2010-19861. 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.

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 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 [phone] or [e-mail].

Dated: August 3, 2010.

Nicole Lurie,

Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services.