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 


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2164 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Notices 

Cosmetic Act (FD&C Act). The 

revocations, which include an 

explanation of the reasons for each 

revocation, are reprinted in this 

document. 

DATES: The Authorizations for the 

BioGX SARS–CoV–2 Reagents for BD 

MAX System, BMC–CReM COVID–19 

Test, and Akron Children’s Hospital 

SARS–CoV–2 Assay are revoked as of 

December 8, 2021. 

ADDRESSES: Submit written requests for 

a single copy of the revocations to the 

Office of Counterterrorism and 

Emerging Threats, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4338, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a fax number to which the 

revocations may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocations. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

240–402–8155 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb-3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

nuclear, and radiological agents. Among 

other things, section 564 of the FD&C 

Act allows FDA to authorize the use of 

an unapproved medical product or an 

unapproved use of an approved medical 

product in certain situations. On April 

2, 2020, FDA issued an EUA to BD for 

the BioGX SARS–CoV–2 Reagents for 

BD MAX System, subject to the terms of 

the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

June 5, 2020 (85 FR 34638), as required 

by section 564(h)(1) of the FD&C Act. 

On July 10, 2020, FDA issued an EUA 

to Boston Medical Center for the BMC– 

CReM COVID–19 Test, subject to the 

terms of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

November 20, 2020 (85 FR 74346), as 

required by section 564(h)(1) of the 

FD&C Act. On September 29, 2020, FDA 

issued an EUA to Akron Children’s 

Hospital for the Akron Children’s 

Hospital SARS–CoV–2 Assay, subject to 

the terms of the Authorization. Notice of 

the issuance of this Authorization was 

published in the Federal Register on 

April 23, 2021 (86 FR 21749), as 

required by section 564(h)(1) of the 

FD&C Act. Subsequent updates to the 

Authorizations were made available on 

FDA’s website. The authorization of a 

device for emergency use under section 

564 of the FD&C Act may, pursuant to 

section 564(g)(2) of the FD&C Act, be 

revoked when the criteria under section 

564(c) of the FD&C Act for issuance of 

such authorization are no longer met 

(section 564(g)(2)(B) of the FD&C Act), 

or other circumstances make such 

revocation appropriate to protect the 

public health or safety (section 

564(g)(2)(C) of the FD&C Act). 

II. EUA Revocation Requests 

On December 3, 2021, FDA received 

a request from BD for the revocation of, 

and on December 8, 2021, FDA revoked, 

the Authorization for the BioGX SARS– 

CoV–2 Reagents for BD MAX System. 

Because BD notified FDA that BD 

discontinued the sale of the authorized 

product and requested FDA revoke the 

Authorization, FDA has determined that 

it is appropriate to protect the public 

health or safety to revoke this 

Authorization. On October 4, 2021 (and 

reconfirmed December 6, 2021), FDA 

received a request from Boston Medical 

Center for the revocation of, and on 

December 8, 2021, FDA revoked, the 

Authorization for the BMC–CReM 

COVID–19 Test. Because Boston 

Medical Center notified FDA that the 

BMC–CReM COVID–19 Test is no longer 

performed pursuant to the EUA and 

requested FDA withdraw the 

Authorization, FDA has determined that 

it is appropriate to protect the public 

health or safety to revoke this 

Authorization. On December 3, 2021, 

FDA received a request from Akron 

Children’s Hospital for the revocation 

of, and on December 8, 2021, FDA 

revoked, the Authorization for the 

Akron Children’s Hospital SARS–CoV– 

2 Assay. Because Akron Children’s 

Hospital notified FDA that it stopped 

performing the Akron Children’s 

Hospital SARS–CoV–2 Assay and 

requested that FDA revoke the 

Authorization, FDA has determined that 

it is appropriate to protect the public 

health or safety to revoke this 

Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocations are available on the internet 

at https://www.regulations.gov/. 

IV. The Revocations 

Having concluded that the criteria for 

revocation of the Authorizations under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUAs for 

BD’s BioGX SARS–CoV–2 Reagents for 

BD MAX System, Boston Medical 

Center’s BMC–CReM COVID–19 Test, 

and Akron Children’s Hospital’s Akron 

Children’s Hospital SARS–CoV–2 

Assay. The revocations in their entirety 

follow and provide an explanation of 

the reasons for each revocation, as 

required by section 564(h)(1) of the 

FD&C Act. 

BILLING CODE 4164–01–P 


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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Notices 2167 

Dated: January 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–00521 Filed 1–12–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Clinical 

Translational Imaging Science Study Section. 

Date: February 17–18, 2022. 


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