Preventive Maintenance and Repair Service Agreement for Emulate Zoe CM1 and CM2 culture modules

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Drug Evaluation and Research (CDER), requirement for Preventive Maintenance and Repair Service Agreement for Emulate Zoe CM1 and CM2 culture modules. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The associated North American Industry Classification System (NAICS) Code is- 811210 - Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34 million.

Background

The Division of Applied Regulatory Science (DARS) in OCP/OTS/CDER is conducting a research program to evaluate the utility of a microphysiological system (MPS) in assessing the bronchopulmonary disposition of anti-infective drugs and predicting drug transfer into milk. MPS barrier models, such as lung alveolar and blood-milk barriers, provide a physiologically relevant in vitro platform that integrates key components epithelial and endothelial cells, along with dynamic fluid flow to better mimic the cellular microenvironment compared to traditional in vitro models. This research aims to assess the concordance between drug concentration profiles obtained from MPS experiments and clinical studies, offering alternative or complementary approaches to clinical research. Evaluating the lung alveolar model may provide critical insights into drug penetration into alveolar epithelial lining fluid (ELF) and support regulatory decision-making in drug development. Similarly, assessing the blood-milk barrier model will determine its predictive accuracy by comparing outputs with available clinical data, including the InfantRisk Human Milk Biorepository (HMB), as well as nonclinical data from various studies. The findings from this study may contribute to the broader regulatory science framework by informing model validation, study design, and the integration of advanced in vitro models into nonclinical and clinical development programs. To ensure the continued success of this research program, proper maintenance of the Emulate machinery is essential to maintain data quality, equipment reliability, and operational continuity. Objectives The objective of the contract is to obtain a one-year maintenance contract including one-time preventative maintenance service and one year of coverage for Emulate machinery, specifically the Zoe CM1 and CM2 culture modules and related equipment, manufactured -by Emulate, Inc. (Boston, USA). This maintenance will provide the FDA with the necessary technology and resources to support research on MPS barrier models. The system will be used to advance scientific capabilities in evaluating bronchopulmonary drug disposition and predicting drug transfer into milk, consistent with the mission of the Center for Drug Evaluation and Research (CDER). The acquired maintenance for machinery and kits will facilitate studies aimed at assessing the utility of MPS barrier models as alternative or complementary approaches to clinical research, contributing to regulatory science and drug development.

Scope

FDA is seeking maintenance for our existing Emulate machinery, the Zoe CM modules and related equipment. Preventative maintenance, corrective/remedial maintenance repair service agreement on CM1 serial numbers: ZOE-CM1 00142 ZOE-CM1-00141 and CM2, serial numbers: ZOE-CM2-00237 ZOE-CM2 00235

Performance Requirements

-The contractor shall provide one (1) scheduled on-site planned preventive maintenance visit per year per instrument. The consumables required for PM visit shall be included in the contract. All costs for labor, travel, and parts required for preventative maintenance shall be included. -The contractor shall provide unlimited on-site corrective maintenance and repairs where problems cannot be resolved remotely after 2 business days. All costs for labor, travel, and parts shall be included. -The maintenance and repair activities shall be performed by the service engineers who are trained and certified by the manufacturer Emulate Inc., and the service provider should follow the Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM-certified replacement parts, components, subassemblies, etc. -The contractor shall include unlimited software and firmware updates during the entire coverage period(s). -The contractor shall include unlimited technical support (via phone and email) on software and hardware related issues and trouble-shooting capabilities, Monday through Friday (excluding Federal Holidays). Access by the FDA COR and system operator personnel to the manufacturer's call center for technical assistance including software, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. -All maintenance and repair pricing must encompass costs for labor, travel, replacement parts, components, subassemblies, and any other necessary expenses related to the system.

Deliverables

Service Records and Reports: Contractor shall provide a service record report in contractor's standard format after each PM or repair visit. -Maintenance services must ensure proper functioning of equipment compatible with lung and blood-milk barriers' MPS chips for Emulate's Zoe Culture Module to enable continuous fluidic flow control. Maintenance coverage must include all compatible MPS chips and equipment, including: a. Ten Chip-S1 Basic Research Kits (BRK-S1-WER-24) with the Chip-S1 Stretchable Chip and accompanying Pod Portable Module. b. Seven Chip-R1 Basic Research Kits (BRK-R1-WER-24) with the Chip-R1 Non-Stretchable Chip and accompanying Pod Portable Module. Maintenance services must ensure proper calibration and functionality of all equipment components, including Steriflip filters and ER-1/ER-2 Chip Activation Reagent systems. Contractor shall provide updated technical documentation and step-by-step instructions for the use of Emulate consumable chips as part of maintenance services. Maintenance coverage must include equipment used with compound distribution kits for drug absorption studies. Contractor shall complete functional QC testing of all equipment during preventative maintenance service to ensure optimal performance and reliability. The Contractor shall guarantee that all required maintenance services shall be performed to ensure equipment remains in optimal, usable and acceptable condition at the address as shown below. - Vendor must notify recipient via email with service scheduling information when maintenance is planned. Other

Government Points of Contact

Attn: to be identified at time of award Vendor will contact the Project Lead: to be identified at time of award by phone or email to schedule maintenance service. Maintenance services must be coordinated with the Project Lead prior to scheduling. No services will be performed without prior authorization from the Project Lead. Vendor must notify recipient via email with service scheduling information when maintenance is planned. Government Furnished Equipment (GFE)/ Government Furnished Information (GFI) - NA

US Food and Drug Administration

10903 New Hampshire Ave, WO 64 Rm 2083 Silver Spring, MD 20993

Period of Performance

Period of Performance will be for One (1) year from date of award, beginning July 15 2026 and ending July 14 2027.

Inspection and Acceptance Criteria

The Government will review all reporting requirement deliverables in accordance with specifications and standards identified in the statement of work or any directives issued by the COR. The contractor shall submit the reporting Requirements/Deliverables to the COR in accordance with the delivery schedule. The COR will perform inspection and acceptance of materials and services. FOB Point Destination. All items shall include shipping and handling to the destination identified herein.

Holidays and Government Closures

Service/Delivery shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or opm.gov. Federal Holidays are as follows:

New Year's Day Labor Day

Martin Luther King, Jr.'s Birthday Columbus Day

Contract Type

Firm Fixed Price Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum intended use of the system and brand name or equal technical requirements. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product/service of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: - Business name, SAM Unique Entity ID 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 if responding to provide a product manufactured by another firm); - Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, ISO certifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. - Three (3) years of past performance information, where the respondent has provided same or substantially similar product/service solutions on the same or near-same requirements. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 ID number and size status) if not the respondent. - The offeror's capability to initiate service on-site within the time specified above. - Offeror shall provide estimated historical on-site response time from the initial call for service until a service technician was on-site for the brand name and model of instrument in this solicitation or a standard target time for onsite performance from initiation of service call. - Service/repair agreement plans that are available for the Make/Model of the system described above. - If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. - 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. - Capability and understanding of accessibility testing and customization to conform with the applicable Section 508 standards identified herein. Provide information if the respondent has an Accessibility Conformance Report (ACR) for the products offered for the Revised 508 Standards. The ACR should be based on the Voluntary Product Accessibility Template Version 2.0 (MS Word) provided by the Industry Technology Industry Council (ITIC). - Provide information if any of these specifications are too restrictive. 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. - If a large business, identify the subcontracting opportunities that would 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 needed; and - Though this is not a request for quote, informational pricing is required The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 26, 2026 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov. Reference CDER-2026-132585.

Notice of Intent

Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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 information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality 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).