SSN_CDER-2026-133237.docx

SOURCES SOUGHT NOTICE

TITLE: Multitron HT Incubator Notice Number: SSN_CDER-2026-133237 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 A RFQ PACKAGE OR SOLICITATION. THERE IS NO RFQ PACKAGE OR SOLICITATION. 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), is issuing this sources sought announcement on behalf of the DPQR/AMRF to:

a) identify vendors capable of providing the equipment and service as detailed in this notice, and

b) vendors capable of providing a domestic product offering. Responses from small and other than small businesses are appreciated and accepted.

NAICS Code:334516 Analytical Laboratory Instrument Manufacturing Small Business Size Standard: Small 1,000 employees Background The Division of Product Quality Research (DPQR) requires a laboratory incubator shaker system to support mammalian cell culture at the Advanced Manufacturing Research Facility (AMRF).

Existing equipment does not provide sufficient capacity or performance to support large-volume cultures (e.g., 5-liter flasks) or meet current operational needs. A new system is required to support reliable cell culture growth while maintaining compatibility with existing Chinese hamster ovary (CHO) suspension culture processes.

Objective The Government is seeking to acquire one incubator-shaker system configured in a triple-stack arrangement, with each unit/module providing fully independent control of temperature, carbon dioxide (CO2) concentration, humidity, and orbital shaking parameters.

Salient Characteristics

· Triple stack incubator configuration

· Independent control of temperature, CO₂, humidity, and orbital shaking

· Compatible with 5-L Erlenmeyer shake flasks

· Adjustable orbital shaking drive

· Integrated humidity control

· CO₂ control system

· UV sterilization capability

· Dark observation window

· Cable passthrough port

· IQ/OQ documentation

· On-site installation and training

· UL certification

Scope of Requirement The Contractor shall provide a commercially available incubator shaker system that supports mammalian cell culture at production-relevant volumes under controlled environmental and agitation conditions.

The system shall:

· Be compatible with existing CHO suspension culture processes

· Support simultaneous processing of multiple culture conditions

· Provide sufficient capacity and operational flexibility

· Operate reliably within a laboratory environment This requirement is limited to the provision of equipment and associated services and does not include process development or modification of existing protocols.

Vendors shall clearly demonstrate how their proposed solution meets each salient characteristic.

Deliverables Any proposed system must be functionally equivalent in performance, configuration, and operational capability to the referenced system. Proposed alternatives shall meet all stated requirements without exception and without requiring changes to established protocols, retraining of personnel, or redevelopment of existing seed-train processes. To meet the purpose and objectives of this requirement, a single Contractor shall be responsible for the complete delivery, installation, qualification, and training associated with the system. The Contractor shall meet all established timelines and shall provide, at a minimum, the following:

Anticipated Deliverables and Timeframe

· Delivery: Within 90–120 calendar days after award

· Installation: Within 10 calendar days after delivery

· IQ/OQ: Within 5 calendar days after installation

· Training: Within 5 calendar days after IQ/OQ for 1-3 end-users

Delivery Location:

Advanced Manufacturing Research Facility (AMRF) 5901 Ammendale Road, Suite D Beltsville, MD 20705

Requested Information from Vendors Interested vendors shall submit a capability statement demonstrating their ability to meet the technical requirements described in this notice.

Company's name, mailing address, Cage Code, and Unique Entity Identifier (UEI)

· Recommended North American Industry Classification System (NAICS) code that your company utilizes for in support of the following equipment: Multitron HT Incubator

· What is your company size? If small, what is your socio-economic status?

· Identify any GSA Schedule contract or other current government-wide contract (e.g., GWAC or BPA) that your company currently holds and offers these products/services under.

· Domestic manufacturing status.

· Technical specifications for the proposed solution.

Disclaimer and Important Notes This is not a Request for Quote (RFQ) and does not commit the Government to award a contract. Responses will be used solely for market research. The FDA will not provide feedback or evaluations of submitted capabilities. Proprietary information should not be submitted. Comment by Johnson, Iris: This is not a RFP. I believe I mention this the last time. This is a RFQ. If you need a break down of RFP vs a RFQ let me know.

Submission Instructions Responses are due by April 17, 2026, 12:00pm and shall be submitted via email and must be submitted in PDF or Microsoft Word format. Capability statements shall not exceed 10 pages and should clearly demonstrate the vendor’s ability to meet the technical requirements identified in this notice.

Responses shall be sent to:

Reagan Davis Contract Specialist Email: Reagan.Davis@fda.hhs.gov Subject: Sources Sought Notice Number: SSN_ CDER-2026-133237 Multitron HT Incubator