-0012,Letter from the Personal Care Products Council and American Cleaning Institute to FDA/CDER re Letter from the Personal Care Products Council Covington and Burling LLP,Supporting & Related Material,Background Material,2015-01-07T05:00:00Z,2015,1,,,2015-01-07T22:09:32Z,,0,0,09000064819ac234
FDA-1975-N-0012-0510,FDA,FDA-1975-N-0012,Letter from the Personal Care Products Council Covington & Burling LLP,Other,Letter(s),2015-01-07T05:00:00Z,2015,1,2015-01-07T05:00:00Z,,2015-01-07T22:04:35Z,,0,0,09000064819ac1ee