[Federal Register Volume 85, Number 237 (Wednesday, December 9, 2020)]
[Notices]
[Pages 79198-79204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26972]


-----------------------------------------------------------------------

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

[[Page 79199]]

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; private-label 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

[[Page 79200]]

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 life-threatening 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

[[Page 79201]]

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

[[Page 79202]]

(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.
---------------------------------------------------------------------------

    \1\ See, 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-advisory-opinion-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.
---------------------------------------------------------------------------

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

[[Page 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

[[Page 79204]]

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