Purchase of liquid nitrogen and carbon dioxide for use in research laboratories

The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER operates 6 total labs that provides mission-critical research supporting review questions, translational science, and emerging public health issues for CDER and FDA. We develop and evaluate 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 projects supporting BsUFA, GDUFA, PDUFA and Opioid research, and for continued preparedness to be able to respond to emergent public health issues when called upon. DARS is completing a wide range of projects to answer scientific questions associated with the review of drug applications. Projects are from disciplines including immunology/toxicology, bioanalytics, proteomics/genomics, microphysiological systems, pharmacokinetics/pharmacodynamics, and electrophysiology. The liquid nitrogen supply is needed for the operation of liquid nitrogen dewars storing valuable biological samples. Carbon dioxide is needed to maintain critical equipment operation, i.e., cell culture incubators.