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U.S. Department of Health and Human Services

About FDA

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Office of Planning

Mission Statement

OPL works collaboratively to provide objective planning, analysis and program evaluation services to improve FDA's policies and performance.

Vision Statement

OPL strives to be a highly respected and sought-after resource for applying social and management sciences to inform FDA's strategic and operational decision making in support of improved public health outcomes.

Key Office Responsibilities:

The Office of Planning, in partnership with FDA senior management, leads the Agency through the full portfolio of planning and performance management activities called for by FDA and Administration leadership and Federal law. Our planning functions include program and policy evaluation studies, economic analyses, performance planning in support of budget formulation, business process planning, and coordination of risk communication policy, research, best practices, and analysis and development of public health outcome measures related to FDA's mission. The Office provides information and analyses that help FDA officials, the Department, and members of Congress make well-informed decisions related to programs, policies, budgets, and strategic planning. We also often serve as FDA liaison to Department and Administration planning activities that affect multiple FDA components. Our key responsibilities include the following:

  •  Design and develop strategic plans, performance management systems, and business process improvements.
  • Analyze management performance trends, Agency cost structure, and use of program resources.
  • Oversee the medical products user fee performance commitments and performance management resources.
  • Analyze cost and benefits of agency regulations.
  • Provide assistance to Agency components in change management, program reinvention, and managing-to-cost.
  • Analyze risk communication activities and assists agency components in planning to improve risk communication effectiveness.

Contact the Office of Planning

Assistant Commissioner for Planning: Malcolm J. Bertoni
Phone: 301-796-4850  E-mail: malcolm.bertoni@fda.hhs.gov

Planning Staff: Timothy Kiang, Director
Phone: 301-796-4717  E-mail: timothy.kiang@fda.hhs.gov

Economics Staff: Clark Nardinelli, Director
Phone: 301-796-9159  E-mail: clark.nardinelli@fda.hhs.gov

Risk Communications Staff: Ji Sun Lee, Director
Phone: 301-796-9164  Email: ji.lee@fda.hhs.gov

Program Evaluation and Process Improvement Staff: Don Lipkey, Director
Phone: 301-796-9168   Email: don.lipkey@fda.hhs.gov

Public Health Measurement and Analysis Staff:  Kara Morgan, Director
Phone: 301-796-8808   Email: kara.morgan@fda.hhs.gov       

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