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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, null, null, "2016-03-22T19:16:48Z", null, 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, null, null, "2016-03-22T19:14:11Z", null, 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, null, null, "2016-03-22T19:17:20Z", null, 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, null, null, "2016-03-22T19:15:32Z", null, 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, null, null, "2016-03-22T19:14:32Z", null, 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, null, null, "2016-03-22T19:15:50Z", null, 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, null, null, "2016-03-22T19:16:37Z", null, 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, null, null, "2016-03-22T19:14:44Z", null, 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, null, null, "2016-03-22T19:14:52Z", null, 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, null, null, "2016-03-22T19:17:06Z", null, 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, null, null, "2016-03-22T19:14:21Z", null, 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, null, null, "2016-03-22T19:17:27Z", null, 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", null, "2015-07-07T19:12:21Z", null, 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", null, "2015-07-07T19:12:15Z", null, 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", null, "2015-07-07T19:11:58Z", null, 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", null, "2015-05-20T18:57:40Z", null, 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, null, null, "2015-05-20T20:21:30Z", null, 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, null, null, "2015-05-20T20:21:37Z", null, 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, null, null, "2015-05-20T20:21:46Z", null, 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", null, "2015-04-24T19:44:06Z", null, 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", null, "2015-04-16T14:07:15Z", null, 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, null, null, "2015-04-09T15:30:33Z", null, 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, null, null, "2015-04-09T16:21:32Z", null, 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, null, null, "2020-02-07T19:33:21Z", null, 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, null, null, "2015-04-09T15:28:05Z", null, 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, null, null, "2015-04-09T15:59:59Z", null, 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, null, null, "2015-04-09T16:15:31Z", null, 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, null, null, "2015-04-09T15:27:13Z", null, 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, null, null, "2015-04-09T15:29:14Z", null, 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, null, null, "2020-02-07T17:27:39Z", null, 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, null, null, "2015-04-09T15:29:33Z", null, 0, 0, "0900006481a95729"], ["FDA-1975-N-0012-0528", "FDA", "FDA-1975-N-0012", "Appendix B: Assessment of the Developmental and \nReproductive (DART) Database for Chloroxylenol Re: Briefing Document from American Cleaning Institute", "Supporting & Related Material", "Background Material", "2015-04-09T04:00:00Z", 2015, 4, null, null, "2015-04-09T15:52:04Z", null, 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, null, null, "2015-04-09T15:30:13Z", null, 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, null, null, "2015-04-09T15:43:08Z", null, 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, null, null, "2015-04-09T15:29:52Z", null, 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", null, "2015-04-09T15:25:57Z", null, 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, null, null, "2015-04-09T15:39:47Z", null, 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, null, null, "2015-04-09T16:06:07Z", null, 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, null, null, "2015-04-09T15:27:37Z", null, 0, 0, "0900006481a95725"], ["FDA-1975-N-0012-0534", "FDA", "FDA-1975-N-0012", "APPENDIX 3 Sanderson H, Counts JL, Stanton KL, Sedlak Rl. 2006. 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