AMENDED DETERMINATION OF A 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 April 19, 2013, pursuant to section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), former Secretary Sebelius determined 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 the avian influenza A (H7N9) virus.

I amend the April 19, 2013, determination of a significant potential for a public health emergency involving the avian influenza A (H7N9) virus, pursuant to section 564(b)(1)(C) of the FD&C Act, and 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 biological agents, namely pandemic influenza A viruses and influenza A viruses with pandemic potential. Because H7N9 is an influenza A virus with pandemic potential, the declaration issued on April 19, 2013, pursuant to section 564(b)(1) of the FD&C Act that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of avian influenza A (H7N9) virus, and that is based on the April 19, 2013, determination, remains in effect until that declaration is terminated in accordance with section 564 of the FD&C Act.