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 CDER-OTS-25-C-1691

The Food and Drug Administration (FDA) is seeking to purchase critical supplies neccesary for the Division of Applied Regulatory Science (DARS) bioanalytical lab to continue supporting mission- critical research focused on review questions, translational science, and emerging public health issues for the Center for Drug Evaluation and Research (CDER) and FDA. DARS operates six total labs that focus on developing and evaluating novel tools, standards, and approaches that increase the regulatory efficiency of developing and reviewing safe and effective CDER products. These operational supplies are essential for the continuance of these projects across all lab groups, and for continued preparedness to be able to respond to emergent public health issues when called upon. We kindly request that each interested vendor also complete and submit the attached vendor feedback form along with a capability statement for consideration.