Procedural and Processing Goals – Meeting Management
The table below summarizes the meeting management goals that address meeting requests, scheduling meetings, and preparing meeting minutes.
|Action||Review Time Goal||Performance Goal
FY 2008 – FY 2012
|Meeting Requests||Notify requestor of formal meeting in writing within 14 days of request.||90% on time|
|Scheduling Meetings||Schedule meetings within goal date (within 30 days of receipt of request for Type A meetings, 60 days for Type B meetings, and 75 days for Type C meetings).* If the requested date for any of these types of meetings is greater than 30, 60, or 75 days, as appropriate, from the date the request is received by FDA, the meeting date should be within 14 days of the requested date.|
|Meeting Minutes||FDA-prepared minutes, clearly outlining agreements, disagreements, issues for further discussion, and action items will be available to the sponsor within 30 days of meeting.|
* Defined in the “Definition of Terms” in Appendix A.
The number of meeting management activities continued to decrease in FY 2008. Meeting requests and scheduling of meetings have decreased for two straight years and meeting minutes have decreased for three straight years (see corresponding graph and table).
|Type||FY 04||FY 05||FY 06||FY 07||FY 08|
|Meeting Request Notifications||2,284||2,487||2,565||2,502||2,344|
FY 2008 Performance
As of September 30, 2008, FDA was not meeting performance goals for meeting management in FY 2008 (see table below). With activities still pending action and not overdue, completing these activities on time will increase overall performance in most areas, but not enough to meet review time goals.
|Type||Performance Goal – Review 90 percent within||Received||Performance as of September 30, 2008||Highest Potential Performance|
|On Time||Overdue||Percent On Time||Pending On Time||On Time||Percent On Time|
|Meeting Requests||Type A||14 Days||362||216||128||63%||18||234||65%|
|Type B||21 Days||1,330||1,086||231||83%||13||1,099||83%|
|Scheduling Meetings*||Type A||30 Days||260||128||91||58%||41||169||65%|
|Type B||60 Days||1,157||852||259||77%||46||898||78%|
|Type C||75 Days||486||361||96||79%||29||390||80%|
|Meeting Minutes||30 Days||1,515||789||516||61%||210||999||66%|
* Not all meeting requests are granted.
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