Notice2025-23914
Authorization of Emergency Use for Two Animal Drugs for the Treatment of New World Screwworm; Availability
Primary source
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Published
December 29, 2025
Effective
October 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the issuance of two Emergency Use Authorizations (EUA) (Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal drug products. FDA has issued one EUA for a new animal drug product as requested by Elanco US Inc. for the treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) (NWS) larvae (myiasis) in dogs and puppies and one EUA for a new animal drug product as requested by Elanco US Inc. for the treatment of infestations caused by NWS larvae (myiasis) in cats and kittens. The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the August 18, 2025, determination by the Secretary of Health and Human Services (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 NWS. On the basis of such determination, the Secretary of HHS declared on August 18, 2025, that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent NWS myiasis in animals. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Full Text
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<title>Federal Register, Volume 90 Issue 245 (Monday, December 29, 2025)</title>
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[Federal Register Volume 90, Number 245 (Monday, December 29, 2025)]
[Notices]
[Pages 60701-60715]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23914]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6971]
Authorization of Emergency Use for Two Animal Drugs for the
Treatment of New World Screwworm; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the issuance of two Emergency Use Authorizations (EUA)
(Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) for new animal drug products. FDA has issued one EUA for a new
animal drug product as requested by Elanco US Inc. for the treatment of
infestations caused by New World screwworm (Cochliomyia hominivorax)
(NWS) larvae (myiasis) in dogs and puppies and one EUA for a new animal
drug product as requested by Elanco US Inc. for the treatment of
infestations caused by NWS larvae (myiasis) in cats and kittens. The
Authorizations contain, among other things, conditions on the emergency
use of the authorized products. The Authorizations follow the August
18, 2025, determination by the Secretary of Health and Human Services
(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 NWS. On the
basis of such determination, the Secretary of HHS declared on August
18, 2025, that circumstances exist justifying the authorization of
emergency use of animal drugs to treat or prevent NWS myiasis in
animals. The Authorizations, which include an explanation of the
reasons for issuance, are reprinted in this document.
DATES: The Authorizations are effective on their dates of issuance:
October 24, 2025, and November 21, 2025, respectively.
ADDRESSES: Submit written requests for single copies of the EUAs to the
Policy and Regulations Staff, Center for Veterinary Medicine, Food and
Drug Administration, 5001 Campus Drive, College Park, MD 20740. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the Authorizations.
[[Page 60702]]
FOR FURTHER INFORMATION CONTACT: Steven Fleischer, Center for
Veterinary Medicine, Food and Drug Administration, 5001 Campus Drive,
College Park, MD 20740, 240-402-0809, <a href="/cdn-cgi/l/email-protection#4c1f38293a2922620a2029253f2f24293e0c2a282d6224243f622b233a"><span class="__cf_email__" data-cfemail="fba88f9e8d9e95d5bd979e928898939e89bb9d9f9ad5939388d59c948d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen public health protections against biological, chemical,
nuclear, and radiological 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
biological, chemical, nuclear, or radiological agents when there are no
adequate, approved, and available alternatives (among other criteria).
II. Criteria for EUA Authorization
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: (A)
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; (B) 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, U.S. Code, of attack with (i) a
biological, chemical, radiological, or nuclear agent or agents
(``CBRN''); 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; \1\ (C) 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;
or (D) 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.
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\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 (see section 564(b)(6) of the FD&C Act).
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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 FDA's website. 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 in an actual or potential emergency 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
sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355,
360(k), 360b, and 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).
Under section 564(c) of the FD&C Act, 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) of the FD&C Act,
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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III. The Authorizations
The Authorizations follow the August 18, 2025, 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 NWS. On
the basis of such determination, the Secretary of HHS declared, on
August 18, 2025, that circumstances exist justifying the authorization
of emergency use of animal drugs to treat or prevent NWS myiasis in
animals. Notice of the Secretary's determination and declaration was
provided in the Federal Register on August 20, 2025 (90 FR 40609).
Having concluded that the criteria for the issuance of the
Authorizations under section 564(c) of the FD&C Act are met, FDA has
issued two authorizations for the emergency use of animal drug
products. On October 24, 2025, FDA issued an EUA to Elanco US Inc. for
the animal drug product Credelio (lotilaner), subject to the terms of
its Authorization. On November 21, 2025, FDA issued an EUA to Elanco US
Inc. for the animal drug product Credelio CAT (lotaliner), subject to
the terms of its Authorization.
The initial Authorizations, included below in their entirety after
section IV of this document (not including the authorized versions of
the fact sheets and other written materials), provide
[[Page 60703]]
explanations of the reasons for issuance, as required by section
564(h)(1) of the FD&C Act. Any subsequent reissuance of the
Authorizations can be found on FDA's web page at: <a href="https://www.fda.gov/animal-veterinary/safety-health/animal-drugs-new-world-screwworm">https://www.fda.gov/animal-veterinary/safety-health/animal-drugs-new-world-screwworm</a>.
IV. Electronic Access
An electronic version of this document and the full text of the
Authorization is available on the internet at: <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
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Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-23914 Filed 12-23-25; 8:45 am]
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</html>Indexed from Federal Register on December 29, 2025.
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