SPECIAL NOTICE
99 -- This is a FEDBIZOP ANNOUNCEMENT requesting technology information for advanced biological identifier technologies to support the Common Identifier for Biological Analytics (CIBA) effort.
- Notice Date
- 11/6/2008
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of the Army, U. S. Army Materiel Command, RDECOM Acquisition Center - Edgewood, RDECOM Acquisition Center - Edgewood, ATTN: AMSSB-ACC-E, 5183 Blackhawk Road, Aberdeen Proving Ground, MD 21010-5424
- ZIP Code
- 21010-5424
- Solicitation Number
- W911SR-09-S-0001
- Archive Date
- 2/4/2009
- Point of Contact
- Gregory J Jamison, 410-436-4448<br />
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address US Army RDECOM, APG Contracting Div., Edgewood Branch, ATTN: AMSSB-ACC-E, 5183 Blackhawk Road, Aberdeen Proving Ground, MD 21010-5424 Description The Joint Product Director for Advanced Detection System (JPD-ADS) under Joint Project Manager for Biological Defense (JPM-BD) is issuing a request for information (RFI), potential sources, and best practice information of available and/or emerging technologies to support the Common Identifier for Biological Analytics (CIBA) effort. CIBA is intended to be a collaborative effort with representation from Department of Defense (DoD) and other federal agencies to strategically plan and develop identifier technologies that can meet various environmental/clinical diagnostic acquisition programs. For this announcement, identification/identifier is defined as the ability to automatically process/prepare and analyze a clinical or environmental sample in order to provide the taxonomic identity at the species level of the bacterium, virus, and toxin of interest contained therein. This CIBA effort is focused on finding what systems are available that use common analytical platforms that can accept environmental or clinical samples from different sources including air, liquid, and solid matrices. CIBA is envisioned to combine both nucleic acid detection and non-nucleic acid detection (not limited to conventional methods) for identification supplemented by a field-expedient, semi-automated, or fully automated sample preparation component. These systems may be used at a deployable laboratory, high-throughput fixed laboratories, clinical diagnostic facility, or man-portable field units. Modularity is encouraged in the material solution approach. Training and operator qualifications are areas for discriminating suitability of candidate systems. This RFI seeks submissions that will provide contributions to any or all of the following CIBA functional components: nucleic acid detection, non-nucleic acid detection (proteins/other molecular targets), automated sample preparation, data-fusion, and a communication subsystem module to allow system connectivity to medical/ information reporting systems. Vendors both domestic and international are encouraged to respond. PART I Technical Criteria. Vendors with technologies, systems, or subsystems in the Technology Readiness Level 5 or higher are of interest to support Government acquisition program(s). CIBA desires a system-of-systems to perform simultaneous orthogonal identification of multiple pathogens, viruses, and toxins in both clinical and environmental samples with specificity of greater than or equal to 95% and achieve levels of threat agent identification (sensitivity) with high fidelity and statistically supported confidence within one (1) hour or less from time of sample introduction. The collected sample may be from various sources (air, liquid, and solid matrices) and processed either on-board or as a separate linked module. The identifier platform will be employed as a man-portable, vehicle mounted, or laboratory based system. Other features of interest include: Equipment "Onboard software capable of device operation, output analysis, and information transfer using conventional methods (such as Ethernet, RS-232, USB 2.0) which can securely interface with existing medical/information reporting systems; "Automatically conduct built-in test (BIT); "Provide local, audio and visual alarms able to be defeated/muted when required; "Operate from external power (47-63 Hz, 100-240 VAC); "Operate from Standard Rechargeable and Non-rechargeable Military Batteries. Battery operations for up to eight (8) hours continuous operation at 25 degrees Celsius. (man portable); "Identifier along with tactical carry case and 24 hours of consumables (including battery requirement for 8 hours of operation) shall conform to Human System Interface constraints and limitations (man portable); " (Operator) Set up time: Less than 5 minutes from tactical carry configuration to last operator action required prior to sample introduction (man portable); "Start up time: Less than 10 minutes (from power on for the system to warm up and be functionally and operationally ready to receive sample). Start up time to include all BIT; "Minimal (less than or equal to 1 hour) operator refresher training and maintenance; "Network ready; "Environmental testing and hardening (underway or completed); "cGMP/FDA compliant for clinical diagnostic system; "Easily transportable and ruggedized (man-portable/mobile platform); Assay "High sensitivity/selectivity (95% at each level of threat agent identification with false identification rate of less than 5%) along with statistically supported confidence; "Total time to answer less than or equal to 1 hour for each collected sample measured from introduction of the sample to system identification (including platform required sample preparation); "Total amount of reagents/consumables per identification cycle must be less than one (1) ml; "cGMP/FDA compliant for clinical diagnostic system; "High throughput capability (laboratory instrument); "Minimal with the objective of no use of external reagents/consumables; "Automated sample preparation for solid/liquid, environmental/clinical samples; "Use of non-hazardous/non-toxic consumables; "Reagent/Shelf-life of greater than 1 year; "Capable of multiplex assay or multiple tests in parallel as well as being adaptable to new agent. Identifying 10 or more agents per cycle is highly desirable. PART II - Submission of Information. Vendors desiring to respond to this request are asked to submit a white paper and a quad chart (available upon request) as a summary template. White paper: Limit the number of pages to ten (10) total (Times New Roman, Font 12, one (1) inch margins) excluding cover and photos included separately. Describe identifier technologies used, current state of technology and technology development plans to meet criteria stated in Part I describing tests planned/completed, current assay limits of identification and confidence level, step-by-step operational start-up and shutdown procedures, required operator skill level, power consumption and sources used/adaptable to, hardware physical dimensions (size in cubic inches, weight in pounds, footprint in square inches, and volume in cubic inches), if battery-operable: battery weight in pounds, consumables (cost and quantity per test, shelf life, production capability, cost of system as presently configured and photographs of complete system and components. The Government is interested in any current commercial applications and/or licensing/intellectual property provisions. Responding vendors also need to state that their company is able to receive a DoD Secret-Level Clearance and to work with CDC/USDA Select Agents. Also, the Government is interested in any companys strategic partnerships or cooperative research and developmental areas the candidate technology may leverage in the developmental process. Two (2) paper copies of the white paper and one (1) electronic copy; plus one (1) paper copy and one (1) electronic copy of photos are required. To be responsive to this announcement, vendors must supply their information as requested in writing by 8 December 2008 to U.S. Army Research, Development, and Engineering Command (RDECOM), 5183 Blackhawk Road, ATTN: AMSRD-ECB-RT-DE (Daniel M. Nowak), Building E3326, Aberdeen Proving Ground, MD 21010. Concurrently an electronic copy of each document will be placed in this Drop Box: Access to the ECBC Drop Box is as follows and good from any Browser https://dropbox.apgea.army.mil/cgi-bin/dropbox.pl. The recipient email address for the Drop Box is monica.kelley1@us.army.mil. ONLY PDF FORMAT IS ACCEPTABLE FOR INFORMATION SUBMITTED. Your files will have a special prefix designation of RFI CIBA, followed by your company name, and then the name of the file. For example: RFI _CIBA_ONI-Art_white paper.pdf. DO NOT use blank spaces in the file name and the file name is not character sensitive. Electronic submissions will be accepted, but not in place of the written submissions. Vendors are requested to provide the name of Contact Person for their company, telephone number, FAX number, email and complete address with each submission of data. The Government is under no obligation to select any participating technologies. This CIBA RFI will offer participants an opportunity to provide unique technology information about their identifier system to JPM-BD/JPD-ADS as well as other DoD and federal organizations. Technology Readiness level* 1- Basic Principles Observed 2- Technology Concept Formulated 3- Proof of Concept 4- Laboratory Enviroment Component/Breadboard Demo 5- Relevant Enviroment Component/Breadboard Demo 6- Prototype Demo in Relevent Enviroment 7- Prototype Demo in Operational Enviroment 8- System Qualified through Test and Demo 9- System Proven in Operational Conditions *TRL derived from DoD Technology Readiness Assessment (TRA) Deskbook, May 2005.
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