"ACTION:
Notice of amendment.
SUMMARY:
The Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to extend the duration of the Declaration to December 31, 2029, and to republish the Declaration in full.
DATES:
This amendment is effective as of January 1, 2025.
SUPPLEMENTARY INFORMATION:
The Public Readiness and Emergency Preparedness (PREP) Act authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving 'willful misconduct' as defined in the PREP Act. Under the PREP Act, a Declaration may be amended as circumstances warrant.
On January 31, 2020, the former Secretary, Alex M. Azar II, declared a public health emergency (PHE) pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation's health care community to the COVID-19 outbreak... The PHE declared under section 319 of the PHS Act ended on May 11, 2023. Nonetheless, as stated in section I of this amended PREP Act Declaration, [HHS Secretary Becerra has] determined there is a credible risk that COVID-19 may in the future constitute such an emergency and [is] amending this Declaration to prepare for and mitigate that risk."