[Federal Register: June 19, 2009 (Volume 74, Number 117)]
[Notices]
[Page 29213-29214]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jn09-82]
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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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