Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Extension of the Comment Period, 82384 [2023-25962]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 88, Number 225 (Friday, November 24, 2023)]
[Notices]
[Page 82384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25962]



[[Page 82384]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-2925]


Defining Durations of Use for Approved Medically Important 
Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for 
Industry; Extension of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice of availability that 
published in the Federal Register of September 26, 2023. In that 
notice, FDA requested comments on the draft guidance for industry (GFI) 
#273 entitled ``Defining Durations of Use for Approved Medically 
Important Antimicrobial Drugs Fed to Food-Producing Animals.'' The 
Agency is taking this action in response to requests for an extension 
to allow interested persons additional time to develop and submit 
comments.

DATES: FDA is extending the comment period on the notice of 
availability published September 26, 2023 (88 FR 66009). Submit either 
electronic or written comments on the draft guidance by January 5, 
2024, to ensure that the Agency considers your comments on this draft 
guidance before it begins work on the final version of the guidance.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:
     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-2023-D-2925 for ``Defining Durations of Use for Approved Medically 
Important Antimicrobial Drugs Fed to Food-Producing Animals.'' 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.

FOR FURTHER INFORMATION CONTACT: John Mussman, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-402-0589, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of September 26, 
2023, FDA published a notice announcing the availability of a draft 
guidance for industry (GFI) #273 entitled ``Defining Durations of Use 
for Approved Medically Important Antimicrobial Drugs Fed to Food-
Producing Animals.'' Interested persons were originally given until 
December 26, 2023, to comment on the draft guidance.
    The Agency received requests for extension of the comment period 
for the draft guidance. After considering the requests, and the fact 
that the original comment period is scheduled to close on December 26, 
2023, FDA has decided to extend the comment period for the draft 
guidance until January 5, 2024. The Agency believes that this extension 
allows adequate time for interested persons to submit comments to 
ensure that FDA can consider the comments before it begins work on the 
final version of the guidance.

    Dated: November 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25962 Filed 11-22-23; 8:45 am]
BILLING CODE 4164-01-P