Preventive Maintenance and Repair Service Agreement for Emulate ZOE CM1 and CM2 Culture Modules

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with FAR RFO part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued. The solicitation number is 75F40126Q132585. This solicitation is issued as a Request for Quote (RFQ) for Preventive Maintenance and Repair Service Agreement for Emulate Zoe CM1 and CM2 culture modules. This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul. 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. This requirement is solicited as unrestricted full and open competition, any sized business may submit a quote. Schedule of Items (all shipping and handling shall be included in the price) Contract Line Item Description Quantity Unit Unit Price Extended Price 1 Base Year: On-site Preventative maintenance service for CM1 serial numbers: ZOE-CM1 00142 ZOE-CM1-00141 and CM2, serial numbers: ZOE-CM2-00237 ZOE- CM2 00235 as specified herein. 12 Months $_________ $___________ Statement of Work Background The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), 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 75F40126Q132585 1 of 17 -- 1 of 17 -- 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 …