8848 Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 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, revocations.25 11.36 284 3.18 ................................ 903 

CB certifications, regulatory audits and assessments, notifications.208 147.29 30,638 0.25 (15 minutes) ........... 7,661 

CB applications for direct accreditation & renewal.1 1 1 90 ................................... 90 

Total ............................................................. ........................ ........................ 30,923 ........................................ 8,654 

1We estimate no capital costs or operating and maintenance costs for the information collection. 

2Figures rounded to the nearest one, one-hundred as calculated based on total number of records and hours. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 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; maintaining 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, certifications, 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 

1We estimate no capital costs, or operating and maintenance costs for the information collection. 

2Figures 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 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 8849 

1The 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. 

2Antimicrobial 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. 

3American Veterinary Medical Association, 

‘‘Antimicrobial Stewardship Definition and Core 

Principles,’’ 2018, https://www.avma.org/KB/ 

Policies/Pages/Antimicrobial-StewardshipDefinition-and-Core-Principles.aspx, accessed 

November 4, 2021. 

4https://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 drugresistant 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 


jspears on DSK121TN23PROD with NOTICES1
8850 Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 

5As 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. 

6CVM 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, 


jspears on DSK121TN23PROD with NOTICES1