{"abstract":"The Food and Drug Administration (FDA) 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 antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being generally recognized as safe for use in health care settings 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, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for these uses. We also are proposing that all health care antiseptic 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/2015/05/01/2015-10174.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21}],"citation":"80 FR 25166","comment_url":"http://www.regulations.gov/commenton/FDA-2015-N-0101-0001","comments_close_on":"2015-10-28","correction_of":null,"corrections":[],"dates":"Submit electronic or written comments by October 28, 2015. See section VIII 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-2015-N-0101"],"dockets":[{"supporting_documents":[{"title":"Response Letter from FDA CDER to American Cleaning Institute","document_id":"FDA-2015-N-0101-1315"},{"title":"Reference 143 - Heller & Burd, Review of Ethanol Dispersion Distribution and Elimination from the Fetal Compartment re Safety and Effectiveness of Health Care 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-2015-N-0101-1051"},{"title":"Reference 39-59 - FDA-1975-N-0012-0227 --- CP7 Tab_12_Appendix_D_Chlorhexidine_Gluconate_Healthcare_Personnel_Handwash_Studies_Tables_1_Thru_9 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; 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