MODIFICATION
A -- Advanced Development of New Antiviral Drugs and Biologicals against Influenza Virus
- Notice Date
- 7/7/2010
- Notice Type
- Modification/Amendment
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, 330 Independence Avenue, SW, Rm G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- 10-100-SOL-00019
- Point of Contact
- Mekeba S. Barrett, Phone: 202-260-1591, RoseMary T Mann, Phone: 202-260-1572
- E-Mail Address
-
mekeba.barrett@hhs.gov, rosemary.mann@hhs.gov
(mekeba.barrett@hhs.gov, rosemary.mann@hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- THIS IS A PRESOLICITATION NOTICE ONLY. Preparedness for public health threats is a major goal of the U.S. Department of Health and Human Services (HHS). A severe 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. The 2009 H1N1 influenza pandemic, along with 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 severe 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 an influenza pandemic. 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/or prophylaxis of pandemic and seasonal influenza leading toward submission of a U.S. approval/licensure application and development of required industrial capacity to support implementation of the influenza antiviral drugs 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 target novel mechanisms of action or to enhance effects of present classes of influenza antiviral agents, formulated for long term stability, long bioavailability, and simple dosing regimens. Ultimately, these influenza antivirals shall be produced at one or more Food and Drug Administration (FDA)-licensed domestic manufacturing facilities and shall provide sufficient surge capacity to contribute substantially to U.S. and ideally global antiviral drug needs during an influenza pandemic. The anticipated period of performance will be for a total of up to five years or 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 August 9, 2010, with proposals being due on or about September 23, 2010. 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 December 30, 2010. THE SOURCES SOUGHT NOTICE FOR THIS PRESOLICITATION NOTICE IS 10-100-SOL-00016.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/OOS/OASPHEP/10-100-SOL-00019/listing.html)
- Record
- SN02197994-W 20100709/100707234748-96668a896e74d7c0008995311f24ca42 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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