75F40126SSN134234 cell enumerator.docx

This is a Sources Sought Notice (SSN) - a market survey designed to collect written information only. This is not a solicitation announcement for proposals and no contract will be awarded from this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement or any follow-up information requests. There is no RFQ, or other iteration of a solicitation associated with this Notice, and no telephone calls will be accepted requesting an RFQ package or solicitation. To protect the procurement integrity of any future acquisition that may arise from this announcement, information regarding a government technical point of contact will not be given and no appointments for presentations will be made.

The Carlson Laboratory at The U.S. Food and Drug Administration (FDA), Center for Biologics and Review (CBER), Office of Vaccine Research and Review (OVRR), Division of Bacterial, Parasitic, and Allergenic Products (DBPAP), Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI) requires a BactoBox cell enumerator for the assessment and development of assays to measure the potency of Live Biotherapeutic Products (LBPs) and Fecal Microbiota Transplantation (FMT) products. The lab is working on development of assays for characterization of microbial products, including single/multi strain live biotherapeutics and more complex products like FMT.

One of the aspects of the Carlson Lab’s work is to assess technology that the industry is using for product development to gain experience with these instruments. The FDA needs to fully understand its capabilities and limitations in order to effectively regulate products where these technologies are being used for product characterization and release. The lab will work to develop/publish methods with this technology and compare its utility for various product types with more conventional methodologies. Meanwhile, the lab has received an increasing number of Investigational New Drug (IND) submissions which propose using the BactoBox counter in lieu of more traditional methods to determine product potency. The lab will evaluate the results of the BactoBox in comparison to the traditional plating and live-dead staining methods to better understand the capability of the BactoBox device for measuring drug product potency.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing, with a Small Business Size Standard of 1,00 employees, and you believe that your firm would be able to provide the FDA with the equipment and/or services described below, please submit an email containing capability statement(s) to timothy.walbert@fda.hhs.gov.

Other than small (large) business concerns are also encouraged to submit capability statements. An interested supplier shall include information about the company and demonstrate that it can meet all the following minimum performance requirements.

The minimum technical requirements that a cell enumerator shall meet are as follows:

*Shall be a stand-alone bacterial flow cytometer for counting live organisms in samples and be customizable in configuration;

*Shall be capable of rapid sample assessment (less than 5 minutes per sample);

*Shall have a 2-log linear range to allow assessment of varied sample concentrations;

*Shall have the ability to enumerate (count) viable/intact bacterial cells;

*Shall be a portable/benchtop design;

*Shall include software for data visualization and analysis;

*Shall include all peripherals and related items required for sample processing and running;

*Shall include dilution dispenser;

*Shall include flow cells;

*Shall include all required consumables for 200 runs;

Delivery Point

U.S. FDA CBER OVRR-DBPAP-LMPCI

Dr. Paul Carlson 10903 New Hampshire Avenue Bldg 52/72, RM 3376 Silver Spring, MD 20993

Responses to this Sources Sought Notice shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar equipment and/or services. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

· Business name and bio, Unique Entity ID (SAM) 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 again if responding to provide a service offered by another firm;

· Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service to include date of sale, description, dollar value, client name, client address, client 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;

· Descriptive literature, brochures, marketing material, etc. detailing the nature of the equipment and/or services the responding firm is regularly engaged in manufacturing or selling;

· The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above;

· If applicable, the offeror’s capability to initiate service within 5 business days of original notification, to include estimated historical on-site response time for the brand name and model of instrument in this requirement;

· If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested;

· If applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available under;

· If a large business, provide whether subcontracting opportunities exist for small business concerns;

· Standard commercial warranty and payment terms;

· Provide place of product manufacture (Country of Origin) 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 required.

Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes. The Government is not responsible for locating or securing any information not identified in the response.

Interested Contractors must respond with capability statements submitted ONLY by email on or before 2:00 pm (Central Time in Jefferson AR) on July 1, 2026, to Tim Walbert at timothy.walbert@fda.hhs.gov. Please reference 75F40126SSN1334234 in the Subject line of the e-mail.

Disclaimer and Important Notes This notice does not obligate the Government to award a contract or 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.

Responses with weblinks will not be opened or viewed. Responses must demonstrate capability, not merely affirm the respondent’s capability (i.e. the response must go beyond the statement that, “XYZ company can provide the instrument, technical support etc.”).

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 or combined synopsis/ solicitation may be published on SAM.gov – Contracting 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).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.