982 Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 

questions—attachments 4.19–A, 4.19–B, 

and 4.–19–D. The questions concerning 

the source of funding have not changed, 

therefore there is no change in the 

burden to States. Form Number: CMS– 

10398 (#24) (OMB control number: 

0938–1148); Frequency: Yearly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

54; Total Annual Responses: 54; Total 

Annual Hours: 2,160. (For policy 

questions regarding this collection 

contact: Richard Kimball at 410–786– 

2278.) 

3. Title of Information Collection: 

Supplemental Payment Reporting under 

the Consolidated Appropriations Act; 

Type of Information Collection Request: 

Extension of a currently approved 

collection; Use: Through passage of 

Division CC, Title II, Section 202 of the 

Consolidated Appropriations Act 

(CAA), Congress added subsection (bb) 

to section 1903 of the Act, which 

requires the Secretary of Health and 

Human Services to establish a system 

for states to submit reports on 

supplemental payments as defined in 

section 1903(bb)(2) of the Act. States are 

required to submit ‘‘reports, as 

determined appropriate by the 

Secretary, on supplemental payment 

data, as a requirement for a State plan 

or State plan amendment [SPA] that 

would provide for a supplemental 

payment’’ as required by section 

1903(bb)(1) of the Act. 

CMS is implementing section 202 of 

the CAA of 2021 by adding new screens 

to the CMS–64 in the MBES system for 

states to report all supplemental 

payments. States will be expected to use 

the form starting for their first quarter 

Federal fiscal year 2022 expenditures 

beginning on January 15, 2022. The 

statute requires CMS to set up a data 

collection system for all state 

supplemental payments. Form Number: 

CMS–10398 (#73) (OMB control 

number: 0938–1148); Frequency: Yearly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

54; Total Annual Responses: 54; Total 

Annual Hours: 3,240. (For policy 

questions regarding this collection 

contact: Richard Kimball at 410–786– 

2278.) 

4. Title of Information Collection: 

Coverage of Routine Patient Cost for 

Items & Services in Qualifying Clinical 

Trials; Type of Information Collection 

Request: New collection; Use: Section 

210 of the Consolidated Appropriations 

Act of 2021 amended section 1905(a) of 

the Social Security Act (the Act) to add 

a new mandatory benefit at 1905(a)(30). 

The new benefit mandates coverage of 

routine patient services and costs 

furnished in connection with 

participation by Medicaid beneficiaries 

in qualifying clinical trials. Routine 

costs for services provided in 

connection with participation in a 

qualifying clinical trial generally 

include any item or service provided to 

the individual under the qualifying 

clinical trial, including any item or 

service provided to prevent, diagnose, 

monitor, or treat complications resulting 

from participation in the qualified 

clinical trial, to the extent that the 

provision of such items or services to 

the individual would otherwise be 

covered under the state plan or waiver. 

We propose that States and territories 

review the preprints completed for a 

Medicaid beneficiary to receive 

coverage of routine patient services and 

costs furnished in connection with 

participation in qualifying clinical 

trials. Completion of the preprint pages 

verifies in the Medicaid state plan that 

the mandatory clinical trials benefit is 

being furnished by a state. Completion 

of the preprint verifies that the 

requirements of a federally sponsored 

clinical trial is appropriate for the 

Medicaid beneficiary. Form Number: 

CMS–10398 (#74) (OMB control 

number: 0938–1148); Frequency: Yearly; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 56. (For policy questions 

regarding this collection contact Kirsten 

Jensen at 410–786–8146.) 

5. Title of Information Collection: 

American Rescue Plan (ARP) 1135 State 

Plan Amendment; Type of Information 

Collection Request: New collection; Use: 

Section 9811 of the ARP established 

new mandatory benefits at section 

1905(a)(4)(E) for COVID–19 vaccine and 

vaccine administration and section 

1905(a)(4)(F) for COVID–19 testing and 

treatment for both Medicaid and CHIP. 

The effective date time period for these 

mandatory benefits is March 11, 2021, 

ending on the last day of the first 

calendar quarter that begins one year 

after the last day of the emergency 

period described in section 

1135(g)(1)(B) of the Social Security Act 

(the Act). Given that regular state plan 

rules do not allow for effective dates 

prior to the first day of the quarter in 

which the state plan amendment (SPA) 

was submitted, we are allowing states to 

use Section 1135 SPA process waiver 

authority to allow states to meet the 

required timeframes of these provisions. 

The SPAs will implement mandatory 

Medicaid coverage and reimbursement 

for COVID–19 vaccine and vaccine 

administration and COVID–19 testing 

and treatment are considered part of the 

Agency’s emergency response to COVID. 

CMS has issued guidance for each of 

these provisions. 

In large part, states have already been 

providing these services throughout the 

course of the pandemic and these SPAs 

will reflect what states have been doing. 

CMS is primarily using an attestation 

approach for states to affirm that they 

are in compliance with the requirements 

of the provisions. 

Form Number: CMS–10398 (#75) 

(OMB control number: 0938–1148); 

Frequency: Once and on occasion; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 168. (For policy 

questions regarding this collection 

contact Kirsten Jensen at 410–786– 

8146.) 

Dated: January 4, 2022. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2022–00119 Filed 1–6–22; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Tenth 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 

expand the authority for certain 

Qualified Persons authorized to 

prescribe, dispense, and administer 

seasonal influenza vaccines under 

section VI of this Declaration. 

DATES: This amendment is effective as 

of January 7, 2022. 

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, 


tkelley on DSK125TN23PROD with NOTICE 
Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 983 

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, July 20, 2021, and 

October 15, 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, Aug. 

24, 2020). On December 3, 2020, the 

former Secretary amended the 

declaration to incorporate Advisory 

Opinions of the General Counsel 

interpreting the PREP Act and the 

Secretary’s Declaration and 

authorizations issued by the 

Department’s Office of the Assistant 

Secretary for Health as an Authority 

Having Jurisdiction to respond; added 

an additional category of qualified 

persons under Section V of the 

Declaration; made explicit that the 

Declaration covers all qualified 

pandemic and epidemic products as 

defined under the PREP Act; added a 

third method of distribution to provide 

liability protections for, among other 

things, private distribution channels; 

made explicit that there can be 

situations where not administering a 

covered countermeasure to a particular 

individual can fall within the PREP Act 

and the Declaration’s liability 

protections; made explicit that there are 

substantive federal legal and policy 

issues and interests in having a unified 

whole-of-nation response to the COVID– 

19 pandemic among federal, state, local, 

and private-sector entities; revised the 

effective time period of the Declaration; 

and republished the declaration in full. 

(85 FR 79190, Dec. 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, Feb. 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, Feb. 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, Feb. 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, Mar. 16, 

2021). On August 4, 2021, Secretary 

Xavier Becerra amended the Declaration 

to clarify categories of Qualified Persons 

and to expand the scope of authority for 

certain Qualified Persons to administer 

seasonal influenza vaccines to adults. 

(86 FR 41977, Aug. 4, 2021). On 

September 14, 2021, Secretary Becerra 

amended the Declaration to expand the 

scope of authority for certain Qualified 

Persons to administer COVID–19 

therapeutics subcutaneously, 

intramuscularly, or orally (86 FR 51160, 

Sept. 14, 2021) and on September 30, 

2021, the Department filed a notice of 

correction to the September 14 notice 

clarifying the terms ‘‘ACIP 

recommendations’’ and ‘‘ACIP’s 

standard immunization schedules.’’ (86 

FR 54696, Oct. 4, 2021). 

Secretary Xavier Becerra now amends 

section V of the Declaration to add 

subsection (j) to expand the scope of 

authority for licensed pharmacists to 

order and administer and qualified 

pharmacy interns to administer seasonal 

influenza vaccines. 

Accordingly, subsection V(j) 

authorizes: 

(j) Any pharmacist who holds an 

active license or certification permitting 

the person to prescribe, dispense, or 

administer vaccines under the law of 

any State or who is authorized under 

Section V(d) of this Declaration who 

prescribes, dispenses, or administers 

seasonal influenza vaccines, or a 

pharmacy intern as authorized under 

the section V(d) of this Declaration who 

administers seasonal influenza vaccines, 

in any jurisdiction where the PREP Act 

applies, other than the State in which 

the license or certification is held, so 

long as the license or certification of the 

pharmacist or pharmacy intern 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; 

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 


tkelley on DSK125TN23PROD with NOTICE 
984 Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 

1 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). 

2See 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). 

3See, 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 

persons so identified in a declaration by 

the Secretary’’ under subsection (b) of 

the PREP Act. 42 U.S.C. 247d–6d(i)(8) 

The Secretary anticipates that there 

will be a need to increase the available 

pool of providers able to order and 

administer seasonal influenza vaccines. 

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. The health care 

system capacity and the vaccination 

workforce are likely to become 

increasingly strained throughout the 

nation. Allowing pharmacists and 

pharmacy interns to administer both 

COVID–19 vaccines and seasonal 

influenza vaccines in jurisdictions 

where the need is greatest would allow 

states maximum flexibility in limiting 

potential impacts of both illnesses. 

Pharmacists and pharmacy interns are 

well positioned to increase access to 

seasonal influenza vaccines and have 

played a critical role in this pandemic 

in overseeing COVID–19 testing and 

vaccine administration. Given their skill 

set and training, as well as looming 

provider shortages, pharmacists and 

pharmacy interns would require 

minimal, if any, additional training to 

administer and would not place any 

undue training burden on providers. 

By this amendment to the Declaration, 

the Secretary expands the authorization 

for an additional category of persons 

who are qualified persons under section 

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

expands the authorization for a 

pharmacist who holds an active license 

or certification permitting the person to 

prescribe, dispense, or administer 

vaccines under the law of any State or 

who is authorized under Section V(d) of 

this Declaration who prescribes, 

dispenses, or administers seasonal 

influenza vaccines, or a pharmacy 

intern as authorized under the section 

V(d) of this Declaration who administers 

seasonal influenza vaccines, in any 

jurisdiction where the PREP Act 

applies, other than the State in which 

the license or certification is held. 

As qualified persons, these licensed 

pharmacists 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 seasonal influenza 

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.1 The opinion relied in 

part on the fact that the Congressional 

delegation of authority to the Secretary 

under the PREP Act to specify a class of 

persons, beyond those who are 

authorized to administer a covered 

countermeasure under State law, as 

‘‘qualified persons’’ would be rendered 

a nullity in the absence of such 

preemption. This opinion is 

incorporated by reference into this 

declaration. Based on the reasoning set 

forth in the May 19, 2020 advisory 

opinion, any State law that would 

otherwise prohibit a member of any of 

the classes of ‘‘qualified persons’’ 

specified in this declaration from 

administering a covered countermeasure 

is likewise preempted. In accordance 

with section 319F–3(i)(8)(A) of the 

Public Health Service Act, a State 

remains free to expand the universe of 

individuals authorized to administer 

covered countermeasures within its 

jurisdiction under State law. 

The plain language of the PREP Act 

makes clear that there is preemption of 

state law as described above. 

Furthermore, preemption of State law is 

justified to respond to the nation-wide 

public health emergency caused by 

COVID–19 as it will enable States to 

quickly expand the vaccination, 

treatment and prevention workforces 

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, as amended on February 2, 

2021, as amended March 11, 2021, as 

amended on August 4, 2021, and as 

amended on September 14, 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 (Dec. 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 2

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; 3


tkelley on DSK125TN23PROD with NOTICE 
Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 985 

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. 

4Some 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 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). 

5Where 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. 

6This 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). 

(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),4 (1) 

vaccines that the Centers for Disease 

Control and Prevention (CDC)/Advisory 

Committee on Immunization Practices 

(ACIP) recommend 5 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 recommends 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 

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 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; 6

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 


tkelley on DSK125TN23PROD with NOTICE 
986 Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 

7See, 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). 

8See COVID–19 Vaccine Training Modules, 

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

training.html. 

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.7

Nothing in this Declaration shall 

preempt state laws that permit 

additional persons to deliver telehealth 

services. 

(f) Any healthcare professional or 

other individual who holds an active 

license or certification permitting the 

person to prescribe, dispense, or 

administer vaccines under the law of 

any State as of the effective date of this 

amendment, or 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 8 and, 

for healthcare providers who are not 

currently practicing, documentation of 

an observation period by a currently 

practicing healthcare professional 

experienced in administering 

intramuscular injections, and for whom 

administering intramuscular injections 

is in their ordinary scope of practice, 

who confirms competency of the 

healthcare provider in preparation and 

administration of the COVID–19 

vaccine(s) to be administered; 

(g) Any member of a uniformed 

service (including members of the 

National Guard in a Title 32 duty status) 

(hereafter in this paragraph ‘‘service 

member’’) or Federal government, 

employee, contractor, or volunteer who 

prescribes, administers, delivers, 

distributes or dispenses a Covered 

Countermeasure. Such Federal 

government service members, 

employees, contractors, or volunteers 

are qualified persons if the following 

requirement is met: The executive 

department or agency by or for which 

the Federal service member, employee, 

contractor, or volunteer is employed, 

contracts, or volunteers has authorized 

or could authorize that service member, 

employee, contractor, or volunteer to 

prescribe, administer, deliver, 

distribute, or dispense the Covered 

Countermeasure as any part of the 

duties or responsibilities of that service 

member, employee, contractor, or 

volunteer, even if those authorized 

duties or responsibilities ordinarily 

would not extend to members of the 

public or otherwise would be more 

limited in scope than the activities such 

service member, employees, contractors, 

or volunteers are authorized to carry out 

under this declaration; and 

(h) The following healthcare 

professionals and students in a 

healthcare profession training program 

subject to the requirements of this 

paragraph: 

1. Any midwife, paramedic, advanced 

or intermediate emergency medical 

technician (EMT), physician assistant, 

respiratory therapist, dentist, podiatrist, 

optometrist or veterinarian licensed or 

certified to practice under the law of 

any state who prescribes, dispenses, or 

administers COVID–19 vaccines that are 

Covered Countermeasures under section 

VI of this Declaration in any jurisdiction 

where the PREP Act applies in 

association with a COVID–19 

vaccination effort by a State, local, 

Tribal or territorial authority or by an 

institution in which the COVID–19 

vaccine covered countermeasure is 

administered; 

2. Any physician, advanced practice 

registered nurse, registered nurse, 

practical nurse, pharmacist, pharmacy 

intern, midwife, paramedic, advanced 

or intermediate EMT, respiratory 

therapist, dentist, physician assistant, 

podiatrist, optometrist, or veterinarian 

who has held an active license or 

certification under the law of any State 

within the last five years, which is 

inactive, expired or lapsed, who 

prescribes, dispenses, or administers 

COVID–19 vaccines that are Covered 

Countermeasures under section VI of 

this Declaration in any jurisdiction 

where the PREP Act applies in 

association with a COVID–19 

vaccination effort by a State, local, 

Tribal or territorial authority or by an 

institution in which the COVID–19 

vaccine covered countermeasure is 

administered, so long as the license or 

certification was active and in good 

standing prior to the date it went 

inactive, expired or lapsed and was not 

revoked by the licensing authority, 

surrendered while under suspension, 

discipline or investigation by a licensing 

authority or surrendered following an 

arrest, and the individual is not on the 

List of Excluded Individuals/Entities 

maintained by the Office of Inspector 

General; 

3. Any medical, nursing, pharmacy, 

pharmacy intern, midwife, paramedic, 

advanced or intermediate EMT, 

physician assistant, respiratory therapy, 

dental, podiatry, optometry or 

veterinary student with appropriate 

training in administering vaccines as 

determined by his or her school or 

training program and supervision by a 

currently practicing healthcare 

professional experienced in 

administering intramuscular injections 

who administers COVID–19 vaccines 

that are Covered Countermeasures 

under section VI of this Declaration in 

any jurisdiction where the PREP Act 

applies in association with a COVID–19 

vaccination effort by a State, local, 

Tribal or territorial authority or by an 

institution in which the COVID–19 

vaccine covered countermeasure is 

administered; 

Subject to the following requirements: 

i. The vaccine must be authorized, 

approved, or licensed by the FDA. 


tkelley on DSK125TN23PROD with NOTICE 
Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 987 

9This 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). 

10Some 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 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). 

11This 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 

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). 

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 Centers for Disease 

Control and Prevention COVID–19 

Vaccine Training Modules and, if 

applicable, such additional training as 

may be required by the State, territory, 

locality, or Tribal area in which they are 

prescribing, dispensing, or 

administering COVID–19 vaccines; 

iv. The healthcare professionals and 

students must have documentation of an 

observation period by a currently 

practicing healthcare professional 

experienced in administering 

intramuscular injections, and for whom 

administering vaccinations is in their 

ordinary scope of practice, who 

confirms competency of the healthcare 

provider or student in preparation and 

administration of the COVID–19 

vaccine(s) to be administered and, if 

applicable, such additional training as 

may be required by the State, territory, 

locality, or Tribal area in which they are 

prescribing, dispensing, or 

administering COVID–19 vaccines; 

v. The healthcare professionals and 

students must have a current certificate 

in basic cardiopulmonary 

resuscitation; 9

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). 

(i) 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) 10

FDA authorized, approved, or licensed 

COVID–19 therapeutics. Such Statelicensed pharmacists and the Statelicensed or registered interns or 

technicians under their supervision are 

qualified persons only if the following 

requirements are met: 

i. The COVID–19 therapeutic must be 

authorized, approved, or licensed by the 

FDA. 

ii. In the case of a licensed pharmacist 

ordering a COVID–19 therapeutic, the 

therapeutic must be ordered for 

subcutaneous, intramuscular, or oral 

administration and in accordance with 

the FDA approval, authorization, or 

licensing. 

iii. In the case of licensed 

pharmacists, qualified pharmacy 

technicians, and licensed or registered 

pharmacy interns administering the 

COVID–19 therapeutic, the therapeutic 

must be administered subcutaneously, 

intramuscularly, or orally in accordance 

with the FDA approval, authorization, 

or licensing. 

iv. In the case of qualified pharmacy 

technicians, the supervising pharmacist 

must be readily and immediately 

available to the qualified pharmacy 

technician. 

v. In the case of COVID–19 

therapeutics administered through 

intramuscular or subcutaneous 

injections, the licensed pharmacist, 

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 

COVID–19 therapeutics, the recognition 

and treatment of emergency reactions to 

COVID–19 therapeutics, and any 

additional training required in the FDA 

approval, authorization, or licensing. 

vi. The licensed pharmacist, licensed 

or registered pharmacy intern and 

qualified pharmacy technician must 

have a current certificate in basic 

cardiopulmonary resuscitation; 11

vii. The licensed pharmacist must 

comply with recordkeeping and 

reporting requirements of the 

jurisdiction in which he or she 

administers COVID–19 therapeutics, 

including informing the patient’s 

primary-care provider when available 

and complying with requirements with 

respect to reporting adverse events. 

viii. The licensed pharmacist, the 

licensed or registered pharmacy intern 

and the qualified pharmacy technician 

must comply with any applicable 


tkelley on DSK125TN23PROD with NOTICE 
988 Federal Register / Vol. 87, No. 5 / Friday, January 7, 2022 / Notices 

requirements (or conditions of use) that 

apply to the administration of COVID– 

19 therapeutics. 

(j) Any pharmacist who holds an 

active license or certification permitting 

the person to prescribe, dispense, or 

administer vaccines under the law of 

any State or who is authorized under 

Section V(d) of this Declaration who 

prescribes, dispenses, or administers 

seasonal influenza vaccines, or a 

pharmacy intern as authorized under 

the section V(d) of this Declaration who 

administers seasonal influenza vaccines, 

in any jurisdiction where the PREP Act 

applies, other than the State in which 

the license or certification is held, so 

long as the license or certification of the 

pharmacist or pharmacy intern 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. 

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 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 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 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. 

Liability protections for Qualified 

Persons under section V(i) of the 

Declaration who are licensed 

pharmacists to order and administer and 

qualified pharmacy technicians and 

licensed or registered pharmacy interns 

to administer COVID–19 therapeutics 

begin on September 9, 2021. 

Liability protections for Qualified 

Persons under section V(j) of the 

Declaration begin on December 30, 

2021. 

Authority: 42 U.S.C. 247d–6d. 

Dated: January 4, 2022. 

Xavier Becerra, 

Secretary, U.S. Department of Health and 

Human Services. 

[FR Doc. 2022–00151 Filed 1–5–22; 11:15 am] 

BILLING CODE P 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

[21X LLUTC01000 L51010000 ER0000 

LVRWJ21J4210; UTU–92733; 00–00000] 

Notice of Availability of the Pine Valley 

Water Supply Project Draft 

Environmental Impact Statement, 

Beaver and Iron Counties, UT 

AGENCY: Bureau of Land Management, 

Interior. 

ACTION: Notice of Availability. 

SUMMARY: In compliance with the 

National Environmental Policy Act of 

1969, as amended (NEPA), and the 

Federal Land Policy and Management 

Act of 1976, as amended (FLPMA), the 

Bureau of Land Management (BLM) 

announces the availability of the Draft 

Environmental Impact Statement (EIS) 

for a right-of-way (ROW) application 

submitted by the Central Iron County 

Water Conservancy District (CICWCD), 

referred to as the Pine Valley Water 

Supply (PVWS) Project. 

DATES: This notice initiates the 45-day 

comment period. To ensure comments 

will be considered, the BLM must 

receive written comments on the 

proposed PVWS Project Draft EIS by 

February 22, 2022. The BLM will 

announce public involvement 

opportunities at least 15 days in 

advance on the BLM ePlanning project 

website at https://eplanning.blm.gov/ 

eplanning-ui/project/1503915/510. 

ADDRESSES: The Draft EIS is available 

for review on the BLM ePlanning project 

website at https://eplanning.blm.gov/ 

eplanning-ui/project/1503915/510. 

Written comments related to the PVWS 

Project Draft EIS may be submitted by 

either of the following methods: 

1. Email: pvwsproject@gmail.com. 

2. Mail: Bureau of Land Management, 

Attn: PVWS, 176 DL Sargent Drive, 

Cedar City, Utah 84721. 

FOR FURTHER INFORMATION CONTACT: 

Brooklynn Cox, Cedar City Field Office 

Realty Specialist, telephone (435) 865– 

3073; 176 DL Sargent Dr., Cedar City, 

UT 84721; pvwsproject@gmail.com. 

Persons who use a telecommunications 

device for the deaf may call the Federal 

Relay Service (FRS) at 1–800–877–8339 

to leave a message or question for the 

above individual. The FRS is available 

24 hours a day, seven days a week. 

Replies are provided during normal 

business hours. If you would like to 

request to view a hard copy, please call 

the Cedar City Field Office for more 

information at (435) 865–3000, Monday 

through Friday, except holidays. 

SUPPLEMENTARY INFORMATION: On June 

15, 2017, CICWCD applied for a ROW 


tkelley on DSK125TN23PROD with NOTICE