Ebola Virus Disease Vaccines, 73314-73319 [2014-28856]
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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices
to the bill-payment or bill history
services that consumers actually signed
up for.)
Parts IV through VIII of the proposed
order are reporting and compliance
provisions. Part IV requires
PaymentsMD to retain documents
relating to its compliance with the
order. The order requires that
PaymentsMD retain all of the
documents for a five-year period. Part V
requires dissemination of the order now
and in the future to all current and
future subsidiaries, principals, officers,
directors, and managers, and to persons
with responsibilities relating to the
subject matter of the order. Part VI
ensures notification to the FTC of
changes in corporate status. Part VII
mandates that PaymentsMD submit a
compliance report to the FTC within 60
days, and periodically thereafter as
requested. Part VIII is a provision
‘‘sunsetting’’ the order after twenty (20)
years, with certain exceptions.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2014–28969 Filed 12–9–14; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Ebola Virus Disease Vaccines
Notice of Declaration under the
Public Readiness and Emergency
Preparedness Act.
ACTION:
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:
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SUMMARY:
Background
The Public Readiness and Emergency
Preparedness Act (‘‘PREP Act’’)
authorizes the Secretary of Health and
Human Services (‘‘the Secretary’’) to
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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
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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
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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; privatelabel distributors; jobbers; brokers;
warehouses and wholesale drug
warehouses; independent wholesale
drug traders; and retail pharmacies.
A program planner means a State or
local government, including an Indian
Tribe; a person employed by the State
or local government; or other person
who supervises or administers a
program 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
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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 lifethreatening disease or condition caused
by such a drug, biological product, or
device; (iii) or a product or technology
intended to enhance the use or effect of
such a drug, biological product, or
device.
A security countermeasure is a drug
or device, as defined in the FD&C Act
or a biological product, as defined in the
PHS Act that: (i) (a) The Secretary
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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:
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(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.
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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
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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
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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.
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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.
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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
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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.
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.
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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)
II. Factors Considered
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Covered Countermeasures are the
following Ebola Virus Disease Vaccines:
(1) Recombinant Replication Deficient
Chimpanzee Adenovirus Type 3Vectored Ebola Zaire Vaccine (ChAd3–
EBO–Z) GlaxoSmithKline [GSK code
name GSK3390107A]
(2) BPSC1001 (rVSV–ZEBOV–GP)
BioProtection Services Corporation,
subsidiary of Newlink Genetics; and
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(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.
VIII. Category of Disease, Health
Condition, or Threat
VII. Limitations on Distribution
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.
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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.
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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)
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.
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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’’),
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Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Notices
within the Department of Health and
Human Services. Information about the
CICP is available at the toll free number
1–855–266–2427 or https://
www.hrsa.gov/cicp/.
XV. Amendments
Dated: December 4, 2014.
Matthew Swain,
Program Analyst, Office of Planning,
Evaluation, and Analysis, Office of the
National Coordinator for Health Information
Technology (ONC), Office of the Secretary
(OS).
42 U.S.C. 247d–6d(b)(4)
[FR Doc. 2014–28855 Filed 12–9–14; 8:45 am]
Any amendments to this declaration
will be published in the Federal
Register.
BILLING CODE 4150–45–P
Authority: 42 U.S.C. 247d–6d.
Dated: December 3, 2014.
Sylvia M. Burwell,
Secretary.
Centers for Disease Control and
Prevention
[FR Doc. 2014–28856 Filed 12–9–14; 8:45 am]
Mine Safety and Health Research
Advisory Committee; Notice of Charter
Renewal
BILLING CODE 4150–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the National Coordinator for
Health Information Technology;
Federal Health IT Strategic Plan: 2015–
2020 Open Comment Period
ONC, HHS.
Notice.
AGENCY:
ACTION:
Authority: Section 3001(c)(3) of the Public
Health Service Act.
Section 3001(c)(3) of the
Public Health Service Act, as added by
the Health Information Technology for
Economic and Clinical Health (HITECH)
Act, requires the National Coordinator
for Health Information Technology
(ONC) to update the Federal Health IT
Strategic Plan (developed June 3, 2008;
last updated on September 15, 2011) in
consultation with other appropriate
federal agencies and in collaboration
with private and public entities. The
Plan was developed in collaboration
across multiple federal agencies, and
ONC will seek input on the draft Plan
from the private sector through the
Health IT Policy Committee. This notice
serves to announce that the public
comment period for the Federal Health
IT Strategic Plan is open through
Tuesday, February 6 at 5:00 p.m.
(Eastern). ONC welcomes and
encourages all comments from the
public regarding the Plan.
In order for your comments to be read
and considered, you must submit your
comment via https://www.healthit.gov/
policy-researchers-implementers/
strategic-plan-public-comments.
FOR FURTHER INFORMATION CONTACT:
Matthew Swain, Program Analyst in the
Office of Planning, Evaluation, and
Analysis, matthew.swain@hhs.gov,
202.205.3754.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:48 Dec 09, 2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 235001
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Mine
Safety and Health Research Advisory
Committee, Centers for Disease Control
and Prevention, Department of Health
and Human Services, has been renewed
for a 2-year period through November
30, 2016.
For information, contact Jeffrey H.
Welsh, B.A., Designated Federal Officer,
Mine Safety and Health Research
Advisory Committee, Centers for
Disease Control and Prevention,
Department of Health and Human
Services, 626 Cochrans Mill Road,
Mailstop P05, Pittsburgh, Pennsylvania
15236, Telephone (412) 386–4040 or fax
(412) 386–6614.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2014–28933 Filed 12–9–14; 8:45 am]
BILLING CODE 4163–18–P
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73319
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
The Centers for Disease Control (CDC)/
Health Resources and Services
Administration (HRSA) Advisory
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment; Notice
of Charter Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the CDC/
HRSA Advisory Committee on HIV,
Viral Hepatitis and STD Prevention and
Treatment, Department of Health and
Human Services, has been renewed for
a 2-year period through November 25,
2016.
Contact Person for More Information:
Johnathan Mermin, M.D., M.P.H.,
Designated Federal Officer, CDC/HRSA
Advisory Committee on HIV, Viral
Hepatitis and STD Prevention and
Treatment, Department of Health and
Human Services, CDC, 1600 Clifton
Road NE., Mailstop E07, Atlanta,
Georgia 30333, telephone (404) 639–
8000 or fax (404) 639–8600.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2014–28932 Filed 12–9–14; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Head Start Impact Study
Participants Beyond 8th Grade.
OMB No.: 0970–0229.
Description: The Administration for
Children and Families (ACF) within the
Department of Health and Human
Services (HHS) will collect follow-up
information from children and families
in the Head Start Impact Study. In
anticipation of conducting a future
follow-up for the study, ACF will collect
information necessary to identify
Sfmt 4703
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]]>Agencies
[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73314-73319]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28856]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 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: December 3, 2014.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2014-28856 Filed 12-9-14; 8:45 am]
BILLING CODE 4150-03-P
