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MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Rese... MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the National Center for Toxicological Research (NCTR) requirement to upgrade an existing ImageXpress Micro Confocal High Content Imaging System (IXMC). The upgrade to include an automated water immersion unit and 40X APO LWD 1.15 NA water immersion objective to the existing system. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The associated North American Industry Classification System (NAICS) Code is-334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees. Statement of Work (SOW): The U.S. Food and Drug Administration (FDA) the National Center for Toxicological Research (NCTR) requires an upgrade to an existing ImageXpress Micro Confocal High Content Imaging System (IXMC). The upgrade to include an automated water immersion unit and 40X APO LWD 1.15 NA water immersion objective to the existing system. The high content imaging system is needed to support multiple projects within the Division of Systems Biology. The current IXM-Confocal High Content Imaging System, serial number 5150127, has the capability for an in-field upgrade for a water immersion unit and water immersion objectives. The upgrade to this technology will significantly increase the resolution by adjusting the refractive index and numerical aperture of the objective lens. This will assist in overcoming the challenges in imaging both channels of the three-dimensional (3D) microphysiological system that is being developed to evaluate hepatoxicity. The upgrade to a water immersion objective provides higher quality imaging that will allow the multi-cell culture in both channels to be imaged. Additionally, the system will be used to support work evaluating the effects of various drugs on cardiomyocytes and for Ca2+ imaging, DNA damage, as well as future 3D cell model systems as alternative models of toxicity studies current being evaluated in neurotoxicity for potential effects on proliferating hiPSCs, on formation of embryoid bodies (EBs), on neural rosette differentiation, and on proliferating and differentiating neural precursor cells (NPC) related to opioid use by pregnant women. The upgrade shall meet the following Scope and Requirements: Upgrade to an automated water immersion unit and 40X APO LWD 1.15 NA water immersion objective to the existing ImageXpress Micro Confocal High Content Imaging System is required to accomplish our goals and shall meet the following needs: • The system must have the capability to be upgradable with Nikon Water Immersion Objectives which must have safety sensors that are compatible with the MetaXpress software 6.XXXX and IXMC firmware. • Upgradable auto water immersion objectives selectivity must include 20X APO LWD 0.95 NA, 40X APO LWD 1.15 NA, and 60X PLAN APO 1.20 NA. • Water immersion Objectives must be connected to Molecular Devices automated Water supply Dispenser Module and have automated drainage in waste bottle for collection. • It shall have widefield imaging capabilities with confocal imaging with >3 log dynamic range. • It shall have a fully automated X-Y and Z stages with resolution better than 100 nanometers • It shall have the ability to acquire from a variety of multi-well plate formats up to 1536 well for high throughput including unusual formats developed for 3D assays with round bottom or trans-well plates. • It shall have High Content Image Analysis software tools capable for 3D image Analysis. • Contractor shall provide the installation of the upgrade on-site where the instrument is located as identified below. The infield upgrade is needed for two projects identified below. Project 1: Imaging in liver microphysiological system to establish cellular assays to predict cytotoxicity and metabolic activity Background: NCTR is investigating drug-induced liver injury (DILI) in a liver microphysiological system (MPS) to evaluate the physiological relevance and clinical predictivity of the system. This MPS is advantageous in that the design allows primary human hepatocytes to be co-cultured with liver non-parenchymal cells consisting of sinusoidal endothelium, Kupffer, and stellate cells in two overlapping cell culture compartments separated by a porous flexible polymer membrane. The co-culture more closely mimics in vivo functionality and physiology. Various cytotoxicity and metabolic assays of interest are being utilized that are available for traditional in vitro studies of DILI, but very few are optimized for this MPS. NCTR is interested in establishing a fluorescence-based optical detection method for effective cellular analysis of protein expression, metabolism, oxygen/glucose concentration and viability. However, due to the three-dimensional architecture of the MPS, the flexible polymeric material used in the system and the fact that cells are cultured in an overlapping condition it is quite difficult to image with a traditional widefield microscope system. The ability to capture images using either widefield or confocal modalities would better enable imaging of the cells in the MPS. Project 2: Human induced pluripotent stem cell based in vitro model to investigate the toxicity of opioids on neural development Purpose: An FDA Drug Safety Communication addressing the safety of certain prescription and over-the-counter pain medications commonly taken by pregnant women was released in 2015. Opioids were communicated as a concern due to possible risk of neural tube defects (NTDs) with first trimester exposure. To assess developmental neurotoxicity, human pluripotent stem cell based in vitro model have been utilized as a new approach methodology (NAM). This type of platform may allow the Agency to (1) determine if certain opioids pose a greater risk to the developing fetus, (2) identify the most susceptible neuronal cell type to drug effects, and (3) provide information as to the mechanism of drug action. In addition, this study may provide valuable supporting evidence of direct or indirect (i.e., maternally mediated) effects of opioid action. Multiple opioids, including morphine, methadone, and codeine, were screened in four human iPSC lines for potential effects on proliferating hiPSCs, on formation of embryoid bodies (EBs), on neural rosette differentiation, and on proliferating and differentiating neural precursor cells (NPC). To complement the assessment of neuronal activity, immunofluorescent imaging will be used to characterize changes in the marker protein localization to the corresponding qRT-PCR expression levels following opioid treatments during neural rosette formation. To capture such phenomena in vitro, we require a highly efficient imaging system with water immersion capability to significantly increase the resolution of the objective. Requirements for project 1: • The system must have the capability to be upgradable with Nikon Water Immersion Objectives which must have safety sensors that are compatible with the MetaXpress software 6.XXXX and IXMC firmware. • Upgradable auto water immersion objectives selectivity must include 20X APO LWD 0.95 NA, 40X APO LWD 1.15 NA, and 60X PLAN APO 1.20 NA. • Water immersion Objectives must be connected to Molecular Devices automated Water supply Dispenser Module and have automated drainage in waste bottle for collection. Period of Performance The upgrade installation shall be completed within 120 calendar days of award. This is a one-time single acquisition to include 90 day warranty covering parts and labor on the upgrade. Location of Performance National Center for Toxicological Research Division of Systems Biology Innovative Safety & Technologies Branch Bldg. 53D-110 Jefferson, AR 72079 FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name, SAM Unique Entity ID 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 if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • Past performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 SAM Unique Entity ID 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. Detailed list of items included and not included on the GSA contract to meet this requirement. • 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. • Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would 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; and • Though this is not a request for quote, informational pricing is encouraged for both the purchase of the instrument and a lease of the instrument. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 18, 2023 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference NCTR-2023-118286. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not 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).