Inactive Total Small Business Set-Aside (FAR 19.5)

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires a High Content Imaging Syste... MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires a High Content Imaging System to perform measurements of intracellular calcium (Ca2+) flux in human donor induced-pluripotent stem cell (iPSCs) cardiomyocytes to acquire more knowledge on molecular changes in the heart to understand the mechanisms’ underlying cardiotoxicity induced by drugs such as anti-cancer drugs, anthracyclines. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing 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 or fewer employees. Technical Requirements: The system shall include: Widefield imaging capabilities with confocal imaging with >3 log dynamic range to capture variability in fluorescent intensity that will be indicative of cytotoxicity and mitochondrial integrity related to cardiotoxicity following treatment with anthracyclines on human-derived iPSC cardiomyocytes. Objectives from 1X to 100X magnification to visualize the synchronous beating of the cardiomyocyte monolayer and assessment of uniformity within the cell culture as well as fluorescent intensity inter-cellularly within a specific treatment well. A fully automated X-Y and Z stages with resolution better than 100 nanometers to observe unique morphological changes of the cardiomyocytes during assays measuring Ca2+ flux. The ability to acquire from a variety of multi-well plate formats up to 1,536 wells for high-throughput including unusual formats developed for 3D assays with round bottom for spheroid formation of cardiomyocytes during specific chemical treatments or trans-well plates for the promotion of a uniform monolayer of cells and formation of cardiomyocyte morphology. The format flexibility allows the ability to investigate multiple conditions with multiple anthracyclines across variable dosages simultaneously. The capabilities for analyzing beat patterns and monitor changes in intracellular Ca2+ flux associated with human iPSC derived cardiomyocyte contractions. The capabilities for a real-time kinetic cellular screening system for identifying early leads into candidate anthracyclines to further investigate severe adverse effects of delay-onset cardiotoxicity. The integrated fluidics with a single channel pipettor capable of dispensing compounds into the well and imaging simultaneously to capture a fast Ca+ response window before, during, and after treatment with the compounds. This data capture will provide unique insight to the understanding of anthracycline metabolism through the entire duration of metabolite formation, uptake, and elimination. The capability to give 100 data points per beat (1s) allowing for better peak analysis. This comprehensive analysis will allow for a level of precision necessary to determine onset of effects during anthracycline treatment and evaluate acute versus longer term observations. High Content Image Analysis software tools specifically for Cardiomyocytes to address the translation of preclinical findings demonstrated in our lab of significant decline in heart function and structure in a rodent model to human cardiomyocytes will be crucial in understanding the molecular basis underlying late-onset anthracycline-induced cardiotoxicity. The ability to investigate the molecular changes in vitro using human donor induced pluripotent stem cells (iPSCs) cardiomyocytes will be an invaluable tool in bridging the knowledge gap from our pre-clinical findings to clinical translation. The capability to provide temporal response curves to analyze and visualize the effect of compounds on beating cells as well as the ability to calculate signal peak parameters based on a dynamic threshold and derivative analysis, and provide amplitude, time, frequency, rate, and width values. These multi-parametric measurements will provide a truly comprehensive assessment of anthracycline treatment effects on intracellular Ca2+ flux and contractility of the human-induced iPSC cardiomyocytes. One-year warranty beginning from date of acceptance. Installation and training. Period of Performance: Delivery, installation and training shall be completed within 30 days of award. Warranty period will begin on date of acceptance and continue for a period of one year. Place of Delivery: 3900 NCTR Rd Bldg. 53D-110 Jefferson, AR 72079 The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered product/services meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying services of a small business, all interested parties may respond. At a minimum, responses shall include the following: Business name, DUNS 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 service can meet the above requirements. All descriptive material necessary for the government to determine whether the service offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. 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. 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; and Though this is not a request for quote, informational pricing is encouraged. 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 5, 2020 by 1:00 PM (Central Time in Jefferson, Arkansas) to warren.dutter@fda.hhs.gov, Reference: FDA-SSN-1227100. Notice of Intent Responses to this Sources 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 beta.SAM.gov – Contracting Opportunities. 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).