2023-02872: Termination of Declaration Authorizing Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68

Summary

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 February 6, 2015, pursuant to section 564 of the FD&C Act, Sylvia M. Burwell, former Secretary of HHS, determined that there was a significant potential for a public health emergency that had a significant potential to affect national security or the health and security of United States citizens living abroad and that involved enterovirus D68 (EV-D68). Also on February 6, 2015, based on that determination, former Secretary Burwell declared that circumstances existed justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68 pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. As of September 2022, the Centers for Disease Control and Prevention's (CDC's) EV-D68 2014 rRT-PCR for which an EUA was issued is no longer produced and all test kits were destroyed. CDC's EV-D68 2014 rRT-PCR was never distributed. On February 6, 2023, pursuant to section 564 of the FD&C Act, the Secretary of HHS determined that there is no longer 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 EV-D68. The Secretary of HHS also determined that circumstances justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68 no longer exist. Based on these determinations, the Secretary of HHS terminated the declaration, effective February 20, 2023, that circumstances justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68 exist.

The agency’s own summary, as published.