Lipidomics Quantification System

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small and large businesses in providing a Lipidomics Quantification System with installation, training, and up to four (4) 1-Year periods for post warranty Preventive and Corrective Maintenance. The associated North American Industry Classification System (NAICS) Code is 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Metabolomics Core Facility serves NCTR and FDA investigators by conducting research to identify new metabolic biomarkers in animals, which is then translated to humans. The premise of the research is to improve the ability to detect drugs and other FDA-regulated products with the potential to have adverse effects and to improve the identification of disease onset and progression to enable earlier, more effective medical intervention. The Lipidomics Quantification System will be used to quantitatively analyze lipids for biomarker analysis. Studies will include, but not be limited to, determining lipid biomarkers of sepsis, analysis of brain and blood samples in neurotoxicity studies, biomarker and mechanistic understanding of cardiotoxicity studies of doxorubicin and Tyrosine Kinase Inhibitors (TKI) including sunitinib, recovery biomarkers in blood acute kidney injury patients, and other future toxicity. Part II: Work Requirements Lipidomics Quantification System At a minimum the contractor shall provide: - Automated, comprehensive system inclusive of Liquid Chromatography, Tandem Mass Spectrometry (LC/MS/MS) and Ion Mobility Analyzer - Isolation, quantification, and differentiation of a minimum of 1000 lipids from 10 different classes of lipids inclusive of phosphatidylcholine (PC), phosphatidylethanolamine (PE), diacylglycerol (DG), triacylglycerol (TG), phosphatidylserine (PS), Lysophosphatidylcholines (lysoPC), Lyso phosphatidylethanolamine (lysoPE), cholesterylesters (CE), free fatty acids (FA) and ceramides. - Standardized sample preparation kits for simple and consistent, reproducible sample preparation - Streamlined workflow to analyze lipids in hundreds of samples in a maximum of 96 hours - Automatic sample logging for batch running and automatic selection of experiments for optimized data acquisition - Automated method selection for specific lipid class/classes selection - User friendly system processing requiring no specialized mass spectrometry experience by system users - Workflow driven software interface - User friendly software for automatic batch running and system tuning and testing - Internal standards for spray stability, minimal carryover contamination, and quantitative analysis of lipids - Differential ion mobility for chemical separations based on molecular size and shape, to separate isomers e.g. lipids, conformers, and isobaric compounds A. Training At a minimum the contractor shall provide: - On-site training for up to three system operators including but not limited to system operations (inclusive of hardware and software), quality control, instrument programming, diagnosing instrument problems, basic and routine preventative maintenance procedures, cleaning requirements, troubleshooting, and system maintenance. C. Minimum Service Requirements I. Warranty At a minimum the contractor shall provide: - Minimum 12-month warranty on the entire system, inclusive of hardware and software components. - Warranty shall be inclusive of parts, labor, and travel expense to commence upon completion and acceptance of system and training. II. System Service Plan: Preventive Maintenance/Corrective Maintenance Service At a minimum, the Contractor shall provide: - One (1) scheduled preventive maintenance visit annually inclusive of parts, travel, and labor expense - Include unlimited corrective/remedial maintenance visits within 3 business days of call for service - Include unlimited technical support, Mondays - Fridays (excluding Federal Holidays) between the hours of 7:00 AM - 5:00 PM Central Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) - Include unlimited software and firmware updates, inclusive of access to system and software upgrades upon inclusion of future lipid classes - All maintenance and repair activities shall be performed by trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc. - Access for the FDA Contracting Officer's Representative (COR) and system operator personnel to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument - Services inclusive of labor, travel, replacement parts, components, subassemblies, etc. D. Turnkey System At a minimum, the Contractor shall provide: - Turn-key solution which shall include, but not be limited to: all hardware, software, components, interfaces, instruments, supplies, kits, standards, on-site familiarization and operation training, required to meet these specifications and the FDA's stated need and intended use for the system. Part III: Supporting Information A. Place of Performance U.S. Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Jefferson, AR 72079 B. Period of Performance System delivery, installation, and training shall be completed within 180 calendar days (or sooner) from date of award. Part IV: Instructions to Prospective Respondents The offeror shall furnish sufficient information necessary for the Government to conclusively determine that the respondent is capable and otherwise qualified to provide the requirements and perform the full range of services identified herein. At a minimum, responses shall include the following: ? Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; ? Past performance information for the Lipidomics Quantification System and preventive and corrective maintenance services identified herein, for the same or substantially similar OEM equipment, to include date of services, description (should also include technical literature and specifications), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent; ? Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the services the responding firm is regularly engaged in providing; ? If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; ? Although this is not a request for quote, informational pricing is encouraged; The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested parties must respond with capability statements, which are due in person, by postal mail or email to the point of contact listed below on or before January 25, 2016 by 9:00 AM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OO|OFBA|OAGS|DAP, Attn: Sondea Blair, 3900 NCTR Road, Bldg 50/Room 421, HFT?320, Jefferson, AR 72079?9502 or email sondea.blair@fda.hhs.gov. Reference Number 1159993 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a combined synopsis/solicitation (No. FDA-16-223-SOL-1159993) may be published via FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).