{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\", docket_id = \"FDA-1975-N-0012\" and posted_year = 2016 sorted by posted_date descending", "rows": [["FDA-1975-N-0012-0723", "FDA", "FDA-1975-N-0012", "Response Letter from American Cleaning Institute (ACI)", "Other", "Letter(s)", "2016-12-12T05:00:00Z", 2016, 12, "2016-12-12T05:00:00Z", null, "2016-12-12T21:52:28Z", null, 0, 0, "09000064823fcc03"], ["FDA-1975-N-0012-0722", "FDA", "FDA-1975-N-0012", "Draft Protocol Study from American Cleaning Institute", "Supporting & Related Material", "Background Material", "2016-11-25T05:00:00Z", 2016, 11, null, null, "2016-11-25T14:19:32Z", null, 0, 0, "09000064823be604"], ["FDA-1975-N-0012-0710", "FDA", "FDA-1975-N-0012", "Reference 58 Infections and Pseudoinfections Due to Povidone-Iodine Solution Contaminated with Pseudomonas cepacia re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:20Z", null, 0, 0, "09000064821bfd1d"], ["FDA-1975-N-0012-0652", "FDA", "FDA-1975-N-0012", "List of References re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:48:25Z", null, 0, 0, "09000064821bfa64"], ["FDA-1975-N-0012-0657", "FDA", "FDA-1975-N-0012", "Reference  5 Minutes_of_Meeting,_11_14_2008 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:39Z", null, 0, 0, "09000064821bfaa7"], ["FDA-1975-N-0012-0670", "FDA", "FDA-1975-N-0012", "Reference 18 Involvement of efflux mechanisms in biocide resistance of Campylobacter jejuni and Campylobacter coli re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:40Z", null, 0, 0, "09000064821bfafe"], ["FDA-1975-N-0012-0683", "FDA", "FDA-1975-N-0012", "Reference 31 Investigation of antibiotic and antibacterial agent cross-resistance in target bacteria from homes of antibacterial product users and nonusers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:36Z", null, 0, 0, "09000064821bfb07"], ["FDA-1975-N-0012-0690", "FDA", "FDA-1975-N-0012", "Reference 38 Use of antibacterial consumer products containing\nquaternary ammonium compounds and drug resistance in the community re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:02Z", null, 0, 0, "09000064821bfb1e"], ["FDA-1975-N-0012-0694", "FDA", "FDA-1975-N-0012", "Reference 42 Cross-resistance to antibiotics of Escherichia coli adapted\nto benzalkonium chloride or exposed to stress-inducers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:42Z", null, 0, 0, "09000064821bfb22"], ["FDA-1975-N-0012-0696", "FDA", "FDA-1975-N-0012", "Reference 44 Adaptive resistance to benzalkonium chloride, amikacin and tobramycin: the effect on susceptibility to other antimicrobials re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:32Z", null, 0, 0, "09000064821bfb24"], ["FDA-1975-N-0012-0700", "FDA", "FDA-1975-N-0012", "Reference 48 330TOXICOLOGY AND CARCINOGENESISSTUDIES OF4-HEXYLRESORCINOL(CAS NO. 136-77-6)IN F344/N RATS AND B6C3Fi MICE(GAVAGE STUDIES) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:14Z", null, 0, 0, "09000064821bfb2c"], ["FDA-1975-N-0012-0716", "FDA", "FDA-1975-N-0012", "Reference 64 NTP Research Concept: Triclocarban re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:37:49Z", null, 0, 0, "09000064821bfb51"], ["FDA-1975-N-0012-0721", "FDA", "FDA-1975-N-0012", "Reference 70 SCCS final Opinion on triclosan June 2010 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:37:25Z", null, 0, 0, "09000064821bfb58"], ["FDA-1975-N-0012-0653", "FDA", "FDA-1975-N-0012", "Reference 1 Transcript of Jan 22 1997 Joint Meeting re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:48:20Z", null, 0, 0, "09000064821bfa65"], ["FDA-1975-N-0012-0661", "FDA", "FDA-1975-N-0012", "Reference  9 Effect of Antibacterial Home Cleaning and Handwashing Products on Infectious Disease Symptoms re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:22Z", null, 0, 0, "09000064821bfaf5"], ["FDA-1975-N-0012-0662", "FDA", "FDA-1975-N-0012", "Reference 10 Elimination of methicillin-resistant Siaphylococcus aureus from a neonatal intensive care unit after hand washing with triclosan re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:17Z", null, 0, 0, "09000064821bfaf6"], ["FDA-1975-N-0012-0663", "FDA", "FDA-1975-N-0012", "Reference 11 Use of 0.3% triclosan (Bacti-Stat*) to eradicate an outbreak of methicillin-resistant Staphylococcus aureus in a neonatal nursery re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:13Z", null, 0, 0, "09000064821bfaf7"], ["FDA-1975-N-0012-0669", "FDA", "FDA-1975-N-0012", "Reference 17 Substrate specificity of the OqxAB multidrug resistance pump in Escherichia coli and selected enteric bacteria re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:44Z", null, 0, 0, "09000064821bfafd"], ["FDA-1975-N-0012-0681", "FDA", "FDA-1975-N-0012", "Reference 29 Prevalence of decreased susceptibility to triclosan in Salmonella enterica isolates from animals and humans and association with multiple drug resistance re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:46Z", null, 0, 0, "09000064821bfb05"], ["FDA-1975-N-0012-0693", "FDA", "FDA-1975-N-0012", "Reference 41 Triclosan resistance in methicillin-resistant Staphylococcus aureus (MRSA) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:48Z", null, 0, 0, "09000064821bfb21"], ["FDA-1975-N-0012-0714", "FDA", "FDA-1975-N-0012", "Reference 62 Pseudobacteremia Caused by Povidone-Iodine Solution Contaminated with Pseudomonas Cepacia re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:00Z", null, 0, 0, "09000064821bfd21"], ["FDA-1975-N-0012-0715", "FDA", "FDA-1975-N-0012", "Reference 63 Triclocarban_HPV_Robust_Study_Summaries re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:37:54Z", null, 0, 0, "09000064821bfd22"], ["FDA-1975-N-0012-0675", "FDA", "FDA-1975-N-0012", "Reference 23 Triclosan Can Select for an AdeIJK-Overexpressing Mutant of Acinetobacter baumannii ATCC 17978 That Displays Reduced Susceptibility to Multiple Antibiotics re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:16Z", null, 0, 0, "09000064821bf8f6"], ["FDA-1975-N-0012-0658", "FDA", "FDA-1975-N-0012", "Reference  6 NDAC 2014 Transcript re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:34Z", null, 0, 0, "09000064821bfaa8"], ["FDA-1975-N-0012-0664", "FDA", "FDA-1975-N-0012", "Reference 12 Quantitative Microbial Risk Assessment of Antibacterial Hand Hygiene Products on Risk of Shigellosis re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:09Z", null, 0, 0, "09000064821bfaf8"], ["FDA-1975-N-0012-0688", "FDA", "FDA-1975-N-0012", "Reference 36 Investigation of antibiotic and antibacterial agent cross-resistance in target bacteria from homes of antibacterial product users and nonusers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:13Z", null, 0, 0, "09000064821bfb0d"], ["FDA-1975-N-0012-0702", "FDA", "FDA-1975-N-0012", "Reference 50 Antimicrobial Effectiveness of Povidone-Iodine and Consequences for New Application Areas. re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:59Z", null, 0, 0, "09000064821bfb2e"], ["FDA-1975-N-0012-0706", "FDA", "FDA-1975-N-0012", "Reference 54 Evaluation of chlorhexidine and povidone iodine activity against methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus faecalis using a surface test re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:39Z", null, 0, 0, "09000064821bfd19"], ["FDA-1975-N-0012-0707", "FDA", "FDA-1975-N-0012", "Reference 55 Iodine and Iodine Compounds re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:35Z", null, 0, 0, "09000064821bfd1a"], ["FDA-1975-N-0012-0667", "FDA", "FDA-1975-N-0012", "Reference 15 Statistical, Epidemiological, and Risk-Assessment Approaches to Evaluating Safety of Vaccines Throughout the Life Cycle at the Food and Drug Administration re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:53Z", null, 0, 0, "09000064821bfafb"], ["FDA-1975-N-0012-0651", "FDA", "FDA-1975-N-0012", "Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Rule", "Final Rule", "2016-09-06T04:00:00Z", 2016, 9, "2016-09-06T04:00:00Z", "2019-04-04T03:59:59Z", "2019-04-03T01:05:19Z", "2016-21337", 0, 0, "09000064821d2e5a"], ["FDA-1975-N-0012-0678", "FDA", "FDA-1975-N-0012", "Reference 26 Resistant Mechanism Study of Benzalkonium Chloride Selected Salmonella Typhimurium Mutants re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:00Z", null, 0, 0, "09000064821bf8f9"], ["FDA-1975-N-0012-0660", "FDA", "FDA-1975-N-0012", "Reference  8 Effect of handwashing on child health: a randomised\ncontrolled trial re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:26Z", null, 0, 0, "09000064821bfaaf"], ["FDA-1975-N-0012-0686", "FDA", "FDA-1975-N-0012", "Reference 34 Relationship between Triclosan and Susceptibilities of Bacteria Isolated from Hands in the Community re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:22Z", null, 0, 0, "09000064821bfb0a"], ["FDA-1975-N-0012-0692", "FDA", "FDA-1975-N-0012", "Reference 40 Adaptive Resistance to Biocides in Salmonella enterica and\nEscherichia coli O157 and Cross-Resistance to Antimicrobial Agents re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:53Z", null, 0, 0, "09000064821bfb20"], ["FDA-1975-N-0012-0704", "FDA", "FDA-1975-N-0012", "Reference 52 Povidone Iodine re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:49Z", null, 0, 0, "09000064821bfb33"], ["FDA-1975-N-0012-0705", "FDA", "FDA-1975-N-0012", "Reference 53 Antiseptic Efficacy of Disinfecting Solutions in Suspension Test in vitro against Methicillin-Resistant Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli in Pressure Sore Wounds after Spinal Cord Injury re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:45Z", null, 0, 0, "09000064821bfb34"], ["FDA-1975-N-0012-0720", "FDA", "FDA-1975-N-0012", "Reference 69 Short-term in vivo exposure to the water contaminant triclosan: Evidence for disruption of thyroxine re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:37:31Z", null, 0, 0, "09000064821bfb57"], ["FDA-1975-N-0012-0673", "FDA", "FDA-1975-N-0012", "Reference 21 Salmonella enterica serovar Typhimurium multidrug\nefflux pumps EmrAB and AcrEF support the major efflux system AcrAB in decreased susceptibility to triclosan re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:26Z", null, 0, 0, "09000064821bf8f4"], ["FDA-1975-N-0012-0689", "FDA", "FDA-1975-N-0012", "Reference 37 The Frequency of Antibiotic-Resistant Bacteria in Homes\nDiffering in Their Use of Surface Antibacterial Agents re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:07Z", null, 0, 0, "09000064821bfb0e"], ["FDA-1975-N-0012-0697", "FDA", "FDA-1975-N-0012", "Reference 45 ICH HARMONISED TRIPARTITE GUIDELINE TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS S1B Current Step 4 version\ndated 16 July 1997 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:28Z", null, 0, 0, "09000064821bfb25"], ["FDA-1975-N-0012-0698", "FDA", "FDA-1975-N-0012", "Reference 46 Guidance for Industry S1B Testing for Carcinogenicity of\nPharmaceuticals re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:24Z", null, 0, 0, "09000064821bfb27"], ["FDA-1975-N-0012-0703", "FDA", "FDA-1975-N-0012", "Reference 51 Povidone\u2013iodine: use in hand disinfection, skin preparation\nand antiseptic irrigation re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:54Z", null, 0, 0, "09000064821bfb32"], ["FDA-1975-N-0012-0676", "FDA", "FDA-1975-N-0012", "Reference 24 Mutations upstream of fabI in triclosan resistant\nStaphylococcus aureus strains are associated with elevated fabI gene expression re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:12Z", null, 0, 0, "09000064821bf8f7"], ["FDA-1975-N-0012-0684", "FDA", "FDA-1975-N-0012", "Reference 32 Chloroxylenol- and triclosan-tolerant bacteria from industrial sources\u2014susceptibility to antibiotics and other biocides re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:32Z", null, 0, 0, "09000064821bfb08"], ["FDA-1975-N-0012-0717", "FDA", "FDA-1975-N-0012", "Reference 65 Scientific Committee on Consumer Products OPINION ON\nDermal Sensitisation Quantitative Risk Assessment (Citral, Farnesol and Phenylacetaldehyde) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:37:45Z", null, 0, 0, "09000064821bfb52"], ["FDA-1975-N-0012-0718", "FDA", "FDA-1975-N-0012", "Reference 66 Newsletter of the European Commission Scientific Committees June 2011 en re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:37:40Z", null, 0, 0, "09000064821bfb55"], ["FDA-1975-N-0012-0712", "FDA", "FDA-1975-N-0012", "Reference 60 CDC Contaminated Povidone-Iodine Solution -- Texas re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:10Z", null, 0, 0, "09000064821bfd1f"], ["FDA-1975-N-0012-0713", "FDA", "FDA-1975-N-0012", "Reference 61 Pseudobacteremia Attributed to Contamination of Povidone-Iodine with Psedomonas cepacia re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:04Z", null, 0, 0, "09000064821bfd20"], ["FDA-1975-N-0012-0655", "FDA", "FDA-1975-N-0012", "Reference  3 NDAC March 2005 Transcript re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:48:08Z", null, 0, 0, "09000064821bfa69"], ["FDA-1975-N-0012-0656", "FDA", "FDA-1975-N-0012", "Reference  4 NDAC October 2005 Transcript re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:45Z", null, 0, 0, "09000064821bfaa6"], ["FDA-1975-N-0012-0709", "FDA", "FDA-1975-N-0012", "Reference 57 Drug Resistance Studies with Topical Antiseptics re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:25Z", null, 0, 0, "09000064821bfd1c"], ["FDA-1975-N-0012-0666", "FDA", "FDA-1975-N-0012", "Reference 14 Quanti\u008e cation and Variability Analysis of Bacterial Cross-Contamination Rates in Common Food Service Tasks re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:57Z", null, 0, 0, "09000064821bfafa"], ["FDA-1975-N-0012-0668", "FDA", "FDA-1975-N-0012", "Reference 16 Recent advances in the potential interconnection between antimicrobial resistance to biocides and antibiotics re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:48Z", null, 0, 0, "09000064821bfafc"], ["FDA-1975-N-0012-0687", "FDA", "FDA-1975-N-0012", "Reference 35 Antibacterial Cleaning Products and Drug Resistance re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:18Z", null, 0, 0, "09000064821bfb0b"], ["FDA-1975-N-0012-0695", "FDA", "FDA-1975-N-0012", "Reference 43 Development of triclosan and antibiotic resistance in Salmonella enterica serovar Typhimurium re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:37Z", null, 0, 0, "09000064821bfb23"], ["FDA-1975-N-0012-0699", "FDA", "FDA-1975-N-0012", "Reference 47 Citizen_Petition_from_Comprehensive_Technology_Center re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:19Z", null, 0, 0, "09000064821bfb2b"], ["FDA-1975-N-0012-0719", "FDA", "FDA-1975-N-0012", "Reference 68 Absorption and Metabolism of Triclosan After Application to the Skin of B6C3F1 Mice re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:37:35Z", null, 0, 0, "09000064821bfb56"], ["FDA-1975-N-0012-0711", "FDA", "FDA-1975-N-0012", "Reference 59 Nosocomial Outbreaks: The Centers for Disease Control\u2019s Hospital Infections Program Experience, 1980-1990 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:15Z", null, 0, 0, "09000064821bfd1e"], ["FDA-1975-N-0012-0672", "FDA", "FDA-1975-N-0012", "Reference 20 Polymorphic Variation in Susceptibility and Metabolism of Triclosan-Resistant Mutants of Escherichia coli and Klebsiella  pneumoniae Clinical Strains Obtained after Exposure to Biocides and Antibiotics re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:31Z", null, 0, 0, "09000064821bf8f3"], ["FDA-1975-N-0012-0674", "FDA", "FDA-1975-N-0012", "Reference 22 Analysis of Triclosan-Selected Salmonella enterica\nMutants of Eight Serovars Revealed Increased Aminoglycoside Susceptibility and Reduced Growth Rates re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:21Z", null, 0, 0, "09000064821bf8f5"], ["FDA-1975-N-0012-0677", "FDA", "FDA-1975-N-0012", "Reference 25 Molecular mechanisms of higher MICs of antibiotics and quaternary ammonium compounds for Escherichia coli isolated from bacteraemia re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:07Z", null, 0, 0, "09000064821bf8f8"], ["FDA-1975-N-0012-0679", "FDA", "FDA-1975-N-0012", "Reference 27 Adapted tolerance to benzalkonium chloride in Escherichia coli K-12 studied by transcriptome and proteome analyses re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:55Z", null, 0, 0, "09000064821bf8fa"], ["FDA-1975-N-0012-0654", "FDA", "FDA-1975-N-0012", "Reference  2 Comment No FDA-1975-N-0012-0081 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:48:15Z", null, 0, 0, "09000064821bfa68"], ["FDA-1975-N-0012-0701", "FDA", "FDA-1975-N-0012", "Reference 49 Molecular Effects of Povidone-Iodine on RElevant Microorganisms: An Electron-Microscopic and Biochemical Study re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:05Z", null, 0, 0, "09000064821bfb2d"], ["FDA-1975-N-0012-0708", "FDA", "FDA-1975-N-0012", "Reference 56 Absence of bacterial resistance to povidone iodine re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:38:30Z", null, 0, 0, "09000064821bfd1b"], ["FDA-1975-N-0012-0671", "FDA", "FDA-1975-N-0012", "Reference 19 Development of antimicrobial resistance in Campylobacter jejuni and Campylobacter coli adapted to biocides re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:41:35Z", null, 0, 0, "09000064821bf8f2"], ["FDA-1975-N-0012-0659", "FDA", "FDA-1975-N-0012", "Reference  7 37 FR 9464, 1972,  Part 130 Procedure for classification of OTC drugs re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:30Z", null, 0, 0, "09000064821bfaae"], ["FDA-1975-N-0012-0680", "FDA", "FDA-1975-N-0012", "Reference 28 Evaluation of Epidemiological Cut-Off Values Indicates\nthat Biocide Resistant Subpopulations Are Uncommon in Natural Isolates of Clinically-Relevant Microorganisms re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:50Z", null, 0, 0, "09000064821bf8fb"], ["FDA-1975-N-0012-0665", "FDA", "FDA-1975-N-0012", "Reference 13 Quanti\u008e cation and Variability Analysis of Bacterial Cross-Contamination Rates in Common Food Service Tasks re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:42:04Z", null, 0, 0, "09000064821bfaf9"], ["FDA-1975-N-0012-0682", "FDA", "FDA-1975-N-0012", "Reference 30 Staphylococcus epidermidis Isolated in 1965 Are More\nSusceptible to Triclosan than Current Isolates re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:41Z", null, 0, 0, "09000064821bfb06"], ["FDA-1975-N-0012-0685", "FDA", "FDA-1975-N-0012", "Reference 33 Chloroxylenol- and triclosan-tolerant bacteria from industrial sources re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:40:27Z", null, 0, 0, "09000064821bfb09"], ["FDA-1975-N-0012-0691", "FDA", "FDA-1975-N-0012", "Reference 39 The Use of Machine Learning Methodologies to Analyse\nAntibiotic and Biocide Susceptibility in Staphylococcus aureus re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2016-09-06T04:00:00Z", 2016, 9, null, null, "2016-09-06T14:39:57Z", null, 0, 0, "09000064821bfb1f"], ["FDA-1975-N-0012-0649", "FDA", "FDA-1975-N-0012", "Letter from Lewis and Harrison (Lonza,Inc.) to FDA CDER", "Other", "Letter(s)", "2016-08-12T04:00:00Z", 2016, 8, "2016-08-12T04:00:00Z", null, "2016-08-12T19:29:47Z", null, 0, 0, "090000648217253d"], ["FDA-1975-N-0012-0650", "FDA", "FDA-1975-N-0012", "Handwashing Habits Child Care Workers GLM 16123 National Online Study with Child Care Providers Conducted on Behalf of the American Cleaning Institute (April 2016)", "Supporting & Related Material", "Background Material", "2016-08-12T04:00:00Z", 2016, 8, null, null, "2016-08-12T19:41:45Z", null, 0, 0, "090000648217253c"], ["FDA-1975-N-0012-0648", "FDA", "FDA-1975-N-0012", "Memorandum of Meeting Minutes Between FDA CDER and Lonza America, Inc", "Other", "Memorandum", 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