FDA,FY 2000 Performance Report for the Prescription Drug User Fee Act of 1992, Appendix B:PDUFA Performance Goals

Appendix B: PDUFA Performance Goals, FY 1998 - FY 2002

Performance Goals: FY 98 / FY 99 / FY 00 / FY 01 / FY 02 | NME Goals | Procedural and Processing Goals | Definition of Terms

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:

FIVE-YEAR REVIEW PERFORMANCE GOALS

Fiscal Year 1998	MEASUREMENT DATE
Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 98 within 12 months of receipt¹.	12 months after end of FY 1998
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
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
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
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
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

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

Fiscal Year 1999	MEASUREMENT DATE
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	MEASUREMENT DATE
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 70 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	MEASUREMENT DATE
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 1 resubmitted original applications received during FY 2001 within 2 months of receipt.	2 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	MEASUREMENT DATE
1. Review and act on 90 percent of standard original NDAs and PLA/BLAs filed during FY 2002 within 10 months of receipt.¹	10 months after end of FY 2002
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 2002
3. Review and act on 90 percent of standard efficacy supplements filed during FY 2002 within 10 months of receipt.	10 months after end of FY 2002
4. Review and act on 90 percent of priority efficacy supplements filed during FY 2002 within 6 months of receipt.	6 months after end of FY 2002
5. Review and act on 90 percent of manufacturing supplements filed during FY 2002 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 2002
6. Review and act on 90 percent of Class 1 resubmitted original applications received during FY 2002 within 2 months of receipt.	2 months after end of FY 2002
7. Review and act on 90 percent of Class 2 resubmitted original applications received during FY 2002 within 6 months of receipt.	6 months after end of FY 2002

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.

PROCEDURAL AND PROCESSING GOALS

Performance Area	Agency Activity	Performance Goal	Performance Level
Meeting Management	Meeting Requests -- Notify requester 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 FY2001 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 FY2001 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 FY2001 and on -- 90% on time
Clinical Holds	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	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	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.
Additional Procedures	Sponsor Notification of Deficiencies in Applications	Centers to notify sponsors of deficiencies via 'information request' (IR) when each discipline has finished its initial review.

Definition of Terms:

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.
A major amendment to an original application submitted within three months of the goal date extends the goal date by three months. Only one extension is allowed for an application.
A resubmitted original application is a complete response to an action letter addressing all identified deficiencies.
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):

Final printed labeling
Draft labeling
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)
Stability updates to support provisional or final dating periods
Commitments to perform Phase 4 studies, including proposals for such studies
Assay validation data
Final release testing on the last 1-2 lots used to support approval
A minor reanalysis of data previously submitted to the application (determined by the agency as fitting the Class 1 category)
Other minor clarifying information (determined by the Agency as fitting the Class 1 category)
Other specific items may be added later as the Agency gains experience with the scheme and will be communicated via guidance documents to industry.

Class 2 resubmissions are resubmissions that include any other items, including any item that would require presentation to an advisory committee.
A Type A Meeting is a meeting that is necessary for an otherwise stalled drug development program to proceed (a "critical path" meeting).
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 requester 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).
A Type C Meeting is any other type of meeting.