[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Pages 16644-16645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05609]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


COVID-19 Emergency Use Authorization Declaration

ACTION: Notice of amendment.

-----------------------------------------------------------------------

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, 
[email protected].

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