Ebola Virus Disease Therapeutics-Amendment, 89476-89481 [2016-29609]

Agencies

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

[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Pages 89476-89481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29609]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Ebola Virus Disease Therapeutics--Amendment

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

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SUMMARY: The Secretary is amending the February 27, 2015, Declaration 
issued pursuant to the Public Health Service Act and amended December 
9, 2015 (80 FR 76536) to extend the effective time period for an 
additional 24 months consistent with the terms of the Declaration and 
republishing the Declaration in its entirety as amended.

DATES: The Amended Declaration is effective as of February 27, 2017.

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.

SUPPLEMENTARY INFORMATION: The Public Readiness and Emergency 
Preparedness Act (PREP Act) authorizes the Secretary of Health and 
Human Services to issue a Declaration to provide liability immunity to 
certain individuals and entities (Covered Persons) against any claim of 
loss caused by, arising out of, relating to, or resulting from the 
administration or use of medical countermeasures (Covered 
Countermeasures), except for claims that meet the PREP Act's definition 
of willful misconduct. The Secretary may, through publication in the 
Federal Register, amend any portion of a Declaration. Using this 
authority, the Secretary is amending the Declaration that provides 
liability immunity to Covered Persons for activities related to the 
Covered Countermeasures, Ebola Virus Disease Therapeutics as listed in 
Section VI of the Declaration to extend the effective time period for 
an additional 24 months, consistent with the terms of this Declaration.
    The PREP Act was enacted on December 30, 2005, as Public Law 109-
148, Division C, Section 2. It amended the Public Health Service (PHS) 
Act, adding section 319F-3, which addresses liability immunity, and 
section 319F-4, which creates a compensation program. These sections 
are codified in the U.S. Code as 42 U.S.C. 247d-6d and 42 U.S.C. 247d-
6e, respectively.
    The Pandemic and All-Hazards Preparedness Reauthorization Act 
(PAHPRA), Public Law 113-5, was enacted on March 13, 2013. Among other 
things, PAHPRA added sections 564A and 564B to the Federal Food, Drug, 
and Cosmetic (FD&C) Act to provide authorities for the emergency use of 
approved products in emergencies and products held for emergency use.
    PAHPRA accordingly amended the definitions of ``Covered 
Countermeasures'' and ``qualified pandemic and epidemic products'' in 
section 319F-3 of the Public Health Service Act (PREP Act provisions), 
so that products made available under these new FD&C Act authorities 
could be covered under PREP Act Declarations. PAHPRA also extended the 
definition of qualified pandemic and epidemic products that may be 
covered under a PREP Act Declaration to include products or 
technologies intended to enhance the use or effect of a drug, 
biological product, or device used against the pandemic or epidemic or 
against adverse events from these products.
    The Ebola virus causes an acute, serious illness that is often 
fatal. From 2014 to 2015, West Africa experienced the largest and most 
complex Ebola outbreak since the virus was first discovered in 1976, 
affecting populations in multiple West African

[[Page 89477]]

countries and travelers from West Africa to the United States (U.S.) 
and other countries. The World Health Organization (WHO) declared the 
Ebola Virus Disease Outbreak as a Public Health Emergency of 
International Concern under the framework of the International Health 
Regulations (2005). In March 2016, WHO determined that the Ebola 
outbreak no longer constituted a Public Health Emergency of 
International Concern, but emphasized the crucial need for continued 
support to prevent, detect and respond rapidly to any new Ebola 
outbreak in West Africa. Thus, there is a continuing need for 
development of vaccines against Ebola Virus Disease.
    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 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 under the conditions stated in the Declaration, including the 
condition that the activities relate to clinical trials permitted to 
proceed after review by the Food and Drug Administration (FDA) that 
administer or use the Covered Countermeasure under an investigational 
new drug application (IND) and that are directly supported by the U.S. 
The Secretary specifies that the term ``directly supported'' in this 
Declaration means that the United States has provided some form of 
tangible support such as supplies, funds, products, technical 
assistance, or staffing. This condition is intended to afford liability 
immunity only to activities related to clinical trials using the 
Covered Countermeasure being conducted in the U.S. and West Africa that 
are directly supported by the U.S.

Section IV, Liability Immunity

    The Secretary must also state that liability protections available 
under the PREP Act are in effect with respect to the Recommended 
Activities. These liability protections provide that, ``[s]ubject to 
other provisions of [the PREP Act], a covered person shall be immune 
from suit and liability under federal and state law with respect to all 
claims for loss caused by, arising out of, relating to, or resulting 
from the administration to or use by an individual of a covered 
countermeasure if a Declaration . . . has been issued with respect to 
such countermeasure.'' In Section IV, the Secretary states that 
liability protections are in effect with respect to the Recommended 
Activities.

Section V, Covered Persons

    The PREP Act's liability immunity applies to Covered Persons with 
respect to administration or use of a Covered Countermeasure. The term 
``Covered Persons'' has a specific meaning and is defined in the PREP 
Act to include manufacturers, distributors, program planners, and 
qualified persons, and their officials, agents, and employees, and the 
U.S. The PREP Act further defines the terms ``manufacturer,'' 
``distributor,'' ``program planner,'' and ``qualified person'' as 
described below.
    A manufacturer includes a contractor or subcontractor of a 
manufacturer; a supplier or licenser of any product, intellectual 
property, service, research tool or component or other article used in 
the design, development, clinical testing, investigation or 
manufacturing of a Covered Countermeasure; and any or all of the 
parents, subsidiaries, affiliates, successors, and assigns of a 
manufacturer.
    A distributor means a person or entity engaged in the distribution 
of drug, biologics, or devices, including but not limited to: 
Manufacturers; repackers; common carriers; contract carriers; air 
carriers; own-label distributors; private-label distributors; jobbers; 
brokers; warehouses and wholesale drug warehouses; independent 
wholesale drug traders; and retail pharmacies.
    A program planner means a state or local government, including an 
Indian tribe; a person employed by the state or local government; or 
other person who supervises or administers a program with respect to 
the administration, dispensing, distribution, provision, or use of a 
Covered Countermeasure, including a person who establishes 
requirements, provides policy guidance, or supplies technical or 
scientific advice or assistance or provides a facility to administer or 
use a Covered Countermeasure in accordance with the Secretary's 
Declaration. Under this definition, a private-sector employer or 
community group or other ``person'' can be a program planner when it 
carries out the described activities.
    A qualified person means a licensed health professional or other 
individual authorized to prescribe, administer, or dispense Covered 
Countermeasures under the law of the state in which the countermeasure 
was prescribed, administered, or dispensed; or a person within a 
category of persons identified as qualified in the Secretary's 
Declaration. Under this definition, the Secretary can describe in the 
Declaration other qualified persons, such as volunteers, who are 
Covered Persons. Section V describes other qualified persons covered by 
this Declaration.
    The PREP Act also defines the word ``person'' as used in the Act: A 
person includes an individual, partnership, corporation, association, 
entity, or public or private corporation, including a federal, state, 
or local government agency or department. Section V describes Covered 
Persons under the Declaration, including Qualified Persons.

Section VI, Covered Countermeasures

    As noted above, section III describes the Secretary's Recommended 
Activities for which liability immunity is in effect. Section VI 
identifies the countermeasures for which the Secretary has recommended 
such activities. The PREP Act states that a

[[Page 89478]]

Covered Countermeasure must be: A ``qualified pandemic or epidemic 
product,'' or a ``security countermeasure,'' as described immediately 
below; or a drug, biological product or device authorized for emergency 
use in accordance with sections 564, 564A, or 564B of the FD&C Act.
    A qualified pandemic or epidemic product means a drug or device, as 
defined in the FD&C Act or a biological product, as defined in the PHS 
Act that is: (i) Manufactured, used, designed, developed, modified, 
licensed or procured to diagnose, mitigate, prevent, treat, or cure a 
pandemic or epidemic or limit the harm such a pandemic or epidemic 
might otherwise cause; (ii) manufactured, used, designed, developed, 
modified, licensed, or procured to diagnose, mitigate, prevent, treat, 
or cure a serious or life-threatening disease or condition caused by 
such a drug, biological product, or device; (iii) or a product or 
technology intended to enhance the use or effect of such a drug, 
biological product, or device.
    A security countermeasure is a drug or device, as defined in the 
FD&C Act or a biological product, as defined in the PHS Act that: 
(i)(a) The Secretary determines to be a priority to diagnose, mitigate, 
prevent, or treat harm from any biological, chemical, radiological, or 
nuclear agent identified as a material threat by the Secretary of 
Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm 
from a condition that may result in adverse health consequences or 
death and may be caused by administering a drug, biological product, or 
device against such an agent; and (ii) is determined by the Secretary 
of Health and Human Services to be a necessary countermeasure to 
protect public health.
    To be a Covered Countermeasure, qualified pandemic or epidemic 
products or security countermeasures also must be approved or cleared 
under the FD&C Act; licensed under the PHS Act; or authorized for 
emergency use under sections 564, 564A, or 564B of the FD&C Act.
    A qualified pandemic or epidemic product also may be a Covered 
Countermeasure when it is subject to an exemption (that is, it is 
permitted to be used under an Investigational Drug Application or an 
Investigational Device Exemption) under the FD&C Act and is the object 
of research for possible use for diagnosis, mitigation, prevention, 
treatment, or cure, or to limit harm of a pandemic or epidemic or 
serious or life-threatening condition caused by such a drug or device. 
A security countermeasure also may be a Covered Countermeasure if it 
may reasonably be determined to qualify for approval or licensing 
within 10 years after the Department's determination that procurement 
of the countermeasure is appropriate.
    Section VI lists the Ebola Virus Disease Therapeutics 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 
clinical trials permitted to proceed after FDA review, that administer 
or use the Covered Countermeasure under an IND, and directly supported 
by the U.S., as described in Section III of this Declaration, through 
present or future federal contracts, cooperative agreements, grants, 
other transactions, interagency agreements, or memoranda of 
understanding or other federal agreements or arrangements.
    This limitation is intended to afford liability immunity to 
activities that are related to clinical trials permitted to proceed 
after FDA review that administer or use the Covered Countermeasure 
under an IND and that are directly supported by the U.S. As stated in 
Section III of the Declaration, the term ``directly support'' means 
that the U.S. has provided some form of tangible support such as 
supplies, funds, products, technical assistance, or staffing. As of the 
date of this Declaration, activities primarily are those with a direct 
connection to the conduct of clinical trials in the U.S. and West 
Africa, but this Declaration also would apply to use in qualifying 
clinical trials outside those areas.
    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

[[Page 89479]]

Act. Under the Secretary's definition, these liability claims are 
precluded if the claims allege an injury caused by physical provision 
of a countermeasure to a recipient, or if the claims are directly due 
to conditions of delivery, distribution, dispensing, or management and 
operation of countermeasure programs at distribution and dispensing 
sites.
    Thus, it is the Secretary's interpretation that, when a Declaration 
is in effect, the Act precludes, for example, liability claims alleging 
negligence by a manufacturer in creating a therapeutic, or negligence 
by a health care provider in prescribing the wrong dose, absent willful 
misconduct. Likewise, the Act precludes a liability claim relating to 
the management and operation of a countermeasure distribution program 
or site, such as a slip-and-fall injury or vehicle collision by a 
recipient receiving a countermeasure at a retail store serving as an 
administration or dispensing location that alleges, for example, lax 
security or chaotic crowd control. However, a liability claim alleging 
an injury occurring at the site that was not directly related to the 
countermeasure activities is not covered, such as a slip-and-fall with 
no direct connection to the countermeasure's administration or use. In 
each case, whether immunity is applicable will depend on the particular 
facts and circumstances.

Section X, Population

    The Secretary must identify, for each Covered Countermeasure 
specified in a Declaration, the population or populations of 
individuals for which liability immunity is in effect with respect to 
administration or use of the countermeasure. This section explains 
which individuals should use the countermeasure or to whom the 
countermeasure should be administered--in short, those who should be 
vaccinated or take a drug or other countermeasure. Section X provides 
that the population includes ``any individual who uses or who is 
administered a Covered Countermeasure in accordance with the 
Declaration.''
    In addition, the PREP Act specifies that liability immunity is 
afforded to manufacturers and distributors without regard to whether 
the countermeasure is used by or administered to this population and to 
program planners and qualified persons when the countermeasure is 
either used by or administered to this population or the program 
planner or qualified person reasonably could have believed the 
recipient was in this population. Section X includes these statutory 
conditions in the Declaration for clarity.

Section 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 or other locations outside the 
U.S. It is possible that claims may arise in regard to administration 
or use of the Covered Countermeasures outside the U.S. that may be 
resolved under U.S. law.
    In addition, the PREP Act specifies that liability immunity is 
afforded to manufacturers and distributors without regard to whether 
the countermeasure is used by or administered to individuals in the 
geographic areas and to program planners and qualified persons when the 
countermeasure is either used or administered in the geographic areas 
or the program planner or qualified person reasonably could have 
believed the countermeasure was used or administered in the areas. 
Section XI includes these statutory conditions in the Declaration for 
clarity.

Section XII, Effective Time Period

    The Secretary must identify for each Covered Countermeasure the 
period or periods during which liability immunity is in effect, 
designated by dates, milestones, or other description of events, 
including factors specified in the PREP Act. Section XII identifies the 
effective time period. The effective time period commences at the start 
of clinical trials permitted to proceed after FDA review that 
administer or use the Covered Countermeasure under an IND and that are 
directly supported by the U.S., as described in Section III of the 
Declaration. Liability immunity is afforded to claims arising from such 
administration or use of the Covered Countermeasures after that date 
that have a causal relationship with any of the Recommended Activities 
stated in this Declaration. Section XII is amended to extend the 
effective time period an additional 24 months.

Section XIII, Additional Time Period of Coverage

    The Secretary must specify a date after the ending date of the 
effective period of the Declaration that is reasonable for 
manufacturers to arrange for disposition of the Covered Countermeasure, 
including return of the product to the manufacturer, and for other 
Covered Persons to take appropriate actions to limit administration or 
use of the Covered Countermeasure. In addition, the PREP Act specifies 
that for Covered Countermeasures that are subject to a Declaration at 
the time they are obtained for the Strategic National Stockpile (SNS) 
under 42 U.S.C. 247d-6b(a), the effective period of the Declaration 
extends through the time the countermeasure is used or administered 
pursuant to a distribution or release from the SNS. Liability immunity 
under the provisions of the PREP Act and the conditions of the 
Declaration continues during these additional time periods. Thus, 
liability immunity is afforded during the ``Effective Time Period,'' 
described under XII of the Declaration, plus the ``Additional Time 
Period'' described under section XIII of the Declaration.
    Section XIII provides for 12 months as the additional time period 
of coverage after expiration of the Declaration. Section XIII also 
explains the extended coverage that applies to products obtained for 
the SNS during the effective period of the Declaration.

Section XIV, Countermeasures Injury Compensation Program

    Section 319F-4 of the PREP Act authorizes the Countermeasures 
Injury Compensation Program (CICP) to provide benefits to eligible 
individuals who sustain a serious physical injury or die as a direct 
result of the administration or use of a Covered Countermeasure. 
Compensation under the CICP for an injury directly caused by a Covered 
Countermeasure is based on the requirements set forth in this 
Declaration, the administrative rules for the Program, and the statute. 
To show direct causation between a Covered Countermeasure and a serious 
physical injury, the statute requires ``compelling, reliable, valid, 
medical and scientific evidence.'' The administrative rules for the 
Program further explain the necessary requirements for eligibility 
under the CICP. Please note that, by statute, requirements for 
compensation under the CICP may not always align with the requirements 
for liability immunity provided under the PREP Act. Section XIV, 
Countermeasures Injury

[[Page 89480]]

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 U.S., only 
otherwise eligible individuals at American embassies, military 
installations abroad (such as military bases, ships, and camps) or at 
North Atlantic Treaty Organization (NATO) installations (subject to the 
NATO Status of Forces Agreement) where American servicemen and 
servicewomen are stationed may be considered for CICP benefits. Other 
individuals outside the U.S. may not be eligible for CICP benefits.

Section XV, Amendments

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

Republished Declaration

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

    This Declaration amends and republishes the February 27, 2015 for 
coverage under the Public Readiness and Emergency Preparedness (PREP) 
Act for Ebola Virus Disease Therapeutics. To the extent any term of the 
February 27, 2015, Declaration is inconsistent with any provision of 
this Republished Declaration, the terms of this Republished Declaration 
are controlling.
I. Determination of Public Health Emergency or Credible Risk of Future 
Public Health Emergency
42 U.S.C. 247d-6d(b)(1)
    I have determined that there is a credible risk that the spread of 
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 the manufacture, testing, development, distribution, 
administration, and use of the Covered Countermeasures under the 
conditions stated in this Declaration, including the condition that the 
activities relate to clinical trials permitted to proceed after review 
by the Food and Drug Administration (FDA) that administer or use the 
Covered Countermeasure under an IND application and that are directly 
supported by the U.S. The term ``directly supported'' in this 
Declaration means that the U.S. has provided some form of tangible 
support such as supplies, funds, products, technical assistance, or 
staffing.
IV. Liability Immunity
42 U.S.C. 247d-6d(a), 247d-6d(b)(1)
    Liability immunity as prescribed in the PREP Act and conditions 
stated in this Declaration is in effect for the Recommended Activities 
described in section III.
V. Covered Persons
42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)
    Covered Persons who are afforded liability immunity under this 
Declaration are manufacturers, distributors, program planners, 
qualified persons, and their officials, agents, and employees, as those 
terms are defined in the PREP Act, and the U.S. In addition, I have 
determined that the following additional persons are qualified persons: 
Any person authorized to prescribe, administer, or dispense the Covered 
Countermeasures or who is otherwise authorized to perform an activity 
to carry out clinical trials permitted to proceed after FDA review that 
administer or use the Covered Countermeasure under an IND and that are 
directly supported by the United States, as described in Section III of 
this Declaration.
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 
Therapeutics: ZMapp monoclonal antibody therapeutic.
    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 clinical trials permitted to 
proceed after FDA review that administer or use the Covered 
Countermeasure under an IND and that are directly supported by the 
United States, as described in Section III of this Declaration, through 
present or future federal contracts, cooperative agreements, grants, 
other transactions, interagency agreements, memoranda of understanding, 
or other federal agreements or arrangements.
    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.

[[Page 89481]]

    Liability immunity is afforded to manufacturers and distributors 
without regard to whether the countermeasure is used by or administered 
to this population; liability immunity is afforded to program planners 
and qualified persons when the countermeasure is used by or 
administered to this population, or the program planner or qualified 
person reasonably could have believed the recipient was in this 
population.
XI. Geographic Area
42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)
    Liability immunity is afforded for the administration or use of a 
Covered Countermeasure without geographic limitation.
    Liability immunity is afforded to manufacturers and distributors 
without regard to whether the countermeasure is used by or administered 
in any designated geographic area; liability immunity is afforded to 
program planners and qualified persons when the countermeasure is used 
by or administered in any designated geographic area, or the program 
planner or qualified person reasonably could have believed the 
recipient was in that geographic area.
XII. Effective Time Period
42 U.S.C. 247d-6d(b)(2)(B)
    Liability immunity for Covered Countermeasures began on February 
27, 2015, and extends through February 26, 2019.
XIII. Additional Time Period of Coverage
42 U.S.C. 247d-6d(b)(3)(B) and (C)
    I have determined that an additional 12 months of liability 
protection is reasonable to allow for the manufacturer(s) to arrange 
for disposition of the Covered Countermeasure, including return of the 
Covered Countermeasures to the manufacturer, and for Covered Persons to 
take such other actions as are appropriate to limit the administration 
or use of the Covered Countermeasures.
    Covered Countermeasures obtained for the SNS during the effective 
period of this Declaration are covered through the date of 
administration or use pursuant to a distribution or release from the 
SNS.
XIV. Countermeasures Injury Compensation Program
42 U.S.C 247d-6e
    The PREP Act authorizes the Countermeasures Injury Compensation 
Program (CICP) to provide benefits to certain individuals or estates of 
individuals who sustain a covered serious physical injury as the direct 
result of the administration or use of the Covered Countermeasures, and 
benefits to certain survivors of individuals who die as a direct result 
of the administration or use of the Covered Countermeasures. The causal 
connection between the countermeasure and the serious physical injury 
must be supported by compelling, reliable, valid, medical and 
scientific evidence in order for the individual to be considered for 
compensation. The CICP is administered by the Health Resources and 
Services Administration, within the Department of Health and Human 
Services. Information about the CICP is available by telephone at 855-
266-2427 (toll-free) or https://www.hrsa.gov/cicp/.
XV. Amendments
42 U.S.C. 247d-6d(b)(4)
    Any amendments to this Declaration will be published in the Federal 
Register.

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

    Dated: December 2, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-29609 Filed 12-9-16; 8:45 am]
 BILLING CODE 4150-28-P