Notice2023-04562
Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern; Revised Draft Guidance for Industry; Availability; Extension of Comment Period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
March 7, 2023
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Drug Administration (FDA or the Agency) is extending the comment period for the notice announcing the availability of a draft guidance for industry that appeared in the Federal Register of December 19, 2022. In that notice, FDA requested comments on draft guidance for industry (GFI) #152 entitled "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern." 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 88 Issue 44 (Tuesday, March 7, 2023)</title>
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[Federal Register Volume 88, Number 44 (Tuesday, March 7, 2023)]
[Notices]
[Pages 14170-14171]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04562]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1998-D-0038]
Evaluating the Safety of Antimicrobial New Animal Drugs With
Regard to Their Microbiological Effects on Bacteria of Human Health
Concern; Revised Draft Guidance for Industry; Availability; Extension
of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; 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 announcing the availability
of a draft guidance for industry that appeared in the Federal Register
of December 19, 2022. In that notice, FDA requested comments on draft
guidance for industry (GFI) #152 entitled ``Evaluating the Safety of
Antimicrobial New Animal Drugs with Regard to their Microbiological
Effects on Bacteria of Human Health Concern.'' 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
December 19, 2022 (87 FR 77619). Submit either electronic or written
comments by May 19, 2023, to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-1998-D-0038 for ``Evaluating the Safety of Antimicrobial New Animal
Drugs with Regard to their Microbiological Effects on Bacteria of Human
Health Concern.'' Received comments 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
[[Page 14171]]
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: Ruby Singh, Center for Veterinary
Medicine (HFV-150), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-402-0794, <a href="/cdn-cgi/l/email-protection#354740574c1b465c5b525d755351541b5d5d461b525a43"><span class="__cf_email__" data-cfemail="88fafdeaf1a6fbe1e6efe0c8eeece9a6e0e0fba6efe7fe">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 19,
2022, FDA published a notice announcing the availability of a draft
guidance for industry entitled ``Evaluating the Safety of Antimicrobial
New Animal Drugs with Regard to their Microbiological Effects on
Bacteria of Human Health Concern,'' and requesting comments on the
proposed GFI.
Interested persons were originally given until March 20, 2023, to
comment on the document. The Agency has received a request for an
extension of the comment period. The request stated that an additional
90 days would allow interested parties to thoroughly consider the
request for input. FDA has considered the request and is extending the
comment period for the request for comments for 60 days, until May 19,
2023. The Agency believes that a 60-day extension allows adequate time
for interested persons to submit comments.
Dated: March 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04562 Filed 3-6-23; 8:45 am]
BILLING CODE 4164-01-P
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