FDA 75F40126SSN134450.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 Evaluation and Research (CBER), Office of Vaccine Research and Review (OVRR), Division of Viral Products (DVP), requires a fully automated laboratory vitrification system designed for preparing cryo-EM specimens by rapidly freezing biological samples in their native, hydrated state.

The FDA uses a cryogenic electron microscope (cryo-EM) to characterize the structural properties of antigens, antibodies, and other biological materials critical to vaccine research and regulatory decision-making, such as: 1) examining the morphology and structural integrity of vaccine antigens; 2) characterizing antibody-antigen interactions; 3) analyzing the size, shape, and distribution of viral particles and protein aggregates; 4) evaluating the quality and consistency of biological products.

To prepare biological specimens for analysis on the electron microscope, samples must be flash frozen in vitrified ethane. DVP requires a system designed solely for this process. It will be used to prepare high-quality vitrified specimens for structural biology studies, including: 1) preparing protein samples for high-resolution cryo-EM imaging; 2) vitrifying virus particles and viral complexes for structural characterization; 3) preparing antibody-antigen complexes for interaction studies; 4) creating vitrified specimens of cellular components and macromolecular assemblies; 5) ensuring reproducible specimen preparation with controlled environmental conditions (temperature and humidity).

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.

Minimum technical requirements that an automated laboratory vitrification system shall meet, to include all necessary components and installed functionality, are as follows:

*Shall be a stand-alone fully-automated vitrification system. Newly manufactured and not used or refurbished or previously used for demonstration;

*Automated Vitrification Capability: Fully automated specimen preparation with programmable parameters including blotting time, blot force, wait time, and drain time;

•Environmental Control: Temperature control range +4°C to +60°C; Humidity control range 0% to mailto:timothy.walbert@fda.hhs.gov

100% relative humidity with real-time monitoring and display;

*Sample Handling: Compatible with standard 3mm cryo-EM grids (various mesh sizes and support films); tweezers/grid handling system with secure grip mechanism;

*Blotting System: Must have dual-sided blotting capability with adjustable blot force and time; shall include filter paper advancement system for fresh blotting surface; this is a key technical requirement for CBER’s regulatory applications;

*Cryogen System: Liquid ethane capability with temperature monitoring and control; shall include user safety features for handling cryogenic liquids;

*User Interface: Touchscreen interface with programmable protocols, parameter storage and recall, and real-time process monitoring;

*Safety Features: Shall have enclosed working chamber, gas detection and ventilation compatibility, emergency stop functionality;

*Integration with Existing Equipment: System shall seamlessly integrate with an existing Tundra Cryo-Transmission Electron Microscope (Cryo-TEM);

*Warranty: Shall include a minimum one-year full manufacturer’s warranty.

Delivery Point – FOB Destination U.S. FDA Center for Biologics Evaluation and Research (CBER)

OVRR- DVP

Bldg. 52/72, Room 1132 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 (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 13, 2026, to Tim Walbert at timothy.walbert@fda.hhs.gov. Please reference 75F40126SSN134450 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 mailto:timothy.walbert@fda.hhs.gov 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.