[Federal Register Volume 80, Number 236 (Wednesday, December 9, 2015)]
[Notices]
[Pages 76529-76536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Botulinum Toxin Medical Countermeasures--Amendment

ACTION: Notice of Amendment to the October 10, 2008, Declaration under 
the Public Readiness and Emergency Preparedness Act.

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SUMMARY: The Secretary is amending the declaration issued on October 
10, 2008 (73 FR 61864) pursuant to section 319F-3 of the Public Health 
Service Act (42 U.S.C. 247d-6d) to: Include 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); clarify the 
description of covered countermeasures; extend the effective time 
period of the declaration; reformat the declaration; modify or clarify 
terms of the declaration; and republish the declaration in its 
entirety, as amended.

DATES: The amendment of the October 10, 2008, 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 a declaration for countermeasures to 
botulinum toxin(s) and the resulting disease(s) from a manmade or 
natural source on October 10, 2008, and is amending this 
declaration.\1\
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    \1\ 73 FR 61869.
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    The major actions taken by this amendment to the botulinum toxin 
countermeasures declaration are the following: (1) Updating the 
description of covered countermeasures to include countermeasures 
authorized for use under sections 564A and 564B of the Federal Food, 
Drug, and Cosmetic (FD&C) Act; \2\ (2) revising the description of 
covered countermeasures to clarify that coverage for vaccines includes 
all components and

[[Page 76530]]

constituent materials of the vaccines, and all devices and their 
constituent components used in the administration of the vaccines; (3) 
revising the description of covered countermeasures to clarify that 
antitoxins are covered; (4) 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; (5) clarifying that liability immunity 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; (6) deleting references to specific federal contracts to 
clarify that immunity is not limited to activities conducted under 
listed contracts; (7) 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; (8) 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; (9) extending the 
time period for which liability immunity is in effect for the Covered 
Countermeasures to December 31, 2022, and (10) changing the entire 
declaration to the new format that was first used with the February 29, 
2012, amendment to the declaration for pandemic influenza to make the 
declaration easier for readers to follow. 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 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. 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 the emergency use of approved products in 
emergencies and products held for emergency use. PAHPRA accordingly 
amended the definitions of ``Covered Countermeasures'' and ``qualified 
pandemic and epidemic products'' in section 319F-3 of the Public Health 
Service Act (the PREP Act provisions), so that products made available 
under these new FD&C Act authorities could be covered under PREP Act 
declarations. PAHPRA also extended the definition of qualified pandemic 
and epidemic products to include products or technologies intended to 
enhance the use or effect of a drug, biological product, or device used 
against the pandemic or epidemic or against adverse events from these 
products.
    Unless otherwise noted, all statutory citations below are to the 
U.S. Code.

Section I, Determination of Public Health Emergency or Credible Risk of 
Future Public Health Emergency

    Before issuing a declaration under the PREP Act, the Secretary is 
required to determine that a disease or other health condition or 
threat to health constitutes a public health emergency or that there is 
a credible risk that the disease, condition, or threat may in the 
future constitute such an emergency.\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 declaration for 
botulinum toxin countermeasures (``declaration''), this determination 
appeared in the declaration's 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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    \3\ 42 U.S.C. 247d-6d(b)(1).
    \4\ 42 U.S.C. 247d.
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    In addition, we made a substantive change to the determination. The 
determination made in the ``whereas'' clauses in the October 10, 2008, 
declaration stated that the Secretary ``determined there is a credible 
risk that botulinum toxin(s) and the resulting disease(s) from a 
manmade or natural sources constitutes a public health emergency.'' The 
Secretary is amending this determination to state that the threat may 
be in the future, to refer to ``exposure'' to botulinum toxins, and to 
refer to both ``diseases'' and ``conditions'' to more accurately 
describe the risk and to be consistent with the language used in the 
PREP Act.\5\ Thus, in this amended declaration, the Secretary 
determines ``that there is a credible risk that exposure to botulinum 
toxin(s) and the resulting diseases or conditions from manmade or 
natural sources may in the future constitute a public health 
emergency.'' This change is provided for clarification.
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    \5\ 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.\6\ 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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    \6\ 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'').\7\ In the 
previous declaration, we included the Recommended Activities in section 
I of the declaration, ``Covered Countermeasures.'' 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. 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'' 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.
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    \7\ 42 U.S.C. 247d-6d(b)(1).

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[[Page 76531]]

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.\8\ 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.'' \9\ In the previous declaration, we included a 
statement referring to liability immunity specified under the PREP Act 
in section I of the declaration, ``Covered Countermeasures.'' The 
declaration now includes 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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    \8\ 42 U.S.C. 247d-6d(b)(1).
    \9\ 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.\10\ The PREP Act further defines the terms 
``manufacturer,'' ``distributor,'' ``program planner,'' and ``qualified 
person'' as described below.\11\
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    \10\ 42 U.S.C. 247d-6d (i)(2).
    \11\ 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; \12\
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    \12\ 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.\13\
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    \13\ 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.\14\ 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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    \14\ 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.\15\ 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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    \15\ 42 U.S.C. 247d-6d(i)(8).
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    The PREP Act also defines the word ``person'' as used in the Act: A 
person includes an individual, partnership, corporation, association, 
entity, or public or private corporation, including a federal, state, 
or local government agency or department.\16\
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    \16\ 42 U.S.C. 247d-6d(i)(5).
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    The provisions regarding Covered Persons previously appeared in the 
declaration as a definition in section IX, ``Definitions'' and in 
section VI, ``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'' authorized 
under an Emergency Use Authorization (EUA) for clarity. We made these 
changes to improve readability and clarity and do not intend them to 
have any substantive legal effect.
    We also modified the description of Covered Persons to include a 
new category of qualified persons: ``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.\17\
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    \17\ 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 \18\ 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.\19\
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    \18\ 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i).
    \19\ 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 \20\ 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

[[Page 76532]]

countermeasure to protect public health.\21\
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    \20\ 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i).
    \21\ 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; \22\ licensed under the PHS Act; \23\ authorized 
for emergency use under sections 564, 564A, or 564B of the FD&C 
Act.\24\
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    \22\ 21 U.S.C. 301 et seq.
    \23\ 42 U.S.C. 262.
    \24\ 21 U.S.C. 360bbb-3, 360bbb-3a, 360bbb-3b.
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    A qualified pandemic or epidemic product also may be a Covered 
Countermeasure when it is subject to an exemption (that is, it is 
permitted to be used under an Investigational Drug Application or an 
Investigational Device Exemption) under the FD&C Act \25\ 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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    \25\ 21 U.S.C. 355(i), 360j(g).
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    Provisions regarding Covered Countermeasures appeared in section I 
of the declaration, ``Covered Countermeasures'' and section IX of the 
declaration, ``Definitions.'' Section I included not only a description 
of the Covered Countermeasure but also 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. We do not intend for this 
change to have any substantive legal effect.
    Section I of the declaration also stated that the declaration 
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 description and definition of the Covered 
Countermeasure that previously appeared in sections I, ``Covered 
Countermeasures'' and IX, ``Definitions.'' Section I referred to the 
Act for the definition of ``Covered Countermeasures,'' and section IX 
defined the term ``Botulinum Toxin Countermeasure'' as ``Any vaccine; 
antimicrobial/antibiotic, other drug or antitoxin; or diagnostic or 
device to identify, prevent or treat botulinum toxin or adverse events 
from such countermeasures (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.''
    We revised the description of botulinum toxin countermeasures to 
clarify that coverage for vaccines includes components and constituent 
materials of the vaccines and device and constituent components used in 
administration of the vaccines and that antitoxins are also covered. 
The definition now reads: ``Any vaccine, including all components and 
constituent materials of these vaccines, and all devices and their 
constituent components used in the administration of these vaccines; 
any antimicrobial/antibiotic; any other drug or antitoxin; any 
biologic; or any diagnostic or other device to identify, prevent or 
treat botulinum toxin or adverse events from such countermeasures.'' 
These changes are intended as clarification, and are not intended to be 
substantive.
    We also added a statement referencing the statutory definitions of 
Covered Countermeasures to make clear that these statutory definitions 
limit the scope of Covered Countermeasures. Specifically, we noted 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 Covered Countermeasures obtained through a particular means of 
distribution.\26\ These limitations on distribution previously appeared 
in section I, ``Covered Countermeasures,'' and section IX, 
``Definitions.'' We now state the limitations in a separate section and 
combine them with relevant definitions for improved readability.
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    \26\ 42 U.S.C. 247d-6d(a)(5), (b)(2)(E).
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    The declaration now 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 the phrase ``other transactions,'' 
which may be used for some Covered Countermeasure activities,\27\ added 
the phrase ``or other Federal agreements'' to clarify that the 
provision is intended to cover all types of federal agreements, and 
added 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. 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 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

[[Page 76533]]

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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    \27\ 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 prior 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.\28\ This information appeared in section II, ``Category 
of Disease.''
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    \28\ 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 IX, ``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 patients/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 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, ``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.\29\ 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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    \29\ 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.\30\ 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.'' The previous 
declaration stated that the population specified in the declaration 
included:
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    \30\ 42 U.S.C. 247d-6d(b)(2)(C).
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    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 to prescribe, administer or dispense the 
countermeasure under an EUA; (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.

[[Page 76534]]

    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 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.\31\ We included these statutory 
conditions in the declaration for clarity.
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    \31\ 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.\32\ This section previously appeared in section V, 
``Geographic Area.''
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    \32\ 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.\33\ We included these statutory conditions in the declaration 
for clarity.
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    \33\ 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.\34\ This section 
previously appeared as section III, ``Effective Time Period.''
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    \34\ 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 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.\35\ In addition, the PREP Act 
specifies that for Covered Countermeasures that are subject to a 
declaration at the time they are obtained for the Strategic National 
Stockpile (SNS) under 42 U.S.C. 247d-6b(a), the effective period of the 
declaration extends through the time the countermeasure is used or 
administered pursuant to a distribution or release from the 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.
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    \35\ 42 U.S.C. 247d-6d(b)(3).
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    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 
provisions as they apply to manufacturers and to other covered persons, 
and to clarify that extended coverage applies to any products obtained 
for the SNS 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 the Countermeasures 
Injury Compensation Program (CICP) to provide benefits to eligible 
individuals who sustain a serious physical injury or die as a direct 
result of the administration or use of a Covered Countermeasure.\36\ 
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,\37\ and the 
statute.\38\ To show direct causation between a Covered Countermeasure 
and a serious physical injury, the statute requires ``compelling, 
reliable, valid, medical and scientific evidence.'' \39\ 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 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.
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    \36\ 42 U.S.C. 247d-6e.
    \37\ 42 CFR part 110.
    \38\ 42 U.S.C. 247d-6e.
    \39\ 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.\40\ This section previously 
appeared in section VIII, ``Amendments.'' The section has been updated 
to reflect that the Republished Declaration amends the prior October 
10, 2008, declaration.
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    \40\ 42 U.S.C. 247d-6d(b)(4).
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Deleted Sections

    The prior declaration included ``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 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 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

[[Page 76535]]

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 Botulinum Toxin Countermeasures

    This declaration amends and republishes the October 10, 2008, 
Declaration Under the PREP Act for botulinum toxin countermeasures. To 
the extent any term of the October 10, 2008, 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 exposure to 
botulinum toxin(s) and the resulting diseases or conditions from 
manmade or natural sources 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 EUA in accordance with section 564 of the FD&C Act; (c) Any 
person authorized to prescribe, administer, or dispense Covered 
Countermeasures in accordance with Section 564A of the FD&C Act.

VI. Covered Countermeasures

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

    Covered Countermeasures are any vaccine, including all components 
and constituent materials of these vaccines, and all devices and their 
constituent components used in the administration of these vaccines; 
any antimicrobial/antibiotic; any other drug or antitoxin; any 
biologic; or any diagnostic or other device to identify, prevent or 
treat botulinum toxin or adverse events from such countermeasures.
    Covered Countermeasures must be ``qualified pandemic or epidemic 
products,'' or ``security countermeasures,'' or drugs, biological 
products, or devices authorized for investigational or emergency use, 
as those terms are defined in the PREP Act, the FD&C Act, and the 
Public Health Service Act.

VII. Limitations on Distribution

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

    I have determined that liability immunity is afforded to Covered 
Persons only for Recommended Activities involving Covered 
Countermeasures that are related to:
    (a) Present or future federal contracts, cooperative agreements, 
grants, other transactions, interagency agreements, memoranda of 
understanding, or other federal agreements, or activities directly 
conducted by the federal government; or
    (b) Activities authorized in accordance with the public health and 
medical response of the Authority Having Jurisdiction to prescribe, 
administer, deliver, distribute or dispense the Covered Countermeasures 
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 
botulinum toxin resulting from exposure to botulinum toxin(s).

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

[[Page 76536]]

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)

    Liability immunity for Covered Countermeasures obtained through 
means of distribution other than in accordance with the public health 
and medical response of the Authority Having Jurisdiction extends 
through December 31, 2022.
    Liability immunity for Covered Countermeasures administered and 
used in accordance with the public health and medical response of the 
Authority Having Jurisdiction begins with a declaration and lasts 
through (1) the final day the emergency declaration is in effect or (2) 
December 31, 2022, whichever occurs first.

XIII. Additional Time Period of Coverage

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

    I have determined that an additional twelve (12) months of 
liability protection is reasonable to allow for the manufacturer(s) to 
arrange for disposition of the Covered Countermeasure, including return 
of the Covered Countermeasures to the manufacturer, and for Covered 
Persons to take such other actions as are appropriate to limit the 
administration or use of the Covered Countermeasures.
    Covered Countermeasures obtained for the 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

2 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 at 855-266-2427 
(toll-free) 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 botulinum toxin countermeasures was 
first published on October 17, 2008. This is the first amendment to 
that declaration.
    Any 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. 2015-31091 Filed 12-8-15; 8:45 am]
BILLING CODE P