Seventh Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 14462-14468 [2021-05401]
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Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Voluntary Partner Surveys To
Implement Executive Order 12862 in
the Health Resources and Services
Administration
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than April 15, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
SUMMARY:
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Voluntary Partner Surveys to Implement
Executive Order 12862 in the Health
Resources and Services Administration,
OMB No. 0915–0212—Extension.
Abstract: In response to Executive
Order 12862, HRSA is proposing to
conduct voluntary customer surveys of
its partners to assess strengths and
weaknesses in program services and
processes. HRSA partners are typically
state or local governments, health care
facilities, health care consortia, health
care providers, and researchers. HRSA
is requesting continued approval of a
generic clearance from OMB to conduct
the partner surveys.
Partner surveys to be conducted by
HRSA might include, for example, mail,
electronic, and/or telephone surveys of
grantees to determine satisfaction with
grant processes or technical assistance
provided by a contractor, or in-class or
virtual evaluation forms completed by
providers who receive training from
HRSA grantees to measure satisfaction
with the training experience. Results of
these surveys will be used to plan and
redirect resources and efforts as needed
to improve services and processes.
Focus groups may also be used to gain
partner input that will inform the design
of mail, electronic and/or telephone
surveys. Focus groups, in-class
evaluation forms, mail surveys,
electronic surveys, and telephone
surveys are expected to be the preferred
data collection methods for this
information collection.
A generic approval allows HRSA to
conduct a limited number of partner
surveys without a full-scale OMB
review of each survey. If this generic
information collection request receives
continued approval, information on
each individual partner survey will not
be published in the Federal Register.
A 60-day notice published in the
Federal Register on December 15, 2020,
vol. 85, No. 241; pp. 81210–11. There
were no public comments.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
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
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
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Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
In-class evaluations .............................................................
Mail/Telephone surveys .......................................................
Focus groups .......................................................................
40,000
12,000
250
1
1
1
40,000
12,000
250
.05
.25
1.50
2,000
3,000
375
Total ..............................................................................
52,250
........................
52,250
........................
5,375
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
Office of the Secretary
[FR Doc. 2021–05349 Filed 3–15–21; 8:45 am]
BILLING CODE 4165–15–P
Seventh Amendment to Declaration
Under the Public Readiness and
Emergency Preparedness Act for
Medical Countermeasures Against
COVID–19
ACTION:
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Notice of amendment.
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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 covered
countermeasures under section VI of
this Declaration.
DATES: This amendment to the
Declaration is effective as of March 11,
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, 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, 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 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,
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SUMMARY:
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2020, October 23, 2020, and January 21,
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
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
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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).
The Acting Secretary now amends
section V of the Declaration to revise
subsection (f) to clarify that observers
should be experienced in administering
intramuscular injections; delete
subsection (g), change the prior
subsection (h) to subsection (g) and add
a new subsection (h) to add additional
categories of qualified persons covered
under the PREP Act, and thus
authorizes: (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
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administered, so long as the license or
certification was active and in good
standing prior to the date it went
inactive, expired or lapsed and was not
revoked by the licensing authority,
surrendered while under suspension,
discipline or investigation by a licensing
authority or surrendered following an
arrest, and the individual is not on the
List of Excluded Individuals/Entities
maintained by the Office of Inspector
General;
3. Any medical, nursing, pharmacy,
pharmacy intern, midwife, paramedic,
advanced or intermediate EMT,
physician assistant, respiratory therapy,
dental, podiatry, optometry or
veterinary student with appropriate
training in administering vaccines as
determined by his or her school or
training program and supervision by a
currently practicing healthcare
professional experienced in
administering intramuscular injections
who administers COVID–19 vaccines
that are Covered Countermeasures
under section VI of this Declaration in
any jurisdiction where the PREP Act
applies in association with a COVID–19
vaccination effort by a State, local,
Tribal or territorial authority or by an
institution in which the COVID–19
vaccine covered countermeasure is
administered;
Subject to the following requirements:
i. The vaccine must be authorized,
approved, or licensed by the FDA;
ii. Vaccination must be ordered and
administered according to 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 intramuscular injections
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
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in basic cardiopulmonary
resuscitation; 1
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).
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
1 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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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 an
additional categories of persons who are
qualified persons under section 247d–
6d(i)(8)(B): licensed healthcare
professionals who may not ordinarily
prescribe, dispense or administer
vaccines, additional healthcare
providers with recently expired
licenses, and students in a healthcare
profession training program, subject to
appropriate training, supervision, and
other specified requirements. The
Acting Secretary anticipates that
significantly more vaccines will be
available to the public in the spring and
summer of 2021, and wants to ensure
that states have the greatest flexibility in
mobilizing the workforce they will need
to engage in the largest vaccination
effort in our Nation’s history. This
amendment thus expands the pool of
vaccinators to individuals who have or
can obtain training and the capability to
administer vaccines even if prescribing,
dispensing and administering vaccines
is not within the scope of their license
or usual responsibilities, allowing
States, Territories, local areas and Tribes
to use these individuals in their
vaccination programs.
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.
As qualified persons, these healthcare
professionals and students in healthcare
profession training programs 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 the
healthcare professionals and students in
healthcare profession training programs
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
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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 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
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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, August 19, 2020, as
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, 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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3, 2020, and as amended on February 2,
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 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://
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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);
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.
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
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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Jkt 253001
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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Sfmt 4703
prescribes, dispenses, or administers
COVID–19 vaccines that are Covered
Countermeasures under section VI of
this Declaration in any jurisdiction
where the PREP Act applies, other than
the State in which the license or
certification is held, in association with
a COVID–19 vaccination effort by a
federal, State, local Tribal or territorial
authority or by an institution in the
State in which the COVID–19 vaccine
covered countermeasure is
administered, so long as the license or
certification of the healthcare
professional has not been suspended or
restricted by any licensing authority,
surrendered while under suspension,
discipline or investigation by a licensing
authority or surrendered following an
arrest, and the individual is not on the
List of Excluded Individuals/Entities
maintained by the Office of Inspector
General, subject to: (i) Documentation of
completion of the Centers for Disease
Control and Prevention COVID–19
(CDC) Vaccine Training Modules 8 and,
for healthcare providers who are not
currently practicing, documentation of
an observation period by a currently
practicing healthcare professional
experienced in administering
intramuscular injections, and for whom
administering intramuscular injections
is in their ordinary scope of practice,
who confirms competency of the
healthcare provider in preparation and
administration of the COVID–19
vaccine(s) to be administered;
(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
8 See COVID–19 Vaccine Training Modules,
available at https://www.cdc.gov/vaccines/covid-19/
training.html.
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public or otherwise would be more
limited in scope than the activities such
service member, employees, contractors,
or volunteers are authorized to carry out
under this declaration; and
(h) The following healthcare
professionals and students in a
healthcare profession training program
subject to the requirements of this
paragraph:
1. Any midwife, paramedic, advanced
or intermediate emergency medical
technician (EMT), physician assistant,
respiratory therapist, dentist, podiatrist,
optometrist or veterinarian licensed or
certified to practice under the law of
any state who prescribes, dispenses, or
administers COVID–19 vaccines that are
Covered Countermeasures under section
VI of this Declaration in any jurisdiction
where the PREP Act applies in
association with a COVID–19
vaccination effort by a State, local,
Tribal or territorial authority or by an
institution in which the COVID–19
vaccine covered countermeasure is
administered;
2. Any physician, advanced practice
registered nurse, registered nurse,
practical nurse, pharmacist, pharmacy
intern, midwife, paramedic, advanced
or intermediate EMT, respiratory
therapist, dentist, physician assistant,
podiatrist, optometrist, or veterinarian
who has held an active license or
certification under the law of any State
within the last five years, which is
inactive, expired or lapsed, who
prescribes, dispenses, or administers
COVID–19 vaccines that are Covered
Countermeasures under section VI of
this Declaration in any jurisdiction
where the PREP Act applies in
association with a COVID–19
vaccination effort by a State, local,
Tribal or territorial authority or by an
institution in which the COVID–19
vaccine covered countermeasure is
administered, so long as the license or
certification was active and in good
standing prior to the date it went
inactive, expired or lapsed and was not
revoked by the licensing authority,
surrendered while under suspension,
discipline or investigation by a licensing
authority or surrendered following an
arrest, and the individual is not on the
List of Excluded Individuals/Entities
maintained by the Office of Inspector
General;
3. Any medical, nursing, pharmacy,
pharmacy intern, midwife, paramedic,
advanced or intermediate EMT,
physician assistant, respiratory therapy,
dental, podiatry, optometry or
veterinary student with appropriate
training in administering vaccines as
determined by his or her school or
training program and supervision by a
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16:52 Mar 15, 2021
Jkt 253001
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; 9
9 This requirement is satisfied by, among other
things, a certification in basic cardiopulmonary
resuscitation by an online program that has
received accreditation from the American Nurses
Credentialing Center, the ACPE, or the
Accreditation Council for Continuing Medical
Education. The phrase ‘‘current certificate in basic
cardiopulmonary resuscitation,’’ when used in the
September 3, 2020 or October 20, 2020 OASH
authorizations, shall be interpreted the same way.
See Guidance for Licensed Pharmacists and
Pharmacy Interns Regarding COVID–19 Vaccines
and Immunity under the PREP Act, OASH, Sept. 3,
2020, available at https://www.hhs.gov/guidance/
sites/default/files/hhs-guidance-documents//
licensed-pharmacists-and-pharmacy-internsregarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act
Coverage for Qualified Pharmacy Technicians and
State-Authorized Pharmacy Interns for Childhood
Vaccines, COVID–19 Vaccines, and COVID–19
Testing, OASH, Oct. 20, 2020, available at https://
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14467
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 l, 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 l, 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
www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
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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 l,
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 l,
2024, whichever occurs first.
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,
2021 and 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.
Norris Cochran,
Acting Secretary, Department of Health and
Human Services.
[FR Doc. 2021–05401 Filed 3–11–21; 4:15 pm]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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[FR Doc. 2021–05351 Filed 3–15–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
[OMB Control Number 1615–0046]
Agency Information Collection
Activities; Extension, Without Change,
of a Currently Approved Collection:
Interagency Alien Witness and
Informant Record
The Department of Homeland
Security (DHS), U.S. Citizenship and
Immigration Services (USCIS) invites
the general public and other Federal
agencies to comment upon this
proposed extension of a currently
approved collection of information. In
accordance with the Paperwork
Reduction Act (PRA) of 1995, the
information collection notice is
published in the Federal Register to
obtain comments regarding the nature of
the information collection, the
categories of respondents, the estimated
SUMMARY:
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, National Institute of Dental
and Craniofacial Research.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
Jkt 253001
Dated: March 10, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
U.S. Citizenship and
Immigration Services, Department of
Homeland Security.
ACTION: 60-day notice.
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meeting
16:52 Mar 15, 2021
Name of Committee: Board of Scientific
Counselors, National Institute of Dental and
Craniofacial Research.
Date: May 18–19, 2021.
Time: 9:00 a.m. to 4:15 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health, 6701
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Alicia J. Dombroski, Ph.D.,
Director, Division of Extramural Activities,
Natl Inst of Dental and Craniofacial Research,
National Institutes of Health, Bethesda, MD
20892.
(Catalogue of Federal Domestic Assistance
Program No. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
AGENCY:
National Institutes of Health
VerDate Sep<11>2014
evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE OF DENTAL &
CRANIOFACIAL RESEARCH, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
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burden (i.e., the time, effort, and
resources used by the respondents to
respond), the estimated cost to the
respondent, and the actual information
collection instruments.
DATES: Comments are encouraged and
will be accepted for 60 days until May
17, 2021.
ADDRESSES: All submissions received
must include the OMB Control Number
1615–0046 in the body of the letter, the
agency name and Docket ID USCIS–
2006–0062. Submit comments via the
Federal eRulemaking Portal website at
https://www.regulations.gov under eDocket ID number USCIS–2006–0062.
USCIS is limiting communications for
this Notice as a result of USCIS’ COVID–
19 response actions.
FOR FURTHER INFORMATION CONTACT:
USCIS, Office of Policy and Strategy,
Regulatory Coordination Division,
Samantha Deshommes, Chief, telephone
number (240) 721–3000 (This is not a
toll-free number. Comments are not
accepted via telephone message). Please
note contact information provided here
is solely for questions regarding this
notice. It is not for individual case
status inquiries. Applicants seeking
information about the status of their
individual cases can check Case Status
Online, available at the USCIS website
at https://www.uscis.gov, or call the
USCIS Contact Center at 800–375–5283
(TTY 800–767–1833).
SUPPLEMENTARY INFORMATION:
Comments
You may access the information
collection instrument with instructions
or additional information by visiting the
Federal eRulemaking Portal site at:
https://www.regulations.gov and
entering USCIS–2006–0062 in the
search box. All submissions will be
posted, without change, to the Federal
eRulemaking Portal at https://
www.regulations.gov, and will include
any personal information you provide.
Therefore, submitting this information
makes it public. You may wish to
consider limiting the amount of
personal information that you provide
in any voluntary submission you make
to DHS. DHS may withhold information
provided in comments from public
viewing that it determines may impact
the privacy of an individual or is
offensive. For additional information,
please read the Privacy Act notice that
is available via the link in the footer of
https://www.regulations.gov.
Written comments and suggestions
from the public and affected agencies
should address one or more of the
following four points:
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[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14462-14468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05401]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Seventh Amendment to Declaration Under the Public Readiness and
Emergency Preparedness Act for Medical Countermeasures Against COVID-19
ACTION: Notice of amendment.
-----------------------------------------------------------------------
[[Page 14463]]
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
covered countermeasures under section VI of this Declaration.
DATES: This amendment to the Declaration is effective as of March 11,
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, 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 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, and January 21, 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 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).
The Acting Secretary now amends section V of the Declaration to
revise subsection (f) to clarify that observers should be experienced
in administering intramuscular injections; delete subsection (g),
change the prior subsection (h) to subsection (g) and add a new
subsection (h) to add additional categories of qualified persons
covered under the PREP Act, and thus authorizes: (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
[[Page 14464]]
administered, so long as the license or certification was active and in
good standing prior to the date it went inactive, expired or lapsed and
was not revoked by the licensing authority, surrendered while under
suspension, discipline or investigation by a licensing authority or
surrendered following an arrest, and the individual is not on the List
of Excluded Individuals/Entities maintained by the Office of Inspector
General;
3. Any medical, nursing, pharmacy, pharmacy intern, midwife,
paramedic, advanced or intermediate EMT, physician assistant,
respiratory therapy, dental, podiatry, optometry or veterinary student
with appropriate training in administering vaccines as determined by
his or her school or training program and supervision by a currently
practicing healthcare professional experienced in administering
intramuscular injections who administers COVID-19 vaccines that are
Covered Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies in association with a COVID-19
vaccination effort by a State, local, Tribal or territorial authority
or by an institution in which the COVID-19 vaccine covered
countermeasure is administered;
Subject to the following requirements:
i. The vaccine must be authorized, approved, or licensed by the
FDA;
ii. Vaccination must be ordered and administered according to
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 intramuscular injections 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; \1\
---------------------------------------------------------------------------
\1\ 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).
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 an additional categories of persons who are qualified
persons under section 247d-6d(i)(8)(B): licensed healthcare
professionals who may not ordinarily prescribe, dispense or administer
vaccines, additional healthcare providers with recently expired
licenses, and students in a healthcare profession training program,
subject to appropriate training, supervision, and other specified
requirements. The Acting Secretary anticipates that significantly more
vaccines will be available to the public in the spring and summer of
2021, and wants to ensure that states have the greatest flexibility in
mobilizing the workforce they will need to engage in the largest
vaccination effort in our Nation's history. This amendment thus expands
the pool of vaccinators to individuals who have or can obtain training
and the capability to administer vaccines even if prescribing,
dispensing and administering vaccines is not within the scope of their
license or usual responsibilities, allowing States, Territories, local
areas and Tribes to use these individuals in their vaccination
programs.
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.
As qualified persons, these healthcare professionals and students
in healthcare profession training programs 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 the healthcare professionals and students in
healthcare profession training programs 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
[[Page 14465]]
``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, 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 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, August 19, 2020, as amended and republished on December
3, 2020, and as amended on February 2, 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 \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:
---------------------------------------------------------------------------
\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\
---------------------------------------------------------------------------
\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 14466]]
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 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\
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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;
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
(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
experienced in administering intramuscular injections, and for whom
administering intramuscular injections is in their ordinary scope of
practice, who confirms competency of the healthcare provider in
preparation and administration of the COVID-19 vaccine(s) to be
administered;
---------------------------------------------------------------------------
\8\ See COVID-19 Vaccine Training Modules, available at https://www.cdc.gov/vaccines/covid-19/training.html.
---------------------------------------------------------------------------
(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
[[Page 14467]]
public or otherwise would be more limited in scope than the activities
such service member, employees, contractors, or volunteers are
authorized to carry out under this declaration; and
(h) The following healthcare professionals and students in a
healthcare profession training program subject to the requirements of
this paragraph:
1. Any midwife, paramedic, advanced or intermediate emergency
medical technician (EMT), physician assistant, respiratory therapist,
dentist, podiatrist, optometrist or veterinarian licensed or certified
to practice under the law of any state who prescribes, dispenses, or
administers COVID-19 vaccines that are Covered Countermeasures under
section VI of this Declaration in any jurisdiction where the PREP Act
applies in association with a COVID-19 vaccination effort by a State,
local, Tribal or territorial authority or by an institution in which
the COVID-19 vaccine covered countermeasure is administered;
2. Any physician, advanced practice registered nurse, registered
nurse, practical nurse, pharmacist, pharmacy intern, midwife,
paramedic, advanced or intermediate EMT, respiratory therapist,
dentist, physician assistant, podiatrist, optometrist, or veterinarian
who has held an active license or certification under the law of any
State within the last five years, which is inactive, expired or lapsed,
who prescribes, dispenses, or administers COVID-19 vaccines that are
Covered Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies in association with a COVID-19
vaccination effort by a State, local, Tribal or territorial authority
or by an institution in which the COVID-19 vaccine covered
countermeasure is administered, so long as the license or certification
was active and in good standing prior to the date it went inactive,
expired or lapsed and was not revoked by the licensing authority,
surrendered while under suspension, discipline or investigation by a
licensing authority or surrendered following an arrest, and the
individual is not on the List of Excluded Individuals/Entities
maintained by the Office of Inspector General;
3. Any medical, nursing, pharmacy, pharmacy intern, midwife,
paramedic, advanced or intermediate EMT, physician assistant,
respiratory therapy, dental, podiatry, optometry or veterinary student
with appropriate training in administering vaccines as determined by
his or her school or training program and supervision by a currently
practicing healthcare professional experienced in administering
intramuscular injections who administers COVID-19 vaccines that are
Covered Countermeasures under section VI of this Declaration in any
jurisdiction where the PREP Act applies in association with a COVID-19
vaccination effort by a State, local, Tribal or territorial authority
or by an institution in which the COVID-19 vaccine covered
countermeasure is administered;
Subject to the following requirements:
i. The vaccine must be authorized, approved, or licensed by the
FDA;
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; \9\
---------------------------------------------------------------------------
\9\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
---------------------------------------------------------------------------
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 l,
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 l, 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
[[Page 14468]]
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
l, 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 l, 2024, whichever occurs first.
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, 2021 and 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.
Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-05401 Filed 3-11-21; 4:15 pm]
BILLING CODE 4150-37-P
