[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]


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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.

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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:
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    \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.
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    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\
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    \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).
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    ix. The licensed pharmacist must complete a minimum of two hours of 
ACPE-approved, immunization-related continuing pharmacy education 
during each State licensing period;
    x. The licensed pharmacist must comply with recordkeeping and 
reporting requirements of the jurisdiction in which he or she 
administers vaccines, including informing the patient's primary-care 
provider when available, submitting the required immunization 
information to the State or local immunization information system 
(vaccine registry), 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\
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    \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).
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    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]
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