Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Notices 31563 

Meeting Procedures 

The Presiding Officers will prepare a 

schedule for persons wishing to testify 

and establish the order of presentation. 

To ensure an opportunity for all 

interested commenters to present their 

views, the Presiding Officers may limit 

the time for providing oral comments 

and may establish other procedures 

related to the conduct of the public 

meeting as appropriate. For instance, 

each person may be permitted up to 

three minutes to testify. In order to 

verify the identity of persons scheduled 

to testify at the virtual public meeting, 

individuals who register to testify will 

be required to join a virtual waiting 

room in advance of the public meeting, 

where they must present a valid, 

government-issued photo identification 

using the video conference feature. 

Individuals who register to testify will 

be contacted by email to schedule their 

identity verification sessions. The 

Presiding Officers may extend the end 

time of the meeting beyond 7:00 p.m. 

EDT, if additional time is needed to 

accommodate demonstrated public 

interest. 

Reasonable Accommodations 

Persons who wish to request 

reasonable accommodations should 

submit a request through the online 

registration website at https://

www.federalreserve.gov/foia/bank-ofmontreal-bank-of-the-west-applicationmaterials.htm, or by calling Jason 

Bouleris, Program Analyst in the OCC’s 

Community Affairs Division, at (202) 

649–6382. Requests should be made no 

later than 12:00 p.m. EDT on June 23, 

2022. Requests submitted after this time 

may not be possible to accommodate. 

Requests should include a detailed 

description of the accommodation 

needed and a way for agency staff to 

contact the requester if more 

information is needed regarding the 

request. 

Extension of the Comment Period 

The Board is extending the comment 

period on the Holding Company 

Application, and the OCC is extending 

the comment period on the Bank 

Application, through 5:00 p.m. EDT on 

July 19, 2022. 

Written comments regarding the 

Holding Company Application may be 

submitted to the Federal Reserve Bank 

of Chicago, Colette A. Fried, Assistant 

Vice President, 230 South LaSalle 

Street, Chicago, Illinois 60604, or 

electronically to 

comments.applications@chi.frb.org; or 

the offices of the Board of Governors, 

Ann E. Misback, Secretary of the Board, 

20th Street and Constitution Avenue 

NW, Washington, DC 20551–0001. In 

general, all written comments will be 

made available on the Board’s website at 

https://www.federalreserve.gov/foia/ 

bank-of-montreal-bank-of-the-westapplication-materials.htm as submitted, 

and will not be edited to remove any 

confidential, contact, or other 

identifying information. 

Written comments on the Bank 

Application may be submitted to Jason 

Almonte, Director for Large Bank 

Licensing at LargeBanks@occ.treas.gov 

or at 340 Madison Avenue, Fifth Floor, 

New York, New York 10173. Written 

comments will be made available on 

OCC’s website at https://www.occ.gov/ 

topics/charters-and-licensing/publiccomment/business-combination-ormerger-applications-comments.html. In 

general, the OCC will publish each 

comment without change, including any 

business or personal information, name 

and address, email addresses, and 

phone numbers. Comments received, 

including attachments and other 

supporting material, are part of the 

public record and subject to public 

disclosure. Do not enclose any 

information in a comment or supporting 

material that is confidential or 

inappropriate for public disclosure. 

Privacy Note 

The Board will make the public 

record of the Holding Company 

Application, including all comments 

received, the written copy of a person’s 

oral testimony at the public meeting (if 

a written copy is provided to the 

agencies), and the transcript of the 

public meeting, available on the Board’s 

public website at: https://

www.federalreserve.gov/foia/bank-ofmontreal-bank-of-the-west-applicationmaterials.htm. The OCC will make the 

public record of the Bank Application, 

including all comments received, the 

written copy of a person’s oral 

testimony at the public meeting (if a 

written copy is provided to the 

agencies), and the transcript of the 

public meeting, available on the OCC’s 

public website at: https://occ.gov/ 

topics/charters-and-licensing/publiccomment/business-combination-ormerger-applications-comments.html. 

Persons submitting comments and/or 

testimony are reminded to include only 

information that they wish to make 

available to the public. 

Michael J. Hsu, 

Acting Comptroller of the Currency. 

By order of the Board of Governors of the 

Federal Reserve System. 

Ann Misback, 

Secretary of the Board. 

[FR Doc. 2022–11070 Filed 5–23–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0307] 

Recommendations To Reduce the 

Possible Risk of Transmission of 

Creutzfeldt-Jakob Disease and Variant 

Creutzfeldt-Jakob Disease by Blood 

and Blood Components; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance entitled ‘‘Recommendations to 

Reduce the Possible Risk of 

Transmission of Creutzfeldt-Jakob 

Disease and Variant Creutzfeldt-Jakob 

Disease by Blood and Blood 

Components.’’ The guidance document 

provides blood establishments that 

collect blood and blood components 

with recommendations intended to 

reduce the possible risk of transmission 

of Creutzfeldt-Jakob disease (CJD) and 

variant Creutzfeldt-Jakob disease (vCJD) 

by blood and blood components. The 

recommendations in the guidance apply 

to the collection of Whole Blood and 

blood components intended for 

transfusion or for use in further 

manufacturing, including Source 

Plasma. The guidance removes the 

recommendations to defer indefinitely 

blood donors for geographic risk of 

possible exposure to bovine spongiform 

encephalopathy for time spent in the 

United Kingdom (U.K.) from 1980 to 

1996 and for time spent in France and 

Ireland from 1980 to 2001, and receipt 

of a blood transfusion in the U.K., 

France, and Ireland from 1980 to the 

present. The guidance also provides 

recommendations for requalification of 

individuals previously deferred for 

these geographic risk factors, provided 

they meet all other eligibility 

requirements. The guidance announced 

in this notice supersedes the guidance 


jspears on DSK121TN23PROD with NOTICES1
31564 Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Notices 

of the same title dated April 2020 and 

updated August 2020 (2020 guidance). 

DATES: The Agency is soliciting public 

comment, but is implementing this 

guidance immediately, because the 

Agency has determined that prior public 

participation is not feasible or 

appropriate. The announcement of the 

guidance is published in the Federal 

Register on May 24, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2012–D–0307 for ‘‘Recommendations to 

Reduce the Possible Risk of 

Transmission of Creutzfeldt-Jakob 

Disease and Variant Creutzfeldt-Jakob 

Disease by Blood and Blood 

Components.’’ Received comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 

1–800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Recommendations 

to Reduce the Possible Risk of 

Transmission of Creutzfeldt-Jakob 

Disease and Variant Creutzfeldt-Jakob 

Disease by Blood and Blood 

Components.’’ The guidance document 

provides blood establishments that 

collect blood and blood components 

with recommendations intended to 

reduce the possible risk of transmission 

of Creutzfeldt-Jakob disease (CJD) and 

variant Creutzfeldt-Jakob disease (vCJD) 

by blood and blood components. The 

recommendations in the guidance apply 

to the collection of Whole Blood and 

blood components intended for 

transfusion or for use in further 

manufacturing, including Source 

Plasma. The guidance removes the 

recommendations in the 2020 guidance 

to defer indefinitely blood donors for: 

(1) Geographic risk of possible exposure 

to bovine spongiform encephalopathy 

for time spent in the U.K. from 1980 to 

1996 and for time spent in France and 

Ireland from 1980 to 2001, and (2) 

receipt of a blood transfusion in the 

U.K., France, and Ireland from 1980 to 

present. The guidance also provides 

recommendations for requalification of 

individuals previously deferred for 

these geographic risk factors, provided 

they meet all other eligibility 

requirements. The guidance announced 

in this notice supersedes the final 

guidance of the same title dated April 

2020 and updated August 2020. In the 

Federal Register of June 17, 2020 (85 FR 

36593), FDA announced the availability 

of the final guidance of the same title 

dated April 2020. The guidance was 

updated in August 2020. 

The recommendations on reducing 

the possible risk of transmission of CJD 

are unchanged from the 2020 guidance. 

The guidance changes the geographic 

deferral recommendations for vCJD risk 

based on new information in the risk 

assessments published by U.K.’s 

Advisory Committee on the Safety of 

Blood, Tissues and Organs and 


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Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Notices 31565 

Medicines and Healthcare Products 

Regulatory Agency. These risk 

assessment models, which FDA has 

independently evaluated, demonstrate 

that, in the U.K., the current risk of vCJD 

transmission by blood and blood 

components would expose transfusion 

recipients to no or minimal additional 

risk of vCJD in the future, and, for blood 

components that are leukocyte reduced, 

the possible risk is even further 

reduced. FDA has determined that the 

recommendations will simplify the 

donor screening process and increase 

the number of eligible donors while 

maintaining the safety of blood and 

blood components. 

FDA is issuing this guidance for 

immediate implementation in 

accordance with § 10.115(g)(2) (21 CFR 

10.115(g)(2)) without initially seeking 

prior comment, because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate (see § 10.115(g)(2) and 

section 701(h)(1)(C)(i) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

371(h)(1)(C)(i))). Specifically, we are not 

seeking prior comment because the 

revised recommendations present a less 

burdensome policy for reducing the risk 

of transmission of CJD and vCJD by 

blood and blood components that is 

consistent with public health, and we 

expect that the revised 

recommendations will increase the 

availability of blood and blood 

components while maintaining the 

safety of blood and blood components. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (§ 10.115). The 

guidance represents the current thinking 

of FDA on ‘‘Recommendations to 

Reduce the Possible Risk of 

Transmission of Creutzfeldt-Jakob 

Disease and Variant Creutzfeldt-Jakob 

Disease by Blood and Blood 

Components.’’ It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR 601.12 have been 

approved under OMB control number 

0910–0338; the collections of 

information in 21 CFR parts 610 and 

630 have been approved under OMB 

control number 0910–0116. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: May 18, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11119 Filed 5–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0150] 

Revocation of Authorization of 

Emergency Use of an In Vitro 

Diagnostic Device 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 

Authorization (EUA) (the Authorization) 

issued to Clinical Research Sequencing 

Platform (CRSP), LLC at the Broad 

Institute of MIT and Harvard (Broad 

Institute) for the CRSP SARS–CoV–2 

Real-time Reverse Transcriptase (RT)- 

PCR Diagnostic Assay. FDA revoked this 

Authorization under the Federal Food, 

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

The revocation, which includes an 

explanation of the reasons for 

revocation, is reprinted in this 

document. 

DATES: The Authorization for the CRSP 

SARS–CoV–2 Real-time Reverse 

Transcriptase (RT)-PCR Diagnostic 

Assay is revoked as of May 5, 2022. 

ADDRESSES: Submit a written request for 

a single copy of the revocation 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 

revocation may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocation. 

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 July 8, 

2020, FDA issued an EUA to the Broad 

Institute for the CRSP SARS–CoV–2 

Real-time Reverse Transcriptase (RT)- 

PCR Diagnostic Assay, 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. Subsequent updates to the 

Authorization 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 Request 

In a request received by FDA on April 

4, 2022, Broad Institute requested 

revocation of, and on May 5, 2022, FDA 

revoked, the Authorization for the CRSP 

SARS–CoV–2 Real-time Reverse 

Transcriptase (RT)-PCR Diagnostic 

Assay. Because the Broad Institute 

notified FDA that it has decided to 

discontinue use of the CRSP SARS– 

CoV–2 Real-time Reverse Transcriptase 

(RT)-PCR Diagnostic Assay and 

requested FDA revoke the EUA for the 

CRSP SARS–CoV–2 Real-time Reverse 

Transcriptase (RT)-PCR Diagnostic 

Assay, FDA has determined that it is 


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