Notice2026-02934
Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Guidance for Industry; Availability
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Published
February 13, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #273 entitled "Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals." This guidance document provides recommendations on how sponsors may voluntarily establish defined durations of use for certain antimicrobial new animal drugs used in or on the medicated feed of food-producing animals that are currently approved with one or more indications that lack a defined duration of use. Establishing defined durations of use within the approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) is intended to mitigate development of antimicrobial resistance for these antimicrobial drugs, which are important to human medicine. It also proposes timelines for sponsors to voluntarily align their affected applications with this guidance.
Full Text
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<title>Federal Register, Volume 91 Issue 30 (Friday, February 13, 2026)</title>
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[Federal Register Volume 91, Number 30 (Friday, February 13, 2026)]
[Notices]
[Pages 6855-6856]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02934]
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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; Guidance for
Industry; 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 (GFI) #273 entitled
``Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals.'' This guidance
document provides recommendations on how sponsors may voluntarily
establish defined durations of use for certain antimicrobial new animal
drugs used in or on the medicated feed of food-producing animals that
are currently approved with one or more indications that lack a defined
duration of use. Establishing defined durations of use within the
approved new animal drug applications (NADAs) and abbreviated new
animal drug applications (ANADAs) is intended to mitigate development
of antimicrobial resistance for these antimicrobial drugs, which are
important to human medicine. It also proposes timelines for sponsors to
voluntarily align their affected applications with this guidance.
DATES: The announcement of the guidance is published in the Federal
Register on February 13, 2026.
ADDRESSES: You may submit either electronic or written comments on
Agency 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-2023-D-2925 for ``Defining Durations of Use for Approved Medically
Important Antimicrobial Drugs Fed to Food-
[[Page 6856]]
Producing Animals.'' 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 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance to the
Policy and Regulations Staff, U.S. Food and Drug Administration, Center
for Veterinary Medicine, CPK1, 5001 Campus Drive, College Park, MD
20740-3835. Send one self-addressed adhesive label to assist that
office in processing your requests. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: <a href="/cdn-cgi/l/email-protection#d1b0a2ba92879c91b7b5b0ffb6bea7"><span class="__cf_email__" data-cfemail="19786a725a4f54597f7d78377e766f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of September 26, 2023 (88 FR 66009), FDA
published the notice of availability for a draft guidance entitled
``Defining Durations of Use for Approved Medically Important
Antimicrobial Drugs Fed to Food-Producing Animals'' giving interested
persons until December 26, 2023, to comment on the draft guidance. In
response to a request for an extension, the comment period was extended
to January 5, 2024 (88 FR 82384, November 24, 2023).
FDA received 4,511 comments on the draft guidance from a variety of
interested parties; 4,495 comments were campaign letters and from
individuals, and 16 comments were from consumer advocacy groups,
industry associations, pharmaceutical companies, academia, and
veterinary organizations. The comments received from the campaign
letters, consumer advocacy groups, and individuals primarily requested
that FDA limit all durations of use to no more than 21 days and
requested that drug sponsors provide data demonstrating that the
established durations do not lead to increased antimicrobial
resistance. The comments from industry associations, pharmaceutical
companies, academia, and veterinary organizations expressed concerns
regarding the timelines proposed in the draft guidance, sought
assurance the antimicrobial resistance mitigation statements be clearly
worded and consistently included on labeling, sought assurance that
data and information used to justify newly-defined durations of use be
of high quality and transparent, and expressed concerns that
veterinarians may authorize the maximum labeled duration in practice if
only a maximum duration is established. All comments were considered as
the guidance was finalized.
Changes were made to the final guidance to (1) revise the
anticipated submissions and overall project timelines, (2) clarify the
discussion regarding mitigation statements with the inclusion of
examples of such statements for illustrative purposes, (3) request that
sponsors propose and justify a typical duration range, in addition to
the maximum permitted duration, that encompasses durations that
veterinarians would authorize in most circumstances, and (4) include
criteria that should be followed to ensure that the justification of
the typical duration range and maximum permitted duration is
comprehensive, focused, balanced, and limits bias. The recommended
directions for use statements in this guidance were revised accordingly
and now describe the typical duration range as well as the maximum
permitted duration. Other editorial changes were made to improve
clarity. The guidance announced in this notice finalizes the draft
guidance dated September 23, 2023.
This level 1 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 defining durations of use for approved
medically important antimicrobial drugs fed to food-producing animals.
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. FDA
considered the applicability of Executive Order 14192, per OMB guidance
in M-25-20, and finds this action to be neither regulatory nor
deregulatory.
II. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 514 have been approved under OMB control number 0910-
0032; the collections of information in section 512(n)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(n)(1)) have been
approved under OMB control number 0910-0669.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-02934 Filed 2-12-26; 8:45 am]
BILLING CODE 4164-01-P
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