Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 10369 

431.428 and in accordance with a 

framework to be provided by CMS. The 

STCs also provide that the monitoring 

framework be subject to change as 

monitoring systems are developed and 

evolve, and that states are required to 

report in a structured manner that 

supports federal tracking and analysis. 

In this 2022 information collection 

request, we have revised the following 

monitoring tools: 

• Monitoring protocol tools: 

Æ Monitoring protocol workbook 

(updated to Version 6.0) 

Æ Monitoring protocol template 

(updated to Version 4.0) 

• Monitoring report tools: 

Æ Monitoring report template 

(updated to Version 4.0) 

Æ Monitoring report workbook 

(updated to Version 6.0) 

This 2022 release incorporates 

updated guidance on reporting metrics, 

narrative information, and other 

clarifications. This release also reflects 

modifications to align with the 

Medicaid Section 1115 Substance Use 

Disorder Demonstrations: Technical 

Specifications for Monitoring Metrics 

Manual Version 4.0 (released September 

2021). 

In addition, this release incorporates 

updated functionality in the 

Performance Metrics Database & 

Analytics (PMDA) system aimed to 

automate aspects of reporting and 

customize tools to ease state burden. 

Updated functionality includes: 

• Auto-population of certain fields 

within the monitoring report tools in 

alignment with the state’s CMSapproved monitoring protocol. 

• Reporting flagged items early in the 

process to reduce resubmission and 

allow CMS to engage with the state 

faster and on a more detailed level. 

• Ensuring the latest version of the 

monitoring tools are utilized by sending 

an email notification to all designated 

demonstration contacts when 

customized monitoring report tools are 

available. 

Form Number: CMS–10398 (#57) 

(OMB control number: 0938–1148); 

Frequency: Once, yearly, and quarterly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

35; Total Annual Responses: 596; Total 

Annual Hours: 6,394. For policy 

questions regarding this collection 

contact: Danielle Daly at 410–786–0897. 

Dated: February 18, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–03936 Filed 2–23–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0013] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Sanitary 

Transportation of Human and Animal 

Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection requirements associated with 

the sanitary transportation of human 

and animal food. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 25, 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 25, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of April 25, 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– 

2013–N–0013 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Sanitary 

Transportation of Human and Animal 

Food.’’ 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 


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10370 Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 

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. 

Sanitary Transportation of Human 

and Animal Food—21 CFR Part 1, 

Subpart O 

OMB Control Number 0910–0773— 

Extension 

This information collection supports 

FDA regulations regarding the sanitary 

transportation of human and animal 

food. The regulations are intended to 

focus on preventing food safety 

problems throughout the food chain and 

were issued under the Sanitary Food 

Transportation Act of 2005 (2005 

SFTA), and the FDA Food Safety 

Modernization Act, enacted in 2011. 

The 2005 SFTA amended the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), in part, by creating section 416 (21 

U.S.C. 350e), which directs us to issue 

regulations to require shippers, carriers 

by motor vehicle or rail vehicle, 

receivers, and other persons engaged in 

the transportation of food to use 

prescribed sanitary transportation 

practices to ensure that food is not 

transported under conditions that may 

render the food adulterated. Section 416 

also directs that we prescribe 

appropriate human and animal food 

transportation practice requirements 

relating to: (1) Sanitation; (2) packaging, 

isolation, and other protective measures; 

(3) limitations on the use of vehicles; (4) 

information to be disclosed to carriers 

and to manufacturers; and (5) 

recordkeeping. 

In addition, the 2005 SFTA created 

section 402(i) of the FD&C Act (21 

U.S.C. 342(i)), which provides that food 

that is transported or offered for 

transport by a shipper, carrier by motor 

vehicle or rail vehicle, receiver, or any 

other person engaged in the 

transportation of food under conditions 

that are not in compliance with the 

regulations issued under section 416 is 

adulterated and section 301(hh) of the 

FD&C Act (21 U.S.C. 331(hh)), which 

prohibits the failure by a shipper, carrier 

by motor vehicle or rail vehicle, 

receiver, or any other person engaged in 

the transportation of food to comply 

with the regulations issued under 

section 416. 

The 2005 SFTA also amended section 

703 of the FD&C Act (21 U.S.C. 373) by 

providing that a shipper, carrier by 

motor vehicle or rail vehicle, receiver, 

or other person subject to section 416 

shall, on request of an officer or 

employee designated by FDA, permit 

the officer or employee, at reasonable 

times, to have access to and to copy all 

records that are required to be kept 

under the regulations issued under 

section 416. 

Accordingly, we issued regulations in 

21 CFR part 1, subpart O (21 CFR 1.900 

through 1.934) that establish 

requirements for the sanitary 

transportation of human and animal 

food, as well as prescribe procedures for 

respondents who wish to request a 

waiver for any requirement. For 

additional information regarding 

Agency implementation of the SFTA, 

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

food/guidance-documents-regulatoryinformation-topic-food-and-dietarysupplements/sanitation-transportationguidance-documents-regulatoryinformation. 

We estimate the burden of the 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per 

recordkeeping Total hours 

1.912; Record retention ........................................ 1,502,032 1 1,502,032 0.083 (5 minutes) ......... 124,669 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We estimate an annual recordkeeping 

burden of 124,669, which assumes 

1,502,032 workers will spend an average 

of 5 minutes on activities related to the 

record retention requirements under 21 

CFR 1.912. We expect these activities 

will likely include documenting 

procedures and training, as well as 

sanitary transportation operations and 

specification requirements. 


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Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 10371 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

1.914; Waiver petitions ........................................................ 2 1 2 24 48 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We estimate one waiver petition from 

each of two firms will be submitted and 

respondents will spend 24 hours to 

prepare and submit the petition to FDA. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden per 

disclosure Total hours 

1.908; Disclosure of sanitary specifications; 

operating temperature conditions.

226 1 226 0.5833 (∼35 minutes) ........... 132 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Finally, we estimate an annual thirdparty disclosure burden of 132 hours, 

assuming each of 226 firms will spend 

an average of 35 minutes, annually, 

disclosing written records as required 

under 21 CFR 1.908. 

Based on an evaluation of the 

information collection, we have made 

no adjustments to our burden estimate. 

Dated: February 16, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03916 Filed 2–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2252] 

Final Assessment of the Program for 

Enhanced Review Transparency and 

Communication in the Biosimilar User 

Fee Act; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following virtual 

public meeting entitled ‘‘Final 

Assessment of the Program for 

Enhanced Review Transparency and 

Communication in the Biosimilar User 

Fee Act (BsUFA)’’ (the Program) and an 

opportunity for public comment. The 

topics to be discussed are the final 

assessment and public stakeholder 

views of the Program. 

DATES: The public meeting will be held 

on March 22, 2022, from 9:30 a.m. to 

12:30 p.m. Eastern Time and will be 

held by webcast only. Submit either 

electronic or written comments on this 

public meeting by May 23, 2022. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: Registration to attend the 

meeting and other information can be 

found at https://www.eventbrite.com/e/ 

public-meeting-on-the-final-assessmentof-the-bsufa-ii-program-tickets229459628927. 

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 May 23, 2022. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

May 23, 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– 

2020–N–2252 for ‘‘Final Assessment of 

the Program for Enhanced Review 

Transparency and Communication in 

the Biosimilar User Fee Act (BsUFA); 

Public Meeting; 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 


jspears on DSK121TN23PROD with NOTICES1