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withdrawn,object_id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-0012-0723,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,,2016-12-12T21:52:28Z,,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,,,2016-11-25T14:19:32Z,,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,,,2016-09-06T14:38:20Z,,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,,,2016-09-06T14:48:25Z,,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,,,2016-09-06T14:42:39Z,,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,,,2016-09-06T14:41:40Z,,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,,,2016-09-06T14:40:36Z,,0,0,09000064821bfb07
FDA-1975-N-0012-0690,FDA,FDA-1975-N-0012,"Reference 38 Use of antibacterial consumer products containing
quaternary 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,,,2016-09-06T14:40:02Z,,0,0,09000064821bfb1e
FDA-1975-N-0012-0694,FDA,FDA-1975-N-0012,"Reference 42 Cross-resistance to antibiotics of Escherichia coli adapted
to 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,,,2016-09-06T14:39:42Z,,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,,,2016-09-06T14:39:32Z,,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,,,2016-09-06T14:39:14Z,,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,,,2016-09-06T14:37:49Z,,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,,,2016-09-06T14:37:25Z,,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,,,2016-09-06T14:48:20Z,,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,,,2016-09-06T14:42:22Z,,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,,,2016-09-06T14:42:17Z,,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,,,2016-09-06T14:42:13Z,,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,,,2016-09-06T14:41:44Z,,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,,,2016-09-06T14:40:46Z,,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,,,2016-09-06T14:39:48Z,,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,,,2016-09-06T14:38:00Z,,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,,,2016-09-06T14:37:54Z,,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,,,2016-09-06T14:41:16Z,,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,,,2016-09-06T14:42:34Z,,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,,,2016-09-06T14:42:09Z,,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,,,2016-09-06T14:40:13Z,,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,,,2016-09-06T14:38:59Z,,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,,,2016-09-06T14:38:39Z,,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,,,2016-09-06T14:38:35Z,,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,,,2016-09-06T14:41:53Z,,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,,,2016-09-06T14:41:00Z,,0,0,09000064821bf8f9
FDA-1975-N-0012-0660,FDA,FDA-1975-N-0012,"Reference  8 Effect of handwashing on child health: a randomised
controlled 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,,,2016-09-06T14:42:26Z,,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,,,2016-09-06T14:40:22Z,,0,0,09000064821bfb0a
FDA-1975-N-0012-0692,FDA,FDA-1975-N-0012,"Reference 40 Adaptive Resistance to Biocides in Salmonella enterica and
Escherichia 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,,,2016-09-06T14:39:53Z,,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,,,2016-09-06T14:38:49Z,,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,,,2016-09-06T14:38:45Z,,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,,,2016-09-06T14:37:31Z,,0,0,09000064821bfb57
FDA-1975-N-0012-0673,FDA,FDA-1975-N-0012,"Reference 21 Salmonella enterica serovar Typhimurium multidrug
efflux 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,,,2016-09-06T14:41:26Z,,0,0,09000064821bf8f4
FDA-1975-N-0012-0689,FDA,FDA-1975-N-0012,"Reference 37 The Frequency of Antibiotic-Resistant Bacteria in Homes
Differing 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,,,2016-09-06T14:40:07Z,,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
dated 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,,,2016-09-06T14:39:28Z,,0,0,09000064821bfb25
FDA-1975-N-0012-0698,FDA,FDA-1975-N-0012,"Reference 46 Guidance for Industry S1B Testing for Carcinogenicity of
Pharmaceuticals 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,,,2016-09-06T14:39:24Z,,0,0,09000064821bfb27
FDA-1975-N-0012-0703,FDA,FDA-1975-N-0012,"Reference 51 Povidone–iodine: use in hand disinfection, skin preparation
and 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,,,2016-09-06T14:38:54Z,,0,0,09000064821bfb32
FDA-1975-N-0012-0676,FDA,FDA-1975-N-0012,"Reference 24 Mutations upstream of fabI in triclosan resistant
Staphylococcus 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,,,2016-09-06T14:41:12Z,,0,0,09000064821bf8f7
FDA-1975-N-0012-0684,FDA,FDA-1975-N-0012,Reference 32 Chloroxylenol- and triclosan-tolerant bacteria from industrial sources—susceptibility 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,,,2016-09-06T14:40:32Z,,0,0,09000064821bfb08
FDA-1975-N-0012-0717,FDA,FDA-1975-N-0012,"Reference 65 Scientific Committee on Consumer Products OPINION ON
Dermal 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,,,2016-09-06T14:37:45Z,,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,,,2016-09-06T14:37:40Z,,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,,,2016-09-06T14:38:10Z,,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,,,2016-09-06T14:38:04Z,,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,,,2016-09-06T14:48:08Z,,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,,,2016-09-06T14:42:45Z,,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,,,2016-09-06T14:38:25Z,,0,0,09000064821bfd1c
FDA-1975-N-0012-0666,FDA,FDA-1975-N-0012,Reference 14 QuantiŽ 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,,,2016-09-06T14:41:57Z,,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,,,2016-09-06T14:41:48Z,,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,,,2016-09-06T14:40:18Z,,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,,,2016-09-06T14:39:37Z,,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,,,2016-09-06T14:39:19Z,,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,,,2016-09-06T14:37:35Z,,0,0,09000064821bfb56
FDA-1975-N-0012-0711,FDA,FDA-1975-N-0012,"Reference 59 Nosocomial Outbreaks: The Centers for Disease Control’s 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,,,2016-09-06T14:38:15Z,,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,,,2016-09-06T14:41:31Z,,0,0,09000064821bf8f3
FDA-1975-N-0012-0674,FDA,FDA-1975-N-0012,"Reference 22 Analysis of Triclosan-Selected Salmonella enterica
Mutants 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,,,2016-09-06T14:41:21Z,,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,,,2016-09-06T14:41:07Z,,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,,,2016-09-06T14:40:55Z,,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,,,2016-09-06T14:48:15Z,,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,,,2016-09-06T14:39:05Z,,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,,,2016-09-06T14:38:30Z,,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,,,2016-09-06T14:41:35Z,,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,,,2016-09-06T14:42:30Z,,0,0,09000064821bfaae
FDA-1975-N-0012-0680,FDA,FDA-1975-N-0012,"Reference 28 Evaluation of Epidemiological Cut-Off Values Indicates
that 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,,,2016-09-06T14:40:50Z,,0,0,09000064821bf8fb
FDA-1975-N-0012-0665,FDA,FDA-1975-N-0012,Reference 13 QuantiŽ 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,,,2016-09-06T14:42:04Z,,0,0,09000064821bfaf9
FDA-1975-N-0012-0682,FDA,FDA-1975-N-0012,"Reference 30 Staphylococcus epidermidis Isolated in 1965 Are More
Susceptible 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,,,2016-09-06T14:40:41Z,,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,,,2016-09-06T14:40:27Z,,0,0,09000064821bfb09
FDA-1975-N-0012-0691,FDA,FDA-1975-N-0012,"Reference 39 The Use of Machine Learning Methodologies to Analyse
Antibiotic 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,,,2016-09-06T14:39:57Z,,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,,2016-08-12T19:29:47Z,,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,,,2016-08-12T19:41:45Z,,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,2016-06-28T04:00:00Z,2016,6,2016-06-28T04:00:00Z,,2016-06-28T11:23:36Z,,0,0,0900006482073c0d
FDA-1975-N-0012-0647,FDA,FDA-1975-N-0012,"Letter from FDA CDER to Lonza America Inc. Re: Meeting Request Granted for May 25, 2016",Other,Agency Response,2016-05-18T04:00:00Z,2016,5,2016-05-18T04:00:00Z,,2016-05-18T12:42:16Z,,0,0,0900006481fda242
FDA-1975-N-0012-0646,FDA,FDA-1975-N-0012,Response from American Cleaning Institute to FDA CDER (re: Benzalkonium Chloride),Other,Response(s),2016-05-06T04:00:00Z,2016,5,2016-05-06T04:00:00Z,,2016-05-06T18:40:24Z,,0,0,0900006481fb26e3
FDA-1975-N-0012-0645,FDA,FDA-1975-N-0012,Response from American Cleaning Institute to FDA CDER (re: Chloroxylenol),Other,Response(s),2016-05-06T04:00:00Z,2016,5,2016-05-06T04:00:00Z,,2016-05-06T18:36:11Z,,0,0,0900006481fb26e2
FDA-1975-N-0012-0644,FDA,FDA-1975-N-0012,"Attachment 1 Agenda for Lonza-FDA Meeting re: Briefing Document from Lonza, Inc. (Lewis & Harrison)",Supporting & Related Material,Background Material,2016-04-26T04:00:00Z,2016,4,,,2016-04-26T19:31:34Z,,0,0,0900006481f8f9e8
FDA-1975-N-0012-0643,FDA,FDA-1975-N-0012,"Draft Protocol for Hormonal Effects Studies: Uterotrophic Bioassay of Benzethonium Chloride USP by Oral (Gavage) in Female Rats re Comment from Lonza Inc, Lewis & Harrison",Supporting & Related Material,Background Material,2016-03-22T04:00:00Z,2016,3,,,2016-03-22T19:48:19Z,,0,0,0900006481983bed
FDA-1975-N-0012-0640,FDA,FDA-1975-N-0012,"Letter from FDA CDER to Lonza America, Inc., American Cleaning Institute and Henkel North America regarding Review of Benzethonium Chloride",Other,Letter(s),2016-03-10T05:00:00Z,2016,3,2016-03-10T05:00:00Z,,2016-03-10T22:07:14Z,,0,0,0900006481ebae9d
FDA-1975-N-0012-0639,FDA,FDA-1975-N-0012,"Letter from FDA CDER to Lonza America, Inc., American Cleaning Institute and Henkel North America regarding Review of Benzalkonium Chloride",Other,Letter(s),2016-03-10T05:00:00Z,2016,3,2016-03-10T05:00:00Z,,2016-03-10T22:04:06Z,,0,0,0900006481eba838
FDA-1975-N-0012-0637,FDA,FDA-1975-N-0012,"Request from Henkel Consumer Goods, Inc.",Other,Request,2016-03-10T05:00:00Z,2016,3,2016-03-10T05:00:00Z,,2016-03-10T21:53:09Z,,0,0,0900006481d6ae19
FDA-1975-N-0012-0638,FDA,FDA-1975-N-0012,Letter from FDA CDER to American Cleaning Institute and Henkel North America regarding Review of Chloroxylenol,Other,Letter(s),2016-03-10T05:00:00Z,2016,3,2016-03-10T05:00:00Z,,2016-03-10T22:01:29Z,,0,0,0900006481eba837