The Division of Planning, Evaluation, and Management (DPEM) provides operational planning, analysis, and evaluation services to inform decisions and improve ORA programs and performance. Our multi-disciplinary team includes analysts and CSOs knowledgeable in public health, business administration, program evaluation, predictive analytics, operations research, modeling/forecasting, statistics, and data visualization. We work in a collaborative, transparent manner that is focused on the client's needs and strives to deliver useful and unbiased analysis to support FDA's mission to protect and promote public health.
Under the direction of John "Chuck" Hassenplug, DPEM is composed of three separate branches that work together to support the overall DPEM mission. They include:
Immediate Office (IO), Felicia Elder, Special Assistant
Led by the National OEI Coordinator, maintains and improves the accuracy of FDA's global Official Establishment Inventory (OEI) through analysis, communication, training, guidance development, and coordination with ORA OEI Coordinators, Registration Monitors, State Liaisons Management, and relevant Center and ORA HQ stakeholders.
Conducts special projects in the areas of predictive analytics and health informatics.
Coordinates data requests or questions related to ORA's work plan accomplishments and performance goals.
Provides analysis to inform strategic hiring, training, and other resource allocation decisions.
Work Planning Branch (WPB), Sarah Pichette, Chief
Coordinates the development of the risk-based ORA Annual Field Work Plan, seeking input and review from the Centers, Field Committees, ORA Office of Operations, and the Field.
Monitors and shares ongoing accomplishments of the ORA Annual Field Work Plan through the use of queries, dashboards, data analysis and visualization.
Analyzes field performance data, evaluates overall field accomplishments in terms of stated goals and resource utilization, and recommends changes in operational program plans and field workforce allocations.
Program Evaluation Branch (PEB), Kristen Kamas, Chief (Acting)
Conducts program evaluations and assessments, maps and improves business processes, develops performance metrics and dashboards, and creates implementation plans for recommended changes.
Provides management analysis services to the Office of Regulatory Affairs Headquarters and Field; designs, develops, and implements management programs, and provides in-house management consulting services.
Develops evaluation policy and guidance materials, based on Agency policy decisions and program evaluation data, for use by the ORA HQ and Field Offices for self-evaluation.
John "Chuck" Hassenplug
Work Planning Branch Director
Program Evaluation Branch Director
Kristen Kamas (Acting)