Notice2021-21652
Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19; Correction
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 4, 2021
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 189 (Monday, October 4, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Pages 54696-54698]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#8fffeee6e8eaa1eaf5eafde1eeece4cfe7e7fca1e8e0f9"><span class="__cf_email__" data-cfemail="5d2d3c343a38733827382f333c3e361d35352e733a322b">[email protected]</span></a>.
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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//licensed-pharmacists-and-pharmacy-interns-regarding-covid-19-vaccines-immunity.pdf</a> (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 <a href="https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf">https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-guidance.pdf</a> (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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on October 4, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.