[Federal Register: November 30, 2007 (Volume 72, Number 230)]
[Notices]               
[Page 67731-67732]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30no07-55]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

 
Amendment to January 26, 2007 Declaration Under the Public 
Readiness and Emergency Preparedness Act

AGENCY: Office of the Assistant Secretary for Preparedness and Response 
(ASPR), HHS.

ACTION: Amendment (to the January 26, 2007 Declaration under the Public 
Readiness and Emergency Preparedness Act).

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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.
    Amendment: Whereas, the H7 and H9 subtypes of avian influenza 
viruses are viewed as likely candidates to evolve into an influenza 
virus strain capable of causing a pandemic of human influenza; and
    Whereas, in accordance with section 319F-3(b)(6) of the Public 
Health Service Act (42 U.S.C. 247d-6d(b)) (``the Act''), I have 
considered the desirability of encouraging 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 these additional medical countermeasures with 
respect to the category of diseases and population described in 
sections II and IV of the declaration published in Federal Register on 
February 1, 2007 (72 FR 4710) (``the Original Declaration'');
    Therefore, pursuant to section 319F-3(b) of the Act, I have 
determined there is a credible risk that the spread of the H7 and H9 
subtypes of avian influenza viruses and resulting disease could in the 
future constitute a public health emergency. In order to reflect the 
addition of medical countermeasures specific to the H7 and H9 subtypes 
of influenza viruses, the Original Declaration is hereby amended as 
follows:
    First ``whereas'' clause, first sentence, insert ``H7 and H9 
vaccines'' following ``(H5N1).''
    Second ``whereas'' clause, first sentence, insert ``H7 and H9'' 
following ``H5N1'' to read ``Whereas an H5N1, [H7 and H9] avian 
influenza viruse[s] may evolve into strain[s] * * *.''
    In Section I, paragraph 2, first sentence insert ``H7 and H9'' 
following ``(H5N1)'' to read ``* * * pandemic countermeasure influenza 
A (H5N1, [H7 and H9]) vaccine[s].''
    In Section I, paragraph 2, third sentence insert ``H7 and H9'' 
following ``(H5N1)'' to read ``* * * pandemic countermeasure influenza 
A (H5N1, [H7 and H9]) vaccine[s] * * *.''
    In Section II, paragraph 1, insert ``or an H7 or H9'' following 
``(H5N1).''

[[Page 67732]]

    In Section VIII, strike the sentence ``This Declaration has not 
previously been amended.'' and replace it with: ``This is the first 
amendment to this Declaration. The Original Declaration was published 
in the Federal Register at 72 FR 4710.''
    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.

DATES: This notice and the attached declaration are effective November 
30, 2007.

FOR FURTHER INFORMATION CONTACT: RADM W. Craig Vanderwage, MD, 
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).

    Dated: November 21, 2007.
Michael O. Leavitt,
Secretary.
[FR Doc. 07-5884 Filed 11-29-07; 8:45 am]

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