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Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices Secretarys Declaration and 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.
The Acting Secretary now amends section V of the Declaration to add additional categories of qualified persons covered under the PREP Act, and thus authorizes:
f Any healthcare professional or other individual who holds an active license or certification permitting the person to prescribe, dispense, or administer vaccines under the law of any State as of the effective date of this amendment, or as authorized under section Vd of this Declaration, who prescribes, dispenses, or administers COVID19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies, other than the State in which the license or certification is held, in association with a COVID19 vaccination effort by a federal, State, local, Tribal, or territorial authority or by an institution in the State in which the COVID19 vaccine covered countermeasure is administered, so long as the license or certification of the healthcare professional has not been suspended or restricted by any licensing authority, surrendered while under suspension, discipline or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to:
i Documentation of completion of the Centers for Disease Control and Prevention COVID19 CDC Vaccine
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Training Modules 1 and, for healthcare providers who are not currently practicing, documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID
19 vaccines to be administered; and g Any physician, advanced practice registered nurse, registered nurse, or practical nurse who has held an active license or certification to prescribe, dispense, or administer vaccines under the law of any State within the last five years, which is inactive, expired or lapsed, who prescribes, dispenses, or administers COVID19 vaccines that are Covered Countermeasures under section VI of this Declaration in any jurisdiction where the PREP Act applies in association with a COVID19
vaccination effort by a federal, State, local, tribal or territorial authority or by an institution in which the COVID19
vaccine covered countermeasure is administered, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline, or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of Inspector General, subject to i documentation of completion of the Centers for Disease Control and Prevention COVID19 Vaccine Training Modules and ii documentation of an observation period by a currently practicing healthcare professional adequately experienced in vaccination who confirms competency of the healthcare provider in preparation and administration of the particular COVID
19 vaccines to be administered.
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 1 See COVID19 Vaccine Training Modules, available at https www.cdc.gov/vaccines/covid-19/
training.html.

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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 two additional categories of persons who are qualified persons under section 247d 6di8B, allowing healthcare providers who are licensed in a State to prescribe, dispense, and/or administer COVID19 vaccines in any State or jurisdiction where the PREP Act applies, and allowing physicians, registered nurses, and practical nurses whose licenses expired within the past five years to prescribe, dispense, and/or administer COVID19 vaccines in any State.
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. Permitting Physicians, registered nurses, and practical nurses who have recently expired licenses also significantly expands the vaccination workforce. There are approximately 160,000 inactive physicians and 350,000
inactive registered nurses and practical nurses in the United States.
These healthcare professionals can safely administer COVID19 vaccines because they all have training in performing injections and observing for side effects and will be required to document completion of the Centers for Disease Control and Prevention CDC
COVID19 Vaccine Training Modules.
Including these healthcare professionals as Qualified Persons under this amended Declaration achieves two purposes. First, the healthcare professionals will be afforded liability protections in accordance with the PREP Act and the terms of this amended Declaration. Second, any State law that would otherwise prohibit the healthcare professionals who are a qualified person from prescribing, dispensing, or administering COVID19
vaccines is preempted. On May 19, 2020, the Office of the General Counsel issued an advisory opinion concluding that, because licensed pharmacists are
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