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

On February 4, 2020, pursuant to section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), former Secretary Azar determined that there is 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 a novel (new) coronavirus (nCOV) first detected in Wuhan City, Hubei Province, China in 2019.

I amend the February 4, 2020 determination of a public health emergency pursuant to section 564(b)(1)(C) of the FD&C Act to determine, pursuant to section 564(b)(1)(C) of the FD&C Act that there is a public health emergency, or 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 and that involves a biological agent, namely the novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV, or SARS-CoV-2). The declarations issued pursuant to section 564(b)(1) of the FD&C Act that circumstances exist justifying the authorization of emergency use of certain in vitro diagnostics, personal respiratory protective devices, other medical devices and drugs and biological products, as set forth in those declarations, and that are based on the February 4, 2020 determination, remain in effect until those declarations are terminated in accordance with section 564 of the FD&C Act.