U.S. FDA SOURCES SOUGHT NOTICE (SSN) Droplet Digital (dd) PCR system 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 Droplet Digital PCR 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 Vector-Borne Viral Diseases (LVVD) requires a droplet digital PCR (ddPCR) system to vastly reduce time spent manually quantifying viral nucleic acids from tissue cultures or infected animals. The laboratory of Vector-Borne Viral Diseases (LVVD) of Division of Viral Products conducts research on several important vector-borne viral pathogens, including Dengue, Zika, and West Nile viruses. The lab is also an integral part of FDA’s taskforce handling work on SARS-CoV-2 in elevated biocontainment during the current COVID-19 pandemic. A frequently-used assay performed in the laboratory is the quantification of viral nucleic acids from tissue cultures or infected animals, i.e., the viral load, to monitor the levels of infection. This process is labor intensive and often takes several hours for researchers to process only a few tissue samples. Moreover, traditional real-time PCR relies on amplifications of starting materials, which does not always provide absolute quantification, and is prone to sample-to-sample contamination because the current instrument does not incorporate HEPA filters. To this end, the LVVD requires a ddPCR instrument that provides better sensitivity, vastly superior quantification, and is designed to prevent sample-to-sample contamination. Minimum Technical Requirements are as follows for a Droplet Digital PCR (ddPCR) instrument system: *Shall be a stand-alone Droplet Digital PCR instrument system with integrated computer workstation and software; *Shall include automated droplet reader, plate sealer, thermal cycler, and all supplies and peripherals for start-up and operation; *Shall be capable of absolute quantification; *Shall be capable of detecting one copy of target sequence from DNA samples, and generating droplets in less than 60 minutes per 96-well plate; *Shall be capable of yielding up to 20,000 droplets per 20ul sample (approximately 2 million partitioned PCR reactions per 96-well plate); *Shall be capable of identifying “points of interest” in viral plaque assays and antiviral drug assays; *Shall integrate HEPA-filtered anti-contamination enclosure; *Shall be capable of linear dynamic range of 5 orders of magnitude in detection of input samples; *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 : 8 weeks after receipt of order Contract Type : Commercial Item-Firm Fixed Price Delivery Address U.S. Food and Drug Administration Center for Biologics Evaluation and Research Bldg. 52/72, Room 5353 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 type of ddPCR 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 ddPCR instrument systems 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 July 5, 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).