Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 14273-14275 [2022-05310]

Download as PDF Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices 2021–P–0959), under 21 CFR 10.30, requesting that the Agency determine whether MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list MPI DMSA KIDNEY REAGENT ((Technetium Tc-99m Succimer Kit), Injectable, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to MPI DMSA KIDNEY REAGENT ((Technetium Tc-99m Succimer Kit), Injectable, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. jspears on DSK121TN23PROD with NOTICES1 Dated: March 7, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–05324 Filed 3–11–22; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:51 Mar 11, 2022 Jkt 256001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–0150] Revocation of Two 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. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT–PCR Diagnostic Panel, and Omnipathology Solutions Medical Corporation for the Omni COVID–19 Assay by RT–PCR. 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 LifeHope 2019-nCoV Real-Time RT– PCR Diagnostic Panel is revoked as of February 7, 2022. The Authorization for the Omni COVID–19 Assay by RT–PCR is revoked as of February 14, 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 selfaddressed 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: SUMMARY: 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 AllHazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5) allows FDA to strengthen the public health PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 14273 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 June 29, 2020, FDA issued an EUA to LifeHope Labs for the LifeHope 2019nCoV Real-Time RT–PCR Diagnostic Panel, 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 17, 2020, FDA issued an EUA to Omnipathology Solutions Medical Corporation for the Omni COVID–19 Assay by RT–PCR, 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 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 In a request received by FDA on January 6, 2022, LifeHope Labs requested discontinuation of, and on February 7, 2022, FDA revoked, the Authorization for the LifeHope 2019nCoV Real-Time RT–PCR Diagnostic Panel. Because LifeHope Labs notified FDA that it is no longer using the LifeHope 2019-nCoV Real-Time RT– PCR Diagnostic Panel and requested FDA discontinue the LifeHope 2019nCoV Real-Time RT–PCR Diagnostic Panel, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. In requests received by FDA on February 7, 2022, and February 9, 2022, Omnipathology Solutions Medical Corporation requested revocation of, and on February 14, 2022, FDA revoked, the Authorization for the Omni COVID– 19 Assay by RT–PCR. Because Omnipathology Solutions Medical Corporation notified FDA that it is no longer using the Omni COVID–19 Assay by RT–PCR and requested FDA revoke the EUA for the Omni COVID–19 Assay by RT–PCR, FDA has determined that it E:\FR\FM\14MRN1.SGM 14MRN1 Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices is appropriate to protect the public health or safety to revoke this Authorization. IV. The Revocations jspears on DSK121TN23PROD with NOTICES1 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/. VerDate Sep<11>2014 17:51 Mar 11, 2022 Jkt 256001 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 EUA of LifeHope Labs for the LifeHope 2019nCoV Real-Time RT–PCR Diagnostic Panel and of Omnipathology Solutions PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 Medical Corporation for the Omni COVID–19 Assay by RT–PCR. 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. BILLING CODE 4164–01–P E:\FR\FM\14MRN1.SGM 14MRN1 EN14MR22.000</GPH> 14274 Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices [FR Doc. 2022–05310 Filed 3–11–22; 8:45 am] BILLING CODE 4164–01–C jspears on DSK121TN23PROD with NOTICES1 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics Centers for Disease Control and Prevention. ACTION: Notice of meeting. AGENCY: VerDate Sep<11>2014 17:51 Mar 11, 2022 Jkt 256001 Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. This meeting is open to the public. The public is welcome to obtain the link to attend this meeting by following the instructions posted on the Committee website: https://ncvhs.hhs.gov/ meetings/full-committee-meeting-10/. Name: National Committee on Vital and Health Statistics (NCVHS), Meeting of the full Committee. SUMMARY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 The meeting will be held Wednesday, March 30, 2022: 11:00 a.m.–3:00 p.m. EST. ADDRESSES: Virtual open meeting. FOR FURTHER INFORMATION CONTACT: Substantive program information may be obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, or via electronic mail to vgh4@ cdc.gov; or by telephone (301) 458– 4715. Summaries of meetings and a roster of Committee members are available on the home page of the DATES: E:\FR\FM\14MRN1.SGM 14MRN1 EN14MR22.001</GPH> Dated: March 3, 2022. Lauren K. Roth, Associate Commissioner for Policy. 14275

Agencies

[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Pages 14273-14275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]


Revocation of Two 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorizations (EUAs) (the 
Authorizations) issued to LifeHope Labs for the LifeHope 2019-nCoV 
Real-Time RT-PCR Diagnostic Panel, and Omnipathology Solutions Medical 
Corporation for the Omni COVID-19 Assay by RT-PCR. 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 LifeHope 2019-nCoV Real-Time RT-PCR 
Diagnostic Panel is revoked as of February 7, 2022. The Authorization 
for the Omni COVID-19 Assay by RT-PCR is revoked as of February 14, 
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 June 29, 2020, FDA issued an 
EUA to LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT-PCR 
Diagnostic Panel, 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 17, 2020, FDA issued an EUA to 
Omnipathology Solutions Medical Corporation for the Omni COVID-19 Assay 
by RT-PCR, 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 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

    In a request received by FDA on January 6, 2022, LifeHope Labs 
requested discontinuation of, and on February 7, 2022, FDA revoked, the 
Authorization for the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic 
Panel. Because LifeHope Labs notified FDA that it is no longer using 
the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel and requested 
FDA discontinue the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic 
Panel, FDA has determined that it is appropriate to protect the public 
health or safety to revoke this Authorization.
    In requests received by FDA on February 7, 2022, and February 9, 
2022, Omnipathology Solutions Medical Corporation requested revocation 
of, and on February 14, 2022, FDA revoked, the Authorization for the 
Omni COVID-19 Assay by RT-PCR. Because Omnipathology Solutions Medical 
Corporation notified FDA that it is no longer using the Omni COVID-19 
Assay by RT-PCR and requested FDA revoke the EUA for the Omni COVID-19 
Assay by RT-PCR, FDA has determined that it

[[Page 14274]]

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 EUA of LifeHope Labs for the LifeHope 2019-nCoV Real-
Time RT-PCR Diagnostic Panel and of Omnipathology Solutions Medical 
Corporation for the Omni COVID-19 Assay by RT-PCR. 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.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN14MR22.000


[[Page 14275]]


[GRAPHIC] [TIFF OMITTED] TN14MR22.001


    Dated: March 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05310 Filed 3-11-22; 8:45 am]
BILLING CODE 4164-01-C

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