Declaration Under the Public Readiness and Emergency Preparedness Act, 61869-61871 [E8-24737]
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61869
Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices
Contract
Manufacturer
Covered countermeasure
797BPA0013 ...........................................
Amgen ...................................................
Neupogen ..............................................
Pub. L. 85–804
Coverage*
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
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
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).
sroberts on PROD1PC70 with NOTICES
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;
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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
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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
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Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices
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.
sroberts on PROD1PC70 with NOTICES
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
VerDate Aug<31>2005
19:18 Oct 16, 2008
Jkt 217001
(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
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Sfmt 4703
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.
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Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices
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
Contract
Manufacturer
Product
HHSO100200700034C .............................
200–2002–00425 ......................................
200–2002–00357 ......................................
200–2002–00004 ......................................
200–2008–24959 ......................................
797BPA0003 .............................................
Bavarian Nordic ......................................
Aventis Pasteur .......................................
Cangene ..................................................
Acambis ..................................................
Acambis ..................................................
Gilead ......................................................
MVA ........................................................
WetVax ....................................................
VIG ..........................................................
ACAM 2000 .............................................
ACAM 2000 warm-base ..........................
Cidofovir ..................................................
Pub. L. 85–
804 coverage*
No.
Yes.
Yes.
Yes.
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. E8–24737 Filed 10–14–08; 4:15 pm]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Pandemic Influenza Vaccine—
Amendment
October 10, 2008.
Office of the Secretary (OS),
Department of Health and Human
Services (HHS).
AGENCY:
Notice of amendment (to the
January 26, 2007 Declaration under the
Public Readiness and Emergency
Preparedness Act, as amended on
February 1, 2007).
ACTION:
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
sroberts on PROD1PC70 with NOTICES
SUMMARY:
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19:18 Oct 16, 2008
Jkt 217001
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.
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Fmt 4703
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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
E:\FR\FM\17OCN1.SGM
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Agencies
[Federal Register Volume 73, Number 202 (Friday, October 17, 2008)]
[Notices]
[Pages 61869-61871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24737]
-----------------------------------------------------------------------
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