NOTICE OF INTENT TO AWARD SOLE SOURCE - QIAGEN Molecular Biology Reagents, Kits, and Consumables

The U.S. Food and Drug Administration (FDA) intends to award a sole-source contract to QIAGEN LLC for the supply of QIAGEN molecular biology reagents, kits, consumables, and related products. The contract will support the Division of Applied Regulatory Science (DARS), Office of Computational Science (OCP/OTS), Center for Drug Evaluation and Research (CDER). The FDA will procure QIAGEN reagents, kits, consumables, and related products for genomics, transcriptomics, proteomics, metabolomics, and other omics analyses. Key points to consider: • The contract is for a base year and four option years, for a total potential ordering period of five years. • The North American Industry Classification System (NAICS) code for this acquisition is 325413, In-Vitro Diagnostic Substance Manufacturing. • The FDA has standardized, validated, and implemented laboratory protocols using QIAGEN reagents and associated technologies. • Continued use of QIAGEN products is necessary to maintain consistency with validated laboratory methods and preserve the integrity and comparability of historical and future research data.