FDA-TRACK CBER Cross Management Support Offices Dashboard

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Contents:

• Center Level Review Measures
• Key Center Director Measures
• Program Measures
  • Office of Communication Outreach and Development (OCOD)
  • Office of Management (OM)
• Key Projects
  • Office of Communication Outreach and Development (OCOD)
  • Office of Management (OM)
• Quarterly Briefing Summaries

Note: Information is as of June 30, 2012.  The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.

Center Level Review Measures

I. Biologics Program Measures

A. Investigational New Drug Applications (IND) and Investigational Device Exemptions (IDE)

1. Number of Commercial, Research, and Emergency IND/IDEs received in the month

 
B. Marketing Applications: Biologics License Applications (BLA); New Drug Applications (NDA); Device Premarket Applications (PMA); and Premarket Notifications (510(k)s)
 

1. Number of marketing applications received in the month

2. Number of actions taken on marketing applications during the month

C.  BLA and NDA Efficacy Supplements and PMA Panel Track Supplements

1. Number of efficacy supplements received in the month

2. Number of actions taken on efficacy supplements during the month

D. Postmarket Requirements (PMR) and Postmarket Commitments (PMC)

1.  Number of PMRs and PMCs established during the month


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Key Center Director Measures

I. Staff Training

A. Percentage of Center employees who receive training during fiscal year. The Fiscal Year (FY) 2011 performance target is 80% of Center employees who receive training during the fiscal year.

1. Cumulative percentage of Center employees who participated in training year-to-date

B. Percentage of Center supervisors, managers, and Senior Executive Service (SES) who participate in supervisory, management, leadership, or SES training during the year. The FY 2011 performance target is 80% of supervisors, managers, and SES who receive supervisory training during the fiscal year.

1. Cumulative percentage of Center supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-date

II. Agency Standardized Training Measures
 

A. Ensure that essential and comprehensive training, education and professional development are provided to employees as required by Section 742 of the Food, Drug and Cosmetic Act

1. Total number of training events in the month
2. Total number of employees who completed the training events in the month

 
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Program Measures

Office of Communication, Outreach and Development (OCOD)

I. Approval Letter Measure

A. Ensure completed CBER approval letters provided to OCOD are reviewed for disclosure and posted on the web by a specified time period. 

1. Percentage of approval letters reviewed for disclosure and posted on the web within 5 business days of receipt in OCOD, excluding days that the Web Content Management System (WCMS) is not operational 

Office of Management (OM)

II. Performance Management Appraisal Program (PMAP) Measure

A. Assure on-time implementation of new PMAPs for CBER employees

1. Percentage of new PMAPs for CBER employees completed on-time, within 30 calendar days of arrival, during the month

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Key Projects
 

Office of Communication Outreach and Development (OCOD)

I. CBER Participation in CBER Liaison and Roundtable Meetings with Industry

Office of Management (OM)

II. Develop an On-boarding Program for CBER

 

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