FDA FY 2008 Budget Summary

Current Law User Fees

($5,244,000)

9

Enable FDA to review medical products in a timely manner and reimburse FDA for color certification and export certificates provided to industry¹

Proposed Generic Drug User Fee

$15,701,000

34

Enhance the review process for Abbreviated New Drug Applications (ANDAs) for generic drug products and respond to the growing number of generic drug applications

 

Total Program Level

 

$105,806,000

 

Proposed User Fees (Non-Add Classified as Mandatory)

Reinspection User Fee

$23,276,000
(Non-Add)

118

Re-proposed new user fees to reimburse for reinspection of FDA-regulated facilities

Food and Animal Export Certification User Fee

$3,741,000
(Non-Add)

23

Re-proposed new user fees to reimburse for issuing food and feed export certificates

 

Total Proposed User Fees

 

$27,017,000

 

¹ In FY 2007, PDUFA collections included a one time increase of $31,600,000 for the final year adjustment under the PDUFA III.  For FY 2008, adjustments include increases for inflation and other increases authorized by the PDUFA statute.  The decrease in FY 2008 is due to this one-time, non-recurring FY 2007 Final Year adjustment. Because FDA has not completed the public comment period regarding FDA’s proposed recommendations for PDUFA reauthorization, the FY 2008 PDUFA estimate is based on straight reauthorization of PDUFA III with no programmatic enhancements or adjustments.