Eleventh Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 30769-30778 [2023-10216]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Office of the Secretary

[Federal Register Volume 88, Number 92 (Friday, May 12, 2023)]
[Notices]
[Pages 30769-30778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10216]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Eleventh 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 update the determination of a 
public health emergency and clarify the disease threat, add two new 
limitations on distribution, extend the time period of coverage for 
certain Covered Countermeasures and Covered Persons, clarify the time 
period of coverage for Covered Persons authorized under the 
Declaration, extend the duration of the Declaration to December 31, 
2024, and to republish the Declaration in full.

DATES: This amendment is effective as of May 11, 2023.

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 
declaration was renewed effective April 26, 2020, July 25, 2020, 
October 23, 2020, January 21, 2021, April 21, 2021, July 20, 2021, 
October 15, 2021, January 14, 2022, April 12, 2022, July 15, 2022, 
October 13, 2022, January 11, 2023, and February 11, 2023. The public 
health emergency declared under section 319 of the PHS Act is 
anticipated to no longer be in effect as of the end of the day on May 
11, 2023. Nonetheless, as stated in section I of this amended PREP Act 
Declaration, I have determined there is a credible risk that COVID-19 
may in the future constitute such an emergency and am thus amending 
this Declaration to prepare for and mitigate that risk.
    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, 2020, 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, 2020, 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, 2020, 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, Aug. 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 i.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 permitted to practice; 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;

[[Page 30770]]

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, Dec. 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, 
Feb. 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, 
Feb. 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, Feb. 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, Mar. 16, 2021).
    On August 4, 2021, I amended the Declaration to clarify categories 
of Qualified Persons and to expand the scope of authority for certain 
Qualified Persons to administer seasonal influenza vaccines to adults. 
(86 FR 41977, Aug. 4, 2021). On September 14, 2021, I amended the 
Declaration to expand the scope of authority for certain Qualified 
Persons to administer COVID-19 therapeutics subcutaneously, 
intramuscularly, or orally (86 FR 51160, Sept. 14, 2021) and on 
September 30, 2021, the Department filed a notice of correction to the 
September 14 notice clarifying the terms ``ACIP recommendations'' and 
``ACIP's standard immunization schedules.'' (86 FR 54696, Oct. 4, 
2021). On January 7, 2022, I amended the Declaration to expand the 
scope of authority for licensed pharmacists to order and administer and 
qualified pharmacy interns to administer seasonal influenza vaccines. 
(87 FR 982, January 7, 2022).
    I am now amending section I of the Declaration to update the 
determination of a public health emergency to state that COVID-19 
presents a credible risk of a future public health emergency. While the 
Public Health Emergency declared pursuant to section 319 of the PHS Act 
is anticipated to no longer be in effect as of the end of the day on 
May 11, 2023, COVID-19 continues to present a credible risk of a future 
public health emergency. Continued coverage under the PREP Act, as 
provided in this Declaration, is intended to prepare for and mitigate 
that credible risk.
    I am amending section VII of the Declaration to add a new 
limitation on distribution to provide coverage under this PREP Act 
Declaration through December 31, 2024 for manufacturing, distribution, 
administration and use of Covered Countermeasures while they are 
authorized for emergency use (EUA) by the Food and Drug Administration 
(FDA) pursuant to section 564 of the Federal Food, Drug & Cosmetic 
(FD&C) Act, regardless of any federal agreement related to 
manufacturing, distribution, administration or use of the 
countermeasures, and regardless of any federal, regional, state, or 
local emergency Declaration. This extended PREP Act coverage extends to 
manufacturers, distributors, program planners, qualified persons 
authorized under state law to administer the Covered Countermeasures, 
and qualified persons who are licensed pharmacists, pharmacy interns, 
and pharmacy technicians authorized under this Declaration to order 
and/or administer the Covered Countermeasures, when consistent with the 
terms of the EUA and is intended to allay any concerns about liability 
risks arising from continued manufacturing, distribution, 
administration or use of Covered Countermeasures while they are 
authorized under an EUA.
    I am also amending section VII of the Declaration to add a new 
limitation on distribution to provide coverage under this PREP Act 
Declaration through December 31, 2024 for manufacturing, distribution, 
administration and use of Covered Countermeasures that are COVID-19 
vaccines licensed by FDA, and any FDA approved or cleared in vitro 
diagnostic product or other device used to treat, diagnose, cure, 
prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a 
virus mutating therefrom regardless of any federal agreement related to 
manufacturing, distribution, administration or use of the vaccines or 
devices, and regardless of any federal, regional, state, or local 
emergency Declaration. This extended PREP Act coverage is intended to 
ensure that COVID-19 vaccines and devices remain eligible for coverage 
under the Countermeasures Injury Compensation Program and to ensure 
consistency in coverage for approved/cleared and authorized devices.
    I am amending section VIII of the Declaration to clarify that the 
category of disease, health condition or health threat includes the 
burden on healthcare providers caused by coterminous seasonal influenza 
infections and COVID-19 infections.
    I am also amending section XII of the Declaration to extend the 
time period of PREP Act coverage through December 31, 2024 to Qualified 
Persons who are licensed pharmacists to order and administer, and 
pharmacy interns and qualified pharmacy technicians to administer, 
Covered Countermeasures that are COVID-19 vaccines, seasonal influenza 
vaccines, and COVID-19 tests regardless of any federal agreement 
related to manufacturing, distribution, administration or use of these 
Covered Countermeasures and regardless of any federal, regional, state 
or local emergency Declaration or other limitations on distribution 
stated in section VII of the Declaration. Extending the time period for 
PREP Act coverage for licensed pharmacists, pharmacy interns, and 
qualified technicians allows for continued access by the recipient 
Population to Covered Countermeasures that are COVID-19 vaccines, 
seasonal influenza vaccines and COVID-19 tests.
    As stated in prior amendments to this Declaration,\1\ licensed 
pharmacists, pharmacy interns and qualified pharmacy technicians are 
well positioned to provide continued access to Covered Countermeasures, 
particularly in certain areas or for certain populations that have too 
few primary-care providers or that are otherwise medically underserved. 
As of 2022, nearly 90 percent of Americans lived within five miles of a 
community pharmacy.\2\ During the COVID-19 pandemic, the majority of 
Americans have received their COVID-19 vaccines and tests from a 
pharmacy. In addition, continued access by the Population to seasonal 
influenza vaccines mitigates risks that seasonal influenza infections, 
in conjunction with COVID-19 infections, could overwhelm healthcare 
providers.
    As qualified persons, these licensed pharmacists, pharmacy interns, 
and qualified pharmacy technicians will be afforded liability 
protections in accordance with the PREP Act and the terms of this 
amended Declaration. To the extent that any State law would otherwise 
prohibit these healthcare

[[Page 30771]]

professionals who are a ``qualified person'' from prescribing, 
dispensing, or administering Covered Countermeasures that are COVID-19 
vaccines, seasonal influenza vaccines or COVID-19 tests, such law is 
preempted.\3\
    Finally, I am amending section XII of this Declaration to clarify 
the time period of coverage for other qualified persons authorized 
under section V of the Declaration, and to extend the duration of the 
Declaration to December 2024 to coincide with the duration of other 
COVID-19 response programs.\4\
    Other conforming changes and technical corrections are made 
throughout the Declaration for consistency and clarity.

Declaration, as Amended, for Public Readiness and Emergency 
Preparedness Act Coverage for Medical Countermeasures Against COVID-19

    To the extent any term previously in the Declaration, including its 
amendments, is inconsistent with any provision of this Republished 
Declaration, the terms of this Republished Declaration are controlling. 
This Declaration must be construed in accordance with the Advisory 
Opinions of the Office of the General Counsel (Advisory Opinions).\5\ I 
incorporate those Advisory Opinions as part of this Declaration. This 
Declaration is a ``requirement'' under the PREP Act.

I. Determination of Public Health Emergency

42 U.S.C. 247d-6d(b)(1)
    I have determined that the spread of SARS-CoV-2 or a virus mutating 
therefrom and the resulting disease COVID-19 constitutes a credible 
risk of a future public health emergency. I further determine that use 
of any respiratory protective device approved by NIOSH under 42 CFR 
part 84, or any successor regulations, is a priority for use during the 
public health emergency that former Secretary Azar declared on January 
31, 2020 under section 319 of the PHS Act for the entire United States 
to aid in the response of the nation's healthcare community to the 
COVID-19 outbreak.

II. Factors Considered

42 U.S.C. 247d-6d(b)(6)
    I have considered the desirability of encouraging the design, 
development, clinical testing, or investigation, manufacture, labeling, 
distribution, formulation, packaging, marketing, promotion, sale, 
purchase, donation, dispensing, prescribing, administration, licensing, 
and use of the Covered Countermeasures.

III. Recommended Activities

42 U.S.C. 247d-6d(b)(1)
    I recommend, under the conditions stated in this Declaration, the 
manufacture, testing, development, distribution, administration, and 
use of the Covered Countermeasures.

IV. Liability Protections

42 U.S.C. 247d-6d(a), 247d-6d(b)(1)
    Liability protections as prescribed in the PREP Act and conditions 
stated in this Declaration are in effect for the Recommended Activities 
described in Section III.

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 \6\ means a provider medication 
order, which includes prescribing of vaccines, or a laboratory order, 
which includes prescribing laboratory orders, if required.
    ``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)
    In addition, I have determined that the following additional 
persons are qualified persons:
    (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; \7\
    (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),\8\ (1) vaccines that 
the Centers for Disease Control and Prevention (CDC)/Advisory Committee 
on Immunization Practices (ACIP) recommend \9\ to persons ages three 
through 18 according to CDC's/ACIP's standard immunization schedule or 
(2) seasonal influenza vaccine administered by qualified pharmacy 
technicians and interns that the CDC/ACIP recommends to persons aged 19 
and older according to CDC's/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:
    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 CDC's/ACIP's COVID-19 vaccine 
recommendation(s).
    iii. In the case of a childhood vaccine, the vaccination must be 
ordered and administered according to CDC's/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 CDC's/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 ACPE to order and 
administer vaccines. Such a training program must include hands on 
injection technique,

[[Page 30772]]

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; \10\
    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.
    (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 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.
    (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.
    (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

[[Page 30773]]

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 
CDC's/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\
    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).
    (i) 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) \14\ FDA authorized, 
approved, or licensed COVID-19 therapeutics. 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:
    i. The COVID-19 therapeutic must be authorized, approved, or 
licensed by the FDA;
    ii. In the case of a licensed pharmacist ordering a COVID-19 
therapeutic, the therapeutic must be ordered for subcutaneous, 
intramuscular, or oral administration and in accordance with the FDA 
approval, authorization, or licensing;
    iii. In the case of licensed pharmacists, qualified pharmacy 
technicians, and licensed or registered pharmacy interns administering 
the COVID-19 therapeutic, the therapeutic must be administered 
subcutaneously, intramuscularly, or orally in accordance with the FDA 
approval, authorization, or licensing;
    iv. In the case of qualified pharmacy technicians, the supervising 
pharmacist must be readily and immediately available to the qualified 
pharmacy technician;
    v. In the case of COVID-19 therapeutics administered through 
intramuscular or subcutaneous injections, the licensed pharmacist, 
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 
COVID-19 therapeutics, the recognition and treatment of emergency 
reactions to COVID-19 therapeutics, and any additional training 
required in the FDA approval, authorization, or licensing;
    vi. The licensed pharmacist, licensed or registered pharmacy intern 
and qualified pharmacy technician must have a current certificate in 
basic cardiopulmonary resuscitation; \15\
    vii. The licensed pharmacist must comply with recordkeeping and 
reporting requirements of the jurisdiction in which he or she 
administers COVID-19 therapeutics; including informing the patient's 
primary-care provider when available and complying with requirements 
with respect to reporting adverse events; and
    viii. The licensed pharmacist, the licensed or registered pharmacy 
intern and the qualified pharmacy technician must comply with any 
applicable requirements (or conditions of use) that apply to the 
administration of COVID-19 therapeutics.
    (j) Any pharmacist who holds an active license or certification 
permitting the person to prescribe, dispense, or administer vaccines 
under the law of any State or who is authorized under Section V(d) of 
this Declaration who prescribes, dispenses, or administers seasonal 
influenza vaccines, or a pharmacy intern as authorized under the 
section V(d) of this Declaration who administers seasonal influenza 
vaccines, in any jurisdiction where the PREP Act applies, other than 
the State in which the license or certification is held, so long as the 
license or certification of the pharmacist or pharmacy intern 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.
    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

[[Page 30774]]

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.

VI. Covered Countermeasures

42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)
    Covered Countermeasures are:
    (a) Any antiviral, any drug, any biologic, any diagnostic, any 
other device, any respiratory protective device, or any vaccine 
manufactured, used, designed, developed, modified, licensed, or 
procured:
    i. To diagnose, mitigate, prevent, treat, or cure COVID-19, or the 
transmission of SARS-CoV-2 or a virus mutating therefrom; or
    ii. to limit the harm that COVID-19, or the transmission of SARS-
CoV-2 or a virus mutating therefrom, might otherwise cause;
    (b) a product manufactured, used, designed, developed, modified, 
licensed, or procured to diagnose, mitigate, prevent, treat, or cure a 
serious or life-threatening disease or condition caused by a product 
described in paragraph (a) above;
    (c) a product or technology intended to enhance the use or effect 
of a product described in paragraph (a) or (b) above; or
    (d) any device used in the administration of any such product, and 
all components and constituent materials of any such product.
    To be a Covered Countermeasure under the Declaration, a product 
must also meet 42 U.S.C. 247d-6d(i)(1)'s definition of ``Covered 
Countermeasure.''

VII. Limitations on Distribution

42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)
    I have determined that liability protections are afforded to 
Covered Persons only for Recommended Activities involving:
    (a) Covered Countermeasures that are related to present or future 
federal contracts, cooperative agreements, grants, other transactions, 
interagency agreements, memoranda of understanding, or other federal 
agreements;
    (b) Covered Countermeasures that are related to activities 
authorized in accordance with the public health and medical response of 
the Authority Having Jurisdiction to prescribe, administer, deliver, 
distribute or dispense the Covered Countermeasures following a 
Declaration of Emergency;
    (c) Covered Countermeasures other than those described in 
subsection (e) that are:
    i. Licensed, approved or cleared by the FDA (or that are permitted 
to be used under an Investigational New Drug Application or an 
Investigational Device Exemption) under the FD&C Act or PHS Act to 
treat, diagnose, cure, prevent, mitigate, or limit the harm from COVID-
19, or the transmission of SARS-CoV-2 or a virus mutating therefrom; or
    ii. a respiratory protective device approved by NIOSH under 42 CFR 
part 84, or any successor regulations, that the Secretary determines to 
be a priority for use during a public health emergency declared under 
section 319 of the PHS Act to prevent, mitigate, or limit the harm from 
COVID-19, or the transmission of SARS-CoV-2 or a virus mutating 
therefrom.
    To qualify for this third distribution channel, a Covered Person 
must manufacture, test, develop, distribute, administer, or use the 
Covered Countermeasure pursuant to the FDA licensure, approval, or 
clearance (or pursuant to an Investigational New Drug Application or 
Investigational Device Exemption), or the NIOSH approval;
    (d) Covered Countermeasures that are authorized by the FDA under 
section 564 of the FD&C Act to treat, diagnose, cure, prevent, 
mitigate, or limit the harm from COVID-19, or the transmission of SARS-
CoV-2 or a virus mutating therefrom. To qualify for this fourth 
distribution channel, a Covered Person must manufacture, test, develop, 
distribute, administer, or use the Covered Countermeasure pursuant to 
the FDA authorization; or
    (e) Covered Countermeasures that are COVID-19 vaccines licensed by 
the FDA to prevent, mitigate, or limit the harm from COVID-19, or the 
transmission of SARS-CoV-2 or a virus mutating therefrom and any 
approved or cleared in vitro diagnostic product or other device used to 
treat, diagnose, cure, prevent, or mitigate COVID-19, or the 
transmission of SARS-CoV-2 or a virus mutating therefrom. To qualify 
for this fifth distribution channel, a Covered Person must manufacture, 
test, develop, distribute, administer, or use the Covered 
Countermeasure pursuant to the FDA license, clearance, or approval.
    As used in this Declaration, the terms ``Authority Having 
Jurisdiction'' and ``Declaration of Emergency'' have the following 
meanings:
    (i) The Authority Having Jurisdiction means the public agency or 
its delegate that has legal responsibility and authority for responding 
to an incident, based on political or geographical (e.g., city, county, 
tribal, state, or federal boundary lines) or functional (e.g., law 
enforcement, public health) range or sphere of authority.
    (ii) A Declaration of Emergency means any declaration by any 
authorized local, regional, state, or federal official of an emergency 
specific to events that indicate an immediate need to administer and 
use the Covered Countermeasures, with the exception of a federal 
declaration in support of an Emergency Use Authorization under Section 
564 of the FD&C Act unless such declaration specifies otherwise.
    I have also determined that, for governmental program planners 
only, liability protections are afforded only to the extent such 
program planners obtain Covered Countermeasures through voluntary 
means, such as (a) donation; (b) commercial sale; (c) deployment of 
Covered Countermeasures from federal stockpiles; or (d) deployment of 
donated, purchased, or otherwise voluntarily obtained Covered 
Countermeasures from state, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat

42 U.S.C. 247d-6d(b)(2)(A)
    The category of disease, health condition, or threat for which I 
recommend the administration or use of the Covered Countermeasures is 
not only COVID-19 caused by SARS-CoV-2, or a virus mutating therefrom, 
but also other diseases, health conditions, or threats that may have 
been caused by COVID-19, SARS-CoV-2, or a virus mutating therefrom, 
including the threat of increased burden on the healthcare system due 
to seasonal influenza infections occurring at the same time as COVID-19 
infections, which will lead to an increase in the rate of infectious 
diseases.

IX. Administration of Covered Countermeasures

42 U.S.C. 247d-6d(a)(2)(B)
    Administration of the Covered Countermeasure means physical 
provision of the countermeasures to recipients, or activities and 
decisions directly relating to public and private delivery, 
distribution and dispensing of the countermeasures to recipients, 
management and operation of countermeasure programs, or management and 
operation of locations for the purpose of distributing and dispensing 
countermeasures. Where there are limited Covered

[[Page 30775]]

Countermeasures, not administering a Covered Countermeasure to one 
individual in order to administer it to another individual can 
constitute ``relating to . . . the administration to . . . an 
individual'' under 42 U.S.C. 247d-6d. For example, consider a situation 
where there is only one dose \16\ of a COVID-19 vaccine, and a person 
in a vulnerable population and a person in a less vulnerable population 
both request it from a healthcare professional. In that situation, the 
healthcare professional administers the one dose to the person who is 
more vulnerable to COVID-19. In that circumstance, the failure to 
administer the COVID-19 vaccine to the person in a less-vulnerable 
population ``relat[es] to . . . the administration to'' the person in a 
vulnerable population. The person in the vulnerable population was able 
to receive the vaccine only because it was not administered to the 
person in the less-vulnerable population. Prioritization or purposeful 
allocation of a Covered Countermeasure, particularly if done in 
accordance with a public health authority's directive, can fall within 
the PREP Act and this Declaration's liability protections.

X. Population

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)
    The populations of individuals to whom the liability protections of 
this Declaration extend include any individual who uses or is 
administered the Covered Countermeasures in accordance with this 
Declaration.
    Liability protections are afforded to manufacturers and 
distributors without regard to whether the countermeasure is used by or 
administered to this population; liability protections are afforded to 
program planners and qualified persons when the countermeasure is used 
by or administered to this population, or the program planner or 
qualified person reasonably could have believed the recipient was in 
this population.

XI. Geographic Area

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)
    Liability protections are afforded for the administration or use of 
a Covered Countermeasure without geographic limitation.
    Liability protections are afforded to manufacturers and 
distributors without regard to whether the Covered Countermeasure is 
used by or administered in any designated geographic area; liability 
protections are afforded to program planners and qualified persons when 
the countermeasure is used by or administered in any designated 
geographic area, or the program planner or qualified person reasonably 
could have believed the recipient was in that geographic area.
    COVID-19 is a global challenge that requires a whole-of-nation 
response. There are substantial federal legal and policy issues, and 
substantial federal legal and policy interests within the meaning of 
Grable & Sons Metal Products, Inc. v. Darue Eng'g. & Mf'g., 545 U.S. 
308 (2005), in having a unified, whole-of-nation response to the COVID-
19 pandemic among federal, state, local, and private-sector entities. 
The world faced an unprecedented pandemic. To effectively respond, 
there needed to be a more consistent pathway for Covered Persons to 
manufacture, distribute, administer or use Covered Countermeasures 
across the nation and the world. Thus, there are substantial federal 
legal and policy issues, and substantial federal legal and policy 
interests within the meaning of Grable & Sons Metal Products, Inc. v. 
Darue Eng'g. & Mf'g., 545 U.S. 308 (2005), in having a uniform 
interpretation of the PREP Act. Under the PREP Act, the sole exception 
to the immunity from suit and liability of covered persons under the 
PREP Act is an exclusive Federal cause of action against a covered 
person for death or serious physical injury proximately caused by 
willful misconduct by such covered person. In all other cases, an 
injured party's exclusive remedy is an administrative remedy under 
section 319F-4 of the PHS Act. Through the PREP Act, Congress delegated 
to me the authority to strike the appropriate Federal-state balance 
with respect to Covered Countermeasures through PREP Act 
Declarations.\17\

XII. Effective Time Period

42 U.S.C. 247d-6d(b)(2)(B)
    The effective time period for Covered Countermeasures and Covered 
Persons depends on the means of distribution identified in Section VII 
of this Declaration as applied to categories of Countermeasures and 
Qualified Persons:
    (a) 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 December 31, 
2024.
    (b) 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 December 31, 2024.
    (c) 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 CDC/ACIP recommends to persons ages three through 18 
according to CDC's/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) December 31, 
2024, whichever occurs first.
    (d) Liability protections for all Covered Countermeasures 
identified in Section VII(c) of this Declaration that are licensed, 
approved or cleared by the FDA begin on December 9, 2020, and last 
through the final day the Declaration of Emergency is in effect or 
December 31, 2024 whichever occurs first. Liability protections for all 
Covered Countermeasures identified in Section VII(c) of this 
Declaration that are approved by NIOSH last for the time period stated 
in section (a) of this Section XII.
    (e) Liability protections for all Covered Countermeasures 
identified in Section VII(d) of this Declaration begin on December 9, 
2020, and last until December 31, 2024, regardless of any Declaration 
of Emergency that might otherwise terminate the time period of coverage 
under paragraphs (c) or (d) of this Section XII.
    (f) Liability protections for all Covered Countermeasures 
identified in Section VII(e) of this Declaration begin on December 9, 
2020, and last until December 31, 2024, regardless of any Declaration 
of Emergency that might otherwise terminate the time period of coverage 
under paragraphs (c) or (d) of this Section XII.
    (g) Liability protections for Manufacturers, Distributors, and 
Program Planners, as defined at 42 U.S.C. 247d-6d(i), begin on February 
4, 2020, and last through the time periods stated in paragraphs (a)-(f) 
of this Section XII.
    (h) Liability protections for Qualified Persons who are 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

[[Page 30776]]

countermeasure was prescribed, administered, or dispensed begin on 
February 4, 2020, and last through the time periods stated in 
paragraphs (a)-(f) of this Section XII.
    (i) Liability protections for Additional Qualified Persons 
identified under section V of the Declaration and in Guidance 
implementing section V of the Declaration begin on the dates listed 
below, and last through the time periods stated in paragraphs (a)-(d) 
of this section XII of the Declaration, unless otherwise stated in this 
paragraph (i).
    i. Liability protections for Qualified Persons under section V(d) 
of the Declaration who are licensed pharmacists to order and 
administer, and licensed or registered pharmacy interns and qualified 
pharmacy technicians to administer CDC/ACIP recommended vaccines for 
persons aged three through 18 (other than seasonal influenza vaccines 
and COVID-19 vaccines) begins on August 24, 2020.
    ii. Liability protections for Qualified Persons under section V(d) 
of the Declaration who are licensed pharmacists to order and 
administer, and licensed or registered pharmacy interns and qualified 
pharmacy technicians to administer CDC/ACIP recommended seasonal 
influenza vaccines for persons aged three through 18 begins on August 
24, 2020, and lasts through December 31, 2024 regardless of the time 
periods stated in paragraphs (c)-(d) of this section XII or limitations 
on distribution stated in section VII (a)-(b) of this Declaration.
    iii. Liability protections for Qualified Persons under section V(d) 
of the Declaration who are licensed pharmacists to order and 
administer, and pharmacy interns and qualified pharmacy technicians to 
administer, COVID-19 vaccines to individuals aged three and above 
begins on February 4, 2020 and lasts through December 31, 2024 
regardless of the time periods stated in paragraphs (c)-(d) of this 
section XII or limitations on distribution stated in section VII (a)-
(b) of this Declaration.
    iv. Liability protections for Qualified Persons under section V(d) 
of the Declaration who are licensed pharmacists to order and 
administer, and pharmacy interns and qualified pharmacy technicians to 
administer, seasonal influenza vaccines to individuals aged nineteen 
and above begins on August 4, 2021 and lasts through December 31, 2024, 
regardless of the time periods stated in paragraphs (c)-(d) of this 
section XII or limitations on distribution stated in section VII (a)-
(b) of this Declaration.
    v. Liability protections for Qualified Persons under section V(e) 
of the Declaration begin on February 4, 2020.
    vi. Liability protections for Qualified Persons under section V(f) 
of the Declaration begin on February 2, 2021.
    vii. Liability protections for Qualified Persons under section V(g) 
of the Declaration begin on February 16, 2021, and last through 
December 31, 2024.
    xiii. Liability protections for Qualified Persons who are 
physicians, advanced practice registered nurses, registered nurses, or 
practical nurses under section V(h) of the Declaration begin on 
February 2, 2021 with additional conditions effective as of March 11, 
2021 and liability protections for all other Qualified persons under 
section V(h) begin on March 11, 2021.
    ix. Liability protections for Qualified Persons under section V(i) 
of the Declaration who are licensed pharmacists to order and administer 
and qualified pharmacy technicians and licensed or registered pharmacy 
interns to administer COVID-19 therapeutics identified in Section 
VII(d) of the Declaration begin on September 9, 2021 and last through 
December 31, 2024 regardless of time periods stated in paragraphs (c)-
(d) of this section or limitations on distribution stated in section 
VII (a)-(b) of this Declaration.
    x. Liability protections for Qualified Persons under section V(i) 
of the Declaration who are licensed pharmacists to order and administer 
and qualified pharmacy technicians and licensed or registered pharmacy 
interns to administer COVID-19 therapeutics identified in Section 
VII(c) of the Declaration begin on September 9, 2021.
    xi. Liability protections for Qualified Persons under section V(j) 
of the Declaration begin on December 30, 2021.
    xii. Liability protections for Qualified Persons authorized under 
Guidance issued by this Department as an Authority Having Jurisdiction 
to respond to a declared emergency, incorporated into this Declaration 
by reference,\18\ to administer COVID-19 tests who are licensed 
pharmacists begin April 8, 2020 and last until December 31, 2024 
regardless of any limitations stated in paragraphs (c)-(d) of this 
Section XII or limitations on distribution stated in section VII (a)-
(b) of this Declaration.
    xiii. Liability protections for Qualified Persons authorized under 
Guidance issued by this Department as an Authority Having Jurisdiction 
to respond to a declared emergency, incorporated into this Declaration 
by reference,\19\ to administer COVID-19 tests who are licensed or 
registered pharmacy interns or qualified pharmacy technicians begin 
October 20, 2020 and last until December 31, 2024 regardless of any 
limitations stated in paragraphs (c)-(d) of this Section XII or 
limitations on distribution stated in section VII (a)-(b) of this 
Declaration.
    xiv. Liability protections for Qualified Persons authorized under 
Guidance issued by this Department as an Authority Having Jurisdiction 
to respond to a declared emergency, incorporated into this Declaration 
by reference,\20\ who are pharmacies when their staff pharmacists order 
and administer, or their pharmacy interns and pharmacy technicians 
administer COVID-19 vaccines to individuals aged three and above, 
seasonal influenza vaccines to individuals aged three through eighteen, 
seasonal influenza vaccines to individuals aged nineteen and above, 
COVID-19 tests, and COVID-19 therapeutics identified in Section VII(d) 
of the Declaration begin October 29, 2020 and last until December 31, 
2024 regardless of any limitations stated in paragraphs (c)-(d) of this 
Section XII or limitations on distribution stated in section VII (a)-
(b) of this Declaration.
    xv. Liability protections for Qualified Persons authorized under 
Guidance issued by this Department as an Authority Having Jurisdiction 
to respond to a declared emergency, incorporated into this Declaration 
by reference,\21\ who are pharmacies when their staff pharmacists order 
and administer, or their pharmacy interns and pharmacy technicians 
administer CDC/ACIP recommended vaccines for persons aged three through 
18 (other than seasonal influenza vaccines and COVID-19 vaccines) and 
countermeasures identified in Section VII(c) of the Declaration begin 
October 29, 2020.
    xv. Liability protections for Qualified Persons authorized under 
Guidance issued by this Department as an Authority Having Jurisdiction 
to respond to a declared emergency, incorporated into this Declaration 
by reference \22\ to prescribe or administer point-of-care COVID-19 
tests, using anterior nares specimen collection or self-collection, for 
screening in congregate facilities across the Nation who are licensed 
healthcare practitioners begin August 31, 2020 and last until December 
31, 2024 regardless of any limitations stated in paragraphs (c)-(d) of 
this Section XII or limitations on distribution stated in section VII 
(a)-(b) of this Declaration.

[[Page 30777]]

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(B) and (C)
    I have determined that an additional 12 months of liability 
protection is reasonable to allow for the manufacturer(s) to arrange 
for disposition of the Covered Countermeasure, including return of the 
Covered Countermeasures to the manufacturer, and for Covered Persons to 
take such other actions as are appropriate to limit the administration 
or use of the Covered Countermeasures.
    Covered Countermeasures obtained for the SNS during the effective 
period of this Declaration are covered through the date of 
administration or use pursuant to a distribution or release from the 
SNS.

XIV. Countermeasures Injury Compensation Program

42 U.S.C 247d-6e
    The PREP Act authorizes the Countermeasures Injury Compensation 
Program (CICP) to provide benefits to certain individuals or estates of 
individuals who sustain a covered serious physical injury as the direct 
result of the administration or use of the Covered Countermeasures, and 
benefits to certain survivors of individuals who die as a direct result 
of the administration or use of the Covered Countermeasures. The causal 
connection between the countermeasure and the serious physical injury 
must be supported by compelling, reliable, valid, medical and 
scientific evidence in order for the individual to be considered for 
compensation. The CICP is administered by the Health Resources and 
Services Administration, within the Department of Health and Human 
Services. Information about the CICP is available at the toll-free 
number 1-855-266-2427 or https://www.hrsa.gov/cicp/.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)
    Amendments to this Declaration will be published in the Federal 
Register, as warranted.
    Authority: 42 U.S.C. 247d-6d.

    Dated: May 9, 2023.
Xavier Becerra,
Secretary, U.S. Department of Health and Human Services.

    \1\ Third Amendment to Declaration Under the Public Readiness 
and Emergency Preparedness Act for Medical Countermeasures Against 
COVID-19, 85 FR 53126 (August 24, 2020); Tenth Amendment to 
Declaration Under the Public Readiness and Emergency Preparedness 
Act for Medical Countermeasures Against COVID-19, 87 FR 982 (April 
14, 2022).
    \2\ Gallagher, A. ``Study: 88.9% of US Population Lives Within 5 
Miles of a Community Pharmacy,'' Pharmacy Times (August 4, 2022) 
available at: https://www.pharmacytimes.com/view/study-88-9-of-us-population-lives-within-5-miles-of-a-community-pharmacy (last 
visited Apr. 21, 2023).
    \3\ 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/advisory-opinion-20-02-hhs-ogc-prep-act.pdf. (last visited April 14, 2023). 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 April 14, 2023).
    \4\ Section 4113, Consolidated Appropriations Act, 2023, Public 
Law 117-328 (December 29, 2022).
    \5\ See, e.g., Advisory Opinion on the Public Readiness and 
Emergency Preparedness Act and the March 10, 2020 Declaration under 
the Act, Apr. 17, 2020, as Modified on 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 Apr. 
3, 2023); 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 Apr. 3, 2023); Advisory Opinion 20-03 on 
the Public Readiness and Emergency Preparedness Act and the 
Secretary's Declaration under the Act, Oct. 22, 2020, as Modified on 
Oct. 23, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/AO3.1.2_Updated_FINAL_SIGNED_10.23.20.pdf (last visited Apr. 3, 
2023); Advisory Opinion 20-04 on the Public Readiness and Emergency 
Preparedness Act and the Secretary's Declaration under the Act, Oct. 
22, 2020, as Modified on Oct. 23, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/AO%204.2_Updated_FINAL_SIGNED_10.23.20.pdf (last visited Apr. 3, 
2023).
    \6\ 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 Apr. 3, 2023); 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 Apr. 3, 
2023).
    \7\ 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 Apr. 3, 2023); 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 Apr. 3, 2023); 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 Apr. 3, 2023); 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 Apr. 3, 2023); 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 Apr. 3, 2023) (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.
    \8\ 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 CPhT certification from either 
the Pharmacy Technician Certification Board or National Healthcareer

[[Page 30778]]

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 Apr. 3, 2023).
    \9\ Where the term CDC/ACIP recommendations, standard 
immunization schedules, or similar language is used, this includes 
both direct CDC recommendations as well as recommendations adopted 
by the CDC Director after recommendation by ACIP, which are commonly 
referred to as ACIP recommendations or schedules.
    \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 Apr. 3, 2023); 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 Apr. 3, 2023).
    \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 Apr. 3, 2023).
    \12\ See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/training.html.
    \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 Apr. 3, 2023); 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 Apr. 3, 2023).
    \14\ 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 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 Apr. 3, 2023).
    \15\ 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 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 Apr. 3, 2023); 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 Apr. 3, 2023).
    \16\ For simplicity, this example assumes a patient only 
requires one dose of the vaccine.
    \17\ 42 U.S.C. 247d-6d(b)(7) provides that ``[n]o court of the 
United States, or of any State, shall have subject matter 
jurisdiction to review, whether by mandamus or otherwise, any action 
by the Secretary under this subsection.''
    \18\ 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 Apr. 3, 2023).
    \19\ 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 Apr. 3, 
2023).
    \20\ PREP Act Authorization for Pharmacies Distributing and 
Administering Certain Covered Countermeasures, OASH, 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 Apr. 14, 2023).
    \21\ PREP Act Authorization for Pharmacies Distributing and 
Administering Certain Covered Countermeasures, OASH, 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 Apr. 14, 2023).
    \22\ 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, August 31, 2023, 
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf (last visited April 14, 2023).

[FR Doc. 2023-10216 Filed 5-11-23; 8:45 am]
BILLING CODE 4150-37-P