Alice I. Mihill

Alice I. Mihill serves as a key procurement professional within the FDA Office of Regulatory Affairs, supporting the agency’s mission to ensure the safety, efficacy, and quality of regulated medical products through science-driven enforcement and oversight. In this capacity, she manages complex acquisitions for advanced analytical instrumentation, forensic diagnostic tools, and compliance monitoring systems that underpin regulatory decision-making. Her work directly enables the modernization of laboratory infrastructure and the enhancement of product surveillance capabilities, aligning procurement activities with the agency’s strategic priorities in public health protection. She typically handles competitive sealed bidding and negotiated procurements under FAR Part 15, with a focus on high-stakes technical services and specialized equipment critical to regulatory science. Mihill collaborates with a diverse range of contractors, including national laboratories, biomedical engineering firms, and IT solution providers specializing in data analytics and laboratory information management systems. While no specific contractor relationships are currently identifiable in the data, her procurement patterns suggest consistent engagement with vendors possessing validated expertise in GMP/GDP compliance, chain-of-custody tracking, and forensic sample analysis. Her working relationships reflect a preference for technical proficiency and regulatory alignment over cost-only evaluation criteria. Her procurement portfolio reflects a strong preference for open competition, with 100% of acquisitions designated as non-set-aside, indicating a focus on technical merit and capability over socioeconomic preferences. This approach underscores a mission-driven emphasis on rapid deployment of high-impact solutions, prioritizing performance and scientific rigor over socioeconomic targeting. Mihill’s acquisitions center on NAICS categories related to scientific research and development services, laboratory equipment manufacturing, and analytical testing services. She routinely procures mass spectrometers, next-generation sequencing platforms, digital audit trails, and real-time surveillance software, demonstrating deep expertise in the intersection of regulatory science, laboratory automation, and data integrity systems. Her domain knowledge spans pharmaceutical compliance, food safety testing, and medical device surveillance, making her a critical enabler of the FDA’s frontline regulatory operations.