Ebola Virus Disease Therapeutics-Amendment, 757-763 [2019-00261]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Office of the Secretary

[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 757-763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Ebola Virus Disease Therapeutics--Amendment

ACTION: Notice of Amendment to the February 27, 2015, Declaration under 
the Public Readiness and Emergency Preparedness Act for Ebola Virus 
Disease Therapeutics, as amended.

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SUMMARY: The Secretary is amending the February 27, 2015, Declaration 
issued pursuant to the Public Health Service Act, amended December 9, 
2015 and December 2, 2016, to update the term ``Ebola Virus Disease'' 
to ``Ebola disease'' (EBOD) throughout the declaration and to clarify 
the definition of EBOD. The amendment also expands the Covered 
Countermeasures beyond the single therapeutic listed in prior 
declarations but limit coverage to Covered Countermeasures that are 
directly supported by the United States (U.S.) Federal Government, 
consistent with the terms of the Declaration, and is republishing the 
Declaration in its entirety as amended.

DATES: The Amended Declaration is applicable beginning December 1, 
2018.

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 Secretary is amending the February 27, 
2015, Declaration issued pursuant to the Public Health Service Act, 
amended December 9, 2015 (80 FR 76536) and December 2, 2016, (81 FR 
89476) to extend the effective time period through December 31, 2023; 
to update the term ``Ebola Virus Disease'' to ``Ebola disease'' (EBOD) 
throughout the declaration and to clarify the definition of EBOD; and 
to expand the Covered Countermeasures beyond the single therapeutic 
listed in prior declarations but limit coverage to Covered 
Countermeasures that are directly supported by the United States (U.S.) 
Federal Government, consistent with the terms of the Declaration, and 
is republishing the Declaration in its entirety as amended.
    The Public Readiness and Emergency Preparedness Act (PREP Act) 
authorizes the Secretary of Health and Human Services to issue a 
Declaration to

[[Page 758]]

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 administration or use of medical 
countermeasures (Covered Countermeasures), except for claims that meet 
the PREP Act's definition of willful misconduct. The Secretary may, 
through publication in the Federal Register, amend any portion of a 
Declaration. Using this authority, the Secretary is amending the 
Declaration that provides liability immunity to Covered Persons for 
activities related to the
    Covered Countermeasures, EBOD therapeutics as listed in Section VI 
of the Declaration to extend the effective time period through December 
31, 2023; to update the term used to identify the disease and clarify 
the definition of ``Ebola disease''; and to expand the Covered 
Countermeasures beyond the single therapeutic listed in prior 
declarations but limit coverage to Covered Countermeasures that are 
directly supported by the U.S. Federal Government, consistent with the 
terms of this Declaration.
    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 in the U.S. Code as 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 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 products.
    Ebola disease is a severe and often fatal illness in humans caused 
by several highly virulent viruses that are members of the family 
Filoviridae. Disease in people has been observed due to four viruses 
classified in a filoviral genus currently called Ebolavirus--Bundibugyo 
virus, Ebola virus, Sudan virus, and Ta[iuml] Forest virus. With an 
average EBOD case fatality rate of around 42 percent, ebolaviruses pose 
a high risk to public health and national security.
    From 2013 to 2016, Western Africa experienced the largest EBOD 
outbreak since the first two ebolaviruses (Ebola virus and Sudan virus) 
were discovered in 1976, and the unprecedented size of the outbreak 
complicated global health response. The outbreak affected populations 
in multiple Western African countries and travelers from Western Africa 
to the U.S. and other countries. The World Health Organization (WHO) 
declared the EBOD outbreak as a Public Health Emergency of 
International Concern under the framework of the International Health 
Regulations (2005). In March 2016, WHO determined that the EBOD 
outbreak no longer constituted a Public Health Emergency of 
International Concern but emphasized the crucial need for continued 
support to prevent, detect, and respond rapidly to any new EBOD 
outbreak in Western Africa. During the 2013 to 2016 outbreak widespread 
transmission was limited to Western African countries; however, 
ebolaviruses present a real threat to national security, because the 
U.S. experienced travel-associated cases of EBOD diagnosed within U.S. 
borders and transmission to health care workers within U.S. borders. 
The recurrent but unpredictable and variable nature of EBOD outbreaks 
and the transmission profile make ebolaviruses threats to the public 
health security of the American people, requiring vigilance and a 
continuing need for development of medical countermeasures.
    Ebola disease is an ongoing public health risk, as the Democratic 
Republic of the Congo (COD) continues to experience EBOD outbreaks and 
there is a risk of extension to surrounding countries. Days after 
announcing the end of the outbreak of EBOD from April to July of 2018 
in COD's [Eacute]quateur Province, the COD Ministry of Health declared 
a new EBOD outbreak in Nord-Kivu Province on August 1, 2018. The 
Ministry of Health, WHO and U.S. Government partners are responding to 
this incident as new cases occur across the densely populated province. 
As demonstrated by the 2013-2016 EBOD outbreak, that resulted in 
disease in several Americans including transmission within the U.S., 
the risk to the U.S. population from EBOD outbreaks in Africa presents 
a national health security issue. Thus, there is a continuing need for 
development of therapeutics against EBOD.
    Unless otherwise noted, all statutory citations below are to the 
U.S. Code.
    To be consistent with the most current World Health Organization 
International Classification of Diseases, the Secretary is amending the 
declaration throughout to use the term EBOD to refer to the disease, 
health condition or threat to health that constitutes or may constitute 
a public health emergency. This change in terminology is not intended 
to have any substantive effect on coverage under the amended 
Declaration.

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 in the 
future constitute such an emergency. This determination is separate and 
apart from a 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, the Secretary 
determines that there is a credible risk that the spread of 
ebolaviruses and the resulting disease may constitute a public health 
emergency.
    In section I, the Secretary also amends the Declaration to clarify 
the definition of Ebola disease, providing that for the purposes of 
this Declaration, Ebola disease (EBOD) is defined as the illness 
resulting from infection by the following viruses of the filoviral 
Ebolavirus genus:

 Bundibugyo virus
 Ebola virus
 Sudan virus
 Ta[iuml] Forest virus
 ebolaviruses with undefined pathogenicity in humans

    This amendment is intended to clarify that the Declaration covers 
EBOD and all therapeutics against viruses and variants of all viruses 
of the Ebolavirus

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genus consistent with the terms of the Declaration.

Section II. Factors Considered

    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, the Secretary states that he has 
considered these factors.

Section III. Recommended Activities

    The Secretary must recommend 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, the Secretary recommends activities for which the immunity is in 
effect under the conditions stated in the Declaration. The Secretary is 
amending the Declaration to remove the condition that Recommended 
Activities only include those that relate to clinical trials permitted 
to proceed after review by the Food and Drug Administration (FDA) that 
administer or use the Covered Countermeasure under an investigational 
new drug application (IND). This amendment continues that coverage, and 
expands liability immunity beyond activities related to clinical trials 
permitted to proceed after review by the FDA, that administer or use 
the Covered Countermeasure under an IND. Section VI of the Declaration 
retains the limitation that Covered Countermeasures are limited to 
those activities involving Covered Countermeasures directly supported 
by the U.S. Federal Government.

Section IV. Liability 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, 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 
U.S. 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 of the 
parents, subsidiaries, affiliates, successors, and assigns of a 
manufacturer.
    A distributor means a person or entity engaged in the distribution 
of drug, biologics, or devices, including but not limited to: 
Manufacturers; repackers; 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 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 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 describes Covered 
Persons under the Declaration, including Qualified Persons.
    The Secretary is amending the Declaration to include the following 
as qualified persons: (a) Any person authorized in accordance with the 
public health and medical emergency response of the Authority Having 
Jurisdiction, 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. In addition, the 
Secretary is amending the declaration to remove the following category 
of qualified persons: Any person authorized to prescribe, administer, 
or dispense the Covered Countermeasures or who is otherwise authorized 
to perform an activity to carry out clinical trials permitted to 
proceed after FDA review that administer or use the Covered 
Countermeasure under an IND and that are directly supported by the U.S. 
These changes are intended to expand qualified persons to those who may 
administer Covered Countermeasures directly supported by the U.S. 
Federal Government in an emergency response, or under an Emergency Use 
Authorization issued by the FDA or other emergency authority of the 
FDA, and to any individuals carrying out activities under clinical 
trials within the scope of the statutory definitions provided in this 
section that involve countermeasures directly supported by the U.S.

Section VI. Covered Countermeasures

    As noted above, section III describes the Secretary's Recommended 
Activities

[[Page 760]]

for which liability immunity is in effect. Section VI identifies the 
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; or a drug, biological 
product or device authorized for emergency use in accordance with 
sections 564, 564A, or 564B of the FD&C 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; 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 the EBOD therapeutics that are Covered 
Countermeasures. The Secretary is expanding the types of Covered 
Countermeasures covered under this Declaration to include classes or 
categories of therapeutics for mitigation or treatment of EBOD as 
defined in section I of this Declaration, including all components and 
constituent materials of these therapeutics, and all devices and their 
constituent components used in the administration of these 
therapeutics.
    This change is intended to expand the types of EBOD therapeutics 
that are included as Covered Countermeasures consistent with the terms 
of this Declaration, including the limitations stated in the Section 
VII of this Declaration. The Declaration continues coverage for EBOD 
therapeutics previously covered under this declaration, ZMapp[supreg] 
monoclonal antibody therapeutic, and extends coverage to encompass all 
categories of EBOD therapeutics.
    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, or devices authorized for investigational or emergency use, 
as those terms are defined in the PREP Act, the FD&C Act, and the PHS 
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 Secretary is amending the Declaration to state that 
liability immunity is afforded to Covered Persons for Recommended 
Activities involving Covered Countermeasures that are directly 
supported by the U.S. Federal Government through past, present or 
future federal contracts, cooperative agreements, grants, other 
transactions, interagency agreements, or memoranda of understanding or 
other federal agreements or arrangements. The Secretary defines the 
term ``directly support'' to mean that the U.S. has provided some form 
of tangible support such as supplies, funds, products, technical 
assistance, or staffing.
    This amendment is intended to expand liability immunity beyond the 
prior limitation to activities that are related to clinical trials 
permitted to proceed after FDA review that administer or use the 
Covered Countermeasure under an IND, but the amendment retains the 
limitation that the activities must be directly supported by the U.S. 
Federal Government as described and defined in this section.

Section VIII. Category of Disease, Health Condition, or Threat

    The Secretary must identify, 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, the Secretary states that the disease 
threat for which he recommends administration or use of the Covered 
Countermeasures is EBOD.

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, the Secretary defines 
``Administration of a Covered Countermeasure'':
    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

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use by an individual of a Covered Countermeasure consistent with Act. 
Under the Secretary's definition; these liability claims are precluded 
if the claims allege an injury caused by physical provision of a 
countermeasure to a recipient, or if the claims are directly due to 
conditions of 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 therapeutic, 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. This section explains 
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.''
    In addition, the PREP Act specifies that liability immunity is 
afforded to manufacturers and distributors without regard to whether 
the countermeasure is used by or administered to this population and 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 includes these statutory 
conditions in the Declaration for clarity.

Section X. 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 with respect to administration or use 
of the countermeasure, 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 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 Africa or other locations 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 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 identifies the 
effective time period. Section XII is amended to extend the effective 
time period to December 31, 2023.

Section XIII. Additional Time Period of Coverage

    The Secretary must specify a date after the ending date of the 
effective period of the Declaration that is reasonable for 
manufacturers to arrange for disposition of the Covered Countermeasure, 
including return of the product to the manufacturer, 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 (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 
pursuant to a distribution or release from the SNS. Liability immunity 
under the provisions of the PREP Act and the conditions of the 
Declaration continues during these additional time periods. Thus, 
liability immunity is afforded during the ``Effective Time Period,'' 
described under XII of the Declaration, plus the ``Additional Time 
Period'' described under section XIII of the Declaration.
    Section XIII 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 products obtained for 
the SNS during the effective period of the Declaration.

Section XIV. Countermeasures Injury Compensation Program

    Section 319F-4 of the PREP Act 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 always align with the requirements 
for liability immunity provided under the PREP Act. Section XIV, 
``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 U.S., only 
otherwise eligible individuals at American embassies, military 
installations abroad (such as military bases, ships, and camps) or at 
North Atlantic Treaty Organization (NATO) installations (subject to the 
NATO

[[Page 762]]

Status of Forces Agreement) where American servicemen and servicewomen 
are stationed may be considered for CICP benefits. Other individuals 
outside the U.S. may not be eligible for CICP benefits.

Section XV. Amendments

    This is the third amendment to the February 27, 2015, Declaration 
(80 FR 73314). The first amendment was issued December 9, 2015 (80 FR 
76536), the second amendment was issued December 2, 2016 (81 FR 89476). 
The Secretary may amend any portion of a Declaration through 
publication in the Federal Register.

Republished Declaration

Declaration, as Amended, Public Readiness and Emergency Preparedness 
Act Coverage for Ebola Disease Therapeutics

    This Declaration amends and republishes the February 27, 2015 for 
coverage under the Public Readiness and Emergency Preparedness (PREP) 
Act for Ebola Disease Therapeutics, as amended December 9, 2015 and 
December 2, 2016. To the extent any term of the February 27, 2015 
Declaration, as amended on December 9, 2015 and December 2, 2016, is 
inconsistent with any provision of this Republished Declaration, the 
terms of this Republished Declaration are controlling.

I. Determination of Public Health Emergency or Credible Risk of Future 
Public Health Emergency

42 U.S.C. 247d-6d(b)(1)

    I have determined that there is a credible risk that the spread of 
ebolaviruses and the resulting disease or conditions, constituting EBOD 
may in the future constitute a public health emergency. For the 
purposes of this Declaration, EBOD is the illness resulting from 
infection by viruses of any of the following viruses of the Ebolavirus 
genus:

 Bundibugyo virus
 Ebola virus
 Sudan virus
 Ta[iuml] Forest virus
 ebolaviruses with undefined pathogenicity in humans

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 the manufacture, testing, development, distribution, 
administration, and use of the Covered Countermeasures under the 
conditions stated in this Declaration.

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 U.S.
    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 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.
    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.

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 the following EBOD therapeutics:
    All classes or categories of therapeutics for mitigation or 
treatment of EBOD as defined in section I of this Declaration, 
including all components and constituent materials of these 
therapeutics, and all devices and their constituent components used in 
the administration of these therapeutics.
    Covered Countermeasures must be ``qualified pandemic or epidemic 
products,'' or ``security countermeasures,'' or drugs, biological 
products, 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 directly supported by the U.S. Federal 
Government, through past, present or future federal contracts, 
cooperative agreements, grants, other transactions, interagency 
agreements, memoranda of understanding, or other federal agreements or 
arrangements. The term ``directly supported'' in this Declaration means 
that the U.S Federal Government has provided some form of tangible 
support such as supplies, funds, products, technical assistance, or 
staffing.
    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.

[[Page 763]]

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 
Ebola disease (EBOD).

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 began on February 
27, 2015 and extends through December 31, 2023.

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(B) and (C)
    I have determined that an additional 12 months of liability 
protection is reasonable to allow for the manufacturer(s) to arrange 
for disposition of the Covered Countermeasure, including return of the 
Covered Countermeasures to the manufacturer, and for Covered Persons to 
take such other actions as are appropriate to limit the administration 
or use of the Covered Countermeasures.
    Covered Countermeasures obtained for the Strategic National 
Stockpile (SNS) during the effective period of this Declaration are 
covered through the date of administration or use pursuant to a 
distribution or release from the SNS.

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 (toll-free) or https://www.hrsa.gov/cicp/.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)
    Any amendments to this Declaration will be published in the Federal 
Register.

    Authority: 42 U.S.C. 247d-6d.

    Dated: January 24, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-00261 Filed 1-30-19; 8:45 am]
BILLING CODE 4150-37-P