Appendix A

PDUFA Performance Goals, FY 1993 - FY 1997

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 YearTiming of MeasurementMeasurement Date [1]
Interim Goals of FY 93
1. Establish an industry/FDA working group upon initiation of the user fee program.Supplemental appropriation dateJuly 2, 1993
2. Initiate a pilot computer-assisted PLA review (CAPLAR) program during FY 93End of FY 93Sept. 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 94Sept. 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 94Sept. 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 94Mar. 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 94Mar. 31, 1995
5. Implement performance tracking and monthly monitoring of CBER performance within 6 months of initial user fee payments.6 months after 7/2/93Jan. 2, 1994
6. Implement project management methodology for all NDA reviews within 12 months of the initiation of user fee payments.12 months after 7/2/93July 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 95Sept. 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 95Sept. 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 95Mar. 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 95Mar. 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 94Dec. 31, 1994
6. Implement project management methodology for all PLA/ELA reviews within 18 months of user fee payments.18 months after 7/2/93Jan. 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 7/2/93Jan. 2, 1995
8. Eliminate overdue backlogs of NDAs within 24 months of initiation of user fees.24 months after 7/2/93July 2, 1995
9. Eliminate overdue backlogs of PLAs, ELAs and PLA/ELA supplements within 24 months of initiation of user fees.24 months after 7/2/93July 2, 1995
10. Adopt uniform computer-assisted NDA standards during FY 95End of FY 95Sept. 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 96Sept. 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 96Sept. 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 96Mar. 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 96Mar. 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 97Mar. 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 97Sept. 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 97Mar. 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 97Sept. 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 97Mar. 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 97Mar. 31, 1998
7. Total review staff increment recruited and on board by end of FY 97.End of FY 97Sept. 30, 1997

Footnotes

  1. The statute allows three additional months for review of original NDA, PLA, or ELA submissions that involve major amendments within the last three months of their usual 6- or 12-month review intervals. In these cases, the measurement dates shown in this Appendix move forward by 3 months.

  2. The term "supplement" applies to both drug and biologic submissions. It includes "amendments" to biologic submissions.