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 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
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/s/
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Kathleen Sebelius |
