James O�Keefe

James O’Keefe serves as a key procurement professional within the FDA Office of Acquisition and Grant Services, supporting the agency’s mission to safeguard public health through strategic acquisition of scientific and technical services. He manages a portfolio of contracts focused on high-precision analytical instrumentation, laboratory infrastructure, and specialized research support services critical to regulatory science. His work ensures the FDA maintains cutting-edge capabilities in drug safety evaluation, medical device testing, and biological product validation, aligning acquisitions with the agency’s scientific priorities and operational needs. O’Keefe maintains consistent working relationships with niche contractors such as Tranquil Clinical and Research Consulting Services LLC, Toxicologic Pathology Associates Inc., and Progenics Pharmaceuticals Inc., partnering primarily with firms offering specialized analytical, toxicological, and laboratory support services. These vendor relationships reflect a preference for subject-matter experts capable of delivering high-compliance, scientifically rigorous deliverables under stringent regulatory standards. His contracting approach emphasizes technical competence, quality assurance, and adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). His procurement patterns show a strong preference for open competition, with 82.1% of awards issued without set-asides, indicating a focus on technical merit and capability over socioeconomic criteria. However, he consistently supports small business participation, with 17.9% of awards designated as total small business set-asides under FAR 19.5, reflecting a balanced commitment to both operational excellence and economic inclusion. O’Keefe’s primary procurement focus lies in NAICS 334516 (Analytical Laboratory Instrument Manufacturing), reflecting deep expertise in acquiring mass spectrometers, chromatography systems, and other high-end lab equipment essential for regulatory testing. He also procures maintenance and repair services under NAICS 811210 and 811310, as well as research and development support under NAICS 541715 and general scientific support services under 561990, demonstrating a comprehensive command of the technical domains underpinning FDA’s scientific mission.