Declaration Under the Public Readiness and Emergency Preparedness Act, 61864-61866 [E8-24734]
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61864
Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices
Contract
Manufacturer
Covered countermeasure
HHSO1002006000015I ............................
HHSO1002006000016I ............................
HHSO100200600015I ..............................
Roche ......................................................
GlaxoSmithKline ......................................
Roche ......................................................
HHSO100200600016I ..............................
GlaxoSmithKline ......................................
797HH7282
797HH7283
797HH8113
797HH8112
Roche ......................................................
GlaxoSmithKline ......................................
GlaxoSmithKline ......................................
Roche ......................................................
Oseltamivir Phosphate (Tamiflu) ..........
Zanamivir (Relenza) .............................
Acquisiton of Tamiflu, 75 mg (state purchases).
Acquisiton of Relenza, 5 mg (state purchases).
Oseltamivir, 75 mg (Tamiflu) (SNS) .......
Relenza (Zanamivir) 5 mg (SNS) ...........
Relenza (Zanamivir) 5 mg (SNS) ...........
Oseltamivir 75 mg (Tamiflu) (SNS) ........
Oseltamivir 45 mg (Tamiflu).
Oseltamivir 30 mg (Tamiflu).
...............................................
...............................................
...............................................
...............................................
[FR Doc. E8–24733 Filed 10–14–08; 4:15 pm]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Declaration Under the Public
Readiness and Emergency
Preparedness Act
October 10, 2008.
Office of the Secretary (OS),
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
SUMMARY: Declaration pursuant to
section 319F–3 of the Public Health
Service Act (42 U.S.C. 247d–6d) to
provide targeted liability protections for
Botulism countermeasures based on a
credible risk that the threat of exposure
to botulinum toxin(s) and the resulting
disease(s) from a manmade or natural
source constitutes a public health
emergency.
This notice and the attached
declaration are effective as of the date of
signature of the declaration.
FOR FURTHER INFORMATION CONTACT:
RADM W.C. Vanderwagen, 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).
DATES:
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HHS Secretary’s Declaration for
Utilization of Public Readiness and
Emergency Preparedness Act for
Botulism Countermeasures
Whereas exposure to botulinum
toxin(s) and the resulting disease(s)
from manmade or natural sources may
cause harm to the general population
sufficient to constitute a public health
emergency;
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Whereas the Secretary of the
Department of Homeland Security has
determined that botulinum toxins
present a material threat against the
United States population sufficient to
affect national security;
Whereas botulinum toxins are
extremely potent and lethal;
Whereas there are covered
countermeasures to treat, identify, or
prevent adverse health consequences or
death from botulinum toxins;
Whereas such botulism
countermeasures, including antitoxins,
for potential pre-exposure and for postexposure prevention and treatment,
diagnostics to identify such exposure,
and additional countermeasures for
treatment of adverse events arising from
use of these botulism countermeasures
exist, or may be the subject of research
and/or development;
Whereas such countermeasures may
be used and administered in accordance
with Federal contracts, cooperative
agreements, grants, interagency
agreements, and memoranda of
understanding, and may also be used
and administered at the Regional, State,
and local level in accordance with the
public health and medical response of
the Authority Having Jurisdiction;
Whereas the possibility of
governmental program planners
obtaining stockpiles from private sector
entities except through voluntary means
such as commercial sale, donation, or
deployment would undermine national
preparedness efforts and should be
discouraged as provided for in section
319F–3(b)(2)(E) of the Public Health
Service Act (42 U.S.C. 247d–6d(b)) (‘‘the
Act’’);
Whereas immunity under section
319F–3(a) of the Act should be available
to governmental program planners for
distributions of Covered
Countermeasures obtained voluntarily,
such as by (1) donation; (2) commercial
sale; (3) deployment of Covered
Countermeasures from Federal
stockpiles; or (4) deployment of
donated, purchased, or otherwise
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Fmt 4703
Sfmt 4703
Pub. L. 85–
804 coverage*
No.
No.
No.
No.
No.
No.
No.
No.
voluntarily obtained Covered
Countermeasures from State, local, or
private stockpiles;
Whereas the extent of immunity
under section 319F–3(a) of the Act
afforded to a governmental program
planner that obtains Covered
Countermeasures except through
voluntary means is not intended to
affect the extent of immunity afforded
other covered persons with respect to
such Covered Countermeasures;
Whereas in accordance with section
319F–3(b)(6) of the Act, I have
considered the desirability of
encouraging the design, development,
clinical testing or investigation,
manufacturing, labeling, distribution,
formulation, packaging, marketing,
promotion, sale, purchase, donation,
dispensing, prescribing, administration,
licensing, and use of such
countermeasures with respect to the
category of disease and population
described in sections II and IV below,
and have found it desirable to encourage
such activities for the covered
countermeasure; and
Whereas to encourage the design,
development, clinical testing or
investigation, manufacturing and
product formulation, labeling,
distribution, packaging, marketing,
promotion, sale, purchase, donation,
dispensing, prescribing, administration,
licensing, and use of medical
countermeasures with respect to the
category of disease and population
described in sections II and IV below, it
is advisable, in accordance with section
319F–3(a) and (b) of the Act, to provide
immunity from liability for covered
persons, as that term is defined at
section 319F–3(i)(2) of the Act, and to
include as such covered persons such
other qualified persons as I have
identified in section VI of this
declaration;
Therefore pursuant to section 319F–
3(b) of the Act, I have determined there
is a credible risk that botulinum toxin(s)
and the resulting disease(s) from a
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manmade or natural sources constitutes
a public health emergency.
I. Covered Countermeasures (As
Required by Section 319F–3(b)(1) of the
Act)
Covered countermeasures are defined
at section 319F–3(i) of the Act. At this
time, and in accordance with the
provisions contained herein, I am
recommending the manufacture, testing,
development, and distribution of
botulinum toxin countermeasures, as
defined in section IX below; and, with
respect to the category of disease and
the population described in sections II
and IV below, the administration and
usage of botulinum toxin
countermeasures.
The immunity specified in section
319F–3(a) of the Act shall only be in
effect with respect to: (1) Present or
future Federal contracts, cooperative
agreements, grants, interagency
agreements, or memoranda of
understanding involving
countermeasures that are used and
administered in accordance with this
declaration and (2) 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 Countermeasure
following a declaration of an emergency,
as defined in section IX below. In
accordance with section 319F–3(b)(2)(E)
of the Act, for governmental program
planners, the immunity specified in
section 319F–3(a) of the Act shall be in
effect to the extent they obtain Covered
Countermeasures through voluntary
means of distribution, 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. For all other covered
persons, including other program
planners, the immunity specified in
section 319F–3(a) of the Act shall, in
accordance with section 319F–3(b)(2)(E)
of the Act, be in effect pursuant to any
means of distribution.
This declaration shall subsequently
refer to the countermeasures identified
above as ‘‘Covered Countermeasures.’’
This declaration shall apply to all
Covered Countermeasures administered
or used during the effective period of
the declaration.
II. Category of Disease (As Required by
Section 319F–3(b)(2)(A) of the Act)
The category of disease, health
condition, or threat to health for which
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I am recommending the administration
or use of the Covered Countermeasure is
botulism resulting from exposure to
botulinum toxin(s).
III. Effective Time Period (As Required
by Section 319F–3(b)(2)(B) of the Act)
With respect to Covered
Countermeasures administered and
used in accordance with present or
future Federal contracts, cooperative
agreements, grants, interagency
agreements, or memoranda of
understanding, the effective period of
time of this Declaration commences on
signature of the declaration and extends
through December 31, 2015.
With respect to Covered
Countermeasures administered and
used in accordance with the public
health and medical response of the
Authority Having Jurisdiction, the
effective period of time of this
Declaration commences on the date of a
declaration of an emergency and lasts
through and includes the final day that
the emergency declaration is in effect
including any extensions thereof.
IV. Population (As Required by Section
319F–3(b)(2)(C) of the Act)
Section 319F–3(a)(4)(A) of the Act
confers immunity on manufacturers,
and distributors of the Covered
Countermeasure, regardless of the
defined population.
Section 319F–3(a)(3)(C)(i) of the Act
confers immunity to covered persons
who may be a program planner or
qualified persons with respect to the
Covered Countermeasure only if a
member of the population specified in
the declaration as persons who use the
Covered Countermeasure or to whom
such a Covered Countermeasure is
administered, is in or connected to the
geographic location specified in this
declaration, or the program planner or
qualified person reasonably could have
believed that these conditions are met.
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
PO 00000
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Fmt 4703
Sfmt 4703
61865
dispense the Covered Countermeasure,
and their officials, agents, employees,
contractors, and volunteers following a
declaration of an emergency; (3) any
person who receives a Covered
Countermeasure from a person
authorized to prescribe, administer or
dispense the countermeasure or who is
otherwise authorized under an
Emergency Use Authorization; and (4)
any person who receives a Covered
Countermeasure in human clinical trials
being conducted directly by the Federal
Government or pursuant to a contract,
grant, or cooperative agreement with the
Federal Government.
V. Geographic Area (As Required by
Section 319F–3(b)(2)(D) of the Act)
Section 319F–3(a) of the Act applies
to the administration and use of the
Covered Countermeasure without
geographic limitation.
VI. Qualified Persons (As Required by
Section 319F–3(i)(8)(b) of the Act)
With regard to the administration or
use of a Covered Countermeasure,
section 319F–3(i)(8)(A) of the Act
defines the term ‘‘qualified person’’ as a
licensed individual who is authorized to
prescribe, administer, or dispense the
Covered Countermeasure under the law
of the State in which such covered
countermeasure was prescribed,
administered or dispensed.
Additional persons who are qualified
persons pursuant to section 319F–
3(i)(8)(B) are the following: (1) 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 Covered Countermeasures, and
their officials, agents, employees,
contractors and volunteers, following a
declaration of an emergency, and (2)
Any person authorized to prescribe,
administer, or dispense Covered
Countermeasures or who is otherwise
authorized under an Emergency Use
Authorization.
VII. Additional Time Periods of
Coverage After Expiration of
Declaration (As required by section
319F–3(b)(3)(B) of the Act)
I have determined that, upon
expiration of the time period specified
in section III above, an additional
twelve (12) months is a reasonable
period to allow for manufacturers to
arrange for disposition and covered
persons to take such other actions as are
appropriate to limit the administration
or use of the Covered Countermeasure,
and the liability protection of section
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Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices
319F–3(a) of the Act shall extend for
that period.
VIII. Amendments
This declaration has not previously
been amended. Any future amendment
to this declaration will be published in
the Federal Register, pursuant to
section 319F–3(b)(4) of the Act.
IX. Definitions
For the purpose of this declaration,
including any claim for loss brought in
accordance with section 319F–3 of the
PHS Act against any covered persons
defined in the Act or this declaration,
the following definitions will be used:
Administration of a Covered
Countermeasure or Administration: 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 Covered Countermeasures to
patients/recipients, management and
operation of delivery systems, and
management and operation of
distribution and dispensing locations.
Authority Having Jurisdiction: 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.
Botulinum Toxin Countermeasure:
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.
Covered Persons: As defined at
section 319F–3(i)(2) of the Act, include
the United States, manufacturers,
distributors, program planners, and
qualified persons. The terms
‘‘manufacturer,’’ ‘‘distributor,’’
‘‘program planner,’’ and ‘‘qualified
person’’ are further defined at sections
319F–3(i)(3), (4), (6), and (8) of the Act.
Declaration of an Emergency: A
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 botulinum toxin
countermeasures, with the exception of
a Federal declaration in support of an
emergency use authorization under
section 564 of the FDCA unless such
declaration specifies otherwise.
This 10th day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Appendix I
List of U.S. Government Contracts
Contract
Manufacturer
Covered countermeasure
HHSO0100200600017C ...........................
03FED03828 .............................................
CDC 200–2003–01010 .............................
CDC 200–2004–07625 .............................
CDC 200–2003–01052 .............................
Cangene ..................................................
PerImmune ..............................................
Cangene ..................................................
Aventis Pasteur .......................................
Aventis Pasteur .......................................
Heptavalent antitoxin ..............................
Heptavalent antitoxin ..............................
Heptavalent antitoxin, Monovalent A ......
Monovalent E ..........................................
Bivalent A and B .....................................
Pub.L. 85–804
coverage*
No.
No.
No.
No.
No.
*Status of indemnification coverage under Pub.L. 85–804 (An Act to authorize the making, amendment and modification of contracts to facilitate the national defense.)
[FR Doc. E8–24734 Filed 10–14–08; 4:15 pm]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Declaration Under the Public
Readiness and Emergency
Preparedness Act
October 10, 2008.
Office of the Secretary (OS),
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
sroberts on PROD1PC70 with NOTICES
VerDate Aug<31>2005
19:18 Oct 16, 2008
Jkt 217001
Acute
Radiation Syndrome (ARS) is an acute
illness that occurs when the entire body
(or most of it) receives a high dose of
radiation, usually over a short period of
time. Radiation exposure can adversely
affect a variety of cells, tissues, and
organ systems, including the
hematopoietic (or blood) system, the
gastrointestinal (GI) tract, skin
(cutaneous) system, and, at higher
SUPPLEMENTARY INFORMATION:
Declaration pursuant to
section 319F–3 of the Public Health
Service Act (42 U.S.C. 247d–6d) to
provide targeted liability protections for
Acute Radiation Syndrome
countermeasures based on a credible
risk that the threat of high dose
radiation exposure following the
deliberate detonation of a nuclear
device, unintentional nuclear release, or
SUMMARY:
other radiological events and the Acute
Radiation Syndrome resulting from such
exposures constitutes a public health
emergency.
DATES: This notice and the attached
declaration are effective as of the date of
signature of the declaration.
FOR FURTHER INFORMATION CONTACT:
RADM W.C. Vanderwagen, 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).
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Frm 00090
Fmt 4703
Sfmt 4703
radiation levels, the lung or kidney and
cerebrovascular/central nervous system
(CNS).
HHS Secretary’s Declaration for
Utilization of Public Readiness and
Emergency Preparedness Act for Acute
Radiation Syndrome
Whereas the risk of a deliberate
detonation of a nuclear device in the
United States intended to cause harm to
the general population, unintentional
radioactive release, or other
radiological/nuclear events are
considered a credible threat to public
health;
Whereas the Secretary of the
Department of Homeland Security has
determined that radiological and
nuclear agents present a material threat
against the United States population
sufficient to affect national security;
Whereas Acute Radiation Syndrome
(ARS) resulting from such incidents
could cause potentially severe adverse
human health effects, including damage
to the following organ systems:
Hematopoietic (blood-forming),
E:\FR\FM\17OCN1.SGM
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Agencies
[Federal Register Volume 73, Number 202 (Friday, October 17, 2008)]
[Notices]
[Pages 61864-61866]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24734]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Declaration Under the Public Readiness and Emergency Preparedness
Act
October 10, 2008.
AGENCY: Office of the Secretary (OS), Department of Health and Human
Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Declaration pursuant to section 319F-3 of the Public Health
Service Act (42 U.S.C. 247d-6d) to provide targeted liability
protections for Botulism countermeasures based on a credible risk that
the threat of exposure to botulinum toxin(s) and the resulting
disease(s) from a manmade or natural source constitutes a public health
emergency.
DATES: This notice and the attached declaration are effective as of the
date of signature of the declaration.
FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, 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).
HHS Secretary's Declaration for Utilization of Public Readiness and
Emergency Preparedness Act for Botulism Countermeasures
Whereas exposure to botulinum toxin(s) and the resulting disease(s)
from manmade or natural sources may cause harm to the general
population sufficient to constitute a public health emergency;
Whereas the Secretary of the Department of Homeland Security has
determined that botulinum toxins present a material threat against the
United States population sufficient to affect national security;
Whereas botulinum toxins are extremely potent and lethal;
Whereas there are covered countermeasures to treat, identify, or
prevent adverse health consequences or death from botulinum toxins;
Whereas such botulism countermeasures, including antitoxins, for
potential pre-exposure and for post-exposure prevention and treatment,
diagnostics to identify such exposure, and additional countermeasures
for treatment of adverse events arising from use of these botulism
countermeasures exist, or may be the subject of research and/or
development;
Whereas such countermeasures may be used and administered in
accordance with Federal contracts, cooperative agreements, grants,
interagency agreements, and memoranda of understanding, and may also be
used and administered at the Regional, State, and local level in
accordance with the public health and medical response of the Authority
Having Jurisdiction;
Whereas the possibility of governmental program planners obtaining
stockpiles from private sector entities except through voluntary means
such as commercial sale, donation, or deployment would undermine
national preparedness efforts and should be discouraged as provided for
in section 319F-3(b)(2)(E) of the Public Health Service Act (42 U.S.C.
247d-6d(b)) (``the Act'');
Whereas immunity under section 319F-3(a) of the Act should be
available to governmental program planners for distributions of Covered
Countermeasures obtained voluntarily, such as by (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;
Whereas the extent of immunity under section 319F-3(a) of the Act
afforded to a governmental program planner that obtains Covered
Countermeasures except through voluntary means is not intended to
affect the extent of immunity afforded other covered persons with
respect to such Covered Countermeasures;
Whereas in accordance with section 319F-3(b)(6) of the Act, I have
considered the desirability of encouraging the design, development,
clinical testing or investigation, manufacturing, labeling,
distribution, formulation, packaging, marketing, promotion, sale,
purchase, donation, dispensing, prescribing, administration, licensing,
and use of such countermeasures with respect to the category of disease
and population described in sections II and IV below, and have found it
desirable to encourage such activities for the covered countermeasure;
and
Whereas to encourage the design, development, clinical testing or
investigation, manufacturing and product formulation, labeling,
distribution, packaging, marketing, promotion, sale, purchase,
donation, dispensing, prescribing, administration, licensing, and use
of medical countermeasures with respect to the category of disease and
population described in sections II and IV below, it is advisable, in
accordance with section 319F-3(a) and (b) of the Act, to provide
immunity from liability for covered persons, as that term is defined at
section 319F-3(i)(2) of the Act, and to include as such covered persons
such other qualified persons as I have identified in section VI of this
declaration;
Therefore pursuant to section 319F-3(b) of the Act, I have
determined there is a credible risk that botulinum toxin(s) and the
resulting disease(s) from a
[[Page 61865]]
manmade or natural sources constitutes a public health emergency.
I. Covered Countermeasures (As Required by Section 319F-3(b)(1) of the
Act)
Covered countermeasures are defined at section 319F-3(i) of the
Act. At this time, and in accordance with the provisions contained
herein, I am recommending the manufacture, testing, development, and
distribution of botulinum toxin countermeasures, as defined in section
IX below; and, with respect to the category of disease and the
population described in sections II and IV below, the administration
and usage of botulinum toxin countermeasures.
The immunity specified in section 319F-3(a) of the Act shall only
be in effect with respect to: (1) Present or future Federal contracts,
cooperative agreements, grants, interagency agreements, or memoranda of
understanding involving countermeasures that are used and administered
in accordance with this declaration and (2) 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 Countermeasure following a declaration of an
emergency, as defined in section IX below. In accordance with section
319F-3(b)(2)(E) of the Act, for governmental program planners, the
immunity specified in section 319F-3(a) of the Act shall be in effect
to the extent they obtain Covered Countermeasures through voluntary
means of distribution, 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. For
all other covered persons, including other program planners, the
immunity specified in section 319F-3(a) of the Act shall, in accordance
with section 319F-3(b)(2)(E) of the Act, be in effect pursuant to any
means of distribution.
This declaration shall subsequently refer to the countermeasures
identified above as ``Covered Countermeasures.''
This declaration shall apply to all Covered Countermeasures
administered or used during the effective period of the declaration.
II. Category of Disease (As Required by Section 319F-3(b)(2)(A) of the
Act)
The category of disease, health condition, or threat to health for
which I am recommending the administration or use of the Covered
Countermeasure is botulism resulting from exposure to botulinum
toxin(s).
III. Effective Time Period (As Required by Section 319F-3(b)(2)(B) of
the Act)
With respect to Covered Countermeasures administered and used in
accordance with present or future Federal contracts, cooperative
agreements, grants, interagency agreements, or memoranda of
understanding, the effective period of time of this Declaration
commences on signature of the declaration and extends through December
31, 2015.
With respect to Covered Countermeasures administered and used in
accordance with the public health and medical response of the Authority
Having Jurisdiction, the effective period of time of this Declaration
commences on the date of a declaration of an emergency and lasts
through and includes the final day that the emergency declaration is in
effect including any extensions thereof.
IV. Population (As Required by Section 319F-3(b)(2)(C) of the Act)
Section 319F-3(a)(4)(A) of the Act confers immunity on
manufacturers, and distributors of the Covered Countermeasure,
regardless of the defined population.
Section 319F-3(a)(3)(C)(i) of the Act confers immunity to covered
persons who may be a program planner or qualified persons with respect
to the Covered Countermeasure only if a member of the population
specified in the declaration as persons who use the Covered
Countermeasure or to whom such a Covered Countermeasure is
administered, is in or connected to the geographic location specified
in this declaration, or the program planner or qualified person
reasonably could have believed that these conditions are met.
The populations specified in this declaration are all persons who
use a Covered Countermeasure or to whom a Covered Countermeasure is
administered in accordance with this declaration, including, but not
limited to: (1) Any person conducting research and development of
Covered Countermeasures directly for the Federal Government or pursuant
to a contract, grant, or cooperative agreement with the Federal
Government; (2) any person who receives a Covered Countermeasure from
persons authorized in accordance with the public health and medical
emergency response of the Authority Having Jurisdiction to prescribe,
administer, deliver, distribute, or dispense the Covered
Countermeasure, and their officials, agents, employees, contractors,
and volunteers following a declaration of an emergency; (3) any person
who receives a Covered Countermeasure from a person authorized to
prescribe, administer or dispense the countermeasure or who is
otherwise authorized under an Emergency Use Authorization; and (4) any
person who receives a Covered Countermeasure in human clinical trials
being conducted directly by the Federal Government or pursuant to a
contract, grant, or cooperative agreement with the Federal Government.
V. Geographic Area (As Required by Section 319F-3(b)(2)(D) of the Act)
Section 319F-3(a) of the Act applies to the administration and use
of the Covered Countermeasure without geographic limitation.
VI. Qualified Persons (As Required by Section 319F-3(i)(8)(b) of the
Act)
With regard to the administration or use of a Covered
Countermeasure, section 319F-3(i)(8)(A) of the Act defines the term
``qualified person'' as a licensed individual who is authorized to
prescribe, administer, or dispense the Covered Countermeasure under the
law of the State in which such covered countermeasure was prescribed,
administered or dispensed.
Additional persons who are qualified persons pursuant to section
319F-3(i)(8)(B) are the following: (1) 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 Covered Countermeasures, and their officials,
agents, employees, contractors and volunteers, following a declaration
of an emergency, and (2) Any person authorized to prescribe,
administer, or dispense Covered Countermeasures or who is otherwise
authorized under an Emergency Use Authorization.
VII. Additional Time Periods of Coverage After Expiration of
Declaration (As required by section 319F-3(b)(3)(B) of the Act)
I have determined that, upon expiration of the time period
specified in section III above, an additional twelve (12) months is a
reasonable period to allow for manufacturers to arrange for disposition
and covered persons to take such other actions as are appropriate to
limit the administration or use of the Covered Countermeasure, and the
liability protection of section
[[Page 61866]]
319F-3(a) of the Act shall extend for that period.
VIII. Amendments
This declaration has not previously been amended. Any future
amendment to this declaration will be published in the Federal
Register, pursuant to section 319F-3(b)(4) of the Act.
IX. Definitions
For the purpose of this declaration, including any claim for loss
brought in accordance with section 319F-3 of the PHS Act against any
covered persons defined in the Act or this declaration, the following
definitions will be used:
Administration of a Covered Countermeasure or Administration: 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 Covered
Countermeasures to patients/recipients, management and operation of
delivery systems, and management and operation of distribution and
dispensing locations.
Authority Having Jurisdiction: 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.
Botulinum Toxin Countermeasure: 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.
Covered Persons: As defined at section 319F-3(i)(2) of the Act,
include the United States, manufacturers, distributors, program
planners, and qualified persons. The terms ``manufacturer,''
``distributor,'' ``program planner,'' and ``qualified person'' are
further defined at sections 319F-3(i)(3), (4), (6), and (8) of the Act.
Declaration of an Emergency: A 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 botulinum toxin
countermeasures, with the exception of a Federal declaration in support
of an emergency use authorization under section 564 of the FDCA unless
such declaration specifies otherwise.
This 10th day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Appendix I
List of U.S. Government Contracts
----------------------------------------------------------------------------------------------------------------
Contract Manufacturer Covered countermeasure Pub.L. 85-804
-------------------------------------------------------------------------------------------------coverage*------
HHSO0100200600017C................ Cangene.................. Heptavalent antitoxin.... No.
03FED03828........................ PerImmune................ Heptavalent antitoxin.... No.
CDC 200-2003-01010................ Cangene.................. Heptavalent antitoxin, No.
Monovalent A.
CDC 200-2004-07625................ Aventis Pasteur.......... Monovalent E............. No.
CDC 200-2003-01052................ Aventis Pasteur.......... Bivalent A and B......... No.
----------------------------------------------------------------------------------------------------------------
*Status of indemnification coverage under Pub.L. 85-804 (An Act to authorize the making, amendment and
modification of contracts to facilitate the national defense.)
[FR Doc. E8-24734 Filed 10-14-08; 4:15 pm]
BILLING CODE 4150-37-P