17 October 2008
Five notices for avian flu,
botulism, radiation,
smallpox and pandemic flu.
[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Notices]
[Page 61861-61864]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc08-92]
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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 pandemic countermeasures based on a credible risk that
an avian influenza virus spreads and evolves into a strain capable of
causing a pandemic of human influenza.
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).
SUPPLEMENTARY INFORMATION: Highly pathogenic avian influenza A viruses
have been spread by infected migratory birds and exports of poultry or
poultry products from Asia through Europe and Africa since 2004, and
could be spread into North America in 2008 or later, and have caused
disease in humans with an associated high case fatality. Section
[[Page 61862]]
319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d), which was
enacted by the Public Readiness and Emergency Preparedness Act, is
intended to alleviate certain liability concerns associated with
pandemic countermeasures, and, therefore, ensure that the
countermeasures are available and can be administered in the event an
avian influenza virus spreads and evolves into a strain capable of
causing a pandemic of human influenza.
HHS Secretary's Declaration for the Use of the Public Readiness and
Emergency Preparedness Act for the Influenza Antivirals
Oseltamivir Phosphate (Tamiflu[reg]) and Zanamivir (Relenza[reg])
Whereas highly pathogenic avian H5N1 influenza A viruses have
spread, through various mechanisms, from Asia through Europe and Africa
since 2004 and have caused disease in humans with an associated high
case fatality. The real possibility that these viruses could be spread
into North America exists as well as the possibility that these H5N1
viruses could participate directly or indirectly in development of a
human pandemic strain;
Whereas avian influenza A viruses might evolve into strains capable
of causing a pandemic of human influenza;
Whereas there are countermeasures to treat, identify, or prevent
adverse health consequences or death from exposure to highly pathogenic
avian influenza A viruses or pandemic influenza in humans;
Whereas such countermeasures include Oseltamivir Phosphate
(Tamiflu[supreg]) and Zanamivir (Relenza[supreg]);
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 countermeasures;
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 the spread of avian influenza
viruses and resulting disease could in the future constitute 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 manufacturing, testing, development, and
distribution; and, with respect to the category of disease and
population described in sections II and IV below, the administration
and usage of the pandemic countermeasures, influenza antiviral drugs
oseltamivir phosphate (Tamiflu[supreg]) and Zanamivir
(Relenza[supreg]). 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
Countermeasures is the threat of or actual human influenza that results
from the infection of humans with highly pathogenic avian influenza A
viruses or other highly pathogenic influenza viruses causing a pandemic
following exposure to the viruses.
[[Page 61863]]
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 to
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 uses the Covered Countermeasure or has the
Covered Countermeasure administered to him and 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 were 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 a Covered Countermeasure without geographic limitation.
VI. Other 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 the manufacturer 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 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: As used in section
319F-3(a)(2)(B) of the Act includes, but is not limited to, public and
private delivery, distribution, and dispensing activities relating to
physical administration of the countermeasures to recipients,
management and operation of delivery systems, and management and
operation of distribution and dispensing locations.
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.
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 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 pandemic
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.
Pandemic Countermeasures: Means the neuraminidase class of
Antivirals Oseltamivir Phosphate (e.g., Tamiflu[reg] and Zanamivir
(e.g., Relenza[reg]).
This 10th day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Appendix I
List of U.S. Government Contracts
[[Page 61864]]
----------------------------------------------------------------------------------------------------------------
Pub. L. 85-804
Contract Manufacturer Covered countermeasure coverage*
----------------------------------------------------------------------------------------------------------------
HHSO1002006000015I................ Roche.................... Oseltamivir Phosphate No.
(Tamiflu[reg]).
HHSO1002006000016I................ GlaxoSmithKline.......... Zanamivir (Relenza[reg]). No.
HHSO100200600015I................. Roche.................... Acquisiton of Tamiflu, 75 No.
mg (state purchases).
HHSO100200600016I................. GlaxoSmithKline.......... Acquisiton of Relenza, 5 No.
mg (state purchases).
797HH7282......................... Roche.................... Oseltamivir, 75 mg No.
(Tamiflu) (SNS).
797HH7283......................... GlaxoSmithKline.......... Relenza (Zanamivir) 5 mg No.
(SNS).
797HH8113......................... GlaxoSmithKline.......... Relenza (Zanamivir) 5 mg No.
(SNS).
797HH8112......................... Roche.................... Oseltamivir 75 mg No.
(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
[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Notices]
[Page 61864-61866]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc08-93]
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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
[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Notices]
[Page 61866-61869]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc08-94]
-----------------------------------------------------------------------
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 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 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).
SUPPLEMENTARY INFORMATION: 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
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),
[[Page 61867]]
gastrointestinal, cutaneous, pulmonary, and cerebrovascular/central
nervous systems;
Whereas there are Covered Countermeasures to treat, identify, or
prevent adverse health consequences or death from ARS;
Whereas such acute radiation syndrome countermeasures for pre-
exposure and post-exposure prevention and treatment, diagnostics to
identify such exposure, and additional countermeasures for treatment of
adverse effects arising from use of these acute radiation syndrome
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 Countermeasures;
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 of an unintentional radioactive
release, a deliberate detonation of a nuclear device, or other
radiological nuclear incident and the resulting incidence of ARS
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 ARS 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
countermeasures against ARS. 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, memoranda of understanding or other documented Federal
cooperative arrangements 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 ARS resulting from an unintentional radioactive
release, a deliberate detonation of a nuclear device, or other
radiological/nuclear events.
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 to
manufacturers and distributors of the Covered
[[Page 61868]]
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 a 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 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:
Acute Radiation Syndrome (ARS): 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-forming) system, the gastrointestinal (GI)
tract, skin (cutaneous) system, and, at higher radiation levels, the
lung (pulmonary) or and cerebrovascular/central nervous system (CNS).
Acute Radiation Syndrome Countermeasure: Any vaccine;
antimicrobial/antibiotic, other drug or antitoxin; or diagnostic or
device to identify, prevent or treat acute radiation syndrome 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.
Administration of a Covered Countermeasure: As used in Section
319F-3(a)(2)(B) of the Act, includes, but is not limited to, public and
private delivery, distribution, and dispensing activities relating to
physical administration of the 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.
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 ARS
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
[[Page 61869]]
----------------------------------------------------------------------------------------------------------------
Contract Manufacturer Covered countermeasure Pub. L. 85-804
----------------------------------------------------------------------------------------------Coverage\*\-------
797BPA0013....................... Amgen................... Neupogen................ 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. E8-24735 Filed 10-14-08; 4:15 pm]
BILLING CODE 4150-37-P
[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Notices]
[Page 61869-61871]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc08-95]
-----------------------------------------------------------------------
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 smallpox countermeasures based on a credible risk that
the threat of exposure to variola virus, the causative agent of
smallpox or other orthopoxvirus and the resulting disease constitutes a
public health emergency.
DATES: This notice and the attached declaration are effective as of the
date of signature of this 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 Smallpox Countermeasures
Whereas significant changes in the nature, regularity and degree of
threats to health posed by the use of infectious agents as weapons of
biological warfare have generated increased concern for the safety of
the general American population, particularly following the deliberate
exposure of a biological agent in 2001;
Whereas the Secretary of the Department of Homeland Security has
determined that the smallpox virus presents a material threat against
the United States population sufficient to affect national security;
Whereas a release of variola virus or other orthopoxvirus in the
United States which may cause harm to the general population is
considered a credible threat to public health;
Whereas variola virus or other orthopox viruses are highly
transmissible and may have a significant mortality rate;
Whereas a large proportion of the United States population is
susceptible to infection by variola virus since routine vaccination was
ended in 1972;
Whereas there are qualified countermeasures to treat, diagnose, or
prevent adverse health consequences or death from exposure to variola
virus or other orthopoxvirus;
Whereas such smallpox countermeasures, including vaccines, and
antivirals for pre-exposure and post-exposure prevention and treatment,
diagnostics to identify such exposure, and additional countermeasures
for treatment of adverse events arising from use of these smallpox
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 the exposure to variola virus
or other orthopoxvirus disease and the resulting disease 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, I am recommending the manufacture, testing,
development, and
[[Page 61870]]
distribution of the smallpox countermeasures, as defined in section IX
below; and, with respect to the category of disease and population
described in sections II and IV below, the administration and usage of
the smallpox 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 for which I am
recommending the administration or use of the Covered Countermeasure is
the threat of smallpox resulting from exposure to variola virus and the
threat of disease resulting from exposure to other orthopox viruses.
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
support of the Smallpox Emergency Personnel Protection Act (SEPPA) of
2003, the effective period of time of this Declaration commences on
January 24, 2008.
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 to
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 319F-3(a) of the Act shall extend for
that period.
[[Page 61871]]
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: 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.
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 smallpox
countermeasures, with the exception of a Federal declaration in support
of an emergency use authorization under section 564 of the Federal
Food, Drug, and Cosmetic Act (FDCA) unless such declaration specifies
otherwise.
Smallpox Countermeasure: Any vaccine; antiviral, other drug; or
diagnostic or device to identify, prevent or treat smallpox or
orthopoxvirus 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 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.
This 10th day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Appendix I
List of U.S. Government Contract
----------------------------------------------------------------------------------------------------------------
Pub. L. 85-804
Contract Manufacturer Product coverage*
----------------------------------------------------------------------------------------------------------------
HHSO100200700034C................. Bavarian Nordic.......... MVA...................... No.
200-2002-00425.................... Aventis Pasteur.......... WetVax................... Yes.
200-2002-00357.................... Cangene.................. VIG...................... Yes.
200-2002-00004.................... Acambis.................. ACAM 2000................ Yes.
200-2008-24959.................... Acambis.................. ACAM 2000 warm-base...... No.
797BPA0003........................ Gilead................... Cidofovir................ 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. E8-24737 Filed 10-14-08; 4:15 pm]
BILLING CODE 4150-37-P
[Federal Register: October 17, 2008 (Volume 73, Number 202)]
[Notices]
[Page 61871-61873]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc08-96]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Pandemic Influenza Vaccine--Amendment
October 10, 2008.
AGENCY: Office of the Secretary (OS), Department of Health and Human
Services (HHS).
ACTION: Notice of amendment (to the January 26, 2007 Declaration under
the Public Readiness and Emergency Preparedness Act, as amended on
February 1, 2007).
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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 pandemic countermeasures based on a credible risk that
avian influenza viruses spread and evolve into strains capable of
causing a pandemic of human influenza.
DATES: This notice and the attached amendment 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 Amendment to the H5N1 Declaration for the Use of the
Public Readiness and Emergency Preparedness Act Dated January 26, 2007
Whereas the January 26, 2007 declaration for H5N1 vaccine
(``Original Declaration'') was amended on February 1, 2007 to add H7
and H9 vaccines and additional, minor modifications to that amendment
are necessary to ensure internal, editorial consistency of the Original
Declaration, as amended.
Whereas the H2 class of influenza viruses, which caused the human
influenza pandemic of 1957 and reappeared recently in U.S. animals
including swine, is viewed as a likely candidate to re-evolve into an
influenza strain capable of causing a pandemic of human influenza;
Whereas the H6 class of influenza viruses, which appeared recently
in animals including domestic fowl, is viewed as a likely candidate to
evolve into an influenza strain capable of causing a pandemic of human
influenza;
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
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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 (42
U.S.C. 247d-6d(b), 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 additional covered
countermeasures with respect to the category of disease and population
described in sections II and IV of the Original Declaration, as
amended, and have found it desirable to encourage such activities for
these additional covered countermeasures; 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 section II and IV of the Original Declaration,
as amended, 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 the Original Declaration, as amended;
Therefore pursuant to section 319F-3(b) of the Act, I have
determined there is a credible risk that the spread of the H2 and H6
subtypes of avian influenza viruses and resulting disease could in the
future constitute a public health emergency. In order to: (1) Reflect
the addition of medical countermeasures specific to the H2 and H6
subtypes of influenza viruses; (2) specify the means of distribution
pursuant to section 319F-3(b)(2)(E) of the Act for which immunity
specified in section 319F-3(a) of the Act shall be in effect; (3)
clarify the applicability of immunity for covered persons and qualified
persons as those terms are defined in the Act and provided for in the
Original Declaration, as amended; and (4) ensure internal, editorial
consistency in the Original Declaration arising from the February 1,
2007 amendment, the Original Declaration, as amended, is hereby further
amended as follows:
In the title, insert ``H2, H6, H7 and H9'' after ``H5N1'' and
replace ``Vaccine'' with ``Vaccines'' to read: ``HHS Secretary's
Declaration for the Use of the Public Readiness and Emergency
Preparedness Act for H5N1, H2, H6, H7 and H9 Vaccines''.
In the second Whereas clause, insert ``H2, H6, H7 or H9'' after
``H5N1'', replace ``viruses'' with ``virus'', and replace ``strains''
with ``strain'' to read: ``Whereas an H5N1, H2, H6, H7 or H9 avian
influenza virus * * *''.
Insert the following Whereas clauses after the first Whereas
clause:
``Whereas, the H2 class of influenza viruses, which caused the
human influenza pandemic of 1957 and reappeared recently in U.S.
animals including swine, is viewed as a likely candidate to re-evolve
into an influenza strain capable of causing a pandemic of human
influenza;
Whereas, the H6 class of influenza viruses, which appeared recently
in animals including domestic fowl, is viewed as a likely candidate to
evolve into an influenza strain capable of causing a pandemic of human
influenza;''
Insert the following Whereas clauses after the second Whereas
clause:
``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 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 section II and IV of the Original Declaration,
as amended, 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 the Original Declaration, as amended;''
In Section I, strike the entire section and replace it with the
following:
``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,
distribution, dispensing; and, with respect to the category of disease
and population described in sections II and IV of the Original
Declaration, the administration and usage of the pandemic
countermeasure influenza A (H5N1) vaccine and H2, H6, H7, and H9
vaccines. The immunity specified in section 319F-3(a) of the Act shall
only be in effect with respect to: present or future Federal contracts,
cooperative agreements, grants, interagency agreements, or memoranda of
understanding for pandemic countermeasure influenza A (H5N1) vaccine
and H2, H6, H7 and H9 vaccines used and administered in accordance with
this declaration. 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
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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 time period of the
declaration.''
In Section II, insert ``H2, H6, H7 or H9'' following ``H5N1.'' to
read ``* * * highly pathogenic avian influenza A (H5N1, H2, H6, H7 or
H9) virus * * *''.
In Section VIII, strike the section in its entirety and replace it
with the following: ``This Declaration has been amended twice. The
Original Declaration was published in the Federal Register at 72 FR
4710. The first amendment to the Original Declaration was published in
the Federal Register at 72 FR 67731. This is the second amendment to
the Original Declaration. Any future amendment to this Declaration will
be published in the Federal Register, pursuant to section 319F-3(b)(4)
of the Act.''
All other provisions of the Original declaration remain in full
force.
This amendment to the Declaration will be published in the Federal
Register, pursuant to section 319F-3(b)(4) of the Act.
This 10th day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Appendix I
List of U.S. Government Contracts
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Contract Manufacturer Covered countermeasure Pub. L. 85-804 Coverage*
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HHSN266200700005C................ St. Jude Children's H5N1, H2, H6, H7, H9.... No.
Research Hospital.
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[FR Doc. E8-24736 Filed 10-14-08; 4:15 pm]
BILLING CODE 4150-37-P
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