Slide 1

CVM Performance of ADUFA Goals

Comments by Diane L. Heinz, DVM, MBA
Regulatory Policy Analyst, ONADE
Rockville, Maryland
April 24, 2007

Slide 2

Overview of the ADUFA Goals Letter

• 5 year goals
• Provides targets for sentinel “Cohort” submissions
• Measures review time performance
• Provides for 90% review time predictability

Slide 3

CVM Five Year Plan to Achieve ADUFA Goals

• Build enhancements into the review process to have a sustained performance level
• Create feedback systems to continue to improve program productivity
• Implement office/division project management oversight of ONADE activities
• Focus on performance by supporting front line review divisions for success

Slide 4

CVM Five Year Plan to Achieve ADUFA Goals

Goals and Objectives

• Plan for completion of submissions received prior to September 30, 2003
• Plan for exceeding ADUFA performance standards for all submissions in queue as measured by Cohort submissions listed in Goals Letter
• Plan for building enhancements into the review process

Slide 5

CVM Five Year Plan to Achieve ADUFA Goals

Goals and Objectives (con’t)

• Implement Activity Time Reporting system
• Convert planning process into Activity Based Costing format
• Implement massive recruitment and training initiative

Slide 6

ADUFA Accomplishments

• We met and exceeded all of our Performance Goals for FY04, FY05, and so far in FY06
• We eliminated the backlog of 833 submissions that were pending on September 30, 2003
• We hired 84% of our ADUFA positions in ONADE, diversifying our staff and functions toward better human capital resource management based on our workload plan 

Slide 7

ADUFA Accomplishments

• ADUFA We implemented Activity Time Reporting, Activity Based Costing, and Project Management to better manage our work
• We engaged the industry in working groups to reduce the number of review cycles, towards an effort to make the drug approval process more efficientAccomplishments

Slide 8

ADUFA Accomplishments

• We continue to be engaged internationally in Codex, VICH, the WTO-hormone issue and HL7
• We are active participants on many levels in Agency initiatives that include such areas as GMPs, risk analysis, animal cloning, transgenics, and antimicrobial resistance
• Our scientists are taking the lead in many areas including process analytical technology, pharmacokinetics, and biotechnology

Slide 9

Submission Review Time (Days) – ADUFA Goals

Slide 10

Sentinal Submissions Received

Slide 11

Submission Review Time (Days) – Performance

Slide 12

Interim Goal - Queue Procedures

• FDA will review all submissions in accordance with procedures for working within a queue
• An application/submission that is not reviewed within the applicable interim goal timeframe will be reviewed with the highest possible priority among those pending

Slide 13

Queue Procedures - Performance

FDA reviews all submissions in accordance with procedures for working within a queue as documented in CVM Policy and Procedure Guide 1243.3020

Slide 14

Complete Review Performance

FDA has provided a complete review of all submissions reported in the performance cohorts

Slide 15

Refuse to File (RTF)

• Within 30 days of submission, FDA will refuse to file an application containing numbers or types of errors, or flaws in the development plan, sufficient to cause the quality of the entire submission to be questioned to the extent that it cannot reasonably be reviewed (21 CFR 514.110)

Slide 16

Refuse to Review (RTR)

Within 60 days of submission, FDA will refuse to review an investigational animal drug submission which is determined to be insufficient on its face or otherwise of unacceptable quality upon initial inspection using criteria and procedures similar to those found in 21 CFR 514.110

Slide 17

RTF/RTR Performance

• Refuse to file
  FY04: 1 original application and 2 supplements
  FY05: 1 original application
  FY06: 2 original applications
• Refuse to review
  FY04: 1 study and 4 protocols
  FY05: 4 studies and 7 protocols
  FY06: 1 study and 8 protocols

Slide 18

Amendments

• FDA may request minor amendments to animal drug applications (original and supplemental) and investigational animal drug submissions to allow for complete review
  - May not extend ADUFA review timeframe
• If a pending application is amended with significant changes, the amended application may be considered resubmitted, thereby effectively resetting the clock to the date FDA received the amendment. The Agency established the same policy for investigational animal drug submissions.

Slide 19

Amendments

• FDA accepted and reviewed:
  FY04: 352 Amendments
  FY05: 364 Amendments
  FY06: 443 Amendments
• About 1 per day
• Did not incomplete submissions to stop the review clock in order to meet performance goals
   

Slide 20

Interim Backlog Goal

• Review and act on pending animal drug applications, supplemental animal drug applications and investigational animal drug submissions within 24 months of initiation of user fee payments (by end of FY05)
• CVM completed the review of the entire backlog, consisting of 833 submissions, by the end of FY04 

Slide 21

Performance Reports to Congress for ADUFA

• FY 2004
• FY 2005