Document ID: FDA-2021-N-1305-0020
Agency: fda
Document Type: Notice
Title: Antimicrobial Drug Use in Companion Animals; Extension of Comment Period
Posted Date: 2022-06-13T04:00Z

[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Pages 35790-35791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12621]

[[Page 35790]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1305]

Antimicrobial Drug Use in Companion Animals; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice that appeared in the 
Federal Register of February 16, 2022. In that notice, FDA requested 
comments on antimicrobial drug use practices in companion animals and 
the potential impacts of such uses on antimicrobial resistance in both 
humans and animals. The Agency is taking this action in response to a 
request for an extension to allow interested persons additional time to 
submit comments.

DATES: FDA is extending the comment period on the notice published 
February 16, 2022 (87 FR 8848). Submit either electronic or written 
comments by September 14, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 14, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 14, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2021-N-1305 for ``Antimicrobial Drug Use in Companion Animals.'' 
Received comments, those filed in a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Barbara Leotta, Center for Veterinary 
Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0605, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of February 16, 
2022, FDA published a notice with a 120-day comment period to request 
comments on antimicrobial drug use practices in companion animals and 
the potential impacts of such uses on antimicrobial resistance in both 
humans and animals. Comments on antimicrobial use practices in 
companion animals will inform FDA's strategy for promoting 
antimicrobial stewardship in companion animals.
    Interested persons were originally given until June 16, 2022, to 
comment on the document. The Agency has received a request for a 90-day 
extension of the comment period. The request conveyed concern that the 
current 120-day comment period does not allow sufficient time to 
develop a meaningful or thoughtful response to the request for 
comments. FDA has

[[Page 35791]]

considered the request and is extending the comment period for the 
request for comments for 90 days, until September 14, 2022. The Agency 
believes that a 90-day extension allows adequate time for interested 
persons to submit comments.

    Dated: June 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12621 Filed 6-10-22; 8:45 am]
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