Pandemic Influenza Vaccine-Amendment, 61871-61873 [E8-24736]
Download as PDF
<![CDATA[
61871
Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices
VIII. Amendments
This declaration has not previously
been amended. Any future amendment
to this declaration will be published in
the Federal Register, pursuant to
section 319F–3(b)(4) of the Act.
IX. Definitions
For the purpose of this declaration,
including any claim for loss brought in
accordance with section 319F–3 of the
PHS Act against any covered persons
defined in the Act or this declaration,
the following definitions will be used:
Administration of a Covered
Countermeasure: As used in Section
319F–3(a)(2)(B) of the Act, includes, but
is not limited to, public and private
delivery, distribution, and dispensing
activities relating to physical
administration of the Covered
Countermeasures to patients/recipients,
management and operation of delivery
systems, and management and operation
of distribution and dispensing locations.
Authority Having Jurisdiction: The
public agency or its delegate that has
legal responsibility and authority for
responding to an incident, based on
political or geographical (e.g., city,
county, tribal, State, or Federal
boundary lines) or functional (e.g., law
enforcement, public health) range or
sphere of authority.
Covered Persons: As defined at
section 319F–3(i)(2) of the Act, include
the United States, manufacturers,
distributors, program planners, and
qualified persons. The terms
‘‘manufacturer,’’ ‘‘distributor,’’
‘‘program planner,’’ and ‘‘qualified
person’’ are further defined at sections
319F–3(i)(3), (4), (6), and (8) of the Act.
Declaration of an 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 smallpox
countermeasures, with the exception of
a Federal declaration in support of an
emergency use authorization under
section 564 of the Federal Food, Drug,
and Cosmetic Act (FDCA) unless such
declaration specifies otherwise.
Smallpox Countermeasure: Any
vaccine; antiviral, other drug; or
diagnostic or device to identify, prevent
or treat smallpox or orthopoxvirus or
adverse events from such
countermeasures (1) Licensed under
section 351 of the Public Health Service
Act; (2) approved under section 505 or
section 515 of the FDCA; (3) cleared
under section 510(k) of the FDCA; (4)
authorized for emergency use under
section 564 of the FDCA; (5) used under
section 505(i) of the FDCA or section
351(a)(3) of the PHS Act, and 21 CFR
Part 312; or (6) used under section
520(g) of the FDCA and 21 CFR part
812.
This 10th day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Appendix I
List of U.S. Government Contract
Contract
Manufacturer
Product
HHSO100200700034C .............................
200–2002–00425 ......................................
200–2002–00357 ......................................
200–2002–00004 ......................................
200–2008–24959 ......................................
797BPA0003 .............................................
Bavarian Nordic ......................................
Aventis Pasteur .......................................
Cangene ..................................................
Acambis ..................................................
Acambis ..................................................
Gilead ......................................................
MVA ........................................................
WetVax ....................................................
VIG ..........................................................
ACAM 2000 .............................................
ACAM 2000 warm-base ..........................
Cidofovir ..................................................
Pub. L. 85–
804 coverage*
No.
Yes.
Yes.
Yes.
No.
No.
* Status of indemnification coverage under Pub. L. 85–804 (An Act to authorize the making, amendment and modification of contracts to facilitate the national defense.)
[FR Doc. E8–24737 Filed 10–14–08; 4:15 pm]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Pandemic Influenza Vaccine—
Amendment
October 10, 2008.
Office of the Secretary (OS),
Department of Health and Human
Services (HHS).
AGENCY:
Notice of amendment (to the
January 26, 2007 Declaration under the
Public Readiness and Emergency
Preparedness Act, as amended on
February 1, 2007).
ACTION:
Declaration pursuant to
section 319F–3 of the Public Health
Service Act (42 U.S.C. 247d–6d) to
provide targeted liability protections for
pandemic countermeasures based on a
credible risk that avian influenza
viruses spread and evolve into strains
sroberts on PROD1PC70 with NOTICES
SUMMARY:
VerDate Aug<31>2005
19:18 Oct 16, 2008
Jkt 217001
capable of causing a pandemic of
human influenza.
DATES: This notice and the attached
amendment are effective as of the date
of signature of the declaration.
FOR FURTHER INFORMATION CONTACT:
RADM W.C. Vanderwagen, Assistant
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue,
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll-free
number).
HHS Secretary’s Amendment to the
H5N1 Declaration for the Use of the
Public Readiness and Emergency
Preparedness Act Dated January 26,
2007
Whereas the January 26, 2007
declaration for H5N1 vaccine (‘‘Original
Declaration’’) was amended on February
1, 2007 to add H7 and H9 vaccines and
additional, minor modifications to that
amendment are necessary to ensure
internal, editorial consistency of the
Original Declaration, as amended.
PO 00000
Frm 00095
Fmt 4703
Sfmt 4703
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 the possibility of
governmental program planners
obtaining stockpiles from private sector
entities except through voluntary means
such as commercial sale, donation, or
deployment would undermine national
preparedness efforts and should be
discouraged as provided for in section
319F–3(b)(2)(E) of the Public Health
Service Act (42 U.S.C. 247d–6d(b)) (‘‘the
Act’’);
Whereas immunity under section
319F–3(a) of the Act should be available
to governmental program planners for
distributions of Covered
E:\FR\FM\17OCN1.SGM
17OCN1
sroberts on PROD1PC70 with NOTICES
61872
Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices
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 (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
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 section II and IV of the
Original Declaration, as 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 such
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 there
is a credible risk that the spread of the
H2 and H6 subtypes of avian influenza
viruses and resulting disease could in
the future constitute a public health
emergency. In order to: (1) Reflect the
addition of medical countermeasures
specific to the H2 and H6 subtypes of
influenza viruses; (2) specify the means
of distribution pursuant to section
319F–3(b)(2)(E) of the Act for which
immunity specified in section 319F–3(a)
VerDate Aug<31>2005
19:18 Oct 16, 2008
Jkt 217001
of the Act shall be in effect; (3) clarify
the applicability of immunity for
covered persons and qualified persons
as those terms are defined in the Act
and provided for in the Original
Declaration, as amended; and (4) ensure
internal, editorial consistency in the
Original Declaration arising from the
February 1, 2007 amendment, the
Original Declaration, as amended, is
hereby further amended as follows:
In the title, insert ‘‘H2, H6, H7 and
H9’’ after ‘‘H5N1’’ and replace
‘‘Vaccine’’ with ‘‘Vaccines’’ to read:
‘‘HHS Secretary’s Declaration for the
Use of the Public Readiness and
Emergency Preparedness Act for H5N1,
H2, H6, H7 and H9 Vaccines’’.
In the second Whereas clause, insert
‘‘H2, H6, H7 or H9’’ after ‘‘H5N1’’,
replace ‘‘viruses’’ with ‘‘virus’’, and
replace ‘‘strains’’ with ‘‘strain’’ to read:
‘‘Whereas an H5N1, H2, H6, H7 or H9
avian influenza virus * * *’’.
Insert the following Whereas clauses
after the first Whereas clause:
‘‘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;’’
Insert the following Whereas clauses
after the second Whereas clause:
‘‘Whereas, the possibility of
governmental program planners
obtaining stockpiles from private sector
entities except through voluntary means
such as commercial sale, donation, or
deployment would undermine national
preparedness efforts and should be
discouraged as provided for in section
319F–3(b)(2)(E) of the Public Health
Service Act (42 U.S.C. 247d–6d(b)) (‘‘the
Act’’);
Whereas, immunity under section
319F–3(a) of the Act should be available
to governmental program planners for
distributions of Covered
Countermeasures obtained voluntarily,
such as by (1) donation; (2) commercial
sale; (3) deployment of Covered
Countermeasures from Federal
stockpiles; or (4) deployment of
donated, purchased, or otherwise
voluntarily obtained Covered
Countermeasures from State, local, or
private stockpiles;
Whereas, the extent of immunity
under section 319F–3(a) of the Act
PO 00000
Frm 00096
Fmt 4703
Sfmt 4703
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 of the
Original Declaration, as 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 such
other qualified persons as I have
identified in section VI of the Original
Declaration, as amended;’’
In Section I, strike the entire section
and replace it with the following:
‘‘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 of the Original
Declaration, the administration and
usage of the pandemic countermeasure
influenza A (H5N1) vaccine and H2, H6,
H7, and H9 vaccines. 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)
vaccine and H2, H6, H7 and H9
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
E:\FR\FM\17OCN1.SGM
17OCN1
61873
Federal Register / Vol. 73, No. 202 / Friday, October 17, 2008 / Notices
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.’’
In Section II, insert ‘‘H2, H6, H7 or
H9’’ following ‘‘H5N1.’’ to read ‘‘* * *
highly pathogenic avian influenza A
(H5N1, H2, H6, H7 or H9) virus * * *’’.
In Section VIII, strike the section in its
entirety and replace it with the
following: ‘‘This Declaration has been
amended twice. The Original
Declaration was published in the
Federal Register at 72 FR 4710. The first
amendment to the Original Declaration
was published in the Federal Register at
72 FR 67731. This is the second
amendment to the Original Declaration.
Any future amendment to this
Contract
Manufacturer
HHSN266200700005C ............................
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH–063–A]
Fire Fighter Fatality Investigation and
Prevention Program (FFFIPP)
Stakeholders’ Meeting
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of Public Meeting and
availability for Public Comment.
sroberts on PROD1PC70 with NOTICES
AGENCY:
SUMMARY: The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC)
announces the following meeting and
request for public comment on the Fire
Fighter Fatality Investigation and
Prevention Program (FFFIPP).
Public Meeting Time and Date: 10
a.m.–5 p.m., CST, November 19, 2008.
Place: Crowne Plaza Hotel, Chicago
O’Hare, 5440 North River Road,
Rosemont, Illinois 66018.
Purpose of Meeting: The public
meeting will seek stakeholder input on
the progress and strategic goals of the
NIOSH Fire Fighter Fatality
Investigation and Prevention Program
(FFFIPP) to ensure that the program is
meeting the needs of the stakeholders,
and to identify ways in which the
program can be improved to increase its
impact on the safety and health of fire
VerDate Aug<31>2005
19:18 Oct 16, 2008
Jkt 217001
Frm 00097
Fmt 4703
Appendix I
List of U.S. Government Contracts
H5N1, H2, H6, H7, H9 ..........................
fighters across the United States. NIOSH
will compile and consider all comments
received at the meeting and through the
NIOSH Docket Office and use them in
making decisions on how to proceed
with the FFFIPP.
Status: This meeting is hosted by
NIOSH and will be open to the public,
limited only by the space available. The
meeting room will accommodate
approximately 75 people.
Interested parties should make hotel
reservations directly with the Crowne
Plaza Hotel, telephone (847) 671–6350
or (800) 972–2494 and reference the
NIOSH FFFIPP Stakeholders Meeting.
Interested parties should confirm their
attendance to this meeting by
completing a registration form on the
NIOSH Web site: https://www.cdc.gov/
niosh/fire/
2008PublicMeetingRegistration.html
Format of Meeting: The NIOSH Acting
Director, Dr. Christine Branche, will
provide opening remarks, followed by
NIOSH presentations that provide an
overview of the Fire Fighter Fatality
Investigation and Prevention Program
(FFFIPP) and summary of Program
changes and improvements since March
2006. NIOSH will present and make
available for stakeholder input a set of
draft Strategic Goals for FFFIPP for
stakeholder consideration and
comment. Stakeholders who have
requested an opportunity to speak prior
to the meeting will present suggestions
for enhancing the impact of the program
and future directions. An opportunity to
make oral presentations will be
provided to all interested parties, given
time on the agenda. Presentations will
be limited to 10 minutes. The meeting
will end with an interactive session
providing the opportunity for
clarification of stakeholder comments.
PO 00000
This 10th day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Covered countermeasure
St. Jude Children’s Research Hospital
[FR Doc. E8–24736 Filed 10–14–08; 4:15 pm]
Declaration will be published in the
Federal Register, pursuant to section
319F–3(b)(4) of the Act.’’
All other provisions of the Original
declaration remain in full force.
This amendment to the Declaration
will be published in the Federal
Register, pursuant to section 319F–
3(b)(4) of the Act.
Sfmt 4703
Pub. L. 85–804
Coverage*
No.
Requests to make presentations at the
meeting should be made by e-mail to
Paul Moore, Chief, Fatality
Investigations Team, e-mail
PMoore@cdc.gov, telephone (304) 285–
6016 or Matt Bowyer, General Engineer,
e-mail MBowyer@cdc.gov, telephone
(304) 285–5991, facsimile (304) 285–
5774, before November 10, 2008. All
requests to present should include the
name, address, telephone number,
relevant business affiliations of the
presenter, and a brief summary of the
presentation. After reviewing the
requests for presentation, NIOSH
FFFIPP staff will notify each presenter
of the approximate time that their
presentation is scheduled to begin. If a
participant is not present when their
presentation is scheduled to begin, the
remaining participants will be heard in
order.
Written comments without an oral
presentation are also encouraged, and
should be submitted to the NIOSH
Docket Office as outlined in the next
section.
Written comments on the usefulness
of the FFFIPP and products for
improving fire fighter safety and health,
suggestions for enhancing the impact of
the program, and comments on the draft
FFFIPP strategic and programmatic
goals may be submitted to the NIOSH
Docket Office, Robert A. Taft
Laboratories, Mailstop C34, 4676
Columbia Parkway, Cincinnati, Ohio
45226, telephone (513) 533–8303,
facsimile (513) 533–8285. Comments
may also be submitted via e-mail to
niocindocket@cdc.gov. All electronic
comments should be formatted as
Microsoft Word. Comments should be
submitted to NIOSH no later than
December 19, 2008, and should
E:\FR\FM\17OCN1.SGM
17OCN1
]]>Agencies
[Federal Register Volume 73, Number 202 (Friday, October 17, 2008)]
[Notices]
[Pages 61871-61873]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24736]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Pandemic Influenza Vaccine--Amendment
October 10, 2008.
AGENCY: Office of the Secretary (OS), Department of Health and Human
Services (HHS).
ACTION: Notice of amendment (to the January 26, 2007 Declaration under
the Public Readiness and Emergency Preparedness Act, as amended on
February 1, 2007).
-----------------------------------------------------------------------
SUMMARY: Declaration pursuant to section 319F-3 of the Public Health
Service Act (42 U.S.C. 247d-6d) to provide targeted liability
protections for pandemic countermeasures based on a credible risk that
avian influenza viruses spread and evolve into strains capable of
causing a pandemic of human influenza.
DATES: This notice and the attached amendment are effective as of the
date of signature of the declaration.
FOR FURTHER INFORMATION CONTACT: RADM W.C. Vanderwagen, Assistant
Secretary for Preparedness and Response, Office of the Secretary,
Department of Health and Human Services, 200 Independence Avenue, SW.,
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free
number).
HHS Secretary's Amendment to the H5N1 Declaration for the Use of the
Public Readiness and Emergency Preparedness Act Dated January 26, 2007
Whereas the January 26, 2007 declaration for H5N1 vaccine
(``Original Declaration'') was amended on February 1, 2007 to add H7
and H9 vaccines and additional, minor modifications to that amendment
are necessary to ensure internal, editorial consistency of the Original
Declaration, as amended.
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 the possibility of governmental program planners obtaining
stockpiles from private sector entities except through voluntary means
such as commercial sale, donation, or deployment would undermine
national preparedness efforts and should be discouraged as provided for
in section 319F-3(b)(2)(E) of the Public Health Service Act (42 U.S.C.
247d-6d(b)) (``the Act'');
Whereas immunity under section 319F-3(a) of the Act should be
available to governmental program planners for distributions of Covered
[[Page 61872]]
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 (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 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 section II and IV of the Original Declaration,
as 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 such 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 there is a credible risk that the spread of the H2 and H6
subtypes of avian influenza viruses and resulting disease could in the
future constitute a public health emergency. In order to: (1) Reflect
the addition of medical countermeasures specific to the H2 and H6
subtypes of influenza viruses; (2) specify the means of distribution
pursuant to section 319F-3(b)(2)(E) of the Act for which immunity
specified in section 319F-3(a) of the Act shall be in effect; (3)
clarify the applicability of immunity for covered persons and qualified
persons as those terms are defined in the Act and provided for in the
Original Declaration, as amended; and (4) ensure internal, editorial
consistency in the Original Declaration arising from the February 1,
2007 amendment, the Original Declaration, as amended, is hereby further
amended as follows:
In the title, insert ``H2, H6, H7 and H9'' after ``H5N1'' and
replace ``Vaccine'' with ``Vaccines'' to read: ``HHS Secretary's
Declaration for the Use of the Public Readiness and Emergency
Preparedness Act for H5N1, H2, H6, H7 and H9 Vaccines''.
In the second Whereas clause, insert ``H2, H6, H7 or H9'' after
``H5N1'', replace ``viruses'' with ``virus'', and replace ``strains''
with ``strain'' to read: ``Whereas an H5N1, H2, H6, H7 or H9 avian
influenza virus * * *''.
Insert the following Whereas clauses after the first Whereas
clause:
``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;''
Insert the following Whereas clauses after the second Whereas
clause:
``Whereas, the possibility of governmental program planners
obtaining stockpiles from private sector entities except through
voluntary means such as commercial sale, donation, or deployment would
undermine national preparedness efforts and should be discouraged as
provided for in section 319F-3(b)(2)(E) of the Public Health Service
Act (42 U.S.C. 247d-6d(b)) (``the Act'');
Whereas, immunity under section 319F-3(a) of the Act should be
available to governmental program planners for distributions of Covered
Countermeasures obtained voluntarily, such as by (1) donation; (2)
commercial sale; (3) deployment of Covered Countermeasures from Federal
stockpiles; or (4) deployment of donated, purchased, or otherwise
voluntarily obtained Covered Countermeasures from State, local, or
private stockpiles;
Whereas, the extent of immunity under section 319F-3(a) of the Act
afforded to a governmental program planner that obtains Covered
Countermeasures except through voluntary means is not intended to
affect the extent of immunity afforded other covered persons with
respect to such covered countermeasures;
Whereas 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 of the Original Declaration,
as 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 such other qualified persons as I have
identified in section VI of the Original Declaration, as amended;''
In Section I, strike the entire section and replace it with the
following:
``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 of the Original
Declaration, the administration and usage of the pandemic
countermeasure influenza A (H5N1) vaccine and H2, H6, H7, and H9
vaccines. 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) vaccine
and H2, H6, H7 and H9 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
[[Page 61873]]
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.''
In Section II, insert ``H2, H6, H7 or H9'' following ``H5N1.'' to
read ``* * * highly pathogenic avian influenza A (H5N1, H2, H6, H7 or
H9) virus * * *''.
In Section VIII, strike the section in its entirety and replace it
with the following: ``This Declaration has been amended twice. The
Original Declaration was published in the Federal Register at 72 FR
4710. The first amendment to the Original Declaration was published in
the Federal Register at 72 FR 67731. This is the second amendment to
the Original Declaration. Any future amendment to this Declaration will
be published in the Federal Register, pursuant to section 319F-3(b)(4)
of the Act.''
All other provisions of the Original declaration remain in full
force.
This amendment to the Declaration will be published in the Federal
Register, pursuant to section 319F-3(b)(4) of the Act.
This 10th day of October, 2008.
Michael O. Leavitt,
Secretary of Health and Human Services.
Appendix I
List of U.S. Government Contracts
----------------------------------------------------------------------------------------------------------------
Contract Manufacturer Covered countermeasure Pub. L. 85-804 Coverage*
----------------------------------------------------------------------------------------------------------------
HHSN266200700005C................ St. Jude Children's H5N1, H2, H6, H7, H9.... No.
Research Hospital.
----------------------------------------------------------------------------------------------------------------
[FR Doc. E8-24736 Filed 10-14-08; 4:15 pm]
BILLING CODE 4150-37-P
