![]() ![]() On January 28, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID-19 vaccines that are covered countermeasures under the Declaration (86 FR 7872, February 2, 2021). On December 3, 2020, the former Secretary amended the declaration to incorporate Advisory Opinions of the General Counsel interpreting the PREP Act and the Secretary’s Declaration and authorizations issued by the Department’s Office of the Assistant Secretary for Health as an Authority Having Jurisdiction to respond added an additional category of qualified persons under Section V of the Declaration made explicit that the Declaration covers all qualified pandemic and epidemic products as defined under the PREP Act added a third method of distribution to provide liability protections for, among other things, private distribution channels made explicit that there can be situations where not administering a covered countermeasure to a particular individual can fall within the PREP Act and the Declaration’s liability protections made explicit that there are substantive federal legal and policy issues and interests in having a unified whole-of-nation response to the COVID-19 pandemic among federal, state, local, and private-sector entities revised the effective time period of the Declaration and republished the declaration in full. ![]() On August 19, the former Secretary amended the declaration to add additional categories of Qualified Persons and amend the category of disease, health condition, or threat for which he recommended the administration or use of the Covered Countermeasures. On June 4, the former Secretary amended the Declaration to clarify that covered countermeasures under the Declaration include qualified countermeasures that limit the harm COVID–19 might otherwise cause. On April 10, the former Secretary amended the Declaration under the PREP Act to extend liability immunity to covered countermeasures authorized under the CARES Act (85 FR 21012, Apr. On March 10, 2020, former Secretary Azar issued a Declaration under the PREP Act for medical countermeasures against COVID–19 (85 FR 15198, Mar. ![]() ![]() Pursuant to section 319 of the PHS Act, the Secretary renewed that declaration effective on April 26, 2020, July 25, 2020, October 23, 2020, and January 21, 2021. 247d, effective January 27, 2020, for the entire United States to aid in the response of the nation’s health care community to the COVID–19 outbreak. Azar II, declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. On January 31, 2020, the former Secretary, Alex M. Section 319F–3 of the PHS Act has been amended by the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113–5, enacted on Maand the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116–136, enacted on March 27, 2020, to expand Countermeasures under the PREP Act. 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. The PREP Act was enacted on December 30, 2005, as Public Law 109– 148, Division C, § 2. Under the PREP Act, a Declaration may be amended as circumstances warrant. Paige Ezernack, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201 20, INFORMATION:The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving ‘‘willful misconduct’’ as defined in the PREP Act. SUMMARY: The Acting Secretary issues this amendment pursuant to section 319F–3 of the Public Health Service Act to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration.ĭATES: This amendment is effective as of February 10, 2021.įOR FURTHER INFORMATION CONTACT: L. DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Sixth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19 ![]()
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