Pandemic Influenza Vaccines-Amendment, 30294-30297 [E9-14948]
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FOR FURTHER INFORMATION CONTACT:
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or Renee Hallman, Contact
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H–303, Washington, DC 20580, (202)
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By direction of the Commission.
Donald S. Clark,
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[FR Doc. E9–14919 Filed 6–24–09; 8:45 am]
BILLING CODE 6750–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
sroberts on PROD1PC70 with NOTICES
Pandemic Influenza Vaccines—
Amendment
Authority: 42 U.S.C. 247d–6d.
Notice of third amendment to
the January 26, 2007 Declaration under
the Public Readiness and Emergency
Preparedness Act, and Republication of
the Declaration, as Amended.
VerDate Nov<24>2008
16:25 Jun 24, 2009
Jkt 217001
Eastern Financial Florida Credit Union.
Eastern Financial Florida Credit Union.
John C. Malone.
Liberty Global, Inc.
Liberty Global, Inc.
GlaxoSmithKline plc.
Stiefel Laboratories, Inc.
Stiefel Laboratories, Inc.
Mr. James Laurence Balsillie.
Mr. Jerry Moyes.
Coyotes Hockey, LLC.
Green Plains Renewable Energy, Inc.
RBF Acquisition II, LLC.
RBF Acquisition II, LLC.
Lime Rock Partners V, LP.
Allis-Chalmers Energy Inc.
Allis-Chalmers Energy Inc.
Aurora Resurgence Fund (C) L.P.
Norwood Promotional Products Holdings, Inc.
Norwood Promotional Products, Inc.
United Technologies Corporation.
Watsco, Inc.
Watsco, Inc.
Watsco, Inc.
United Technologies Corporation.
Carrier Sales and Distribution, LLC.
TC PipeLines, LP.
TransCanada Corporation.
North Baja Pipeline, LLC.
BioMarin Pharmaceutical Inc.
Medicis Pharmaceutical Corporation.
Medicis Pediatrics, Inc.
Windstream Corporation.
D&E Communications, Inc.
D&E Communications, Inc.
SUMMARY: Amendment to 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 Acting Secretary’s determination,
under section 319F–3(b) of the Act, that
the risk that the spread of H1N1 swine
influenza viruses (now known as 2009
H1N1 Influenza A, or 2009 H1N1
influenza) and resulting disease
constitutes a public health emergency;
and republication of the declaration to
reflect the declaration in its entirety, as
amended.
DATES: The third amendment and
republication of the declaration are
effective as of June 15, 2009.
Office of the Secretary
ACTION:
Party name
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).
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HHS Secretary’s Amendment to the
Declaration for the Use of the Public
Readiness and Emergency
Preparedness Act for H5N1, H2, H6,
and H9 Vaccines
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 that affects or has
significant potential to affect the
national security (‘‘2009 H1N1
influenza’’);
Whereas, the World Health
Organization has established a
Pandemic alert phase 5 for the 2009
H1N1 influenza virus currently
circulating worldwide;
Whereas, vaccination may be effective
to protect persons from the threat of
2009 H1N1 influenza;
Whereas, Secretary Michael O. Leavitt
issued a Declaration for the Use of the
Public Readiness and Emergency
Preparedness Act dated January 26,
2007 (‘‘Original Declaration’’), as
amended on November 30, 2007 and
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Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Notices
October 17, 2008 with respect to certain
avian influenza viruses; minor
modifications are necessary to correct
previous, minor, editorial errors; and
republication of the Original
Declaration, as amended, in its entirety
is necessary for clarity;
Whereas, the findings made by the
Secretary in the Original Declaration, as
amended, continue to apply generally,
and apply with equal force as to the
2009 H1N1 influenza;
Whereas, in accordance with section
319F–3(b)(6) of the Act (42 U.S.C. 247d–
6d(b), 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 additional covered
countermeasures with respect to the
category of disease and population
described in sections II and IV of the
Original Declaration, as amended, and
as hereby further amended, and have
found it desirable to encourage such
activities for these additional 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 of the
Original Declaration, as amended, and
as hereby further amended, 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 other
qualified persons as I have identified in
section VI of the Original Declaration, as
amended;
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. In order to extend the
Original Declaration, as amended, to
apply to the 2009 H1N1 influenza and
to correct previous, minor, editorial
errors, the Original Declaration, as
amended, is hereby further amended
and republished as follows:
In the title, strike ‘‘and H9’’ and insert
‘‘H9, and 2009 H1N1’’.
In the first ‘‘whereas’’ clause, first
sentence, strike ‘‘(H5N1). H7 and H9
vaccines’’ and insert ‘‘H5N1, H7, and
H9’’.
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After the fourth ‘‘whereas’’ clause,
insert a new recital as follows:
Whereas, on April 26, 2009, Acting
Secretary Charles E. Johnson
determined under section 319 of the
Public Health Service Act, (42 U.S.C.
247d), that a public emergency exists
nationwide involving the 2009 H1N1
influenza virus that affects or has
significant potential to affect the
national security (now called ‘‘2009
H1N1 influenza’’);
In the ninth ‘‘whereas’’ clause, insert
‘‘,’’ after ‘‘IV’’; strike ‘‘of the Original
Declaration, as amended,’’; insert ‘‘;’’
after ‘‘VI’’; and strike ‘‘of the Original
Declaration;’’.
In the ‘‘therefore’’ clause concluding
the recitals, strike the period and insert
‘‘, and that the 2009 H1N1 influenza
constitutes a public health emergency.’’.
In section I, second paragraph, first
sentence, strike all after ‘‘influenza A’’
and insert ‘‘H5N1, H2, H6, H7, H9, and
2009 H1N1 vaccines and any associated
adjuvants.’’.
In section I, second paragraph, second
sentence, strike all after ‘‘influenza A’’
and insert ‘‘H5N1, H2, H6, H7, H9, and
2009 H1N1 vaccines used and
administered in accordance with this
declaration.’’.
Strike the current section II, ‘‘Category
of Disease,’’ in its entirety and replace
as follows:
II. Category of Disease (as Required by
Section 319F–3(b)(2)(A) of the Act)
The category of disease 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 following exposure to the virus
with (1) highly pathogenic avian
influenza A (H5N1, H2, H6, H7, or H9)
virus; or (2) 2009 H1N1 influenza.
In section III, strike the period and
insert ‘‘; except that with respect to 2009
H1N1 influenza vaccine, the effective
period commences on June 15, 2009 and
extends through March 31, 2013.’’
In Section VIII, strike the section in its
entirety and replace it with the
following:
The Declaration for the Use of the
Public Readiness and Emergency
Preparedness Act for H5N1 vaccines
was published on January 26, 2007 and
amended on November 30, 2007 to add
H7 and H9 vaccines and on October 17,
2008 to add H2 and H6 vaccines. This
Declaration incorporates all
amendments prior to the date of its
publication in the Federal Register. Any
future amendment to this Declaration
will be published in the Federal
Register, pursuant to section 319F–
2(b)(4) of the Act.
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All other provisions of the Original
Declaration, as amended, remain in full
force.
Republication of HHS Secretary’s
Original Declaration, as Amended, for
the Use of the Public Readiness and
Emergency Preparedness Act for H5N1,
H2, H6, H9, and 2009 H1N1 Vaccines
To the extent any term of the original
January 27, 2007 Declaration or any
amendment thereto is inconsistent with
any provision of this republished
Declaration, the terms of this
republished Declaration are controlling.
HHS Secretary’s Declaration for the Use
of the Public Readiness and Emergency
Preparedness Act for H5N1, H2, H6, H9,
and 2009 H1N1 Vaccines
Whereas highly pathogenic avian
influenza A H5N1, H7, and H9 have
spread by infected migratory birds and
exports of live poultry from Asia
through Europe and Africa since 2004,
and could spread into North America in
2006 or later, and have caused disease
in humans with an associated high case
fatality upon infection with this virus;
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, an H5N1, H2, H6, H7 or H9
avian influenza virus may evolve into
strain capable of causing a pandemic of
human influenza;
Whereas, on April 26, 2009, Acting
Secretary Charles E. Johnson
determined under section 319 of the
Public Health Service Act, (42 U.S.C.
247d), that a public health emergency
exists nationwide involving the Swine
Influenza A virus that affects or has
significant potential to affect the
national security (now called ‘‘2009
H1N1 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’’);
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Federal Register / Vol. 74, No. 121 / Thursday, June 25, 2009 / Notices
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, 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 section II and IV 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;
Whereas, in accordance with section
319F–3(b)(6) of the Public Health
Service Act (42 U.S.C. 247d–6d(b)) (‘‘the
Act’’), I have considered the desirability
of encouraging 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, and have found it desirable to
encourage such activities for the
Covered Countermeasures;
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, and that 2009 H1N1
influenza constitutes a public health
emergency.
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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 manufacture, testing,
development, distribution, dispensing;
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 influenza A
H5N1, H2, H6, H7, H9, and 2009 H1N1
Vaccines and any associated adjuvants.
The immunity specified in section
319F–3(a) of the Act shall only be in
effect with respect to: Present or future
Federal contracts, cooperative
agreements, grants, interagency
agreements, or memoranda of
understanding for pandemic
countermeasure influenza A H5N1, H2,
H6, H7, H9, and 2009 H1N1 vaccines
used and administered in accordance
with this declaration. 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 time period
of the declaration.
II. Category of Disease (as Required by
Section 319F–3(b)(2)(A) of the Act)
The category of disease 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 following exposure to the virus
with (1) highly pathogenic avian
influenza A (H5N1, H2, H6, H7, or H9)
virus; or (2) 2009 H1N1 influenza.
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III. Effective Time Period (as Required
by Section 319F–3(b)(2)(B) of the Act)
The effective period of time of this
Declaration commences on December 1,
2006 and extends through February 28,
2010; except that with respect to 2009
H1N1 influenza vaccine, the effective
period commences on June 15, 2009 and
extends through March 31, 2013.
IV. Population (as Required by Section
319F–3(b)(2)(C) of the Act)
Section 319F–3(a)(4)(A) confers
immunity to manufacturers and
distributors of the Covered
Countermeasure, regardless of the
defined population.
Section 319F–3(a)(3)(C)(i) confers
immunity to covered persons who could
be program planners or qualified
persons with respect to the Covered
Countermeasure only if a member of the
population specified in the declaration
administers or uses the Covered
Countermeasure 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 the following: (1) All
persons who use a Covered
Countermeasure or to whom such a
Covered Countermeasure is
administered as an Investigational New
Drug in a human clinical trial
conducted directly by the Federal
Government, or pursuant to a contract,
grant or cooperative agreement with the
Federal Government; (2) all persons
who use a Covered Countermeasure or
to whom such a Countermeasure is
administered in a pre-pandemic phase,
as defined below; and/or (3) all persons
who use a Covered Countermeasure, or
to whom such a Covered
Countermeasure is administered in a
pandemic phase, as defined below.
V. Geographic Area (as Required by
Section 319F–3(b)(2)(D) of the Act)
Section 319F–3(a) 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
countermeasure under the law of the
State in which such Covered
Countermeasure was prescribed,
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administered or dispensed. Additional
persons who are qualified persons
pursuant to section 319F–3(i)(8)(B) are
the following: None.
VII. Additional Time Periods of
Coverage After Expiration of
Declaration (as Required by Section
319F–3(b)(3)(B) of the Act)
A. I have determined that, upon
expiration of the applicable 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
of the Covered Countermeasure,
including the return of such product to
the manufacturer, and for 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.
B. The Federal Government shall
purchase the entire production of
Covered Countermeasures under the
contracts specifically listed by contract
number in section I for the stockpile
under section 319F–2 of the Act, and
shall be subject to the time-period
extension of section 319F–3(b)(3)(C).
Production under future contracts for
the same vaccine will also be subject to
the time-period extension of section
319F–3(b)(3)(C).
sroberts on PROD1PC70 with NOTICES
VIII. Amendments
The Declaration for the Use of the
Public Readiness and Emergency
Preparedness Act for H5N1 vaccines
was published on January 26, 2007 and
amended on November 30, 2007 to add
H7 and H9 vaccines and on October 17,
2008 to add H2 and H6 vaccines. This
Declaration incorporates all
amendments prior to the date of its
publication in the Federal Register. Any
future amendment to this Declaration
will be published in the Federal
Register, pursuant to section 319F–
2(b)(4) of the Act.
IX. Definitions
For the purposes of this declaration,
‘‘pre-pandemic phase’’ means the
following stages, as defined in the
National Strategy for Pandemic
Influenza: Implementation Plan
(Homeland Security Council, May
2006): (0) New Domestic Animal
Outbreak in At-Risk Country; (1)
Suspected Human Outbreak Overseas;
(2) Confirmed Human Outbreak
Overseas; and (3) Widespread Human
Outbreaks in Multiple Locations
Overseas. For the purposes of this
declaration, ‘‘pandemic phase’’ means
the following stages, as defined in the
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National Strategy for Pandemic
Influenza: Implementation Plan
(Homeland Security Council, May
2006): (4) First Human Case in North
America; and (5) Spread Throughout
United States.
Dated: June 15, 2009.
Kathleen Sebelius,
Secretary.
Appendix
I. List of U.S. Government Contracts—
Covered H5N1 Vaccine Contracts
[January 26, 2007]
1. HHSN266200400031C
2. HHSN266200400032C
3. HHSN266200300039C
4. HHSN266200400045C
5. HHSN266200205459C
6. HHSN266200205460C
7. HHSN266200205461C
8. HHSN266200205462C
9. HHSN266200205463C
10. HHSN266200205464C
11. HHSN266200205465C
12. HHSN266199905357C
13. HHSN266200300068C
14. HHSN266200005413C
15. HHSO100200600021C (formerly
200200409981)
16. HHSO100200500004C
17. HHSO100200500005I
18. HHSO100200700026I
19. HHSO100200700027I
20. HHSO100200700028I
21. HHSO100200600010C
22. HHSO100200600011C
23. HHSO100200600012C
24. HHSO100200600013C
25. HHSO100200600014C
26. HHSO100200600022C (formerly
200200511758)
27. HHSO100200600023C (formerly
200200410431)
28. CRADA No. AI–0155 NIAID/
MedImmune
29. HHSO100200700029C
30. HHSO100200700030C
31. HHSO100200700031C
[FR Doc. E9–14948 Filed 6–24–09; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–09–09BX]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects.
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Alternatively, to obtain a copy of the
data collection plans and instrument,
call 404–639–5960 and send comments
to Maryam I. Daneshvar, CDC Reports
Clearance Officer, 1600 Clifton Road,
NE., MS–D74, Atlanta, Georgia 30333;
comments may also be sent by e-mail to
omb@cdc.gov.
Comments are invited on (a) whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have a
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarify of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of information technology. Written
comments should be received within 60
days of this notice.
Proposed Project
Clostridium difficile Infection (CDI)
Surveillance—New—National Center for
Preparedness, Detection, and Control of
Infectious Diseases (NCPDCID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Steady increases in the rate and
severity of Clostridium difficile infection
(CDI) indicate a clear need to conduct
longitudinal assessments of the impact
of CDI in the United States. C. difficile
is an anaerobic, spore-forming, gram
positive bacillus that produces two
pathogenic toxins: A and B. CDI ranges
in severity from mild diarrhea to
fulminant colitis and death.
Transmission of C. difficile occurs
primarily in healthcare facilities, where
environmental contamination by C.
difficile spores and exposure to
antimicrobial drugs are common. No
longer limited to healthcare
environments, community-associated
CDI is the focus of increasing attention.
Recently, several cases of serious CDI
have been reported in what have been
considered low-risk populations,
including healthy persons living in the
community and peri-partum women.
For this proposed data collection, the
surveillance population will consist of
persons residing in the catchment area
of the participating Emerging Infections
Program (EIP) sites. This surveillance
poses no more than minimal risk to the
study participants as there will be no
interventions or modifications to the
care study participants receive. EIP
surveillance personnel will perform
active case finding from laboratory
reports of stool specimens testing
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Agencies
[Federal Register Volume 74, Number 121 (Thursday, June 25, 2009)]
[Notices]
[Pages 30294-30297]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14948]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Pandemic Influenza Vaccines--Amendment
Authority: 42 U.S.C. 247d-6d.
ACTION: Notice of third amendment to the January 26, 2007 Declaration
under the Public Readiness and Emergency Preparedness Act, and
Republication of the Declaration, as Amended.
-----------------------------------------------------------------------
SUMMARY: Amendment to 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 Acting
Secretary's determination, under section 319F-3(b) of the Act, that the
risk that the spread of H1N1 swine influenza viruses (now known as 2009
H1N1 Influenza A, or 2009 H1N1 influenza) and resulting disease
constitutes a public health emergency; and republication of the
declaration to reflect the declaration in its entirety, as amended.
DATES: The third amendment and republication of the declaration are
effective as of June 15, 2009.
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 Declaration for the Use of the Public
Readiness and Emergency Preparedness Act for H5N1, H2, H6, and H9
Vaccines
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 that affects or has
significant potential to affect the national security (``2009 H1N1
influenza'');
Whereas, the World Health Organization has established a Pandemic
alert phase 5 for the 2009 H1N1 influenza virus currently circulating
worldwide;
Whereas, vaccination may be effective to protect persons from the
threat of 2009 H1N1 influenza;
Whereas, Secretary Michael O. Leavitt issued a Declaration for the
Use of the Public Readiness and Emergency Preparedness Act dated
January 26, 2007 (``Original Declaration''), as amended on November 30,
2007 and
[[Page 30295]]
October 17, 2008 with respect to certain avian influenza viruses; minor
modifications are necessary to correct previous, minor, editorial
errors; and republication of the Original Declaration, as amended, in
its entirety is necessary for clarity;
Whereas, the findings made by the Secretary in the Original
Declaration, as amended, continue to apply generally, and apply with
equal force as to the 2009 H1N1 influenza;
Whereas, in accordance with section 319F-3(b)(6) of the Act (42
U.S.C. 247d-6d(b), 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 additional covered
countermeasures with respect to the category of disease and population
described in sections II and IV of the Original Declaration, as
amended, and as hereby further amended, and have found it desirable to
encourage such activities for these additional 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 of the Original Declaration,
as amended, and as hereby further amended, 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
other qualified persons as I have identified in section VI of the
Original Declaration, as amended;
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. In order to extend the Original Declaration,
as amended, to apply to the 2009 H1N1 influenza and to correct
previous, minor, editorial errors, the Original Declaration, as
amended, is hereby further amended and republished as follows:
In the title, strike ``and H9'' and insert ``H9, and 2009 H1N1''.
In the first ``whereas'' clause, first sentence, strike ``(H5N1).
H7 and H9 vaccines'' and insert ``H5N1, H7, and H9''.
After the fourth ``whereas'' clause, insert a new recital as
follows:
Whereas, on April 26, 2009, Acting Secretary Charles E. Johnson
determined under section 319 of the Public Health Service Act, (42
U.S.C. 247d), that a public emergency exists nationwide involving the
2009 H1N1 influenza virus that affects or has significant potential to
affect the national security (now called ``2009 H1N1 influenza'');
In the ninth ``whereas'' clause, insert ``,'' after ``IV''; strike
``of the Original Declaration, as amended,''; insert ``;'' after
``VI''; and strike ``of the Original Declaration;''.
In the ``therefore'' clause concluding the recitals, strike the
period and insert ``, and that the 2009 H1N1 influenza constitutes a
public health emergency.''.
In section I, second paragraph, first sentence, strike all after
``influenza A'' and insert ``H5N1, H2, H6, H7, H9, and 2009 H1N1
vaccines and any associated adjuvants.''.
In section I, second paragraph, second sentence, strike all after
``influenza A'' and insert ``H5N1, H2, H6, H7, H9, and 2009 H1N1
vaccines used and administered in accordance with this declaration.''.
Strike the current section II, ``Category of Disease,'' in its
entirety and replace as follows:
II. Category of Disease (as Required by Section 319F-3(b)(2)(A) of the
Act)
The category of disease 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
following exposure to the virus with (1) highly pathogenic avian
influenza A (H5N1, H2, H6, H7, or H9) virus; or (2) 2009 H1N1
influenza.
In section III, strike the period and insert ``; except that with
respect to 2009 H1N1 influenza vaccine, the effective period commences
on June 15, 2009 and extends through March 31, 2013.''
In Section VIII, strike the section in its entirety and replace it
with the following:
The Declaration for the Use of the Public Readiness and Emergency
Preparedness Act for H5N1 vaccines was published on January 26, 2007
and amended on November 30, 2007 to add H7 and H9 vaccines and on
October 17, 2008 to add H2 and H6 vaccines. This Declaration
incorporates all amendments prior to the date of its publication in the
Federal Register. Any future amendment to this Declaration will be
published in the Federal Register, pursuant to section 319F-2(b)(4) of
the Act.
All other provisions of the Original Declaration, as amended,
remain in full force.
Republication of HHS Secretary's Original Declaration, as Amended, for
the Use of the Public Readiness and Emergency Preparedness Act for
H5N1, H2, H6, H9, and 2009 H1N1 Vaccines
To the extent any term of the original January 27, 2007 Declaration
or any amendment thereto is inconsistent with any provision of this
republished Declaration, the terms of this republished Declaration are
controlling.
HHS Secretary's Declaration for the Use of the Public Readiness and
Emergency Preparedness Act for H5N1, H2, H6, H9, and 2009 H1N1 Vaccines
Whereas highly pathogenic avian influenza A H5N1, H7, and H9 have
spread by infected migratory birds and exports of live poultry from
Asia through Europe and Africa since 2004, and could spread into North
America in 2006 or later, and have caused disease in humans with an
associated high case fatality upon infection with this virus;
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, an H5N1, H2, H6, H7 or H9 avian influenza virus may evolve
into strain capable of causing a pandemic of human influenza;
Whereas, on April 26, 2009, Acting Secretary Charles E. Johnson
determined under section 319 of the Public Health Service Act, (42
U.S.C. 247d), that a public health emergency exists nationwide
involving the Swine Influenza A virus that affects or has significant
potential to affect the national security (now called ``2009 H1N1
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'');
[[Page 30296]]
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, 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 section II and IV 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;
Whereas, in accordance with section 319F-3(b)(6) of the Public
Health Service Act (42 U.S.C. 247d-6d(b)) (``the Act''), I have
considered the desirability of encouraging 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, and have found it desirable to encourage such activities for the
Covered Countermeasures;
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, and that 2009 H1N1 influenza 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 manufacture, testing, development,
distribution, dispensing; 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 influenza A
H5N1, H2, H6, H7, H9, and 2009 H1N1 Vaccines and any associated
adjuvants. The immunity specified in section 319F-3(a) of the Act shall
only be in effect with respect to: Present or future Federal contracts,
cooperative agreements, grants, interagency agreements, or memoranda of
understanding for pandemic countermeasure influenza A H5N1, H2, H6, H7,
H9, and 2009 H1N1 vaccines used and administered in accordance with
this declaration. 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 time period of the
declaration.
II. Category of Disease (as Required by Section 319F-3(b)(2)(A) of the
Act)
The category of disease 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
following exposure to the virus with (1) highly pathogenic avian
influenza A (H5N1, H2, H6, H7, or H9) virus; or (2) 2009 H1N1
influenza.
III. Effective Time Period (as Required by Section 319F-3(b)(2)(B) of
the Act)
The effective period of time of this Declaration commences on
December 1, 2006 and extends through February 28, 2010; except that
with respect to 2009 H1N1 influenza vaccine, the effective period
commences on June 15, 2009 and extends through March 31, 2013.
IV. Population (as Required by Section 319F-3(b)(2)(C) of the Act)
Section 319F-3(a)(4)(A) confers immunity to manufacturers and
distributors of the Covered Countermeasure, regardless of the defined
population.
Section 319F-3(a)(3)(C)(i) confers immunity to covered persons who
could be program planners or qualified persons with respect to the
Covered Countermeasure only if a member of the population specified in
the declaration administers or uses the Covered Countermeasure 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 the following:
(1) All persons who use a Covered Countermeasure or to whom such a
Covered Countermeasure is administered as an Investigational New Drug
in a human clinical trial conducted directly by the Federal Government,
or pursuant to a contract, grant or cooperative agreement with the
Federal Government; (2) all persons who use a Covered Countermeasure or
to whom such a Countermeasure is administered in a pre-pandemic phase,
as defined below; and/or (3) all persons who use a Covered
Countermeasure, or to whom such a Covered Countermeasure is
administered in a pandemic phase, as defined below.
V. Geographic Area (as Required by Section 319F-3(b)(2)(D) of the Act)
Section 319F-3(a) 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 countermeasure under the law of
the State in which such Covered Countermeasure was prescribed,
[[Page 30297]]
administered or dispensed. Additional persons who are qualified persons
pursuant to section 319F-3(i)(8)(B) are the following: None.
VII. Additional Time Periods of Coverage After Expiration of
Declaration (as Required by Section 319F-3(b)(3)(B) of the Act)
A. I have determined that, upon expiration of the applicable 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 of the Covered Countermeasure, including the return of such
product to the manufacturer, and for 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.
B. The Federal Government shall purchase the entire production of
Covered Countermeasures under the contracts specifically listed by
contract number in section I for the stockpile under section 319F-2 of
the Act, and shall be subject to the time-period extension of section
319F-3(b)(3)(C). Production under future contracts for the same vaccine
will also be subject to the time-period extension of section 319F-
3(b)(3)(C).
VIII. Amendments
The Declaration for the Use of the Public Readiness and Emergency
Preparedness Act for H5N1 vaccines was published on January 26, 2007
and amended on November 30, 2007 to add H7 and H9 vaccines and on
October 17, 2008 to add H2 and H6 vaccines. This Declaration
incorporates all amendments prior to the date of its publication in the
Federal Register. Any future amendment to this Declaration will be
published in the Federal Register, pursuant to section 319F-2(b)(4) of
the Act.
IX. Definitions
For the purposes of this declaration, ``pre-pandemic phase'' means
the following stages, as defined in the National Strategy for Pandemic
Influenza: Implementation Plan (Homeland Security Council, May 2006):
(0) New Domestic Animal Outbreak in At-Risk Country; (1) Suspected
Human Outbreak Overseas; (2) Confirmed Human Outbreak Overseas; and (3)
Widespread Human Outbreaks in Multiple Locations Overseas. For the
purposes of this declaration, ``pandemic phase'' means the following
stages, as defined in the National Strategy for Pandemic Influenza:
Implementation Plan (Homeland Security Council, May 2006): (4) First
Human Case in North America; and (5) Spread Throughout United States.
Dated: June 15, 2009.
Kathleen Sebelius,
Secretary.
Appendix
I. List of U.S. Government Contracts--Covered H5N1 Vaccine Contracts
[January 26, 2007]
1. HHSN266200400031C
2. HHSN266200400032C
3. HHSN266200300039C
4. HHSN266200400045C
5. HHSN266200205459C
6. HHSN266200205460C
7. HHSN266200205461C
8. HHSN266200205462C
9. HHSN266200205463C
10. HHSN266200205464C
11. HHSN266200205465C
12. HHSN266199905357C
13. HHSN266200300068C
14. HHSN266200005413C
15. HHSO100200600021C (formerly 200200409981)
16. HHSO100200500004C
17. HHSO100200500005I
18. HHSO100200700026I
19. HHSO100200700027I
20. HHSO100200700028I
21. HHSO100200600010C
22. HHSO100200600011C
23. HHSO100200600012C
24. HHSO100200600013C
25. HHSO100200600014C
26. HHSO100200600022C (formerly 200200511758)
27. HHSO100200600023C (formerly 200200410431)
28. CRADA No. AI-0155 NIAID/MedImmune
29. HHSO100200700029C
30. HHSO100200700030C
31. HHSO100200700031C
[FR Doc. E9-14948 Filed 6-24-09; 8:45 am]
BILLING CODE 4150-37-P