The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a declaration (PREP Act declaration) that 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 determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. 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.
Public Readiness and Emergency Preparedness Act (PREP) Act Declarations
- Ebola Virus Disease Vaccines – December 3, 2014 – Notice of Declaration under the Public Readiness and Emergency Preparedness Act
- Pandemic Influenza Vaccine – Notice of Amendment to the March 1, 2010 Republished Declaration under the Public Readiness and Emergency Preparedness Act
Original Declaration and Past Amendments:
– Amendment to Pandemic Influenza Vaccine (to add additional provisions) – March 1, 2010 – Public Readiness and Emergency Preparedness (PREP) Act Declaration
– H5N1 Pandemic Influenza Vaccine – January 26, 2007- Public Readiness and Emergency Preparedness Act (PREP) Act Declaration
– Amendment to H5N1 Pandemic Influenza Vaccine (to add H7 and H9) – November 21, 2007- Public Readiness and Emergency Preparedness (PREP) Act Declaration
– Amendment to Pandemic Influenza Vaccine (to add H2, H6, H7, H9) – October 17, 2008- Public Readiness and Emergency Preparedness (PREP) Act Declaration
– Amendment to H5N1 Pandemic Influenza Vaccine (to add H1N1) – June 15, 2009 – Public Readiness and Emergency Preparedness (PREP) Act Declaration
– Amendment to H5N1 Pandemic Influenza Vaccine (to add additional provisions) – September 28, 2009 – Public Readiness and Emergency Preparedness (PREP) Act Declaration - Anthrax Countermeasures – October 1, 2008- Public Readiness and Emergency Preparedness (PREP) Act Declaration
- Botulism Countermeasures – October 17, 2008- Public Readiness and Emergency Preparedness (PREP) Act Declaration
- Pandemic Antiviral Countermeasures – October 17, 2008- Public Readiness and Emergency Preparedness (PREP) Act Declaration
- Smallpox Countermeasures – October 17, 2008- Public Readiness and Emergency Preparedness (PREP) Act Declaration
- Acute Radiation Syndrome Countermeasures – October 17, 2008- Public Readiness and Emergency Preparedness (PREP) Act Declaration
- Pandemic Influenza Diagnostics, Personal Respiratory, Protection Devices and Respiratory Support Devices – December 22, 2008 – Public Readiness and Emergency Preparedness (PREP) Act Declaration
