Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19; Correction, 54696-54698 [2021-21652]
Download as PDF
<![CDATA[
54696
Federal Register / Vol. 86, No. 189 / Monday, October 4, 2021 / Notices
ANNUALIZED BURDEN HOUR TABLE
Number of
responses per
respondents
Average
burden per
response
Forms
(if necessary)
Respondents
(if necessary)
Number of
respondents
Federal Financial Report (SF–
425) and Federal Financial Report Attachment (SF–425A).
Grant-seeking organizations .......
100,000 .....................
1
1
100,000
Grant-seeking organizations .......
100,000 .....................
1
1
100,000
.....................................................
...................................
1
........................
200,000
Total .....................................
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
Services, 200 Independence Avenue
SW, Washington, DC 20201; 202–260–
0365, paige.ezernack@hhs.gov.
[FR Doc. 2021–21560 Filed 10–1–21; 8:45 am]
Corrections
Corrections to technical errors that
appeared in sections V(d) and (h) and
XII of the final notice published in the
Federal Register on September 14, 2021
at 86 FR 51160 entitled ‘‘Ninth
Amendment to Declaration Under the
Public Readiness and Emergency
Preparedness Act for Medical
Countermeasures Against COVID–19.
These corrections are made to clarify
that when the term Advisory Committee
on Immunization Practices (ACIP)
schedule or recommendation is used in
the declaration, that refers to
recommendations made to the Centers
for Disease Control and Prevention
(CDC) by the ACIP in its advisory role
under the Federal Advisory Committee
Act. Such recommendations are taken
into consideration when the CDC issues
its recommendations, as adopted by the
CDC Director. These have historically
been published in CDC’s Morbidity and
Mortality Weekly Report under the title
‘‘ACIP recommendations.’’ The term
‘‘CDC’’ is added throughout the
declaration whenever referring to ACIP
recommendations or schedules to also
recognizes coverage of
recommendations issued directly by the
CDC. Subsection V(d) is clarified to
read:
(d) A State-licensed pharmacist who
orders and administers, and pharmacy
interns and qualified pharmacy
technicians who administer (if the
pharmacy intern or technician acts
under the supervision of such
pharmacist and the pharmacy intern or
technician is licensed or registered by
his or her State board of pharmacy),1 (1)
BILLING CODE 4151–AE–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Declaration Under the Public
Readiness and Emergency
Preparedness Act for Medical
Countermeasures Against COVID–19;
Correction
ACTION:
Notice, correction.
This document clarifies a
term that appeared in the ‘‘Declaration
Under the Public Readiness and
Emergency Preparedness Act for
Medical Countermeasures Against
COVID–19,’’ including in the final
notice published in the Federal Register
on September 14, 2021, entitled ‘‘Ninth
Amendment to Declaration Under the
Public Readiness and Emergency
Preparedness Act for Medical
Countermeasures Against COVID–19.’’
Specifically, this document
supplements the references to the
Advisory Committee on Immunization
Practices (ACIP) with references to the
Centers for Disease Control and
Prevention (CDC). This change is being
made to clarify that what are commonly
referred to as ‘‘ACIP recommendations’’
and ‘‘ACIP standard immunization
schedules’’ are in fact recommendations
and schedules made by the CDC after
consultation with ACIP. The addition of
‘‘CDC’’ is also intended to recognize
coverage of recommendations issued
directly by the CDC. This clarification
also applies to related guidance and
opinions.
DATES: This correction is applicable
September 30, 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
SUMMARY:
VerDate Sep<11>2014
22:52 Oct 01, 2021
Jkt 256001
1 Some states do not require pharmacy interns to
be licensed or registered by the state board of
pharmacy. As used herein, ‘‘State-licensed or
registered intern’’ (or equivalent phrases) refers to
pharmacy interns authorized by the state or board
of pharmacy in the state in which the practical
pharmacy internship occurs. The authorization can,
but need not, take the form of a license from, or
registration with, the State board of pharmacy.
Similarly, states vary on licensure and registration
requirements for pharmacy technicians. Some states
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
Total burden
hours
Vaccines that the CDC/ACIP
recommend 2 to persons ages three
through 18 according to CDC’s/ACIP’s
standard immunization schedule or (2)
seasonal influenza vaccine administered
by qualified pharmacy technicians and
interns that the CDC/ACIP recommend
to persons aged 19 and older according
to CDC’s/ACIP’s standard immunization
schedule; or (3) FDA authorized or FDA
licensed COVID–19 vaccines to persons
ages three or older. Such State-licensed
pharmacists and the State-licensed or
registered interns or technicians under
their supervision are qualified persons
only if the following requirements are
met:
i. The vaccine must be authorized,
approved, or licensed by the FDA;
ii. In the case of a COVID–19 vaccine,
the vaccination must be ordered and
administered according to CDC’s/ACIP’s
COVID–19 vaccine recommendation(s);
iii. In the case of a childhood vaccine,
the vaccination must be ordered and
administered according to CDC’s/ACIP’s
standard immunization schedule;
iv. In the case of seasonal influenza
vaccine administered by qualified
pharmacy technicians and interns, the
vaccination must be ordered and
require certain education, training, and/or
certification for licensure or registration; others
either have no prerequisites for licensure or
registration or do not require licensure or
registration at all. As used herein, to be a ‘‘qualified
pharmacy technician,’’ pharmacy technicians
working in states with licensure and/or registration
requirements must be licensed and/or registered in
accordance with state requirements; pharmacy
technicians working in states without licensure
and/or registration requirements must have a CPhT
certification from either the Pharmacy Technician
Certification Board or National Healthcareer
Association. See Guidance for PREP Act Coverage
for Qualified Pharmacy Technicians and StateAuthorized Pharmacy Interns for Childhood
Vaccines, COVID–19 Vaccines, and COVID–19
Testing, OASH, Oct. 20, 2020 at 2, available at
https://www.hhs.gov/guidance/sites/default/files/
hhs-guidance-documents//prep-act-guidance.pdf
(last visited Jan. 24, 2021).
2 Where the term CDC/ACIP recommendations,
standard immunization schedules, or similar
language is used, this includes both direct CDC
recommendations as well as recommendations
adopted by the CDC Director after recommendation
by ACIP, which are commonly referred to as ACIP
recommendations or schedules.
E:\FR\FM\04OCN1.SGM
04OCN1
Federal Register / Vol. 86, No. 189 / Monday, October 4, 2021 / Notices
administered according to CDC’s/ACIP’s
standard immunization schedule;
v. In the case of pharmacy
technicians, the supervising pharmacist
must be readily and immediately
available to the immunizing qualified
pharmacy technician;
vi. The licensed pharmacist must
have completed the immunization
training that the licensing State requires
for pharmacists to order and administer
vaccines. If the State does not specify
training requirements for the licensed
pharmacist to order and administer
vaccines, the licensed pharmacist must
complete a vaccination training program
of at least 20 hours that is approved by
the Accreditation Council for Pharmacy
Education (ACPE) to order and
administer vaccines. Such a training
program must include hands on
injection technique, clinical evaluation
of indications and contraindications of
vaccines, and the recognition and
treatment of emergency reactions to
vaccines;
vii. The licensed or registered
pharmacy intern and qualified
pharmacy technician must complete a
practical training program that is
approved by the ACPE. This training
program must include hands-on
injection technique, clinical evaluation
of indications and contraindications of
vaccines, and the recognition and
treatment of emergency reactions to
vaccines;
viii. The licensed pharmacist,
licensed or registered pharmacy intern
and qualified pharmacy technician must
have a current certificate in basic
cardiopulmonary resuscitation; 3
ix. The licensed pharmacist must
complete a minimum of two hours of
ACPE-approved, immunization-related
continuing pharmacy education during
each State licensing period;
3 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).
VerDate Sep<11>2014
22:52 Oct 01, 2021
Jkt 256001
x. The licensed pharmacist must
comply with recordkeeping and
reporting requirements of the
jurisdiction in which he or she
administers vaccines, including
informing the patient’s primary-care
provider when available, submitting the
required immunization information to
the State or local immunization
information system (vaccine registry),
complying with requirements with
respect to reporting adverse events, and
complying with requirements whereby
the person administering a vaccine must
review the vaccine registry or other
vaccination records prior to
administering a vaccine;
xi. The licensed pharmacist must
inform his or her childhood vaccination
patients and the adult caregiver
accompanying the child of the
importance of a well-child visit with a
pediatrician or other licensed primary
care provider and refer patients as
appropriate; and
xii. The licensed pharmacist, the
licensed or registered pharmacy intern
and the qualified pharmacy technician
must comply with any applicable
requirements (or conditions of use) as
set forth in the CDC COVID–19
vaccination provider agreement and any
other federal requirements that apply to
the administration of COVID–19
vaccine(s).
Section V(h) is clarified to read:
(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
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
54697
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 CDC’s/ACIP’s
COVID–19 vaccine recommendation(s);
iii. The healthcare professionals and
students must have documentation of
completion of the CDC 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
E:\FR\FM\04OCN1.SGM
04OCN1
54698
Federal Register / Vol. 86, No. 189 / Monday, October 4, 2021 / Notices
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; 4
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 CDC COVID–19
vaccination provider agreement and any
other federal requirements that apply to
the administration of COVID–19
vaccine(s).
Section XII is clarified to read:
‘‘Liability protections for all Covered
Countermeasures administered and
used in accordance with the public
health and medical response of the
Authority Having Jurisdiction, as
identified in Section VII(b) of this
Declaration, begin with a Declaration of
Emergency as that term is defined in
Section VII (except that, with respect to
qualified persons who order or
4 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).
VerDate Sep<11>2014
22:52 Oct 01, 2021
Jkt 256001
administer a routine childhood
vaccination that CDC/ACIP recommends
to persons ages three through 18
according to CDC’s/ACIP’s standard
immunization schedule, liability
protections began on August 24, 2020),
and last through (a) the final day the
Declaration of Emergency is in effect, or
(b) October l, 2024, whichever occurs
first.’’ This amendment does not change
effective dates under Section XII.
Karuna Seshasai,
Executive Secretary to the Department, U.S.
Department of Health and Human Services.
[FR Doc. 2021–21652 Filed 9–30–21; 4:15 pm]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council provides advice on
how to prevent or reduce the burden of
Alzheimer’s disease and related
dementias on people with the disease
and their caregivers. During the October
25, 2021 meeting the Advisory Council
will hear presentations about ways to
support and strengthen the long-term
services and supports direct care
workforce, both paid and unpaid, to
support access to care, improve the
quality of caregiving, and meet the
growing demand for long-term care
dementia services. The Advisory
Council will also hear about a recent
workshop on the behavioral and social
research and clinical practice
implications of preclinical diagnosis of
AD/ADRD, as well as the AD/ADRD
decadal study conducted by the
National Academies of Sciences,
Engineering, and Medicine. Federal
representatives will provide updates on
work towards the goals of the National
Plan to Address Alzheimer’s Disease in
the last quarter.
DATES: The meeting will be held on
October 25, 2021 from 1:00 p.m. to 4:30
p.m. EST.
ADDRESSES: The meeting will be virtual,
streaming live at www.hhs.gov/live.
Comments: Time is allocated on the
agenda to hear public comments from
4:00 p.m. to 4:30 p.m. The time for oral
comments will be limited to two (2)
minutes per individual. In order to
SUMMARY:
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
provide a public comment, please
register by emailing your name to
napa@hhs.gov by Thursday, October 21.
On Friday, October 22, registered
commenters will receive both a dial-in
number and a link to join the meeting
virtually; individuals will have the
choice to either join virtually via the
link, or to call in only by using the dialin number. Note: There may be a 30–45
second delay in the livestream video
presentation of the conference. For this
reason, if you have pre-registered to
submit a public comment, it is
important to connect to the meeting by
3:45 p.m. to ensure that you do not miss
your name and allotted time when
called. If you miss your name and
allotted time to speak, you may not be
able to make your public comment. All
participant audio lines will be muted for
the duration of the meeting and only
unmuted by the Host at the time of the
participant’s public comment. Should
you have questions during the session
email napa@hhs.gov and someone will
respond to your message as quickly as
possible.
In order to ensure accuracy, please
submit a written copy of oral comments
for the record by emailing napa@
hhs.gov by Tuesday, October 26. These
comments will be shared on the website
and reflected in the meeting minutes.
In lieu of oral comments, formal
written comments may be submitted for
the record by Tuesday, October 26 to
Helen Lamont, Ph.D., OASPE, 200
Independence Avenue SW, Room 424E,
Washington, DC 20201. Comments may
also be sent to napa@hhs.gov. Those
submitting written comments should
identify themselves and any relevant
organizational affiliations.
FOR FURTHER INFORMATION CONTACT:
Helen Lamont, 202–260–6075,
helen.lamont@hhs.gov. Note: The
meeting will be available to the public
live at www.hhs.gov/live.
SUPPLEMENTARY INFORMATION: Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. app. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: Long-term
services and supports workforce and
caregiving.
Procedure and Agenda: The meeting
will be webcast at www.hhs.gov/live and
video recordings will be added to the
National Alzheimer’s Project Act
website when available, after the
meeting.
Authority: 42 U.S.C. 11225; Section
2(e)(3) of the National Alzheimer’s
Project Act. The panel is governed by
provisions of Public Law 92–463, as
amended (5 U.S.C. appendix 2), which
E:\FR\FM\04OCN1.SGM
04OCN1
]]>Agencies
[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Pages 54696-54698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21652]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Declaration Under the Public Readiness and Emergency Preparedness
Act for Medical Countermeasures Against COVID-19; Correction
ACTION: Notice, correction.
-----------------------------------------------------------------------
SUMMARY: This document clarifies a term that appeared in the
``Declaration Under the Public Readiness and Emergency Preparedness Act
for Medical Countermeasures Against COVID-19,'' including in the final
notice published in the Federal Register on September 14, 2021,
entitled ``Ninth Amendment to Declaration Under the Public Readiness
and Emergency Preparedness Act for Medical Countermeasures Against
COVID-19.'' Specifically, this document supplements the references to
the Advisory Committee on Immunization Practices (ACIP) with references
to the Centers for Disease Control and Prevention (CDC). This change is
being made to clarify that what are commonly referred to as ``ACIP
recommendations'' and ``ACIP standard immunization schedules'' are in
fact recommendations and schedules made by the CDC after consultation
with ACIP. The addition of ``CDC'' is also intended to recognize
coverage of recommendations issued directly by the CDC. This
clarification also applies to related guidance and opinions.
DATES: This correction is applicable September 30, 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].
Corrections
Corrections to technical errors that appeared in sections V(d) and
(h) and XII of the final notice published in the Federal Register on
September 14, 2021 at 86 FR 51160 entitled ``Ninth Amendment to
Declaration Under the Public Readiness and Emergency Preparedness Act
for Medical Countermeasures Against COVID-19. These corrections are
made to clarify that when the term Advisory Committee on Immunization
Practices (ACIP) schedule or recommendation is used in the declaration,
that refers to recommendations made to the Centers for Disease Control
and Prevention (CDC) by the ACIP in its advisory role under the Federal
Advisory Committee Act. Such recommendations are taken into
consideration when the CDC issues its recommendations, as adopted by
the CDC Director. These have historically been published in CDC's
Morbidity and Mortality Weekly Report under the title ``ACIP
recommendations.'' The term ``CDC'' is added throughout the declaration
whenever referring to ACIP recommendations or schedules to also
recognizes coverage of recommendations issued directly by the CDC.
Subsection V(d) is clarified to read:
(d) A State-licensed pharmacist who orders and administers, and
pharmacy interns and qualified pharmacy technicians who administer (if
the pharmacy intern or technician acts under the supervision of such
pharmacist and the pharmacy intern or technician is licensed or
registered by his or her State board of pharmacy),\1\ (1) Vaccines that
the CDC/ACIP recommend \2\ to persons ages three through 18 according
to CDC's/ACIP's standard immunization schedule or (2) seasonal
influenza vaccine administered by qualified pharmacy technicians and
interns that the CDC/ACIP recommend to persons aged 19 and older
according to CDC's/ACIP's standard immunization schedule; or (3) FDA
authorized or FDA licensed COVID-19 vaccines to persons ages three or
older. Such State-licensed pharmacists and the State-licensed or
registered interns or technicians under their supervision are qualified
persons only if the following requirements are met:
---------------------------------------------------------------------------
\1\ Some states do not require pharmacy interns to be licensed
or registered by the state board of pharmacy. As used herein,
``State-licensed or registered intern'' (or equivalent phrases)
refers to pharmacy interns authorized by the state or board of
pharmacy in the state in which the practical pharmacy internship
occurs. The authorization can, but need not, take the form of a
license from, or registration with, the State board of pharmacy.
Similarly, states vary on licensure and registration requirements
for pharmacy technicians. Some states require certain education,
training, and/or certification for licensure or registration; others
either have no prerequisites for licensure or registration or do not
require licensure or registration at all. As used herein, to be a
``qualified pharmacy technician,'' pharmacy technicians working in
states with licensure and/or registration requirements must be
licensed and/or registered in accordance with state requirements;
pharmacy technicians working in states without licensure and/or
registration requirements must have a CPhT certification from either
the Pharmacy Technician Certification Board or National Healthcareer
Association. See Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020 at 2, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
\2\ Where the term CDC/ACIP recommendations, standard
immunization schedules, or similar language is used, this includes
both direct CDC recommendations as well as recommendations adopted
by the CDC Director after recommendation by ACIP, which are commonly
referred to as ACIP recommendations or schedules.
---------------------------------------------------------------------------
i. The vaccine must be authorized, approved, or licensed by the
FDA;
ii. In the case of a COVID-19 vaccine, the vaccination must be
ordered and administered according to CDC's/ACIP's COVID-19 vaccine
recommendation(s);
iii. In the case of a childhood vaccine, the vaccination must be
ordered and administered according to CDC's/ACIP's standard
immunization schedule;
iv. In the case of seasonal influenza vaccine administered by
qualified pharmacy technicians and interns, the vaccination must be
ordered and
[[Page 54697]]
administered according to CDC's/ACIP's standard immunization schedule;
v. In the case of pharmacy technicians, the supervising pharmacist
must be readily and immediately available to the immunizing qualified
pharmacy technician;
vi. The licensed pharmacist must have completed the immunization
training that the licensing State requires for pharmacists to order and
administer vaccines. If the State does not specify training
requirements for the licensed pharmacist to order and administer
vaccines, the licensed pharmacist must complete a vaccination training
program of at least 20 hours that is approved by the Accreditation
Council for Pharmacy Education (ACPE) to order and administer vaccines.
Such a training program must include hands on injection technique,
clinical evaluation of indications and contraindications of vaccines,
and the recognition and treatment of emergency reactions to vaccines;
vii. The licensed or registered pharmacy intern and qualified
pharmacy technician must complete a practical training program that is
approved by the ACPE. This training program must include hands-on
injection technique, clinical evaluation of indications and
contraindications of vaccines, and the recognition and treatment of
emergency reactions to vaccines;
viii. The licensed pharmacist, licensed or registered pharmacy
intern and qualified pharmacy technician must have a current
certificate in basic cardiopulmonary resuscitation; \3\
---------------------------------------------------------------------------
\3\ This requirement is satisfied by, among other things, a
certification in basic cardiopulmonary resuscitation by an online
program that has received accreditation from the American Nurses
Credentialing Center, the ACPE, or the Accreditation Council for
Continuing Medical Education. The phrase ``current certificate in
basic cardiopulmonary resuscitation,'' when used in the September 3,
2020 or October 20, 2020 OASH authorizations, shall be interpreted
the same way. See Guidance for Licensed Pharmacists and Pharmacy
Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act,
OASH, Sept. 3, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf (last
visited Jan. 24, 2021); Guidance for PREP Act Coverage for Qualified
Pharmacy Technicians and State-Authorized Pharmacy Interns for
Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing, OASH,
Oct. 20, 2020, available at https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf (last
visited Jan. 24, 2021).
---------------------------------------------------------------------------
ix. The licensed pharmacist must complete a minimum of two hours of
ACPE-approved, immunization-related continuing pharmacy education
during each State licensing period;
x. The licensed pharmacist must comply with recordkeeping and
reporting requirements of the jurisdiction in which he or she
administers vaccines, including informing the patient's primary-care
provider when available, submitting the required immunization
information to the State or local immunization information system
(vaccine registry), complying with requirements with respect to
reporting adverse events, and complying with requirements whereby the
person administering a vaccine must review the vaccine registry or
other vaccination records prior to administering a vaccine;
xi. The licensed pharmacist must inform his or her childhood
vaccination patients and the adult caregiver accompanying the child of
the importance of a well-child visit with a pediatrician or other
licensed primary care provider and refer patients as appropriate; and
xii. The licensed pharmacist, the licensed or registered pharmacy
intern and the qualified pharmacy technician must comply with any
applicable requirements (or conditions of use) as set forth in the CDC
COVID-19 vaccination provider agreement and any other federal
requirements that apply to the administration of COVID-19 vaccine(s).
Section V(h) is clarified to read:
(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
CDC's/ACIP's COVID-19 vaccine recommendation(s);
iii. The healthcare professionals and students must have
documentation of completion of the CDC 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
[[Page 54698]]
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; \4\
---------------------------------------------------------------------------
\4\ 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 CDC
COVID-19 vaccination provider agreement and any other federal
requirements that apply to the administration of COVID-19 vaccine(s).
Section XII is clarified to read:
``Liability protections for all Covered Countermeasures
administered and used in accordance with the public health and medical
response of the Authority Having Jurisdiction, as identified in Section
VII(b) of this Declaration, begin with a Declaration of Emergency as
that term is defined in Section VII (except that, with respect to
qualified persons who order or administer a routine childhood
vaccination that CDC/ACIP recommends to persons ages three through 18
according to CDC's/ACIP's standard immunization schedule, liability
protections began on August 24, 2020), and last through (a) the final
day the Declaration of Emergency is in effect, or (b) October l, 2024,
whichever occurs first.'' This amendment does not change effective
dates under Section XII.
Karuna Seshasai,
Executive Secretary to the Department, U.S. Department of Health and
Human Services.
[FR Doc. 2021-21652 Filed 9-30-21; 4:15 pm]
BILLING CODE 4150-37-P
