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U.S. Department of Health and Human Services

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Assumptions - Revenue Levels and Adjustments

 

Table of Contents: PDUFA III Five-Year Plan

Previous Section : Workload and Workload Adjustments

The statute sets revenue levels for the five years of PDUFA III. They are:

Statutory PDUFA III Revenue Levels

  2003 2004 2005 2006 2007
Product Fees $74,300,000 $77,000,000 $84,000,000 $86,434,000 $86,434,000
Establishment Fees $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Application Fees $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000
Total $222,900,000 $231,000,000 $252,000,000 $259,300,000 $259,300,000

These statutory revenue levels are to be adjusted for inflation. When the inflation assumptions described in Assumption 1 are applied to the statutory revenue levels above, the inflation adjusted revenue levels that result are set forth in the table below:

Inflation Adjusted PDUFA III Revenue Levels

  2003 2004 2005 2006 2007
Product Fees $74,300,000 $80,287,900 $91,160,341 $97,628,935 $101,612,196
Establishment Fees $74,300,000 $80,287,900 $91,160,341 $97,627,806 $101,611,020
Application Fees $74,300,000 $80,287,900 $91,160,341 $97,627,806 $101,611,020
Total $222,900,000 $240,863,700 $273,481,024 $292,884,546 $304,834,236

The inflation adjusted revenue levels are to be adjusted again for workload. As stated in Assumption 2, above, no workload adjustment is being made in the initial PDUFA III Five-year Plan. However, in future years there may be a further adjustment to these revenue levels for workload in future revisions of this plan.

Next Section : Assumptions - Anticipated Collections

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