Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Notices 99875 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Unaccompanied Children Office of the 

Ombuds (UCOO) Statement of 

Organization, Functions, and 

Delegations of Authority 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services (HHS). 

ACTION: Notice of reorganization; 

Establishment of the Unaccompanied 

Children Office of the Ombuds (UCOO). 

SUMMARY: The Administration for 

Children and Families (ACF) has 

reorganized to establish the 

Unaccompanied Children Office of the 

Ombuds (UCOO) within the Immediate 

Office of the Assistant Secretary, to be 

headed by a Director (‘‘Ombuds’’), who 

reports directly to the HHS Assistant 

Secretary for Children and Families. 

FOR FURTHER INFORMATION CONTACT: 

Leah Chavla, Senior Advisor, 

Administration for Children and 

Families, 330 C Street SW, Washington, 

DC 20201, (202) 838–3307. 

SUPPLEMENTARY INFORMATION: This 

notice amends Part K of the Statement 

of Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Administration for 

Children and Families (ACF), as 

follows: Chapter KA, Immediate Office 

of the Assistant Secretary as last 

amended by 88 FR 17229–17233 dated 

March 22, 2023. 

I. Amend Chapter K, Administration for 

Children and Families, Chapter KA, 

Office of the Assistant Secretary for 

Children and Families, Subchapter 

KA.10 Organization, by Adding 

Unaccompanied Children Office of 

the Ombuds (KAO) 

II. Amend Chapter KA, Office of the 

Assistant Secretary for Children and 

Families, by Establishing Chapter KAO, 

Unaccompanied Children Office of the 

Ombuds 

KAO.00 Mission. The Mission of the 

Unaccompanied Children Office of the 

Ombuds (UCOO) is to be an 

independent, impartial office with 

authority to receive reports, including 

confidential and informal reports, of 

concerns regarding the care and custody 

of unaccompanied children; to 

investigate such reports; to work 

collaboratively with the Office of 

Refugee Resettlement (ORR) to 

potentially resolve such reports; issue 

its own reports concerning UCOO’s 

efforts; and make recommendations to 

ORR regarding UC program policies and 

procedures related to protecting 

unaccompanied children in the care and 

custody of ORR. 

KAO.10 Organization. The UCOO is 

headed by a Director (‘‘Ombuds’’), who 

reports directly to the ACF Assistant 

Secretary, and consists of: 

Immediate Office of the Ombuds for 

Unaccompanied Children (KAO1) 

Division of Case Management (KAO2) 

Division of Operations (KAO3) 

KAO.20 Functions. The UCOO may 

engage in activities including, but not 

limited to: (1) Receiving reports from 

unaccompanied children, potential 

sponsors, other stakeholders in a child’s 

case, and the public regarding ORR’s 

adherence to its regulations and 

standards; (2) Investigating 

implementation of or adherence to 

Federal law and ORR regulations, in 

response to reports it receives, and 

meeting with interested parties to 

receive input on ORR’s compliance with 

Federal law and ORR policy; (3) 

Requesting and receiving information or 

documents, such as the Ombuds deems 

relevant, from ORR and ORR care 

provider facilities, to determine 

implementation of and adherence to 

Federal law and ORR policy; (4) 

Preparing formal reports and 

recommendations on findings to publish 

or present, including an annual report 

describing activities conducted in the 

prior year; (5) Conducting 

investigations, interviews, and site visits 

at care provider facilities as necessary to 

aid in the preparation of reports and 

recommendations; (6) Visiting ORR care 

providers in which unaccompanied 

children are or will be housed; (7) 

Reviewing individual circumstances, 

including, but not limited to, concerns 

about unaccompanied children’s access 

to services, ability to communicate with 

service providers, parents/legal 

guardians of children in ORR custody, 

sponsors, and matters related to 

transfers within or discharge from ORR 

care; (8) Making efforts to resolve 

complaints or concerns raised by 

interested parties as it relates to ORR’s 

implementation or adherence to Federal 

law or ORR policy; (9) Hiring and 

retaining others, including, but not 

limited to, independent experts, 

specialists, assistants, interpreters, and 

translators to assist the Ombuds in the 

performance of their duties; (10) Making 

non-binding recommendations to ORR 

regarding its policies and procedures, 

specific to protecting unaccompanied 

children in the care of ORR; (11) 

Providing general educational 

information about pertinent laws, 

regulations, and policies, ORR child 

advocates, and legal services as 

appropriate; and (12) Advising and 

updating the Director of ORR, Assistant 

Secretary, and the Secretary, as 

appropriate, on the status of ORR’s 

implementation and adherence with 

Federal law or ORR policy. 

The Ombuds shall manage the files, 

records, and other information of the 

program, regardless of format, and such 

files must be maintained in a manner 

that preserves the confidentiality of the 

records except in instances of imminent 

harm or judicial action and is prohibited 

from using or sharing information for 

any immigration enforcement related 

purpose. 

III. Continuation of Policy 

Except as inconsistent with this 

reorganization, all statements of policy 

and interpretations with respect to 

organizational components affected by 

this notice within ACF, heretofore 

issued and in effect on this date of this 

reorganization are continued in full 

force and effect. 

IV. Delegation of Authority 

All delegations and re-delegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them, or 

their successors, pending further redelegations, provided they are 

consistent with this reorganization. 

V. Funds, Personnel, and Equipment 

Transfer of organizations and 

functions affected by this reorganization 

shall be accompanied in each instance 

by direct and support funds, positions, 

personnel, records, equipment, 

supplies, and other resources. 

This reorganization will be effective 

upon date of signature. 

Xavier Becerra, 

Secretary, Health and Human Services. 

[FR Doc. 2024–29188 Filed 12–9–24; 11:15 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

12th 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 


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99876 Federal Register / Vol. 89, No. 238 / Wednesday, December 11, 2024 / Notices 

extend the duration of the Declaration to 

December 31, 2029, and to republish the 

Declaration in full. 

DATES: This amendment is effective as 

of January 1, 2025. 

FOR FURTHER INFORMATION CONTACT: L. 

Paige Ezernack, Administration for 

Strategic Preparedness and Response, 

U.S. Department of Health and Human 

Services, 400 7th St. SW, Washington, 

DC 20024; 202–260–0365, 

paige.ezernack@hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Public Readiness and Emergency 

Preparedness (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, section 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 (PHE) 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 declaration was renewed effective 

April 26, 2020, July 25, 2020, October 

23, 2020, January 21, 2021, April 21, 

2021, July 20, 2021, October 15, 2021, 

January 14, 2022, April 12, 2022, July 

15, 2022, October 13, 2022, January 11, 

2023, and February 11, 2023. The PHE 

declared under section 319 of the PHS 

Act ended on May 11, 2023. 

Nonetheless, as stated in section I of this 

amended PREP Act Declaration, I have 

determined there is a credible risk that 

COVID–19 may in the future constitute 

such an emergency and am thus 

amending this Declaration to prepare for 

and mitigate that risk. 

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, 

2020, 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, 2020, 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, 

2020, 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, i.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 permitted to 

practice; 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, I 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, I 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). On January 7, 

2022, I amended the Declaration to 

expand the scope of authority for 

licensed pharmacists to order and 

administer and qualified pharmacy 

interns to administer seasonal influenza 

vaccines (87 FR 982, January 7, 2022). 

On May 9, 2023, I amended the 

Declaration to update the determination 

of a PHE to state that COVID–19 

continues to present a credible risk of a 

future PHE after the end of the PHE 

declared pursuant to section 319 of the 

PHS Act; to add a new limitation on 

distribution to provide coverage under 

the PREP Act Declaration through 

December 31, 2024, for manufacturing, 

distribution, administration and use of 

Covered Countermeasures while they 

are authorized for emergency use (EUA) 

by the U.S. Food and Drug 


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Administration (FDA) pursuant to 

section 564 of the Federal Food, Drug & 

Cosmetic (FD&C) Act, regardless of any 

Federal agreement related to 

manufacturing, distribution, 

administration or use of the 

countermeasures, and regardless of any 

Federal, regional, state, or local 

emergency Declaration; to add a new 

limitation on distribution to provide 

coverage under this PREP Act 

Declaration through December 31, 2024, 

for manufacturing, distribution, 

administration and use of Covered 

Countermeasures that are COVID–19 

vaccines licensed by FDA, and any 

FDA-approved or cleared in vitro 

diagnostic product or other device used 

to treat, diagnose, cure, prevent, or 

mitigate COVID–19, or the transmission 

of SARS–CoV–2 or a virus mutating 

therefrom regardless of any Federal 

agreement related to manufacturing, 

distribution, administration or use of 

the vaccines, and regardless of any 

Federal, regional, state, or local 

emergency Declaration; to clarify that 

the category of disease, health condition 

or health threat includes the burden on 

healthcare providers caused by 

coterminous seasonal influenza 

infections and COVID–19 infections; to 

extend the time period of PREP Act 

coverage through December 31, 2024, to 

Qualified Persons who are licensed 

pharmacists to order and administer, 

and pharmacy interns and qualified 

pharmacy technicians to administer, 

Covered Countermeasures that are 

COVID–19 vaccines, seasonal influenza 

vaccines, and COVID–19 tests regardless 

of any Federal agreement related to 

manufacturing, distribution, 

administration or use of these Covered 

Countermeasures and regardless of any 

Federal, regional, state, or local 

emergency Declaration or other 

limitations on distribution stated in 

section VII of the Declaration; to clarify 

the time period of coverage for other 

qualified persons authorized under 

section V of the Declaration; and to 

extend the duration of the Declaration to 

December 2024 (88 FR 30769, May 12, 

2023). 

I am now amending section XII of the 

Declaration to extend the time period of 

PREP Act coverage through December 

31, 2029. COVID–19 continues to 

present a credible risk of a future public 

health emergency. COVID–19 continues 

to cause significant serious illness, 

morbidity, and mortality during 

outbreaks. The risk of domestic cases is 

high due to ongoing outbreaks that 

continue domestically and 

internationally in the year since the PHE 

for COVID–19 ended. Development of 

and stockpiling vaccines, therapeutics, 

devices, and diagnostics for COVID–19 

continues to be needed for U.S. 

preparedness against the credible threat 

of a public health emergency due to 

outbreaks of COVID–19. Continued 

coverage under the PREP Act, as 

provided in this Declaration, is intended 

to prepare for and mitigate the credible 

risk presented by COVID–19. This 

includes extending the time period for 

PREP Act coverage for licensed 

pharmacists, pharmacy interns, and 

qualified technicians, which allows for 

continued access by the recipient 

Population to Covered Countermeasures 

that are COVID–19 vaccines, seasonal 

influenza vaccines and COVID–19 tests. 

As stated in prior amendments to this 

Declaration, licensed pharmacists, 

pharmacy interns and qualified 

pharmacy technicians are well 

positioned to provide continued access 

to Covered Countermeasures, 

particularly in certain areas or for 

certain populations that have too few 

primary-care providers or that are 

otherwise medically underserved. As of 

2022, nearly 90 percent of Americans 

lived within five miles of a community 

pharmacy. During the COVID–19 

pandemic, the majority of Americans 

have received their COVID–19 vaccines 

and tests from a pharmacy. In addition, 

continued access by the Population to 

seasonal influenza vaccines mitigates 

risks that seasonal influenza infections, 

in conjunction with COVID–19 

infections, could overwhelm healthcare 

providers. 

As qualified persons, these licensed 

pharmacists, pharmacy interns, and 

qualified pharmacy technicians will be 

afforded liability protections in 

accordance with the PREP Act and the 

terms of this amended Declaration. To 

the extent that any State law would 

otherwise prohibit these healthcare 

professionals who are a ‘‘qualified 

person’’ from prescribing, dispensing, or 

administering Covered Countermeasures 

that are COVID–19 vaccines, seasonal 

influenza vaccines or COVID–19 tests, 

such law is preempted. 

Other conforming changes and 

technical corrections are made 

throughout the Declaration for 

consistency and clarity. 

Declaration, as Amended, for Public 

Readiness and Emergency 

Preparedness Act Coverage for Medical 

Countermeasures Against COVID–19 

To the extent any term previously in 

the Declaration, including its 

amendments, is inconsistent with any 

provision of this Republished 

Declaration, the terms of this 

Republished Declaration are controlling. 

This Declaration must be construed in 

accordance with the Advisory Opinions 

of the Office of the General Counsel 

(Advisory Opinions). I incorporate those 

Advisory Opinions as part of this 

Declaration. Declaration is a 

‘‘requirement’’ under the PREP Act. 

I. Determination of Public Health 

Emergency 

42 U.S.C. 247d–6d(b)(1) 

I have determined that the spread of 

SARS–CoV–2 or a virus mutating 

therefrom and the resulting disease 

COVID–19 constitutes a credible risk of 

a future public health emergency. I have 

also determined that use of any 

respiratory protective device approved 

by the National Institute for 

Occupational Safety and Health 

(NIOSH) under 42 CFR part 84, or any 

successor regulations, was a priority for 

use during the public health emergency 

that former Secretary Azar declared on 

January 31, 2020, under section 319 of 

the PHS Act for the entire United States 

to aid in the response of the nation’s 

healthcare community to the COVID–19 

outbreak, and that ended on May 11, 

2023. 

II. Factors Considered 

42 U.S.C. 247d–6d(b)(6) 

I have considered the desirability of 

encouraging the design, development, 

clinical testing, or investigation, 

manufacture, labeling, distribution, 

formulation, packaging, marketing, 

promotion, sale, purchase, donation, 

dispensing, prescribing, administration, 

licensing, and use of the Covered 

Countermeasures. 

III. Recommended Activities 

42 U.S.C. 247d–6d(b)(1) 

I recommend, under the conditions 

stated in this Declaration, the 

manufacture, testing, development, 

distribution, administration, and use of 

the Covered Countermeasures. 

IV. Liability Protections 

42 U.S.C. 247d–6d(a), 247d–6d(b)(1) 

Liability protections as prescribed in 

the PREP Act and conditions stated in 

this Declaration are in effect for the 

Recommended Activities described in 

Section III. 

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, 


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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 means a 

provider medication order, which 

includes prescribing of vaccines, or a 

laboratory order, which includes 

prescribing laboratory orders, if 

required. 

‘‘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) 

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; 

(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), (1) 

vaccines that the Centers for Disease 

Control and Prevention (CDC)/Advisory 

Committee on Immunization Practices 

(ACIP) recommend 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 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 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 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; 

ix. The licensed pharmacist must 

complete a minimum of two hours of 

ACPE-approved, immunization-related 

continuing pharmacy education during 

each State licensing period; 

x. The licensed pharmacist must 

comply with recordkeeping and 

reporting requirements of the 

jurisdiction in which he or she 

administers vaccines, including 

informing the patient’s primary care 

provider when available, submitting the 

required immunization information to 

the State or local immunization 

information system (vaccine registry), 

complying with requirements with 

respect to reporting adverse events, and 

complying with requirements whereby 

the person administering a vaccine must 

review the vaccine registry or other 

vaccination records prior to 

administering a vaccine; 

xi. The licensed pharmacist must 

inform his or her childhood-vaccination 

patients and the adult caregiver 

accompanying the child of the 

importance of a well-child visit with a 

pediatrician or other licensed primary 

care provider and refer patients as 

appropriate; and 

xii. The licensed pharmacist, the 

licensed or registered pharmacy intern 

and the qualified pharmacy technician 

must comply with any applicable 

requirements (or conditions of use) as 

set forth in the CDC COVID–19 

vaccination provider agreement and any 

other federal requirements that apply to 

the administration of COVID–19 

vaccine(s). 

(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. 

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 


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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 Documentation of 

completion of the COVID–19 (CDC) 

Vaccine Training Modules 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. 

(h) The following healthcare 

professionals and students in a 

healthcare profession training program 

subject to the requirements of this 

paragraph: 

1. Any midwife, paramedic, advanced 

or intermediate emergency medical 

technician (EMT), physician assistant, 

respiratory therapist, dentist, podiatrist, 

optometrist, or veterinarian licensed or 

certified to practice under the law of 

any state who prescribes, dispenses, or 

administers COVID–19 vaccines that are 

Covered Countermeasures under section 

VI of this Declaration in any jurisdiction 

where the PREP Act applies in 

association with a COVID–19 

vaccination effort by a state, local, tribal 

or territorial authority or by an 

institution in which the COVID–19 

vaccine covered countermeasure is 

administered; 

2. Any physician, advanced practice 

registered nurse, registered nurse, 

practical nurse, pharmacist, pharmacy 

intern, midwife, paramedic, advanced 

or intermediate EMT, respiratory 

therapist, dentist, physician assistant, 

podiatrist, optometrist, or veterinarian 

who has held an active license or 

certification under the law of any State 

within the last five years, which is 

inactive, expired or lapsed, who 

prescribes, dispenses, or administers 

COVID–19 vaccines that are Covered 

Countermeasures under section VI of 

this Declaration in any jurisdiction 

where the PREP Act applies in 

association with a COVID–19 

vaccination effort by a state, local, tribal 

or territorial authority or by an 

institution in which the COVID–19 

vaccine Covered Countermeasure is 

administered, so long as the license or 

certification was active and in good 

standing prior to the date it went 

inactive, expired or lapsed and was not 

revoked by the licensing authority, 

surrendered while under suspension, 

discipline, or investigation by a 

licensing authority or surrendered 

following an arrest, and the individual 

is not on the List of Excluded 

Individuals/Entities maintained by the 

Office of Inspector General; 

3. Any medical, nursing, pharmacy, 

pharmacy intern, midwife, paramedic, 

advanced or intermediate EMT, 

physician assistant, respiratory therapy, 

dental, podiatry, optometry or 

veterinary student with appropriate 

training in administering vaccines as 

determined by his or her school or 

training program and supervision by a 

currently practicing healthcare 

professional experienced in 

administering intramuscular injections 

who administers COVID–19 vaccines 

that are Covered Countermeasures 

under section VI of this Declaration in 

any jurisdiction where the PREP Act 

applies in association with a COVID–19 

vaccination effort by a state, local, tribal 

or territorial authority or by an 

institution in which the COVID–19 

vaccine Covered Countermeasure is 

administered; 

Subject to the following requirements: 

i. The vaccine must be authorized, 

approved, or licensed by the FDA; 

ii. Vaccination must be ordered and 

administered according to CDC’s/ACIP’s 

COVID–19 vaccine recommendation(s); 

iii. The healthcare professionals and 

students must have documentation of 

completion of the CDC COVID–19 

Vaccine Training Modules; and if 

applicable, such additional training as 

may be required by the state, territory, 

locality, or tribal area in which they are 

prescribing, dispensing, or 

administering COVID–19 vaccines; 

iv. The healthcare professionals and 

students must have documentation of an 

observation period by a currently 

practicing healthcare professional 

experienced in administering 

intramuscular injections, and for whom 

administering vaccinations is in their 

ordinary scope of practice, who 

confirms competency of the healthcare 

provider or student in preparation and 

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; 

vi. The healthcare professionals and 

students must comply with 

recordkeeping and reporting 

requirements of the jurisdiction in 

which he or she administers vaccines, 

including informing the patient’s 

primary-care provider when available, 

submitting the required immunization 

information to the state or local 

immunization information system 

(vaccine registry), complying with 

requirements with respect to reporting 

adverse events, and complying with 

requirements whereby the person 

administering a vaccine must review the 

vaccine registry or other vaccination 

records prior to administering a vaccine; 

and 

vii. The healthcare professionals and 

students comply with any applicable 

requirements (or conditions of use) as 

set forth in the CDC COVID–19 

vaccination provider agreement and any 

other federal requirements that apply to 


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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) 

FDA-authorized, approved, or licensed 

COVID–19 therapeutics. Such Statelicensed 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 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; 

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; and 

viii. The licensed pharmacist, the 

licensed or registered pharmacy intern 

and the qualified pharmacy technician 

must comply with any applicable 

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. 

VI. Covered Countermeasures 

42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C. 

247d–6d(i)(1) and (7) 

Covered Countermeasures are: 

(a) Any antiviral, any drug, any 

biologic, any diagnostic, any other 

device, any respiratory protective 

device, or any vaccine manufactured, 

used, designed, developed, modified, 

licensed, or procured: 

i. To diagnose, mitigate, prevent, treat, 

or cure COVID–19, or the transmission 

of SARS–CoV–2 or a virus mutating 

therefrom; or 

ii. to limit the harm that COVID–19, 

or the transmission of SARS–CoV–2 or 

a virus mutating therefrom, might 

otherwise cause; 

(b) a product manufactured, used, 

designed, developed, modified, 

licensed, or procured to diagnose, 

mitigate, prevent, treat, or cure a serious 

or life-threatening disease or condition 

caused by a product described in 

paragraph (a) above; 

(c) a product or technology intended 

to enhance the use or effect of a product 

described in paragraph (a) or (b) above; 

or 

(d) any device used in the 

administration of any such product, and 

all components and constituent 

materials of any such product. 

To be a Covered Countermeasure 

under the Declaration, a product must 

also meet 42 U.S.C. 247d–6d(i)(1)’s 

definition of ‘‘Covered 

Countermeasure.’’ 

VII. Limitations on Distribution 

42 U.S.C. 247d–6d(a)(5) and (b)(2)(E) 

I have determined that liability 

protections are afforded to Covered 

Persons only for Recommended 

Activities involving: 

(a) Covered Countermeasures that are 

related to present or future federal 

contracts, cooperative agreements, 

grants, other transactions, interagency 

agreements, memoranda of 

understanding, or other federal 

agreements; 

(b) Covered Countermeasures that are 

related to activities authorized in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction to prescribe, 

administer, deliver, distribute or 

dispense the Covered Countermeasures 

following a Declaration of Emergency; 

(c) Covered Countermeasures other 

than licensed COVID–19 vaccines that 

are: 

i. Licensed, approved, or cleared by 

the FDA (or that are permitted to be 

used under an Investigational New Drug 

Application or an Investigational Device 

Exemption) under the FD&C Act or PHS 

Act to treat, diagnose, cure, prevent, 

mitigate, or limit the harm from COVID– 

19, or the transmission of SARS–CoV– 

2 or a virus mutating therefrom; or 

ii. A respiratory protective device 

approved by NIOSH under 42 CFR part 

84, or any successor regulations, that the 

Secretary determines to be a priority for 

use during a public health emergency 

declared under section 319 of the PHS 

Act to prevent, mitigate, or limit the 

harm from COVID–19, or the 

transmission of SARS–CoV–2 or a virus 

mutating therefrom. 

To qualify for this third distribution 

channel, a Covered Person must 


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manufacture, test, develop, distribute, 

administer, or use the Covered 

Countermeasure pursuant to the FDA 

licensure, approval, or clearance (or 

pursuant to an Investigational New Drug 

Application or Investigational Device 

Exemption), or the NIOSH approval; 

(d) Covered Countermeasures that are 

authorized by the FDA under section 

564 of the FD&C Act to treat, diagnose, 

cure, prevent, mitigate, or limit the 

harm from COVID–19, or the 

transmission of SARS–CoV–2 or a virus 

mutating therefrom. To qualify for this 

fourth distribution channel, a Covered 

Person must manufacture, test, develop, 

distribute, administer, or use the 

Covered Countermeasure pursuant to 

the FDA authorization; or 

(e) Covered Countermeasures that are 

COVID–19 vaccines licensed by the 

FDA to prevent, mitigate, or limit the 

harm from COVID–19, or the 

transmission of SARS–CoV–2 or a virus 

mutating therefrom and any approved or 

cleared in vitro diagnostic product or 

other device used to treat, diagnose, 

cure, prevent, or mitigate COVID–19, or 

the transmission of SARS–CoV–2 or a 

virus mutating therefrom. To qualify for 

this fifth distribution channel, a 

Covered Person must manufacture, test, 

develop, distribute, administer, or use 

the Covered Countermeasure pursuant 

to the FDA license, clearance, or 

approval. 

As used in this Declaration, the terms 

‘‘Authority Having Jurisdiction’’ and 

‘‘Declaration of Emergency’’ have the 

following meanings: 

(i) The Authority Having Jurisdiction 

means the public agency or its delegate 

that has legal responsibility and 

authority for responding to an incident, 

based on political or geographical (e.g., 

city, county, tribal, state, or federal 

boundary lines) or functional (e.g., law 

enforcement, public health) range or 

sphere of authority. 

(ii) A Declaration of Emergency means 

any declaration by any authorized local, 

regional, state, or federal official of an 

emergency specific to events that 

indicate an immediate need to 

administer and use the Covered 

Countermeasures, with the exception of 

a federal declaration in support of an 

Emergency Use Authorization under 

section 564 of the FD&C Act unless such 

declaration specifies otherwise. 

I have also determined that, for 

governmental program planners only, 

liability protections are afforded only to 

the extent such program planners obtain 

Covered Countermeasures through 

voluntary means, such as (a) donation; 

(b) commercial sale; (c) deployment of 

Covered Countermeasures from federal 

stockpiles; or (d) deployment of 

donated, purchased, or otherwise 

voluntarily obtained Covered 

Countermeasures from state, local, or 

private stockpiles. 

VIII. Category of Disease, Health 

Condition, or Threat 

42 U.S.C. 247d–6d(b)(2)(A) 

The category of disease, health 

condition, or threat for which I 

recommend the administration or use of 

the Covered Countermeasures is not 

only COVID–19 caused by SARS–CoV– 

2, or a virus mutating therefrom, but 

also other diseases, health conditions, or 

threats that may have been caused by 

COVID–19, SARS–CoV–2, or a virus 

mutating therefrom, including the threat 

of increased burden on the healthcare 

system due to seasonal influenza 

infections occurring at the same time as 

COVID–19 infections, which will lead to 

an increase in the rate of infectious 

diseases. 

IX. Administration of Covered 

Countermeasures 

42 U.S.C. 247d–6d(a)(2)(B) 

Administration of the Covered 

Countermeasure means physical 

provision of the countermeasures to 

recipients, or activities and decisions 

directly relating to public and private 

delivery, distribution and dispensing of 

the countermeasures to recipients, 

management and operation of 

countermeasure programs, or 

management and operation of locations 

for the purpose of distributing and 

dispensing countermeasures. Where 

there are limited Covered 

Countermeasures, not administering a 

Covered Countermeasure to one 

individual in order to administer it to 

another individual can constitute 

‘‘relating to . . . the administration to 

. . . an individual’’ under 42 U.S.C. 

247d-6d. For example, consider a 

situation where there is only one dose 

of a COVID–19 vaccine, and a person in 

a vulnerable population and a person in 

a less vulnerable population both 

request it from a healthcare 

professional. In that situation, the 

healthcare professional administers the 

one dose to the person who is more 

vulnerable to COVID–19. In that 

circumstance, the failure to administer 

the COVID–19 vaccine to the person in 

a less-vulnerable population ‘‘relat[es] 

to . . . the administration to’’ the 

person in a vulnerable population. The 

person in the vulnerable population was 

able to receive the vaccine only because 

it was not administered to the person in 

the less-vulnerable population. 

Prioritization or purposeful allocation of 

a Covered Countermeasure, particularly 

if done in accordance with a public 

health authority’s directive, can fall 

within the PREP Act and this 

Declaration’s liability protections. 

X. Population 

42 U.S.C. 247d–6d(a)(4), 247d– 

6d(b)(2)(C) 

The populations of individuals to 

whom the liability protections of this 

Declaration extend include any 

individual who uses or is administered 

the Covered Countermeasures in 

accordance with this Declaration. 

Liability protections are afforded to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered to this 

population; liability protections are 

afforded to program planners and 

qualified persons when the 

countermeasure is used by or 

administered to this population, or the 

program planner or qualified person 

reasonably could have believed the 

recipient was in this population. 

XI. Geographic Area 

42 U.S.C. 247d–6d(a)(4), 247d– 

6d(b)(2)(D) 

Liability protections are afforded for 

the administration or use of a Covered 

Countermeasure without geographic 

limitation. 

Liability protections are afforded to 

manufacturers and distributors without 

regard to whether the Covered 

Countermeasure is used by or 

administered in any designated 

geographic area; liability protections are 

afforded to program planners and 

qualified persons when the 

countermeasure is used by or 

administered in any designated 

geographic area, or the program planner 

or qualified person reasonably could 

have believed the recipient was in that 

geographic area. 

COVID–19 is a global challenge that 

requires a whole-of-nation response. 

There are substantial federal legal and 

policy issues, and substantial federal 

legal and policy interests within the 

meaning of Grable & Sons Metal 

Products, Inc. v. Darue Eng’g. & Mf’g., 

545 U.S. 308 (2005), in having a unified, 

whole-of-nation response to the COVID– 

19 pandemic among federal, state, local, 

and private-sector entities. The world 

faced an unprecedented pandemic. To 

effectively respond, there needed to be 

a more consistent pathway for Covered 

Persons to manufacture, distribute, 

administer or use Covered 

Countermeasures across the nation and 

the world. Thus, there are substantial 

federal legal and policy issues, and 

substantial federal legal and policy 


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interests within the meaning of Grable 

& Sons Metal Products, Inc. v. Darue 

Eng’g. & Mf’g., 545 U.S. 308 (2005), in 

having a uniform interpretation of the 

PREP Act. Under the PREP Act, the sole 

exception to the immunity from suit and 

liability of covered persons under the 

PREP Act is an exclusive federal cause 

of action against a covered person for 

death or serious physical injury 

proximately caused by willful 

misconduct by such covered person. In 

all other cases, an injured party’s 

exclusive remedy is an administrative 

remedy under section 319F–4 of the 

PHS Act. Through the PREP Act, 

Congress delegated to me the authority 

to strike the appropriate federal-state 

balance with respect to Covered 

Countermeasures through PREP Act 

Declarations. 

XII. Effective Time Period 

42 U.S.C. 247d–6d(b)(2)(B) 

The effective time period for Covered 

Countermeasures and Covered Persons 

depends on the means of distribution 

identified in Section VII of this 

Declaration as applied to categories of 

Countermeasures and Qualified Persons: 

(a) 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 

December 31, 2029. 

(b) 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 December 31, 2029. 

(c) 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) December 31, 2029, whichever 

occurs first. 

(d) Liability protections for all 

Covered Countermeasures identified in 

section VII(c)(i) of this Declaration begin 

on December 9, 2020, and last through 

the final day the Declaration of 

Emergency is in effect or December 31, 

2029, whichever occurs first. Liability 

protections for all Covered 

Countermeasures identified in section 

VII(c)(ii) of this Declaration last for the 

time period stated in section (a) of this 

section XII if applicable, or otherwise 

December 31, 2024. 

(e) Liability protections for all 

Covered Countermeasures identified in 

section VII(d) of this Declaration begin 

on December 9, 2020, and last until 

December 31, 2029, regardless of any 

Declaration of Emergency that might 

otherwise terminate the time period of 

coverage under paragraphs (c) or (d) of 

this section XII. 

(f) Liability protections for all Covered 

Countermeasures identified in section 

VII(e) of this Declaration begin on 

December 9, 2020, and last until 

December 31, 2029, regardless of any 

Declaration of Emergency that might 

otherwise terminate the time period of 

coverage under paragraphs (c) or (d) of 

this section XII. 

(g) Liability protections for 

Manufacturers, Distributors, and 

Program Planners, as defined at 42 

U.S.C. 247d–6d(i), begin on February 4, 

2020, and last through the time periods 

stated in paragraphs (a)–(f) of this 

section XII. 

(h) Liability protections for Qualified 

Persons who are 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 begin on 

February 4, 2020, and last through the 

time periods stated in paragraphs (a)–(f) 

of this section XII. 

(i) Liability protections for Additional 

Qualified Persons identified under 

section V of the Declaration and in 

Guidance implementing section V of the 

Declaration begin on the dates listed 

below, and last through the time periods 

stated in paragraphs (a)–(d) of this 

section XII of the Declaration, unless 

otherwise stated in this paragraph (i). 

i. Liability protections for Qualified 

Persons under section V(d) of the 

Declaration who are licensed 

pharmacists to order and administer, 

and licensed or registered pharmacy 

interns and qualified pharmacy 

technicians to administer CDC/ACIP 

recommended vaccines for persons aged 

three through 18 (other than seasonal 

influenza vaccines and COVID–19 

vaccines) begins on August 24, 2020. 

ii. Liability protections for Qualified 

Persons under section V(d) of the 

Declaration who are licensed 

pharmacists to order and administer, 

and licensed or registered pharmacy 

interns and qualified pharmacy 

technicians to administer CDC/ACIP 

recommended seasonal influenza 

vaccines for persons aged three through 

18 begins on August 24, 2020, and lasts 

through December 31, 2029, regardless 

of the time periods stated in paragraphs 

(c)–(d) of this section XII or limitations 

on distribution stated in section VII (a)– 

(b) of this Declaration. 

iii. Liability protections for Qualified 

Persons under section V(d) of the 

Declaration who are licensed 

pharmacists to order and administer, 

and pharmacy interns and qualified 

pharmacy technicians to administer, 

COVID–19 vaccines to individuals aged 

three and above begins on February 4, 

2020, and lasts through December 31, 

2029, regardless of the time periods 

stated in paragraphs (c)–(d) of this 

section XII or limitations on distribution 

stated in section VII (a)–(b) of this 

Declaration. 

iv. Liability protections for Qualified 

Persons under section V(d) of the 

Declaration who are licensed 

pharmacists to order and administer, 

and pharmacy interns and qualified 

pharmacy technicians to administer, 

seasonal influenza vaccines to 

individuals aged nineteen and above 

begins on August 4, 2021, and lasts 

through December 31, 2029, regardless 

of the time periods stated in paragraphs 

(c)–(d) of this section XII or limitations 

on distribution stated in section VII (a)– 

(b) of this Declaration. 

v. Liability protections for Qualified 

Persons under section V(e) of the 

Declaration begin on February 4, 2020. 

vi. Liability protections for Qualified 

Persons under section V(f) of the 

Declaration begin on February 2, 2021. 

vii. Liability protections for Qualified 

Persons under section V(g) of the 

Declaration begin on February 16, 2021, 

and last through December 31, 2029. 

viii. Liability protections for Qualified 

Persons who are physicians, advanced 

practice registered nurses, registered 

nurses, or practical nurses under section 

V(h) of the Declaration begin on 

February 2, 2021, with additional 

conditions effective as of March 11, 

2021, and liability protections for all 

other Qualified persons under section 

V(h) begin on March 11, 2021. 

ix. 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 

identified in section VII(d) of the 

Declaration begin on September 9, 2021, 


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and last through December 31, 2029, 

regardless of time periods stated in 

paragraphs (c)–(d) of this section or 

limitations on distribution stated in 

section VII (a)–(b) of this Declaration. 

x. 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 

identified in section VII(c) of the 

Declaration begin on September 9, 2021. 

xi. Liability protections for Qualified 

Persons under section V(j) of the 

Declaration begin on December 30, 

2021. 

xii. Liability protections for Qualified 

Persons authorized under Guidance 

issued by this Department as an 

Authority Having Jurisdiction to 

respond to a declared emergency, 

incorporated into this Declaration by 

reference, to administer COVID–19 tests 

who are licensed pharmacists begin 

April 8, 2020, and last until December 

31, 2029, regardless of any limitations 

stated in paragraphs (c)–(d) of this 

section XII or limitations on distribution 

stated in section VII (a)–(b) of this 

Declaration. 

xiii. Liability protections for Qualified 

Persons authorized under Guidance 

issued by this Department as an 

Authority Having Jurisdiction to 

respond to a declared emergency, 

incorporated into this Declaration by 

reference, to administer COVID–19 tests 

who are licensed or registered pharmacy 

interns or qualified pharmacy 

technicians begin October 20, 2020, and 

last until December 31, 2029, regardless 

of any limitations stated in paragraphs 

(c)–(d) of this section XII or limitations 

on distribution stated in section VII (a)– 

(b) of this Declaration. 

xiv. Liability protections for Qualified 

Persons authorized under Guidance 

issued by this Department as an 

Authority Having Jurisdiction to 

respond to a declared emergency, 

incorporated into this Declaration by 

reference, who are pharmacies when 

their staff pharmacists order and 

administer, or their pharmacy interns 

and pharmacy technicians administer 

COVID–19 vaccines to individuals aged 

three and above, seasonal influenza 

vaccines to individuals aged three 

through eighteen, seasonal influenza 

vaccines to individuals aged nineteen 

and above, COVID–19 tests, and 

COVID–19 therapeutics identified in 

section VII(d) of the Declaration begin 

October 29, 2020, and last until 

December 31, 2029, regardless of any 

limitations stated in paragraphs (c)–(d) 

of this section XII or limitations on 

distribution stated in section VII (a)–(b) 

of this Declaration. 

xv. Liability protections for Qualified 

Persons authorized under Guidance 

issued by this Department as an 

Authority Having Jurisdiction to 

respond to a declared emergency, 

incorporated into this Declaration by 

reference, who are pharmacies when 

their staff pharmacists order and 

administer, or their pharmacy interns 

and pharmacy technicians administer 

CDC/ACIP recommended vaccines for 

persons aged three through 18 (other 

than seasonal influenza vaccines and 

COVID–19 vaccines) and 

countermeasures identified in section 

VII(c) of the Declaration begin October 

29, 2020. 

xvi. Liability protections for Qualified 

Persons authorized under Guidance 

issued by this Department as an 

Authority Having Jurisdiction to 

respond to a declared emergency, 

incorporated into this Declaration by 

reference to prescribe or administer 

point-of-care COVID–19 tests, using 

anterior nares specimen collection or 

self-collection, for screening in 

congregate facilities across the Nation 

who are licensed healthcare 

practitioners begin August 31, 2020, and 

last until December 31, 2029, regardless 

of any limitations stated in paragraphs 

(c)–(d) of this section XII or limitations 

on distribution stated in section VII (a)– 

(b) of this Declaration. 

XIII. Additional Time Period of 

Coverage 

42 U.S.C. 247d–6d(b)(3)(B) and (C) 

I have determined that an additional 

12 months of liability protection is 

reasonable to allow for the 

manufacturer(s) to arrange for 

disposition of the Covered 

Countermeasure, including return of the 

Covered Countermeasures to the 

manufacturer, and for Covered Persons 

to take such other actions as are 

appropriate to limit the administration 

or use of the Covered Countermeasures. 

Covered Countermeasures obtained 

for the Strategic National Stockpile 

(SNS) during the effective period of this 

Declaration are covered through the date 

of administration or use pursuant to a 

distribution or release from the SNS, 

including NIOSH Approved® respirators 

that have been rescinded or are beyond 

their manufacturers’ declared shelf life. 

XIV. Countermeasures Injury 

Compensation Program 

42 U.S.C 247d–6e 

The PREP Act authorizes the 

Countermeasures Injury Compensation 

Program (CICP) to provide benefits to 

certain individuals or estates of 

individuals who sustain a covered 

serious physical injury as the direct 

result of the administration or use of the 

Covered Countermeasures, and benefits 

to certain survivors of individuals who 

die as a direct result of the 

administration or use of the Covered 

Countermeasures. The causal 

connection between the countermeasure 

and the serious physical injury must be 

supported by compelling, reliable, valid, 

medical, and scientific evidence in 

order for the individual to be considered 

for compensation. The CICP is 

administered by the Health Resources 

and Services Administration, within the 

U.S. Department of Health and Human 

Services. Information about the CICP is 

available at the toll-free number 1–855– 

266–2427 or http://www.hrsa.gov/cicp/. 

XV. Amendments 

42 U.S.C. 247d–6d(b)(4) 

Amendments to this Declaration will 

be published in the Federal Register, as 

warranted. 

Authority: 42 U.S.C. 247d–6d. 

Dated: December 6, 2024. 

Xavier Becerra, 

Secretary, U.S. Department of Health and 

Human Services. 

[FR Doc. 2024–29108 Filed 12–10–24; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Request for Public Comments on the 

Scientific Report of the 2025 Dietary 

Guidelines Advisory Committee 

AGENCY: Office of Disease Prevention 

and Health Promotion, Office of the 

Assistant Secretary for Health (OASH), 

U.S. Department of Health and Human 

Services (HHS); Food, Nutrition, and 

Consumer Services (FNCS), U.S. 

Department of Agriculture (USDA). 

ACTION: Notice and request for public 

comments on the Scientific Report of 

the 2025 Dietary Guidelines Advisory 

Committee (Scientific Report). 

SUMMARY: The Departments of Health 

and Human Services and Agriculture 

invite the public to provide written 

comments and virtual oral comments on 

the Scientific Report. 

DATES: The written and oral comment 

collection dates are scheduled as 

follows: 

• Once the Scientific Report is 

published online, the public will have 

60 days to provide written comments to 

HHS and USDA; this public comment 

period closes on the 60th calendar day 


lotter on DSK11XQN23PROD with NOTICES1