documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

85 rows where docket_id = "FDA-1975-N-0012" and posted_year = 2016 sorted by posted_date descending

✎ View and edit SQL

This data as json, CSV (advanced)

Suggested facets: subtype, posted_date, comment_start_date, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)

document_type 3

posted_year 1

  • 2016 · 85 ✖

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1975-N-0012-0723 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response Letter from American Cleaning Institute (ACI) Other Letter(s) 2016-12-12T05:00:00Z 2016 12 2016-12-12T05:00:00Z   2016-12-12T21:52:28Z   0 0 09000064823fcc03
FDA-1975-N-0012-0722 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Draft Protocol Study from American Cleaning Institute Supporting & Related Material Background Material 2016-11-25T05:00:00Z 2016 11     2016-11-25T14:19:32Z   0 0 09000064823be604
FDA-1975-N-0012-0710 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 58 Infections and Pseudoinfections Due to Povidone-Iodine Solution Contaminated with Pseudomonas cepacia re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:20Z   0 0 09000064821bfd1d
FDA-1975-N-0012-0652 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 List of References re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:48:25Z   0 0 09000064821bfa64
FDA-1975-N-0012-0657 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 5 Minutes_of_Meeting,_11_14_2008 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:39Z   0 0 09000064821bfaa7
FDA-1975-N-0012-0670 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 18 Involvement of efflux mechanisms in biocide resistance of Campylobacter jejuni and Campylobacter coli re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:40Z   0 0 09000064821bfafe
FDA-1975-N-0012-0683 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 31 Investigation of antibiotic and antibacterial agent cross-resistance in target bacteria from homes of antibacterial product users and nonusers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:36Z   0 0 09000064821bfb07
FDA-1975-N-0012-0690 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 38 Use of antibacterial consumer products containing quaternary ammonium compounds and drug resistance in the community re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:02Z   0 0 09000064821bfb1e
FDA-1975-N-0012-0694 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 42 Cross-resistance to antibiotics of Escherichia coli adapted to benzalkonium chloride or exposed to stress-inducers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:42Z   0 0 09000064821bfb22
FDA-1975-N-0012-0696 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 44 Adaptive resistance to benzalkonium chloride, amikacin and tobramycin: the effect on susceptibility to other antimicrobials re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:32Z   0 0 09000064821bfb24
FDA-1975-N-0012-0700 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 48 330TOXICOLOGY AND CARCINOGENESISSTUDIES OF4-HEXYLRESORCINOL(CAS NO. 136-77-6)IN F344/N RATS AND B6C3Fi MICE(GAVAGE STUDIES) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:14Z   0 0 09000064821bfb2c
FDA-1975-N-0012-0716 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 64 NTP Research Concept: Triclocarban re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:37:49Z   0 0 09000064821bfb51
FDA-1975-N-0012-0721 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 70 SCCS final Opinion on triclosan June 2010 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:37:25Z   0 0 09000064821bfb58
FDA-1975-N-0012-0653 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 1 Transcript of Jan 22 1997 Joint Meeting re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:48:20Z   0 0 09000064821bfa65
FDA-1975-N-0012-0661 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 9 Effect of Antibacterial Home Cleaning and Handwashing Products on Infectious Disease Symptoms re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:22Z   0 0 09000064821bfaf5
FDA-1975-N-0012-0662 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 10 Elimination of methicillin-resistant Siaphylococcus aureus from a neonatal intensive care unit after hand washing with triclosan re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:17Z   0 0 09000064821bfaf6
FDA-1975-N-0012-0663 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 11 Use of 0.3% triclosan (Bacti-Stat*) to eradicate an outbreak of methicillin-resistant Staphylococcus aureus in a neonatal nursery re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:13Z   0 0 09000064821bfaf7
FDA-1975-N-0012-0669 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 17 Substrate specificity of the OqxAB multidrug resistance pump in Escherichia coli and selected enteric bacteria re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:44Z   0 0 09000064821bfafd
FDA-1975-N-0012-0681 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 29 Prevalence of decreased susceptibility to triclosan in Salmonella enterica isolates from animals and humans and association with multiple drug resistance re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:46Z   0 0 09000064821bfb05
FDA-1975-N-0012-0693 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 41 Triclosan resistance in methicillin-resistant Staphylococcus aureus (MRSA) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:48Z   0 0 09000064821bfb21
FDA-1975-N-0012-0714 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 62 Pseudobacteremia Caused by Povidone-Iodine Solution Contaminated with Pseudomonas Cepacia re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:00Z   0 0 09000064821bfd21
FDA-1975-N-0012-0715 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 63 Triclocarban_HPV_Robust_Study_Summaries re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:37:54Z   0 0 09000064821bfd22
FDA-1975-N-0012-0675 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 23 Triclosan Can Select for an AdeIJK-Overexpressing Mutant of Acinetobacter baumannii ATCC 17978 That Displays Reduced Susceptibility to Multiple Antibiotics re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:16Z   0 0 09000064821bf8f6
FDA-1975-N-0012-0658 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 6 NDAC 2014 Transcript re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:34Z   0 0 09000064821bfaa8
FDA-1975-N-0012-0664 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 12 Quantitative Microbial Risk Assessment of Antibacterial Hand Hygiene Products on Risk of Shigellosis re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:09Z   0 0 09000064821bfaf8
FDA-1975-N-0012-0688 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 36 Investigation of antibiotic and antibacterial agent cross-resistance in target bacteria from homes of antibacterial product users and nonusers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:13Z   0 0 09000064821bfb0d
FDA-1975-N-0012-0702 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 50 Antimicrobial Effectiveness of Povidone-Iodine and Consequences for New Application Areas. re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:59Z   0 0 09000064821bfb2e
FDA-1975-N-0012-0706 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 54 Evaluation of chlorhexidine and povidone iodine activity against methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus faecalis using a surface test re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:39Z   0 0 09000064821bfd19
FDA-1975-N-0012-0707 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 55 Iodine and Iodine Compounds re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:35Z   0 0 09000064821bfd1a
FDA-1975-N-0012-0667 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 15 Statistical, Epidemiological, and Risk-Assessment Approaches to Evaluating Safety of Vaccines Throughout the Life Cycle at the Food and Drug Administration re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:53Z   0 0 09000064821bfafb
FDA-1975-N-0012-0651 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Rule Final Rule 2016-09-06T04:00:00Z 2016 9 2016-09-06T04:00:00Z 2019-04-04T03:59:59Z 2019-04-03T01:05:19Z 2016-21337 0 0 09000064821d2e5a
FDA-1975-N-0012-0678 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 26 Resistant Mechanism Study of Benzalkonium Chloride Selected Salmonella Typhimurium Mutants re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:00Z   0 0 09000064821bf8f9
FDA-1975-N-0012-0660 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 8 Effect of handwashing on child health: a randomised controlled trial re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:26Z   0 0 09000064821bfaaf
FDA-1975-N-0012-0686 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 34 Relationship between Triclosan and Susceptibilities of Bacteria Isolated from Hands in the Community re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:22Z   0 0 09000064821bfb0a
FDA-1975-N-0012-0692 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 40 Adaptive Resistance to Biocides in Salmonella enterica and Escherichia coli O157 and Cross-Resistance to Antimicrobial Agents re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:53Z   0 0 09000064821bfb20
FDA-1975-N-0012-0704 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 52 Povidone Iodine re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:49Z   0 0 09000064821bfb33
FDA-1975-N-0012-0705 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 53 Antiseptic Efficacy of Disinfecting Solutions in Suspension Test in vitro against Methicillin-Resistant Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli in Pressure Sore Wounds after Spinal Cord Injury re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:45Z   0 0 09000064821bfb34
FDA-1975-N-0012-0720 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 69 Short-term in vivo exposure to the water contaminant triclosan: Evidence for disruption of thyroxine re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:37:31Z   0 0 09000064821bfb57
FDA-1975-N-0012-0673 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 21 Salmonella enterica serovar Typhimurium multidrug efflux pumps EmrAB and AcrEF support the major efflux system AcrAB in decreased susceptibility to triclosan re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:26Z   0 0 09000064821bf8f4
FDA-1975-N-0012-0689 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 37 The Frequency of Antibiotic-Resistant Bacteria in Homes Differing in Their Use of Surface Antibacterial Agents re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:07Z   0 0 09000064821bfb0e
FDA-1975-N-0012-0697 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 45 ICH HARMONISED TRIPARTITE GUIDELINE TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS S1B Current Step 4 version dated 16 July 1997 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:28Z   0 0 09000064821bfb25
FDA-1975-N-0012-0698 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 46 Guidance for Industry S1B Testing for Carcinogenicity of Pharmaceuticals re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:24Z   0 0 09000064821bfb27
FDA-1975-N-0012-0703 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 51 Povidone–iodine: use in hand disinfection, skin preparation and antiseptic irrigation re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:54Z   0 0 09000064821bfb32
FDA-1975-N-0012-0676 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 24 Mutations upstream of fabI in triclosan resistant Staphylococcus aureus strains are associated with elevated fabI gene expression re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:12Z   0 0 09000064821bf8f7
FDA-1975-N-0012-0684 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 32 Chloroxylenol- and triclosan-tolerant bacteria from industrial sources—susceptibility to antibiotics and other biocides re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:32Z   0 0 09000064821bfb08
FDA-1975-N-0012-0717 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 65 Scientific Committee on Consumer Products OPINION ON Dermal Sensitisation Quantitative Risk Assessment (Citral, Farnesol and Phenylacetaldehyde) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:37:45Z   0 0 09000064821bfb52
FDA-1975-N-0012-0718 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 66 Newsletter of the European Commission Scientific Committees June 2011 en re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:37:40Z   0 0 09000064821bfb55
FDA-1975-N-0012-0712 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 60 CDC Contaminated Povidone-Iodine Solution -- Texas re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:10Z   0 0 09000064821bfd1f
FDA-1975-N-0012-0713 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 61 Pseudobacteremia Attributed to Contamination of Povidone-Iodine with Psedomonas cepacia re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:04Z   0 0 09000064821bfd20
FDA-1975-N-0012-0655 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 3 NDAC March 2005 Transcript re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:48:08Z   0 0 09000064821bfa69
FDA-1975-N-0012-0656 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 4 NDAC October 2005 Transcript re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:45Z   0 0 09000064821bfaa6
FDA-1975-N-0012-0709 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 57 Drug Resistance Studies with Topical Antiseptics re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:25Z   0 0 09000064821bfd1c
FDA-1975-N-0012-0666 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 14 QuantiŽ cation and Variability Analysis of Bacterial Cross-Contamination Rates in Common Food Service Tasks re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:57Z   0 0 09000064821bfafa
FDA-1975-N-0012-0668 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 16 Recent advances in the potential interconnection between antimicrobial resistance to biocides and antibiotics re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:48Z   0 0 09000064821bfafc
FDA-1975-N-0012-0687 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 35 Antibacterial Cleaning Products and Drug Resistance re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:18Z   0 0 09000064821bfb0b
FDA-1975-N-0012-0695 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 43 Development of triclosan and antibiotic resistance in Salmonella enterica serovar Typhimurium re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:37Z   0 0 09000064821bfb23
FDA-1975-N-0012-0699 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 47 Citizen_Petition_from_Comprehensive_Technology_Center re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:19Z   0 0 09000064821bfb2b
FDA-1975-N-0012-0719 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 68 Absorption and Metabolism of Triclosan After Application to the Skin of B6C3F1 Mice re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:37:35Z   0 0 09000064821bfb56
FDA-1975-N-0012-0711 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 59 Nosocomial Outbreaks: The Centers for Disease Control’s Hospital Infections Program Experience, 1980-1990 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:15Z   0 0 09000064821bfd1e
FDA-1975-N-0012-0672 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 20 Polymorphic Variation in Susceptibility and Metabolism of Triclosan-Resistant Mutants of Escherichia coli and Klebsiella pneumoniae Clinical Strains Obtained after Exposure to Biocides and Antibiotics re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:31Z   0 0 09000064821bf8f3
FDA-1975-N-0012-0674 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 22 Analysis of Triclosan-Selected Salmonella enterica Mutants of Eight Serovars Revealed Increased Aminoglycoside Susceptibility and Reduced Growth Rates re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:21Z   0 0 09000064821bf8f5
FDA-1975-N-0012-0677 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 25 Molecular mechanisms of higher MICs of antibiotics and quaternary ammonium compounds for Escherichia coli isolated from bacteraemia re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:07Z   0 0 09000064821bf8f8
FDA-1975-N-0012-0679 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 27 Adapted tolerance to benzalkonium chloride in Escherichia coli K-12 studied by transcriptome and proteome analyses re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:55Z   0 0 09000064821bf8fa
FDA-1975-N-0012-0654 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 2 Comment No FDA-1975-N-0012-0081 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:48:15Z   0 0 09000064821bfa68
FDA-1975-N-0012-0701 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 49 Molecular Effects of Povidone-Iodine on RElevant Microorganisms: An Electron-Microscopic and Biochemical Study re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:05Z   0 0 09000064821bfb2d
FDA-1975-N-0012-0708 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 56 Absence of bacterial resistance to povidone iodine re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:38:30Z   0 0 09000064821bfd1b
FDA-1975-N-0012-0671 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 19 Development of antimicrobial resistance in Campylobacter jejuni and Campylobacter coli adapted to biocides re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:41:35Z   0 0 09000064821bf8f2
FDA-1975-N-0012-0659 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 7 37 FR 9464, 1972, Part 130 Procedure for classification of OTC drugs re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:30Z   0 0 09000064821bfaae
FDA-1975-N-0012-0680 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 28 Evaluation of Epidemiological Cut-Off Values Indicates that Biocide Resistant Subpopulations Are Uncommon in Natural Isolates of Clinically-Relevant Microorganisms re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:50Z   0 0 09000064821bf8fb
FDA-1975-N-0012-0665 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 13 QuantiŽ cation and Variability Analysis of Bacterial Cross-Contamination Rates in Common Food Service Tasks re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:42:04Z   0 0 09000064821bfaf9
FDA-1975-N-0012-0682 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 30 Staphylococcus epidermidis Isolated in 1965 Are More Susceptible to Triclosan than Current Isolates re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:41Z   0 0 09000064821bfb06
FDA-1975-N-0012-0685 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 33 Chloroxylenol- and triclosan-tolerant bacteria from industrial sources re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:40:27Z   0 0 09000064821bfb09
FDA-1975-N-0012-0691 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Reference 39 The Use of Machine Learning Methodologies to Analyse Antibiotic and Biocide Susceptibility in Staphylococcus aureus re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use Supporting & Related Material Background Material 2016-09-06T04:00:00Z 2016 9     2016-09-06T14:39:57Z   0 0 09000064821bfb1f
FDA-1975-N-0012-0649 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from Lewis and Harrison (Lonza,Inc.) to FDA CDER Other Letter(s) 2016-08-12T04:00:00Z 2016 8 2016-08-12T04:00:00Z   2016-08-12T19:29:47Z   0 0 090000648217253d
FDA-1975-N-0012-0650 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Handwashing Habits Child Care Workers GLM 16123 National Online Study with Child Care Providers Conducted on Behalf of the American Cleaning Institute (April 2016) Supporting & Related Material Background Material 2016-08-12T04:00:00Z 2016 8     2016-08-12T19:41:45Z   0 0 090000648217253c
FDA-1975-N-0012-0648 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Memorandum of Meeting Minutes Between FDA CDER and Lonza America, Inc Other Memorandum 2016-06-28T04:00:00Z 2016 6 2016-06-28T04:00:00Z   2016-06-28T11:23:36Z   0 0 0900006482073c0d
FDA-1975-N-0012-0647 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA CDER to Lonza America Inc. Re: Meeting Request Granted for May 25, 2016 Other Agency Response 2016-05-18T04:00:00Z 2016 5 2016-05-18T04:00:00Z   2016-05-18T12:42:16Z   0 0 0900006481fda242
FDA-1975-N-0012-0646 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response from American Cleaning Institute to FDA CDER (re: Benzalkonium Chloride) Other Response(s) 2016-05-06T04:00:00Z 2016 5 2016-05-06T04:00:00Z   2016-05-06T18:40:24Z   0 0 0900006481fb26e3
FDA-1975-N-0012-0645 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Response from American Cleaning Institute to FDA CDER (re: Chloroxylenol) Other Response(s) 2016-05-06T04:00:00Z 2016 5 2016-05-06T04:00:00Z   2016-05-06T18:36:11Z   0 0 0900006481fb26e2
FDA-1975-N-0012-0644 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Attachment 1 Agenda for Lonza-FDA Meeting re: Briefing Document from Lonza, Inc. (Lewis & Harrison) Supporting & Related Material Background Material 2016-04-26T04:00:00Z 2016 4     2016-04-26T19:31:34Z   0 0 0900006481f8f9e8
FDA-1975-N-0012-0643 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Draft Protocol for Hormonal Effects Studies: Uterotrophic Bioassay of Benzethonium Chloride USP by Oral (Gavage) in Female Rats re Comment from Lonza Inc, Lewis & Harrison Supporting & Related Material Background Material 2016-03-22T04:00:00Z 2016 3     2016-03-22T19:48:19Z   0 0 0900006481983bed
FDA-1975-N-0012-0640 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA CDER to Lonza America, Inc., American Cleaning Institute and Henkel North America regarding Review of Benzethonium Chloride Other Letter(s) 2016-03-10T05:00:00Z 2016 3 2016-03-10T05:00:00Z   2016-03-10T22:07:14Z   0 0 0900006481ebae9d
FDA-1975-N-0012-0639 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA CDER to Lonza America, Inc., American Cleaning Institute and Henkel North America regarding Review of Benzalkonium Chloride Other Letter(s) 2016-03-10T05:00:00Z 2016 3 2016-03-10T05:00:00Z   2016-03-10T22:04:06Z   0 0 0900006481eba838
FDA-1975-N-0012-0637 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Request from Henkel Consumer Goods, Inc. Other Request 2016-03-10T05:00:00Z 2016 3 2016-03-10T05:00:00Z   2016-03-10T21:53:09Z   0 0 0900006481d6ae19
FDA-1975-N-0012-0638 FDA Health Care Antiseptic Drug Products for Over-the-Counter (OTC) Human Use; CLOSED FDA-1975-N-0012 Letter from FDA CDER to American Cleaning Institute and Henkel North America regarding Review of Chloroxylenol Other Letter(s) 2016-03-10T05:00:00Z 2016 3 2016-03-10T05:00:00Z   2016-03-10T22:01:29Z   0 0 0900006481eba837

Advanced export

JSON shape: default, array, newline-delimited, object

CSV options: 

CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);