Malcolm J. Bertoni, Acting Assistant Commissioner for Planning
Bioinformatics Board, Margo Burnette, Executive Director
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
Critical Path Steering Committee, Lisa Rovin, J.D., Manager
We assist the Office of Critical Path Programs by managing the Critical Path Steering Committee, which is responsible for FDA-wide coordination of the Initiative. The goal of the Agency's Critical Path Initiative is to help modernize the scientific tools and standards used to evaluate the safety and quality of medical, veterinary, food, and cosmetic products, the nutritional value of food products, and the efficacy of medical and veterinary products. For more information on the Critical Path Initiative go to http://www.fda.gov/oc/initiatives/criticalpath/
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 First Cycle Review Performance Proposals under PDUFA III. In addition, OPL monitors the overall status of PDUFA implementation. 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/default.htm.
Malcolm J. Bertoni, 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
- 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.
John Uzzell, Director
We play an integral role in carrying out the FDA's mission. Assessing various aspects of Agency program performance allows staff 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 significantly 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 DHHS in the development of the annual DHHS evaluation plan.
- Applies quantitative and qualitative techniques to assess systems, processes, and operations to help Agency officials discover optimal courses of action.
- Assists and consults with Agency components to design, develop and complete FDA User Fee performance reports for Congress.
- Approves survey methodology, design, and questionnaires within the Agency prior to Office of Management and Budget (OMB) clearance under the Paperwork Reduction Act. Reviews Memoranda of Need which require the collection of health research data and advises Agency components on the planning and design of health research studies
Clark Nardinelli, Director
We conduct economic analyses of alternative actions that are
used as input to or support for policy decisions and major
regulations. We are the agency focal point for economic analysis
assistance and consultation; and we review and clear agency
economic analyses of regulations. We ensure that economic analyses
of FDA regulations comport with relevant legal requirements.
We develop, maintain and analyze data on FDA-related industries
to forecast trends and evaluate major problems affecting the
agency. We advise and assist the Commissioner and other key
officials on a day-to-day basis concerning economic factors
relating to current and proposed agency activities. We provide
agency representation to Congress, OMB, HHS, and other outside
organizations and groups on economic issues relating to agency
responsibilities and actions. We provide economic research
material for use by agency officials in preparing testimony
before congressional committees and in developing replies to
inquiries directed to the agency.