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U.S. Department of Health and Human Services

About FDA

FDA-TRACK

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 completed FDA-TRACK performance measures and projects view the Archive Index

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Results

Number of results: 78

ItemProgramOfficeStrategic PlanStrategic Goal/Area
1Number of scientific manuscripts published and external presentations developed facilitating development of MCMCBERN/ACBER Strategic PlanIncrease the nation's preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious diseases
2Fecal Microbiome Transplantation WorkshopCBERN/ACBER Strategic PlanIncrease the nation's preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious diseases
3Enhance information sharing with other National Regulatory Authorities to discuss approaches to safety and effectiveness of vaccines CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
4Enhance collaboration with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
5Engage in WHO pre-qualification of diagnostics pilot programme for HIV CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
6Collaborate in the development of a standardized Factor XIa reference reagent for Immune Globulin Thrombogenicity Testing CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
7Execute Cooperative Agreement with World Health Organization (WHO) CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
8Scientific collaboration and management of the Cooperative Agreement with WHO (World Health Organization) CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
9Scientific collaboration and management of the Cooperative Agreement with WHO (World Health Organization)CBERN/ACBER Strategic PlanImprove global public health through international collaboration including research and information sharing
10Number of Original INDs and IDEs received and actions taken in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
11Number of marketing applications received and actions taken in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
12Number of efficacy supplements received and actions taken in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
13Number of BLA manufacturing supplements received and actions taken in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
14Number of Fast track designations granted in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
15Number of applications approved under Accelerated Approval in the quarter CBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
16Number of Priority Reviews completed in the quarter CBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
17Number of orphan drugs addressing rare diseases approved in the quarter CBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
18Number of PMRs and PMCs established during the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
19Number of meetings held and cancelled in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
20Number of meeting summaries issued in the quarterCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
21Percentage 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 operationalCBERN/ACBER Strategic PlanEnhance the ability of advances in science and technology to facilitate development of safe and effective biological products
22Percentage of blood and blood component recalls classified by OCBQ under DRC, within 45 days of receipt of additional informationCBERN/ACBER Strategic PlanEnsure the safety of biological products
23Percentage of lot distribution reports received by OBE in the quarter that were entered into the RMS-BLA within 7 days CBERN/ACBER Strategic PlanEnsure the safety of biological products
24Review of Adverse Event ReportsCBERN/ACBER Strategic PlanEnsure the safety of biological products
25Review of Adverse Event Reports CBERN/ACBER Strategic PlanEnsure the safety of biological products
26Number of site visits and number of site visit reports that are finalized in the quarter CBERN/ACBER Strategic PlanAdvance regulatory science and research
27Delivery and Installation of Critical Scientific Equipment at White Oak Facilities CBERN/ACBER Strategic PlanAdvance regulatory science and research
28Procurement and Delivery of Critical Scientific Equipment at White Oak Facilities CBERN/ACBER Strategic PlanAdvance regulatory science and research
29Percentage of PMAPs for new CBER employees completed on-time, within 30 calendar days of action, during the monthCBERN/ACBER Strategic PlanManage for organizational excellence and accountability
30Percentage of advisory committee members and temporary voting members granted conflict of interest waivers during the quarterCBERN/ACBER Strategic PlanManage for organizational excellence and accountability
31CBER Participation in CBER Liaison and Roundtable Meetings with IndustryCBERN/ACBER Strategic PlanManage for organizational excellence and accountability
32Total number of training events in the monthCBERN/AN/AN/A
33Total number of employees who completed the training events in the monthCBERN/AN/AN/A
34Cumulative percentage of Center employees who participated in training year-to-dateCBERN/AN/AN/A
35Cumulative percentage of Center supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-dateCBERN/AN/AN/A
36Number of Commercial, Research, and Emergency IND/IDEs received in the monthCBEROffice of ManagementN/AN/A
37Number of Reported Serious Adverse Events from the Adverse Event Reporting System that were reviewed by a medical officer during the monthCBEROffice of Biostatistics and EpidemiologyN/AN/A
38Number 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 EpidemiologyN/AN/A
39Percentage 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 QualityN/AN/A
40Percentage 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 QualityN/AN/A
41Expansion of the Scope of Accredited CBER Test MethodsCBEROffice of Compliance & Biologics QualityN/AN/A
42Percentage 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 ReviewN/AN/A
43Percentage of times a decision is issued for a 510(k) within 90 daysCBEROffice of Blood Research and ReviewN/AN/A
44Percentage of written meeting responses sent greater than two FDA business days in advance of the meetingCBEROffice of Blood Research and ReviewN/AN/A
45Public Workshop on “Statistical Process Controls for Blood Establishments”CBEROffice of Blood Research and ReviewN/AN/A
46Percentage 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 TherapiesN/AN/A
47Percentage of times that meeting minutes are sent within 30 days of the meeting date (PDUFA)CBEROffice of Cellular, Tissue and Gene TherapiesN/AN/A
48OCTGT Reviewer ToolsCBEROffice of Cellular, Tissue and Gene TherapiesN/AN/A
49Percentage 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 ReviewN/AN/A
50Percentage of OCOD & OM employees who participated in training during the monthCBERN/AN/AN/A
51Cumulative percentage of OCOD & OM employees who participated in training year-to-dateCBERN/AN/AN/A
52Percentage of OCOD & OM supervisors, managers, and SES who participated in supervisory, management, or SES training during the monthCBERN/AN/AN/A
53Cumulative-percentage of OCOD & OM supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-dateCBERN/AN/AN/A
54Percentage of OBE & OCBQ employees who participated in training during the monthCBERN/AN/AN/A
55Cumulative percentage of OBE & OCBQ employees who participated in training year-to-dateCBERN/AN/AN/A
56Percentage of OBE & OCBQ supervisors, managers, and SES who participated in supervisory, management, or SES training during the monthCBERN/AN/AN/A
57Cumulative percentage of OBE & OCBQ supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-dateCBERN/AN/AN/A
58Percentage of OBRR, OCTGT, & OVRR employees who participated in training during the monthCBERN/AN/AN/A
59Cumulative percentage of OBRR, OCTGT, & OVRR employees who participated in training year-to-dateCBERN/AN/AN/A
60Percentage of OBRR, OCTGT, & OVRR supervisors, managers, and SES who participated in supervisory, management, or SES training during the monthCBERN/AN/AN/A
61Cumulative percentage of OBRR, OCTGT, & OVRR supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-dateCBERN/AN/AN/A
62Percentage of completed CBER action packages posted on the web within 30 days of complete action package receipt in OCODCBEROffice of Communication, Outreach, and DevelopmentN/AN/A
63Blood Risk Assessment WorkshopCBEROffice of Biostatistics and EpidemiologyN/AN/A
64Vaccine Database InitiativeCBEROffice of Biostatistics and EpidemiologyN/AN/A
65Quality Assurance Program (Phase I)CBEROffice of Blood Research and ReviewN/AN/A
66Quality Assurance Program (Phase II)CBEROffice of Blood Research and ReviewN/AN/A
67Public Workshop on Measurement Methods for Hemoglobin and Iron Stores in Blood DonorsCBEROffice of Blood Research and ReviewN/AN/A
68Public Workshop on Placental/Umbilical Cord Blood ProductsCBEROffice of Compliance & Biologics QualityN/AN/A
69Vaccine Roundtable MeetingCBEROffice of Compliance & Biologics QualityN/AN/A
70Expansion of Electronic Submissions Gateway Lot Release PilotCBEROffice of Compliance & Biologics QualityN/AN/A
71H1N1 Electronic Lot Release Submission PilotCBEROffice of Compliance & Biologics QualityN/AN/A
72Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric PopulationsCBEROffice of Cellular, Tissue and Gene TherapiesN/AN/A
73Public Workshop on Placental Umbilical Cord Blood ProductsCBEROffice of Cellular, Tissue and Gene TherapiesN/AN/A
74CBER Twitter PageCBEROffice of Communication, Outreach, and DevelopmentN/AN/A
75Maintain full AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accreditation for the CBER Animal FacilityCBEROffice of ManagementN/AN/A
76Develop an On-boarding Program for CBERCBEROffice of ManagementN/AN/A
77Enhanced Regulatory Workflow through Project Management SystemCBEROffice of Vaccines Research and ReviewN/AN/A
78Cytomegalovirus Vaccine WorkshopCBEROffice of Vaccines Research and ReviewN/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.