Inactive Total Small Business Set-Aside (FAR 19.5)

DESCRIPTION: The National Institute on Mental Health (NIDA), is seeking Capability Statements from Other Than Small Business (OTSB) organizations under the North American Industry Classification Syste... DESCRIPTION: The National Institute on Mental Health (NIDA), is seeking Capability Statements from Other Than Small Business (OTSB) organizations under the North American Industry Classification System (NAICS) code 334510, that are manufacturers of a 3T Human MRI System with an Integrated Local High Performance Gradient Subsystem to be used to provide clinical and preclinical human MRI research. This instrument is necessary to provide high-quality, high temporal-resolution scanning with multi-echo data collection in routine functional MRI studies performed in NIMH’s function MRI Facility This is a Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; (2) the availability of capable Small Businesses; HUBZone Small Businesses; Service-Disabled, Veteran-Owned Small Businesses; 8(a) Small Businesses; Veteran-Owned Small Businesses; Woman-Owned Small Businesses; or Small Disadvantaged Businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The established NAICS code is 334510, Electromedical and Electrotherapeutic Apparatus Manufacturing. The U.S. Small Business Administration establishes a size standard for 334510 as 1,250 employees or less. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). BACKGROUND INFORMATION AND OBJECTIVE: The National Institute of Mental Health FMRIF is a core resource of the National Institutes of Health (NIH) intramural research program. The FMRIF was created by the NIMH and the NINDS in 1999. Its function is to serve as a resource by which all NIH institutes can perform Magnetic Resonance Imaging (MRI) studies that further the understanding of healthy and diseased brain anatomy, function and physiology. The FMRIF currently operates three 3T and two 7T MRI human MRI systems. The specific objective of this purchase is the acquisition of a 3T MRI System which includes a dedicated, high-performance, local gradient subsystem. The acquisition will allow the FMRIF to be able to provide the latest tools and techniques to NIH researchers to collect high quality brain imaging data from patients and research volunteers and develop novel scanning protocols advancing the state-of-the-art for structural and functional brain imaging. The upgraded system is to be used for clinical and preclinical human MRI research. REQUIREMENT: One 3T MRI Scanner which meets the following performance requirements: A whole-body 3T actively shielded magnet High power (2 MVA) gradient driver amplifier and power supplies Local gradient with (at least) 37 cm free, available internal diameter providing with 250 mT/m max amplitude and 500 T/m/s slew rate A RF receiver system with at least 64-channels, with two 32-channel P-ports available for RF coil connections RF receivers providing digital sampling bandwidth of (at least) 1 MHz, sampling with at least 16-bit resolution and providing user access to raw (i.e. pre-image reconstruction) MR sampled data. Head RF receiver coil suitable for high performance, accelerated (i.e. GRAPPA, SENSE and Simultaneous Multislice or Multiband) imaging. A high-end, dedicated image reconstruction computer incorporating software for advance image reconstruction algorithms A high-end host computer operator console for MRI protocol planning, scanner operations, and image storage and review. Customer available and configurable 10Gb network interfaces for data transfer on host and reconstruction computers. Trade-in and removal of Obsolete MRI equipment: The existing GE Signa MR750 3T system, designated FMRIF 3TA (Vendor ID: 301496MR3T5MR), will be available as trade-in value as part of the purchase. The obsolete system will be extracted and removed from the FMRIF Center as part of this purchase. Turnkey Installation: The purchase will include the turnkey installation of the new, replacement MRI system, including installation of the MRI system magnet, electronic equipment and system console; in-suite connections to the facility power and cooling supplies; and all construction necessary to bring the MRI system console and magnet rooms to meet environmental standards required for clinical and research usage in the NIH Clinical Center. Additionally, installation of the current system should not adversely affect the operational state of any other MRI systems in the facility at system handover. MRI Systems Training: The offeror shall provide on-site training to FMRIF staff in the operation of all hardware and software / applications that will be required for routine operation of the upgraded or replaced MRI Systems. The Contractor shall additionally provide access to training in pulse sequence and reconstruction software development for staff involved in methods development. Salient characteristics The FMRIF/NIMH requires a 3T MRI system suitable for human patient studies with the following components: 3T superconducting magnet Local gradient system with: Maximum gradient strength of at least 250 mT/m Maximum slew rate of at least 500 T/m/s Radio frequency electronics and an operator console Vendor-specified documentation for non-significant risk for human subject scanning is required for this system; FDA 510(k) clearance is preferred. The characteristics needed for each component are given below. However, the vendor is encouraged to offer a system with best possible specifications, and the proposed enhancements will be considered and evaluated during the technical review of the quotations. Magnet Superconducting and actively shielded magnet with a field strength of 3.0 T (Tesla). Field homogeneity (fully shimmed with superconducting and/or passive shims) less than 5 ppm peak-to-peak over a 45 cm diameter spherical volume (DSV) and a water spectral linewidth of less than 0.1 ppm full width half height (FWHH) over a 25 cm DSV. Drift of the main field less than 0.1 ppm/hour. The magnet will employ zero boil-off technology. The system will include a switch to shut-off the main field quickly and safely in case of an emergency. The location of the switch is to be determined during system installation. Ramp time: The time required to ramp the magnet up and down to and from field following installation or service procedures will be specified by the vendor. A faster ramp time is preferred. It is important that the 0.5 mT contour of the magnet fringe field shall be contained within the installation room[M[1] . The magnet shall be delivered to the site via a 10 ft x 10 ft ceiling hatch. Room temperature shim and gradient coils The room temperature active shim coil set should consist of at least 8 channels (3 first order and 5 second order terms) and a power supply. All room temperature active shims will be under computer control within the software environment used to run the rest of the console. The gradient amplifiers will be capable of generating at least 250 mT/m magnetic field gradient along each axis with a slew rate of at least 500 T/m/s with the system’s supplied coil. The gradient waveform control unit should operate with at least 10 us time resolution, 16-bit amplitude resolution. The gradient field stability will be better than 0.5% at maximum gradient strength on each axis. The system will be equipped with a hardware/software mechanism to protect the gradients and gradient amplifiers from overheating. RF Electronics Transmitter system The transmitter system will be capable of operating 2-port, independently controllable RF transmit channels capable of operating at frequencies suitable for protons. RF transmit amplifiers should independently supplied at least 3 kW pulsed, linear, power on-resonance. All RF channels will be driven by independent waveform generators with adequate waveform memory and capable of amplitude and phase modulation. RF transmit power monitoring will be provided on all individual channels with an automatic mechanism to ensure that the estimated local and average SAR remains below the FDA/IEC guidelines. There will also be a system to limit the RF power to individual transmit elements. Receiver system The receiver system will include a minimum of 64 digital receivers capable of receiving on-resonance MRI signal in parallel. Receivers will have a minimum of 1 MHz bandwidth with at least 16-bit dynamic range. The system will include software that enables all receivers to be used within the full range of imaging sequences. RF coils and T/R switches The system will be delivered with a minimum of one RF coil suitable for MRI of the human head, a dual-channel transmit, and 32-channel receive array (2Tx/32Rx) The vendor will provide specifications and tools to allow the use of customer developed RF coils. External gating and Monitoring A subsystem for gated acquisition of data with a minimum of two (2) independent external signals will be included, with a minimum of 4 BNC TTL output lines. The system will provide digital recording and real-time display of respiratory and cardiac signals. Console The vendor will supply a state-of-the-art host computer with current scanner operation and image viewing software. The system will be equipped with software for acquisition and processing of advanced neuro-MRI applications. The system will be equipped with automatic shimming software to optimize all active shims for each subject. The system will be capable of acquiring reconstructing in real-time 64-channel data with accelerated (R4) gradient-echo echo planar imaging (GE-EPI) for 30 min at 128x96 resolution and maximum slices per TR. At least 1TB of disk storage for reconstructed images and at least 1TB for raw data storage shall be provided. A 10 Gb ethernet for general network communications with external systems is preferred. The vendor will supply the source code of purchased pulse sequences and off-line software tools to enable local development of pulse sequences and image reconstruction techniques. Scanner table A dockable scanner table with accurate landmarking will be provided for precise positioning of subjects at the isocenter of the magnet that must be compatible with supplied gradients and designed to minimize vibrations. Warranties The vendor shall: Provide warranty for all parts and labor to repair any defects or failure in supplied items for one year from the date of Government acceptance of the system. Guarantee to upgrade at no additional cost any components that become outdated due to advances in design made by the vendor for within the one-year warranty period. Supply any software upgrades free of charge within the one-year warranty period. Delivery, Installation and Training: The vendor shall deliver and install the complete system on-site (including all connections to quench ducts, vacuum pumps, cryogens for magnet ramp up, etc.) and ensure that the initial performance of all equipment satisfies the required specifications within 12 months following contract award. The vendor will provide a minimum, ten days of applications training in which staff of the FMRIF are trained in the operation of the new head gradient system. Such training is to include patient handling and basic upkeep tasks, as well as operation of the system for acquisition of images. Training must also cover functions for data viewing and any online analysis features provided on the scanner. Acceptance and evaluation: The vendor shall demonstrate minimum specifications for all of the items listed including magnetic field drift and homogeneity, gradient performance, multiple receiver acquisition, image reconstruction, RF coils, RF power delivery and monitoring are met or exceeded. Acquire T2*-weighted spoiled gradient-echo (SPGR) imaging with multiple echoes, at high spatial resolution suitable for applications such as quantitative susceptibility mapping in brain. Acquire whole-brain echo-planar imaging (EPI) suitable for neuro-functional MRI applications, at high spatial and temporal resolution (1mm, TR=800ms) with real-time reconstruction for acquisition times of 20 minutes. Capabilities of the system for simultaneous multi-slice EPI should be demonstrated. Demonstrate the ability, using a graphical user interface, to prescribe the geometry and location of targeted area of interest, the imaging experiments listed below in principal and oblique scan planes with minimal field of view allowed by the maximum gradient strength and receiver bandwidth. In all cases, the ghosting artifacts shall be less than 1% of average image intensity. There shall be no evidence of RF noise in the images. Multiple-slice, multiple-echo image sets of up to at least 1024 x 1024. Capability for T1 weighting with inversion recovery. Capability of fat suppression. Demonstrate the ability to perform sequences such as magnetization prepared rapid acquisition gradient-echo, fluid attenuated inversion recovery, fast spin-echo and MR angiography. Gradient-echo (GE) and spin-echo (SE) echo-planar imaging (EPI). The pixel-wise temporal standard deviation (tSD) of the image signal (GE-EPI, 32 channel coil, 2.5 mm isotropic resolution, TR 2 s, minimum-full TE, unaccelerated, 150 volumes, oil phantom) without detrending shall be less than 3 times the tSD of a noise region without signal. The tSD of the mean signal within an ROI (400 pixels, at the center of the slice at iso-center) shall be less than 0.3% of the mean signal. The amplitude of the EPI image ghosts shall be less than 3% of the mean signal intensity. Demonstrate acquisition and real time reconstruction of 32 channel data with accelerated (R4) gradient-echo echo planar imaging (GE-EPI) for 30 min at 128x128 resolution and maximum slices per TR. Demonstrate acquisition and reconstruction of simultaneous multi-slice (SMS) EPI using a 32-channel receiver array. Demonstrate that image reconstruction can keep pace with an 8x SMS, 2mm isotropic EPI acquisition with maximum number of slices per TR for a continuous total scan period of at least 20 minutes. Demonstrate diffusion-weighted MRI with SE-EPI on an oil phantom with following parameters: 2 mm isotropic resolution, 80 slices, b-value =3000 s/mm2, greater than 60 diffusion directions, TE= 100 ms (full k-space), TR=11 s, and in-plane acceleration factor =2. The amplitude of the EPI image ghosts shall be less than 3% of the mean signal intensity without diffusion weighting. Quantity 1 x MRI system Delivery Date The vendor will prepare the site, deliver and install the complete system on-site (including all connections to quench ducts, vacuum pumps, cryogens for magnet ramp up etc.) and ensure that the initial performance of all equipment satisfies the required specifications within 18 -24 months following contract award. Period of Performance: Siting and handover within base year, followed by one year of warranty, followed by option years for maintenance. Options(s) Magnet warranty: The vendor should provide options for warranty extension for an additional one to four years after the initial year of warranty for both the magnet and the cryo-refrigeration system. The vendor should also provide options for extended service contracts (1-4 years) after the initial warranty expires. MR750 Trade-in: The FMRIF/NIMH currently owns a 3T MRI system (GE Discovery MR750, including magnet in Room 10/B1D65) which will be replaced by the 3T system requested in this solicitation. Vendor is invited to include trade-in value for this existing 3T system as a part of this contract. Turnkey install: The vendor should provide pricing and some relevant details for a turn-key installation of the system which includes all site preparation and modification as well as work required to meet NIH design requirements and review. Inspection and architectural drawings of the site can be made available to assist in preparation of the quotation. INSTRUCTIONS: Companies that believe they possess the capabilities to provide the required product should submit documentation of their ability to meet each of the requirements to the Contracting Officer. The capability statement must specifically address each of the requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) or BPAs by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. The established NAICS code is 334510. Respondents must provide clear and convincing documentation of their capability of providing the products and support services specified in this notice. Also, information must be provided in sufficient details of the respondents’ (a) staff expertise, including their availability, experience, formal and other training; (b) capability to perform the work; (c) prior completed projects of similar nature; (d) compliance with requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed above. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. The information submitted must be in an outline format that addresses each of the elements of the requirement and in the capability statement paragraphs stated herein. A cover page and an executive summary may be included but is not required. Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Rob Bailey at Rob.Bailey@nih.gov, NO LATER THAN 1:00 p.m. EST on July 29, 2025. The Subject line for the submission should include this Sources Sought Number and organization name. NIDA will not accept paper or faxed capability statements. THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. 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 pre-solicitation synopsis and solicitation may be published on SAM.gov. 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).