[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

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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