[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73314-73319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28856]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Ebola Virus Disease Vaccines
ACTION: Notice of Declaration under the Public Readiness and Emergency
Preparedness Act.
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SUMMARY: The Secretary is issuing a declaration pursuant to section
319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide
liability protection for activities related to Ebola Virus Disease
Vaccines consistent with the terms of the declaration.
DATES: The declaration is effective as of December 3, 2014.
FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, MSPH, 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 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
Background
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 administration or use of medical countermeasures (``Covered
Countermeasures''), except for claims that meet the PREP Act's
definition of willful misconduct. Using this authority, the Secretary
is issuing a declaration to provide liability immunity to Covered
Persons for activities related to the Covered Countermeasures, Ebola
Virus Disease Vaccines as listed in Section VI of the Declaration,
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,
& Cosmetic (FD&C) Act to provide new emergency authorities for
dispensing 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 (the 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.
The Ebola virus causes an acute, serious illness that is often
fatal. Since March 2014, West Africa has been experiencing the largest
and most complex Ebola outbreak since the Ebola virus was first
discovered in 1976, affecting populations in multiple West African
Countries and travelers from West Africa to the United States and other
countries. The World Health Organization has declared the Ebola Virus
Disease Outbreak as a Public Health Emergency of International Concern
(PHEIC) under the framework of the International Health Regulations
(2005).
Unless otherwise noted, all statutory citations below are to the
U.S. Code.
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 Ebola virus
and the resulting disease may in the future constitute a public health
emergency.
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 she 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.
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
[[Page 73315]]
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
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 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 who is 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 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 exempted under the FD&C Act for use as an
investigational drug or device that 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
ten years after the Department's determination that procurement of the
countermeasure is appropriate.
Section VI lists the Ebola Virus Disease Vaccines that are Covered
Countermeasures.
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 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:
[[Page 73316]]
(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 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, 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 she recommends administration or use of the Covered
Countermeasures is Ebola virus disease.
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 use by an
individual of a Covered Countermeasure consistent with the terms of a
declaration issued under the 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 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 West Africa. 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.
[[Page 73317]]
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 explains the
effective time periods for different means of distribution of Covered
Countermeasures.
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 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.
Section XIII provides for twelve (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 Strategic National Stockpile during the effective
period of the declaration.
Section XIV, Countermeasures Injury Compensation Program
Section 319F-4 of the PREP Act authorizes a 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 if
countermeasures are administered or used outside the United States,
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 United States may not be eligible for CICP
benefits.
Section XV, Amendments
The Secretary may amend any portion of a declaration through
publication in the Federal Register.
Declaration
Declaration, Public Readiness and Emergency Preparedness Act Coverage
for Ebola Virus
Disease Vaccines
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
Ebola virus and the resulting disease or conditions may in the future
constitute a public health emergency.
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; (c) any person authorized to prescribe, administer, or
dispense Covered Countermeasures using Emergency Use Instructions or
under an order issued 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 the following Ebola Virus Disease
Vaccines:
(1) Recombinant Replication Deficient Chimpanzee Adenovirus Type 3-
Vectored Ebola Zaire Vaccine (ChAd3-EBO-Z) GlaxoSmithKline [GSK code
name GSK3390107A]
(2) BPSC1001 (rVSV-ZEBOV-GP) BioProtection Services Corporation,
subsidiary of Newlink Genetics; and
[[Page 73318]]
(3) Ad26.ZEBOV/MVA-BN-Filo (MVA-mBN226B) Janssen Corporation,
subsidiary of Johnson & Johnson/Bavarian Nordic.
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 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.
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
Ebola virus disease.
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 begins on the date of signature and
extends for twelve (12) months from that date.
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)
twelve (12) months from the date of signature, 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 twelve (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 a 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 (``HRSA''),
[[Page 73319]]
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)
Any amendments to this declaration will be published in the Federal
Register.
Authority: 42 U.S.C. 247d-6d.
Dated: December 3, 2014.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2014-28856 Filed 12-9-14; 8:45 am]
BILLING CODE 4150-03-P