[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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