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Federal Register/Vol. 81, No. 126/Thursday, June 30, 2016

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Federal Register/Vol. 81, No. 126/Thursday, June 30, 2016 42912 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Proposed Rules DEPARTMENT OF HEALTH AND instructions for submitting comments. information that you do not wish to be HUMAN SERVICES Comments submitted electronically, made publicly available, submit your including attachments, to http:// comments only as a written/paper Food and Drug Administration www.regulations.gov will be posted to submission. You should submit two the docket unchanged. Because your copies total. One copy will include the 21 CFR Part 310 comment will be made public, you are information you claim to be confidential [Docket No. FDA–2016–N–0124 (Formerly solely responsible for ensuring that your with a heading or cover note that states Part of Docket No. FDA–1975–N–0012)] comment does not include any ‘‘THIS DOCUMENT CONTAINS confidential information that you or a CONFIDENTIAL INFORMATION.’’ The RIN 0910–AF69 third party may not wish to be posted, Agency will review this copy, including such as medical information, your or the claimed confidential information, in Safety and Effectiveness of Consumer anyone else’s Social Security number, or its consideration of comments. The Antiseptics; Topical Antimicrobial confidential business information, such second copy, which will have the Drug Products for Over-the-Counter as a manufacturing process. Please note claimed confidential information Human Use; Proposed Amendment of that if you include your name, contact redacted/blacked out, will be available the Tentative Final Monograph; information, or other information that for public viewing and posted on http:// Reopening of Administrative Record identifies you in the body of your www.regulations.gov. Submit both AGENCY: Food and Drug Administration, comments, that information will be copies to the Division of Dockets HHS. posted on http://www.regulations.gov. Management. If you do not wish your • ACTION: Proposed rule. If you want to submit a comment name and contact information to be with confidential information that you made publicly available, you can SUMMARY: The Food and Drug do not wish to be made available to the provide this information on the cover Administration (FDA or Agency) is public, submit the comment as a sheet and not in the body of your issuing this proposed rule to amend the written/paper submission and in the comments and you must identify this 1994 tentative final monograph or manner detailed (see ‘‘Written/Paper information as ‘‘confidential.’’ Any proposed rule (the 1994 TFM) for over- Submissions’’ and ‘‘Instructions’’). We information marked as ‘‘confidential’’ the-counter (OTC) antiseptic drug note however, that the OTC drug will not be disclosed except in products. In this proposed rule, we are monograph process is a public process; accordance with 21 CFR 10.20 and other proposing to establish conditions under and, the Agency intends to consider applicable disclosure law. For more which OTC consumer antiseptic only non-confidential material that is information about FDA’s posting of products intended for use without water submitted to the docket for this comments to public dockets, see 80 FR (referred to throughout as consumer rulemaking or that is otherwise publicly 56469, September 18, 2015, or access antiseptic rubs or consumer rubs) are available in evaluating if a relevant the information at: http://www.fda.gov/ generally recognized as safe and ingredient is GRAS/GRAE. regulatoryinformation/dockets/ generally recognized as effective (GRAS/ default.htm. GRAE). In the 1994 TFM, certain Written/Paper Submissions Docket: For access to the docket to antiseptic active ingredients were Submit written/paper submissions as read background documents or the proposed as being GRAS for antiseptic follows: electronic and written/paper comments rub use by consumers based on safety • Mail/Hand delivery/Courier (for received, go to http:// data evaluated by FDA as part of its written/paper submissions): Division of www.regulations.gov and insert the ongoing review of OTC antiseptic drug Dockets Management (HFA–305), Food docket number, found in brackets in the products. However, in light of more and Drug Administration, 5630 Fishers heading of this document, into the recent scientific developments and Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts changes in the use patterns of these • For written/paper comments and/or go to the Division of Dockets products, we are now proposing that submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm. additional safety data are necessary to Management, FDA will post your 1061, Rockville, MD 20852. support the safety of antiseptic active comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: ingredients for this use. We also are except for information submitted, Anita Kumar, Center for Drug proposing that all consumer antiseptic marked and identified, as confidential, Evaluation and Research, Food and rub active ingredients have in vitro data if submitted as detailed in Drug Administration, 10903 New characterizing the ingredient’s ‘‘Instructions.’’ Hampshire Ave., Bldg. 22, Rm. 5445, antimicrobial properties and in vivo Instructions: All submissions received Silver Spring, MD 20993, 301–796– clinical simulation studies showing that must include the Docket No. FDA– 1032. specified log reductions in the amount 2016–N–0124 for ‘‘Safety and of certain bacteria are achieved using Effectiveness of Consumer Antiseptics; SUPPLEMENTARY INFORMATION: the ingredient. Topical Antimicrobial Drug Products for Table of Contents Over-the-Counter Human Use; Proposed DATES: Submit electronic or written I. Executive Summary comments by December 27, 2016. See Amendment of the Tentative Final A. Purpose of the Regulatory Action section IX of this document for the Monograph; Reopening of B. Summary of the Major Provisions of the proposed effective date of a final rule Administrative Record.’’ Received Regulatory Action in Question based on this proposed rule. comments will be placed in the docket C. Effectiveness ADDRESSES: You may submit comments and, except for those submitted as D. Safety as follows: ‘‘Confidential Submissions,’’ publicly E. Active Ingredients viewable at http://www.regulations.gov F. Costs and Benefits Electronic Submissions II. Introduction or at the Division of Dockets A. Terminology Used in the OTC Drug Submit electronic comments in the Management between 9 a.m. and 4 p.m., Review Regulations following way: Monday through Friday. B. Topical Antiseptics • Federal eRulemaking Portal: http:// • Confidential Submissions—To C. This Proposed Rule Covers Only www.regulations.gov. Follow the submit a comment with confidential Consumer Antiseptic Rubs VerDate Sep<11>2014 21:25 Jun 29, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\30JNP3.SGM 30JNP3 sradovich on DSK3GDR082PROD with PROPOSALS3 Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / Proposed Rules 42913 D. Comment Period information we have identified and posed by the use of certain consumer III. Background placed in the docket. This proposed rule antiseptic products, as well as input A. Significant Rulemakings Relevant to applies to active ingredients used in from the Nonprescription Drugs This Proposed Rule consumer antiseptic rub products that Advisory Committee (NDAC) that met in B. Public Meetings Relevant to This Proposed Rule are sometimes referred to as rubs, leave- March 2005 (the March 2005 NDAC) C. Comments Received by FDA on products, or hand ‘‘sanitizers,’’ as and October 2005 (the October 2005 IV. Active Ingredients With Insufficient well as to consumer antiseptic wipes. NDAC), has prompted us to reevaluate Evidence of Eligibility for the OTC Drug These products are intended to be used the data needed for classifying active Review when soap and water are not available, ingredients used in consumer rubs as A. Eligibility for the OTC Drug Review and are left on and not rinsed off with GRAE. The reevaluation of effectiveness B. Eligibility of Certain Active Ingredients water. We will refer to them here as will help to ensure that the level of for the OTC Drug Review consumer antiseptic rubs or consumer effectiveness achieved is adequate to V. Ingredients Previously Proposed as Not Generally Recognized as Safe and rubs. In separate rulemakings (78 FR offset newly identified safety concerns Effective 76444, December 17, 2013; 80 FR 25166, (see new information described in the VI. Summary of Proposed Classifications of May 1, 2015), we proposed conditions safety section of this executive OTC Consumer Antiseptic Rub Active under which OTC consumer antiseptic summary). We continue to propose the Ingredients washes and OTC antiseptics intended use of surrogate endpoints (bacterial log VII. Effectiveness (Generally Recognized as for use by health care professionals in reductions) as a demonstration of Effective) Determination a hospital setting or other health care effectiveness for consumer antiseptic A. Evaluation of Effectiveness Data situation outside the hospital are GRAS/ rubs combined with in vitro testing to B. Current Standards: Studies Needed To Support a Generally Recognized as GRAE. Those antiseptic products are not characterize the antimicrobial activity of Effective Determination addressed in this proposed rule. the ingredient. However, the log reductions required for the C. Impact of Application Parameters on B. Summary of the Major Provisions of demonstration of effectiveness for Efficacy the Regulatory Action in Question VIII.
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