Qiagen Molecular Biology Reagents, Kits, and Consumables

for Purchase of QIAGEN Molecular Biology Reagents, Kits, and Consumables Announcement No.: FDA-26- 1289149 The U.S. Food and Drug Administration (FDA) hereby provides notice of its intent to award a sole-source, single-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract to QIAGEN LLC for the supply of QIAGEN molecular biology reagents, kits, consumables, and related products in support of the Division of Applied Regulatory Science (DARS), (OCP/OTS), Center for Drug Evaluation and Research (CDER). Individual Firm-Fixed-Price (FFP) Task Orders will be issued throughout the ordering period based on program

requirements and the availability of funding. The anticipated ordering period consists of a Base Year and four (4) Option Years, for a total potential ordering period of five (5) years. The North American Industry System (NAICS) code for this acquisition is 325413, In-Vitro Diagnostic Substance Manufacturing. The FDA intends to procure QIAGEN reagents, kits, consumables, and related products supporting genomics, transcriptomics, proteomics, metabolomics, and other omics analyses, including the isolation, purification, amplification, sequencing, characterization, and analysis of DNA, RNA, proteins, and related biomolecules. This acquisition is being conducted on a sole-source basis pursuant to FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency

Requirements. DARS has standardized, validated, and implemented laboratory protocols, standard operating procedures (SOPs), workflows, and analytical frameworks using QIAGEN reagents and associated technologies. Continued use of QIAGEN products is necessary to maintain consistency with validated laboratory methods, preserve the integrity and comparability of historical and future research data, and avoid the time, cost, and scientific risk associated with redevelopment, validation, and verification of laboratory methods using alternative products. The Government intends to solicit and negotiate directly with QIAGEN LLC. The determination not to compete this proposed contract action is solely within the discretion of the Government. This notice is not a request for competitive quotations or proposals. However, responsible sources that believe they can satisfy the Government's

requirements may submit a written capability statement demonstrating their ability to provide products that meet the Government's

requirements. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Any response to this notice must demonstrate clear and convincing evidence that the respondent can satisfy the Government's

requirements without adversely affecting FDA's validated laboratory methods, ongoing scientific research, data integrity, or mission