Sources Sought Notice FDA Office of Clinical Pharmacology (OCP)/Division of Applied Regulatory Science (DARS) Purchase of Phenomenex High-Pressure Liquid Chromatography (HPLC) Core-Shell Technology Columns and Consumables

The Food and Drug Administration's Office of Clinical Pharmacology, Division of Applied Regulatory Science (DARS), is seeking to procure High-Pressure Liquid Chromatography (HPLC) Core-Shell Technology Columns and Consumables to support mission-critical bioanalytical research across six laboratories. The procurement specifically targets the purchase of 34 Phenomenex HPLC columns across five different variants, including Kinetex 2.6 m XB-C18, EVO C18, Biphenyl, C8, and HILIC columns, all with 50 x 2.1 mm dimensions. These supplies are essential for DARS's ongoing research focused on regulatory review questions, translational science, and emerging public health issues such as opioid drug interactions and complex in vitro model evaluations for the Center for Drug Evaluation and Research. Interested vendors must submit capability statements limited to 10 pages, detailing their technical qualifications, business size, socioeconomic status, and Unique Entity Identifier, along with completed vendor feedback forms. The response deadline is July 1, 2025, at 5:00 PM EST, with submissions required electronically to Brandon Rafus.

This opportunity is designated as a Total Small Business set-aside under NAICS code 541715, specifically targeting SBA certified HUBZone, service-disabled veteran-owned, 8(a), and woman-owned small businesses. The procurement involves purchasing specific quantities of each column type, ranging from 6-10 units per variant, totaling 34 HPLC columns across all categories. The contract structure will utilize a Firm-Fixed Price arrangement, though specific budget ranges or award values are not disclosed in the sources sought documentation. No incumbent contractors are identified in the available materials, and the solicitation number CDER-OTS-25-C-1691 indicates this is a new procurement opportunity. The FDA emphasizes that this sources sought notice serves as market research to determine the appropriate acquisition method and assess small business participation capabilities, rather than constituting a formal solicitation commitment.