[Federal Register: December 22, 2008 (Volume 73, Number 246)]
[Notices]
[Page 78362-78364]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de08-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Declaration Under the Public Readiness and Emergency Preparedness
Act
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 influenza diagnostics, personal respiratory
protection devices, and respiratory support devices 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 H5N1
viruses have been spread by infected migratory birds and exports of
poultry or poultry products from Asia through Europe and Africa since
2003, and could spread into North America in 2008 or later, and have
caused disease in humans, with over 60% of infected people dying from
H5N1. In addition to H5N1, other animal influenza A viruses have also
caused disease in humans, including H2N2, H7N7, H7N2, and H9N2
influenza A viruses, and also pose a pandemic threat. Section 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 Pandemic Influenza Diagnostics, Personal
Respiratory Protection Devices, and Respiratory Support Devices
Whereas highly pathogenic avian H5N1 influenza A viruses have
spread, through various mechanisms, from Asia through Europe and Africa
since 2003 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 other animal influenza viruses such as H2N2, H7N2, H7N7 and
H9N2 viruses have also caused illness among humans and pose a pandemic
threat;
Whereas avian H5N1 or other influenza A viruses might evolve into
strains capable of causing a pandemic of human influenza;
Whereas there are countermeasures to identify, reduce exposure to,
or support patients infected by highly pathogenic avian H5N1 influenza
A viruses, other animal influenza viruses that pose a pandemic threat,
or pandemic influenza in humans;
Whereas such countermeasures that currently exist or may be the
subject of research and development include diagnostics to identify
avian or other animal influenza A viruses that pose a pandemic threat,
or to otherwise aid in the diagnosis of pandemic influenza; personal
respiratory protection devices to reduce exposure to avian or other
animal influenza A viruses; and respiratory support devices to support
patients infected by avian or other animal influenza A viruses;
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,
[[Page 78363]]
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 and other
influenza viruses that pose a pandemic threat 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, clinical 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 pandemic influenza diagnostics, personal
respiratory protection devices, and respiratory support devices, as
defined in section IX of this declaration. 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 H5N1
influenza A viruses or other animal influenza A viruses that are, or
may be capable of developing into, a pandemic strain.
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,
or otherwise uses a Covered Countermeasure under direction from, a
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, or otherwise uses a Covered
Countermeasure under direction 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.
[[Page 78364]]
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 Influenza Diagnostics: means diagnostics to identify avian
or other animal influenza A viruses that pose a pandemic threat, or to
otherwise aid in the diagnosis of pandemic influenza, when (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.
Pandemic Influenza Personal Respiratory Protection Devices: means
personal respiratory protection devices for use by the general public
to reduce wearer exposure to pathogenic biological airborne
particulates during public health medical emergencies, such as an
influenza pandemic, when (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.
Pandemic Influenza Respiratory Support Devices: means devices to
support respiratory function for patients infected with highly
pathogenic influenza A H5N1 viruses or other influenza viruses that
pose a pandemic threat when (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.
Dated: December 17, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8-30510 Filed 12-18-08; 4:15 pm]
BILLING CODE 4150-37-P