Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 38163 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13606 Filed 6–24–22; 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 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 Quanterix 

Corp. for the Simoa Semi-Quantitative 

SARS–CoV–2 IgG Antibody Test and for 

the Simoa SARS–CoV–2 N Protein 

Antigen Test. 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 for the 

Simoa Semi-Quantitative SARS–CoV–2 

IgG Antibody Test and for the Simoa 

SARS–CoV–2 N Protein Antigen Test 

are revoked as of May 10, 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 

December 23, 2020, FDA issued an EUA 

to Quanterix Corp. for the Simoa SemiQuantitative SARS–CoV–2 IgG 

Antibody Test, 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 January 5, 2021, FDA 

issued an EUA to Quanterix Corp. for 

the Simoa SARS–CoV–2 N Protein 

Antigen Test, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on April 23, 2021, 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 requests received by FDA on May 

5, 2022, and May 9, 2022, Quanterix 

Corp. requested withdrawal of, and on 

May 10, 2022, FDA revoked, the 

Authorization for the Simoa SemiQuantitative SARS–CoV–2 IgG 

Antibody Test. Because Quanterix Corp. 

notified FDA that Quanterix Corp. did 

not distribute the authorized product in 

the United States and requested FDA to 

withdraw the authorization of the Simoa 

Semi-Quantitative SARS–CoV–2 IgG 

Antibody Test, FDA determined that it 

is appropriate to protect the public 

health or safety to revoke this 

Authorization. 

In requests received by FDA on May 

5, 2022, and May 9, 2022, Quanterix 

Corp. requested withdrawal of, and on 

May 10, 2022, FDA revoked, the 

Authorization for the Simoa SARS– 

CoV–2 N Protein Antigen Test. Because 

Quanterix Corp. notified FDA that 

Quanterix Corp. has discontinued 

distribution of the authorized product 

and requested FDA withdraw the 

authorization of the Simoa SARS–CoV– 

2 N Protein Antigen Test, FDA 

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 of 

Quanterix Corp. for the Simoa SemiQuantitative SARS–CoV–2 IgG 

Antibody Test and for the Simoa SARS– 

CoV–2 N Protein Antigen Test. 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. 


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38164 Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 


jspears on DSK121TN23PROD with NOTICES1EN27JN22.004</GPH>
Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 38165 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13639 Filed 6–24–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0584] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Pilot Survey To 

Develop Standardized Reporting 

Forms for Federally Funded Public 

Health Projects 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by July 27, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 


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