[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8848-8850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03245]


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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; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
soliciting comments from the public on antimicrobial drug use practices 
in companion animals and the potential impacts of such uses on 
antimicrobial resistance in both humans and animals. We are issuing 
this notice as part of our objective to engage with our stakeholders to 
develop and implement a strategy for promoting antimicrobial 
stewardship in companion animals. Specific questions and information 
requests are included in this notice to help guide input from 
stakeholders and other members of the public. FDA's Center for 
Veterinary Medicine (CVM) intends to use the information provided to 
assist in the development of strategies to promote antimicrobial 
stewardship in companion animals.

DATES: Submit either electronic or written comments on the notice by 
June 16, 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 June 16, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 16, 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: 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

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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.
    <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, 
Request for Comments.'' 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 
https://www.regulations.gov 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 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: 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#b7f5d6c5d5d6c5d699fbd2d8c3c3d6f7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="98daf9eafaf9eaf9b6d4fdf7ececf9d8fefcf9b6f0f0ebb6fff7ee">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    Antimicrobial drugs \1\ have been widely used in human and 
veterinary medicine for more than 80 years, with tremendous benefits to 
both human and animal health. The development of resistance \2\ to this 
important class of drugs, and the resulting loss of the drugs' 
effectiveness, poses a serious threat to human and animal health. 
Because antimicrobial drug use can contribute to the emergence of drug-
resistant organisms, these drugs should be used judiciously in both 
human and veterinary medicine to slow the development of resistance and 
preserve their utility. While judicious use efforts often focus on 
antimicrobial drug use in food-producing animal species (e.g., cattle, 
swine, chickens, and turkeys), there is also a need to better 
understand how the use of antimicrobial drugs to treat companion 
animals (e.g., dogs, cats, and horses) might contribute to populations 
of resistant bacteria in these species and the humans exposed to them.
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    \1\ The term ``antimicrobial'' refers broadly to drugs with 
activity against a variety of microorganisms including bacteria, 
viruses, fungi, and parasites. Antimicrobial drugs that have 
specific activity against bacteria are referred to as antibacterial 
or antibiotic drugs. The broader term ``antimicrobial,'' however, 
commonly used in reference to drugs with activity against bacteria, 
is used in this document interchangeably with the terms 
antibacterial or antibiotic.
    \2\ Antimicrobial resistance is the ability of bacteria or other 
microbes to resist the effects of a drug. Antimicrobial resistance, 
as it relates to bacterial organisms, occurs when bacteria change in 
some way that reduces or eliminates the effectiveness of drugs, 
chemicals, or other agents designed to treat bacterial infections.
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    As part of its regulatory mission, CVM is responsible for ensuring 
the safety and effectiveness of animal drugs, including antimicrobial 
drugs, and has taken important steps to update the approved use 
conditions of medically important antimicrobial drugs (i.e., 
antimicrobial drugs important for treating human disease) to support 
their judicious use in animals. CVM believes that the concept of 
antimicrobial stewardship encompasses several important principles of 
judicious use that are critical to slowing the rate at which bacteria 
develop resistance to antimicrobial drugs. In simple terms, we believe 
medically important antimicrobial drugs should only be used in animals 
when necessary to treat, control, or prevent disease. In addition, when 
such use is necessary, these antimicrobial drugs should be used in an 
optimal manner under the oversight of a licensed veterinarian. We 
acknowledge and support the many efforts that multiple stakeholders and 
animal health organizations have already taken to promote antimicrobial 
stewardship practices. For example, the American Veterinary Medical 
Association defined antimicrobial stewardship as ``the actions 
veterinarians take individually and as a profession to preserve the 
effectiveness and availability of antimicrobial drugs through 
conscientious oversight and responsible medical decision making while 
safeguarding animal, public, and environmental health.'' \3\
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    \3\ American Veterinary Medical Association, ``Antimicrobial 
Stewardship Definition and Core Principles,'' 2018, https://www.avma.org/KB/Policies/Pages/Antimicrobial-Stewardship-Definition-and-Core-Principles.aspx, accessed November 4, 2021.
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    In September of 2018, CVM published a five-year action plan 
entitled ``Supporting Antimicrobial Stewardship in Veterinary Settings, 
Goals for Fiscal Years 2019-2023,'' \4\ which outlines goals and 
objectives for promoting the judicious use of antimicrobial drugs in 
animals and includes specific actions CVM intends to undertake in order 
to carry out those goals and objectives. The purpose of this notice is 
to address Goal 1 of the five-year action plan, ``Align Antimicrobial 
Drug Product Use with the Principles of Antimicrobial Stewardship,'' 
which includes an

[[Page 8850]]

objective to engage with our stakeholders to develop and implement a 
strategy for promoting antimicrobial stewardship in companion 
animals.\5\ One of the actions related to this objective (Action 1.2.1 
under Phase 1 Actions \6\) is to obtain public input regarding 
antimicrobial use practices in companion animals and the impact of such 
use practices on the development of resistance.
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    \4\ https://www.fda.gov/media/115776/download.
    \5\ As a part of the plan, CVM established three goals, which 
include: (1) Align antimicrobial drug product use with the 
principles of antimicrobial stewardship; (2) foster stewardship of 
antimicrobials in veterinary settings; and (3) enhance monitoring of 
antimicrobial resistance and antimicrobial drug use in animals. See 
the five-year action plan at p. 5.
    \6\ CVM intends to initiate the actions outlined in the plan in 
two phases, with Phase 1 activities being initiated between FY 2019 
and FY 2021 and Phase 2 activities being initiated between FY 2022 
and FY 2023. See the five-year action plan at pp. 5-6.
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II. Questions for Consideration

    CVM seeks input on the following questions and information 
requests:
    1. Please describe if antimicrobial use practices in companion 
animals have impacted the development of antimicrobial resistance in 
bacterial pathogens of companion animals. Please provide information, 
data, and/or references to support your response.
    2. Please describe if antimicrobial use practices in companion 
animals, including extralabel use, have impacted the development of 
antimicrobial resistance in human bacterial pathogens. If possible, 
please describe whether the impact was the result of direct or indirect 
contact between humans and the treated companion animals. Are there 
specific concerns about the development of antimicrobial resistance in 
human bacterial pathogens when particular antimicrobial drugs or drug 
classes are used in companion animals? Please provide information, 
data, and/or references to support your response.
    3. How should the human medical importance of particular 
antimicrobial drugs or drug classes be considered when deciding 
whether, or under what conditions, to use such drugs in companion 
animals?
    4. How can CVM best engage with our stakeholders on promoting 
antimicrobial stewardship for companion animals? Examples of 
stakeholders include other government agencies, the pharmaceutical 
industry, public health organizations (both public and private 
entities), veterinary professional organizations, veterinary schools, 
veterinarians, pet owners, and veterinary diagnostic laboratories.
    5. How can CVM encourage the development of antimicrobial drugs 
consistent with the principles of antimicrobial stewardship for the 
treatment of infectious diseases in companion animals for which there 
are no FDA-approved animal drugs?
    a. What bacterial diseases affecting companion animals are most in 
need of an FDA-approved animal antimicrobial drug?
    b. What safety and effectiveness study design considerations 
present challenges for developing antimicrobial drugs to address 
specific infectious diseases in companion animals (e.g., Lyme disease, 
sepsis, or osteomyelitis)? Are there alternative study designs that 
would address these challenges? If not, what role(s) could the 
stakeholder groups identified in question 4 play in developing such 
alternative study designs?
    c. Are there specific infectious diseases in companion animals for 
which topical formulations of antimicrobial drugs (e.g., medicated 
shampoos, rinses, or ointments) may be a better alternative than using 
systemic antimicrobial drugs from the perspective of antimicrobial 
stewardship? If so, what role(s) could the stakeholder groups 
identified in question 4 play toward fostering the use of such topical 
antimicrobial formulations?
    6. Labeling:
    a. What information on currently approved animal drug labeling 
helps the veterinarian prescribe or use an antimicrobial drug in a 
manner consistent with the principles of antimicrobial stewardship?
    b. What additional information could be added to the approved 
animal drug labeling to improve the veterinarian's ability to prescribe 
or use an antimicrobial drug in a manner consistent with the principles 
of antimicrobial stewardship?
    c. Is there a need for materials containing labeling information 
and/or information about antimicrobial stewardship that veterinarians 
could provide to the client when they prescribe an antimicrobial drug 
(e.g., client information sheets or other educational handouts)?
    7. With respect to the use of antimicrobial drugs in companion 
animals, what other actions should CVM consider taking to foster 
greater antimicrobial stewardship?

    Dated: February 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03245 Filed 2-15-22; 8:45 am]
BILLING CODE 4164-01-P


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