Eighth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 41977-41982 [2021-16681]
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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
successfully been matched to an
approved practice site.
Likely Respondents: Clinicians
participating in the NHSC SP and the
S2S LRP.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden
per response
(in hours)
Total burden
hours
Travel Request Worksheet ..................................................
300
2
600
.0667
40.02
Total ..............................................................................
300
........................
600
........................
40.02
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–16597 Filed 8–3–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Eighth Amendment to Declaration
Under the Public Readiness and
Emergency Preparedness Act for
Medical Countermeasures Against
COVID–19
ACTION:
Notice of amendment.
The Secretary issues this
amendment pursuant to section 319F–3
of the Public Health Service Act to
clarify and expand the authority for
certain Qualified Persons authorized to
prescribe, dispense, and administer
covered countermeasures under section
VI of this Declaration.
DATES: This amendment is effective as
of August 4, 2021.
FOR FURTHER INFORMATION CONTACT: L.
Paige Ezernack, Office of the Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SUMMARY:
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Number of
responses per
respondent
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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,
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,
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the Secretary renewed that declaration
effective on April 26, 2020, July 25,
2020, October 23, 2020, January 21,
2021, April 21, 2021 and July 20, 2021.
On March 10, 2020, former Secretary
Azar issued a Declaration under the
PREP Act for medical countermeasures
against COVID–19 (85 FR 15198, Mar.
17, 2020) (the Declaration). On April 10,
the former Secretary amended the
Declaration under the PREP Act to
extend liability immunity to covered
countermeasures authorized under the
CARES Act (85 FR 21012, Apr. 15,
2020). On June 4, the former Secretary
amended the Declaration to clarify that
covered countermeasures under the
Declaration include qualified
countermeasures that limit the harm
COVID–19 might otherwise cause. (85
FR 35100, June 8, 2020). On August 19,
the former Secretary amended the
declaration to add additional categories
of Qualified Persons and amend the
category of disease, health condition, or
threat for which he recommended the
administration or use of the Covered
Countermeasures. (85 FR 52136, August
24, 2020). On December 3, 2020, the
former Secretary amended the
declaration to incorporate Advisory
Opinions of the General Counsel
interpreting the PREP Act and the
Secretary’s Declaration and
authorizations issued by the
Department’s Office of the Assistant
Secretary for Health as an Authority
Having Jurisdiction to respond; added
an additional category of qualified
persons under Section V of the
Declaration; made explicit that the
Declaration covers all qualified
pandemic and epidemic products as
defined under the PREP Act; added a
third method of distribution to provide
liability protections for, among other
things, private distribution channels;
made explicit that there can be
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situations where not administering a
covered countermeasure to a particular
individual can fall within the PREP Act
and the Declaration’s liability
protections; made explicit that there are
substantive federal legal and policy
issues and interests in having a unified
whole-of-nation response to the COVID–
19 pandemic among federal, state, local,
and private-sector entities; revised the
effective time period of the Declaration;
and republished the declaration in full.
(85 FR 79190, December 9, 2020). On
February 2, 2021, the Acting Secretary
Norris Cochran amended the
Declaration to add additional categories
of Qualified Persons authorized to
prescribe, dispense, and administer
COVID–19 vaccines that are covered
countermeasures under the Declaration
(86 FR 7872, February 2, 2021). On
February 16, 2021, the Acting Secretary
amended the Declaration to add
additional categories of Qualified
Persons authorized to prescribe,
dispense, and administer COVID–19
vaccines that are covered
countermeasures under the Declaration
(86 FR 9516, February 16, 2021) and on
February 22, 2021, the Department filed
a notice of correction to the February 2
and February 16 notices correcting
effective dates stated in the Declaration,
and correcting the description of
qualified persons added by the February
16, 2021 amendment. (86 FR 10588,
February 22, 2021). On March 11, 2021,
the Acting Secretary amended the
Declaration to add additional Qualified
Persons authorized to prescribe,
dispense, and administer covered
countermeasures under the Declaration.
(86 FR 14462 March 16, 2021).
Secretary Xavier Becerra now amends
section V of the Declaration to revise
subsections (d) and (f) to clarify that
qualified pharmacy technicians are
Qualified Persons covered by the
Declaration, and to expand the scope of
authority for qualified pharmacy
technicians to administer seasonal
influenza vaccines to adults within the
state where they are authorized to
practice and for interns to administer
seasonal influenza vaccines to adults
consistent with other terms and
conditions of the Declaration.
Accordingly, subsection V(d)
authorizes:
(d) A State-licensed pharmacist who
orders and administers, and pharmacy
interns and qualified pharmacy
technicians who administer (if the
pharmacy intern or technician acts
under the supervision of such
pharmacist and the pharmacy intern or
technician is licensed or registered by
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his or her State board of pharmacy),1 (1)
vaccines that the Advisory Committee
on Immunization Practices (ACIP)
recommends to persons ages three
through 18 according to ACIP’s standard
immunization schedule or (2) seasonal
influenza vaccine administered by
qualified pharmacy technicians and
interns that the ACIP recommends to
persons aged 19 and older according to
ACIP’s standard immunization
schedule; or (3) FDA authorized or FDA
licensed COVID –19 vaccines to persons
ages three or older. Such State-licensed
pharmacists and the State-licensed or
registered interns or technicians under
their supervision are qualified persons
only if the following requirements are
met:
i. The vaccine must be authorized,
approved, or licensed by the FDA;
ii. In the case of a COVID–19 vaccine,
the vaccination must be ordered and
administered according to ACIP’s
COVID–19 vaccine recommendation(s);
iii. In the case of a childhood vaccine,
the vaccination must be ordered and
administered according to ACIP’s
standard immunization schedule;
iv. In the case of seasonal influenza
vaccine administered by qualified
pharmacy technicians and interns, the
vaccination must be ordered and
administered according to ACIP’s
standard immunization schedule;
v. In the case of pharmacy
technicians, the supervising pharmacist
must be readily and immediately
available to the immunizing qualified
pharmacy technician;
vi. The licensed pharmacist must
have completed the immunization
1 Some states do not require pharmacy interns to
be licensed or registered by the state board of
pharmacy. As used herein, ‘‘State-licensed or
registered intern’’ (or equivalent phrases) refers to
pharmacy interns authorized by the state or board
of pharmacy in the state in which the practical
pharmacy internship occurs. The authorization can,
but need not, take the form of a license from, or
registration with, the State board of pharmacy.
Similarly, states vary on licensure and registration
requirements for pharmacy technicians. Some states
require certain education, training, and/or
certification for licensure or registration; others
either have no prerequisites for licensure or
registration or do not require licensure or
registration at all. As used herein, to be a ‘‘qualified
pharmacy technician,’’ pharmacy technicians
working in states with licensure and/or registration
requirements must be licensed and/or registered in
accordance with state requirements; pharmacy
technicians working in states without licensure
and/or registration requirements must have a
Certified Pharmacy Technician (CPhT) certification
from either the Pharmacy Technician Certification
Board or National Healthcareer Association. See
Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized
Pharmacy Interns for Childhood Vaccines, COVID–
19 Vaccines, and COVID–19 Testing, OASH, Oct.
20, 2020 at 2, available at https://www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf (last visited Jan.
24, 2021).
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training that the licensing State requires
for pharmacists to order and administer
vaccines. If the State does not specify
training requirements for the licensed
pharmacist to order and administer
vaccines, the licensed pharmacist must
complete a vaccination training program
of at least 20 hours that is approved by
the Accreditation Council for Pharmacy
Education (ACPE) to order and
administer vaccines. Such a training
program must include hands on
injection technique, clinical evaluation
of indications and contraindications of
vaccines, and the recognition and
treatment of emergency reactions to
vaccines;
vii. The licensed or registered
pharmacy intern and qualified
pharmacy technician must complete a
practical training program that is
approved by the ACPE. This training
program must include hands-on
injection technique, clinical evaluation
of indications and contraindications of
vaccines, and the recognition and
treatment of emergency reactions to
vaccines;
viii. The licensed pharmacist,
licensed or registered pharmacy intern
and qualified pharmacy technician must
have a current certificate in basic
cardiopulmonary resuscitation; 2
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),
2 This requirement is satisfied by, among other
things, a certification in basic cardiopulmonary
resuscitation by an online program that has
received accreditation from the American Nurses
Credentialing Center, the ACPE, or the
Accreditation Council for Continuing Medical
Education. The phrase ‘‘current certificate in basic
cardiopulmonary resuscitation,’’ when used in the
September 3, 2020 or October 20, 2020 OASH
authorizations, shall be interpreted the same way.
See Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID–19 Vaccines
and Immunity under the PREP Act, OASH, Sept. 3,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents//
licensed-pharmacists-and-pharmacy-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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complying with requirements with
respect to reporting adverse events, and
complying with requirements whereby
the person administering a vaccine must
review the vaccine registry or other
vaccination records prior to
administering a vaccine;
xi. The licensed pharmacist must
inform his or her childhood-vaccination
patients and the adult caregiver
accompanying the child of the
importance of a well-child visit with a
pediatrician or other licensed primary
care provider and refer patients as
appropriate; and
xii. The licensed pharmacist, the
licensed or registered pharmacy intern
and the qualified pharmacy technician
must comply with any applicable
requirements (or conditions of use) as
set forth in the Centers for Disease
Control and Prevention (CDC) COVID–
19 vaccination provider agreement and
any other federal requirements that
apply to the administration of COVID–
19 vaccine(s).
Further, the initial phrase of
subsection V(f) is revised to state
authorize ‘‘Any healthcare professional
or other individual who holds an active
license or certification permitting the
person to prescribe, dispense, or
administer vaccines under the law of
any State as of the effective date of this
amendment, or a pharmacist or
pharmacy intern as authorized under
the section V(d) of this
Declaration. . . .’’
Description of This Amendment by
Section
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Section V. Covered Persons
Under the PREP Act and the
Declaration, a ‘‘qualified person’’ is a
‘‘covered person.’’ Subject to certain
limitations, a covered person is immune
from suit and liability under Federal
and State law with respect to all claims
for loss caused by, arising out of,
relating to, or resulting from the
administration or use of a covered
countermeasure if a declaration under
the PREP Act has been issued with
respect to such countermeasure.
‘‘Qualified person’’ includes (A) a
licensed health professional or other
individual who is authorized to
prescribe, administer, or dispense such
countermeasures under the law of the
State in which the countermeasure was
prescribed, administered, or dispensed;
or (B) ‘‘a person within a category of
persons so identified in a declaration by
the Secretary’’ under subsection (b) of
the PREP Act. 42 U.S.C. 247d–6d(i)(8)
By this amendment to the Declaration,
the Secretary clarifies and expands the
authorization for a category of persons
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who are qualified persons under section
247d–6d(i)(8)(B). First, the amendment
clarifies that qualified pharmacy
technicians are authorized to administer
Childhood vaccinations and COVID–19
vaccinations that are Covered
Countermeasures under section VI of
this Declaration. The Department has
authorized qualified pharmacy
technicians to administer these vaccines
under section V(a) of the Declaration
through Guidance issued by the
Assistant Secretary for Health.3 This
amendment adds qualified pharmacy
technicians to section V(d) of the
Declaration, to clarify that these
healthcare professionals are authorized
subject to the conditions stated in that
subsection. In addition, the amendment
expands the authorization for qualified
pharmacy technicians and interns to
administer seasonal influenza vaccines
under the supervision of a pharmacist to
persons aged 19 and older consistent
with ACIP recommendations. The
Secretary anticipates that there will be
a need for the adult population to
receive both COVID–19 and seasonal
influenza vaccines throughout the
2021–2022 influenza season. Health
risks may increase for individuals who
contract seasonal influenza concurrently
with COVID–19, thus expanding the
scope of authorized vaccinators for
seasonal influenza lessens the harm
otherwise caused by COVID–19.
While influenza incidence was lower
than anticipated last fall and winter, the
same cannot be assumed for the 2021–
2022 flu season, as states have largely
lifted the community mitigation
measures previously in place at the
height of the COVID–19 pandemic.
Seasonal influenza has the potential to
inflict significant burden and strain on
the U.S. healthcare system in its own
right; and in conjunction with the
ongoing COVID–19 pandemic, a spike in
influenza cases could overwhelm
healthcare providers. Like the
vaccination against COVID–19, the
vaccination against influenza requires
many people to be vaccinated within a
short period of time, potentially creating
a surge on the system. Concern also
remains regarding the emergence of
SARS-CoV–2 variants and their
potential to cause disease both among
vaccinated and unvaccinated
populations. It is yet to be determined
if COVID–19 vaccine boosters will be
3 Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized
Pharmacy Interns for Childhood Vaccines, COVID–
19 Vaccines, and COVID–19 Testing, OASH, Oct.
20, 2020, available at https://www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf (last visited June
17, 2021).
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41979
recommended; however, if boosters
become necessary, allowing pharmacy
interns and technicians to administer
both COVID–19 vaccines and influenza
vaccines would allow states maximum
flexibility in limiting potential impacts
of both illnesses. ACIP also recently
voted unanimously in favor of COVID–
19 and influenza vaccine coadministration.4 5 Like COVID–19
vaccines, influenza vaccines are
administered as intramuscular (IM)
injections, and would require minimal,
if any, additional training to administer,
and would not place any undue training
burden on providers.
As qualified persons, these qualified
pharmacy technicians and interns will
be afforded liability protections in
accordance with the PREP Act and the
terms of this amended Declaration.
Second, to the extent that any State law
that would otherwise prohibit these
healthcare professionals who are a
‘‘qualified person’’ from prescribing,
dispensing, or administering COVID–19
vaccines or other Covered
Countermeasures, such law is
preempted. On May 19, 2020, the Office
of the General Counsel issued an
advisory opinion concluding that,
because licensed pharmacists are
‘‘qualified persons’’ under this
declaration, the PREP Act preempts
state law that would otherwise prohibit
such pharmacists from ordering and
administering authorized COVID–19
diagnostic tests.6 The opinion relied in
part on the fact that the Congressional
delegation of authority to the Secretary
under the PREP Act to specify a class of
persons, beyond those who are
authorized to administer a covered
countermeasure under State law, as
‘‘qualified persons’’ would be rendered
a nullity in the absence of such
preemption. This opinion is
incorporated by reference into this
declaration. Based on the reasoning set
forth in the May 19, 2020 advisory
opinion, any State law that would
otherwise prohibit a member of any of
the classes of ‘‘qualified persons’’
4 https://www.medpagetoday.com/
meetingcoverage/acip/93283.
5 https://www.aappublications.org/news/2021/06/
24/acip-flu-rabies-dengue-062421.
6 Department of Health and Human Services
General Counsel Advisory Opinion on the Public
Readiness and Emergency Preparedness Act, May
19, 2020, available at: https://www.hhs.gov/
guidance/sites/default/files/hhs-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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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
workforce with additional qualified
healthcare professionals where State or
local requirements might otherwise
inhibit or delay allowing these
healthcare professionals to participate
in the COVID–19 countermeasure
program.
Amendments to Declaration
Amended Declaration for Public
Readiness and Emergency Preparedness
Act Coverage for medical
countermeasures against COVID–19.
Section V of the March 10, 2020
Declaration under the PREP Act for
medical countermeasures against
COVID–19, as amended April 10, 2020,
June 4, 2020, August 19, 2020, as
amended and republished on December
3, 2020, and as amended on February 2,
2021, and as amended March 11, 2021,
is further amended pursuant to section
319F–3(b)(4) of the PHS Act as
described below. All other sections of
the Declaration remain in effect as
republished at 85 FR 79190 (December
9, 2020).
1. Covered Persons, section V, delete
in full and replace with:
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V. Covered Persons
42 U.S.C. 247d–6d(i)(2), (3), (4), (6), (8)(A)
and (B)
Covered Persons who are afforded liability
immunity under this Declaration are
‘‘manufacturers,’’ ‘‘distributors,’’ ‘‘program
planners,’’ ‘‘qualified persons,’’ and their
officials, agents, and employees, as those
terms are defined in the PREP Act, and the
United States. ‘‘Order’’ as used herein and in
guidance issued by the Office of the Assistant
Secretary for Health 7 means a provider
7 See Guidance for Licensed Pharmacists, COVID–
19 Testing, and Immunity Under the PREP Act,
OASH, Apr. 8, 2020, available at https://
www.hhs.gov/guidance/sites/default/files/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).
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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; 8
(b) Any person authorized to prescribe,
administer, or dispense the Covered
Countermeasures or who is otherwise
authorized to perform an activity under an
Emergency Use Authorization in accordance
with Section 564 of the FD&C Act;
(c) Any person authorized to prescribe,
administer, or dispense Covered
Countermeasures in accordance with Section
564A of the FD&C Act;
(d) A State-licensed pharmacist who orders
and administers, and pharmacy interns and
qualified pharmacy technicians who
administer (if the pharmacy intern or
technician acts under the supervision of such
pharmacist and the pharmacy intern or
technician is licensed or registered by his or
her State board of pharmacy),9 (1) vaccines
8 See, e.g., Guidance for Licensed Pharmacists,
COVID–19 Testing, and Immunity Under the PREP
Act, OASH, Apr. 8, 2020, available at https://
www.hhs.gov/guidance/sites/default/files/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
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.
9 Some states do not require pharmacy interns to
be licensed or registered by the state board of
pharmacy. As used herein, ‘‘State-licensed or
registered intern’’ (or equivalent phrases) refers to
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that the Advisory Committee on
Immunization Practices (ACIP) recommends
to persons ages three through 18 according to
ACIP’s standard immunization schedule or
(2) seasonal influenza vaccine administered
by qualified pharmacy technicians and
interns that the ACIP recommends to persons
aged 19 and older according to ACIP’s
standard immunization schedule; or (3) FDA
authorized or FDA licensed COVID –19
vaccines to persons ages three or older. Such
State-licensed pharmacists and the Statelicensed 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 ACIP’s COVID–19
vaccine recommendation(s);
iii. In the case of a childhood vaccine, the
vaccination must be ordered and
administered according to ACIP’s standard
immunization schedule;
iv. In the case of seasonal influenza
vaccine administered by qualified pharmacy
technicians and interns, the vaccination must
be ordered and administered according to
ACIP’s standard immunization schedule;
v. In the case of pharmacy technicians, the
supervising pharmacist must be readily and
immediately available to the immunizing
qualified pharmacy technician;
vi. The licensed pharmacist must have
completed the immunization training that the
licensing State requires for pharmacists to
order and administer vaccines. If the State
does not specify training requirements for the
licensed pharmacist to order and administer
vaccines, the licensed pharmacist must
complete a vaccination training program of at
least 20 hours that is approved by the
Accreditation Council for Pharmacy
Education (ACPE) to order and administer
vaccines. Such a training program must
include hands on injection technique,
clinical evaluation of indications and
contraindications of vaccines, and the
pharmacy interns authorized by the state or board
of pharmacy in the state in which the practical
pharmacy internship occurs. The authorization can,
but need not, take the form of a license from, or
registration with, the State board of pharmacy.
Similarly, states vary on licensure and registration
requirements for pharmacy technicians. Some states
require certain education, training, and/or
certification for licensure or registration; others
either have no prerequisites for licensure or
registration or do not require licensure or
registration at all. As used herein, to be a ‘‘qualified
pharmacy technician,’’ pharmacy technicians
working in states with licensure and/or registration
requirements must be licensed and/or registered in
accordance with state requirements; pharmacy
technicians working in states without licensure
and/or registration requirements must have a
Certified Pharmacy Technician (CPhT) certification
from either the Pharmacy Technician Certification
Board or National Healthcareer Association. See
Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized
Pharmacy Interns for Childhood Vaccines, COVID–
19 Vaccines, and COVID–19 Testing, OASH, Oct.
20, 2020 at 2, available at https://www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf (last visited Jan.
24, 2021).
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recognition and treatment of emergency
reactions to vaccines;
vii. The licensed or registered pharmacy
intern and qualified pharmacy technician
must complete a practical training program
that is approved by the ACPE. This training
program must include hands-on injection
technique, clinical evaluation of indications
and contraindications of vaccines, and the
recognition and treatment of emergency
reactions to vaccines;
viii. The licensed pharmacist, licensed or
registered pharmacy intern and qualified
pharmacy technician must have a current
certificate in basic cardiopulmonary
resuscitation; 10
ix. The licensed pharmacist must complete
a minimum of two hours of ACPE-approved,
immunization-related continuing pharmacy
education during each State licensing period;
x. The licensed pharmacist must comply
with recordkeeping and reporting
requirements of the jurisdiction in which he
or she administers vaccines, including
informing the patient’s primary-care provider
when available, submitting the required
immunization information to the State or
local immunization information system
(vaccine registry), complying with
requirements with respect to reporting
adverse events, and complying with
requirements whereby the person
administering a vaccine must review the
vaccine registry or other vaccination records
prior to administering a vaccine;
xi. The licensed pharmacist must inform
his or her childhood-vaccination patients and
the adult caregiver accompanying the child
of the importance of a well-child visit with
a pediatrician or other licensed primary care
provider and refer patients as appropriate;
and
xii. The licensed pharmacist, the licensed
or registered pharmacy intern and the
qualified pharmacy technician must comply
with any applicable requirements (or
conditions of use) as set forth in the Centers
for Disease Control and Prevention (CDC)
COVID–19 vaccination provider agreement
and any other federal requirements that
apply to the administration of COVID–19
vaccine(s).
(e) Healthcare personnel using telehealth to
order or administer Covered
10 This requirement is satisfied by, among other
things, a certification in basic cardiopulmonary
resuscitation by an online program that has
received accreditation from the American Nurses
Credentialing Center, the ACPE, or the
Accreditation Council for Continuing Medical
Education. The phrase ‘‘current certificate in basic
cardiopulmonary resuscitation,’’ when used in the
September 3, 2020 or October 20, 2020 OASH
authorizations, shall be interpreted the same way.
See Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID–19 Vaccines
and Immunity under the PREP Act, OASH, Sept. 3,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents//
licensed-pharmacists-and-pharmacy-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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16:45 Aug 03, 2021
Jkt 253001
Countermeasures for patients in a state other
than the state where the healthcare personnel
are licensed or otherwise permitted to
practice. When ordering and administering
Covered Countermeasures by means of
telehealth to patients in a state where the
healthcare personnel are not already
permitted to practice, the healthcare
personnel must comply with all requirements
for ordering and administering Covered
Countermeasures to patients by means of
telehealth in the state where the healthcare
personnel are permitted to practice. Any state
law that prohibits or effectively prohibits
such a qualified person from ordering and
administering Covered Countermeasures by
means of telehealth is preempted.11 Nothing
in this Declaration shall preempt state laws
that permit additional persons to deliver
telehealth services;
(f) Any healthcare professional or other
individual who holds an active license or
certification permitting the person to
prescribe, dispense, or administer vaccines
under the law of any State as of the effective
date of this amendment, or a pharmacist or
pharmacy intern as authorized under the
section V(d) of this Declaration, who
prescribes, dispenses, or administers COVID–
19 vaccines that are Covered
Countermeasures under section VI of this
Declaration in any jurisdiction where the
PREP Act applies, other than the State in
which the license or certification is held, in
association with a COVID–19 vaccination
effort by a federal, State, local Tribal or
territorial authority or by an institution in the
State in which the COVID–19 vaccine
covered countermeasure is administered, so
long as the license or certification of the
healthcare professional has not been
suspended or restricted by any licensing
authority, surrendered while under
suspension, discipline or investigation by a
licensing authority or surrendered following
an arrest, and the individual is not on the
List of Excluded Individuals/Entities
maintained by the Office of Inspector
General, subject to: (i) Documentation of
completion of the Centers for Disease Control
and Prevention COVID–19 (CDC) Vaccine
Training Modules 12 and, for healthcare
providers who are not currently practicing,
documentation of an observation period by a
currently practicing healthcare professional
experienced in administering intramuscular
injections, and for whom administering
intramuscular injections is in their ordinary
scope of practice, who confirms competency
of the healthcare provider in preparation and
administration of the COVID–19 vaccine(s) to
be administered;
(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
11 See, e.g.,Advisory Opinion 20–02 on the Public
Readiness and Emergency Preparedness Act and the
Secretary’s Declaration under the Act, May 19,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents/
advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last
visited Jan. 24, 2021).
12 See COVID–19 Vaccine Training Modules,
available at https://www.cdc.gov/vaccines/covid-19/
training.html.
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41981
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,
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podiatry, optometry or veterinary student
with appropriate training in administering
vaccines as determined by his or her school
or training program and supervision by a
currently practicing healthcare professional
experienced in administering intramuscular
injections who administers COVID–19
vaccines that are Covered Countermeasures
under section VI of this Declaration in any
jurisdiction where the PREP Act applies in
association with a COVID–19 vaccination
effort by a State, local, Tribal or territorial
authority or by an institution in which the
COVID–19 vaccine covered countermeasure
is administered;
Subject to the following requirements:
i. The vaccine must be authorized,
approved, or licensed by the FDA;
ii. Vaccination must be ordered and
administered according to ACIP’s COVID–19
vaccine recommendation(s);
iii. The healthcare professionals and
students must have documentation of
completion of the Centers for Disease Control
and Prevention COVID–19 Vaccine Training
Modules and, if applicable, such additional
training as may be required by the State,
territory, locality, or Tribal area in which
they are prescribing, dispensing, or
administering COVID–19 vaccines;
iv. The healthcare professionals and
students must have documentation of an
observation period by a currently practicing
healthcare professional experienced in
administering intramuscular injections, and
for whom administering vaccinations is in
their ordinary scope of practice, who
confirms competency of the healthcare
provider or student in preparation and
administration of the COVID–19 vaccine(s) to
be administered and, if applicable, such
additional training as may be required by the
State, territory, locality, or Tribal area in
which they are prescribing, dispensing, or
administering COVID–19 vaccines;
v. The healthcare professionals and
students must have a current certificate in
basic cardiopulmonary resuscitation; 13
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
13 This requirement is satisfied by, among other
things, a certification in basic cardiopulmonary
resuscitation by an online program that has
received accreditation from the American Nurses
Credentialing Center, the ACPE, or the
Accreditation Council for Continuing Medical
Education. The phrase ‘‘current certificate in basic
cardiopulmonary resuscitation,’’ when used in the
September 3, 2020 or October 20, 2020 OASH
authorizations, shall be interpreted the same way.
See Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID–19 Vaccines
and Immunity under the PREP Act, OASH, Sept. 3,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents//
licensed-pharmacists-and-pharmacy-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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16:45 Aug 03, 2021
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primary-care provider when available,
submitting the required immunization
information to the State or local
immunization information system (vaccine
registry), complying with requirements with
respect to reporting adverse events, and
complying with requirements whereby the
person administering a vaccine must review
the vaccine registry or other vaccination
records prior to administering a vaccine; and
vii. The healthcare professionals and
students comply with any applicable
requirements (or conditions of use) as set
forth in the Centers for Disease Control and
Prevention (CDC) COVID–19 vaccination
provider agreement and any other federal
requirements that apply to the administration
of COVID–19 vaccine(s).
Nothing in this Declaration shall be
construed to affect the National Vaccine
Injury Compensation Program, including an
injured party’s ability to obtain compensation
under that program. Covered
countermeasures that are subject to the
National Vaccine Injury Compensation
Program authorized under 42 U.S.C. 300aa–
10 et seq. are covered under this Declaration
for the purposes of liability immunity and
injury compensation only to the extent that
injury compensation is not provided under
that Program. All other terms and conditions
of the Declaration apply to such covered
countermeasures.
2. Effective Time Period, section XII,
delete in full and replace with:
Liability protections for any respiratory
protective device approved by NIOSH under
42 CFR part 84, or any successor regulations,
through the means of distribution identified
in Section VII(a) of this Declaration, begin on
March 27, 2020 and extend through October
1, 2024.
Liability protections for all other Covered
Countermeasures identified in Section VI of
this Declaration, through means of
distribution identified in Section VII(a) of
this Declaration, begin on February 4, 2020
and extend through October 1, 2024.
Liability protections for all Covered
Countermeasures administered and used in
accordance with the public health and
medical response of the Authority Having
Jurisdiction, as identified in Section VII(b) of
this Declaration, begin with a Declaration of
Emergency as that term is defined in Section
VII (except that, with respect to qualified
persons who order or administer a routine
childhood vaccination that ACIP
recommends to persons ages three through 18
according to ACIP’s standard immunization
schedule, liability protections began on
August 24, 2020), and last through (a) the
final day the Declaration of Emergency is in
effect, or (b) October 1, 2024, whichever
occurs first.
Liability protections for all Covered
Countermeasures identified in Section VII(c)
of this Declaration begin on December 9,
2020 and last through (a) the final day the
Declaration of Emergency is in effect. or (b)
October 1, 2024. whichever occurs first.
Liability protections for Qualified Persons
under section V(d) of the Declaration who are
qualified pharmacy technicians and interns
to administer seasonal influenza vaccine to
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persons aged 19 and older begin on August
4, 2021.
Liability protections for Qualified Persons
under section V(f) of the Declaration begin on
February 2, 2021, and last through October 1,
2024.
Liability protections for Qualified Persons
under section V(g) of the Declaration begin
on February 16, 2021, and last through
October 1, 2024.
Liability protections for Qualified Persons
who are physicians, advanced practice
registered nurses, registered nurses, or
practical nurses under section V(h) of the
Declaration begins on February 2, 2021 and
last through October 1, 2024, with additional
conditions effective as of March 11, 2021and
liability protections for all other Qualified
persons under section V(h) begins on March
11, 2021 and last through October 1, 2024.
Authority: 42 U.S.C. 247d–6d.
Dated: July 30, 2021.
Xavier Becerra,
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–16681 Filed 8–2–21; 11:15 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Fogarty International Center; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Fogarty International
Center Advisory Board.
The meeting will be open to the
public via online meeting. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
Contact Person listed below in advance
of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Fogarty International
Center Advisory Board.
Date: September 9–10, 2021.
Closed: September 09, 2021, 12:00 p.m. to
3:30 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 86, Number 147 (Wednesday, August 4, 2021)]
[Notices]
[Pages 41977-41982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16681]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Eighth Amendment to Declaration Under the Public Readiness and
Emergency Preparedness Act for Medical Countermeasures Against COVID-19
ACTION: Notice of amendment.
-----------------------------------------------------------------------
SUMMARY: The Secretary issues this amendment pursuant to section 319F-3
of the Public Health Service Act to clarify and expand the authority
for certain Qualified Persons authorized to prescribe, dispense, and
administer covered countermeasures under section VI of this
Declaration.
DATES: This amendment is effective as of August 4, 2021.
FOR FURTHER INFORMATION CONTACT: L. Paige Ezernack, Office of the
Assistant Secretary for Preparedness and Response, Office of the
Secretary, Department of Health and Human Services, 200 Independence
Avenue SW, Washington, DC 20201; 202-260-0365, [email protected].
SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes the Secretary of Health and
Human Services (the Secretary) to issue a Declaration to provide
liability immunity to certain individuals and entities (Covered
Persons) against any claim of loss caused by, arising out of, relating
to, or resulting from the manufacture, distribution, administration, or
use of medical countermeasures (Covered Countermeasures), except for
claims involving ``willful misconduct'' as defined in the PREP Act.
Under the PREP Act, a Declaration may be amended as circumstances
warrant.
The PREP Act was enacted on December 30, 2005, as Public Law 109-
148, Division C, Sec. 2. It amended the Public Health Service (PHS)
Act, adding section 319F-3, which addresses liability immunity, and
section 319F-4, which creates a compensation program. These sections
are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.
Section 319F-3 of the PHS Act has been amended by the Pandemic and All-
Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5,
enacted on March 13, 2013, and the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, Public Law 116-136, enacted on March 27,
2020, to expand Covered Countermeasures under the PREP Act.
On January 31, 2020, the former Secretary, Alex M. Azar II,
declared a public health emergency pursuant to section 319 of the PHS
Act, 42 U.S.C. 247d, effective January 27, 2020, for the entire United
States to aid in the response of the nation's health care community to
the COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the
Secretary renewed that declaration effective on April 26, 2020, July
25, 2020, October 23, 2020, January 21, 2021, April 21, 2021 and July
20, 2021.
On March 10, 2020, former Secretary Azar issued a Declaration under
the PREP Act for medical countermeasures against COVID-19 (85 FR 15198,
Mar. 17, 2020) (the Declaration). On April 10, the former Secretary
amended the Declaration under the PREP Act to extend liability immunity
to covered countermeasures authorized under the CARES Act (85 FR 21012,
Apr. 15, 2020). On June 4, the former Secretary amended the Declaration
to clarify that covered countermeasures under the Declaration include
qualified countermeasures that limit the harm COVID-19 might otherwise
cause. (85 FR 35100, June 8, 2020). On August 19, the former Secretary
amended the declaration to add additional categories of Qualified
Persons and amend the category of disease, health condition, or threat
for which he recommended the administration or use of the Covered
Countermeasures. (85 FR 52136, August 24, 2020). On December 3, 2020,
the former Secretary amended the declaration to incorporate Advisory
Opinions of the General Counsel interpreting the PREP Act and the
Secretary's Declaration and authorizations issued by the Department's
Office of the Assistant Secretary for Health as an Authority Having
Jurisdiction to respond; added an additional category of qualified
persons under Section V of the Declaration; made explicit that the
Declaration covers all qualified pandemic and epidemic products as
defined under the PREP Act; added a third method of distribution to
provide liability protections for, among other things, private
distribution channels; made explicit that there can be
[[Page 41978]]
situations where not administering a covered countermeasure to a
particular individual can fall within the PREP Act and the
Declaration's liability protections; made explicit that there are
substantive federal legal and policy issues and interests in having a
unified whole-of-nation response to the COVID-19 pandemic among
federal, state, local, and private-sector entities; revised the
effective time period of the Declaration; and republished the
declaration in full. (85 FR 79190, December 9, 2020). On February 2,
2021, the Acting Secretary Norris Cochran amended the Declaration to
add additional categories of Qualified Persons authorized to prescribe,
dispense, and administer COVID-19 vaccines that are covered
countermeasures under the Declaration (86 FR 7872, February 2, 2021).
On February 16, 2021, the Acting Secretary amended the Declaration to
add additional categories of Qualified Persons authorized to prescribe,
dispense, and administer COVID-19 vaccines that are covered
countermeasures under the Declaration (86 FR 9516, February 16, 2021)
and on February 22, 2021, the Department filed a notice of correction
to the February 2 and February 16 notices correcting effective dates
stated in the Declaration, and correcting the description of qualified
persons added by the February 16, 2021 amendment. (86 FR 10588,
February 22, 2021). On March 11, 2021, the Acting Secretary amended the
Declaration to add additional Qualified Persons authorized to
prescribe, dispense, and administer covered countermeasures under the
Declaration. (86 FR 14462 March 16, 2021).
Secretary Xavier Becerra now amends section V of the Declaration to
revise subsections (d) and (f) to clarify that qualified pharmacy
technicians are Qualified Persons covered by the Declaration, and to
expand the scope of authority for qualified pharmacy technicians to
administer seasonal influenza vaccines to adults within the state where
they are authorized to practice and for interns to administer seasonal
influenza vaccines to adults consistent with other terms and conditions
of the Declaration.
Accordingly, subsection V(d) authorizes:
(d) A State-licensed pharmacist who orders and administers, and
pharmacy interns and qualified pharmacy technicians who administer (if
the pharmacy intern or technician acts under the supervision of such
pharmacist and the pharmacy intern or technician is licensed or
registered by his or her State board of pharmacy),\1\ (1) vaccines that
the Advisory Committee on Immunization Practices (ACIP) recommends to
persons ages three through 18 according to ACIP's standard immunization
schedule or (2) seasonal influenza vaccine administered by qualified
pharmacy technicians and interns that the ACIP recommends to persons
aged 19 and older according to ACIP's standard immunization schedule;
or (3) FDA authorized or FDA licensed COVID -19 vaccines to persons
ages three or older. Such State-licensed pharmacists and the State-
licensed or registered interns or technicians under their supervision
are qualified persons only if the following requirements are met:
---------------------------------------------------------------------------
\1\ Some states do not require pharmacy interns to be licensed
or registered by the state board of pharmacy. As used herein,
``State-licensed or registered intern'' (or equivalent phrases)
refers to pharmacy interns authorized by the state or board of
pharmacy in the state in which the practical pharmacy internship
occurs. The authorization can, but need not, take the form of a
license from, or registration with, the State board of pharmacy.
Similarly, states vary on licensure and registration requirements
for pharmacy technicians. Some states require certain education,
training, and/or certification for licensure or registration; others
either have no prerequisites for licensure or registration or do not
require licensure or registration at all. As used herein, to be a
``qualified pharmacy technician,'' pharmacy technicians working in
states with licensure and/or registration requirements must be
licensed and/or registered in accordance with state requirements;
pharmacy technicians working in states without licensure and/or
registration requirements must have a Certified Pharmacy Technician
(CPhT) certification from either the Pharmacy Technician
Certification Board or National Healthcareer Association. See
Guidance for PREP Act Coverage for Qualified Pharmacy Technicians
and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-
19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2,
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24,
2021).
---------------------------------------------------------------------------
i. The vaccine must be authorized, approved, or licensed by the
FDA;
ii. In the case of a COVID-19 vaccine, the vaccination must be
ordered and administered according to ACIP's COVID-19 vaccine
recommendation(s);
iii. In the case of a childhood vaccine, the vaccination must be
ordered and administered according to ACIP's standard immunization
schedule;
iv. In the case of seasonal influenza vaccine administered by
qualified pharmacy technicians and interns, the vaccination must be
ordered and administered according to ACIP's standard immunization
schedule;
v. In the case of pharmacy technicians, the supervising pharmacist
must be readily and immediately available to the immunizing qualified
pharmacy technician;
vi. The licensed pharmacist must have completed the immunization
training that the licensing State requires for pharmacists to order and
administer vaccines. If the State does not specify training
requirements for the licensed pharmacist to order and administer
vaccines, the licensed pharmacist must complete a vaccination training
program of at least 20 hours that is approved by the Accreditation
Council for Pharmacy Education (ACPE) to order and administer vaccines.
Such a training program must include hands on injection technique,
clinical evaluation of indications and contraindications of vaccines,
and the recognition and treatment of emergency reactions to vaccines;
vii. The licensed or registered pharmacy intern and qualified
pharmacy technician must complete a practical training program that is
approved by the ACPE. This training program must include hands-on
injection technique, clinical evaluation of indications and
contraindications of vaccines, and the recognition and treatment of
emergency reactions to vaccines;
viii. The licensed pharmacist, licensed or registered pharmacy
intern and qualified pharmacy technician must have a current
certificate in basic cardiopulmonary resuscitation; \2\
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\2\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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ix. The licensed pharmacist must complete a minimum of two hours of
ACPE-approved, immunization-related continuing pharmacy education
during each State licensing period;
x. The licensed pharmacist must comply with recordkeeping and
reporting requirements of the jurisdiction in which he or she
administers vaccines, including informing the patient's primary-care
provider when available, submitting the required immunization
information to the State or local immunization information system
(vaccine registry),
[[Page 41979]]
complying with requirements with respect to reporting adverse events,
and complying with requirements whereby the person administering a
vaccine must review the vaccine registry or other vaccination records
prior to administering a vaccine;
xi. The licensed pharmacist must inform his or her childhood-
vaccination patients and the adult caregiver accompanying the child of
the importance of a well-child visit with a pediatrician or other
licensed primary care provider and refer patients as appropriate; and
xii. The licensed pharmacist, the licensed or registered pharmacy
intern and the qualified pharmacy technician must comply with any
applicable requirements (or conditions of use) as set forth in the
Centers for Disease Control and Prevention (CDC) COVID-19 vaccination
provider agreement and any other federal requirements that apply to the
administration of COVID-19 vaccine(s).
Further, the initial phrase of subsection V(f) is revised to state
authorize ``Any healthcare professional or other individual who holds
an active license or certification permitting the person to prescribe,
dispense, or administer vaccines under the law of any State as of the
effective date of this amendment, or a pharmacist or pharmacy intern as
authorized under the section V(d) of this Declaration. . . .''
Description of This Amendment by Section
Section V. Covered Persons
Under the PREP Act and the Declaration, a ``qualified person'' is a
``covered person.'' Subject to certain limitations, a covered person is
immune from suit and liability under Federal and State law with respect
to all claims for loss caused by, arising out of, relating to, or
resulting from the administration or use of a covered countermeasure if
a declaration under the PREP Act has been issued with respect to such
countermeasure. ``Qualified person'' includes (A) a licensed health
professional or other individual who is authorized to prescribe,
administer, or dispense such countermeasures under the law of the State
in which the countermeasure was prescribed, administered, or dispensed;
or (B) ``a person within a category of persons so identified in a
declaration by the Secretary'' under subsection (b) of the PREP Act. 42
U.S.C. 247d-6d(i)(8)
By this amendment to the Declaration, the Secretary clarifies and
expands the authorization for a category of persons who are qualified
persons under section 247d-6d(i)(8)(B). First, the amendment clarifies
that qualified pharmacy technicians are authorized to administer
Childhood vaccinations and COVID-19 vaccinations that are Covered
Countermeasures under section VI of this Declaration. The Department
has authorized qualified pharmacy technicians to administer these
vaccines under section V(a) of the Declaration through Guidance issued
by the Assistant Secretary for Health.\3\ This amendment adds qualified
pharmacy technicians to section V(d) of the Declaration, to clarify
that these healthcare professionals are authorized subject to the
conditions stated in that subsection. In addition, the amendment
expands the authorization for qualified pharmacy technicians and
interns to administer seasonal influenza vaccines under the supervision
of a pharmacist to persons aged 19 and older consistent with ACIP
recommendations. The Secretary anticipates that there will be a need
for the adult population to receive both COVID-19 and seasonal
influenza vaccines throughout the 2021-2022 influenza season. Health
risks may increase for individuals who contract seasonal influenza
concurrently with COVID-19, thus expanding the scope of authorized
vaccinators for seasonal influenza lessens the harm otherwise caused by
COVID-19.
---------------------------------------------------------------------------
\3\ Guidance for PREP Act Coverage for Qualified Pharmacy
Technicians and State-Authorized Pharmacy Interns for Childhood
Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH, Oct. 20,
2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited June 17,
2021).
---------------------------------------------------------------------------
While influenza incidence was lower than anticipated last fall and
winter, the same cannot be assumed for the 2021-2022 flu season, as
states have largely lifted the community mitigation measures previously
in place at the height of the COVID-19 pandemic. Seasonal influenza has
the potential to inflict significant burden and strain on the U.S.
healthcare system in its own right; and in conjunction with the ongoing
COVID-19 pandemic, a spike in influenza cases could overwhelm
healthcare providers. Like the vaccination against COVID-19, the
vaccination against influenza requires many people to be vaccinated
within a short period of time, potentially creating a surge on the
system. Concern also remains regarding the emergence of SARS-CoV-2
variants and their potential to cause disease both among vaccinated and
unvaccinated populations. It is yet to be determined if COVID-19
vaccine boosters will be recommended; however, if boosters become
necessary, allowing pharmacy interns and technicians to administer both
COVID-19 vaccines and influenza vaccines would allow states maximum
flexibility in limiting potential impacts of both illnesses. ACIP also
recently voted unanimously in favor of COVID-19 and influenza vaccine
co-administration.4 5 Like COVID-19 vaccines, influenza
vaccines are administered as intramuscular (IM) injections, and would
require minimal, if any, additional training to administer, and would
not place any undue training burden on providers.
---------------------------------------------------------------------------
\4\ https://www.medpagetoday.com/meetingcoverage/acip/93283.
\5\ https://www.aappublications.org/news/2021/06/24/acip-flu-rabies-dengue-062421.
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As qualified persons, these qualified pharmacy technicians and
interns will be afforded liability protections in accordance with the
PREP Act and the terms of this amended Declaration. Second, to the
extent that any State law that would otherwise prohibit these
healthcare professionals who are a ``qualified person'' from
prescribing, dispensing, or administering COVID-19 vaccines or other
Covered Countermeasures, such law is preempted. On May 19, 2020, the
Office of the General Counsel issued an advisory opinion concluding
that, because licensed pharmacists are ``qualified persons'' under this
declaration, the PREP Act preempts state law that would otherwise
prohibit such pharmacists from ordering and administering authorized
COVID-19 diagnostic tests.\6\ The opinion relied in part on the fact
that the Congressional delegation of authority to the Secretary under
the PREP Act to specify a class of persons, beyond those who are
authorized to administer a covered countermeasure under State law, as
``qualified persons'' would be rendered a nullity in the absence of
such preemption. This opinion is incorporated by reference into this
declaration. Based on the reasoning set forth in the May 19, 2020
advisory opinion, any State law that would otherwise prohibit a member
of any of the classes of ``qualified persons''
[[Page 41980]]
specified in this declaration from administering a covered
countermeasure is likewise preempted. In accordance with section 319F-
3(i)(8)(A) of the Public Health Service Act, a State remains free to
expand the universe of individuals authorized to administer covered
countermeasures within its jurisdiction under State law.
---------------------------------------------------------------------------
\6\ Department of Health and Human Services General Counsel
Advisory Opinion on the Public Readiness and Emergency Preparedness
Act, May 19, 2020, available at: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-advisory-opinion-hhs-ogc.pdf/ (last visited Jan. 24, 2021). See also, Department of
Justice Office of Legal Counsel Advisory Opinion for Robert P.
Charrow, General Counsel of the Department of Health and Human
Services, January 12, 2021, available at: https://www.justice.gov/sites/default/files/opinions/attachments/2021/01/19/2021-01-19-prep-act-preemption.pdf (last visited Jan. 24, 2021).
---------------------------------------------------------------------------
The plain language of the PREP Act makes clear that there is
preemption of state law as described above. Furthermore, preemption of
State law is justified to respond to the nation-wide public health
emergency caused by COVID-19 as it will enable States to quickly expand
the vaccination workforce with additional qualified healthcare
professionals where State or local requirements might otherwise inhibit
or delay allowing these healthcare professionals to participate in the
COVID-19 countermeasure program.
Amendments to Declaration
Amended Declaration for Public Readiness and Emergency Preparedness
Act Coverage for medical countermeasures against COVID-19.
Section V of the March 10, 2020 Declaration under the PREP Act for
medical countermeasures against COVID-19, as amended April 10, 2020,
June 4, 2020, August 19, 2020, as amended and republished on December
3, 2020, and as amended on February 2, 2021, and as amended March 11,
2021, is further amended pursuant to section 319F-3(b)(4) of the PHS
Act as described below. All other sections of the Declaration remain in
effect as republished at 85 FR 79190 (December 9, 2020).
1. Covered Persons, section V, delete in full and replace with:
V. Covered Persons
42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)
Covered Persons who are afforded liability immunity under this
Declaration are ``manufacturers,'' ``distributors,'' ``program
planners,'' ``qualified persons,'' and their officials, agents, and
employees, as those terms are defined in the PREP Act, and the
United States. ``Order'' as used herein and in guidance issued by
the Office of the Assistant Secretary for Health \7\ means a
provider medication order, which includes prescribing of vaccines,
or a laboratory order, which includes prescribing laboratory orders,
if required. In addition, I have determined that the following
additional persons are qualified persons:
---------------------------------------------------------------------------
\7\ See Guidance for Licensed Pharmacists, COVID-19 Testing, and
Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at
https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for
Licensed Pharmacists and Pharmacy Interns Regarding COVID-19
Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020,
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24,
2021).
---------------------------------------------------------------------------
(a) Any person authorized in accordance with the public health
and medical emergency response of the Authority Having Jurisdiction,
as described in Section VII below, to prescribe, administer,
deliver, distribute or dispense the Covered Countermeasures, and
their officials, agents, employees, contractors and volunteers,
following a Declaration of an Emergency, as that term is defined in
Section VII of this Declaration; \8\
---------------------------------------------------------------------------
\8\ See, e.g., Guidance for Licensed Pharmacists, COVID-19
Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020,
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance
for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes,
Assisted-Living Facilities, Long-Term-Care Facilities, and other
Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-coverage-for-screening-in-congregate-settings.pdf (last
visited Jan. 24, 2021); Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the
PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act
Coverage for Qualified Pharmacy Technicians and State-Authorized
Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and
COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021); PREP Act
Authorization for Pharmacies Distributing and Administering Certain
Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH
PREP Act Authorizations). Nothing herein shall suggest that, for
purposes of the Declaration, the foregoing are the only persons
authorized in accordance with the public health and medical
emergency response of the Authority Having Jurisdiction.
---------------------------------------------------------------------------
(b) Any person authorized to prescribe, administer, or dispense
the Covered Countermeasures or who is otherwise authorized to
perform an activity under an Emergency Use Authorization in
accordance with Section 564 of the FD&C Act;
(c) Any person authorized to prescribe, administer, or dispense
Covered Countermeasures in accordance with Section 564A of the FD&C
Act;
(d) A State-licensed pharmacist who orders and administers, and
pharmacy interns and qualified pharmacy technicians who administer
(if the pharmacy intern or technician acts under the supervision of
such pharmacist and the pharmacy intern or technician is licensed or
registered by his or her State board of pharmacy),\9\ (1) vaccines
that the Advisory Committee on Immunization Practices (ACIP)
recommends to persons ages three through 18 according to ACIP's
standard immunization schedule or (2) seasonal influenza vaccine
administered by qualified pharmacy technicians and interns that the
ACIP recommends to persons aged 19 and older according to ACIP's
standard immunization schedule; or (3) FDA authorized or FDA
licensed COVID -19 vaccines to persons ages three or older. Such
State-licensed pharmacists and the State-licensed or registered
interns or technicians under their supervision are qualified persons
only if the following requirements are met:
---------------------------------------------------------------------------
\9\ Some states do not require pharmacy interns to be licensed
or registered by the state board of pharmacy. As used herein,
``State-licensed or registered intern'' (or equivalent phrases)
refers to pharmacy interns authorized by the state or board of
pharmacy in the state in which the practical pharmacy internship
occurs. The authorization can, but need not, take the form of a
license from, or registration with, the State board of pharmacy.
Similarly, states vary on licensure and registration requirements
for pharmacy technicians. Some states require certain education,
training, and/or certification for licensure or registration; others
either have no prerequisites for licensure or registration or do not
require licensure or registration at all. As used herein, to be a
``qualified pharmacy technician,'' pharmacy technicians working in
states with licensure and/or registration requirements must be
licensed and/or registered in accordance with state requirements;
pharmacy technicians working in states without licensure and/or
registration requirements must have a Certified Pharmacy Technician
(CPhT) certification from either the Pharmacy Technician
Certification Board or National Healthcareer Association. See
Guidance for PREP Act Coverage for Qualified Pharmacy Technicians
and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-
19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2,
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24,
2021).
---------------------------------------------------------------------------
i. The vaccine must be authorized, approved, or licensed by the
FDA;
ii. In the case of a COVID-19 vaccine, the vaccination must be
ordered and administered according to ACIP's COVID-19 vaccine
recommendation(s);
iii. In the case of a childhood vaccine, the vaccination must be
ordered and administered according to ACIP's standard immunization
schedule;
iv. In the case of seasonal influenza vaccine administered by
qualified pharmacy technicians and interns, the vaccination must be
ordered and administered according to ACIP's standard immunization
schedule;
v. In the case of pharmacy technicians, the supervising
pharmacist must be readily and immediately available to the
immunizing qualified pharmacy technician;
vi. The licensed pharmacist must have completed the immunization
training that the licensing State requires for pharmacists to order
and administer vaccines. If the State does not specify training
requirements for the licensed pharmacist to order and administer
vaccines, the licensed pharmacist must complete a vaccination
training program of at least 20 hours that is approved by the
Accreditation Council for Pharmacy Education (ACPE) to order and
administer vaccines. Such a training program must include hands on
injection technique, clinical evaluation of indications and
contraindications of vaccines, and the
[[Page 41981]]
recognition and treatment of emergency reactions to vaccines;
vii. The licensed or registered pharmacy intern and qualified
pharmacy technician must complete a practical training program that
is approved by the ACPE. This training program must include hands-on
injection technique, clinical evaluation of indications and
contraindications of vaccines, and the recognition and treatment of
emergency reactions to vaccines;
viii. The licensed pharmacist, licensed or registered pharmacy
intern and qualified pharmacy technician must have a current
certificate in basic cardiopulmonary resuscitation; \10\
---------------------------------------------------------------------------
\10\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
---------------------------------------------------------------------------
ix. The licensed pharmacist must complete a minimum of two hours
of ACPE-approved, immunization-related continuing pharmacy education
during each State licensing period;
x. The licensed pharmacist must comply with recordkeeping and
reporting requirements of the jurisdiction in which he or she
administers vaccines, including informing the patient's primary-care
provider when available, submitting the required immunization
information to the State or local immunization information system
(vaccine registry), complying with requirements with respect to
reporting adverse events, and complying with requirements whereby
the person administering a vaccine must review the vaccine registry
or other vaccination records prior to administering a vaccine;
xi. The licensed pharmacist must inform his or her childhood-
vaccination patients and the adult caregiver accompanying the child
of the importance of a well-child visit with a pediatrician or other
licensed primary care provider and refer patients as appropriate;
and
xii. The licensed pharmacist, the licensed or registered
pharmacy intern and the qualified pharmacy technician must comply
with any applicable requirements (or conditions of use) as set forth
in the Centers for Disease Control and Prevention (CDC) COVID-19
vaccination provider agreement and any other federal requirements
that apply to the administration of COVID-19 vaccine(s).
(e) Healthcare personnel using telehealth to order or administer
Covered Countermeasures for patients in a state other than the state
where the healthcare personnel are licensed or otherwise permitted
to practice. When ordering and administering Covered Countermeasures
by means of telehealth to patients in a state where the healthcare
personnel are not already permitted to practice, the healthcare
personnel must comply with all requirements for ordering and
administering Covered Countermeasures to patients by means of
telehealth in the state where the healthcare personnel are permitted
to practice. Any state law that prohibits or effectively prohibits
such a qualified person from ordering and administering Covered
Countermeasures by means of telehealth is preempted.\11\ Nothing in
this Declaration shall preempt state laws that permit additional
persons to deliver telehealth services;
---------------------------------------------------------------------------
\11\ See, e.g.,Advisory Opinion 20-02 on the Public Readiness
and Emergency Preparedness Act and the Secretary's Declaration under
the Act, May 19, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021).
---------------------------------------------------------------------------
(f) Any healthcare professional or other individual who holds an
active license or certification permitting the person to prescribe,
dispense, or administer vaccines under the law of any State as of
the effective date of this amendment, or a pharmacist or pharmacy
intern as authorized under the section V(d) of this Declaration, who
prescribes, dispenses, or administers COVID-19 vaccines that are
Covered Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies, other than the State in
which the license or certification is held, in association with a
COVID-19 vaccination effort by a federal, State, local Tribal or
territorial authority or by an institution in the State in which the
COVID-19 vaccine covered countermeasure is administered, so long as
the license or certification of the healthcare professional has not
been suspended or restricted by any licensing authority, surrendered
while under suspension, discipline or investigation by a licensing
authority or surrendered following an arrest, and the individual is
not on the List of Excluded Individuals/Entities maintained by the
Office of Inspector General, subject to: (i) Documentation of
completion of the Centers for Disease Control and Prevention COVID-
19 (CDC) Vaccine Training Modules \12\ and, for healthcare providers
who are not currently practicing, documentation of an observation
period by a currently practicing healthcare professional experienced
in administering intramuscular injections, and for whom
administering intramuscular injections is in their ordinary scope of
practice, who confirms competency of the healthcare provider in
preparation and administration of the COVID-19 vaccine(s) to be
administered;
---------------------------------------------------------------------------
\12\ See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/training.html.
---------------------------------------------------------------------------
(g) Any member of a uniformed service (including members of the
National Guard in a Title 32 duty status) (hereafter in this
paragraph ``service member'') or Federal government, employee,
contractor, or volunteer who prescribes, administers, delivers,
distributes or dispenses a Covered Countermeasure. Such Federal
government service members, employees, contractors, or volunteers
are qualified persons if the following requirement is met: The
executive department or agency by or for which the Federal service
member, employee, contractor, or volunteer is employed, contracts,
or volunteers has authorized or could authorize that service member,
employee, contractor, or volunteer to prescribe, administer,
deliver, distribute, or dispense the Covered Countermeasure as any
part of the duties or responsibilities of that service member,
employee, contractor, or volunteer, even if those authorized duties
or responsibilities ordinarily would not extend to members of the
public or otherwise would be more limited in scope than the
activities such service member, employees, contractors, or
volunteers are authorized to carry out under this declaration; and
(h) The following healthcare professionals and students in a
healthcare profession training program subject to the requirements
of this paragraph:
1. Any midwife, paramedic, advanced or intermediate emergency
medical technician (EMT), physician assistant, respiratory
therapist, dentist, podiatrist, optometrist or veterinarian licensed
or certified to practice under the law of any state who prescribes,
dispenses, or administers COVID-19 vaccines that are Covered
Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies in association with a COVID-
19 vaccination effort by a State, local, Tribal or territorial
authority or by an institution in which the COVID-19 vaccine covered
countermeasure is administered;
2. Any physician, advanced practice registered nurse, registered
nurse, practical nurse, pharmacist, pharmacy intern, midwife,
paramedic, advanced or intermediate EMT, respiratory therapist,
dentist, physician assistant, podiatrist, optometrist, or
veterinarian who has held an active license or certification under
the law of any State within the last five years, which is inactive,
expired or lapsed, who prescribes, dispenses, or administers COVID-
19 vaccines that are Covered Countermeasures under section VI of
this Declaration in any jurisdiction where the PREP Act applies in
association with a COVID-19 vaccination effort by a State, local,
Tribal or territorial authority or by an institution in which the
COVID-19 vaccine covered countermeasure is administered, so long as
the license or certification was active and in good standing prior
to the date it went inactive, expired or lapsed and was not revoked
by the licensing authority, surrendered while under suspension,
discipline or investigation by a licensing authority or surrendered
following an arrest, and the individual is not on the List of
Excluded Individuals/Entities maintained by the Office of Inspector
General;
3. Any medical, nursing, pharmacy, pharmacy intern, midwife,
paramedic, advanced or intermediate EMT, physician assistant,
respiratory therapy, dental,
[[Page 41982]]
podiatry, optometry or veterinary student with appropriate training
in administering vaccines as determined by his or her school or
training program and supervision by a currently practicing
healthcare professional experienced in administering intramuscular
injections who administers COVID-19 vaccines that are Covered
Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies in association with a COVID-
19 vaccination effort by a State, local, Tribal or territorial
authority or by an institution in which the COVID-19 vaccine covered
countermeasure is administered;
Subject to the following requirements:
i. The vaccine must be authorized, approved, or licensed by the
FDA;
ii. Vaccination must be ordered and administered according to
ACIP's COVID-19 vaccine recommendation(s);
iii. The healthcare professionals and students must have
documentation of completion of the Centers for Disease Control and
Prevention COVID-19 Vaccine Training Modules and, if applicable,
such additional training as may be required by the State, territory,
locality, or Tribal area in which they are prescribing, dispensing,
or administering COVID-19 vaccines;
iv. The healthcare professionals and students must have
documentation of an observation period by a currently practicing
healthcare professional experienced in administering intramuscular
injections, and for whom administering vaccinations is in their
ordinary scope of practice, who confirms competency of the
healthcare provider or student in preparation and administration of
the COVID-19 vaccine(s) to be administered and, if applicable, such
additional training as may be required by the State, territory,
locality, or Tribal area in which they are prescribing, dispensing,
or administering COVID-19 vaccines;
v. The healthcare professionals and students must have a current
certificate in basic cardiopulmonary resuscitation; \13\
---------------------------------------------------------------------------
\13\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
---------------------------------------------------------------------------
vi. The healthcare professionals and students must comply with
recordkeeping and reporting requirements of the jurisdiction in
which he or she administers vaccines, including informing the
patient's primary-care provider when available, submitting the
required immunization information to the State or local immunization
information system (vaccine registry), complying with requirements
with respect to reporting adverse events, and complying with
requirements whereby the person administering a vaccine must review
the vaccine registry or other vaccination records prior to
administering a vaccine; and
vii. The healthcare professionals and students comply with any
applicable requirements (or conditions of use) as set forth in the
Centers for Disease Control and Prevention (CDC) COVID-19
vaccination provider agreement and any other federal requirements
that apply to the administration of COVID-19 vaccine(s).
Nothing in this Declaration shall be construed to affect the
National Vaccine Injury Compensation Program, including an injured
party's ability to obtain compensation under that program. Covered
countermeasures that are subject to the National Vaccine Injury
Compensation Program authorized under 42 U.S.C. 300aa-10 et seq. are
covered under this Declaration for the purposes of liability
immunity and injury compensation only to the extent that injury
compensation is not provided under that Program. All other terms and
conditions of the Declaration apply to such covered countermeasures.
2. Effective Time Period, section XII, delete in full and replace
with:
Liability protections for any respiratory protective device
approved by NIOSH under 42 CFR part 84, or any successor
regulations, through the means of distribution identified in Section
VII(a) of this Declaration, begin on March 27, 2020 and extend
through October 1, 2024.
Liability protections for all other Covered Countermeasures
identified in Section VI of this Declaration, through means of
distribution identified in Section VII(a) of this Declaration, begin
on February 4, 2020 and extend through October 1, 2024.
Liability protections for all Covered Countermeasures
administered and used in accordance with the public health and
medical response of the Authority Having Jurisdiction, as identified
in Section VII(b) of this Declaration, begin with a Declaration of
Emergency as that term is defined in Section VII (except that, with
respect to qualified persons who order or administer a routine
childhood vaccination that ACIP recommends to persons ages three
through 18 according to ACIP's standard immunization schedule,
liability protections began on August 24, 2020), and last through
(a) the final day the Declaration of Emergency is in effect, or (b)
October 1, 2024, whichever occurs first.
Liability protections for all Covered Countermeasures identified
in Section VII(c) of this Declaration begin on December 9, 2020 and
last through (a) the final day the Declaration of Emergency is in
effect. or (b) October 1, 2024. whichever occurs first.
Liability protections for Qualified Persons under section V(d)
of the Declaration who are qualified pharmacy technicians and
interns to administer seasonal influenza vaccine to persons aged 19
and older begin on August 4, 2021.
Liability protections for Qualified Persons under section V(f)
of the Declaration begin on February 2, 2021, and last through
October 1, 2024.
Liability protections for Qualified Persons under section V(g)
of the Declaration begin on February 16, 2021, and last through
October 1, 2024.
Liability protections for Qualified Persons who are physicians,
advanced practice registered nurses, registered nurses, or practical
nurses under section V(h) of the Declaration begins on February 2,
2021 and last through October 1, 2024, with additional conditions
effective as of March 11, 2021and liability protections for all
other Qualified persons under section V(h) begins on March 11, 2021
and last through October 1, 2024.
Authority: 42 U.S.C. 247d-6d.
Dated: July 30, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-16681 Filed 8-2-21; 11:15 am]
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