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Office of the Secretary Pandemic Influenza Vaccines--Amendment

Original post made by Daniel, Another Pleasanton neighborhood, on Aug 30, 2009

[Federal Register: June 25, 2009 (Volume 74, Number 121)]

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Posted by Daniel
a resident of Another Pleasanton neighborhood
on Aug 30, 2009 at 8:58 am

Countermeasures Injury Compensation Program

About the Public Readiness and Emergency Preparedness Act (PREP Act)
full-text Public Readiness and Emergency Preparedness Act (PREP Act)
The PREP Act provides compensation to individuals for serious physical injuries or deaths from pandemic, epidemic, or security countermeasures identified in a declaration issued by the Secretary pursuant to section 319F-3(b) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d-6d). The PREP Act which is a part of the “Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza Act of 2006” (PL 109-148), was enacted on December 30, 2005, and confers broad liability protections on covered persons, as defined in section 319F-3(i)(2) of the PHS Act, and compensation to individuals injured by the receipt of covered countermeasures, as defined in section 319F-3(i)(1) of the PHS Act, in the event of designated public health emergencies.

Passed primarily to address the pandemic influenza threat, the PREP Act provides liability protections after a Secretarial declaration of covered countermeasures for any disease or health condition that the Secretary views as constituting a public health emergency, either presently or in the future. Liability protections cover the manufacture, testing, development, distribution, or use of the designated covered countermeasure absent willful misconduct as defined in section 319F-3(c)(1) of the PHS Act. A Secretarial declaration specifies the categories of health threats or conditions for which countermeasures are recommended, the period liability protections are in effect, the population of individuals protected, and the geographic areas for which the protections are in effect.

In addition to liability protections, the PREP Act provides the Secretary the authority, which was delegated by the Secretary on November 8, 2006 to the Administrator of the Health Resources and Services Administration, to compensate eligible individuals for covered injuries from a covered countermeasure


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