Notice2026-18008
Emergency Use Authorization Declaration
Primary source
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Published
September 3, 2026
Effective
July 15, 2026
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 July 15, 2026, the Secretary of War determined under the FD&C that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of an attack with a chemical, biological, radiological, or nuclear agent or agents; or an attack by an agent or agents that may cause, or are otherwise associated with an imminently life-threatening and specific risk to those forces. Injuries arising from these attacks may cause those forces to experience moderate to severe acute pain and place them at risk of developing life-threatening hemodynamic instability, including shock or respiratory distress. On the basis of this determination, the Secretary of HHS declared on August 31, 2026, pursuant to the FD&C Act, that circumstances exist justifying the authorization of emergency use of drugs identified and supported by the Department of War (DOW) as addressing an unmet military operations- related medical need for use to manage moderate to severe acute pain in casualties caused by, or associated with, an emergency involving biological, chemical, radiological, or nuclear agent or agents, or agents of military combat, including firearms, projectiles, and explosive devices, that may cause, or may otherwise be associated with, an imminently life-threatening and specific risk to U.S. military forces, subject to the terms of any authorization issued under that section.
Full Text
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<title>Federal Register, Volume 91 Issue 170 (Thursday, September 3, 2026)</title>
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[Federal Register Volume 91, Number 170 (Thursday, September 3, 2026)]
[Notices]
[Pages 56655-56656]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18008]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Emergency Use Authorization Declaration
AGENCY: U.S. Department of Health and Human Services (HHS).
ACTION: Notice.
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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 July 15, 2026, the Secretary of War determined
under the FD&C that there is a military emergency, or a significant
potential for a military emergency, involving a heightened risk to U.S.
military forces of an attack with a chemical, biological, radiological,
or nuclear agent or agents; or an attack by an agent or agents that may
cause, or are otherwise associated with an imminently life-threatening
and specific risk to those forces. Injuries arising from these attacks
may cause those forces to experience moderate to severe acute pain and
place them at risk of developing life-threatening hemodynamic
instability, including shock or respiratory distress. On the basis of
this determination, the Secretary of HHS declared on August 31, 2026,
pursuant to the FD&C Act, that circumstances exist justifying the
authorization of emergency use of drugs identified and supported by the
Department of War (DOW) as addressing an unmet military operations-
related medical need for use to manage moderate to severe acute pain in
casualties caused by, or associated with, an emergency involving
biological, chemical, radiological, or nuclear agent or agents, or
agents of military combat, including firearms, projectiles, and
explosive devices, that may cause, or may otherwise be associated with,
an imminently life-threatening and specific risk to U.S. military
forces, subject to the terms of any authorization issued under that
section.
DATES: The determination was effective July 15, 2026, and the
declaration was effective August 31, 2026.
FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, telephone at (202)
260-
[[Page 56656]]
0365 or via email at <a href="/cdn-cgi/l/email-protection#f282939b9597dc978897809c939199b29a9a81dc959d84"><span class="__cf_email__" data-cfemail="b6c6d7dfd1d398d3ccd3c4d8d7d5ddf6dedec598d1d9c0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 564 of the FD&C Act, HHS has the ability to take
certain steps to help facilitate the availability of medical
countermeasures based on one of four determinations under section
564(b): (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
the Homeland Security pursuant to section 319F-2 of the Public Health
Service (PHS) Act \1\ sufficient to affect national security or the
health and security of U.S. citizens living abroad; (3) a determination
by the Secretary of Defense [War] 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 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 U.S. military forces; or (4) 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 CBRN agent
or agents, or a disease or condition that may be attributable to such
agent or agents.
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\1\ 42 U.S.C. 247d-6b, which states: ``[t]he Homeland Security
Secretary, in consultation with the Secretary and the heads of other
agencies as appropriate, shall on an ongoing basis--(i) assess
current and emerging threats of chemical, biological, radiological,
and nuclear agents; and (ii) determine which of such agents present
a material threat against the United States population sufficient to
affect national security.''
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Based on any of these four determinations, the Secretary of HHS may
declare that circumstances exist that justify the issuance of emergency
use authorizations (EUAs), at which point the Commissioner of the U.S.
Food and Drug Administration (FDA), acting under delegated authority
from the Secretary of HHS, may issue an EUA or EUAs authorizing the
emergency use of an unapproved medical product or an unapproved use of
an approved medical product in certain emergency circumstances, if the
criteria for issuance of an authorization under section 564 of the FD&C
Act are met.
II. Determination by the Secretary of War
On July 15, 2026 the Secretary of War determined, pursuant to sec.
564(b)(1)(B) of the FD&C Act, that there is a military emergency, or a
significant potential for a military emergency, involving a heightened
risk to U.S. military forces of an attack with a chemical, biological,
radiological, or nuclear agent or agents; or an attack by an agent or
agents that may cause, or are otherwise associated with, an imminently
life-threatening and specific risk to U.S. military forces (including
agents of military combat such as firearms, projectiles, and explosive
devices). Injuries arising from these attacks may cause U.S. military
forces to experience moderate to severe acute pain and place them at
risk of developing life-threatening hemodynamic instability, including
shock or respiratory distress.
III. Declaration of the Secretary of HHS
On August 31, 2026, on the basis of the Secretary of War's
determination that there is a military emergency or significant
potential for a military emergency involving a heightened risk to U.S.
military forces of an attack with an agent or agents that may cause, or
are otherwise associated with an imminently life-threatening and
specific risk to those forces, I declared that circumstances exist
justifying the authorization of emergency use of drugs identified and
supported by the DOW as addressing an unmet military operations-related
medical need for use to manage moderate to severe acute pain in
casualties caused by, or associated with, an emergency involving
biological, chemical, radiological, or nuclear agent or agents, or
agents of military combat, including firearms, projectiles, and
explosive devices, that may cause, or may otherwise be associated with,
an imminently life-threatening and specific risk to U.S. military
forces, subject to the terms of any authorization issued under that
section.
Notice of any EUAs issued by the FDA Commissioner pursuant to this
determination and declaration will be provided promptly in the Federal
Register as required under section 564 of the FD&C Act.
Robert F. Kennedy, Jr.,
Secretary, Health and Human Services.
[FR Doc. 2026-18008 Filed 9-2-26; 8:45 am]
BILLING CODE 4150-37-P
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