SSN 75F40126SSN135511.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY FOR

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. NO

TELEPHONE CALLS WILL BE ACCEPTED REQUESTING AN RFQ PACKAGE OR

SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE PROCUREMENT,

IF ANY, THAT MAY ARISE FROM THIS ANNOUNCEMENT, INFORMATION

REGARDING THE TECHNICAL POINT OF CONTACT WILL NOT BE GIVEN AND

NO APPOINTMENTS FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) issues this Sources Sought Notice (SSN) on behalf of the National Center for Toxicological Research (NCTR), Division of Genetic and Molecular Toxicology (DGMT) laboratory in order to determine if there are existing small business sources capable of providing an Agilent Cytation 9 Cell Imaging Multimode Reader, or equivalent instrument to combine multimode detection with advanced high-content imaging, providing capabilities required for a broad range of studies utilizing modern in vitro systems, including 3D spheroids, organoids, and other human-relevant cell culture models. The system will be used for screening applications and the development, evaluation, and validation of New Approach Methodologies (NAMs). This system will modernize and improve the predictive value of in vitro genotoxicity data for making regulatory decisions that protect human health and welfare. The instrument shall meet or exceed the requirements listed below.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 334516 – Analytical Laboratory 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 product described below, please submit an email to suzanne.martella@fda.hhs.gov.

Other than small business concerns and vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum specifications included below—to include the country of manufacture of products offered.

Minimum Performance Requirements:

1. The instrument shall provide automated, high-throughput image acquisition and analysis in multi-well plate formats.

2. Shall provide capability of automatic image capturing system.

3. Configurable upright and inverted microscopy and filter- and monochromator-based multimode microplate reading within a single hardware platform.

4. Image analysis and with add-on modules for application-specific analyses.

mailto:suzanne.martella@fda.hhs.gov

5. System shall include all accessories to achieve the research goals listed in the above, not limited to filters, LEDs, objectives, assemblies, holders, plates, and adapters.

6. System shall operate using standard 120V 15-amp power supply.

7. Contractor shall provide unlimited free telephone, e-mail and fax technical support for one-year starting date of government acceptance.

8. The Contractor must provide written verification or a formal Letter of Authorization (LOA)/Letter of Supply (LOS) directly from the Original Equipment Manufacturer (OEM), Agilent Technologies, verifying they are an authorized reseller fully certified to sell, install, and support the Cytation 9 platform.

Salient Characteristics: The system shall meet the following general functions:

1. Automated digital microscopy and multimode detection in one system.

2. Plate reader shall use optics to automatically identify samples of interest for imaging.

3. Shall be compatible with 6 to 384-well microplates, microscope slides, and counting chambers.

4. Must offer fluorescence, brightfield, color brightfield, phase contrast, and high contrast brightfield imaging modes, as well as optional upright transmitted and reflected imaging modes.

5. Be capable of performing fluorescence, absorbance, and luminescence microplate reading.

6. Ability to integrate with available automated incubator with eight-microplate (or other labware) capacity to automate live cell imaging workflows to assure fully integrated software control.

The System’s Imaging shall include the following minimum functions:

1. End-point, time lapse, Z-stack, and montage imaging methods.

2. Six-objective capacity for inverted microscope.

3. Four microscopy color channels for inverted microscopy including dedicated laser autofocus position.

4. 1.25x to 20x magnification with inverted microscope system, to cover broad imaging applications.

5. Fluorescence, phase contrast color brightfield, user-selectable brightfield, and high-contrast brightfield imaging with inverted microscope.

6. Reflected and transmitted light microscopy capability with upright microscope.

7. 16-bit CMOS wide field of view monochrome camera with dynamic range of > 65,000 fluorescence units for inverted microscope.

8. Autofocus, auto-exposure, and auto-LED intensity adjustments.

9. Dedicated filter position for available proprietary laser auto-focus cube.

10. Include image analysis software for image processing, automatic cell counting, and subpopulation analysis.

11. Be able to conduct various image processes including stitching, Z-projection, and digital phase contrast.

Multimode plate reading function shall include:

1. Optical system for flexibility, combining a monochromator fluorescence optical system with a filter-based fluorescence optical system.

2. Quadruple monochromators with variable bandwidths from 9 to 50 nm in 1 nm increments for fluorescence.

3. Various detection modes including UV-Vis absorbance, fluorescence intensity, luminescence, fluorescence polarization, time-resolved fluorescence, and Alpha assays.

4. Compatibility with 2 μL low-volume microplate accessory with 16 or 48-sample micro spots for direct nucleic acid quantification, as well as fluorescence and luminescence measurements.

5. Data analysis software for quantitative and qualitative analysis.

Delivery, Installation, Training and Additional System Requirements:

1. The components and equipment shall be newly manufactured, not used and refurbished or previously used for demonstration.

2. Offered systems shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need.

3. The Contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include shipping. The system shall be delivered with all necessary supplies, accessories, and standard kits required for installation and start-up.

4. Installation shall be conducted by factory-certified service personnel, who shall demonstrate that all modules start up properly, are correctly installed and connected.

5. The system and associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the system and controlling software. All manuals and documentation shall be provided in hard copy and/or electronic format.

6. Upon acceptance of the system, the Contractor shall provide on-site operator training/familiarization for 3-5 users. Such familiarization shall include system operations, calibration, optimization, troubleshooting and basic operational maintenance procedures.

7. Systems shall be warranted for a minimum of one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty shall be included with the equipment and not separately priced. Warranty services shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, immediate access to system improvements and updates, labor and travel costs. Phone and email technical support shall be included for a minimum of one (1) year.

8. The Government is offering the following trade-in equipment. Trade-in instruments are offered in “as is” condition. Contractor shall assume all costs for packaging and shipping trade-in equipment

• Agilent BioTek Cytation 3 System with the following specifications:

o Serial No. 160920B o Location of equipment (Building 14-1027) o Instrument History: General laboratory use. Used multiple times per week or daily o Age/when acquired: 10 years/Year of Manufacture: 2016, Year of Purchase: 2017 o Condition: Nonfunctional as of May 2026 o Last service date: Unknown

9. The Contractor shall possess an active, verified instrument buyback or trade-in program agreement with Agilent Technologies enabling the acceptance of the legacy government-owned asset detailed below, and must demonstrate the logistical capability to apply a manufacturer-backed credit of a minimum of 43.1% pricing concession directly as a deduction on any resulting instrument quote.

Delivery Terms: Delivery, installation, and onsite training shall be completed within 60 days of contract award at the below address:

US FDA/NCTR

3900 NCTR Rd Building 14-1027 Jefferson AR 72079

POC: will be appointed and contact information will be given upon contract award.

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar 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 to include date of sale, description of services provided, contract 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 Unique Entity ID (SAM) number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of what 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 services meet the technical requirements identified above.

• 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 on.

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• Provide place of manufacture or 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 needed.

• Though this is not a request for quote, informational pricing for the products 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 which are to be submitted by email only to the point of contact listed below on or before 12:00 pm (Central Time in Jefferson AR) on June 22, 2026 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40126SSN135511.

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.

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 mailto:suzanne.martella@fda.hhs.gov 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 in 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.