Determination of a 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 a 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.

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 avian influenza A (H7N9) virus pursuant to section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, 21 U.S.C. § 360bbb-3 subject to the terms of any authorization issued under that section.

This declaration is a declaration of an emergency with respect to in vitro diagnostics as defined in the Public Readiness and Emergency Preparedness (PREP) Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt, December 17, 2008.

April 19, 2013 _____________________________ Date

/s/ _____________________________ Kathleen Sebelius ​