Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 3306-3313 [2022-01139]
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<![CDATA[
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Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices
TABLE 3—CDRH GUIDANCES AND COLLECTIONS—Continued
COVID–19 guidance
title
CFR cite referenced
in COVID–19
guidance
Another guidance
referenced in
COVID–
19 guidance
807, subparts A through D ....
807, subpart E .......................
820 .........................................
830 and 801.20 ......................
................................................
................................................
................................................
................................................
OMB
Control
No(s).
New Collection
covered by PHE
PRA Waiver
0910–0625
0910–0120
0910–0073
0910–0720
Manufacturer voluntary reporting to FDA of viral transport
media manufacturing capacity information.
Manufacturer voluntary reporting to FDA of sterile phosphate buffered saline/saline
manufacturing capacity information.
Policy for Coronavirus Disease–2019 Tests During
the Public Health Emergency (Revised November
2021) (document number
20010–R4).
803 .........................................
Emergency Use Authorization
of Medical Products and
Related Authorities; Guidance for Industry and Other
Stakeholders.
0910–0595
Administrative Procedures for
Clinical Laboratory Improvement Amendments of
1988 Categorization.
0910–0607
Medical Device Reporting ......
0910–0437
Confirmation to FDA that the
developer of a diagnostic or
serology test on FDA’s notification lists and for which
an Emergency Use Authorization (EUA) request was
submitted, wants FDA to
continue reviewing its EUA
request.
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IV. Electronic Access
Persons with access to the internet
may obtain COVID–19-related guidances
at:
• FDA web page entitled ‘‘COVID–19Related Guidance Documents for
Industry, FDA Staff, and Other
Stakeholders,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders;
• FDA web page entitled ‘‘Search for
FDA Guidance Documents’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or
• https://www.regulations.gov.
VerDate Sep<11>2014
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Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01146 Filed 1–20–22; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2022–N–0049]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Revocation of Five 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
SUMMARY:
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Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices
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Authorizations) issued to Cellex Inc. for
the Cellex q–SARS–CoV–2 IgG/IgM
Rapid Test, BioMe´rieux SA for the
SARS–COV–2 R–GENE, Siemens
Healthcare Diagnostics Inc. for the
Atellica IM SARS–CoV–2 IgG (COV2G),
Siemens Healthcare Diagnostics Inc. for
the ADVIA Centaur SARS–CoV–2 IgG
(COV2G), and Cepheid for the Xpert
Omni SARS–CoV–2. 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 Cellex
q–SARS–CoV–2 IgG/IgM Rapid Test is
revoked as of December 10, 2021. The
Authorizations for the SARS–COV–2 R–
GENE, Atellica IM SARS–CoV–2 IgG
(COV2G), and ADVIA Centaur SARS–
CoV–2 IgG (COV2G) are revoked as of
December 17, 2021. The Authorization
for the Xpert Omni SARS–CoV–2 is
revoked as of December 20, 2021.
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:
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
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
1, 2020, FDA issued an EUA to Cellex
Inc. for the Cellex q–SARS–CoV–2 IgG/
IgM Rapid Test, subject to the terms of
the Authorization. Notice of the
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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.
On May 6, 2020, FDA issued an EUA to
BioMe´rieux SA for the SARS–COV–2 R–
GENE, subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on July 14, 2020 (85 FR
42407), as required by section 564(h)(1)
of the FD&C Act. On July 31, 2020, FDA
issued an EUA to Siemens Healthcare
Diagnostics Inc. for the Atellica IM
SARS–CoV–2 IgG (COV2G), 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 July 31, 2020, FDA issued
an EUA to Siemens Healthcare
Diagnostics Inc. for the ADVIA Centaur
SARS–CoV–2 IgG (COV2G), 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 November 27, 2020, FDA
issued an EUA to Cepheid for the Xpert
Omni SARS–CoV–2, 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 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
On December 7, 2021, Cellex
requested withdrawal of, and on
December 10, 2021, FDA revoked, the
Authorization for the Cellex q–SARS–
CoV–2 IgG/IgM Rapid Test. Because
Cellex requested that FDA withdraw the
Authorization and FDA understands the
product is no longer being distributed,
FDA has determined that it is
appropriate to protect the public health
or safety to revoke this Authorization.
On December 10, 2021, FDA received a
request from BioMe´rieux SA for the
revocation of, and on December 17,
2021, FDA revoked, the Authorization
for the SARS–COV–2 R–GENE. Because
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BioMe´rieux SA notified FDA that
BioMe´rieux SA has decided to no longer
commercially support the authorized
product and requested FDA revoke the
Authorization, FDA has determined that
it is appropriate to protect the public
health or safety to revoke this
Authorization. On December 9, 2021,
FDA received a request from Siemens
Healthcare Diagnostics Inc. for the
voluntary removal of, and on December
17, 2021, FDA revoked, the
Authorization for the Atellica IM SARS–
CoV–2 IgG (COV2G). Because Siemens
Healthcare Diagnostics Inc. notified
FDA that Siemens Healthcare
Diagnostics Inc. has decided to no
longer market the authorized product
and requested FDA voluntarily remove
the Atellica IM SARS–CoV–2 IgG
(COV2G) from FDA’s list of authorized
devices, FDA has determined that it is
appropriate to protect the public health
or safety to revoke this Authorization.
On December 9, 2021, FDA received a
request from Siemens Healthcare
Diagnostics Inc. for the voluntary
removal of, and on December 17, 2021,
FDA revoked, the Authorization for the
ADVIA Centaur SARS–CoV–2 IgG
(COV2G). Because Siemens Healthcare
Diagnostics Inc. notified FDA that
Siemens Healthcare Diagnostics Inc. has
decided to no longer market the
authorized product and requested FDA
voluntarily remove the ADVIA Centaur
SARS–CoV–2 IgG (COV2G) from FDA’s
list of authorized devices, FDA has
determined that it is appropriate to
protect the public health or safety to
revoke this Authorization. On December
17, 2021, FDA received a request from
Cepheid for the revocation of, and on
December 20, 2021, FDA revoked, the
Authorization for the Xpert Omni
SARS–CoV–2. Because Cepheid has
notified FDA that Cepheid has not
commercially distributed any of the
Xpert Omni SARS–CoV–2 product due
to the current public clinical needs
being met by Cepheid’s other EUA tests
that are available and requested FDA
revoke the EUA for the Xpert Omni
SARS–CoV–2, 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
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Cellex Inc.’s Cellex q–SARS–CoV–2 IgG/
IgM Rapid Test, BioMe´rieux SA’s
SARS–COV–2 R–GENE, Siemens
Healthcare Diagnostics Inc.’s Atellica IM
SARS–CoV–2 IgG (COV2G), Siemens
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Healthcare Diagnostics Inc.’s ADVIA
Centaur SARS–CoV–2 IgG (COV2G), and
Cepheid’s Xpert Omni SARS–CoV–2.
The revocations in their entirety follow
and provide an explanation of the
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reasons for each revocation, as required
by section 564(h)(1) of the FD&C Act.
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3312
Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices
Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–01139 Filed 1–20–22; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
[OMB No. 0915–0298—Revision]
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Maternal and Child
Health Bureau Performance Measures
for Discretionary Grant Information
System
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 22, 2022.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or by mail to the
HRSA Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the acting
HRSA Information Collection Clearance
Officer at (301) 443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information collection request title for
reference.
Information Collection Request Title:
Maternal and Child Health Bureau
(MCHB) Performance Measures for
jspears on DSK121TN23PROD with NOTICES1
SUMMARY:
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Discretionary Grant Information System
(DGIS), OMB No. 0915–0298—Revision.
Abstract: Approval from OMB is
sought to implement minor revisions to
the MCHB Performance Measures for
DGIS. Most of these measures are
specific to certain types of programs and
are not required of all grantees. The
measures are categorized by domain
(Adolescent Health, Capacity Building,
Child Health, Children with Special
Health Care Needs, Lifecourse/
Crosscutting, Maternal/Women Health,
and Perinatal/Infant Health), in addition
to some program-specific measures.
Grant programs are assigned domains
based on their activities and individual
grantees respond to only a limited
number of performance measures that
are relevant to their specific program.
Need and Proposed Use of the
Information: The performance data
collected through the DGIS serves
several purposes, including grantee
monitoring, program planning,
performance reporting, and the ability to
demonstrate alignment between MCHB
discretionary programs and the Title V
MCH Services Block Grant program.
HRSA is making the following changes
to the current OMB package for MCHB
DGIS to more closely align data
collection forms with current program
activities:
Removing the following existing
forms: Core 1 (Grant Impact), Capacity
Building 2 (Technical Assistance),
Capacity Building 7 (Direct Annual
Access to Maternal and Child Health
(MCH) Data), Training Form 13 (Diverse
Adolescent Involvement (LEAHspecific)), Financial Form 2 (Project
Funding Profile), and Financial Form 4
(Project Budget and Expenditures);
Adding the following new form:
Training Form 14 (Teleconsultation and
Training for Mental and Behavioral
Health) and Leadership, Education, and
Advancement in Undergraduate
Pathways Training Program Trainee
Information Form;
Revising the following existing forms:
F2F (Family to Family Form 1),
Financial Form 1 (MCHB Project Budget
Details), Financial Form 4 (new name:
MCH Discretionary Grant Project
Abstract), and MCH Training Program
Data Forms;
Revising and Renumbering the
following forms: Core 3 (Health Equity)
will become the new Core 1 (Health
Equity), Financial Form 3 (Budget
Details by Types of Individuals Served)
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will become the new Financial Form 2
(Budget Details by Types of Individuals
Served), Financial Form 5 (Number of
Individuals Served (Unduplicated)) will
become the new Financial Form 3
(Number of Individuals Served
(Unduplicated)), and Financial Form 6
(Project Abstract) will become the new
Financial Form 4 (Project Abstract); and
Renumbering the following forms:
Core 2 (Quality Improvement) will
become the new Capacity Building 4
(Quality Improvement), Capacity
Building 3 (Impact Measurement) will
become the new Capacity Building 2
(Impact Measurement), Capacity
Building 4 (Sustainability) will become
the new Capacity Building 3
(Sustainability), and Training 14
(Medium-Term Trainees Skill and
Knowledge (PPC-Specific)) will become
the new Training 13 (Medium-Term
Trainees Skill and Knowledge (PPCSpecific)).
Non-substantive revisions also
include updates to terminology, goals,
benchmark data sources, and
significance sections included in the
measures’ detail sheets. A performance
measure detail sheet defines and
describes each performance measure.
Forms and detail sheets showing the
proposed revisions are available upon
request.
This revision will facilitate more
efficient and accurate reporting of
information related to capacity building
activities, financial and demographic
data, and training activities.
Likely Respondents: The grantees for
MCHB Discretionary Grant Programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
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]]>Agencies
[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3306-3313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01139]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0049]
Revocation of Five 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
[[Page 3307]]
Authorizations) issued to Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/
IgM Rapid Test, BioM[eacute]rieux SA for the SARS-COV-2 R-GENE, Siemens
Healthcare Diagnostics Inc. for the Atellica IM SARS-CoV-2 IgG (COV2G),
Siemens Healthcare Diagnostics Inc. for the ADVIA Centaur SARS-CoV-2
IgG (COV2G), and Cepheid for the Xpert Omni SARS-CoV-2. 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 Cellex q-SARS-CoV-2 IgG/IgM Rapid Test
is revoked as of December 10, 2021. The Authorizations for the SARS-
COV-2 R-GENE, Atellica IM SARS-CoV-2 IgG (COV2G), and ADVIA Centaur
SARS-CoV-2 IgG (COV2G) are revoked as of December 17, 2021. The
Authorization for the Xpert Omni SARS-CoV-2 is revoked as of December
20, 2021.
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 April 1, 2020, FDA issued an
EUA to Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test,
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.
On May 6, 2020, FDA issued an EUA to BioM[eacute]rieux SA for the SARS-
COV-2 R-GENE, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
July 14, 2020 (85 FR 42407), as required by section 564(h)(1) of the
FD&C Act. On July 31, 2020, FDA issued an EUA to Siemens Healthcare
Diagnostics Inc. for the Atellica IM SARS-CoV-2 IgG (COV2G), 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 July 31, 2020, FDA issued an EUA to Siemens Healthcare Diagnostics
Inc. for the ADVIA Centaur SARS-CoV-2 IgG (COV2G), 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 November 27, 2020,
FDA issued an EUA to Cepheid for the Xpert Omni SARS-CoV-2, 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 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
On December 7, 2021, Cellex requested withdrawal of, and on
December 10, 2021, FDA revoked, the Authorization for the Cellex q-
SARS-CoV-2 IgG/IgM Rapid Test. Because Cellex requested that FDA
withdraw the Authorization and FDA understands the product is no longer
being distributed, FDA has determined that it is appropriate to protect
the public health or safety to revoke this Authorization. On December
10, 2021, FDA received a request from BioM[eacute]rieux SA for the
revocation of, and on December 17, 2021, FDA revoked, the Authorization
for the SARS-COV-2 R-GENE. Because BioM[eacute]rieux SA notified FDA
that BioM[eacute]rieux SA has decided to no longer commercially support
the authorized product and requested FDA revoke the Authorization, FDA
has determined that it is appropriate to protect the public health or
safety to revoke this Authorization. On December 9, 2021, FDA received
a request from Siemens Healthcare Diagnostics Inc. for the voluntary
removal of, and on December 17, 2021, FDA revoked, the Authorization
for the Atellica IM SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare
Diagnostics Inc. notified FDA that Siemens Healthcare Diagnostics Inc.
has decided to no longer market the authorized product and requested
FDA voluntarily remove the Atellica IM SARS-CoV-2 IgG (COV2G) from
FDA's list of authorized devices, FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization. On December 9, 2021, FDA received a request from Siemens
Healthcare Diagnostics Inc. for the voluntary removal of, and on
December 17, 2021, FDA revoked, the Authorization for the ADVIA Centaur
SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare Diagnostics Inc.
notified FDA that Siemens Healthcare Diagnostics Inc. has decided to no
longer market the authorized product and requested FDA voluntarily
remove the ADVIA Centaur SARS-CoV-2 IgG (COV2G) from FDA's list of
authorized devices, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization. On
December 17, 2021, FDA received a request from Cepheid for the
revocation of, and on December 20, 2021, FDA revoked, the Authorization
for the Xpert Omni SARS-CoV-2. Because Cepheid has notified FDA that
Cepheid has not commercially distributed any of the Xpert Omni SARS-
CoV-2 product due to the current public clinical needs being met by
Cepheid's other EUA tests that are available and requested FDA revoke
the EUA for the Xpert Omni SARS-CoV-2, 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
[[Page 3308]]
Cellex Inc.'s Cellex q-SARS-CoV-2 IgG/IgM Rapid Test, BioM[eacute]rieux
SA's SARS-COV-2 R-GENE, Siemens Healthcare Diagnostics Inc.'s Atellica
IM SARS-CoV-2 IgG (COV2G), Siemens Healthcare Diagnostics Inc.'s ADVIA
Centaur SARS-CoV-2 IgG (COV2G), and Cepheid's Xpert Omni SARS-CoV-2.
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] TN21JA22.005
[[Page 3309]]
[GRAPHIC] [TIFF OMITTED] TN21JA22.006
[[Page 3310]]
[GRAPHIC] [TIFF OMITTED] TN21JA22.007
[[Page 3311]]
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[GRAPHIC] [TIFF OMITTED] TN21JA22.009
[[Page 3313]]
Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01139 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-C
