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214 rows where docket_id = "FDA-2016-N-0124" and posted_year = 2016 sorted by posted_date descending

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  • 2016 · 214 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2016-N-0124-0256 FDA None FDA-2016-N-0124 Advice Letter from FDA CDER to American Chemistry Council Supporting & Related Material Letter 2016-12-30T05:00:00Z 2016 12     2016-12-30T18:09:27Z   0 0 0900006482442593
FDA-2016-N-0124-0213 FDA None FDA-2016-N-0124 Safety and Effectiveness of Consumer Antiseptic Rub Products; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-07-19T04:00:00Z 2016 7     2016-07-19T15:35:39Z   0 0 09000064820cc4d9
FDA-2016-N-0124-0069 FDA None FDA-2016-N-0124 Reference 29-8 Kampf et al, Efficacy of ethanol based foams, 2010 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:17:15Z   0 0 09000064820750b2
FDA-2016-N-0124-0196 FDA None FDA-2016-N-0124 List of References re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:00:05Z   0 0 0900006482079de4
FDA-2016-N-0124-0206 FDA None FDA-2016-N-0124 Econ Reference 10 – Johnston et al, The alcohol hand rub a good soap substitute re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:03:30Z   0 0 0900006482079e34
FDA-2016-N-0124-0165 FDA None FDA-2016-N-0124 Reference 121 - FDA-1975-N-0012-0633 -Study 8 Volume 2 of 2 Gill M W et al Chronic Dietary Toxicity Oncogenicity Study re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:50:20Z   0 0 09000064820755dd
FDA-2016-N-0124-0172 FDA None FDA-2016-N-0124 Reference 128- Loughlin et al, Pseudomonas Cells Adapted to BKC & Antibiotics re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:52:29Z   0 0 09000064820755e5
FDA-2016-N-0124-0173 FDA None FDA-2016-N-0124 Reference 129 - Joynson et al, Adaptive Resistance to BKC & antibiotics re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:53:11Z   0 0 09000064820755e6
FDA-2016-N-0124-0179 FDA None FDA-2016-N-0124 Reference 135 - Bevan et al, Two Generation Reproductive Toxicity Study with Isopropanol in Rats re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:54:47Z   0 0 090000648207561a
FDA-2016-N-0124-0180 FDA None FDA-2016-N-0124 178 Reference 136 - McEvoy et al, The Effect of High Concentration Isopropanol on the Growth of a Solvent-Tolerant Strain of Chlorella vulgaris re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:55:03Z   0 0 090000648207561b
FDA-2016-N-0124-0195 FDA None FDA-2016-N-0124 Reference 151 - Burleigh-Flayer et al, Isopropanol Vapor Inhalation Oncogenicity Study in Fisher 344 Rats and CD-1 Mice re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:59:42Z   0 0 090000648207562c
FDA-2016-N-0124-0113 FDA None FDA-2016-N-0124 Reference 69 - Karatzas et al, Salmonella and TCS resistance 2007 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:33:46Z   0 0 0900006482075516
FDA-2016-N-0124-0132 FDA None FDA-2016-N-0124 Reference 88 - NTP Toxicology and Carcinogenesis Studies of Benzethonium Chloride CAS 121-54-0 in F344N Rats and B6C3F1 Mice 1995 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:40:36Z   0 0 090000648207555b
FDA-2016-N-0124-0015 FDA None FDA-2016-N-0124 Reference 13 - 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; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:00:58Z   0 0 0900006482075449
FDA-2016-N-0124-0037 FDA None FDA-2016-N-0124 Reference 24-11 Prazuck et al. Reducing gastroenteritis occurences re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:07:41Z   0 0 0900006482075474
FDA-2016-N-0124-0046 FDA None FDA-2016-N-0124 Reference 24-20 Lennel et al., Alcohol-based hand-disinfection reduced children’s absence from Swedish day care centers re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:10:15Z   0 0 090000648207547d
FDA-2016-N-0124-0051 FDA None FDA-2016-N-0124 Reference 24-25 Savolainen-Kopra et al., STOPFLU is it possible to reduce number of days re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:11:41Z   0 0 0900006482075486
FDA-2016-N-0124-0111 FDA None FDA-2016-N-0124 Reference 67 - FDA draft guidance for industry, Bioanalytical Method Validation (Revision 1)September 2013 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:33:12Z   0 0 0900006482075514
FDA-2016-N-0124-0112 FDA None FDA-2016-N-0124 Reference 68 - Chuanchuen et al, Triclosan cross-resistance in Pseudomonas 2001 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:33:29Z   0 0 0900006482075515
FDA-2016-N-0124-0074 FDA None FDA-2016-N-0124 Reference 30 - Briefing NDAC 3-23-2005 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:18:47Z   0 0 09000064820750b7
FDA-2016-N-0124-0075 FDA None FDA-2016-N-0124 Reference 31 - Lennell et al, Alcohol based hand disinfection re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:19:08Z   0 0 09000064820750b8
FDA-2016-N-0124-0076 FDA None FDA-2016-N-0124 Reference 32 - Comments from docket FDA-1975-N-0012 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:19:37Z   0 0 09000064820750b9
FDA-2016-N-0124-0078 FDA None FDA-2016-N-0124 Reference 34 - Pandejpong et al, Appropriate time-interval application of alcohol hand gel re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:20:18Z   0 0 09000064820750cb
FDA-2016-N-0124-0086 FDA None FDA-2016-N-0124 Reference 42 - Ahn et al, In vitro Biologic Activities of the Antimicrobials TCC Its Analogs and TSC in Bioassay Screens re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:23:23Z   0 0 09000064820750d3
FDA-2016-N-0124-0096 FDA None FDA-2016-N-0124 Reference 52 - Anway et al, Epigenetic Transgenerational Actions of Endocrine Disruptors re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:28:23Z   0 0 09000064820750e8
FDA-2016-N-0124-0103 FDA None FDA-2016-N-0124 Reference 59 - ICH Guideline Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5R2 November 2005 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:30:43Z   0 0 09000064820750f7
FDA-2016-N-0124-0016 FDA None FDA-2016-N-0124 Reference 14 - FDA-1975-N-0012-0062 -- C4 Ref re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:01:16Z   0 0 090000648207544a
FDA-2016-N-0124-0044 FDA None FDA-2016-N-0124 Reference 24-18 Yalcin et al.,Hand washing and adolescents. A study from seven schools in KonyaTurkey re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:09:39Z   0 0 090000648207547b
FDA-2016-N-0124-0053 FDA None FDA-2016-N-0124 Reference 24-27 Van Camp et al.,Hand sanitizer and rates of acute illness in military aviation personnel re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:12:23Z   0 0 0900006482075488
FDA-2016-N-0124-0085 FDA None FDA-2016-N-0124 Reference 41 - FDA Guideline on OTC Sunscreen safety and effectiveness re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:22:55Z   0 0 09000064820750d2
FDA-2016-N-0124-0087 FDA None FDA-2016-N-0124 Reference 44 - Crofton et al, Short-Term In Vivo Exposure to the Water Contaminant TCS re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:24:07Z   0 0 09000064820750e0
FDA-2016-N-0124-0088 FDA None FDA-2016-N-0124 Reference 45 - Gee et al, Oestrogenic and Androgenic Activity of TCS and Breast Cancer Cells re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:24:26Z   0 0 09000064820750e1
FDA-2016-N-0124-0097 FDA None FDA-2016-N-0124 Reference 53 - Bernal & Jirtle, Epigenetic Disruption - The Effects of Early Developmental Exposures re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:28:42Z   0 0 09000064820750f1
FDA-2016-N-0124-0105 FDA None FDA-2016-N-0124 Reference 61 - FDA Guideline for Industry, M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:31:21Z   0 0 09000064820750f9
FDA-2016-N-0124-0003 FDA None FDA-2016-N-0124 Reference 1 - Brown et al, Can alcohol Based Hand Rub Solutions Cause You to Lose your Driver's License re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:55:56Z   0 0 09000064820752eb
FDA-2016-N-0124-0009 FDA None FDA-2016-N-0124 Reference 7 - FDA-1975-N-0012-0081 -- C12 Vol 1 and 2 6-13-1995 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:58:09Z   0 0 0900006482075443
FDA-2016-N-0124-0010 FDA None FDA-2016-N-0124 Reference 8 - Transcript of March 23, 2005 NDAC meeting re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:58:31Z   0 0 0900006482075444
FDA-2016-N-0124-0190 FDA None FDA-2016-N-0124 Reference 146 - Martinez et al, A Comparison of the Absorption and Metabolism of Isopropyl Alcohol by Oral Dermal and Inhalation Routes re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:58:07Z   0 0 09000064820759b8
FDA-2016-N-0124-0169 FDA None FDA-2016-N-0124 Reference 125 - Bore et al, Adapted Tolerance to BKC in Ecoli Studied by Transcriptome and Proteome Analyses re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:51:21Z   0 0 09000064820755e1
FDA-2016-N-0124-0170 FDA None FDA-2016-N-0124 Reference 126 - Chuanchuen et al, Susceptibilities to Antimicrobials and Disinfectants in Salmonella Isolates Obtained from Poultry and Swine re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:51:49Z   0 0 09000064820755e3
FDA-2016-N-0124-0205 FDA None FDA-2016-N-0124 Econ Reference 9 – Turner et al, Dermal absorption of isopropyl alcohol from a commercial hand rub implications for its use in hand decontamination re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:03:14Z   0 0 0900006482079e33
FDA-2016-N-0124-0118 FDA None FDA-2016-N-0124 Reference 74 - Levy, Active Efflux a Common Mechanism for Biocide and Antibiotic Resistance re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:35:31Z   0 0 0900006482075532
FDA-2016-N-0124-0119 FDA None FDA-2016-N-0124 Reference 75 - Russell, Do Biocides Select for Antibiotic Resistance re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:35:50Z   0 0 0900006482075533
FDA-2016-N-0124-0149 FDA None FDA-2016-N-0124 Reference 105 - McDonnell, Alcohols re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:45:52Z   0 0 0900006482075591
FDA-2016-N-0124-0152 FDA None FDA-2016-N-0124 Reference 108 - Benzalkonium safety in CIR review re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:46:49Z   0 0 0900006482075595
FDA-2016-N-0124-0032 FDA None FDA-2016-N-0124 Reference 24-6 Larson et al., Impact of non pharmaceutical interventions re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:06:18Z   0 0 0900006482075465
FDA-2016-N-0124-0042 FDA None FDA-2016-N-0124 Reference 24-16 Gerald et al., Redesigning large school based trial re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:09:05Z   0 0 0900006482075479
FDA-2016-N-0124-0043 FDA None FDA-2016-N-0124 Reference 24-17 Pandejpong et al, Appropriate time-interval application of alcohol hand gel re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:09:22Z   0 0 090000648207547a
FDA-2016-N-0124-0052 FDA None FDA-2016-N-0124 Reference 24-26 Mott, P. J. et al., Alcohol-based instant hand sanitizer use in military settings a prospective cohort study of Army basic trainees re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:12:08Z   0 0 0900006482075487
FDA-2016-N-0124-0063 FDA None FDA-2016-N-0124 Reference 29-2 Salmon et al , Health Care Workers hand contamination, 2014 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:15:09Z   0 0 090000648207549c
FDA-2016-N-0124-0202 FDA None FDA-2016-N-0124 Econ Reference 6 – Levy, Antibacterial Household Products Cause for Concern re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:02:22Z   0 0 0900006482079de9
FDA-2016-N-0124-0209 FDA None FDA-2016-N-0124 Econ Reference 13 – Bessonneau et al, Assessment of Exposure to Alcohol Vapor from Alcohol-Based Hand Rubs re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:04:17Z   0 0 0900006482079e37
FDA-2016-N-0124-0212 FDA None FDA-2016-N-0124 Econ Reference 16 – Direct Source Products, Disposable Wet Wipes re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:05:33Z   0 0 0900006482079e3a
FDA-2016-N-0124-0161 FDA None FDA-2016-N-0124 Reference 117 - FDA-1975-N-0012-0629 -Study 8 Volume 1 of 3 Gill M W et al Chronic Dietary Toxicity Oncogenicity Study re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:49:14Z   0 0 09000064820755ba
FDA-2016-N-0124-0192 FDA None FDA-2016-N-0124 Reference 148 - Kapp et al, Isopropanol Summary of TSCA Test Rule Studies and Relevance to Hazard Identification re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:58:44Z   0 0 09000064820759ba
FDA-2016-N-0124-0201 FDA None FDA-2016-N-0124 Econ Reference 5 – Miller et al, Does the Clinical Use of Ethanol-Based Hand Sanitizer Elevate Blood Alcohol Levels A Prospective Study re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:02:04Z   0 0 0900006482079de8
FDA-2016-N-0124-0168 FDA None FDA-2016-N-0124 Reference 124 - Langsrud Ecoli cross R to BKC & antibiotics 2004 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:51:06Z   0 0 09000064820755e0
FDA-2016-N-0124-0181 FDA None FDA-2016-N-0124 Reference 137 - Geng et al, Biodegration of Isopropanol by a Solvent-Tolerant Paracoccus Strain re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:55:23Z   0 0 090000648207561c
FDA-2016-N-0124-0186 FDA None FDA-2016-N-0124 Reference 142 - Puschel, Percuteous Alcohol Intoxication re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:57:04Z   0 0 09000064820759b4
FDA-2016-N-0124-0114 FDA None FDA-2016-N-0124 Reference 70 - McMurry et al, Overexpression of marA, soxS, acrAB Produces Resistance to TCS in Laboratory Strains re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:34:01Z   0 0 0900006482075517
FDA-2016-N-0124-0121 FDA None FDA-2016-N-0124 Reference 77 - Martinez, Role of Natural Environments in the Evolution of Resistance Traits in Pathogenic Bacteria re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:37:14Z   0 0 0900006482075535
FDA-2016-N-0124-0134 FDA None FDA-2016-N-0124 Reference 90 - IARC Monorgaphs on the Evaluation of Carcinogenic Risks to Humans 2010 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:41:08Z   0 0 090000648207555d
FDA-2016-N-0124-0014 FDA None FDA-2016-N-0124 Reference 12 - Comments from docket FDA-1975-N-0012 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:00:38Z   0 0 0900006482075448
FDA-2016-N-0124-0073 FDA None FDA-2016-N-0124 Reference 29-12 Barbut et al, Comparison of antimicrobial efficacy, 2007 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:18:30Z   0 0 09000064820750b6
FDA-2016-N-0124-0082 FDA None FDA-2016-N-0124 Reference 38 - Kampf et al, Efficacy of ethanol based hand foams re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:21:55Z   0 0 09000064820750cf
FDA-2016-N-0124-0101 FDA None FDA-2016-N-0124 Reference 57 - ICH S1B Guideline Testing for Carcinogenicity of Pharmaceuticals re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:29:56Z   0 0 09000064820750f5
FDA-2016-N-0124-0004 FDA None FDA-2016-N-0124 Reference 2 - Calafat et al, Urinary Concentration of Triclosan in the US Population re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:56:18Z   0 0 09000064820752ec
FDA-2016-N-0124-0006 FDA None FDA-2016-N-0124 Reference 4 - Kramer et al, Quantity of Ethanol Absorption After Excessive Hand Disinfection re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:56:57Z   0 0 09000064820752ee
FDA-2016-N-0124-0011 FDA None FDA-2016-N-0124 Reference 9 - Transcript of the 10-20-2005 NDAC re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:59:38Z   0 0 0900006482075445
FDA-2016-N-0124-0045 FDA None FDA-2016-N-0124 Reference 24-19 Ramos et al., Inspections of hand washing supplies and hand sanitizer in public schools re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:09:58Z   0 0 090000648207547c
FDA-2016-N-0124-0047 FDA None FDA-2016-N-0124 Reference 24-21 Kinnula et al., Safety of alcohol hand gel use among children and personnel at a child day care center re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:10:30Z   0 0 0900006482075482
FDA-2016-N-0124-0090 FDA None FDA-2016-N-0124 Reference 47 - Kumar et al, Disruption of LH-Induced Testosterone Biosynthesis in Testicular Leydig Cells by TCS re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:25:25Z   0 0 09000064820750e3
FDA-2016-N-0124-0098 FDA None FDA-2016-N-0124 Reference 54 - Alexander et al, Timing and Magnitude of Increases in Levothyroxine Requirements During Pregnancy in Women with Hypothyroidism re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:29:08Z   0 0 09000064820750f2
FDA-2016-N-0124-0100 FDA None FDA-2016-N-0124 Reference 56 - Pop et al, Low Maternal Free Thyroxine Concentrations During Early Pregnancy are Associated with Impaired re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:29:41Z   0 0 09000064820750f4
FDA-2016-N-0124-0007 FDA None FDA-2016-N-0124 Reference 5 - Does the Clinical Use of Ethanol-Baesed Hand Sanitizer Elevate Blood Alcohol Levels re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T14:57:33Z   0 0 0900006482075441
FDA-2016-N-0124-0013 FDA None FDA-2016-N-0124 Reference 11 - Transcript of the September 3, 2014 NDAC meeting re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:00:14Z   0 0 0900006482075447
FDA-2016-N-0124-0067 FDA None FDA-2016-N-0124 Reference 29-6 Edmonds et al, Comparative efficacy of hand rubs, 2012 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:16:39Z   0 0 09000064820750b0
FDA-2016-N-0124-0175 FDA None FDA-2016-N-0124 Reference 131 - Faber et al, Review of Reproductive and Developmental Toxicity Studies with Isopropanol re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:53:42Z   0 0 0900006482075616
FDA-2016-N-0124-0211 FDA None FDA-2016-N-0124 Econ Reference 15 – Aiello et al, Effect of Hand Hygiene on Infectious Disease Risk in the Community Setting A Meta-Analysis re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T16:04:51Z   0 0 0900006482079e39
FDA-2016-N-0124-0120 FDA None FDA-2016-N-0124 Reference 76 - Yazdankhah et al, TCS and Antimicrobial Resistance in Bacteria re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:36:23Z   0 0 0900006482075534
FDA-2016-N-0124-0130 FDA None FDA-2016-N-0124 Reference 86 - Flynn et al, Permeation of Hairless Mouse Skin II Membrane Sectioning Techniques re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:40:03Z   0 0 0900006482075559
FDA-2016-N-0124-0139 FDA None FDA-2016-N-0124 Reference 95 - NIAAA Fetal Alcohol Exposure re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:42:37Z   0 0 090000648207556e
FDA-2016-N-0124-0146 FDA None FDA-2016-N-0124 Reference 102 - Little et al, Effects of Alcohol on the Hypothalamic-Pituitary-Gonadal Axis in the Developing Male Rat re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:44:54Z   0 0 0900006482075575
FDA-2016-N-0124-0155 FDA None FDA-2016-N-0124 Reference 111 - FDA-1975-N-0012-0623 -Study 2 Van Miller J P and Weaver E V Ninety Day Dietary Toxicity Study with ADBAC in Rats re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:47:37Z   0 0 09000064820755b4
FDA-2016-N-0124-0160 FDA None FDA-2016-N-0124 Reference 116 - FDA-1975-N-0012-0628 - Study 7 Neeper Bradley Theresa L Two Generation Reproduction Study re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:48:58Z   0 0 09000064820755b9
FDA-2016-N-0124-0017 FDA None FDA-2016-N-0124 Reference 15 - 1975-N-0012-115- - Ref C42 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:01:33Z   0 0 090000648207506f
FDA-2016-N-0124-0022 FDA None FDA-2016-N-0124 Reference 20 - FDA-1975-N-0012-0102--Ref C30 veg oil et al re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:03:15Z   0 0 0900006482075074
FDA-2016-N-0124-0024 FDA None FDA-2016-N-0124 Reference 22 - CDC Clean Hands Save Lives re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:03:49Z   0 0 0900006482075076
FDA-2016-N-0124-0026 FDA None FDA-2016-N-0124 Reference 24- FDA review of clinical outcome studies in consumer use settings, 2015 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:04:23Z   0 0 0900006482075078
FDA-2016-N-0124-0163 FDA None FDA-2016-N-0124 Reference 119 - FDA-1975-N-0012-0631 -Study 8 Volume 3 of 3 Gill M W et al Chronic Dietary Toxicity Oncogenicity Study re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:49:44Z   0 0 09000064820755bc
FDA-2016-N-0124-0166 FDA None FDA-2016-N-0124 Reference 122 - Braoudaki TCS cross resistance in E coli strains 2004 re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:50:34Z   0 0 09000064820755de
FDA-2016-N-0124-0171 FDA None FDA-2016-N-0124 Reference 127 - Lear et al, PCMX & TCS Tolerant Bacteria from Industrial Sources re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:52:10Z   0 0 09000064820755e4
FDA-2016-N-0124-0185 FDA None FDA-2016-N-0124 Reference 141 - Below et al, Dermal and Pulmonary Absorption of Proan-1-ol and Propan-2-ol From Hand Rubs re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:56:48Z   0 0 09000064820759b3
FDA-2016-N-0124-0116 FDA None FDA-2016-N-0124 Reference 72 - Tabak et al, Effect of TCS on Salmonella at Different Growth Stages and in Biofilms re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:34:35Z   0 0 0900006482075519
FDA-2016-N-0124-0124 FDA None FDA-2016-N-0124 Reference 80 - Kolpin et al, Pharmaceuticals Hormones and Other Organic Wastewater Contaminants in US Streams re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:38:20Z   0 0 0900006482075538
FDA-2016-N-0124-0127 FDA None FDA-2016-N-0124 Reference 83 - Behl et al, Hydration and Percutaneous Absorption I re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:39:15Z   0 0 0900006482075556
FDA-2016-N-0124-0133 FDA None FDA-2016-N-0124 Reference 89 - Stenback, The Tumorigenic Effect of Ethanol re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:40:52Z   0 0 090000648207555c
FDA-2016-N-0124-0157 FDA None FDA-2016-N-0124 Reference 113 - FDA-1975-N-0012-0625 -Study 4 Gill M W and Wagner C L Ninety Day Subchronic Dermal Toxicity Study with ADBAC re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:48:12Z   0 0 09000064820755b6
FDA-2016-N-0124-0034 FDA None FDA-2016-N-0124 Reference 24-8 Larson et al., Preventing viral upper respiratory infections re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:06:51Z   0 0 0900006482075467
FDA-2016-N-0124-0050 FDA None FDA-2016-N-0124 Reference 24-24 Hubner et al., Effectiveness of alcohol-based hand disinfectants in a public administration re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Supporting & Related Material Background Material 2016-06-30T04:00:00Z 2016 6     2016-06-30T15:11:23Z   0 0 0900006482075485

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