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MARKET RESEARCH PURPOSES ONLY 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. Statement of Work 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 mod…

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