{"abstract":"The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are generally recognized as safe and generally recognized as effective (GRAS/GRAE). In the 1994 TFM, certain antiseptic active ingredients were proposed as being GRAS for antiseptic rub use by consumers based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments and changes in the use patterns of these products, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use. We also are proposing that all consumer antiseptic rub active ingredients have in vitro data characterizing the ingredient's antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/06/30/2016-15410.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21}],"citation":"81 FR 42912","comment_url":null,"comments_close_on":"2016-12-27","correction_of":null,"corrections":[],"dates":"Submit electronic or written comments by December 27, 2016. See section IX of this document for the proposed effective date of a final rule based on this proposed rule.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-0124 (Formerly Part of Docket No. FDA-1975-N-0012)"],"dockets":[{"supporting_documents":[{"title":"Reference 25 - Kunisada, T., et al., Investigation on the Efficacy of Povidone-Iodine Against Antiseptic re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0346"},{"title":"Reference 33 - Weber, D. J. and W. A. Rutala, Use of Germicides in the Home and the Healthcare re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0325"},{"title":"Reference 40 - Lanker Klossner, B., et al., Nondevelopment of Resistance by Bacteria During Hospital Use of Povidone-Iodine re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0318"},{"title":"Reference 18 - Haley, C. E., et al., Bactericidal Activity of Antiseptics Against Methicillin-Resistant Staphylococcus re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0309"},{"title":"Reference 20 - Kolawole, D. O., Resistance Mechanisms of Mucoid-Grown Staphylococcus aureus to the Antibacterial Action of Some Disinfectants re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0307"},{"title":"Reference 2 – 6 – Volume_V_5_of_9_Published_Cited_References_Part_2_of_2_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0294"},{"title":"Econ Reference 10 – Johnston et al, The alcohol hand rub a good soap substitute re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2016-N-0124-0206"},{"title":"Econ Reference 5 – Miller et al, Does the Clinical Use of Ethanol-Based Hand Sanitizer Elevate Blood Alcohol Levels A Prospective Study re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2016-N-0124-0201"},{"title":"List of References re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2016-N-0124-0196"},{"title":"Reference 151 - Burleigh-Flayer et al, Isopropanol Vapor Inhalation Oncogenicity Study in Fisher 344 Rats and CD-1 Mice re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2016-N-0124-0195"}],"agency_name":"FDA","documents":[{"comment_count":50,"comment_start_date":"2016-06-30","updated_at":"2023-03-01T01:01:47.221-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-0124-0001","allow_late_comments":null,"id":"FDA-2016-N-0124-0001","comment_end_date":"2016-12-28","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":301,"id":"FDA-2016-N-0124","title":"Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record"}],"document_number":"2016-15410","effective_on":null,"end_page":42937,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/06/30/2016-15410.xml","html_url":"https://www.federalregister.gov/documents/2016/06/30/2016-15410/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-15410?publication_date=2016-06-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-06-30/2016-15410/mods.xml","not_received_for_publication":null,"page_length":26,"page_views":{"count":19021,"last_updated":"2026-07-26 04:15:02 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-06-30/pdf/2016-15410.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-15410.pdf?1467204387","publication_date":"2016-06-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/06/30/2016-15410.txt","regulation_id_number_info":{"0910-AF69":{"issue":"201604","html_url":"https://www.federalregister.gov/regulations/0910-AF69/over-the-counter-otc-drug-review-topical-antimicrobial-drug-products","title":"Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AF69&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0910-AF69"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 25 - Kunisada, T., et al., Investigation on the Efficacy of Povidone-Iodine Against Antiseptic re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0346"},{"title":"Reference 33 - Weber, D. J. and W. A. Rutala, Use of Germicides in the Home and the Healthcare re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0325"},{"title":"Reference 40 - Lanker Klossner, B., et al., Nondevelopment of Resistance by Bacteria During Hospital Use of Povidone-Iodine re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0318"},{"title":"Reference 18 - Haley, C. E., et al., Bactericidal Activity of Antiseptics Against Methicillin-Resistant Staphylococcus re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0309"},{"title":"Reference 20 - Kolawole, D. O., Resistance Mechanisms of Mucoid-Grown Staphylococcus aureus to the Antibacterial Action of Some Disinfectants re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0307"},{"title":"Reference 2 – 6 – Volume_V_5_of_9_Published_Cited_References_Part_2_of_2_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","document_id":"FDA-2016-N-0124-0294"},{"title":"Econ Reference 10 – Johnston et al, The alcohol hand rub a good soap substitute re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2016-N-0124-0206"},{"title":"Econ Reference 5 – Miller et al, Does the Clinical Use of Ethanol-Based Hand Sanitizer Elevate Blood Alcohol Levels A Prospective Study re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2016-N-0124-0201"},{"title":"List of References re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2016-N-0124-0196"},{"title":"Reference 151 - Burleigh-Flayer et al, Isopropanol Vapor Inhalation Oncogenicity Study in Fisher 344 Rats and CD-1 Mice re Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2016-N-0124-0195"}],"comments_count":50,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-0124","supporting_documents_count":301,"docket_id":"FDA-2016-N-0124","document_id":"FDA-2016-N-0124-0001","regulation_id_number":null,"title":"Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","checked_regulationsdotgov_at":"2023-03-01T06:01:46Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":42912,"subtype":null,"title":"Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","toc_doc":"Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph; Reopening of Administrative Record","toc_subject":"Safety and Effectiveness of Consumer Antiseptics:","topics":["Administrative practice and procedure","Drugs","Labeling","Medical devices","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":81}