[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Notices]
[Pages 41977-41982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Eighth 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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SUMMARY: The Secretary issues this amendment pursuant to section 319F-3 
of the Public Health Service Act to clarify and expand the authority 
for certain Qualified Persons authorized to prescribe, dispense, and 
administer covered countermeasures under section VI of this 
Declaration.

DATES: This amendment is effective as of August 4, 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, Sec.  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, January 21, 2021, April 21, 2021 and July 
20, 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

[[Page 41978]]

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). On March 11, 2021, the Acting Secretary amended the 
Declaration to add additional Qualified Persons authorized to 
prescribe, dispense, and administer covered countermeasures under the 
Declaration. (86 FR 14462 March 16, 2021).
    Secretary Xavier Becerra now amends section V of the Declaration to 
revise subsections (d) and (f) to clarify that qualified pharmacy 
technicians are Qualified Persons covered by the Declaration, and to 
expand the scope of authority for qualified pharmacy technicians to 
administer seasonal influenza vaccines to adults within the state where 
they are authorized to practice and for interns to administer seasonal 
influenza vaccines to adults consistent with other terms and conditions 
of the Declaration.
    Accordingly, subsection V(d) authorizes:
    (d) A State-licensed pharmacist who orders and administers, and 
pharmacy interns and qualified pharmacy technicians who administer (if 
the pharmacy intern or technician acts under the supervision of such 
pharmacist and the pharmacy intern or technician is licensed or 
registered by his or her State board of pharmacy),\1\ (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) seasonal influenza vaccine administered by qualified 
pharmacy technicians and interns that the ACIP recommends to persons 
aged 19 and older according to ACIP's standard immunization schedule; 
or (3) 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 or technicians under their supervision 
are qualified persons only if the following requirements are met:
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    \1\ 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. 
Similarly, states vary on licensure and registration requirements 
for pharmacy technicians. Some states require certain education, 
training, and/or certification for licensure or registration; others 
either have no prerequisites for licensure or registration or do not 
require licensure or registration at all. As used herein, to be a 
``qualified pharmacy technician,'' pharmacy technicians working in 
states with licensure and/or registration requirements must be 
licensed and/or registered in accordance with state requirements; 
pharmacy technicians working in states without licensure and/or 
registration requirements must have a Certified Pharmacy Technician 
(CPhT) certification from either the Pharmacy Technician 
Certification Board or National Healthcareer Association. 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);
    iii. In the case of a childhood vaccine, the vaccination must be 
ordered and administered according to ACIP's standard immunization 
schedule;
    iv. In the case of seasonal influenza vaccine administered by 
qualified pharmacy technicians and interns, the vaccination must be 
ordered and administered according to ACIP's standard immunization 
schedule;
    v. In the case of pharmacy technicians, the supervising pharmacist 
must be readily and immediately available to the immunizing qualified 
pharmacy technician;
    vi. 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;
    vii. The licensed or registered pharmacy intern and qualified 
pharmacy technician 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;
    viii. The licensed pharmacist, licensed or registered pharmacy 
intern and qualified pharmacy technician must have a current 
certificate in basic cardiopulmonary resuscitation; \2\
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    \2\ 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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    ix. The licensed pharmacist must complete a minimum of two hours of 
ACPE-approved, immunization-related continuing pharmacy education 
during each State licensing period;
    x. 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),

[[Page 41979]]

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;
    xi. 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
    xii. The licensed pharmacist, the licensed or registered pharmacy 
intern and the qualified pharmacy technician 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).
    Further, the initial phrase of subsection V(f) is revised to state 
authorize ``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 a pharmacist or pharmacy intern as 
authorized under the section V(d) of this Declaration. . . .''

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 Secretary clarifies and 
expands the authorization for a category of persons who are qualified 
persons under section 247d-6d(i)(8)(B). First, the amendment clarifies 
that qualified pharmacy technicians are authorized to administer 
Childhood vaccinations and COVID-19 vaccinations that are Covered 
Countermeasures under section VI of this Declaration. The Department 
has authorized qualified pharmacy technicians to administer these 
vaccines under section V(a) of the Declaration through Guidance issued 
by the Assistant Secretary for Health.\3\ This amendment adds qualified 
pharmacy technicians to section V(d) of the Declaration, to clarify 
that these healthcare professionals are authorized subject to the 
conditions stated in that subsection. In addition, the amendment 
expands the authorization for qualified pharmacy technicians and 
interns to administer seasonal influenza vaccines under the supervision 
of a pharmacist to persons aged 19 and older consistent with ACIP 
recommendations. The Secretary anticipates that there will be a need 
for the adult population to receive both COVID-19 and seasonal 
influenza vaccines throughout the 2021-2022 influenza season. Health 
risks may increase for individuals who contract seasonal influenza 
concurrently with COVID-19, thus expanding the scope of authorized 
vaccinators for seasonal influenza lessens the harm otherwise caused by 
COVID-19.
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    \3\ 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 June 17, 
2021).
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    While influenza incidence was lower than anticipated last fall and 
winter, the same cannot be assumed for the 2021-2022 flu season, as 
states have largely lifted the community mitigation measures previously 
in place at the height of the COVID-19 pandemic. Seasonal influenza has 
the potential to inflict significant burden and strain on the U.S. 
healthcare system in its own right; and in conjunction with the ongoing 
COVID-19 pandemic, a spike in influenza cases could overwhelm 
healthcare providers. Like the vaccination against COVID-19, the 
vaccination against influenza requires many people to be vaccinated 
within a short period of time, potentially creating a surge on the 
system. Concern also remains regarding the emergence of SARS-CoV-2 
variants and their potential to cause disease both among vaccinated and 
unvaccinated populations. It is yet to be determined if COVID-19 
vaccine boosters will be recommended; however, if boosters become 
necessary, allowing pharmacy interns and technicians to administer both 
COVID-19 vaccines and influenza vaccines would allow states maximum 
flexibility in limiting potential impacts of both illnesses. ACIP also 
recently voted unanimously in favor of COVID-19 and influenza vaccine 
co-administration.4 5 Like COVID-19 vaccines, influenza 
vaccines are administered as intramuscular (IM) injections, and would 
require minimal, if any, additional training to administer, and would 
not place any undue training burden on providers.
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    \4\ https://www.medpagetoday.com/meetingcoverage/acip/93283.
    \5\ https://www.aappublications.org/news/2021/06/24/acip-flu-rabies-dengue-062421.
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    As qualified persons, these qualified pharmacy technicians and 
interns 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 these 
healthcare professionals 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 ``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.\6\ 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''

[[Page 41980]]

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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    \6\ 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 countermeasure 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, and as amended March 11, 
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 \7\ 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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    \7\ 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; \8\
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    \8\ 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 and qualified pharmacy technicians who administer 
(if the pharmacy intern or technician acts under the supervision of 
such pharmacist and the pharmacy intern or technician is licensed or 
registered by his or her State board of pharmacy),\9\ (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) seasonal influenza vaccine 
administered by qualified pharmacy technicians and interns that the 
ACIP recommends to persons aged 19 and older according to ACIP's 
standard immunization schedule; or (3) 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 or technicians under their supervision are qualified persons 
only if the following requirements are met:
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    \9\ 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. 
Similarly, states vary on licensure and registration requirements 
for pharmacy technicians. Some states require certain education, 
training, and/or certification for licensure or registration; others 
either have no prerequisites for licensure or registration or do not 
require licensure or registration at all. As used herein, to be a 
``qualified pharmacy technician,'' pharmacy technicians working in 
states with licensure and/or registration requirements must be 
licensed and/or registered in accordance with state requirements; 
pharmacy technicians working in states without licensure and/or 
registration requirements must have a Certified Pharmacy Technician 
(CPhT) certification from either the Pharmacy Technician 
Certification Board or National Healthcareer Association. 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);
    iii. In the case of a childhood vaccine, the vaccination must be 
ordered and administered according to ACIP's standard immunization 
schedule;
    iv. In the case of seasonal influenza vaccine administered by 
qualified pharmacy technicians and interns, the vaccination must be 
ordered and administered according to ACIP's standard immunization 
schedule;
    v. In the case of pharmacy technicians, the supervising 
pharmacist must be readily and immediately available to the 
immunizing qualified pharmacy technician;
    vi. 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

[[Page 41981]]

recognition and treatment of emergency reactions to vaccines;
    vii. The licensed or registered pharmacy intern and qualified 
pharmacy technician 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;
    viii. The licensed pharmacist, licensed or registered pharmacy 
intern and qualified pharmacy technician must have a current 
certificate in basic cardiopulmonary resuscitation; \10\
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    \10\ 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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    ix. The licensed pharmacist must complete a minimum of two hours 
of ACPE-approved, immunization-related continuing pharmacy education 
during each State licensing period;
    x. 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;
    xi. 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
    xii. The licensed pharmacist, the licensed or registered 
pharmacy intern and the qualified pharmacy technician 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.\11\ Nothing in 
this Declaration shall preempt state laws that permit additional 
persons to deliver telehealth services;
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    \11\ 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 a pharmacist or pharmacy 
intern 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 \12\ 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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    \12\ 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 
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,

[[Page 41982]]

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; \13\
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    \13\ 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 1, 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 1, 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 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 1, 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 1, 2024. whichever occurs first.
    Liability protections for Qualified Persons under section V(d) 
of the Declaration who are qualified pharmacy technicians and 
interns to administer seasonal influenza vaccine to persons aged 19 
and older begin on August 4, 2021.
    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, 2021and 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.

    Dated: July 30, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-16681 Filed 8-2-21; 11:15 am]
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