9516 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued 

Activity; 21 CFR part Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

Multiple distributor data and distributor tracking records— 

821.30(c)(2) and (d) ......................................................... 22,000 1 22,000 1 22,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 592,276 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2One-time burden. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity; 21 CFR part Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Acquisition of tracked devices and final distributor data— 

821.30(a) and (b) ............................................................. 22,000 1 22,000 1 22,000 

Multiple distributor data and distributor tracking records— 

821.30(c)(2) and (d) ......................................................... 1,100 1 1,100 1 1,100 

Total .............................................................................. ........................ ........................ ........................ ........................ 23,100 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimate for this 

information collection has not changed 

since the last OMB approval. 

Dated: February 9, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03017 Filed 2–12–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Sixth Amendment to Declaration Under 

the Public Readiness and Emergency 

Preparedness Act for Medical 

Countermeasures Against COVID–19 

ACTION: Notice of amendment. 

SUMMARY: The Acting Secretary issues 

this amendment pursuant to section 

319F–3 of the Public Health Service Act 

to add additional categories of Qualified 

Persons authorized to prescribe, 

dispense, and administer covered 

countermeasures under section VI of 

this Declaration. 

DATES: This amendment to the 

Declaration is effective as of February 

16, 2021. 

FOR FURTHER INFORMATION CONTACT: L. 

Paige Ezernack, Office of the Assistant 

Secretary for Preparedness and 

Response, Office of the Secretary, 

Department of Health andHuman 

Services, 200 Independence Avenue 

SW, Washington, DC 20201; 202–260– 

0365, paige.ezernack@hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Public Readiness and Emergency 

Preparedness Act (PREP Act) authorizes 

the Secretary of Health and Human 

Services (the Secretary) to issue a 

Declaration to provide liability 

immunity to certain individuals and 

entities (Covered Persons) against any 

claim of loss caused by, arising out of, 

relating to, or resulting from the 

manufacture, distribution, 

administration, or use of medical 

countermeasures (Covered 

Countermeasures), except for claims 

involving ‘‘willful misconduct’’ as 

defined in the PREP Act. Under the 

PREP Act, a Declaration may be 

amended as circumstances warrant. 

The PREP Act was enacted on 

December 30, 2005, as Public Law 109– 

148, Division C, 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 Countermeasures under 

the PREP Act. 

On January 31, 2020, 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, and January 21, 

2021. 

On March 10, 2020, former Secretary 

Azar issued a Declaration under the 

PREP Act for medical countermeasures 

against COVID–19 (85 FR 15198, Mar. 

17, 2020) (the Declaration). On April 10, 

the former Secretary amended the 

Declaration under the PREP Act to 

extend liability immunity to covered 

countermeasures authorized under the 

CARES Act (85 FR 21012, Apr. 15, 

2020). On June 4, the former Secretary 

amended the Declaration to clarify that 

covered countermeasures under the 

Declaration include qualified 

countermeasures that limit the harm 

COVID–19 might otherwise cause. (85 

FR 35100, June 8, 2020). On August 19, 

the former Secretary amended the 

declaration to add additional categories 

of Qualified Persons and amend the 

category of disease, health condition, or 

threat for which he recommended the 

administration or use of the Covered 

Countermeasures. (85 FR 52136, August 

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

former Secretary amended the 

declaration to incorporate Advisory 

Opinions of the General Counsel 

interpreting the PREP Act and the 

Secretary’s Declaration and 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 9517 

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, 2020, 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). 

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 December 9, 2020). On 

January 28, 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 7872, February 2, 2021). 

The Acting Secretary now amends 

section V of the Declaration to add a 

new subsection (h) to add an additional 

category of qualified persons covered 

under the PREP Act, and thus 

authorizes: 

(h) Any Federal government 

employee, contractor, or volunteer who 

prescribes, administers, delivers, 

distributes or dispenses a Covered 

Countermeasure. Such Federal 

government employees, contractors, or 

volunteers are qualified persons if the 

following requirement is met: The 

executive department or agency by or 

for which the Federal employee, 

contractor, or volunteer is employed, 

contracts, or volunteers has authorized 

or could authorize that employee, 

contractor, or volunteer to prescribe, 

administer, deliver, distribute, or 

dispense the Covered Countermeasure 

as any part of the duties or 

responsibilities of that 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 employees, contractors, or 

volunteers are authorized to carry out 

under this declaration. 

Description of This Amendment by 

Section 

Section V. Covered Persons 

Under the PREP Act and the 

Declaration, a ‘‘qualified person’’ is a 

‘‘covered person.’’ Subject to certain 

limitations, a covered person is immune 

from suit and liability under Federal 

and State law with respect to all claims 

for loss caused by, arising out of, 

relating to, or resulting from the 

administration or use of a covered 

countermeasure if a declaration under 

the PREP Act has been issued with 

respect to such countermeasure. 

‘‘Qualified person’’ includes (A) a 

licensed health professional or other 

individual who is authorized to 

prescribe, administer, or dispense such 

countermeasures under the law of the 

State in which the countermeasure was 

prescribed, administered, or dispensed; 

or (B) ‘‘a person within a category of 

persons so identified in a declaration by 

the Secretary’’ under subsection (b) of 

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

By this amendment to the Declaration, 

the Acting Secretary identifies an 

additional category of persons who are 

qualified persons under section 247d– 

6d(i)(8)(B): Federal employees, 

contractors and volunteers authorized 

by their Department or agency to 

prescribe, administer, deliver, 

distribute, or dispense the Covered 

Countermeasure as any part of their 

duties or responsibilities. 

The Acting Secretary has determined 

that there is an urgent need to expand 

the pool of available COVID–19 

vaccinators in order to respond 

effectively to the pandemic. As vaccine 

supply is made more widely available 

over the coming months, health care 

system capacity and the vaccination 

workforce are likely to become 

increasingly strained throughout the 

Nation. The United States is deploying 

federal personnel, contractors and 

volunteers to assist in the national 

COVID–19 vaccination program. While 

the United States is a covered person 

under the PREP Act and the Declaration, 

this amendment clarifies that federal 

employees, contractors and volunteers 

are also qualified persons authorized by 

the Secretary to prescribe, dispense, or 

administer covered countermeasures, 

consistent with the terms and 

conditions of the Declaration. 

As qualified persons, these 

employees, contractors and volunteers 

will be afforded liability protections in 

accordance with the PREP Act and the 

terms of this amended Declaration in 

addition to the protection that is 

afforded to the United States as a 

covered person. Second, to the extent 

that any State law that would otherwise 

prohibit the employees, contractors, or 

volunteers who are a ‘‘qualified person’’ 

from prescribing, dispensing, or 

administering COVID–19 vaccines or 

other Covered Countermeasures, such 

law is preempted. On May 19, 2020, the 

Office of the General Counsel issued an 

advisory opinion concluding that, 

because licensed pharmacists are 

‘‘qualified persons’’ under this 

declaration, the PREP Act preempts 

state law that would otherwise prohibit 

such pharmacists from ordering and 

administering authorized COVID–19 

diagnostic tests.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 

workforce with additional qualified 

healthcare professionals where State or 

local requirements might otherwise 

inhibit or delay allowing these 

healthcare professionals to participate 

in the COVID–19 vaccination program. 


khammond on DSKJM1Z7X2PROD with NOTICES
9518 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

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 

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. See 

Guidance for PREP Act Coverage for Qualified 

Pharmacy Technicians and State-Authorized 

Pharmacy Interns for Childhood Vaccines, COVID– 

19 Vaccines, and COVID–19 Testing, OASH, Oct. 

20, 2020 at 2, available at https://www.hhs.gov/ 

guidance/sites/default/files/hhs-guidancedocuments//prep-act-guidance.pdf (last visited Jan. 

24, 2021). 

5This 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:// 

Amendments to Declaration 

Amended Declaration for Public 

Readiness and Emergency Preparedness 

Act Coverage for medical 

countermeasures against COVID–19. 

Section V of the March 10, 2020 

Declaration under the PREP Act for 

medical countermeasures against 

COVID–19, as amended April 10, 2020, 

June 4, 2020, August 19, 2020, as 

amended and republished on December 

3, 2020, and as amended on February 2, 

2021, is further amended pursuant to 

section 319F–3(b)(4) of the PHS Act as 

described below. All other sections of 

the Declaration remain in effect as 

republished at 85 FR 79190 (December 

9, 2020). 

1. Covered Persons, section V, delete 

in full and replace with: 

V. Covered Persons 

42 U.S.C. 247d–6d(i)(2), (3), (4), (6), 

(8)(A) and (B) 

Covered Persons who are afforded 

liability immunity under this 

Declaration are ‘‘manufacturers,’’ 

‘‘distributors,’’ ‘‘program planners,’’ 

‘‘qualified persons,’’ and their officials, 

agents, and employees, as those terms 

are defined in the PREP Act, and the 

United States. ‘‘Order’’ as used herein 

and in guidance issued by the Office of 

the Assistant Secretary for Health 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

(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 who administer (if the pharmacy 

intern acts under the supervision of 

such pharmacist and the pharmacy 

intern is licensed or registered by his or 

her State board of pharmacy),4 (1) 

vaccines that the Advisory Committee 

on Immunization Practices (ACIP) 

recommends to persons ages three 

through 18 according to ACIP’s standard 

immunization schedule or (2) 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 

under their supervision are qualified 

persons only if the following 

requirements are met: 

i. The vaccine must be authorized, 

approved, or licensed by the FDA; 

ii. In the case of a COVID–19 vaccine, 

the vaccination must be ordered and 

administered according to ACIP’s 

COVID–19 vaccine recommendation(s). 

iii. In the case of a childhood vaccine, 

the vaccination must be ordered and 

administered according to ACIP’s 

standard immunization schedule; 

iv. The licensed pharmacist must 

have completed the immunization 

training that the licensing State requires 

in order 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; 

v. The licensed or registered 

pharmacy intern 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; 

vi. The licensed pharmacist and 

licensed or registered pharmacy intern 

must have a current certificate in basic 

cardiopulmonary resuscitation; 5


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 9519 

www.hhs.gov/guidance/sites/default/files/hhsguidance-documents//prep-act-guidance.pdf (last 

visited Jan. 24, 2021). 

6See, 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). 

7See COVID–19 Vaccine Training Modules, 

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

training.html. 

vii. The licensed pharmacist must 

complete a minimum of two hours of 

ACPE-approved, immunization-related 

continuing pharmacy education during 

each State licensing period; 

viii. 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; 

ix. 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 

x. The licensed pharmacist and the 

licensed or registered pharmacy intern 

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.6

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 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 7 and, 

for healthcare providers who are not 

currently practicing, documentation of 

an observation period by a currently 

practicing healthcare professional 

adequately experienced in vaccination 

who confirms competency of the 

healthcare provider in preparation and 

administration of the particular COVID– 

19 vaccine(s) to be administered; and 

(g) Any physician, advanced practice 

registered nurse, registered nurse, or 

practical nurse who has held an active 

license or certification to prescribe, 

dispense, or administer vaccines 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 federal, 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, subject to (i) documentation of 

completion of the Centers for Disease 

Control and Prevention COVID–19 

Vaccine Training Modules and (ii) 

documentation of an observation period 

by a currently practicing healthcare 

professional adequately experienced in 

vaccination who confirms competency 

of the healthcare provider in 

preparation and administration of the 

particular COVID–19 vaccine(s) to be 

administered. 

(h) Any Federal government 

employee, contractor, or volunteer who 

prescribes, administers, delivers, 

distributes or dispenses a Covered 

Countermeasure. Such Federal 

government employees, contractors, or 

volunteers are qualified persons if the 

following requirement is met: The 

executive department or agency by or 

for which the Federal employee, 

contractor, or volunteer is employed, 

contracts, or volunteers has authorized 

or could authorize that employee, 

contractor, or volunteer to prescribe, 

administer, deliver, distribute, or 

dispense the Covered Countermeasure 

as any part of the duties or 

responsibilities of that 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 ien scope than the 

activities such employees, contractors, 

or volunteers are authorized to carry out 

under this declaration. 

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. 


khammond on DSKJM1Z7X2PROD with NOTICES
9520 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

2. Effective Time Period, Section XII, 

Add to the End of the Section: 

Liability protections for Qualified 

Persons under sections V(f) and V(d) of 

the declaration begin on February 8, 

2021 and last through October 1, 2024. 

Authority: 42 U.S.C. 247d–6d. 

Norris Cochran, 

Acting Secretary, Department of Health and 

Human Services. 

[FR Doc. 2021–03106 Filed 2–11–21; 4:15 pm] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Peter Soukas, J.D., 301–594–8730; 

peter.soukas@nih.gov. Licensing 

information and copies of the patent 

applications listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Rockville, MD, 20852; tel. 

301–496–2644. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Epstein-Barr Virus Antibody That 

Blocks Fusion And Neutralizes Virus 

Infection of B Cells 

Description of Technology 

Epstein-Barr virus (EBV) is the most 

common cause of infectious 

mononucleosis and is associated with 

nearly 200,000 cancers and 140,000 

deaths each year. EBV-associated 

cancers include Hodgkin’s lymphoma, 

non-Hodgkin’s lymphoma, Burkitt B cell 

lymphoma, and EBV post-transplant 

lymphoproliferative disease. The latent 

reservoir for EBV in the body is the B 

lymphocyte. Thus, blocking B cell 

infection is important for reducing EBVrelated disease. 

EBV can infect both B cells and 

epithelial cells; however, the method of 

entry differs between these two cell 

types. To initiate B cell infection, EBV 

glycoprotein 350 (gp350) binds to 

compliment receptor 2 (CR2; also 

known as CD21), followed by binding of 

glycoprotein 42 (gp42) to HLA class II 

molecules, which triggers fusion of EBV 

with the B cell, allowing virus entry into 

the cell. Fusion also requires the EBV 

proteins gH/gL, which are found 

complexed with gp42 as a heterotrimer, 

and gB. Infection of epithelial cells is 

initiated by the binding of the EBV 

protein BMRF2 to cellular integrins, 

followed by binding of gH/gL to ephrin 

receptor A2 and integrins, which 

triggers fusion by EBV gB. 

Monoclonal antibodies that 

specifically bind EBV gp42 are 

described by this invention. The gp42- 

specific antibodies are capable of 

neutralizing EBV infection and 

inhibiting fusion of EBV with B cells. 

The monoclonal antibodies can be used 

for the treatment or prophylaxis of EBV 

infection, prevention of EBV-associated 

disease or infection in 

immunocompromised subjects, 

diagnosis of EBV infection, and 

detection of EBV in a biological sample. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications 

• Viral diagnostics 

• Viral therapeutics 

• Viral prophylaxis 

• Vaccine research 

Competitive Advantages 

• Ease of manufacture 

• Strongly neutralizing antibodies 

• Alternative to EBV vaccines 

Development Stage 

• In vivo data assessment (animal) 

Inventors: Jeffrey Cohen (NIAID), Wei 

Bu (NIAID), Nathan Board (NIAID), 

Kennichi Dowdell (NIAID). 

Intellectual Property: HHS Reference 

No. E–020–2020–0—U.S. Provisional 

Application No. 62/979,070, filed 

February 20, 2020. 

Licensing Contact: Peter Soukas, J.D., 

301–594–8730; peter.soukas@nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize for development of a 

vaccine for respiratory or other 

infections. For collaboration 

opportunities, please contact Peter 

Soukas, J.D., 301–594–8730; 

peter.soukas@nih.gov. 

Dated: January 28, 2021. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2021–03045 Filed 2–12–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

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

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Renal RC2 

Applications. 

Date: March 19, 2021. 

Time: 3:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Ryan G. Morris, Ph.D., 

Scientific Review Officer, Review Branch, 

Division of Extramural Activities, NIDDK, 

National Institutes of Health, 6707 

Democracy Boulevard, Room 7015, Bethesda, 

MD 20892–2542, 301–594–4721, 

ryan.morris@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 


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