Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability, 8205-8208 [2024-02356]
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Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0008]
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting—FSYX Ocular
Pressure Adjusting Pump System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency)
announces a forthcoming public
advisory committee meeting of the
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public.
DATES: The meeting will take place
virtually on March 21, 2024, from 9 a.m.
to 6 p.m. Eastern Time.
ADDRESSES: All meeting participants
will be heard, viewed, captioned, and
recorded for this advisory committee
meeting via an online teleconferencing
and/or video conferencing platform.
Answers to commonly asked questions
about FDA advisory committee
meetings, including information
regarding special accommodations due
to a disability may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
Akinola Awojope, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring,
MD 20993–0002, Akinola.Awojope@
fda.hhs.gov, 301–636–0512, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last-minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before the meeting.
SUPPLEMENTARY INFORMATION:
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Agenda: The meeting presentations
will be heard, viewed, captioned, and
recorded through an online
teleconferencing platform. On March 21,
2024, the committee will discuss and
make recommendations on information
related to the De Novo request by
Balance Ophthalmics, Inc. for the safety
and effectiveness of the FSYX Ocular
Pressure Adjusting Pump (FSYX OPAP)
System. The FSYX OPAP System is
indicated as adjunctive therapy for the
reduction of intraocular pressure (IOP)
during use in adult patients with openangle glaucoma and IOP ≤21 mmHg.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available on FDA’s
website at the time of the advisory
committee meeting, and the background
material will be posted on FDA’s
website after the meeting. Background
material and the link to the online
teleconference meeting room will be
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down and select the
appropriate advisory committee meeting
link. The meeting will include slide
presentations with audio components to
allow the presentation of materials in a
manner that most closely resembles an
in-person advisory committee meeting.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before March 5, 2024. Oral
presentations from the public will be
scheduled on March 21, 2024, between
approximately 1 p.m. and 2 p.m. Eastern
Time. Those individuals interested in
making formal oral presentations should
notify the contact person (see FOR
FURTHER INFORMATION CONTACT). The
notification should include a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 26, 2024. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
February 27, 2024.
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8205
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact AnnMarie
Williams at Annmarie.Williams@
fda.hhs.gov or 240–507–6496 at least 7
days in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.). This meeting notice
also serves as notice that, pursuant to 21
CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the
location of advisory committee meetings
are hereby waived to allow for this
meeting to take place using an online
meeting platform. This waiver is in the
interest of allowing greater transparency
and opportunities for public
participation, in addition to
convenience for advisory committee
members, speakers, and guest speakers.
The conditions for issuance of a waiver
under 21 CFR 10.19 are met.
Dated: February 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–02361 Filed 2–5–24; 8:45 am]
BILLING CODE 4164–01–P
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
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
Authorization (EUAs) (the
Authorizations) issued to Southern
California Permanente Medical Group,
for the Kaiser Permanente High
Throughput SARS–CoV–2 Assay, that
SUMMARY:
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8206
Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices
includes the Kaiser Permanente Saliva
Home Collection Kit, and Drexel
University College of Medicine, for the
SARS–CoV–2 DUCoM–PDL Modified
Tetracore Assay. FDA revoked the
Authorizations under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) as
requested by the Authorization holder.
The revocations, which include an
explanation of the reasons for each
revocation, are reprinted at the end of
this document.
DATES: The revocation of the
Authorization for the Southern
California Permanente Medical Group’s
Kaiser Permanente High Throughput
SARS–CoV–2 Assay, that includes the
Kaiser Permanente Saliva Home
Collection Kit, is effective as of
September 29, 2023. The revocation of
the Authorization for the Drexel
University College of Medicine for the
SARS–CoV–2 DUCoM–PDL Modified
Tetracore Assay is effective as of
October 5, 2023.
ADDRESSES: Submit written requests 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:
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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
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18:15 Feb 05, 2024
Jkt 262001
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 April 19, 2021, FDA issued the
Authorization to Southern California
Permanente Medical Group, for the
Kaiser Permanente High Throughput
SARS–CoV–2 Assay, that includes the
Kaiser Permanente Saliva Home
Collection Kit, 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 28, 2023, FDA issued the
Authorization to Drexel University
College of Medicine, for the SARS–
CoV–2 DUCoM–PDL Modified Tetracore
Assay, subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on January 25, 2024
(89 FR 4952), 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. Authorizations Revocation Requests
In a request received by FDA on May
11, 2023, Southern California
Permanente Medical Group requested
the withdrawal of, and on September
29, 2023, FDA revoked, the
Authorization for the Southern
California Permanente Medical Group’s
Kaiser Permanente High Throughput
SARS–CoV–2 Assay, that includes the
Kaiser Permanente Saliva Home
Collection Kit. Because Southern
California Permanente Medical Group
notified FDA that they have stopped
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distributing the Kaiser Permanente
Saliva Home Collection Kit at the end of
May 2023 and have also stopped
receiving and processing the kits and
requested FDA withdraw the Southern
California Permanente Medical Group’s
Kaiser Permanente High Throughput
SARS–CoV–2 Assay, that includes the
Kaiser Permanente Saliva Home
Collection Kit, 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
September 29, 2023, Drexel University
College of Medicine requested the
withdrawal of, and on October 5, 2023,
FDA revoked, the Authorization for the
Drexel University College of Medicine’s
SARS–CoV–2 DUCoM–PDL Modified
Tetracore Assay. Because Drexel
University College of Medicine notified
FDA that they have discontinued the
use of SARS–CoV–2 DUCoM–PDL
Modified Tetracore Assay at Drexel
University, Drexel Medicine Diagnostics
and requested FDA withdraw the Drexel
University College of Medicine’s SARS–
CoV–2 DUCoM–PDL Modified Tetracore
Assay, FDA has determined that it is
appropriate to protect the public health
or safety to revoke this Authorization.
III. Electronic Access
An electronic version of this
document and the full text of the
revocations are available on the internet
at https://www.regulations.gov/.
IV. The Revocations
Having concluded that the criteria for
revocation of the Authorizations under
section 564(g)(2)(C) of the FD&C Act are
met, FDA has revoked the EUA of
Southern California Permanente
Medical Group’s Kaiser Permanente
High Throughput SARS–CoV–2 Assay,
that includes the Kaiser Permanente
Saliva Home Collection Kit, and Drexel
University College of Medicine’s SARS–
CoV–2 DUCoM–PDL Modified Tetracore
Assay. The revocation in its entirety
follows and provide an explanation of
the reasons for revocation, as required
by section 564(h)(1) of the FD&C Act.
BILLING CODE 4161–01–P
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Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices
8207
U.S. FOOD & DRUG
APM!NISTIIAT!ON
September 29, 2023
Kenneth Van Hom, PhD, D(ABMM)
Technical Director, Microbiology
Southern California Permanente Medical Group
Regional Reference Laboratories, Chino Hills
13000 Peyton Drive
Chino Hills, CA 91709
Re: Revocation ofEUA203058
Dear Dr. Van Hom:
This letter is in response to the request from Southern California Permanente Medical Group, in
a letter received May 11, 2023, that the U.S. Food and Drug Administration (FDA) tenninate the
EUA for the Kaiser Pennanente High Throughput SARS-CoV-2 Assay, that includes the Kaiser
Petmanente Saliva Home Collection Kit, issued on April 19, 2021 and subsequently re-issued on
September 21, 2021. Southem Califomia Pennanente Medical Group indicated that they have
stopped distributing the Kaiser Pennanente Saliva Home Collection Kit at the end of May 2023
and have also stopped receiving and processing the kits as of the date of this letter, and requested
that the EUA be terminated.
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 tl1e public health or
safety (section 564(g)(2)(C) of the Act). Because Southern Califomia Permanente Medical
Group bas requested that FDA tern1inate the EUA for the Kaiser Pennanente High Tirroughput
SARS-CoV-2 Assay, FDA has detennined that it is appropriate to protect tl1e public health or
safety to revoke this authorization. Accordingly, FDA hereby revokes EUA203058 for the Kaiser
Permanente High Throughput SARS-CoV-2 Assay, pursuant to section 564(g)(2)(C) of the Act.
As of the date of this letter, the Kaiser Penuanente High Throughput SARS-CoV-2 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(h)(l)
ofthe Act
Sincerely,
!Isl!
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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
8208
Federal Register / Vol. 89, No. 25 / Tuesday, February 6, 2024 / Notices
-·■ U.S. FOOD & DRUG
. ADMIN1$TllATIOI\I
October 5, 2023
Donald C. Hall, Jr. Ph.D.
Director of Operations
Drexel Medicine -Diagnostics
College of Medicine, Drexel tJnhrersity
245 N. 15th Street, Room 510&
Philadelphia; PA 19102
Re: Revocation ofEUA220099
Dear Dr. Hall:
This letter is in response to the request frori1 Drexel University College of Medicine, in 1:111 email
receive_d September 29, 2023, that the U.S. Food and Drug Administration (FDA) withdraw the
EUA for the- SARS~CoV-2 DUCoM-PDL Modified Tetracore Assay,. issued on April 19, 2021.
Drexel University College of Medicine indicated that they have discontinued use of the SARSCoV-2 DUCoM•PDL Modified Tetracore Assay at Drexel University, DrexelMedicine
Diagnostics.located at 245 N. 15th Street, Room 5401, Philadelphia, PA 19102.
The authorization ofa device for emergency use under section 564ofthe Federal Food, Drug,
and Cos111etic Act (the Act) (21 U.S.C. 360bbb~3) may, pursua11t to section 564(g)(2) of the Act,
be revoked when circumstances make such revocation. appropriate to protect the public health or
safety (section 564(g)(2)(C) ofthe Act), Because Drexel University College ofMedicine has.
requested that FDA withdraw the EUA for the SARS•CoV-2 DUCoM-PDL Modified Tetracore
Assay; FDA has determined that it is appropriate to protect the public health or safety to revoke
this authorization. Accordingly, FDA hereby revokes EUA220099 for the SARS-Co\M
DUCoM-PDL M<xiified TetraCQte Assay, pursuant to section 564(g)(2)(G) of the Act; As of the
date of this letter, the SARS•CoV-2DlJCoM•PDL Modified Tetracore Assay is no longer
authorized for emergency use by FDA.
N◊tice of this. revocation will be published in the Federal Register, pursuant to section 564(h)(l)
•
•
of the Act.
Sincerely,
I!$/!
Jeffrey E. Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
FoQd and Drug Administration
[FR Doc. 2024–02356 Filed 2–5–24; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE 4161–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2021–D–1031]
AGENCY:
Food and Drug Administration,
HHS.
18:15 Feb 05, 2024
Jkt 262001
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Reporting Amount of Listed Drugs and
Biological Products Under Section
510(j)(3) of the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry;
Availability.’’ This guidance addresses
the process through which registrants of
drug establishments should submit
reports to FDA on the amount of each
listed drug manufactured, prepared,
SUMMARY:
Food and Drug Administration
Reporting Amount of Listed Drugs and
Biological Products Under Section
510(j)(3) of the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry;
Availability
VerDate Sep<11>2014
ACTION:
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Date: February 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
]]>Agencies
[Federal Register Volume 89, Number 25 (Tuesday, February 6, 2024)]
[Notices]
[Pages 8205-8208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02356]
-----------------------------------------------------------------------
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 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 Authorization (EUAs) (the
Authorizations) issued to Southern California Permanente Medical Group,
for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that
[[Page 8206]]
includes the Kaiser Permanente Saliva Home Collection Kit, and Drexel
University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified
Tetracore Assay. FDA revoked the Authorizations under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization
holder. The revocations, which include an explanation of the reasons
for each revocation, are reprinted at the end of this document.
DATES: The revocation of the Authorization for the Southern California
Permanente Medical Group's Kaiser Permanente High Throughput SARS-CoV-2
Assay, that includes the Kaiser Permanente Saliva Home Collection Kit,
is effective as of September 29, 2023. The revocation of the
Authorization for the Drexel University College of Medicine for the
SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay is effective as of
October 5, 2023.
ADDRESSES: Submit written requests 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 April 19, 2021, FDA
issued the Authorization to Southern California Permanente Medical
Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that
includes the Kaiser Permanente Saliva Home Collection Kit, 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 28, 2023, FDA issued the Authorization to Drexel
University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified
Tetracore Assay, subject to the terms of the Authorization. Notice of
the issuance of this Authorization was published in the Federal
Register on January 25, 2024 (89 FR 4952), 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. Authorizations Revocation Requests
In a request received by FDA on May 11, 2023, Southern California
Permanente Medical Group requested the withdrawal of, and on September
29, 2023, FDA revoked, the Authorization for the Southern California
Permanente Medical Group's Kaiser Permanente High Throughput SARS-CoV-2
Assay, that includes the Kaiser Permanente Saliva Home Collection Kit.
Because Southern California Permanente Medical Group notified FDA that
they have stopped distributing the Kaiser Permanente Saliva Home
Collection Kit at the end of May 2023 and have also stopped receiving
and processing the kits and requested FDA withdraw the Southern
California Permanente Medical Group's Kaiser Permanente High Throughput
SARS-CoV-2 Assay, that includes the Kaiser Permanente Saliva Home
Collection Kit, 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 September 29, 2023, Drexel
University College of Medicine requested the withdrawal of, and on
October 5, 2023, FDA revoked, the Authorization for the Drexel
University College of Medicine's SARS-CoV-2 DUCoM-PDL Modified
Tetracore Assay. Because Drexel University College of Medicine notified
FDA that they have discontinued the use of SARS-CoV-2 DUCoM-PDL
Modified Tetracore Assay at Drexel University, Drexel Medicine
Diagnostics and requested FDA withdraw the Drexel University College of
Medicine's SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization.
III. Electronic Access
An electronic version of this document and the full text of the
revocations are available on the internet at https://www.regulations.gov/.
IV. The Revocations
Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA of Southern California Permanente Medical Group's
Kaiser Permanente High Throughput SARS-CoV-2 Assay, that includes the
Kaiser Permanente Saliva Home Collection Kit, and Drexel University
College of Medicine's SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay.
The revocation in its entirety follows and provide an explanation of
the reasons for revocation, as required by section 564(h)(1) of the
FD&C Act.
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[GRAPHIC] [TIFF OMITTED] TN06FE24.023
Date: February 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02356 Filed 2-5-24; 8:45 am]
BILLING CODE 4161-01-C
