Notice2023-05609
COVID-19 Emergency Use Authorization Declaration
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 20, 2023
Issuing agencies
Health and Human Services Department
Abstract
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On March 15, 2023, the Secretary amended the February 4, 2020 determination made pursuant to section 564 of the FD&C Act and determined pursuant to his authority under section 564(b)(1)(C) 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 United States citizens living abroad and that involves a biological agent, namely the novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV, or SARS-CoV-2).
Full Text
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<title>Federal Register, Volume 88 Issue 53 (Monday, March 20, 2023)</title>
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[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Pages 16644-16645]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05609]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
COVID-19 Emergency Use Authorization Declaration
ACTION: Notice of amendment.
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SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to section 564 of the Federal Food, Drug, and
Cosmetic (FD&C) Act. On March 15, 2023, the Secretary amended the
February 4, 2020 determination made pursuant to section 564 of the FD&C
Act and determined pursuant to his authority under section 564(b)(1)(C)
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 United
States citizens living abroad and that involves a biological agent,
namely the novel (new) coronavirus (nCoV) first detected in Wuhan City,
Hubei Province, China in 2019 (2019-nCoV, or SARS-CoV-2).
DATES: The section 564(b)(1)(C) determination that was originally
issued on February 4, 2020, is amended as of March 15, 2023.
FOR FURTHER INFORMATION CONTACT: Paige Ezernack: 202-260-0365,
<a href="/cdn-cgi/l/email-protection#cfbfaea6a8aae1aab5aabda1aeaca48fa7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="5a2a3b333d3f743f203f28343b39311a323229743d352c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 564 of the FD&C Act, the Commissioner of the Food and
Drug Administration (FDA), acting under delegated authority from the
Secretary of HHS, may issue an EUA authorizing (1) the emergency use of
an unapproved drug, an unapproved or uncleared device, an unlicensed
biological product, or an unapproved animal drug; or (2) an unapproved
use of an approved drug, approved or cleared device, licensed
biological product, or conditionally approved animal drug. Before an
EUA may be issued, the Secretary of HHS must declare that circumstances
exist justifying the authorization based on one of four determinations:
(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 chemical,
biological, radiological, or nuclear (``CBRN'') agent or agents; (2)
the identification of a material threat by the Secretary of Homeland
Security pursuant to section 319F-2 of the Public Health Service (PHS)
Act sufficient to affect national security or the health and security
of United States citizens living abroad; (3) 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 United States military forces, including personnel operating
under the authority of title 10 or title 50, of attack with (i) a CBRN
agent or agents; or (ii) an agent or agents that may cause, or are
otherwise associated with, an imminently life-threatening and specific
risk to United States military forces; or (4) a determination by the
Secretary 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 United States citizens living abroad, and that involves a
CBRN agent or agents, or a disease or condition that may be
attributable to such agent or agents.
Based on any of these four determinations, the Secretary of HHS may
then issue a declaration(s) that circumstances exist that justify the
issuance of an EUA(s), at which point the FDA Commissioner may issue an
EUA(s) for certain products if the criteria for issuance under section
564 of the FD&C Act are met. The section 564 declaration(s) terminate
only when the Secretary of HHS determines that the termination
requirements of section 564(b)(2)(A) of the FD&C Act are met.
Additionally, section 564(b)(3) provides that the Secretary shall
provide advance notice, by publication in the Federal Register, that a
declaration(s) under section 564 will be terminated.
II. Determination by the Secretary of Health and Human Services
On February 4, 2020, pursuant to his authority under section 564 of
the FD&C Act, the Secretary of HHS determined that the circumstances in
section 564(b)(1) exist because ``there is a public health emergency
that has a significant potential to affect national security or the
health and security of United States citizens living abroad and that
involves a novel (new) coronavirus (nCoV) first detected in Wuhan City,
Hubei Province, China in 2019 (2019-nCoV).'' 85 FR 7316.
It is now well established that SARS-CoV-2 is constantly evolving
and continues to be an ongoing challenge. As of January 30, 2023, SARS-
CoV-2 has led to over 753 million cases of COVID-19, including 6.8
million deaths worldwide. This is due, in part, to variations in the
virus that may allow it to spread more easily or make it resistant to
treatments or decreased vaccine effectiveness. There is also a risk
that eventually a variant will emerge that will escape the protection
provided by the current generation of vaccines against severe disease.
For example, the SARS-CoV-2 Omicron variant has continued to evolve
into sublineages with additional mutations in the spike glycoprotein
and the
[[Page 16645]]
receptor binding domain. Evolution of the virus also raises similar
concerns about the continued efficacy of certain categories of
therapeutics, such as monoclonal antibodies. The distribution of
Omicron sublineages varies at different points in time in different
regions of the world. The large number of mutations in the Omicron
variant sublineages and the ongoing evolution of the virus remain a
concern for potential evasion of vaccine immunity.
In light of this, I have now amended the February 4, 2020
determination to recognize the fact 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 United States citizens living
abroad'' and that involves a biological agent, namely the novel (new)
coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China
in 2019 (2019-nCoV, or SARS-CoV-2). (Emphasis added). If the current
conditions change such that there is no longer a ``public health
emergency'' within the meaning of section 564, the section 564(b)(1)(C)
determination would remain in place because I have determined that
there is also a ``significant potential for a public health emergency''
under that section. This avoids the need to issue a new determination
under section 564 when there is no longer a ``public health
emergency,'' but there is still a ``significant potential for a public
health emergency'' involving SARS-CoV-2.
The four previously-issued section 564 declarations that refer to
the February 4, 2020 determination have not been terminated by the
Secretary because, among other things, the circumstances described in
section 564(b)(1) continue to exist--i.e., COVID-19, a disease
attributable to SARS-CoV-2, continues to present 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 United States citizens living
abroad. Consistent with section 564(f), the currently-in-effect
Emergency Use Authorizations (EUAs) issued under those section 564
declarations remain in effect until the earlier of the termination of
relevant section 564 declarations under section 564(b), or revocation
of the EUAs. Therefore, these EUAs continue in effect.
III. Declarations of the Secretary of Health and Human Services; EUAs
Issued Under the Declarations
Based on the February 4, 2020 determination, in February and March
2020, the Secretary of HHS, pursuant to section 564 of the FD&C Act and
subject to the terms of any authorization issued under that section,
declared that circumstances exist justifying the authorization of
emergency use of: (1) in vitro diagnostics for detection and/or
diagnosis of this novel coronavirus, 85 FR 7316; (2) personal
respiratory protective devices, 85 FR 13907; (3) other medical devices
including alternative products used as medical devices, 85 FR 17335;
and (4) drugs and biological products, 85 FR 18250.
These section 564 declarations continue in effect. Specifically,
under section 564(b)(2)(A), a declaration made under section 564 will
not terminate unless the Secretary determines that ``the circumstances
described in [section 564(b)(1)] have ceased to exist,'' or there is
``a change in the approval status of the [authorized] product such that
the circumstances described in subsection (a)(2) have ceased to
exist.'' Section 564(b)(2)(A) of the FD&C Act. The first basis for
termination is not met because the circumstances described in section
564(b)(1) have not ceased to exist; to the contrary, as described
above, I have determined that the circumstances described in section
564(b)(1)(C) continue to exist. The second basis for termination is not
met because each declaration covers many products, or emergency uses of
products, at least some of which remain ``unapproved'' within the
meaning of section 564(a)(2).
Consistent with section 564(f), the EUAs issued under these
declarations remain in effect until the earlier of the termination of
relevant section 564 declarations or revocation of the EUAs.
Accordingly, the currently-in-effect EUAs issued under the section 564
determination/declarations for COVID-19 also continue in effect.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-05609 Filed 3-17-23; 8:45 am]
BILLING CODE 4150-37-P
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