U.S. Food and Drug Administration

Office of Planning


The Office of Planning, in partnership with FDA senior management, guides the Agency through its rapidly changing environment to attain significant public health outcomes. Our planning function identifies emerging issues with the greatest potential impact on FDA and establishes forums for dialogue among FDA leaders that produce knowledge, shape new strategies, establish priorities and optimize use of resources and provide information and analyses that helps FDA officials, the Department, and members of Congress make decisions related to programs, policies, budgets, and strategic planning.

Our Mission

The Office of Planning implements the Agency's responsibilities associated with the Government Performance and Results Act, the Prescription Drug User Fee Act, and Executive Orders pertaining to economic analysis of regulatory policies and OMB/HHS directives regarding strategic management. These responsibilities include the following:

  • Design and develop strategic plans, performance management systems, and operational/business process plans.
  • Analyze management performance trends, Agency cost structure, and use of program resources.
  • Oversee the Prescription Drug and User Fee Act of 2002 performance and use of resources.
  • Analyze cost and benefits of agency regulations.
  • Provide assistance to Agency components in change management, program reinvention, and managing-to-cost.
  • Analyze changes in domestic health-care system and changes in international and trade issues that relate to FDA responsibilities.


FDA Strategic Action Plan

Outlines how FDA is taking new steps to protect and advance public health. The plan sets a framework for achieving four broad goals for the Agency.

Economic Analyses

Analyses of the economic impact of new and revised regulatory requirements on affected industries.

Prescription Drug User Fee Act

Information about this act, including links to the performance and financial plans since 1995.

FDA Amendments Act

Description of this act, with links to News Updates and full text of the act.

Government Performance and Results Act

Description of the purpose and requirements of this act, with links to FDA's performance plans since 1999.