DETERMINATION OF A SIGNIFICANT POTENTIAL FOR A PUBLIC HEALTH EMERGENCY AND DECLARATION THAT CIRCUMSTANCES EXIST JUSTFYING AN AUTHORIZATION PURSUANT TO SECTION 564(b) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. § 360bbb-3(b)

Pursuant to section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), I hereby determine 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).

On the basis of this determination, I also hereby declare that circumstances exist justifying the authorization of emergency use of animal drugs to treat or prevent New World Screwworm myiasis in animals, pursuant to section 564(b)(1) of the FD&C Act, subject to the terms of any authorization issued under that section.