The Prescription Drug User Fee Act of 1992, Public Law 102-571, authorized revenues from fees paid by the pharmaceutical industry to expedite review by the Food and Drug Administration (FDA) of human drug applications. The Food and Drug Administration Modernization Act of 1997 (FDAMA), Public Law 105-115, extended this authorization until FY 2002. Along with the extension of revenues, the FDA agreed to meet increasingly stringent review time frames and other procedural performance goals.

FDAMA requires FDA to submit two annual reports to Congress for each fiscal year during which fees are collected: 1) a performance report due within 60 days of the end of the fiscal year, and 2) a financial report due within 120 days of the end of the fiscal year. This document fulfills the first of these requirements for Fiscal Year 1998.