Obligation of User Fee Revenues (FY 2010 PDUFA)
Back to Table of Contents: FY 2010 PDUFA Financial Report
User fee revenues are expended only for costs necessary to support the process for the review of human drug applications, as defined in PDUFA. Allowable and excludable costs for the process of the review of human drug applications are defined in Appendix C. In FY 2010, FDA obligated $573,258,400 from user fee revenues.
Statement of PDUFA Fee Obligations by Expense Category
Personnel Compensation and Benefits
Travel and Transportation
Equipment and Supplies
As of September 30, 2009 and 2010
FDA dedicated 1,277 staff years to the review of human drug applications in FY 1992, before PDUFA was enacted. (In this report the time worked by one full time person for one year is referred to as either a “staff year” or as a “full-time-equivalent” (FTE).) FDA conducted a time reporting study in 1993 to determine the percentage of time each organizational component devoted to user fee-related activities. The data from this study allowed FDA to calculate the personnel-related costs of the drug review process. The percentages are updated regularly through additional time surveys, which are consistent with the method used by independent consultants in FY 1993. More detailed information about the development of the costs associated with the review of human drug applications can be found in Appendix D
In FY 2010, PDUFA fees and appropriations paid for a total of 3,760 staff years, 2,483 more staff years than were used in FY 1992 for the review process of human drug applications, before user fees were authorized. Employee salary and benefits paid from user fees in FY 2010 totaled over 60 percent of the obligations from fees. This includes all pay and benefits for the additional personnel. The FY 2010 PDUFA Performance Report, which discusses FDA’s progress in meeting the goals set for FDA in PDUFA IV, and overall FDA application review performance, is being transmitted separately to Congress.
In FY 2010, FDA completed significant steps in migrating most of the software systems to the new data centers and established processes and procedures for the development and deployment of applications in the new data centers. The following were the most significant:
The Information and Computer Technologies for the 21st Century (ICT21) project was initiated by FDA to provide an Agency-wide computing platform for the 21st Century that is scalable, flexible, and reliable and effectively meets business requirements. The Office of Information Management (OIM) implemented two new state of the art electronic data centers under the ICT21 initiatives. The target technologies and application architecture were defined for the new data centers which resulted in a more secure environment and standardized system development. FDA was actively involved throughout the year in the immense task of analyzing, documenting, and migrating hundreds of applications to the new data centers in different environments such as Development, Test, Pre-Production, and Production. Substantial efforts were made to use shared environments to achieve efficiency and common technical architecture across centers. FDA successfully migrated most of the software systems to the new data centers. OIM also refined standard operating procedures for effectively developing and deploying systems in the new data center environments.
In conjunction with the implementation of the new data centers, OIM has also defined and implemented a centralized security program, allowing for better oversight of both the networks and environments which resulted in robust and secured environments.
The Enterprise Architecture (EA) team continued to refine the IT Investment Management (ITIM) process to govern all of the FDA IT investments so that they advance towards the target architecture. The governance framework enables the standardized evaluation, prioritization, and processing of requests for IT investments, products and services. The ITIM process aligns related Federal and the Department of Health and Human Services (HHS) defined processes such as the Capital Planning and Investment Control (CPIC), the Federal Enterprise Architecture (FEA), and the HHS Enterprise Architecture Repository (HEAR). The baseline data for the target (current state analysis and data collection) has been captured and modeled in HEAR. In addition, the IT Strategic Plan (ITSP) has been reviewed and, together with the investment portfolio gap analysis, the data will serve as a foundation for target architecture planning. The EA staff has established FDA compliance with HHS mandates and demonstrated effective oversight through rationalization, accounting, and reduction of FDA’s portfolio and technical footprint.
The EA work provides comprehensive enterprise architecture, a defined target state, and a governance process for ensuring that IT investments match business needs and the strategic goals of the organization.
OIM established different divisions to support Agency-wide IT requirements and continued to support current centers and office IT systems. In FY 2010, OIM’s Division of Systems (DOS) continued to evolve and formulate a new organization structure to support system development efforts and deliver coordinated and efficient systems in support of increasingly complicated business requirements. DOS established vertical and horizontal task groups to support system development across Centers while leveraging common system development life cycle components. Vertical task groups support system development across Centers based on business functionality and product lines. Horizontal task groups support common components across system development, such as project management support, testing support, quality management, data management, and configuration management. System development efforts leverage services of horizontal task groups to minimize redundancy, resulting in a structured approach to system development. DOS has centralized project management tools for software delivery and continues to implement the Enterprise Performance Lifecycle (EPLC) methodology across projects. This consistency will allow for improved monitoring and control techniques to track issues and quality throughout the lifecycle of a project.
The Document Archiving Reporting and Regulatory Tracking System (DARRTS) is a flexible, integrated, fully electronic workflow tracking and information management system to receive, log, track, assign, process, manage, and report official submissions with internal stakeholders. The system maintains the official submission records and manages and tracks all communications, documentation, meetings, and deadlines concerning submissions. The earlier release of DARRTS integrated multiple legacy applications and implemented a web-based secured application. The two releases in FY2010 addressed multiple enhancements such as IND, NDA Volume Accountability System (INVAS) maintenance screens, mass assignments, Tracked Safety Issues (TSI) modifications, etc. Additionally, DARRTS was successfully migrated to the new Data Center.