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

As of this date, I hereby determine pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act 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 United States citizens living abroad that involves monkeypox virus.

On the basis of this determination, I hereby declare that circumstances exist justifying the authorization of emergency use of vaccines pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.