Advanced Development of New Antiviral Agents against Influenza Virus

Preparedness for public health threats is a major goal of the U.S. Department of Health and Human Services (HHS). An influenza pandemic has a great potential to cause large numbers of deaths and illnesses over a short time period. A pandemic occurs when there is an antigenic shift in influenza A virus and transmission of a new strain to which most or all of the world's population is susceptible. Estimates for the next pandemic, extrapolating from those of the 20th century, range from about 100,000 to over 2 million deaths in the U.S. alone. Influenza antiviral drugs and influenza vaccines are considered a primary means to decrease the mortality and morbidity associated with the next pandemic. HHS is pursuing multiple and parallel strategies to close the gap between current antiviral drug and influenza vaccine supply and the HHS goal of stockpiling licensed and new antiviral drugs and pre-pandemic vaccines as part of the strategic plan for pandemic preparedness. The Department of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA) contemplates single or multiple awards of contracts to support advanced stage development of new antiviral agents for the treatment and prophylaxis of pandemic and seasonal influenza leading toward submission of a U.S. licensure application and development of required industrial capacity to support implementation of the influenza antivirals at full production capacity at or before the onset of a pandemic. HHS is particularly interested in the advanced development of new influenza antiviral agents designed to affect different targets of influenza virus infection or to enhance effects of present classes of influenza antiviral agents, formulated for long term stability, long bioavailability, and simple dosing regimens. The contract(s) resulting from this solicitation will be for advanced development, not acquisition. Incremental multi-year funding for cost-reimbursement contracts to biopharmaceutical companies will be provided to support this effort. The manufacturing site of antivirals may be in an FDA-approved U.S. facility or foreign manufacturing facility provided that the product can be stockpiled, has a shelf life that is consistent with long term pandemic preparedness, and where production capacity is sufficient for rapid fulfillment of U.S. pandemic stockpile needs at or before the onset of an influenza pandemic. Ultimately, these influenza antiviral agents shall be produced at one or more Food and Drug Administration (FDA)-approved manufacturing facilities and shall provide sufficient surge capacity to contribute substantially to U.S. and ideally global antiviral needs during an influenza pandemic. The anticipated period of performance will be for a total of up to 60 months. Additional details and requirements will be described in the solicitation. A Request for Proposal (RFP) will be available electronically through the FedBizOpps on or about October 4, 2008, with proposals being due on or about November 17, 2008. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to the award of a contract. It is the offeror's responsibility to monitor this internet site ( www.fbo.gov ) for the release of this solicitation as well as any amendments. Potential offerors will be responsible for downloading their own copy of the solicitation and any amendments via this website. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26. All responses should be identified with the RFP number, 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 April 2008.