{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2016-N-0124\" sorted by posted_date descending", "rows": [["FDA-2016-N-0124-0413", "FDA", "FDA-2016-N-0124", "FINAL Third Extension Deferral Letter", "Other", "Letter(s)", "2022-05-31T04:00:00Z", 2022, 5, "2022-05-31T04:00:00Z", null, "2022-05-31T14:54:57Z", null, 0, 0, "0900006483e57838"], ["FDA-2016-N-0124-0410", "FDA", "FDA-2016-N-0124", "Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small\nEntity Compliance Guide; Availability", "Notice", "Notice of Availability", "2020-12-31T05:00:00Z", 2020, 12, "2020-12-31T05:00:00Z", null, "2020-12-31T14:14:51Z", "2020-28929", 0, 0, "09000064849d654d"], ["FDA-2016-N-0124-0411", "FDA", "FDA-2016-N-0124", "Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small\nEntity Compliance Guide; Availability", "Other", "Guidance", "2020-12-31T05:00:00Z", 2020, 12, "2020-12-31T05:00:00Z", null, "2024-11-12T23:26:51Z", null, 1, 0, "09000064849d6159"], ["FDA-2016-N-0124-0409", "FDA", "FDA-2016-N-0124", "The American CIeaning Institute Progress Report", "Other", "Report", "2020-12-04T05:00:00Z", 2020, 12, "2020-12-04T05:00:00Z", null, "2020-12-04T16:13:10Z", null, 0, 0, "0900006484986dd5"], ["FDA-2016-N-0124-0408", "FDA", "FDA-2016-N-0124", "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", null, "2020-11-23T13:08:25Z", null, 0, 0, "0900006484970496"], ["FDA-2016-N-0124-0407", "FDA", "FDA-2016-N-0124", "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", null, "2020-11-20T14:38:40Z", null, 0, 0, "090000648496ca62"], ["FDA-2016-N-0124-0406", "FDA", "FDA-2016-N-0124", "ACI Advice November 18 2020", "Other", "Letter(s)", "2020-11-20T05:00:00Z", 2020, 11, "2020-11-20T05:00:00Z", null, "2020-11-20T14:34:16Z", null, 0, 0, "090000648496ca5c"], ["FDA-2016-N-0124-0405", "FDA", "FDA-2016-N-0124", "ACI BZT Monograph Meeting Minutes Written Responses", "Supporting & Related Material", "Meeting Materials", "2020-10-06T04:00:00Z", 2020, 10, null, null, "2020-10-06T14:59:41Z", null, 0, 0, "09000064848de180"], ["FDA-2016-N-0124-0404", "FDA", "FDA-2016-N-0124", "Meeting Minutes for Lonza & Henkel\u2019s benzalkonium chloride consumer antiseptic hand wash July 30 2020", "Other", "Minutes", "2020-08-26T04:00:00Z", 2020, 8, "2020-08-26T04:00:00Z", null, "2020-08-26T13:56:29Z", null, 0, 0, "09000064848202dd"], ["FDA-2016-N-0124-0395", "FDA", "FDA-2016-N-0124", "Lonza Inc. Data Listing 16.2.7.1: Adverse Events Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:09:31Z", null, 0, 0, "0900006484719149"], ["FDA-2016-N-0124-0389", "FDA", "FDA-2016-N-0124", "Lonza, Inc. and Henkel Corporation, Inc. Signatures of Authors, Principal Investigator, and Sponsor's Medical Officer re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T20:51:09Z", null, 0, 0, "0900006484719143"], ["FDA-2016-N-0124-0403", "FDA", "FDA-2016-N-0124", "Lonza Inc. Table 14.1.1: Summary of Subject Enrollment and Disposition re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:27:08Z", null, 0, 0, "0900006484719220"], ["FDA-2016-N-0124-0393", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.5.1: Plasma Concentration (ng/L) - C12 homologs\nSafety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:04:49Z", null, 0, 0, "0900006484719147"], ["FDA-2016-N-0124-0386", "FDA", "FDA-2016-N-0124", "Henkel Corporation, Inc. Lonza Inc. Case Report Form Booklet\nFinal Version # 1.0 November 04, 2019 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T20:42:31Z", null, 0, 0, "0900006484719140"], ["FDA-2016-N-0124-0390", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.1 Subject Disposition and Population Inclusion All Enrolled Subjects (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T20:59:15Z", null, 0, 0, "0900006484719144"], ["FDA-2016-N-0124-0399", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.11: Childbearing Potential and Urine Pregnancy Test Results All Female Subjects (N= 20) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:17:26Z", null, 0, 0, "090000648471921c"], ["FDA-2016-N-0124-0402", "FDA", "FDA-2016-N-0124", "Lonza Inc. Figure 14.2.2.1: Individual Subject Plasma Levels, Linear for C12 and C14 homologs, PK Population Subject Number: 0001 at Day 1 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:25:07Z", null, 0, 0, "090000648471921f"], ["FDA-2016-N-0124-0400", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.12: Comments Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:19:32Z", null, 0, 0, "090000648471921d"], ["FDA-2016-N-0124-0387", "FDA", "FDA-2016-N-0124", "Lonza Inc. INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T20:45:15Z", null, 0, 0, "0900006484719141"], ["FDA-2016-N-0124-0385", "FDA", "FDA-2016-N-0124", "Henkel Corporation, Inc. Lonza Inc. A Pilot Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin with Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T20:42:03Z", null, 0, 0, "0900006484718cdb"], ["FDA-2016-N-0124-0391", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.2 Protocol Deviations Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:01:01Z", null, 0, 0, "0900006484719145"], ["FDA-2016-N-0124-0396", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.8: Vital Signs Test Results Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:11:56Z", null, 0, 0, "0900006484719219"], ["FDA-2016-N-0124-0398", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.10.1: Laboratory Test Results, Chemistry, Part 1 Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:15:35Z", null, 0, 0, "090000648471921b"], ["FDA-2016-N-0124-0397", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.9: Physical Examination Results - Abnormal Findings Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:13:50Z", null, 0, 0, "090000648471921a"], ["FDA-2016-N-0124-0401", "FDA", "FDA-2016-N-0124", "Henkel Corporation, Inc. Lonza Inc.A Pilot Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin with Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:23:13Z", null, 0, 0, "090000648471921e"], ["FDA-2016-N-0124-0394", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.6.1: Hand Wash and Packaging Weights Details Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:07:10Z", null, 0, 0, "0900006484719148"], ["FDA-2016-N-0124-0384", "FDA", "FDA-2016-N-0124", "Lonza Inc. A Pivotal Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin in Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T20:42:18Z", null, 0, 0, "0900006484718cd5"], ["FDA-2016-N-0124-0392", "FDA", "FDA-2016-N-0124", "Lonza Inc. Listing 16.2.4.1: Demographics and Baseline Characteristics Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T21:02:58Z", null, 0, 0, "0900006484719146"], ["FDA-2016-N-0124-0388", "FDA", "FDA-2016-N-0124", "Curriculum Vitaes re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T20:48:34Z", null, 0, 0, "0900006484719142"], ["FDA-2016-N-0124-0370", "FDA", "FDA-2016-N-0124", "16-5-4-representative-chromatograms", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:22:34Z", null, 0, 0, "090000648470d5dd"], ["FDA-2016-N-0124-0383", "FDA", "FDA-2016-N-0124", "16-6-ba-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:37:09Z", null, 0, 0, "090000648470d617"], ["FDA-2016-N-0124-0375", "FDA", "FDA-2016-N-0124", "16-5-2-coas-of-reference-standards", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:30:08Z", null, 0, 0, "090000648470d52b"], ["FDA-2016-N-0124-0361", "FDA", "FDA-2016-N-0124", "Appendix 3_lonza_pmut_052019_csr", "Supporting & Related Material", "Background Material", "2020-06-25T04:00:00Z", 2020, 6, null, null, "2020-06-25T17:15:28Z", null, 0, 0, "090000648470bb28"], ["FDA-2016-N-0124-0367", "FDA", "FDA-2016-N-0124", "16-5-7-incurred-samples-reanalysis-sop", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:22:05Z", null, 0, 0, "090000648470d5d1"], ["FDA-2016-N-0124-0376", "FDA", "FDA-2016-N-0124", "16-5-3-representative-chromatograms", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:31:05Z", null, 0, 0, "090000648470d52c"], ["FDA-2016-N-0124-0369", "FDA", "FDA-2016-N-0124", "16-5-5-result-tables-of-all-runs", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:22:24Z", null, 0, 0, "090000648470d5d5"], ["FDA-2016-N-0124-0359", "FDA", "FDA-2016-N-0124", "Appendix 1_Lonza FINAL July 3_2019 Prelim Meeting Preliminary Commt for July 2019 MTG", "Supporting & Related Material", "Background Material", "2020-06-25T04:00:00Z", 2020, 6, null, null, "2020-06-25T17:15:13Z", null, 0, 0, "090000648470bb2a"], ["FDA-2016-N-0124-0378", "FDA", "FDA-2016-N-0124", "16-5-5-Criteria-for-sample-reanalysis-and-reporting-sop", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:32:46Z", null, 0, 0, "090000648470d2b0"], ["FDA-2016-N-0124-0362", "FDA", "FDA-2016-N-0124", "16-6-ba-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:21:06Z", null, 0, 0, "090000648470d1e6"], ["FDA-2016-N-0124-0379", "FDA", "FDA-2016-N-0124", "16-5-6-incurred-samples-reanalysis-sop", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:33:33Z", null, 0, 0, "090000648470d2b6"], ["FDA-2016-N-0124-0371", "FDA", "FDA-2016-N-0124", "16-5-3-multianalyte-reanalysis-batches-data", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:22:43Z", null, 0, 0, "090000648470d5df"], ["FDA-2016-N-0124-0372", "FDA", "FDA-2016-N-0124", "16-5-2-coas-of-reference-standards", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:22:54Z", null, 0, 0, "090000648470d5e1"], ["FDA-2016-N-0124-0364", "FDA", "FDA-2016-N-0124", "16-6-2-ba-2nd-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:21:26Z", null, 0, 0, "090000648470d1ea"], ["FDA-2016-N-0124-0374", "FDA", "FDA-2016-N-0124", "16-5-1-preparation-acceptance-criteria-for-cc-qc-sop", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:29:21Z", null, 0, 0, "090000648470d52a"], ["FDA-2016-N-0124-0357", "FDA", "FDA-2016-N-0124", "Briefing Document BAC June 2020_Final", "Other", "Memo", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T17:12:57Z", null, 0, 0, "090000648470c918"], ["FDA-2016-N-0124-0368", "FDA", "FDA-2016-N-0124", "16-5-6-Criteria-for-sample-reanalysis-and-reporting-sop", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:22:15Z", null, 0, 0, "090000648470d5d3"], ["FDA-2016-N-0124-0381", "FDA", "FDA-2016-N-0124", "16-6-1-ba-1st-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:35:16Z", null, 0, 0, "090000648470d2b8"], ["FDA-2016-N-0124-0373", "FDA", "FDA-2016-N-0124", "16-5-1-preparation-acceptance-criteria-for-cc-qc-sop", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:23:04Z", null, 0, 0, "090000648470d5e3"], ["FDA-2016-N-0124-0358", "FDA", "FDA-2016-N-0124", "Lonza Study No_TKL MC000520 CSP Final v1.0 19June2020 - signed", "Other", "Studies", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T17:13:28Z", null, 0, 0, "090000648470c91a"], ["FDA-2016-N-0124-0360", "FDA", "FDA-2016-N-0124", "Appendix 2_BAC IVDP Foaming  Liquid Handwashes 06.2020 CRL FINAL Report", "Supporting & Related Material", "Background Material", "2020-06-25T04:00:00Z", 2020, 6, null, null, "2020-06-25T17:15:20Z", null, 0, 0, "090000648470bb29"], ["FDA-2016-N-0124-0377", "FDA", "FDA-2016-N-0124", "16-5-4-result-tables-of-all-runs", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:32:00Z", null, 0, 0, "090000648470d52d"], ["FDA-2016-N-0124-0365", "FDA", "FDA-2016-N-0124", "16-6-1-ba-1st-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:21:36Z", null, 0, 0, "090000648470d5cd"], ["FDA-2016-N-0124-0380", "FDA", "FDA-2016-N-0124", "16-5-bioanalyt-pmut-052019", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:34:23Z", null, 0, 0, "090000648470d2b7"], ["FDA-2016-N-0124-0363", "FDA", "FDA-2016-N-0124", "16-6-3-ba-3rd-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:21:15Z", null, 0, 0, "090000648470d1e8"], ["FDA-2016-N-0124-0382", "FDA", "FDA-2016-N-0124", "16-6-2-ba-2nd-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:36:15Z", null, 0, 0, "090000648470d2b9"], ["FDA-2016-N-0124-0366", "FDA", "FDA-2016-N-0124", "16-5-bioanalyt-pmut-052019", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:21:55Z", null, 0, 0, "090000648470d5cf"], ["FDA-2016-N-0124-0356", "FDA", "FDA-2016-N-0124", "MONOGRAPH Meeting Granted Letter Lonza and Henkel  2020 Benzalkonium Hand Soaps", "Other", "Request", "2020-06-24T04:00:00Z", 2020, 6, "2020-06-24T04:00:00Z", null, "2020-06-24T13:02:40Z", null, 0, 0, "0900006484704aad"], ["FDA-2016-N-0124-0354", "FDA", "FDA-2016-N-0124", "Request for Type C Meeting from Lewis and Harrison to FDA CDER/DNDP/ ODE IV", "Other", "Request", "2020-03-13T04:00:00Z", 2020, 3, "2020-03-13T04:00:00Z", null, "2020-03-13T20:20:10Z", null, 0, 0, "0900006484443e02"], ["FDA-2016-N-0124-0353", "FDA", "FDA-2016-N-0124", "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, "2019-10-17T15:39:32Z", null, 0, 0, "09000064840b4539"], ["FDA-2016-N-0124-0352", "FDA", "FDA-2016-N-0124", "Lonza FINAL July 3_2019 Prelim Meeting Preliminary Comment for July 2019 MTG (002)", "Other", "Minutes", "2019-09-19T04:00:00Z", 2019, 9, "2019-09-19T04:00:00Z", null, "2019-09-19T18:24:21Z", null, 0, 0, "0900006483f9ee0c"], ["FDA-2016-N-0124-0351", "FDA", "FDA-2016-N-0124", "Letter from FDA CDER to American Cleaning Institute", "Other", "Letter(s)", "2019-08-09T04:00:00Z", 2019, 8, "2019-08-09T04:00:00Z", null, "2019-08-09T12:57:05Z", null, 0, 0, "0900006483e1e09f"], ["FDA-2016-N-0124-0350", "FDA", "FDA-2016-N-0124", "Letter from FDA CDER to American Cleaning Institute", "Other", "Letter(s)", "2019-07-15T04:00:00Z", 2019, 7, "2019-07-15T04:00:00Z", null, "2019-07-15T18:46:13Z", null, 0, 0, "0900006483d91e24"], ["FDA-2016-N-0124-0349", "FDA", "FDA-2016-N-0124", "LONZA Meeting Request for July 9 Cancelled", "Other", "Letter(s)", "2019-07-09T04:00:00Z", 2019, 7, "2019-07-09T04:00:00Z", null, "2019-07-09T15:55:34Z", null, 0, 0, "0900006483d6f60a"], ["FDA-2016-N-0124-0348", "FDA", "FDA-2016-N-0124", "Letter from FDA CDER to Lewis & Harrison", "Other", "Letter(s)", "2019-06-12T04:00:00Z", 2019, 6, "2019-06-12T04:00:00Z", null, "2019-09-19T16:52:24Z", null, 0, 0, "0900006483d09577"], ["FDA-2016-N-0124-0307", "FDA", "FDA-2016-N-0124", "Reference 20 - Kolawole, D. O., Resistance Mechanisms of Mucoid-Grown Staphylococcus aureus to the Antibacterial Action of Some Disinfectants re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:42Z", null, 0, 0, "0900006483b6a60c"], ["FDA-2016-N-0124-0318", "FDA", "FDA-2016-N-0124", "Reference 40 - Lanker Klossner, B., et al., Nondevelopment of Resistance by Bacteria During Hospital Use of Povidone-Iodine re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:52Z", null, 0, 0, "0900006483b6a95d"], ["FDA-2016-N-0124-0294", "FDA", "FDA-2016-N-0124", "Reference 2 \u2013 6 \u2013 Volume_V_5_of_9_Published_Cited_References_Part_2_of_2_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:32Z", null, 0, 0, "0900006483b6a5f0"], ["FDA-2016-N-0124-0325", "FDA", "FDA-2016-N-0124", "Reference 33 - Weber, D. J. and W. A. Rutala, Use of Germicides in the Home and the Healthcare re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:59Z", null, 0, 0, "0900006483b6a62c"], ["FDA-2016-N-0124-0333", "FDA", "FDA-2016-N-0124", "Reference 49 - Copitch, J. L., et al., Prevalence of Decreased Susceptibility to Triclosan in Salmonella re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:59:07Z", null, 0, 0, "0900006483b6a63f"], ["FDA-2016-N-0124-0344", "FDA", "FDA-2016-N-0124", "Reference 35 - Akinkunmi, E. O. and A. Lamikanra, Susceptibility of Community Associated Methicillin Resistant re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T19:00:48Z", null, 0, 0, "0900006483b6a62e"], ["FDA-2016-N-0124-0297", "FDA", "FDA-2016-N-0124", "Reference 2 \u2013 3 \u2013 Volume_IV_3_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:34Z", null, 0, 0, "0900006483b6a4d3"], ["FDA-2016-N-0124-0343", "FDA", "FDA-2016-N-0124", "Reference 36 - Kawamura-Sato, K., et al., Reduction of Disinfectant Bactericidal Activities in Clinically Isolated Acinetobacter species in the re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T19:00:48Z", null, 0, 0, "0900006483b6a959"], ["FDA-2016-N-0124-0341", "FDA", "FDA-2016-N-0124", "Reference 41 - Oggioni, M. R., et al., Significant Differences Characterize the Correlation Coefficients Between Biocide and Antibiotic re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T19:00:46Z", null, 0, 0, "0900006483b6a960"], ["FDA-2016-N-0124-0312", "FDA", "FDA-2016-N-0124", "Reference 15 - Nagai, I. and H. Ogase, Absence of Role for Plasmids in Resistance to Multiple Disinfectants in Three re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:46Z", null, 0, 0, "0900006483b6a93b"], ["FDA-2016-N-0124-0320", "FDA", "FDA-2016-N-0124", "Reference 38 - Khor, S. Y. and M. Jegathesan, In-Use testing of Disinfectants in Malaysian Government Hospitals re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:54Z", null, 0, 0, "0900006483b6a95b"], ["FDA-2016-N-0124-0302", "FDA", "FDA-2016-N-0124", "Reference.List.Consumer.Rub.Final.Rule.2019 re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:38Z", null, 0, 0, "0900006483b6a46b"], ["FDA-2016-N-0124-0300", "FDA", "FDA-2016-N-0124", "Reference 2 - Comment submitted in Docket No. FDA-1975-N-0012-0081.  Volume_I_1_of_9_Soap_ and_Detergent_ re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:37Z", null, 0, 0, "0900006483b6a4cf"], ["FDA-2016-N-0124-0332", "FDA", "FDA-2016-N-0124", "Reference 50 - FDA Deferral Letter for Benzalkonium Chloride in Consumer Rub Antiseptics on October 31, 2017 re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:59:06Z", null, 0, 0, "0900006483b6a640"], ["FDA-2016-N-0124-0310", "FDA", "FDA-2016-N-0124", "Reference 17 - Sakagami, Y. and K. Kajimura, Bactericidal Activities of Disinfectants against Vancomycin re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:45Z", null, 0, 0, "0900006483b6a93d"], ["FDA-2016-N-0124-0345", "FDA", "FDA-2016-N-0124", "Reference 26 - Lacey, R. W., et al., Antiseptic Resistance in Methicillin-Resistant Staphylococcus aureus re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T19:00:49Z", null, 0, 0, "0900006483b6a625"], ["FDA-2016-N-0124-0347", "FDA", "FDA-2016-N-0124", "Reference 7 \u2013 1 FDA Deferral Letter for Isopropyl Alcohol in Consumer Rub Antiseptics on October 31, 2017 re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T19:00:51Z", null, 0, 0, "0900006483b6a929"], ["FDA-2016-N-0124-0309", "FDA", "FDA-2016-N-0124", "Reference 18 - Haley, C. E., et al., Bactericidal Activity of Antiseptics Against Methicillin-Resistant Staphylococcus re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:44Z", null, 0, 0, "0900006483b6a60a"], ["FDA-2016-N-0124-0346", "FDA", "FDA-2016-N-0124", "Reference 25 - Kunisada, T., et al., Investigation on the Efficacy of Povidone-Iodine Against Antiseptic re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T19:00:50Z", null, 0, 0, "0900006483b6a613"], ["FDA-2016-N-0124-0287", "FDA", "FDA-2016-N-0124", "Reference 4 -  Transcript of the October 20, 2005, Meeting of the Nonprescription Drugs Advisory Committee re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:28Z", null, 0, 0, "0900006483b6a925"], ["FDA-2016-N-0124-0321", "FDA", "FDA-2016-N-0124", "Reference 9 \u2013 Kramer, A., et. al., Quantity of Ethanol Absorption After Excessive Hand Disinfection Using Three Commercially re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:55Z", null, 0, 0, "0900006483b6a92c"], ["FDA-2016-N-0124-0313", "FDA", "FDA-2016-N-0124", "Reference 14 - Czerwinski, S. E., et al., Novel Water-Based Antiseptic Lotion Demonstrates Rapid, Broad- Spectrum Kill Compared re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:47Z", null, 0, 0, "0900006483b6a93a"], ["FDA-2016-N-0124-0292", "FDA", "FDA-2016-N-0124", "Reference 2 \u2013 8 \u2013 Volume_VII_7_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:31Z", null, 0, 0, "0900006483b6a5f5"], ["FDA-2016-N-0124-0289", "FDA", "FDA-2016-N-0124", "Reference 2 \u2013 11 \u2013 Volume_IX_9_of_9_Publsihed_Cited_ References_Part_2_of_2_re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:29Z", null, 0, 0, "0900006483b6a5f8"], ["FDA-2016-N-0124-0286", "FDA", "FDA-2016-N-0124", "Reference 5 - Summary Minutes of the November 14, 2008, Feedback Meeting with Personal  re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:27Z", null, 0, 0, "0900006483b6a926"], ["FDA-2016-N-0124-0319", "FDA", "FDA-2016-N-0124", "Reference 39 - Rikimaru, T., et al., Bactericidal Activities of Commonly Used Antiseptics Against Multidrug-Resistant Mycobacterium re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:53Z", null, 0, 0, "0900006483b6a95c"], ["FDA-2016-N-0124-0327", "FDA", "FDA-2016-N-0124", "Reference 31 - Noguchi, N., et al., Susceptibilities to Antiseptic Agents and Distribution of Antiseptic- Resistance Genes qacAB and smr re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:59:01Z", null, 0, 0, "0900006483b6a62a"], ["FDA-2016-N-0124-0324", "FDA", "FDA-2016-N-0124", "Reference 34 - Rajamohan, G., et al., Biocide-Tolerant Multidrug-Resistant Acinetobacter baumannii Clinical Strains Are Associated with re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:58Z", null, 0, 0, "0900006483b6a62d"], ["FDA-2016-N-0124-0329", "FDA", "FDA-2016-N-0124", "Reference 29 - Babaei, M et al Extremely re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:59:03Z", null, 0, 0, "0900006483b6a628"], ["FDA-2016-N-0124-0311", "FDA", "FDA-2016-N-0124", "Reference 16 - Geraldo, I. M., et al., Rapid Antibacterial Activity of 2 Novel Hand Soaps re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use", "Supporting & Related Material", "Background Material", "2019-06-05T04:00:00Z", 2019, 6, null, null, "2019-06-05T18:58:46Z", null, 0, 0, "0900006483b6a93c"], ["FDA-2016-N-0124-0315", "FDA", "FDA-2016-N-0124", "Reference 12 - Food and Drug Administration, Guidance for Industry. 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