{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\", docket_id = \"FDA-1975-N-0012\" and posted_year = 2020 sorted by posted_date descending", "rows": [["FDA-1975-N-0012-0835", "FDA", "FDA-1975-N-0012", "The American CIeaning Institute Progress Report", "Other", "Report", "2020-12-04T05:00:00Z", 2020, 12, "2020-12-04T05:00:00Z", null, "2020-12-04T16:11:45Z", null, 0, 0, "0900006484986dd3"], ["FDA-1975-N-0012-0834", "FDA", "FDA-1975-N-0012", "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, "2020-11-23T13:04:07Z", null, 0, 0, "0900006484970492"], ["FDA-1975-N-0012-0833", "FDA", "FDA-1975-N-0012", "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, "2020-11-20T14:36:43Z", null, 0, 0, "090000648496ca5e"], ["FDA-1975-N-0012-0832", "FDA", "FDA-1975-N-0012", "ACI Advice November 18 2020", "Other", "Letter(s)", "2020-11-20T05:00:00Z", 2020, 11, "2020-11-20T05:00:00Z", null, "2020-11-20T14:31:06Z", null, 0, 0, "090000648496c57e"], ["FDA-1975-N-0012-0831", "FDA", "FDA-1975-N-0012", "ACI BZT Monograph Meeting Minutes Written Responses", "Supporting & Related Material", "Meeting Materials", "2020-10-06T04:00:00Z", 2020, 10, null, null, "2020-10-06T14:24:05Z", null, 0, 0, "09000064848be3df"], ["FDA-1975-N-0012-0830", "FDA", "FDA-1975-N-0012", "Meeting Minutes for Lonza & Henkel\u2019s benzalkonium chloride consumer antiseptic handwash July 30 2020", "Other", "Minutes", "2020-08-26T04:00:00Z", 2020, 8, "2020-08-26T04:00:00Z", null, "2020-08-26T13:57:23Z", null, 0, 0, "09000064848202db"], ["FDA-1975-N-0012-0812", "FDA", "FDA-1975-N-0012", "Lonza Inc. APPROVED BY INTEGREVIEW IRB\nOCTOBER 25, 2019 THIS IS AN IMPORTANT DOCUMENT - KEEP FOR FUTURE REFERENCE VERSION CONTROL jr/9-27-19 rss/10-25-19\nINFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDYre 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, "2020-06-29T18:59:45Z", null, 0, 0, "0900006484717944"], ["FDA-1975-N-0012-0829", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T20:15:29Z", null, 0, 0, "0900006484718b64"], ["FDA-1975-N-0012-0827", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T20:15:09Z", null, 0, 0, "0900006484718b62"], ["FDA-1975-N-0012-0816", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T19:39:45Z", null, 0, 0, "0900006484718732"], ["FDA-1975-N-0012-0819", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T19:40:29Z", null, 0, 0, "0900006484718935"], ["FDA-1975-N-0012-0826", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T20:04:17Z", null, 0, 0, "0900006484718a12"], ["FDA-1975-N-0012-0817", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T19:39:55Z", null, 0, 0, "0900006484718733"], ["FDA-1975-N-0012-0828", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T20:15:19Z", null, 0, 0, "0900006484718b63"], ["FDA-1975-N-0012-0823", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T19:59:00Z", null, 0, 0, "090000648471893e"], ["FDA-1975-N-0012-0821", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T19:58:43Z", null, 0, 0, "090000648471893c"], ["FDA-1975-N-0012-0815", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T19:39:36Z", null, 0, 0, "0900006484718731"], ["FDA-1975-N-0012-0810", "FDA", "FDA-1975-N-0012", "Lonza Inc. A Pilot Maximal Use Study to Measure the Systemic\nAbsorption of Benzalkonium Chloride (BAC) After\nExaggerated Use of the Antimicrobial Soap on Intact Skin in\nHealthy 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, "2020-06-29T18:59:17Z", null, 0, 0, "0900006484717942"], ["FDA-1975-N-0012-0813", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T18:59:58Z", null, 0, 0, "0900006484717945"], ["FDA-1975-N-0012-0809", "FDA", "FDA-1975-N-0012", "Lonza Study No_TKL MC000520 CSP Final 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", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T18:59:02Z", null, 0, 0, "090000648471742e"], ["FDA-1975-N-0012-0811", "FDA", "FDA-1975-N-0012", "Lonza Inc. Case Report Form Booklet Final Version # 1.0\nNovember 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, "2020-06-29T18:59:35Z", null, 0, 0, "0900006484717943"], ["FDA-1975-N-0012-0820", "FDA", "FDA-1975-N-0012", "Lonza Inc. Statistical Analysis Plan 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, "2020-06-29T19:58:33Z", null, 0, 0, "090000648471849a"], ["FDA-1975-N-0012-0822", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T19:58:52Z", null, 0, 0, "090000648471893d"], ["FDA-1975-N-0012-0824", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T19:59:09Z", null, 0, 0, "0900006484718a0f"], ["FDA-1975-N-0012-0814", "FDA", "FDA-1975-N-0012", "Lonza 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, "2020-06-29T19:17:24Z", null, 0, 0, "09000064847183f5"], ["FDA-1975-N-0012-0818", "FDA", "FDA-1975-N-0012", "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 \nSORRY", "Supporting & Related Material", "Background Material", "2020-06-29T04:00:00Z", 2020, 6, null, null, "2020-06-29T19:40:18Z", null, 0, 0, "0900006484718734"], ["FDA-1975-N-0012-0825", "FDA", "FDA-1975-N-0012", "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, "2020-06-29T20:01:41Z", null, 0, 0, "0900006484718a11"], ["FDA-1975-N-0012-0788", "FDA", "FDA-1975-N-0012", "16-5-2-coas-of-reference-standards", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:03:08Z", null, 0, 0, "090000648470d126"], ["FDA-1975-N-0012-0787", "FDA", "FDA-1975-N-0012", "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, "2020-06-25T19:01:40Z", null, 0, 0, "090000648470d125"], ["FDA-1975-N-0012-0797", "FDA", "FDA-1975-N-0012", "16-6-3-ba-3rd-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:17:07Z", null, 0, 0, "090000648470d515"], ["FDA-1975-N-0012-0785", "FDA", "FDA-1975-N-0012", "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, "2020-06-25T17:09:01Z", null, 0, 0, "090000648470c91d"], ["FDA-1975-N-0012-0807", "FDA", "FDA-1975-N-0012", "16-5-2-coas-of-reference-standards", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:41:14Z", null, 0, 0, "090000648470d834"], ["FDA-1975-N-0012-0800", "FDA", "FDA-1975-N-0012", "16-6-2-ba-2nd-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:40:02Z", null, 0, 0, "090000648470d80c"], ["FDA-1975-N-0012-0799", "FDA", "FDA-1975-N-0012", "16-6-ba-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:39:52Z", null, 0, 0, "090000648470d5e5"], ["FDA-1975-N-0012-0796", "FDA", "FDA-1975-N-0012", "16-6-2-ba-2nd-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:15:53Z", null, 0, 0, "090000648470d0ff"], ["FDA-1975-N-0012-0808", "FDA", "FDA-1975-N-0012", "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, "2020-06-25T19:41:23Z", null, 0, 0, "090000648470d836"], ["FDA-1975-N-0012-0802", "FDA", "FDA-1975-N-0012", "16-5-bioanalyt-pmut-052019", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:40:28Z", null, 0, 0, "090000648470d810"], ["FDA-1975-N-0012-0803", "FDA", "FDA-1975-N-0012", "16-5-6-incurred-samples-reanalysis-sop", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:40:37Z", null, 0, 0, "090000648470d812"], ["FDA-1975-N-0012-0790", "FDA", "FDA-1975-N-0012", "16-5-4-representative-chromatograms", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:07:11Z", null, 0, 0, "090000648470d128"], ["FDA-1975-N-0012-0805", "FDA", "FDA-1975-N-0012", "16-5-4-result-tables-of-all-runs", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:40:57Z", null, 0, 0, "090000648470d830"], ["FDA-1975-N-0012-0786", "FDA", "FDA-1975-N-0012", "Appendix 3_lonza_pmut_052019_csr", "Supporting & Related Material", "Background Material", "2020-06-25T04:00:00Z", 2020, 6, null, null, "2020-06-25T17:10:56Z", null, 0, 0, "090000648470c964"], ["FDA-1975-N-0012-0784", "FDA", "FDA-1975-N-0012", "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, "2020-06-25T17:09:14Z", null, 0, 0, "090000648470c91c"], ["FDA-1975-N-0012-0793", "FDA", "FDA-1975-N-0012", "16-5-7-incurred-samples-reanalysis-sop", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:11:20Z", null, 0, 0, "090000648470d174"], ["FDA-1975-N-0012-0791", "FDA", "FDA-1975-N-0012", "16-5-5-result-tables-of-all-runs", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:08:19Z", null, 0, 0, "090000648470d129"], ["FDA-1975-N-0012-0782", "FDA", "FDA-1975-N-0012", "Briefing Document BAC June 2020_Final", "Other", "Memo", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T17:00:38Z", null, 0, 0, "090000648470c914"], ["FDA-1975-N-0012-0806", "FDA", "FDA-1975-N-0012", "16-5-3-representative-chromatograms", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:41:06Z", null, 0, 0, "090000648470d832"], ["FDA-1975-N-0012-0789", "FDA", "FDA-1975-N-0012", "16-5-3-multianalyte-reanalysis-batches-data", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:04:41Z", null, 0, 0, "090000648470d127"], ["FDA-1975-N-0012-0804", "FDA", "FDA-1975-N-0012", "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, "2020-06-25T19:40:46Z", null, 0, 0, "090000648470d814"], ["FDA-1975-N-0012-0783", "FDA", "FDA-1975-N-0012", "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, "2020-06-25T17:01:52Z", null, 0, 0, "090000648470c915"], ["FDA-1975-N-0012-0792", "FDA", "FDA-1975-N-0012", "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, "2020-06-25T19:10:02Z", null, 0, 0, "090000648470d0db"], ["FDA-1975-N-0012-0801", "FDA", "FDA-1975-N-0012", "16-6-1-ba-1st-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:40:18Z", null, 0, 0, "090000648470d80e"], ["FDA-1975-N-0012-0794", "FDA", "FDA-1975-N-0012", "16-5-bioanalyt-pmut-052019", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:12:35Z", null, 0, 0, "090000648470d175"], ["FDA-1975-N-0012-0798", "FDA", "FDA-1975-N-0012", "16-6-ba-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:18:17Z", null, 0, 0, "090000648470d516"], ["FDA-1975-N-0012-0795", "FDA", "FDA-1975-N-0012", "16-6-1-ba-1st-add-to-validationreport", "Other", "Report", "2020-06-25T04:00:00Z", 2020, 6, "2020-06-25T04:00:00Z", null, "2020-06-25T19:14:43Z", null, 0, 0, "090000648470d0fe"], ["FDA-1975-N-0012-0781", "FDA", "FDA-1975-N-0012", "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, "2020-06-24T13:01:00Z", null, 0, 0, "0900006484704aa9"]], "truncated": false, "filtered_table_rows_count": 55, "expanded_columns": [], "expandable_columns": [[{"column": "docket_id", "other_table": "dockets", "other_column": "id"}, "title"]], "columns": ["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"], "primary_keys": ["id"], "units": {}, "query": {"sql": "select 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 from documents where \"agency_id\" = :p0 and \"docket_id\" = :p1 and \"posted_year\" = :p2 order by posted_date desc limit 101", "params": {"p0": "FDA", "p1": 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