About FDA
JINAD Submissions
FY 2009 AGDUFA Performance Report Table of Contents
Goal: Review and act on JINAD study and protocol submissions
The table below summarizes the review time and performance goals for JINAD study and protocol submissions. Over the 5-year period defined by AGDUFA, the number of review days is incrementally reduced for each type of submission while the goal of reviewing 90 percent of submissions remains constant.
Submission Type | Review Time Goal (Days) | Performance | ||||
|---|---|---|---|---|---|---|
FY 2009 | FY 2010 | FY 2011 | FY 2012 | FY 2013 | ||
JINAD Studies | 700 | 680 | 500 | 380 | 270 | 90% on time |
JINAD Protocols | 400 | 390 | 290 | 190 | 100 | |
Workload
A total of 15 JINAD submissions were received in FY 2009 and all were accepted for review (see corresponding graph and table). Eight submissions were JINAD studies and seven were JINAD protocols (see corresponding graph and table).
JINAD Submissions
| Type | FY 09 | FY 10 | FY 11 | FY 12 | FY 13 |
|---|---|---|---|---|---|
| JINAD Studies | 8 | -- | -- | -- | -- |
| JINAD Protocols | 7 | -- | -- | -- | -- |
| Total | 15 | -- | -- | -- | -- |
Performance
FY 2009 Submissions
As of September 30, 2009, performance data was available for almost two-thirds (5 of 8) of the JINAD study submissions, and FDA met the review time goal for all submissions (see table below). Performance data was available for almost one-third (2 of 7) of the JINAD protocol submissions, and FDA met the review time goal for all submissions. With three JINAD study submissions and five JINAD protocol submissions still pending within goal, FDA has the potential to exceed the performance goals.
JINAD Submission | Filed | Performance Goal | Performance as of | |||
|---|---|---|---|---|---|---|
Act on | On Time | Overdue | Percent On Time | Pending Within Goal | ||
Studies | 8 | 700 days | 5 | 0 | 100% | 3 |
Protocols | 7 | 400 days | 2 | 0 | 100% | 5 |
Next page: Appendix A: Commitment Letter from HHS Secretary to Congress
