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 Center for Biologics Evaluation and Research’s (CBER) requirement for an automated benchtop flow cytometry 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. Background The Division of Blood Components and Devices (DBCD), Laboratory of Cellular Hematology, has a research project to study the microbial reduction and micro RNA profiles in stored platelets and blood products. This work involves sorting human platelets from the animal platelets by florescent antibody labeling of the cell surface of the human platelets and analyzing through a flow cytometer. This work requires an automated benchtop flow cytometry system. Our current flow Cytometer is old and discontinued by the company. As a result, it may no longer be supported for technical performance, parts, and Maintenance. Therefore, it will be replaced with a new Flow Cytometer. Technical Requirements Have 488nm and 640nm lasers, Forward Scatter Detector (FSC) Photodiode, and Tube type Photomultiplier Tube Photomultiplier Tube (PMT) detectors for Fluorescence Detection. Be able to collect pulse area, height, and width on all parameters simultaneously. Have fixed alignment optics in conjunction with spatially separated solid-state lasers. Able to easily replace optical filters and mirrors for experimental flexibility. Sensitivity Measurement; Minimum values: FITC >15; PE >80; PerCP >9; PerCP-Cy5.5 >25; PE-Cy7 >120; APC >40; APC-Cy7 >16 FSC Resolution 1.0 μm SSC Resolution 0.5 μm Shall perform real-time statistics via the acquisition software. Must be capable of analyzing In-Vitro Diagnostic at most minuscule 30 logical gates. Have minimal sample carryover, less than .03% possible in single tube mode. The operating system must include CQ software that automatically determines and or adjusts Laser delays, Area Scaling Factor, Linear range, Fluorescence detector efficiency, Optical background, and Electronic Noise for accurate and repeatable results. Must be able to export FCS 2.0/3.0/3.1 data files Software must be compatible with existing CBER Center cytometers for ease and accuracy of assay replication. The fluidics system must run various saline sheath fluids, including isotonic electrolyte balanced sheath, for assay replication. True benchtop design Shall have at least three color basic In-Vitro Diagnostic (IVD) equipped with a workstation computer and printer bundle to carry out the work and perform data analysis. The FDA is offering a trade-in of the existing FACS Calibur flow cytometer. Trade-in instrument is offered in “as is” condition. Installation, Training and Additional System Requirements. The contractor shall provide in-side delivery, installation/assembly and operator familiarization training for the system. The contractor shall provide training (in addition to installation of the system) for up to two personnel to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements. Offered system shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware and components otherwise required to meet these specifications and the FDA’s stated need. The system shall be delivered with all necessary supplies and accessories required for installation and start-up. The system shall be warranted for not less than one (1) year from FDA acceptance of the equipment to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year. FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery, installation and staff familiarization training shall occur within the contractor’s normal manufacturing lead times for these items but shall be no more than 90 calendars days from date of award. FOB Point of Delivery for Services and Supplies will be the FDA located at CBER 10903 New Hampshire Ave. Silver Spring, MD 20993 Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum 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, 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 manufacture and/or sale in which the offeror has provided same or substantially similar system 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. Estimated Trade-in credit for existing flow cytometer. 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 9, 2021 by 13:00 hours (Central Time in Jefferson, Arkansas) to
[email protected]. Reference FDA1243044. 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).