Index Entries

March 17, 2020
Federal Register
Department of Health and Human Services (HHS)

"Summary: The Secretary is issuing this Declaration pursuant to section 319F–3 of the Public Health Service [PHS] Act to provide liability immunity for activities related to medical countermeasures against COVID–19...

Section III. Activities Covered by This Declaration Under the PREP Act’s Liability Immunity

The Secretary must delineate the activities for which the PREP [Public Readiness and Emergency Preparedness] Act’s liability immunity is in effect. These activities may include, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more Covered Countermeasures (Recommended Activities)... 

Section IV. Limited Immunity

The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, '[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.’ In Section IV of the Declaration, the Secretary states that liability protections are in effect with respect to the Recommended Activities.

Section V. Covered Persons

Section V of the Declaration describes Covered Persons, including Qualified Persons. The PREP Act defines Covered Persons to include, among others, the United States, and those that manufacturer, distribute, administer, prescribe or use Covered Countermeasures...

Section VI. Covered Countermeasures

... The PREP Act states that a ‘Covered Countermeasure’ must be a ‘qualified pandemic or epidemic product,’ or a ‘security countermeasure,’ as described immediately below; or a drug, biological product or device authorized for emergency use.

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