Document ID: FDA-2023-N-0109-0001
Agency: fda
Document Type: Notice
Title: Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic
Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2023-02-01T05:00Z

[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Pages 6751-6756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02074]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0109]

Revocation of Four 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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to Mammoth Biosciences, Inc. for the SARS-CoV-2 
DETECTR Reagent Kit and DETECTR

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BOOST SARS-CoV-2 Reagent Kit, to the University of Arizona Genetics 
Core for Clinical Services for the COVID-19 ELISA pan-Ig Antibody Test, 
and to ChromaCode, Inc. for the HDPCR SARS-CoV-2 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 Authorizations for the SARS-CoV-2 DETECTR Reagent Kit and 
DETECTR BOOST SARS-CoV-2 Reagent Kit are revoked as of December 15, 
2022. The Authorization for the COVID-19 ELISA pan-Ig Antibody Test is 
revoked as of December 16, 2022. The Authorization for the HDPCR SARS-
CoV-2 Assay is revoked as of January 3, 2023.

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 self-addressed 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 Ross, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 301-796-8510 (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 
All-Hazards 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 August 31, 2020, FDA issued 
an EUA to Mammoth Biosciences, Inc. for the SARS-CoV-2 DETECTR Reagent 
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 January 21, 2022, FDA issued an EUA to Mammoth Biosciences, 
Inc. for the DETECTR BOOST SARS-CoV-2 Reagent Kit, subject to the terms 
of the Authorization. Notice of the issuance of this Authorization was 
published in the Federal Register on March 22, 2022 (87 FR 16196), as 
required by section 564(h)(1) of the FD&C Act. On August 31, 2020, FDA 
issued an EUA to the University of Arizona Genetics Core for Clinical 
Services for the COVID-19 ELISA pan-Ig Antibody Test, 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 9, 2020, FDA issued an EUA to ChromaCode, Inc. for the HDPCR 
SARS-CoV-2 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 revisions 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

    On October 20, 2022, FDA received requests from Mammoth 
Biosciences, Inc. for the withdrawal of, and on December 15, 2022, FDA 
revoked, the Authorizations for the SARS-CoV-2 DETECTR Reagent Kit and 
DETECTR BOOST SARS-CoV-2 Reagent Kit. Because Mammoth Biosciences, Inc. 
requested FDA withdraw the EUAs for the SARS-CoV-2 DETECTR Reagent Kit 
and DETECTR BOOST SARS-CoV-2 Reagent Kit, FDA has determined that it is 
appropriate to protect the public health or safety to revoke these 
Authorizations. On December 14, 2022, FDA received a request from the 
University of Arizona Genetics Core for Clinical Services for the 
withdrawal of, and on December 16, 2022, FDA revoked, the Authorization 
for the COVID-19 ELISA pan-Ig Antibody Test. Because the University of 
Arizona Genetics Core for Clinical Services requested FDA withdraw the 
EUA for the COVID-19 ELISA pan-Ig Antibody Test, FDA has determined 
that it is appropriate to protect the public health or safety to revoke 
this Authorization. On December 2, 2022, FDA received a request from 
ChromaCode, Inc., for the revocation of, and on January 3, 2023, FDA 
revoked, the Authorization for the HDPCR SARS-CoV-2 Assay. Because 
ChromaCode, Inc. requested FDA revoke the EUA for the HDPCR SARS-CoV-2 
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 Mammoth Biosciences, Inc.'s SARS-CoV-2 DETECTR 
Reagent Kit and DETECTR BOOST SARS-CoV-2 Reagent Kit, the University of 
Arizona Genetics Core for Clinical Services's COVID-19 ELISA pan-Ig 
Antibody Test, and ChromaCode, Inc.'s HDPCR SARS-CoV-2 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.
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    Dated: January 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02074 Filed 1-31-23; 8:45 am]
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