80 FR 76536 - Ebola Virus Disease Therapeutics-Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 80, Issue 236 (December 9, 2015)

Page Range		76536-76541
FR Document		2015-31089
The Secretary is amending the February 27, 2015 Declaration issued pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) (80 FR 22534) to extend the effective time period for an additional twelve (12) months consistent with the terms of the Declaration and republishing the Declaration in its entirety as amended.
Federal Register, Volume 80 Issue 236 (Wednesday, December 9, 2015)
[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76536-76541]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31089]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Secretary is amending the February 27, 2015 Declaration 
issued pursuant to section 319F-3 of the Public Health Service Act (42 
U.S.C. 247d-6d) (80 FR 22534) to extend the effective time period for 
an additional twelve (12) 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, 2016.

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:

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. The Secretary may, though 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 twelve (12) months, consistent with the terms of this 
Declaration.

[[Page 76537]]

    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. Since March 2014, West Africa has been experiencing the largest 
and most complex Ebola outbreak since the virus was first discovered in 
1976, affecting populations in multiple West African countries and 
travelers from West Africa to the United States (U.S.) and other 
countries. The World Health Organization declared the Ebola Virus 
Disease Outbreak as a Public Health Emergency of International Concern 
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 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

[[Page 76538]]

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 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

[[Page 76539]]

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 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. 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 twelve (12) 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 twelve (12) months as the additional time 
period of coverage after expiration of the

[[Page 76540]]

Declaration. Section XIII also explains the extended coverage that 
applies to products obtained for the SNS during the effective period of 
the Declaration.

Section XIV, Countermeasures Injury Compensation Program

    Section 319F-4 of the PREP Act authorizes the Countermeasures 
Injury Compensation Program (CICP) to provide benefits to eligible 
individuals who sustain a serious physical injury or die as a direct 
result of the administration or use of a Covered Countermeasure. 
Compensation under the CICP for an injury directly caused by a Covered 
Countermeasure is based on the requirements set forth in this 
Declaration, the administrative rules for the Program, and the statute. 
To show direct causation between a Covered Countermeasure and a serious 
physical injury, the statute requires ``compelling, reliable, valid, 
medical and scientific evidence.''
    The administrative rules for the Program further explain the 
necessary requirements for eligibility under the CICP. Please note 
that, by statute, requirements for compensation under the CICP may not 
always align with the requirements for liability immunity provided 
under the PREP Act. Section XIV, Countermeasures Injury Compensation 
Program explains the types of injury and standard of evidence needed to 
be considered for compensation under the CICP.
    Further, the administrative rules for the CICP specify 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 first amendment to the February 27, 2015, Declaration 
(80 FR 73314). 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.

[[Page 76541]]

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 began on February 
27, 2015, and extends for twenty-four (24) months.

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 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 http://www.hrsa.gov/cicp/.

XV. Amendments

42 U.S.C. 247d-6d(b)(4)

    Any amendments to this Declaration will be published in the Federal 
Register.

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

    Dated: December 1, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015-31089 Filed 12-8-15; 8:45 am]
BILLING CODE P
76536 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices

for purpose of distributing and XIII. Additional Time Period of Dated: December 1, 2015.
dispensing countermeasures. Coverage Sylvia M. Burwell,
42 U.S.C. 247d–6d(b)(3)(A), (B) and (C) Secretary.
X. Population
[FR Doc. 2015–31091 Filed 12–8–15; 8:45 am]
42 U.S.C. 247d–6d(a)(4), 247d– I have determined that an additional
BILLING CODE P
twelve (12) months of liability
6d(b)(2)(C)
protection is reasonable to allow for the
The populations of individuals manufacturer(s) to arrange for DEPARTMENT OF HEALTH AND
include any individual who uses or is disposition of the Covered HUMAN SERVICES
administered the Covered Countermeasure, including return of the
Countermeasures in accordance with Covered Countermeasures to the Office of the Secretary
this declaration. manufacturer, and for Covered Persons
to take such other actions as are Ebola Virus Disease Therapeutics—
Liability immunity is afforded to appropriate to limit the administration Amendment
manufacturers and distributors without or use of the Covered Countermeasures.
regard to whether the countermeasure is Covered Countermeasures obtained ACTION: Notice of Amendment to the
used by or administered to this for the SNS during the effective period February 27, 2015, Declaration under
population; liability immunity is of this declaration for Covered the Public Readiness and Emergency
afforded to program planners and Countermeasures obtained through Preparedness Act.
qualified persons when the means of distribution other than in
SUMMARY: The Secretary is amending the
countermeasure is used by or accordance with the public health and
February 27, 2015 Declaration issued
administered to this population or the medical response of the Authority
pursuant to section 319F–3 of the Public
program planner or qualified person Having Jurisdiction are covered through
Health Service Act (42 U.S.C. 247d–6d)
reasonably could have believed the the date of administration or use
(80 FR 22534) to extend the effective
recipient was in this population. pursuant to a distribution or release
time period for an additional twelve (12)
from the SNS.
XI. Geographic Area months consistent with the terms of the
XIV. Countermeasures Injury Declaration and republishing the
42 U.S.C. 247d–6d(a)(4), 247d– Compensation Program Declaration in its entirety as amended.
6d(b)(2)(D) 2 U.S.C. 247d–6e DATES: The Amended Declaration is
effective as of February 27, 2016.
Liability immunity is afforded for the The PREP Act authorizes the
FOR FURTHER INFORMATION CONTACT:
administration or use of a Covered Countermeasures Injury Compensation
Nicole Lurie, MD, MSPH, Assistant
Countermeasure without geographic Program (CICP) to provide benefits to
Secretary for Preparedness and
limitation. certain individuals or estates of
Response, Office of the Secretary,
individuals who sustain a serious
Liability immunity is afforded to Department of Health and Human
physical covered injury as the direct
manufacturers and distributors without Services, 200 Independence Avenue
result of the administration or use of the
regard to whether the countermeasure is Covered Countermeasures and/or SW., Washington, DC 20201; Telephone
used by or administered in these benefits to certain survivors of 202–205–2882.
geographic areas; liability immunity is individuals who die as a direct result of SUPPLEMENTARY INFORMATION:
afforded to program planners and the administration or use of the Covered Background
qualified persons when the Countermeasures. The causal
countermeasure is used by or The Public Readiness and Emergency
connection between the countermeasure
administered in these geographic areas, Preparedness Act (PREP Act) authorizes
and the serious physical injury must be
or the program planner or qualified the Secretary of Health and Human
supported by compelling, reliable, valid,
person reasonably could have believed Services (the Secretary) to issue a
medical and scientific evidence in order
the recipient was in these geographic Declaration to provide liability
for the individual to be considered for
areas. immunity to certain individuals and
compensation. The CICP is
entities (Covered Persons) against any
XII. Effective Time Period administered by the Health Resources
claim of loss caused by, arising out of,
and Services Administration, within the
relating to, or resulting from the
42 U.S.C. 247d–6d(b)(2)(B) Department of Health and Human
administration or use of medical
Services. Information about the CICP is
Liability immunity for Covered countermeasures (Covered
available at 855–266–2427 (toll-free) or
Countermeasures obtained through Countermeasures), except for claims
http://www.hrsa.gov/cicp/.
means of distribution other than in that meet the PREP Act’s definition of
accordance with the public health and XV. Amendments willful misconduct. The Secretary may,
medical response of the Authority though publication in the Federal
42 U.S.C. 247d–6d(b)(4)
Having Jurisdiction extends through Register, amend any portion of a
The October 10, 2008, Declaration Declaration. Using this authority, the
December 31, 2022. Under the Public Readiness and Secretary is amending the Declaration
Liability immunity for Covered Emergency Preparedness Act for that provides liability immunity to
Countermeasures administered and botulinum toxin countermeasures was
mstockstill on DSK4VPTVN1PROD with NOTICES

Covered Persons for activities related to
used in accordance with the public first published on October 17, 2008. the Covered Countermeasures, Ebola
health and medical response of the This is the first amendment to that Virus Disease Therapeutics as listed in
Authority Having Jurisdiction begins declaration. Section VI of the Declaration to extend
with a declaration and lasts through (1) Any further amendments to this the effective time period for an
the final day the emergency declaration declaration will be published in the additional twelve (12) months,
is in effect or (2) December 31, 2022, Federal Register. consistent with the terms of this
whichever occurs first. Authority: 42 U.S.C. 247d–6d. Declaration.

VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1
Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76537

The PREP Act was enacted on determination is separate and apart from PREP Act are in effect with respect to
December 30, 2005, as Public Law 109– a Declaration issued by the Secretary the Recommended Activities. These
148, Division C, Section 2. It amended under section 319 of the PHS Act that liability protections provide that,
the Public Health Service (PHS) Act, a disease or disorder presents a public ‘‘[s]ubject to other provisions of [the
adding section 319F–3, which addresses health emergency or that a public health PREP Act], a covered person shall be
liability immunity, and section 319F–4, emergency, including significant immune from suit and liability under
which creates a compensation program. outbreaks of infectious diseases or Federal and State law with respect to all
These sections are codified in the U.S. bioterrorist attacks, otherwise exists, or claims for loss caused by, arising out of,
Code as 42 U.S.C. 247d–6d and 42 other Declarations or determinations relating to, or resulting from the
U.S.C. 247d–6e, respectively. made under other authorities of the administration to or use by an
The Pandemic and All-Hazards Secretary. Accordingly, in Section I, the individual of a covered countermeasure
Preparedness Reauthorization Act Secretary determines that there is a if a Declaration . . . has been issued
(PAHPRA), Public Law 113–5, was credible risk that the spread of Ebola with respect to such countermeasure.’’
enacted on March 13, 2013. Among virus and the resulting disease may In Section IV, the Secretary states that
other things, PAHPRA added sections constitute a public health emergency. liability protections are in effect with
564A and 564B to the Federal Food, respect to the Recommended Activities.
Drug, and Cosmetic (FD&C) Act to Section II, Factors Considered
provide authorities for the emergency In deciding whether and under what Section V, Covered Persons
use of approved products in circumstances to issue a Declaration The PREP Act’s liability immunity
emergencies and products held for with respect to a Covered applies to Covered Persons with respect
emergency use. Countermeasure, the Secretary must to administration or use of a Covered
PAHPRA accordingly amended the consider the desirability of encouraging Countermeasure. The term ‘‘Covered
definitions of ‘‘Covered the design, development, clinical testing Persons’’ has a specific meaning and is
Countermeasures’’ and ‘‘qualified or investigation, manufacture, labeling, defined in the PREP Act to include
pandemic and epidemic products’’ in distribution, formulation, packaging, manufacturers, distributors, program
section 319F–3 of the Public Health marketing, promotion, sale, purchase, planners, and qualified persons, and
Service Act (PREP Act provisions), so donation, dispensing, prescribing, their officials, agents, and employees,
that products made available under administration, licensing, and use of the and the U.S. The PREP Act further
these new FD&C Act authorities could countermeasure. In Section II, the defines the terms ‘‘manufacturer,’’
be covered under PREP Act Secretary states that she has considered ‘‘distributor,’’ ‘‘program planner,’’ and
Declarations. PAHPRA also extended these factors. ‘‘qualified person’’ as described below.
the definition of qualified pandemic and A manufacturer includes a contractor
Section III, Recommended Activities or subcontractor of a manufacturer; a
epidemic products that may be covered
under a PREP Act Declaration to include The Secretary must recommend the supplier or licenser of any product,
products or technologies intended to activities for which the PREP Act’s intellectual property, service, research
enhance the use or effect of a drug, liability immunity is in effect. These tool or component or other article used
biological product, or device used activities may include, under conditions in the design, development, clinical
against the pandemic or epidemic or as the Secretary may specify, the testing, investigation or manufacturing
against adverse events from these manufacture, testing, development, of a Covered Countermeasure; and any
products. distribution, administration, or use of or all of the parents, subsidiaries,
The Ebola virus causes an acute, one or more Covered Countermeasures affiliates, successors, and assigns of a
serious illness that is often fatal. Since (‘‘Recommended Activities’’). In Section manufacturer.
March 2014, West Africa has been III, the Secretary recommends activities A distributor means a person or entity
experiencing the largest and most for which the immunity is in effect engaged in the distribution of drug,
complex Ebola outbreak since the virus under the conditions stated in the biologics, or devices, including but not
was first discovered in 1976, affecting Declaration, including the condition limited to: manufacturers; repackers;
populations in multiple West African that the activities relate to clinical trials common carriers; contract carriers; air
countries and travelers from West Africa permitted to proceed after review by the carriers; own-label distributors; private-
to the United States (U.S.) and other Food and Drug Administration (FDA) label distributors; jobbers; brokers;
countries. The World Health that administer or use the Covered warehouses and wholesale drug
Organization declared the Ebola Virus Countermeasure under an warehouses; independent wholesale
Disease Outbreak as a Public Health investigational new drug application drug traders; and retail pharmacies.
Emergency of International Concern (IND) and that are directly supported by A program planner means a state or
under the framework of the the U.S. The Secretary specifies that the local government, including an Indian
International Health Regulations (2005). term ‘‘directly supported’’ in this tribe; a person employed by the state or
Unless otherwise noted, all statutory Declaration means that the United local government; or other person who
citations below are to the U.S. Code. States has provided some form of supervises or administers a program
tangible support such as supplies, with respect to the administration,
Section I, Determination of Public dispensing, distribution, provision, or
funds, products, technical assistance, or
Health Emergency or Credible Risk of use of a Covered Countermeasure,
staffing. This condition is intended to
Future Public Health Emergency including a person who establishes
afford liability immunity only to
mstockstill on DSK4VPTVN1PROD with NOTICES

Before issuing a Declaration under the activities related to clinical trials using requirements, provides policy guidance,
PREP Act, the Secretary is required to the Covered Countermeasure being or supplies technical or scientific advice
determine that a disease or other health conducted in the U.S. and West Africa or assistance or provides a facility to
condition or threat to health constitutes that are directly supported by the U.S. administer or use a Covered
a public health emergency or that there Countermeasure in accordance with the
is a credible risk that the disease, Section IV, Liability Immunity Secretary’s Declaration. Under this
condition, or threat may in the future The Secretary must also state that definition, a private-sector employer or
constitute such an emergency. This liability protections available under the community group or other ‘‘person’’ can

VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1
76538 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices

be a program planner when it carries out PHS Act that: (i)(a) The Secretary Activities related to clinical trials
the described activities. determines to be a priority to diagnose, permitted to proceed after FDA review,
A qualified person means a licensed mitigate, prevent, or treat harm from any that administer or use the Covered
health professional or other individual biological, chemical, radiological, or Countermeasure under an IND, and
authorized to prescribe, administer, or nuclear agent identified as a material directly supported by the U.S., as
dispense Covered Countermeasures threat by the Secretary of Homeland described in Section III of this
under the law of the state in which the Security, or (b) to diagnose, mitigate, Declaration, through present or future
countermeasure was prescribed, prevent, or treat harm from a condition federal contracts, cooperative
administered, or dispensed; or a person that may result in adverse health agreements, grants, other transactions,
within a category of persons identified consequences or death and may be interagency agreements, or memoranda
as qualified in the Secretary’s caused by administering a drug, of understanding or other federal
Declaration. Under this definition, the biological product, or device against agreements or arrangements.
Secretary can describe in the such an agent; and (ii) is determined by This limitation is intended to afford
Declaration other qualified persons, the Secretary of Health and Human liability immunity to activities that are
such as volunteers, who are Covered Services to be a necessary related to clinical trials permitted to
Persons. Section V describes other countermeasure to protect public health. proceed after FDA review that
qualified persons covered by this To be a Covered Countermeasure, administer or use the Covered
Declaration. qualified pandemic or epidemic Countermeasure under an IND and that
The PREP Act also defines the word products or security countermeasures are directly supported by the U.S. As
‘‘person’’ as used in the Act: A person also must be approved or cleared under stated in Section III of the Declaration,
includes an individual, partnership, the FD&C Act; licensed under the PHS the term ‘‘directly support’’ means that
corporation, association, entity, or Act; or authorized for emergency use the U.S. has provided some form of
public or private corporation, including under sections 564, 564A, or 564B of the tangible support such as supplies,
a federal, State, or local government FD&C Act. funds, products, technical assistance, or
agency or department. Section V A qualified pandemic or epidemic staffing. As of the date of this
describes Covered Persons under the product also may be a Covered Declaration, activities primarily are
Declaration, including Qualified Countermeasure when it is subject to an those with a direct connection to the
Persons. exemption (that is, it is permitted to be conduct of clinical trials in the U.S. and
used under an Investigational Drug West Africa, but this Declaration also
Section VI, Covered Countermeasures
Application or an Investigational Device would apply to use in qualifying
As noted above, section III describes Exemption) under the FD&C Act and is clinical trials outside those areas.
the Secretary’s Recommended Activities the object of research for possible use For governmental program planners
for which liability immunity is in effect. for diagnosis, mitigation, prevention, only, liability immunity is afforded only
Section VI identifies the treatment, or cure, or to limit harm of to the extent they obtain Covered
countermeasures for which the a pandemic or epidemic or serious or Countermeasures through voluntary
Secretary has recommended such life-threatening condition caused by means, such as (1) donation; (2)
activities. The PREP Act states that a such a drug or device. A security commercial sale; (3) deployment of
Covered Countermeasure must be: A countermeasure also may be a Covered Covered Countermeasures from federal
‘‘qualified pandemic or epidemic Countermeasure if it may reasonably be stockpiles; or (4) deployment of
product,’’ or a ‘‘security determined to qualify for approval or donated, purchased, or otherwise
countermeasure,’’ as described licensing within 10 years after the voluntarily obtained Covered
immediately below; or a drug, biological Department’s determination that Countermeasures from State, local, or
product or device authorized for procurement of the countermeasure is private stockpiles.
emergency use in accordance with appropriate. This last limitation on distribution is
sections 564, 564A, or 564B of the FD&C Section VI lists the Ebola Virus intended to deter program planners that
Act. Disease Therapeutics that are Covered are government entities from seizing
A qualified pandemic or epidemic Countermeasures. Section VI also refers privately held stockpiles of Covered
product means a drug or device, as to the statutory definitions of Covered Countermeasures. It does not apply to
defined in the FD&C Act or a biological Countermeasures to make clear that any other Covered Persons, including
product, as defined in the PHS Act that these statutory definitions limit the other program planners who are not
is: (i) Manufactured, used, designed, scope of Covered Countermeasures. government entities.
developed, modified, licensed or Specifically, the Declaration notes that
procured to diagnose, mitigate, prevent, Covered Countermeasures must be Section VIII, Category of Disease,
treat, or cure a pandemic or epidemic or ‘‘qualified pandemic or epidemic Health Condition, or Threat
limit the harm such a pandemic or products, or security countermeasures, The Secretary must identify, for each
epidemic might otherwise cause; (ii) or drugs, biological products, or devices Covered Countermeasure, the categories
manufactured, used, designed, authorized for investigational or of diseases, health conditions, or threats
developed, modified, licensed, or emergency use, as those terms are to health for which the Secretary
procured to diagnose, mitigate, prevent, defined in the PREP Act, the FD&C Act, recommends the administration or use
treat, or cure a serious or life- and the Public Health Service Act.’’ of the countermeasure. In Section VIII,
threatening disease or condition caused the Secretary states that the disease
Section VII, Limitations on Distribution
mstockstill on DSK4VPTVN1PROD with NOTICES

by such a drug, biological product, or threat for which she recommends
device; (iii) or a product or technology The Secretary may specify that administration or use of the Covered
intended to enhance the use or effect of liability immunity is in effect only to Countermeasures is Ebola virus disease.
such a drug, biological product, or Covered Countermeasures obtained
device. through a particular means of Section IX, Administration of Covered
A security countermeasure is a drug distribution. The Declaration states that Countermeasures
or device, as defined in the FD&C Act liability immunity is afforded to The PREP Act does not explicitly
or a biological product, as defined in the Covered Persons for Recommended define the term ‘‘administration’’ but

VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1
Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76539

does assign the Secretary the and-fall with no direct connection to the the countermeasure is either used or
responsibility to provide relevant countermeasure’s administration or use. administered in the geographic areas or
conditions in the Declaration. In Section In each case, whether immunity is the program planner or qualified person
IX, the Secretary defines applicable will depend on the particular reasonably could have believed the
‘‘Administration of a Covered facts and circumstances. countermeasure was used or
Countermeasure:’’ administered in the areas. Section XI
Administration of a Covered Section X, Population
includes these statutory conditions in
Countermeasure means physical The Secretary must identify, for each the Declaration for clarity.
provision of the countermeasures to Covered Countermeasure specified in a
recipients, or activities and decisions Declaration, the population or Section XII, Effective Time Period
directly relating to public and private populations of individuals for which The Secretary must identify for each
delivery, distribution, and dispensing of liability immunity is in effect with Covered Countermeasure the period or
the countermeasures to recipients; respect to administration or use of the periods during which liability immunity
management and operation of countermeasure. This section explains is in effect, designated by dates,
countermeasure programs; or which individuals should use the milestones, or other description of
management and operation of locations countermeasure or to whom the events, including factors specified in the
for purpose of distributing and countermeasure should be PREP Act. Section XII identifies the
dispensing countermeasures. administered—in short, those who effective time period. The effective time
The definition of ‘‘administration’’ should be vaccinated or take a drug or period commences at the start of clinical
extends only to physical provision of a other countermeasure. Section X trials permitted to proceed after FDA
countermeasure to a recipient, such as provides that the population includes review that administer or use the
vaccination or handing drugs to ‘‘any individual who uses or who is Covered Countermeasure under an IND
patients, and to activities related to administered a Covered Countermeasure and that are directly supported by the
management and operation of programs in accordance with the Declaration.’’ U.S., as described in Section III of the
and locations for providing In addition, the PREP Act specifies Declaration. Liability immunity is
countermeasures to recipients, such as that liability immunity is afforded to afforded to claims arising from such
decisions and actions involving security manufacturers and distributors without administration or use of the Covered
and queuing, but only insofar as those regard to whether the countermeasure is Countermeasures after that date that
activities directly relate to the used by or administered to this have a causal relationship with any of
countermeasure activities. Claims for Population and to program planners and the Recommended Activities stated in
which Covered Persons are provided qualified persons when the this Declaration. Section XII is amended
immunity under the Act are losses countermeasure is either used by or to extend the effective time period an
caused by, arising out of, relating to, or administered to this population or the additional twelve (12) months.
resulting from the administration to or program planner or qualified person
Section XIII, Additional Time Period of
use by an individual of a Covered reasonably could have believed the
Coverage
Countermeasure consistent with the recipient was in this population.
terms of a Declaration issued under the Section X includes these statutory The Secretary must specify a date
Act. Under the Secretary’s definition, conditions in the Declaration for clarity. after the ending date of the effective
these liability claims are precluded if period of the Declaration that is
Section XI, Geographic Area reasonable for manufacturers to arrange
the claims allege an injury caused by
physical provision of a countermeasure The Secretary must identify, for each for disposition of the Covered
to a recipient, or if the claims are Covered Countermeasure specified in Countermeasure, including return of the
directly due to conditions of delivery, the Declaration, the geographic area or product to the manufacturer, and for
distribution, dispensing, or management areas for which liability immunity is in other Covered Persons to take
and operation of countermeasure effect with respect to administration or appropriate actions to limit
programs at distribution and dispensing use of the countermeasure, including, as administration or use of the Covered
sites. appropriate, whether the Declaration Countermeasure. In addition, the PREP
Thus, it is the Secretary’s applies only to individuals physically Act specifies that for Covered
interpretation that, when a Declaration present in the area or, in addition, Countermeasures that are subject to a
is in effect, the Act precludes, for applies to individuals who have a Declaration at the time they are obtained
example, liability claims alleging described connection to the area. for the Strategic National Stockpile
negligence by a manufacturer in creating Section XI provides that liability (SNS) under 42 U.S.C. 247d–6b(a), the
a therapeutic, or negligence by a health immunity is afforded for the effective period of the Declaration
care provider in prescribing the wrong administration or use of a Covered extends through the time the
dose, absent willful misconduct. Countermeasure without geographic countermeasure is used or administered
Likewise, the Act precludes a liability limitation. This could include claims pursuant to a distribution or release
claim relating to the management and related to administration or use in West from the SNS. Liability immunity under
operation of a countermeasure Africa. It is possible that claims may the provisions of the PREP Act and the
distribution program or site, such as a arise in regard to administration or use conditions of the Declaration continues
slip-and-fall injury or vehicle collision of the Covered Countermeasures outside during these additional time periods.
by a recipient receiving a the U.S. that may be resolved under U.S. Thus, liability immunity is afforded
mstockstill on DSK4VPTVN1PROD with NOTICES

countermeasure at a retail store serving law. during the ‘‘Effective Time Period,’’
as an administration or dispensing In addition, the PREP Act specifies described under XII of the Declaration,
location that alleges, for example, lax that liability immunity is afforded to plus the ‘‘Additional Time Period’’
security or chaotic crowd control. manufacturers and distributors without described under section XIII of the
However, a liability claim alleging an regard to whether the countermeasure is Declaration.
injury occurring at the site that was not used by or administered to individuals Section XIII provides for twelve (12)
directly related to the countermeasure in the geographic areas and to program months as the additional time period of
activities is not covered, such as a slip- planners and qualified persons when coverage after expiration of the

VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1
76540 Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices

Declaration. Section XIII also explains and Emergency Preparedness (PREP) employees, as those terms are defined in
the extended coverage that applies to Act for Ebola Virus Disease the PREP Act, and the U.S. In addition,
products obtained for the SNS during Therapeutics. To the extent any term of I have determined that the following
the effective period of the Declaration. the February 27, 2015, Declaration is additional persons are qualified
inconsistent with any provision of this persons: Any person authorized to
Section XIV, Countermeasures Injury
Republished Declaration, the terms of prescribe, administer, or dispense the
Compensation Program
this Republished Declaration are Covered Countermeasures or who is
Section 319F–4 of the PREP Act controlling. otherwise authorized to perform an
authorizes the Countermeasures Injury
Compensation Program (CICP) to I. Determination of Public Health activity to carry out clinical trials
provide benefits to eligible individuals Emergency or Credible Risk of Future permitted to proceed after FDA review
who sustain a serious physical injury or Public Health Emergency that administer or use the Covered
die as a direct result of the 42 U.S.C. 247d–6d(b)(1) Countermeasure under an IND and that
administration or use of a Covered are directly supported by the United
I have determined that there is a States, as described in Section III of this
Countermeasure. Compensation under
credible risk that the spread of Ebola Declaration.
the CICP for an injury directly caused by
virus and the resulting disease or
a Covered Countermeasure is based on
conditions may in the future constitute VI. Covered Countermeasures
the requirements set forth in this
a public health emergency.
Declaration, the administrative rules for 42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C.
the Program, and the statute. To show II. Factors Considered 247d–6d(i)(1) and (7)
direct causation between a Covered
42 U.S.C. 247d–6d(b)(6) Covered Countermeasures are the
Countermeasure and a serious physical
injury, the statute requires ‘‘compelling, I have considered the desirability of following Ebola Virus Disease
reliable, valid, medical and scientific encouraging the design, development, Therapeutics: ZMapp monoclonal
evidence.’’ clinical testing, or investigation, antibody therapeutic.
The administrative rules for the manufacture, labeling, distribution,
Covered Countermeasures must be
Program further explain the necessary formulation, packaging, marketing,
promotion, sale, purchase, donation, ‘‘qualified pandemic or epidemic
requirements for eligibility under the
dispensing, prescribing, administration, products,’’ or ‘‘security
CICP. Please note that, by statute,
requirements for compensation under licensing, and use of the Covered countermeasures,’’ or drugs, biological
the CICP may not always align with the Countermeasures. products, or devices authorized for
requirements for liability immunity investigational or emergency use, as
III. Recommended Activities those terms are defined in the PREP Act,
provided under the PREP Act. Section
XIV, Countermeasures Injury 42 U.S.C. 247d–6d(b)(1) the FD&C Act, and the Public Health
Compensation Program explains the I recommend the manufacture, Service Act.
types of injury and standard of evidence testing, development, distribution, VII. Limitations on Distribution
needed to be considered for administration, and use of the Covered
compensation under the CICP. Countermeasures under the conditions 42 U.S.C. 247d–6d(a)(5) and (b)(2)(E)
Further, the administrative rules for stated in this Declaration, including the
the CICP specify if countermeasures are I have determined that liability
condition that the activities relate to
administered or used outside the U.S., immunity is afforded to Covered
clinical trials permitted to proceed after
only otherwise eligible individuals at Persons only for Recommended
review by the Food and Drug
American embassies, military Activities involving Covered
Administration (FDA) that administer or
installations abroad (such as military use the Covered Countermeasure under Countermeasures that are related to
bases, ships, and camps) or at North an IND application and that are directly clinical trials permitted to proceed after
Atlantic Treaty Organization (NATO) supported by the U.S. The term FDA review that administer or use the
installations (subject to the NATO ‘‘directly supported’’ in this Declaration Covered Countermeasure under an IND
Status of Forces Agreement) where means that the U.S. has provided some and that are directly supported by the
American servicemen and form of tangible support such as United States, as described in Section III
servicewomen are stationed may be supplies, funds, products, technical of this Declaration, through present or
considered for CICP benefits. Other assistance, or staffing. future federal contracts, cooperative
individuals outside the U.S. may not be agreements, grants, other transactions,
eligible for CICP benefits. IV. Liability Immunity interagency agreements, memoranda of
Section XV, Amendments 42 U.S.C. 247d–6d(a), 247d–6d(b)(1) understanding, or other federal
Liability immunity as prescribed in agreements or arrangements.
This is the first amendment to the
February 27, 2015, Declaration (80 FR the PREP Act and conditions stated in I have also determined that for
73314). The Secretary may amend any this Declaration is in effect for the governmental program planners only,
portion of a Declaration through Recommended Activities described in liability immunity is afforded only to
publication in the Federal Register. section III. the extent such program planners obtain
V. Covered Persons Covered Countermeasures through
Republished Declaration
voluntary means, such as (1) donation;
mstockstill on DSK4VPTVN1PROD with NOTICES

Declaration, as Amended, Public 42 U.S.C. 247d–6d(i)(2), (3), (4), (6), (2) commercial sale; (3) deployment of
Readiness and Emergency (8)(A) and (B) Covered Countermeasures from federal
Preparedness Act Coverage for Ebola Covered Persons who are afforded stockpiles; or (4) deployment of
Virus Disease Therapeutics liability immunity under this donated, purchased, or otherwise
This Declaration amends and Declaration are manufacturers, voluntarily obtained Covered
republishes the February 27, 2015 for distributors, program planners, qualified Countermeasures from State, local, or
coverage under the Public Readiness persons, and their officials, agents, and private stockpiles.

VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1
Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices 76541

VIII. Category of Disease, Health XII. Effective Time Period Dated: December 1, 2015.
Condition, or Threat Sylvia M. Burwell,
42 U.S.C. 247d–6d(b)(2)(B)
Secretary.
42 U.S.C. 247d–6d(b)(2)(A)
Liability immunity for Covered [FR Doc. 2015–31089 Filed 12–8–15; 8:45 am]
The category of disease, health Countermeasures began on February 27, BILLING CODE P
condition, or threat for which I
2015, and extends for twenty-four (24)
recommend the administration or use of
months.
the Covered Countermeasures is Ebola DEPARTMENT OF HEALTH AND
virus disease. XIII. Additional Time Period of HUMAN SERVICES
IX. Administration of Covered Coverage
Office of the Secretary
Countermeasures 42 U.S.C. 247d–6d(b)(3)(B) and (C)
42 U.S.C. 247d–6d(a)(2)(B) Ebola Virus Disease Vaccines—
I have determined that an additional Amendment
Administration of the Covered twelve (12) months of liability
Countermeasure means physical protection is reasonable to allow for the ACTION: Notice of Amendment to the
provision of the countermeasures to manufacturer(s) to arrange for December 3, 2014 Declaration under the
recipients, or activities and decisions disposition of the Covered Public Readiness and Emergency
directly relating to public and private Countermeasure, including return of the Preparedness Act.
delivery, distribution and dispensing of Covered Countermeasures to the
the countermeasures to recipients, SUMMARY: The Secretary is amending the
manufacturer, and for Covered Persons Declaration issued pursuant to section
management and operation of to take such other actions as are
countermeasure programs, or 319F–3 of the Public Health Service Act
appropriate to limit the administration (42 U.S.C. 247d–6d) on December 3,
management and operation of locations or use of the Covered Countermeasures.
for purpose of distributing and 2014 (79 FR 73314) to extend the
dispensing countermeasures. Covered Countermeasures obtained effective time period for an additional
for the SNS during the effective period twelve (12 months) to clarify the list of
X. Population of this Declaration are covered through Covered Countermeasures, and to clarify
42 U.S.C. 247d–6d(a)(4), 247d– the date of administration or use Covered Persons consistent with the
6d(b)(2)(C) pursuant to a distribution or release terms of the declaration and
from the SNS. republishing the Declaration in its
The populations of individuals entirety as amended.
include any individual who uses or is XIV. Countermeasures Injury DATES: The Amended Declaration is
administered the Covered Compensation Program effective as of December 3, 2015.
Countermeasures in accordance with
42 U.S.C 247d–6e FOR FURTHER INFORMATION CONTACT:
this Declaration.
Nicole Lurie, MD, MSPH, Assistant
Liability immunity is afforded to The PREP Act authorizes the Secretary for Preparedness and
manufacturers and distributors without Countermeasures Injury Compensation Response, Office of the Secretary,
regard to whether the countermeasure is
Program (CICP) to provide benefits to Department of Health and Human
used by or administered to this
certain individuals or estates of Services, 200 Independence Avenue
population; liability immunity is
individuals who sustain a covered SW., Washington, DC 20201, Telephone
afforded to program planners and
serious physical injury as the direct 202–205–2882.
qualified persons when the
countermeasure is used by or result of the administration or use of the SUPPLEMENTARY INFORMATION:
administered to this population, or the Covered Countermeasures, and benefits
Background
program planner or qualified person to certain survivors of individuals who
die as a direct result of the The Public Readiness and Emergency
reasonably could have believed the Preparedness Act (PREP Act) authorizes
recipient was in this population. administration or use of the Covered
Countermeasures. The causal the Secretary of Health and Human
XI. Geographic Area connection between the countermeasure Services (the Secretary) to issue a
and the serious physical injury must be Declaration to provide liability
42 U.S.C. 247d–6d(a)(4), 247d– immunity to certain individuals and
6d(b)(2)(D) supported by compelling, reliable, valid,
medical and scientific evidence in order entities (Covered Persons) against any
Liability immunity is afforded for the claim of loss caused by, arising out of,
for the individual to be considered for
administration or use of a Covered relating to, or resulting from the
compensation. The CICP is
Countermeasure without geographic administration or use of medical
administered by the Health Resources
limitation. countermeasures (Covered
Liability immunity is afforded to and Services Administration, within the Countermeasures), except for claims
manufacturers and distributors without Department of Health and Human that meet the PREP Act’s definition of
regard to whether the countermeasure is Services. Information about the CICP is willful misconduct. The Secretary may,
used by or administered in any available by telephone at 855–266–2427 though publication in the Federal
designated geographic area; liability (toll-free) or http://www.hrsa.gov/cicp/. Register, amend any portion of a
mstockstill on DSK4VPTVN1PROD with NOTICES

immunity is afforded to program XV. Amendments Declaration. Using this authority, the
planners and qualified persons when Secretary is amending the Declaration
the countermeasure is used by or 42 U.S.C. 247d–6d(b)(4) that provides liability immunity to
administered in any designated Covered Persons for activities related to
geographic area, or the program planner Any amendments to this Declaration the Covered Countermeasures, Ebola
or qualified person reasonably could will be published in the Federal Virus Disease Vaccines listed in Section
have believed the recipient was in that Register. VI of the Declaration, to extend the
geographic area. Authority: 42 U.S.C. 247d–6d. effective time period for an additional

VerDate Sep<11>2014 18:21 Dec 08, 2015 Jkt 238001 PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 E:\FR\FM\09DEN1.SGM 09DEN1
Document Created: 2015-12-14 13:33:06
Document Modified: 2015-12-14 13:33:06
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of Amendment to the February 27, 2015, Declaration under the Public Readiness and Emergency Preparedness Act.
Dates		The Amended Declaration is effective as of February 27, 2016.
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.
FR Citation		80 FR 76536
80 FR 76536 - Ebola Virus Disease Therapeutics-Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 80, Issue 236 (December 9, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
