Office of Policy and Planning

Mission

The Office of Policy and Planning (OPPl) provides strategic policy direction, planning, and data-driven analysis for the Food and Drug Administration (FDA) to more effectively and efficiently protect and promote the public health. 

OPPl does this by:

• developing significant and cross-cutting policy and engaging in strategic problem solving;
• serving as FDA’s focal point for the development, coordination, oversight, and processing of regulations, guidances and other policy documents;
• conducting economic analyses, program evaluations, and special studies; and 
• leading overall FDA strategic, performance, and business process planning, including the development of outcome measures.

Offices and Staffs

OPPl consist of two main offices, the Office of Policy and the Office of Planning. Both Offices collaborate and coordinate on projects.

Our Policy component handles high-priority, cross-cutting, and novel regulatory issues and coordinates the issuance and publication of all FDA regulations, notices, and guidance documents.

Our Planning component provides program planning, coordination, and quantitative analytical services to support policy analysis and program management across the agency. 

Policy

The Policy Development and Coordination Staff works on a broad range of policy initiatives, whether they involve new FDA policies on a particular issue, drafting priority regulations and guidance documents, or advising senior Agency officials on complex regulatory matters. Our past assignments have included “mad cow” disease, transgenic animals, dietary supplement regulation, drug importation, food safety, tissue regulation, and human subject protection. The management and staff are composed primarily of policy analysts and project managers who have backgrounds in medicine, pharmacy, public health, biological sciences, and/or law.

The Regulations, Policy, and Management Staff is responsible for matters relating to the clearance and publication of FDA’s regulations and guidance documents. This staff edits documents to meet federal specifications, clears documents through the Department of Health and Human Services, the Office of Management and Budget, and other federal agencies, and handles other rulemaking efforts. The Regulations Policy and Management Staff consists primarily of regulatory counsels and writer-editors.

Planning

The Immediate Office of the Assistant Commissioner for Planning leads the agency’s strategic planning process, with support from the Planning Staff.  It also leads the Prescription Drug User Fee performance management program and the agency-wide business process modeling and analysis to support business process improvement and automation agency-wide.  The immediate office manages special cross-agency programs, including the FDA Risk Communication Advisory Committee and the FDA's internal Communication Council. The Assistant Commissioner for Planning is the agency’s senior performance official for complying with GPRA and related OMB requirements.

The Economics Staff provides economic analyses for FDA regulations and policy issues and conducts economic studies to forecast trends and analyze major problems facing FDA. The staff is composed of economists and operations research analysts.

The Evaluation Staff conducts program and analytical studies to support FDA’s policy development efforts, and is FDA’s liaison to the Department of Health and Human Services for program evaluation matters, and prepares annual user fee performance reports to Congress. The staff is composed of program analysts and operations research analysts.

The Planning Staff coordinates the development of annual performance goals and long-term outcome measures that support the FDA Strategic Action Plan and comply with the requirements of the Government Performance and Results Act (GPRA).  This work includes budget formulation performance analyses, and on-going assessment of performance data. The staff consists of program analysts and operations research analysts.