[Federal Register Volume 74, Number 190 (Friday, October 2, 2009)]
[Notices]
[Pages 50968-50970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23761]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Declaration Under the Public Readiness and Emergency Preparedness
Act
September 28, 2009.
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 the Secretary's
finding under the Act that the 2009-H1N1 virus strain and the resulting
disease, 2009-H1N1 influenza, 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: Dr. Nicole Lurie, 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).
[[Page 50969]]
HHS Secretary's Declaration for the Use of the Public Readiness and
Emergency Preparedness Act for the Influenza Antiviral Peramivir
Whereas, on April 26, 2009, Acting Secretary Charles Johnson
determined under section 319 of the Public Health Service Act, (42
U.S.C. 247d) (``the Act''), that a public health emergency exists
nationwide involving the Swine influenza A virus (now known as ``2009-
H1N1 influenza'') that affects or has significant potential to affect
the national security;
Whereas, on July 24, 2009, Secretary Kathleen Sebelius renewed the
determination under section 319 of the Public Health Service Act, (42
U.S.C. 247d) (``the Act''), that a public health emergency exists
nationwide involving the Swine influenza A virus (now known as ``2009-
H1N1 influenza'') that affects or has significant potential to affect
the national security;
Whereas, the World Health Organization has established a Pandemic
alert phase 6 for the 2009-H1N1 influenza virus currently circulating
worldwide;
Whereas there are countermeasures under development to treat,
identify, or prevent adverse health consequences or death from exposure
to 2009-H1N1 influenza;
Whereas such countermeasures include peramivir;
Whereas such countermeasures may be used and administered in
accordance with Federal contracts, cooperative agreements, grants,
interagency agreements, clinical trials 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 Act (42 U.S.C. 247d-6d(b));
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 that 2009-H1N1 influenza and 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, 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 countermeasure peramivir. 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, clinical trials 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 2009-H1N1 influenza.
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, clinical trials agreements
or memoranda of understanding involving countermeasures, the effective
period of time of this Declaration commenced on April 26, 2009, and
extends through June 1, 2010. With respect to Covered Countermeasures
administered and used in accordance with the public
[[Page 50970]]
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, or until June 1, 2010, whichever is earlier.
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 pursuant to an
Investigational New Drug Application (IND) in effect, including 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. Compensation Fund
Section 319F-4 of the Act provides benefits to eligible individuals
who sustain a covered injury directly caused by the administration or
use of a Covered Countermeasure. The Countermeasure Injury Compensation
Program (CICP), within the Health Resources and Services Administration
(HRSA), administers this compensation program. Information about the
CICP is available at 1-888-275-4772 or http://www.hrsa.gov/countermeasurescomp/default.htm.
IX. 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.
X. 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),
respectively, 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 peramivir, an antiviral from the
neuraminidase inhibitor class of influenza antiviral drugs.
Dated: September 25, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-23761 Filed 10-1-09; 8:45 am]
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