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U.S. FDA SOURCES SOUGHT NOTICE (SSN) Automated nucleic acid extraction instrument SSN #: 75F40123R118419 Posted Date: June 27, 2023 Response Date: July 7, 2023, 2:00 pm CDT Classification: 6640 – Labo... U.S. FDA SOURCES SOUGHT NOTICE (SSN) Automated nucleic acid extraction instrument SSN #: 75F40123R118419 Posted Date: June 27, 2023 Response Date: July 7, 2023, 2:00 pm CDT Classification: 6640 – Laboratory Equipment and Supplies NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing, Small Business Size Standard: 1,000 employees MARKET RESEARCH PURPOSES ONLY - NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a Sources Sought notice to determine the availability of SAM.gov-registered small businesses capable of supplying the scientific instrument system described herein. 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 The U.S. Food and Drug Administration (FDA) Office of Acquisitions and Grants Services (OAGS) presents this Sources Sought Notice (SSN) on behalf of the Center for Biologics Evaluation and Research (CBER), Office of Vaccine Research and Review (OVRR), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), to identify existing small businesses capable of providing an automated nucleic acid extraction system for ongoing research within the Center. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing, Small Business Size Standard: 1,000 employees, and believe that your firm is capable of providing this type of instrument system, please submit a capability statement by e-mail to timothy.walbert@fda.hhs.gov. by the date and time specified above, providing all information as required below. Background The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Division of Bacterial, Parasitic and Allergenic Products (DBPAP) functions within the Office of Vaccine Research and Review (OVRR), whose mission is to protect and enhance public health by assuring the availability of safe and effective vaccines, allergenic extracts, and other related products. DBPAP requires an automated nucleic acid extraction instrument system for their ongoing research. Ongoing studies and experiments in DBPAP’s Carlson Laboratory require the use of purified nucleic acids for a number of assays such as polymerase chain reaction (PCR) and next generation sequencing (NGS). Our current workflows for the extraction and purification of nucleic acids are limited to manual processes which are labor intensive and inefficient. Manual processes have higher risk than automation for user error or sample contamination affecting downstream processing and data collection. Automation of the nucleic acid extraction processes will help to reduce the number of work hours spent extracting and improve overall consistency and reliability of experimental data. The instrument will be used for multiple projects in the lab. The Carlson Laboratory also uses purified nucleic acids in a number of different active research projects including pathogen detection, evaluation of diagnostic protocols, quantifying microbial load, and gene expression analysis. The instrument should be able to process 24 samples per run for the intended downstream processes. The lab will benefit from an automated nucleic acid extraction instrument to reduce labor, improve the quality of generated data, and provide for increased efficiency. Minimum Technical Requirements are as follows for an automated nucleic acid extraction instrument system: *Shall be capable of processing 24 samples per run; *Shall include both magnetic and liquid handling capabilities, as well as heating capability; *Shall be compatible with pre-filled reagent cartridges; *Shall reliably produce uncontaminated isolated nucleic acids; *Width and depth of unit shall not exceed 75 cm and 60 cm, respectively, due to restricted laboratory counter space; *Shall include software and license necessary for operation, data collection and transfer; *Shall have physical connectivity (i.e., USB port) that does not require additional connectivity to the network or internet; *Shall have standard run protocols for commercially available kits; *Shall be able to run modified or custom protocols to meet the lab's specific or changing needs; *Shall not require regular calibration outside of regular preventative maintenance; *Shall include all shipping/handling/delivery fees FOB Destination; *Shall include 1-year full manufacturer’s warranty to include replacement parts and service. Contract Type: Commercial Item-Firm Fixed Price Delivery Address: U.S. Food and Drug Administration CBER-OVRR-DBPAP Bldg. 52/72, Room 3376 Silver Spring, MD 20993-0002 Responses to this Sources Sought notice shall unequivocally demonstrate the respondent is currently engaged in providing the equipment or services described herein and meeting all technical requirements set forth above. Although the target audience for this Notice are small businesses or small businesses capable of providing these stocks 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; Descriptive literature, brochures, marketing material, etc. detailing the automated nucleic acid extraction instruments which the responding firm is regularly engaged in providing; should include a capability statement that unequivocally demonstrates that the technical requirements and delivery time identified above can be met; Provide recent (within the last three (3) years) and relevant past performance information for the manufacture and/or sale in which the offeror has provided identical or substantially similar instruments. 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 Identifier (UEI) and size status) if not the respondent; 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 products or services required is currently available on a “Best in Class” or other Government-wide or HHS-wide contract; Respondent shall provide country (or countries) of origin for the products and/or services offered in response to this solicitation, and shall include any other applicable information to enable review and analysis pursuant 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 7, 2023, to Tim Walbert, Contract Specialist, at the following address: timothy.walbert@fda.hhs.gov. 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).