SOLICITATION NOTICE
A -- Advanced Development of New Antiviral Agents for Influenza
- Notice Date
- 5/15/2006
- Notice Type
- Solicitation Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Office of Public Health Emergency Preparedness, Office of Research and Development Coordination 200 Independence Avenue, SW Room 636G, Washington, DC, 20201
- ZIP Code
- 20201
- Solicitation Number
- DHHS-ORDC-VB-06-01
- Response Due
- 7/18/2006
- Description
- 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. Three pandemics occurred during the 20th century, the most severe of which, in 1918, caused over 500,000 U.S. deaths and more than 20 million deaths worldwide. Within the scientific community, it is generally believed that the occurrence of another influenza pandemic is most likely. Recent outbreaks of human disease caused by avian H5, H9, and H7 influenza strains in Asia, Europe, and North America highlight the potential of new strains to be introduced into the population. 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 Office of Public Health Emergency Preparedness and Office of Research and Development Coordination contemplates single or multiple awards of contracts to support advanced stage development of new antiviral compounds 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 drugs, formulated for long term stability, long bioavailability, and simple dosing regimens. Incremental multi-year funding for cost-reimbursement contracts to biopharmaceutical companies will be provided to support this effort. Ultimately, these influenza antivirals shall be produced at one or more Food and Drug Administration (FDA)-licensed manufacturing facilities and shall provide sufficient surge capacity to contribute substantially to U.S. and ideally global antivirals needs during an influenza pandemic. The anticipated period of performance will be for a total of up to five years. Additional details and requirements will be described in the solicitation. RFP-DHHS-ORDC-VB-06-01 will be available electronically through the FedBizOpps on or about May 31, 2006 with proposals being due on or about July 18, 2006. 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 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 RFP No. DHHS-ORDC-VB-06-01, 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 in Fall 2006.
- Record
- SN01048046-W 20060517/060515220234 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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