66 -- Magnetic Resonance Imager (MRI) with Peripherals

The Food and Drug Administration intends to make an award on a sole source basis to Bruker Biospin, 15 Fortune Drive, Manning Park, Billerica, Massachusetts 01821-3991 for the items listed below. The requirement will be awarded using Simplified Acquisition Procedures in accordance with FAR 13.5 (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is FDA-SOL-07-00412. This solicitation is issued as a Request for Proposal (RFP). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-19, Aug 17, 2007. (iv) The associated North American Industry Classification System (NAICS) Code is 334516 - Analytical Laboratory Instrument Manufacturing, Small Business Size Standard 500 Employees. (v) The Food and Drug Administration is soliciting for supplies per the description as follows: Scheduled items include: A hardware and software system which can provide for high resolution in vivo MRI and MRS in selected tissue volumes and 2-D and 3-D image reconstruction based on the principles of nuclear magnetic spectroscopy in preclinical health and drug toxicity studies in rodents and small primates. Experiments include but are not limited to gradient echo, spin-echo, turbo spin echo, diffusion weighted imaging, time-of-flight angiography, echo-planar imaging with gradient-echo and spin-echo options, functional imaging, perfusion imaging, PRESS/STEAM single voxel magnetic resonance spectroscopy, spectroscopic imaging (CSI), and heteronuclear imaging applications. I. Computerized magnetic resonance imaging (MRI) to consist of: A. Magnet System: Superconducting magnet (minimum operation field of 7.0 Tesla) Bore width of at least 300 mm Actively shielded cryomagnet Field stability or drift rate <0.05 ppm/hour Field homogeneity 10 ppm over 18 cm DSV Antivibration Legs Animal magnet table attached to magnet Required filters, cables, and connectors Helium filling required once a year with the use of a cryo-cooler or cryo-refrigerator Site inspection before delivery B. Gradient/Shim System: Suitable for magnet field strength and bore size of MRI system Gradient suitable for imaging rats and small- to medium-sized primate. Actively shielded gradients and shims Shims are at least strong second order Minimum 6 shim output channels Suitable shim power supply Chiller for actively-shielded gradient system C. Hardware for MRI and MRS experiments: RF system include 4 transmitter and 4 receiver channels FR system should be expandable to 16 transmitter and 16 receiver channels and it is desirable to have complete control of attenuation and phase for each transmit/receive channel. Separate amplifier for proton Separate amplifier for X-nuclei Digital RF control Linear RF amplifier Gradient amplifier and control Waveform generator Preamplifier Frequency synthesizer for all RF channels Pulse shaping capabilities Full pulse field x-y-z-gradient capabilities Decoupling ability for all RF channels Digital acquisition and control system for homonuclear and heteronuclear applications Receiver system consisting of preamplifier, digital receiver and digital processing capabilities for homonuclear and heteronuclear applications D. Computer: Complete computer and computer operating system to run MRI operational and processing software on LINUX Operating system At least 19 inch flat panel monitor At least 48X CD-RW-ROM, At least 16 X DVD+RW Minimum 200 GB hard drive 2 X10/100/1000 Network adapters Keyboard/Mouse Laser Printer 1200 DPI resolution E. Coil RF-resonator or birdcage coil for small to medium-sized primates Active RF decoupling for receiving coils consisting of coil control and power supply Complete phase array receive coil and other associated needs to set up for optimal MRI and MRS of rat (weight up to 500 g) brain. Complete phase array receive coil and other required needs to set up for MRI and MRS of small primates (weight ~1-2 or more kg) brain. F. Bed Suitable bed for rats that can be used with phased-array imaging coils. Hardware and software for animal physiology monitoring system. System include primate holder integrated with RF coil and 4-coil phased array coil for parallel imaging. A non-magnetic cart designed to interface with front of the magnet and the primate holder to facilitate easy transfer from animal room to the magnet G. Computer Software Acquisition software and license Software and license for conventional MRI data processing Software and license for 2D and 3D MRI visualization tools for image selection, loading, and storing Software and license for MRI pulse programming capabilities Software and license for MRS data acquisition and processing Software and license for pulse shaping capabilities Software and license for physiological monitoring Software and license for contrast modules Software and license for synchronous imaging to subtract out motion due to respiratory and cardio movements Ports to support workstation connections Free software upgrades for a year H. Installation: Complete shipping, handling and installation Verification of specifications for at least Pulse widths All coils S/N 2D and 3D imaging Pulse shapes RF homogeneity Gradient control Temperature control Digital filters Complete set of user manuals and instrument electronic and RF schematics Delivery must take place before 6-10 months after the contract is signed I. Warranty: Final Test of MRI system with all accessories and coils Minimum 1 Year Warranty parts and labor on MRI system Instrument technical support for a minimum of five years (parts, phone, and service visits as needed) Parts and service contact for first two years after delivery Annual preventive maintenance contract for chiller for first year Free training course or courses for two people Complete of documentation and manuals J. Optional: Second computer licenses for all MRI and MRS processing softwares Gradient insert for rodents RF system for 8 transmitter and 8 receiver channels Other available MRI and MRS software and associated licenses not listed above Basic warming system with warm water, pump, thermostat connected to a blanket Complete phase array receive coil and other associated needs to set up for optimal MRI and MRS of rat (weight up to 500g) cardiac or chest region. Complete phased array receive coils and required set up for MRI and MRS of small primates (weight ~1-2 or more kg) cardiac or chest region. Faraday Cage Parts and service contract for third year Annual preventive maintenance for chiller for second and third years Set of surface receive coils for rat and small to medium sized primate brains An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to finish required representations, and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. (vi) Contract type: Commercial Item - Firm Fixed Price. Simplified procurement procedures will be utilized. (vii) The period of performance is 6 to 10 months or less after receipt of order (ARO). FOB Point Destination, with services on-site. FOB Point of Delivery for Services and Supplies provided will be the Food and Drug Administration, NCTR, Jefferson Laboratories, 3900 NCTR Road, Jefferson, AR 72079-9502. JUSTIFICATION: The FDA, National Center for Toxicological Research has ongoing collaborative protocols and experiments where pre-clinical studies are in use utilizing a Bruker Biospin MRI. In order to maintain and achieve a high level of scientific interaction, it is imperative that the NCTR have the ability to collaborate with shared software/hardware, data analyses, service support and component interchange (coil manufacturing) for optimal utilization of these MRI systems. (viii) The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None. (x) Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. Offers must be submitted on a SF-1449, which can be found at http://www.gsa.gov/Portal/gsa/ep/formslibrary.do?formType=SF (xii) The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. (xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes of Executive Orders - Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6, 52.219-8, 52.219-9, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-39, 52.225-1, 52.225-13, 52.232-33 and 52.232-34. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov. CCR Requirement - Company must be registered on Central Contractor Registration (CCR) before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. (xiii) A standard commercial warranty on parts and workmanship is required. (xiv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. (xv) Applicable Numbered Note(s) 22 (xvi) This is not a solicitation for competitive proposals. However, if any interested party believes they can meet the above requirement, they may submit a statement of capabilities in writing, to the Government point of contact. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive proposal. The proposal must reference solicitation number FDA-07-00412. The Offers are due in person, by mail or fax on or before September 11, 2007 by 14:30 hours (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas), at Food and Drug Administration OC/OSS/OFFAS 3900 NCTR Road, Jefferson, AR 72079-9502. (xvii) For information regarding this solicitation, please contact Barbara Arnold @ (870) 543-7483, FAX (870) 543-7990, email barbara.arnold@fda.hhs.gov.