[Federal Register Volume 73, Number 202 (Friday, October 17, 2008)]
[Notices]
[Pages 61871-61873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24736]
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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).
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SUMMARY: Declaration pursuant to section 319F-3 of the Public Health
Service Act (42 U.S.C. 247d-6d) to provide targeted liability
protections for pandemic countermeasures based on 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
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Contract Manufacturer Covered countermeasure Pub. L. 85-804 Coverage*
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HHSN266200700005C................ St. Jude Children's H5N1, H2, H6, H7, H9.... No.
Research Hospital.
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[FR Doc. E8-24736 Filed 10-14-08; 4:15 pm]
BILLING CODE 4150-37-P