SAM #70246b8e2f2146b49edb1a644b276466

FDA Sole Source IDIQ for QIAGEN Molecular Biology Reagents and Consumables

This notice announces the FDA's intent to award a sole-source IDIQ contract for molecular biology reagents and consumables. - Agency: U.S. Food and Drug Administration (FDA), Division of Applied Regulatory Science (DARS), Office of Computational Science (OCP/OTS), Center for Drug Evaluation and Research (CDER) - Contract Type: Indefinite Delivery/Indefinite Quantity (IDIQ) - Vendor/OEM: QIAGEN LLC - Products: Molecular biology reagents, kits, consumables, and related items - Used for genomics, transcriptomics, proteomics, metabolomics, and other omics analyses - Supports isolation, purification, amplification, sequencing, characterization, and analysis of DNA, RNA, proteins, and biomolecules - Justification: FDA laboratory protocols are standardized and validated with QIAGEN products; continued use is required for data integrity and comparability - Procurement Method: Sole source under FAR 6.302-1 (Only One Responsible Source) - NAICS Code: 325413 (In-Vitro Diagnostic Substance Manufacturing) - Period of Performance: Base year plus four option years (up to five years total) - No specific part numbers or quantities listed - Commercial opportunity is limited to QIAGEN products; no other vendors or OEMs mentioned

Description

NOTICE OF INTENT TO AWARD SOLE SOURCE

Project: IDIQ 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), Office of Computational Science (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 Classification 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 objectives. The Government will not be responsible for any costs incurred in responding to this notice.

Questions, comments, or capability statements regarding this Notice of Intent shall be submitted via email only to:

Elena Tatarov

Contract Specialist

elena.tatarov@fda.hhs.gov

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