87 FR 135 pgs. 42488-42490 - Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Type: NOTICEVolume: 87Number: 135Pages: 42488 - 42490
Pages: 42488, 42489, 42490Docket number: [Docket No. FDA-2021-N-0412]
FR document: [FR Doc. 2022-15160 Filed 7-14-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
SUMMARY:
[top] 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
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.
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[Federal Register graphic "EN15JY22.008" is not available. Please view the graphic in the PDF version of this document.]
Dated: July 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15160 Filed 7-14-22; 8:45 am]
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