SOURCES SOUGHT
68 -- Request for Information (RFI) ORDC-06-01 for Advanced Development of Antiviral Agents for Prophylactic /Therapeutic Usage during Seasonal / Pandemic Influenza Outbreaks
- Notice Date
- 1/20/2006
- Notice Type
- Sources Sought
- 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
- Reference-Number-RFI-ORDC-06-01
- Response Due
- 2/13/2006
- Archive Date
- 2/28/2006
- Description
- *** BACKGROUND *** The National Pandemic Plan of 2005 designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical response for pandemic preparedness and response. Following the issuance of the HHS Pandemic Plan of 2005, the Office of Public Health Emergency Preparedness (OPHEP) was made responsible for the advanced development, establishment of surge capacity, and acquisition of medical countermeasures such as vaccines and antiviral drugs that may be used to contain, control, and mitigate the mortality and morbidity associated with influenza pandemics in the U.S. The tactical and logistical implementation of policies and decisions regarding these pandemic medical countermeasures is the responsibility of the Office of Research and Development Coordination (ORDC) in OPHEP. ***DESCRIPTION*** This is a Request for Information (RFI) only. It is not a request for proposals and does not commit the U.S. Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the U.S. Government and will not be returned. HHS/OPHEP/ORDC has an interest in identifying potential prophylactic / therapeutic agents likely to be effective in preventing or reducing influenza virus infection. The appropriate use of these antiviral agents during an influenza seasonal or pandemic outbreaks may delay or contain influenza infections in local communities, may reduce the morbidity and mortality, and may mitigate the overwhelming load that will be placed on the healthcare system. Currently there are two main classes of FDA-licensed antiviral drugs that interfere with the influenza virus infection: adamantanes which act as M2 ion channel blockers (amantidine and rimantidine) and viral neuraminidase inhibitors (zanamivir and oseltamivir phosphate). The U.S. Government has an interest in identifying sources of new antiviral drugs and compounds which could be used potentially during circulation of influenza viruses in a community for treatment or prevention of infection during epidemic or pandemic events. Potential antiviral drugs of interest include neuraminidase inhibitors, inhibitors of hemagglutinin-mediated functions, drugs that block influenza receptor binding, inhibitors of influenza virus fusion, influenza virus RNA polymerase inhibitors, new inhibitors of M2 ion channel activity, snRNAi, polyclonal/monoclonal antibody cocktails, other viral replication inhibitory compounds and other drugs sharing anti-influenza effects. Of particular interest are those antiviral agents that are in clinical development for prevention and/or treatment of influenza infections and that may exhibit longer or greater product shelf-life, efficacy, bioavailability, half-life, and pharmacokinetics for treatment after influenza infection or post exposure. Additionally, of interest are those agents that can be delivered both orally (or by other needleless technology) and parenterally, depending upon the clinical status of the recipient. Interested organizations that have potential candidate drugs or compounds are invited to submit a statement of capability, product description, and development status to HHS/OPHEP/ORDC. Specifically, submitted information depending upon the stage of product development provide the following: (1) a description of the potential antiviral drug including chemical structure, physical chemical characteristics and biological activity; (2) a description of the method of synthesis, isolation or purification and potency assays; (3) a description of the mechanism of action; (4) a description of the proposed production process; (5) a description of the proposed preclinical or clinical studies; (6) a description of the proposed formulation, dosage and route of administration; (7) regulatory pathway, limitations, and possible obstacles; (8) an estimate of production capacity, manufacturing sites, and timelines and estimated retail costs; and (9) intellectual property accessibility. Data obtained from this RFI will be used by HHS in making recommendations and decisions on the development of an appropriate procurement strategy for National Pandemic Preparedness. All information submitted to HHS will be kept confidential as allowed by relevant federal law. Information must be submitted by 3:00 pm, February 13, 2006. Responses should be limited to 50 pages in an electronic and hard copy formats and can be e-mailed to the attention of Darrick A. Early, Contract Specialist, phone 202-205-5668, email darrick.early@hhs.gov. Please ensure that at least one electronic and TWO (2) HARD COPIES of all responses are submitted.
- Record
- SN00969671-W 20060122/060120211827 (fbodaily.com)
- Source
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