Notice2022-12621
Antimicrobial Drug Use in Companion Animals; Extension of Comment Period
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 113 (Monday, June 13, 2022)</title>
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[Federal Register Volume 87, Number 113 (Monday, June 13, 2022)]
[Notices]
[Pages 35790-35791]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#5a383b28383b283b74363f352e2e3b1a3c3e3b74323229743d352c"><span class="__cf_email__" data-cfemail="d2b0b3a0b0b3a0b3fcbeb7bda6a6b392b4b6b3fcbabaa1fcb5bda4">[email protected]</span></a>.
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]
BILLING CODE 4164-01-P
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