{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2015-N-0101\" sorted by posted_date descending", "rows": [["FDA-2015-N-0101-1505", "FDA", "FDA-2015-N-0101", "Response Letter from FDA CDER to American Cleaning Institute", "Other", "Letter(s)", "2025-06-13T04:00:00Z", 2025, 6, "2025-06-13T04:00:00Z", null, "2025-06-13T19:01:10Z", null, 0, 0, "09000064b8e0622c"], ["FDA-2015-N-0101-1504", "FDA", "FDA-2015-N-0101", "Response Letter from FDA CDER to Cardinal Health", "Other", "Letter(s)", "2025-06-13T04:00:00Z", 2025, 6, "2025-06-13T04:00:00Z", null, "2025-06-13T19:01:02Z", null, 0, 0, "09000064b8e0622a"], ["FDA-2015-N-0101-1503", "FDA", "FDA-2015-N-0101", "Meeting Minutes 05/09/18 \u2013 Benzalkonium chloride and benzethonium chloride", "Other", "Minutes", "2023-02-17T05:00:00Z", 2023, 2, "2023-02-17T05:00:00Z", null, "2023-02-17T15:18:05Z", null, 0, 0, "09000064856b008c"], ["FDA-2015-N-0101-1502", 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"2020-11-20T14:33:15Z", null, 0, 0, "090000648496c580"], ["FDA-2015-N-0101-1490", "FDA", "FDA-2015-N-0101", "Request for Extension from Cardinal Health", "Other", "Request for Extension", "2020-10-19T04:00:00Z", 2020, 10, "2020-10-19T04:00:00Z", null, "2020-10-19T14:58:37Z", null, 0, 0, "09000064849112cd"], ["FDA-2015-N-0101-1489", "FDA", "FDA-2015-N-0101", "ACI BZT Monograph Meeting Minutes Written Responses", "Supporting & Related Material", "Meeting Materials", "2020-10-06T04:00:00Z", 2020, 10, null, null, "2020-10-06T14:57:14Z", null, 0, 0, "09000064848de17f"], ["FDA-2015-N-0101-1491", "FDA", "FDA-2015-N-0101", "Advice Letter from FDA CDER to ACI Advice Povidone-Iodine-SP", "Other", "Letter(s)", "2020-09-30T04:00:00Z", 2020, 9, "2020-05-27T04:00:00Z", null, "2020-10-19T21:03:50Z", null, 0, 0, "0900006484918e18"], ["FDA-2015-N-0101-1487", "FDA", "FDA-2015-N-0101", "FINAL Third Extension Deferral Letter from FDA CDER to American Cleaning Institute", "Other", "Letter(s)", "2019-10-17T04:00:00Z", 2019, 10, "2019-10-17T04:00:00Z", null, "2019-10-17T15:37:24Z", null, 0, 0, "09000064840b4534"], ["FDA-2015-N-0101-1485", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to Cardinal Health", "Other", "Letter(s)", "2019-10-10T04:00:00Z", 2019, 10, "2019-10-10T04:00:00Z", null, "2019-10-10T20:32:21Z", null, 0, 0, "090000648407ecdf"], ["FDA-2015-N-0101-1486", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to Cardinal Health", "Other", "Letter(s)", "2019-10-10T04:00:00Z", 2019, 10, "2019-10-10T04:00:00Z", null, "2019-10-10T20:44:43Z", null, 0, 0, "090000648407ece2"], ["FDA-2015-N-0101-1484", "FDA", "FDA-2015-N-0101", "Report from American Chemistry Council", "Other", "Report", "2019-09-13T04:00:00Z", 2019, 9, "2019-09-13T04:00:00Z", null, "2019-09-13T19:44:23Z", null, 0, 0, "0900006483f377cf"], ["FDA-2015-N-0101-1482", "FDA", "FDA-2015-N-0101", "ACI FINAL Advice Letter re MARCH 7 2019 Submission", "Other", "Letter(s)", "2019-08-29T04:00:00Z", 2019, 8, "2019-08-29T04:00:00Z", null, "2019-08-29T15:18:50Z", null, 0, 0, "0900006483ed93e3"], ["FDA-2015-N-0101-1478", "FDA", "FDA-2015-N-0101", "Report from American Cleaning Institute (ACI) part 1 of 4", "Other", "Report", "2019-08-09T04:00:00Z", 2019, 8, "2019-08-09T04:00:00Z", null, "2019-08-09T14:01:36Z", null, 0, 0, "0900006483e17457"], ["FDA-2015-N-0101-1476", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to Cardinal Health", "Other", "Letter(s)", "2019-08-09T04:00:00Z", 2019, 8, "2019-08-09T04:00:00Z", null, "2019-08-09T12:53:53Z", null, 0, 0, "0900006483e1e010"], ["FDA-2015-N-0101-1477", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to American Cleaning Institute", "Other", "Letter(s)", "2019-08-09T04:00:00Z", 2019, 8, "2019-08-09T04:00:00Z", null, "2019-08-09T12:55:36Z", null, 0, 0, "0900006483e1e016"], ["FDA-2015-N-0101-1480", "FDA", "FDA-2015-N-0101", "Report from American Cleaning Institute (ACI) part 3 of 4", "Other", "Report", "2019-08-09T04:00:00Z", 2019, 8, "2019-08-09T04:00:00Z", null, "2019-08-09T15:44:35Z", null, 0, 0, "0900006483e17b71"], ["FDA-2015-N-0101-1479", "FDA", "FDA-2015-N-0101", "Report from American Cleaning Institute (ACI) part 2 of 4", "Other", "Report", "2019-08-09T04:00:00Z", 2019, 8, "2019-08-09T04:00:00Z", null, "2019-08-09T14:47:35Z", null, 0, 0, "0900006483e17a11"], ["FDA-2015-N-0101-1481", "FDA", "FDA-2015-N-0101", "Report from American Cleaning Institute (ACI) part 4 of 4", "Other", "Report", "2019-08-09T04:00:00Z", 2019, 8, "2019-08-09T04:00:00Z", null, "2019-08-09T16:06:49Z", null, 0, 0, "0900006483e17e57"], ["FDA-2015-N-0101-1475", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to American Cleaning Institute", "Other", "Letter(s)", "2019-07-15T04:00:00Z", 2019, 7, "2019-07-15T04:00:00Z", null, "2019-07-15T18:44:01Z", null, 0, 0, "0900006483d91e22"], ["FDA-2015-N-0101-1473", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to Cardinal Health", "Other", "Letter(s)", "2019-07-03T04:00:00Z", 2019, 7, "2019-07-03T04:00:00Z", null, "2019-07-03T12:02:44Z", null, 0, 0, "0900006483d5b379"], ["FDA-2015-N-0101-1471", "FDA", "FDA-2015-N-0101", "Cardinal Health Meeting Minutes", "Other", "Minutes", "2019-05-21T04:00:00Z", 2019, 5, "2019-05-21T04:00:00Z", null, "2019-05-21T11:13:18Z", null, 0, 0, "0900006483ca7399"], ["FDA-2015-N-0101-1470", "FDA", "FDA-2015-N-0101", "Request for Extension from Cardinal Health", "Other", "Request for Extension", "2019-04-16T04:00:00Z", 2019, 4, "2019-04-16T04:00:00Z", null, "2019-04-16T16:21:39Z", null, 0, 0, "0900006483ba8c32"], ["FDA-2015-N-0101-1468", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to Ciba Specialty Chemicals Corporation", "Other", "Letter(s)", "2019-04-11T04:00:00Z", 2019, 4, "2019-04-11T04:00:00Z", null, "2019-04-11T16:42:14Z", null, 0, 0, "0900006483b85637"], ["FDA-2015-N-0101-1466", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to Ciba Specialty Chemicals Corporation", "Other", "Letter(s)", "2019-04-11T04:00:00Z", 2019, 4, "2019-04-11T04:00:00Z", null, "2019-04-11T16:36:33Z", null, 0, 0, "0900006483b8558f"], ["FDA-2015-N-0101-1467", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to Bayer Corporation", "Other", "Letter(s)", "2019-04-11T04:00:00Z", 2019, 4, "2019-04-11T04:00:00Z", null, "2019-04-11T16:39:49Z", null, 0, 0, "0900006483b85632"], ["FDA-2015-N-0101-1465", "FDA", "FDA-2015-N-0101", "Report from American Cleaning Institute (ACI)", "Other", "Report", "2019-03-13T04:00:00Z", 2019, 3, "2019-03-13T04:00:00Z", null, "2019-03-13T20:49:19Z", null, 0, 0, "0900006483ad853f"], ["FDA-2015-N-0101-1464", "FDA", "FDA-2015-N-0101", "Letter from FDA CDER to CARDINAL HEALTH", "Other", "Letter(s)", "2019-03-04T05:00:00Z", 2019, 3, "2019-03-04T05:00:00Z", null, "2019-03-04T17:47:56Z", null, 0, 0, "0900006483abbf02"], ["FDA-2015-N-0101-1463", "FDA", "FDA-2015-N-0101", "Meeting Granted Letter from FDA CDER to Cardinal Health", "Other", "Approval", "2018-12-31T05:00:00Z", 2018, 12, "2018-12-31T05:00:00Z", null, "2018-12-31T22:18:50Z", null, 0, 0, "09000064839d240f"], ["FDA-2015-N-0101-1462", "FDA", "FDA-2015-N-0101", "Letter from CardinalHealth", "Other", "Letter(s)", "2018-11-23T05:00:00Z", 2018, 11, "2018-11-23T05:00:00Z", null, "2018-11-23T18:03:40Z", null, 0, 0, "090000648385a622"], ["FDA-2015-N-0101-1460", "FDA", "FDA-2015-N-0101", "Report from Cardinal Health part 3 of 4", "Other", "Report", "2018-11-19T05:00:00Z", 2018, 11, "2018-11-19T05:00:00Z", null, "2018-11-19T17:14:42Z", null, 0, 0, "09000064838e3c72"], ["FDA-2015-N-0101-1461", "FDA", "FDA-2015-N-0101", "Report from Cardinal Health part 4 of 4", "Other", "Report", "2018-11-19T05:00:00Z", 2018, 11, "2018-11-19T05:00:00Z", null, "2018-11-19T17:17:51Z", null, 0, 0, "09000064838e3c93"], ["FDA-2015-N-0101-1458", "FDA", "FDA-2015-N-0101", "Report from Cardinal Health part 1 of 4", "Other", "Report", "2018-11-19T05:00:00Z", 2018, 11, "2018-11-19T05:00:00Z", null, "2018-11-19T17:13:11Z", null, 0, 0, "09000064838e3c5b"], ["FDA-2015-N-0101-1459", "FDA", "FDA-2015-N-0101", "Report from Cardinal Health part 2 of 4", "Other", "Report", "2018-11-19T05:00:00Z", 2018, 11, "2018-11-19T05:00:00Z", null, "2018-11-19T17:15:16Z", null, 0, 0, "09000064838e3c60"], ["FDA-2015-N-0101-1456", "FDA", "FDA-2015-N-0101", "Response from FDA CDER to American Cleaning Institute", "Other", "Agency Response", "2018-08-07T04:00:00Z", 2018, 8, "2018-08-07T04:00:00Z", null, "2018-08-07T19:23:21Z", null, 0, 0, "09000064835e728a"], ["FDA-2015-N-0101-1455", "FDA", "FDA-2015-N-0101", "American Chemistry Council FINAL letter July 25 2018", "Other", "Agency Response", "2018-07-25T04:00:00Z", 2018, 7, "2018-07-25T04:00:00Z", null, "2018-07-25T13:54:20Z", null, 0, 0, "0900006483555882"], ["FDA-2015-N-0101-1454", "FDA", "FDA-2015-N-0101", "FDA CDER FINAL Advice Letter - ACI Final Report Time-Kill Study-2", "Other", "Response(s)", "2018-07-06T04:00:00Z", 2018, 7, "2018-07-06T04:00:00Z", null, "2018-07-06T11:42:16Z", null, 0, 0, "09000064834b08d3"], ["FDA-2015-N-0101-1453", "FDA", "FDA-2015-N-0101", "Supplement from American Chemistry Council", "Other", "Supplement (SUP)", "2018-05-23T04:00:00Z", 2018, 5, "2018-05-23T04:00:00Z", null, "2018-05-23T20:41:08Z", null, 0, 0, "09000064832a2c55"], ["FDA-2015-N-0101-1452", "FDA", "FDA-2015-N-0101", "Meeting Granted Letter 05/09/2018", "Other", "Letter(s)", "2018-04-23T04:00:00Z", 2018, 4, "2018-04-23T04:00:00Z", null, "2018-04-23T15:11:41Z", null, 0, 0, "09000064831aa877"], ["FDA-2015-N-0101-1451", "FDA", "FDA-2015-N-0101", "Report from American Cleaning Institute", "Other", "Report", "2018-04-17T04:00:00Z", 2018, 4, "2018-04-17T04:00:00Z", null, "2018-04-17T20:51:06Z", null, 0, 0, "0900006483136056"], ["FDA-2015-N-0101-1450", "FDA", "FDA-2015-N-0101", "Grant of Second Extension April 12_2018", "Other", "Extension of Time", "2018-04-16T04:00:00Z", 2018, 4, "2018-04-16T04:00:00Z", null, "2018-04-16T14:59:47Z", null, 0, 0, "0900006483146ff2"], ["FDA-2015-N-0101-1449", "FDA", "FDA-2015-N-0101", "Final Validation Reports (Bionanalysis Report) from Lonza Inc., and Henkel Consumer Goods, Inc., (Lewis & Harrison)", "Other", "Report", "2018-04-11T04:00:00Z", 2018, 4, "2018-04-11T04:00:00Z", null, "2018-04-11T20:11:00Z", null, 0, 0, "09000064831182c1"], ["FDA-2015-N-0101-1448", "FDA", "FDA-2015-N-0101", "Briefing Documents from Lonza Inc., and Henkel Consumer Goods, Inc., (Lewis & Harrison)", "Other", "Studies", "2018-04-11T04:00:00Z", 2018, 4, "2018-04-11T04:00:00Z", null, "2018-04-11T19:59:30Z", null, 0, 0, "09000064831174b0"], ["FDA-2015-N-0101-1447", "FDA", "FDA-2015-N-0101", "MEETING MINUTES - ETOH Monograph Meeting", "Other", "Letter(s)", "2018-03-30T04:00:00Z", 2018, 3, "2018-03-30T04:00:00Z", null, "2018-03-30T15:25:34Z", null, 0, 0, "0900006483074aca"], ["FDA-2015-N-0101-1446", "FDA", "FDA-2015-N-0101", "Report from American Cleaning Institute", "Other", "Report", "2018-03-05T05:00:00Z", 2018, 3, "2018-03-05T05:00:00Z", null, "2018-03-05T15:47:32Z", null, 0, 0, "0900006482f6401f"], ["FDA-2015-N-0101-1445", "FDA", "FDA-2015-N-0101", "Supplement from Richard Sedlak", "Other", "Supplement (SUP)", "2018-02-22T05:00:00Z", 2018, 2, "2018-02-22T05:00:00Z", null, "2018-02-22T19:57:51Z", null, 0, 0, "0900006482f53515"], ["FDA-2015-N-0101-1444", "FDA", "FDA-2015-N-0101", "Meeting Granted Letter ACI020818", "Other", "Letter(s)", "2018-02-14T05:00:00Z", 2018, 2, "2018-02-14T05:00:00Z", null, "2018-02-14T16:08:54Z", null, 0, 0, "0900006482f31647"], ["FDA-2015-N-0101-1442", "FDA", "FDA-2015-N-0101", "Letter from American Cleaning Institute", "Other", "Letter(s)", "2018-02-09T05:00:00Z", 2018, 2, "2018-02-09T05:00:00Z", null, "2018-02-09T15:38:54Z", null, 0, 0, "0900006482ef8532"], ["FDA-2015-N-0101-1443", "FDA", "FDA-2015-N-0101", "Request for Meeting from Lonza Inc. and Henkel Consumer Goods, Inc. (Lewis & Harrison)", "Other", "Request", "2018-02-09T05:00:00Z", 2018, 2, "2018-02-09T05:00:00Z", null, "2018-02-09T16:20:44Z", null, 0, 0, "0900006482f07041"], ["FDA-2015-N-0101-1440", "FDA", "FDA-2015-N-0101", "Letter from FDA to American Cleaning Institute", "Other", "Letter(s)", "2018-02-08T05:00:00Z", 2018, 2, "2018-02-08T05:00:00Z", null, "2018-02-08T16:52:52Z", null, 0, 0, "0900006482f00f2d"], ["FDA-2015-N-0101-1441", "FDA", "FDA-2015-N-0101", "Meeting Materials from The American Cleaning Institute", "Other", "Meeting Exhibits", "2018-02-08T05:00:00Z", 2018, 2, "2018-02-08T05:00:00Z", null, "2018-02-08T21:00:46Z", null, 0, 0, "0900006482f0252a"], ["FDA-2015-N-0101-1384", "FDA", "FDA-2015-N-0101", "033 Reference 22 - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Guideline for Industry. The need for Carcinogenicity Studies re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:06:57Z", null, 0, 0, "0900006482cea5a1"], ["FDA-2015-N-0101-1388", "FDA", "FDA-2015-N-0101", "037 Reference 26 - Guidance for Industry, M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:09:27Z", null, 0, 0, "0900006482cea5a5"], ["FDA-2015-N-0101-1376", "FDA", "FDA-2015-N-0101", "025 Reference 14 - FDA_Letter_regarding_Deferral_of_Isopropyl_Alcohol re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:59:34Z", null, 0, 0, "0900006482cea90f"], ["FDA-2015-N-0101-1377", "FDA", "FDA-2015-N-0101", "026 Reference 15 - FDA_Letter_regarding_Deferral_of_Povidone_Iodine re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:00:28Z", null, 0, 0, "0900006482cea910"], ["FDA-2015-N-0101-1378", "FDA", "FDA-2015-N-0101", "027 Reference 16 - Wheelock and Lookinland, Effect of surgical hand scrub time on subsequent bacterial growth re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:01:26Z", null, 0, 0, "0900006482cea911"], ["FDA-2015-N-0101-1399", "FDA", "FDA-2015-N-0101", "048 Reference 37 - Sivaji et al 1986 Disinfectant Induced Changes in the Antibiotic Sensitivity and Phage Typing Pattern in S aureus re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:17:42Z", null, 0, 0, "0900006482cea5b0"], ["FDA-2015-N-0101-1402", "FDA", "FDA-2015-N-0101", "051 Reference 40 - Kunisada et al, Investigation on the efficacy of povidone-iodine against antiseptic-resistant species re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:19:37Z", null, 0, 0, "0900006482cea5b3"], ["FDA-2015-N-0101-1412", "FDA", "FDA-2015-N-0101", "063 Reference 52 - Kawamura-Sato et al, Correlation between Reduced Susceptibility to Disinfectants and Multidrug Resistance among Clinical Isolates of Acinetobacter Species re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:27:44Z", null, 0, 0, "0900006482cea7c9"], ["FDA-2015-N-0101-1417", "FDA", "FDA-2015-N-0101", "068 Reference 57 - Wiegand et al, Analysis of the Adaptation Capacity of Staphylococcus Aureus to Commonly Used Antiseptics by Microplate Laser Nephelometry re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:31:48Z", null, 0, 0, "0900006482cea7ce"], ["FDA-2015-N-0101-1369", "FDA", "FDA-2015-N-0101", "018 Reference 7 - CDC, Guideline for Hand Hygiene in Health-Care Settings. Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:52:56Z", null, 0, 0, "0900006482cea908"], ["FDA-2015-N-0101-1375", "FDA", "FDA-2015-N-0101", "024 Reference 13 - FDA_Letter_regarding_Deferral_of_Ethyl_Alcohol re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:58:37Z", null, 0, 0, "0900006482cea90e"], ["FDA-2015-N-0101-1386", "FDA", "FDA-2015-N-0101", "035 Reference 24 - FDA, Redbook 2000 IV.C.9.a Reproduction and Developmental Toxicity Studies Guidelines for Reproduction Studies re Safety and Effectiveness of 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"Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:05:34Z", null, 0, 0, "0900006482cea915"], ["FDA-2015-N-0101-1408", "FDA", "FDA-2015-N-0101", "059 Reference 48 - Weber et al, Use of germicides in the home and the healthcare setting re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:24:53Z", null, 0, 0, "0900006482cea5ba"], ["FDA-2015-N-0101-1371", "FDA", "FDA-2015-N-0101", "020 Reference 9 - Innovations in Health Care- Antisepsis as a Case Study re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:55:17Z", null, 0, 0, "0900006482cea90a"], ["FDA-2015-N-0101-1351", "FDA", "FDA-2015-N-0101", "Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial\nDrug Products for Over-the-Counter Human Use", "Rule", "Final Rule", "2017-12-20T05:00:00Z", 2017, 12, "2017-12-20T05:00:00Z", null, "2017-12-20T14:10:12Z", "2017-27317", 0, 0, "0900006482d3e4e3"], ["FDA-2015-N-0101-1355", "FDA", "FDA-2015-N-0101", "003 Reference 2 -2 - Volume_II_2_of_9_Feedback_Meeting_and_Working_Texts_From_the_Feedback_Meeting_March_29_1995_Attachment_1_through_6_re_Comment_from_Soap_Deter re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:40:41Z", null, 0, 0, "0900006482ce9f70"], ["FDA-2015-N-0101-1359", "FDA", "FDA-2015-N-0101", "007 Reference 2 -6 - Volume_V_5_of_9_References_Continuation_re_Comment_from_Soap_Detergent_Association_(SDA) re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:43:42Z", null, 0, 0, "0900006482cea4ba"], ["FDA-2015-N-0101-1362", "FDA", "FDA-2015-N-0101", "010 Reference 2 -9 - Volume_VII_7_of_9_References_Continuation_re_C12 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:46:40Z", null, 0, 0, "0900006482cea4bd"], ["FDA-2015-N-0101-1391", "FDA", "FDA-2015-N-0101", "040 Reference 29 - Novel Water-Based Antiseptic Lotion Demonstrates Rapid, Broad-Spectrum Kill Compared with Alcohol Antiseptic re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:11:44Z", null, 0, 0, "0900006482cea5a8"], ["FDA-2015-N-0101-1395", "FDA", "FDA-2015-N-0101", "044 Reference 33 - Bactericidal Activity of Antiseptics against Methicillin-Resistant Staphylococcus Aureus re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:14:42Z", null, 0, 0, "0900006482cea5ac"], ["FDA-2015-N-0101-1398", "FDA", "FDA-2015-N-0101", "047 Reference 36 - Sivaji and Mandal 1987 Antibiotic Resistance and Serotypic Variations in E coli Induced by Disinfectants re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:17:10Z", null, 0, 0, "0900006482cea5af"], ["FDA-2015-N-0101-1406", "FDA", "FDA-2015-N-0101", "056 Reference 45 - Ghasemzadeh-Moghaddam et al, Methicillin-Susceptible and -Resistant Staphylococcus Aureus with High-Level Antiseptic re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:22:32Z", null, 0, 0, "0900006482cea5b7"], ["FDA-2015-N-0101-1372", "FDA", "FDA-2015-N-0101", "021 Reference 10 - FDA_Letter_regarding_Deferral_of_Benzalkonium_Chloride re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:56:00Z", null, 0, 0, "0900006482cea90b"], ["FDA-2015-N-0101-1422", "FDA", "FDA-2015-N-0101", "073 Reference 62 - Barry et al, Lack of Effect of Antibiotic Resistance on Susceptibility of Microorganisms to Chlorhexidine Gluconate or Povidone Iodine re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:37:21Z", null, 0, 0, "0900006482ceabe2"], ["FDA-2015-N-0101-1434", "FDA", "FDA-2015-N-0101", "085 Reference 74 - Copitch et al, Prevalence of decreased susceptibility to triclosan in Salmonella enterica isolates from animals and humans and association with multiple re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:42:47Z", null, 0, 0, "0900006482ceabee"], ["FDA-2015-N-0101-1437", "FDA", "FDA-2015-N-0101", "088 Reference 77 - Joynson et al, Adaptive Resistance to Benzalkonium Chloride, Amikacin and Tobramycin re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:44:09Z", null, 0, 0, "0900006482ceabf1"], ["FDA-2015-N-0101-1390", "FDA", "FDA-2015-N-0101", "039 Reference 28 - Comparative in vitro activities of topical wound care products against community-associated methicillin-resistant Staphylococcus aureus re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:10:56Z", null, 0, 0, "0900006482cea5a7"], ["FDA-2015-N-0101-1400", "FDA", "FDA-2015-N-0101", "049 Reference 38 - Comparative in vitro efficacy of antimicrobial re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:18:18Z", null, 0, 0, "0900006482cea5b1"], ["FDA-2015-N-0101-1367", "FDA", "FDA-2015-N-0101", "016 Reference 5 - Part 130 New Drugs-Procedures for Classification of Over-the-Counter Drugs re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:51:15Z", null, 0, 0, "0900006482cea906"], ["FDA-2015-N-0101-1368", "FDA", "FDA-2015-N-0101", "017 Reference 6 - Tuuli et al, A randomized trial comparing skin antiseptic agents at cesarean delivery re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:51:57Z", null, 0, 0, "0900006482cea907"], ["FDA-2015-N-0101-1370", "FDA", "FDA-2015-N-0101", "019 Reference 8 - Mangram et al, Guideline for prevention of surgical site infection re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:53:43Z", null, 0, 0, "0900006482cea909"], ["FDA-2015-N-0101-1353", "FDA", "FDA-2015-N-0101", "001 Reference 1 - Transcript of the January 22, 1997, Meeting of the Joint Nonprescription Drugs and Anti-Infective Drugs Advisory Committees re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:39:14Z", null, 0, 0, "0900006482ce9f6e"], ["FDA-2015-N-0101-1360", "FDA", "FDA-2015-N-0101", "008 Reference 2 -7 - Volume_V_5_of_9_Published_Cited_References_Part_2_of_2_re_Comment_from_Soap_Detergent_Association_(SDA) re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:45:27Z", null, 0, 0, "0900006482cea4bb"], ["FDA-2015-N-0101-1387", "FDA", "FDA-2015-N-0101", "036 Reference 25 - USEPA, Guidelines for Reproductive Toxicity Risk Assessment re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:08:53Z", null, 0, 0, "0900006482cea5a4"], ["FDA-2015-N-0101-1421", "FDA", "FDA-2015-N-0101", "072 Reference 61 - Gorden and Mclure, In-vitro comparison of bactericidal activity of povidone iodine and re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:36:19Z", null, 0, 0, "0900006482ceabe1"], ["FDA-2015-N-0101-1428", "FDA", "FDA-2015-N-0101", "079 Reference 68 - Coelho et al, The Use of Machine Learning Methodologies to Analyse Antibiotic and Biocide Susceptibility in Staphylococcus Aureus re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:41:52Z", null, 0, 0, "0900006482ceabe8"], ["FDA-2015-N-0101-1392", "FDA", "FDA-2015-N-0101", "041 Reference 30 - Absence of role for plasmids in resistance to multiple disinfectants in three stains re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:12:26Z", null, 0, 0, "0900006482cea5a9"], ["FDA-2015-N-0101-1409", "FDA", "FDA-2015-N-0101", "060 Reference 49 - Rajamohan et al, Biocide-Tolerant Multidrug-Resistant Acinetobacter Baumannii Clinical Strains Are Associated with re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:25:34Z", null, 0, 0, "0900006482cea5bb"], ["FDA-2015-N-0101-1415", "FDA", "FDA-2015-N-0101", "066 Reference 55 - Lanker Klossner et al, Nondevelopment of resistance by bacteria during hospital use of povidone-iodine re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T15:30:41Z", null, 0, 0, "0900006482cea7cc"], ["FDA-2015-N-0101-1365", "FDA", "FDA-2015-N-0101", "014 Reference 3 - Transcript of the March 23, 2005, Nonprescription Drugs Advisory Committee re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2017-12-20T05:00:00Z", 2017, 12, null, null, "2017-12-20T14:49:43Z", null, 0, 0, "0900006482cea904"], ["FDA-2015-N-0101-1366", "FDA", "FDA-2015-N-0101", "015 Reference 4 - Transcript of the September 3, 2014, Meeting of the Nonprescription Drugs Advisory Committee 2014 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", 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