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U.S. Department of Health and Human Services

About FDA

FDA-TRACK Archive

The list below provides information on FDA’s performance measures and projects as aligned to FDA strategic priorities and program offices. This list enables you to view charts of performance data and progress on important projects and programs.

To view current FDA-TRACK performance measures and projects view the Active Index

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Results

Number of results: 53

ItemProgramOfficeFY
Completed
Strategic PlanStrategic Goal/Area
1Fecal Microbiome Transplantation WorkshopCBERN/A2013CBER Strategic PlanIncrease the nation's preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious diseases
2Enhance information sharing with other National Regulatory Authorities to discuss approaches to safety and effectiveness of vaccines CBERN/A2013CBER Strategic PlanImprove global public health through international collaboration including research and information sharing
3Execute Cooperative Agreement with World Health Organization (WHO) CBERN/A2013CBER Strategic PlanImprove global public health through international collaboration including research and information sharing
4Scientific collaboration and management of the Cooperative Agreement with WHO (World Health Organization) CBERN/A2014CBER Strategic PlanImprove global public health through international collaboration including research and information sharing
5Review of Adverse Event Reports CBERN/A2013CBER Strategic PlanEnsure the safety of biological products
6Procurement and Delivery of Critical Scientific Equipment at White Oak Facilities CBERN/A2013CBER Strategic PlanAdvance regulatory science and research
7Total number of training events in the monthCBERN/A2012N/AN/A
8Total number of employees who completed the training events in the monthCBERN/A2012N/AN/A
9Cumulative percentage of Center employees who participated in training year-to-dateCBERN/A2012N/AN/A
10Cumulative percentage of Center supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-dateCBERN/A2012N/AN/A
11Number of Commercial, Research, and Emergency IND/IDEs received in the monthCBEROffice of Management2012N/AN/A
12Number of Reported Serious Adverse Events from the Adverse Event Reporting System that were reviewed by a medical officer during the monthCBEROffice of Biostatistics and Epidemiology2012N/AN/A
13Number of Reported Serious Adverse Events from the Vaccine Adverse Event Reporting System that were reviewed by a medical officer during the monthCBEROffice of Biostatistics and Epidemiology2012N/AN/A
14Percentage of manufacturing supplements (CBE and CBE-30 day Supplements) with action due dates occurring during the month that were reviewed and acted upon within 6 months of receipt (PDUFA)CBEROffice of Compliance & Biologics Quality2012N/AN/A
15Percentage of manufacturing supplements requiring prior approval with action due dates occurring during the month that were reviewed and acted upon within 4 months of receiptCBEROffice of Compliance & Biologics Quality2012N/AN/A
16Expansion of the Scope of Accredited CBER Test MethodsCBEROffice of Compliance & Biologics Quality2013N/AN/A
17Percentage of manufacturing supplements requiring prior approval with action due dates occurring during the month that were reviewed and acted upon within 4 months of receiptCBEROffice of Blood Research and Review2012N/AN/A
18Percentage of times a decision is issued for a 510(k) within 90 daysCBEROffice of Blood Research and Review2012N/AN/A
19Percentage of written meeting responses sent greater than two FDA business days in advance of the meetingCBEROffice of Blood Research and Review2012N/AN/A
20Public Workshop on “Statistical Process Controls for Blood Establishments”CBEROffice of Blood Research and Review2013N/AN/A
21Percentage of times a written response to a meeting request (including date, time and place for the meeting, as well as expected Center participants) is provided within the PDUFA timeframesCBEROffice of Cellular, Tissue and Gene Therapies2012N/AN/A
22Percentage of times that meeting minutes are sent within 30 days of the meeting date (PDUFA)CBEROffice of Cellular, Tissue and Gene Therapies2012N/AN/A
23OCTGT Reviewer ToolsCBEROffice of Cellular, Tissue and Gene Therapies2013N/AN/A
24Percentage of BLA manufacturing supplements with action due dates occurring during the month that were reviewed and acted upon within 4 months of receiptCBEROffice of Vaccines Research and Review2012N/AN/A
25Percentage of OCOD & OM employees who participated in training during the monthCBERN/A2010N/AN/A
26Cumulative percentage of OCOD & OM employees who participated in training year-to-dateCBERN/A2010N/AN/A
27Percentage of OCOD & OM supervisors, managers, and SES who participated in supervisory, management, or SES training during the monthCBERN/A2010N/AN/A
28Cumulative-percentage of OCOD & OM supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-dateCBERN/A2010N/AN/A
29Percentage of OBE & OCBQ employees who participated in training during the monthCBERN/A2010N/AN/A
30Cumulative percentage of OBE & OCBQ employees who participated in training year-to-dateCBERN/A2010N/AN/A
31Percentage of OBE & OCBQ supervisors, managers, and SES who participated in supervisory, management, or SES training during the monthCBERN/A2010N/AN/A
32Cumulative percentage of OBE & OCBQ supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-dateCBERN/A2010N/AN/A
33Percentage of OBRR, OCTGT, & OVRR employees who participated in training during the monthCBERN/A2010N/AN/A
34Cumulative percentage of OBRR, OCTGT, & OVRR employees who participated in training year-to-dateCBERN/A2010N/AN/A
35Percentage of OBRR, OCTGT, & OVRR supervisors, managers, and SES who participated in supervisory, management, or SES training during the monthCBERN/A2010N/AN/A
36Cumulative percentage of OBRR, OCTGT, & OVRR supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-dateCBERN/A2010N/AN/A
37Percentage of completed CBER action packages posted on the web within 30 days of complete action package receipt in OCODCBEROffice of Communication, Outreach, and Development2011N/AN/A
38Blood Risk Assessment WorkshopCBEROffice of Biostatistics and Epidemiology2010N/AN/A
39Vaccine Database InitiativeCBEROffice of Biostatistics and Epidemiology2012N/AN/A
40Quality Assurance Program (Phase I)CBEROffice of Blood Research and Review2011N/AN/A
41Quality Assurance Program (Phase II)CBEROffice of Blood Research and Review2012N/AN/A
42Public Workshop on Measurement Methods for Hemoglobin and Iron Stores in Blood DonorsCBEROffice of Blood Research and Review2012N/AN/A
43Public Workshop on Placental/Umbilical Cord Blood ProductsCBEROffice of Compliance & Biologics Quality2010N/AN/A
44Vaccine Roundtable MeetingCBEROffice of Compliance & Biologics Quality2010N/AN/A
45Expansion of Electronic Submissions Gateway Lot Release PilotCBEROffice of Compliance & Biologics Quality2011N/AN/A
46H1N1 Electronic Lot Release Submission PilotCBEROffice of Compliance & Biologics Quality2011N/AN/A
47Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric PopulationsCBEROffice of Cellular, Tissue and Gene Therapies2011N/AN/A
48Public Workshop on Placental Umbilical Cord Blood ProductsCBEROffice of Cellular, Tissue and Gene Therapies2010N/AN/A
49CBER Twitter PageCBEROffice of Communication, Outreach, and Development2012N/AN/A
50Maintain full AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accreditation for the CBER Animal FacilityCBEROffice of Management2011N/AN/A
51Develop an On-boarding Program for CBERCBEROffice of Management2012N/AN/A
52Enhanced Regulatory Workflow through Project Management SystemCBEROffice of Vaccines Research and Review2011N/AN/A
53Cytomegalovirus Vaccine WorkshopCBEROffice of Vaccines Research and Review2012N/AN/A

Note: 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. Information in the Archive Index may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.