Document ID: FDA-2021-N-0412-0004
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection  and/or Diagnosis of COVID–19; Availability
Posted Date: 2022-07-15T04:00Z

[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Pages 42488-42490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15160]

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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, Health and Human Services (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 ScienCell Research Laboratories (ScienCell) for the ScienCell 
SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection

[[Page 42489]]

Kit. 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 ScienCell SARS-CoV-2 Coronavirus Real-
time RT-PCR (RT-qPCR) Detection Kit is revoked as of June 7, 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, 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 
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 April 3, 2020, FDA issued an 
EUA to ScienCell for the ScienCell SARS-CoV-2 Coronavirus Real-time RT-
PCR (RT-qPCR) Detection Kit, subject to the terms of the Authorization. 
Notice of the issuance of this Authorization was published in the 
Federal Register on June 5, 2020 (85 FR 34638), 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 June 2, 2022, ScienCell requested 
revocation of, and on June 7, 2022, FDA revoked, the Authorization for 
the ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) 
Detection Kit. Because ScienCell notified FDA that ScienCell decided to 
discontinue distribution of the ScienCell SARS-CoV-2 Coronavirus Real-
time RT-PCR (RTqPCR) Detection Kit and requested FDA revoke the EUA for 
the ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) 
Detection Kit, 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 ScienCell for the ScienCell SARS-CoV-2 
Coronavirus Real-time RT-PCR (RTqPCR) Detection Kit. 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.

[[Page 42490]]

[GRAPHIC] [TIFF OMITTED] TN15JY22.008

    Dated: July 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15160 Filed 7-14-22; 8:45 am]
BILLING CODE 4164-01-P