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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 Res... 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 for quantitative proteomics measurement of cardiotoxicity biomarkers in human plasma samples. 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-541380- Testing Laboratories; Small Business Size Standard is $16.5 million. The U.S. Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR), Jefferson, AR requires quantitative proteomics measurement of cardiotoxicity biomarkers in 150 human plasma samples. The analysis service shall be performed using multiplex immunoassays based on dual antibody recognition. The analysis shall be specific to human samples. Targeted proteins shall be involved in multiple biological processes of cardiovascular disease, cardiometabolism, and inflammation, including but not limited to angiogenesis, blood vessel morphogenesis, catabolic process, chemotaxis, inflammatory response, MAPK cascade, proteolysis, cell adhesion, cell communication, development process, transport, tumor immunity, vascular and tissue remodeling, etc. The analysis shall be highly sensitive, specific, and reproducible for measurement of targeted proteins in a high throughput fashion. Since sample volume is limited, the analysis shall be able to measure all the proteins in single assays using low microliters of human plasma. The plasma samples will be ready for shipment within 30 calendar days after contract award. Upon receipt of samples, the contractor shall perform the required proteomics analysis which shall be delivered within 30 calendar days from receipt of the government provided human plasma samples. All data will be provided to NCTR in a Microsoft Excel spreadsheet via email or an internet site for downloading. The service company does not own the data (i.e., intellectual property). NCTR/FDA is the owner of the data. Minimum performance requirements. 1. The proteomics analysis shall be multiplex immunoassay that is capable of quantifying >1400 proteins across 150 plasma samples simultaneously in 96-well plates with 384-plex capabilities. 2. The proteomics analysis shall couple an antibody-based immunoassay with the powerful properties of next generation sequencing (NGS) for a greater specificity. 3. The proteomics analysis shall be capable of measuring >1400 proteins in approximately three microliters of plasma sample. 4. The proteomics analysis shall be able to achieve a high level of multiplexing while maintaining exceptional data quality. 5. The proteomics analysis shall provide sensitivity that spans from femtogram to microgram levels of the proteins and average intra-assay coefficient of variation (CV) of <10% and interassay CV of <20%. 6. The proteomics analysis shall not show cross-reactivity due to unspecific binding of antibodies or must be able to exclude any antibody cross-reactivity that may occur during the multiplexed assay from the detection process. 7. The proteomics analysis shall be able of analyze human plasma samples using human-specific protein panels, including proteins related to cardiometabolism, inflammation, and oncology. 8. Data provided must be normalized using specific internal controls added to each sample to reduce intra-assay variability, and all data will be provided to NCTR in a Microsoft Excel spreadsheet. 9. The remainder of the plasma samples shall be shipped back to NCTR. FOB Point of Delivery for Services and Supplies will be the FDA located at NCTR 3900 NCTR Road, Jefferson, AR 72079 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 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, 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 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, 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 sale in which the offeror has provided same or substantially similar service 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 DUNS 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. 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 June 7, 2021 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference FDA1242919. 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 beta.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).