Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 41977 

successfully been matched to an 

approved practice site. 

Likely Respondents: Clinicians 

participating in the NHSC SP and the 

S2S LRP. 

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

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden 

per response 

(in hours) 

Total burden 

hours 

Travel Request Worksheet .................................................. 300 2 600 .0667 40.02 

Total .............................................................................. 300 ........................ 600 ........................ 40.02 

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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–16597 Filed 8–3–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Eighth Amendment to Declaration 

Under the Public Readiness and 

Emergency Preparedness Act for 

Medical Countermeasures Against 

COVID–19 

ACTION: Notice of amendment. 

SUMMARY: The Secretary issues this 

amendment pursuant to section 319F–3 

of the Public Health Service Act to 

clarify and expand the authority for 

certain Qualified Persons authorized to 

prescribe, dispense, and administer 

covered countermeasures under section 

VI of this Declaration. 

DATES: This amendment is effective as 

of August 4, 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, § 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, January 21, 

2021, April 21, 2021 and July 20, 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 


lotter on DSK11XQN23PROD with NOTICES1
41978 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 

1Some 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 

Certified Pharmacy Technician (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-guidancedocuments//prep-act-guidance.pdf (last visited Jan. 

24, 2021). 

2This 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). 

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). On March 11, 2021, 

the Acting Secretary amended the 

Declaration to add additional Qualified 

Persons authorized to prescribe, 

dispense, and administer covered 

countermeasures under the Declaration. 

(86 FR 14462 March 16, 2021). 

Secretary Xavier Becerra now amends 

section V of the Declaration to revise 

subsections (d) and (f) to clarify that 

qualified pharmacy technicians are 

Qualified Persons covered by the 

Declaration, and to expand the scope of 

authority for qualified pharmacy 

technicians to administer seasonal 

influenza vaccines to adults within the 

state where they are authorized to 

practice and for interns to administer 

seasonal influenza vaccines to adults 

consistent with other terms and 

conditions of the Declaration. 

Accordingly, subsection V(d) 

authorizes: 

(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 Advisory Committee 

on Immunization Practices (ACIP) 

recommends to persons ages three 

through 18 according to ACIP’s standard 

immunization schedule or (2) seasonal 

influenza vaccine administered by 

qualified pharmacy technicians and 

interns that the ACIP recommends to 

persons aged 19 and older according to 

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 ACIP’s 

COVID–19 vaccine recommendation(s); 

iii. In the case of a childhood vaccine, 

the vaccination must be ordered and 

administered according to 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 

administered according to 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; 2

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), 


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Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 41979 

3 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-guidancedocuments//prep-act-guidance.pdf (last visited June 

17, 2021). 

4https://www.medpagetoday.com/ 

meetingcoverage/acip/93283. 

5https://www.aappublications.org/news/2021/06/ 

24/acip-flu-rabies-dengue-062421. 

6 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). 

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 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). 

Further, the initial phrase of 

subsection V(f) is revised to state 

authorize ‘‘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 a pharmacist or 

pharmacy intern as authorized under 

the section V(d) of this 

Declaration. . . .’’ 

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 Secretary clarifies and expands the 

authorization for a category of persons 

who are qualified persons under section 

247d–6d(i)(8)(B). First, the amendment 

clarifies that qualified pharmacy 

technicians are authorized to administer 

Childhood vaccinations and COVID–19 

vaccinations that are Covered 

Countermeasures under section VI of 

this Declaration. The Department has 

authorized qualified pharmacy 

technicians to administer these vaccines 

under section V(a) of the Declaration 

through Guidance issued by the 

Assistant Secretary for Health.3 This 

amendment adds qualified pharmacy 

technicians to section V(d) of the 

Declaration, to clarify that these 

healthcare professionals are authorized 

subject to the conditions stated in that 

subsection. In addition, the amendment 

expands the authorization for qualified 

pharmacy technicians and interns to 

administer seasonal influenza vaccines 

under the supervision of a pharmacist to 

persons aged 19 and older consistent 

with ACIP recommendations. The 

Secretary anticipates that there will be 

a need for the adult population to 

receive both COVID–19 and seasonal 

influenza vaccines throughout the 

2021–2022 influenza season. Health 

risks may increase for individuals who 

contract seasonal influenza concurrently 

with COVID–19, thus expanding the 

scope of authorized vaccinators for 

seasonal influenza lessens the harm 

otherwise caused by COVID–19. 

While influenza incidence was lower 

than anticipated last fall and winter, the 

same cannot be assumed for the 2021– 

2022 flu season, as states have largely 

lifted the community mitigation 

measures previously in place at the 

height of the COVID–19 pandemic. 

Seasonal influenza has the potential to 

inflict significant burden and strain on 

the U.S. healthcare system in its own 

right; and in conjunction with the 

ongoing COVID–19 pandemic, a spike in 

influenza cases could overwhelm 

healthcare providers. Like the 

vaccination against COVID–19, the 

vaccination against influenza requires 

many people to be vaccinated within a 

short period of time, potentially creating 

a surge on the system. Concern also 

remains regarding the emergence of 

SARS-CoV–2 variants and their 

potential to cause disease both among 

vaccinated and unvaccinated 

populations. It is yet to be determined 

if COVID–19 vaccine boosters will be 

recommended; however, if boosters 

become necessary, allowing pharmacy 

interns and technicians to administer 

both COVID–19 vaccines and influenza 

vaccines would allow states maximum 

flexibility in limiting potential impacts 

of both illnesses. ACIP also recently 

voted unanimously in favor of COVID– 

19 and influenza vaccine coadministration.4 5 Like COVID–19 

vaccines, influenza vaccines are 

administered as intramuscular (IM) 

injections, and would require minimal, 

if any, additional training to administer, 

and would not place any undue training 

burden on providers. 

As qualified persons, these qualified 

pharmacy technicians and interns 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 these 

healthcare professionals 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 

‘‘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.6 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’’ 


lotter on DSK11XQN23PROD with NOTICES1
41980 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 

7See 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-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-pharmacistsand-pharmacy-interns-regarding-covid-19-vaccinesimmunity.pdf (last visited Jan. 24, 2021). 

8See, 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-19- 

tests.pdf (last visited Jan. 24, 2021); Guidance for 

PREP Act Coverage for COVID–19 Screening Tests 

at Nursing Homes, Assisted-Living Facilities, LongTerm-Care Facilities, and other Congregate 

Facilities, OASH, Aug. 31, 2020, available at 

https://www.hhs.gov/guidance/sites/default/files/ 

hhs-guidance-documents/prep-act-coverage-forscreening-in-congregate-settings.pdf (last visited 

Jan. 24, 2021); Guidance for Licensed Pharmacists 

and Pharmacy Interns Regarding COVID–19 

Vaccines and Immunity under the PREP Act, 

OASH, Sept. 3, 2020, available at https://

www.hhs.gov/guidance/sites/default/files/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. 

9Some 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 

Certified Pharmacy Technician (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-guidancedocuments//prep-act-guidance.pdf (last visited Jan. 

24, 2021). 

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 countermeasure 

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, and as amended March 11, 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 7 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; 8

(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 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),9 (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) seasonal influenza vaccine administered 

by qualified pharmacy technicians and 

interns that the ACIP recommends to persons 

aged 19 and older according to 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 Statelicensed 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 ACIP’s COVID–19 

vaccine recommendation(s); 

iii. In the case of a childhood vaccine, the 

vaccination must be ordered and 

administered according to 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 administered according to 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 41981 

10This 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). 

11See, 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). 

12See COVID–19 Vaccine Training Modules, 

available at https://www.cdc.gov/vaccines/covid-19/ 

training.html. 

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; 10

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 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.11 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 a pharmacist or 

pharmacy intern 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 12 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 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, 


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41982 Federal Register / Vol. 86, No. 147 / Wednesday, August 4, 2021 / Notices 

13This 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). 

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; 13

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 

1, 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 1, 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 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 1, 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 1, 2024. whichever occurs first. 

Liability protections for Qualified Persons 

under section V(d) of the Declaration who are 

qualified pharmacy technicians and interns 

to administer seasonal influenza vaccine to 

persons aged 19 and older begin on August 

4, 2021. 

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, 2021and 

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. 

Dated: July 30, 2021. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–16681 Filed 8–2–21; 11:15 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Fogarty International Center; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Fogarty International 

Center Advisory Board. 

The meeting will be open to the 

public via online meeting. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

Contact Person listed below in advance 

of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Fogarty International 

Center Advisory Board. 

Date: September 9–10, 2021. 

Closed: September 09, 2021, 12:00 p.m. to 

3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 


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