Fifth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 7872-7876 [2021-02174]
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Fifth Amendment to Declaration Under
the Public Readiness and Emergency
Preparedness Act for Medical
Countermeasures Against COVID–19
ACTION:
Notice of amendment.
SUMMARY: The Acting Secretary issues
this amendment pursuant to section
319F–3 of the Public Health Service Act
to add additional categories of Qualified
Persons authorized to prescribe,
dispense, and administer COVID–19
vaccines that are covered
countermeasures under section VI of
this Declaration.
DATES: This amendment to the
Declaration is effective as of February 2,
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; Telephone:
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,
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relating to, or resulting from the
manufacture, distribution,
administration, or use of medical
countermeasures (Covered
Countermeasures), except for claims
involving ‘‘willful misconduct’’ as
defined in the PREP Act. Under the
PREP Act, a Declaration may be
amended as circumstances warrant.
The PREP Act was enacted on
December 30, 2005, as Public Law 109–
148, Division C, section 2. It amended
the Public Health Service (PHS) Act,
adding section 319F–3, which addresses
liability immunity, and section 319F–4,
which creates a compensation program.
These sections are codified at 42 U.S.C.
247d–6d and 42 U.S.C. 247d–6e,
respectively. Section 319F–3 of the PHS
Act has been amended by the Pandemic
and All-Hazards Preparedness
Reauthorization Act (PAHPRA), Public
Law 113–5, enacted on March 13, 2013
and the Coronavirus Aid, Relief, and
Economic Security (CARES) Act, Public
Law 116–136, enacted on March 27,
2020, to expand Countermeasures under
the PREP Act.
On January 31, 2020, former Secretary
Alex M. Azar II declared a public health
emergency pursuant to section 319 of
the PHS Act, 42 U.S.C. 247d, effective
January 27, 2020, for the entire United
States to aid in the response of the
nation’s health care community to the
COVID–19 outbreak. Pursuant to section
319 of the PHS Act, the Secretary
renewed that declaration effective on
April 26, 2020, July 25, 2020, October
23, 2020, and January 21, 2121.
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 51236, 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
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Secretary’s Declaration and
authorizations issued by the
Department’s Office of the Assistant
Secretary for Health as an Authority
Having Jurisdiction to respond; added
an additional category of qualified
persons under Section V of the
Declaration; made explicit that the
Declaration covers all qualified
pandemic and epidemic products as
defined under the PREP Act; added a
third method of distribution to provide
liability protections for, among other
things, private distribution channels;
made explicit that there can be
situations where not administering a
covered countermeasure to a particular
individual can fall within the PREP Act
and the Declaration’s liability
protections; made explicit that there are
substantive Federal legal and policy
issues and interests in having a unified
whole-of-nation response to the COVID–
19 pandemic among Federal, state,
local, and private-sector entities; revised
the effective time period of the
Declaration; and republished the
declaration in full. (85 FR 79190
December 9, 2020).
The Acting Secretary now amends
section V of the Declaration to add
additional categories of qualified
persons covered under the PREP Act,
and thus authorizes:
(f) Any healthcare professional or
other individual who holds an active
license or certification permitting the
person to prescribe, dispense, or
administer vaccines under the law of
any State as of the effective date of this
amendment, or as authorized under
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
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Training Modules 1 and, for healthcare
providers who are not currently
practicing, documentation of an
observation period by a currently
practicing healthcare professional
adequately experienced in vaccination
who confirms competency of the
healthcare provider in preparation and
administration of the particular COVID–
19 vaccine(s) to be administered; and
(g) Any physician, advanced practice
registered nurse, registered nurse, or
practical nurse who has held an active
license or certification to prescribe,
dispense, or administer vaccines 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 federal, 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, subject to (i)
documentation of completion of the
Centers for Disease Control and
Prevention COVID–19 Vaccine Training
Modules and (ii) documentation of an
observation period by a currently
practicing healthcare professional
adequately experienced in vaccination
who confirms competency of the
healthcare provider in preparation and
administration of the particular COVID–
19 vaccine(s) to be administered.
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
1 See COVID–19 Vaccine Training Modules,
available at https://www.cdc.gov/vaccines/covid-19/
training.html.
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respect to such countermeasure.
‘‘Qualified person’’ includes (A) a
licensed health professional or other
individual who is authorized to
prescribe, administer, or dispense such
countermeasures under the law of the
State in which the countermeasure was
prescribed, administered, or dispensed;
or (B) ‘‘a person within a category of
persons so identified in a declaration by
the Secretary’’ under subsection (b) of
the PREP Act. 42 U.S.C. 247d–6d(i)(8).
By this amendment to the Declaration,
the Acting Secretary identifies two
additional categories of persons who are
qualified persons under section 247d–
6d(i)(8)(B), allowing healthcare
providers who are licensed in a State to
prescribe, dispense, and/or administer
COVID–19 vaccines in any State or
jurisdiction where the PREP Act
applies, and allowing physicians,
registered nurses, and practical nurses
whose licenses expired within the past
five years to prescribe, dispense, and/or
administer COVID–19 vaccines in any
State.
The Acting Secretary has determined
that there is an urgent need to expand
the pool of available COVID–19
vaccinators in order to respond
effectively to the pandemic. As vaccine
supply is made more widely available
over the coming months, health care
system capacity and the vaccination
workforce are likely to become
increasingly strained throughout the
Nation. Permitting Physicians,
registered nurses, and practical nurses
who have recently expired licenses also
significantly expands the vaccination
workforce. There are approximately
160,000 inactive physicians and 350,000
inactive registered nurses and practical
nurses in the United States.
These healthcare professionals can
safely administer COVID–19 vaccines
because they all have training in
performing injections and observing for
side effects and will be required to
document completion of the Centers for
Disease Control and Prevention (CDC)
COVID–19 Vaccine Training Modules.
Including these healthcare
professionals as Qualified Persons
under this amended Declaration
achieves two purposes. First, the
healthcare professionals will be afforded
liability protections in accordance with
the PREP Act and the terms of this
amended Declaration. Second, any State
law that would otherwise prohibit the
healthcare professionals who are a
‘‘qualified person’’ from prescribing,
dispensing, or administering COVID–19
vaccines is preempted. On May 19,
2020, the Office of the General Counsel
issued an advisory opinion concluding
that, because licensed pharmacists are
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‘‘qualified persons’’ under this
declaration, the PREP Act preempts
state law that would otherwise prohibit
such pharmacists from ordering and
administering authorized COVID–19
diagnostic tests.2 The opinion relied in
part on the fact that the Congressional
delegation of authority to the Secretary
under the PREP Act to specify a class of
persons, beyond those who are
authorized to administer a covered
countermeasure under State law, as
‘‘qualified persons’’ would be rendered
a nullity in the absence of such
preemption. This opinion is
incorporated by reference into this
declaration. Based on the reasoning set
forth in the May 19, 2020 advisory
opinion, any State law that would
otherwise prohibit a member of any of
the classes of ‘‘qualified persons’’
specified in this declaration from
administering a covered countermeasure
is likewise preempted. In accordance
with section 319F–3(i)(8)(A) of the
Public Health Service Act, a State
remains free to expand the universe of
individuals authorized to administer
covered countermeasures within its
jurisdiction under State law.
The plain language of the PREP Act
makes clear that there is complete
preemption of state law as described
above. Furthermore, preemption of State
law is justified to respond to the nationwide public health emergency caused
by COVID–19 as it will enable States to
quickly expand the vaccination
workforce with additional qualified
healthcare professionals where State or
local requirements might otherwise
inhibit or delay allowing these
healthcare professionals to participate
in the COVID–19 vaccination program.
Amendments to Declaration
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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, and August 19, 2020 and
amended and republished on December
2 Department of Health and Human Services
General Counsel Advisory Opinion on the Public
Readiness and Emergency Preparedness Act, May
19, 2020, available at: https://www.hhs.gov/
guidance/sites/default/files/hhs-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, 2020, 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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3, 2020 is further amended pursuant to
section 319F–3(b)(4) of the PHS Act as
described below. All other sections of
the Declaration remain in effect as
republished at 85 FR 79190 (December
9, 2020).
1. Covered Persons, section V, delete
in full and replace with:
V. Covered Persons
42 U.S.C. 247d–6d(i)(2), (3), (4), (6),
(8)(A) and (B)
Covered Persons who are afforded
liability immunity under this
Declaration are ‘‘manufacturers,’’
‘‘distributors,’’ ‘‘program planners,’’
‘‘qualified persons,’’ and their officials,
agents, and employees, as those terms
are defined in the PREP Act, and the
United States. ‘‘Order’’ as used herein
and in guidance issued by the Office of
the Assistant Secretary for Health 3
means a provider medication order,
which includes prescribing of vaccines,
or a laboratory order, which includes
prescribing laboratory orders, if
required. In addition, I have determined
that the following additional persons are
qualified persons:
(a) Any person authorized in
accordance with the public health and
medical emergency response of the
Authority Having Jurisdiction, as
described in Section VII below, to
prescribe, administer, deliver, distribute
or dispense the Covered
Countermeasures, and their officials,
agents, employees, contractors and
volunteers, following a Declaration of an
Emergency, as that term is defined in
Section VII of this Declaration; 4
3 See Guidance for Licensed Pharmacists, COVID–
19 Testing, and Immunity Under the PREP Act,
OASH, Apr. 8, 2020, available at https://
www.hhs.gov/guidance/sites/default/files/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).
4 See, e.g., Guidance for Licensed Pharmacists,
COVID–19 Testing, and Immunity Under the PREP
Act, OASH, Apr. 8, 2020, available at https://
www.hhs.gov/guidance/sites/default/files/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/hhs-
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(b) Any person authorized to
prescribe, administer, or dispense the
Covered Countermeasures or who is
otherwise authorized to perform an
activity under an Emergency Use
Authorization in accordance with
Section 564 of the FD&C Act;
(c) Any person authorized to
prescribe, administer, or dispense
Covered Countermeasures in accordance
with Section 564A of the FD&C Act;
(d) A State-licensed pharmacist who
orders and administers, and pharmacy
interns who administer (if the pharmacy
intern acts under the supervision of
such pharmacist and the pharmacy
intern is licensed or registered by his or
her State board of pharmacy),5 (1)
vaccines that the Advisory Committee
on Immunization Practices (ACIP)
recommends to persons ages three
through 18 according to ACIP’s standard
immunization schedule or (2) FDA
authorized or FDA licensed COVID –19
vaccines to persons ages three or older.
Such State-licensed pharmacists and the
State-licensed or registered interns
under their supervision are qualified
persons only if the following
requirements are met:
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).
guidance-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.
5 Some states do not require pharmacy interns to
be licensed or registered by the state board of
pharmacy. As used herein, ‘‘State-licensed or
registered intern’’ (or equivalent phrases) refers to
pharmacy interns authorized by the state or board
of pharmacy in the state in which the practical
pharmacy internship occurs. The authorization can,
but need not, take the form of a license from, or
registration with, the State board of pharmacy. See
Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized
Pharmacy Interns for Childhood Vaccines, COVID–
19 Vaccines, and COVID–19 Testing, OASH, Oct.
20, 2020 at 2, available at https://www.hhs.gov/
guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf (last visited Jan.
24, 2021).
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iii. In the case of a childhood vaccine,
the vaccination must be ordered and
administered according to ACIP’s
standard immunization schedule;
iv. The licensed pharmacist must
have completed the immunization
training that the licensing State requires
in order for pharmacists to order and
administer vaccines. If the State does
not specify training requirements for the
licensed pharmacist to order and
administer vaccines, the licensed
pharmacist must complete a vaccination
training program of at least 20 hours
that is approved by the Accreditation
Council for Pharmacy Education (ACPE)
to order and administer vaccines. Such
a training program must include hands
on injection technique, clinical
evaluation of indications and
contraindications of vaccines, and the
recognition and treatment of emergency
reactions to vaccines;
v. The licensed or registered
pharmacy intern must complete a
practical training program that is
approved by the ACPE. This training
program must include hands-on
injection technique, clinical evaluation
of indications and contraindications of
vaccines, and the recognition and
treatment of emergency reactions to
vaccines;
vi. The licensed pharmacist and
licensed or registered pharmacy intern
must have a current certificate in basic
cardiopulmonary resuscitation; 6
vii. The licensed pharmacist must
complete a minimum of two hours of
ACPE-approved, immunization-related
continuing pharmacy education during
each State licensing period;
viii. The licensed pharmacist must
comply with recordkeeping and
reporting requirements of the
jurisdiction in which he or she
administers vaccines, including
informing the patient’s primary-care
6 This requirement is satisfied by, among other
things, a certification in basic cardiopulmonary
resuscitation by an online program that has
received accreditation from the American Nurses
Credentialing Center, the ACPE, or the
Accreditation Council for Continuing Medical
Education. The phrase ‘‘current certificate in basic
cardiopulmonary resuscitation,’’ when used in the
September 3, 2020 or October 20, 2020 OASH
authorizations, shall be interpreted the same way.
See Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID–19 Vaccines
and Immunity under the PREP Act, OASH, Sept. 3,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents//
licensed-pharmacists-and-pharmacy-internsregarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act
Coverage for Qualified Pharmacy Technicians and
State-Authorized Pharmacy Interns for Childhood
Vaccines, COVID–19 Vaccines, and COVID–19
Testing, OASH, Oct. 20, 2020, available at https://
www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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provider when available, submitting the
required immunization information to
the State or local immunization
information system (vaccine registry),
complying with requirements with
respect to reporting adverse events, and
complying with requirements whereby
the person administering a vaccine must
review the vaccine registry or other
vaccination records prior to
administering a vaccine;
ix. The licensed pharmacist must
inform his or her childhood-vaccination
patients and the adult caregiver
accompanying the child of the
importance of a well-child visit with a
pediatrician or other licensed primary
care provider and refer patients as
appropriate; and
x. The licensed pharmacist and the
licensed or registered pharmacy intern
must comply with any applicable
requirements (or conditions of use) as
set forth in the Centers for Disease
Control and Prevention (CDC) COVID–
19 vaccination provider agreement and
any other federal requirements that
apply to the administration of COVID–
19 vaccine(s).
(e) Healthcare personnel using
telehealth to order or administer
Covered Countermeasures for patients
in a state other than the state where the
healthcare personnel are licensed or
otherwise permitted to practice. When
ordering and administering Covered
Countermeasures by means of telehealth
to patients in a state where the
healthcare personnel are not already
permitted to practice, the healthcare
personnel must comply with all
requirements for ordering and
administering Covered Countermeasures
to patients by means of telehealth in the
state where the healthcare personnel are
permitted to practice. Any state law that
prohibits or effectively prohibits such a
qualified person from ordering and
administering Covered Countermeasures
by means of telehealth is preempted.7
Nothing in this Declaration shall
preempt state laws that permit
additional persons to deliver telehealth
services.
(f) Any healthcare professional or
other individual who holds an active
license or certification permitting the
person to prescribe, dispense, or
administer vaccines under the law of
any State as of the effective date of this
amendment, or as authorized under the
section V(d) of this Declaration, who
7 See, e.g., Advisory Opinion 20–02 on the Public
Readiness and Emergency Preparedness Act and the
Secretary’s Declaration under the Act, May 19,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents/
advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last
visited Jan. 24, 2021).
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prescribes, dispenses, or administers
COVID–19 vaccines that are Covered
Countermeasures under section VI of
this Declaration in any jurisdiction
where the PREP Act applies, other than
the State in which the license or
certification is held, in association with
a COVID–19 vaccination effort by a
federal, State, local Tribal or territorial
authority or by an institution in the
State in which the COVID–19 vaccine
covered countermeasure is
administered, so long as the license or
certification of the healthcare
professional has not been suspended or
restricted by any licensing authority,
surrendered while under suspension,
discipline or investigation by a licensing
authority or surrendered following an
arrest, and the individual is not on the
List of Excluded Individuals/Entities
maintained by the Office of Inspector
General, subject to: (i) Documentation of
completion of the Centers for Disease
Control and Prevention COVID–19
(CDC) Vaccine Training Modules 8 and,
for healthcare providers who are not
currently practicing, documentation of
an observation period by a currently
practicing healthcare professional
adequately experienced in vaccination
who confirms competency of the
healthcare provider in preparation and
administration of the particular COVID–
19 vaccine(s) to be administered; and
(g) Any physician, advanced practice
registered nurse, registered nurse, or
practical nurse who has held an active
license or certification to prescribe,
dispense, or administer vaccines 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 federal, 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
8 See COVID–19 Vaccine Training Modules,
available at https://www2.cdc.gov/vaccines/ed/
covid19/index.asp (last visited Jan. 23, 2021)
https://www.cdc.gov/vaccines/covid-19/
training.html.
E:\FR\FM\02FEN1.SGM
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Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Notices
General, subject to (i) documentation of
completion of the Centers for Disease
Control and Prevention COVID–19
Vaccine Training Modules and (ii)
documentation of an observation period
by a currently practicing healthcare
professional adequately experienced in
vaccination who confirms competency
of the healthcare provider in
preparation and administration of the
particular COVID–19 vaccine(s) to be
administered.
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,
add to the end of the section:
Liability protections for Qualified
Persons under sections V(f) and V(d) of
the declaration begin on January 28,
2021, and last through October 1, 2024.
Authority: 42 U.S.C. 247d–6d.
Norris Cochran,
Acting Secretary, Department of Health and
Human Services.
[FR Doc. 2021–02174 Filed 1–29–21; 4:15 pm]
BILLING CODE 4150–37–P
INTERNATIONAL TRADE
COMMISSION
[Investigation Nos. 701–TA–663–664 and
731–TA–1555–1556 (Preliminary)]
Granular Polytetrafluoroethylene
(PTFE) Resin From India and Russia;
Institution of Anti-Dumping and
Countervailing Duty Investigations and
Scheduling of Preliminary Phase
Investigations
United States International
Trade Commission.
ACTION: Notice.
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
SUMMARY: The Commission hereby gives
notice of the institution of investigations
and commencement of preliminary
phase antidumping and countervailing
duty investigation Nos. 701–TA–663–
664 and 731–TA–1555–1556
(Preliminary) pursuant to the Tariff Act
of 1930 (‘‘the Act’’) to determine
whether there is a reasonable indication
that an industry in the United States is
VerDate Sep<11>2014
19:08 Feb 01, 2021
Jkt 253001
materially injured or threatened with
material injury, or the establishment of
an industry in the United States is
materially retarded, by reason of
imports of granular
polytetrafluoroethylene (PTFE) resin
from India and Russia, provided for in
subheading 3904.61.00 of the
Harmonized Tariff Schedule of the
United States, that are alleged to be sold
in the United States at less than fair
value and alleged to be subsidized by
the Governments of India and Russia.
Unless the Department of Commerce
(‘‘Commerce’’) extends the time for
initiation, the Commission must reach a
preliminary determination in
antidumping and countervailing duty
investigations in 45 days, or in this case
by March 15, 2021. The Commission’s
views must be transmitted to Commerce
within five business days thereafter, or
by March 22, 2021.
DATES: January 27, 2021.
FOR FURTHER INFORMATION CONTACT:
Keysha Martinez ((202) 205–2136),
Office of Investigations, U.S.
International Trade Commission, 500 E
Street SW, Washington, DC 20436.
Hearing-impaired persons can obtain
information on this matter by contacting
the Commission’s TDD terminal on 202–
205–1810. Persons with mobility
impairments who will need special
assistance in gaining access to the
Commission should contact the Office
of the Secretary at 202–205–2000.
General information concerning the
Commission may also be obtained by
accessing its internet server (https://
www.usitc.gov). The public record for
these investigations may be viewed on
the Commission’s electronic docket
(EDIS) at https://edis.usitc.gov.
SUPPLEMENTARY INFORMATION:
Background.—These investigations are
being instituted, pursuant to sections
703(a) and 733(a) of the Tariff Act of
1930 (19 U.S.C. 1671b(a) and 1673b(a)),
in response to a petition filed on
January 27, 2021, by Daikin America,
Inc., Orangeburg, New York.
For further information concerning
the conduct of these investigations and
rules of general application, consult the
Commission’s Rules of Practice and
Procedure, part 201, subparts A and B
(19 CFR part 201), and part 207,
subparts A and B (19 CFR part 207).
Participation in the investigations and
public service list.—Persons (other than
petitioners) wishing to participate in the
investigations as parties must file an
entry of appearance with the Secretary
to the Commission, as provided in
§§ 201.11 and 207.10 of the
Commission’s rules, not later than seven
days after publication of this notice in
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
the Federal Register. Industrial users
and (if the merchandise under
investigation is sold at the retail level)
representative consumer organizations
have the right to appear as parties in
Commission antidumping duty and
countervailing duty investigations. The
Secretary will prepare a public service
list containing the names and addresses
of all persons, or their representatives,
who are parties to these investigations
upon the expiration of the period for
filing entries of appearance.
Limited disclosure of business
proprietary information (BPI) under an
administrative protective order (APO)
and BPI service list.—Pursuant to
§ 207.7(a) of the Commission’s rules, the
Secretary will make BPI gathered in
these investigations available to
authorized applicants representing
interested parties (as defined in 19
U.S.C. 1677(9)) who are parties to the
investigations under the APO issued in
the investigations, provided that the
application is made not later than seven
days after the publication of this notice
in the Federal Register. A separate
service list will be maintained by the
Secretary for those parties authorized to
receive BPI under the APO.
Conference.— In light of the
restrictions on access to the Commission
building due to the COVID–19
pandemic, the Commission is
conducting the staff conference through
video conferencing on February 17,
2021. Requests to appear at the
conference should be emailed to
preliminaryconferences@usitc.gov (DO
NOT FILE ON EDIS) on or before
February 12, 2021. Please provide an
email address for each conference
participant in the email. Information on
conference procedures will be provided
separately and guidance on joining the
video conference will be available on
the Commission’s Daily Calendar. A
nonparty who has testimony that may
aid the Commission’s deliberations may
request permission to participate by
submitting a short statement.
Please note the Secretary’s Office will
accept only electronic filings during this
time. Filings must be made through the
Commission’s Electronic Document
Information System (EDIS, https://
edis.usitc.gov). No in-person paperbased filings or paper copies of any
electronic filings will be accepted until
further notice.
Written submissions.—As provided in
§§ 201.8 and 207.15 of the
Commission’s rules, any person may
submit to the Commission on or before
February 22, 2021, a written brief
containing information and arguments
pertinent to the subject matter of the
investigations. Parties shall file written
E:\FR\FM\02FEN1.SGM
02FEN1
Agencies
[Federal Register Volume 86, Number 20 (Tuesday, February 2, 2021)]
[Notices]
[Pages 7872-7876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02174]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Fifth Amendment to Declaration Under the Public Readiness and
Emergency Preparedness Act for Medical Countermeasures Against COVID-19
ACTION: Notice of amendment.
-----------------------------------------------------------------------
SUMMARY: The Acting Secretary issues this amendment pursuant to section
319F-3 of the Public Health Service Act to add additional categories of
Qualified Persons authorized to prescribe, dispense, and administer
COVID-19 vaccines that are covered countermeasures under section VI of
this Declaration.
DATES: This amendment to the Declaration is effective as of February 2,
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; Telephone: 202-260-0365;
paige.[email protected].
SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes the Secretary of Health and
Human Services (the Secretary) to issue a Declaration to provide
liability immunity to certain individuals and entities (Covered
Persons) against any claim of loss caused by, arising out of, relating
to, or resulting from the manufacture, distribution, administration, or
use of medical countermeasures (Covered Countermeasures), except for
claims involving ``willful misconduct'' as defined in the PREP Act.
Under the PREP Act, a Declaration may be amended as circumstances
warrant.
The PREP Act was enacted on December 30, 2005, as Public Law 109-
148, Division C, section 2. It amended the Public Health Service (PHS)
Act, adding section 319F-3, which addresses liability immunity, and
section 319F-4, which creates a compensation program. These sections
are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.
Section 319F-3 of the PHS Act has been amended by the Pandemic and All-
Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5,
enacted on March 13, 2013 and the Coronavirus Aid, Relief, and Economic
Security (CARES) Act, Public Law 116-136, enacted on March 27, 2020, to
expand Countermeasures under the PREP Act.
On January 31, 2020, former Secretary Alex M. Azar II declared a
public health emergency pursuant to section 319 of the PHS Act, 42
U.S.C. 247d, effective January 27, 2020, for the entire United States
to aid in the response of the nation's health care community to the
COVID-19 outbreak. Pursuant to section 319 of the PHS Act, the
Secretary renewed that declaration effective on April 26, 2020, July
25, 2020, October 23, 2020, and January 21, 2121.
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 51236, 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
[[Page 7873]]
Secretary's Declaration and authorizations issued by the Department's
Office of the Assistant Secretary for Health as an Authority Having
Jurisdiction to respond; added an additional category of qualified
persons under Section V of the Declaration; made explicit that the
Declaration covers all qualified pandemic and epidemic products as
defined under the PREP Act; added a third method of distribution to
provide liability protections for, among other things, private
distribution channels; made explicit that there can be situations where
not administering a covered countermeasure to a particular individual
can fall within the PREP Act and the Declaration's liability
protections; made explicit that there are substantive Federal legal and
policy issues and interests in having a unified whole-of-nation
response to the COVID-19 pandemic among Federal, state, local, and
private-sector entities; revised the effective time period of the
Declaration; and republished the declaration in full. (85 FR 79190
December 9, 2020).
The Acting Secretary now amends section V of the Declaration to add
additional categories of qualified persons covered under the PREP Act,
and thus authorizes:
(f) Any healthcare professional or other individual who holds an
active license or certification permitting the person to prescribe,
dispense, or administer vaccines under the law of any State as of the
effective date of this amendment, or as authorized under 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 \1\ and, for
healthcare providers who are not currently practicing, documentation of
an observation period by a currently practicing healthcare professional
adequately experienced in vaccination who confirms competency of the
healthcare provider in preparation and administration of the particular
COVID-19 vaccine(s) to be administered; and
---------------------------------------------------------------------------
\1\ See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/training.html.
---------------------------------------------------------------------------
(g) Any physician, advanced practice registered nurse, registered
nurse, or practical nurse who has held an active license or
certification to prescribe, dispense, or administer vaccines 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 federal, 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, subject to (i)
documentation of completion of the Centers for Disease Control and
Prevention COVID-19 Vaccine Training Modules and (ii) documentation of
an observation period by a currently practicing healthcare professional
adequately experienced in vaccination who confirms competency of the
healthcare provider in preparation and administration of the particular
COVID-19 vaccine(s) to be administered.
Description of This Amendment by Section
Section V. Covered Persons
Under the PREP Act and the Declaration, a ``qualified person'' is a
``covered person.'' Subject to certain limitations, a covered person is
immune from suit and liability under Federal and State law with respect
to all claims for loss caused by, arising out of, relating to, or
resulting from the administration or use of a covered countermeasure if
a declaration under the PREP Act has been issued with respect to such
countermeasure. ``Qualified person'' includes (A) a licensed health
professional or other individual who is authorized to prescribe,
administer, or dispense such countermeasures under the law of the State
in which the countermeasure was prescribed, administered, or dispensed;
or (B) ``a person within a category of persons so identified in a
declaration by the Secretary'' under subsection (b) of the PREP Act. 42
U.S.C. 247d-6d(i)(8).
By this amendment to the Declaration, the Acting Secretary
identifies two additional categories of persons who are qualified
persons under section 247d-6d(i)(8)(B), allowing healthcare providers
who are licensed in a State to prescribe, dispense, and/or administer
COVID-19 vaccines in any State or jurisdiction where the PREP Act
applies, and allowing physicians, registered nurses, and practical
nurses whose licenses expired within the past five years to prescribe,
dispense, and/or administer COVID-19 vaccines in any State.
The Acting Secretary has determined that there is an urgent need to
expand the pool of available COVID-19 vaccinators in order to respond
effectively to the pandemic. As vaccine supply is made more widely
available over the coming months, health care system capacity and the
vaccination workforce are likely to become increasingly strained
throughout the Nation. Permitting Physicians, registered nurses, and
practical nurses who have recently expired licenses also significantly
expands the vaccination workforce. There are approximately 160,000
inactive physicians and 350,000 inactive registered nurses and
practical nurses in the United States.
These healthcare professionals can safely administer COVID-19
vaccines because they all have training in performing injections and
observing for side effects and will be required to document completion
of the Centers for Disease Control and Prevention (CDC) COVID-19
Vaccine Training Modules.
Including these healthcare professionals as Qualified Persons under
this amended Declaration achieves two purposes. First, the healthcare
professionals will be afforded liability protections in accordance with
the PREP Act and the terms of this amended Declaration. Second, any
State law that would otherwise prohibit the healthcare professionals
who are a ``qualified person'' from prescribing, dispensing, or
administering COVID-19 vaccines is preempted. On May 19, 2020, the
Office of the General Counsel issued an advisory opinion concluding
that, because licensed pharmacists are
[[Page 7874]]
``qualified persons'' under this declaration, the PREP Act preempts
state law that would otherwise prohibit such pharmacists from ordering
and administering authorized COVID-19 diagnostic tests.\2\ The opinion
relied in part on the fact that the Congressional delegation of
authority to the Secretary under the PREP Act to specify a class of
persons, beyond those who are authorized to administer a covered
countermeasure under State law, as ``qualified persons'' would be
rendered a nullity in the absence of such preemption. This opinion is
incorporated by reference into this declaration. Based on the reasoning
set forth in the May 19, 2020 advisory opinion, any State law that
would otherwise prohibit a member of any of the classes of ``qualified
persons'' specified in this declaration from administering a covered
countermeasure is likewise preempted. In accordance with section 319F-
3(i)(8)(A) of the Public Health Service Act, a State remains free to
expand the universe of individuals authorized to administer covered
countermeasures within its jurisdiction under State law.
---------------------------------------------------------------------------
\2\ Department of Health and Human Services General Counsel
Advisory Opinion on the Public Readiness and Emergency Preparedness
Act, May 19, 2020, available at: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/prep-act-advisory-opinion-hhs-ogc.pdf/ (last visited Jan. 24, 2021). See also, Department of
Justice Office of Legal Counsel Advisory Opinion for Robert P.
Charrow, General Counsel of the Department of Health and Human
Services, January 12, 2020, 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
complete preemption of state law as described above. Furthermore,
preemption of State law is justified to respond to the nation-wide
public health emergency caused by COVID-19 as it will enable States to
quickly expand the vaccination workforce with additional qualified
healthcare professionals where State or local requirements might
otherwise inhibit or delay allowing these healthcare professionals to
participate in the COVID-19 vaccination program.
Amendments to Declaration
Amended Declaration for Public Readiness and Emergency Preparedness
Act Coverage for medical countermeasures against COVID-19.
Section V of the March 10, 2020 Declaration under the PREP Act for
medical countermeasures against COVID-19, as amended April 10, 2020,
June 4, 2020, and August 19, 2020 and amended and republished on
December 3, 2020 is further amended pursuant to section 319F-3(b)(4) of
the PHS Act as described below. All other sections of the Declaration
remain in effect as republished at 85 FR 79190 (December 9, 2020).
1. Covered Persons, section V, delete in full and replace with:
V. Covered Persons
42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)
Covered Persons who are afforded liability immunity under this
Declaration are ``manufacturers,'' ``distributors,'' ``program
planners,'' ``qualified persons,'' and their officials, agents, and
employees, as those terms are defined in the PREP Act, and the United
States. ``Order'' as used herein and in guidance issued by the Office
of the Assistant Secretary for Health \3\ means a provider medication
order, which includes prescribing of vaccines, or a laboratory order,
which includes prescribing laboratory orders, if required. In addition,
I have determined that the following additional persons are qualified
persons:
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\3\ See Guidance for Licensed Pharmacists, COVID-19 Testing, and
Immunity Under the PREP Act, OASH, Apr. 8, 2020, available at
https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance for
Licensed Pharmacists and Pharmacy Interns Regarding COVID-19
Vaccines and Immunity under the PREP Act, OASH, Sept. 3, 2020,
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24,
2021).
---------------------------------------------------------------------------
(a) Any person authorized in accordance with the public health and
medical emergency response of the Authority Having Jurisdiction, as
described in Section VII below, to prescribe, administer, deliver,
distribute or dispense the Covered Countermeasures, and their
officials, agents, employees, contractors and volunteers, following a
Declaration of an Emergency, as that term is defined in Section VII of
this Declaration; \4\
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\4\ See, e.g., Guidance for Licensed Pharmacists, COVID-19
Testing, and Immunity Under the PREP Act, OASH, Apr. 8, 2020,
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf (last visited Jan. 24, 2021); Guidance
for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes,
Assisted-Living Facilities, Long-Term-Care Facilities, and other
Congregate Facilities, OASH, Aug. 31, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-coverage-for-screening-in-congregate-settings.pdf (last
visited Jan. 24, 2021); Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the
PREP Act, OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last visited Jan. 24, 2021); Guidance for PREP Act
Coverage for Qualified Pharmacy Technicians and State-Authorized
Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and
COVID-19 Testing, OASH, Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24, 2021); PREP Act
Authorization for Pharmacies Distributing and Administering Certain
Covered Countermeasures, Oct. 29, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-authorization-pharmacies-administering-covered-countermeasures.pdf (last visited Jan. 24, 2021) (collectively, OASH
PREP Act Authorizations). Nothing herein shall suggest that, for
purposes of the Declaration, the foregoing are the only persons
authorized in accordance with the public health and medical
emergency response of the Authority Having Jurisdiction.
---------------------------------------------------------------------------
(b) Any person authorized to prescribe, administer, or dispense the
Covered Countermeasures or who is otherwise authorized to perform an
activity under an Emergency Use Authorization in accordance with
Section 564 of the FD&C Act;
(c) Any person authorized to prescribe, administer, or dispense
Covered Countermeasures in accordance with Section 564A of the FD&C
Act;
(d) A State-licensed pharmacist who orders and administers, and
pharmacy interns who administer (if the pharmacy intern acts under the
supervision of such pharmacist and the pharmacy intern is licensed or
registered by his or her State board of pharmacy),\5\ (1) vaccines that
the Advisory Committee on Immunization Practices (ACIP) recommends to
persons ages three through 18 according to ACIP's standard immunization
schedule or (2) FDA authorized or FDA licensed COVID -19 vaccines to
persons ages three or older. Such State-licensed pharmacists and the
State-licensed or registered interns under their supervision are
qualified persons only if the following requirements are met:
---------------------------------------------------------------------------
\5\ Some states do not require pharmacy interns to be licensed
or registered by the state board of pharmacy. As used herein,
``State-licensed or registered intern'' (or equivalent phrases)
refers to pharmacy interns authorized by the state or board of
pharmacy in the state in which the practical pharmacy internship
occurs. The authorization can, but need not, take the form of a
license from, or registration with, the State board of pharmacy. See
Guidance for PREP Act Coverage for Qualified Pharmacy Technicians
and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-
19 Vaccines, and COVID-19 Testing, OASH, Oct. 20, 2020 at 2,
available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last visited Jan. 24,
2021).
---------------------------------------------------------------------------
i. The vaccine must be authorized, approved, or licensed by the
FDA;
ii. In the case of a COVID-19 vaccine, the vaccination must be
ordered and administered according to ACIP's COVID-19 vaccine
recommendation(s).
[[Page 7875]]
iii. In the case of a childhood vaccine, the vaccination must be
ordered and administered according to ACIP's standard immunization
schedule;
iv. The licensed pharmacist must have completed the immunization
training that the licensing State requires in order for pharmacists to
order and administer vaccines. If the State does not specify training
requirements for the licensed pharmacist to order and administer
vaccines, the licensed pharmacist must complete a vaccination training
program of at least 20 hours that is approved by the Accreditation
Council for Pharmacy Education (ACPE) to order and administer vaccines.
Such a training program must include hands on injection technique,
clinical evaluation of indications and contraindications of vaccines,
and the recognition and treatment of emergency reactions to vaccines;
v. The licensed or registered pharmacy intern must complete a
practical training program that is approved by the ACPE. This training
program must include hands-on injection technique, clinical evaluation
of indications and contraindications of vaccines, and the recognition
and treatment of emergency reactions to vaccines;
vi. The licensed pharmacist and licensed or registered pharmacy
intern must have a current certificate in basic cardiopulmonary
resuscitation; \6\
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\6\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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vii. The licensed pharmacist must complete a minimum of two hours
of ACPE-approved, immunization-related continuing pharmacy education
during each State licensing period;
viii. The licensed pharmacist must comply with recordkeeping and
reporting requirements of the jurisdiction in which he or she
administers vaccines, including informing the patient's primary-care
provider when available, submitting the required immunization
information to the State or local immunization information system
(vaccine registry), complying with requirements with respect to
reporting adverse events, and complying with requirements whereby the
person administering a vaccine must review the vaccine registry or
other vaccination records prior to administering a vaccine;
ix. The licensed pharmacist must inform his or her childhood-
vaccination patients and the adult caregiver accompanying the child of
the importance of a well-child visit with a pediatrician or other
licensed primary care provider and refer patients as appropriate; and
x. The licensed pharmacist and the licensed or registered pharmacy
intern must comply with any applicable requirements (or conditions of
use) as set forth in the Centers for Disease Control and Prevention
(CDC) COVID-19 vaccination provider agreement and any other federal
requirements that apply to the administration of COVID- 19 vaccine(s).
(e) Healthcare personnel using telehealth to order or administer
Covered Countermeasures for patients in a state other than the state
where the healthcare personnel are licensed or otherwise permitted to
practice. When ordering and administering Covered Countermeasures by
means of telehealth to patients in a state where the healthcare
personnel are not already permitted to practice, the healthcare
personnel must comply with all requirements for ordering and
administering Covered Countermeasures to patients by means of
telehealth in the state where the healthcare personnel are permitted to
practice. Any state law that prohibits or effectively prohibits such a
qualified person from ordering and administering Covered
Countermeasures by means of telehealth is preempted.\7\ Nothing in this
Declaration shall preempt state laws that permit additional persons to
deliver telehealth services.
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\7\ See, e.g., Advisory Opinion 20-02 on the Public Readiness
and Emergency Preparedness Act and the Secretary's Declaration under
the Act, May 19, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/advisory-opinion-20-02-hhs-ogc-prep-act.pdf (last visited Jan. 24, 2021).
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(f) Any healthcare professional or other individual who holds an
active license or certification permitting the person to prescribe,
dispense, or administer vaccines under the law of any State as of the
effective date of this amendment, or as authorized under the section
V(d) of this Declaration, who prescribes, dispenses, or administers
COVID-19 vaccines that are Covered Countermeasures under section VI of
this Declaration in any jurisdiction where the PREP Act applies, other
than the State in which the license or certification is held, in
association with a COVID-19 vaccination effort by a federal, State,
local Tribal or territorial authority or by an institution in the State
in which the COVID-19 vaccine covered countermeasure is administered,
so long as the license or certification of the healthcare professional
has not been suspended or restricted by any licensing authority,
surrendered while under suspension, discipline or investigation by a
licensing authority or surrendered following an arrest, and the
individual is not on the List of Excluded Individuals/Entities
maintained by the Office of Inspector General, subject to: (i)
Documentation of completion of the Centers for Disease Control and
Prevention COVID-19 (CDC) Vaccine Training Modules \8\ and, for
healthcare providers who are not currently practicing, documentation of
an observation period by a currently practicing healthcare professional
adequately experienced in vaccination who confirms competency of the
healthcare provider in preparation and administration of the particular
COVID-19 vaccine(s) to be administered; and
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\8\ See COVID-19 Vaccine Training Modules, available at https://www2.cdc.gov/vaccines/ed/covid19/index.asp (last visited Jan. 23,
2021) https://www.cdc.gov/vaccines/covid-19/training.html.
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(g) Any physician, advanced practice registered nurse, registered
nurse, or practical nurse who has held an active license or
certification to prescribe, dispense, or administer vaccines 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 federal, 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
[[Page 7876]]
General, subject to (i) documentation of completion of the Centers for
Disease Control and Prevention COVID-19 Vaccine Training Modules and
(ii) documentation of an observation period by a currently practicing
healthcare professional adequately experienced in vaccination who
confirms competency of the healthcare provider in preparation and
administration of the particular COVID-19 vaccine(s) to be
administered.
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, add to the end of the
section:
Liability protections for Qualified Persons under sections V(f) and
V(d) of the declaration begin on January 28, 2021, and last through
October 1, 2024.
Authority: 42 U.S.C. 247d-6d.
Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-02174 Filed 1-29-21; 4:15 pm]
BILLING CODE 4150-37-P