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withdrawn,object_id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-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,,2025-06-13T19:01:10Z,,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,,2025-06-13T19:01:02Z,,0,0,09000064b8e0622a
FDA-2015-N-0101-1503,FDA,FDA-2015-N-0101,Meeting Minutes 05/09/18 – Benzalkonium chloride and benzethonium chloride,Other,Minutes,2023-02-17T05:00:00Z,2023,2,2023-02-17T05:00:00Z,,2023-02-17T15:18:05Z,,0,0,09000064856b008c
FDA-2015-N-0101-1502,FDA,FDA-2015-N-0101,FINAL Third Extension Deferral Letter,Other,Letter(s),2022-05-31T04:00:00Z,2022,5,2022-05-31T04:00:00Z,,2022-05-31T14:52:21Z,,0,0,0900006483e573e0
FDA-2015-N-0101-1498,FDA,FDA-2015-N-0101,FDA Extension Deferral Letter from FDA CDER to Cardinal Health,Other,Letter(s),2021-04-08T04:00:00Z,2021,4,2021-04-08T04:00:00Z,,2021-04-08T15:54:51Z,,0,0,0900006484aa01b4
FDA-2015-N-0101-1497,FDA,FDA-2015-N-0101,Meeting Request and Briefing Document Benzethonium Chloride (BZT) - In Vivo Efficacy,Other,Brief,2020-12-10T05:00:00Z,2020,12,2020-12-10T05:00:00Z,,2020-12-10T17:39:34Z,,0,0,09000064849960ea
FDA-2015-N-0101-1496,FDA,FDA-2015-N-0101,America Cleaning Institute Meeting Request Cover Letter - BZT Efficacy,Other,Letter(s),2020-12-10T05:00:00Z,2020,12,2020-12-10T05:00:00Z,,2020-12-10T17:39:21Z,,0,0,09000064849960e8
FDA-2015-N-0101-1495,FDA,FDA-2015-N-0101,The American CIeaning Institute Progress Report,Other,Report,2020-12-04T05:00:00Z,2020,12,2020-12-04T05:00:00Z,,2020-12-04T16:06:56Z,,0,0,0900006484986dcc
FDA-2015-N-0101-1494,FDA,FDA-2015-N-0101,FDA Updated Response to ACI July 2020 Progress Report (ethanol bzk pmcx bzec pi),Other,Letter(s),2020-11-23T05:00:00Z,2020,11,2020-11-23T05:00:00Z,,2020-11-23T13:06:06Z,,0,0,0900006484970494
FDA-2015-N-0101-1493,FDA,FDA-2015-N-0101,FDA Response to ACI July 2020 Progress Report (ethanol bzk pmcx bzec pi),Other,Agency Response,2020-11-20T05:00:00Z,2020,11,2020-11-20T05:00:00Z,,2020-11-20T14:38:10Z,,0,0,090000648496ca60
FDA-2015-N-0101-1492,FDA,FDA-2015-N-0101,ACI Advice November 18 2020,Other,Letter(s),2020-11-20T05:00:00Z,2020,11,2020-11-20T05:00:00Z,,2020-11-20T14:33:15Z,,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,,2020-10-19T14:58:37Z,,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,,,2020-10-06T14:57:14Z,,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,,2020-10-19T21:03:50Z,,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,,2019-10-17T15:37:24Z,,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,,2019-10-10T20:32:21Z,,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,,2019-10-10T20:44:43Z,,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,,2019-09-13T19:44:23Z,,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,,2019-08-29T15:18:50Z,,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,,2019-08-09T14:01:36Z,,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,,2019-08-09T12:53:53Z,,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,,2019-08-09T12:55:36Z,,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,,2019-08-09T15:44:35Z,,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,,2019-08-09T14:47:35Z,,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,,2019-08-09T16:06:49Z,,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,,2019-07-15T18:44:01Z,,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,,2019-07-03T12:02:44Z,,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,,2019-05-21T11:13:18Z,,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,,2019-04-16T16:21:39Z,,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,,2019-04-11T16:42:14Z,,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,,2019-04-11T16:36:33Z,,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,,2019-04-11T16:39:49Z,,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,,2019-03-13T20:49:19Z,,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,,2019-03-04T17:47:56Z,,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,,2018-12-31T22:18:50Z,,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,,2018-11-23T18:03:40Z,,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,,2018-11-19T17:14:42Z,,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,,2018-11-19T17:17:51Z,,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,,2018-11-19T17:13:11Z,,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,,2018-11-19T17:15:16Z,,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,,2018-08-07T19:23:21Z,,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,,2018-07-25T13:54:20Z,,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,,2018-07-06T11:42:16Z,,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,,2018-05-23T20:41:08Z,,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,,2018-04-23T15:11:41Z,,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,,2018-04-17T20:51:06Z,,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,,2018-04-16T14:59:47Z,,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,,2018-04-11T20:11:00Z,,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,,2018-04-11T19:59:30Z,,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,,2018-03-30T15:25:34Z,,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,,2018-03-05T15:47:32Z,,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,,2018-02-22T19:57:51Z,,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,,2018-02-14T16:08:54Z,,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,,2018-02-09T15:38:54Z,,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,,2018-02-09T16:20:44Z,,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,,2018-02-08T16:52:52Z,,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,,2018-02-08T21:00:46Z,,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,,,2017-12-20T15:06:57Z,,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,,,2017-12-20T15:09:27Z,,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,,,2017-12-20T14:59:34Z,,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,,,2017-12-20T15:00:28Z,,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,,,2017-12-20T15:01:26Z,,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,,,2017-12-20T15:17:42Z,,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,,,2017-12-20T15:19:37Z,,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,,,2017-12-20T15:27:44Z,,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,,,2017-12-20T15:31:48Z,,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,,,2017-12-20T14:52:56Z,,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,,,2017-12-20T14:58:37Z,,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 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,,,2017-12-20T15:08:17Z,,0,0,0900006482cea5a3
FDA-2015-N-0101-1364,FDA,FDA-2015-N-0101,013 Reference 2 -12 - Volume_IX_9_of_9_Published_Cited_References_Part_2_of_2_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,,,2017-12-20T14:48:33Z,,0,0,0900006482cea4c0
FDA-2015-N-0101-1382,FDA,FDA-2015-N-0101,031 Reference 20 - Phenolphthalein Exposure Causes Multiple Carcinogenic Effects in Experimental Model Systems 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,,,2017-12-20T15:05:34Z,,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,,,2017-12-20T15:24:53Z,,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,,,2017-12-20T14:55:17Z,,0,0,0900006482cea90a
FDA-2015-N-0101-1351,FDA,FDA-2015-N-0101,"Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial
Drug Products for Over-the-Counter Human Use",Rule,Final Rule,2017-12-20T05:00:00Z,2017,12,2017-12-20T05:00:00Z,,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,,,2017-12-20T14:40:41Z,,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,,,2017-12-20T14:43:42Z,,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,,,2017-12-20T14:46:40Z,,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,,,2017-12-20T15:11:44Z,,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,,,2017-12-20T15:14:42Z,,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,,,2017-12-20T15:17:10Z,,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,,,2017-12-20T15:22:32Z,,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,,,2017-12-20T14:56:00Z,,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,,,2017-12-20T15:37:21Z,,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,,,2017-12-20T15:42:47Z,,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,,,2017-12-20T15:44:09Z,,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,,,2017-12-20T15:10:56Z,,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,,,2017-12-20T15:18:18Z,,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,,,2017-12-20T14:51:15Z,,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,,,2017-12-20T14:51:57Z,,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,,,2017-12-20T14:53:43Z,,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,,,2017-12-20T14:39:14Z,,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,,,2017-12-20T14:45:27Z,,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,,,2017-12-20T15:08:53Z,,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,,,2017-12-20T15:36:19Z,,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,,,2017-12-20T15:41:52Z,,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,,,2017-12-20T15:12:26Z,,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,,,2017-12-20T15:25:34Z,,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,,,2017-12-20T15:30:41Z,,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,,,2017-12-20T14:49:43Z,,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,2017-12-20T05:00:00Z,2017,12,,,2017-12-20T14:50:24Z,,0,0,0900006482cea905