Obligation of User Fee Revenues
Back to Table of Contents: FY 2009 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 2009, FDA obligated $512,051,400 from user fee revenues.
FOOD AND DRUG ADMINISTRATION
STATEMENT OF PDUFA FEE OBLIGATIONS BY EXPENSE CATEGORY
As of September 30, 2008 and 2009
Expense Category FY 2008 FY 2009 Personnel Compensation and Benefits $247,753,981 $317,836,710 Travel and Transportation $6,753,378 $4,903,162 Rent $12,682,864 $20,893,636 Communications $9,203,524 $13,477,913 Contract Services $160,945,543 $132,439,531 Equipment and Supplies $12,592,575 $21,891,912 Other $608,536 $608,536 Total Obligations: $450,786,835 $512,051,400
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 parallel 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 2009, PDUFA fees and appropriations paid for a total of 3,526 staff years, 2,249 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 2009 totaled over 60 percent of the obligations from fees. This includes all pay and benefits for the additional personnel.
In FY 2009, FDA completed significant steps in the development of new systems or consolidation of legacy information systems. The following were the most significant:
The Enterprise Architecture (EA) team developed the IT Investment Management (ITIM) process to govern all of the FDA IT investments so that they advance towards the target architecture. A governance framework enables the standardized evaluation, prioritization, and processing of requests for IT investments, products and services. The ITIM process aligns to related Federal and HHS defined processes such as the Capital Planning and Investment Control (CPIC), the Federal Enterprise Architecture (FEA), and the HHS Enterprise Architecture Repository (HEAR).
New IT requests are also reviewed for Enterprise Information Management (EIM) alignment, prioritized, and reviewed through a standardized assessment for all new IT investments. Major initiatives are added to the end-state solution architecture and the EIM roadmap to document and monitor the project as it is defined and implemented. As the scope and needs of the agency change, these projects will influence the EIM vision through its Strategic Capabilities and Building Blocks so that the vision is continually updated as well, to reflect changes within the FDA.
The EA work provides a 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.
Through the organizational restructuring efforts, the Office of Information Management (OIM) has worked through challenges bringing the different IT offices together to support not only enterprise initiatives, but also maintain support for the current Center and Office systems. Initial work is underway to evaluate the various standards, technologies and platforms with the goal of defining a target system framework. OIM also created standard operating processes to prioritize the development of common functional IT components. As part of the common components framework initiatives, a repository was developed to house and make available common components code, documents, and associated implementation guidance for systems to develop in a consistent way.
Additionally, as part of the migration process to the new data centers, work is focused on documenting common processes and components, and testing target architecture assumptions. Among many aspects, common services include centralized documentation, policy, standard operating procedures, technology, components, configuration management, security, governance, and issue tracking.
As of June 1, 2009, the FDA no longer accepts drug registration and listing information in paper format without a waiver. This decreases paper reviews and supplements the electronic requirements associated with Structured Product Labeling (SPL). FDA has worked diligently to ensure information, assistance, training, and vendor education is available and offers best practices to regulated parties to increase the success rate of electronic submissions. In FY 2009, the IT-related guidance, Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing (5/28/09), was published in final form. This guidance was published to assist regulated parties in submitting registration and listing information in electronic format. As of September 30, 2009, no waivers have been granted.
Information and Computing Technologies for the 21st Century (ICT21) provides an agency-wide computing environment for the 21st century that is efficient, effective, scalable, flexible, reliable, and meets the FDA business requirements. The successful delivery of these objectives will enable the FDA to create a secure infrastructure, with improved service, response times, and overall performance.
The FDA has successfully designed and prepared for two new data centers, one for development and testing, and another for pre-production and production data. The pre-production environment will allow for more testing and collaboration with the regulated industry as IT systems evolve. In conjunction with the development 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.