Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 12459 

information collected and reported in an 

oversight role of state Medicaid 

managed care programs. 

Among the proposed changes, this 

iteration also accommodates the use of 

reporting templates for existing 

reporting requirements at 42 CFR 

438.207(d) for network adequacy and 

access and § 438.74 for medical loss 

ratio. The templates are intended to 

help states by articulating the specific 

data elements needed and by providing 

an easy to use format that facilitates 

CMS’ tracking and analysis. The data 

gathered from these reports will enable 

CMS to ensure state compliance with 

regulatory requirements. 

Form Number: CMS–10108 (OMB 

control number: 0938–0920); Frequency: 

Occasionally; Affected Public: 

Individuals or households, Private 

sector (business or other for-profit and 

not-for-profit institutions), and State, 

local or Tribal Government; Number of 

Respondents: 609; Total Annual 

Responses: 13,742,805; Total Annual 

Hours: 1,682,411. (For policy questions 

regarding this collection contact Amy 

Gentile at 410–786–3499.) 

Dated: March 1, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–04645 Filed 3–3–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0150] 

Revocation of Two 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 Bio-Rad 

Laboratories for the BioPlex 2200 

SARS–CoV–2 IgG, and Quotient Suisse 

SA for the MosaiQ COVID–19 Antibody 

Magazine. FDA revoked these 

Authorizations under the Federal Food, 

Drug, and 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 are revoked 

as of January 11, 2022. 

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 July 1, 

2021, FDA issued an EUA to Bio-Rad 

Laboratories for the BioPlex 2200 

SARS–CoV–2 IgG, subject to the terms 

of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

October 28, 2021 (86 FR 59738), as 

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

FD&C Act. On September 25, 2020, FDA 

issued an EUA to Quotient Suisse SA 

for the MosaiQ COVID–19 Antibody 

Magazine, 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 

In a request received by FDA on 

December 20, 2021, Bio-Rad 

Laboratories requested revocation of, 

and on January 11, 2022, FDA revoked, 

the Authorization for the BioPlex 2200 

SARS–CoV–2 IgG. Because Bio-Rad 

Laboratories notified FDA that Bio-Rad 

Laboratories has not commercialized the 

authorized product in the United States 

and requested FDA revoke the BioPlex 

2200 SARS–CoV–2 IgG, FDA has 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

In a request received by FDA on 

December 22, 2021, Quotient Suisse SA 

requested termination of, and on 

January 11, 2022, FDA revoked, the 

Authorization for the MosaiQ COVID– 

19 Antibody Magazine. Because 

Quotient Suisse SA notified FDA that 

Quotient Suisse SA has decided not to 

continue to commercially support the 

product and requested FDA terminate 

the MosaiQ COVID–19 Antibody 

Magazine, 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 EUA of BioRad Laboratories for the BioPlex 2200 

SARS–CoV–2 IgG and of Quotient 

Suisse SA for the MosaiQ COVID–19 

Antibody Magazine. 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 


lotter on DSK11XQN23PROD with NOTICES1
12460 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 


lotter on DSK11XQN23PROD with NOTICES1EN04MR22.003</GPH>

I.lnda Staswitik 

Regulatory Affi1irs Pr◊jecfMaiiaaer 

Bio-Rad Laboratories 

4000 A.lftedNobelOt 

Hetcules, CA 94541 

Re: RevocationotEUA:llJ2689 

Dear Lirtda StaSwitlf: 

Januaiy.n .• 2:022 

· Thisletter is fu response toa request from Bio~R.ad tab oratories~ received December 20, 2021, 

that the U.S. Food and D:ntgAdministtation (EDA) revoke theBioP}eJ(o 2200 SARS~o V..;2JgG 

-.EUA2Q2689' issued on July 1, 2:021 atid revised September 23, 2021.· The BfoPlex 2200 SARSCov ~2 lgG Panelbasnotbeen. commertjalii~ by Bio-Rad in theU.S; 

The authorization ofa:.devi¢efot eititrgency useunderse:;ction 5'64 ofthe Federal.F<>od:. Drug, 

and C:c1sn:1efie-Act(theAct) (21 US.Ct 360bbb.:3) may, pursuanHo section564(g)(2)oftheAc:t; 

~e n:ivoked when circuml!tances make suc;h revocation appropfuite to protect-~ pub He health 9r 

safety (section564(g)(2)(C) ofthe Act). BecauseBfo-Rad has notified FDA that Bio~Rad has.not 

com:inercja:Ii~d tht:i authorized productin the U$, and requested FDArevoke:the I3i0:Ple,c 2200 

SARS~CQ V-2 tgG,,,. EUA20:2689, FDA hruI detennined thatitis app.ropriateto protectthe publk 

health-or safefy torev<>ke this auU:torization, Al:'cordingly, FDA hereby revokes EUA202689 for 

the :BioPlex 2200 SARS-CtiV•.2 lgG, purimantto section 564(g)(2)(C) of the Act As of the: date 

of: lllis letter, the 13ioJ>le,x 2200 SAAS--CoV~2 IgQ is no lottgeuuthorizedJor emergency useQy FDA, .. 

Notiteo:fihis tevocatlM Will tie published in thaFedtraiiwgtiter, putsuantto section564(h)(l) 

Qf~eAct. 

Sincerely, 

Isl 

JacquelineA O':Shaughnessy, Ph,D. 

Ac1ing Chief Scientist · 

Food and DtugAdmmistratfon 
Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 12461 

Dated: February 28, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04635 Filed 3–3–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–D–1825 and FDA– 

2020–D–1136] 

Guidance Documents Related to 

Coronavirus Disease 2019; 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 FDA 

guidance documents related to the 

Coronavirus Disease 2019 (COVID–19) 

public health emergency (PHE). This 

notice of availability (NOA) is pursuant 

to the process that FDA announced, in 

the Federal Register of March 25, 2020, 

for making available to the public 

COVID–19-related guidances. The 

guidances identified in this notice 

address issues related to the COVID–19 

PHE and have been issued in 

accordance with the process announced 

in the March 25, 2020, notice. The 

guidances have been implemented 


lotter on DSK11XQN23PROD with NOTICES1EN04MR22.004</GPH>

U.S. FOOD & DRUG 

ADMINISTRATION 

Michael Campbell 

Head of Regulatory Affairs & Quality 

Quotient Suisse SA 

Route de Crassier 13 

Eysins, VD 1262 

S,vitzerland 

Re: Revocation ofEUA201083 

Dear Michael Campbell: 

January 11, 2022 

This letter is in response to a request from Quotient Suisse SA, received December 22, 2021, that 

the U.S. Food and Drug Administration (FDA) terminate the MosaiQ COVID-19 Antibody 

Magazine-EUA201083 issued on September 25, 2020 and amended April 27, 2021 and 

September 23, 202 l. Quotient Suisse SA decided not to continue to commercially support the 

MosaiQ COVID-19 Antibody Magazine. 

The authorization of a device for emergency use under section 564 of the Federal Food, Drug; 

and Cosmetic Act (the Act) (21 U.S. C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked when circumstances make such revocation appropriate to protect the public health or 

safety (section 564(g)(2)(C) of the Act). Because Quotient Suisse SA has notified FDA that 

Quotient Suisse SA has decided not to continue to commercially support the product and 

requested FDA terminate the MosaiQ COVID-19 Antibody Magazine - EUA20 I 083, FDA has 

determined that it is appropriate to protect the public health or safety to revoke this authorization. 

Accordingly, FDA hereby revokes EUA201083 for the MosaiQ COVID-19 Antibody Magazine, 

pursuantto section 564(g)(2)(C) of the Act. As of the date of this letter, the MosaiQ COVID-19 

Antibody Magazine is no longer authorized for emergency use by FDA. 

Notice of this revocation will be published in the Federal Register, pursuantto section 564(h)( 1) 

of the Act. 

Sincerely, 

/s/ 

Jacqueline A. ff Shaughnessy, Ph.D. 

Acting Chief Scientist 

Food and Drug Administration