[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14462-14468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Seventh Amendment to Declaration Under the Public Readiness and 
Emergency Preparedness Act for Medical Countermeasures Against COVID-19

ACTION: Notice of amendment.

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[[Page 14463]]

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.

DATES: This amendment to the Declaration is effective as of March 11, 
2021.

FOR FURTHER INFORMATION CONTACT: L. 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; 202-260-0365, [email protected].

SUPPLEMENTARY 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. 
Under the PREP Act, a Declaration may be amended as circumstances 
warrant.
    The PREP Act was enacted on December 30, 2005, as Public Law 109-
148, Division C, section 2. 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. These sections 
are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively. 
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 March 13, 2013 and the Coronavirus Aid, Relief, and Economic 
Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to 
expand Covered Countermeasures under the PREP Act.
    On January 31, 2020, the former Secretary, Alex M. Azar II, 
declared a public health emergency pursuant to section 319 of the PHS 
Act, 42 U.S.C. 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. 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.
    On March 10, 2020, former Secretary Azar issued a Declaration under 
the PREP Act for medical countermeasures against COVID-19 (85 FR 15198, 
Mar. 17, 2020) (the Declaration). 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. 15, 2020). 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. (85 FR 35100, June 8, 2020). 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. (85 FR 52136, August 24, 2020). 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. (85 FR 79190, 
December 9, 2020). On February 2, 2021, the Acting Secretary Norris 
Cochran 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 February 16, 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 9516, February 16, 2021) and on February 22, 2021, 
the Department filed a notice of correction to the February 2 and 
February 16 notices correcting effective dates stated in the 
Declaration, and correcting the description of qualified persons added 
by the February 16, 2021 amendment. (86 FR 10588, February 22, 2021).
    The Acting Secretary now amends section V of the Declaration to 
revise subsection (f) to clarify that observers should be experienced 
in administering intramuscular injections; delete subsection (g), 
change the prior subsection (h) to subsection (g) and add a new 
subsection (h) to add additional categories of qualified persons 
covered under the PREP Act, and thus authorizes: (h) The following 
healthcare professionals and students in a healthcare profession 
training program subject to the requirements of this paragraph:
    1. Any midwife, paramedic, advanced or intermediate emergency 
medical technician (EMT), physician assistant, respiratory therapist, 
dentist, podiatrist, optometrist or veterinarian licensed or certified 
to practice under the law of any state who prescribes, dispenses, or 
administers COVID-19 vaccines that are Covered Countermeasures under 
section VI of this Declaration in any jurisdiction where the PREP Act 
applies in association with a COVID-19 vaccination effort by a State, 
local, Tribal or territorial authority or by an institution in which 
the COVID-19 vaccine covered countermeasure is administered;
    2. Any physician, advanced practice registered nurse, registered 
nurse, practical nurse, pharmacist, pharmacy intern, midwife, 
paramedic, advanced or intermediate EMT, respiratory therapist, 
dentist, physician assistant, podiatrist, optometrist, or veterinarian 
who has held an active license or certification under the law of any 
State within the last five years, which is inactive, expired or lapsed, 
who prescribes, dispenses, or administers COVID-19 vaccines that are 
Covered Countermeasures under section VI of this Declaration in any 
jurisdiction where the PREP Act applies in association with a COVID-19 
vaccination effort by a State, local, Tribal or territorial authority 
or by an institution in which the COVID-19 vaccine covered 
countermeasure is

[[Page 14464]]

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;
    3. Any medical, nursing, pharmacy, pharmacy intern, midwife, 
paramedic, advanced or intermediate EMT, physician assistant, 
respiratory therapy, dental, podiatry, optometry or veterinary student 
with appropriate training in administering vaccines as determined by 
his or her school or training program and supervision by a currently 
practicing healthcare professional experienced in administering 
intramuscular injections who administers COVID-19 vaccines that are 
Covered Countermeasures under section VI of this Declaration in any 
jurisdiction where the PREP Act applies in association with a COVID-19 
vaccination effort by a State, local, Tribal or territorial authority 
or by an institution in which the COVID-19 vaccine covered 
countermeasure is administered;
    Subject to the following requirements:
    i. The vaccine must be authorized, approved, or licensed by the 
FDA;
    ii. Vaccination must be ordered and administered according to 
ACIP's COVID-19 vaccine recommendation(s);
    iii. The healthcare professionals and students must have 
documentation of completion of the Centers for Disease Control and 
Prevention COVID-19 Vaccine Training Modules and, if applicable, such 
additional training as may be required by the State, territory, 
locality, or Tribal area in which they are prescribing, dispensing, or 
administering COVID-19 vaccines;
    iv. The healthcare professionals and students must have 
documentation of an observation period by a currently practicing 
healthcare professional experienced in administering intramuscular 
injections, and for whom administering intramuscular injections is in 
their ordinary scope of practice, who confirms competency of the 
healthcare provider or student in preparation and administration of the 
COVID-19 vaccine(s) to be administered and, if applicable, such 
additional training as may be required by the State, territory, 
locality, or Tribal area in which they are prescribing, dispensing, or 
administering COVID-19 vaccines;
    v. The healthcare professionals and students must have a current 
certificate in basic cardiopulmonary resuscitation; \1\
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    \1\ This requirement is satisfied by, among other things, a 
certification in basic cardiopulmonary resuscitation by an online 
program that has received accreditation from the American Nurses 
Credentialing Center, the ACPE, or the Accreditation Council for 
Continuing Medical Education. The phrase ``current certificate in 
basic cardiopulmonary resuscitation,'' when used in the September 3, 
2020 or October 20, 2020 OASH authorizations, shall be interpreted 
the same way. See Guidance for Licensed Pharmacists and Pharmacy 
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, 
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last 
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified 
Pharmacy Technicians and State-Authorized Pharmacy Interns for 
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, 
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last 
visited Jan. 24, 2021).
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    vi. The healthcare professionals and students must comply with 
recordkeeping and reporting requirements of the jurisdiction in which 
he or she administers vaccines, including informing the patient's 
primary-care provider when available, submitting the required 
immunization information to the State or local immunization information 
system (vaccine registry), complying with requirements with respect to 
reporting adverse events, and complying with requirements whereby the 
person administering a vaccine must review the vaccine registry or 
other vaccination records prior to administering a vaccine; and
    vii. The healthcare professionals and students comply with any 
applicable requirements (or conditions of use) as set forth in the 
Centers for Disease Control and Prevention (CDC) COVID-19 vaccination 
provider agreement and any other federal requirements that apply to the 
administration of COVID- 19 vaccine(s).

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. 247d-6d(i)(8).
    By this amendment to the Declaration, the Acting Secretary 
identifies an additional categories of persons who are qualified 
persons under section 247d-6d(i)(8)(B): licensed healthcare 
professionals who may not ordinarily prescribe, dispense or administer 
vaccines, additional healthcare providers with recently expired 
licenses, and students in a healthcare profession training program, 
subject to appropriate training, supervision, and other specified 
requirements. The Acting Secretary anticipates that significantly more 
vaccines will be available to the public in the spring and summer of 
2021, and wants to ensure that states have the greatest flexibility in 
mobilizing the workforce they will need to engage in the largest 
vaccination effort in our Nation's history. This amendment thus expands 
the pool of vaccinators to individuals who have or can obtain training 
and the capability to administer vaccines even if prescribing, 
dispensing and administering vaccines is not within the scope of their 
license or usual responsibilities, allowing States, Territories, local 
areas and Tribes to use these individuals in their vaccination 
programs.
    The Acting Secretary has determined that there is an urgent need to 
expand the pool of available COVID-19 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.
    As qualified persons, these healthcare professionals and students 
in healthcare profession training programs will be afforded liability 
protections in accordance with the PREP Act and the terms of this 
amended Declaration. Second, to the extent that any State law that 
would otherwise prohibit the healthcare professionals and students in 
healthcare profession training programs who are a ``qualified person'' 
from prescribing, dispensing, or administering COVID-19 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

[[Page 14465]]

``qualified persons'' under this declaration, the PREP Act preempts 
state law that would otherwise prohibit such pharmacists from ordering 
and administering authorized COVID-19 diagnostic tests.\2\ 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 319F-
3(i)(8)(A) 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.
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    \2\ 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-guidance-documents/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, 2021, 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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    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 COVID-19 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 
COVID-19 vaccination program.

Amendments to Declaration

    Amended Declaration for Public Readiness and Emergency Preparedness 
Act Coverage for medical countermeasures against COVID-19.
    Section V of the March 10, 2020 Declaration under the PREP Act for 
medical countermeasures against COVID-19, as amended April 10, 2020, 
June 4, 2020, August 19, 2020, as amended and republished on December 
3, 2020, and as amended on February 2, 2021, is further amended 
pursuant to section 319F-3(b)(4) of the PHS Act as described below. All 
other sections of the Declaration remain in effect as republished at 85 
FR 79190 (December 9, 2020).
    1. Covered Persons, section V, delete in full and replace with:
V. Covered Persons
42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)
    Covered Persons who are afforded liability immunity under this 
Declaration are ``manufacturers,'' ``distributors,'' ``program 
planners,'' ``qualified persons,'' and their officials, agents, and 
employees, as those terms are defined in the PREP Act, and the United 
States. ``Order'' as used herein and in guidance issued by the Office 
of the Assistant Secretary for Health \3\ means a provider medication 
order, which includes prescribing of vaccines, or a laboratory order, 
which includes prescribing laboratory orders, if required. In addition, 
I have determined that the following additional persons are qualified 
persons:
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    \3\ See Guidance for Licensed Pharmacists, COVID-19 Testing, and 
Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at 
https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for 
Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 
Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020, 
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 
2021).
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    (a) Any person authorized in accordance with the public health and 
medical emergency response of the Authority Having Jurisdiction, as 
described in Section VII below, to prescribe, administer, deliver, 
distribute or dispense the Covered Countermeasures, and their 
officials, agents, employees, contractors and volunteers, following a 
Declaration of an Emergency, as that term is defined in Section VII of 
this Declaration; \4\
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    \4\ See, e.g., Guidance for Licensed Pharmacists, COVID-19 
Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020, 
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance 
for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, 
Assisted-Living Facilities, Long-Term-Care Facilities, and other 
Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf (last 
visited Jan. 24, 2021); Guidance for Licensed Pharmacists and 
Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the 
PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act 
Coverage for Qualified Pharmacy Technicians and State-Authorized 
Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and 
COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021); PREP Act 
Authorization for Pharmacies Distributing and Administering Certain 
Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH 
PREP Act Authorizations). Nothing herein shall suggest that, for 
purposes of the Declaration, the foregoing are the only persons 
authorized in accordance with the public health and medical 
emergency response of the Authority Having Jurisdiction.
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    (b) Any person authorized to prescribe, administer, or dispense the 
Covered Countermeasures or who is otherwise authorized to perform an 
activity under an Emergency Use Authorization in accordance with 
Section 564 of the FD&C Act;
    (c) Any person authorized to prescribe, administer, or dispense 
Covered Countermeasures in accordance with Section 564A of the FD&C 
Act;
    (d) A State-licensed pharmacist who orders and administers, and 
pharmacy interns who administer (if the pharmacy intern acts under the 
supervision of such pharmacist and the pharmacy intern is licensed or 
registered by his or her State board of pharmacy),\5\ (1) vaccines that 
the Advisory Committee on Immunization Practices (ACIP) recommends to 
persons ages three through 18 according to ACIP's standard immunization 
schedule or (2) FDA authorized or FDA licensed COVID-19 vaccines to 
persons ages three or older. Such State-licensed pharmacists and the 
State-licensed or registered interns under their supervision are 
qualified persons only if the following requirements are met:
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    \5\ Some states do not require pharmacy interns to be licensed 
or registered by the state board of pharmacy. As used herein, 
``State-licensed or registered intern'' (or equivalent phrases) 
refers to pharmacy interns authorized by the state or board of 
pharmacy in the state in which the practical pharmacy internship 
occurs. The authorization can, but need not, take the form of a 
license from, or registration with, the State board of pharmacy. See 
Guidance for PREP Act Coverage for Qualified Pharmacy Technicians 
and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-
19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2, 
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 
2021).
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    i. The vaccine must be authorized, approved, or licensed by the 
FDA;
    ii. In the case of a COVID-19 vaccine, the vaccination must be 
ordered and administered according to ACIP's COVID-19 vaccine 
recommendation(s);

[[Page 14466]]

    iii. In the case of a childhood vaccine, the vaccination must be 
ordered and administered according to ACIP's standard immunization 
schedule;
    iv. The licensed pharmacist must have completed the immunization 
training that the licensing State requires for pharmacists to order and 
administer vaccines. If the State does not specify training 
requirements for the licensed pharmacist to order and administer 
vaccines, the licensed pharmacist must complete a vaccination training 
program of at least 20 hours that is approved by the Accreditation 
Council for Pharmacy Education (ACPE) to order and administer vaccines. 
Such a training program must include hands on injection technique, 
clinical evaluation of indications and contraindications of vaccines, 
and the recognition and treatment of emergency reactions to vaccines;
    v. The licensed or registered pharmacy intern must complete a 
practical training program that is approved by the ACPE. This training 
program must include hands-on injection technique, clinical evaluation 
of indications and contraindications of vaccines, and the recognition 
and treatment of emergency reactions to vaccines;
    vi. The licensed pharmacist and licensed or registered pharmacy 
intern must have a current certificate in basic cardiopulmonary 
resuscitation; \6\
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    \6\ This requirement is satisfied by, among other things, a 
certification in basic cardiopulmonary resuscitation by an online 
program that has received accreditation from the American Nurses 
Credentialing Center, the ACPE, or the Accreditation Council for 
Continuing Medical Education. The phrase ``current certificate in 
basic cardiopulmonary resuscitation,'' when used in the September 3, 
2020 or October 20, 2020 OASH authorizations, shall be interpreted 
the same way. See Guidance for Licensed Pharmacists and Pharmacy 
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, 
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last 
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified 
Pharmacy Technicians and State-Authorized Pharmacy Interns for 
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, 
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last 
visited Jan. 24, 2021).
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    vii. The licensed pharmacist must complete a minimum of two hours 
of ACPE-approved, immunization-related continuing pharmacy education 
during each State licensing period;
    viii. The licensed pharmacist must comply with recordkeeping and 
reporting requirements of the jurisdiction in which he or she 
administers vaccines, including informing the patient's primary-care 
provider when available, submitting the required immunization 
information to the State or local immunization information system 
(vaccine registry), complying with requirements with respect to 
reporting adverse events, and complying with requirements whereby the 
person administering a vaccine must review the vaccine registry or 
other vaccination records prior to administering a vaccine;
    ix. The licensed pharmacist must inform his or her childhood-
vaccination patients and the adult caregiver accompanying the child of 
the importance of a well-child visit with a pediatrician or other 
licensed primary care provider and refer patients as appropriate; and
    x. The licensed pharmacist and the licensed or registered pharmacy 
intern must comply with any applicable requirements (or conditions of 
use) as set forth in the Centers for Disease Control and Prevention 
(CDC) COVID-19 vaccination provider agreement and any other federal 
requirements that apply to the administration of COVID-19 vaccine(s).
    (e) Healthcare personnel using telehealth to order or administer 
Covered Countermeasures for patients in a state other than the state 
where the healthcare personnel are licensed or otherwise permitted to 
practice. When ordering and administering Covered Countermeasures by 
means of telehealth to patients in a state where the healthcare 
personnel are not already permitted to practice, the healthcare 
personnel must comply with all requirements for ordering and 
administering Covered Countermeasures to patients by means of 
telehealth in the state where the healthcare personnel are permitted to 
practice. Any state law that prohibits or effectively prohibits such a 
qualified person from ordering and administering Covered 
Countermeasures by means of telehealth is preempted.\7\ Nothing in this 
Declaration shall preempt state laws that permit additional persons to 
deliver telehealth services;
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    \7\ See, e.g., Advisory Opinion 20-02 on the Public Readiness 
and Emergency Preparedness Act and the Secretary's Declaration under 
the Act, May 19, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021).
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    (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 the section 
V(d) of this Declaration, who prescribes, dispenses, or administers 
COVID-19 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 COVID-19 vaccination effort by a federal, State, 
local Tribal or territorial authority or by an institution in the State 
in which the COVID-19 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 COVID-19 (CDC) Vaccine Training Modules \8\ and, for 
healthcare providers who are not currently practicing, documentation of 
an observation period by a currently practicing healthcare professional 
experienced in administering intramuscular injections, and for whom 
administering intramuscular injections is in their ordinary scope of 
practice, who confirms competency of the healthcare provider in 
preparation and administration of the COVID-19 vaccine(s) to be 
administered;
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    \8\ See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/training.html.
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    (g) Any member of a uniformed service (including members of the 
National Guard in a Title 32 duty status) (hereafter in this paragraph 
``service member'') or Federal government, employee, contractor, or 
volunteer who prescribes, administers, delivers, distributes or 
dispenses a Covered Countermeasure. Such Federal government service 
members, employees, contractors, or volunteers are qualified persons if 
the following requirement is met: the executive department or agency by 
or for which the Federal service member, employee, contractor, or 
volunteer is employed, contracts, or volunteers has authorized or could 
authorize that service member, employee, contractor, or volunteer to 
prescribe, administer, deliver, distribute, or dispense the Covered 
Countermeasure as any part of the duties or responsibilities of that 
service member, employee, contractor, or volunteer, even if those 
authorized duties or responsibilities ordinarily would not extend to 
members of the

[[Page 14467]]

public or otherwise would be more limited in scope than the activities 
such service member, employees, contractors, or volunteers are 
authorized to carry out under this declaration; and
    (h) The following healthcare professionals and students in a 
healthcare profession training program subject to the requirements of 
this paragraph:
    1. Any midwife, paramedic, advanced or intermediate emergency 
medical technician (EMT), physician assistant, respiratory therapist, 
dentist, podiatrist, optometrist or veterinarian licensed or certified 
to practice under the law of any state who prescribes, dispenses, or 
administers COVID-19 vaccines that are Covered Countermeasures under 
section VI of this Declaration in any jurisdiction where the PREP Act 
applies in association with a COVID-19 vaccination effort by a State, 
local, Tribal or territorial authority or by an institution in which 
the COVID-19 vaccine covered countermeasure is administered;
    2. Any physician, advanced practice registered nurse, registered 
nurse, practical nurse, pharmacist, pharmacy intern, midwife, 
paramedic, advanced or intermediate EMT, respiratory therapist, 
dentist, physician assistant, podiatrist, optometrist, or veterinarian 
who has held an active license or certification under the law of any 
State within the last five years, which is inactive, expired or lapsed, 
who prescribes, dispenses, or administers COVID-19 vaccines that are 
Covered Countermeasures under section VI of this Declaration in any 
jurisdiction where the PREP Act applies in association with a COVID-19 
vaccination effort by a State, local, Tribal or territorial authority 
or by an institution in which the COVID-19 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;
    3. Any medical, nursing, pharmacy, pharmacy intern, midwife, 
paramedic, advanced or intermediate EMT, physician assistant, 
respiratory therapy, dental, podiatry, optometry or veterinary student 
with appropriate training in administering vaccines as determined by 
his or her school or training program and supervision by a currently 
practicing healthcare professional experienced in administering 
intramuscular injections who administers COVID-19 vaccines that are 
Covered Countermeasures under section VI of this Declaration in any 
jurisdiction where the PREP Act applies in association with a COVID-19 
vaccination effort by a State, local, Tribal or territorial authority 
or by an institution in which the COVID-19 vaccine covered 
countermeasure is administered;
    Subject to the following requirements:
    i. The vaccine must be authorized, approved, or licensed by the 
FDA;
    ii. Vaccination must be ordered and administered according to 
ACIP's COVID-19 vaccine recommendation(s);
    iii. The healthcare professionals and students must have 
documentation of completion of the Centers for Disease Control and 
Prevention COVID-19 Vaccine Training Modules and, if applicable, such 
additional training as may be required by the State, territory, 
locality, or Tribal area in which they are prescribing, dispensing, or 
administering COVID-19 vaccines;
    iv. The healthcare professionals and students must have 
documentation of an observation period by a currently practicing 
healthcare professional experienced in administering intramuscular 
injections, and for whom administering vaccinations is in their 
ordinary scope of practice, who confirms competency of the healthcare 
provider or student in preparation and administration of the COVID-19 
vaccine(s) to be administered and, if applicable, such additional 
training as may be required by the State, territory, locality, or 
Tribal area in which they are prescribing, dispensing, or administering 
COVID-19 vaccines;
    v. The healthcare professionals and students must have a current 
certificate in basic cardiopulmonary resuscitation; \9\
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    \9\ This requirement is satisfied by, among other things, a 
certification in basic cardiopulmonary resuscitation by an online 
program that has received accreditation from the American Nurses 
Credentialing Center, the ACPE, or the Accreditation Council for 
Continuing Medical Education. The phrase ``current certificate in 
basic cardiopulmonary resuscitation,'' when used in the September 3, 
2020 or October 20, 2020 OASH authorizations, shall be interpreted 
the same way. See Guidance for Licensed Pharmacists and Pharmacy 
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act, 
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last 
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified 
Pharmacy Technicians and State-Authorized Pharmacy Interns for 
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, 
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last 
visited Jan. 24, 2021).
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    vi. The healthcare professionals and students must comply with 
recordkeeping and reporting requirements of the jurisdiction in which 
he or she administers vaccines, including informing the patient's 
primary-care provider when available, submitting the required 
immunization information to the State or local immunization information 
system (vaccine registry), complying with requirements with respect to 
reporting adverse events, and complying with requirements whereby the 
person administering a vaccine must review the vaccine registry or 
other vaccination records prior to administering a vaccine; and
    vii. The healthcare professionals and students comply with any 
applicable requirements (or conditions of use) as set forth in the 
Centers for Disease Control and Prevention (CDC) COVID-19 vaccination 
provider agreement and any other federal requirements that apply to the 
administration of COVID-19 vaccine(s).
    Nothing in this Declaration shall be construed to affect the 
National Vaccine Injury Compensation Program, including an injured 
party's ability to obtain compensation under that program. Covered 
countermeasures that are subject to the National Vaccine Injury 
Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are 
covered under this Declaration for the purposes of liability immunity 
and injury compensation only to the extent that injury compensation is 
not provided under that Program. All other terms and conditions of the 
Declaration apply to such covered countermeasures.
    2. Effective Time Period, section XII, delete in full and replace 
with:
    Liability protections for any respiratory protective device 
approved by NIOSH under 42 CFR part 84, or any successor regulations, 
through the means of distribution identified in Section VII(a) of this 
Declaration, begin on March 27, 2020 and extend through October l, 
2024.
    Liability protections for all other Covered Countermeasures 
identified in Section VI of this Declaration, through means of 
distribution identified in Section VII(a) of this Declaration, begin on 
February 4, 2020 and extend through October l, 2024.
    Liability protections for all Covered Countermeasures administered 
and used in accordance with the public health and medical response of 
the Authority Having Jurisdiction, as

[[Page 14468]]

identified in Section VII(b) of this Declaration, begin with a 
Declaration of Emergency as that term is defined in Section VII (except 
that, with respect to qualified persons who order or administer a 
routine childhood vaccination that ACIP recommends to persons ages 
three through 18 according to ACIP's standard immunization schedule, 
liability protections began on August 24, 2020), and last through (a) 
the final day the Declaration of Emergency is in effect, or (b) October 
l, 2024, whichever occurs first.
    Liability protections for all Covered Countermeasures identified in 
Section VII(c) of this Declaration begin on December 9, 2020 and last 
through (a) the final day the Declaration of Emergency is in effect, or 
(b) October l, 2024, whichever occurs first.
    Liability protections for Qualified Persons under section V(f) of 
the declaration begin on February 2, 2021, and last through October 1, 
2024.
    Liability protections for Qualified Persons under section V(g) of 
the declaration begin on February 16, 2021, and last through October 1, 
2024.
    Liability protections for Qualified Persons who are physicians, 
advanced practice registered nurses, registered nurses, or practical 
nurses under section V(h) of the declaration begins on February 2, 2021 
and last through October 1, 2024, with additional conditions effective 
as of March 11, 2021 and liability protections for all other Qualified 
persons under section V(h) begins on March 11, 2021 and last through 
October 1, 2024.

    Authority: 42 U.S.C. 247d-6d.

Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-05401 Filed 3-11-21; 4:15 pm]
BILLING CODE 4150-37-P