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withdrawn,object_id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-0101-1384,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
FDA-2015-N-0101-1424,FDA,FDA-2015-N-0101,"075 Reference 64 - Sakuragi et al, Bactericidal activity of skin disinfectants on 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,,,2017-12-20T15:39:10Z,,0,0,0900006482ceabe4
FDA-2015-N-0101-1426,FDA,FDA-2015-N-0101,"077 Reference 66 - Payne et al, Antiseptics-A forgotten weapon in the control of antibiotic resistant bacteria in hospital 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,,,2017-12-20T15:40:30Z,,0,0,0900006482ceabe6
FDA-2015-N-0101-1397,FDA,FDA-2015-N-0101,046 Reference 35 - Resistance Mechanisms of Mucoid-Grown Staphylococcus Aureus to the Antibacterial Action of Some Disinfectants and Antiseptics 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,,,2017-12-20T15:16:10Z,,0,0,0900006482cea5ae
FDA-2015-N-0101-1403,FDA,FDA-2015-N-0101,"052 Reference 41 - Lacey et al, Antiseptic resistance in 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,,,2017-12-20T15:20:22Z,,0,0,0900006482cea5b4
FDA-2015-N-0101-1404,FDA,FDA-2015-N-0101,053 Reference 42 - Sensitivities to Biocides and Distribution of Biocide Resistance Genes in Quaternary Ammonium Compound 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,,,2017-12-20T15:21:02Z,,0,0,0900006482cea5b5
FDA-2015-N-0101-1439,FDA,FDA-2015-N-0101,"057 Reference 46 - Noguchi et al, Susceptibilities to antiseptic agents and distribution of antiseptic-resistance genes qacAB and smr of 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,,,2017-12-20T15:44:57Z,,0,0,0900006482cea5b8
FDA-2015-N-0101-1416,FDA,FDA-2015-N-0101,"067 Reference 56 - Prince et al, Drug Resistance Studies with Topical Antiseptics 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,,,2017-12-20T15:31:14Z,,0,0,0900006482cea7cd
FDA-2015-N-0101-1352,FDA,FDA-2015-N-0101,Reference List 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,,,2017-12-20T14:39:02Z,,0,0,0900006482ce9f6c
FDA-2015-N-0101-1420,FDA,FDA-2015-N-0101,071 Reference 60 - Yasuda et al 1993 Comparison of Bactericidal Activities of Various Disinfectants Against MSSA and MRSA 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,,,2017-12-20T15:33:42Z,,0,0,0900006482ceabe0
FDA-2015-N-0101-1431,FDA,FDA-2015-N-0101,"082 Reference 71 - Shi et al, Prevalence of Antiseptic-Resistance Genes in Staphylococci Isolated from Orthokeratology Lens and Spectacle 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,,,2017-12-20T15:42:18Z,,0,0,0900006482ceabeb
FDA-2015-N-0101-1410,FDA,FDA-2015-N-0101,"061 Reference 50 - Akinkunmi et al, Susceptibility of Community Associated Methicillin Resistant Staphylococcus Aureus Isolated 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,,,2017-12-20T15:26:11Z,,0,0,0900006482cea5bc
FDA-2015-N-0101-1411,FDA,FDA-2015-N-0101,"062 Reference 51 - Kawamura-Sato et al, Reduction of Disinfectant Bactericidal Activities in Clinically Isolated 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,,,2017-12-20T15:27:02Z,,0,0,0900006482cea7c8
FDA-2015-N-0101-1358,FDA,FDA-2015-N-0101,006 Reference 2 -5 - Volume_IV_4_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,,,2017-12-20T14:42:55Z,,0,0,0900006482ce9f73
FDA-2015-N-0101-1381,FDA,FDA-2015-N-0101,"030 Reference 19 - Summary Minutes of the September 3, 2014 Nonprescription Drugs Advisory Committee Meeting 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,,,2017-12-20T15:04:42Z,,0,0,0900006482cea914
FDA-2015-N-0101-1423,FDA,FDA-2015-N-0101,"074 Reference 63 - Rikimaru et al, Efficacy of Common Antiseptics against Multidrug-Resistant Mycobacterium Tuberculosis 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,,,2017-12-20T15:38:33Z,,0,0,0900006482ceabe3
FDA-2015-N-0101-1427,FDA,FDA-2015-N-0101,"078 Reference 67 - Oggioni et al, Significant Differences Characterise the Correlation Coefficients between Biocide and Antibiotic 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,,,2017-12-20T15:41:13Z,,0,0,0900006482ceabe7
FDA-2015-N-0101-1430,FDA,FDA-2015-N-0101,"081 Reference 70 - Buffet-Bataillon et al, Effect of higher minimum inhibitory concentrations of quaternary ammonium compounds in clinical E. coli isolates on antibiotic 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,,,2017-12-20T15:42:07Z,,0,0,0900006482ceabea
FDA-2015-N-0101-1432,FDA,FDA-2015-N-0101,"083 Reference 72 - Lambert, Comparative Analysis of Antibiotic and Antimicrobial Biocide Susceptibility Data in Clinical Isolates of Methicillin-Sensitive 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,,,2017-12-20T15:42:30Z,,0,0,0900006482ceabec
FDA-2015-N-0101-1433,FDA,FDA-2015-N-0101,"084 Reference 73 - Morrissey et al, Evaluation of Epidemiological Cut-Off Values Indicates that Biocide Resistant Subpopulations Are Uncommon in Natural Isolates of Clinically 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,,,2017-12-20T15:42:39Z,,0,0,0900006482ceabed
FDA-2015-N-0101-1438,FDA,FDA-2015-N-0101,"089 Reference 78 - FDA Regulatory Impact Analysis, Safety and Effectiveness for Health Care Antiseptics 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,,,2017-12-20T15:44:18Z,,0,0,0900006482ceabf2
FDA-2015-N-0101-1414,FDA,FDA-2015-N-0101,"065 Reference 54 - Rikimaru et al, Bactericidal Activities of Commonly Used Antiseptics against Multidrug-Resistant 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,,,2017-12-20T15:30:01Z,,0,0,0900006482cea7cb
FDA-2015-N-0101-1374,FDA,FDA-2015-N-0101,023 Reference 12 - FDA_Letter_regarding_Deferral_of_Chloroxylenol 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,,,2017-12-20T14:57:59Z,,0,0,0900006482cea90d
FDA-2015-N-0101-1425,FDA,FDA-2015-N-0101,"076 Reference 65 - Sanchez et al, The Biocide Triclosan Selects Stenotrophomonas Maltophilia Mutants That Overproduce the Smedef 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,,,2017-12-20T15:39:48Z,,0,0,0900006482ceabe5
FDA-2015-N-0101-1436,FDA,FDA-2015-N-0101,"087 Reference 76 - Langsrud et al, Cross-Resistance to Antibiotics of Escherichia Coli Adapted to Benzalkonium Chloride or 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,,,2017-12-20T15:43:57Z,,0,0,0900006482ceabf0
FDA-2015-N-0101-1389,FDA,FDA-2015-N-0101,"038 Reference 27 - Guidance for Industry, Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers 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,,,2017-12-20T15:10:10Z,,0,0,0900006482cea5a6
FDA-2015-N-0101-1394,FDA,FDA-2015-N-0101,043 Reference 32 - Bactericidal Activities of Disinfectants against Vancomycin-Resistant Enterococci 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,,,2017-12-20T15:14:05Z,,0,0,0900006482cea5ab
FDA-2015-N-0101-1401,FDA,FDA-2015-N-0101,050 Reference 39 - Evaluation of Chlorhexidine and Povidone Iodine Activity 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,,,2017-12-20T15:18:56Z,,0,0,0900006482cea5b2
FDA-2015-N-0101-1405,FDA,FDA-2015-N-0101,"054 Reference 43 - Furi et al, Evaluation of reduced susceptibility to quaternary ammonium compounds and bisbiguanides in clinical isolates and laboratory-generated mutants 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,,,2017-12-20T15:21:58Z,,0,0,0900006482cea5b6
FDA-2015-N-0101-1407,FDA,FDA-2015-N-0101,"058 Reference 47 - Shamsudin et al, High Prevalence of QacaB Carriage among Clinical Isolates of Meticillin-Resistant Staphylococcus 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,,,2017-12-20T15:23:52Z,,0,0,0900006482cea5b9
FDA-2015-N-0101-1413,FDA,FDA-2015-N-0101,"064 Reference 53 - Khor, In use Testing of disinfectants in Malaysian government hospitals 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,,,2017-12-20T15:28:35Z,,0,0,0900006482cea7ca
FDA-2015-N-0101-1363,FDA,FDA-2015-N-0101,012 Reference 2 -11 - Volume_IX_9_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,,,2017-12-20T14:47:47Z,,0,0,0900006482cea4bf
FDA-2015-N-0101-1379,FDA,FDA-2015-N-0101,028 Reference 17 - Rotter et al Population Kinetics of the Skin Flora on Gloved Hands Following Surgical Hand Disinfection 2007 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,,,2017-12-20T15:03:07Z,,0,0,0900006482cea912
FDA-2015-N-0101-1380,FDA,FDA-2015-N-0101,"029 Reference 18 - Beldame et al, Surgical glove bacterial contamination and perforation during total hip arthroplasty implantation- When gloves should be changed 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,,,2017-12-20T15:03:52Z,,0,0,0900006482cea913
FDA-2015-N-0101-1361,FDA,FDA-2015-N-0101,009 Reference 2 -8 - Volume_VI_6_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,,,2017-12-20T14:46:05Z,,0,0,0900006482cea4bc
FDA-2015-N-0101-1385,FDA,FDA-2015-N-0101,"034 Reference 23 - FDA, Draft Guidance for Industry on Endocrine Disruptin Potention of 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,,,2017-12-20T15:07:37Z,,0,0,0900006482cea5a2
FDA-2015-N-0101-1373,FDA,FDA-2015-N-0101,022 Reference 11 - FDA_Letter_regarding_Deferral_of_Benzethonium_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,,,2017-12-20T14:57:24Z,,0,0,0900006482cea90c
FDA-2015-N-0101-1429,FDA,FDA-2015-N-0101,"080 Reference 69 - Stickler et al, Antiseptic and antibiotic resistance in gram-negative bacteria causing urinary tract infection in spinal cord injured patients 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,,,2017-12-20T15:41:57Z,,0,0,0900006482ceabe9
FDA-2015-N-0101-1435,FDA,FDA-2015-N-0101,"086 Reference 75 - Braoudaki et al, Adaptive Resistance to Biocides in Salmonella Enterica and Escherichia Coli O157 and Cross-Resistance 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,,,2017-12-20T15:43:04Z,,0,0,0900006482ceabef
FDA-2015-N-0101-1396,FDA,FDA-2015-N-0101,045 Reference 34 - Comparative Susceptibility of Resident and Transient Hand Bacteria to Para-Chloro-Meta-Xylenol and Triclosan 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,,,2017-12-20T15:15:24Z,,0,0,0900006482cea5ad
FDA-2015-N-0101-1356,FDA,FDA-2015-N-0101,004 Reference 2 -3 - Volume_III_3_of_9_Reference_List_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,,,2017-12-20T14:41:36Z,,0,0,0900006482ce9f71
FDA-2015-N-0101-1354,FDA,FDA-2015-N-0101,002 Reference 2 -1 - Volume_I_1_of_9_Soap_and_Detergent_Association_SDA_Comment_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,,,2017-12-20T14:39:26Z,,0,0,0900006482ce9f6f
FDA-2015-N-0101-1357,FDA,FDA-2015-N-0101,005 Reference 2 -4 - Volume_IV_4_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,,,2017-12-20T14:42:14Z,,0,0,0900006482ce9f72
FDA-2015-N-0101-1383,FDA,FDA-2015-N-0101,032 Reference 21 - Briefing Document for a NDAC meeting September 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,,,2017-12-20T15:06:21Z,,0,0,0900006482cea917
FDA-2015-N-0101-1418,FDA,FDA-2015-N-0101,"069 Reference 58 - Giacometti et al, Antiseptic Compounds Still Active against Bacterial Strains Isolated from Surgical Wound Infections 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,,,2017-12-20T15:32:20Z,,0,0,0900006482ceabde
FDA-2015-N-0101-1419,FDA,FDA-2015-N-0101,070 Reference 59 - Gocke et al 1985 In vitro Studies of the Killing of Clinical Ioslates by Povidone-Iodine Solutions 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,,,2017-12-20T15:33:00Z,,0,0,0900006482ceabdf
FDA-2015-N-0101-1393,FDA,FDA-2015-N-0101,042 Reference 31 - Geraldo et al Rapid Antibacterial Activity of 2 Noval Hand Soaps 2008 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,,,2017-12-20T15:13:12Z,,0,0,0900006482cea5aa
FDA-2015-N-0101-1349,FDA,FDA-2015-N-0101,Report from American Cleaning Institute,Other,Report,2017-12-19T05:00:00Z,2017,12,2017-12-19T05:00:00Z,,2017-12-19T20:38:13Z,,0,0,0900006482d142ac
FDA-2015-N-0101-1348,FDA,FDA-2015-N-0101,Letter from American Cleaning Institute,Other,Letter(s),2017-11-24T05:00:00Z,2017,11,2017-11-24T05:00:00Z,,2017-11-24T15:29:46Z,,0,0,0900006482c51176
FDA-2015-N-0101-1347,FDA,FDA-2015-N-0101,Supplement from American Chemistry Council,Other,Supplement (SUP),2017-10-18T04:00:00Z,2017,10,2017-10-18T04:00:00Z,,2017-10-18T19:39:02Z,,0,0,0900006482ba06d0
FDA-2015-N-0101-1346,FDA,FDA-2015-N-0101,Letter to Medtronic re Isopropyl Alcohol Deferral,Other,Letter(s),2017-10-03T04:00:00Z,2017,10,2017-10-03T04:00:00Z,,2017-10-03T16:25:17Z,,0,0,0900006482b9515a
FDA-2015-N-0101-1344,FDA,FDA-2015-N-0101,Supplement from American Chemistry Council,Other,Supplement (SUP),2017-09-27T04:00:00Z,2017,9,2017-09-27T04:00:00Z,,2017-09-27T20:22:49Z,,0,0,0900006482b777ee
FDA-2015-N-0101-1345,FDA,FDA-2015-N-0101,Supplement from American Chemistry Council,Other,Supplement (SUP),2017-09-27T04:00:00Z,2017,9,2017-09-27T04:00:00Z,,2017-09-27T20:24:34Z,,0,0,0900006482b77df3
FDA-2015-N-0101-1343,FDA,FDA-2015-N-0101,Letter from FDA to American Cleaning Institute,Other,Letter(s),2017-09-11T04:00:00Z,2017,9,2017-09-11T04:00:00Z,,2017-09-11T12:07:41Z,,0,0,0900006482b1a92e
FDA-2015-N-0101-1338,FDA,FDA-2015-N-0101,Letter from Medtronic,Other,Letter(s),2017-05-08T04:00:00Z,2017,5,2017-05-08T04:00:00Z,,2017-05-08T15:49:53Z,,0,0,0900006482577b21
FDA-2015-N-0101-1337,FDA,FDA-2015-N-0101,Letter from American Chemistry Council,Other,Letter(s),2017-05-08T04:00:00Z,2017,5,2015-05-01T04:00:00Z,2015-10-29T03:59:59Z,2017-05-08T15:46:40Z,,0,0,090000648255f81f
FDA-2015-N-0101-1327,FDA,FDA-2015-N-0101,Report from The American Cleaning Institute (ACI),Other,Report,2017-02-14T05:00:00Z,2017,2,2017-02-14T05:00:00Z,,2017-03-22T17:18:48Z,,0,0,09000064824c0c81
FDA-2015-N-0101-1321,FDA,FDA-2015-N-0101,FDA Letter regarding Deferral of Benzalkonium Chloride,Other,Letter(s),2017-01-19T05:00:00Z,2017,1,2017-01-19T05:00:00Z,,2017-01-19T15:14:59Z,,0,0,09000064824849ae