2162 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Notices 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: January 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00561 Filed 1–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0414] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Manufactured 

Food Regulatory Program Standards 

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 the information 

collection provisions of the 

Manufactured Food Regulatory Program 

Standards. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 14, 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 March 14, 

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

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 14, 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– 

2010–N–0414 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Manufactured Food Regulatory Program 

Standards.’’ 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: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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 


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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Notices 2163 

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. 

Manufactured Food Regulatory 

Program Standards 

OMB Control Number 0910–0601— 

Extension 

This information collection supports 

FDA’s ‘‘Manufactured Food Regulatory 

Program Standards’’ (2019) (https://

www.fda.gov/media/131392/download). 

We recommend that States use these 

program standards as the framework to 

design and manage their manufactured 

food programs. There are 44 State 

programs currently enrolled in the 

Manufactured Food Regulatory Program 

Standards (MFRPS) under cooperative 

agreements. 

The goal of the MFRPS is to 

implement a nationally integrated, riskbased, food safety system focused on 

protecting public health. The MFRPS 

establish a uniform basis for measuring 

and improving the performance of 

prevention, intervention, and response 

activities of manufactured food 

regulatory programs in the United 

States. The development and 

implementation of the standards will 

help Federal and State programs better 

direct their regulatory activities toward 

reducing foodborne illness. For more 

information we invite you to visit our 

website at: https://www.fda.gov/federalstate-local-tribal-and-territorialofficials/regulatory-program-standards/ 

manufactured-food-regulatory-programstandards-mfrps. 

FDA recommends that a State 

program enrolled in the MFRPS use the 

worksheets and forms contained in the 

standards; however, alternate forms that 

are equivalent may be used. The State 

program maintains documentation 

(guidance, procedures, documents, and 

forms) required by the 10 standards, 

which must be current and fit for use. 

In the first year of implementing the 

program standards, the State program 

conducts a baseline self-assessment of 

the documentation to determine if it 

meets the elements of each standard. 

The State program must participate in 

additional verification audits in 

subsequent years. After 5 years, FDA 

will conduct a comprehensive program 

audit of the documentation. As part of 

the program audit, the auditor reviews 

the records and supporting documents 

required by the criteria in each standard 

to determine if the self-assessment and 

improvement plan accurately reflect the 

State program’s level of conformance 

with each of the standards. If the State 

program fails to meet all program 

elements and documentation 

requirements of a standard, it develops 

a strategic plan which includes the 

following: (1) The individual element of 

documentation requirement of the 

standard that was not met, (2) 

improvements needed to meet the 

program element or documentation 

requirement of the standard, and (3) 

projected completion dates for each 

task. 

Description of Respondents: 

Respondents are State Departments of 

Agriculture or Health enrolled in the 

MFRPS (State Governments). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Type of respondent; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

State Governments; Development and reporting of data 

consistent with MFRPS .................................................... 44 1 44 569 25,036 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Type of respondent; activity Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

State Governments; Maintenance of data records consistent with MFRPS .......................................................... 44 10 440 40 17,600 

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

We have adjusted the number of 

respondents to the information 

collection to reflect the enrollment of an 

additional State since our last 

evaluation. 

Dated: January 6, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00559 Filed 1–12–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0973] 

Revocation of Three Authorizations of 

Emergency Use of In Vitro Diagnostic 

Devices for Detection and/or Diagnosis 

of COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorizations (EUAs) (the 

Authorizations) issued to Becton, 

Dickinson & Company (BD) for the 

BioGX SARS–CoV–2 Reagents for BD 

MAX System, Boston Medical Center for 

the BMC–CReM COVID–19 Test, and 

Akron Children’s Hospital for the Akron 

Children’s Hospital SARS–CoV–2 

Assay. FDA revoked these 

Authorizations on December 8, 2021, 

under the Federal Food, Drug, and 


jspears on DSK121TN23PROD with NOTICES1