[Federal Register Volume 74, Number 117 (Friday, June 19, 2009)]
[Notices]
[Pages 29213-29214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Pandemic Influenza Antivirals--Amendment

AGENCY: Department of Health and Human Services, Office of the 
Secretary.
    Subject: Pandemic Influenza Antivirals--Amendment.

    Authority:  42 U.S.C. 247d-6d.

ACTION: Notice of amendment (to the October 10, 2008 Declaration under 
the Public Readiness and Emergency Preparedness Act).

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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 April 26 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.

DATES: This notice and the attached amendment are effective as of April 
26, 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).

[[Page 29214]]

HHS Secretary's Amendment to the Declaration for the Use of the Public 
Readiness and Emergency Preparedness Act for the Influenza Antivirals 
Oseltamivir Phosphate (Tamiflu[supreg]) and Zanamivir (Relenza[supreg]) 
Dated October 10, 2008

    Whereas the October 10, 2008 declaration for Oseltamivir Phosphate 
(Tamiflu([supreg])) and Zanamivir (Relenza[supreg]) (``Original 
Declaration'') applies to administration of the aforementioned covered 
countermeasures to address the threat of or actual human influenza that 
results from the infection of humans with highly pathogenic avian 
influenza A viruses or other highly pathogenic influenza viruses 
causing a pandemic following exposure to the viruses;
    Whereas the current detection of H1N1 swine flu in Mexico and the 
United States may have the potential to evolve into an influenza strain 
capable of causing a pandemic of human influenza;
    Whereas the aforementioned covered countermeasures may be effective 
to protect persons from either the threat of H1N1 swine influenza, or 
to treat persons with H1N1 swine influenza;
    Whereas the findings made by the Secretary in the Original 
Declaration continue to apply generally, and apply with equal force as 
to swine 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 or approval, and use of 
additional covered countermeasures with respect to the category of 
disease in section II 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 or 
approval, and use of medical countermeasures with respect to the 
category of disease described in section II 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 that the risk that the spread of H1N1 swine influenza 
viruses and resulting disease constitutes a public health emergency. In 
order to clarify that the Original Declaration applies to H1N1 swine 
flu influenza, as well as other influenza strains which originate from 
animals and which have pandemic potential, the Original Declaration, is 
hereby amended as follows:
    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, health condition, or threat to health for 
which I am recommending the administration or use of the Covered 
Countermeasures is the threat of or actual human influenza that results 
from the infection of humans with highly pathogenic avian H5N1 
influenza A viruses or other animal influenza A viruses (including, but 
not limited to, H1N1 swine influenza) that are, or may be capable of 
developing into, a pandemic strain.
    In section VIII, strike the section in its entirety and replace it 
with the following: ``This Declaration has been amended. The Original 
Declaration was published in the Federal Register at 73 FR 61861. This 
is the first 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.

    Dated: June 11, 2009.
Kathleen Sebelius,
Secretary.
[FR Doc. E9-14412 Filed 6-18-09; 8:45 am]
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