FY 2001 PDUFA Financial Report: Obligation of User Fee Revenues
Previous Section: User Fee Revenues
User fee revenues are expended only for costs necessary to support the process for the review of human drug applications, as defined in FDAMA. Allowable and excludable costs for the process for the review of human drug applications are defined in Appendix C. In FY 2001, FDA continued to improve and expedite the activities involved with the process for review of human drug applications, obligating $160,713,000 from user fees.
|Expense Category||FY 2000||FY 2001|
|Personnel Compensation and Benefits||$95,145,000||$107,331,472|
|Travel and Transportation||$4,034,000||$3,757,259|
|Equipment and Supplies||$11,196,000||$11,614,462|
FDA dedicated 1,277 FTE's (Full Time Equivalents or staff-years) to the review of human drug applications in FY 1992, before PDUFA was enacted. A time reporting study was undertaken in 1993 to determine the percentage of time each division devotes to user fee related activities. This allowed calculation of FTE related costs. The percentages are updated regularly through additional time surveys, which parallel the method used by independent consultants in FY 1993. The development of these user fee related costs associated with the review of human drug applications is described in more detail Appendix D.
In FY 2001, PDUFA fees and appropriations paid for 1063 more FTE's than were used in 1992 for the process for the review of human drug applications, and 54 more FTE's than were funded in the preceding year. FDA's payroll costs paid from user fee funds in FY 2001 totaled $107,331,472-representing almost 67% of the funds expended. This includes all pay and benefits for the additional FTE's and costs of the FY 2001 payroll increases for the baseline FTE's.
A substantial amount of the remaining funds were spent on information technology (IT). FDA is engaged in an Agency-wide IT program to support the transition from a largely paper-based regulatory submission and review environment to an electronic environment. This effort is called the Electronic Regulatory Submission and Review (ERSR) program. ERSR is comprised of a variety of projects, each of which is designed to satisfy a different part of the overall PDUFA IT goal that:
the agency shall develop and update its information management infrastructure to allow, by FY 2002, the paperless receipt and processing of exemptions for investigational new drugs (IND's) and human drug applications….
The major ERSR project areas are described below.
Standards and Guidance. These projects promote consistent exchange of electronic information between the FDA and external constituents. At the completion of FY 2000, several technical standards had been established and supporting guidance documents were provided to external constituents.
Capability to Receive Electronic Submissions. These projects implement procedures and technology to support electronic submissions in lieu of paper. Progress in this area includes the establishment of Electronic Document Rooms that permit the receipt of electronic submissions in physical media format (e.g., CD-ROM, magnetic tape) from industry.
Electronic Review. These projects enable FDA reviewers and field inspectors to conduct review activities in an electronic environment. Progress in this area includes the implementation of electronic document management systems that facilitate electronic collaboration between review staff and the expansion of existing management information systems that track the status of each review.
- Updated Infrastructure - These projects include the implementation of underlying technologies required to support the transition to a paperless review environment. Progress in this area included installing new computer hardware and software, increasing network capacity, updating the skills of technical support staff, and training for reviewers.
The total expenditure of $160,713,000 in FY 2001 is an increase of about 9% over FY 2000 amounts spent from fee revenue. This spending amount is consistent with the latest PDUFA II Five-Year Plan Update, and is in excess of the revenues FDA collected in FY 2001. Spending at this level was possible because FDA spent less than it collected in several earlier years, and the amounts carried over are available to FDA for spending on the drug review process in subsequent years, as explained in the next section of this report.
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