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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices authorizations issued by the Departments 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 Declarations 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.
85 FR 79190 December 9, 2020. On January 28, 2021, the Acting Secretary amended the Declaration to add additional categories of Qualified Persons authorized to prescribe, dispense, and administer COVID19
vaccines that are covered countermeasures under the Declaration 86 FR 7872, February 2, 2021.
The Acting Secretary now amends section V of the Declaration to add a new subsection h to add an additional category of qualified persons covered under the PREP Act, and thus authorizes:
h Any Federal government employee, contractor, or volunteer who prescribes, administers, delivers, distributes or dispenses a Covered Countermeasure. Such Federal government employees, contractors, or volunteers are qualified persons if the following requirement is met: The executive department or agency by or for which the Federal employee, contractor, or volunteer is employed, contracts, or volunteers has authorized or could authorize that employee, contractor, or volunteer to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of the duties or responsibilities of that employee, contractor, or volunteer, even if those authorized duties or responsibilities ordinarily would not extend to members of the public or otherwise would be more limited in scope than the activities such employees, contractors, or volunteers are authorized to carry out under this declaration.

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Description of This Amendment by Section Section V. Covered Persons Under the PREP Act and the Declaration, a qualified person is a covered person. Subject to certain limitations, a covered person is 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 or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure.
Qualified person includes A a licensed health professional or other individual who is authorized to prescribe, administer, or dispense such countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispensed;
or B a person within a category of persons so identified in a declaration by the Secretary under subsection b of the PREP Act. 42 U.S.C. 247d6di8
By this amendment to the Declaration, the Acting Secretary identifies an additional category of persons who are qualified persons under section 247d 6di8B: Federal employees, contractors and volunteers authorized by their Department or agency to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasure as any part of their duties or responsibilities.
The Acting Secretary has determined that there is an urgent need to expand the pool of available COVID19
vaccinators in order to respond effectively to the pandemic. As vaccine supply is made more widely available over the coming months, health care system capacity and the vaccination workforce are likely to become increasingly strained throughout the Nation. The United States is deploying federal personnel, contractors and volunteers to assist in the national COVID19 vaccination program. While the United States is a covered person under the PREP Act and the Declaration, this amendment clarifies that federal employees, contractors and volunteers are also qualified persons authorized by the Secretary to prescribe, dispense, or administer covered countermeasures, consistent with the terms and conditions of the Declaration.
As qualified persons, these employees, contractors and volunteers will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration in addition to the protection that is afforded to the United States as a covered person. Second, to the extent
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that any State law that would otherwise prohibit the employees, contractors, or volunteers who are a qualified person from prescribing, dispensing, or administering COVID19 vaccines or other Covered Countermeasures, such law is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are qualified persons under this declaration, the PREP Act preempts state law that would otherwise prohibit such pharmacists from ordering and administering authorized COVID19
diagnostic tests.1 The opinion relied in part on the fact that the Congressional delegation of authority to the Secretary under the PREP Act to specify a class of persons, beyond those who are authorized to administer a covered countermeasure under State law, as qualified persons would be rendered a nullity in the absence of such preemption. This opinion is incorporated by reference into this declaration. Based on the reasoning set forth in the May 19, 2020 advisory opinion, any State law that would otherwise prohibit a member of any of the classes of qualified persons specified in this declaration from administering a covered countermeasure is likewise preempted. In accordance with section 319F3i8A of the Public Health Service Act, a State remains free to expand the universe of individuals authorized to administer covered countermeasures within its jurisdiction under State law.
The plain language of the PREP Act makes clear that there is preemption of state law as described above.
Furthermore, preemption of State law is justified to respond to the nation-wide public health emergency caused by COVID19 as it will enable States to quickly expand the vaccination workforce with additional qualified healthcare professionals where State or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID19 vaccination program.
1 Department of Health and Human Services General Counsel Advisory Opinion on the Public Readiness and Emergency Preparedness Act, May 19, 2020, available at: https www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments/prep-act-advisory-opinion-hhs-ogc.pdf/
last visited Jan. 24, 2021. See also, Department of Justice Office of Legal Counsel Advisory Opinion for Robert P. Charrow, General Counsel of the Department of Health and Human Services, January 12, 2020, available at: https www.justice.gov/sites/
default/files/opinions/attachments/2021/01/19/
2021-01-19-prep-act-preemption.pdf last visited Jan. 24, 2021.

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