RELENZA VACCINE

This proposed contract action is for Relenza Vaccine for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1. This is a sole source requirement that is proprietary to Glaxosmithkline LLC. No other supplies or services have been identified that will satisfy the government's needs The agency's minimum requirements are This is a requirement of the USDA-APHIS,NVS Pogram Office at Kansas City Missouri. The NVS seeks the purchase 2520 packages of the Zanamivir Inhalation Powder (Relenza) for treating or prevent the spread of flu virus. The Contractor shall deliver units to storage sites located in Jessup, MD and Dulles, VA. The specific addresses will be provided prior to delivery. SCOPE. This specification covers the requirement of Zanamivir for Inhalation. The product is indicated for treatment of uncomplicated acute illness due to influenza A and B virus. The following specification summarizes this procurement requirement: Dosage Forms and Strengths: - Each RELENZA ROTADISK contains 4 regularly spaced double-foil blisters with each blister containing a powder mixture of 5 mg of zanamivir and 20 mg of lactose. - Blister for oral inhalation: 5 mg. Four 5-mg blisters of powder on a ROTADISK for oral inhalation via DISKHALER. Packaged in carton containing 5 ROTADISKs (total of 10 doses) and 1 DISKHALER inhalation device - Packaged in carton containing 5 ROTADISKs (total of 10 doses) and 1 DISKHALER inhalation device. - Each foil pack must be clearly marked with the manufacturer's product Identification code. Provide price quote for an order of 2,520 packages SALIENT CHARACTERISTICS - Shall be a powder mixture of 5 mg of Zanamivir and 20mg of Lactose. Other Requirements Shelf Life: Shall have a shelf life of 84 months. Not less than 78 months of the expiration dating period shall remain at time of delivery to the Government. Shelf-life Rotation/Extension: The Contractor shall provide a proposal and cost estimate to rotate and replace any or all of the stock with fresh product 1 year before shelf-life expirers. Provide any capability and proposed cost to test and extend shelf-life including relabeling of product. PREPARATION FOR DELIVERY Preservation. Preservation shall be commercial. Each unit, as specified shall be supplied in a suitable sealed commercial container. Packing. Packing shall be commercial. Exterior (shipping) container shall contain one unit Unitization. Material shall be unitized on 4-way entry pallets. Packing list. Packing list shall be supplied as specified in Medical Marking Standard No. 1C. Labeling and Marking. Marking requirements per Medical material Exterior and Unitized Load shall include National Stock Number (NSN), expiration date, NDC, lot, (control) number and legends "Store at 25oC (77oF); excursions permitted to 15o to 30oC (59o to 86oF) (see USP Controlled Room Temperature), or similar commercial legends. Shelf-Life Markings. Shelf life markings may include the expiration date, date of manufacture, inspection/test date, This notice of intent is not a request for competitive proposals. A determination by the Government not to compete this proposed contract action is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether it will become necessary to conduct a competitive procurement.