Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2026-07509 · Docket No. FDA-2026-N-3799

Summary

The Food and Drug Administration (FDA or the Agency) is announcing the issuance of four Emergency Use Authorizations (EUA) (Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for new animal products. FDA has issued three EUAs for animal products as requested by Boehringer Ingelheim Animal Health USA, Inc. (Boehringer) for the prevention of infestations caused by New World screwworm ( Cochliomyia hominivorax ) (NWS) larvae (myiasis) in certain cattle, and for the treatment of such infestations in dogs, and cats. FDA has issued one EUA for an animal product as requested by Health and Hygiene (Pty) Ltd. for the prevention and treatment of infestations caused by NWS larvae (myiasis) in cattle, horses, minor species of hoof stock ( e.g., sheep, goats, deer), raptors and other wild birds, pet birds, and captive wild, exotic, and zoo mammals. 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.

Dates

The Authorizations are effective on their dates of issuance: February 5, 2026, February 18, 2026, and March 10, 2026, respectively.

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. 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). 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. 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. 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 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 four authorizations for the emergency use of animal products. On February 5, 2026, FDA issued an EUA to Boehringer for the animal product Ivomec (ivermectin), subject to the terms of its Authorization. On February 18, 2026, FDA issued two EUAs to Boehringer for the animal products NexGard (afoxolaner) and NexGard COMBO (esafoxolaner, eprinomectin, and praziquantel topical solution), subject to the terms of their Authorizations. On March 10, 2026, FDA issued an EUA to Health and Hygiene (Pty) Ltd for the animal product F10 Antiseptic Wound Spray with Insecticide (benzalkonium chloride, polyhexanide and cypermethrin topical 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: https://www.fda.gov/animal-veterinary/safety-health/new-world-screwworm-information-veterinarians. IV. Electronic Access An electronic version of this document and the full text of the Authorization is available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. BILLING CODE 4164-01-P EN17AP26.000 EN17AP26.001 EN17AP26.002 EN17AP26.003 EN17AP26.004 EN17AP26.005 EN17AP26.006 EN17AP26.007 EN17AP26.008 EN17AP26.009 EN17AP26.010 EN17AP26.011 EN17AP26.012 EN17AP26.013 EN17AP26.014 EN17AP26.015 EN17AP26.016 EN17AP26.017 EN17AP26.018 EN17AP26.019 EN17AP26.020 EN17AP26.021 EN17AP26.022 EN17AP26.023 EN17AP26.024 EN17AP26.025 EN17AP26.026 EN17AP26.027 Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-07509 Filed 4-16-26; 8:45 am]