[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Notices]
[Pages 21819-21825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09455]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Nerve Agents and Certain Insecticides (Organophosphorus and/or 
Carbamate) Countermeasures

AGENCY: Department of Health and Human Services, Office of the 
Secretary.

ACTION: Notice.

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SUMMARY: The Secretary is issuing a declaration pursuant to section 
319F-3 of the Public Health Service Act to

[[Page 21820]]

provide liability protections consistent with that authority for 
medical countermeasures against nerve agents and organophosphorus 
insecticides that result in organophosphorus poisoning and carbamate 
insecticides that result in carbamate poisoning.

DATES: The declaration is effective as of April 11, 2017.

FOR FURTHER INFORMATION CONTACT: George W. Korch Jr., Ph.D., Acting 
Assistant Secretary for Preparedness and Response, Office of the 
Secretary, Department of Health and Human Services, 200 Independence 
Avenue SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not 
a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

    The Public Readiness and Emergency Preparedness Act (PREP Act) 
authorizes the Secretary of the U.S. Department 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. Using this authority, the Secretary is issuing 
this declaration for medical countermeasures against nerve agents and 
organophosphorus insecticides that result in organophosphorus poisoning 
and carbamate insecticides that result in carbamate poisoning. The 
purpose of issuing this declaration is to strengthen preparedness 
against these threats that pose an ongoing credible risk of a future 
public health emergency and does not indicate a change in threat 
information.
    The declaration is published in full. We explain both the 
substantive and format changes in this supplementary section.
    The PREP Act was enacted on December 30, 2005 as Public Law 109-
148, Division C, Section 2. It amended the Public Health Service 
(``PHS'') Act, adding section 319F-3, which addresses liability 
immunity, and section 319F-4, which creates a compensation program. 
These sections are codified in the U.S. Code as 42 U.S.C. 247d-6d and 
42 U.S.C. 247d-6e, respectively. The Pandemic and All-Hazards 
Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, was 
enacted on March 13, 2013. Among other things, PAHPRA added sections 
564A and 564B to the Federal Food, Drug & Cosmetic (FD&C) Act to 
provide new emergency authorities for dispensing approved products in 
emergencies and products held for emergency use. PAHPRA accordingly 
amended the definitions of Covered Countermeasures and qualified 
pandemic and epidemic products in section 319F-3 of the Public Health 
Service Act (the PREP Act provisions), so that products made available 
under these new FD&C Act authorities could be covered under PREP Act 
declarations. PAHPRA also extended the definition of qualified pandemic 
and epidemic products 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.
    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.\1\ This determination is separate 
and apart from a declaration issued by the Secretary under section 319 
of the PHS Act \2\ 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. The declaration states in section I the 
Secretary's determination that there is a credible risk that the 
release of nerve agents or organophosphorus insecticides and the 
resulting organophosphorus poisoning or the release of carbamate 
insecticides and the resulting carbamate poisoning may, in the future, 
constitute a public health emergency.
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    \1\ 42 U.S.C. 247d-6d(b)(1).
    \2\ 42 U.S.C. 247d.
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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.\3\ The declaration states these considerations in 
section II.
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    \3\ 42 U.S.C. 247d-6d(b)(6).
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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).\4\ The 
declaration states the Recommended Activities in section III.
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    \4\ 42 U.S.C. 247d-6d(b)(1).
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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.\5\ 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.'' \6\ The declaration includes the statement that 
liability immunity is in effect for Recommended Activities in section 
IV.
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    \5\ 42 U.S.C. 247d-6d(b)(1).
    \6\ 42 U.S.C. 247d-6d(a)(1).
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Section V, Covered Persons

    The PREP Act's liability immunity applies to Covered Persons with 
respect to administration or use of a Covered Countermeasure. The term 
``Covered Persons'' has a specific meaning, and is defined in the PREP 
Act to include manufacturers, distributors, program planners, and 
qualified persons, and their officials, agents, and employees, and the 
United States.\7\ The PREP Act further defines the terms 
``manufacturer,'' ``distributor,'' ``program planner,'' and ``qualified 
person'' as described below.\8\
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    \7\ 42 U.S.C. 247d-6d(i)(2).
    \8\ 42 U.S.C. 247d-6d(i).
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    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,

[[Page 21821]]

affiliates, successors, and assigns of a manufacturer; \9\
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    \9\ 42 U.S.C. 247d-6d(i)(4).
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    A distributor means a person or entity engaged in the distribution 
of drugs, 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; \10\
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    \10\ 42 U.S.C. 247d-6d(i)(3).
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    A program planner means a state or local government, including a 
Native American 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.\11\ 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.
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    \11\ 42 U.S.C. 247d-6d(i)(6).
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    A qualified person means a licensed health professional or other 
individual who is authorized to prescribe, administer, or dispense 
Covered Countermeasures under the law of the state in which the 
countermeasure was prescribed, administered, or dispensed; or, a person 
within a category of persons identified as qualified in the Secretary's 
declaration.\12\ 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.
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    \12\ 42 U.S.C. 247d-6d(i)(8).
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    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.\13\
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    \13\ 42 U.S.C. 247d-6d(i)(5).
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    The declaration lists Covered Persons in section V to include 
manufacturers, distributors, program planners, qualified persons, and 
their officials, agents, and employees, as those terms are defined in 
the PREP Act, and the United States.
    The declaration also lists in section V Additional Covered Persons 
to include: (a) Any person authorized in accordance with the public 
health and medical emergency response of the Authority Having 
Jurisdiction, . . . to prescribe, administer, deliver, distribute or 
dispense the Covered Countermeasures, and their officials, agents, 
employees, contractors and volunteers, following a declaration of an 
emergency; (b) any person authorized to prescribe, administer, or 
dispense the Covered Countermeasures or who is otherwise authorized to 
perform an activity under an Emergency Use Authorization in accordance 
with section 564 of the FD&C Act; and, (c) any person authorized to 
prescribe, administer, or dispense Covered Countermeasures in 
accordance with Section 564A of the FD&C Act.

Section VI, Covered Countermeasures

    As noted above, section III describes the Secretary's Recommended 
Activities for which liability immunity is in effect. This section 
identifies the countermeasures for which the Secretary has recommended 
such activities. The PREP Act states that a Covered Countermeasure must 
be a ``qualified pandemic or epidemic product,'' or a ``security 
countermeasure,'' as described immediately below; or a drug, biological 
product or device authorized for emergency use in accordance with 
section 564, 564A, or 564B of the FD&C Act.\14\
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    \14\ 42 U.S.C. 247d-6d(i)(1). Sections 564, 564A, and 564B of 
the FD&C Act may be found at 21 U.S.C. 360bbb-3, 360bbb-3a, and 
360bbb-3b.
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    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 \15\ 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.\16\
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    \15\ 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i).
    \16\ 42 U.S.C. 247d-6d(i)(1)(A), (i)(7).
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    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 \17\ 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.\18\
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    \17\ 21 U.S.C. 321(g)(1), (h);42 U.S.C. 262(i).
    \18\ 42 U.S.C. 247d-6d(i)(1)(B),(c)(1)(B).
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    To be a Covered Countermeasure, qualified pandemic or epidemic 
products and security countermeasures also must be approved or cleared 
under the FD&C Act; \19\ licensed under the PHS Act; \20\ authorized 
for emergency use under sections 564, 564A, or 564B of the FD&C 
Act.\21\ A qualified pandemic or epidemic product also may be a Covered 
Countermeasure when it is exempted under the FD&C Act for use as an 
investigational drug or device \22\ that is the object of research for 
possible use for diagnosis, mitigation, prevention, treatment, cure or 
limit harm of a pandemic or epidemic or serious or life-threatening 
condition caused by such a drug or device. A security countermeasure 
also may be a Covered Countermeasure if it may reasonably be determined 
to qualify for approval or licensing within ten years after the 
Department's determination that procurement of the countermeasure is 
appropriate.
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    \19\ 21 U.S.C. 301 et seq.
    \20\ 42 U.S.C. 262.
    \21\ 21 U.S.C. 360bbb-3, 360bbb-3a, 360bbb-3b.
    \22\ 21 U.S.C. 355(i), 360j(g).
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    The declaration describes the Covered Countermeasures in Section VI 
as: Any antidote; any other drug; all components and constituent 
materials of these antidotes and other drugs; all devices and their 
constituent components used in the administration of these antidotes 
and other drugs; any diagnostic; or any other device to identify, 
prevent, or treat organophosphorus or carbamate poisoning or adverse 
events from such countermeasures.
    The declaration also includes in section VI a statement referencing 
the statutory definitions of Covered Countermeasures to make clear that 
these statutory definitions limit the scope of Covered Countermeasures.

Section VII, Limitations on Distribution

    The Secretary may specify that liability immunity is in effect only 
to Covered Countermeasures obtained

[[Page 21822]]

through a particular means of distribution.\23\
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    \23\ 42 U.S.C. 247d-6d(a)(5), (b)(2)(E).
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    The declaration states in section VII that liability immunity is 
afforded to Covered Persons for Recommended Activities related to: (a) 
Present or future Federal contracts, cooperative agreements, grants, 
other transactions, interagency agreements, or memoranda of 
understanding or other Federal agreements or activities directly 
conducted by the Federal Government; or (b) Activities authorized in 
accordance with the public health and medical response of the Authority 
Having Jurisdiction to prescribe, administer, deliver, distribute, or 
dispense the Covered Countermeasures to respond to an event covered by 
a declared emergency, including authorized activities that occur as 
part of the response before the formal declaration of an emergency. The 
declaration also provides in section VII definitions for ``Authority 
Having Jurisdiction'' and ``Declaration of an Emergency:''
    i. The Authority Having Jurisdiction means the public agency or its 
delegate that has legal responsibility and authority for responding to 
an incident, based on political or geographical (e.g., city, county, 
Tribal, State, or Federal boundary lines) or functional (e.g., law 
enforcement, public health) range or sphere of authority.
    ii. A declaration of emergency means any declaration by any 
authorized local, regional, State, or Federal official of an emergency 
specific to events that indicate an immediate need to administer and 
use the Covered Countermeasures, with the exception of a Federal 
declaration in support of an Emergency Use Authorization under section 
564 of the FD&C Act unless such declaration specifies otherwise;
    Subsection (b) is intended to cover distribution, dispensing, 
administration, or use of the covered countermeasure under a formal 
government-authorized response to circumstances at any time those 
activities occur to respond to an event that gives rise to a declared 
emergency. Subsection (b) is not intended to be limited to cover those 
activities only after an emergency is formally declared and includes 
authorized activities that occur as part of the response before the 
formal declaration of an emergency. The Secretary recognizes that in 
emergency circumstances, distribution, dispensing, administration, or 
use of countermeasures may need to be expedient and may occur prior to 
a formal declaration of an emergency. This concern is particularly 
critical for the countermeasures covered by this declaration, where the 
Covered Countermeasures may need to be administered within minutes of 
exposure to a nerve agent to save lives. Thus, the Secretary is 
clarifying that coverage under subsection (b) is intended to cover any 
distribution, dispensing, administration, or use in accordance with the 
Authority Having Jurisdiction at any time that those activities address 
the emergency circumstances that gave rise to the declared emergency 
even if the activities occur prior to the declaration itself.
    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 
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.\24\ The declaration states in section VIII that the 
category of disease, health condition, or threat for which the 
Secretary recommends administration or use of the countermeasures is 
organophosphorus or carbamate poisoning.
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    \24\ 42 U.S.C. 247d-6d(b)(2)(A).
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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. The declaration defines administration 
in section IX as: 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.
    This definition of ``administration'' is intended to extend 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.\25\ 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.
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    \25\ 42 U.S.C. 247d-6d(a).
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    Thus, it is the Secretary's interpretation that, when a declaration 
is in effect, the Act precludes, for example, liability claims alleging 
negligence by a manufacturer in creating a vaccine, or negligence by a 
health care provider in prescribing the wrong dose, absent willful 
misconduct. Likewise, the Act precludes a liability claim relating to 
the management and operation of a countermeasure distribution program 
or site, such as a slip-and-fall injury or vehicle collision by a 
recipient receiving a countermeasure at a retail store serving as an 
administration or dispensing location that alleges, for example, lax 
security or chaotic crowd control. However, a liability claim alleging 
an injury occurring at the site that was not directly related to the 
countermeasure activities is not covered, such as a slip and fall with 
no direct connection to the countermeasure's administration or use. In 
each case, whether immunity is applicable will depend on the particular 
facts and circumstances.

[[Page 21823]]

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.\26\ 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. The declaration 
provides in section X that the population includes any individual who 
uses or who is administered a Covered Countermeasure in accordance with 
the declaration.
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    \26\ 42 U.S.C. 247d-6d(b)(2)(C).
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    In addition, the PREP Act specifies that liability immunity is 
afforded: (1) To manufacturers and distributors without regard to 
whether the countermeasure is used by or administered to this 
population; and (2) to program planners and qualified persons when the 
countermeasure is either used by or administered to this population or 
the program planner or qualified person reasonably could have believed 
the recipient was in this population.\27\ We included these statutory 
conditions in the declaration section X for clarity.
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    \27\ 42 U.S.C. 247d-6d(a)(4).
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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.\28\ The declaration states in section XI that there are no 
limitations on geographic area.
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    \28\ 42 U.S.C. 247d-6d(b)(2)(D).
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    In addition, the PREP Act specifies that liability immunity is 
afforded: (1) To manufacturers and distributors without regard to 
whether the countermeasure is used by or administered to individuals in 
the geographic areas; and (2) to program planners and qualified persons 
when the countermeasure is either used or administered in the 
geographic areas or the program planner or qualified person reasonably 
could have believed the countermeasure was used or administered in the 
areas.\29\ We included these statutory conditions in the declaration 
section XI for clarity.
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    \29\ 42 U.S.C. 247d-6d(a)(4).
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Section XII, Effective Time Period

    The Secretary must identify, for each Covered Countermeasure, the 
period or periods during which liability immunity is in effect, 
designated by dates, milestones, or other description of events, 
including factors specified in the PREP Act.\30\
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    \30\ 42 U.S.C. 246d-6d(b)(2)(B), (b)(6).
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    The declaration states in section XII when liability immunity takes 
effect for different means of distribution within that time period.

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.\31\ In addition, the PREP Act 
specifies that for Covered Countermeasures that are subject to a 
declaration at the time they are obtained for the Strategic National 
Stockpile under 42 U.S.C. 247d-6b(a), the effective period of the 
declaration extends through the time the countermeasure is used or 
administered pursuant to a distribution or release from the Stockpile. 
Liability immunity under the provisions of the PREP Act and the 
conditions of the declaration continues during these additional time 
periods. Thus, liability immunity is afforded during the ``Effective 
Time Period,'' described under section XII of the declaration, plus the 
``Additional Time Period of Coverage'' described under section XIII of 
the declaration.
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    \31\ 42 U.S.C. 247d-6d(b)(3).
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    The declaration states in section XIII that the additional time 
period is twelve (12) months and also states that extended coverage 
applies to any products obtained for the Strategic National Stockpile 
during the effective period of the declaration. We included the 
statutory provision for clarity.

Section XIV, Countermeasures Injury Compensation Program

    Section 319F-4 of the PREP Act authorizes a Countermeasures Injury 
Compensation Program (CICP) to provide benefits to eligible individuals 
who sustain a serious physical injury or die as a direct result of the 
administration or use of a Covered Countermeasure.\32\ 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,\33\ and the 
statute.\34\ To show direct causation between a Covered Countermeasure 
and a serious physical injury, the statute requires ``compelling, 
reliable, valid, medical and scientific evidence.'' \35\ 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. The declaration explains in section XIV, ``Countermeasures 
Injury Compensation Program'' the types of injury and standard of 
evidence needed to be considered for compensation under the CICP. 
Further, the administrative rules for the CICP specify if 
countermeasures are administered or used outside the United States, 
only otherwise eligible individuals at American embassies, military 
installations abroad (such as military bases, ships, and camps) or at 
North Atlantic Treaty Organization (NATO) installations (subject to the 
NATO Status of Forces Agreement) where American servicemen and 
servicewomen are stationed may be considered for CICP benefits. Other 
individuals outside the United States may not be eligible for CICP 
benefits.
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    \32\ 42 U.S.C. 247d-6e.
    \33\ 42 CFR part 110.
    \34\ 42 U.S.C. 247d-6e.
    \35\ 42 U.S.C. 247d-6e(b)(4).
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Section XV, Amendments

    The Secretary may amend any portion of a declaration through 
publication in the Federal Register.\36\ The declaration states in 
section XV that any amendments to this declaration will be published in 
the Federal Register.
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    \36\ 42 U.S.C. 247d-6d(b)(4).
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Declaration

Declaration for Public Readiness and Emergency Preparedness Act 
Coverage for Nerve Agents and Certain Insecticides (Organophosphorus 
and/or Carbamate) Countermeasures

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 release of 
nerve agents or organophosphorus insecticides and the resulting 
organophosphorus

[[Page 21824]]

poisoning or release of carbamate insecticides and the resulting 
carbamate poisoning may, in the future, constitute a public health 
emergency.

II. Factors Considered

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

    I have considered the desirability of encouraging the design, 
development, clinical testing or investigation, manufacture, labeling, 
distribution, formulation, packaging, marketing, promotion, sale, 
purchase, donation, dispensing, prescribing, administration, licensing, 
and use of the Covered Countermeasures.

III. Recommended Activities

42 U.S.C. 247d-6d(b)(1)

    I recommend, under the conditions stated in this declaration, the 
manufacture, testing, development, distribution, administration, or use 
of the Covered Countermeasures.

IV. Liability Immunity

42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

    Liability immunity as prescribed in the PREP Act and conditions 
stated in this declaration is in effect for the Recommended Activities 
described in section III.

V. Covered Persons

42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

    Covered Persons who are afforded liability immunity under this 
declaration are ``manufacturers,'' ``distributors,'' ``program 
planners,'' ``qualified persons,'' and their officials, agents, and 
employees, as those terms are defined in the PREP Act, and the United 
States.
    In addition, I have determined that the following additional 
persons are qualified persons: (a) Any person authorized in accordance 
with the public health and medical emergency response of the Authority 
Having Jurisdiction, as described in section VII below, to prescribe, 
administer, deliver, distribute or dispense the Covered 
Countermeasures, and their officials, agents, employees, contractors 
and volunteers, following a declaration of an emergency; (b) Any person 
authorized to prescribe, administer, or dispense the Covered 
Countermeasures or who is otherwise authorized to perform an activity 
under an Emergency Use Authorization in accordance with section 564 of 
the FD&C Act; (c) Any person authorized to prescribe, administer, or 
dispense Covered Countermeasures in accordance with Section 564A of the 
FD&C Act.

VI. Covered Countermeasures

42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

    Covered Countermeasures are: Any antidote; any other drug; all 
components and constituent materials of these antidotes and other 
drugs; all devices and their constituent components used in the 
administration of these antidotes and other drugs; any diagnostic; or 
any other device to identify, prevent, or treat organophosphorus or 
carbamate poisoning or adverse events from such countermeasures.
    Covered Countermeasures must be ``qualified pandemic or epidemic 
products,'' or ``security countermeasures,'' or drugs, biological 
products, or devices authorized for investigational or emergency use, 
as those terms are defined in the PREP Act, the FD&C Act, and the 
Public Health Service Act.

VII. Limitations on Distribution

42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

    I have determined that liability immunity is afforded to Covered 
Persons only for Recommended Activities involving Covered 
Countermeasures that are related to:
    (a) Present or future Federal contracts, cooperative agreements, 
grants, other transactions, interagency agreements, memoranda of 
understanding, or other Federal agreements, or activities directly 
conducted by the Federal Government; or
    (b) Activities authorized in accordance with the public health and 
medical response of the Authority Having Jurisdiction to prescribe, 
administer, deliver, distribute or dispense the Covered Countermeasures 
to respond to an event covered by a declared emergency, including 
authorized activities that occur as part of the response before the 
formal declaration of an emergency.
    i. The Authority Having Jurisdiction means the public agency or its 
delegate that has legal responsibility and authority for responding to 
an incident, based on political or geographical (e.g., city, county, 
Tribal, State, or Federal boundary lines) or functional (e.g., law 
enforcement, public health) range or sphere of authority.
    ii. A declaration of emergency means any declaration by any 
authorized local, regional, State, or Federal official of an emergency 
specific to events that indicate an immediate need to administer and 
use the Covered Countermeasures, with the exception of a Federal 
declaration in support of an Emergency Use Authorization under section 
564 of the FD&C Act unless such declaration specifies otherwise;
    I have also determined that for governmental program planners only, 
liability immunity is afforded only to the extent such program planners 
obtain Covered Countermeasures through voluntary means, such as (1) 
donation; (2) commercial sale; (3) deployment of Covered 
Countermeasures from Federal stockpiles; or (4) deployment of donated, 
purchased, or otherwise voluntarily obtained Covered Countermeasures 
from State, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat

42 U.S.C. 247d-6d(b)(2)(A)

    The category of disease, health condition, or threat for which I 
recommend the administration or use of the Covered Countermeasures is 
organophosphorus or carbamate poisoning.

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.

[[Page 21825]]

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 these geographic areas; liability immunity is afforded to program 
planners and qualified persons when the countermeasure is used by or 
administered in these geographic areas, or the program planner or 
qualified person reasonably could have believed the recipient was in 
these geographic areas.

XII. Effective Time Period

42 U.S.C. 247d-6d(b)(2)(B)

    Liability immunity for Covered Countermeasures obtained through 
means of distribution other than in accordance with the public health 
and medical response of the Authority Having Jurisdiction extends 
through December 31, 2022.
    Liability immunity for Covered Countermeasures administered and 
used in accordance with the public health and medical response of the 
Authority Having Jurisdiction begins on the date the response to an 
event covered by an emergency declaration begins, including authorized 
activities that occur as part of the response before the formal 
declaration of an emergency, and lasts through (1) the final day the 
emergency declaration is in effect or (2) December 31, 2022, whichever 
occurs first.

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(A), (B) and (C)

    I have determined that an additional twelve (12) months of 
liability protection is reasonable to allow for the manufacturer(s) to 
arrange for disposition of the Covered Countermeasure, including return 
of the Covered Countermeasures to the manufacturer, and for Covered 
Persons to take such other actions as are appropriate to limit the 
administration or use of the Covered Countermeasures.
    Covered Countermeasures obtained for the Strategic National 
Stockpile (``SNS'') during the effective period of this declaration for 
Covered Countermeasures obtained through means of distribution other 
than in accordance with the public health and medical response of the 
Authority Having Jurisdiction are covered through the date of 
administration or use pursuant to a distribution or release from the 
SNS.

XIV. Countermeasures Injury Compensation Program

42 U.S.C. 247d-6e

    The PREP Act authorizes a Countermeasures Injury Compensation 
Program (``CICP'') to provide benefits to certain individuals or 
estates of individuals who sustain a serious physical covered injury as 
the direct result of the administration or use of a Covered 
Countermeasure and/or benefits to certain survivors of individuals who 
die as a direct result of the administration or use of the Covered 
Countermeasure. The causal connection between the countermeasure and 
the serious physical injury must be supported by compelling, reliable, 
valid, medical and scientific evidence in order for the individual to 
be considered for compensation. The CICP is administered by the Health 
Resources and Services Administration (``HRSA''), within the Department 
of Health and Human Services. Information about the CICP is available 
at the toll free number 1-855-266-2427 or http://www.hrsa.gov/cicp/.

XV. Amendments

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

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

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

    Dated: May 4, 2017.
Thomas E. Price,
Secretary.
[FR Doc. 2017-09455 Filed 5-9-17; 8:45 am]
BILLING CODE 4150-03-P