Revocation of Eleven Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 69192-69205 [2023-22188]
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69192
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
support disaster survivors during
response missions. ACF is requesting
immediate approval for this information
collection but also requesting comments
to inform any updates prior to
requesting an extension of approval
within six months.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act (PRA) of 1995, ACF is
soliciting public comment on the
specific aspects of the information
collection described in this notice.
These comments will be considered
prior to requesting an extension of
approval.
under 44 U.S.C. 3507 (subsection j). The
information collected is essential to the
mission of the agency and an
unanticipated event occurred that could
reasonably result in public harm if
normal PRA clearance procedures are
followed. ACF is requesting expedited
processing to ensure that the agency is
operationally ready to support disaster
survivors in Hawai’i who were impacted
by the wildfires that began August 8,
2023, on Maui County. A request for
review under normal procedures will be
submitted within 180 days of the
approval for this request.
Respondents: Disaster Survivors.
Copies of the proposed
collection of information can be
obtained and comments may be
submitted by emailing infocollection@
acf.hhs.gov. Identify all by the title of
the information collection.
SUPPLEMENTARY INFORMATION:
Description: OHSEPR’s case managers
would use this collection during an
intake assessment to identify a disaster
survivor’s unmet needs and to work
with the survivor to develop a case
management plan based on the
survivor’s responses. ACF is requesting
that OMB grant a 180-day approval for
this request under procedures for
expedited processing, as authorized
ADDRESSES:
ANNUAL BURDEN ESTIMATES
ddrumheller on DSK120RN23PROD with NOTICES1
Total
number of
responses per
respondent
Annual
number of
respondents
Data collection
Average
burden hours
per response
Annual
burden hours
Disaster Human Services Case Management Intake Assessment—Survivor
Case Management Plan—Case Manager .......................................................
Resource Referral Form—Case Manager .......................................................
Case Record Notes—Case Manager ..............................................................
Survivor Satisfaction Survey—Survivor ...........................................................
9,000
180
180
180
9,000
1
50
50
50
1
1.5
1
1
1
.25
13,500
9,000
9,000
9,000
2,250
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
42,750
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Comments will be considered and any
necessary updates to materials made
prior to, and responses provided in, the
submission to OMB that will follow this
public comment period.
Authority: The Disaster Human
Services Case Management Program is
authorized through appropriations
language under the Children and
Families Services account. It is operated
by the ACF Office of Human Services
Emergency Preparedness and Response,
which is the lead in HHS for human
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service preparation for, response to, and
recovery from, natural disasters.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–22294 Filed 10–4–23; 8:45 am]
BILLING CODE 4184–PC–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4182]
Revocation of Eleven Authorizations of
Emergency Use of In Vitro Diagnostic
Device 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 Luminostics,
Inc., for the Clip COVID Rapid Antigen
Test; NeuMoDx Molecular, Inc., a
QIAGEN Company, for the NeuMoDx
Flu A–B/RSV/SARS–CoV–2 Vantage
Assay; LGC, Biosearch Technologies for
the SARS–CoV–2 Real-Time and EndPoint RT–PCR Test; LGC, Biosearch
Technologies, for the Biosearch
SUMMARY:
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Technologies SARS–CoV–2 ultra-highthroughput End-Point RT–PCR Test;
Becton, Dickinson and Co. for the BD
Veritor At-Home COVID–19 Test; Verily
Life Sciences for the Verily COVID–19
RT–PCR Test; Clinical Research
Sequencing Platform (CRSP), LLC at the
Broad Institute of MIT and Harvard for
the CRSP SARS–CoV–2 Real-time
Reverse Transcriptase (RT)–PCR
Diagnostic Assay (Version 3); Xtrava
Health for the SPERA COVID–19 Ag
Test; Exact Sciences Laboratories for the
COVID–Flu Multiplex Assay; Exact
Sciences Laboratories for the SARS–
CoV–2 (N gene detection) Test; and dba
SpectronRx for the Hymon SARS–CoV–
2 Test Kit. FDA revoked these
Authorizations under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) as
requested by the Authorization holders.
The revocations, which include an
explanation of the reasons for each
revocation, are reprinted in this
document.
The Authorization for the
Luminostics, Inc.’s, Clip COVID Rapid
Antigen Test is revoked as of May 5,
2023. The Authorization for the
NeuMoDx Molecular, Inc., a QIAGEN
Company, for the NeuMoDx Flu A–B/
RSV/SARS–CoV–2 Vantage Assay is
revoked as of May 24, 2023. The
Authorization for the LGC, Biosearch
Technologies for the SARS–CoV–2 Real-
DATES:
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Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
Time and End-Point RT–PCR Test is
revoked as of June 1, 2023. The
Authorization for the LGC, Biosearch
Technologies, for the Biosearch
Technologies SARS–CoV–2 ultra-highthroughput End-Point RT–PCR Test is
revoked as of June 1, 2023. The
Authorization for the Becton, Dickinson
and Co.’s BD Veritor At-Home COVID–
19 Test is revoked as of June 15, 2023.
The Authorization for the Verily Life
Sciences’ Verily COVID–19 RT–PCR
Test is revoked as of June 21, 2023. The
Authorization for the Clinical Research
Sequencing Platform (CRSP), LLC at the
Broad Institute of MIT and Harvard for
the CRSP SARS–CoV–2 Real-time
Reverse Transcriptase (RT)-PCR
Diagnostic Assay (Version 3) is revoked
as of July 3, 2023. The Authorization for
the Xtrava Health’s SPERA COVID–19
Ag Test is revoked as of August 3, 2023.
The Authorization for the Exact
Sciences Laboratories’ COVID–Flu
Multiplex Assay is revoked as of August
18, 2023. The Authorization for the
Exact Sciences Laboratories’ SARS–
CoV–2 (N gene detection) Test is
revoked as of August 18, 2023. The
Authorization for the dba SpectronRx’s
Hymon SARS–CoV–2 Test Kit is
revoked as of August 23, 2023.
ADDRESSES: Submit a written request for
a single copy of the revocations to the
Office of Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, 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: Kim
Sapsford-Medintz, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216,
Silver Spring, MD 20993–0002, 301–
796–0311 (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,
radiological, or nuclear agent or agents.
Among other things, section 564 of the
FD&C Act allows FDA to authorize the
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use of an unapproved medical product
or an unapproved use of an approved
medical product in certain situations.
On December 7, 2020, FDA issued the
Authorization to Luminostics, Inc., for
the for the Clip COVID Rapid Antigen
Test, 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 March
25, 2021, FDA issued the Authorization
to NeuMoDx Molecular, Inc., a QIAGEN
Company, for the NeuMoDx Flu A–B/
RSV/SARS–CoV–2 Vantage Assay,
subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on July 23, 2021 (86 FR
39040), as required by section 564(h)(1)
of the FD&C Act. On April 15, 2021,
FDA issued the Authorization to LGC,
Biosearch Technologies for the SARS–
CoV–2 Real-Time and End-Point RT–
PCR Test. Notice of the issuance of this
Authorization was published in the
Federal Register on July 23, 2021 (86 FR
39040), subject to the terms of the
Authorization. On August 24, 2021,
FDA issued the Authorization to Becton,
Dickinson and Co. for the BD Veritor AtHome COVID–19 Test, subject to the
terms of the Authorization. Notice of the
issuance of this Authorization was
published in the Federal Register on
October 28, 2021 (86 FR 59740), as
required by section 564(h)(1) of the
FD&C Act. On April 26, 2022, FDA
issued the Authorization to LGC,
Biosearch Technologies, for the
Biosearch Technologies SARS–CoV–2
ultra-high-throughput End-Point RT–
PCR Test, subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on July 22, 2022 (87 FR
43877), as required by section 564(h)(1)
of the FD&C Act. On September 8, 2020,
FDA issued the Authorization to Verily
Life Sciences for the Verily COVID–19
RT–PCR Test, 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 March 5,
2021, FDA issued the Authorization to
Clinical Research Sequencing Platform
(CRSP), LLC at the Broad Institute of
MIT and Harvard for the CRSP SARS–
CoV–2 Real-time Reverse Transcriptase
(RT)-PCR Diagnostic Assay (Version 3),
subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on July 23, 2021 (86 FR
39040), as required by section 564(h)(1)
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69193
of the FD&C Act. On October 12, 2021,
FDA issued the Authorization to Xtrava
Health for the SPERA COVID–19 Ag
Test, subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on March 22, 2022 (87
FR 16198), as required by section
564(h)(1) of the FD&C Act. On July 1,
2021, FDA issued the Authorization to
Exact Sciences Laboratories for the
COVID–Flu Multiplex Assay, subject to
the terms of the Authorization. Notice of
the issuance of this Authorization was
published in the Federal Register on
October 28, 2021 (86 FR 59740), as
required by section 564(h)(1) of the
FD&C Act. On March 31, 2020, FDA
issued the Authorization to Exact
Sciences Laboratories for the SARS–
CoV–2 (N gene detection) Test, 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 May 22, 2020, FDA
issued the Authorization to dba
SpectronRx for the Hymon SARS–CoV–
2 Test 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.
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. Authorization Revocation Requests
In a request received by FDA on May
2, 2023, Luminostics, Inc. requested the
withdrawal of, and on May 5, 2023,
FDA revoked, the Authorization for the
Luminostics, Inc.’s Clip COVID Rapid
Antigen Test. Because Luminostics, Inc.
notified FDA that there are no viable
Clip COVID Rapid Antigen Test reagents
remaining in distribution in the United
States and requested FDA withdraw the
Luminostics, Inc.’s Clip COVID Rapid
Antigen Test, FDA has determined that
it is appropriate to protect the public
health or safety to revoke this
Authorization.
In a request received by FDA on May
11, 2023, NeuMoDx Molecular, Inc., a
QIAGEN Company requested revocation
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ddrumheller on DSK120RN23PROD with NOTICES1
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Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
of, and on May 24, 2023, FDA revoked,
the Authorization for the NeuMoDx
Molecular, Inc., a QIAGEN Company’s,
NeuMoDx Flu A–B/RSV/SARS–CoV–2
Vantage Assay. Because NeuMoDx
Molecular, Inc., a QIAGEN Company,
notified FDA that it has decided to
discontinue distribution of the
NeuMoDx Flu A–B/RSV/SARS–CoV–2
Vantage Assay in the United States and
requested FDA voluntary revocation of
the EUA for the NeuMoDx Flu A–B/
RSV/SARS–CoV–2 Vantage Assay, FDA
has determined that it is appropriate to
protect the public health or safety to
revoke this Authorization.
In a request received by FDA on May
1, 2023, LGC, Biosearch Technologies
requested revocation of, and on June 1,
2023, FDA revoked, the Authorization
for the LGC Biosearch Technologies’
SARS–CoV–2 Real-Time and End-Point
RT–PCR Test. Because LGC, Biosearch
Technologies notified FDA that it is no
longer marketing the SARS–CoV–2 RealTime and End-Point RT–PCR Test and
requested FDA revoke the EUA for the
LGC Biosearch Technologies SARS–
CoV–2 Real-Time and End-Point RT–
PCR Test, FDA has determined that it is
appropriate to protect the public health
or safety to revoke this Authorization.
In a request received by FDA on May
1, 2023, LGC, Biosearch Technologies
requested revocation of, and on June 1,
2023, FDA revoked, the Authorization
for the LGC Biosearch Technologies’
SARS–CoV–2 ultra-high-throughput
End-Point RT–PCR Test. Because LGC,
Biosearch Technologies notified FDA
that it is no longer marketing the SARS–
CoV–2 ultra-high-throughput End-Point
RT–PCR Test and requested FDA revoke
the EUA for the LGC Biosearch
Technologies SARS–CoV–2 ultra-highthroughput End-Point RT–PCR Test,
FDA has determined that it is
appropriate to protect the public health
or safety to revoke this Authorization.
In a request received by FDA on May
30, 2023, Becton, Dickinson and Co.
requested withdrawal of, and on June
15, 2023, FDA revoked, the
Authorization for the Becton, Dickinson
and Co.’s BD Veritor At-Home COVID–
19 Test. Because Becton, Dickinson and
Co. notified FDA that it has
discontinued the sale of BD Veritor AtHome COVID–19 Test and requested
FDA withdraw the EUA for the Becton,
Dickinson and Co.’s BD Veritor AtHome COVID–19 Test, FDA has
determined that it is appropriate to
protect the public health or safety to
revoke this Authorization.
In a request received by FDA on June
13, 2023, Verily Life Sciences requested
withdrawal of, and on June 21, 2023,
FDA revoked, the Authorization for the
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Verily Life Sciences’ Verily COVID–19
RT–PCR Test. Because Verily Life
Sciences notified FDA that it is no
longer distributing the Verily COVID–19
Nasal Swab Kits (authorized as part of
the Verily COVID–19 RT–PCR Test) or
offering testing services at the Verily
Life Sciences’ laboratory using the
Verily COVID–19 RT–PCR Test and
requested FDA withdraw the EUA for
the Verily Life Sciences’ Verily COVID–
19 RT–PCR Test, FDA has determined
that it is appropriate to protect the
public health or safety to revoke this
Authorization.
In a request received by FDA on June
14, 2023, Clinical Research Sequencing
Platform (CRSP), LLC at the Broad
Institute of MIT and Harvard, requested
voluntary revocation of, and on July 3,
2023, FDA revoked, the Authorization
for the CRSP, LLC at the Broad Institute
of MIT and Harvard’s CRSP SARS–CoV–
2 Real-time Reverse Transcriptase (RT)–
PCR Diagnostic Assay (Version 3).
Because CRSP, LLC at the Broad
Institute of MIT and Harvard notified
FDA that it is no longer distributing the
CRSP Self-swab Kits (authorized as part
of the CRSP SARS–CoV–2 Real-time
RT–PCR Diagnostic Assay (Version 3))
or offering testing services at the CRSP,
LLC at the Broad Institute of MIT and
Harvard laboratory using the CRSP
SARS–CoV–2 Real-time RT–PCR
Diagnostic Assay (Version 3), and
requested FDA revoke the EUA for the
CRSP, LLC at the Broad Institute of MIT
and Harvard’s CRSP SARS–CoV–2 Realtime RT–PCR Diagnostic Assay (Version
3), FDA has determined that it is
appropriate to protect the public health
or safety to revoke this Authorization.
In a request received by FDA on July
18, 2023, Xtrava Health requested the
withdrawal of, and on August 3, 2023,
FDA revoked, the Authorization for the
Xtrava Health’s SPERA COVID–19 Ag
Test. Because Xtrava Health notified
FDA that there are no SPERA COVID–
19 Ag Test reagents in distribution in
the United States and requested FDA
withdraw the Xtrava Health’s, SPERA
COVID–19 Ag Test, FDA has
determined that it is appropriate to
protect the public health or safety to
revoke this Authorization.
In a request received by FDA on
August 1, 2023, Exact Sciences
Laboratories requested the withdrawal
of, and on August 18, 2023, FDA
revoked, the Authorization for the Exact
Sciences Laboratories’ COVID-Flu
Multiplex Assay. Because Exact
Sciences Laboratories notified FDA that
they have discontinued use of the
COVID-Flu Multiplex Assay at Exact
Sciences Laboratories and requested
FDA withdraw the Exact Sciences
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Laboratories’ COVID-Flu Multiplex
Assay, FDA has determined that it is
appropriate to protect the public health
or safety to revoke this Authorization.
In a request received by FDA on
August 1, 2023, Exact Sciences
Laboratories requested the withdrawal
of, and on August 18, 2023, FDA
revoked, the Authorization for the Exact
Sciences Laboratories’ SARS–CoV–2 (N
gene detection) Test. Because Exact
Sciences Laboratories notified FDA that
they have discontinued use of the
SARS–CoV–2 (N gene detection) Test at
Exact Sciences Laboratories and
requested FDA withdraw the Exact
Sciences Laboratories’ SARS–CoV–2 (N
gene detection) Test, FDA has
determined that it is appropriate to
protect the public health or safety to
revoke this Authorization.
In a request received by FDA on
March 24, 2023, dba SpectronRx
requested the withdrawal of, and on
August 23, 2023, FDA revoked, the
Authorization for the dba SpectronRx’s
Hymon SARS–CoV–2 Test Kit. Because
dba SpectronRx notified FDA that they
are discontinuing the distribution of the
Hymon SARS–CoV–2 Test Kit and
requested FDA withdraw the dba
SpectronRx for the Hymon SARS–CoV–
2 Test 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
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
Luminostics, Inc.’s, Clip COVID Rapid
Antigen Test, NeuMoDx Molecular, Inc.,
a QIAGEN Company’s, NeuMoDx Flu
A–B/RSV/SARS–CoV–2 Vantage Assay,
LGC Biosearch Technologies’ SARS–
CoV–2 Real-Time and End-Point RT–
PCR Test, LGC Biosearch Technologies’
SARS–CoV–2 ultra-high-throughput
End-Point RT–PCR Test, Becton,
Dickinson and Co.’s BD Veritor AtHome COVID–19 Test, Verily Life
Sciences’ Verily COVID–19 RT–PCR
Test, Clinical Research Sequencing
Platform (CRSP), LLC at the Broad
Institute of MIT and Harvard’s CRSP
SARS–CoV–2 Real-time Reverse
Transcriptase (RT)–PCR Diagnostic
Assay (Version 3), Xtrava Health’s
SPERA COVID–19 Ag Test, Exact
Sciences Laboratories’ COVID-Flu
Multiplex Assay, Exact Sciences
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Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
Laboratories’ SARS–CoV–2 (N gene
detection) Test, and dba SpectronRx’s
Hymon SARS–CoV–2 Test Kit. These
revocations in their entirety follow and
provide an explanation of the reasons
69195
for each revocation, as required by
section 564(h)(1) of the FD&C Act.
BILLING CODE 4164–01–P
BalaR:aja Ph.Di
President and CEO
Luminosti¢s, lt1c.
483898'.emontSlvd, Suittlll:2,
Fretnont; C~ 9453'8
Re: R.evocation ot'EUA:2U290'7
C>ellt Dr. Raja:
This letter fa in response to tlte request. ftoinLtitninosti(..'li, me., in aletterreceived Mar 2, 2023,
that the U. $; Food and Drug Administration (FDA)WithdraW the EU A for the Clip COVID
lllq>id Antigen test issued on December 7,. 2020, reissued March 4, 20~2. and revised on
September 23, 2021, and November 1, 2022:. FDA understands that as oftlte date of this letter
tltere .are no viable Clip COVIDRapid Antigen Test reagents remaining in distributionin the
United States.
The allthorizajionof a <ievke for emergeu,cy use under sec#on 564 of the Fei.teral Food, Drug;
and Cosmetfo Act (the Act)(21 U.S.C, 360bbb~3) may,pursua.ntto section 564(g)(2) ofthe A~
be revoked when citcwnstartces maki: such revocation appropriate t<> protect the pub Ii¢ health <>r
saf~y (~cti◊rt 564(g)(2)(C) of the A~). :aecause Ll,lttlln<>Stics; Inc; h!i$ requested FDA withdraw
the EUAfor the Clip Covto R.aptd Antigen Test, FDA bas determined tliai iHs appropriate to
protect the public health ·or safety to revokethis authorization:. . Accordingly,.FDA hereby revokes
EUA.202907 for the Clip covm Rapid Antigen Test, pim.uanno section 564(3X2)(C)of tlte
A(..1:, As ofthe date <>fthi& letter, the Clip COVIORapid Antigen. Test isJ10 l<>ngerffllthorized :for
emergen1;1y llSe by FDA.
•
•
•
Notice ofthis revocatiQn will he published 1n theFWeraiRegiste1tpursuant to section 564(h)(l)
oftheAct.
Sincerely.
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18:37 Oct 04, 2023
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EN05OC23.066</GPH>
ddrumheller on DSK120RN23PROD with NOTICES1
Jeffrey E. Shuret\ M.D., J.D.
Directctt
Center for Devices and Radiological Health
Fo.od and Drug Administratio11
69196
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
1"'".. -••·~•1,,
{.
U.S. FOOD & DRUG
ADMINISTRATION
May 24, 2023
Eveline Arnold, Ph.D.
Director, Regulatory Affairs
Clinical, Medical, and Regulatory Affairs (CMRA)
NeuMoDx Molecular, Inc., a QIAGEN Company
1250 Eisenhower Place
Ann Arbor, MI 48108
Re: Revocation ofEUA202947
Dear Dr. Arnold:
TI1is letter is in response to QIAGEN's request on behalf ofNeuMoDx Molecular, Inc., a
QIAGEN Company, in an email received May 11, 2023, that the U.S. Food and Drug
Administration (FDA) revoke the EUAforthe Neu1foDx Flu A-B/RSV/SARS-CoV-2 Vantage
Assay issued on March 25, 2021, and revised on September 23, 2021. QIAGEN has decided to
discontinue distribution of the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay in the
United States and requested volut1tary revocation of the EUA.
TI1e authorization of a device for emergency use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,
be revoked ,;vhen circumstances make such revocation appropriate to protect the public health or
safety (section 564(g)(2)(C) of the Act). Because QIAGEN, on behalf of NeuMoDx Molecular,
Inc., has requested FDA revoke the EUA for the NeuMoDx Flt1 A-B/RSV/SARS-CoV-2
Vantage Assay, FDA has detem1ined that it is appropriate to protect the public health or safety to
revoke this authorization. Accordingly, FDA hereby revokes EU A202947 for the NeuMoDx Flu
A-B/RSV/SARS-CoV-2 Vantage Assay, pursuant to section 564(g)(2)(C) of the Act. As ofthe
date of this letter, the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay is no longer
authorized for emergency use by FDA.
Notice of this revocation will be published in the Federal Register, pursuant to section 564(11)(1)
of the Act.
Sincerely,
//s//
VerDate Sep<11>2014
18:37 Oct 04, 2023
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Jeffrey E. Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
food and Drug Administration
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
69197
U.S. FOOD & DRUG
AOMINIST!IAT!ON
June 1, 2023
Ray Bandziulis, Ph.D.
Director of Regulatory Affairs
LGC, Biosearch Technologies
2905 Parameter Street
Middleton, WI 53562
Re: Revocation ofEUA203030
Dear Dr. Bandziulis:
TI1is letter is in response to the request from LGC, Biosearch Technologies, in an email received
May l, 2023, that the U.S. Food and Drug Administration (FDA) revoke the EUA for the
Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test issued on April
15, 2021, and revised on September 23, 2021 and May 3, 2022. LGC, Biosearch Technologies
indicated that they are no longer marketing the authorized product and requested that the EDA be
revoked. FDA understands that, as of the date of this letter, there are no viable Biosearch
Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test reagents remaining in
distribution in the United States.
The authorization ofa device for emergency use under section 564 of the Federal Food, Dmg,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(gX2) ofthe Act,
be revoked when circumstances make such revocation appropriate to protect the public health or
safety (section 564(gX2)(C) ofthe Act). Because LGC, Biosearch Technologies has requested
that FDA revoke the EUA for Biosearch Technologies SARS-CoV-2 Real-Time and End-Point
RT-PCR Test, FDA has detennined that it is appropriate, to protect the public health or safety, to
revoke this authorization. Accordingly, FDA hereby revokes EUA203030 for the Biosearch
Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test, pursuant to section
564(g)(2)(C) ofthe Act. As of the date of this letter, the Biosearch Technologies SARS-CoV-2
Real-Time and End-Point RT-PCR Test is no longer authorized for emergency use by FDA.
Notice of this revocation will be published in the Federal Register, pursuant to section 564(hXl)
of the Act.
Sincerely,
ifs!/
VerDate Sep<11>2014
18:37 Oct 04, 2023
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ddrumheller on DSK120RN23PROD with NOTICES1
Jeflrey E. Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
69198
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
u~s. FOOD:& DRUG
AOMIN!URAJJON
Ray Baridziulis,.Ph.D.
Ditectot ofRegulatory Affairs
LOC,.BiosearchTe¢lmologij;)!;
2905 Parameter Street
Midcileton, WI 53562
Re: Re-vocation ofEUA.210561
Dear Dt. Bandziulfa:
This letter is in response to the request from LGC, Biosearch Technologies, in an email received
May l; 2023, thattheUS. Food and Drug Administration (FDA) revoke the EUA for the
Biosearch Technologies SARS-CoV-2 ultfii>-high-throughput End~Point RT,PCR Test issued on
April 26, 2022. LGC; Biosearch Tecl:mologies indicated that they are no longer nlarketing the
authorized product and requ~edthatthe EUA be revoked, FDA understands that as of the date
of this.letter customers will discontinue use ofthe Biosearch·Technologies SARS-Co V-2ultra•
hlgh~throughput End-Point RT;;PCR Test reagents.
1:he authorization of a: device for emergency use under section 564.ofthe Federal FoO<l, Drug,
and Cosmetic Act (the Act)(21 us;c. 360bbb~3) may, pursuantto section 564(g)(2) of the Act,
be revoked when circumstances mak.e such revocation appropriate to protect the public health ot
s:a:fety (section564(gX2)(C) of the Act). Because LGC, Biosearch Technologies has requested
FDA revoke the EUA for Biosearch Technologies SARS-CoV.:.2 ultra.:.high-throughput EndPoint RT~.PCR Test, FDA has determined that it is appropriate to protect the public health or
safety to revoke this authorization. Accorciingly, FDA hereby revokes EUA210561 for the
Biosearch Technologies SAR.S~CoV-2 ultra-high-throughput End.Point RT--PCR T~ pursuant
to section 564(g)(2)(C)of theAct. As of the date ofthis letter, the Biosea:rch Technologi1:1s
SARS-CoV-2 ultra-high-throughput End-PointRT~PCR Test is no longer authorized for
emergency use by FDA
Notice of this revocation will be published in the Federal Register; pursuant to. sectron 564(h)(1)
oftheAct.
Sincerely.
!Isl!
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Jefiley E. Sharen. M.D.,. J.D.
Director
Center for Devices and Radiological Health
Food at),d Drug Administration
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
69199
■ Al)MJIIISTUTION
U.S. FOOD & DRUG
Jm1e 15, 2023
Amanda Ker,
Regulatory Speciallst
Becton. Dickinson and Co.
7 Loveton Circle
Sparks, MD 21152
Re: Revocationof]):UA210417
Dear Amanda Ker:
'U1is letter is in response to the request.from Becton, Dickinson and Co («BD"), in an email
received May 30, 2023, tha:t the U.S. Food and Drug Administration (FDA) withdraw the EU A
for the BD Veritor At-Home COVID· 19 Test issued on AugU$t 24, 2021, reissued on November
22, 2021 and revised on August 4, 2022, November 1, 2022 and February 21, 2023 .. BD
indicated that they discontinued the sale. the authorized product and requested that the EUA be
withdrawn. FDA understands that as of the date ofthis letter there are no viable.BD Veritor AtHome COVID-19 Test reagents re1naining in distribution in the United States.
'The authorization of a device for emergency use under section 564 of the Federal .Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb·3) may, pursuant fo section 564(g)(2) of the Act,
be revoked when circumstances make si.1ch revocation appropriate to protect the public health or
safety (section 564(g)(2)(C) of the Act). Becau$e Bb has requested. FDA withdraw the EUA for
the BD Veritor At-Home COVID-1.9 Test, FDA has d.etermined that it is appropriate t(Yprotect
the public health or safety to revoke this authorization. Accordingly, FDAhereby revokes
EUA210417 for the BD Veritor At-Home COVlD• 19 Test, pursuant to section. 564(g)(2)(C) of
the Act. As of the date of this Jetter, the BD Veritor At-Home COVID-19 Test is no longer
authorized for emergency use by FDA.
Notice ofthi$ revocation will be published in the FederalRegister, pursuant to section 564(h)(l)
oftheAct.
Sincerely,
VerDate Sep<11>2014
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Jeffrey E. Sbti.ten, ttD,, J.D.
Director
Center for Devices and .Radiological Health
Food and Drug Administration
69200
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
U.S. FOOD & DRUG
ADMIMl$TU,TIOl4
June 21, 2023
Aarthi Srinivasan
Regulatory Affairs
Verily Life Sciences
269 E Grand Ave.
South Sa,n Francisco, CA 94080
Re: Revocation ofEUA.202054
Dear Aarthi Srinivasan:
This letter is in response to the request from Verily Life Sciences, it1 an email received June 13,
2023, that the U.S. Food and Drug Admil1istration (FDA)withdraw the EUA for the Verily
COVID-19 RT-PCR Test issued on September 8, 2020,reissued ml December 18, 2020, March
30, 2021, and November 8, 2021, and revised on September 23,.2021 and November 15, 2022.
Verily Life Sciences indicated that they are no longer distributing the Verily COVID-19 Nasal
Swab Kits (authorized as part of the Verily COVID-19 RT-PCR Test) or offering testil1g services
at the Vet'ily Life Scierices laboratory usitlgthe Verily COVID-19 RT-PCR Test andteqttested
that the EUA be withdrawn.
The authorization of a device for e111erge11cy use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursua11tto section 564(g)(2) of the Act,
be revoked when circitmstances make such revocation appropriate to protect the public health or
safety (section 564(g)(2)(C) of the Act). Because Verily Life Sciences has requested FDA
withdraw the EUAforthe Verily COVID-19 RT-PCR Test, FDA has detemiined that it is
appropriate to ptotect the public· health or safety to revoke this authorization. Accordingly, FDA
hereby revokes EUA202054 fotthe Verily COVID-19 RT-PCR Test, pursuant to section
564(g)(2)(C) of the Act. As of the date of this letter, the Verily COVID-19 RT-PCR Test is no
longer authorized for emergency use by FDA.
Notice of this i-evocation will be published in the Federal Register, pursuant to section 564(hX1)
ofthe Act.
Sirtcerely,
VerDate Sep<11>2014
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Jeffrey E. Shuren, M.D., J.D.
Director
Center for Devices at:td Radiological Health
Food and Drug Admmistration
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
69201
U.S. FOOD & DRUG
Ab MINISTRATION
July 3, 2023
Charles Kolifrath
Associate Director, Regulatory Affairs, Oe11omics Platform
Clinical Research Sequencing Platfonn (CRSP), LLC at the Broad Institute of MIT and Harvard
320 Charles Street
Cambridge, MA 02141
Re: Revocation ofEUA210089
Dear Charles Kolifrath:
This letter is in response to the requestfrom Clinical Research Sequencing Platform (CRSP),
LLC at the Broad Institute of MIT and Harvard, in an email received June 14, 2023, that the U.S.
Food and Drug Administration (FDA) revoke the EUA for the CRSP SARS-CoV-2 Real-time
Reverse. Transcriptase (RT}-PCR Diagnostic Assay (Version 3) issued on March 5, 2021,
reissued on May 13, 2021, and June 3, 2022, and revised on September 23, 2021. In addition, on
June 15, 2021, FDA included the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)PCR Diagnostic Assay (Version 3) under Exhibit l of the April 20, 2021, pooling and serial
testing amendment. Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute
of MIT and Harvard indicated that as of the date of this letter they are no longer distributing the
CRSP Self-swab Kits (authorized as part of the CRSP SARS-CoV-2 Real-time Reverse
Transcriptase (RT)-PCR Diagnostic Assay (Version 3)) or offering testing services al the
Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard
laboratory using the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic
Assay (Version 3) and.requested voluntary revocation ofthe EUA.
The authorization of a device for emergency use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,
be revoked when circumstances make such revocation appropriate to protect the public health or
safety (section 564(g)(2)(C) of the Act), Because Clinical Research Sequencing Platform
(CRSP), LLC at the Broad Institute of.MIT and Harvard has requested voluntary revocation of
the EUA for the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic
Assay (Version 3), FDA has determined that it is appropriate to protect the public health or
safety to revoke this authorization. Accordingly, .FDA hereby revokes EUA210089 for the CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3),
pursuant to section 564(g)(2)(C) of the Act. As of the date of this letter, the CRSP SARS-CoV•2
Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) is no longer
authorized for emergency use by FDA.
Page 2 ...., Charles Kolitrath,. Clini()S} .Ilesearch SeqttencingPlatfonn (CRSP). LLC attrn? Broad
~itµte of MIT an~ Harvard
Notice ofthis revocation win be published in the FederatRegister; pursuant to.section 564(h)(l)
ofthe Act.
Sincerely,
Director
Center for Devices and Radiological Health
Food and Dtug Administration
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JeffreyE. Slmren, M.D,; J.D.
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!ls/I
69202
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
August 3, 2023
Iman Sadr.eddin
Co-Founder, COO
Xtrava Health
3080 Olcott Street, Suite C20l
Santa Clara, CA 95054
Re: Revotation of.EUA210544
Dear Mr. tman Sadreddin:
This letter is in response to the request from Xtrava Health, in an email received July 18, 2023,
that the U.S. Food and Drug Administration (FDA) withdraw the BUA for the SPERA COVID•
19 Ag Test issued on October 12, 2021, revised on November I, 2022, and reissued May 22,
2023. FDA understands that as of the date of this letter there are no SPERA COVID-19 Ag Test
reagents in distribution in the United States,
The authorization of a device for emergency use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,
be revoked. when circumstances make such revocation appropriate to protect the public health or
safety (si':lction 564(g)(2)(C) of the Act) . Because Xtrava Health has requested that FDA
withdraw the EU A for the SPERA COVID-19 Ag Test, FDA has determined that it is
appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA
hereby revokes BUA2.I0:544 for the SPERA COVID-19 Ag Test, pursuant to section
564(g)(2)(C) of the Act. As ofthe date of this letter, the SPERA COVlD-19 Ag Test is.no longer
authorized for emergency use by FDA.
Notice of this revocation will be p'ublished in the Federal RegLster, pursuant to section 564(h)(l)
oftheAct.
Sincerely,
!Isl/
VerDate Sep<11>2014
18:37 Oct 04, 2023
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ddrumheller on DSK120RN23PROD with NOTICES1
Jeffrey E. Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
69203
■ U.S. FOOD & DRUG
AOMINISTIIATION
August 18, 2023
lb;iago Braga
Sr, Regulatory Affairs Specialist
Exact Sciences Laboratories
650 Forward Drive
Madison, WI 53711
Re: Revocation ofEUA203022
.Dear Tiiiago Braga;
This letter is in response to the request from Exact Sciences Laboratories, in a letter received via
email AtJgust 1, 2023, that the U.S. Food aitd Drug Administration (FDA) withdraw the EUA for
the COVID-Flu Multiplex Assay issued on July 1, 2021, and revised on Septe:mber 23, 2021,
February 14, 2022, and August 2, 2022. Exact Sciences Laboratories indicated thatthey have
discontinued use of the COVID-Flu Multiplex Assay at Exact Sciences Laboratories) located at
650 Forward Drive, Madison, WI 53711, and requested tbat the EUA be withdrawn,
The authorizati()n of a device for emergency use uitder section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U:S.C. 360bbb-3) may,.pursµant to section 564(g)(2) of the Act,
be revoked when circumstances make such revocation appropriate to protect the public health or
safety (section 564(g)(2)(C) of the Act). Because Exact Sciences Laborat()ries has requested
FDA withdraw the EUA for the COVID~Flu Multiplex Assay, FDA has determined that it.is
appropriate to protect the public health or safety to {'.evoke this authorization. Accordingly, FDA
hereby revokes EUA203022 for the COVIl)~Flu Mul!.iplex Assay,.pursuant to section
564(g)(2)(C) oftbe Act. As of the date of this letter, the COVIO•,Flil Multiplex Assay is 1:io
longer authod.zed fot emerge11cy use byFDA
Notice of this revocation will be published in the Federal Register, pursuantto section 564(11)(1)
of the Act.
Sincerely,
VerDate Sep<11>2014
18:37 Oct 04, 2023
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Ellen J. Flanner:y; J.D.
Deputy Center Director for Policy
Director, Office of Policy
Ce11tei: for Devices and Radiological Health
Food andDrugAdministration
69204
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
U.S. FOOD & DR.UG
AOMHmmv,m::iN
Ailgust 18, 2023
'Thiago Braga
Sr. Regulatory A:ftairs Specialist
Exact Sciences Laboratories
650 Forward Drive
Madison, WI 53711
Re: Revocation ofEUA200367
Dear Thiago Braga:
111is .letter is in response to the request from Exact S.ciences uiboratories, in a letter received via
email August 1,. 2023, that the U.S. Food and Drug Administration (FDA) withdraw the EUA for
the SARS-CoV-2 (N gene detection) Test that was originally authorized under the March 31,
2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests
for Detection of Nucleic Acid from SARS-CoV-2 (High Complexity LDT Umb.rella EUA) on
May 22, 2020, and then issued an individual EUA on August 3, 2020, that was revised on
August 28, 2020, and September 23, 2021. Exact Sciences Laboratories indicated that they have
discontinued use of the SARS-Co V-2 (N gene detection) Test at Exact Sciences Laboratories,
located at 650 .Foi:ward Drive, Madison, WI 53711 and 145 E. Badger Road Ste. 100, Madison,
WI 53713, and requested that the EUA be withdrawn.
The authorization ofa device for emergency use under section 564 of the FederaLFood, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,
be revoked whe11circumstances make such revoc.ation appropriate to protect the public health or
safety (section 564(g)(2)© ofthe Act). Because Exact Sciences .Laboratories has requested FDA
withdr.aw the EUA for the SARS•CoV-2 (N gene detection) Test, FDA has detennined that it is
appropriate to protect the public health. or safety to revoke this authorization. Accordingly, FDA
hereby revokes rmA200367 for th.e SARS-Co V-2 (N gene detection) Test, pursuant to section.
564(g)(2)(C) ofthe Act. As of the date of this letter, the SARS-CoV-2 (N gene detection) Test is
110 longer authorized foremergency use by FDA.
Notice of this revocatio.n will be published in the Federal. Register, pursuant to section 564(h)(l)
of the Act.
•
Sincerely,
Ifs/!
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Elle11 J. Flannery, J.D.
Deputy Center Director for Policy
Director, Office ofPolicy
Center for Devices and Radiological Health
Food aa1d Drug Administration
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices
69205
U.S. FOOD & DRUG
llt'IMINISTRAT!ON
August 23, 2023
Beth Kraemer, RPh
Director of Quality, Regulato1y & Technical Compliance
dba SpectronR,x
9550 Zionsville Rd Suite 1
Indianapolis, IN 46268
Re: Revocation ofEUA200415
Dear Beth Kraemer:
This letter is in response to the request from dha SpectronRx, received via email on March 24,
2023, that the U.S. Food and Drng Administration (FDA) revoke the EUA for the Hymon SARSCo V-2 Test Kit issued on May 22, 2020, and amended on August 11, 2020. dba SpectronRx
indicated that they are discontinuing the distribution of the Hymon SARS-Co V-2 Test Kit and
requested that the EUA be revoked. FDA understands that as of the date of this letter there will
no longer be any viable Hymon SARS-CoV-2 Test Kit reagents remaining in distribution in the
United States.
The authorization of a device for emergency use under section 564 of the Federal Food, Drug,
and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act,
be revoked when circumstances make such revocation appropriate to protect the public health or
safety (section 564(gX2XC) of the Act). Because dba SpcctronRx has requested that FDA
tenninate the EUA for the Hymon SARS-CoV-2 Test Kit, FDA has determined that it is
appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA
hereby revokes EUA200415 for the Hymon SARS-CoV-2 Test Kit, pursuant to section
564(gX2)(C) of the Act. As of the date of this Jetter, the Hymon SARS-CoV-2 Test Kit is no
longer authorized for emergency use by FDA.
Notice of this revocation will be published in the Federal Register, pursuant to section 564(h)(l)
ofthe Act.
Sincerely,
llslf
Jeffrey E. Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
[FR Doc. 2023–22188 Filed 10–4–23; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
BILLING CODE 4164–01–C
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2023–D–1848]
Stimulant Use Disorders: Developing
Drugs for Treatment; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Sep<11>2014
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The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Stimulant Use Disorders: Developing
Drugs for Treatment.’’ The purpose of
this draft guidance is to assist sponsors
in the clinical development of drugs for
the treatment of stimulant use disorders.
Specifically, this guidance addresses
FDA’s current recommendations
regarding the overall development
program and clinical trial designs for
the development of drugs to support
indications of treatment of moderate to
SUMMARY:
E:\FR\FM\05OCN1.SGM
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Dated: October 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Pages 69192-69205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22188]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4182]
Revocation of Eleven Authorizations of Emergency Use of In Vitro
Diagnostic Device 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 Luminostics, Inc., for the Clip COVID Rapid
Antigen Test; NeuMoDx Molecular, Inc., a QIAGEN Company, for the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay; LGC, Biosearch
Technologies for the SARS-CoV-2 Real-Time and End-Point RT-PCR Test;
LGC, Biosearch Technologies, for the Biosearch Technologies SARS-CoV-2
ultra-high-throughput End-Point RT-PCR Test; Becton, Dickinson and Co.
for the BD Veritor At-Home COVID-19 Test; Verily Life Sciences for the
Verily COVID-19 RT-PCR Test; Clinical Research Sequencing Platform
(CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Version 3); Xtrava Health for the SPERA COVID-19 Ag Test; Exact
Sciences Laboratories for the COVID-Flu Multiplex Assay; Exact Sciences
Laboratories for the SARS-CoV-2 (N gene detection) Test; and dba
SpectronRx for the Hymon SARS-CoV-2 Test Kit. FDA revoked these
Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) as requested by the Authorization holders. The revocations, which
include an explanation of the reasons for each revocation, are
reprinted in this document.
DATES: The Authorization for the Luminostics, Inc.'s, Clip COVID Rapid
Antigen Test is revoked as of May 5, 2023. The Authorization for the
NeuMoDx Molecular, Inc., a QIAGEN Company, for the NeuMoDx Flu A-B/RSV/
SARS-CoV-2 Vantage Assay is revoked as of May 24, 2023. The
Authorization for the LGC, Biosearch Technologies for the SARS-CoV-2
Real-
[[Page 69193]]
Time and End-Point RT-PCR Test is revoked as of June 1, 2023. The
Authorization for the LGC, Biosearch Technologies, for the Biosearch
Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test is
revoked as of June 1, 2023. The Authorization for the Becton, Dickinson
and Co.'s BD Veritor At-Home COVID-19 Test is revoked as of June 15,
2023. The Authorization for the Verily Life Sciences' Verily COVID-19
RT-PCR Test is revoked as of June 21, 2023. The Authorization for the
Clinical Research Sequencing Platform (CRSP), LLC at the Broad
Institute of MIT and Harvard for the CRSP SARS-CoV-2 Real-time Reverse
Transcriptase (RT)-PCR Diagnostic Assay (Version 3) is revoked as of
July 3, 2023. The Authorization for the Xtrava Health's SPERA COVID-19
Ag Test is revoked as of August 3, 2023. The Authorization for the
Exact Sciences Laboratories' COVID-Flu Multiplex Assay is revoked as of
August 18, 2023. The Authorization for the Exact Sciences Laboratories'
SARS-CoV-2 (N gene detection) Test is revoked as of August 18, 2023.
The Authorization for the dba SpectronRx's Hymon SARS-CoV-2 Test Kit is
revoked as of August 23, 2023.
ADDRESSES: Submit a written request for a single copy of the
revocations to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, 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: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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, radiological, or nuclear agent or 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 December 7, 2020,
FDA issued the Authorization to Luminostics, Inc., for the for the Clip
COVID Rapid Antigen Test, 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 March 25, 2021, FDA issued the
Authorization to NeuMoDx Molecular, Inc., a QIAGEN Company, for the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, subject to the terms of
the Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on July 23, 2021 (86 FR 39040), as
required by section 564(h)(1) of the FD&C Act. On April 15, 2021, FDA
issued the Authorization to LGC, Biosearch Technologies for the SARS-
CoV-2 Real-Time and End-Point RT-PCR Test. Notice of the issuance of
this Authorization was published in the Federal Register on July 23,
2021 (86 FR 39040), subject to the terms of the Authorization. On
August 24, 2021, FDA issued the Authorization to Becton, Dickinson and
Co. for the BD Veritor At-Home COVID-19 Test, subject to the terms of
the Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on October 28, 2021 (86 FR 59740), as
required by section 564(h)(1) of the FD&C Act. On April 26, 2022, FDA
issued the Authorization to LGC, Biosearch Technologies, for the
Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-
PCR Test, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
July 22, 2022 (87 FR 43877), as required by section 564(h)(1) of the
FD&C Act. On September 8, 2020, FDA issued the Authorization to Verily
Life Sciences for the Verily COVID-19 RT-PCR Test, 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 March 5, 2021, FDA
issued the Authorization to Clinical Research Sequencing Platform
(CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Version 3), subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
July 23, 2021 (86 FR 39040), as required by section 564(h)(1) of the
FD&C Act. On October 12, 2021, FDA issued the Authorization to Xtrava
Health for the SPERA COVID-19 Ag Test, subject to the terms of the
Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on March 22, 2022 (87 FR 16198), as
required by section 564(h)(1) of the FD&C Act. On July 1, 2021, FDA
issued the Authorization to Exact Sciences Laboratories for the COVID-
Flu Multiplex Assay, subject to the terms of the Authorization. Notice
of the issuance of this Authorization was published in the Federal
Register on October 28, 2021 (86 FR 59740), as required by section
564(h)(1) of the FD&C Act. On March 31, 2020, FDA issued the
Authorization to Exact Sciences Laboratories for the SARS-CoV-2 (N gene
detection) Test, 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 May 22, 2020, FDA issued the
Authorization to dba SpectronRx for the Hymon SARS-CoV-2 Test 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.
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. Authorization Revocation Requests
In a request received by FDA on May 2, 2023, Luminostics, Inc.
requested the withdrawal of, and on May 5, 2023, FDA revoked, the
Authorization for the Luminostics, Inc.'s Clip COVID Rapid Antigen
Test. Because Luminostics, Inc. notified FDA that there are no viable
Clip COVID Rapid Antigen Test reagents remaining in distribution in the
United States and requested FDA withdraw the Luminostics, Inc.'s Clip
COVID Rapid Antigen Test, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization.
In a request received by FDA on May 11, 2023, NeuMoDx Molecular,
Inc., a QIAGEN Company requested revocation
[[Page 69194]]
of, and on May 24, 2023, FDA revoked, the Authorization for the NeuMoDx
Molecular, Inc., a QIAGEN Company's, NeuMoDx Flu A-B/RSV/SARS-CoV-2
Vantage Assay. Because NeuMoDx Molecular, Inc., a QIAGEN Company,
notified FDA that it has decided to discontinue distribution of the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay in the United States and
requested FDA voluntary revocation of the EUA for the NeuMoDx Flu A-B/
RSV/SARS-CoV-2 Vantage Assay, FDA has determined that it is appropriate
to protect the public health or safety to revoke this Authorization.
In a request received by FDA on May 1, 2023, LGC, Biosearch
Technologies requested revocation of, and on June 1, 2023, FDA revoked,
the Authorization for the LGC Biosearch Technologies' SARS-CoV-2 Real-
Time and End-Point RT-PCR Test. Because LGC, Biosearch Technologies
notified FDA that it is no longer marketing the SARS-CoV-2 Real-Time
and End-Point RT-PCR Test and requested FDA revoke the EUA for the LGC
Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test,
FDA has determined that it is appropriate to protect the public health
or safety to revoke this Authorization.
In a request received by FDA on May 1, 2023, LGC, Biosearch
Technologies requested revocation of, and on June 1, 2023, FDA revoked,
the Authorization for the LGC Biosearch Technologies' SARS-CoV-2 ultra-
high-throughput End-Point RT-PCR Test. Because LGC, Biosearch
Technologies notified FDA that it is no longer marketing the SARS-CoV-2
ultra-high-throughput End-Point RT-PCR Test and requested FDA revoke
the EUA for the LGC Biosearch Technologies SARS-CoV-2 ultra-high-
throughput End-Point RT-PCR Test, FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization.
In a request received by FDA on May 30, 2023, Becton, Dickinson and
Co. requested withdrawal of, and on June 15, 2023, FDA revoked, the
Authorization for the Becton, Dickinson and Co.'s BD Veritor At-Home
COVID-19 Test. Because Becton, Dickinson and Co. notified FDA that it
has discontinued the sale of BD Veritor At-Home COVID-19 Test and
requested FDA withdraw the EUA for the Becton, Dickinson and Co.'s BD
Veritor At-Home COVID-19 Test, FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization.
In a request received by FDA on June 13, 2023, Verily Life Sciences
requested withdrawal of, and on June 21, 2023, FDA revoked, the
Authorization for the Verily Life Sciences' Verily COVID-19 RT-PCR
Test. Because Verily Life Sciences notified FDA that it is no longer
distributing the Verily COVID-19 Nasal Swab Kits (authorized as part of
the Verily COVID-19 RT-PCR Test) or offering testing services at the
Verily Life Sciences' laboratory using the Verily COVID-19 RT-PCR Test
and requested FDA withdraw the EUA for the Verily Life Sciences' Verily
COVID-19 RT-PCR Test, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization.
In a request received by FDA on June 14, 2023, Clinical Research
Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and
Harvard, requested voluntary revocation of, and on July 3, 2023, FDA
revoked, the Authorization for the CRSP, LLC at the Broad Institute of
MIT and Harvard's CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-
PCR Diagnostic Assay (Version 3). Because CRSP, LLC at the Broad
Institute of MIT and Harvard notified FDA that it is no longer
distributing the CRSP Self-swab Kits (authorized as part of the CRSP
SARS-CoV-2 Real-time RT-PCR Diagnostic Assay (Version 3)) or offering
testing services at the CRSP, LLC at the Broad Institute of MIT and
Harvard laboratory using the CRSP SARS-CoV-2 Real-time RT-PCR
Diagnostic Assay (Version 3), and requested FDA revoke the EUA for the
CRSP, LLC at the Broad Institute of MIT and Harvard's CRSP SARS-CoV-2
Real-time RT-PCR Diagnostic Assay (Version 3), FDA has determined that
it is appropriate to protect the public health or safety to revoke this
Authorization.
In a request received by FDA on July 18, 2023, Xtrava Health
requested the withdrawal of, and on August 3, 2023, FDA revoked, the
Authorization for the Xtrava Health's SPERA COVID-19 Ag Test. Because
Xtrava Health notified FDA that there are no SPERA COVID-19 Ag Test
reagents in distribution in the United States and requested FDA
withdraw the Xtrava Health's, SPERA COVID-19 Ag Test, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization.
In a request received by FDA on August 1, 2023, Exact Sciences
Laboratories requested the withdrawal of, and on August 18, 2023, FDA
revoked, the Authorization for the Exact Sciences Laboratories' COVID-
Flu Multiplex Assay. Because Exact Sciences Laboratories notified FDA
that they have discontinued use of the COVID-Flu Multiplex Assay at
Exact Sciences Laboratories and requested FDA withdraw the Exact
Sciences Laboratories' COVID-Flu Multiplex Assay, FDA has determined
that it is appropriate to protect the public health or safety to revoke
this Authorization.
In a request received by FDA on August 1, 2023, Exact Sciences
Laboratories requested the withdrawal of, and on August 18, 2023, FDA
revoked, the Authorization for the Exact Sciences Laboratories' SARS-
CoV-2 (N gene detection) Test. Because Exact Sciences Laboratories
notified FDA that they have discontinued use of the SARS-CoV-2 (N gene
detection) Test at Exact Sciences Laboratories and requested FDA
withdraw the Exact Sciences Laboratories' SARS-CoV-2 (N gene detection)
Test, FDA has determined that it is appropriate to protect the public
health or safety to revoke this Authorization.
In a request received by FDA on March 24, 2023, dba SpectronRx
requested the withdrawal of, and on August 23, 2023, FDA revoked, the
Authorization for the dba SpectronRx's Hymon SARS-CoV-2 Test Kit.
Because dba SpectronRx notified FDA that they are discontinuing the
distribution of the Hymon SARS-CoV-2 Test Kit and requested FDA
withdraw the dba SpectronRx for the Hymon SARS-CoV-2 Test 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
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 Luminostics, Inc.'s, Clip COVID Rapid Antigen
Test, NeuMoDx Molecular, Inc., a QIAGEN Company's, NeuMoDx Flu A-B/RSV/
SARS-CoV-2 Vantage Assay, LGC Biosearch Technologies' SARS-CoV-2 Real-
Time and End-Point RT-PCR Test, LGC Biosearch Technologies' SARS-CoV-2
ultra-high-throughput End-Point RT-PCR Test, Becton, Dickinson and
Co.'s BD Veritor At-Home COVID-19 Test, Verily Life Sciences' Verily
COVID-19 RT-PCR Test, Clinical Research Sequencing Platform (CRSP), LLC
at the Broad Institute of MIT and Harvard's CRSP SARS-CoV-2 Real-time
Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3), Xtrava
Health's SPERA COVID-19 Ag Test, Exact Sciences Laboratories' COVID-Flu
Multiplex Assay, Exact Sciences
[[Page 69195]]
Laboratories' SARS-CoV-2 (N gene detection) Test, and dba SpectronRx's
Hymon SARS-CoV-2 Test Kit. These 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
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Dated: October 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22188 Filed 10-4-23; 8:45 am]
BILLING CODE 4164-01-C
