# Presentation: 934706

## CDRH FY 05 Scorecard Report Through 2nd Quarter FY 05 

**Robert Navazio 7/1/05**

**The “Yugo” version 05**
**At a glance....**

## Summarize Center-Wide FY 05 data through 2nd Quarter

Identify areas where we have good data and areas where we still have problems with data collection

Provide background to Executive Committee to make additional decisions on FY 05 
scorecard numerators and denominators
performance targets

Discuss how we are using Office and Center results to manage our programs in FY 05

- Identify areas where we have good data and areas where we still have problems with data collection
- Provide background to Executive Committee to make additional decisions on FY 05
- scorecard numerators and denominators
- performance targets
- Discuss how we are using Office and Center results to manage our programs in FY 05

**Purpose of Presentation**

## Are We Meeting our Targets? (Have we set targets?)

**Are We Meeting our Targets? ****(Have we set targets?)**

- KRA 1 :**Public Health Promotion**

**Y**

- KRA 2: **Public Health Protection**

- KRA 3: **Effective Management in **
**       ****Accordance with TPLC**

- KRA 4: Knowledge Management  and
-          **Stakeholder Collaboration**

- KRA 5: **Workforce Excellence**

*Green:  ****Meeting Targets***
*       **Yellow:  ****Not Meeting all ******	******Targets: Need to ******	******review + drill down***
*     **Red:   ****More than X% of      ******	******measures not meeting ******	******targets**** (need to review)*
*     **White:  ****Need to work on ******	******setting the right ******	******measures + targets***

**G**

**Y**

**Y**

**W**

## Keep in Mind (What gets measured gets done!)

- Measures: the fewer the better
- Measures should be intermediate outcome based whenever possible (not just outputs)
- Measures focus on key success factors
- Measures should be integrated through the organization
- Measures need to have targets from baseline data rather than arbitrary numbers

## KRA 1:  Performance Updates for MDUFMA  Decision Goals and Cycle Actions:  FY 04 Receipt Cohort (as of 3/31/05)

** ****Expedited PMAs with an FDA Decision within 300 total FDA days **
** ****and on-time cycle actions **

|  | 2nd Quarter
FY 05 |
| --- | --- |
| # Meeting goal | 22 |
| # Not Meeting goal | 6 |
| # Awaiting MDUFMA Decision | 6 |
| Total Received and Filed in Receipt Cohort | 14 |
| Total Received | 14 |

-            Best
-          Case 82%

- FY 05
- Dec.
- Target
- 70%

- Worst Case 65%

**Includes 14 of 20 on-time cycle actions**

## KRA1:  Performance Updates for MDUFMA Decision Goals and Cycle Actions: FY 04 Receipt Cohort (as of 3/31/05)

**   ****Original PMAs and PMA Panel Track Supplements with an FDA decision within 320 total FDA days and on-time cycle actions**

|  | 2nd Quarter
FY 05 |
| --- | --- |
| # Meeting Goal | 87 |
| # Not meeting goal | 7 |
| # Awaiting MDUFMA Decision | 18 |
| Total Received and Filed in Receipt Cohort | 47 |
| Total Received | 47 |

-                   Best
-               Case 94%

- FY 06
- Dec. Target
- 80%

- Worst Case
- 78%

**Incudes 58 of 65 on-time cycle actions**

## KRA 1:  Performance Updates for MDUFMA Decision Goals and Cycle Actions: FY 04 Receipt Cohort (as of 3/31/05)

**            ****180 Day PMA Supplements with an FDA decision within 180 total FDA ****	****  days and on-time cycle actions**

|  | 2nd Quarter 
FY 05 |
| --- | --- |
| # Meeting Goal | 220 |
| # Not Meeting Goal | 13 |
| # Awaiting MDUFMA Decision | Cohort
closed |
| Total in Receipt Cohort | 103 |

**FY 05 Decision**
**Target**
**80%**

** ****94%**

**Includes 220 of 233 on-time cycle actions**

## KRA 1:  Performance Updates for MDUFMA   Decision Goals and Cycle Actions FY 04 Receipt Cohort (as of 3/31/05)

** ****510(k) Applications with an FDA decision within 90 total days**
** ****and on-time cycle actions**

|  | 2nd Quarter FY 05 |
| --- | --- |
| # Meeting Goal | 4,402 |
| # Not Meeting Goal | 1,066 |
| # Awaiting MDUFMA Decision | 161 |
| Total MDUFMA Receipt Cohort | 3,359 |
| Other | 273 |
| Total | 3,632 |

**Worst Case**
**78%**

**FY 05 **
**Dec. Target**
**75%**

**        ****Best Case 81%**

**Includes 1667 of 2109 on-time cycle actions**

## % IDE originals approved in first 30 day cycle

- 1B CDRH Access to Investigational Devices

**KRA 1: Public Health Promotion**

**Baseline Receipt Cohort**

**N= 224**

**Didn’t Meet**
**70%Target**

**Y**

## CDRH 1-C: % of On-time Review

**Consults, second quarter FY 05**

- _Note:_  Review consult data reported by OSB, OCER, OSEL and OC.

_**FY 04 On-Time Review Consults**_
**Expedited Review Consults = 96% (44/46)**
**Pre-IDE & IDE Review Consults = 99% (629/636) **
**Other Review Consults = 98% (2,189/2,227)**

**Met FY 05**
**Target**
**90%**

**G**

## 2A CDRH Public Health Protection    Response Rating
2A-1  11 avg. days to review death and serious injury adverse event reports
2A-2  1 day for PMI action teams to decide on action plan
2A-4  Developing baseline for days to process recalls
2A-5  Developing baseline for days to process warning letters and untitled letters 

- 2A-1  11 avg. days to review death and serious injury adverse event reports
- 2A-2  1 day for PMI action teams to decide on action plan
- 2A-4  Developing baseline for days to process recalls
- 2A-5  Developing baseline for days to process warning letters and untitled letters

**KRA 2: Public Health Protection**

## 2B CDRH Public Health Protection Resolution Rating     
4 Legal actions
27 Class I and II recalls
52 Letters
2C CDRH Mammography Safety 
98% certified mammography facilities free of the most serious violations (exceeds target of 97%)
97% certified mammography facilities free of serious violations (exceeds target of 94%)

- 4 Legal actions
- 27 Class I and II recalls
- 52 Letters
**2C CDRH Mammography Safety**
- 98% certified mammography facilities free of the most serious violations (exceeds target of 97%)
- 97% certified mammography facilities free of serious violations (exceeds target of 94%)

**KRA 2: Public Health Protection**

**G**

**Y**

## From the scorecard data reported in the March 2005 budget review CDRH:
Didn’t meet an operating dollar target from 40% to 60%;
Met a payroll dollars target from 45% to 55%;
Didn’t meet a cash award dollars target from 40% to 60%

- Didn’t meet an operating dollar target from 40% to 60%;
- Met a payroll dollars target from 45% to 55%;
- Didn’t meet a cash award dollars target from 40% to 60%

**     ****3A CDRH Financial Accountability Index****  **

**KRA 3: Effective Management **
**In Accordance with TPLC**

**Y**

**G**

**Y**

## CDRH hired 130 of 152 MDUFMA hires approved for FY 03 + FY 04 (85% over two year period)
As of 4/2/05, CDRH had hired 41% (27 of 66 ) MDUFMA user fee and appropriated hires approved in FY 05 and approved in prior years but not yet on board
Didn’t meet the FY 05 target of 75% because of hiring freeze

- As of 4/2/05, CDRH had hired 41% (27 of 66 ) MDUFMA user fee and appropriated hires approved in FY 05 and approved in prior years but not yet on board
- Didn’t meet the FY 05 target of 75% because of hiring freeze

**3B CDRH MDUFMA Hires Percent**

**KRA 3: Effective Management **
**In Accordance with TPLC**

**Y**

## 
CDRH is executing 20 FY 05 project management plans
In the second quarter project management plan milestones were verified and updated if necessary, and there were 36 second quarter milestones
For the third quarter, standard project management plan status reported 85% (51 of 60) third quarter milestones were complete or on time

- CDRH is executing 20 FY 05 project management plans
- In the second quarter project management plan milestones were verified and updated if necessary, and there were 36 second quarter milestones
- For the third quarter, standard project management plan status reported 85% (51 of 60) third quarter milestones were complete or on time

**3C CDRH**** ****Project Management Plan Percent**
** ****of on-target milestones**

**KRA 3: Effective Management **
**In Accordance with TPLC**

**G**

## 4A CDRH Industry Meeting Number
853 Business Meetings with Industry in FY 04
379  Business Meetings in Second Quarter FY 05 
         (If we continue at this rate, annual total over 1,500)
4B CDRH Stakeholder Communication Level
Each Office reported progress on major projects
Over 134 web pages developed and updated
4,000 people on patient safety list serve

- 853 Business Meetings with Industry in FY 04
- 379  **Business Meetings in Second Quarter FY 05 **
**         ****(If we continue at this rate, annual total over 1,500)**
**4B CDRH Stakeholder Communication Level**
- Each Office reported progress on major projects
- Over 134 web pages developed and updated
- 4,000 people on patient safety list serve

**KRA 4: Knowledge Management**
**And Stakeholder Collaboration**

**G**

## 4C CDRH Customer Survey Rating, Device Review
This year, 78% of overall close-ended responses had positive perceptions of CDRH review programs,  comparable to 79% last year   
However, last year only 4% open-ended responses thought guidance improvements were needed
This year,13% open-ended responses thought guidance improvements were needed.  Specific guidance improvements were  made  

- This year, 78% of overall close-ended responses had positive perceptions of CDRH review programs,  comparable to 79% last year
- However, last year only 4% open-ended responses thought guidance improvements were needed
- This year,13% open-ended responses thought guidance improvements were needed.  Specific guidance improvements were  made

**KRA 4: Knowledge Management**
**And Stakeholder Collaboration**

**G**

**Y**

## KRA 4: Knowledge Management

- CDRH set an FY 05 target to send 70% of high priority guidances FY 05 target for CDRH to approve and send to FDA
- As of 3/31/05, CDRH sent 46% (19 of 41) to FDA
- CDRH also targeted to update and send to FDA 10% of high priority existing guidances
- Guidance coordinators developing a list of high priority existing guidances to update

**KRA 4: Knowledge Management**
**And Stakeholder Collaboration**

**G**

## KRA 4: Knowledge Management

- FDA recognized 695 standards for review as of end FY 04
- A Federal Register update for FY 05 is pending
- Developing baseline data to set target

**KRA 4: Knowledge Management**
**And Stakeholder Collaboration**

## KRA 5 Workforce Excellence

**5A-1 and 5A-3  FY 05 training hours **
**Training hours will not be reported until OCER identifies source(s) for more kinds of training hours than senior staff approved to report in FY 04**

## KRA 5 Workforce Excellence

**5A-2 Training Dollars Spent**
**In FY 04, CDRH spent $1.4M on training and travel related to training**
**That was 5% of the $28.8M operating budget**
**Senior staff approved this numerator & denominator for Center scorecard.  **
**Offices will set targets for training dollars spent per person for their scorecards when data is available.**
**In 2****nd**** quarter FY 05, 6 Offices spent $.5M on training and training-related travel, 1.6 % of their operating.  **

**Y**

## KRA 5 Workforce Excellence CDRH Training Dollar Comparisons

|  | FY 04 | 2nd Quarter
FY 05 |
| --- | --- | --- |
| Training 
Dollars | $1.4M | $.5M 
 |
| % of 
Operating
Dollars | 5% | 1.6%
 |

## KRA 5: Workforce Excellence

**5B-1CDRH External Expertise Level**:

-    External
-   Expertise
-    Dollars
-  In Millions

- External expertise investments include contracts and fellowships to supplement
- CDRH internal expertise.  It includes areas like MDFP, ORISE, MEDSUN, database
- development, web development, and software development.  It does not include basic
- services like document control, animal care, MDR contract, registration and listing,
- scanning, database maintenance, and web usability.

**KRA 5: Workforce Excellence**

**On target to exceed 10% annual target. $6.2M cum. is 6% of operating + payroll for 7 Offices reporting mid-year**

**$13.2M**

**$13.6M:   10% of Operating and Payroll**

**G**

## KRA 5: Workforce Excellence5B-1CDRH Ext Expertise Level

**$13.6M ext exp**
**47% operating**
**10% whole budget**

**$6.2M ext exp**
**66% operating**
**6% whole budget midyear**