Eleventh Amendment to the Declaration under the PREP Act for COVID-19 Medical Countermeasures On May 9, 2023, Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issues 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. A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations. The end of the COVID-19 Public Health Emergency Declaration does not automatically terminate PREP Act coverage. To learn more, view our COVID-19 PREP Act FAQs. PREP Act
Update
The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:
COVID-19 PREP Act Declarations
Declaration and Amendments
Advisory Opinions of the General Counsel
HHS Guidance
Other Current PREP Act Declarations Smallpox, Mpox, and Other Orthopox
Viral Hemorrhagic Fevers
Nerve Agents and Insecticides
Zika Virus
Pandemic Influenza
Anthrax
Acute Radiation Syndrome
About the PREP Act
PREP Act Frequently Asked Questions
Expanding the COVID-19 Vaccination Workforce
FAQs
What is the purpose of the Public Readiness and Emergency Preparedness Act? ›
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 ...
Is the PREP Act still active? ›On May 9, 2023—two days before the Secretary terminated the Section 319 PHE—HHS issued the Eleventh Amendment to the Declaration. This amendment, first announced on April 14, 2023, extends PREP Act immunity for certain COVID-19 countermeasures through December 31, 2024.
What is the immunity under the PREP Act? ›Public Readiness and Emergency Preparedness (PREP) Act
The declaration provides immunity from liability (except for willful misconduct) for claims: of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions.
A PREP Act declaration provides immunity from tort liability claims (except willful misconduct) to individuals or organizations involved in the manufacture, distribution, or dispensing of medical countermeasures.
What is the primary purpose of the emergency preparedness Program? ›The function of these plans is to ensure everyone's safety during an emergency. If there is a fire, a dangerous individual on the grounds, or a natural disaster, the school needs to determine how it will proceed in these circ*mstances.
What is willful misconduct under the PREP Act? ›It is defined in the PREP Act as an act or failure to act that is taken: intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and. in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
What are the exceptions to the PREP Act? ›The only exception to liability immunity under the PREP Act is a claim for willful misconduct, which is defined in the PREP Act as an act or omission that is taken (i) intentionally to achieve a wrongful purpose; (ii) knowingly without legal or factual justification; and (iii) in disregard of a known or obvious risk ...
When must emergency preparedness drills be conducted? ›Emergency preparedness drills must be conducted as frequently as necessary. The frequency of drills will depend on various factors such as the specific emergency situations that need to be prepared for, the level of risk in the area, and any legal or regulatory requirements.
Is EUA still in effect? ›Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met. For additional resources from HHS, see: COVID-19 Public Health Emergency (PHE).
What is qualified immunity in the 4th Amendment? ›The Supreme Court has held that use of force by police and correctional officers violates the Fourth Amendment when it is “excessive.” Police and correctional officers receive qualified immunity if it isn't clearly established that their use of force was excessive.
What is the Prep Coverage Act? ›
Introduced in House (06/27/2023) This bill requires private health insurance plans to cover prescription drugs that prevent HIV, including related screenings, diagnostic procedures, administrative fees, and clinical follow-ups, without any cost-sharing obligation for the plan holder.
What is the new qualified immunity? ›Qualified immunity is a judicial doctrine developed by the Supreme Court that shields public officials from liability for misconduct, even when they have broken the law.
What is the rule 33 in Minnesota? ›Rule 33.
Interrogatories may, without leave of court, be served upon any party after service of the summons and complaint. No party may serve more than a total of 50 interrogatories upon any other party unless permitted to do so by the court upon motion, notice and a showing of good cause.
Interpleader. Persons having claims against the plaintiff may be joined as defendants and required to interplead, in an action brought for that purpose, when their claims are such that the plaintiff is or may be exposed to multiple liability.
What is the rule 21 in Minnesota? ›Rule 21.
Parties may be dropped or added by order of the court on motion of any party or upon the court's own initiative at any stage of the action and on such terms as are just. Any claim against a party may be severed and proceeded with separately.
An emergency plan specifies procedures for handling sudden or unexpected situations. The objective is to be prepared to: Prevent fatalities and injuries. Reduce damage to buildings, stock, and equipment.
What was the purpose of the Federal emergency Act? ›The act established the Federal Emergency Relief Administration, a grant-making agency authorized to distribute federal aid to the states for relief. By the end of December 1935, FERA had distributed over $3.1 billion and employed more than 20 million people.
What is the one main purpose of the emergency planning process? ›These efforts can stop an emergency event from happening or reduce the impact of an incident that does occur. Emergency planning can also help schools identify and address gaps in procedures and empower school staff and local first responders to understand and manage their responsibilities.
What is the purpose of the disaster preparedness program? ›Preparing for disasters saves countless lives, speeds up people's recovery and saves money. The IFRC supports National Societies to continually improve their local preparedness and response capacity—ultimately preventing and reducing the impacts of disasters on communities.