Organization

Malcolm J. Bertoni, Assistant Commissioner for Planning

• Immediate Office
• Planning Staff
• Evaluation Staff
• Economics Staff

Immediate Office

Bioinformatics Board

We provide staff and management support to the Bioinformatics Board. The Bioinformatics Board coordinates and oversees all activities related to business automation planning, acquisition, and implementation decisions throughout FDA.  The Bioinformatics Board also ensures coordination of activities among FDA representatives to the Federal Health Architecture program and other federal health informatics initiatives, the FDA Regulation Policy Council, the FDA Data Standards Council, and the Enterprise Architecture Review Board, particularly with regard to business process planning and regulatory policies. For more information on the Bioinformatics Board, go to http://www.fda.gov/smg/vol3/2000/2010_7.html

Prescription Drug User Fee Act (PDUFA), William Hagan, M.B.A., Project Manager

The Office of Planning (OPL) is responsible for managing PDUFA performance management funds for projects to improve the new drug review process and for evaluating PDUFA initiatives. OPL is project managing a CDER, CBER, and OC Quality Systems Group to coordinate performance management projects. OPL is also responsible for project managing evaluations of certain PDUFA initiatives such as the implementation of Good Review Management Principles (GRMPs) and the Electronic Review Environment. In addition, OPL monitors the overall status of PDUFA performance commitments. For more information on PDUFA, go to http://www.fda.gov/oc/pdufa/default.htm

Risk Communications Planning, Nancy M. Ostrove, PhD, Director of Risk Communications

In this program, our objective is to assess and enhance FDA's approaches to effectively communicating, in ways that the public will appropriately understand and apply, the risks and benefits of using FDA-regulated products. This includes providing leadership in identifying, developing, conducting and promoting cross-cutting research, promoting understandable communication, and finding ways to improve the consistency and effectiveness of our communication approaches. This program also directs the activities of FDA's Risk Communication Advisory Committee, which was established: to advise on strategies and programs to communicate the risks and benefits of FDA-regulated products so as to facilitate optimal use; to review and evaluate FDA's and others' research relevant to such communication; and to facilitate interactively sharing risk and benefit information with the public to help people make informed independent judgments about use of FDA-regulated products. For more information about the Risk Communication Advisory Committee, visit: http://www.fda.gov/oc/advisory/OCRCACACpg.html .

Planning Staff
Pat Stewart, Deputy Director

We, in partnership with FDA senior management leaders, guide the Agency through our rapidly changing environment to attain significant public health outcomes. Our planning function has three goals: 1) 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; 2) leads and constantly improves performance measurement system that establishes measurable goals and clearly defined outcomes consistent with FDA's priorities; and 3) ensures that internal and external stakeholders clearly understand FDA's challenges, achievements and future directions.

Our planning activities serve one or more of the following purposes:

• Directs the Agency long-range planning process under the Government Performance and Results Act, including strategic and annual performance planning, and coordinates it with the HHS long-range planning process.
• Assists and consults with Agency components in their performance planning.
• Consults with and supports the Office of Financial Management in preparation of the Agency budget.
• Coordinates the Agency functional (regulatory, research, etc.) planning processes and supports Agency staff units in planning design, preparation, coordination, and execution.
• Conducts analysis of resource requests submitted by Agency components in order to develop resource recommendations for the Commissioner, to support the planning process, and to fulfill HHS requirements.
• Applies mathematical disciplines and management engineering techniques, such as the use of time analysis, mathematical interpretations, statistical analyses, and other quantitative techniques to assess resource adequacy.

Evaluation Staff
John Uzzell, Director

We play an integral role in carrying out the FDA's mission. Assessing various aspects of Agency program performance provides opportunities to identify means of improving that performance. The evaluation function we perform has three goals: 1) provide information and analyses that helps Agency officials, the Department, and members of Congress make decisions related to programs, policies, budgets, and strategic planning; 2) help FDA managers improve program operations and performance; and 3) disseminate evaluation results and methodological tools useful to FDA program managers and, in some cases, to the larger public health community.

Our evaluation activities serve one or more of the following purposes:

• Performs program and policy evaluations and analytical studies of broad Agency issues. Recommends alternative courses of action to increase effectiveness of agency allocation of resources and to improve program and project performance.
• Monitors program evaluation activities in Agency components and collaborates with Health and Human Services (HHS) in the development of the annual HHS evaluation plan.
• Applies quantitative and qualitative techniques to assess systems, processes, and operations to help Agency officials discover optimal courses of action.
• Collaborates with Agency components to design, develop and complete FDA User Fee performance reports for Congress.

Economics Staff
Clark Nardinelli, Director

We do all of the economic analysis for the Office of the Commissioner and for most of the rest of the FDA. We ensure that cost-benefit and cost-effectiveness analyses of FDA regulations fulfill all economic requirements, as well as provide the best possible economic information to the FDA management and staff responsible for regulatory decisions. We collect, maintain, and analyze data on FDA-regulated products and carry out special research projects on significant topics affecting the agency or its responsibilities. In all of these activities, we serve as objective, unbiased economic analysts who let management and staffs know the economic implications of actions and events. In this role, we advise and assist the Commissioner and other key officials on a day-to-day basis on the economic implications of current and proposed agency activities. We see that economic data used by the agency are of the highest quality and that the methods used to analyze them are appropriate. We also present the economics of FDA activities outside the agency. We supply FDA representation on economic matters to the Department of Health and Human Services, the Office of Management and Budget, Congress, and other outside organizations and groups. We supply economic research material for use by agency officials in preparing testimony before congressional committees and in developing replies to inquiries directed to the agency. As a behavioral science, applied economics is particularly relevant to policies likely to influence the behavior of patients, industry, or healthcare professionals. We therefore carry out background research on many of the most pressing healthcare problems facing the agency. Topics we have recently studied as part of special research projects include: the returns of market exclusivity granted to drug sponsors who conduct pediatric trials; the market size for follow-on protein-based drug products; the agency’s workload associated with increasing review activities under the Prescription Drug User Fee Act; potential economic gains associated with genetically-engineered animals; trends in drug approvals; measures of drug safety; and effects of potential financial conflicts-of-interest on FDA advisory committees.