Declaration Under the Public Readiness and Emergency Preparedness Act, 50968-50970 [E9-23761]
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50968
Federal Register / Vol. 74, No. 190 / Friday, October 2, 2009 / Notices
all (both rural and non–rural)
incumbent local exchange
carriers(LECs) must provide the
National Exchange Carrier Association
(NECA) with the loop cost and loop
count data required by 47 CFR 63.611 of
the Commission’s rules for each of its
study areas and, if applicable, for each
wire center (that term is defined in 47
CFR Part 54).
Loops are the telephone lines running
from the carrier’s switching facilities to
the customer. The loop cost and loop
count information is to be field annually
with NECA by July 31st of each year,
and may be updated quarterly pursuant
to 47 CFR 63.612. Pursuant to section
36.613, the information filed on July
31st of each year will be used to
calculate universal service support for
each study area and is filed by NECA
with the Commission by October 1 of
each year. An incumbent LEC is define
as a carrier that meets the definition of
‘‘incumbent local exchange carrier’’ in
47 CFR 51.5 of the Commission’s rules.
Section 63.612(a) also requires non–
rural carriers to file loop counts (no loop
cost data) on a quarterly basis. The
Commission requires that non–rural
carriers submit quarterly loop counts in
order to ensure that universal service
fund (USF) support for non–rural
carriers is accurately calculated when
competitive eligible
telecommunications carriers (ETCs) are
present in the incumbent LECs’
operating areas. Quarterly loop cost and
loop count data filings are voluntary for
rural carriers. When a competitive ETC,
however, is operating in an incumbent
rural carrier’s territory, the incumbent
rural carrier is required to submit
quarterly loop count data. Quarterly
filings of loop counts are necessary
because if an incumbent rural carrier
does not update its loop count data
more often than annually, but its
competitor does, the competitor’s more
recent data may include loops captured
from the incumbent since the
incumbent’s last filing. Thus, the
incumbent would continue to receive
USF support at the same per line
support amount that the incumbent LEC
receives in the same operating territory.
In order to receive such support, the
competitive ETC must file loop count
data with the USAC on a quarterly basis.
The reporting requirements are
necessary to implement the
congressional mandate for universal
service. The requirements are necessary
to verify that rural and non–rural LECs
are eligible to receive universal service
support. Information filed with NECA
pursuant to section 36.611 is used to
calculate universal service support
payments to eligible carriers. Without
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this information, NECA and USAC
(Universal Service Administration
Company) would not be able to
calculate such payments to eligible
carriers.
Federal Communications Commission.
Marlene H. Dortch,
Secretary.
[FR Doc. E9–23768 Filed 10–1–09; 8:45 am]
BILLING CODE: 6712–01–S
FEDERAL ACCOUNTING STANDARDS
ADVISORY BOARD
Notice of Issuance of Statement of
Federal Financial Accounting Standard
36, Reporting Comprehensive LongTerm Fiscal Projections for the U.S.
Government
AGENCY: Federal Accounting Standards
Advisory Board.
ACTION: Notice.
Board Action: Pursuant to 31 U.S.C.
3511(d), the Federal Advisory
Committee Act (Pub. L. 92–463), as
amended, and the FASAB Rules of
Procedure, as amended in April, 2004,
notice is hereby given that the Federal
Accounting Standards Advisory Board
(FASAB) has issued Statement of
Federal Financial Accounting Standard
36, Reporting Comprehensive LongTerm Fiscal Projections for the U.S.
Government.
The standard is available on the
FASAB home page https://
www.fasab.gov/standards.html. Copies
can be obtained by contacting FASAB at
(202) 512–7350.
FOR FURTHER INFORMATION CONTACT:
Wendy Payne, Executive Director, at
(202) 512–7350.
Authority: Federal Advisory Committee
Act, Public Law 92–463.
Dated: September 29, 2009.
Charles Jackson,
Federal Register Liaison Officer.
[FR Doc. E9–23816 Filed 10–1–09; 8:45 am]
BILLING CODE 1610–02–P
FEDERAL RESERVE SYSTEM
Change in Bank Control Notices;
Acquisition of Shares of Bank or Bank
Holding Companies
The notificants listed below have
applied under the Change in Bank
Control Act (12 U.S.C. 1817(j)) and
§ 225.41 of the Board’s Regulation Y (12
CFR 225.41) to acquire a bank or bank
holding company. The factors that are
considered in acting on the notices are
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set forth in paragraph 7 of the Act (12
U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the office of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than October
19, 2009.
A. Federal Reserve Bank of
Minneapolis (Jacqueline G. King,
Community Affairs Officer) 90
Hennepin Avenue, Minneapolis,
Minnesota 55480–0291:
1. Earl E. Geiger, Bloomington,
Minnesota; to acquire voting shares of
Heritage Bancshares Group, Inc.,
Willmar, Minnesota, and thereby
indirectly acquire voting shares of
Heritage Bank, NA, Spicer, Minnesota,
and Heritage Bank, NA, Holstein, Iowa.
Board of Governors of the Federal Reserve
System, September 29, 2009.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E9–23804 Filed 10–1–09; 8:45 am]
BILLING CODE 6210–01–S
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.
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).
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Federal Register / Vol. 74, No. 190 / Friday, October 2, 2009 / Notices
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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
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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
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
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50969
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
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50970
Federal Register / Vol. 74, No. 190 / Friday, October 2, 2009 / Notices
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.
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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.
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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 https://
www.hrsa.gov/countermeasurescomp/
default.htm.
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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]
BILLING CODE 4150–37–P
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Agencies
[Federal Register Volume 74, Number 190 (Friday, October 2, 2009)]
[Notices]
[Pages 50968-50970]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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 https://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]
BILLING CODE 4150-37-P