[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76506-76514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31087]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Pandemic Influenza Medical Countermeasures--Amendment

ACTION: Notice of Amendment to the October 17, 2008, Declaration under 
the Public Readiness and Emergency Preparedness Act, as amended June 
11, 2009; the December 22, 2008, Declaration under the Public Readiness 
and Emergency Preparedness Act, and the February 29, 2012, Declaration 
under the Public Readiness and Emergency Preparedness Act.

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SUMMARY: The Secretary is amending the declarations issued on October 
10, 2008 (73 FR 61861), as amended June 11, 2009 (74 FR 29213); 
December 17, 2008 (73 FR 78362); and February 29, 2012 (77 FR 13329), 
pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 
247d-6d) to: Cover vaccines, antivirals, diagnostics and devices used 
against pandemic influenza A viruses in a single declaration; extend 
coverage to additional antivirals and devices and to biologics and 
other drugs; simplify descriptions of covered diagnostics and devices; 
clarify the disease threat and description of pandemic influenza A 
viruses and influenza A viruses with pandemic potential; include 
coverage for countermeasures authorized for use under sections 564A and 
564B of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 U.S.C. 
360bbb-3a and 360bbb-3b); extend the effective time period of the prior 
declarations; reformat the declarations for antivirals and for 
diagnostics and devices; modify or clarify terms of the declarations; 
and republish the prior declarations as a single declaration in its 
entirety, as amended.

DATES: The amendment of the October 10, 2008, declaration as amended 
June 11, 2009, the December 17, 2008, declaration and February 29, 
2012, declaration is effective as of January 1, 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 issued several declarations for 
countermeasures against pandemic influenza: (1) An October 10, 2008, 
declaration covering the neuraminidase class of antivirals Oseltamivir 
Phosphate (e.g., Tamiflu) and Zanamivir (e.g. Relenza) (hereinafter, 
``antivirals declaration''); (2) a December 17, 2008, declaration 
covering pandemic influenza diagnostics, personal respiratory 
protection devices, and respiratory support devices (hereinafter 
``diagnostics and other devices declaration''); and a February 29, 
2012, amended declaration covering pandemic influenza vaccines 
(hereinafter, ``vaccines declaration'') and is amending these 
declarations.\1\
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    \1\ 73 FR 61861, 73 FR 78362, 74 FR 29213, 77 FR 13329.
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    The major actions taken by this amendment to the pandemic influenza 
countermeasures declarations include the following: (1) Issuing a 
single declaration to cover vaccines, antivirals, diagnostics and other 
devices used against pandemic influenza A viruses; (2) extending 
coverage to additional antivirals and devices and to biologics and 
other drugs; (3) updating the description of Covered Countermeasures to 
include those authorized for use under sections 564A and 564B of the 
Federal Food, Drug, and Cosmetic (FD&C) Act; \2\ (4) clarifying the 
disease threat and the description of pandemic influenza A viruses and 
influenza A viruses with pandemic potential; (5) changing the 
description of qualified persons to include persons authorized to 
prescribe, administer, or dispense Covered Countermeasures in 
accordance with Section 564A of the FD&C Act; (6) clarifying that 
liability immunity for antivirals, diagnostics and other devices 
extends to other transactions and to activities related to any federal 
agreements including clinical trials agreements by adding the terms 
``other transactions'' and ``other federal agreements'' to the clause 
describing the types of federal agreements for which immunity is in 
effect; (7) deleting references to specific federal contracts in the 
antivirals declaration to clarify that immunity is not limited to 
activities conducted under listed contracts; (8) clarifying that 
liability immunity extends to activities directly conducted by the 
federal government by adding the phrase ``or directly conducted by the 
federal Government'' to the section describing methods of distribution 
for which liability immunity is in effect; (9) narrowing the definition 
of ``administration'' in the antivirals declaration and in the 
diagnostics and other devices declaration to cover ``slip-and-fall'' 
claims only to the extent they are directly tied to the operation of a 
countermeasure program; (10) extending the time period for which 
liability immunity is in effect for all of the Covered Countermeasures 
to December 31, 2022, and; (11) changing the antivirals declaration and 
the diagnostics and other devices declaration to the format used for 
the February 29, 2012, amendment to the declaration for pandemic 
influenza. Other minor modifications and clarifications are also made, 
as more fully explained below.
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    \2\ 21 U.S.C. 360bbb-3a and 360bbb-3b.
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    The vaccines, antivirals, and diagnostics and other devices 
declarations are republished as a single pandemic influenza 
countermeasures declaration (hereinafter, ``declaration'') in full. We 
explain the substantive and format changes in this supplementary 
section.

[[Page 76507]]

    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 FD&C Act to provide 
new authorities for 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 
(the PREP Act provisions), so that products made available under these 
new FD&C Act authorities could be covered under PREP Act declarations. 
PAHPRA 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.\3\ This determination is separate 
and apart from a declaration issued by the Secretary under section 319 
of the PHS Act \4\ 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. In the previous PREP Act declarations for 
antivirals and for diagnostics and other devices, this determination 
appeared in the declarations' introduction as the conclusion to the 
``whereas'' clauses. In the vaccines declaration, this determination 
appeared in section I. This change to the antivirals and the 
diagnostics and other devices declarations was made to improve 
readability and is not intended to have any substantive legal effect.
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    \3\ 42 U.S.C. 247d-6d(b)(1).
    \4\ 42 U.S.C. 247d.
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    In addition, a substantive change was made to the determination. 
The determination made in the ``whereas'' clauses in the antivirals 
declaration and the determination made in the diagnostics and other 
devices declaration stated that the Secretary ``determined there is a 
credible risk that the spread of avian and other influenza viruses that 
pose a pandemic threat and resulting disease could in the future 
constitute a public health emergency.'' The antivirals declaration also 
determined that ``the spread of H1N1 swine influenza viruses and 
resulting disease constitutes a public health emergency.'' The 
Secretary is amending these determinations to refer to ``influenza A 
viruses'' rather than ``avian influenza viruses'' to make the 
determinations in the antivirals declaration and the diagnostics and 
other devices declaration consistent with the determination made in the 
more recent vaccines declaration and to ensure that the health threat 
is described comprehensively. The declaration now reads: ``I have 
determined that there is a credible risk that pandemic influenza A 
viruses, and influenza A viruses with pandemic potential could cause an 
influenza pandemic with resulting disease that may in the future 
constitute a public health emergency.'' This change is made for 
clarification and consistency.

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.\5\ We stated these considerations in the introductory 
``whereas'' clauses to the antivirals declaration, the diagnostics and 
other devices declaration, and in section II of the vaccines 
declaration. This change was made to the antivirals declaration and the 
diagnostics and other devices declaration to improve readability; it is 
not intended to have any substantive legal effect.
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    \5\ 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'').\6\ In the 
previous antivirals declaration and devices and other diagnostics 
declaration, we included the Recommended Activities in section I of the 
Covered Countermeasures declaration. In the vaccines declaration, 
Recommended Activities appeared in section III. This change was made to 
the antivirals and diagnostics and other devices declarations to 
improve readability and we do not intend that it have any substantive 
legal effect. In addition, we deleted the phrases ``as defined in 
section IX below'' and ``with respect to the category of disease and 
population described in sections II and IV below'' from these 
declarations for consistency with formatting changes, and changed ``and 
usage'' to ``or use'' for consistency with the statute. These changes 
are not intended to have any substantive legal effect. We also deleted 
specific references to the influenza antiviral drugs Oseltamivir 
Phosphate (Tamiflu) and Zanamivir (Relenza) from the antivirals 
declaration. This change could expand coverage if new antivirals, other 
drugs, or biologics against pandemic influenza are developed; to the 
extent coverage is consistent with the statute and the terms of this 
declaration.
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    \6\ 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.\7\ 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.'' \8\ In the previous antivirals declaration and 
diagnostics and other devices declaration, we included a statement

[[Page 76508]]

referring to liability immunity specified under the PREP Act in section 
I of the declaration, ``Covered Countermeasures.'' The vaccines 
declaration included a statement regarding liability in section IV. The 
declaration includes the statement that liability immunity is in effect 
for Recommended Activities in a separate section IV. This change was 
made to the antivirals and diagnostics and other devices declarations 
to improve readability and we do not intend that it have any 
substantive legal effect.
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    \7\ 42 U.S.C. 247d-6d(b)(1).
    \8\ 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. ``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.\9\ The PREP Act further defines the terms ``manufacturer,'' 
``distributor,'' ``program planner,'' and ``qualified person'' as 
described below.\10\
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    \9\ 42 U.S.C. 247d-6d(i)(2).
    \10\ 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, affiliates, successors, and assigns of a 
manufacturer.\11\
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    \11\ 42 U.S.C. 247d-6d(i)(4).
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    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.\12\
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    \12\ 42 U.S.C. 247d-6d(i)(3).
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    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.\13\ 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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    \13\ 42 U.S.C. 247d-6d(i)(6).
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    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.\14\ 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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    \14\ 42 U.S.C. 247d-6d(i)(8).
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    The PREP Act 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.\15\
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    \15\ 42 U.S.C. 247d-6d(i)(5).
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    The provisions regarding Covered Persons appeared in the antivirals 
declaration and diagnostics and other devices declaration as a 
definition in section IX, ``Definitions'' and in section VI, 
``Qualified Persons.'' We combined these two provisions into a section 
V, ``Covered Persons'' and added ``to perform an activity'' to the 
description of ``Other Qualified Persons'' authorized under an 
Emergency Use Authorization for clarity. We made these changes to 
improve readability and clarity and do not intend them to have any 
substantive legal effect. The vaccine declaration included a 
description of Covered Persons in section V.
    We also modified the description of Covered Persons in the 
antivirals declaration, the diagnostics and other devices declaration, 
and the vaccines declaration to include a new category of qualified 
persons in this declaration: ``Any person authorized to prescribe, 
administer, or dispense covered countermeasures in accordance with 
Section 564A of the FD&C Act.'' This change ensures that persons who 
prescribe, administer, or dispense Covered Countermeasures in 
accordance with section 564A of the FD&C Act are Covered Persons under 
the declaration.

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.\16\
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    \16\ 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 \17\ 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.\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)(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 \19\ 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.\20\
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    \19\ 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i).
    \20\ 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 must be approved or cleared under 
the FD&C Act; \21\ licensed under the PHS Act; \22\ or authorized for 
emergency use

[[Page 76509]]

under sections 564, 564A, or 564B of the FD&C Act.\23\
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    \21\ 21 U.S.C. 301 et seq.
    \22\ 42 U.S.C. 262.
    \23\ 21 U.S.C. 360bbb-3, 360bbb-3a, 360bbb-3b.
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    A qualified pandemic or epidemic product 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 \24\ and 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 10 years after the Department's determination that procurement 
of the countermeasure is appropriate.
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    \24\ 21 U.S.C. 355(i), 360j(g).
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    Provisions regarding Covered Countermeasures appeared in section I 
of the antivirals declaration and the diagnostics and other devices 
declaration, ``Covered Countermeasures'' and section IX of these 
declarations, ``Definitions.'' Section I of these declarations included 
a description of the Covered Countermeasure and the Secretary's 
recommendation, statement regarding liability immunity, and additional 
conditions characterizing countermeasures. We have combined sections I 
and IX and simplified the language so that it now only identifies the 
Covered Countermeasures. We have relocated the other conditions 
previously included in the ``Covered Countermeasure'' section to new 
sections, ``Recommended Activities,'' ``Liability Immunity,'' and 
``Limitations on Distribution,'' to improve readability and for 
consistency with the vaccines declaration. We do not intend for this 
change to have any substantive legal effect.
    Section I of the antivirals declaration and the diagnostics and 
other devices declaration also stated that the declarations applied to 
Covered Countermeasures administered or used during the effective time 
period of the declaration. We have deleted this language as it is 
redundant of the provisions stated in sections XII, ``Effective Time 
Period,'' and XIII, ``Additional Time Period of Coverage.''
    We have also revised the descriptions and definitions of the 
Covered Countermeasure that previously appeared in section IX, 
``Definitions'' of the antivirals and the diagnostics and other devices 
declarations.
    Section IX of the antivirals declaration defined the term 
``Pandemic Countermeasures'' as: ``the neuraminidase class of 
Antivirals Oseltamivir Phosphate (e.g., Tamiflu) and Zanamivir (e.g., 
Relenza).'' The declaration now refers to ``any antiviral, any other 
drug'' and ``any biologic.'' This substantive change is made for 
consistency with other PREP Act declarations and to extend coverage to 
antiviral drugs, other drugs, and biologics that may be developed for 
use against pandemic influenza, to the extent coverage is consistent 
with the statute and terms of this declaration.
    Section IX of the diagnostics and other devices declaration 
included the following definitions:

    ``Pandemic Influenza Diagnostics: Means diagnostics to identify 
avian or other animal influenza A viruses that pose a pandemic 
threat, or to otherwise aid in the diagnosis of pandemic influenza, 
when (1) Licensed under section 351 of the Public Health Service 
Act; (2) approved under section 505 or section 515 of the Federal 
Food, Drug, and Cosmetic Act (FDCA); (3) cleared under section 
510(k) of the FDCA; (4) authorized for emergency use under section 
564 of the FDCA; (5) used under section 505(i) of the FDCA or 
section 351(a)(3) of the PHS Act, and 21 CFR part 312; or (6) used 
under section 520(g) of the FDCA and 21 CFR part 812.''
    ``Pandemic Influenza Personal Respiratory Protection Devices: 
Means personal respiratory protection devices for use by the general 
public to reduce wearer exposure to pathogenic biological airborne 
particulates during public health medical emergencies, such as an 
influenza pandemic, when (1) Licensed under section 351 of the 
Public Health Service Act; (2) approved under section 505 or section 
515 of the Federal Food, Drug, and Cosmetic Act (FDCA); (3) cleared 
under section 510(k) of the FDCA; (4) authorized for emergency use 
under section 564 of the FDCA; (5) used under section 505(i) of the 
FDCA or section 351(a)(3) of the PHS Act, and 21 CFR part 312; or 
(6) used under section 520(g) of the FDCA and 21 CFR part 812.''
    ``Pandemic Influenza Respiratory Support Devices: Means devices 
to support respiratory function for patients infected with highly 
pathogenic influenza A H5N1 viruses or other influenza viruses that 
pose a pandemic threat when (1) Licensed under section 351 of the 
Public Health Service Act; (2) approved under section 505 or section 
515 of the Federal Food, Drug, and Cosmetic Act (FDCA); (3) cleared 
under section 510(k) of the FDCA; (4) authorized for emergency use 
under section 564 of the FDCA; (5) used under section 505(i) of the 
FDCA or section 351(a)(3) of the PHS Act, and 21 CFR part 312; or 
(6) used under section 520(g) of the FDCA and 21 CFR part 812.

    The declaration now refers to ``any diagnostic and any other 
device.'' This change is intended to extend coverage to any diagnostic 
or other device used as Covered Countermeasures against pandemic 
influenza to the extent consistent with the statute and the terms of 
the declaration.
    The vaccines declaration included the following description of 
Covered Countermeasures in section VI:

    Covered Countermeasures are vaccines against pandemic influenza 
A viruses and influenza A viruses with pandemic potential, all 
components and constituent materials of these vaccines, and all 
devices and their constituent components used in the administration 
of these vaccines, except that influenza A vaccines and their 
associated components, constituent materials and devices covered 
under the National Vaccine Injury Compensation Program are not 
Covered Countermeasures.

    This description of vaccines is unchanged but has been combined 
with the description of antivirals and other drugs, biologics, and 
diagnostics and other devices into a single description.
    The description of covered countermeasures in this declaration now 
reads:

    Covered countermeasures are any antiviral, any other drug, any 
biologic, any diagnostic, any other device, or any vaccine used 
against pandemic influenza A viruses and influenza A viruses with 
pandemic potential, all components and constituent materials of 
vaccines, and all devices and their constitution components used in 
the administration of vaccines, except that vaccines against 
influenza A and their associated components, constitute materials 
and devices covered under the National Vaccine Injury Compensation 
Program are not Covered Countermeasures.

    Section I of the antivirals and diagnostics and other devices 
declarations also referred to the Act for the definition of ``Covered 
Countermeasures.'' We include a statement in the declaration 
referencing the statutory definitions of Covered Countermeasures to 
make clear that these statutory definitions limit the scope of Covered 
Countermeasures. Specifically, we note that they ``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.'' By referencing the statutory 
provisions, the revised definition also incorporates changes to the 
PREP Act definitions of Covered Countermeasure and qualified pandemic 
or epidemic product made by PAHPRA.

Section VII, Limitations on Distribution

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

[[Page 76510]]

Covered Countermeasures obtained through a particular means of 
distribution.\25\ These limitations on distribution previously appeared 
in section I, ``Covered Countermeasures,'' and section IX, 
``Definitions'' of the antivirals and diagnostics and other devices 
declaration, and in section VII of the vaccines declaration. This 
declaration states the limitations in a separate section and combines 
them with relevant definitions for improved readability.
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    \25\ 42 U.S.C. 247d-6d(a)(5), (b)(2)(E).
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    The declaration states 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 
following a declaration of an emergency.
    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.
    In regard to (a), we added to the antivirals declaration and the 
diagnostics and other devices declaration the phrase ``other 
transactions,'' which may be used for some Covered Countermeasure 
activities,\26\ and added the phrase ``or other Federal agreements'' to 
clarify that the provision is intended to cover all types of federal 
agreements. We also added to the antivirals declaration, the 
diagnostics and other devices declaration, and the vaccines declaration 
the phrase ``or activities directly conducted by the Federal 
Government'' to clarify that activities such as manufacture of vaccines 
for clinical trials by the HHS National Institutes of Health Vaccine 
Research Center or distribution of countermeasures by federal employees 
are covered. In the antivirals and diagnostics and other devices 
declarations, we also changed the conjunction ``and'' to ``or'' between 
(a) and (b) to clarify that immunity is available under either of these 
circumstances; the activities do not have to both relate to a federal 
award or agreement and be used in a public health and medical response 
in order for immunity to apply. The conjunction ``and'' used in the 
previous declaration was a drafting error; the Secretary's intent in 
that previous declarations has been the meaning conferred by the term 
``or.'' Provisions (a) and (b) are intended to afford immunity to 
federal government conducted and supported activities that precede a 
public health emergency and to activities in accordance with all 
Authorities Having Jurisdiction during a declared public health 
emergency. These changes are intended as clarifications and to improve 
readability, and are not intended as substantive changes.
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    \26\ See, e.g., 42 U.S.C. 247d-7d(c)(5).
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    In regard to (b), the meaning of the terms ``Authority Having 
Jurisdiction'' and ``Declaration of an Emergency'' are unchanged.
    Finally, we slightly modified the last limitation in the antivirals 
declaration and the diagnostics and other devices declaration by 
deleting extraneous statutory references and other language and by 
replacing the final sentence with the word ``only'' after ``planners'' 
to improve readability. We do not intend for the changes to this 
provision to alter its substantive legal effect. As stated in the 
``whereas'' clauses of the prior declarations, 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.\27\ This information appeared in section II, ``Category 
of Disease'' of the antivirals and diagnostics and other devices 
declarations, and in section VIII of the vaccines declaration.
---------------------------------------------------------------------------

    \27\ 42 U.S.C. 247d-6d(b)(2)(A).
---------------------------------------------------------------------------

    In addition, we have made the following substantive changes. The 
antivirals declaration described the category of disease as ``the 
threat of or actual human influenza that results from the infection of 
humans with highly pathogenic avian H5N1 influenza A viruses or other 
animal Influenza A viruses (including, but not limited to, H1N1 swine 
influenza) that are, or may be capable of developing into, a pandemic 
strain.'' The diagnostics and other devices declaration described the 
threat as: ``The threat of or actual human influenza that results from 
the infection of humans with highly pathogenic avian H5N1 influenza A 
viruses or other animal influenza A viruses that are, or maybe capable 
of developing into, a pandemic strain.'' These descriptions have been 
modified to delete references to specific viral strains and to animal 
influenza viruses, to instead refer to ``pandemic influenza A viruses 
and influenza A viruses with pandemic potential.'' This change is made 
to the antivirals and diagnostics and other devices declarations to 
ensure that the category of disease is described comprehensively and 
for consistency with the vaccines declaration.
    We have also revised the description of pandemic influenza A 
viruses and influenza A viruses with pandemic potential that appeared 
in the vaccines declaration to clarify that viruses circulating in 
humans are included in the definition, and added the revised definition 
to the antivirals and diagnostics and other devices declarations: 
Pandemic influenza A viruses and influenza A viruses with pandemic 
potential mean: Animal viruses and/or human influenza A viruses that 
are circulating in wild birds, domestic animals and/or humans that 
cause or have significant potential to cause sporadic or ongoing human 
infections, or historically have caused pandemics in humans, or have 
mutated to cause pandemics in humans, and for which the majority of the 
population is immunologically naive.

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. This definition previously appeared in 
section IX, ``Definitions'' of the antivirals declaration and 
diagnostics and other devices declaration. We have moved it to a 
separate section to improve readability. The Secretary has also 
narrowed the definition of ``administration'' that was provided in 
these declarations. These declarations previously defined 
``administration'' to include physical provision of a Covered 
Countermeasure, as well as management and operation of systems and 
locations

[[Page 76511]]

at which Covered Countermeasures may be provided to recipients:
    Administration of a Covered Countermeasure: As used in section 
319F-3(a)(2)(B) of the Act includes, but is not limited to, public and 
private delivery, distribution, and dispensing activities relating to 
physical administration of the countermeasures to patients/recipients, 
management and operation of delivery systems, and management and 
operation of distribution and dispensing locations.
    The definition has been revised for the antivirals declaration and 
the diagnostics and other devices declaration as follows:
    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.
    As clarified in the antivirals declaration and the diagnostics and 
other devices declaration, 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.\28\ 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.
---------------------------------------------------------------------------

    \28\ 42 U.S.C. 247d-6d(a).
---------------------------------------------------------------------------

    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 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.\29\ 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. These provisions 
previously appeared in section IV, ``Population,'' of the antivirals 
declaration and the diagnostics and other devices declaration and 
section X of the vaccines declaration. The antivirals declaration and 
diagnostics and other devices declaration stated that the population 
specified in the declaration included:
---------------------------------------------------------------------------

    \29\ 42 U.S.C. 247d-6d(b)(2)(C).
---------------------------------------------------------------------------

    The populations specified in this declaration are all persons who 
use a Covered Countermeasure or to whom a Covered Countermeasure is 
administered in accordance with this declaration, including, but not 
limited to: (1) Any person conducting research and development of 
Covered Countermeasures directly for the federal government or pursuant 
to a contract, grant, or cooperative agreement with the federal 
government; (2) Any person who receives a Covered Countermeasure from 
persons 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 
Countermeasure, and their officials, agents, employees, contractors, 
and volunteers following a declaration of an emergency; (3) Any person 
who receives a Covered Countermeasure from a person authorized to 
prescribe, administer or dispense the countermeasure or who is 
otherwise authorized under an Emergency Use Authorization; (4) Any 
person who receives a Covered Countermeasure as an investigational new 
drug in human clinical trials being conducted directly by the federal 
government or pursuant to a contract, grant, or cooperative agreement 
with the federal government.
    We have amended the antivirals declaration and the diagnostics and 
other devices declaration to provide that the population includes ``any 
individual who uses or who is administered a Covered Countermeasure in 
accordance with the declaration.'' We believe this broad statement 
encompasses all of the previously listed populations given as examples 
of that phrase and ensures that no populations that use or are 
administered the Covered Countermeasures in accordance with the terms 
of the declaration are omitted.
    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.\30\ We included these statutory 
conditions in the declaration for clarity.
---------------------------------------------------------------------------

    \30\ 42 U.S.C. 247d-6d(a)(4).
---------------------------------------------------------------------------

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.\31\ This section previously appeared in section V, 
``Geographic Area'' of the antivirals declaration and diagnostics and 
other devices declaration, and section XI of the vaccines declaration.
---------------------------------------------------------------------------

    \31\ 42 U.S.C. 247d-6d(b)(2)(D).
---------------------------------------------------------------------------

    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

[[Page 76512]]

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.\32\ We included these statutory 
conditions in the declaration for clarity.
---------------------------------------------------------------------------

    \32\ 42 U.S.C. 247d-6d(a)(4).
---------------------------------------------------------------------------

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.\33\ This section appeared 
in the antivirals declaration and the diagnostics and other devices 
declaration as section III, ``Effective Time Period'' and in the 
vaccines declaration in section XII.
---------------------------------------------------------------------------

    \33\ 42 U.S.C. 246d-6d(b)(2)(B), (b)(6).
---------------------------------------------------------------------------

    The declaration is amended to clarify when liability takes effect 
for different means of distribution. These changes are intended to have 
no legal effect. The declaration is also amended to extend the period 
for which liability immunity is in effect. The previous declaration was 
in effect through December 31, 2015. We have extended the effective 
time period to December 31, 2022.

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.\34\ In addition, the PREP Act 
specifies that for Covered Countermeasures that are subject to a 
declaration at the time they are obtained for the Strategic National 
Stockpile under 42 U.S.C. 247d-6b(a), the effective period of the 
declaration extends through the time the countermeasure is used or 
administered pursuant to a distribution or release from the Stockpile. 
Liability immunity under the provisions of the PREP Act and the 
conditions of the declaration continues during these additional time 
periods. Thus, liability immunity is afforded during the ``Effective 
Time Period,'' described under XII of the declaration, plus the 
``Additional Time Period'' described under section XIII of the 
declaration.
---------------------------------------------------------------------------

    \34\ 42 U.S.C. 247d-6d(b)(3).
---------------------------------------------------------------------------

    The provision for additional time periods appeared as section VII, 
``Additional Time Periods of Coverage After Expiration of the 
Declaration'' in the antivirals declaration and the diagnostics and 
other devices declaration, and in section XIII of the vaccines 
declaration. The provision is amended in the antivirals declaration and 
the diagnostics and other devices declaration to clarify the statutory 
provisions as they apply to manufacturers and to other covered persons, 
and to clarify 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.\35\ 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,\36\ and the 
statute.\37\ To show direct causation between a Covered Countermeasure 
and a serious physical injury, the statute requires ``compelling, 
reliable, valid, medical and scientific evidence.'' \38\ 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. We have added section XIV, ``Countermeasures Injury 
Compensation Program'' to the antivirals and diagnostics and other 
devices declarations to explain the types of injury and standard of 
evidence needed to be considered for compensation under the CICP. We 
included this information to inform readers of this Program.
---------------------------------------------------------------------------

    \35\ 42 U.S.C. 247d-6e.
    \36\ 42 CFR part 110.
    \37\ 42 U.S.C.247d-6e.
    \38\ 42 U.S.C.247d-6e(b)(4).
---------------------------------------------------------------------------

Section XV, Amendments

    The Secretary may amend any portion of a declaration through 
publication in the Federal Register.\39\ This section appeared in 
section VIII, ``Amendments'' of the antivirals declaration and the 
diagnostics and other devices declaration, and section XV of the 
vaccines declaration. The section has been updated to reflect that the 
Republished Declaration amends the prior October 10, 2008 (as amended 
June 11, 2009), December 17, 2008, and February 29, 2012 declarations.
---------------------------------------------------------------------------

    \39\ 42 U.S.C. 247d-6d(b)(4).
---------------------------------------------------------------------------

Deleted Sections

    The prior antivirals declaration and diagnostics and other devices 
declaration included a number of ``whereas'' clauses as introductory to 
the declaration. As described above, we have incorporated whereas 
clauses that made necessary findings under the PREP Act into the text 
of the declaration itself. We have deleted the remaining whereas 
clauses. We do not intend this change to have legal effect.
    The prior antivirals declaration and diagnostics and other devices 
declaration contained a definitions section. These definitions have 
been incorporated into the relevant sections of the declaration as 
noted above, and modified or deleted where indicated above.
    An appendix previously appeared in the antivirals declaration that 
listed federal government contracts for research, development, and 
procurement of Covered Countermeasures. We deleted this appendix to 
clarify that liability immunity under the provisions of the PREP Act 
and terms of the declaration is not limited to the contracts listed in 
the appendix. Coverage is available for any award or agreement that 
meets the description provided in section VII of the declaration. In 
addition, deleting the appendix relieves the Department of the need to 
periodically update the appendix.
    We made these deletions for clarity and do not intend them to have 
legal effect.

Republished Declaration

Declaration, as Amended, for Public Readiness and Emergency 
Preparedness Act Coverage for Pandemic Influenza Countermeasures

    This declaration amends the October 17, 2008, Declaration under the 
Public Readiness and Emergency Preparedness Act, as amended on June 11, 
2009; the December 22, 2008, Declaration under the Public Readiness and 
Emergency Preparedness Act; and the February 29, 2012, Declaration 
under the Public Readiness and Emergency Preparedness

[[Page 76513]]

Act. It republishes these prior declarations as a single declaration. 
To the extent any term of the prior declarations are 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 there is a credible risk that pandemic influenza 
A viruses and influenza A viruses with pandemic potential could cause 
an influenza pandemic with resulting disease that may 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, and; (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 antiviral, any other drug, any 
biologic, any diagnostic, any other device, or any vaccine used against 
pandemic influenza A viruses and influenza A viruses with pandemic 
potential, all components and constituent materials of vaccines, and 
all devices and their constitution components used in the 
administration of vaccines, except that vaccines against influenza A 
and their associated components, constitute materials and devices 
covered under the National Vaccine Injury Compensation Program are not 
Covered 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 
following a declaration of an emergency.
    i. The Authority Having Jurisdiction means the public agency or its 
delegate that has legal responsibility and authority for responding to 
an incident, based on political or geographical (e.g., city, county, 
tribal, state, or federal boundary lines) or functional (e.g., law 
enforcement, public health) range or sphere of authority.
    ii. A declaration of emergency means any declaration by any 
authorized local, regional, state, or federal official of an emergency 
specific to events that indicate an immediate need to administer and 
use the Covered Countermeasures, with the exception of a federal 
declaration in support of an Emergency Use Authorization under section 
564 of the FD&C Act unless such declaration specifies otherwise;
    I have also determined that for governmental program planners only, 
liability immunity is afforded only to the extent such program planners 
obtain Covered Countermeasures through voluntary means, such as (1) 
donation; (2) commercial sale; (3) deployment of Covered 
Countermeasures from federal stockpiles; or (4) deployment of donated, 
purchased, or otherwise voluntarily obtained Covered Countermeasures 
from state, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat

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

    The category of disease, health condition, or threat for which I 
recommend the administration or use of the Covered Countermeasures is 
the threat of or actual human influenza that results from the infection 
of humans following exposure to pandemic influenza A viruses or 
influenza A viruses with pandemic potential.
    Pandemic influenza A viruses and influenza A viruses with pandemic 
potential mean: Animal viruses and/or human influenza A viruses 
circulating in wild birds, domestic animals and/or humans that cause or 
have significant potential to cause sporadic or ongoing human 
infections, or historically have caused pandemics in humans, or have 
mutated to cause pandemics in humans, and for which the majority of the 
population is immunologically naive.

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

[[Page 76514]]

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 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)

    For any Covered Countermeasure subsequently covered under the 
National Vaccine Injury Compensation Program, liability immunity under 
this declaration expires immediately upon such coverage.
    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 or until a Covered Countermeasure is covered 
under the National Vaccine Injury Compensation Program, as applicable, 
whichever occurs first.
    Liability immunity for Covered Countermeasures administered and 
used in accordance with the public health and medical response of the 
Authority Having Jurisdiction begins with a declaration and lasts 
through (1) the final day the emergency declaration is in effect; (2) 
December 31, 2022; or (3) until a Covered Countermeasure is covered 
under the National Vaccine Injury Compensation Program, as applicable, 
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 other appropriate actions 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 the 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 the Covered Countermeasures and/
or 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 toll-free at 1-855-
266-2427 or http://www.hrsa.gov/cicp/.

XV. Amendments

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

    The October 10, 2008, Declaration Under the Public Readiness and 
Emergency Preparedness Act for pandemic influenza antivirals was first 
published on October 17, 2008, and amended on June 11, 2009. This is 
the second amendment to that declaration.
    The December 17, 2008, Declaration Under the Public Readiness and 
Emergency Preparedness Act for diagnostics and other devices was first 
published on December 22, 2008. This is the first amendment to that 
declaration.
    The Declaration for the Use of the Public Readiness and Emergency 
Preparedness Act for H5N1 vaccines was first published on January 26, 
2007. The declaration was amended on November 30, 2007, to add H7 and 
H9 vaccines; amended on October 17, 2008, to add H2 and H6 vaccines; 
amended on June 15, 2009, to add 2009 H1N1 vaccines and republished in 
its entirety; amended on September 28, 2009, to provide targeted 
liability protections for pandemic countermeasures to enhance 
distribution and to add provisions consistent with other declarations 
and republished in its entirety; amended on March 1, 2010, to revise 
the Covered Countermeasures to include countermeasures against pandemic 
influenza A viruses, extend the effective date and republished in its 
entirety; and amended on February 29, 2012, to extend the effective 
time period, reformat the declaration, and republish the declaration.
    This declaration incorporates all amendments to these declarations 
prior to the date of its publication in the Federal Register. Further 
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. 2015-31087 Filed 12-8-15; 8:45 am]
BILLING CODE P