Antimicrobial Drug Use in Companion Animals; Request for Comments

CourtFood And Drug Administration
Citation87 FR 8848
Record Number2022-03245
Published date16 February 2022
Federal Register, Volume 87 Issue 32 (Wednesday, February 16, 2022)
[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:
                 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
                [[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 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-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.
                 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, [email protected].
                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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