8846 Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations, 

and a list of all nominees along with 

their current re ́sume ́s. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

voting member to represent industry 

interests for the committee. The 

interested organizations are not bound 

by the list of nominees in selecting a 

candidate. However, if no individual is 

selected within 60 days, the 

Commissioner will select the voting 

member to represent industry interests. 

III. Nomination Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a voting 

industry representative. Nominations 

must include a current, complete 

re ́sume ́ or curriculum vitae for each 

nominee including current business 

address and telephone number, email 

address if available, and a signed copy 

of the Acknowledgement and Consent 

form available at the FDA Advisory 

Nomination Portal (see ADDRESSES). 

Nominations must also specify the 

advisory committee for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the committee. (Persons who nominate 

themselves as voting industry 

representatives will not participate in 

the selection process.) 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: February 10, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03257 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–2019–N–0721] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Accreditation of 

Third-Party Certification Bodies To 

Conduct Food Safety Audits and Issue 

Certifications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection requirements for the 

accreditation of third-party certification 

bodies to conduct food safety audits and 

issue certifications. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 18, 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 April 18, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 18, 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 

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– 

2019–N–0721 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Accreditation of Third-Party 

Certification Bodies to Conduct Food 

Safety Audits and Issue Certifications.’’ 

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 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 32 / Wednesday, February 16, 2022 / Notices 8847 

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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Accreditation of Third-Party 

Certification Bodies To Conduct Food 

Safety Audits and Issue Certifications— 

21 CFR Part 1, Subpart M 

OMB Control Number 0910–0750— 

Extension 

This information collection helps to 

implement FDA’s Accredited ThirdParty Certification Program (also 

referred to as the third-party food 

program), established and administered 

under section 808 of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 384d), and codified in 21 CFR 

part 1, subpart M (21 CFR parts 1.600 

through 1.725) of Agency regulations. 

The regulations communicate eligibility 

criteria, assessment standards, and 

establish procedures and requirements 

for participation. For more information 

visit our website at https://www.fda.gov/ 

food/importing-food-products-unitedstates/accredited-third-partycertification-program. 

Under the third-party food program, 

accreditation bodies (ABs) apply to FDA 

for recognition. Recognized ABs 

accredit third-party certification bodies 

(CBs) under the program, except in 

limited circumstances. The accredited 

CBs conduct food safety audits and 

issue food or facility certifications to 

eligible foreign entities. FDA uses 

certifications issued by accredited thirdparty auditors/CBs in deciding whether 

to admit certain imported food (both 

food for human and other animals) into 

the United States. Under the third-party 

program, FDA may grant recognition of 

an AB for up to 5 years from the date 

of recognition. Current third-party 

program AB participants are recognized 

for the duration from 2018 to 2023 and 

will need to submit renewal of 

recognition applications to continue 

their participation. 

There are approximately 200,000 

foreign food (both food for human and 

other animals) exporters who offer their 

food products for import into the United 

States. These foreign food exporters 

include approximately 130,000 food 

production facilities and approximately 

71,000 farms. A proportion of these 

foreign food exporters may offer food 

subject to mandatory certification 

requirements under section 801(q)(3) of 

the FD&C Act (21 U.S.C. 381(q)(3)). In 

that case, to continue exporting food 

products into the United States, eligible 

entities must either obtain certification 

from a CB accredited under the thirdparty program, or obtain certification 

from a foreign government designated 

by FDA. We assume in any given year, 

75 foreign food exporters will be subject 

to requirements in section 801(q) of the 

FD&C Act. 

Participating in the third-party 

accreditation program helps reduce the 

number of redundant audits necessary 

to assess compliance with food safety 

requirements of the FD&C Act and 

applicable regulations. Required data 

elements are submitted using FDA’s 

Unified Registration Listing System 

(FURLS), an electronic portal (Forms 

FDA 3997 for ABs and 3997a for CBs) 

that enables respondents to complete 

data fields and provide information to 

FDA electronically. The AB and CB 

portals provide a standardized format 

for entering information, prompting 

respondents for input and facilitating 

FDA’s review of the submittal. 

Instructions may be accessed at https:// 

www.fda.gov/food/importing-foodproducts-united-states/accredited-thirdparty-certification-program. 

Respondents to the collection of 

information are eligible entities seeking 

audits, certification, and/or 

recertification by accredited CBs 

participating in the third-party program, 

and ABs and CBs seeking to comply 

with the recognition requirements. An 

eligible entity is a foreign entity in the 

import supply chain of food for 

consumption in the United States that 

chooses to be subject to a food safety 

audit conducted by an accredited thirdparty CB. 

We estimate the burden of this 

collection of information as follows: 


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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