I. Advancing Regulatory Science for Medical Counter Measures (MCM) Development Measures

A. Communicate Advances in MCM Regulatory Science

1. Number of scientific manuscripts published and external presentations developed facilitating development of MCM published in the quarter

I. International Collaboration Measures

1. Enhance collaboration with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection
2. Engage in WHO pre-qualification of diagnostics pilot programme for HIV
3. Collaborate in the development of a standardized Factor XIa reference reagent for Immune Globulin Thrombogenicity Testing
4. Scientific collaboration and management of the Cooperative Agreement with WHO (World Health Organization) Year 4

I. Review Measures at the Center Level

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

1. Number of Original INDs and IDEs received and number of actions taken in the quarter that were within / past goal dates

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 / overdue in the quarter and the number of actions taken during the quarter that were within / past goal dates

C. BLA and NDA Efficacy Supplements; PMA Panel Track Supplements; Abbreviated New Drug Application (ANDA), Biosimilar Biological Project Application (BBPA) and NDA Supplements

1. Number of efficacy supplements received / overdue in the quarter and the number of actions taken during the quarter that were within / past goal dates

D. BLA manufacturing supplements (all types)

1. Number of BLA manufacturing supplements received / overdue in the quarter and number of actions taken during the quarter that were within / past goal dates

E. Fast track designations granted, Accelerated Approval, and Priority Reviews

1. Number of Fast track designations granted in the quarter
2. Number of applications approved under Accelerated Approval in the quarter
3. Number of Priority Reviews completed in the quarter
4. Number of orphan drugs addressing rare diseases approved in the quarter
5. Number of Breakthrough Therapy Designation Requests Received, Approvals, and Withdrawn After Granting (WAG) and Rescinded

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

1. Number of PMRs and PMCs established and fulfilled / released during the quarter

G. Meetings (all types)

1. Number of meetings held in the quarter and number of meetings cancelled by the requestor in the quarter because written feedback was provided prior to the scheduled meeting
2. Number of meeting summaries issued in the quarter and the number of meeting summaries issued in the quarter that were past goal dates

II. Approval Letter Measure

A. Ensure completed CBER approval letters provided to Office of Communication Outreach and Development (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

I. Product Recall Measures

A. Increase the percentage of blood and blood component recalls classified by the Office of Compliance and Biologics Quality (OCBQ) under the Direct Recall Classification program (DRC), within 45 days of receipt of additional information

1. Increase the percentage of blood and blood component recalls classified by the Office of Compliance and Biologics Quality (OCBQ) under the Direct Recall Classification program (DRC), within 45 days of receipt of additional information
2. Percentage of blood and blood component recalls classified by OCBQ under DRC, within 45 days of receipt of additional information

II. Use of Lot Distribution Data to Estimate Patient Exposure for Epidemiological Analysis of Adverse Event Reports Measure

A. Reported lot distribution data uploaded for use in the CBER regulatory database in the quarter

1. Percentage of lot distribution reports received by OBE in the quarter that were entered into the Regulatory Management System-Biologics License Application(RMS-BLA) within 7 days

III. Review of Adverse Event Reports

A. Consistent and timely review of initial serious adverse event reports

1. Percentage of serious adverse event reports reviewed within 90 days of submission

I. Site Visits of Research Labs Measure

A.Site Visits and Site Visit Reports

1. Number of site visits and number of site visit reports that are finalized in the quarter

I. 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 action, during the quarter

II. Committee Member Waiver Measures

A. Limit percentage of advisory committee members and temporary voting members granted conflict of interest waivers

1. Percentage of advisory committee members and temporary voting members granted conflict of interest waivers this quarter