[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48691-48692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Single Source Cooperative Agreement Award for the World Health 
Organization (WHO) To Continue Development of Sustainable Influenza 
Vaccine Production

AGENCY: Department of Health and Human Services, Assistant Secretary 
for Preparedness and Response, Biomedical Advanced Research Development 
Authority

ACTION: Notice.

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SUMMARY: Notification of Single Source Cooperative Agreement Award for 
the World Health Organization (WHO) To Continue Development of 
Sustainable Influenza Vaccine Production Capacity in Under-Resourced 
Nations CFDA: 93.360.

    Statutory Authority:  Section 319L of the Public Health Service 
(PHS) Act, 42 U.S.C. 247d-7e as amended by Title IV of the Pandemic 
and All-Hazards Preparedness Act (PAHPA), Pub. L. 109-417; and the 
Consolidated Appropriations Act, 2010, Pub. L. 111-117.

    Amount of Single Source Award: $6,400,000.
    Project Period: September 30, 2010 through September 29, 2013.
    In FY 2010, BARDA plans to provide a Single Source Continuation 
Award to the World Health Organization to support the International 
Vaccine Production Capacity-Building Program. BARDA currently funds the 
development of vaccine manufacturing capacity in ten developing and 
emerging-economy countries worldwide via a cooperative agreement with 
the World Health Organization (WHO). The WHO has proven to be a key 
partner and integral to the success of the program, which has been in 
existence since 2006. Continuing the partnership with the WHO will 
prove critical to the long-term viability of this program while 
bolstering the influenza vaccine manufacturing capabilities of resource 
poor nations and global pandemic preparedness overall.
    Single Source Justification: The International Vaccine Capacity 
Building Program, supported by the Department of Health and Human 
Services, Assistant Secretary for Preparedness and Response, Biomedical 
Advanced Research and Development Authority was developed and has been 
operational since 2006. In light of the threat of an influenza pandemic 
it was originally designed with the goals of bolstering both 
international and domestic pandemic preparedness and response. The 
fundamental approach in achieving these goals has been through the 
development of the influenza vaccine production capabilities of under 
resourced nations in the hopes that they will ultimately be able to 
produce vaccines to protect the local, regional, and international 
public health. The program is supported by a collaborative of U.S. 
Government agencies, international organizations, foreign ministries 
and/or other foreign institutions dedicated to achieving these goals.
    The WHO is the only global organization with the experience and 
scientific standing to accomplish the program goals. It is the 
recognized world health authority within the United Nations system. 
Similarly, the liaison and support functions that the WHO plays within 
the international vaccine production capacity building program cannot 
be duplicated or replicated. Through standing consultation and dialog 
with its members states on all aspects of public health, WHO is the 
only partner able to ensure synchronization of building of production 
capacity in developing countries for influenza vaccine with other 
pandemic preparedness activities and with increase of demand for 
seasonal influenza immunization.
    The WHO's strong collaborative relationships with foreign 
governments, programmatic support, and familiarity with international 
vaccine production institutions have been and will be critical to the 
future viability of this program. Over the history of the International 
Vaccine Production Capacity Building program, the WHO has provided 
unique and invaluable support to the project. Similarly, the WHO has 
also independently funded other nations/institutions working to 
strengthen their influenza vaccine production capacity; also 
demonstrating

[[Page 48692]]

their commitment to the success of this program. The WHO represents a 
key stakeholder in the implementation of the program; providing unique 
functions, technical and scientific expertise, and capabilities that no 
other organization in the world has.
    Additional Information: The agency program contact is Dr. Michael 
Perdue, whom can be contacted at (202) 260-0966 or 
[email protected].

    Dated: August 3, 2010.
Nicole Lurie,
Assistant Secretary for Preparedness and Response, U.S. Department of 
Health and Human Services.
[FR Doc. 2010-19861 Filed 8-10-10; 8:45 am]
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