The Department of Health and Human Services has a requirement for the acquisition of avian influenza H5N1 vaccine for the Strategic National Stockpile (SNS). A key goal of the US Pandemic Preparedness Plan is to build sufficient stockpiles of pre-pandemic vaccine in order to immunize a 20 million member critical workforce prior to and at the onset of an influenza pandemic. As part of a pandemic vaccine stockpile preparedness measure, the objective of this solicitation is to continue establishment and maintenance of an active and evolving U.S. stockpile of H5N1 vaccine for usage at the time a pandemic is declared. Therefore HHS wishes at this time to obtain H5N1 vaccine manufactured during the open window for seasonal influenza vaccine manufacturing using the U.S.-licensed commercial scale manufacturing process and facilities for seasonal trivalent egg-based inactivated influenza vaccines and the H5N1 virus seed stock derived from the virus reassortant of avian influenza H5N1 virus strain from the WHO list of recommended vaccine strains. HHS shall designate the specific virus strains for production by the Contractors. The U. S. Department of Health and Human Services, through the Office of the Assistant Secretary for Preparedness and Response, contemplates single or multiple contract awards. Potential offerors must be able to manufacture an egg-based inactivated monovalent H5N1 vaccine at commercial scale using the same facilities, systems, equipment, and processes employed for their FDA-licensed seasonal trivalent influenza vaccine and using H5N1 virus reference strains prescribed by HHS. Bulk vaccines and bulk adjuvants shall be manufactured in the U.S. When an Offeror is going to use a manufacturing facility outside the U.S the bulk vaccine and adjuvant shall be shipped to the US as soon as the bulks are lot released and accepted. Formulation/fill/finish activities of vaccine and adjuvant shall be carried out in the U.S. The primary purpose of this Request for Proposal (RFP) is for the acquisition of bulk vaccine product (15 micrograms per dose) to be formulated and filled into multi-dose vials, based on the availability of funds. The minimum guarantee under this contract is 250,000 bulk antigen doses for the base year. Potential offerors must meet the following mandatory criteria: 1) hold an active U.S. license for seasonal inter-pandemic egg-based inactivated trivalent vaccine at the time of H5N1 vaccine bulk manufacturing); 2) successful experience in the bulk manufacturing of H5N1 vaccine at commercial scale using the licensed manufacturing process; and 3) bulk manufacturing facilities in compliance with current WHO biosafety guidelines for avian influenza vaccine manufacturing including BSL2+ enhanced biocontainment facilities and procedures. The contract will include a one-year base period with 2 one-year option periods. Additional details and requirements will be described in the solicitation. RFP-BARDA-08-25 will be available electronically through the FedBizOpps on or about July 30, 2008. Proposals will be due on or about August 28, 2008. The solicitation will utilize oral presentations for technical evaluation. Cost proposals and other required information must be submitted in written format (see solicitation for requirements). Any offeror who meet the mandatory requirements may submit a proposal that will be considered by the Government. This notice does not commit the Government to the award of a contract or contracts. This solicitation is being issued as full and open competition; however, small and small disadvantaged businesses are highly encouraged to participate in this acquisition. Please note on your solicitation request your business size status. Only written or email requests, directly from the requestor, for this solicitation will be accepted. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26. All responses should be identified with HHS-BARDA-08-25, name of firm, name of requestor, mailing address, telephone number, fax number, email address and should be submitted to the Contracting Office Address identified in this notice. Multiple awards may result from this solicitation with an estimated award date of on or about September 12, 2008.