Document ID: FDA-2016-N-0124-0410
Agency: fda
Document Type: Notice
Title: Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small
Entity Compliance Guide; Availability
Posted Date: 2020-12-31T05:00Z

[Federal Register Volume 85, Number 251 (Thursday, December 31, 2020)]
[Notices]
[Pages 86937-86938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28929]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0124 (Formerly Docket No. FDA-1975-N-0012)]

Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for 
Inclusion in Final Monograph Questions and Answers; Guidance for 
Industry; Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Consumer 
Antiseptic Rub Final Rule Questions and Answers.'' We are issuing this 
guidance in accordance with the Small Business Regulatory Enforcement 
Fairness Act to help small businesses understand and comply with the 
Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for 
Inclusion in Final Monograph (Consumer Antiseptic Rub FR). In the 
Consumer Antiseptic Rub FR, FDA established that 28 active ingredients 
used in nonprescription (also known as over-the-counter (OTC)) consumer 
antiseptic products intended for use without water (consumer antiseptic 
rubs) are not eligible for evaluation under FDA's OTC Drug Review, 
which was used to evaluate the safety and effectiveness of OTC drug 
products marketed in the United States on or before May 1972. The 
Consumer Antiseptic Rub FR also established that three active 
ingredients used in consumer antiseptic rubs are eligible for 
evaluation under the OTC Drug Review and granted requests to 
temporarily defer further rulemaking on these three eligible 
ingredients to allow for the development and submission of new safety 
and effectiveness data.

DATES: The announcement of the guidance is published in the Federal 
Register on December 31, 2020.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0124 for ``Consumer Antiseptic Rub Final Rule Questions and 
Answers.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at https://www.regulations.gov or at the Dockets Management Staff 
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Anita Kumar, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5445, Silver Spring, MD 20993-0002, 301-
796-1032.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Consumer Antiseptic Rub Final Rule

[[Page 86938]]

Questions and Answers.'' We are issuing this guidance in accordance 
with section 212 of the Small Business Regulatory Enforcement Fairness 
Act (Pub. L. 104-121, as amended by Pub. L. 110-28) \1\ to help small 
businesses understand and comply with the Consumer Antiseptic Rub FR 
(84 FR 14847, April 12, 2019), which established that 28 active 
ingredients are not eligible for evaluation under FDA's OTC Drug Review 
for use in consumer antiseptic rubs. Drug products containing these 
ineligible active ingredients will require approval under a new drug 
application or abbreviated new drug application before they can be 
marketed. In this final action, FDA also established that three active 
ingredients used in consumer antiseptic rubs are eligible for 
evaluation under the OTC Drug Review and granted requests to 
temporarily defer further rulemaking on these three ingredients to 
allow interested parties to complete the studies necessary to fill the 
safety and effectiveness data gaps identified for these three 
ingredients.
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    \1\ 5 U.S.C. 601 (note).
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    This guidance reviews the content and effect of the final action, 
including identifying which active ingredients were found eligible and 
which were found not eligible for evaluation under the OTC Drug Review 
for use in consumer antiseptic rubs. In addition, this guidance 
explains when and how manufacturers must comply with the final action.
    This Level 2 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on how small businesses can better 
understand and comply with the Consumer Antiseptic Rub FR. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: December 23, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28929 Filed 12-30-20; 8:45 am]
BILLING CODE 4164-01-P