The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564(b) of the Federal Food, Drug, and Cosmetic (FD) Act, 21 U.S.C. 360bbb-3(b)(4). On April 19, 2013, the Secretary 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.
On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A (H7N9) virus pursuant to section 564(b)(1) of the FD&C Act, 21 U.S.C. § 360bbb-3(b)(1), subject to the terms of any authorization issued under that section. The Secretary also specified that this declaration is a declaration of an emergency with respect to in vitro diagnostics as defined under 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 on December 17, 2008.1