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FBO DAILY ISSUE OF OCTOBER 23, 2005 FBO #1427
SPECIAL NOTICE

99 -- Request for Information (RFI) for Joint Biological Warfare (BW) Medical Diagnostic Equipment Roadmap Study Effort, in support of the DoD Joint Biological Agent Identification and Diagnostic System (JBAIDS) Program.

Notice Date
10/21/2005
 
Notice Type
Special Notice
 
NAICS
541710 — Research and Development in the Physical, Engineering, and Life Sciences
 
Contracting Office
US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
 
ZIP Code
35807-3801
 
Solicitation Number
USA-SNOTE-051021-001
 
Archive Date
12/20/2005
 
Description
This is a Request for Information (RFI). The Joint Program Executive Office for Chemical Biological Defense (JPEO-CBD) is requesting information to survey both available and emerging technologies or retrospective analytical systems that may be incor portated into a military detection and diagnostic system to meet the needs of all U.S. DoD military services as part of the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Program. This RFI is specifically seeking information on techn ologies that may support pre-planned product improvement and delivery of a Block III version of the JBAIDS system. Information gathered in response to this RFI will be used to support the JPEO-CBD and JBAIDS program office in strategic planning for develo pment of a Block III acquisition strategy. The Block I JBAIDS system has successfully been developed to Government specification with fielding initiated in 2005. Block I capabilities include assays for 16 targets representing 14 different pathogens that have demonstrated greater than 90% sensitivity at the 90% confidence level in a variety of both environmental and clinical matrices with specificity greater than 90% against genetic near neighbors. Block II JBAIDS adds analytical capabilities supporting i dentification of toxins; no specification currently exists for the Block II device. For the Block III effort, the potential technology solution may not be limited to conventional and/or previously fielded detection strategies; systems utilizing mas spectr ometry, terahertz detection, and other emerging approaches are examples of technologies under consideration. A detailed system specification is beyond the scope of this RFI and only the fundamental technology needs will be highlighted within this notice. The desired Block III JBAIDS system will perform simultaneous identification of multiple toxins and pathogens in both clinical and environmental samples with specificity of greater than or equal to 95% and achieve levels of threat agent detection (sensiti vity) with high fidelity and statistically supported confidence. Capability is desired to test both clinical specimens and environmental samples for a broad spectrum (e.g. n=50) of high regret pathogens. Manufacturing of this device and associated assays must be GMP compliant, as Block III JBAIDS will be required to obtain FDA approval as a clinical diagnostic device prior to fielding. Minimal logistics and personnel support is desired for operation of the Block III JBAIDS system. Capability of the syst em to operate using minimal or no fluidics or reagent-less systems are highly desirable. Sample preparation must be automated and integrated within the device. The system must be able to be successfully operated by personnel with limited training and tec hnical skill sets. The final design must be hand-held, easily transportable, ruggedized, and be of minimal weight. The system must have onboard software that is capable of device operation, output analysis, and information transfer using conventional met hods (such as ethernet or serial communication) which can interface with existing DoD medical/information reporting systems. In contrast to prior efforts under the JBAIDS program, candidates with technologies/systems under development in the prototype sta ge and early developmental efforts will be considered. The desired development timeframe would be for the system to achieve technology readiness level (TRL) of 5 or higher to support program initiation and specified military testing along with initiation of supporting FDA trials in 3-5 years. However, information on the level of development achievable at both the 3 year and 5 year timeframe is desired. JPEO-CBD definitions for TRLs are available upon written request as noted below. The following informa tion is requested from prospective companies electing to respond to the RFI: 1) Notification in writing to the Government Point of Contact (POC), and 2) Addres s in writing the company's ability to develop the proposed JBAIDS Block III system addressing the fundamental technology needs for the system as outlined above. Candidates interested in this RFI are asked to use a quad chart (available upon request), as a template for initial responses back to the Government. Candidates are encouraged to additionally provide brief technology developmental plans for how the proposed Block III system can be developed to 1) eliminate the need for a specialized technician for operation, 2) integration of sample preparation and detection into singular device, and 3) miniaturization of the device to accommodate a handheld format. Plans should address strategic partnerships or cooperative research and developmental areas the can didate technology may leverage in the developmental process. The Government may request meetings with the candidates to provide more in depth technical briefings as necessary to complete the survey. Responses to the RFI will be accpeted for review if rec eived by 4:00pm EST on 14 November 2005. Responding companies also need to state their company is eligible to receive a DoD Secret-Level Clearance. Companies desiring to respond to this RFI should contact the Government POC, Ms. Kristin Korte for a copy of the JPEO-CBD Assigning Technologies Readiness Levels reference document and the summary quad chart. Ms. Korte's contact information is as follows: email kristin.korte@jpeocbd.osd.mil, phone (703)681-0813, and mailing address: JPEO-CBD, Attn Ms. Kristi n Korte, 5203 Leesburg Pike, Suite 1609, Skyline 2, Falls Church VA 22041. The JPEO-CBD referenced material will be emailed to requesting companies. Written responses to this RFI should be forwarded to Ms. Korte via email and hardcopy to the above mentio ned mailing address. The above technical material responses from contractors will be used in developing a DoD Biological Warfare (BW) medical diagnostic equipment roadmap for future DoD investment strategies. This RFI is issued soley for information and planning purposes only and does not constitute a solicitation or the issuance thereof. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are soley responsible for all expenses associated with responding to this RFI.
 
Record
SN00919400-W 20051023/051022080523 (fbodaily.com)
 
Source
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)

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