Botulinum Toxin Medical Countermeasures-Amendment, 76529-76536 [2015-31091]
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Federal Register / Vol. 80, No. 236 / Wednesday, December 9, 2015 / Notices
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.
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.
XIV. Countermeasures Injury
Compensation Program
XI. Geographic Area
42 U.S.C 247d–6e
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
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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
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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.
42 U.S.C. 247d–6d(b)(3)(A), (B) and (C)
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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
https://www.hrsa.gov/cicp/.
Dated: December 1, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015–31094 Filed 12–8–15; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Botulinum Toxin Medical
Countermeasures—Amendment
Notice of Amendment to the
October 10, 2008, Declaration under the
Public Readiness and Emergency
Preparedness Act.
ACTION:
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76529
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:
SUMMARY:
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
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
1 73
2 21
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FR 61869.
U.S.C. 360bbb–3a and 360bbb–3b.
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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.
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
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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.
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.
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.
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.
5 See
3 42
U.S.C. 247d–6d(b)(1).
4 42 U.S.C. 247d.
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42 U.S.C. 247d–6d(b)(1).
U.S.C. 247d–6d(b)(6).
7 42 U.S.C. 247d–6d(b)(1).
6 42
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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.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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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
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
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; privatelabel distributors; jobbers; brokers;
warehouses and wholesale drug
U.S.C. 247d–6d(b)(1).
9 42 U.S.C. 247d–6d(a)(1).
10 42 U.S.C. 247d–6d (i)(2).
11 42 U.S.C. 247d–6d(i).
12 42 U.S.C. 247d–6d(i)(4).
warehouses; independent wholesale
drug traders; and retail pharmacies.13
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.
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.
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
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
8 42
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13 42
U.S.C. 247d–6d(i)(3).
U.S.C. 247d–6d(i)(6).
15 42 U.S.C. 247d–6d(i)(8).
16 42 U.S.C. 247d–6d(i)(5).
14 42
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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
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
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
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.
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).
20 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i).
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countermeasure to protect public
health.21
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
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 lifethreatening 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.
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
21 42
U.S.C. 247d–6d(i)(1)(B), (c)(1)(B).
U.S.C. 301 et seq.
23 42 U.S.C. 262.
24 21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b.
25 21 U.S.C. 355(i), 360j(g).
22 21
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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
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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.
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
26 42
U.S.C. 247d–6d(a)(5), (b)(2)(E).
e.g., 42 U.S.C. 247d–7d(c)(5).
27 See,
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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.
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.
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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.’’
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
28 42
U.S.C. 247d–6d(b)(2)(A).
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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.
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
29 42
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U.S.C. 247d–6d(a).
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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:
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.
30 42
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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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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.’’
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.
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
U.S.C. 247d–6d(a)(4).
U.S.C. 247d–6d(b)(2)(D).
33 42 U.S.C. 247d–6d(a)(4).
events, including factors specified in the
PREP Act.34 This section previously
appeared as section III, ‘‘Effective Time
Period.’’
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.
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
31 42
32 42
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34 42
35 42
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U.S.C. 246d–6d(b)(2)(B), (b)(6).
U.S.C. 247d–6d(b)(3).
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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.
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.
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
36 42
U.S.C. 247d–6e.
CFR part 110.
38 42 U.S.C. 247d–6e.
39 42 U.S.C. 247d–6e(b)(4).
40 42 U.S.C. 247d–6d(b)(4).
37 42
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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
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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.
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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,
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76535
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
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for purpose of distributing and
dispensing countermeasures.
XIII. Additional Time Period of
Coverage
X. Population
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.
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
XIV. Countermeasures Injury
Compensation Program
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
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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.
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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
https://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.
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Dated: December 1, 2015.
Sylvia M. Burwell,
Secretary.
[FR Doc. 2015–31091 Filed 12–8–15; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Ebola Virus Disease Therapeutics—
Amendment
Notice of Amendment to the
February 27, 2015, Declaration under
the Public Readiness and Emergency
Preparedness Act.
ACTION:
The Secretary is amending the
February 27, 2015 Declaration issued
pursuant to section 319F–3 of the Public
Health Service Act (42 U.S.C. 247d–6d)
(80 FR 22534) to extend the effective
time period for an additional twelve (12)
months consistent with the terms of the
Declaration and republishing the
Declaration in its entirety as amended.
DATES: The Amended Declaration is
effective as of February 27, 2016.
FOR FURTHER INFORMATION CONTACT:
Nicole Lurie, MD, MSPH, Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW., Washington, DC 20201; Telephone
202–205–2882.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
The Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes
the Secretary of Health and Human
Services (the Secretary) to issue a
Declaration to provide liability
immunity to certain individuals and
entities (Covered Persons) against any
claim of loss caused by, arising out of,
relating to, or resulting from the
administration or use of medical
countermeasures (Covered
Countermeasures), except for claims
that meet the PREP Act’s definition of
willful misconduct. The Secretary may,
though publication in the Federal
Register, amend any portion of a
Declaration. Using this authority, the
Secretary is amending the Declaration
that provides liability immunity to
Covered Persons for activities related to
the Covered Countermeasures, Ebola
Virus Disease Therapeutics as listed in
Section VI of the Declaration to extend
the effective time period for an
additional twelve (12) months,
consistent with the terms of this
Declaration.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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]
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