42 C.F.R. § 110.1
This part implements the Public Readiness and Emergency Preparedness Act (PREP Act), which amended the Public Health Service Act (herein after "PHS Act" or "the Act") by including section 319F-3, and section 319F-4 entitled "Covered Countermeasure Process." Section 319F-4 of the PHS Act directs the Secretary of Health and Human Services, following issuance of a declaration under section 319F-3(b), to establish procedures for the Countermeasures Injury Compensation Program (herein after "CICP" or "the Program") to provide medical and lost employment income benefits to certain individuals who sustained a covered injury as the direct result of the administration or use of a covered countermeasure consistent with a declaration issued pursuant to section 319F-3(b), or in the good faith belief that administration or use of the covered countermeasure was consistent with a declaration. Also, if the Secretary determines that an individual died as a direct result of a covered injury, the Act provides for certain survivors of that individual to receive death benefits.
42 C.F.R. § 110.1