Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2022-N-0049]

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# SUMMARY:

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to BillionToOne, Inc. for the qSanger-COVID-19 Assay, RTA Laboratories Biological Products Pharmaceutical and Machinery Industry (RTA) for the Diagnovital SARS-CoV-2 Real-Time PCR Kit, DiaSorin Inc. for the DiaSorin LIAISON SARS-CoV-2 IgM Assay, and CENTOGENE US, LLC for both the CentoFast-SARS-CoV-2 RT-PCR Assay and CentoSure SARS-CoV-2 RT-PCR 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 Authorization for the qSanger-COVID-19 Assay is revoked as of March 10, 2022. The Authorization for the Diagnovital SARS-CoV-2 Real-Time PCR Kit is revoked as of March 14, 2022. The Authorization for the DiaSorin LIAISON SARS-CoV-2 IgM Assay is revoked as of March 15, 2022. The Authorizations for the CentoFast-SARS-CoV-2 RT-PCR Assay and CentoSure SARS-CoV-2 RT-PCR Assay are revoked as of March 17, 2022.

# 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 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 September 4, 2020, FDA issued an EUA to BillionToOne, Inc. for the qSanger-COVID-19 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. On June 12, 2020, FDA issued an EUA to RTA for the Diagnovital SARS-CoV-2 Real-Time PCR 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 September 29, 2020, FDA issued an EUA to DiaSorin Inc. for the DiaSorin LIAISON SARS-CoV-2 IgM Assay, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the                     **Federal Register**                     on April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the FD&C Act. On July 1, 2020, FDA issued an EUA to CENTOGENE US, LLC for the CentoFast-SARS-CoV-2 RT-PCR 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. On September 29, 2020, FDA issued an EUA to CENTOGENE US, LLC for the CentoSure SARS-CoV-2 RT-PCR Assay, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the                     **Federal Register**                     on April 23, 2021 (86 FR 21749), as required by section 564(h)(1) of the FD&C Act. Subsequent changes 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                           ( print page 22901)                        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 February 25, 2022, BillionToOne, Inc. requested revocation of, and on March 10, 2022, FDA revoked, the Authorization for the qSanger-COVID-19 Assay. Because BillionToOne, Inc. notified FDA that it has decided to discontinue distribution of the qSanger-COVID-19 Assay and requested FDA revoke the EUA for the qSanger-COVID-19 Assay, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. FDA received a request dated February 15, 2022, from RTA for the revocation of, and on March 14, 2022, FDA revoked, the Authorization for the Diagnovital SARS-CoV-2 Real-Time PCR Kit. Because RTA notified FDA that the EUA for the Diagnovital SARS-CoV-2 Real-Time PCR Kit is no longer required and requested that FDA revoke the EUA for the Diagnovital SARS-CoV-2 Real-Time PCR Kit, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On March 10, 2022, FDA received a request from DiaSorin Inc. for the revocation of, and on March 15, 2022, FDA revoked, the Authorization for the DiaSorin LIAISON SARS-CoV-2 IgM Assay. Because DiaSorin Inc. notified FDA that DiaSorin Inc. has decided to discontinue commercial distribution and support of the DiaSorin LIAISON SARS-CoV-2 IgM Assay and requested FDA revoke the EUA for the DiaSorin LIAISON SARS-CoV-2 IgM Assay, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On March 14, 2022, FDA received a request from CENTOGENE US, LLC. for the revocation of, and on March 17, 2022, FDA revoked, the Authorization for the CentoFast-SARS-CoV-2 RT-PCR Assay. Because CENTOGENE US, LLC. notified FDA that it does not offer the CentoFast-SARS-CoV-2 RT-PCR Assay anymore and requested FDA revoke the EUA for the CentoFast-SARS-CoV-2 RT-PCR Assay, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On March 14, 2022, FDA received a request from CENTOGENE US, LLC. for the revocation of, and on March 17, 2022, FDA revoked, the Authorization for the CentoSure SARS-CoV-2 RT-PCR Assay. Because CENTOGENE US, LLC. notified FDA that it does not offer the CentoSure SARS-CoV-2 RT-PCR Assay anymore and requested FDA revoke the EUA for the CentoSure SARS-CoV-2 RT-PCR 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 BillionToOne, Inc.'s qSanger-COVID-19 Assay, RTA's Diagnovital SARS-CoV-2 Real-Time PCR Kit, DiaSorin Inc.'s DiaSorin LIAISON SARS-CoV-2 IgM Assay, and CENTOGENE US, LLC's CentoFast-SARS-CoV-2 RT-PCR Assay and CentoSure SARS-CoV-2 RT-PCR 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.
      ( print page 22902)          ( print page 22903)          ( print page 22904)          ( print page 22905)          ( print page 22906)    

Dated: April 12, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

BILLING CODE 4164-01-P

[FR Doc. 2022-08230 Filed 4-15-22; 8:45 am]

BILLING CODE 4164-01-C