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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31566 Federal Register / Vol. 87, No. 100 / Tuesday, May 24, 2022 / Notices 

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 

revocation is available on the internet at 

https://www.regulations.gov/. 

IV. The Revocation 

Having concluded that the criteria for 

revocation of the Authorization under 

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

met, FDA has revoked the EUA of Broad 

Institute for the CRSP SARS–CoV–2 

Real-time Reverse Transcriptase (RT)- 

PCR Diagnostic Assay. The revocation 

in its entirety follows and provides an 

explanation of the reasons for 

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. 100 / Tuesday, May 24, 2022 / Notices 31567 

Dated: May 17, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–11122 Filed 5–23–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2002–D–0362] 

Blood Pressure and Pulse Donor 

Eligibility Requirements: Compliance 

Policy; Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance entitled ‘‘Blood Pressure and 

Pulse Donor Eligibility Requirements: 

Compliance Policy; Draft Guidance for 

Industry.’’ The draft guidance document 

addresses certain regulatory 

requirements for determining donor 

eligibility that apply to blood 

establishments that collect blood and 

blood components for transfusion or for 

further manufacturing use, including 

Source Plasma. In a final rule dated May 

22, 2015, FDA amended the regulations 

applicable to blood establishments for 

determining donor eligibility and testing 

blood and blood components. The 

revised requirements were implemented 

in order to assure the safety of the blood 

supply and to protect donor health. 

DATES: 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– 

2022–D–0362 for ‘‘Blood Pressure and 

Pulse Donor Eligibility Requirements: 

Compliance Policy; Draft Guidance for 

Industry.’’ 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: 

Myrna Hanna, 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 draft document entitled ‘‘Blood 

Pressure and Pulse Donor Eligibility 

Requirements: Compliance Policy; Draft 

Guidance for Industry.’’ The draft 

guidance document addresses certain 

regulatory requirements for determining 

donor eligibility that apply to blood 

establishments that collection blood 

components for transfusion or for 

further manufacturing use, including 

Source Plasma. In the final rule dated 

May 22, 2015 (80 FR 29841) entitled 

‘‘Requirements for Blood and Blood 

Components Intended for Transfusion 

or for Further Manufacturing Use,’’ FDA 

amended the regulations applicable to 

blood establishments for determining 

donor eligibility and testing blood and 


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