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60474 Federal Register/Vol. 82, No. 243/Wednesday, December 20 60474 Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Rules and Regulations DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: ingredients are benzalkonium chloride, benzethonium chloride, chloroxylenol, HUMAN SERVICES Table of Contents alcohol (also referred to as ethanol or Food and Drug Administration I. Executive Summary ethyl alcohol), isopropyl alcohol, and A. Purpose of the Final Rule povidone-iodine. Accordingly, FDA 21 CFR Part 310 B. Summary of the Major Provisions of the does not make a GRAS/GRAE Final Rule determination in this final rule for these [Docket No. FDA–2015–N–0101] C. Costs and Benefits six active ingredients for use as OTC RIN 0910–AH40 II. Table of Abbreviations and Acronyms health care antiseptics. The monograph Commonly Used in This Document or nonmonograph status of these six Safety and Effectiveness of Health III. Introduction A. Terminology Used in the OTC Drug ingredients will be addressed, either Care Antiseptics; Topical Antimicrobial Review Regulations after completion and analysis of ongoing Drug Products for Over-the-Counter B. Topical Antiseptics studies to address the safety and Human Use C. This Final Rule Covers Only Health Care effectiveness data gaps of these Antiseptics ingredients or at a later date, if these AGENCY: Food and Drug Administration, IV. Background studies are not completed. HHS. A. Significant Rulemakings Relevant to This rulemaking finalizes the ACTION: Final rule. This Final Rule nonmonograph status of the remaining B. Public Meetings Relevant to This Final 24 active ingredients intended for use in SUMMARY: The Food and Drug Rule health care antiseptics identified in the Administration (FDA, the Agency, or C. Scope of This Final Rule 2015 Health Care Antiseptic PR. No we) is issuing this final rule establishing D. Eligibility for the OTC Drug Review additional data were submitted to that certain active ingredients used in V. Comments on the Proposed Rule and FDA Response support monograph conditions for these nonprescription (also known as over- A. Introduction 24 health care antiseptic active the-counter or OTC) antiseptic products B. General Comments on the Proposed ingredients. Therefore, this rule intended for use by health care Rule and FDA Response finalizes the 2015 Health Care professionals in a hospital setting or C. Comments on Eligibility of Active Antiseptic PR and finds that 24 health other health care situations outside the Ingredients and FDA Response care antiseptic active ingredients are not hospital are not generally recognized as D. Comments on Effectiveness and FDA GRAS/GRAE for use as OTC health care safe and effective (GRAS/GRAE). FDA is Response antiseptics. Accordingly, OTC health issuing this final rule after considering E. Comments on Safety and FDA Response F. Comments on the Preliminary care antiseptic drugs containing any of the recommendations of the Regulatory Impact Analysis and FDA these 24 active ingredients are new Nonprescription Drugs Advisory Response drugs under section 201(p) of the Committee (NDAC); public comments VI. Ingredients Not Generally Recognized as Federal Food, Drug, and Cosmetic Act on the Agency’s notices of proposed Safe and Effective (FD&C Act) (21 U.S.C. 321(p)) for which rulemaking; and all data and VII. Compliance Date approved applications under section information on OTC health care VIII. Summary of Regulatory Impact Analysis 505 of the FD&C Act (21 U.S.C. 355) and antiseptic products that have come to A. Introduction part 314 (21 CFR 314) of the regulations the Agency’s attention. This final rule B. Summary of Costs and Benefits IX. Paperwork Reduction Act of 1995 are required for marketing and may be finalizes the 1994 tentative final X. Analysis of Environmental Impact misbranded under section 502 of the monograph (TFM) for OTC health care XI. Federalism FD&C Act (21 U.S.C. 352). antiseptic drug products that published XII. References This final rule covers only OTC health in the Federal Register of June 17, 1994 care antiseptics that are intended for use (the 1994 TFM) as amended by the I. Executive Summary by health care professionals in a proposed rule published in the Federal hospital setting or other health care Register (FR) of May 1, 2015 (2015 A. Purpose of the Final Rule situations outside the hospital. This Health Care Antiseptic Proposed Rule This final rule finalizes the 2015 final rule does not cover consumer (PR)). Health Care Antiseptic PR. This final rule applies to health care antiseptic antiseptic washes (78 FR 76444, 81 FR DATES: This rule is effective December products that are intended for use by 61106); consumer antiseptic rubs (81 FR 20, 2018. health care professionals in a hospital 42912); antiseptics identified as ‘‘first ADDRESSES: For access to the docket to setting or other health care situations aid antiseptics’’ in the 1991 First Aid read background documents or the outside the hospital. Health care tentative final monograph (TFM) (56 FR electronic and written/paper comments antiseptic products include health care 33644); or antiseptics used by the food received, go to https:// personnel hand washes, health care industry. www.regulations.gov and insert the personnel hand rubs, surgical hand B. Summary of the Major Provisions of docket number found in brackets in the scrubs, surgical hand rubs, and patient the Final Rule heading of this final rule, into the antiseptic skin preparations (i.e., patient ‘‘Search’’ box and follow the prompts, preoperative and preinjection skin 1. Safety and/or go to the Dockets Management preparations). Several important scientific Staff, 5630 Fishers Lane, Rm. 1061, In response to several requests developments that affect the safety Rockville, MD 20852. submitted to the 2015 Health Care evaluation of OTC health care antiseptic FOR FURTHER INFORMATION CONTACT: Antiseptic PR, FDA has deferred further active ingredients have occurred since Michelle M. Jackson, Center for Drug rulemaking on six active ingredients FDA’s 1994 safety evaluation. Improved Evaluation and Research, Food and used in OTC health care antiseptic analytical methods now exist that can Drug Administration, 10903 New products to allow for the development detect and more accurately measure Hampshire Ave., Bldg. 22, Rm. 5420, and submission to the record of new these active ingredients at lower levels Silver Spring, MD 20993–0002, 301– safety and effectiveness data for these in the bloodstream and tissue. 796–0923. ingredients. The deferred active Consequently, new data suggest that the VerDate Sep<11>2014 19:43 Dec 19, 2017 Jkt 244001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\20DER2.SGM 20DER2 ethrower on DSK3G9T082PROD with RULES Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Rules and Regulations 60475 systemic exposure to these active clinical practice, as well as input from 1972. To our knowledge, there is only ingredients is higher than previously the 2005 NDAC, prompted us to one ineligible product currently on the thought, and new information about the reevaluate the data needed to determine market, an alcohol-containing surgical potential risks from systemic absorption whether health care antiseptic active hand scrub, which is affected by this and long-term exposure is now ingredients are generally recognized as rule. available. New safety information also effective (GRAE). We continued to Benefits are quantified as the volume suggests that widespread antiseptic use propose the use of surrogate endpoints reduction in exposure to triclosan found could have an impact on the (bacterial log reductions) as a in health care antiseptic products development of bacterial resistance. To demonstration of effectiveness for affected by the rule, but these benefits support a classification of generally health care antiseptics combined with are not monetized. Annual benefits are recognized as safe (GRAS) for health in vitro testing to characterize the estimated to be a reduction in exposure care antiseptic active ingredients, we antimicrobial activity of the active of 88,000 kilograms (kg) of triclosan per proposed that additional data were ingredient (80 FR 25166). year. needed to demonstrate that those We have considered the Costs are calculated as the one-time ingredients meet current safety recommendations from the public costs associated with reformulating standards (80 FR 25166 at 25179 to meetings held by the Agency on health care antiseptic products 25195). antiseptics (see section IV.B, table 2) containing the active ingredient The minimum data needed to and evaluated the available literature, as triclosan and relabeling reformulated demonstrate safety for all health care well as the data, the comments, and products. We believe that the alcohol- antiseptic active ingredients fall into other information that were submitted containing surgical hand scrub that is four broad categories: (1) Human safety to the rulemaking on the effectiveness of affected by this rule is likely to be studies described in current FDA the 24 non-deferred health care removed from the market. We categorize guidance (e.g., maximal usage trial or antiseptic active ingredients addressed the associated loss of sales revenue as a ‘‘MUsT’’); (2) nonclinical safety studies in this final rule. Since the publication transfer from one manufacturer to described in current FDA guidance (e.g., of the 2015 Health Care Antiseptic PR, another and not a cost, because we developmental and reproductive no new data or information was assume that the supply of other, highly toxicity studies and carcinogenicity submitted on the effectiveness of these substitutable, products is highly elastic. studies); (3) data to characterize 24 non-deferred health care antiseptic Annualizing the one-time costs over a potential hormonal effects; and (4) data active ingredients. Consequently, there 10-year period, we estimate total to evaluate the development of is insufficient data to support a GRAE annualized costs to range from $1.1 to antimicrobial resistance. determination for these ingredients. $4.1 million at a 3 percent discount rate, We have considered the and from $1.2 to $4.7 million at a 7 C.
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