Office of the Secretary; Emergency Use Authorization; Monkeypox Virus Vaccine
Primary source
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Issuing agencies
Abstract
The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On August 9, 2022, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad that involves monkeypox virus. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of vaccines for use against monkeypox virus pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.
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