The horizontal bar graph provides FDA final and preliminary “on-time” performance on actions related to original PMAs, Panel-track PMA Supplements, and Premarket Reports. With one exception, performance data for FYs 2003 and 2004 is presented to demonstrate FDA performance prior to the initiation of five on-time goals in FYs 2005 and 2006. On-time goals range from 75 to 90 percent of actions. Preliminary data shows that FDA is meeting or exceeding, with two exceptions, the performance level that is set for these goals prior to and during FYs 2005 and 2006. One exception relates to an FDA on-time goal in FY 2005 to issue a major deficiency letter as the second or later action where the preliminary performance result was slightly below the 75 percent goal. The other exception relates to an FDA on-time goal during FYs 2003 and 2005 to act on an amendment containing a complete response to an approvable letter where the preliminary performance results were below the 90 percent goal.
The horizontal bar graph provides FDA final and preliminary “on-time” performance on actions related to Expedited PMAs. With one exception, performance for FYs 2003 and 2004 is presented to demonstrate FDA performance prior to the initiation of five on-time goals in FYs 2005 and 2006. On-time goals range from 70 to 90 percent of actions. Final FDA performance data indicated FDA met or exceeded all on-time goals with one reported in FY 2003 and two reported in FY 2005. Preliminary performance data indicated that FDA is meeting or exceeding, with two exceptions, the performance level that is set for these goals prior to and during FYs 2005 and 2006. One exception relates to an FDA on-time goal in FY 2005 to make an FDA decision where the preliminary performance result was slightly below 70 percent. The other exception relates to an FDA on-time goal during FY 2004 to act on an amendment containing a complete response to an approvable letter where the preliminary performance results were below the 90 percent goal.
The horizontal bar graph provides FDA final and preliminary “on-time” performance on actions related to 180-day PMA Supplements. Performance for FYs 2003 and 2004 is presented to demonstrate FDA performance prior to the initiation of four on-time goals in FY 2005 and FY 2006. On-time goals range from 80 to 85 percent of actions. Final and preliminary performance data indicated FDA exceeding the performance levels that were set for each of these goals.
The horizontal bar graph provides FDA preliminary “on-time” performance on actions related to 510(k)s. Performance for FYs 2003 and 2004 is presented to demonstrate FDA performance prior to the initiation of three on-time goals in FY 2005 and FY 2006. On-time goals range from 70 to 80 percent of actions. Preliminary performance data indicate FDA is exceeding all three goals.
The horizontal bar graph provides FDA final and preliminary “on-time” performance on actions related to Biologics Licensing Applications. Performance for FYs 2003, 2004, and 2005 is presented to demonstrate FDA performance prior to the initiation of two on-time goals in FY 2006. Both on-time goals were at 75 percent of actions. There were no submissions to act on in FY 2006 for both goals.
The horizontal bar graph provides FDA final and preliminary “on-time” performance on actions related to BLA Supplements. Performance for FYs 2003, 2004, and 2005 is presented to demonstrate FDA performance prior to the initiation of three on-time goals in FY 2006. All three on-time goals were at 75 percent of actions. Preliminary performance results show FDA exceeding the goal to review and act on BLA manufacturing supplements that require prior approval. The other two goals had no submissions to act on in FY 2006.
The horizontal bar graph provides FDA final and preliminary “on-time” performance on actions related to original BLA and BLA Efficacy Supplement Resubmissions. Performance for FYs 2003 and 2004 is presented to demonstrate FDA performance prior to the initiation of two on-time goals in FY 2005 and FY 2006. Both on-time goals ranged from 75 to 80 percent of actions. Final and preliminary performance data indicate FDA is exceeding both on-time goals, with no submissions to act on in FY 2006 for the goal to review and act on Class 1 resubmissions.
Page 15 -The vertical clustered column graph presents submissions and amendments related to PMA and Panel-track PMA supplements for FYs 2003 to 2006. The scale is in increments of 20 with a range from 0 to 60. It indicates that the number of submissions, initially at 50 in FY 2003, decreased slightly in FY 2004, increased to 58 in FY 2005, and then decreased to just above the FY 2003 level in FY 2006. The number of amendments, just over 25 in FY 2003, increased slightly in FY 2004, increased to a 4-year high of 45 in FY 2005, and then decreased dramatically to the lowest level in 4 years at just below 5. It is footnoted that additional amendments can still be submitted for cohorts not closed.
Page 19 -The vertical clustered column graph presents submissions and amendments related to Expedited PMAs for FYs 2003 to 2006. The scale is in increments of 5 with a range from 0 to 15. It indicates that the number of submissions increased more than fourfold from 3 in FY 2003 to 14 in FY 2004, decreased to 6 in FY 2005, and then fell to a 4-year low of 2 in FY 2006. The number of amendments followed a similar pattern, with an initial increase from 3 in FY 2003 to 10 in FY 2004, followed by a drop to 5 in FY 2005, and then to 0 in FY 2006. It is footnoted that additional amendments can still be submitted for cohorts not closed.
Page 23 -The vertical clustered column graph presents submissions and amendments related to 180-day PMA supplements for FYs 2003 to 2006. The scale is in increments of 50 with a range from 0 to 250. It indicates that the number of submissions decreased by about one-half from just over 200 submitted in FY 2003 to slightly above 100 in FY 2004, decreased slightly still staying above 100 in FY2005, and then increased to 131 in FY 2006. It is footnoted that FY 2003 submission data were revised to reflect updated information unavailable for the FY 2005 MDUFA Performance Report. The number of amendments initially increased from 25 in FY 2003 to 42 in FY 2004, decreased to 30 in FY 2005, and fell to just under 10 in FY 2006. It is footnoted that additional amendments can still be submitted for cohorts not closed.
Page 27 –The vertical clustered column graph presents submissions related to 510(k) Premarket Notifications for FYs 2003 to 2006. The scale is in increments of 1,000 with a range from 0 to 4,500. It indicates that the number of 510(k) submissions decreased slightly from the initial level of approximately 4,300 in FY 2003 to approximately 3,700 in FY 2004, then leveled off in FY 2005 at about the FY 2004 level, and increased slightly in FY 2006 to approximately 3,900. The number of 510(k) MDUFMA cohort submissions, which are a subset of all submissions that exclude those that were closed for any reason other than an SE or NSE decision, also decreased slightly from the initial level of just below 4,000 in FY 2003 to approximately 3,400 in FY 2004, increased slightly in FY 2005, then returned close to the FY 2003 level in FY 2006. It is footnoted that the numbers of MDUFMA cohort submissions are not final.
Page 30 –The vertical column graph presents submissions and amendments related to standard and priority original BLA submissions for FYs 2003 to 2006. The scale is in increments of 10 with a range from 0 to 50. It indicates that in FY 2004, the number of standard submissions increased to 9 over the FY 2003 level when there were no submissions, increased to 15 in FY 2005, and then increased nearly three-fold in FY 2006 to 43. No priority BLAs were received from FYs 2003 through 2006.
Page 32 –The vertical column graph presents standard and priority BLA efficacy supplements and BLA manufacturing supplements that require prior approval for FYs 2003 to 2006. The scale is in increments of 10 with a range from 0 to 80. It indicates that three standard BLA efficacy supplements were received from FYs 2003-2006, with all received in FY 2003. No priority BLA efficacy supplements were received in FYs 2003-2006. BLA manufacturing supplements that require prior approval were the only type of BLA supplements with receipts in all four fiscal years. The number of BLA manufacturing supplements was 73 in FY 2003. The BLA manufacturing supplements dropped slightly to 62 in FY 2004, then dropped again to 25 in FY 2005, and remained at the same level in FY 2006.
Page 34 -The vertical stacked column graph presents Class1 and Class 2 resubmitted BLAs and BLA efficacy supplements for FYs 2003 to 2006. The scale is in increments of 5 with a range from 0 to 15. It indicates that no Class 1 resubmissions were received in FYs 2003, 2004, and 2006, while five were received in FY 2005. The number of Class 2 resubmissions approximately doubled each consecutive year beginning in FY 2003 and continuing through FY 2005. However, these numbers were relatively small with two Class 2 resubmissions in FY 2003 and nine in FY 2005. In FY 2006, the number fell to approximately the FY 2004 level.