![]() On January 31, 2020, the former Secretary, Alex M. Section 319F–3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, enacted on Maand the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116–136, enacted on March 27, 2020, to expand Countermeasures under the PREP Act. 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. The PREP Act was enacted on December 30, 2005, as Public Law 109– 148, Division C, § 2. ![]() Under the PREP Act, a Declaration may be amended as circumstances warrant. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201 20, INFORMATION:The Public Readiness and Emergency Preparedness Act (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. SUMMARY: The Acting Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration.ĭATES: This amendment is effective as of February 10, 2021.įOR FURTHER INFORMATION CONTACT: L. DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Sixth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19
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