Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures, 21819-21825 [2017-09455]
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Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Notices
name and contact information to be
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56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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docket number, found in brackets in the
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Submit written requests for single
copies of the draft revised Blueprint to
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and Drug Administration, 10001 New
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your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft revised Blueprint.
FOR FURTHER INFORMATION CONTACT:
Janelle Derbis, Center for Drug
Evaluation and Research (HFD–1), Food
and Drug Administration 20 North
Michigan Ave., Suite 510, Chicago, IL
60602, 312–596–6516.
FDA is
announcing the availability of draft
revisions to the ‘‘FDA Blueprint for
Prescriber Education for ExtendedRelease and Long-Acting Opioid
Analgesics’’ (draft revisions to the
Blueprint). In addition to seeking
comment on the draft revisions to the
Blueprint, FDA expects the draft
revisions to create important context for
discussions at a public workshop on
issues and challenges associated with
Federal efforts to support training on
pain management and the safe
prescribing, dispensing, and patient use
of opioids (safe use of opioids) for
health care providers. That workshop,
which is scheduled for May 9–10, 2017,
was previously announced in the
Federal Register on April 18, 2017 (82
FR 18300).
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SUPPLEMENTARY INFORMATION:
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I. Background
On July 12, 2012, FDA approved an
ER/LA Opioid Analgesics REMS,
including an FDA-created ‘‘Blueprint for
Prescriber Education for ExtendedRelease and Long-Acting (ER/LA)
Opioid Analgesics.’’ The goal of the
REMS is to reduce serious adverse
outcomes resulting from inappropriate
prescribing, misuse, and abuse of ER/LA
opioid analgesics while maintaining
patient access to pain medications.
The ER/LA Opioid Analgesics REMS
requires that training in the form of
accredited continuing education be
made available to health care providers
who prescribe ER/LA opioid analgesics.
The accredited continuing education
must include all elements of the FDA
Blueprint, which includes a basic
outline and the core messages related to
ER/LA opioid analgesics. FDA
developed the Blueprint following
extensive input from stakeholders and
sought input on a draft version on
November 7, 2011 (76 FR 68766), before
approving it in 2012 as part of the ER/
LA Opioid Analgesics REMS.
On May 3–4, 2016, FDA convened a
joint meeting of the Drug Safety and
Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug
Products Advisory Committee to discuss
whether this REMS assures safe use of
these products; whether or not it is
unduly burdensome to patient access to
the drugs; and whether it (to the extent
practicable) minimizes the burden to the
health care delivery system (March 14,
2016, 81 FR 13372). FDA also sought
input on possible modifications to the
ER/LA Opioid Analgesic REMS,
including expansion of the scope and
content of prescriber training and
expansion of the REMS program to
include immediate release (IR) opioid
analgesics. Advisory Committee
members were in favor of modifying the
REMS program to include the IR opioid
analgesics as well as broadening the
training program to include pain
management. The majority of the
members were in favor of a requirement
for all prescribers to complete training.
Many of the members recommended
that the required training program be
implemented through mechanisms
outside the FDA REMS authority. The
majority of members also stated that
other health care providers involved in
the management of pain should be
included as a target audience for
education, though they did not specify
that the training should be mandatory
for non-prescribing health care
providers.
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21819
II. Potential Modifications to the FDA
Blueprint
FDA is considering modifications to
the existing Blueprint in light of
recommendations from the May 2016
Advisory Committee meeting. The draft
revisions to the Blueprint being made
available pursuant to this notice would
broaden the Blueprint to include
information on pain management,
including the principles of acute and
chronic pain management; nonpharmacologic treatments for pain; and
pharmacologic treatments for pain (both
non-opioid analgesic and opioid
analgesic). FDA intends to consider
public input as it considers
modifications to the ER/LA Opioid
Analgesics REMS.
III. May 2017 Public Workshop
On April 18, 2017, FDA published a
notice announcing a public workshop
scheduled for May 9–10, 2017, to seek
input on issues and challenges
associated with Federal efforts to
support training on pain management
and the safe prescribing, dispensing,
and patient use of opioids (safe use of
opioids) for health care providers.
Through the public workshop, FDA
hopes to obtain additional insight from
a variety of stakeholders on how best to
ensure that health care providers receive
training in pain management and the
safe use of opioids. The draft revisions
to the Blueprint being made available at
https://www.fda.gov/Drugs/NewsEvents/
ucm553931.htm are intended to provide
important context for the public
workshop’s discussion. However, the
Blueprint itself will not be a discussion
topic at the workshop. FDA intends to
consider any comments submitted to
this docket as it considers possible
modifications to the ER/LA Opioid
Analgesics REMS.
Dated: May 4, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–09442 Filed 5–9–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Nerve Agents and Certain Insecticides
(Organophosphorus and/or
Carbamate) Countermeasures
Department of Health and
Human Services, Office of the Secretary.
ACTION: Notice.
AGENCY:
The Secretary is issuing a
declaration pursuant to section 319F–3
of the Public Health Service Act to
SUMMARY:
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provide liability protections consistent
with that authority for medical
countermeasures against nerve agents
and organophosphorus insecticides that
result in organophosphorus poisoning
and carbamate insecticides that result in
carbamate poisoning.
DATES: The declaration is effective as of
April 11, 2017.
FOR FURTHER INFORMATION CONTACT:
George W. Korch Jr., Ph.D., Acting
Assistant Secretary for Preparedness
and Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
Background
The Public Readiness and Emergency
Preparedness Act (PREP Act) authorizes
the Secretary of the U.S. Department of
Health and Human Services to issue a
declaration to provide liability
immunity to certain individuals and
entities (Covered Persons) against any
claim of loss caused by, arising out of,
relating to, or resulting from the
administration or use of medical
countermeasures (Covered
Countermeasures), except for claims
that meet the PREP Act’s definition of
willful misconduct. Using this
authority, the Secretary is issuing this
declaration for medical
countermeasures against nerve agents
and organophosphorus insecticides that
result in organophosphorus poisoning
and carbamate insecticides that result in
carbamate poisoning. The purpose of
issuing this declaration is to strengthen
preparedness against these threats that
pose an ongoing credible risk of a future
public health emergency and does not
indicate a change in threat information.
The declaration is published in full.
We explain both the substantive and
format changes in this supplementary
section.
The PREP Act was enacted on
December 30, 2005 as Public Law 109–
148, Division C, Section 2. It amended
the Public Health Service (‘‘PHS’’) Act,
adding section 319F–3, which addresses
liability immunity, and section 319F–4,
which creates a compensation program.
These sections are codified in the U.S.
Code as 42 U.S.C. 247d–6d and 42
U.S.C. 247d–6e, respectively. The
Pandemic and All-Hazards
Preparedness Reauthorization Act
(PAHPRA), Public Law 113–5, was
enacted on March 13, 2013. Among
other things, PAHPRA added sections
564A and 564B to the Federal Food,
Drug & Cosmetic (FD&C) Act to provide
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new emergency authorities for
dispensing approved products in
emergencies and products held for
emergency use. PAHPRA accordingly
amended the definitions of Covered
Countermeasures and qualified
pandemic and epidemic products in
section 319F–3 of the Public Health
Service Act (the PREP Act provisions),
so that products made available under
these new FD&C Act authorities could
be covered under PREP Act
declarations. PAHPRA also extended
the definition of qualified pandemic and
epidemic products to include products
or technologies intended to enhance the
use or effect of a drug, biological
product, or device used against the
pandemic or epidemic or against
adverse events from these products.
Unless otherwise noted, all statutory
citations below are to the U.S. Code.
Section I, Determination of Public
Health Emergency or Credible Risk of
Future Public Health Emergency
Before issuing a declaration under the
PREP Act, the Secretary is required to
determine that a disease or other health
condition or threat to health constitutes
a public health emergency or that there
is a credible risk that the disease,
condition, or threat may in the future
constitute such an emergency.1 This
determination is separate and apart from
a declaration issued by the Secretary
under section 319 of the PHS Act 2 that
a disease or disorder presents a public
health emergency or that, a public
health emergency, including significant
outbreaks of infectious diseases or
bioterrorist attacks, otherwise exists, or
other declarations or determinations
made under other authorities of the
Secretary. The declaration states in
section I the Secretary’s determination
that there is a credible risk that the
release of nerve agents or
organophosphorus insecticides and the
resulting organophosphorus poisoning
or the release of carbamate insecticides
and the resulting carbamate poisoning
may, in the future, constitute a public
health emergency.
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,
1 42
2 42
PO 00000
U.S.C. 247d–6d(b)(1).
U.S.C. 247d.
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administration, licensing, and use of the
countermeasure.3 The declaration states
these considerations in section II.
Section III, Recommended Activities
The Secretary must recommend the
activities for which the PREP Act’s
liability immunity is in effect. These
activities may include, under conditions
as the Secretary may specify, the
manufacture, testing, development,
distribution, administration, or use of
one or more Covered Countermeasures
(Recommended Activities).4 The
declaration states the Recommended
Activities in section III.
Section IV, Liability Immunity
The Secretary must also state that
liability protections available under the
PREP Act are in effect with respect to
the Recommended Activities.5 These
liability protections provide that,
‘‘[s]ubject to other provisions of [the
PREP Act], a covered person shall be
immune from suit and liability under
Federal and State law with respect to all
claims for loss caused by, arising out of,
relating to, or resulting from the
administration to or use by an
individual of a covered countermeasure
if a declaration . . . has been issued
with respect to such countermeasure.’’ 6
The declaration includes the statement
that liability immunity is in effect for
Recommended Activities in section IV.
Section V, Covered Persons
The PREP Act’s liability immunity
applies to Covered Persons with respect
to administration or use of a Covered
Countermeasure. The term ‘‘Covered
Persons’’ has a specific meaning, and is
defined in the PREP Act to include
manufacturers, distributors, program
planners, and qualified persons, and
their officials, agents, and employees,
and the United States.7 The PREP Act
further defines the terms
‘‘manufacturer,’’ ‘‘distributor,’’
‘‘program planner,’’ and ‘‘qualified
person’’ as described below.8
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,
3 42
U.S.C. 247d–6d(b)(6).
U.S.C. 247d–6d(b)(1).
5 42 U.S.C. 247d–6d(b)(1).
6 42 U.S.C. 247d–6d(a)(1).
7 42 U.S.C. 247d–6d(i)(2).
8 42 U.S.C. 247d–6d(i).
4 42
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affiliates, successors, and assigns of a
manufacturer; 9
A distributor means a person or entity
engaged in the distribution of drugs,
biologics, or devices, including but not
limited to: Manufacturers; repackers;
common carriers; contract carriers; air
carriers; own-label distributors; privatelabel distributors; jobbers; brokers;
warehouses and wholesale drug
warehouses; independent wholesale
drug traders; and, retail pharmacies; 10
A program planner means a state or
local government, including a Native
American Tribe; a person employed by
the state or local government; or other
person who supervises or administers a
program with respect to the
administration, dispensing, distribution,
provision, or use of a Covered
Countermeasure, including a person
who establishes requirements, provides
policy guidance, or supplies technical
or scientific advice or assistance or
provides a facility to administer or use
a Covered Countermeasure in
accordance with the Secretary’s
declaration.11 Under this definition, a
private sector employer or community
group or other person can be a program
planner when it carries out the
described activities.
A qualified person means a licensed
health professional or other individual
who is authorized to prescribe,
administer, or dispense Covered
Countermeasures under the law of the
state in which the countermeasure was
prescribed, administered, or dispensed;
or, a person within a category of persons
identified as qualified in the Secretary’s
declaration.12 Under this definition, the
Secretary can describe in the declaration
other qualified persons, such as
volunteers, who are Covered Persons.
Section V describes other qualified
persons covered by this declaration.
The PREP Act also defines the word
‘‘person’’ as used in the Act: A person
includes an individual, partnership,
corporation, association, entity, or
public or private corporation, including
a federal, state, or local government
agency or department.13
The declaration lists Covered Persons
in section V to include manufacturers,
distributors, program planners, qualified
persons, and their officials, agents, and
employees, as those terms are defined in
the PREP Act, and the United States.
The declaration also lists in section V
Additional Covered Persons to include:
(a) Any person authorized in accordance
U.S.C. 247d–6d(i)(4).
10 42 U.S.C. 247d–6d(i)(3).
11 42 U.S.C. 247d–6d(i)(6).
12 42 U.S.C. 247d–6d(i)(8).
13 42 U.S.C. 247d–6d(i)(5).
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Section VI, Covered Countermeasures
As noted above, section III describes
the Secretary’s Recommended Activities
for which liability immunity is in effect.
This section identifies the
countermeasures for which the
Secretary has recommended such
activities. The PREP Act states that a
Covered Countermeasure must be a
‘‘qualified pandemic or epidemic
product,’’ or a ‘‘security
countermeasure,’’ as described
immediately below; or a drug, biological
product or device authorized for
emergency use in accordance with
section 564, 564A, or 564B of the FD&C
Act.14
A qualified pandemic or epidemic
product means a drug or device, as
defined in the FD&C Act or a biological
product, as defined in the PHS Act 15
that is: (i) Manufactured, used,
designed, developed, modified, licensed
or procured to diagnose, mitigate,
prevent, treat, or cure a pandemic or
epidemic or limit the harm such a
pandemic or epidemic might otherwise
cause; (ii) manufactured, used,
designed, developed, modified,
licensed, or procured to diagnose,
mitigate, prevent, treat, or cure a serious
or life-threatening disease or condition
caused by such a drug, biological
product or device; (iii) or, a product or
technology intended to enhance the use
or effect of such a drug, biological
product, or device.16
A security countermeasure is a drug
or device, as defined in the FD&C Act
or a biological product, as defined in the
PHS Act 17 that: (i)(a) The Secretary
determines to be a priority to diagnose,
mitigate, prevent or treat harm from any
14 42 U.S.C. 247d–6d(i)(1). Sections 564, 564A,
and 564B of the FD&C Act may be found at 21
U.S.C. 360bbb–3, 360bbb–3a, and 360bbb–3b.
15 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i).
16 42 U.S.C. 247d–6d(i)(1)(A), (i)(7).
17 21 U.S.C. 321(g)(1), (h);42 U.S.C. 262(i).
9 42
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with the public health and medical
emergency response of the Authority
Having Jurisdiction, . . . to prescribe,
administer, deliver, distribute or
dispense the Covered Countermeasures,
and their officials, agents, employees,
contractors and volunteers, following a
declaration of an emergency; (b) any
person authorized to prescribe,
administer, or dispense the Covered
Countermeasures or who is otherwise
authorized to perform an activity under
an Emergency Use Authorization in
accordance with section 564 of the
FD&C Act; and, (c) any person
authorized to prescribe, administer, or
dispense Covered Countermeasures in
accordance with Section 564A of the
FD&C Act.
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biological, chemical, radiological, or
nuclear agent identified as a material
threat by the Secretary of Homeland
Security, or (b) to diagnose, mitigate,
prevent, or treat harm from a condition
that may result in adverse health
consequences or death and may be
caused by administering a drug,
biological product, or device against
such an agent; and (ii) is determined by
the Secretary of Health and Human
Services to be a necessary
countermeasure to protect public
health.18
To be a Covered Countermeasure,
qualified pandemic or epidemic
products and security countermeasures
also must be approved or cleared under
the FD&C Act; 19 licensed under the PHS
Act; 20 authorized for emergency use
under sections 564, 564A, or 564B of the
FD&C Act.21 A qualified pandemic or
epidemic product also may be a Covered
Countermeasure when it is exempted
under the FD&C Act for use as an
investigational drug or device 22 that is
the object of research for possible use
for diagnosis, mitigation, prevention,
treatment, cure or limit harm of a
pandemic or epidemic or serious or 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 ten years after the
Department’s determination that
procurement of the countermeasure is
appropriate.
The declaration describes the Covered
Countermeasures in Section VI as: Any
antidote; any other drug; all components
and constituent materials of these
antidotes and other drugs; all devices
and their constituent components used
in the administration of these antidotes
and other drugs; any diagnostic; or any
other device to identify, prevent, or treat
organophosphorus or carbamate
poisoning or adverse events from such
countermeasures.
The declaration also includes in
section VI a statement referencing the
statutory definitions of Covered
Countermeasures to make clear that
these statutory definitions limit the
scope of Covered Countermeasures.
Section VII, Limitations on Distribution
The Secretary may specify that
liability immunity is in effect only to
Covered Countermeasures obtained
18 42
U.S.C. 247d–6d(i)(1)(B),(c)(1)(B).
U.S.C. 301 et seq.
20 42 U.S.C. 262.
21 21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b.
22 21 U.S.C. 355(i), 360j(g).
19 21
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through a particular means of
distribution.23
The declaration states in section VII
that liability immunity is afforded to
Covered Persons for Recommended
Activities related to: (a) Present or
future Federal contracts, cooperative
agreements, grants, other transactions,
interagency agreements, or memoranda
of understanding or other Federal
agreements or activities directly
conducted by the Federal Government;
or (b) Activities authorized in
accordance with the public health and
medical response of the Authority
Having Jurisdiction to prescribe,
administer, deliver, distribute, or
dispense the Covered Countermeasures
to respond to an event covered by a
declared emergency, including
authorized activities that occur as part
of the response before the formal
declaration of an emergency. The
declaration also provides in section VII
definitions for ‘‘Authority Having
Jurisdiction’’ and ‘‘Declaration of an
Emergency:’’
i. The Authority Having Jurisdiction
means the public agency or its delegate
that has legal responsibility and
authority for responding to an incident,
based on political or geographical (e.g.,
city, county, Tribal, State, or Federal
boundary lines) or functional (e.g., law
enforcement, public health) range or
sphere of authority.
ii. A declaration of emergency means
any declaration by any authorized local,
regional, State, or Federal official of an
emergency specific to events that
indicate an immediate need to
administer and use the Covered
Countermeasures, with the exception of
a Federal declaration in support of an
Emergency Use Authorization under
section 564 of the FD&C Act unless such
declaration specifies otherwise;
Subsection (b) is intended to cover
distribution, dispensing, administration,
or use of the covered countermeasure
under a formal government-authorized
response to circumstances at any time
those activities occur to respond to an
event that gives rise to a declared
emergency. Subsection (b) is not
intended to be limited to cover those
activities only after an emergency is
formally declared and includes
authorized activities that occur as part
of the response before the formal
declaration of an emergency. The
Secretary recognizes that in emergency
circumstances, distribution, dispensing,
administration, or use of
countermeasures may need to be
expedient and may occur prior to a
formal declaration of an emergency.
23 42
U.S.C. 247d–6d(a)(5), (b)(2)(E).
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This concern is particularly critical for
the countermeasures covered by this
declaration, where the Covered
Countermeasures may need to be
administered within minutes of
exposure to a nerve agent to save lives.
Thus, the Secretary is clarifying that
coverage under subsection (b) is
intended to cover any distribution,
dispensing, administration, or use in
accordance with the Authority Having
Jurisdiction at any time that those
activities address the emergency
circumstances that gave rise to the
declared emergency even if the
activities occur prior to the declaration
itself.
For governmental program planners
only, liability immunity is afforded only
to the extent they obtain Covered
Countermeasures through voluntary
means, such as (1) donation; (2)
commercial sale; (3) deployment of
Covered Countermeasures from Federal
stockpiles; or (4) deployment of
donated, purchased, or otherwise
voluntarily obtained Covered
Countermeasures from State, local, or
private stockpiles. This limitation on
distribution is intended to deter
program planners that are government
entities from seizing privately held
stockpiles of Covered Countermeasures.
It does not apply to any other Covered
Persons, including other program
planners who are not government
entities.
Section VIII, Category of Disease,
Health Condition, or Threat
The Secretary must identify, for each
Covered Countermeasure, the categories
of diseases, health conditions, or threats
to health for which the Secretary
recommends the administration or use
of the countermeasure.24 The
declaration states in section VIII that the
category of disease, health condition, or
threat for which the Secretary
recommends administration or use of
the countermeasures is
organophosphorus or carbamate
poisoning.
Section IX, Administration of Covered
Countermeasures
The PREP Act does not explicitly
define the term ‘‘administration’’ but
does assign the Secretary the
responsibility to provide relevant
conditions in the declaration. The
declaration defines administration in
section IX as: Administration of a
Covered Countermeasure means
physical provision of the
countermeasures to recipients, or
activities and decisions directly relating
24 42
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U.S.C. 247d–6d(b)(2)(A).
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to public and private delivery,
distribution and dispensing of the
countermeasures to recipients;
management and operation of
countermeasure programs; or
management and operation of locations
for purpose of distributing and
dispensing countermeasures.
This definition of ‘‘administration’’ is
intended to extend only to physical
provision of a countermeasure to a
recipient, such as vaccination or
handing drugs to patients, and to
activities related to management and
operation of programs and locations for
providing countermeasures to
recipients, such as decisions and actions
involving security and queuing, but
only insofar as those activities directly
relate to the countermeasure activities.
Claims for which Covered Persons are
provided immunity under the Act are
losses caused by, arising out of, relating
to, or resulting from the administration
to or use by an individual of a Covered
Countermeasure consistent with the
terms of a declaration issued under the
Act.25 Under the Secretary’s definition,
these liability claims are precluded if
the claims allege an injury caused by
physical provision of a countermeasure
to a recipient, or if the claims are
directly due to conditions of delivery,
distribution, dispensing, or management
and operation of countermeasure
programs at distribution and dispensing
sites.
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.
25 42
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Section X, Population
The Secretary must identify, for each
Covered Countermeasure specified in a
declaration, the population or
populations of individuals for which
liability immunity is in effect with
respect to administration or use of the
countermeasure.26 This section explains
which individuals should use the
countermeasure or to whom the
countermeasure should be
administered—in short, those who
should be vaccinated or take a drug or
other countermeasure. The declaration
provides in section X that the
population includes any individual who
uses or who is administered a Covered
Countermeasure in accordance with the
declaration.
In addition, the PREP Act specifies
that liability immunity is afforded: (1)
To manufacturers and distributors
without regard to whether the
countermeasure is used by or
administered to this population; and (2)
to program planners and qualified
persons when the countermeasure is
either used by or administered to this
population or the program planner or
qualified person reasonably could have
believed the recipient was in this
population.27 We included these
statutory conditions in the declaration
section X for clarity.
Section XI, Geographic Area
The Secretary must identify, for each
Covered Countermeasure specified in
the declaration, the geographic area or
areas for which liability immunity is in
effect with respect to administration or
use of the countermeasure, including, as
appropriate, whether the declaration
applies only to individuals physically
present in the area or, in addition,
applies to individuals who have a
described connection to the area.28 The
declaration states in section XI that
there are no limitations on geographic
area.
In addition, the PREP Act specifies
that liability immunity is afforded: (1)
To manufacturers and distributors
without regard to whether the
countermeasure is used by or
administered to individuals in the
geographic areas; and (2) to program
planners and qualified persons when
the countermeasure is either used or
administered in the geographic areas or
the program planner or qualified person
reasonably could have believed the
countermeasure was used or
administered in the areas.29 We
26 42
U.S.C. 247d–6d(b)(2)(C).
27 42 U.S.C. 247d–6d(a)(4).
28 42 U.S.C. 247d–6d(b)(2)(D).
29 42 U.S.C. 247d–6d(a)(4).
VerDate Sep<11>2014
15:21 May 09, 2017
included these statutory conditions in
the declaration section XI 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
events, including factors specified in the
PREP Act.30
The declaration states in section XII
when liability immunity takes effect for
different means of distribution within
that time period.
Section XIII, Additional Time Period of
Coverage
The Secretary must specify a date
after the ending date of the effective
period of the declaration that is
reasonable for manufacturers to arrange
for disposition of the Covered
Countermeasure, including return of the
product to the manufacturer, and for
other Covered Persons to take
appropriate actions to limit
administration or use of the Covered
Countermeasure.31 In addition, the
PREP Act specifies that for Covered
Countermeasures that are subject to a
declaration at the time they are obtained
for the Strategic National Stockpile
under 42 U.S.C. 247d–6b(a), the
effective period of the declaration
extends through the time the
countermeasure is used or administered
pursuant to a distribution or release
from the Stockpile. Liability immunity
under the provisions of the PREP Act
and the conditions of the declaration
continues during these additional time
periods. Thus, liability immunity is
afforded during the ‘‘Effective Time
Period,’’ described under section XII of
the declaration, plus the ‘‘Additional
Time Period of Coverage’’ described
under section XIII of the declaration.
The declaration states in section XIII
that the additional time period is twelve
(12) months and also states that
extended coverage applies to any
products obtained for the Strategic
National Stockpile during the effective
period of the declaration. We included
the statutory provision for clarity.
Section XIV, Countermeasures Injury
Compensation Program
Section 319F–4 of the PREP Act
authorizes a Countermeasures Injury
Compensation Program (CICP) to
provide benefits to eligible individuals
who sustain a serious physical injury or
die as a direct result of the
administration or use of a Covered
30 42
31 42
Jkt 241001
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U.S.C. 247d–6d(b)(3).
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21823
Countermeasure.32 Compensation under
the CICP for an injury directly caused by
a Covered Countermeasure is based on
the requirements set forth in this
declaration, the administrative rules for
the Program,33 and the statute.34 To
show direct causation between a
Covered Countermeasure and a serious
physical injury, the statute requires
‘‘compelling, reliable, valid, medical
and scientific evidence.’’ 35 The
administrative rules for the Program
further explain the necessary
requirements for eligibility under the
CICP. Please note that, by statute,
requirements for compensation under
the CICP may not always align with the
requirements for liability immunity
provided under the PREP Act. The
declaration explains in section XIV,
‘‘Countermeasures Injury Compensation
Program’’ the types of injury and
standard of evidence needed to be
considered for compensation under the
CICP. Further, the administrative rules
for the CICP specify if countermeasures
are administered or used outside the
United States, only otherwise eligible
individuals at American embassies,
military installations abroad (such as
military bases, ships, and camps) or at
North Atlantic Treaty Organization
(NATO) installations (subject to the
NATO Status of Forces Agreement)
where American servicemen and
servicewomen are stationed may be
considered for CICP benefits. Other
individuals outside the United States
may not be eligible for CICP benefits.
Section XV, Amendments
The Secretary may amend any portion
of a declaration through publication in
the Federal Register.36 The declaration
states in section XV that any
amendments to this declaration will be
published in the Federal Register.
Declaration
Declaration for Public Readiness and
Emergency Preparedness Act Coverage
for Nerve Agents and Certain
Insecticides (Organophosphorus and/or
Carbamate) Countermeasures
I. Determination of Public Health
Emergency or Credible Risk of Future
Public Health Emergency
42 U.S.C. 247d–6d(b)(1)
I have determined that there is a
credible risk that the release of nerve
agents or organophosphorus insecticides
and the resulting organophosphorus
32 42
U.S.C. 247d–6e.
CFR part 110.
34 42 U.S.C. 247d–6e.
35 42 U.S.C. 247d–6e(b)(4).
36 42 U.S.C. 247d–6d(b)(4).
33 42
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poisoning or release of carbamate
insecticides and the resulting carbamate
poisoning may, in the future, constitute
a public health emergency.
II. Factors Considered
42 U.S.C. 247d–6d(b)(6)
I have considered the desirability of
encouraging the design, development,
clinical testing or investigation,
manufacture, labeling, distribution,
formulation, packaging, marketing,
promotion, sale, purchase, donation,
dispensing, prescribing, administration,
licensing, and use of the Covered
Countermeasures.
III. Recommended Activities
42 U.S.C. 247d–6d(b)(1)
I recommend, under the conditions
stated in this declaration, the
manufacture, testing, development,
distribution, administration, or use of
the Covered Countermeasures.
jstallworth on DSK7TPTVN1PROD with NOTICES
V. Covered Persons
42 U.S.C. 247d–6d(i)(2), (3), (4), (6),
(8)(A) and (B)
Covered Persons who are afforded
liability immunity under this
declaration are ‘‘manufacturers,’’
‘‘distributors,’’ ‘‘program planners,’’
‘‘qualified persons,’’ and their officials,
agents, and employees, as those terms
are defined in the PREP Act, and the
United States.
In addition, I have determined that
the following additional persons are
qualified persons: (a) Any person
authorized in accordance with the
public health and medical emergency
response of the Authority Having
Jurisdiction, as described in section VII
below, to prescribe, administer, deliver,
distribute or dispense the Covered
Countermeasures, and their officials,
agents, employees, contractors and
volunteers, following a declaration of an
emergency; (b) Any person authorized
to prescribe, administer, or dispense the
Covered Countermeasures or who is
otherwise authorized to perform an
activity under an Emergency Use
Authorization in accordance with
section 564 of the FD&C Act; (c) Any
person authorized to prescribe,
administer, or dispense Covered
Countermeasures in accordance with
Section 564A of the FD&C Act.
Jkt 241001
Covered Countermeasures are: Any
antidote; any other drug; all components
and constituent materials of these
antidotes and other drugs; all devices
and their constituent components used
in the administration of these antidotes
and other drugs; any diagnostic; or any
other device to identify, prevent, or treat
organophosphorus or carbamate
poisoning or adverse events from such
countermeasures.
Covered Countermeasures must be
‘‘qualified pandemic or epidemic
products,’’ or ‘‘security
countermeasures,’’ or drugs, biological
products, or devices authorized for
investigational or emergency use, as
those terms are defined in the PREP Act,
the FD&C Act, and the Public Health
Service Act.
42 U.S.C. 247d–6d(a)(5) and (b)(2)(E)
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.
15:21 May 09, 2017
42 U.S.C. 247d–6b(c)(1)(B), 42 U.S.C.
247d–6d(i)(1) and (7)
VII. Limitations on Distribution
IV. Liability Immunity
VerDate Sep<11>2014
VI. Covered Countermeasures
I have determined that liability
immunity is afforded to Covered
Persons only for Recommended
Activities involving Covered
Countermeasures that are related to:
(a) Present or future Federal contracts,
cooperative agreements, grants, other
transactions, interagency agreements,
memoranda of understanding, or other
Federal agreements, or activities directly
conducted by the Federal Government;
or
(b) Activities authorized in
accordance with the public health and
medical response of the Authority
Having Jurisdiction to prescribe,
administer, deliver, distribute or
dispense the Covered Countermeasures
to respond to an event covered by a
declared emergency, including
authorized activities that occur as part
of the response before the formal
declaration of an emergency.
i. The Authority Having Jurisdiction
means the public agency or its delegate
that has legal responsibility and
authority for responding to an incident,
based on political or geographical (e.g.,
city, county, Tribal, State, or Federal
boundary lines) or functional (e.g., law
enforcement, public health) range or
sphere of authority.
ii. A declaration of emergency means
any declaration by any authorized local,
regional, State, or Federal official of an
emergency specific to events that
indicate an immediate need to
administer and use the Covered
Countermeasures, with the exception of
a Federal declaration in support of an
Emergency Use Authorization under
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Fmt 4703
Sfmt 4703
section 564 of the FD&C Act unless such
declaration specifies otherwise;
I have also determined that for
governmental program planners only,
liability immunity is afforded only to
the extent such program planners obtain
Covered Countermeasures through
voluntary means, such as (1) donation;
(2) commercial sale; (3) deployment of
Covered Countermeasures from Federal
stockpiles; or (4) deployment of
donated, purchased, or otherwise
voluntarily obtained Covered
Countermeasures from State, local, or
private stockpiles.
VIII. Category of Disease, Health
Condition, or Threat
42 U.S.C. 247d–6d(b)(2)(A)
The category of disease, health
condition, or threat for which I
recommend the administration or use of
the Covered Countermeasures is
organophosphorus or carbamate
poisoning.
IX. Administration of Covered
Countermeasures
42 U.S.C. 247d–6d(a)(2)(B)
Administration of the Covered
Countermeasure means physical
provision of the countermeasures to
recipients, or activities and decisions
directly relating to public and private
delivery, distribution and dispensing of
the countermeasures to recipients,
management and operation of
countermeasure programs, or
management and operation of locations
for purpose of distributing and
dispensing countermeasures.
X. Population
42 U.S.C. 247d–6d(a)(4), 247d–
6d(b)(2)(C)
The populations of individuals
include any individual who uses or is
administered the Covered
Countermeasures in accordance with
this declaration.
Liability immunity is afforded to
manufacturers and distributors without
regard to whether the countermeasure is
used by or administered to this
population; liability immunity is
afforded to program planners and
qualified persons when the
countermeasure is used by or
administered to this population or the
program planner or qualified person
reasonably could have believed the
recipient was in this population.
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Federal Register / Vol. 82, No. 89 / Wednesday, May 10, 2017 / Notices
XI. Geographic Area
42 U.S.C. 247d–6d(a)(4), 247d–
6d(b)(2)(D)
Liability immunity is afforded for the
administration or use of a Covered
Countermeasure without geographic
limitation.
Liability immunity is afforded to
manufacturers and distributors without
regard to whether the countermeasure is
used by or administered in these
geographic areas; liability immunity is
afforded to program planners and
qualified persons when the
countermeasure is used by or
administered in these geographic areas,
or the program planner or qualified
person reasonably could have believed
the recipient was in these geographic
areas.
XII. Effective Time Period
42 U.S.C. 247d–6d(b)(2)(B)
Liability immunity for Covered
Countermeasures obtained through
means of distribution other than in
accordance with the public health and
medical response of the Authority
Having Jurisdiction extends through
December 31, 2022.
Liability immunity for Covered
Countermeasures administered and
used in accordance with the public
health and medical response of the
Authority Having Jurisdiction begins on
the date the response to an event
covered by an emergency declaration
begins, including authorized activities
that occur as part of the response before
the formal declaration of an emergency,
and lasts through (1) the final day the
emergency declaration is in effect or (2)
December 31, 2022, whichever occurs
first.
Having Jurisdiction are covered through
the date of administration or use
pursuant to a distribution or release
from the SNS.
XIV. Countermeasures Injury
Compensation Program
42 U.S.C. 247d–6e
The PREP Act authorizes a
Countermeasures Injury Compensation
Program (‘‘CICP’’) to provide benefits to
certain individuals or estates of
individuals who sustain a serious
physical covered injury as the direct
result of the administration or use of a
Covered Countermeasure and/or
benefits to certain survivors of
individuals who die as a direct result of
the administration or use of the Covered
Countermeasure. The causal connection
between the countermeasure and the
serious physical injury must be
supported by compelling, reliable, valid,
medical and scientific evidence in order
for the individual to be considered for
compensation. The CICP is
administered by the Health Resources
and Services Administration (‘‘HRSA’’),
within the Department of Health and
Human Services. Information about the
CICP is available at the toll free number
1–855–266–2427 or https://
www.hrsa.gov/cicp/.
XV. Amendments
42 U.S.C. 247d–6d(b)(4)
Any amendments to this declaration
will be published in the Federal
Register.
Authority: 42 U.S.C. 247d–6d.
Dated: May 4, 2017.
Thomas E. Price,
Secretary.
[FR Doc. 2017–09455 Filed 5–9–17; 8:45 am]
jstallworth on DSK7TPTVN1PROD with NOTICES
XIII. Additional Time Period of
Coverage
BILLING CODE 4150–03–P
42 U.S.C. 247d–6d(b)(3)(A), (B) and (C)
I have determined that an additional
twelve (12) months of liability
protection is reasonable to allow for the
manufacturer(s) to arrange for
disposition of the Covered
Countermeasure, including return of the
Covered Countermeasures to the
manufacturer, and for Covered Persons
to take such other actions as are
appropriate to limit the administration
or use of the Covered Countermeasures.
Covered Countermeasures obtained
for the Strategic National Stockpile
(‘‘SNS’’) during the effective period of
this declaration for Covered
Countermeasures obtained through
means of distribution other than in
accordance with the public health and
medical response of the Authority
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
15:21 May 09, 2017
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21825
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Learning Disabilities
Research Centers.
Date: June 22–23, 2017.
Time: 7:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Beacon Hotel and Corporate
Quarters, 1615 Rhode Island Avenue NW.,
Washington, DC 20036
Contact Person: Marita R. Hopmann, Ph.D.,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health & Human
Development, 6710B Rockledge Drive,
Bethesda, MD 20892, Phone: 301–435–6911,
Email: HopmannM@mail.nih.gov.
Name of Committee: National Institute of
Child Health and Human Development Initial
Review Group; Developmental Biology
Subcommittee.
Date: July 24, 2017.
Time: 8:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites, Chevy Chase, MD.
Contact Person: Cathy J. Wedeen, Ph.D.,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, 6710B Rockledge
Drive, Bethesda, MD 20892, 301–435–6878,
wedeenc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: May 4, 2017.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–09413 Filed 5–9–17; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
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]]>Agencies
[Federal Register Volume 82, Number 89 (Wednesday, May 10, 2017)]
[Notices]
[Pages 21819-21825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09455]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Nerve Agents and Certain Insecticides (Organophosphorus and/or
Carbamate) Countermeasures
AGENCY: Department of Health and Human Services, Office of the
Secretary.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Secretary is issuing a declaration pursuant to section
319F-3 of the Public Health Service Act to
[[Page 21820]]
provide liability protections consistent with that authority for
medical countermeasures against nerve agents and organophosphorus
insecticides that result in organophosphorus poisoning and carbamate
insecticides that result in carbamate poisoning.
DATES: The declaration is effective as of April 11, 2017.
FOR FURTHER INFORMATION CONTACT: George W. Korch Jr., Ph.D., Acting
Assistant Secretary for Preparedness and Response, Office of the
Secretary, Department of Health and Human Services, 200 Independence
Avenue SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not
a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The Public Readiness and Emergency Preparedness Act (PREP Act)
authorizes the Secretary of the U.S. Department of Health and Human
Services to issue a declaration to provide liability immunity to
certain individuals and entities (Covered Persons) against any claim of
loss caused by, arising out of, relating to, or resulting from the
administration or use of medical countermeasures (Covered
Countermeasures), except for claims that meet the PREP Act's definition
of willful misconduct. Using this authority, the Secretary is issuing
this declaration for medical countermeasures against nerve agents and
organophosphorus insecticides that result in organophosphorus poisoning
and carbamate insecticides that result in carbamate poisoning. The
purpose of issuing this declaration is to strengthen preparedness
against these threats that pose an ongoing credible risk of a future
public health emergency and does not indicate a change in threat
information.
The declaration is published in full. We explain both the
substantive and format changes in this supplementary section.
The PREP Act was enacted on December 30, 2005 as Public Law 109-
148, Division C, Section 2. It amended the Public Health Service
(``PHS'') Act, adding section 319F-3, which addresses liability
immunity, and section 319F-4, which creates a compensation program.
These sections are codified in the U.S. Code as 42 U.S.C. 247d-6d and
42 U.S.C. 247d-6e, respectively. The Pandemic and All-Hazards
Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, was
enacted on March 13, 2013. Among other things, PAHPRA added sections
564A and 564B to the Federal Food, Drug & Cosmetic (FD&C) Act to
provide new emergency authorities for dispensing approved products in
emergencies and products held for emergency use. PAHPRA accordingly
amended the definitions of Covered Countermeasures and qualified
pandemic and epidemic products in section 319F-3 of the Public Health
Service Act (the PREP Act provisions), so that products made available
under these new FD&C Act authorities could be covered under PREP Act
declarations. PAHPRA also extended the definition of qualified pandemic
and epidemic products to include products or technologies intended to
enhance the use or effect of a drug, biological product, or device used
against the pandemic or epidemic or against adverse events from these
products.
Unless otherwise noted, all statutory citations below are to the
U.S. Code.
Section I, Determination of Public Health Emergency or Credible Risk of
Future Public Health Emergency
Before issuing a declaration under the PREP Act, the Secretary is
required to determine that a disease or other health condition or
threat to health constitutes a public health emergency or that there is
a credible risk that the disease, condition, or threat may in the
future constitute such an emergency.\1\ This determination is separate
and apart from a declaration issued by the Secretary under section 319
of the PHS Act \2\ that a disease or disorder presents a public health
emergency or that, a public health emergency, including significant
outbreaks of infectious diseases or bioterrorist attacks, otherwise
exists, or other declarations or determinations made under other
authorities of the Secretary. The declaration states in section I the
Secretary's determination that there is a credible risk that the
release of nerve agents or organophosphorus insecticides and the
resulting organophosphorus poisoning or the release of carbamate
insecticides and the resulting carbamate poisoning may, in the future,
constitute a public health emergency.
---------------------------------------------------------------------------
\1\ 42 U.S.C. 247d-6d(b)(1).
\2\ 42 U.S.C. 247d.
---------------------------------------------------------------------------
Section II, Factors Considered
In deciding whether and under what circumstances to issue a
declaration with respect to a Covered Countermeasure, the Secretary
must consider the desirability of encouraging the design, development,
clinical testing or investigation, manufacture, labeling, distribution,
formulation, packaging, marketing, promotion, sale, purchase, donation,
dispensing, prescribing, administration, licensing, and use of the
countermeasure.\3\ The declaration states these considerations in
section II.
---------------------------------------------------------------------------
\3\ 42 U.S.C. 247d-6d(b)(6).
---------------------------------------------------------------------------
Section III, Recommended Activities
The Secretary must recommend the activities for which the PREP
Act's liability immunity is in effect. These activities may include,
under conditions as the Secretary may specify, the manufacture,
testing, development, distribution, administration, or use of one or
more Covered Countermeasures (Recommended Activities).\4\ The
declaration states the Recommended Activities in section III.
---------------------------------------------------------------------------
\4\ 42 U.S.C. 247d-6d(b)(1).
---------------------------------------------------------------------------
Section IV, Liability Immunity
The Secretary must also state that liability protections available
under the PREP Act are in effect with respect to the Recommended
Activities.\5\ These liability protections provide that, ``[s]ubject to
other provisions of [the PREP Act], a covered person shall be immune
from suit and liability under Federal and State law with respect to all
claims for loss caused by, arising out of, relating to, or resulting
from the administration to or use by an individual of a covered
countermeasure if a declaration . . . has been issued with respect to
such countermeasure.'' \6\ The declaration includes the statement that
liability immunity is in effect for Recommended Activities in section
IV.
---------------------------------------------------------------------------
\5\ 42 U.S.C. 247d-6d(b)(1).
\6\ 42 U.S.C. 247d-6d(a)(1).
---------------------------------------------------------------------------
Section V, Covered Persons
The PREP Act's liability immunity applies to Covered Persons with
respect to administration or use of a Covered Countermeasure. The term
``Covered Persons'' has a specific meaning, and is defined in the PREP
Act to include manufacturers, distributors, program planners, and
qualified persons, and their officials, agents, and employees, and the
United States.\7\ The PREP Act further defines the terms
``manufacturer,'' ``distributor,'' ``program planner,'' and ``qualified
person'' as described below.\8\
---------------------------------------------------------------------------
\7\ 42 U.S.C. 247d-6d(i)(2).
\8\ 42 U.S.C. 247d-6d(i).
---------------------------------------------------------------------------
A manufacturer includes a contractor or subcontractor of a
manufacturer; a supplier or licenser of any product, intellectual
property, service, research tool or component or other article used in
the design, development, clinical testing, investigation or
manufacturing of a Covered Countermeasure; and any or all of the
parents, subsidiaries,
[[Page 21821]]
affiliates, successors, and assigns of a manufacturer; \9\
---------------------------------------------------------------------------
\9\ 42 U.S.C. 247d-6d(i)(4).
---------------------------------------------------------------------------
A distributor means a person or entity engaged in the distribution
of drugs, biologics, or devices, including but not limited to:
Manufacturers; repackers; common carriers; contract carriers; air
carriers; own-label distributors; private-label distributors; jobbers;
brokers; warehouses and wholesale drug warehouses; independent
wholesale drug traders; and, retail pharmacies; \10\
---------------------------------------------------------------------------
\10\ 42 U.S.C. 247d-6d(i)(3).
---------------------------------------------------------------------------
A program planner means a state or local government, including a
Native American Tribe; a person employed by the state or local
government; or other person who supervises or administers a program
with respect to the administration, dispensing, distribution,
provision, or use of a Covered Countermeasure, including a person who
establishes requirements, provides policy guidance, or supplies
technical or scientific advice or assistance or provides a facility to
administer or use a Covered Countermeasure in accordance with the
Secretary's declaration.\11\ Under this definition, a private sector
employer or community group or other person can be a program planner
when it carries out the described activities.
---------------------------------------------------------------------------
\11\ 42 U.S.C. 247d-6d(i)(6).
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A qualified person means a licensed health professional or other
individual who is authorized to prescribe, administer, or dispense
Covered Countermeasures under the law of the state in which the
countermeasure was prescribed, administered, or dispensed; or, a person
within a category of persons identified as qualified in the Secretary's
declaration.\12\ Under this definition, the Secretary can describe in
the declaration other qualified persons, such as volunteers, who are
Covered Persons. Section V describes other qualified persons covered by
this declaration.
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\12\ 42 U.S.C. 247d-6d(i)(8).
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The PREP Act also defines the word ``person'' as used in the Act: A
person includes an individual, partnership, corporation, association,
entity, or public or private corporation, including a federal, state,
or local government agency or department.\13\
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\13\ 42 U.S.C. 247d-6d(i)(5).
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The declaration lists Covered Persons in section V to include
manufacturers, distributors, program planners, qualified persons, and
their officials, agents, and employees, as those terms are defined in
the PREP Act, and the United States.
The declaration also lists in section V Additional Covered Persons
to include: (a) Any person authorized in accordance with the public
health and medical emergency response of the Authority Having
Jurisdiction, . . . to prescribe, administer, deliver, distribute or
dispense the Covered Countermeasures, and their officials, agents,
employees, contractors and volunteers, following a declaration of an
emergency; (b) any person authorized to prescribe, administer, or
dispense the Covered Countermeasures or who is otherwise authorized to
perform an activity under an Emergency Use Authorization in accordance
with section 564 of the FD&C Act; and, (c) any person authorized to
prescribe, administer, or dispense Covered Countermeasures in
accordance with Section 564A of the FD&C Act.
Section VI, Covered Countermeasures
As noted above, section III describes the Secretary's Recommended
Activities for which liability immunity is in effect. This section
identifies the countermeasures for which the Secretary has recommended
such activities. The PREP Act states that a Covered Countermeasure must
be a ``qualified pandemic or epidemic product,'' or a ``security
countermeasure,'' as described immediately below; or a drug, biological
product or device authorized for emergency use in accordance with
section 564, 564A, or 564B of the FD&C Act.\14\
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\14\ 42 U.S.C. 247d-6d(i)(1). Sections 564, 564A, and 564B of
the FD&C Act may be found at 21 U.S.C. 360bbb-3, 360bbb-3a, and
360bbb-3b.
---------------------------------------------------------------------------
A qualified pandemic or epidemic product means a drug or device, as
defined in the FD&C Act or a biological product, as defined in the PHS
Act \15\ that is: (i) Manufactured, used, designed, developed,
modified, licensed or procured to diagnose, mitigate, prevent, treat,
or cure a pandemic or epidemic or limit the harm such a pandemic or
epidemic might otherwise cause; (ii) manufactured, used, designed,
developed, modified, licensed, or procured to diagnose, mitigate,
prevent, treat, or cure a serious or life-threatening disease or
condition caused by such a drug, biological product or device; (iii)
or, a product or technology intended to enhance the use or effect of
such a drug, biological product, or device.\16\
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\15\ 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i).
\16\ 42 U.S.C. 247d-6d(i)(1)(A), (i)(7).
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A security countermeasure is a drug or device, as defined in the
FD&C Act or a biological product, as defined in the PHS Act \17\ that:
(i)(a) The Secretary determines to be a priority to diagnose, mitigate,
prevent or treat harm from any biological, chemical, radiological, or
nuclear agent identified as a material threat by the Secretary of
Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm
from a condition that may result in adverse health consequences or
death and may be caused by administering a drug, biological product, or
device against such an agent; and (ii) is determined by the Secretary
of Health and Human Services to be a necessary countermeasure to
protect public health.\18\
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\17\ 21 U.S.C. 321(g)(1), (h);42 U.S.C. 262(i).
\18\ 42 U.S.C. 247d-6d(i)(1)(B),(c)(1)(B).
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To be a Covered Countermeasure, qualified pandemic or epidemic
products and security countermeasures also must be approved or cleared
under the FD&C Act; \19\ licensed under the PHS Act; \20\ authorized
for emergency use under sections 564, 564A, or 564B of the FD&C
Act.\21\ A qualified pandemic or epidemic product also may be a Covered
Countermeasure when it is exempted under the FD&C Act for use as an
investigational drug or device \22\ that is the object of research for
possible use for diagnosis, mitigation, prevention, treatment, cure or
limit harm of a pandemic or epidemic or serious or life-threatening
condition caused by such a drug or device. A security countermeasure
also may be a Covered Countermeasure if it may reasonably be determined
to qualify for approval or licensing within ten years after the
Department's determination that procurement of the countermeasure is
appropriate.
---------------------------------------------------------------------------
\19\ 21 U.S.C. 301 et seq.
\20\ 42 U.S.C. 262.
\21\ 21 U.S.C. 360bbb-3, 360bbb-3a, 360bbb-3b.
\22\ 21 U.S.C. 355(i), 360j(g).
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The declaration describes the Covered Countermeasures in Section VI
as: Any antidote; any other drug; all components and constituent
materials of these antidotes and other drugs; all devices and their
constituent components used in the administration of these antidotes
and other drugs; any diagnostic; or any other device to identify,
prevent, or treat organophosphorus or carbamate poisoning or adverse
events from such countermeasures.
The declaration also includes in section VI a statement referencing
the statutory definitions of Covered Countermeasures to make clear that
these statutory definitions limit the scope of Covered Countermeasures.
Section VII, Limitations on Distribution
The Secretary may specify that liability immunity is in effect only
to Covered Countermeasures obtained
[[Page 21822]]
through a particular means of distribution.\23\
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\23\ 42 U.S.C. 247d-6d(a)(5), (b)(2)(E).
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The declaration states in section VII that liability immunity is
afforded to Covered Persons for Recommended Activities related to: (a)
Present or future Federal contracts, cooperative agreements, grants,
other transactions, interagency agreements, or memoranda of
understanding or other Federal agreements or activities directly
conducted by the Federal Government; or (b) Activities authorized in
accordance with the public health and medical response of the Authority
Having Jurisdiction to prescribe, administer, deliver, distribute, or
dispense the Covered Countermeasures to respond to an event covered by
a declared emergency, including authorized activities that occur as
part of the response before the formal declaration of an emergency. The
declaration also provides in section VII definitions for ``Authority
Having Jurisdiction'' and ``Declaration of an Emergency:''
i. The Authority Having Jurisdiction means the public agency or its
delegate that has legal responsibility and authority for responding to
an incident, based on political or geographical (e.g., city, county,
Tribal, State, or Federal boundary lines) or functional (e.g., law
enforcement, public health) range or sphere of authority.
ii. A declaration of emergency means any declaration by any
authorized local, regional, State, or Federal official of an emergency
specific to events that indicate an immediate need to administer and
use the Covered Countermeasures, with the exception of a Federal
declaration in support of an Emergency Use Authorization under section
564 of the FD&C Act unless such declaration specifies otherwise;
Subsection (b) is intended to cover distribution, dispensing,
administration, or use of the covered countermeasure under a formal
government-authorized response to circumstances at any time those
activities occur to respond to an event that gives rise to a declared
emergency. Subsection (b) is not intended to be limited to cover those
activities only after an emergency is formally declared and includes
authorized activities that occur as part of the response before the
formal declaration of an emergency. The Secretary recognizes that in
emergency circumstances, distribution, dispensing, administration, or
use of countermeasures may need to be expedient and may occur prior to
a formal declaration of an emergency. This concern is particularly
critical for the countermeasures covered by this declaration, where the
Covered Countermeasures may need to be administered within minutes of
exposure to a nerve agent to save lives. Thus, the Secretary is
clarifying that coverage under subsection (b) is intended to cover any
distribution, dispensing, administration, or use in accordance with the
Authority Having Jurisdiction at any time that those activities address
the emergency circumstances that gave rise to the declared emergency
even if the activities occur prior to the declaration itself.
For governmental program planners only, liability immunity is
afforded only to the extent they obtain Covered Countermeasures through
voluntary means, such as (1) donation; (2) commercial sale; (3)
deployment of Covered Countermeasures from Federal stockpiles; or (4)
deployment of donated, purchased, or otherwise voluntarily obtained
Covered Countermeasures from State, local, or private stockpiles. This
limitation on distribution is intended to deter program planners that
are government entities from seizing privately held stockpiles of
Covered Countermeasures. It does not apply to any other Covered
Persons, including other program planners who are not government
entities.
Section VIII, Category of Disease, Health Condition, or Threat
The Secretary must identify, for each Covered Countermeasure, the
categories of diseases, health conditions, or threats to health for
which the Secretary recommends the administration or use of the
countermeasure.\24\ The declaration states in section VIII that the
category of disease, health condition, or threat for which the
Secretary recommends administration or use of the countermeasures is
organophosphorus or carbamate poisoning.
---------------------------------------------------------------------------
\24\ 42 U.S.C. 247d-6d(b)(2)(A).
---------------------------------------------------------------------------
Section IX, Administration of Covered Countermeasures
The PREP Act does not explicitly define the term ``administration''
but does assign the Secretary the responsibility to provide relevant
conditions in the declaration. The declaration defines administration
in section IX as: Administration of a Covered Countermeasure means
physical provision of the countermeasures to recipients, or activities
and decisions directly relating to public and private delivery,
distribution and dispensing of the countermeasures to recipients;
management and operation of countermeasure programs; or management and
operation of locations for purpose of distributing and dispensing
countermeasures.
This definition of ``administration'' is intended to extend only to
physical provision of a countermeasure to a recipient, such as
vaccination or handing drugs to patients, and to activities related to
management and operation of programs and locations for providing
countermeasures to recipients, such as decisions and actions involving
security and queuing, but only insofar as those activities directly
relate to the countermeasure activities. Claims for which Covered
Persons are provided immunity under the Act are losses caused by,
arising out of, relating to, or resulting from the administration to or
use by an individual of a Covered Countermeasure consistent with the
terms of a declaration issued under the Act.\25\ Under the Secretary's
definition, these liability claims are precluded if the claims allege
an injury caused by physical provision of a countermeasure to a
recipient, or if the claims are directly due to conditions of delivery,
distribution, dispensing, or management and operation of countermeasure
programs at distribution and dispensing sites.
---------------------------------------------------------------------------
\25\ 42 U.S.C. 247d-6d(a).
---------------------------------------------------------------------------
Thus, it is the Secretary's interpretation that, when a declaration
is in effect, the Act precludes, for example, liability claims alleging
negligence by a manufacturer in creating a vaccine, or negligence by a
health care provider in prescribing the wrong dose, absent willful
misconduct. Likewise, the Act precludes a liability claim relating to
the management and operation of a countermeasure distribution program
or site, such as a slip-and-fall injury or vehicle collision by a
recipient receiving a countermeasure at a retail store serving as an
administration or dispensing location that alleges, for example, lax
security or chaotic crowd control. However, a liability claim alleging
an injury occurring at the site that was not directly related to the
countermeasure activities is not covered, such as a slip and fall with
no direct connection to the countermeasure's administration or use. In
each case, whether immunity is applicable will depend on the particular
facts and circumstances.
[[Page 21823]]
Section X, Population
The Secretary must identify, for each Covered Countermeasure
specified in a declaration, the population or populations of
individuals for which liability immunity is in effect with respect to
administration or use of the countermeasure.\26\ This section explains
which individuals should use the countermeasure or to whom the
countermeasure should be administered--in short, those who should be
vaccinated or take a drug or other countermeasure. The declaration
provides in section X that the population includes any individual who
uses or who is administered a Covered Countermeasure in accordance with
the declaration.
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\26\ 42 U.S.C. 247d-6d(b)(2)(C).
---------------------------------------------------------------------------
In addition, the PREP Act specifies that liability immunity is
afforded: (1) To manufacturers and distributors without regard to
whether the countermeasure is used by or administered to this
population; and (2) to program planners and qualified persons when the
countermeasure is either used by or administered to this population or
the program planner or qualified person reasonably could have believed
the recipient was in this population.\27\ We included these statutory
conditions in the declaration section X for clarity.
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\27\ 42 U.S.C. 247d-6d(a)(4).
---------------------------------------------------------------------------
Section XI, Geographic Area
The Secretary must identify, for each Covered Countermeasure
specified in the declaration, the geographic area or areas for which
liability immunity is in effect with respect to administration or use
of the countermeasure, including, as appropriate, whether the
declaration applies only to individuals physically present in the area
or, in addition, applies to individuals who have a described connection
to the area.\28\ The declaration states in section XI that there are no
limitations on geographic area.
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\28\ 42 U.S.C. 247d-6d(b)(2)(D).
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In addition, the PREP Act specifies that liability immunity is
afforded: (1) To manufacturers and distributors without regard to
whether the countermeasure is used by or administered to individuals in
the geographic areas; and (2) to program planners and qualified persons
when the countermeasure is either used or administered in the
geographic areas or the program planner or qualified person reasonably
could have believed the countermeasure was used or administered in the
areas.\29\ We included these statutory conditions in the declaration
section XI for clarity.
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\29\ 42 U.S.C. 247d-6d(a)(4).
---------------------------------------------------------------------------
Section XII, Effective Time Period
The Secretary must identify, for each Covered Countermeasure, the
period or periods during which liability immunity is in effect,
designated by dates, milestones, or other description of events,
including factors specified in the PREP Act.\30\
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\30\ 42 U.S.C. 246d-6d(b)(2)(B), (b)(6).
---------------------------------------------------------------------------
The declaration states in section XII when liability immunity takes
effect for different means of distribution within that time period.
Section XIII, Additional Time Period of Coverage
The Secretary must specify a date after the ending date of the
effective period of the declaration that is reasonable for
manufacturers to arrange for disposition of the Covered Countermeasure,
including return of the product to the manufacturer, and for other
Covered Persons to take appropriate actions to limit administration or
use of the Covered Countermeasure.\31\ In addition, the PREP Act
specifies that for Covered Countermeasures that are subject to a
declaration at the time they are obtained for the Strategic National
Stockpile under 42 U.S.C. 247d-6b(a), the effective period of the
declaration extends through the time the countermeasure is used or
administered pursuant to a distribution or release from the Stockpile.
Liability immunity under the provisions of the PREP Act and the
conditions of the declaration continues during these additional time
periods. Thus, liability immunity is afforded during the ``Effective
Time Period,'' described under section XII of the declaration, plus the
``Additional Time Period of Coverage'' described under section XIII of
the declaration.
---------------------------------------------------------------------------
\31\ 42 U.S.C. 247d-6d(b)(3).
---------------------------------------------------------------------------
The declaration states in section XIII that the additional time
period is twelve (12) months and also states that extended coverage
applies to any products obtained for the Strategic National Stockpile
during the effective period of the declaration. We included the
statutory provision for clarity.
Section XIV, Countermeasures Injury Compensation Program
Section 319F-4 of the PREP Act authorizes a Countermeasures Injury
Compensation Program (CICP) to provide benefits to eligible individuals
who sustain a serious physical injury or die as a direct result of the
administration or use of a Covered Countermeasure.\32\ Compensation
under the CICP for an injury directly caused by a Covered
Countermeasure is based on the requirements set forth in this
declaration, the administrative rules for the Program,\33\ and the
statute.\34\ To show direct causation between a Covered Countermeasure
and a serious physical injury, the statute requires ``compelling,
reliable, valid, medical and scientific evidence.'' \35\ The
administrative rules for the Program further explain the necessary
requirements for eligibility under the CICP. Please note that, by
statute, requirements for compensation under the CICP may not always
align with the requirements for liability immunity provided under the
PREP Act. The declaration explains in section XIV, ``Countermeasures
Injury Compensation Program'' the types of injury and standard of
evidence needed to be considered for compensation under the CICP.
Further, the administrative rules for the CICP specify if
countermeasures are administered or used outside the United States,
only otherwise eligible individuals at American embassies, military
installations abroad (such as military bases, ships, and camps) or at
North Atlantic Treaty Organization (NATO) installations (subject to the
NATO Status of Forces Agreement) where American servicemen and
servicewomen are stationed may be considered for CICP benefits. Other
individuals outside the United States may not be eligible for CICP
benefits.
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\32\ 42 U.S.C. 247d-6e.
\33\ 42 CFR part 110.
\34\ 42 U.S.C. 247d-6e.
\35\ 42 U.S.C. 247d-6e(b)(4).
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Section XV, Amendments
The Secretary may amend any portion of a declaration through
publication in the Federal Register.\36\ The declaration states in
section XV that any amendments to this declaration will be published in
the Federal Register.
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\36\ 42 U.S.C. 247d-6d(b)(4).
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Declaration
Declaration for Public Readiness and Emergency Preparedness Act
Coverage for Nerve Agents and Certain Insecticides (Organophosphorus
and/or Carbamate) Countermeasures
I. Determination of Public Health Emergency or Credible Risk of Future
Public Health Emergency
42 U.S.C. 247d-6d(b)(1)
I have determined that there is a credible risk that the release of
nerve agents or organophosphorus insecticides and the resulting
organophosphorus
[[Page 21824]]
poisoning or release of carbamate insecticides and the resulting
carbamate poisoning may, in the future, constitute a public health
emergency.
II. Factors Considered
42 U.S.C. 247d-6d(b)(6)
I have considered the desirability of encouraging the design,
development, clinical testing or investigation, manufacture, labeling,
distribution, formulation, packaging, marketing, promotion, sale,
purchase, donation, dispensing, prescribing, administration, licensing,
and use of the Covered Countermeasures.
III. Recommended Activities
42 U.S.C. 247d-6d(b)(1)
I recommend, under the conditions stated in this declaration, the
manufacture, testing, development, distribution, administration, or use
of the Covered Countermeasures.
IV. Liability Immunity
42 U.S.C. 247d-6d(a), 247d-6d(b)(1)
Liability immunity as prescribed in the PREP Act and conditions
stated in this declaration is in effect for the Recommended Activities
described in section III.
V. Covered Persons
42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)
Covered Persons who are afforded liability immunity under this
declaration are ``manufacturers,'' ``distributors,'' ``program
planners,'' ``qualified persons,'' and their officials, agents, and
employees, as those terms are defined in the PREP Act, and the United
States.
In addition, I have determined that the following additional
persons are qualified persons: (a) Any person authorized in accordance
with the public health and medical emergency response of the Authority
Having Jurisdiction, as described in section VII below, to prescribe,
administer, deliver, distribute or dispense the Covered
Countermeasures, and their officials, agents, employees, contractors
and volunteers, following a declaration of an emergency; (b) Any person
authorized to prescribe, administer, or dispense the Covered
Countermeasures or who is otherwise authorized to perform an activity
under an Emergency Use Authorization in accordance with section 564 of
the FD&C Act; (c) Any person authorized to prescribe, administer, or
dispense Covered Countermeasures in accordance with Section 564A of the
FD&C Act.
VI. Covered Countermeasures
42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)
Covered Countermeasures are: Any antidote; any other drug; all
components and constituent materials of these antidotes and other
drugs; all devices and their constituent components used in the
administration of these antidotes and other drugs; any diagnostic; or
any other device to identify, prevent, or treat organophosphorus or
carbamate poisoning or adverse events from such countermeasures.
Covered Countermeasures must be ``qualified pandemic or epidemic
products,'' or ``security countermeasures,'' or drugs, biological
products, or devices authorized for investigational or emergency use,
as those terms are defined in the PREP Act, the FD&C Act, and the
Public Health Service Act.
VII. Limitations on Distribution
42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)
I have determined that liability immunity is afforded to Covered
Persons only for Recommended Activities involving Covered
Countermeasures that are related to:
(a) Present or future Federal contracts, cooperative agreements,
grants, other transactions, interagency agreements, memoranda of
understanding, or other Federal agreements, or activities directly
conducted by the Federal Government; or
(b) Activities authorized in accordance with the public health and
medical response of the Authority Having Jurisdiction to prescribe,
administer, deliver, distribute or dispense the Covered Countermeasures
to respond to an event covered by a declared emergency, including
authorized activities that occur as part of the response before the
formal declaration of an emergency.
i. The Authority Having Jurisdiction means the public agency or its
delegate that has legal responsibility and authority for responding to
an incident, based on political or geographical (e.g., city, county,
Tribal, State, or Federal boundary lines) or functional (e.g., law
enforcement, public health) range or sphere of authority.
ii. A declaration of emergency means any declaration by any
authorized local, regional, State, or Federal official of an emergency
specific to events that indicate an immediate need to administer and
use the Covered Countermeasures, with the exception of a Federal
declaration in support of an Emergency Use Authorization under section
564 of the FD&C Act unless such declaration specifies otherwise;
I have also determined that for governmental program planners only,
liability immunity is afforded only to the extent such program planners
obtain Covered Countermeasures through voluntary means, such as (1)
donation; (2) commercial sale; (3) deployment of Covered
Countermeasures from Federal stockpiles; or (4) deployment of donated,
purchased, or otherwise voluntarily obtained Covered Countermeasures
from State, local, or private stockpiles.
VIII. Category of Disease, Health Condition, or Threat
42 U.S.C. 247d-6d(b)(2)(A)
The category of disease, health condition, or threat for which I
recommend the administration or use of the Covered Countermeasures is
organophosphorus or carbamate poisoning.
IX. Administration of Covered Countermeasures
42 U.S.C. 247d-6d(a)(2)(B)
Administration of the Covered Countermeasure means physical
provision of the countermeasures to recipients, or activities and
decisions directly relating to public and private delivery,
distribution and dispensing of the countermeasures to recipients,
management and operation of countermeasure programs, or management and
operation of locations for purpose of distributing and dispensing
countermeasures.
X. Population
42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)
The populations of individuals include any individual who uses or
is administered the Covered Countermeasures in accordance with this
declaration.
Liability immunity is afforded to manufacturers and distributors
without regard to whether the countermeasure is used by or administered
to this population; liability immunity is afforded to program planners
and qualified persons when the countermeasure is used by or
administered to this population or the program planner or qualified
person reasonably could have believed the recipient was in this
population.
[[Page 21825]]
XI. Geographic Area
42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)
Liability immunity is afforded for the administration or use of a
Covered Countermeasure without geographic limitation.
Liability immunity is afforded to manufacturers and distributors
without regard to whether the countermeasure is used by or administered
in these geographic areas; liability immunity is afforded to program
planners and qualified persons when the countermeasure is used by or
administered in these geographic areas, or the program planner or
qualified person reasonably could have believed the recipient was in
these geographic areas.
XII. Effective Time Period
42 U.S.C. 247d-6d(b)(2)(B)
Liability immunity for Covered Countermeasures obtained through
means of distribution other than in accordance with the public health
and medical response of the Authority Having Jurisdiction extends
through December 31, 2022.
Liability immunity for Covered Countermeasures administered and
used in accordance with the public health and medical response of the
Authority Having Jurisdiction begins on the date the response to an
event covered by an emergency declaration begins, including authorized
activities that occur as part of the response before the formal
declaration of an emergency, and lasts through (1) the final day the
emergency declaration is in effect or (2) December 31, 2022, whichever
occurs first.
XIII. Additional Time Period of Coverage
42 U.S.C. 247d-6d(b)(3)(A), (B) and (C)
I have determined that an additional twelve (12) months of
liability protection is reasonable to allow for the manufacturer(s) to
arrange for disposition of the Covered Countermeasure, including return
of the Covered Countermeasures to the manufacturer, and for Covered
Persons to take such other actions as are appropriate to limit the
administration or use of the Covered Countermeasures.
Covered Countermeasures obtained for the Strategic National
Stockpile (``SNS'') during the effective period of this declaration for
Covered Countermeasures obtained through means of distribution other
than in accordance with the public health and medical response of the
Authority Having Jurisdiction are covered through the date of
administration or use pursuant to a distribution or release from the
SNS.
XIV. Countermeasures Injury Compensation Program
42 U.S.C. 247d-6e
The PREP Act authorizes a Countermeasures Injury Compensation
Program (``CICP'') to provide benefits to certain individuals or
estates of individuals who sustain a serious physical covered injury as
the direct result of the administration or use of a Covered
Countermeasure and/or benefits to certain survivors of individuals who
die as a direct result of the administration or use of the Covered
Countermeasure. The causal connection between the countermeasure and
the serious physical injury must be supported by compelling, reliable,
valid, medical and scientific evidence in order for the individual to
be considered for compensation. The CICP is administered by the Health
Resources and Services Administration (``HRSA''), within the Department
of Health and Human Services. Information about the CICP is available
at the toll free number 1-855-266-2427 or https://www.hrsa.gov/cicp/.
XV. Amendments
42 U.S.C. 247d-6d(b)(4)
Any amendments to this declaration will be published in the Federal
Register.
Authority: 42 U.S.C. 247d-6d.
Dated: May 4, 2017.
Thomas E. Price,
Secretary.
[FR Doc. 2017-09455 Filed 5-9-17; 8:45 am]
BILLING CODE 4150-03-P
