Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 15412-15415 [2023-05053]
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15412
Federal Register / Vol. 88, No. 48 / Monday, March 13, 2023 / Notices
document instructs that Custom Device
Annual Reports should be written in
English and explains that respondents
should direct two copies, including at
least one hard copy, to:
Attn: Custom Device Annual Report
Submission Coordinator, Division of
Analysis and Program Operations,
Office of Compliance, Center for Devices
and Radiological Health, U.S. Food and
Drug Administration, Bldg. 66, Rm.
2622, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002.
Although the submission of Custom
Device Annual Reports are not required
electronically, we strongly encourage
submitting one of the two required
copies as an eCopy (i.e., a PDF file on
a CD, DVD, or flash drive). Technical
instructions are also provided in the
guidance document entitled ‘‘eCopy
Program for Medical Device
Submissions: Guidance for Industry and
Food and Drug Administration Staff’’
(April 2020); available for download at
https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
UCM313794.pdf for more information
about submitting an eCopy.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Annual reporting for custom devices under 520(b) of the
FD&C Act .........................................................................
34
1
34
40
1,360
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: March 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05051 Filed 3–10–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0973]
Revocation of Three Authorizations of
Emergency Use of In Vitro Diagnostic
Devices for Detection and/or Diagnosis
of COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorizations (EUAs) (the
Authorizations) issued to Abbott
Diagnostics Scarborough, Inc. (Abbott)
for the BinaxNOW COVID–19 Ag 2
Card, and Standard BioTools, Inc.
(Standard) for the Advanta Dx SARS–
CoV–2 RT–PCR Assay and Advanta Dx
COVID–19 EASE Assay. FDA revoked
these Authorizations under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). The revocations, which include an
explanation of the reasons for each
revocation, are reprinted in this
document.
DATES: The Authorization for the
BinaxNOW COVID–19 Ag 2 Card is
revoked as of January 31, 2023. The
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SUMMARY:
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19:32 Mar 10, 2023
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Authorizations for the Advanta Dx
SARS–CoV–2 RT–PCR Assay and
Advanta Dx COVID–19 EASE Assay are
revoked as of February 1, 2023.
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 Ross, Office of Counterterrorism
and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4332, Silver Spring,
MD 20993–0002, 301–796–8510 (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 March
31, 2021, FDA issued an EUA to Abbott
for the BinaxNOW COVID–19 Ag 2
Card, subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Federal Register on July 23, 2021 (86 FR
39040), as required by section 564(h)(1)
of the FD&C Act. On August 25, 2020,
FDA issued an EUA to Standard (then
known as Fluidigm Corp.) for the
Advanta Dx SARS–CoV–2 RT–PCR
Assay, subject to the terms of the
Authorization. Notice of the issuance of
this Authorization was published in the
Federal Register on November 20, 2020
(85 FR 74346), as required by section
564(h)(1) of the FD&C Act. On February
7, 2022, FDA issued an EUA to Standard
(then known as Fluidigm Corp.) for the
Advanta Dx COVID–19 EASE Assay,
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. Subsequent revisions
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 January 20, 2023, FDA received a
request from Abbott for the revocation
of, and on January 31, 2023, FDA
revoked, the Authorization for the
BinaxNOW COVID–19 Ag 2 Card.
Because Abbott requested FDA revoke
the EUA for the BinaxNOW COVID–19
Ag 2 Card, FDA has determined that it
is appropriate to protect the public
health or safety to revoke this
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Federal Register / Vol. 88, No. 48 / Monday, March 13, 2023 / Notices
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Jkt 259001
appropriate to protect the public health
or safety to revoke these Authorizations.
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
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Frm 00045
Fmt 4703
Sfmt 4725
section 564(g)(2)(C) of the FD&C Act are
met, FDA has revoked the EUAs for
Abbott’s BinaxNOW COVID–19 Ag 2
Card, and Standard’s Advanta Dx
SARS–CoV–2 RT–PCR Assay and
Advanta Dx COVID–19 EASE Assay.
The revocations in their entirety follow
and provide an explanation of the
reasons for each revocation, as required
by section 564(h)(1) of the FD&C Act.
BILLING CODE 4164–01–P
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Authorization. On January 30, 2023,
FDA received a request from Standard
for the withdrawal of, and on February
1, 2023, FDA revoked, the
Authorizations for the Advanta Dx
SARS–CoV–2 RT–PCR Assay and
Advanta Dx COVID–19 EASE Assay.
Because Standard requested FDA
withdraw the EUAs for the Advanta Dx
SARS–CoV–2 RT–PCR Assay and
Advanta Dx COVID–19 EASE Assay,
FDA has determined that it is
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19:32 Mar 10, 2023
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15414
Federal Register / Vol. 88, No. 48 / Monday, March 13, 2023 / Notices
[FR Doc. 2023–05053 Filed 3–10–23; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2023–N–0623]
BILLING CODE 4164–01–C
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Antimicrobial Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
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19:32 Mar 10, 2023
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The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Antimicrobial Drugs
Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held
virtually on April 17, 2023, from 9 a.m.
to 4:30 p.m. Eastern Time.
DATES:
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Dated: March 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
15415
]]>Agencies
[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Pages 15412-15415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05053]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0973]
Revocation of Three Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection and/or Diagnosis of COVID-19;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Abbott Diagnostics Scarborough, Inc. (Abbott)
for the BinaxNOW COVID-19 Ag 2 Card, and Standard BioTools, Inc.
(Standard) for the Advanta Dx SARS-CoV-2 RT-PCR Assay and Advanta Dx
COVID-19 EASE Assay. FDA revoked these Authorizations under the Federal
Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include
an explanation of the reasons for each revocation, are reprinted in
this document.
DATES: The Authorization for the BinaxNOW COVID-19 Ag 2 Card is revoked
as of January 31, 2023. The Authorizations for the Advanta Dx SARS-CoV-
2 RT-PCR Assay and Advanta Dx COVID-19 EASE Assay are revoked as of
February 1, 2023.
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 Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 301-796-8510 (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 March 31, 2021, FDA issued an
EUA to Abbott for the BinaxNOW COVID-19 Ag 2 Card, 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 August 25, 2020, FDA
issued an EUA to Standard (then known as Fluidigm Corp.) for the
Advanta Dx SARS-CoV-2 RT-PCR Assay, subject to the terms of the
Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on November 20, 2020 (85 FR 74346),
as required by section 564(h)(1) of the FD&C Act. On February 7, 2022,
FDA issued an EUA to Standard (then known as Fluidigm Corp.) for the
Advanta Dx COVID-19 EASE Assay, 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. Subsequent revisions 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 January 20, 2023, FDA received a request from Abbott for the
revocation of, and on January 31, 2023, FDA revoked, the Authorization
for the BinaxNOW COVID-19 Ag 2 Card. Because Abbott requested FDA
revoke the EUA for the BinaxNOW COVID-19 Ag 2 Card, FDA has determined
that it is appropriate to protect the public health or safety to revoke
this
[[Page 15413]]
Authorization. On January 30, 2023, FDA received a request from
Standard for the withdrawal of, and on February 1, 2023, FDA revoked,
the Authorizations for the Advanta Dx SARS-CoV-2 RT-PCR Assay and
Advanta Dx COVID-19 EASE Assay. Because Standard requested FDA withdraw
the EUAs for the Advanta Dx SARS-CoV-2 RT-PCR Assay and Advanta Dx
COVID-19 EASE Assay, FDA has determined that it is appropriate to
protect the public health or safety to revoke these Authorizations.
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 Abbott's BinaxNOW COVID-19 Ag 2 Card, and
Standard's Advanta Dx SARS-CoV-2 RT-PCR Assay and Advanta Dx COVID-19
EASE Assay. The revocations in their entirety follow and provide an
explanation of the reasons for each revocation, as required by section
564(h)(1) of the FD&C Act.
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[GRAPHIC] [TIFF OMITTED] TN13MR23.016
[[Page 15414]]
[GRAPHIC] [TIFF OMITTED] TN13MR23.017
[[Page 15415]]
[GRAPHIC] [TIFF OMITTED] TN13MR23.018
Dated: March 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05053 Filed 3-10-23; 8:45 am]
BILLING CODE 4164-01-C
