Notice2026-15951
Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Availability
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Published
August 6, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final 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." This guidance document informs interested parties about FDA's current method for evaluating potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process.
Full Text
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<title>Federal Register, Volume 91 Issue 150 (Thursday, August 6, 2026)</title>
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[Federal Register Volume 91, Number 150 (Thursday, August 6, 2026)]
[Notices]
[Pages 50860-50861]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-15951]
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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; 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, Agency, or we) is
announcing the availability of a final 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.'' This guidance document informs interested parties about
FDA's current method for evaluating potential microbiological effects
of antimicrobial new animal drugs on bacteria of human health concern
as part of the new animal drug application process.
DATES: The announcement of the guidance is published in the Federal
Register on August 6, 2026.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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 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, Center for Veterinary Medicine, Food and
Drug Administration, 5001 Campus Drive, College Park, MD 20740. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Ron Miller, Center for Veterinary
Medicine, Food and Drug Administration, 5001 Campus Drive, College
Park, MD 20740, 240-402-0795, <a href="/cdn-cgi/l/email-protection#97e5f8f9b9fafefbfbf2e5d7f1f3f6b9ffffe4b9f0f8e1"><span class="__cf_email__" data-cfemail="25574a4b0b484c49494057654341440b4d4d560b424a53">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In 2003, FDA issued GFI #152, entitled ``Evaluating the Safety of
Antimicrobial New Animal Drugs with Regard to their Microbiological
Effects on Bacteria of Human Health Concern.'' GFI #152 outlines a
qualitative risk assessment methodology as a process for evaluating
foodborne antimicrobial resistance concerns related to the use of
antimicrobial drugs in food-producing animals. GFI #152 also contains
an appendix, commonly referred to as ``Appendix A,'' in which FDA ranks
antimicrobial drugs according to their relative importance to human
medicine: ``critically important,'' ``highly important,'' or
``important.'' As stated in the guidance, the drug/drug class rankings
provided in the Appendix are intended specifically to inform one
component of the described qualitative risk assessment methodology, and
they are not intended to be used as a standalone guide for
antimicrobial use in veterinary practice or otherwise to serve as a
standalone risk management tool.
The list, as published in 2003, of medically important
antimicrobial drugs
[[Page 50861]]
in Appendix A reflects FDA's thinking at the time of publication. It
was envisioned at the time of publication of GFI #152 that the Agency
would reassess the rankings provided in Appendix A periodically to
confirm that the rankings are consistent with contemporary practices
and needs. As noted in GFI #152, the development of new antimicrobial
drugs for human therapy, the emergence or re-emergence of diseases in
humans, and changes in prescribing practices, are some factors that may
cause the human medical importance rankings to change over time.
Given the considerable advances in science that have taken place
since 2003, new relevant information has become available. In light of
those advances and the new information now available, FDA published a
document in the Federal Register of October 13, 2020 (85 FR 64481),
announcing a public meeting and requesting comments on a concept paper
entitled ``Potential Approach for Ranking of Antimicrobial Drugs
According to Their Importance in Human Medicine: A Risk Management Tool
for Antimicrobial New Animal Drugs.'' FDA received more than 60 comment
submissions from pharmaceutical companies, academia, organizations, and
private citizens on this concept paper. In the Federal Register of
December 19, 2022 (87 FR 77619), FDA announced the availability of
draft revised GFI #152 entitled ``Evaluating the Safety of
Antimicrobial New Animal Drugs with Regard to their Microbiological
Effects on Bacteria of Human Health Concern.'' Interested parties were
originally given until March 20, 2023, to comment on the guidance. In
the Federal Register of March 7, 2023 (88 FR 14170), FDA extended the
comment period for the guidance to May 19, 2023.
FDA received over 9,200 comments on the draft guidance that appear
to have been the result of 2 write-in campaigns. These campaigns asked
FDA to ``quit delaying efforts to stop the overuse of antibiotics in
meat production,'' ``stop allowing the meat industry to use antibiotics
to counter unhealthy conditions in livestock facilities,'' ``treat all
drugs used in human medicine as medically important. . .,'' and said
that ``FDA must make a plan for updating [the list of medically
important drugs in Appendix A] more frequently.'' With the exception of
the comment that FDA should treat all drugs used in human medicine as
medically important, these comments expressed broad policy views and
did not address specific recommendations in the draft guidance.
Twenty-two comments outside of the write-in campaigns were
submitted by animal pharmaceutical companies, food animal producers,
veterinarians, consumer and public health interest groups, a State
agriculture department, and other organizations and individuals. These
comments offered feedback and suggestions addressing specific
recommendations in the draft guidance.
FDA considered all comments as we finalized the guidance. In the
final guidance, we made several changes, including: providing a more
detailed description of hazard characterization; combining sections of
the guidance discussing Application of Risk Management Strategies and
Risk Management; clarifying why the ranking of medically important
drugs in Appendix A should not be used alone to dictate risk management
decisions, but instead be used to inform one component of the risk
assessment process as described in the guidance; and addressing why FDA
excludes topicals in our ranking of medically important antimicrobials.
In addition, we made editorial changes to improve clarity.
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 ``Evaluating the Safety of Antimicrobial
New Animal Drugs with Regard to their Microbiological Effects on
Bacteria of Human Health Concern.'' 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 under this E.O.
II. Paperwork Reduction Act of 1995
While this guidance contains no 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.
III. Electronic Access
Persons with access to the internet may obtain the 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. 2026-15951 Filed 8-5-26; 8:45 am]
BILLING CODE 4164-01-P
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