Procedural and Processing Goals – Special Protocol Assessments
The table below summarizes the annual review time and performance goals for the response to the requests for special protocol assessments.
|Action||Review Time Goal||Performance Goal
FY 2008 – FY 2012
|Special Protocol Question Assessment and Agreement||Respond to sponsor's request for evaluation of protocol design within 45 days of receipt.||90% on time|
In FY 2008, special protocol assessment requests reversed a three-year trend of increases, decreasing to levels close to FY 2004 (see corresponding graph and table).
Requests for Special Protocol Assessments
|FY 04||FY 05||FY 06||FY 07*||FY 08|
* FY 2007 counts were updated to reflect corrections to the FY 2007 PDUFA Performance Report.
FY 2008 Performance
As of September 30, 2008, performance data was available for over four-fifths (313 of 354) of the sponsors’ requests for evaluation of protocol designs received in FY 2008, and FDA was not meeting the performance goal (see table below). With 41 assessments pending action and not overdue, FDA can increase performance, but not enough to meet the performance goal.
|Performance Goal||Total Received||Performance as of September 30, 2008||Highest Potential Performance|
|On Time||Overdue||Percent On Time||Pending On Time||On Time||Percent On Time|
|Respond to 90 percent within 45 Days||354||269||44||86%||41||310||88%|
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