APPENDIX B:  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 original Prescription Drug User Fee Act of 1992.  In those letters, the timing of a number of the goals was conditional either (l) 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 supplements2 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 supplements2 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 within 18 months of initiation of user fee payments. 18 months after 7/2/93 Jan. 2, 1995
8. Eliminate overdue backlog of NDAs within 24 months of initiation of user fees. 24 months after 7/2/93 July 2, 1995
9. Eliminate overdue backlog 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
INTERIM GOALS OF FY 97
1. Review and act upon 90 percent of complete NDA and PLA/ELA submissions for priority applications received during FY 97 within 6 months after submission date. 6 months after end of FY 97 Mar. 31, 1998
2. Review and act upon 90 percent of complete NDA and PLA/ELA submissions for standard applications received during FY 97 within 12 months after submission date. 12 months after end of FY 97 Sept. 30, 1998
3. Review and act upon 90 percent of priority supplements received during FY 97 within 6 months after submission date. 6 months after end of FY 97 Mar. 31, 1998
4. Review and act upon 90 percent of standard supplements received during FY 97 that require review of clinical data (e.g., efficacy supplements) within 12 months after submission. 12 months after end of FY 97 Sept. 30, 1998
5. Review and act upon 90 percent of supplements received during FY 97 that do not require review of clinical data (e.g., manufacturing supplements) within 6 months after submission date. 6 months after end of FY 97 Mar. 31, 1998
6. Review and act upon 90 percent of resubmitted applications received during FY 97 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
 

Notes:

  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 biologics submissions.

 
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