Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 3995-3997 [2023-01180]
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3995
Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
Estimated Total Annual Burden
Hours: 751,461.
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.
Authority: 42 U.S.C. 666(a)(1), (a)(8),
and (b)(6).
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–01130 Filed 1–20–23; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Tribal Budget and Narrative
Justification Template (OMB #: 0970–
0548)
Office of Child Support
Enforcement, Administration for
Children and Families, U.S. Department
of Health and Human Services.
ACTION: Request for public comments.
AGENCY:
The Office of Child Support
Enforcement (OCSE), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing to renew
the collection of expenditure estimate
forms for the tribal child support
enforcement program through an
optional financial reporting form, Tribal
Budget and Narrative Justification
Template (Office of Management and
Budget (OMB) #: 0970–0548; expiration
date June 30, 2023). No changes are
proposed.
SUMMARY:
Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
DATES:
of the information collection described
above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: To receive child support
funding under 45 CFR part 309, tribes
and tribal organizations must submit the
financial forms described in 45 CFR
309.130(b) and other forms as the
Secretary may designate, due no later
than August 1 annually. This optional
template is designed for tribes operating
an approved tribal child support
enforcement program to use in
preparing their annual budget and
narrative justification estimates in
accordance with the tribal child support
enforcement regulations. The optional
Tribal Budget and Narrative Justification
Template helps improve efficiency and
establish uniformity and consistency in
the annual budget submission and
review process. Tribes may use the
Excel or Word version of the template
to submit the required financial
information.
Respondents: Tribes and Tribal
Organizations administering a tribal
child support program under title IV–D
of the Social Security Act.
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Total number
of responses
per respondent
52
8
3
3
khammond on DSKJM1Z7X2PROD with NOTICES
Tribal Budget and Narrative Justification—Excel ..............
Tribal Budget and Narrative Justification—Word ..............
Estimated Total Annual Burden
Hours: 992.
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.
VerDate Sep<11>2014
16:44 Jan 20, 2023
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Authority: 45 CFR 309.
[FR Doc. 2023–01129 Filed 1–20–23; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1584]
Authorization of Emergency Use of
Certain Medical Devices During
COVID–19; Availability
Food and Drug Administration,
HHS.
ACTION:
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Notice.
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16
20
Total burden
hours
2,496
480
Annual burden
hours
832
160
The Food and Drug
Administration (FDA or Agency) is
announcing the issuance of Emergency
Use Authorizations (EUAs) (the
Authorizations) for certain medical
devices related to the Coronavirus
Disease 2019 (COVID–19) public health
emergency. FDA has issued the
Authorizations listed in this document
under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). These
Authorizations contain, among other
things, conditions on the emergency use
of the authorized products. The
Authorizations follow the February 4,
2020, determination by the Secretary of
Health and Human Services (HHS) that
there is a public health emergency that
has a significant potential to affect
national security or the health and
security of U.S. citizens living abroad
and that involves the virus that causes
SUMMARY:
John M. Sweet, Jr.,
ACF/OPRE Certifying Officer.
AGENCY:
Average
burden hours
per response
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Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
COVID–19, and the subsequent
declarations on February 4, 2020, March
2, 2020, and March 24, 2020, that
circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection and/or
diagnosis of the virus that causes
COVID–19, personal respiratory
protective devices, and medical devices,
including alternative products used as
medical devices, respectively, subject to
the terms of any authorization issued
under the FD&C Act. These
Authorizations, which include an
explanation of the reasons for issuance,
are listed in this document, and can be
accessed on FDA’s website from the
links indicated.
DATES: These Authorizations are
effective on their date of issuance.
ADDRESSES: Submit written requests for
single copies of an EUA 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 Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
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) 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.
With this EUA authority, FDA can help
ensure that medical countermeasures
may be used in emergencies to diagnose,
treat, or prevent serious or lifethreatening diseases or conditions
caused by a biological, chemical,
radiological, or nuclear agent or agents
when there are no adequate, approved,
and available alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) a
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Jkt 259001
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50 of the
U.S. Code, of attack with (A) a
biological, chemical, radiological, or
nuclear agent or agents; or (B) an agent
or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces; 1 (3) a
determination by the Secretary of HHS
that there is a public health emergency,
or a significant potential for a public
health emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad, and that
involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Under section
564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available
on the internet website of FDA. Section
564 of the FD&C Act permits FDA to
authorize the introduction into
interstate commerce of a drug, device, or
biological product intended for use
when the Secretary of HHS has declared
that circumstances exist justifying the
authorization of emergency use.
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
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Products appropriate for emergency use
may include products and uses that are
not approved, cleared, or licensed under
section 505, 510(k), 512, or 515 of the
FD&C Act (21 U.S.C. 355, 360(k), 360b,
or 360e) or section 351 of the PHS Act
(42 U.S.C. 262), or conditionally
approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 2 concludes: (1) that an agent
referred to in a declaration of emergency
or threat can cause a serious or lifethreatening disease or condition; (2)
that, based on the totality of scientific
evidence available to FDA, including
data from adequate and well-controlled
clinical trials, if available, it is
reasonable to believe that (A) the
product may be effective in diagnosing,
treating, or preventing (i) such disease
or condition; or (ii) a serious or lifethreatening disease or condition caused
by a product authorized under section
564, approved or cleared under the
FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating,
or preventing such a disease or
condition caused by such an agent; and
(B) the known and potential benefits of
the product, when used to diagnose,
prevent, or treat such disease or
condition, outweigh the known and
potential risks of the product, taking
into consideration the material threat
posed by the agent or agents identified
in a declaration under section
564(b)(1)(D) of the FD&C Act, if
applicable; (3) that there is no adequate,
approved, and available alternative to
the product for diagnosing, preventing,
or treating such disease or condition; (4)
in the case of a determination described
in section 564(b)(1)(B)(ii), that the
request for emergency use is made by
the Secretary of Defense; and (5) that
such other criteria as may be prescribed
by regulation are satisfied. No other
criteria for issuance have been
prescribed by regulation under section
564(c)(4) of the FD&C Act.
II. Electronic Access
An electronic version of this
document and the full text of the
Authorizations are available on the
internet and can be accessed from
https://www.fda.gov/emergency2 The Secretary of HHS has delegated the
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
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Federal Register / Vol. 88, No. 14 / Monday, January 23, 2023 / Notices
preparedness-and-response/mcm-legalregulatory-and-policy-framework/
emergency-use-authorization.
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III. The Authorizations
Having concluded that the criteria for
the issuance of the following
Authorizations under section 564(c) of
the FD&C Act are met, FDA has
authorized the emergency use of the
following products for diagnosing,
treating, or preventing COVID–19
subject to the terms of each
Authorization. The Authorizations in
their entirety, including any authorized
fact sheets and other written materials,
can be accessed from the FDA web page
entitled ‘‘Emergency Use
Authorization,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. The lists that follow
include Authorizations issued from June
16, 2022, through December 6, 2022,
and we have included explanations of
the reasons for their issuance, as
required by section 564(h)(1) of the
FD&C Act. In addition, the EUAs that
have been reissued can be accessed from
FDA’s web page: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
FDA is hereby announcing the
following Authorizations for molecular
diagnostic and antigen tests for COVID–
19, excluding multianalyte tests: 3
• Genabio Diagnostics Inc.’s Genabio
COVID–19 Rapid Self-Test Kit, issued
July 8, 2022;
• Watmind USA’s Speedy Swab Rapid
COVID–19 Antigen Self-Test, issued
July 8, 2022;
• Predicine, Inc.’s Predicine SARS–
CoV–2 RT–PCR Test, issued July 19,
2022;
• Aptitude Medical Systems Inc.’s
Metrix COVID–19 Test, issued
October 18, 2022;
• Nanobiosym Precision Testing
Services’s The Nano Test for COVID–
19, issued November 8, 2022;
• ANP Technologies, Inc.’s NIDS
COVID–19 Antigen Home Test, issued
November 17, 2022;
3 As set forth in the EUAs for these products, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the products may be effective in
diagnosing COVID–19, and that the known and
potential benefits of the products, when used for
diagnosing COVID–19, outweigh the known and
potential risks of such products; and (3) there is no
adequate, approved, and available alternative to the
emergency use of the products.
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• Beijing Hotgen Biotech Co., Ltd.’s
Hotgen COVID–19 Antigen Home
Test, issued November 17, 2022;
• Premier Medical Laboratory Services’s
Diversified Medical Healthcare
SARS–CoV–2 Assay, issued
November 18, 2022;
• CorDx, Inc.’s CorDx COVID–19 Ag
Test, issued November 21, 2022;
• Azure Biotech Inc.’s Fastep COVID–
19 Antigen Home Test, issued
November 21, 2022;
• ACON Laboratories, Inc.’s Flowflex
COVID–19 Antigen Rapid Test, issued
December 6, 2022.
FDA is hereby announcing the
following Authorization for a
multianalyte test:
• Lucira Health, Inc.’s Lucira COVID–19
and Flu Test, issued November 22,
2022.4
FDA is hereby announcing the
following Authorization for a serology
test:
• Diazyme Laboratories, Inc.’s Diazyme
SARS–CoV–2 Neutralizing Antibody
CLIA Kit, issued December 6, 2022.5
In addition, on November 1, 2022,
FDA issued a letter to Developers of
Antigen In Vitro Diagnostics (IVDs)
Authorized for Emergency Use for
Coronavirus Disease 2019 (COVID–19)
as of Today’s Date (November 1, 2022)
for Revisions Related to Serial (Repeat)
Testing for the EUAs of Antigen IVDs.6
4 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19, through the simultaneous
qualitative detection and differentiation of SARS–
CoV–2, influenza A virus, and/or influenza B virus
RNA, and that the known and potential benefits of
the product, when used for diagnosing COVID–19,
outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
5 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing recent or prior infection with SARS–
CoV–2 by identifying individuals with an adaptive
immune response to the virus that causes COVID–
19, and that the known and potential benefits of the
product, when used for such use, outweigh the
known and potential risks of the product; and (3)
there is no adequate, approved, and available
alternative to the emergency use of the product.
6 FDA concluded revisions to the EUAs of the
tests that are within the scope of the November 1,
2022, letter is appropriate to protect the public
health or safety and revised all such EUAs pursuant
to section 564(g)(2)(C) of the FD&C Act, including
to revise the authorized use and to establish the
additional condition set forth in the letter, as
permitted by section 564(e) of the FD&C Act. The
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3997
Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–01180 Filed 1–20–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier OS–0945–0003]
Agency Information Collection
Request. 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before February 22, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 264–0041. When submitting
comments or requesting information,
please include the document identifier
0945–0003–30D and project title for
reference.
SUMMARY:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
SUPPLEMENTARY INFORMATION:
action is based on the available scientific evidence
on the impact of serial testing on the performance
of SARS–CoV–2 antigen tests. (Refer to:
‘‘Performance of Screening for SARS–CoV–2 using
Rapid Antigen Tests to Detect Incidence of
Symptomatic and Asymptomatic SARS–CoV–2
Infection: findings from the Test Us at Home
prospective cohort study’’ at https://
www.medrxiv.org/content/10.1101/
2022.08.05.22278466v1.) The letter revised all
current EUAs for antigen SARS–CoV–2 IVD devices
as of November 1, 2022, by: (1) revising the
authorized use to be for serial testing at least twice
over 3 days for individuals with symptoms of
COVID–19 and, for tests previously authorized for
testing individuals without symptoms, revising the
authorized use to be for serial testing at least thrice
over 5 days for individuals without symptoms of
COVID–19, (2) establishing a new condition of
authorization regarding updating authorized
labeling, and (3) eliminating a condition of
authorization regarding evaluating clinical
performance to support the serial screening claim.
E:\FR\FM\23JAN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Notices]
[Pages 3995-3997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01180]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1584]
Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the issuance of Emergency Use Authorizations (EUAs) (the
Authorizations) for certain medical devices related to the Coronavirus
Disease 2019 (COVID-19) public health emergency. FDA has issued the
Authorizations listed in this document under the Federal Food, Drug,
and Cosmetic Act (FD&C Act). These Authorizations contain, among other
things, conditions on the emergency use of the authorized products. The
Authorizations follow the February 4, 2020, determination by the
Secretary of Health and Human Services (HHS) that there is a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad and
that involves the virus that causes
[[Page 3996]]
COVID-19, and the subsequent declarations on February 4, 2020, March 2,
2020, and March 24, 2020, that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for detection
and/or diagnosis of the virus that causes COVID-19, personal
respiratory protective devices, and medical devices, including
alternative products used as medical devices, respectively, subject to
the terms of any authorization issued under the FD&C Act. These
Authorizations, which include an explanation of the reasons for
issuance, are listed in this document, and can be accessed on FDA's
website from the links indicated.
DATES: These Authorizations are effective on their date of issuance.
ADDRESSES: Submit written requests for single copies of an EUA 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 Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.
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) 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. With this EUA authority, FDA can help ensure that
medical countermeasures may be used in emergencies to diagnose, treat,
or prevent serious or life-threatening diseases or conditions caused by
a biological, chemical, radiological, or nuclear agent or agents when
there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
a determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces, including personnel operating under the
authority of title 10 or title 50 of the U.S. Code, of attack with (A)
a biological, chemical, radiological, or nuclear agent or agents; or
(B) an agent or agents that may cause, or are otherwise associated
with, an imminently life-threatening and specific risk to U.S. military
forces; \1\ (3) a determination by the Secretary of HHS that there is a
public health emergency, or a significant potential for a public health
emergency, that affects, or has a significant potential to affect,
national security or the health and security of U.S. citizens living
abroad, and that involves a biological, chemical, radiological, or
nuclear agent or agents, or a disease or condition that may be
attributable to such agent or agents; or (4) the identification of a
material threat by the Secretary of Homeland Security pursuant to
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security
of U.S. citizens living abroad.
---------------------------------------------------------------------------
\1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------
Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Under section 564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available on the internet website of
FDA. Section 564 of the FD&C Act permits FDA to authorize the
introduction into interstate commerce of a drug, device, or biological
product intended for use when the Secretary of HHS has declared that
circumstances exist justifying the authorization of emergency use.
Products appropriate for emergency use may include products and uses
that are not approved, cleared, or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an
EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \2\ concludes: (1) that an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that (A) the product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; (4) in
the case of a determination described in section 564(b)(1)(B)(ii), that
the request for emergency use is made by the Secretary of Defense; and
(5) that such other criteria as may be prescribed by regulation are
satisfied. No other criteria for issuance have been prescribed by
regulation under section 564(c)(4) of the FD&C Act.
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\2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
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II. Electronic Access
An electronic version of this document and the full text of the
Authorizations are available on the internet and can be accessed from
https://www.fda.gov/emergency-
[[Page 3997]]
preparedness-and-response/mcm-legal-regulatory-and-policy-framework/
emergency-use-authorization.
III. The Authorizations
Having concluded that the criteria for the issuance of the
following Authorizations under section 564(c) of the FD&C Act are met,
FDA has authorized the emergency use of the following products for
diagnosing, treating, or preventing COVID-19 subject to the terms of
each Authorization. The Authorizations in their entirety, including any
authorized fact sheets and other written materials, can be accessed
from the FDA web page entitled ``Emergency Use Authorization,''
available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
The lists that follow include Authorizations issued from June 16, 2022,
through December 6, 2022, and we have included explanations of the
reasons for their issuance, as required by section 564(h)(1) of the
FD&C Act. In addition, the EUAs that have been reissued can be accessed
from FDA's web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
FDA is hereby announcing the following Authorizations for molecular
diagnostic and antigen tests for COVID-19, excluding multianalyte
tests: \3\
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\3\ As set forth in the EUAs for these products, FDA has
concluded that: (1) SARS-CoV-2 can cause a serious or life-
threatening disease or condition, including severe respiratory
illness, to humans infected by this virus; (2) based on the totality
of scientific evidence available to FDA, it is reasonable to believe
that the products may be effective in diagnosing COVID-19, and that
the known and potential benefits of the products, when used for
diagnosing COVID-19, outweigh the known and potential risks of such
products; and (3) there is no adequate, approved, and available
alternative to the emergency use of the products.
Genabio Diagnostics Inc.'s Genabio COVID-19 Rapid Self-Test
Kit, issued July 8, 2022;
Watmind USA's Speedy Swab Rapid COVID-19 Antigen Self-Test,
issued July 8, 2022;
Predicine, Inc.'s Predicine SARS-CoV-2 RT-PCR Test, issued
July 19, 2022;
Aptitude Medical Systems Inc.'s Metrix COVID-19 Test, issued
October 18, 2022;
Nanobiosym Precision Testing Services's The Nano Test for
COVID-19, issued November 8, 2022;
ANP Technologies, Inc.'s NIDS COVID-19 Antigen Home Test,
issued November 17, 2022;
Beijing Hotgen Biotech Co., Ltd.'s Hotgen COVID-19 Antigen
Home Test, issued November 17, 2022;
Premier Medical Laboratory Services's Diversified Medical
Healthcare SARS-CoV-2 Assay, issued November 18, 2022;
CorDx, Inc.'s CorDx COVID-19 Ag Test, issued November 21,
2022;
Azure Biotech Inc.'s Fastep COVID-19 Antigen Home Test, issued
November 21, 2022;
ACON Laboratories, Inc.'s Flowflex COVID-19 Antigen Rapid
Test, issued December 6, 2022.
FDA is hereby announcing the following Authorization for a
multianalyte test:
Lucira Health, Inc.'s Lucira COVID-19 and Flu Test, issued
November 22, 2022.\4\
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\4\ As set forth in the EUA for this product, FDA has concluded
that: (1) SARS-CoV-2 can cause a serious or life-threatening disease
or condition, including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of scientific
evidence available to FDA, it is reasonable to believe that the
product may be effective in diagnosing COVID-19, through the
simultaneous qualitative detection and differentiation of SARS-CoV-
2, influenza A virus, and/or influenza B virus RNA, and that the
known and potential benefits of the product, when used for
diagnosing COVID-19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved, and available
alternative to the emergency use of the product.
FDA is hereby announcing the following Authorization for a serology
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test:
Diazyme Laboratories, Inc.'s Diazyme SARS-CoV-2 Neutralizing
Antibody CLIA Kit, issued December 6, 2022.\5\
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\5\ As set forth in the EUA for this product, FDA has concluded
that: (1) SARS-CoV-2 can cause a serious or life-threatening disease
or condition, including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of scientific
evidence available to FDA, it is reasonable to believe that the
product may be effective in diagnosing recent or prior infection
with SARS-CoV-2 by identifying individuals with an adaptive immune
response to the virus that causes COVID-19, and that the known and
potential benefits of the product, when used for such use, outweigh
the known and potential risks of the product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.
In addition, on November 1, 2022, FDA issued a letter to Developers
of Antigen In Vitro Diagnostics (IVDs) Authorized for Emergency Use for
Coronavirus Disease 2019 (COVID-19) as of Today's Date (November 1,
2022) for Revisions Related to Serial (Repeat) Testing for the EUAs of
Antigen IVDs.\6\
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\6\ FDA concluded revisions to the EUAs of the tests that are
within the scope of the November 1, 2022, letter is appropriate to
protect the public health or safety and revised all such EUAs
pursuant to section 564(g)(2)(C) of the FD&C Act, including to
revise the authorized use and to establish the additional condition
set forth in the letter, as permitted by section 564(e) of the FD&C
Act. The action is based on the available scientific evidence on the
impact of serial testing on the performance of SARS-CoV-2 antigen
tests. (Refer to: ``Performance of Screening for SARS-CoV-2 using
Rapid Antigen Tests to Detect Incidence of Symptomatic and
Asymptomatic SARS-CoV-2 Infection: findings from the Test Us at Home
prospective cohort study'' at https://www.medrxiv.org/content/10.1101/2022.08.05.22278466v1.) The letter revised all current EUAs
for antigen SARS-CoV-2 IVD devices as of November 1, 2022, by: (1)
revising the authorized use to be for serial testing at least twice
over 3 days for individuals with symptoms of COVID-19 and, for tests
previously authorized for testing individuals without symptoms,
revising the authorized use to be for serial testing at least thrice
over 5 days for individuals without symptoms of COVID-19, (2)
establishing a new condition of authorization regarding updating
authorized labeling, and (3) eliminating a condition of
authorization regarding evaluating clinical performance to support
the serial screening claim.
Dated: January 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01180 Filed 1-20-23; 8:45 am]
BILLING CODE 4164-01-P
