FDA OC Financial Management Information Systems
Investment ID: 009-000005323
Overview
Program Title
FDA OC Financial Management Information Systems
Description
Supports FDA s regulatory mission by collecting 2 billion dollars in User Fees and reporting their use by FDA Centers. Facilitates management of fees and appropriations and provides financial information to support budget formulation and execution.
Type of Program
Major IT Investments
Multi-Agency Category
Financial Management
Associated Websites
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/default.htm, https://userfees.fda.gov/OA_HTML/irecLogin.jsp, http://www.fda.gov/ForIndustry/UserFees/default.htm, http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm, http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm
Investment Detail
Congress requires FDA to collect User Fees and to provide accurate and timely user fee information. Fees totaled nearly $2.2 Billion in Fiscal Year 2018, roughly 45% of FDA's annual budget enabling FDA to fulfill its mission. UFS is projected to collect in excess of $2.4 Billion in Fiscal Year 19. Public benefits include faster review and reduced time to market for new products. The User Fee System (UFS) enables FDA to meet Congressional requirements for collection and reporting. Benefits include efficiency and transparency in fee collecting and recording. UFS generates over 50,000 invoices and collects about 48,000 payments a year. Its external interface enables industry customers to submit fees and view the payment status. Customer feedback is positive. Interfaces with HHS' UFMS and related systems ensure that fees are reported accurately. UFS has been in operation since 2005 and is largely steady state, with regular competitive awards for O&M support and enhancements. Enhancements are incorporated as needed to address additional Fees resulting from Congressional Acts. Upgrades are done to retain technical currency. Options for alternatives to UFS' highly customized services are not currently under consideration. Major reengineering of UFS' highly customized features would far exceed the cost of maintaining the current system. IBAPS will result in improvements in the accuracy and consistency of FDA's resource management, and enables budget staff to focus on analyses for decision making. This helps the FDA enhance the availability of information on budget formulation, budget execution, financial management, performance and strategic management and external systems to support improved decision making, accountability, and transparency.