65 -- Biological Diagnostics Manufacturing II

***THIS REQUEST FOR INFORMATION (RFI) HAS BEEN CANCELLED. PLEASE REFER TO 2006-Q-08478*** The National Pandemic Plan of 2005 designates the Department of Health and Human Services (HHS) as the lead agency for public health and medicine for pandemic preparedness and response. Following the issuance of the Department of Health and Human Services Pandemic Plan of 2005, the Office of Public Health Emergency Preparedness (OPHEP) was assigned the responsibility for the establishment of surge capacity, advanced development, , and acquisition of medical countermeasures such as diagnostics, vaccines and antiviral drugs that may be used to diagnosis, 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. The Office of Research and Development Coordination of the Office of Public Health Emergency Preparedness has an interest in identifying potential platforms, technologies, methods, assays and reagents that can be applied to the detection, diagnosis and monitoring of influenza virus infections and disease. The use of appropriate diagnostic assays and equipment during influenza seasonal or pandemic outbreaks may provide for more timely and accurate detection of influenza outbreaks and thus delay or contain influenza infections in local communities, may reduce the morbidity and mortality, and may mitigate the increased load that will be placed on the healthcare system. Early detection of influenza by the use of appropriate tests will allow for the determination of the parameters of the pandemic in sufficient time to provide effective disease central measures. Rapid, accurate high throughput laboratory bench systems and portable low cost point of care (POC) systems are both needed to identify and characterize the outbreak as quickly as possible and to provide timely data and information to guide and monitor effective response measures. Responses to this RFI may address either or both of these areas (High throughput on POC) of identified interest but should clearly indicate which area of need is being addressed in the response. Rapid diagnostics for influenza viruses currently lack sufficient specificity and sensitivity and timeliness of results to provide clinically relevant information. Diagnostic platforms and assays for influenza and influenza like illnesses are needed to provide timely diagnostic information to health care providers in the face of an emerging pandemic. Information is being sought on assays, methods and platforms that may meet near term and long-term program needs. The responses should address the following issues: - Sensitivity-relative to culture of clinically significant levels of virus 10 to 106 TC/DO/ML if a specified influenza A virus strain - Specificity- ability to differentiate the target organism in the presence of a ten fold excess of near neighbors to distinguish specific strains of influenza virus. - Sample handling and preparation - Throughput capacity. - Platform flexibility/adaptability. - Operational simplicity. - Portability. - Non-Cross Reactivity-ability to detect influenza virus in presence of [illegible] and pathogenic microorganisms. - Estimates of cost factors. HHS will use information obtained by this RFI 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. Please submit information in the following format: 1) Name of Submitter 2) Address of Submitter 3) Name of Device, Assay or technology 4) Technical / Method Summary 5) Device specifications 6) Performance Summary including any supportive data 7) Clinical samples tested to date 8) Viral strains tested to date 9) Points of Contact 10) Bibliography and/or References Information must be submitted by April 28, 2006. Responses should be limited to 20 pages, 12 Font, Times Roman, single space, one sided or equivalent in an electronic and hard copy formats and can be e-mailed to the attention of Jeff Miller, Contract Specialist, phone 770-488-2651, e-mail afx2@cdc.gov. Please ensure that at least one electronic and TWO (2) HARD COPIES of all responses are submitted.