Tenth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 982-988 [2022-00151]
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questions—attachments 4.19–A, 4.19–B,
and 4.–19–D. The questions concerning
the source of funding have not changed,
therefore there is no change in the
burden to States. Form Number: CMS–
10398 (#24) (OMB control number:
0938–1148); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
54; Total Annual Responses: 54; Total
Annual Hours: 2,160. (For policy
questions regarding this collection
contact: Richard Kimball at 410–786–
2278.)
3. Title of Information Collection:
Supplemental Payment Reporting under
the Consolidated Appropriations Act;
Type of Information Collection Request:
Extension of a currently approved
collection; Use: Through passage of
Division CC, Title II, Section 202 of the
Consolidated Appropriations Act
(CAA), Congress added subsection (bb)
to section 1903 of the Act, which
requires the Secretary of Health and
Human Services to establish a system
for states to submit reports on
supplemental payments as defined in
section 1903(bb)(2) of the Act. States are
required to submit ‘‘reports, as
determined appropriate by the
Secretary, on supplemental payment
data, as a requirement for a State plan
or State plan amendment [SPA] that
would provide for a supplemental
payment’’ as required by section
1903(bb)(1) of the Act.
CMS is implementing section 202 of
the CAA of 2021 by adding new screens
to the CMS–64 in the MBES system for
states to report all supplemental
payments. States will be expected to use
the form starting for their first quarter
Federal fiscal year 2022 expenditures
beginning on January 15, 2022. The
statute requires CMS to set up a data
collection system for all state
supplemental payments. Form Number:
CMS–10398 (#73) (OMB control
number: 0938–1148); Frequency: Yearly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
54; Total Annual Responses: 54; Total
Annual Hours: 3,240. (For policy
questions regarding this collection
contact: Richard Kimball at 410–786–
2278.)
4. Title of Information Collection:
Coverage of Routine Patient Cost for
Items & Services in Qualifying Clinical
Trials; Type of Information Collection
Request: New collection; Use: Section
210 of the Consolidated Appropriations
Act of 2021 amended section 1905(a) of
the Social Security Act (the Act) to add
a new mandatory benefit at 1905(a)(30).
The new benefit mandates coverage of
routine patient services and costs
furnished in connection with
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participation by Medicaid beneficiaries
in qualifying clinical trials. Routine
costs for services provided in
connection with participation in a
qualifying clinical trial generally
include any item or service provided to
the individual under the qualifying
clinical trial, including any item or
service provided to prevent, diagnose,
monitor, or treat complications resulting
from participation in the qualified
clinical trial, to the extent that the
provision of such items or services to
the individual would otherwise be
covered under the state plan or waiver.
We propose that States and territories
review the preprints completed for a
Medicaid beneficiary to receive
coverage of routine patient services and
costs furnished in connection with
participation in qualifying clinical
trials. Completion of the preprint pages
verifies in the Medicaid state plan that
the mandatory clinical trials benefit is
being furnished by a state. Completion
of the preprint verifies that the
requirements of a federally sponsored
clinical trial is appropriate for the
Medicaid beneficiary. Form Number:
CMS–10398 (#74) (OMB control
number: 0938–1148); Frequency: Yearly;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 56; Total
Annual Hours: 56. (For policy questions
regarding this collection contact Kirsten
Jensen at 410–786–8146.)
5. Title of Information Collection:
American Rescue Plan (ARP) 1135 State
Plan Amendment; Type of Information
Collection Request: New collection; Use:
Section 9811 of the ARP established
new mandatory benefits at section
1905(a)(4)(E) for COVID–19 vaccine and
vaccine administration and section
1905(a)(4)(F) for COVID–19 testing and
treatment for both Medicaid and CHIP.
The effective date time period for these
mandatory benefits is March 11, 2021,
ending on the last day of the first
calendar quarter that begins one year
after the last day of the emergency
period described in section
1135(g)(1)(B) of the Social Security Act
(the Act). Given that regular state plan
rules do not allow for effective dates
prior to the first day of the quarter in
which the state plan amendment (SPA)
was submitted, we are allowing states to
use Section 1135 SPA process waiver
authority to allow states to meet the
required timeframes of these provisions.
The SPAs will implement mandatory
Medicaid coverage and reimbursement
for COVID–19 vaccine and vaccine
administration and COVID–19 testing
and treatment are considered part of the
Agency’s emergency response to COVID.
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CMS has issued guidance for each of
these provisions.
In large part, states have already been
providing these services throughout the
course of the pandemic and these SPAs
will reflect what states have been doing.
CMS is primarily using an attestation
approach for states to affirm that they
are in compliance with the requirements
of the provisions.
Form Number: CMS–10398 (#75)
(OMB control number: 0938–1148);
Frequency: Once and on occasion;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 56; Total
Annual Hours: 168. (For policy
questions regarding this collection
contact Kirsten Jensen at 410–786–
8146.)
Dated: January 4, 2022.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2022–00119 Filed 1–6–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Tenth Amendment to Declaration
Under the Public Readiness and
Emergency Preparedness Act for
Medical Countermeasures Against
COVID–19
ACTION:
Notice of amendment.
The Secretary issues this
amendment pursuant to section 319F–3
of the Public Health Service Act to
expand the authority for certain
Qualified Persons authorized to
prescribe, dispense, and administer
seasonal influenza vaccines under
section VI of this Declaration.
DATES: This amendment is effective as
of January 7, 2022.
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, paige.ezernack@hhs.gov.
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,
SUMMARY:
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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, § 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, July 20, 2021, and
October 15, 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, Aug.
24, 2020). On December 3, 2020, the
former Secretary amended the
declaration to incorporate Advisory
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Opinions of the General Counsel
interpreting the PREP Act and the
Secretary’s Declaration and
authorizations issued by the
Department’s Office of the Assistant
Secretary for Health as an Authority
Having Jurisdiction to respond; added
an additional category of qualified
persons under Section V of the
Declaration; made explicit that the
Declaration covers all qualified
pandemic and epidemic products as
defined under the PREP Act; added a
third method of distribution to provide
liability protections for, among other
things, private distribution channels;
made explicit that there can be
situations where not administering a
covered countermeasure to a particular
individual can fall within the PREP Act
and the Declaration’s liability
protections; made explicit that there are
substantive federal legal and policy
issues and interests in having a unified
whole-of-nation response to the COVID–
19 pandemic among federal, state, local,
and private-sector entities; revised the
effective time period of the Declaration;
and republished the declaration in full.
(85 FR 79190, 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, Secretary
Xavier Becerra 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, Secretary Becerra
amended the Declaration to expand the
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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).
Secretary Xavier Becerra now amends
section V of the Declaration to add
subsection (j) to expand the scope of
authority for licensed pharmacists to
order and administer and qualified
pharmacy interns to administer seasonal
influenza vaccines.
Accordingly, subsection V(j)
authorizes:
(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;
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
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persons so identified in a declaration by
the Secretary’’ under subsection (b) of
the PREP Act. 42 U.S.C. 247d–6d(i)(8)
The Secretary anticipates that there
will be a need to increase the available
pool of providers able to order and
administer seasonal influenza vaccines.
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. The health care
system capacity and the vaccination
workforce are likely to become
increasingly strained throughout the
nation. Allowing pharmacists and
pharmacy interns to administer both
COVID–19 vaccines and seasonal
influenza vaccines in jurisdictions
where the need is greatest would allow
states maximum flexibility in limiting
potential impacts of both illnesses.
Pharmacists and pharmacy interns are
well positioned to increase access to
seasonal influenza vaccines and have
played a critical role in this pandemic
in overseeing COVID–19 testing and
vaccine administration. Given their skill
set and training, as well as looming
provider shortages, pharmacists and
pharmacy interns would require
minimal, if any, additional training to
administer and would not place any
undue training burden on providers.
By this amendment to the Declaration,
the Secretary expands the authorization
for an additional category of persons
who are qualified persons under section
247d–6d(i)(8)(B). First, the amendment
expands the authorization for a
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.
As qualified persons, these licensed
pharmacists 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 seasonal influenza
vaccines or other Covered
Countermeasures, such law is
preempted. On May 19, 2020, the Office
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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.1 The opinion relied in
part on the fact that the Congressional
delegation of authority to the Secretary
under the PREP Act to specify a class of
persons, beyond those who are
authorized to administer a covered
countermeasure under State law, as
‘‘qualified persons’’ would be rendered
a nullity in the absence of such
preemption. This opinion is
incorporated by reference into this
declaration. Based on the reasoning set
forth in the May 19, 2020 advisory
opinion, any State law that would
otherwise prohibit a member of any of
the classes of ‘‘qualified persons’’
specified in this declaration from
administering a covered countermeasure
is likewise preempted. In accordance
with section 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.
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,
treatment and prevention workforces
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
1 Department of Health and Human Services
General Counsel Advisory Opinion on the Public
Readiness and Emergency Preparedness Act, May
19, 2020, available at: https://www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments/prep-act-advisory-opinion-hhs-ogc.pdf/
(last visited Jan. 24, 2021). See also, Department of
Justice Office of Legal Counsel Advisory Opinion
for Robert P. Charrow, General Counsel of the
Department of Health and Human Services, January
12, 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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medical countermeasures against
COVID–19, as amended April 10, 2020,
June 4, 2020, August 19, 2020, as
amended and republished on December
3, 2020, as amended on February 2,
2021, as amended March 11, 2021, as
amended on August 4, 2021, and as
amended on September 14, 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 (Dec. 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 2
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:
(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; 3
2 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/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19tests.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-pharmacistsand-pharmacy-interns-regarding-covid-19-vaccinesimmunity.pdf (last visited Jan. 24, 2021).
3 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/hhsguidance-documents//authorizing-licensedpharmacists-to-order-and-administer-covid-19tests.pdf (last visited Jan. 24, 2021); Guidance for
PREP Act Coverage for COVID–19 Screening Tests
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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),4 (1)
at Nursing Homes, Assisted-Living Facilities, LongTerm-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-forscreening-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/hhsguidance-documents//licensed-pharmacists-andpharmacy-interns-regarding-covid-19-vaccinesimmunity.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//prepact-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-guidancedocuments//prep-act-authorization-pharmaciesadministering-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.
4 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-
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vaccines that the Centers for Disease
Control and Prevention (CDC)/Advisory
Committee on Immunization Practices
(ACIP) recommend 5 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,
clinical evaluation of indications and
contraindications of vaccines, and the
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).
5 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.
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985
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; 6
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
6 This requirement is satisfied by, among other
things, a certification in basic cardiopulmonary
resuscitation by an online program that has
received accreditation from the American Nurses
Credentialing Center, the ACPE, or the
Accreditation Council for Continuing Medical
Education. The phrase ‘‘current certificate in basic
cardiopulmonary resuscitation,’’ when used in the
September 3, 2020 or October 20, 2020 OASH
authorizations, shall be interpreted the same way.
See Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID–19 Vaccines
and Immunity under the PREP Act, OASH, Sept. 3,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents//
licensed-pharmacists-and-pharmacy-internsregarding-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/hhsguidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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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.7
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,
7 See, e.g., Advisory Opinion 20–02 on the Public
Readiness and Emergency Preparedness Act and the
Secretary’s Declaration under the Act, May 19,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents/
advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last
visited Jan. 24, 2021).
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discipline or investigation by a licensing
authority or surrendered following an
arrest, and the individual is not on the
List of Excluded Individuals/Entities
maintained by the Office of Inspector
General, subject to: (i) Documentation of
completion of the Centers for Disease
Control and Prevention COVID–19
(CDC) Vaccine Training Modules 8 and,
for healthcare providers who are not
currently practicing, documentation of
an observation period by a currently
practicing healthcare professional
experienced in administering
intramuscular injections, and for whom
administering intramuscular injections
is in their ordinary scope of practice,
who confirms competency of the
healthcare provider in preparation and
administration of the COVID–19
vaccine(s) to be administered;
(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
8 See COVID–19 Vaccine Training Modules,
available at https://www.cdc.gov/vaccines/covid-19/
training.html.
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administers COVID–19 vaccines that are
Covered Countermeasures under section
VI of this Declaration in any jurisdiction
where the PREP Act applies in
association with a COVID–19
vaccination effort by a State, local,
Tribal or territorial authority or by an
institution in which the COVID–19
vaccine covered countermeasure is
administered;
2. Any physician, advanced practice
registered nurse, registered nurse,
practical nurse, pharmacist, pharmacy
intern, midwife, paramedic, advanced
or intermediate EMT, respiratory
therapist, dentist, physician assistant,
podiatrist, optometrist, or veterinarian
who has held an active license or
certification under the law of any State
within the last five years, which is
inactive, expired or lapsed, who
prescribes, dispenses, or administers
COVID–19 vaccines that are Covered
Countermeasures under section VI of
this Declaration in any jurisdiction
where the PREP Act applies in
association with a COVID–19
vaccination effort by a State, local,
Tribal or territorial authority or by an
institution in which the COVID–19
vaccine covered countermeasure is
administered, so long as the license or
certification was active and in good
standing prior to the date it went
inactive, expired or lapsed and was not
revoked by the licensing authority,
surrendered while under suspension,
discipline or investigation by a licensing
authority or surrendered following an
arrest, and the individual is not on the
List of Excluded Individuals/Entities
maintained by the Office of Inspector
General;
3. Any medical, nursing, pharmacy,
pharmacy intern, midwife, paramedic,
advanced or intermediate EMT,
physician assistant, respiratory therapy,
dental, podiatry, optometry or
veterinary student with appropriate
training in administering vaccines as
determined by his or her school or
training program and supervision by a
currently practicing healthcare
professional experienced in
administering intramuscular injections
who administers COVID–19 vaccines
that are Covered Countermeasures
under section VI of this Declaration in
any jurisdiction where the PREP Act
applies in association with a COVID–19
vaccination effort by a State, local,
Tribal or territorial authority or by an
institution in which the COVID–19
vaccine covered countermeasure is
administered;
Subject to the following requirements:
i. The vaccine must be authorized,
approved, or licensed by the FDA.
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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; 9
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
9 This requirement is satisfied by, among other
things, a certification in basic cardiopulmonary
resuscitation by an online program that has
received accreditation from the American Nurses
Credentialing Center, the ACPE, or the
Accreditation Council for Continuing Medical
Education. The phrase ‘‘current certificate in basic
cardiopulmonary resuscitation,’’ when used in the
September 3, 2020 or October 20, 2020 OASH
authorizations, shall be interpreted the same way.
See Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID–19 Vaccines
and Immunity under the PREP Act, OASH, Sept. 3,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents//
licensed-pharmacists-and-pharmacy-internsregarding-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/hhsguidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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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) 10
FDA authorized, approved, or licensed
COVID–19 therapeutics. Such Statelicensed pharmacists and the Statelicensed 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
10 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 StateAuthorized 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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987
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; 11
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.
viii. The licensed pharmacist, the
licensed or registered pharmacy intern
and the qualified pharmacy technician
must comply with any applicable
11 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-internsregarding-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/hhsguidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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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
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
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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) 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 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.
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
begin on September 9, 2021.
Liability protections for Qualified
Persons under section V(j) of the
Declaration begin on December 30,
2021.
Authority: 42 U.S.C. 247d–6d.
Dated: January 4, 2022.
Xavier Becerra,
Secretary, U.S. Department of Health and
Human Services.
[FR Doc. 2022–00151 Filed 1–5–22; 11:15 am]
BILLING CODE P
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DEPARTMENT OF THE INTERIOR
Bureau of Land Management
[21X LLUTC01000 L51010000 ER0000
LVRWJ21J4210; UTU–92733; 00–00000]
Notice of Availability of the Pine Valley
Water Supply Project Draft
Environmental Impact Statement,
Beaver and Iron Counties, UT
Bureau of Land Management,
Interior.
ACTION: Notice of Availability.
AGENCY:
In compliance with the
National Environmental Policy Act of
1969, as amended (NEPA), and the
Federal Land Policy and Management
Act of 1976, as amended (FLPMA), the
Bureau of Land Management (BLM)
announces the availability of the Draft
Environmental Impact Statement (EIS)
for a right-of-way (ROW) application
submitted by the Central Iron County
Water Conservancy District (CICWCD),
referred to as the Pine Valley Water
Supply (PVWS) Project.
DATES: This notice initiates the 45-day
comment period. To ensure comments
will be considered, the BLM must
receive written comments on the
proposed PVWS Project Draft EIS by
February 22, 2022. The BLM will
announce public involvement
opportunities at least 15 days in
advance on the BLM ePlanning project
website at https://eplanning.blm.gov/
eplanning-ui/project/1503915/510.
ADDRESSES: The Draft EIS is available
for review on the BLM ePlanning project
website at https://eplanning.blm.gov/
eplanning-ui/project/1503915/510.
Written comments related to the PVWS
Project Draft EIS may be submitted by
either of the following methods:
1. Email: pvwsproject@gmail.com.
2. Mail: Bureau of Land Management,
Attn: PVWS, 176 DL Sargent Drive,
Cedar City, Utah 84721.
FOR FURTHER INFORMATION CONTACT:
Brooklynn Cox, Cedar City Field Office
Realty Specialist, telephone (435) 865–
3073; 176 DL Sargent Dr., Cedar City,
UT 84721; pvwsproject@gmail.com.
Persons who use a telecommunications
device for the deaf may call the Federal
Relay Service (FRS) at 1–800–877–8339
to leave a message or question for the
above individual. The FRS is available
24 hours a day, seven days a week.
Replies are provided during normal
business hours. If you would like to
request to view a hard copy, please call
the Cedar City Field Office for more
information at (435) 865–3000, Monday
through Friday, except holidays.
SUPPLEMENTARY INFORMATION: On June
15, 2017, CICWCD applied for a ROW
SUMMARY:
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]]>Agencies
[Federal Register Volume 87, Number 5 (Friday, January 7, 2022)]
[Notices]
[Pages 982-988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00151]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Tenth Amendment to Declaration Under the Public Readiness and
Emergency Preparedness Act for Medical Countermeasures Against COVID-19
ACTION: Notice of amendment.
-----------------------------------------------------------------------
SUMMARY: The Secretary issues this amendment pursuant to section 319F-3
of the Public Health Service Act to expand the authority for certain
Qualified Persons authorized to prescribe, dispense, and administer
seasonal influenza vaccines under section VI of this Declaration.
DATES: This amendment is effective as of January 7, 2022.
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,
[[Page 983]]
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, July 20,
2021, and October 15, 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, 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; made explicit that the
Declaration covers all qualified pandemic and epidemic products as
defined under the PREP Act; added a third method of distribution to
provide liability protections for, among other things, private
distribution channels; made explicit that there can be situations where
not administering a covered countermeasure to a particular individual
can fall within the PREP Act and the Declaration's liability
protections; made explicit that there are substantive federal legal and
policy issues and interests in having a unified whole-of-nation
response to the COVID-19 pandemic among federal, state, local, and
private-sector entities; revised the effective time period of the
Declaration; and republished the declaration in full. (85 FR 79190,
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, Secretary Xavier Becerra 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, Secretary Becerra 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).
Secretary Xavier Becerra now amends section V of the Declaration to
add subsection (j) to expand the scope of authority for licensed
pharmacists to order and administer and qualified pharmacy interns to
administer seasonal influenza vaccines.
Accordingly, subsection V(j) authorizes:
(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;
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
[[Page 984]]
persons so identified in a declaration by the Secretary'' under
subsection (b) of the PREP Act. 42 U.S.C. 247d-6d(i)(8)
The Secretary anticipates that there will be a need to increase the
available pool of providers able to order and administer seasonal
influenza vaccines. 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. The health
care system capacity and the vaccination workforce are likely to become
increasingly strained throughout the nation. Allowing pharmacists and
pharmacy interns to administer both COVID-19 vaccines and seasonal
influenza vaccines in jurisdictions where the need is greatest would
allow states maximum flexibility in limiting potential impacts of both
illnesses. Pharmacists and pharmacy interns are well positioned to
increase access to seasonal influenza vaccines and have played a
critical role in this pandemic in overseeing COVID-19 testing and
vaccine administration. Given their skill set and training, as well as
looming provider shortages, pharmacists and pharmacy interns would
require minimal, if any, additional training to administer and would
not place any undue training burden on providers.
By this amendment to the Declaration, the Secretary expands the
authorization for an additional category of persons who are qualified
persons under section 247d-6d(i)(8)(B). First, the amendment expands
the authorization for a 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.
As qualified persons, these licensed pharmacists 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 seasonal influenza 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.\1\ The opinion relied in part on the fact that the
Congressional delegation of authority to the Secretary under the PREP
Act to specify a class of persons, beyond those who are authorized to
administer a covered countermeasure under State law, as ``qualified
persons'' would be rendered a nullity in the absence of such
preemption. This opinion is incorporated by reference into this
declaration. Based on the reasoning set forth in the May 19, 2020
advisory opinion, any State law that would otherwise prohibit a member
of any of the classes of ``qualified persons'' specified in this
declaration from administering a covered countermeasure is likewise
preempted. In accordance with section 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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\1\ Department of Health and Human Services General Counsel
Advisory Opinion on the Public Readiness and Emergency Preparedness
Act, May 19, 2020, available at: https://www.hhs.gov/guidance/sites/default/files/hhs-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, treatment and prevention workforces 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, as amended on February 2, 2021, as amended March 11, 2021, as
amended on August 4, 2021, and as amended on September 14, 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 (Dec. 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 \2\ 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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\2\ 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; \3\
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\3\ 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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[[Page 985]]
(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),\4\ (1) vaccines that
the Centers for Disease Control and Prevention (CDC)/Advisory Committee
on Immunization Practices (ACIP) recommend \5\ 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:
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\4\ 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 Jan. 24, 2021).
\5\ 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.
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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 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, 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; \6\
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\6\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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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
[[Page 986]]
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.\7\ Nothing in this
Declaration shall preempt state laws that permit additional persons to
deliver telehealth services.
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\7\ See, e.g., Advisory Opinion 20-02 on the Public Readiness
and Emergency Preparedness Act and the Secretary's Declaration under
the Act, May 19, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021).
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(f) Any healthcare professional or other individual who holds an
active license or certification permitting the person to prescribe,
dispense, or administer vaccines under the law of any State as of the
effective date of this amendment, or 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
\8\ and, for healthcare providers who are not currently practicing,
documentation of an observation period by a currently practicing
healthcare professional experienced in administering intramuscular
injections, and for whom administering intramuscular injections is in
their ordinary scope of practice, who confirms competency of the
healthcare provider in preparation and administration of the COVID-19
vaccine(s) to be administered;
---------------------------------------------------------------------------
\8\ See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/training.html.
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(g) Any member of a uniformed service (including members of the
National Guard in a Title 32 duty status) (hereafter in this paragraph
``service member'') or Federal government, employee, contractor, or
volunteer who prescribes, administers, delivers, distributes or
dispenses a Covered Countermeasure. Such Federal government service
members, employees, contractors, or volunteers are qualified persons if
the following requirement is met: The executive department or agency by
or for which the Federal service member, employee, contractor, or
volunteer is employed, contracts, or volunteers has authorized or could
authorize that service member, employee, contractor, or volunteer to
prescribe, administer, deliver, distribute, or dispense the Covered
Countermeasure as any part of the duties or responsibilities of that
service member, employee, contractor, or volunteer, even if those
authorized duties or responsibilities ordinarily would not extend to
members of the public or otherwise would be more limited in scope than
the activities such service member, employees, contractors, or
volunteers are authorized to carry out under this declaration; and
(h) The following healthcare professionals and students in a
healthcare profession training program subject to the requirements of
this paragraph:
1. Any midwife, paramedic, advanced or intermediate emergency
medical technician (EMT), physician assistant, respiratory therapist,
dentist, podiatrist, optometrist or veterinarian licensed or certified
to practice under the law of any state who prescribes, dispenses, or
administers COVID-19 vaccines that are Covered Countermeasures under
section VI of this Declaration in any jurisdiction where the PREP Act
applies in association with a COVID-19 vaccination effort by a State,
local, Tribal or territorial authority or by an institution in which
the COVID-19 vaccine covered countermeasure is administered;
2. Any physician, advanced practice registered nurse, registered
nurse, practical nurse, pharmacist, pharmacy intern, midwife,
paramedic, advanced or intermediate EMT, respiratory therapist,
dentist, physician assistant, podiatrist, optometrist, or veterinarian
who has held an active license or certification under the law of any
State within the last five years, which is inactive, expired or lapsed,
who prescribes, dispenses, or administers COVID-19 vaccines that are
Covered Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies in association with a COVID-19
vaccination effort by a State, local, Tribal or territorial authority
or by an institution in which the COVID-19 vaccine covered
countermeasure is administered, so long as the license or certification
was active and in good standing prior to the date it went inactive,
expired or lapsed and was not revoked by the licensing authority,
surrendered while under suspension, discipline or investigation by a
licensing authority or surrendered following an arrest, and the
individual is not on the List of Excluded Individuals/Entities
maintained by the Office of Inspector General;
3. Any medical, nursing, pharmacy, pharmacy intern, midwife,
paramedic, advanced or intermediate EMT, physician assistant,
respiratory therapy, dental, podiatry, optometry or veterinary student
with appropriate training in administering vaccines as determined by
his or her school or training program and supervision by a currently
practicing healthcare professional experienced in administering
intramuscular injections who administers COVID-19 vaccines that are
Covered Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies in association with a COVID-19
vaccination effort by a State, local, Tribal or territorial authority
or by an institution in which the COVID-19 vaccine covered
countermeasure is administered;
Subject to the following requirements:
i. The vaccine must be authorized, approved, or licensed by the
FDA.
[[Page 987]]
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; \9\
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\9\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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vi. The healthcare professionals and students must comply with
recordkeeping and reporting requirements of the jurisdiction in which
he or she administers vaccines, including informing the patient's
primary-care provider when available, submitting the required
immunization information to the State or local immunization information
system (vaccine registry), complying with requirements with respect to
reporting adverse events, and complying with requirements whereby the
person administering a vaccine must review the vaccine registry or
other vaccination records prior to administering a vaccine; and
vii. The healthcare professionals and students comply with any
applicable requirements (or conditions of use) as set forth in the
Centers for Disease Control and Prevention (CDC) COVID-19 vaccination
provider agreement and any other federal requirements that apply to the
administration of COVID-19 vaccine(s).
(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) \10\ 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:
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\10\ 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 Jan. 24, 2021).
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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; \11\
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\11\ 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 Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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vii. The licensed pharmacist must 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.
viii. The licensed pharmacist, the licensed or registered pharmacy
intern and the qualified pharmacy technician must comply with any
applicable
[[Page 988]]
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 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 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) 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
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.
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 begin on September 9, 2021.
Liability protections for Qualified Persons under section V(j) of
the Declaration begin on December 30, 2021.
Authority: 42 U.S.C. 247d-6d.
Dated: January 4, 2022.
Xavier Becerra,
Secretary, U.S. Department of Health and Human Services.
[FR Doc. 2022-00151 Filed 1-5-22; 11:15 am]
BILLING CODE P
