APPENDIX C: PDUFA PERFORMANCE GOALS, FY 1998 - FY 2002

The following list presents by fiscal year the performance measures set forth in the letters referenced in the Food and Drug Administration Modernization Act of 1997. The following chart lists the goals by fiscal year with appropriate goal measurement dates:

 

I. FIVE-YEAR REVIEW PERFORMANCE GOALS
MEASUREMENT DATE
Fiscal Year 1998
1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 98 within 12 months of receipt.1 12 months after end of FY 1998
2. Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 98 within 6 months of receipt.1 6 months after end of FY 1998
3. Review and act on 90 percent of standard efficacy supplements filed during FY 98 within 12 months of receipt. 12 months after end of FY 1998
4. Review and act on 90 percent of priority efficacy supplements filed during FY 98 within 6 months of receipt. 6 months after end of FY 1998
5. Review and act on 90 percent of manufacturing supplements filed during FY 98 within 6 months of receipt. 6 months after end of FY 1998
6. Review and act on 90 percent of resubmitted original applications received during FY 98 within 6 months of receipt, and review and act on 30 percent of Class 1 resubmitted original applications within 2 months of receipt. 6 months after end of FY 1998
 
Fiscal Year 1999
1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 99 within 12 months of receipt and review and act on 30 percent within 10 months of receipt.1  12 months after end of FY 99
2. Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 99 within 6 months of receipt.1 6 months after end of FY 99
3. Review and act on 90 percent of standard efficacy supplements filed during FY 99 within 12 months of receipt and review and act on 30 percent within 10 months of receipt. 12 months after end of FY 99
 4. Review and act on 90 percent of priority efficacy supplements filed during FY 99 within 6 months of receipt. 6 months after end of FY 99
5. Review and act on 90 percent of manufacturing supplements filed during FY 99 within 6 months of receipt and review and act on 30 percent of manufacturing supplements requiring prior approval within 4 months of receipt. 6 months after end of FY 99
 6. Review and act on 90 percent of Class 1 resubmitted original applications received during FY 99 within 4 months of receipt, and review and act on 50 percent within 2 months of receipt. 4 months after end of FY 99
 7. Review and act on 90 percent of Class 2 resubmitted original applications received during FY 99 within 6 months of receipt. 6 months after end of FY 99
 
Fiscal Year 2000  
 1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 2000 within 12 months of receipt and review and act on 50 percent within 10 months of receipt.1 12 months after end of FY 2000
 2. Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 2000 within 6 months of receipt.1 6 months after end of FY 2000
3. Review and act on 90 percent of standard efficacy supplements filed during FY 2000 within 12 months of receipt and review and act on 50 percent within 10 months of receipt. 12 months after end of FY 2000
4. Review and act on 90 percent of priority efficacy supplements filed during FY 2000 within 6 months of receipt. 6 months after end of FY 2000
5. Review and act on 90 percent of manufacturing supplements filed during FY 2000 within 6 months of receipt and review and act on 50 percent of manufacturing supplements requiring prior approval within 4 months of receipt. 6 months after end of FY 2000
6. Review and act on 90 percent of Class 1 resubmitted original applications received during FY 2000 within 4 months of receipt, and review and act on 50 percent within 2 months of receipt. 4 months after end of FY 2000
7. Review and act on 90 percent of Class 2 resubmitted original applications received during FY 2000 within 6 months of receipt. 6 months after end of FY 2000
 

 

 Fiscal Year 2001  
 1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 2001 within 12 months of receipt and review and act on 70 percent within 10 months of receipt.1 12 months after end of FY 2001
2. Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 2001 within 6 months of receipt.1 6 months after end of FY 2001
3. Review and act on 90 percent of standard efficacy supplements filed during FY 2001 within 12 months of receipt and review and act on 70 percent within 10 months of receipt. 12 months after end of FY 2001
4. Review and act on 90 percent of priority efficacy supplements filed during FY 2001 within 6 months of receipt. 6 months after end of FY 2001
5. Review and act on 90 percent of manufacturing supplements filed during FY 2001 within 6 months of receipt and review and act on 70 percent of manufacturing supplements requiring prior approval within 4 months of receipt. 6 months after end of FY 2001
 6. Review and act on 90 percent of Class 1resubmitted original applications received during FY 2001 within 4 months of receipt, and review and act on 70 percent within 2 months of receipt. 4 months after end of FY 2001
 7. Review and act on 90 percent of Class 2 resubmitted original applications received during FY 2001 within 6 months of receipt. 6 months after end of FY 2001
 
Fiscal Year 2002  
 1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 2002 within 10 months of receipt.1 12 months after end of FY 2001
2. Review and act on 90 percent of priority original NDAs and PLA/BLAs filed during FY 2002 within 6 months of receipt.1 6 months after end of FY 2001
3. Review and act on 90 percent of standard efficacy supplements filed during FY 2002 within 10 months of receipt. 12 months after end of FY 2001
4. Review and act on 90 percent of priority efficacy supplements filed during FY 2001 within 6 months of receipt. 6 months after end of FY 2001
5. Review and act on 90 percent of manufacturing supplements filed during FY 2001 within 6 months of receipt and review and act on 90 percent of manufacturing supplements requiring prior approval within 4 months of receipt. 6 months after end of FY 2001
6. Review and act on 90 percent of Class 1resubmitted original applications received during FY 2001within 2 months of receipt. 4 months after end of FY 2001
7. Review and act on 90 percent of Class 2 resubmitted original applications received during FY 2001 within 6 months of receipt. 6 months after end of FY 2001

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

II. NEW MOLECULAR ENTITY (NME) PERFORMANCE GOALS

The performance goals for standard and priority original NMEs will be the same as for all of the original NDAs but will be reported separately.

For biological products, for purposes of this performance goal, all original PLA/BLAs will be considered to be NMEs.

III. Procedural and Processing Goals
 

Performance Area
Activity
Performance Goal
Performance Level
Meeting Management Meeting Requests -- Notify requestor of formal meeting in writing (date, time, place, and participants) within 14 days of receipt of request FY 1999 requests -- 70% on time  
FY 2000 -- 80% on time  
FY 2001 and on -- 90% on time
Scheduling Meetings -- Schedule meetings within goal date or within 14 days of requested date if longer than goal date. Type A Meetings within 30 days of receipt of request FY 1999 requests -- 70% on time  
FY 2000 -- 80% on time  
FY 2001 and on -- 90% on time
Type B Meetings within 60 days of receipt of request
Type C Meetings within 75 days of receipt of request
Meeting Minutes -- Agency prepared minutes, clearly outlining agreements, disagreements, issues for further discussion and action times will be available to sponsor within 30 calendar days of meeting FY 1999 meetings -- 70% on time  
FY 2000 -- 80% on time  
FY 2001 and on -- 90% on time
Clinical Holds Center response to sponsor's complete response to a clinical hold within 30 days of receipt of sponsor's response FY 1998 -- 75% on time  
FY 1999 and on -- 90% on time
Major Dispute Resolution Center response to sponsor's appeal of decision within 30 days of receipt of sponsor's appeal FY 1999 -- 70% on time  
FY 2000 -- 80 % on time  
FY 2001 and on -90% on time
Special Protocol Question Assessment and Agreement Center response to sponsor's request for evaluation of protocol design  within 45 days of receipt of protocol and questions FY 1999 -- 60% on time  
FY 2000 -- 70% on time  
FY 2001 -- 80% on time  
FY 2002 -- 90% on time
Electronic Applications and Submissions Paperless Application Processing Agency to develop and update information systems to allow paperless receipt and processing of INDs, human drug applications, and related submissions by end of FY 2002.
Additional Procedures Simplification of Action Letters Centers to amend regulations and processes to provide for issuance of "Approval" (AP) or "Complete Response" (CR) action letters.
Sponsor Notification of Deficiencies in Applications Centers to notify sponsors of deficiencies via "information request" (IR) when each discipline has finished its initial review.
 

Definitions of Terms:

 A.  The term "review and act on" is understood to mean the issuance of a complete action letter after the complete review of a filed complete application. The action letter, if it is not an approval, will set forth in detail the specific deficiencies and, where appropriate, the actions necessary to place the application in condition for approval.

B.  A major amendment to an original application submitted within three months of the goal date extends the goal date by three months.

C.  A resubmitted original application is a complete response to an action letter addressing all identified deficiencies.

D.  Class 1 resubmitted applications are applications resubmitted after a complete response letter (or a not approvable or approvable letter) that include the following items only (or combinations of these items):

  
1. Final printed labeling
2. Draft labeling
3. Safety updates submitted in the same format, including tabulations, as the original safety submission with new data and changes highlighted (except when large amounts of new information including important new adverse experiences not previously reported with the product are presented in the resubmission)
4. Stability updates to support provisional or final dating periods
5. Commitments to perform Phase 4 studies, including proposals for such studies
6. Assay validation data
7. Final release testing on the last 1-2 lots used to support approval
8. A minor reanalysis of data previously submitted to the application (determined by the agency as fitting the Class 1 category)
9. Other minor clarifying information (determined by the Agency as fitting the Class 1 category)
10. Other specific items may be added later as the Agency gains experience with the scheme and will be communicated via guidance documents to industry.
 
E.  Class 2 resubmissions are resubmissions that include any other items, including any item that would require presentation to an advisory committee.

F.  A Type A Meeting is a meeting that is necessary for an otherwise stalled drug development program to proceed (a "critical path" meeting).

G.  A Type B Meeting is a 1) pre-IND, 2) end of Phase 1 (for Subpart E or Subpart H or similar products) or end of Phase 2/pre-Phase 3, or 3) a pre- NDA/PLA/BLA meeting. Each requestor should usually only request 1 each of these Type B meetings for each potential application (NDA/PLA/BLA) (or combination of closely related products, i.e., same active ingredient but different dosage forms being developed concurrently).

H.  A Type C Meeting is any other type of meeting.
 
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