Foot and Mouth Disease (FMD) and Rift Valley Fever (RVF) Vaccine Production

The Department of Homeland Security, Science and Technology Directorate, intends to award one contract for FMD and RVF vaccine production using FAR Part 15 RFP procedures. A written solicitation will be issued. This will be a full and open competition, and DHS shall consider all proposals submitted by responsible sources. The anticipated award date is August, 2009. Description of Work: Pursuant to Homeland Security Presidential Directive-9 (HSPD-9), the Secretary of Homeland Security is responsible for coordinating the overall national effort to enhance the protection of the critical infrastructure and key resources of the United States. This includes the defense of agriculture and food. Under HSPD-9, DHS is tasked with accelerating and enhancing the development of countermeasures - including vaccines - for Foreign Animal Diseases (FADs). HSPD-9 also recognized the need for a federal stockpile and mandated the creation of the National Veterinary Stockpile. This effort is to support the development and production of Foot and Mouth Disease (FMD) and Rift Valley Fever (RVF) vaccines for the National Veterinary Stockpile. Specifically, the Contractor will be required to: (a) Produce master seeds (MS) for replication, deficient, human adenovirus serotype 5 vectored FMD (AdFMD) vaccines master seed cell lines (MSC) for FMD and RVF vaccines; (b) Produce pre-licensing serials (PLS) for AdFMD vaccines; (c) Develop AdFMD vaccine process improvement and yield optimization methods to decrease cost of goods of AdFMD vaccines; (d) Develop in vitro relative potency release assays for AdFMD vaccines; (e) Provide regulatory services, including management of clinical studies, to enable submission of a CVB product license applications for several AdFMD vaccine; and (f) Produce MS and master seed cell line (MSC) for rationally designed marker RVF vaccines. Only entities that have or are capable of obtaining a U.S. Veterinary Biologics Establishment License (see (CFR 102.3(a)) will be eligible for the award of this contract. Performance under this contract will occur at the Contractor's place of business. Deliveries, including the master seeds, cell lines, and proof of regulatory compliance, are to be shipped to a TBD DHS address. It is anticipated that this will be a 4 year effort, with a 1 year base period and 3 one year option periods.