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 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 Middle East respiratory syndrome coronavirus (MERS-CoV).
On the basis of this determination, I also hereby declare that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Middle East respiratory syndrome coronavirus (MERS-CoV) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, subject to the terms of any authorization issued under that section.
May 29, 2013