FDA联邦公报公告四种动物药获新世界螺旋蝇(NWS)紧急使用授权，但授权实为2026年8–9月已签发，今日仅为程序性刊登

4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0004]
Authorization of Emergency Use for Four Animal Drugs for the Prevention and Treatment
of New World Screwworm; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the
issuance of four 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 Elanco US Inc. for application on or around wounds for the
prevention of infestations caused by New World screwworm (Cochliomyia hominivorax; NWS)
larvae (myiasis) in sheep, cattle, goats, swine, camelids, and the following captive and captured
wildlife species: cervids, American bison, bighorn sheep, and Sonoran pronghorn. FDA has
issued one EUA for an animal product as requested by Zoetis Inc. for the treatment of
infestations caused by NWS (myiasis) in dogs and puppies. FDA has issued one EUA for an
animal product as requested by Bimeda Animal Health Ltd. for the prevention of infestations
caused by NWS (myiasis) in cattle. FDA has issued one EUA for an animal product as requested
by Sergeant’s Pet Care Products LLC for the treatment and prevention of infestations caused by
NWS (myiasis) in dogs, puppies, cats and kittens 2 pounds of body weight or greater and 4
weeks of age and older. 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: August 7, 2026, August 13,
2026, August 27, 2026, and September 3, 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, Crystal.Groesbeck@fda.hhs.gov.
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.
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

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).

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), FDA2
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

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.

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.
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 August 7, 2026, FDA issued an EUA to Elanco US Inc. for the animal product
CLiK Extra (dicyclanil topical suspension) wound spray, subject to the terms of its
Authorization. On August 13, 2026, FDA issued an EUA to Zoetis Inc. for the animal product
Simparica TRIO (sarolaner, moxidectin, and pyrantel chewable tablets), subject to the terms of
its Authorization. On August 27, 2026, FDA issued an EUA to Bimeda Animal Health Ltd. for
the animal product Bimectin (ivermectin) injection, subject to the terms of its Authorization. On
September 3, 2026, FDA issued an EUA to Sergeant’s Pet Care Products LLC for the animal
product CAPSTAR (nitenpyram) tablets, 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-informationveterinarians.
IV. Electronic Access
An electronic version of this document and the full text of the Authorizations are
available on the internet at: https://www.fda.gov/emergency-preparedness-and-response/mcmlegal-regulatory-and-policy-framework/emergency-use-authorization.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-21084 Filed: 10/14/2026 8:45 am; Publication Date: 10/15/2026]