BCG VACCINE

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. 2. This solicitation is a request for quotations (RFQ) 2020-SS88. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-07. 3. This is a combined synopsis/solicitation for BGC Vaccine. The government intends to award a firm-fixed price purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. This procurement is set-aside for small business only. The associated North American Industrial Classification System (NAICS) code for this procurement is 325414 with a small business size standard of 1250 emp 4. Supplies Required APHIS Ames intends to make a one-time purchase for BCG vaccine. 5. Product Specifications General Statement of Work (SOW) for the USDA APHIS VS BCG vaccine production 1.0 General 1.1 Background The mission of the USDA-VS NVSL is to provide diagnostic testing and reagents for program diseases including bovine tuberculosis. The bacille Calmette-Guerin (BCG) vaccine requested will be used to evaluate the vaccine performance in dairy cattle and deer for potential use in the TB eradication program. 1.2 Objective Produce a master seed that will meet CVB production standards for vaccine approval, using a supplied isolate. Then produce 10,000 doses of non-lyophilized vaccine for parenteral injection in cattle and 5,000 doses of lyophilized cake for oral use in deer. The company will be expected to maintain the master seed for an additional 5 years for future vaccine production requests. 1.3 Scope of Work The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work. The Contractor shall assure that the material conforms to the specifications in the contract prior to delivery. Upon delivery, at destination, the Government reserves the right to reject any or all parts of a shipment, if in the opinion of the Government, does not meet the requirements contained herein. SPECIFICATIONS FOR USDA APHIS VS BCG vaccine The National Veterinary Services Laboratories will provide a pure isolate of BCG for use. A master seed must be produced according to CVB specifications for future approval. This master seed must be shared back to NVSL for distribution to Mexico. Initially 10,000 doses for parenteral injection must be produced containing 106 viable CFU/dose. The vaccine may be either 1 or 2 mL dose aliquots and be prepared in 5 multidose vials. Lyophilization is not required. For the oral deer vaccine, 5,000 doses of lyophilized cake containing 108 CFU/dose will be required in 5 dose vials. The master seed must be maintained for at least 5 years. Deer and cattle vaccine products may be fulfilled and delivered separately. 6. Delivery FOB destination to: to USDA, APHIS AMES IA 50010 Delivery within 30-60 days delivery ARO. Schedule 10,000 doses of non-lyophilized vaccine for parenteral injection in cattle 5 dose vials quantity Ea $ 5,000 doses of lyophilized cake for oral use in deer 5 dose vials quantity EA $