FDA-2015-N-0101; and FDA-2016-N-0124
DE PARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 November 18, 2020 Docket Nos. FDA-1975-N-0012; FDA-2015-N-0101; and FDA-2016-N-0124 The American Cleaning Institute Attention: James Kim, PhD Vice President, Science and Regulatory Affairs 1401 H Street, N.W. Suite 700 Washington, D.C. 20005 Re: Benzalkonium Chloride, Benzethonium Chloride, Chloroxylenol, Ethanol, and Povidone-Iodine Dear Dr. Kim: This letter responds to The American Cleaning Institute’s (ACI’s) July 14, 2020 communication regarding the deferral from final rulemaking under the over-the-counter (OTC) Drug Review on benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, and povidone-iodine for use in nonprescription (often referred to as over-the-counter or OTC) consumer antiseptic wash, health care antiseptic, and consumer antiseptic rub drug products. In March 2016, FDA issued letters granting requests to defer three active ingredients— benzalkonium chloride, benzethonium chloride, and chloroxylenol—from inclusion in the final rulemaking for the December 2013 proposed rule for OTC consumer antiseptic washes (78 FR 76444). Similarly, in January 2017, FDA issued letters granting requests to defer six active ingredients—benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, povidone- iodine, and isopropyl alcohol—from inclusion in the final rulemaking for the May 2015 proposed rule for OTC health care antiseptics (80 FR 25166). In October 2017, FDA issued letters granting requests to defer three active
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