12th Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Office of the Secretary ACTION: Notice of amendment. SUMMARY: The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to ( printed page 99876) 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. FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Administration for Strategic Preparedness and Response, U.S. Department of Health and Human Services, 400 7th St. SW, Washington, DC 20024; 202-260-0365, paige.ezernack@hhs.gov . 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. The PREP Act was enacted on December 30, 2005, as Public Law 109-148 , Division C, section 2. It amended the Public Health Service (PHS) Act, adding section 319F-3, which addresses liability immunity, and section 319F-4, which creates a compensation program. These s…