Pandemic Influenza Vaccines-Amendment, 13329-13336 [2012-5312]

Agencies

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

[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13329-13336]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5312]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Pandemic Influenza Vaccines--Amendment

ACTION: Notice of Amendment to the March 1, 2010 Republished 
Declaration under the Public Readiness and Emergency Preparedness Act.

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SUMMARY: Amendment to declaration issued on March 1, 2010 (75 FR 10268) 
pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 
247d-6d) to extend the effective time period, reformat the declaration, 
modify or clarify terms of the declaration and republish the 
declaration in its entirety, as amended.

DATES: The amendment of the republished declaration issued on March 1, 
2010 is effective as of February 29, 2012.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, MSPH, Assistant

[[Page 13330]]

Secretary for Preparedness and Response, Office of the Secretary, 
Department of Health and Human Services, 200 Independence Avenue SW., 
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free 
number).

SUPPLEMENTARY INFORMATION:

Background

    The Public Readiness and Emergency Preparedness Act (``PREP Act'') 
authorizes the Secretary of Health and Human Services (``the 
Secretary'') to issue a declaration to provide liability immunity to 
certain individuals and entities (``Covered Persons'') against any 
claim of loss caused by, arising out of, relating to, or resulting from 
the administration or use of medical countermeasures (``Covered 
Countermeasures''), except for claims that meet the PREP Act's 
definition of willful misconduct. Using this authority, the Secretary 
issued a declaration for pandemic influenza vaccines, which has been 
amended a number of times. The original pandemic influenza vaccine 
declaration was published on January 26, 2007,\1\ and was amended on 
November 21, 2007,\2\ October 17, 2008,\3\ June 15, 2009,\4\ September 
28, 2009 \5\ and March 1, 2010.\6\ The March 1, 2010 amendment is 
effective through February 28, 2012. The original declaration and its 
amendments, as well as additional information about the PREP Act and 
the Secretary's declarations for other medical countermeasures, can be 
found here: https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.
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    \1\ 72 FR 4710 (2007).
    \2\ 72 FR 67731 (2007).
    \3\ 73 FR 61871 (2008).
    \4\ 74 FR 30294 (2009).
    \5\ 74 FR 51153 (2009).
    \6\ 75 FR 10268 (2010).
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    The major actions taken by this pandemic influenza vaccine 
declaration are the following: (1) Changing the format to make the 
declaration easier for readers to follow; (2) clarifying that liability 
immunity is provided not only to vaccines and adjuvants, but also to 
vaccine components and constituent materials used as part of a covered 
vaccine; (3) explicitly extending liability immunity to devices and 
their constituent components used in the administration of vaccines, 
e.g., needles (which provides for uniform coverage for devices, 
regardless of whether they are manufactured or packaged with the 
vaccine or combined later for administration by a healthcare provider); 
(4) clarifying that liability immunity extends to recommended 
activities related to any Federal agreements including e.g., clinical 
trials agreements by adding the term ``other Federal agreements'' to 
the clause describing the types of federal agreements for which 
immunity is in effect; (5) narrowing the definition of 
``administration'' to cover ``slip and fall'' claims only to the extent 
they are directly tied to the operation of a countermeasure program; 
and (6) extending the time period for which liability immunity is in 
effect for the Covered Countermeasures to December 31, 2015. Other 
modifications and clarifications are also made, as more fully explained 
below.
    The declaration is republished 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, 119 Stat 2818. 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. 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.\7\ This determination is separate 
and apart from a declaration issued by the Secretary under section 319 
of the PHS Act, 42 U.S.C. 247d, 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 previous PREP Act declarations 
(``declaration'' or ``declarations''), this determination appeared in 
the declarations' introduction as the conclusion to the ``whereas'' 
clauses. The determination is now stated in the first section of the 
declaration. This change was made to improve readability and is not 
intended to have any substantive legal effect.
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    \7\ 42 U.S.C. 247d-6d(b)(1).
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    In addition, we made a substantive change to the determination. The 
determination made in the ``whereas'' clauses in the March 1, 2010 
declaration stated that the Secretary ``determined there is a credible 
risk that the spread of pandemic influenza A viruses and those with 
pandemic potential and resulting disease does or could constitute a 
public health emergency.'' The Secretary is amending this 
determination: (1) To substitute ``may in the future'' for ``could'' in 
order to be consistent with the language used in the PREP Act \8\; and 
(2) to remove the words ``the spread of'' and ``does or'' to clarify 
that the 2009 H1N1 Influenza virus and resulting disease are not 
currently causing a public health emergency. As discussed further in 
section VI of this supplementary information section, we also changed 
``and those'' to ``and influenza A viruses with'' for clarity. We also 
specified that the viruses could potentially cause an influenza 
pandemic . Thus, in this amended declaration, the Secretary determines 
``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.''
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    \8\ See 42 U.S.C. 247d-6d(b)(1).
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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.\9\ We previously stated these considerations in the 
introductory ``whereas'' clauses to the declaration. The declaration 
now states these considerations in section II. We made this change to 
improve readability and do not intend that it have any substantive 
legal effect.
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    \9\ 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

[[Page 13331]]

(``Recommended Activities'').\10\ In previous declarations, we included 
the Recommended Activities in the introductory ``whereas'' clauses to 
the declaration. The declaration now states them in section III. We 
made this change to improve readability and do not intend that it have 
any substantive legal effect.
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    \10\ 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.\11\ 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.'' \12\ In previous declarations, we included this 
statement in section I of the declaration, entitled ``Covered 
Countermeasures.'' The declaration now makes the statement that 
liability immunity is in effect for Recommended Activities in a 
separate section IV. We made this change to improve readability and do 
not intend that it have any substantive legal effect.
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    \11\ 42 U.S.C. 247d-6d(b)(1).
    \12\ 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.\13\ The PREP Act further defines the terms 
``manufacturer,'' ``distributor,'' ``program planner,'' and ``qualified 
person'' as described below.\14\
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    \13\ 42 U.S.C. 247d-6d (i)(2).
    \14\ 42 U.S.C. 247d-6d(i).

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; \15\
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    \15\ 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; \16\
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    \16\ 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; \17\ 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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    \17\ 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.\18\ 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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    \18\ 42 U.S.C. 247d-6d(i)(8).

    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; \19\
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    \19\ 42 U.S.C. 247d-6d(i)(5).
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    The provisions regarding Covered Persons previously appeared as a 
definition in section X, ``Definitions'' and as section VI, ``Other 
Qualified Persons.'' We combined these two provisions into a new 
section V, ``Covered Persons'' and added ``to perform an activity'' to 
the description of ``Other Qualified Persons'' for clarity. We made 
these changes to improve readability and clarity and do not intend them 
to have any substantive legal effect.

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 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).\20\
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    \20\ 42 U.S.C. 247d-6d(i)(1). Section 564 of the FD&C Act may be 
found at 21 U.S.C. 360bbb-3.
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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 \21\, that is: 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; or 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.\22\
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    \21\ 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i)
    \22\ 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 \23\ that: 
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 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 is determined by the Secretary of 
Health and Human Services to be a necessary countermeasure to protect 
public health.\24\
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    \23\ 21 U.S.C. 321(g)(1), (h);42 U.S.C. 262(i).
    \24\ 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; \25\ licensed under the PHS Act; \26\ or authorized 
for emergency use under the FD&C Act.\27\ In addition, a qualified 
pandemic or epidemic product may be a Covered Countermeasure when it is 
exempted under the FD&C Act for use as an investigational drug or 
device \28\ that is the object of research for

[[Page 13332]]

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 eight years after the 
Department's determination that procurement of the countermeasure is 
appropriate.
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    \25\ 21 U.S.C. 301 et seq.
    \26\ 42 U.S.C. 262.
    \27\ 21 U.S.C. 360bbb-3.
    \28\ 21 U.S.C. 355(i), 360j(g).
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    Provisions regarding Covered Countermeasures previously appeared in 
section I of the declaration, ``Covered Countermeasures,'' and included 
not only a description of the Covered Countermeasure but also 
additional conditions characterizing countermeasures. We have 
simplified this section so that it now only identifies the Covered 
Countermeasures. We have relocated the other conditions previously 
included in the ``Covered Countermeasure'' section to a new section, 
``Limitations on Distribution,'' to improve readability. We do not 
intend for this change to have any substantive legal effect.
    We have also revised the definition of the Covered Countermeasure. 
Previously, the declaration included in section X, ``Definitions,'' a 
definition of the term ``Pandemic influenza A viruses and those with 
pandemic potential.'' In this declaration, the Secretary defines the 
Covered Countermeasures as ``vaccines against pandemic influenza A 
viruses and influenza A viruses with pandemic potential.'' We replaced 
the phrase ``and those'' with ``and influenza A'' before ``viruses with 
pandemic potential'' to clarify that the declaration covers vaccines 
only for influenza A viruses that have pandemic potential, not all 
influenza viruses that have pandemic potential. This change is made 
throughout the declaration wherever the phrase is used. We also changed 
``and any associated adjuvants'' to ``and all components and 
constituent materials of these vaccines'' to clarify the Secretary's 
intent that all components and constituent materials, such as 
preservatives, diluents, antibiotics as well as adjuvants are covered 
as part of the vaccine. This change does not negatively affect the 
Secretary's view that the manufacturer of an adjuvant used in a vaccine 
qualifying as a covered countermeasure would qualify as a manufacturer 
under this declaration and would be afforded the liability immunity 
provided by the PREP Act. We also added ``and all devices and their 
constituent components used in the administration of these vaccines'' 
to clarify that coverage extends to these devices when used in the 
administration of these vaccines. Devices such as needles, syringes, 
and aerosols, and their components and constituent materials are an 
integral part of the administration of the vaccine. They are covered 
regardless of whether they are manufactured or packaged with the 
vaccine, or combined later for administration by a healthcare provider. 
Finally, we added a statement referencing the statutory definitions of 
Covered Countermeasures to indicate that certain statutory requirements 
must also be met. These statutory requirements are discussed in the 
first two paragraphs of this section of the preamble.
    Finally, we moved language previously included in section VIII, 
``Category of Disease, Health Condition, or Threat'' and modified 
previous section VI, ``Covered Countermeasures,'' to provide that 
vaccines (including any components and constituent materials and 
devices used to administer vaccines) covered under the National Vaccine 
Injury Compensation Program are not covered countermeasures under this 
declaration. This language was moved from previous section X to section 
VI to clarify the Secretary's determination concerning coverage of 
vaccines under this declaration in the event that a strain of influenza 
meeting the requirements set forth in section VIII is included in 
vaccines covered by the National Vaccine Injury Compensation Program. 
In such circumstances, such vaccines (those covered by the National 
Vaccine Injury Compensation Program) would be automatically excluded 
from this declaration. However, to the extent that the same strain of 
influenza is included in other vaccines that are not covered by the 
National Vaccine Injury Compensation Program, such vaccines could still 
qualify as covered countermeasures under this declaration (assuming 
they meet other requirements set forth in this declaration, including 
the description of the disease, health condition, or threat set forth 
in section VIII). Currently, the only types of influenza vaccines 
covered by the National Vaccine Injury Compensation Program are 
trivalent influenza vaccines. Thus, such vaccines are not covered by 
this declaration. This modification is meant to clarify that 
potentially one formulation of influenza vaccines (e.g., monovalent or 
quadrivalent vaccines) could qualify as covered countermeasures under 
this declaration (if such vaccines were not covered under the National 
Vaccine Injury Compensation Program) and, at the same time, another 
influenza vaccine containing the exact same strain of influenza virus 
(e.g., a trivalent influenza vaccine) could be covered by the National 
Vaccine Injury Compensation Program (and excluded from coverage under 
this declaration).

Section VII, Limitations on Distribution

    The Secretary may specify that liability immunity is in effect only 
to Covered Countermeasures obtained through a particular means of 
distribution.\29\ These limitations on distribution previously appeared 
in section I, ``Covered Countermeasures,'' and section X, 
``Definitions.'' We now state the limitations in a separate section and 
combine them with relevant definitions for improved readability. The 
declaration states that liability immunity is afforded to Covered 
Persons for Recommended Activities related to:
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    \29\ 42 U.S.C. 247d-6d(a)(5), (b)(2)(E).
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    (a) Present or future Federal contracts, cooperative agreements, 
grants, other transactions, interagency agreements, or memoranda of 
understanding or other Federal agreements; or
    (b) Activities authorized in accordance with the public health and 
medical response of the Authority Having Jurisdiction to prescribe, 
administer, deliver, distribute or dispense the pandemic 
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 the phrase ``other transactions'', which 
may be used for some Covered Countermeasure activities,\30\ and the 
phrase ``or other Federal agreements'' to clarify that the provision is 
intended to cover all types of Federal agreements. We 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 previous 
declarations was a drafting error; the Secretary's intent in those 
previous declarations has been the meaning conferred by the term

[[Page 13333]]

``or''. Provisions (a) and (b) are intended to afford immunity to 
Federal government supported activities that precede a public health 
emergency and to activities in accordance with all Authorities Having 
Jurisdiction during a declared public health emergency.
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    \30\ 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 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 March 1, 2010 declaration, 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.\31\ This information previously appeared in section II, 
``Category of Disease,'' and in section X, ``Definitions.'' These 
provisions now are combined into a single section to improve 
readability. In addition, we replaced the description of the influenza 
A virus as it previously appeared in section II with the term 
``pandemic influenza A viruses and influenza A viruses with pandemic 
potential'' and then followed that term with the definition that 
previously appeared in section X. We made these changes to remove 
redundancy and improve consistency and do not intend for it to alter 
the substantive legal effect. Finally, we removed the phrase ``except 
those included in seasonal influenza vaccines and/or covered under the 
National Vaccine Injury Compensation Program'' from this section and 
instead included similar language in section VI, for clarity as 
described above.
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    \31\ 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. This definition previously appeared in 
section X, ``Definitions.'' We have moved it to a separate section to 
improve readability. The Secretary has also narrowed the definition of 
``administration'' that was previously provided in the declaration. The 
declaration previously defined the term ``administration'' to include 
physical provision of a Covered Countermeasure, as well as management 
and operation of systems and locations 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 
recipients, management and operation of delivery systems, and 
management and operation of distribution and dispensing locations.

    The definition has been revised as follows:

    Administration of a Covered Countermeasure: As used in section 
319F-3(a)(2)(B) of the Act, 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, 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.\32\ 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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    \32\ 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.

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.\33\ 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,'' and section X, 
``Definitions,'' stating that the population included any person who 
used or was administered a Covered Countermeasure: In a clinical trial 
conducted or supported by the Federal Government; in a pre-pandemic 
phase, or in a pandemic phase. We have amended the 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 accurately encompasses all 
of the previously listed populations and ensures that no populations 
that use or are administered the Covered Countermeasures in accordance 
with the terms of the declaration are omitted, including those who use 
or are administered the Covered Countermeasures in a post pandemic

[[Page 13334]]

phase during the disposition period, discussed below in section XII. We 
deleted definitions of ``pre-pandemic phase'' and ``pandemic phase'' as 
those descriptions and distinctions did not prove to be useful or 
necessary in practice. These definitions presumed the first outbreak 
would be outside of the United States, which will not necessarily be 
the case.
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    \33\ 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.\34\ We included these statutory 
conditions in the declaration for clarity.
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    \34\ 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.\35\ This section previously appeared in section V, 
``Geographic Area.''
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    \35\ 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.\36\ We included these statutory conditions in the declaration 
for clarity.
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    \36\ 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.\37\ This section 
previously appeared as section III, ``Effective Time Period.''
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    \37\ 42 U.S.C. 246d-6d(b)(2)(B), (b)(6).
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    The declaration is amended to clarify when liability takes effect 
for different distribution methods, and to extend the period for which 
liability immunity is in effect. Rather than referring to the September 
28, 2009 declaration as defining when the effective period commenced, 
we have incorporated language from that declaration. We also clarified 
that for any Covered Countermeasure that becomes covered under the 
National Vaccine Injury Compensation Program after the declaration is 
issued, liability immunity expires under the PREP Act immediately upon 
such coverage. We made these changes for clarity and do not intend them 
to have legal effect.

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.\38\ 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. The provision for additional time periods previously 
appeared as section VII, ``Additional Time Periods of Coverage After 
Expiration of the Declaration''. The provision is amended to clarify 
the statutory provision 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.
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    \38\ 42 U.S.C. 247d-6d(b)(3).
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Section XIV, Countermeasures Injury Compensation Program

    Section 319F-4 of the PREP Act authorizes a Countermeasures Injury 
Compensation Program (CICP) to provide benefits to eligible individuals 
who sustain a serious physical injury or die as a direct result of the 
administration or use of a Covered Countermeasure.\39\ 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,\40\ and the 
statute.\41\ To show direct causation between a Covered Countermeasure 
and a serious physical injury, the statute requires ``compelling, 
reliable, valid, medical and scientific evidence.'' \42\ 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. This section previously appeared as section VIII, 
``Compensation Fund.'' We have added language to explain the type of 
injury and standard of evidence needed to be considered for 
compensation under the CICP. We included this information for clarity.
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    \39\ 42 U.S.C. 247d-6e.
    \40\ 42 CFR Part 110.
    \41\ 42 U.S.C.247d-6e.
    \42\ 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.\43\ This section previously 
appeared in section IX, ``Amendments.'' The section has been updated to 
reflect that this declaration amends the prior March 1, 2010 
declaration and that the declaration incorporates all prior amendments.
---------------------------------------------------------------------------

    \43\ 42 U.S.C. 247d-6d(b)(4).
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Deleted Sections

    The prior 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 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

[[Page 13335]]

the appendix. Coverage is available for any award or agreement that 
meets the description provided in section I 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 Vaccines Against Pandemic Influenza A 
Viruses and Influenza A Viruses With Pandemic Potential

    This declaration amends and republishes the March 1, 2010 
Republished Declaration, as Amended, for coverage under the Public 
Readiness and Emergency Preparedness (``PREP'') Act for Pandemic 
Influenza Vaccines, 42 U.S.C. 247d-6d, 247d-6e. To the extent any term 
of the March 1, 2010 Republished Declaration is inconsistent with any 
provision of this Republished Declaration, the terms of this 
Republished Declaration are controlling.

I. Determination of Public Health Emergency or Credible Risk of Future 
Public Health Emergency

42 U.S.C. 247d-6d(b)(1)
    I have determined that there is a credible risk that 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.

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 Federal Food, Drug, and Cosmetic 
Act (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 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.
    Covered Countermeasures must be ``qualified pandemic or epidemic 
products,'' or ``security countermeasures,'' or drugs, biological 
products, or devices authorized for emergency use, as those terms are 
defined in the PREP Act, the FD&C Act, and the Public Health Service 
Act.

VII. Limitations on Distribution

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

    I have determined that liability immunity is afforded to Covered 
Persons only for Recommended Activities involving Covered 
Countermeasures that are related to:

    (a) Present or future Federal contracts, cooperative agreements, 
grants, other transactions, interagency agreements, memoranda of 
understanding, or other Federal agreements;

or

    (b) Activities authorized in accordance with the public health and 
medical response of the Authority Having Jurisdiction to prescribe, 
administer, deliver, distribute or dispense the Covered Countermeasures 
following a declaration of an emergency.
    i. The Authority Having Jurisdiction means the public agency or its 
delegate that has legal responsibility and authority for responding to 
an incident, based on political or geographical (e.g., city, county, 
Tribal, State, or Federal boundary lines) or functional (e.g., law 
enforcement, public health) range or sphere of authority.
    ii. A declaration of emergency means any declaration by any 
authorized local, regional, State, or Federal official of an emergency 
specific to events that indicate an immediate need to administer and 
use the Covered Countermeasures, with the exception of a Federal 
declaration in support of an emergency use authorization under section 
564 of the FD&C Act unless such declaration specifies otherwise;
    I have also determined that for governmental program planners only, 
liability immunity is afforded only to the extent such program planners 
obtain Covered Countermeasures through voluntary means, such as (1) 
donation; (2) commercial sale; (3) deployment of Covered 
Countermeasures from Federal stockpiles; or (4) deployment of donated, 
purchased, or otherwise voluntarily obtained Covered Countermeasures 
from State, local, or private stockpiles.

VIII. Category of Disease, Health Condition, or Threat

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

    The category of disease, health condition, or threat for which I 
recommend the administration or use of the Covered Countermeasures is 
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.
    (a) Pandemic influenza A viruses and influenza A viruses with 
pandemic potential mean: animal and/or human influenza A viruses that 
are circulating in wild birds and/or domestic animals 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 na[iuml]ve.

[[Page 13336]]

    (b)

IX. Administration of Covered Countermeasures

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

    Administration of the Covered Countermeasure means physical 
provision of the countermeasures to recipients, or activities and 
decisions directly relating to public and private delivery, 
distribution and dispensing of the countermeasures to recipients, 
management and operation of countermeasure programs, or management and 
operation of locations for purpose of distributing and dispensing 
countermeasures.

X. Population

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)

    The populations of individuals include any individual who uses or 
is administered the Covered Countermeasures in accordance with this 
declaration.
    Liability immunity is afforded to manufacturers and distributors 
without regard to whether the countermeasure is used by or administered 
to this population; liability immunity is afforded to program planners 
and qualified persons when the countermeasure is used by or 
administered to this population or the program planner or qualified 
person reasonably could have believed the recipient was in this 
population.

XI. Geographic Area

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

    Liability immunity is afforded for the administration or use of a 
Covered Countermeasure without geographic limitation.
    Liability immunity is afforded to manufacturers and distributors 
without regard to whether the countermeasure is used by or administered 
in 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 
expires immediately upon such coverage.
    Liability immunity began June 15, 2009 for Covered Countermeasures 
against the 2009 H1N1 pandemic influenza and is provided through 
December 31, 2015 or until the Covered Countermeasure is covered under 
the National Vaccine Injury Compensation Program, whichever occurs 
first.
    Liability immunity for countermeasures against other pandemic 
influenza A viruses and influenza A viruses with pandemic potential for 
means of distribution other than those in accordance with the public 
health and medical response of the Authority Having Jurisdiction begins 
on December 1, 2006 and lasts through December 31, 2015 or until the 
Covered Countermeasure is covered under the National Vaccine Injury 
Compensation Program, whichever occurs first.
    Liability immunity for Covered Countermeasures against other 
pandemic influenza A viruses or influenza A viruses with pandemic 
potential administered or 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 that the emergency 
declaration is in effect, (2) December 31, 2015, or (3) until the 
Covered Countermeasure is covered under the National Vaccine Injury 
Compensation Program, whichever occurs first.

XIII. Additional Time Period of Coverage

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

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

XIV. Countermeasures Injury Compensation Program

42 U.S.C 247d-6e

    The PREP Act authorizes a Countermeasures Injury Compensation 
Program (CICP) to provide benefits to certain individuals who sustain a 
serious physical covered injury as the direct result of the 
administration or use of the Covered Countermeasures and benefits to 
survivors or estates of individuals who die as a direct result of the 
administration or use of the Covered Countermeasures. The causal 
connection between the countermeasure and the serious physical injury 
must be supported by compelling, reliable, valid, medical and 
scientific evidence in order for the individual to be considered for 
compensation. The CICP is administered by the Health Resources and 
Services Administration (HRSA), within the Department of Health and 
Human Services. Information about the CICP is available at the toll 
free number 1-888-275-4772 or at https://www.hrsa.gov/countermeasurescomp/default.htm.

XV. Amendments

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

    The Declaration for the Use of the Public Readiness and Emergency 
Preparedness Act for H5N1 was first published on January 26, 2007. That 
declaration provided liability immunity for vaccines against H5N1 
pandemic influenza under the terms and conditions stated in the 
declaration. 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; and amended on March 1, 2010 to revise 
the Covered Countermeasures and extend the effective date and 
republished in its entirety. This declaration incorporates all 
amendments prior to the date of its publication in the Federal 
Register.
    Any further amendments to this declaration will be published in the 
Federal Register.

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

    Dated: February 28, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-5312 Filed 3-5-12; 8:45 am]
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