75F40126SSN133943 Zeiss AI sample finder.pdf

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 U.S. Food and Drug Administration (FDA), Center for Biologics Research and Review (CBER), Office of Compliance and Biologics Quality (OCBQ), Division of Biological Standards and Quality Control (DBSQC), Laboratory of Biochemistry, Virology and Immunochemistry (LBVI), requires an AI Sample Finder for an existing Zeiss AXIO Observer Z1 inverted fluorescence motorized microscope, S/N:

383400118, which is currently used in lot release testing of the Flumist influenza virus vaccine. This acquisition is considered mission-critical for the testing and release of influenza virus vaccine as it relates to its impact on the general health of the entire U.S. population.

The AI Sample Finder automates slide preparation and navigation, reducing experiment setup times from minutes to seconds. It handles sample placement, focusing, and identifying areas of interest using a specialized camera, darkfield composite contrast, and deep learning algorithms the AI component). The addition of the Sample Finder will increase testing efficiency by significantly reducing the time used in sample testing and ultimately reduce lead times to health providers across the country. The installation includes an upgrade of the microscopy software, microscope stage upgrade, a new camera and adapter, and the Bioapps Toolkit.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Laboratory Analytical Instrument Manufacturing, with a Small Business Size Standard of 1,000 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 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.

Essential to this acquisition is the use of “brand name or equal” when describing specific components and their salient performance characteristics in this RFI. In this case, “brand name or equal” applies to the AI Sample Finder and software in its entirety. Where an offeror submits an “equal” product, to be accepted it shall meet all of the specific physical, functional, and performance features listed below under Minimum Technical Requirements.

Salient characteristics that the Zeiss “or equal” AI Sample Finder shall meet are as follows:

*Shall seamlessly integrate with an existing Zeiss AXIO Observer Z1 inverted fluorescence motorized microscope, S/N: 383400118, which will house the AI Sample Finder equipment;

*AI Sample Finder shall include the following Zeiss or equal sub-components:

*Camera Axiocam 305 mono R2;

*C-mount adapter 60N C 2/3" 0.63x;

mailto:timothy.walbert@fda.hhs.gov

*Scanning stage 130x100 PIEZO;

*Stage controller XY PIEZO WSB CAN;

*Universal mounting frame K-M;

*AI sample finder f/Observer;

*Zen Toolkit for Bio Apps DLic;

*Software upgrade with motorized acquisition toolkit ZEN 3.10 DLic.

Delivery Point

U.S. FDA CBER LBVI

Attn: TBD Bldg. 52/72, Room G239 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

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 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 June 1, 2026 to Tim Walbert at timothy.walbert@fda.hhs.gov. Please reference 75F40126SSN133943 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 mailto:timothy.walbert@fda.hhs.gov provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.