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Assumptions - All Statutory Triggers Will Be Met

Table of Contents: PDUFA III Five-Year Plan

Previous Section : Assumptions - Support of PDUFA II Fee Base Levels

The law allows FDA to collect and spend PDUFA III revenues each year only if three specific conditions are met. This plan assumes that each of the three statutory conditions will be met each year:

  • Total FDA appropriations each year (exclusive of user fees and rent payments to GSA) must total at least as much as FDA received in FY 1997, adjusted for inflation at the rate of change in the Consumer Price index since FY 1997. For FY 2005 and later, the chart below assumes that this will be a change of 2.5 percent each year. The assumed rates will be updated in future revisions of this plan. The estimates are as follows:

    Fiscal
    Year
    1997 Amount
    ($ Millions) Less Rent and
    User Fees
    Est. Adjustment Factor
    (Actual factors through
    FY 2004, estimated for
    later years)
    Minimum
    Appropriation
    ($ Millions)
    Actual
    Appropriation
    ($ Millions)
    Less Rent and Fees
    2003 $820 1.1224 $920 $1,275
    2004 $820 1.1473 $941  
    2005 $820 1.1760 $964  
    2006 $820 1.2054 $988  
    2007 $820 1.2355 $1,013  


    FDA meets this trigger consistently, even though for most years since FY 1997 FDA did not receive increases to cover the cost of pay increases and inflation for its core programs-which was the original intent of this trigger. FDA meets this trigger primarily because FDA has received appropriation increases earmarked for specific initiatives since FY 1997 (e.g., food safety, tobacco, counter-terrorism).
  • Each year FDA must actually spend at least as much from appropriations on the human drug review process as it spent from appropriations on this process in FY 1997, adjusted for inflation at the rate of change in the Consumer Price index since FY 1997. For FY 2005 and later, the chart below assumes that this will be a change of 2.5 percent each year. The assumed rates will be updated in future revisions of this plan. The estimates are in the table below:

    Fiscal
    Year
    1997 Amount
    Spent on Drug
    Review from
    Appropriations
    ($ Millions)
    Adjustment Factor
    (Actual factors through
    FY 2004, estimated for
    later years)
    Minimum Drug
    Review
    Spending from
    Appropriations
    ($ Millions)
    Actual Drug
    Review Spending
    from
    Appropriations
    ($ Millions)
    2003 $148 1.1224 $166  
    2004 $148 1.1473 $170  
    2005 $148 1.1760 $174  
    2006 $148 1.2054 $178  
    2007 $148 1.2355 $183  


    If FDA spending from appropriations on the drug review process is less than 5 percent of the specified minimum above, no fees may legally be collected or spent for the year. FDA will not know exactly how much it has spent from appropriations until after the end of the year when final accounting reports are prepared. FDA plans to spend this minimum from appropriations each year. In years when FDA programs do not receive appropriations to cover costs of inflation and mandatory pay increases, core FDA programs other than drug review may have to be further reduced to assure that appropriated spending for drug review meets the requirements of this trigger.
  • PDUFA fee revenues may be collected and spent only to the extent provided each year in FDA's appropriation. If collections exceed appropriations, the surplus can be kept by FDA and used to reduce anticipated collections in a future year.

    Fiscal
    Year
    PDUFA Fees
    Provided in
    Appropriations
    ($ Millions)1
    PDUFA Fees
    Actually Collected
    ($ Millions)
    as of 9/30/2002
    Overage, if Any
    ($ Millions)
    2003 $222.9    
    2004      
    2005      
    2006      
    2007      
    1Actual amount shown for 2003. In updates of the plan, amounts appropriated in subsequent years and amounts actually collected each year will be added to this table.

 

Next Section : Assumptions - Human Resources May Be Acquired By Either Hiring Or Contracting