The U.S. Food and Drug Administration (FDA), specifically the Center for Drug Evaluation and Research (CDER), is soliciting quotations for the purchase of Nanion consumables to support ion channel pharmacology experiments using the SyncroPatch 384 automated patch clamp system. This solicitation, designated as CDER-2025-127932, is a total small business set-aside under NAICS code 334516 for Analytical Laboratory Instrument Manufacturing. The contract involves providing consumables over a 12-month period, with the potential for a 12-month extension, delivered in four separate batches throughout the year.
Key details include delivery to the FDA's Silver Spring, MD location, with acceptance at destination. Bidders are required to submit firm-fixed price quotes with complete pricing information, and the evaluation will be based on the lowest price that meets technical specifications. A series of Federal Acquisition Regulations (FAR) clauses and provisions must be adhered to, ensuring compliance with federal standards for contracting, labor laws, and reporting. This solicitation emphasizes the FDA's commitment to leveraging small businesses in fulfilling governmental needs while ensuring regulatory compliance throughout the procurement process.
The Statement of Work (SOW) outlines the requirements for the purchase of Nanion consumables to support ion channel pharmacology experiments using the SyncroPatch 384 automated patch clamp system at the Office of Clinical Pharmacology, FDA. The purpose is to facilitate research on drug effects on ion channels, essential for understanding drug safety and efficacy. The SOW specifies the need for four deliveries of consumables over 12 months, including NPC-384 low resistance chips and various internal and external recording solutions, with each batch requiring timely delivery every three months. Detailed responsibilities for the contractor include packing and shipping the products to the FDA, with coordination needed with specific contacts. The document emphasizes the importance of using Nanion’s proprietary materials to ensure data consistency with prior research. The project underscores the FDA’s commitment to advancing drug safety through precise and regulated scientific practices.