The following list presents by fiscal year the performance measures set forth in the letters referenced in Section 102(3) of the PDUFA. In those letters, the timing of a number of the goals was conditional either (1) on the date (July 2, 1993) upon which a supplemental appropriation was enacted to permit FDA to collect PDUFA user fees, or (2) a specific performance interval (e.g., 6 or 12 months after submission). The following chart lists the 29 goals by fiscal year with appropriate goal measurement dates:
Interim Goals by Fiscal Year | Timing of Measurement | Measurement Date [1] |
---|---|---|
Interim Goals of FY 93 | ||
1. Establish an industry/FDA working group upon initiation of the user fee program. | Supplemental appropriation date | July 2, 1993 |
2. Initiate a pilot computer-assisted PLA review (CAPLAR) program during FY 93 | End of FY 93 | Sept. 30, 1993 |
Interim Goals of FY 94 | ||
1. Review and act upon 55 percent of complete NDA and PLA/ELA submissions received during FY 94 within 12 months after submission date. | 12 months after end of FY 94 | Sept. 30, 1995 |
2. Review and act upon 55 percent of efficacy supplements [2] received during FY 94 within 12 months after submission date. | 12 months after end of FY 94 | Sept. 30, 1995 |
3. Review and act upon 55 percent of manufacturing supplements [2] received during FY 94 within 6 months after submission date. | 6 months after end of FY 94 | Mar. 31, 1995 |
4. Review and act upon 55 percent of resubmitted applications received during FY 94 within 6 months after the resubmission date. | 6 months after end of FY 94 | Mar. 31, 1995 |
5. Implement performance tracking and monthly monitoring of CBER performance within 6 months of initial user fee payments. | 6 months after 7/2/93 | Jan. 2, 1994 |
6. Implement project management methodology for all NDA reviews within 12 months of the initiation of user fee payments. | 12 months after 7/2/93 | July 2, 1994 |
Interim Goals of FY 95 | ||
1. Review and act upon 70 percent of complete NDA and PLA/ELA submissions received during FY 95 within 12 months after submission date. | 12 months after end of FY 95 | Sept. 30, 1996 |
2. Review and act upon 70 percent of efficacy supplements received during FY 95 within 12 months after submission date. | 12 months after end of FY 95 | Sept. 30, 1996 |
3. Review and act upon 70 percent of manufacturing supplements received during FY 95 within 6 months after submission date. | 6 months after end of FY 95 | Mar. 31, 1996 |
4. Review and act upon 70 percent of resubmitted applications received during FY 95 within 6 months after the resubmission date. | 6 months after end of FY 95 | Mar. 31, 1996 |
5. Recruit and bring on board 50 percent of FDA incremental review staff by first quarter of FY 95. | 3 months after end of FY 94 | Dec. 31, 1994 |
6. Implement project management methodology for all PLA/ELA reviews within 18 months of user fee payments. | 18 months after 7/2/93 | Jan. 2, 1995 |
7. Eliminate overdue backlogs of efficacy and manufacturing supplements to NDAs withn 18 months of initiation of user fee payments. | 18 months after 7/2/93 | Jan. 2, 1995 |
8. Eliminate overdue backlogs of NDAs within 24 months of initiation of user fees. | 24 months after 7/2/93 | July 2, 1995 |
9. Eliminate overdue backlogs of PLAs, ELAs and PLA/ELA supplements within 24 months of initiation of user fees. | 24 months after 7/2/93 | July 2, 1995 |
10. Adopt uniform computer-assisted NDA standards during FY 95 | End of FY 95 | Sept. 30, 1995 |
Interim Goals of FY 96 | ||
1. Review and act upon 80 percent of complete NDA and PLA/ELA submissions received during FY 96 within 12 months after submission date. | 12 months after end of FY 96 | Sept. 30, 1997 |
2. Review and act upon 80 percent of efficacy supplements received during FY 96 within 12 months after submission date. | 12 months after end of FY 96 | Sept. 30, 1997 |
3. Review and act upon 80 percent of manufacturing supplements received during FY 96 within 6 months after submission date. | 6 months after end of FY 96 | Mar. 31, 1997 |
4. Review and act upon 80 percent of resubmitted applications received during FY 96 within 6 months after the resubmission date. | 6 months after end of FY 96 | Mar. 31, 1997 |
Five-Year Goals of FY 97 | ||
1. Review 90 percent of complete PLAs, ELAs, and NDAs for priority applications within 6 months after submission date. | 6 months after end of FY 97 | Mar. 31, 1998 |
2. Review 90 percent of complete PLAs, ELAs, and NDAs for standard applications within 12 months after submission date. | 12 months after end of fY 97 | Sept. 30, 1998 |
3. Review 90 percent of priority supplements to PLAs, ELAs, and NDAs within 6 months after submission date. | 6 months after end of FY 97 | Mar. 31, 1998 |
4. Review 90 percent of standard supplements to PLAs, ELAs, and NDAs that require review of clinical data (efficacy supplements) within 12 months after submission. | 12 months after end of FY 97 | Sept. 30, 1998 |
5. Review 90 percent of supplements to PLAs, ELAs, and NDAs that do not require review of clinical data (manufacturing supplements) within 6 months after submission date. | 6 months after end of FY 97 | Mar. 31, 1998 |
6. Review 90 percent of complete applications resubmitted following receipt of a non-approval letter within 6 months after the resubmission date. | 6 months after end of FY 97 | Mar. 31, 1998 |
7. Total review staff increment recruited and on board by end of FY 97. | End of FY 97 | Sept. 30, 1997 |