Doctor discharge letter template8/26/2023 COVID-19 PREP Act Declarations and Amendments (HHS).Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020).The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024. On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The HHS Secretary has issued several Declarations pursuant to section 319F-3 of the PHS Act to provide liability immunity for activities related to medical countermeasures against COVID-19. The PREP Act amended the Public Health Service Act (PHS Act) to add section 319F-3 (42 U.S.C. Information on the PREP Act can be found here. Public Readiness and Emergency Preparedness Act (PREP Act) Information on terminated and revoked EUAs can be found in archived information. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below. On February 4, 2020, the HHS Secretary determined that there is 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 virus that causes COVID-19. Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense. Learn more about these health care information forms for individuals from the Internal Revenue Service.Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.
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