Authorization of Emergency Use for Three Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of three Emergency Use Authorizations (EUA or Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued one EUA for an animal product as requested by Zoetis Inc. for the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax; NWS) larvae (myiasis) in dairy cattle, horses, swine, sheep, and deer. FDA has issued one EUA for an animal product as requested by Felix Pharmaceuticals Pvt. Ltd. for the treatment of infestations caused by NWS myiasis in dogs, puppies, cats, and kittens. FDA has issued one EUA for an animal product as requested by Alberta Vet Labs Ltd for the short-term prevention of infestations caused by NWS myiasis in horses. 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 significant potential for a public health emergency that 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 91 Issue 167 (Monday, August 31, 2026)</title>
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[Federal Register Volume 91, Number 167 (Monday, August 31, 2026)]
[Notices]
[Pages 55861-55886]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17719]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-N-0004]


Authorization of Emergency Use for Three Animal Drugs for the 
Prevention and 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 three Emergency Use Authorizations (EUA or 
Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) for new animal products. FDA has issued one EUA for an animal 
product as requested by Zoetis Inc. for the prevention and treatment of 
infestations caused by New World screwworm (Cochliomyia hominivorax; 
NWS) larvae (myiasis) in dairy cattle, horses, swine, sheep, and deer. 
FDA has issued one EUA for an animal product as requested by Felix 
Pharmaceuticals Pvt. Ltd. for the treatment of infestations caused by 
NWS myiasis in dogs, puppies, cats, and kittens. FDA has issued one EUA 
for an animal product as requested by Alberta Vet Labs Ltd for the 
short-term prevention of infestations caused by NWS myiasis in horses. 
The Authorizations contain, among other things, conditions on the 
emergency use of the authorized products. The Authorizations follow the 
August 18,

[[Page 55862]]

2025, determination by the Secretary of Health and Human Services (HHS) 
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 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: May 
19, 2026, June 11, 2026, and July 15, 2026, 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.

FOR FURTHER INFORMATION CONTACT: Crystal Groesbeck, Center for 
Veterinary Medicine, Food and Drug Administration, 5001 Campus Drive, 
College Park, MD 20740, 240-402-0819, <a href="/cdn-cgi/l/email-protection#df9cada6acabbeb3f198adb0baacbdbabcb49fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="6e2d1c171d1a0f0240291c010b1d0c0b0d052e080a0f4006061d40090118">[email&#160;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 (CBRN); (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 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 significant potential for a public 
health emergency that has a significant potential to affect national 
security or the health and

[[Page 55863]]

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 three authorizations for the emergency use of animal products. 
On May 19, 2026, FDA issued an EUA to Zoetis Inc. for the animal 
product Dectomax/Dectomax-CA1 (doramectin injection), subject to the 
terms of its Authorization. On June 11, 2026, FDA issued an EUA to 
Felix Pharmaceuticals Pvt. Ltd. for the animal product Nitenpyram 
Tablets (nitenpyram), subject to the terms of its Authorization. On 
July 15, 2026, FDA issued an EUA to Alberta Vet Labs Ltd for the animal 
product Ivermectin Liquid for Horses (ivermectin oral solution), 
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 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/new-world-screwworm-information-veterinarians">https://www.fda.gov/animal-veterinary/safety-health/new-world-screwworm-information-veterinarians</a>.

IV. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations are 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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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17719 Filed 8-28-26; 8:45 am]
BILLING CODE 4164-01-C


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