75F40124R00030_SSN.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED

FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR

ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO

THIS ANNOUNCEMENT OR ANY FOLLOW-UP INFORMATION REQUESTS. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the National Center for Toxicological Research (NCTR)/Division of Neurotoxicology in order to determine if there are existing small business sources capable of providing a magnetic resonance imaging (MRI) system with 4 (1-year Post-Warranty Maintenance Option periods).

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Yolanda.rankin@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background: The Food and Drug Administration (FDA)/National Center for Toxicological Research (NCTR)/Division of Neurotoxicology has a requirement for a magnetic resonance imaging (MRI) system with 4 (1-year Post-Warranty Maintenance option periods). The MRI is needed to continue and advance the FDA mission critical research and regulatory science. The MRI is needed to investigate multiple problems related to various types of organ toxicity in vivo, including neurotoxicity and hepatotoxicity. MRI is a powerful tool in all areas of life science, including toxicological sciences, which can study the same animal repeatedly without causing any harm. This allows to optimize the toxicological research, significantly decrease the number of laboratory animals used, and provide the valuable information not accessible by any other means.

The quality of MRI in terms of resolution, noise, and scan times, depends strongly on the magnetic field strength.

Minimum Technical Requirements for a Magnetic Resonance Imaging (MRI) system:

• Shall have a field magnetic strength of 9.0 Tesla or higher.

• Shall have a minimum accessible bore size (with gradient insert) of 100 mm.

• Shall a minimum gradient strength of 600 mT/m.

• Shall include pulse sequences for quantitative relaxometry, diffusion, and spectroscopy methods.

• The system shall be RF-shielded without requirement of external RF shielding.

• Shall include at least second-order shims.

Installation, Training and Warranty Requirements:

• The system and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and trouble shooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

• The offeror shall ship, deliver, install the equipment and provide all labor, travel, kits and tools, etc, to install the equipment at the address provided below, to include inside delivery.

• The offeror shall provide training 90 days after installation for the equipment for proper operation of the instrument.

• The offeror shall warrant the entire system for a period of at least one (1) year from acceptance by FDA. The warranty shall include: unlimited telephone/e-mail support for questions regarding operation, onsite visits for diagnosis of problems and repairs inclusive of all parts, labor, and travel expenses at no additional cost to the FDA.

Minimum Performance Requirements for 4 (1-year Post Warranty Maintenance Option Period):

• The Contractor shall provide one (1) scheduled on-site (hardware and software) planned preventive maintenance visit per year.

• The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 3 business days of call for service where problems cannot be resolved remotely after 2 business days.

• The Maintenance and Repair activities shall be performed following the Original Equipment

Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc.

• The Contractor shall include unlimited software and firmware updates during the coverage period(s).

• The Contractor shall include unlimited technical support Monday through Friday (excluding Federal Holidays) 8:00AM – 5:00PM Central Time.

• All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

Estimated Delivery Date: 12 months after award

Option Year 1: 03/18/2025 thru 03/17/2026 Option Year 2: 03/18/2026 thru 03/17/2027 Option Year 3: 03/18/2027 thru 03/17/2028 Option Year 4: 03/18/2028 thru 03/17/2029

Delivery Location:

Food and Drug Administration National Center for Toxicological Research 3900 NCTR Road Building 62, Rooms 106-108 Jefferson, AR 72079

Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide a written report to the FDA Technical Representative and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

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, 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.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, 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 the manufacturer (to include UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered services meet the technical requirements identified above.

• The offeror shall advise if the product and/or service is on a Best-in-Class contract.

• If applicable, the offeror shall clearly identify where the offered product is made.

• 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 a large business, provide if subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• 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.

• The Government is not responsible for locating or securing any information, not identified in the response.

• Informational pricing is desired.

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before January 31, 2024, by 13:00 hours (Central Time in Dallas, Texas) at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Yolanda Rankin, email yolanda.rankin@fda.hhs.gov.

Reference: 75F40124R00030.

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. Though this is not a request for quote, informational pricing for the service would be helpful.