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 nerve agents or certain insecticides (organophosphorus and/or carbamate).
On the basis of this determination, I also hereby declare that circumstances exist justifying the authorization of emergency use of injectable treatments for nerve agent or certain insecticide (organophosphorus and/or carbamate) poisoning pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act, subject to the terms of any authorization issued under that section.
/s/
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Thomas E. Price, M.D. |
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April 11, 2017
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Date |
