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) is issuing this source 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 the items and services described herein. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered. 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 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to
[email protected]. Background: The Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR) Division of Neurotoxicology requires “Brand Name or Equal” Emulate Inc., Chip-R1 Rigid Chips, to evaluate if a novel brain-chip system that models pediatric and adult rates of cerebral blood flow (CBF) can be used to assess neurotoxicity induced by CD19 CAR T-cells. To construct the brain-chips, brain cells derived from human induced pluripotent stem cells (hiPSCs) will be cultured on a microphysiological chip (Chip-R1), constructed from rigid plastics and a polycarbonate porous membrane. Each Chip-R1 connects to a Pod-2 module that stores up to 4 mL of cell culture media for each microfluidic channel. Media can flow through the microfluidic channels by connecting the Chip-R1 and Pod-2 modules, to the Zoë Culture Module 2 (CM2), which in turn is controlled by the Orb Hub Module 1 (HM1). Altogether, Zoë CM2 and Orb HM1 are known as the Human Emulation System. This requirement includes preventive maintenance and repair services for three Zoë CM2 Culture Modules and one Orb Hub Module to ensure optimal working performance for the support of ongoing research. Preventive maintenance and repair services are required on the following instruments: Zoe CM2, Serial Number: 00174 Zoe CM2, Serial Number: 00175 Zoe CM2, Serial Number: 00176 Orb HM1, Serial Number: 00153 This requirement is configured as Brand Name or Equal: - Emulate Inc., Chip-R1 Rigid Chip Minimum Technical Requirements: Chip-R1 specifications: Top channel: Width x height dimensions- 1,000 µm x 1,000 µm. Area at membrane- 26.66 mm2. Channel volume- 24.52 µL. Imaging distance from bottom of chip to top of membrane- 172 µm. Bottom channel: Width x height dimensions- 1,050 µm x 100 µm. Area at membrane- 29.46 mm2. Volume- 2.97 µL. Membrane: Pore diameter- 3.0 µm. Pore spacing- Random distribution (Track-etched membrane). Porosity- 2.8%. Thickness- 22 µm. Shall have a 1-year shelf life. Shall be sterile. Chip carrier specifications: Shall be compatible with Chip-R1. Shall have a 1-year shelf life. Shall be sterile. Pod Portable module specifications: Shall be compatible with Chip-R1. Shall have a volume capacity- 4 mL. Shall be compatible with Zoë CM2. Shall have a 1-year shelf life. Shall be sterile. Additional Requirements : Shall be newly manufactured, not used or refurbished, or previously used for demonstration. Shall be warranted for not less than one (1) year from FDA acceptance. Preventive Maintenance and Repair Services Minimum Performance Requirements : The Contractor shall provide one (1) scheduled on-site planned preventive maintenance visits (including parts) per year. The Contractor shall provide unlimited On-Site Corrective Maintenance/Repairs within 2 business days of call for service where problems cannot be resolved remotely after 2 business days. The Maintenance and Repair activities shall be performed by the service engineers who are trained and certified by the Original Equipment Manufacturer (OEM). The service provider should follow the OEM specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. The service plan shall include access to OEM technical developments, repair procedure bulletins, and unlimited software, firmware, and application updates. The Contractor shall provide factory-certified replacement parts. The Contractor shall include unlimited technical support (via phone and email) on software and hardware and troubleshooting with any equipment issues, Monday through Friday (excluding Federal Holidays). All maintenance/repair pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, consumables, etc. for the system. Deliverables: 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 COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Place of Performance: FOB Point Destination. All items shall include shipping, handling and inside delivery to the destination identified herein. FDA - NCTR 3900 NCTR Rd Jefferson, Arkansas 72079 Period of Performance: Delivery and preventive maintenance service shall occur within 120 calendar days from date of award. Preventive maintenance and repair service period of performance shall begin upon date of award and continue for a period of 12 months. Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. 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, unique entity identification (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 items/services meet the technical requirements identified above. 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 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 whether 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. Informational pricing is desired. The Government is not responsible for locating or securing any information, not identified in the response. Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before April 28, 2025 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA | OO | OFBA | OAGS | DAP, Attn: Warren Dutter, email
[email protected]. Reference: FDA-SSN-128406. 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 and Proprietary Information: 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. Pending market research findings, the supply of Chip-R1 Rigid Chips may be solicited separately from Preventive Maintenance and Repair Services to enhance competition.