79198 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

25 42 U.S.C. 247d–6d(b)(7) provides that ‘‘[n]o 

court of the United States, or of any State, shall 

have subject matter jurisdiction to review, whether 

by mandamus or otherwise, any action by the 

Secretary under this subsection.’’ 

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 particular 

Covered Countermeasures through PREP 

Act declarations.25

XII. Effective Time Period 

42 U.S.C. 247d–6d(b)(2)(B) 

Liability protections for any 

respiratory protective device approved 

by NIOSH under 42 CFR part 84, or any 

successor regulations, through the 

means of distribution identified in 

Section VII(a) of this Declaration, begin 

on March 27, 2020 and extend through 

October 1, 2024. 

Liability protections for all other 

Covered Countermeasures identified in 

Section VI of this Declaration, through 

means of distribution identified in 

Section VII(a) of this Declaration, begin 

on February 4, 2020 and extend through 

October 1, 2024. 

Liability protections for all Covered 

Countermeasures administered and 

used in accordance with the public 

health and medical response of the 

Authority Having Jurisdiction, as 

identified in Section VII(b) of this 

Declaration, begin with a Declaration of 

Emergency as that term is defined in 

Section VII (except that, with respect to 

qualified persons who order or 

administer a routine childhood 

vaccination that ACIP recommends to 

persons ages three through 18 according 

to ACIP’s standard immunization 

schedule, liability protections began on 

August 24, 2020), and last through (a) 

the final day the Declaration of 

Emergency is in effect, or (b) October 1, 

2024, whichever occurs first. 

Liability protections for all Covered 

Countermeasures identified in Section 

VII(c) of this Declaration begin on the 

date of this amended Declaration and 

last through (a) the final day the 

Declaration of Emergency is in effect, or 

(b) October 1, 2024, whichever occurs 

first. 

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 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. 

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 

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 3, 2020. 

Alex M. Azar II, 

Secretary of Health and Human Services. 

[FR Doc. 2020–26977 Filed 12–8–20; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Declaration Under the Public 

Readiness and Emergency 

Preparedness Act for 

Countermeasures Against 

Marburgvirus and/or Marburg Disease 

SUMMARY: The Secretary is issuing this 

Declaration pursuant to section 319F–3 

of the Public Health Service Act to 

provide limited immunity for activities 

related to countermeasures against 

marburgvirus and/or Marburg disease. 

DATES: The Declaration is effective as of 

November 25, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Robert P. Kadlec, MD, MTM&H, MS, 

Assistant Secretary for Preparedness 

and Response, Office of the Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue 

SW, Washington, DC 20201; Telephone: 

202–205–2882. 

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. This 

Declaration is subject to amendment 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. 

The Pandemic and All-Hazards 

Preparedness Reauthorization Act 

(PAHPRA), Public Law 113–5, was 

enacted on March 13, 2013. Among 

other things, PAHPRA added sections 

564A and 564B to the Federal Food, 

Drug, and Cosmetic (FD&C) Act to 

provide new authorities for the 

emergency use of approved products in 

emergencies and products held for 

emergency use. PAHPRA accordingly 

amended the definitions of ‘‘Covered 

Countermeasures’’ and ‘‘qualified 

pandemic and epidemic products’’ in 

Section 319F–3 of the Public Health 

Service Act (PREP Act provisions), so 

that products made available under 

these new FD&C Act authorities could 

be covered under PREP Act 

Declarations. PAHPRA also extended 

the definition of qualified pandemic and 

epidemic products that may be covered 

under a PREP Act Declaration to include 

products or technologies intended to 

enhance the use or effect of a drug, 

biological product, or device used 

against the pandemic or epidemic or 

against adverse events from these 


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products. The Coronavirus Aid, Relief, 

and Economic Security (CARES) Act, 

Public Law 116–136, enacted on March 

27, 2020, amended section 319F– 

3(i)(1)(D) of the PHS Act, to create a new 

category of covered countermeasures to 

the PREP Act, namely, respiratory 

protective devices approved by the 

National Institute for Occupational 

Safety and Health (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. 

Marburg disease is a severe and often 

fatal illness in humans caused by 

marburgviruses, a group of filoviruses of 

the same family as ebolaviruses. 

Marburg disease is a highly virulent 

disease that causes hemorrhagic fever, 

with a case fatality rate of 

approximately 88 percent. Humans can 

become infected with marburgviruses, 

but it is largely unknown how 

marburgvirus transmits from its animal 

host to humans. For previous cases, 

unprotected contact with infected bat 

feces or aerosols was deemed the most 

likely route of infection. After the initial 

crossover of the virus from host animal 

to humans, transmission can occur 

through person-to-person contact. This 

may happen in several ways: Direct 

contact to droplets of body fluids from 

infected persons, or contact with 

equipment and other objects 

contaminated with infectious blood or 

tissues. The virus can spread between 

humans in close environments and 

through direct contact. A common route 

of infection is through nosocomial 

transmission. 

Marburgvirus was first recognized in 

1967, when outbreaks of hemorrhagic 

fever occurred simultaneously in 

laboratories in Marburg and Frankfurt, 

Germany and in Belgrade, Yugoslavia 

(now Serbia). Thirty-one people became 

ill, initially laboratory workers followed 

by several medical personnel and family 

members who had cared for them; seven 

deaths were reported. The first people 

infected had been exposed to imported 

African green monkeys or their tissues 

while conducting research. 

From 1975–2014, there have been 10 

reported outbreaks of Marburg disease, 

and all but one of these outbreaks had 

an apparent or suspected origin in 

Africa. These outbreaks have resulted in 

a total of 435 reported human cases of 

Marburg disease and 366 deaths among 

those reported cases; a case fatality rate 

of approximately of 84%. The recurrent 

but unpredictable and variable nature of 

Marburg disease outbreaks and the 

transmission profile makes 

marburgviruses a threat to the public 

health security of the American people, 

requiring vigilance and a continuing 

need for development of medical 

countermeasures. Similar to 

determinations and experiences with 

Ebola virus outbreaks, marburgvirus has 

been determined to have the potential to 

be a threat to US public health security. 

Description of This Declaration by 

Section 

Section I. Determination of Public 

Health Emergency or Credible Risk of 

Future Public Health Emergency 

Before issuing a Declaration under the 

PREP Act, the Secretary is required to 

determine that a disease or other health 

condition or threat to health constitutes 

a public health emergency or that there 

is a credible risk that the disease, 

condition, or threat may constitute such 

an emergency. 

This determination is separate and 

apart from the Declaration issued by the 

Secretary under Section 319 of the PHS 

Act that a disease or disorder presents 

a public health emergency or that a 

public health emergency, including 

significant outbreaks of infectious 

diseases or bioterrorist attacks, 

otherwise exists, or other Declarations 

or determinations made under other 

authorities of the Secretary. 

Accordingly, in Section I of the 

Declaration, the Secretary determines 

that marburgviruses and Marburg 

disease are a credible risk such that 

Marburg disease or marburgviruses may 

in the future constitute a public health 

emergency. 

Section II. Factors Considered by the 

Secretary 

In deciding whether and under what 

circumstances to issue a Declaration 

with respect to a Covered 

Countermeasure, the Secretary must 

consider 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 

countermeasure. In Section II of the 

Declaration, the Secretary states that he 

has considered these factors. 

Section III. Activities Covered by This 

Declaration Under the PREP Act’s 

Liability Immunity 

The Secretary must delineate the 

activities for which the PREP Act’s 

liability immunity is in effect. These 

activities may include, under conditions 

as the Secretary may specify, the 

manufacture, testing, development, 

distribution, administration, or use of 

one or more Covered Countermeasures 

(Recommended Activities). In Section 

III of the Declaration, the Secretary sets 

out the activities for which the 

immunity is in effect. 

Section IV. Limited Immunity 

The Secretary must also state that 

liability protections available under the 

PREP Act are in effect with respect to 

the Recommended Activities. These 

liability protections provide that, 

‘‘[s]ubject to other provisions of [the 

PREP Act], a covered person shall be 

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 to or use by an 

individual of a covered countermeasure 

if a Declaration has been issued with 

respect to such countermeasure.’’ In 

Section IV of the Declaration, the 

Secretary states that liability protections 

are in effect with respect to the 

Recommended Activities. 

Section V. Covered Persons 

The PREP Act’s liability immunity 

applies to ‘‘Covered Persons’’ with 

respect to administration or use of a 

Covered Countermeasure. The term 

‘‘Covered Persons’’ has a specific 

meaning and is defined in the PREP Act 

to include manufacturers, distributors, 

program planners, and qualified 

persons, and their officials, agents, and 

employees, and the United States. The 

PREP Act further defines the terms 

‘‘manufacturer,’’ ‘‘distributor,’’ 

‘‘program planner,’’ and ‘‘qualified 

person’’ as described below. 

A manufacturer includes a contractor 

or subcontractor of a manufacturer; a 

supplier or licenser of any product, 

intellectual property, service, research 

tool or component or other article used 

in the design, development, clinical 

testing, investigation or manufacturing 

of a Covered Countermeasure; and any 

or all the parents, subsidiaries, affiliates, 

successors, and assigns of a 

manufacturer. 

A distributor means a person or entity 

engaged in the distribution of drugs, 

biologics, or devices, including but not 

limited to: Manufacturers; re-packers; 

common carriers; contract carriers; air 

carriers; own-label distributors; privatelabel distributors; jobbers; brokers; 

warehouses and wholesale drug 

warehouses; independent wholesale 

drug traders; and retail pharmacies. 

A program planner means a state or 

local government, including an Indian 

tribe; a person employed by the state or 

local government; or other person who 

supervises or administers a program 


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with respect to the administration, 

dispensing, distribution, provision, or 

use of a Covered Countermeasure, 

including a person who establishes 

requirements, provides policy guidance, 

or supplies technical or scientific advice 

or assistance or provides a facility to 

administer or use a Covered 

Countermeasure in accordance with the 

Secretary’s Declaration. Under this 

definition, a private sector employer or 

community group or other ‘‘person’’ can 

be a program planner when it carries out 

the described activities. 

A qualified person means a licensed 

health professional or other individual 

authorized to prescribe, administer, or 

dispense Covered Countermeasures 

under the law of the state in which the 

Covered Countermeasure was 

prescribed, administered, or dispensed; 

or a person within a category of persons 

identified as qualified in the Secretary’s 

Declaration. Under this definition, the 

Secretary can describe in the 

Declaration other qualified persons, 

such as volunteers, who are Covered 

Persons. Section V describes other 

qualified persons covered by this 

Declaration. The PREP Act also defines 

the word ‘‘person’’ as used in the Act: 

A person includes an individual, 

partnership, corporation, association, 

entity, or public or private corporation, 

including a federal, state, or local 

government agency or department. 

Section V of the Declaration describes 

Covered Persons, including Qualified 

Persons. The Declaration includes all 

persons and entities defined as Covered 

Persons under the PREP Act. 

Section VI. Covered Countermeasures 

As noted above, Section III of the 

Declaration describes the activities 

(referred to as ‘‘Recommended 

Activities’’) for which liability 

immunity is in effect. Section VI of the 

Declaration identifies the Covered 

Countermeasures for which the 

Secretary has recommended such 

activities. The PREP Act states that a 

‘‘Covered Countermeasure’’ must be a 

‘‘qualified pandemic or epidemic 

product,’’ or a ‘‘security 

countermeasure,’’ as described 

immediately below; a drug, biological 

product or device authorized for 

emergency use in accordance with 

Sections 564, 564A, or 564B of the 

FD&C Act; or respiratory protective 

devices approved by the National 

Institute for Occupational Safety and 

Health (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. 

A qualified pandemic or epidemic 

product means a drug or device, as 

defined in the FD&C Act or a biological 

product, as defined in the PHS Act that 

is (i) Manufactured, used, designed, 

developed, modified, licensed or 

procured to diagnose, mitigate, prevent, 

treat, or cure a pandemic or epidemic or 

limit the harm such a pandemic or 

epidemic might otherwise cause; (ii) 

manufactured, used, designed, 

developed, modified, licensed, or 

procured to diagnose, mitigate, prevent, 

treat, or cure a serious or lifethreatening disease or condition caused 

by such a drug, biological product, or 

device; (iii) or a product or technology 

intended to enhance the use or effect of 

such a drug, biological product, or 

device. 

A security countermeasure is a drug 

or device, as defined in the FD&C Act 

or a biological product, as defined in the 

PHS Act that (i)(a) The Secretary 

determines to be a priority to diagnose, 

mitigate, prevent, or treat harm from any 

biological, chemical, radiological, or 

nuclear agent identified as a material 

threat by the Secretary of Homeland 

Security, or (b) to diagnose, mitigate, 

prevent, or treat harm from a condition 

that may result in adverse health 

consequences or death and may be 

caused by administering a drug, 

biological product, or device against 

such an agent; and (ii) is determined by 

the Secretary of Health and Human 

Services to be a necessary 

countermeasure to protect public health. 

To be a Covered Countermeasure, 

qualified pandemic or epidemic 

products or security countermeasures 

also must be approved or cleared under 

the FD&C Act; approved by the National 

Institute for Occupational Safety and 

Health (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; licensed under the PHS Act; or 

authorized for emergency use under 

Sections 564, 564A, or 564B of the 

FD&C Act. 

A qualified pandemic or epidemic 

product also may be a Covered 

Countermeasure when it is subject to an 

exemption (that is, it is permitted to be 

used under an Investigational Drug 

Application or an Investigational Device 

Exemption) under the FD&C Act and is 

the object of research for possible use 

for diagnosis, mitigation, prevention, 

treatment, or cure, or to limit harm of 

a pandemic or epidemic or serious or 

life-threatening condition caused by 

such a drug or device. 

A security countermeasure also may 

be a Covered Countermeasure if it may 

reasonably be determined to qualify for 

approval or licensing within 10 years 

after the Department’s determination 

that procurement of the countermeasure 

is appropriate. 

Section VI lists countermeasures 

against marburgvirus and/or Marburg 

disease that are Covered 

Countermeasures under this declaration. 

Section VI also refers to the statutory 

definitions of Covered Countermeasures 

to make clear that these statutory 

definitions limit the scope of Covered 

Countermeasures. Specifically, the 

Declaration notes that Covered 

Countermeasures must be ‘‘qualified 

pandemic or epidemic products,’’ or 

‘‘security countermeasures,’’ or drugs, 

biological products, respiratory 

protective devices, or devices 

authorized for investigational or 

emergency use, as those terms are 

defined in the PREP Act, the FD&C Act, 

and the Public Health Service Act. 

Section VII. Limitations on Distribution 

The Secretary may specify that 

liability immunity is in effect only to 

Covered Countermeasures obtained 

through a particular means of 

distribution. The Declaration states that 

liability immunity is afforded to 

Covered Persons for Recommended 

Activities related to (a) Present or future 

federal contracts, cooperative 

agreements, grants, other transactions, 

interagency agreements, or memoranda 

of understanding or other federal 

agreements; or (b) 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 an 

emergency. 

Section VII defines the terms 

‘‘Authority Having Jurisdiction’’ and 

‘‘Declaration of an emergency.’’ We have 

specified in the definition that 

Authorities having jurisdiction include 

federal, state, local, and tribal 

authorities and institutions or 

organizations acting on behalf of those 

governmental entities. 

For governmental program planners 

only, liability immunity is afforded only 

to the extent they obtain Covered 

Countermeasures through voluntary 

means, such as (1) donation; (2) 

commercial sale; (3) deployment of 

Covered Countermeasures from federal 

stockpiles; or (4) deployment of 

donated, purchased, or otherwise 

voluntarily obtained Covered 

Countermeasures from state, local, or 

private stockpiles. This last limitation 

on distribution is intended to deter 

program planners that are government 


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entities from seizing privately held 

stockpiles of Covered Countermeasures. 

It does not apply to any other Covered 

Persons, including other program 

planners who are not government 

entities. 

Section VIII. Category of Disease, Health 

Condition, or Threat 

The Secretary must identify in the 

Declaration, for each Covered 

Countermeasure, the categories of 

diseases, health conditions, or threats to 

health for which the Secretary 

recommends the administration or use 

of the countermeasure. In Section VIII of 

the Declaration, the Secretary states that 

the disease threat for which he 

recommends administration or use of 

the Covered Countermeasures is 

Marburg disease caused by 

marburgviruses or virus mutating 

therefrom. 

Section IX. Administration of Covered 

Countermeasures 

The PREP Act does not explicitly 

define the term ‘‘administration’’ but 

does assign the Secretary the 

responsibility to provide relevant 

conditions in the Declaration. In Section 

IX of the Declaration, the Secretary 

defines ‘‘Administration of a Covered 

Countermeasure,’’ as follows: 

Administration of a 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 purpose of 

distributing and dispensing countermeasures. 

The definition of ‘‘administration’’ 

extends only to physical provision of a 

countermeasure to a recipient, such as 

vaccination or handing drugs to 

patients, and to activities related to 

management and operation of programs 

and locations for providing 

countermeasures to recipients, such as 

decisions and actions involving security 

and queuing, but only insofar as those 

activities directly relate to the 

countermeasure activities. Claims for 

which Covered Persons are provided 

immunity under the Act are losses 

caused by, arising out of, relating to, or 

resulting from the administration to or 

use by an individual of a Covered 

Countermeasure consistent with the 

terms of a Declaration issued under the 

Act. Under the definition, these liability 

claims are precluded if they allege an 

injury caused by a countermeasure, or if 

the claims are due to manufacture, 

delivery, distribution, dispensing, or 

management and operation of 

countermeasure programs at 

distribution and dispensing sites. 

Thus, it is the Secretary’s 

interpretation that, when a Declaration 

is in effect, the Act precludes, for 

example, liability claims alleging 

negligence by a manufacturer in creating 

a vaccine, or negligence by a health care 

provider in prescribing the wrong dose, 

absent willful misconduct. Likewise, the 

Act precludes a liability claim relating 

to the management and operation of a 

countermeasure distribution program or 

site, such as a slip-and-fall injury or 

vehicle collision by a recipient receiving 

a countermeasure at a retail store 

serving as an administration or 

dispensing location that alleges, for 

example, lax security or chaotic crowd 

control. However, a liability claim 

alleging an injury occurring at the site 

that was not directly related to the 

countermeasure activities is not 

covered, such as a slip and fall with no 

direct connection to the 

countermeasure’s administration or use. 

In each case, whether immunity is 

applicable will depend on the particular 

facts and circumstances. 

Section X. Population 

The Secretary must identify, for each 

Covered Countermeasure specified in a 

Declaration, the population or 

populations of individuals for which 

liability immunity is in effect with 

respect to administration or use of the 

countermeasure. Section X of the 

Declaration identifies which individuals 

should use the countermeasure or to 

whom the countermeasure should be 

administered—in short, those who 

should be vaccinated or take a drug or 

other countermeasure. Section X 

provides that the population includes 

‘‘any individual who uses or who is 

administered a Covered Countermeasure 

in accordance with the Declaration.’’ 

It should be noted that under the 

PREP Act, liability protection extends 

beyond the Population specified in the 

Declaration. Specifically, liability 

immunity is afforded (1) To 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered to this 

population, and (2) to program planners 

and qualified persons when the 

countermeasure is either used by or 

administered to this population or the 

program planner or qualified person 

reasonably could have believed the 

recipient was in this population. 

Section X of the Declaration includes 

these statutory conditions in the 

Declaration for clarity. 

Section XI. Geographic Area 

The Secretary must identify, for each 

Covered Countermeasure specified in 

the Declaration, the geographic area or 

areas for which liability immunity is in 

effect, including, as appropriate, 

whether the Declaration applies only to 

individuals physically present in the 

area or, in addition, applies to 

individuals who have a described 

connection to the area. Section XI of the 

Declaration provides that liability 

immunity is afforded for the 

administration or use of a Covered 

Countermeasure without geographic 

limitation. This could include claims 

related to administration or use in 

countries outside the U.S. It is possible 

that claims may arise in regard to 

administration or use of the Covered 

Countermeasures outside the U.S. that 

may be resolved under U.S. law. 

In addition, the PREP Act specifies 

that liability immunity is afforded (1) to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered to individuals 

in the geographic areas, and (2) to 

program planners and qualified persons 

when the countermeasure is either used 

or administered in the geographic areas 

or the program planner or qualified 

person reasonably could have believed 

the countermeasure was used or 

administered in the areas. Section XI of 

the Declaration includes these statutory 

conditions in the Declaration for clarity. 

Section XII. Effective Time Period 

The Secretary must identify, for each 

Covered Countermeasure, the period or 

periods during which liability immunity 

is in effect, designated by dates, 

milestones, or other description of 

events, including factors specified in the 

PREP Act. Section XII of the Declaration 

extends the effective period for different 

means of distribution of Covered 

Countermeasures through August 1, 

2025. 

Section XIII. Additional Time Period of 

Coverage 

The Secretary must specify a date 

after the ending date of the effective 

time period of the Declaration that is 

reasonable for manufacturers to arrange 

for disposition of the Covered 

Countermeasure, including accepting 

returns of Covered Countermeasures, 

and for other Covered Persons to take 

appropriate actions to limit 

administration or use of the Covered 

Countermeasure. In addition, the PREP 

Act specifies that, for Covered 

Countermeasures that are subject to a 

Declaration at the time they are obtained 

for the Strategic National Stockpile 


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1See, e.g., Advisory Opinion on the Public 

Readiness and Emergency Preparedness Act and the 

March 10, 2020 Declaration under the Act, Apr. 17, 

2020, as Modified on May 19, 2020, available at 

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

hhs-guidance-documents/prep-act-advisoryopinion-hhs-ogc.pdf (last visited Nov. 24, 2020); 

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 Nov. 24, 2020); Advisory Opinion 20–03 on 

the Public Readiness and Emergency Preparedness 

Act and the Secretary’s Declaration under the Act, 

Oct. 22, 2020, as Modified on Oct. 23, 2020, 

available at https://www.hhs.gov/guidance/sites/ 

default/files/hhs-guidance-documents/AO3.1.2_

Updated_FINAL_SIGNED_10.23.20.pdf (last visited 

Nov. 24, 2020); Advisory Opinion 20–04 on the 

Public Readiness and Emergency Preparedness Act 

and the Secretary’s Declaration under the Act, Oct. 

22, 2020, as Modified on Oct. 23, 2020, available 

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

hhs-guidance-documents/AO%204.2_Updated_

FINAL_SIGNED_10.23.20.pdf (last visited Nov. 24, 

2020). This is not to suggest that other PREP Act 

declarations should be construed in a manner 

contrary to the interpretation provided in the 

Advisory Opinions. 

(SNS) under 42 U.S.C. 247d–6b(a), the 

effective period of the Declaration 

extends through the time the 

countermeasure is used or administered. 

Liability immunity under the provisions 

of the PREP Act and the conditions of 

the Declaration continue during these 

additional time periods. Thus, liability 

immunity is afforded during the 

‘‘Effective Time Period,’’ described 

under Section XII of the Declaration, 

plus the ‘‘Additional Time Period’’ 

described under Section XIII of the 

Declaration. 

Section XIII of the Declaration 

provides for 12 months as the 

Additional Time Period of coverage 

after expiration of the Declaration. 

Section XIII also explains the extended 

coverage that applies to any product 

obtained for the SNS during the 

effective period of the Declaration. 

Section XIV. Countermeasures Injury 

Compensation Program 

Section 319F–4 of the PHS Act, 42 

U.S.C. 247d–6e, authorizes the 

Countermeasures Injury Compensation 

Program (CICP) to provide benefits to 

eligible individuals who sustain a 

serious physical injury or die as a direct 

result of the administration or use of a 

Covered Countermeasure. 

Compensation under the CICP for an 

injury directly caused by a Covered 

Countermeasure is based on the 

requirements set forth in this 

Declaration, the administrative rules for 

the Program, and the statute. To show 

direct causation between a Covered 

Countermeasure and a serious physical 

injury, the statute requires ‘‘compelling, 

reliable, valid, medical and scientific 

evidence.’’ The administrative rules for 

the Program further explain the 

necessary requirements for eligibility 

under the CICP. Please note that, by 

statute, requirements for compensation 

under the CICP may not align with the 

requirements for liability immunity 

provided under the PREP Act. Section 

XIV of the Declaration, 

‘‘Countermeasures Injury Compensation 

Program,’’ explains the types of injury 

and standard of evidence needed to be 

considered for compensation under the 

CICP. 

Further, the administrative rules for 

the CICP specify that if countermeasures 

are administered or used outside the 

United States, only otherwise eligible 

individuals at United States embassies, 

military installations abroad (such as 

military bases, ships, and camps) or at 

North Atlantic Treaty Organization 

(NATO) installations (subject to the 

NATO Status of Forces Agreement) 

where American servicemen and 

servicewomen are stationed may be 

considered for CICP benefits. Other 

individuals outside the United States 

may not be eligible for CICP benefits. 

Section XV. Amendments 

Section XV of the Declaration 

confirms that the Secretary may amend 

any portion of this Declaration through 

publication in the Federal Register. 

Declaration 

Declaration for Public Readiness and 

Emergency Preparedness Act Coverage 

for Countermeasures Against 

Marburgvirus and/or Marburg Disease 

I. Determination of Public Health 

Emergency 

42 U.S.C. 247d–6d(b)(1) 

I have determined that Marburg 

disease and marburgviruses are a 

credible risk such that Marburg disease 

or marburgviruses may in the future 

constitute a public health emergency. 

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.1 This Declaration is a 

‘‘requirement’’ under the PREP Act. 

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 Immunity 

42 U.S.C. 247d–6d(a), 247d–6d(b)(1) 

Liability immunity as prescribed in 

the PREP Act and conditions stated in 

this Declaration is 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, 

agents, and employees, as those terms 

are defined in the PREP Act, and the 

United States. 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; (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; and (c) 

any person authorized to prescribe, 

administer, or dispense Covered 

Countermeasures in accordance with 

Section 564A of the FD&C Act. 

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 any 

antiviral, any other drug, any biologic, 

any diagnostic, any other device, or any 

vaccine, used to treat, diagnose, cure, 

prevent, or mitigate Marburg disease, or 

the transmission of marburgviruses or a 

virus mutating therefrom, or any device 

used in the administration of any such 

product, and all components and 

constituent materials of any such 

product, or countermeasures for adverse 

effects of these countermeasures, and 


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Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 79203 

countermeasures that otherwise limit 

the harm caused by the health threat. 

Covered Countermeasures must be 

‘‘qualified pandemic or epidemic 

products,’’ or ‘‘security 

countermeasures,’’ or drugs, biological 

products, respiratory protective devices 

or devices authorized for investigational 

or emergency use, as those terms are 

defined in the PREP Act, the FD&C Act, 

and the Public Health Service Act. 

VII. Limitations on Distribution 

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

I have determined that liability 

immunity is afforded to Covered 

Persons only for Recommended 

Activities involving Covered 

Countermeasures that are related to: 

(a) Present or future federal contracts, 

cooperative agreements, grants, other 

transactions, interagency agreements, 

memoranda of understanding, or other 

federal agreements; or 

(b) 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 an 

emergency. 

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 immunity is afforded only to 

the extent such program planners obtain 

Covered Countermeasures through 

voluntary means, such as (1) donation; 

(2) commercial sale; (3) deployment of 

Covered Countermeasures from federal 

stockpiles; or (4) 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 

Marburg disease caused by 

marburgviruses or virus mutating 

therefrom. 

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 purpose of distributing and 

dispensing countermeasures. 

X. Population 

42 U.S.C. 247d–6d(a)(4), 247d– 

6d(b)(2)(C) 

The populations of individuals 

include any individual who uses or is 

administered the Covered 

Countermeasures in accordance with 

this Declaration. 

Liability immunity is afforded to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered to this 

population; liability immunity is 

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 immunity is afforded for the 

administration or use of a Covered 

Countermeasure without geographic 

limitation. 

Liability immunity is afforded to 

manufacturers and distributors without 

regard to whether the countermeasure is 

used by or administered in any 

designated geographic area; liability 

immunity is 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. 

XII. Effective Time Period 

42 U.S.C. 247d–6d(b)(2)(B) 

Liability immunity for Covered 

Countermeasures through means of 

distribution, as identified in Section 

VII(a) of this Declaration, other than in 

accordance with the public health and 

medical response of the Authority 

Having Jurisdiction and extends through 

August 1, 2025. 

Liability immunity for Covered 

Countermeasures administered and 

used in accordance with the public 

health and medical response of the 

Authority Having Jurisdiction begins 

with a Declaration and lasts through (1) 

the final day the emergency Declaration 

is in effect, or (2) August 1, 2025, 

whichever occurs first. 

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 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. 

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 


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79204 Federal Register / Vol. 85, No. 237 / Wednesday, December 9, 2020 / Notices 

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 2, 2020. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2020–26972 Filed 12–8–20; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Amended Notice 

of Meeting 

Notice is hereby given of a change in 

the meeting of the Advisory Committee 

to the Director, National Institutes of 

Health, December 10, 12:00 p.m. to 

December 11, 05:00 p.m. National 

Institutes of Health, Building 1, Wilson 

Hall, 1 Center Drive, Bethesda, MD, 

20892 (Virtual Meeting) which was 

published in the Federal Register on 

11/30/2020, 85 FR 76590. 

The meeting notice is amended to 

change the meeting start time on 

December 10, 2020 from 12:00 p.m. to 

12:30 p.m. The meeting is open to the 

public. 

Dated: December 4, 2020. 

Natasha M. Copeland, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–27055 Filed 12–8–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Notice of Issuance of Final 

Determination Concerning Three 

Vehicle Tracking Devices, a Satellite 

Device, an NFC Reader, and an NFC 

Keyring FOB 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of final determination. 

SUMMARY: This document provides 

notice that U.S. Customs and Border 

Protection (CBP) has issued a final 

determination concerning the country of 

origin of three vehicle tracking devices, 

a satellite device, a near field 

communication (NFC) reader, and an 

NFC keyring fob. Based upon the facts 

presented, CBP has concluded that the 

country of origin of the three vehicle 

tracking devices, the satellite device, 

and the NFC reader is Canada for 

purposes of U.S. Government 

procurement. The country of origin of 

the NFC keyring fob will be determined 

by the country of origin of the 

contactless integrated circuit (IC), which 

is usually Taiwan, but if unavailable, 

then either Thailand or Singapore will 

be the source country and the country 

of origin for purposes of U.S. 

Government procurement. 

DATES: The final determination was 

issued on November 25, 2020. A copy 

of the final determination is attached. 

Any party-at-interest, as defined in 19 

CFR 177.22(d), may seek judicial review 

of this final determination within 

January 8, 2021. 

FOR FURTHER INFORMATION CONTACT: Beth 

Jenior, Valuation and Special Programs 

Branch, Regulations and Rulings, Office 

of Trade, at (202) 325–0347. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that on November 25, 

2020, pursuant to subpart B of part 177, 

U.S. Customs and Border Protection 

Regulations (19 CFR part 177, subpart 

B), CBP issued a final determination 

concerning the country of origin of three 

vehicle tracking devices, one satellite 

device, one NFC reader, and one NFC 

keyring fob imported by Geotab USA, 

Inc. (Geotab), which may be offered to 

the U.S. Government under an 

undesignated government procurement 

contract. This final determination, 

Headquarters Ruling Letter H309128, 

was issued under procedures set forth at 

19 CFR part 177, subpart B, which 

implements Title III of the Trade 

Agreements Act of 1979, as amended 

(19 U.S.C. 2511–18). In the final 

determination, CBP concluded that the 

country of origin of the three vehicle 

tracking devices, the satellite device, 

and the NFC reader is Canada for 

purposes of U.S. Government 

procurement. Regarding the NFC 

keyring fob, CBP concluded that the 

country of origin will be the country 

where the contactless integrated circuit 

is manufactured. In most cases, this will 

be Taiwan, but if the contactless 

integrated circuit cannot be sourced 

there, then it will be sourced from either 

Thailand or Singapore, and the 

corresponding sourcing country would 

then be the country of origin for 

purposes of U.S. Government 

procurement. 

Section 177.29, CBP Regulations (19 

CFR 177.29), provides that a notice of 

final determination shall be published 

in the Federal Register within 60 days 

of the date the final determination is 

issued. Section 177.30, CBP Regulations 

(19 CFR 177.30), provides that any 

party-at-interest, as defined in 19 CFR 

177.22(d), may seek judicial review of a 

final determination within 30 days of 

publication of such determination in the 

Federal Register. 

Dated: November 25, 2020. 

Alice A. Kipel, 

Executive Director, Regulations and Rulings, 

Office of Trade. 

HQ H309128 

November 25, 2020 

OT:RR:CTF:VS H309128 EGJ 

CATEGORY: Origin 

Mr. James Lay 

Geotab USA, Inc. 

770 E Pilot Rd., Suite A 

Las Vegas, NV 89119 

Re: U.S. Government Procurement; 

Country of Origin of Three Vehicle 

Tracking Devices, Satellite Device, NFC 

Reader, and NFC Keyring Fob; 

Substantial Transformation 

Dear Mr. Lay 

This is in response to your ruling 

request, dated February 6, 2020, 

requesting a final determination on 

behalf of Geotab USA, Inc. (‘‘Geotab’’) 

pursuant to subpart B of Part 177 of the 

U.S. Customs and Border Protection 

(‘‘CBP’’) Regulations (19 CFR part 177). 

This final determination concerns the 

country of origin of three vehicle 

tracking devices, one satellite device, 

one near field communication (‘‘NFC’’) 

reader, and one NFC identification 

keyring fob. As a U.S. importer, Geotab 

is a party-at-interest within the meaning 

of 19 CFR 177.22(d)(1) and is entitled to 

request this final determination. 

Facts 

Geotab is a technology company 

which designs and imports vehicle 

tracking systems, and has submitted six 

different products for our review. The 

products’ descriptions, pictures, and 

manufacturing processes are set forth 

below. 

Product Descriptions 

The first three products are telematics 

devices, which are designed to transmit 

vehicle tracking information over long 

distances. Specifically, the three 

products are: 


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