[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 764-770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00260]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Ebola Virus Disease Vaccines--Amendment
ACTION: Notice of Amendment to the December 3, 2014, Declaration under
the Public Readiness and Emergency Preparedness Act for Ebola Virus
Disease Vaccines, as amended.
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SUMMARY: The Secretary is amending the Declaration issued pursuant to
the Public Health Service Act on December 3, 2014, as amended on
December 1, 2015 and December 2, 2016, to update the term ``Ebola Virus
Disease'' to
[[Page 765]]
``Ebola disease'' (EBOD) throughout the declaration and to clarify the
definition of EBOD. The amendment also expands the Covered
Countermeasures beyond the three vaccines 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 Declaration
issued pursuant to section 319F-3 of the Public Health Service Act on
December 3, 2014 (79 FR 73314), as amended on December 1, 2015 (80 FR
76541) and December 2, 2016 (81 FR 89471), 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 three vaccines 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 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
vaccines 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 three
vaccines 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 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 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 Western African countries and travelers from Western Africa to the
U.S. and other countries. In 2014, 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 makes 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 vaccines 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.
[[Page 766]]
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 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 vaccines against viruses and variants of all viruses of the
Ebolavirus 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.
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.
Section VI. Covered Countermeasures
As noted above, section III describes the Secretary's Recommended
Activities for which liability immunity is in effect. This section
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
[[Page 767]]
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 vaccines that are Covered
Countermeasures. The Secretary is expanding the types of Covered
Countermeasures covered under this Declaration to include monovalent or
multivalent ebolavirus or filovirus vaccine types against any single or
combinations of the pathogens resulting in EBOD as defined in Section I
of this Declaration, all components and constituent materials of these
vaccines, and all devices and their constituent components used in the
administration of these vaccines:
(1) Inactivated virus vaccines
(2) Live-attenuated vaccines
(3) mRNA vaccines
(4) DNA vaccines
(5) Subunit vaccines
(6) Peptide and/or polysaccharide and/or conjugate vaccines
(7) Virion-like particles vaccines
(8) Nanoparticle vaccines
(9) Recombinant vaccines
(10) Viral vector-based vaccines
This change is intended to expand the types of EBOD vaccines that
are included as Covered Countermeasures consistent with the terms of
this declaration, including the limitations stated in Section VII of
this Declaration. The Declaration continues coverage for EBOD vaccines
previously afforded under this declaration: (1) ``Recombinant
Replication Deficient Chimpanzee Adenovirus Type 3-Vectored Ebola Zaire
Vaccine'' (ChAd3-EBO-Z); (2) ``Recombinant Vesicular Stomatitis Virus-
vectored vaccine expressing EBOV-Zaire glycoprotein'' (rVSV-ZEBOV-GP),
and; (3) ``Ad26.ZEBOV/MVA-BN-Filo'' (MVA-mBN226B), and extends coverage
to encompass all categories of EBOD vaccines.
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 specifies that
the term ``directly supported'' in this Declaration means that the U.
S. has provided some form of tangible support such as supplies, funds,
products, technical assistance, or staffing.
The Secretary is amending the Declaration to delete the limitation
to activities authorized in accordance with the public health and
medical response of the Authority Having Jurisdiction to prescribe,
administer, deliver, distribute, or dispense the Covered
Countermeasures following a Declaration of an emergency. In accordance
with the PREP Act, termination of this limitation has only future
effect, and does not alter coverage provided under the Declaration
prior to the effective date of this amendment. However, we do not
believe that this amendment substantively alters liability protections
previously afforded under the Declaration, given that the Declaration
previously only covered specific EBOD vaccines that were directly
supported by the U.S. Federal Government. The amendments to Sections VI
and VII of this Declaration are intended to expand coverage under the
Declaration to all categories of EBOD vaccines but retain the
limitation to those EBOD vaccines that are directly supported by the
U.S. Federal Government. We note that the Declaration still covers
activities authorized in accordance with the public health and medical
response of the Authority Having Jurisdiction to prescribe, administer,
deliver, distribute, or dispense EBOD vaccines following a declaration
of an emergency when the activities also involve Covered
Countermeasures directly supported by the U.S. Federal Government.
Accordingly, individuals carrying out 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 are still listed as qualified persons under Section V of the
declaration. Section V also 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.
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
[[Page 768]]
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 PREP 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 PREP Act. Under the Secretary's
definition, these liability claims are precluded if they 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 PREP 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. 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: (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 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 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 is amended to
extend the effective time period for distribution of Covered
Countermeasures consistent with Section VII of this Declaration through
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 Stockpile. 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.
[[Page 769]]
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 any 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 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 US, 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 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 Declaration issued December 3,
2014 (79 FR 73314). The first amendment was issued December 1, 2015 (80
FR 76541). The second amendment was issued December 2, 2016 (81 FR
89471). The Secretary may amend any portion of this Declaration through
publication in the Federal Register.
Republished Declaration
Declaration, as Amended, for Public Readiness and Emergency
Preparedness Act Coverage for Ebola Disease Vaccines
This Declaration amends and republishes the December 3, 2014,
Declaration, as amended on December 1, 2015 and December 2, 2016, for
coverage under the Public Readiness and Emergency Preparedness
(``PREP'') Act for Ebola Disease Vaccines. To the extent any term of
the December 3, 2014, Declaration, as amended on December 1, 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, 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 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; or (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 vaccines:
All monovalent or multivalent ebolavirus or filovirus vaccine types
against any single or combinations of the pathogens resulting in EBOD
as defined in Section I of this Declaration, all components and
constituent materials of these vaccines, and all devices and their
constituent
[[Page 770]]
components used in the administration of these vaccines:
(1) Inactivated virus vaccines
(2) Live-attenuated vaccines
(3) mRNA vaccines
(4) DNA vaccines
(5) Subunit vaccines
(6) Peptide and/or polysaccharide and/or conjugate vaccines
(7) Virion-like particles vaccines
(8) Nanoparticle vaccines
(9) Recombinant vaccines
(10) Viral vector-based vaccines
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.
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 December 3,
2014, 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 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.
Authority: 42 U.S.C. 247d-6d.
Dated: January 24, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-00260 Filed 1-30-19; 8:45 am]
BILLING CODE 4150-37-P