[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61334-61335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21998]



[[Page 61334]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0412]


Revocation of Authorization of Emergency Use of an In Vitro 
Diagnostic Device 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 Authorization (EUA) (the Authorization) 
issued to Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo 
SARS-CoV-2 Assay. FDA revoked this Authorization under the Federal 
Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes 
an explanation of the reasons for revocation, is reprinted in this 
document.

DATES: The Authorization for the Laboratorio Clinico Toledo SARS-CoV-2 
Assay is revoked as of September 21, 2022.

ADDRESSES: Submit a written request for a single copy of the revocation 
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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the revocation.

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, 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 July 6, 2020, FDA issued an 
EUA to Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo 
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 updates to the Authorization 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 Request

    In a request received by FDA on September 8, 2022, Laboratorio 
Clinico Toledo requested withdrawal of, and on September 21, 2022, FDA 
revoked, the Authorization for the Laboratorio Clinico Toledo SARS-CoV-
2 Assay. Because Laboratorio Clinico Toledo notified FDA that 
Laboratorio Clinico Toledo has decided to no longer test using the 
Laboratorio Clinico Toledo SARS-CoV-2 Assay and requested FDA withdraw 
the EUA for the Laboratorio Clinico Toledo 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 
revocation is available on the internet at https://www.regulations.gov/.

IV. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA of Laboratorio Clinico Toledo for the Laboratorio 
Clinico Toledo SARS-CoV-2 Assay. The revocation in its entirety follows 
and provides an explanation of the reasons for revocation, as required 
by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

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[GRAPHIC] [TIFF OMITTED] TN11OC22.000


    Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21998 Filed 10-7-22; 8:45 am]
BILLING CODE 4164-01-C


