Notice2022-03245
Antimicrobial Drug Use in Companion Animals; Request for Comments
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
February 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 32 (Wednesday, February 16, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8848-8850]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03245]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: <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
[[Page 8849]]
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-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
<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.
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\3\ American Veterinary Medical Association, ``Antimicrobial
Stewardship Definition and Core Principles,'' 2018, <a href="https://www.avma.org/KB/Policies/Pages/Antimicrobial-Stewardship-Definition-and-Core-Principles.aspx">https://www.avma.org/KB/Policies/Pages/Antimicrobial-Stewardship-Definition-and-Core-Principles.aspx</a>, accessed November 4, 2021.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\4\ <a href="https://www.fda.gov/media/115776/download">https://www.fda.gov/media/115776/download</a>.
\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.
---------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on February 16, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.