SSN 75F40126SSN133126.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 Center for Drug Evaluation and Research (CDER), Division of Applied Regulatory Science (DARS) in order to determine if there are existing small business sources capable of providing various multi-well plates (12, 48, and/or 96-well) plates, with a minimum of 700 electrodes per plate for their Axion Maestro Pro Multielectrode Array (MEA) platform for microphysiological studies in hiPSC cells. The plates will provide the FDA with the required technology needed for experiments, will be used to support FDA scientists throughout FDA Centers, and will enable scientific capabilities consistent with Center for Drug Evaluation and Research (CDER)’s mission.

This requirement is for an Indefinite Delivery, Indefinite Quantity (IDIQ) that will consist of a Base year plus four (4) option years.

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 service described below, please submit an email to suzanne.martella@fda.hhs.gov. Other than small business concerns are also encouraged to submit capability statements. The vendor shall include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background:

The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is conducting a research program to evaluate the usefulness of Multielectrode Array Systems (MEA). MEA plates combined with human induced pluripotent stem cells have been identified as a potential alternative to traditional in-vitro models. High throughput MEA systems consist of both hardware such as plates, and software for recording and analyzing electrical signals of excitable cells. MEA plates are designed to maintain cells in a microenvironment to better recapitulate the in-vivo physiological environment compared to traditional cell culture methods. The MEA is used across multiple program areas. The experiments mailto:suzanne.martella@fda.hhs.gov conducted support regulatory science research projects to support drug safety and efficacy assessment.

Technical Requirements:

• The components and/or products shall be newly manufactured, not used, refurbished, or previously used for demonstration.

• Each plate shall have real-time well-by-well review of raw signals from each electrode simultaneously and real-time plate-wide feedback on electrophysiological activity, as well as High signal quality - ability to adjust analog and digital filters.

• Each plate shall also have Temperature and electrical stimulation control, automatic search and identification of cardiac T-wave capabilities, automatic search and identification of neural network burst capabilities, and automatic calculation beat-by-beat measurements, as well as electrode and well averages for field potentials.

• Plates shall have the capability to measure parameters including: field potential duration, beat period, conduction velocity, and depolarization, spike amplitude, slope, beat amplitude, and excitation-contraction delay, viability, mean firing rate, burst duration, burst frequency, network durst duration, network burst frequency

• Plates shall have the capability to pace with electrical stimulation.

Plates that will be required throughout the period of this IDIQ and estimated quantities (each year):

• M768-tMEA-96B; Est QTY: unknown at this time

• M768-tMEA-96W; Est QTY: 50 Boxes of 5 plates, 10 each year

• M768-tMEA-48B; Est QTY: unknown at this time

• M768-tMEA-48W; Est QTY: 25 Boxes of 5 plates, 5 each year

• M768-tMEA-48OPT; Est QTY: 25 Boxes of 5 plates , 5 each year

• M768-tMEA-96OPT: Est QTY: unknown at this time

• M768-tMEA-12W; Est QTY: unknown at this time

• M384-tMEA-24W; Est QTY: unknown at this time

• M384-tMEA-24OPT; Est QTY: unknown at this time

• M384-tMEA-6B; Est QTY: unknown at this time

• M384-tMEA-6W; Est QTY: unknown at this time

* At any time and throughout the life of this IDIQ, at the request of either the Contractor or the Government, the Contractor may propose additional pricing for additional plates or as the technology refresh of existing plates that may become available. Any additional products will be negotiated on a case-by-case basis and, upon determination by the Government that they are necessary for performance and are both fair and reasonable, can be issued in the order. The new category may be incorporated by modification into the Section B Pricing Table of any resulting contract.

Period(s) of Performance: The IDIQ will have the following anticipated periods of performance:

Base year: 07/31/2026 – 07/30/2027 Option Year 1: 07/31/2027 – 07/30/2028 Option Year 2: 07/31/2028 – 07/30/2029 Option Year 3: 07/31/2029 – 07/30/2030 Option Year 4: 07/31/2030 – 07/30/2031

Each Order resulting from the IDIQ shall be funded at the time the Order is placed; Orders will be placed based on funds availability and the needs of the Federal Government.

Delivery Terms: Within 30 days after receipt of an order, deliveries shall be made to the Center for Drug Evaluation and Research (CDER) at the following address:

US FDA/CDER

10903 New Hampshire Ave WO 64 Room 2014 Silver Spring MD 20993

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 product/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 products provided, contract dollar value, client name, client address, client contact name, client point of contact (POC) mailing address (if different from that provided for client), client POC phone number, client POC 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, including the provision of the specified plates identified above. Capability statements must provide sufficient information that unequivocally demonstrates that the technical requirements identified above can be met and have previously been met (see “Past Performance” paragraph above).

• Letter of Supply: Quoters who are authorized resellers of an item, and not the manufacturer, shall provide a copy of their letter of supply or other documentation substantiating their relationship as an authorized reseller of the proposed manufacturer’s product. The documentation shall be on the Original Equipment Manufacturer (OEM) letterhead and include contact information for the individual who has signed the letter.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the 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.

• Identification of AbilityOne Contracts available that can meet the requirement.

• 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 3:00 pm (Central Time in Jefferson AR) on June 3, 2026 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F40126SSN133126.

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.

mailto:suzanne.martella@fda.hhs.gov

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 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. Though this is not a request for quote, informational pricing for the service would be helpful.