DECLARATION THAT CIRCUMSTANCES EXIST JUSTIFYING AUTHORIZATIONS PURSUANT TO SECTION 564 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. § 360bbb-3(b)
As of this date, on the basis of my August 9, 2022 determination 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, I hereby declare that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola
Orthopoxvirus, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
September 7, 2022