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  5. Exhibit 4-18 long description
  1. Prescription Drug User Fee Amendments

Exhibit 4-18 long description

The total number of Fast-Track products in divisions that had Pilot 1 products was 3 in 2003, 9 in 2004, and 11 in 2005, with an average of 8 fast-track applications per year at a cost of 190-360 direct hours. The total estimated annual incremental increase for fast-track products was 1,520-2,880 hours per year.