22900 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 

specified in the DATES section of this 

notice. 

If you are not presenting during the 

CLFS Annual Public Meeting, you may 

view the meeting via webinar or listenonly by teleconference. If you would 

like to listen to or view the meeting, 

teleconference dial-in and webinar 

information will appear on the final 

CLFS Annual Public Meeting agenda, 

which will be posted on the CMS 

website when available at http://

www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ClinicalLab

FeeSched/index.html?redirect=/ 

ClinicalLabFeeSched/. 

IV. Special Accommodations 

Individuals viewing or listening to the 

meeting who are hearing or visually 

impaired and have special 

requirements, or a condition that 

requires special assistance, should send 

an email to the resource box (CDLT_

Annual_Public_Meeting@cms.hhs.gov). 

The deadline for submitting this request 

is listed in the DATES section of this 

notice. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Administrator of the Centers for 

Medicare & Medicaid Services (CMS), 

Chiquita Brooks-LaSure, having 

reviewed and approved this document, 

authorizes Lynette Wilson, who is the 

Federal Register Liaison, to 

electronically sign this document for 

purposes of publication in the Federal 

Register. 

Dated: April 13, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–08259 Filed 4–15–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0049] 

Revocation of Five 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 BillionToOne, 

Inc. for the qSanger-COVID–19 Assay, 

RTA Laboratories Biological Products 

Pharmaceutical and Machinery Industry 

(RTA) for the Diagnovital SARS–CoV–2 

Real-Time PCR Kit, DiaSorin Inc. for the 

DiaSorin LIAISON SARS–CoV–2 IgM 

Assay, and CENTOGENE US, LLC for 

both the CentoFast-SARS–CoV–2 RT– 

PCR Assay and CentoSure SARS–CoV– 

2 RT–PCR Assay. 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 Authorization for the 

qSanger-COVID–19 Assay is revoked as 

of March 10, 2022. The Authorization 

for the Diagnovital SARS–CoV–2 RealTime PCR Kit is revoked as of March 14, 

2022. The Authorization for the 

DiaSorin LIAISON SARS–CoV–2 IgM 

Assay is revoked as of March 15, 2022. 

The Authorizations for the CentoFastSARS–CoV–2 RT–PCR Assay and 

CentoSure SARS–CoV–2 RT–PCR Assay 

are revoked as of March 17, 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 

September 4, 2020, FDA issued an EUA 

to BillionToOne, Inc. for the qSangerCOVID–19 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. On June 12, 2020, FDA 

issued an EUA to RTA for the 

Diagnovital SARS–CoV–2 Real-Time 

PCR Kit, 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 DiaSorin Inc. for the DiaSorin 

LIAISON SARS–CoV–2 IgM 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. On July 1, 

2020, FDA issued an EUA to 

CENTOGENE US, LLC for the 

CentoFast-SARS–CoV–2 RT–PCR 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. On 

September 29, 2020, FDA issued an 

EUA to CENTOGENE US, LLC for the 

CentoSure SARS–CoV–2 RT–PCR 

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 

changes 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 


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Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 22901 

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 February 25, 2022, BillionToOne, 

Inc. requested revocation of, and on 

March 10, 2022, FDA revoked, the 

Authorization for the qSanger-COVID– 

19 Assay. Because BillionToOne, Inc. 

notified FDA that it has decided to 

discontinue distribution of the qSangerCOVID–19 Assay and requested FDA 

revoke the EUA for the qSanger-COVID– 

19 Assay, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

FDA received a request dated February 

15, 2022, from RTA for the revocation 

of, and on March 14, 2022, FDA 

revoked, the Authorization for the 

Diagnovital SARS–CoV–2 Real-Time 

PCR Kit. Because RTA notified FDA that 

the EUA for the Diagnovital SARS– 

CoV–2 Real-Time PCR Kit is no longer 

required and requested that FDA revoke 

the EUA for the Diagnovital SARS– 

CoV–2 Real-Time PCR Kit, FDA has 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. On March 10, 

2022, FDA received a request from 

DiaSorin Inc. for the revocation of, and 

on March 15, 2022, FDA revoked, the 

Authorization for the DiaSorin LIAISON 

SARS–CoV–2 IgM Assay. Because 

DiaSorin Inc. notified FDA that 

DiaSorin Inc. has decided to 

discontinue commercial distribution 

and support of the DiaSorin LIAISON 

SARS–CoV–2 IgM Assay and requested 

FDA revoke the EUA for the DiaSorin 

LIAISON SARS–CoV–2 IgM Assay, FDA 

has determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. On March 14, 

2022, FDA received a request from 

CENTOGENE US, LLC. for the 

revocation of, and on March 17, 2022, 

FDA revoked, the Authorization for the 

CentoFast-SARS–CoV–2 RT–PCR Assay. 

Because CENTOGENE US, LLC. notified 

FDA that it does not offer the CentoFastSARS–CoV–2 RT–PCR Assay anymore 

and requested FDA revoke the EUA for 

the CentoFast-SARS–CoV–2 RT–PCR 

Assay, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

On March 14, 2022, FDA received a 

request from CENTOGENE US, LLC. for 

the revocation of, and on March 17, 

2022, FDA revoked, the Authorization 

for the CentoSure SARS–CoV–2 RT– 

PCR Assay. Because CENTOGENE US, 

LLC. notified FDA that it does not offer 

the CentoSure SARS–CoV–2 RT–PCR 

Assay anymore and requested FDA 

revoke the EUA for the CentoSure 

SARS–CoV–2 RT–PCR Assay, 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 

BillionToOne, Inc.’s qSanger–COVID–19 

Assay, RTA’s Diagnovital SARS–CoV–2 

Real-Time PCR Kit, DiaSorin Inc.’s 

DiaSorin LIAISON SARS–CoV–2 IgM 

Assay, and CENTOGENE US, LLC’s 

CentoFast–SARS–CoV–2 RT–PCR Assay 

and CentoSure SARS–CoV–2 RT–PCR 

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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22902 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 


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■ U.S. F.OOD & DRUG 

AOMINl!lTIH\TION 

Anna Rolda, MS 

Sr. Manager, Qualify & Regulatory Affairs 

BillionToOne, Inc. 

1035 O'Brien Drive 

Menlo Park, CA 94025 

Re: Revocation ofEUA201 on 

Dear Ms. Rolda: 

March 10, 2022 

This letter is .in response to the request from BillionToOne; Inc., received via email on February 

25, 2022, that the U.S. Food and Drug Administration (FDA) revoke the BUA for the qSangerCOVID• 19 Assay issued on September 4, 2020, and amended on June 23, 2021, and September 

23, 2021. BillionToOne, Inc. indicated that it has decided to discontinue distribution of the 

q Sanger-COVID-19 Assay and there is not any viable/non-expired product remaining in 

distribution. 

The authorization of adevicefot emergency use under section 564 ofthe 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 Bi!IionToOne, Inc. has notified FDA that it has 

decided to discontinue distribution of1he qSanger-COVID-19 Assay and requested FDA revoke 

the EU A for the qSanger-COVID-19 Assay, FDA has determined that it is appropriate to protect 

the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes 

EU A20 l 022 for the qSanger-COVID• 19 Assay, pursuant to section 564(g)(2)(C) of the Act. As 

of the date of this letter, the qSan1,rer-COVID-l9 Assay is no longer au1horized for emergency 

use by FDA 

Notice of this revocation will be published in the .Federal Register, pursuant to section 564(h)(l) 

of the Act. · 

Sincerely, 

Isl 

Jacqueline A O'Shaughnessy, Ph.D. 

Acting Chief Scientist 

Food and Drug Administration 
Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 22903 


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March 14, 2022 

llknur Cetin 

Quality Assurance Manager 

RTA Laboratories Biological Products Pharmaceutical and Machinery Industry (RTA Laboratuvarlari 

Biyolojik Urunler Ilac ve Makine San) 

76 TW Alexander Drive 

Research Triangle Park, NC 27709 

Re: Revocation ofEUA200486 

Dear Ilknur Cetin, 

This letter is in response to RTA Laboratories Biological Products Pharmaceutical and Machinery 

Industry's (RTA's) request dated February 15, 2022, that the U.S. Food and Drug Administration (FDA) 

revoke the Emergency Use Authorization (EUA2004 86) for the Diagno vital SARS-Co V -2 Real-Time PCR 

Kit issued on June 12, 2020 and revised on September 23, 2021. In its February 15, 2022, letter, RTA 

requested revocation of the EUA effective February 15, 2022, as the product will no longer be distributed 

or used by that date. FDA understands that RTA has decided not to continue to commercially support the 

Diagnovital SARS-Co V-2 Real-Time PCR Kit. 

The authorization ofa device for emergency use under section 564 of the Federal Food, Drug, and 

Cosmetic Act (the Act) (21 U.S. C. 3 60bbb-3) may, pursuantto 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 RTA has notified FDA that the EUA forthe Diagnovital SA RS-Co V-2 

Real-Time PCR Kit is no longer required and requested that FDA revoke the EUA for the Diagnovital 

SARS-Co V-2 Real-Time PCR Kit, FDA has determined that it is appropriate to protect the public health or 

safety to revoke this authorization. Accordingly, FDA hereby revokes EUA200486 for the Diagnovital 

SARS-Co V-2 Real-Time PCR Kit, pursuant to section 564(g)(2)(C) of the Act. As of the date of this letter. 

the Diagnovital SARS-CoV-2 Real-Time PCR Kit is no longer authori,:ed for emergency use by FDA. 

Notice or this revocation will be published in the Federal Register, pursuant to section 564(h)(l) or the Act 

Sincerely, 

Isl 

Jacqueline A. O'Shaughnessy, Ph.D. 

Acting Chief Scientist 

Food and Drug Administration 
22904 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 


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Mari Meyer 

DiaSorin Inc. 

U.S. FOOD & DRUG ADMINISTRATION 

1951 Northwestern Avenue 

Stillwater, MN 55082-0285 

Re: Revocation ofEUA202004 

Dear Mari Meyer: 

March 15, 2022 

This letter is in response to a request from DiaSorm Inc., received March 10, 2022, that the U.S. 

Food and Drug Administration (FDA) revoke the DiaSorin LIAISON SARS-Co V -2 IgM AssayEU A202004 issued on September 29, 2020, and revised September 23, 2021. DiaSorin Inc. has 

decided to discontinue commercial distributionandsupportofthe DiaSorin LIAISON SARSCo V-2 TgM Assay and there is not any viable/non-expired prnductremainingin distribution. 

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. 3 60 bb b-3) may, pursuantto section 5 64(g)(2) of the Act, 

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

safety (section 564(g)(2)(C} of the Act). BecauseDiaSorm Inc. has notified FDA that DiaSorin 

Inc, has decided to discontinue commercial distribution and support oftheDiaSorin LIAISON 

SARS-CoV-2 IgM Assay and requested FDArevoketheEUAforthe DiaSorin LIAISON 

SA RS-Co V -2 I gM Assay, FD A has determined that it is appropriate to protect the public health 

or safety to revoke this authori7atiOn. Accordingly, FDA hereby revokes EUA202004 for the 

DiaSorin LIAISON SARS-CoV-2 IgM Assay, pursuant to section 564(g)(2)(C) oftheAct. As of 

the date of this letter, the DiaSorin LIAISON SARS-CoV-2 lgM Assay is no longer authorized 

for emergency use by FDA 

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

of the Act. 

Sincerely, 

Isl 

Jacqueline A. O'Shaughnes:sy, Ph.D. 

Acting Chief Scientist 

Food and Drug Administration 
Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 22905 


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Or. Florian Vogel 

Chief Process Officer 

CENTOGENE GmbH 

AmStrande7 

18055 Rostock 

Germany 

Re: Revocation ofEUA201018 

Dear Dr. Vogel: 

March 17,.2022 

This letter is in response to the request from CENTOGENE US, LLC. ("Centogene"), received 

on March 14, 2022, thatthe U.S. Food and Drug Administration (FDA) revoke the EUA for the 

CentoFast•SARS-CoV-2 RT-PCR Assay issued on July l, 2020, and amended on August 13, 

2021, and September 23, 202 l. Centogene indicated that it does not offer this test anymore. 

FDA understands Centogene has notified all associated laboratories to also stop using this test 

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) ofthe 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 Centogenehas notified FDA that it does not 

offer the CentoFast-SARS-Co V-2 RT-PCR Assay anymore and requested FDA revoke the EUA 

for the CentoFast-SARS-Co V-2 RT-PCR Assay, FDA has determined that it is appropriate to 

protect the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes 

EUA2010I8 for the CentoFast-SARS-CoV-2RT-PCRAssay, pursuantto section 564(g)(2)(C) 

of the Act. As of the date of this letter, the CentoFast-SARS-Co V -2 RT-PCR Assay is no longer 

authorized for emergency use by FDA. 

Notice of this revocation will be published in the Federal Register, pursuant to section 564(h)(l) 

of the Act 

Sincerely, 

Isl 

Jacqueline A O'Shaughnessy, Ph.D. 

Acting Chief Scientist 

Food and Drug Administration 

Cc: Justin Bingham, CENTOGENE US, LLC. 
22906 Federal Register / Vol. 87, No. 74 / Monday, April 18, 2022 / Notices 

Dated: April 12, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08230 Filed 4–15–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–0430] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Generic Clearance 

for Quick Turnaround Testing of 

Communication Effectiveness 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we, 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 


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Dr. Florian Vogel 

Chief Process Officer 

CENTOGENE GmbH 

Am Strande? 

18055 Rostocl( 

Germany 

&DRUG 

Re: Revocation ofEUA202546 

Dear Dr. Vogel: 

March 17, 2022 

This letter is. in response to the request from CENTOGENE US, LLC. ("Centogene"), received 

on March 14, 2022, that the U.S. Food and Drug Administration (FDA) revoke the EUAforthe 

CentoSure SA RS-Co V ·2 RT-PCR Assay issued on September 29, 2020, and amended on August 

13, 2021, and September 23, 2021. Centogene indicated that it does not offer this test anymore. 

FDA understands Centogene and has notified associated laboratories to also stop using this test 

The authorization ofa 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). BecauseCentogenehas notified FDA that it does not 

offer the CentoSure SARS-CoV-2 RT-PCR Assay anymore and requested FDA revoke the EUA 

for the CentoSure SARS-CoV-2 RT-PCR Assay, FDA has determined that it is appropriate to 

protect the public health or safety to revoke this authorization. Accordingly, FDA herebyrevokes 

EUA202546 for the CentoSureSARS-CoV-2 RT-PCRAssay, pursuantto section 564(g)(2)(C) 

of the Act. As of the date of this letter, the CentoSure SARS-CoV-2 RT-PCR Assay is no longer 

authorized for emergency use by FDA 

Notice of this revocation will be published in the Federal Register, pursuant to section 564(11)(1) 

of the Act. 

Sincerely, 

Isl 

Jacqueline A. O'Shaughnessy, Ph.D. 

Acting Chief Scientist 

Food and Drug Administration 

Cc: Justin Bingham, CENTOGENE US, LLC.