U.S. FDA SOURCES SOUGHT NOTICE (SSN) Single Cell Partitioning Instrument SSN #: 75F40122R112313 Posted Date: June 8, 2022 Response Date: June 17, 2022 Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the single cell partitioning instrument described below. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposal, Request for Quotation, or an indication the Government intends to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a Small Business Set-Aside is possible. The appropriate NAICS code for the acquisition is 334516 – Analytical Laboratory Instrument Manufacturing, Small Business Size Standard 1.000 Employees. Requirement and Background The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Laboratory of Emerging Pathogens (LEP) Division of Microbiology requires a single-cell partitioning instrument to analyze the immune response within single cells at the transcriptomic and epigenomic levels to develop biomarkers for bloodborne pathogens. Single-cell transcriptomic studies will lead FDA researchers to a broader, deeper understanding of the pathogenesis of bloodborne pathogens at the single-cell level. These studies will also (1) enable scientists to decipher the immune response to these pathogens in the blood cells to develop better biomarkers for identifying them, and (2) support work within the LEP designed to establish correlates of immune protection for the parasitic vaccines. Minimum Technical Requirements are as follows for a single-cell partitioning instrument: *Shall be a stand-alone single cell partitioning instrument, newly manufactured and not used or refurbished or employed for demonstration; *Shall be capable of single-cell partitioning for Transcriptome and Immune Profiling analyses; *Shall be capable of single nuclei partitioning for Epigenome analysis and combined Transcriptome and Epigenome analysis; *Shall be capable of generating single-cell transcript counts from up to 80,000 cells per instrument cycle (run); *Shall be capable of producing >90,000 individual nanoliter-scale partitions leveraging 3 million or more unique barcodes; *Shall capture cells at high efficiency up to 65%; *Shall indicate low doublet rate of 0.9% per 1,000 cells; *Shall be capable of deep profiling of complex cell populations with high-throughput digital gene expression of individual cells; *Shall be capable of accessing the whole transcriptome with an unbiased approach appropriate for discovery work; *Shall perform target enrichment of the same library sample before sequencing to focus on a subset of relevant target genes; *Shall measure additional phenotypes with barcoding technology; *Shall include turn-key analysis pipelines and visualization software for users of all levels of users (novice to expert);novice and expert users alike; *Shall include a microfluidics chip compatible with a wide range of eukaryotic cell sizes and types. *Capable of rapid time to lysis to provide accurate view of a transcriptome with minimal impact on expression; *Shall include on-site training/instrument familiarization for FDA staff and researchers; *Shall include minimum one-year full manufacturer warranty commencing from date of acceptance and functionality. Delivery Terms : September 30, 2022 Contract Type : Commercial Item-Firm Fixed Price Period(s) of Performance (Estimated) Delivery of single-cell partitioning instrument July 1, 2022 – September 30, 2022 Delivery Address: U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 72, Room 4358 109003 New Hampshire Ave. Silver Spring, MD 20993-0002 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in supplying the single-cell partitioning instrument system described herein. Although the target audience for this Notice are small businesses or small businesses capable of providing this equipment from another small business, all interested parties may respond. At a minimum, responses in the form of a Capability Statement shall include the following: Business name and bio, SAM Unique Entity Identifier (UEI), 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 again if responding with the capability of providing an instrument offered by another firm; Descriptive literature, brochures, marketing material, etc. detailing the single-cell partitioning instruments which the responding firm is regularly engaged in providing. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements identified above can be met; Provide recent (within the last three years) and relevant past performance information where the offeror has provided same or substantially similar instrument systems. 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 and phone number, and e-mail address (if different from that provided for client); If applicable, standard commercial warranty and payment terms; If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SIN’s that are applicable to this potential requirement are also requested; If a large business, provide documentation of any subcontracting opportunities which exist for small business concerns; 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; Respondent shall advise if the services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract. If applicable, respondent shall provide place (country) of product/service manufacture or performance and any other applicable information to enable review and analysis pertaining to the requirements under the Buy American Act and requirements relating to Executive Order 14005 Ensuring the Future is Made in All of America by All of America’s Workers, in the event that a nonavailability waiver request submitted through the Made in America Office (MIAO) Digital Waiver Portal is required. Interested parties shall respond with Capability Statements as described above by e-mail only, before 2:00 pm (Central Daylight Time - Local Prevailing Time in Jefferson, Arkansas) on June 13, 2022, to Tim Walbert, Contract Specialist, at the following e-mail address:
[email protected]. 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/or combined synopsis-solicitation may be published on SAM/Federal Contract Opportunities (formerly FBO) at https://sam.gov/content/opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality and Proprietary Information 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).