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 (CBER) requirement for a Multiparameter Flow Cytometric Cell Sorter with Spectral Analysis and Cell Imaging instrument (Imaging Cell Sorter). 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 – Multiparameter Flow Cytometric Cell Sorter with Spectral Analysis and Cell Imaging A. Introduction The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) requires a Multiparameter Flow Cytometric Cell Sorter with Spectral Analysis and Cell Imaging (Imaging Cell Sorter) capabilities for the CBER Flow Cytometry Core (CFCC) for the White Oak facility. This Imaging Cell Sorter will match performance when executing Spectral Analyzer cell collection experiments, with the added advantage of image capture. Further, this cell sorting system will replace current CFCC instrumentation soon to be retired. B. Background CBER has established a Flow Cytometry and Cell Sorting Core (CFCC) at the White Oak campus. The CFCC currently includes several cell sorting instruments (Becton Dickenson (BD) FACS Aria and FACSAria Fusion). CBER has included Spectral Analysis capabilities with additional analyzers (Cytek Aurora and Northern Lights). CBER requires a Spectral Analyzing Cell Sorter so we may match performance when executing cell collection experiments developed on the Spectral Analyzers. Spectral Analyzers use specialized spectral separation technology – Specialized Prisms or Coarse Wavelength Division Multiplexing -- to capture all fluorescence, then software deconvolution algorithms are used to separate signals for individual markers. The benefit of this process is that spillover correction is unnecessary, and measurements are more accurate. Further, adding new dyes to assays / expanding colors is facilitated since the new fluorescence signals are likewise separated through spectral analysis. This allows FDA investigators to expand parameters beyond our present limit of 20 and provides for assays up to 48 different markers. New image capture technology is now included in an Imaging Cell Sorter. Digital images are captured as cells are analyzed, and this extra capability improves quality control (cell identification, aggregate correction) while adding analytical benefit along with image-based cell sorting. This state-of-the-art cell separation technology will greatly enhance the research capabilities in the Core. Further, we will be better able to anticipate regulatory requirements for assays developed using spectral analysis technology. C. Scope The Contractor shall provide one (1) completely configured Multiparameter Flow Cytometric Cell Sorter Cell Sorter with Spectral Analysis and Cell Imaging capabilities (Imaging Cell Sorter). The CBER Flow Cytometry Core for the White Oak facility. This Imaging Cell Sorter shall include all necessary accessories, software, hardware, drivers, libraries, equipment, supplies, adapters, cables, workstations/monitors, filters, lasers, plates, slides, tubes, as a safe, seamless, turn-key solution. The Contractor shall be responsible for inside delivery, installation, standard installation/performance testing, training, warranty and up to four (4) 1-year option periods for post-warranty maintenance. This Imaging Cell Sorter will be used for a wide range of applications and CBER Core clients. In order to expand access and ease scheduling limitations, the Core will train core clients to operate this system. For this purpose, ease-of-use features are important. The system shall operate optimally without requiring daily optical alignment. Additionally, daily performance evaluations shall be automated, and this performance evaluation shall provide updates to optimization and experiment protocol setup. These protocols shall be savable and updated automatically according to the automated performance evaluation process. Part II: Work Requirements A. Technical Requirements: The Multiparameter Flow Cytometric Cell Sorter Cell Sorter with Spectral Analysis and Cell Imaging shall provide: Traditional analysis plus full spectrum unmixing. Allow autofluorescence as a unique spectral plot which can be subtracted from sample. Acquisition and analysis software included. Optics optimized and validated for dyes typical to flow cytometry 5 spatially separated lasers, specifications as indicated below: Ultra Violet Laser (UV; 355nm) Violet Laser (Violet; 405nm) Blue Laser (Blue; 488nm) Yellow-Green (YG; 561nm) Red Laser (Red; 640nm) Emission optics as indicated below: 78 fluorescence detectors Forward Scatter and Side Scatter, Axial Light loss Image detectors Variable sample handling to include: 5ml and 15ml sample tubes Sample Mixing, heating, cooling. Variable Sort Collection: 6-way tube sorting, 96 and 384 well (standard depth). Image sorting. Index Sorting. 1.5ml, 5ml, and 15ml collection tubes 70 mm, 85 mm, 100 mm and 130 mm nozzle sizes. Sort Modes Multiple default sort modes. Biosafety Primary: Hepa Filter engineered into sort chamber for aerosol management. Secondary: Specifically designed Biosafety Class 2 Type A2 cabinet tested to major WW biosafety standards. B. Installation, Testing and Training Requirements: The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include inside delivery. The equipment shall be tested once installed to verify all aspects of the system are operating within parameters of the required specifications. The Contractor shall demonstrate upon completion of installation and testing that the item meets all specifications. All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system. Upon acceptance of the system, training shall be provided to a minimum of two (2) attendees/users by the Contractor’s trained and certified personnel. C. Post-Warranty Service Requirements: At a minimum, the Contractor shall provide the following services during the option periods for post-warranty: Two (2) preventative maintenance visits per contract year inclusive of all labor, travel, and parts, components, subassemblies, etc. necessary to provide the service. Unlimited on-site corrective/remedial maintenance/repairs to be scheduled at the time of service request within five (5) calendar days from service call. On-site repair service shall be inclusive of all labor, travel, certified replacement parts, components, subassemblies, etc. needed to return the system to operational capacity. Unlimited technical support and trouble-shooting assistance, Mondays – Fridays (excluding Federal Holidays) during contractors normal business hours, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.) Formally trained and certified technicians/engineers for all maintenance and repair activities performed, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc. Unlimited software and firmware updates. 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 by email 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 Contracting Officer’s Representative and Contract Specialist by email, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed. Shipping Destinations: FDA at White Oak Building 52, Room 1151 10903 New Hampshire Avenue Silver Spring, MD 20993Arkansas Regional Laboratory POC: to be provided at award. 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 should be no more than 90 calendars days from date of award. 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. 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. 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 February 23, 2023 by 13:00 hours (Central Time in Jefferson, Arkansas) to
[email protected]. Reference CBER-2023-116864. 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).