Antimicrobial Drug Use in Companion Animals; Request for Comments
| Published date | 16 February 2022 |
| Citation | 87 FR 8848 |
| Record Number | 2022-03245 |
| Section | Notices |
| Court | Food And Drug Administration |
8848
Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices
T
ABLE
1—E
STIMATED
A
NNUAL
R
EPORTING
B
URDEN
1
21 CFR part 1, subpart M Number of
respondents
Number of
responses per
respondent
2
Total annual
responses
Average
burden per
response
2
Total hours
AB applications. renewals, notifications, revoca-
tions. 25 11.36 284 3.18 ................................ 903
CB certifications, regulatory audits and assess-
ments, notifications. 208 147.29 30,638 0.25 (15 minutes) ........... 7,661
CB applications for direct accreditation & re-
newal. 1 1 1 90 ................................... 90
Total ............................................................. ........................ ........................ 30,923 ........................................ 8,654
1
We estimate no capital costs or operating and maintenance costs for the information collection.
2
Figures rounded to the nearest one, one-hundred as calculated based on total number of records and hours.
T
ABLE
2—E
STIMATED
A
NNUAL
R
ECORDKEEPING
B
URDEN
1
21 CFR part 1, subpart M Number of
recordkeepers
Number of
records
per
recordkeeper
2
Total annual
records
Average
burden per
recordkeeping
2
Total hours
AB documenting certification procedures; main-
taining applicable records. 25 426.56 10,664 0.25 (∼15 minutes) ......... 2,677
AB establishing and updating public list of CBs 25 1 25 52.8 ................................ 1,320
CB documenting procedures for accreditation;
maintaining applicable records (audits, certifi-
cations, serious risks).
208 112.72 23,446 0.35 (∼20 minutes) ......... 8,228
CB establishing & updating public list of eligible
entities. 208 1.31 273 44.19 .............................. 12,064
Contract modification
2
......................................... 7 9 63 2 ..................................... 126
Total ............................................................. ........................ ........................ 34,471 ........................................ 24,415
1
We estimate no capital costs, or operating and maintenance costs for the information collection.
2
Figures rounded to the nearest one, one-hundred as calculated based on total number of records and hours.
We include in our estimate reporting
burden attributable to required
submissions, including notifications, to
FDA; and recordkeeping burden
attributable to the time we assume
necessary for searching data sources,
and preparing and maintaining records
described in the applicable regulations.
We estimate that 25 ABs will accredit
CBs who conduct food safety audits of
foreign eligible entities that offer food
for import to the United States. We also
estimate the 208 accredited CBs will
participate in the third-party program.
In addition, we expect that one CB will
apply and participate in the third-party
program via direct accreditation by
FDA. Finally, we attribute nominal
burden to recordkeeping attendant to
contractual modifications that may be
part of accreditation.
Based on a review of the information
collection since last OMB approval, we
have made only nominal adjustments to
our burden estimate.
Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–03306 Filed 2–15–22; 8:45 am]
BILLING CODE 4164–01–P
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 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
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Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices
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.
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.
4
https://www.fda.gov/media/115776/download.
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,
Barbara.Leotta@fda.hhs.gov.
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.
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
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
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Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices
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.
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.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0008]
Cellular, Tissue and Gene Therapies
Advisory Committee; Notice of Meeting
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice.
SUMMARY
: The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Cellular, Tissue, and
Gene Therapies Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. At least one portion of the
meeting will be closed to the public.
DATES
: The meeting will be held
virtually on March 10, 2022, from 10
a.m. to 1:30 p.m. Eastern Time.
ADDRESSES
: Please note that due to the
impact of the COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. The online web
conference meeting will be available at
the following link on the day of the
meeting: https://youtu.be/silb2C_Ro8I.
FOR FURTHER INFORMATION CONTACT
:
Christina Vert or Tonica Burke, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
1244, Silver Spring, MD 20993–0002,
240–402–8054, ctgtac@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before joining the meeting.
SUPPLEMENTARY INFORMATION
:
Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On March 10,
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