Declaration under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

May 11, 2023 – About 1 hour ago, HHS filed the Eleventh Amendment to Declaration Under the Public Readiness and Emergency.  It is scheduled for publication in tomorrow’s Federal Register. The Amendment is effective today.

The Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to update the determination of a public health emergency and clarify the disease threat, 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, extend the duration of the Declaration to December 31, 2024, and to republish the Declaration in full.

The Amendment chronicles the PHE in relation to authorization of the PHE and the resulting actions taken to protect the citizens of the U.S.  It also provides details as to actions going forward at the end of the declared PHE, starting in the middle of page 4.

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. 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, § 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 sections This document is scheduled to be published in the Federal Register on 05/12/2023 and available online at, and on are codified at 42 U.S.C. 247d–6d and 42 U.S.C. 247d–6e, respectively. 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 March 13, 2013, and the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116–136, enacted on March 27, 2020, to expand Covered Countermeasures under the PREP Act.

Following the historical actions, the HHS Secretary speaks to the purpose of this Eleventh Amendment. There is a lot of information in this 31-page Amendment filing.

You’ll also find access to this Federal Register publication on the Briggs COVID-19 Resources webpage.