About FDA
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 the FDA Bioinformatics Board.
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, go to the Prescription Drug User Fee Act (PDUFA).
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, go to the Risk Communication Advisory Committee.