2011-22214. Supplement to the FY2010 Single-Source Cooperative Agreement With the World Health Organization (WHO)

AGENCY:

Biomedical Advanced Research Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

In FY 2011, HHS/ASPR/BARDA plans to supplement the FY2010 “Single-Source Cooperative Agreement with the World Health Organization (WHO) to Continue Development of Sustainable Influenza Vaccine Production Capacity in Under Resourced Nations”. 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 amount of Single Source Award is $6,021,535. The project period is September 1, 2011, through August 31, 2012.

SUPPLEMENTARY INFORMATION:

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, Office of the 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. Rick Bright, whom can be contacted at [phone] or [e-mail].

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.

Dated: August 25, 2011.

Nicole Lurie,

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