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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 marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

Number of results: 74

	Item	Program	Office	Program Status	Type	Download
1	Number of scientific manuscripts published and external presentations developed facilitating development of MCM	CBER	N/A	Active	Program Measures
2	Fecal Microbiome Transplantation Workshop	CBER	N/A	Active	Program Measures
3	Enhance information sharing with other National Regulatory Authorities to discuss approaches to safety and effectiveness of vaccines	CBER	N/A	Active	Program Measures
4	Enhance collaboration with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection	CBER	N/A	Active	Program Measures
5	Engage in WHO pre-qualification of diagnostics pilot programme for HIV	CBER	N/A	Active	Program Measures
6	Collaborate in the development of a standardized Factor XIa reference reagent for Immune Globulin Thrombogenicity Testing	CBER	N/A	Active	Program Measures
7	Execute Cooperative Agreement with World Health Organization (WHO)	CBER	N/A	Active	Key Projects
8	Number of Original INDs and IDEs received and actions taken in the quarter	CBER	N/A	Active	Program Measures
9	Number of marketing applications received and actions taken in the quarter	CBER	N/A	Active	Program Measures
10	Number of efficacy supplements received and actions taken in the quarter	CBER	N/A	Active	Program Measures
11	Number of BLA manufacturing supplements received and actions taken in the quarter	CBER	N/A	Active	Program Measures
12	Number of Fast track designations granted in the quarter	CBER	N/A	Active	Program Measures
13	Number of applications approved under Accelerated Approval in the quarter	CBER	N/A	Active	Program Measures
14	Number of Priority Reviews completed in the quarter	CBER	N/A	Active	Program Measures
15	Number of orphan drugs addressing rare diseases approved in the quarter	CBER	N/A	Active	Program Measures
16	Number of PMRs and PMCs established during the quarter	CBER	N/A	Active	Program Measures
17	Number of meetings held and cancelled in the quarter	CBER	N/A	Active	Program Measures
18	Number of meeting summaries issued in the quarter	CBER	N/A	Active	Program Measures
19	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	CBER	N/A	Active	Program Measures
20	Percentage of blood and blood component recalls classified by OCBQ under DRC, within 45 days of receipt of additional information	CBER	N/A	Active	Program Measures
21	Percentage of lot distribution reports received by OBE in the quarter that were entered into the RMS-BLA within 7 days	CBER	N/A	Active	Program Measures
22	Review of Adverse Event Reports	CBER	N/A	Active	Key Projects
23	Number of site visits and number of site visit reports that are finalized in the quarter	CBER	N/A	Active	Program Measures
24	Procurement and Delivery of Critical Scientific Equipment at White Oak Facilities	CBER	N/A	Active	Key Projects
25	Percentage of PMAPs for new CBER employees completed on-time, within 30 calendar days of arrival, during the month	CBER	N/A	Active	Program Measures
26	Percentage of advisory committee members and temporary voting members granted conflict of interest waivers during the quarter	CBER	N/A	Active	Program Measures
27	CBER Participation in CBER Liaison and Roundtable Meetings with Industry	CBER	N/A	Active	Key Projects
28	Total number of training events in the month	CBER	N/A	Completed	Key Center Director Measures
29	Total number of employees who completed the training events in the month	CBER	N/A	Completed	Key Center Director Measures
30	Cumulative percentage of Center employees who participated in training year-to-date	CBER	N/A	Completed	Key Center Director Measures
31	Cumulative percentage of Center supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-date	CBER	N/A	Completed	Key Center Director Measures
32	Number of Commercial, Research, and Emergency IND/IDEs received in the month	CBER	Office of Management	Completed	Program Measures
33	Number of Reported Serious Adverse Events from the Adverse Event Reporting System that were reviewed by a medical officer during the month	CBER	Office of Biostatistics and Epidemiology	Completed	Program Measures
34	Number of Reported Serious Adverse Events from the Vaccine Adverse Event Reporting System that were reviewed by a medical officer during the month	CBER	Office of Biostatistics and Epidemiology	Completed	Program Measures
35	Percentage 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)	CBER	Office of Compliance & Biologics Quality	Completed	Program Measures
36	Percentage of manufacturing supplements requiring prior approval with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt	CBER	Office of Compliance & Biologics Quality	Completed	Program Measures
37	Expansion of the Scope of Accredited CBER Test Methods	CBER	Office of Compliance & Biologics Quality	Completed	Key Projects
38	Percentage of manufacturing supplements requiring prior approval with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt	CBER	Office of Blood Research and Review	Completed	Program Measures
39	Percentage of times a decision is issued for a 510(k) within 90 days	CBER	Office of Blood Research and Review	Completed	Program Measures
40	Percentage of written meeting responses sent greater than two FDA business days in advance of the meeting	CBER	Office of Blood Research and Review	Completed	Program Measures
41	Public Workshop on “Statistical Process Controls for Blood Establishments”	CBER	Office of Blood Research and Review	Completed	Key Projects
42	Percentage 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 timeframes	CBER	Office of Cellular, Tissue and Gene Therapies	Completed	Program Measures
43	Percentage of times that meeting minutes are sent within 30 days of the meeting date (PDUFA)	CBER	Office of Cellular, Tissue and Gene Therapies	Completed	Program Measures
44	OCTGT Reviewer Tools	CBER	Office of Cellular, Tissue and Gene Therapies	Completed	Key Projects
45	Percentage of BLA manufacturing supplements with action due dates occurring during the month that were reviewed and acted upon within 4 months of receipt	CBER	Office of Vaccines Research and Review	Completed	Program Measures
46	Percentage of OCOD & OM employees who participated in training during the month	CBER	N/A	Completed	Key Center Director Measures
47	Cumulative percentage of OCOD & OM employees who participated in training year-to-date	CBER	N/A	Completed	Key Center Director Measures
48	Percentage of OCOD & OM supervisors, managers, and SES who participated in supervisory, management, or SES training during the month	CBER	N/A	Completed	Key Center Director Measures
49	Cumulative-percentage of OCOD & OM supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-date	CBER	N/A	Completed	Key Center Director Measures
50	Percentage of OBE & OCBQ employees who participated in training during the month	CBER	N/A	Completed	Key Center Director Measures
51	Cumulative percentage of OBE & OCBQ employees who participated in training year-to-date	CBER	N/A	Completed	Key Center Director Measures
52	Percentage of OBE & OCBQ supervisors, managers, and SES who participated in supervisory, management, or SES training during the month	CBER	N/A	Completed	Key Center Director Measures
53	Cumulative percentage of OBE & OCBQ supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-date	CBER	N/A	Completed	Key Center Director Measures
54	Percentage of OBRR, OCTGT, & OVRR employees who participated in training during the month	CBER	N/A	Completed	Key Center Director Measures
55	Cumulative percentage of OBRR, OCTGT, & OVRR employees who participated in training year-to-date	CBER	N/A	Completed	Key Center Director Measures
56	Percentage of OBRR, OCTGT, & OVRR supervisors, managers, and SES who participated in supervisory, management, or SES training during the month	CBER	N/A	Completed	Key Center Director Measures
57	Cumulative percentage of OBRR, OCTGT, & OVRR supervisors, managers, and SES who participated in supervisory, management, or SES training year-to-date	CBER	N/A	Completed	Key Center Director Measures
58	Percentage of completed CBER action packages posted on the web within 30 days of complete action package receipt in OCOD	CBER	Office of Communication, Outreach, and Development	Completed	Program Measures
59	Blood Risk Assessment Workshop	CBER	Office of Biostatistics and Epidemiology	Completed	Key Projects
60	Vaccine Database Initiative	CBER	Office of Biostatistics and Epidemiology	Completed	Key Projects
61	Quality Assurance Program (Phase I)	CBER	Office of Blood Research and Review	Completed	Key Projects
62	Quality Assurance Program (Phase II)	CBER	Office of Blood Research and Review	Completed	Key Projects
63	Public Workshop on Measurement Methods for Hemoglobin and Iron Stores in Blood Donors	CBER	Office of Blood Research and Review	Completed	Key Projects
64	Public Workshop on Placental/Umbilical Cord Blood Products	CBER	Office of Compliance & Biologics Quality	Completed	Key Projects
65	Vaccine Roundtable Meeting	CBER	Office of Compliance & Biologics Quality	Completed	Key Projects
66	Expansion of Electronic Submissions Gateway Lot Release Pilot	CBER	Office of Compliance & Biologics Quality	Completed	Key Projects
67	H1N1 Electronic Lot Release Submission Pilot	CBER	Office of Compliance & Biologics Quality	Completed	Key Projects
68	Public Workshop on Cell and Gene Therapy Clinical Trials in Pediatric Populations	CBER	Office of Cellular, Tissue and Gene Therapies	Completed	Key Projects
69	Public Workshop on Placental Umbilical Cord Blood Products	CBER	Office of Cellular, Tissue and Gene Therapies	Completed	Key Projects
70	CBER Twitter Page	CBER	Office of Communication, Outreach, and Development	Completed	Key Projects
71	Maintain full AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International) accreditation for the CBER Animal Facility	CBER	Office of Management	Completed	Key Projects
72	Develop an On-boarding Program for CBER	CBER	Office of Management	Completed	Key Projects
73	Enhanced Regulatory Workflow through Project Management System	CBER	Office of Vaccines Research and Review	Completed	Key Projects
74	Cytomegalovirus Vaccine Workshop	CBER	Office of Vaccines Research and Review	Completed	Key Projects