15198Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices Ohio, Court of Federal Claims No: 20 0225V 71. Shannon Peers, Dresser, Pennsylvania, Court of Federal Claims No: 200231V.

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What is the PREP Act for immunity?

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.

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 are codified at 42 U.S.C. 247d–6d and 42 U.S.C.

For countermeasures falling under Section VII(a)—those relating to federal contracts or other federal agreements—PREP Act immunity generally extends through October 1, 2024.

The PREP Act specifies four types of covered countermeasures: (i) a qualified “pandemic or epidemic product”; (ii) a “security countermeasure”; (iii) a drug, biological product, or device that the U.S. Food and Drug Administration Page 3 Congressional Research Service 3 (FDA) has authorized for emergency use; and (iv) ...

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