PERMITTEE

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), National Animal Health Policy, Riverdale, MD, intends to issue a sole source purchase order for Permittee services with Transboundary Animal Biologics (TABI) for the USDA Permit 428A for distribution and sale of foot and mouth disease virus, killed virus (FMDV-KV) from the approved and inspected foreign manufacturing facility, Biogenesis-Bago, Argentina.. The 9 CFR 104.2 defines a Permittee as a person who resides in the United States or operates a business establishment in the United States to whom a permit to import biological products has been issued. Without a Permittee vaccines cannot be imported for distribution and sale. The Permittee is the conduit of information submitted to and from the USDA and the foreign manufacturer. Other than approved labels, all submissions and correspondence related to Permittee 428A are considered confidential business. As a result, without the foreign manufacturer approving the Permittee, it's unlikely the product permitting process can function. The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. This notice of intent is not a request for competitive proposals. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government.