[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.
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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
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]]
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Pub. L. 85-804
Contract Manufacturer Covered countermeasure coverage*
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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).
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[FR Doc. E8-24733 Filed 10-14-08; 4:15 pm]
BILLING CODE 4150-37-P