Notice2025-15918
Declaration of Emergency Pursuant to the Federal Food, Drug, and Cosmetic Act for New World Screwworm
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
August 20, 2025
Effective
August 18, 2025
Issuing agencies
Health and Human Services Department
Abstract
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C) Act. On August 18, 2025, the Secretary determined, pursuant to his authority under the FD&C Act, that there is a significant potential for 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 New World Screwworm (Cochliomyia hominivorax) (NWS).
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 159 (Wednesday, August 20, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 159 (Wednesday, August 20, 2025)]
[Notices]
[Pages 40609-40610]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15918]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Declaration of Emergency Pursuant to the Federal Food, Drug, and
Cosmetic Act for New World Screwworm
AGENCY: Office of the Secretary, Department of Health and Human
Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary of Health and Human Services (HHS) is issuing
this notice pursuant to the Federal Food, Drug, and Cosmetic (FD&C)
Act. On August 18, 2025, the Secretary determined, pursuant to his
authority under the FD&C Act, that there is a significant potential for
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 New World Screwworm (Cochliomyia
hominivorax) (NWS).
DATES: The determination and declaration were effective August 18,
2025.
FOR FURTHER INFORMATION CONTACT: Tristan Colonius, Chief Veterinary
Officer, U.S. Food and Drug Administration, 5001 Campus Drive, College
Park, MD 20740, <a href="/cdn-cgi/l/email-protection#88dcfae1fbfce9e6a6ebe7e4e7e6e1fdfbc8eeece9a6e0e0fba6efe7fe"><span class="__cf_email__" data-cfemail="5f0b2d362c2b3e31713c30333031362a2c1f393b3e7137372c71383029">[email protected]</span></a>, 301-796-2624.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 564 of the Federal Food, Drug, and Cosmetic Act (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 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 [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 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
declare that circumstances exist that justify Emergency Use
Authorization (EUA), at which point the Commissioner of Food and Drugs
of the U.S. 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, or an unlicensed biological product; or (2) an unapproved use
of an approved drug, approved or cleared device, or licensed biological
product, if the criteria for issuance of an authorization under section
564 of the FD&C Act are met.
The Commissioner of Food and Drugs requested that the Secretary
issue the declaration to allow FDA to take measures based on
information currently available about NWS. The determination that there
is a significant potential for 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 NWS
(Cochliomyia hominivorax), and the declaration that circumstances exist
justifying the authorization of emergency use of animal drugs to treat
or prevent NWS myiasis in animals by the Secretary, enable the
Commissioner of Food and Drugs to issue EUAs for animal drugs for
prevention or treatment of New World Screwworm myiasis.
II. Determination by the Secretary of Health and Human Services
On August 18, 2025, I determined, pursuant to my authority under
section 564(b)(1)(C) of the FD&C Act, that there is a significant
potential for 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 New World
Screwworm (Cochliomyia hominivorax).
III. Declaration of the Secretary of Health and Human Services
On August 18, 2025, pursuant to section 564(b)(1) of the FD&C Act
and subject to the terms of any authorization issued under that
section, I declare that circumstances exist justifying the
authorization of emergency use of animal drugs to treat or prevent New
World Screwworm myiasis in animals. This declaration remains in effect
until the declaration is terminated in
[[Page 40610]]
accordance with section 564 of the FD&C Act.
Robert F. Kennedy, Jr.,
Secretary, U.S. Department of Health and Human Services.
[FR Doc. 2025-15918 Filed 8-19-25; 8:45 am]
BILLING CODE 4161-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 20, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.