Rabbit Coil MRI Sources Sought Notice FDA-SSN-120799 MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Division of Neurotoxicology in order to determine if there are existing small or large business sources capable of providing 1H Phased Array Radiofrequency Coil for Rabbit Brain (MRI Coil) . The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The appropriate NAICS code for the acquisition is 334510 Electromedical and Electrotherapeutic Apparatus: Small Business Size standards –1,250 employees. Background: The National Center for Toxicological Research (NCTR) is the only FDA Center located outside the Washington D.C. metropolitan area. The one-million square foot research campus in Jefferson, Arkansas plays a critical role in the missions of FDA and the Department of Health and Human Services to promote and protect public health. The division of Neurotoxicology protocol S00820 requires a contract to purchase a new 1H Phased Array Radiofrequency Coil for Rabbit Brain (MRI COIL). This coil is specifically designed for rabbit brain imaging/spectroscopy applications and will be used to study rabbits with NCTR MRI equipment. The coil is adaptable to the wide range of applications, including anatomical scanning, measuring cerebral blood flow and water diffusion, magnetic relaxation, neuronal activation, neurometabolite profiling. This coil is fully compatible with our 4.7T MRI system, which can provide the best sensitivity for given size and therefore will be necessary for use in rabbits to accomplish FDA mission-critical research projects carried out at NCTR. This requirement is as Brand Name or Equal configuration: Rapid MR International (1) 1H Phased Array for Rabbit Brain MRI Coil Item# P-H04LE-047 Minimum Technical Requirements: Shall- Internal physical size fit to the rabbit head (at least 72 x 72 mm) External size to fit into existing volume transmit coil (197 mm ID) Homogeneous field of view centered on the rabbit brain (40 x 30 x 50 mm, W x H x L) 1H Phased Array for Rabbit Brain MRI Coil Surface phased array receive only, actively decoupled 4 channels fixed tuned to 200.3 MHz including preamplifiers interface to Bruker BioSpec with Avance III electronics automatic coil recognition by programmed HWIDS chip Other Requirements: Due to maintaining data quality and comparison to previous related studies using our MRI equipment, this specific MRI coil is needed. Failure to meet such requirements could result in variations in data collection . Anticipated Delivery/Performance: FOB Destination: Shipping, handling, in-side delivery, and validation shall be not later than 30 calendar days after receipt of contract award. The period of performance for the post warranty maintenance option periods in any resultant award will be estimated based on the date of award, required delivery, installation, and offered warranty period of the systems. Place of Delivery/Performance: US Food and Drug Administration National Center for Toxicological Research (NCTR) 3900 NCTR Road, Bldg 62, room M05 Jefferson, AR 72079 Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing 1H Phased Array Rabbit Coil MRI services. Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following: Business name and bio, SAM UEI number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the minimum technical/performance requirements identified above, to include descriptive material, literature, brochures and other information. Past Performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar instrument solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, dollar value, client name, client address, client 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 company (to include the firm’s SAM Unique Entity Identifier (UEI) number and size status) if not the respondent. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. If applicable, identification of Best in Class (BIC) contract information or other Government Wide or HHS Wide Contracts that the equipment/service is available on. If a large business, provide if subcontracting opportunities exist for small business concerns. Standard commercial warranty. Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed. Though this is not a request for quote, informational pricing is requested. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before December 8, 2023, by 12:00 PM EST to
[email protected], and reference: FDA‐SSN‐120799 Notice of Intent: Responses to this source sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole‐source 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 pre‐solicitation synopsis and solicitation may be published in 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). Additional Notes: If the stated requirements appear restrictive, please submit comments detailing the concern. Requirement document (Statement of Work) is attached to this posting.