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U.S. Department of Health and Human Services

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FDA-TRACK Active

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:239

 ItemProgramOfficeStrategic PlanStrategic Goal/Area
1 Percent of FDA advisory committee member positions vacant at the end of the month ADVISORY COMMITTEES N/A N/A N/A
2 Percent of CBER advisory committee member positions vacant at the end of the month ADVISORY COMMITTEES N/A N/A N/A
3 Percent of CDER advisory committee member positions vacant at the end of the month ADVISORY COMMITTEES N/A N/A N/A
4 Percent of CDRH advisory committee member positions vacant at the end of the month ADVISORY COMMITTEES N/A N/A N/A
5 Percent of CFSAN advisory committee member positions vacant at the end of the month ADVISORY COMMITTEES N/A N/A N/A
6 Percent of CTP advisory committee member positions vacant at the end of the month ADVISORY COMMITTEES N/A N/A N/A
7 Percent of NCTR advisory committee member positions vacant at the end of the month ADVISORY COMMITTEES N/A N/A N/A
8 Percent of OC advisory committee member positions vacant at the end of the month ADVISORY COMMITTEES N/A N/A N/A
9 Percent of advisory committee members participating in meetings in the month who were granted waivers ADVISORY COMMITTEES N/A N/A N/A
10 Number of scientific manuscripts published and external presentations developed facilitating development of MCM CBER N/A CBER Strategic Plan Increase the nation's preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious diseases
11 Enhance collaboration with other foreign regulatory agencies and international partners to strengthen regulatory capacity and enhance global public health protection CBER N/A CBER Strategic Plan Improve global public health through international collaboration including research and information sharing
12 Engage in WHO pre-qualification of diagnostics pilot programme for HIV CBER N/A CBER Strategic Plan Improve global public health through international collaboration including research and information sharing
13 Collaborate in the development of a standardized Factor XIa reference reagent for Immune Globulin Thrombogenicity Testing CBER N/A CBER Strategic Plan Improve global public health through international collaboration including research and information sharing
14 Number of Original INDs and IDEs received and actions taken in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
15 Number of marketing applications received and actions taken in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
16 Number of efficacy supplements received and actions taken in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
17 Number of BLA manufacturing supplements received and actions taken in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
18 Number of Fast track designations granted in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
19 Number of applications approved under Accelerated Approval in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
20 Number of Priority Reviews completed in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
21 Number of orphan drugs addressing rare diseases approved in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
22 Number of Breakthrough Therapy Requests Received, Approvals, and Withdrawn After Granting (WAG) and Rescinded CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
23 Number of PMRs and PMCs established during the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
24 Number of meetings held and cancelled in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
25 Number of meeting summaries issued in the quarter CBER N/A CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
26 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 CBER Strategic Plan Enhance the ability of advances in science and technology to facilitate development of safe and effective biological products
27 Percentage of blood and blood component recalls classified by OCBQ under DRC, within 45 days of receipt of additional information CBER N/A CBER Strategic Plan Ensure the safety of biological products
28 Percentage of lot distribution reports received by OBE in the quarter that were entered into the RMS-BLA within 7 days CBER N/A CBER Strategic Plan Ensure the safety of biological products
29 Review of Adverse Event Reports CBER N/A CBER Strategic Plan Ensure the safety of biological products
30 Number of site visits and number of site visit reports that are finalized in the quarter CBER N/A CBER Strategic Plan Advance regulatory science and research
31 Percentage of PMAPs for new CBER employees completed on-time, within 30 calendar days of action, during the month CBER N/A CBER Strategic Plan Manage for organizational excellence and accountability
32 Percentage of advisory committee members and temporary voting members granted conflict of interest waivers during the quarter CBER N/A CBER Strategic Plan Manage for organizational excellence and accountability
33 Number of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submitted and approved CDER Office of New Drugs N/A Regulatory Review and Drug Safety
34 Number of New Molecular Entity (NME) NDAs and new BLAs submitted and approved CDER Office of New Drugs N/A Regulatory Review and Drug Safety
35 Number of NDA and BLA efficacy supplements submitted CDER Office of New Drugs N/A Regulatory Review and Drug Safety
36 Percentage of NDA related submissions in eCTD format and Total Number of NDA related submissions CDER Office of Strategic Programs N/A Regulatory Review and Drug Safety
37 Number of Fast Track designations, Accelerated Approval, Orphan Drugs for Rare Diseases, and First Generics granted/approved CDER Office of New Drugs N/A Regulatory Review and Drug Safety
38 Cumulative number of Presidential Emergency Plan for AIDS Relief (PEPFAR) drug approvals since 2004 CDER Office of New Drugs N/A Regulatory Review and Drug Safety
39 Number of pediatric studies completed (under both PREA and BPCA) and deferred (under PREA) CDER Office of New Drugs N/A Regulatory Review and Drug Safety
40 Number of biosimilar investigational new drug applications (INDs) received in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
41 Number of initial advisory meeting requests received and meetings held in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
42 Number of biosimilar biological product development (BPD) Type 1-4 meeting requests received and meetings held in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
43 Cumulative number of biosimilar development programs in the BPD Program in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
44 Number of 351(k) BLAs approved in the month CDER Office of New Drugs N/A Regulatory Review and Drug Safety
45 Number of core initial promotional campaign material reviews completed in the month and percentage completed within timeframe CDER Office of Prescription Drug Promotion N/A Regulatory Review and Drug Safety
46 Number of Postmarketing Requirements (PMRs) and Commitments(PMCs) established and fullfilled/released CDER Office of New Drugs N/A Regulatory Review and Drug Safety
47 Number of 18 month, ten thousand patient reviews initiated CDER Office of Surveillance and Epidemiology N/A Regulatory Review and Drug Safety
48 Number of Adverse Events (AE) reported for drugs/biological products CDER Office of Surveillance and Epidemiology N/A Regulatory Review and Drug Safety
49 Number of Risk Evaluation Mitigation Strategy (REMS) reviews, assessments, and approvals CDER Office of Surveillance and Epidemiology N/A Regulatory Review and Drug Safety
50 Number of pediatric safety reviews completed (BPCA, PREA, and Pediatric Rule) CDER Office of Surveillance and Epidemiology N/A Regulatory Review and Drug Safety
51 Percentage of complaints preliminarily reviewed and acknowledged within 30 days of receipt CDER Office of Prescription Drug Promotion N/A Drug Quality and Compliance
52 Number of recalls classified and products impacted by recall CDER Office of Compliance N/A Drug Quality and Compliance
53 Percentage of recall classifications meeting the 26 calendar-day timeframe in the month CDER Office of Compliance N/A Drug Quality and Compliance
54 Number of compounding recall events CDER Office of Compliance N/A Drug Quality and Compliance
55 Number of warning letters issued to compounders and 503B outsourcing facilities CDER Office of Compliance N/A Drug Quality and Compliance
56 Number of state referral letters issued concerning compounders CDER Office of Compliance N/A Drug Quality and Compliance
57 Number of injuctions/consent decrees against compounders and 503B outsourcing facilities CDER Office of Compliance N/A Drug Quality and Compliance
58 Total number of registered outsourcing facilities CDER Office of Compliance N/A Drug Quality and Compliance
59 Pilot Project Program under the Drug Supply Chain Security Act CDER Office of Compliance N/A Drug Quality and Compliance
60 Number of external presentations to Societies, Consortia, Industrial and Government organizations CDER Office of Communications N/A Transparency and Public Outreach
61 Number of Drug Safety Communications (DSCs) CDER Office of Communications N/A Transparency and Public Outreach
62 Number of presentations, interactions with sponsors, and interagency working group meetings for drug development CDER Office of Counter-Terrorism and Emergency Coordination N/A Transparency and Public Outreach
63 Rare Diseases Program CDER Office of New Drugs N/A Transparency and Public Outreach
64 Number of scientific and review publications published CDER All N/A Regulatory Science and Research
65 Number of guidances issued CDER Office of Regulatory Policy N/A Regulatory Science and Research
66 Number of electronic patient records (from national and international clinical registries, claims data, and EHRs) with device identification that CDRH gained access to CDRH All CDRH Strategic Plan Establish a National Evaluation System for Medical Devices
67 Percentage increase of the number of premarket and postmarket regulatory decisions that leverage real-world evidence (compared to FY2015 baseline) CDRH All CDRH Strategic Plan Establish a National Evaluation System for Medical Devices
68 Number of patient groups that participated in a mechanism for CDRH employees to obtain patient input on key pre- and postmarket issues CDRH All CDRH Strategic Plan Partner with Patients
69 Percentage of CDRH employees that interact with patients as part of their job duties CDRH All CDRH Strategic Plan Partner with Patients
70 Percentage of PMA, de novo and HDE decisions that includes a public summary of available and relevant patient perspective data considered CDRH All CDRH Strategic Plan Partner with Patients
71 Number of patient perspective studies (e.g., evaluating patient reported outcomes (PRO) or patient preferences (PPI)) used in support of premarket and postmarket regulatory decisions (compared to FY 2015 baseline) CDRH All CDRH Strategic Plan Partner with Patients
72 Percent increase of the number of CDRH staff with quality and process improvement credentials to improve organizational excellence (compared to FY 2015 baseline) CDRH All CDRH Strategic Plan Promote a Culture of Quality and Organizational Excellence
73 Strengthen Product and Manufacturing Quality within the Medical Device Ecosystem Milestones CDRH All CDRH Strategic Plan Promote a Culture of Quality and Organizational Excellence
74 Total number of firms with environmental samples taken during the month CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
75 Total number of sub-samples as related to the environmental samples during the month CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
76 Total number of firms that had positive environmental samples during the month CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
77 Total number of positive findings (may or may not be actionable depending on sampling location) during the month CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
78 Number of recall recommendations during the month entered in the Recall Enterprise System (RES) resulting from environmental positives CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
79 Number of domestic compliance actions (warning letters, injunctions, seizures) taken during the month related to environmental positive findings (subset of enforcement actions) CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
80 Number of positive findings added to the Whole Genome Sequencing database CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
81 Number of positive findings with a clinical match to a known foodborne illness pathogen CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
82 Number of recall recommendations resulting from a Whole Genome Sequencing Match CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
83 Number of domestic compliance actions (warning letters, injunctions, seizures) taken during the month related to a found Whole Genome Sequencing match CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
84 Total number of RFR submissions received in the month CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
85 Total number of Risk Control Reviews (RCRs) initiated for Primary RFR entries in the month CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
86 Total number of seizures and injunctions in the month that are linked to a previous RFR entry CFSAN Office of Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
87 Percentage of low-acid canned and acidified food violations reduced due to implementation of new "smart" filing form CFSAN Office of Food Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
88 Percentage of FDA regulators trained on new preventive controls for human food regulation and conducting inspections against the Preventive Controls for Human Food regulation. CFSAN Office of Food Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
89 Percentage of State regulators trained on new preventive controls for human food regulation and conducting inspections against the Preventive Controls for Human Food regulation. CFSAN Office of Food Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
90 Percentage of the food industry subject to the preventive controls regulation participating in training conducted bv FDA or funded by FDA or training using FDA-recognized curricula CFSAN Office of Food Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
91 Cumulative number of sequences generated from archived collections of isolates in Office of Regulatory Affairs to enhance compliance and enforcement databases CFSAN Office of Regulatory Science FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
92 Percentage of regulatory cases referred to OFS that were reviewed within the timeframe given to OFS in the Case Management System (measures time in OFS only) in the month CFSAN Office of Food Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
93 Number of website page views, top pages viewed, top search engine used to view site, and average number of seconds spent on site CFSAN Office of Analytics and Outreach FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
94 Percentage of NDI notification reviews completed during the month within 75 days of filing CFSAN Office of Dietary Supplement Programs FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
95 Median number of days to complete NDI notification reviews during the month CFSAN Office of Dietary Supplement Programs FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
96 Percentage of NDI notification reviews completed to which FDA objected CFSAN Office of Dietary Supplement Programs FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
97 Percentage of food and color additive petition reviews completed during the quarter within 360 days of filing CFSAN Office of Food Additive Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
98 Total number of food and color additive petition actions published in the Federal Register during the quarter CFSAN Office of Food Additive Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
99 Percentage of GRAS notice reviews completed during the quarter within 180 days of filing CFSAN Office of Food Additive Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
100 Percentage of food contact substance notification reviews completed during the month within 110 days of original or amended receipt CFSAN Office of Food Additive Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
101 Number of GenomeTrackr labs operational CFSAN Office of Regulatory Science FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
102 Number of Institute for Food Safety and Health (IFSH) Industry WGS Workgroup Members CFSAN Office of Regulatory Science FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
103 Promote Safe Production of Molluscan Shellfish for Human Consumption: Vibrio Forecasting and Assistance CFSAN Office of Food Safety FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
104 Percentage of new or reformulated infant formula notification reviews completed during the month within 90 days of filing CFSAN Office of Nutrition and Food Labeling FVM Strategic Plan FY 2016-2025 Nutrition: Foster an Environment to Promote Healthy and Safe Food Choices
105 Median number of days to complete new or reformulated infant formula notification reviews during the month CFSAN Office of Nutrition and Food Labeling FVM Strategic Plan FY 2016-2025 Nutrition: Foster an Environment to Promote Healthy and Safe Food Choices
106 Percentage of analytical package reviews received via FDA's electronic Compliance Management System (CMS) that meet Office of Compliance (OC) timeframes as specified in CMS in the quarter CFSAN Office of Regulatory Science FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
107 Percentage of color additive regulatory package reviews received via FDA's electronic Compliance Management System (CMS) that meet Office of Compliance (OC) timeframes as specified in CMS in the quarter CFSAN Office of Cosmetics and Colors FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
108 Total number of tweets in the quarter CFSAN Office of Cosmetics and Colors FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
109 Number of translated Web pages (new translations added this fiscal year) available CFSAN Office of Cosmetics and Colors FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
110 Percentage of media responses provided by due date in the quarter CFSAN Office of Cosmetics and Colors FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
111 Number of isolates sequenced by Genome-Trakr Network CFSAN Office of Regulatory Science FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
112 Cumulative number of compliance actions/cases supported by WGS (in conjunction with OAO) CFSAN Office of Regulatory Science FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
113 Sequencing-based analytical methods for microbial contaminant detection CFSAN Office of Applied Research and Safety Assessment FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
114 New Technologies/Methodologies to Assess Chemical Food Safety CFSAN Office of Applied Research and Safety Assessment FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
115 Establishment of a Parasitology Program to Align with the Scientific and Operational Activities of FDA/CFSAN’s mission CFSAN Office of Applied Research and Safety Assessment FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
116 Genometrakr Program CFSAN Office of Regulatory Science FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
117 Human Pathogen on Plants (HPOP) CFSAN Office of Regulatory Science FVM Strategic Plan FY 2016-2025 Organizational Excellence: Continuously Improve the Leadership, Management, Staffing, and Organizational Capacity of the FVM Program to Protect Public Health
118 Cumulative number of Retailer Compliance Check Inspections completed in the month CTP Office of Compliance and Enforcement CTP Strategic Areas Compliance and Enforcement
119 Cumulative Number of Warning Letters issued against Tobacco Retailers(excluding internet based) in the FY CTP Office of Compliance and Enforcement CTP Strategic Areas Compliance and Enforcement
120 Cumulative number of Civil Money Penalties filed for the FY against Tobacco Retailers (excluding internet based) CTP Office of Compliance and Enforcement CTP Strategic Areas Compliance and Enforcement
121 Cumlative number of Compliance Training for Retailers and Small Businesses CTP Office of Compliance and Enforcement CTP Strategic Areas Compliance and Enforcement
122 Cumulative number of regulatory and enforcement actions as a result of significant violations observed during an inspection or surveillance activity for FY CTP Office of Compliance and Enforcement CTP Strategic Areas Compliance and Enforcement
123 Number of CTP public education campaign interactions CTP Office of Health Communication and Education CTP Strategic Areas Public Education
124 Number of CTP-attended trade shows and conference exhibits held during the quarter CTP Office of Health Communication and Education CTP Strategic Areas Public Education
125 Number of CTP-developed materials requested and distributed by type during the quarter CTP Office of Health Communication and Education CTP Strategic Areas Public Education
126 Number of print and broadcast interviews with FDA or CTP spokesperson on CTP news announcements during the month CTP Office of Health Communication and Education CTP Strategic Areas Public Education
127 Number of Twitter Tweets, Retweets, replies, and clickthroughs CTP Office of Health Communication and Education CTP Strategic Areas Public Education
128 Number of distinct individuals visiting www.fda.gov/tobacco during the month CTP Office of Health Communication and Education CTP Strategic Areas Public Education
129 Cumlative number of product applications received since Program Inception CTP Office of Science CTP Strategic Areas Science and Research
130 Cumlative number of Regular SE applications received since Program Inception CTP Office of Science CTP Strategic Areas Science and Research
131 Cumlative number of Provisional SE applications received since Program Inception CTP Office of Science CTP Strategic Areas Science and Research
132 Cumlative number of Exemption from SE applications received since Program Inception CTP Office of Science CTP Strategic Areas Science and Research
133 Cumlative number of PMTA applications received since Program Inception CTP Office of Science CTP Strategic Areas Science and Research
134 Cumlative number of MRTPA applications received since Program Inception CTP Office of Science CTP Strategic Areas Science and Research
135 Total number of research grants funded, contracts funded, and inter-agency agreement projects ongoing biannually CTP Office of Science CTP Strategic Areas Science and Research
136 Population Assessment of Tobacco and Health (PATH) Study CTP Office of Science CTP Strategic Areas Science and Research
137 National Youth Tobacco Survey CTP Office of Science CTP Strategic Areas Science and Research
138 Cumulative dollar amount and percentage of user fees collected CTP Office of Management CTP Strategic Areas Core Operations
139 Percentage of export certificates for drug related products issued within 20 day CVM Office of Surveillance and Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
140 Percentage of export certificates for animal food related products issued within 20 days CVM Office of Surveillance and Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
141 Percentage of Health Hazard Events (HHEs) received from OSC Division of Compliance reviewed by the due date CVM Office of Surveillance and Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
142 Number of jerky pet treat related complaints received CVM Office of Research FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
143 Number of non-jerky pet treat related complaints received CVM Office of Research FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
144 Number of proficiency tests and training CVM Office of Research FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
145 Percentage of GRAS notifications reviewed by CVM within 300 days CVM Office of Surveillance and Compliance FVM Strategic Plan FY 2016-2025 Food Safety: Protect Americas Consumers and Animals from Foreseeable Hazards
146 Percentage of warning letter recommendation packages reviewed within 25 days CVM Office of Surveillance and Compliance FVM Strategic Plan FY 2016-2025 Animal Health: Protect Human and Animal Health by Enhancing the Safety and Effectiveness of Animal Health Products
147 Number of manuscripts submitted to peer-reviewed journals in the quarter NCTR N/A NCTR Strategic Plan Promote global interactions in regulatory science
148 Percentage of manuscripts submitted to scientific journals in the last 12 months which were accepted for publication in the quarter NCTR N/A NCTR Strategic Plan Promote global interactions in regulatory science
149 Total number of GovDelivery Subscriptions (Research Highlights + Quarter Page) at the end of the quarter NCTR N/A NCTR Strategic Plan Promote global interactions in regulatory science
150 Bisphenol A (BPA) Data Gap Analysis NCTR Division of Biochemical Toxicology NCTR Strategic Plan Advance scientific approaches and tools required to support public health
151 Percentage of animal care/diet preparation technical personnel who are AALAS certified NCTR Office of Scientific Coordination NCTR Strategic Plan Improve administrative management and develop new communication materials and methods to support HHS/FDA science goals
152 Number of animal rooms scheduled for sentinel animal surveillance during the month NCTR Office of Scientific Coordination NCTR Strategic Plan Improve administrative management and develop new communication materials and methods to support HHS/FDA science goals
153 Number of animal rooms where sentinel animal surveillance was conducted during the month NCTR Office of Scientific Coordination NCTR Strategic Plan Improve administrative management and develop new communication materials and methods to support HHS/FDA science goals
154 Physiologically-Based Pharmacokinetic (PBPK) Modeling of Nanomedicine NCTR Office of Scientific Coordination NCTR Strategic Plan Advance scientific approaches and tools required to support public health
155 Sequencing Quality Control Phase II (SEQC2) NCTR Division of Bioinformatics and Biostatistics NCTR Strategic Plan Advance scientific approaches and tools required to support public health
156 Average American Customer Satisfaction Index (ACSI) evaluation score from surveys completed on the mobile site during the month OC ADMIN Office of External Affairs OEA Strategic Plan Provide leadership throughout the Agency on communication strategies and practices
157 Number of commmunication materials cleared during the month which followed HHS clearance procedures OC ADMIN Office of External Affairs OEA Strategic Plan Provide leadership throughout the Agency on communication strategies and practices
158 Percentage increase of FDA Facebook page likes received during the month OC ADMIN Office of External Affairs OEA Strategic Plan Provide leadership throughout the Agency on communication strategies and practices
159 Number of visits to the FDA Patient Network Website during the month OC ADMIN Office of External Affairs OEA Strategic Plan Enhance outreach to external stakeholders
160 Average bounce rate of visitors to the newsroom on fda.gov during the month OC ADMIN Office of External Affairs OEA Strategic Plan Enhance outreach to external stakeholders
161 Number of MedWatch e-list subscribers during the month OC ADMIN Office of External Affairs OEA Strategic Plan Enhance outreach to external stakeholders
162 Total correspondence received by OES during the month which require FDA response OC ADMIN Office of the Executive Secretariat OES Strategic Plan Respond effectively and efficiently to external correspondence and related inquiries from industry and the general public on behalf of the Commissioner
163 Number of Federal Register (FR) Docket Check requests received in the month by the Division of Dockets Management (DDM) OC ADMIN Office of the Executive Secretariat OES Strategic Plan Manage review and assignment of document management process in response to requests from the Regulation Editorial Staff (RES) and process non-urgent and urgent Federal Register (FR) docket checks timely
164 Number of FOIA requests received in the month OC ADMIN Office of the Executive Secretariat OES Strategic Plan Manage and process FOIA requests
165 Establishment of the Office of Laboratory Safety and Science (OLSS) OC ADMIN Office of Laboratory Science and Safety N/A N/A
166 Commissioner’s Fellowship Program OCS Office of Scientific Professional Development OCS Strategic Priorities Support an environment of scientific excellence, learning and integrity
167 Centers of Excellence in Regulatory Science and Innovation (CERSI) Established in 2014 OCS Office of Regulatory Science and Innovation OCS Strategic Priorities Support mission critical targeted research and raise the profile of regulatory science
168 FDA Program for Extramural Regulatory Science and Innovation (PERSI) OCS Office of Regulatory Science and Innovation OCS Strategic Priorities Support mission critical targeted research and raise the profile of regulatory science
169 Office of the Chief Scientist Intramural Research Grants OCS Office of Regulatory Science and Innovation OCS Strategic Priorities Support mission critical targeted research and raise the profile of regulatory science
170 Percentage of Commissioner's Fellows who graduated and who were retained OCS Office of Scientific Professional Development OCS Strategic Priorities Support an environment of scientific excellence, learning and integrity
171 Number of projects, presentations, and manuscripts completed by Commissioner's Fellows OCS Office of Scientific Professional Development OCS Strategic Priorities Support an environment of scientific excellence, learning and integrity
172 Number of FDA sponsored regulatory science training events, participants, and Continuing Education (CE) credits awarded OCS Office of Scientific Professional Development OCS Strategic Priorities Support an environment of scientific excellence, learning and integrity
173 Animal Models of Pregnancy to Address Medical Countermeasures (MCM) for Influenza and Chemical, Biological, Radiological and Nuclear Threats in the 'At-Risk' Population of Pregnant Women MEDICAL COUNTERMEASURES INITIATIVE N/A OCS Strategic Priorities Ensure that our nation is prepared for threats of emerging infectious diseases, pandemics and terrorism
174 PrecisionFDA OCS Office of Health Informatics OCS Core Operations
175 OpenFDA OCS Office of Health Informatics OCS Core Operations
176 OWH Intramural Research Program OCS Office of Women Health OCS Strategic Priorities Support mission critical targeted research and raise the profile of regulatory science
177 Take Time to Care Outreach Program - FY17 Activities OCS Office of Women Health OCS Strategic Priorities Support mission critical targeted research and raise the profile of regulatory science
178 Language Access Program OCS Office of Minority Health OCS Strategic Priorities Support mission critical targeted research and raise the profile of regulatory science
179 Diversity in Clinical Trials OCS Office of Minority Health OCS Strategic Priorities Support mission critical targeted research and raise the profile of regulatory science
180 Strengthening FDA Outreach and Communication Programs to Minority Health Care Providers and Patients OCS Office of Minority Health OCS Strategic Priorities Support mission critical targeted research and raise the profile of regulatory science
181 Number of inspections completed by personnel based in-country during the month by commodity OIP Office of International Programs N/A N/A
182 Promote equality, fairness, understanding and acceptance of diversity at the FDA OPERATIONS Office of Equal Employment Opportunity Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #1: Strategic Partnerships
183 Maintain timeliness of payments to vendors per HHS mandates OPERATIONS Office of Finance, Budget, and Acquisition Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #3: Management Processes
184 Maintain compliance with the Department of Treasury and HHS' policies and strategies for managing FDA's accounts receivables OPERATIONS Office of Finance, Budget, and Acquisition Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #3: Management Processes
185 Monitor contracts awarded to small businesses to ensure annual targets are met OPERATIONS Office of Finance, Budget, and Acquisition Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #3: Management Processes
186 Maintain number of Personal Identification Verification (PIV) Cards issued annually OPERATIONS Office of Security Operations Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #3: Management Processes
187 Discrimination complaint timeliness measures OPERATIONS Office of Equal Employment Opportunity Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #3: Management Processes
188 Ensure 90% of all FDA Information Systems have a valid Authority to Operate (ATO) for the fiscal year OPERATIONS Office of Information Management and Technology Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #3: Management Processes
189 Total number of emergency preparedness exercises which FDA participated in planning, executing, or evaluating during the month OPERATIONS Office of Crisis Management Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #1: Strategic Partnerships
190 Cumulative number of emergency preparedness exercises in which FDA participates in during the fiscal year OPERATIONS Office of Crisis Management Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #1: Strategic Partnerships
191 Number of incidents involving FDA-regulated products that are coordinated by the Office of Emergency Operations (OEO) during the month OPERATIONS Office of Crisis Management Office of Operations Strategic Plan 2015 - 2018 Strategic Priority #1: Strategic Partnerships
192 Number of import food field exams ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
193 Number of domestic FSMA high risk food establishment inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
194 Number of registered domestic blood bank and biologics manufacturing inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
195 Number of human foreign and domestic tissue establishment inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
196 Number of foreign and domestic high-risk human drug inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
197 Number of compounding firms inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
198 Number of adverse drug event (ADE) inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
199 Number risk evaluation and mitigation strategies (REMS) inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
200 Number of targeted prohibited material Bovine Spongiform Encephalopathy (BSE) inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
201 Number of highest risk foreign and domestic animal drug pre-approval establishments ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
202 Number of high risk domestic and foreign animal feed establishment inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
203 Number of Class II and Class III device inspections ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
204 Cumulative number of convictions and money recovered at the end of the quarter ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
205 Number of accredited ORA labs ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
206 Further develop a national integrated food safety system through the adoption of increased participation in the Voluntary Retail Food Program Standard ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
207 Increase laboratory surge capacity in the event of terrorist attack on the food supply. ORA N/A FDA Strategic Priorities 2014-2018 Enhance Oversight of FDA-Regulated Products
208 Number of Medical Device Bioresearch Monitoring (BIMO) inspections ORA N/A FDA Strategic Priorities 2014-2018 Improve and Safeguard Access to FDA-Regulated Products to Benefit Health
209 Number of external presentations to societies, consortia, industry and government organizations in the month ORA N/A FDA Strategic Priorities 2014-2018 Promote Better Informed Decisions About the Use of FDA-Regulated Products
210 Number of guidances and regulations issued OSMP Office of Special Medical Programs N/A N/A
211 Percentage of RFD decisions issued in the month reviewed within 60 days OSMP Office of Combination Products N/A N/A
212 Total number of RFDs filed by OCP in the month OSMP Office of Combination Products N/A N/A
213 Total number of orphan drug designation reviews completed in the month OSMP Office of Orphan Products Development N/A N/A
214 Total number of orphan drug designation requests received in the month OSMP Office of Orphan Products Development N/A N/A
215 Percentage of orphan drug designation reviews completed in 120 days or less OSMP Office of Orphan Products Development N/A N/A
216 Total number of orphan drug designation decisions that resulted in orphan designation in the month OSMP Office of Orphan Products Development N/A N/A
217 Total number of orphan drug approvals in the month OSMP Office of Orphan Products Development N/A N/A
218 Total number of HUD designation reviews completed in the month OSMP Office of Orphan Products Development N/A N/A
219 Total number of HUD designation requests received in the month OSMP Office of Orphan Products Development N/A N/A
220 Percentage of HUD designation reviews completed in 45 days or less OSMP Office of Orphan Products Development N/A N/A
221 Total number of HUD decisions that resulted in HUD designation in the month OSMP Office of Orphan Products Development N/A N/A
222 Cumulative number of pediatric devices that have been provided assistance by the Pediatric Device Consortia OSMP Office of Orphan Products Development N/A N/A
223 Total number of RPD requests (designations and consults) received in the month OSMP Office of Orphan Products Development N/A N/A
224 Percentage of 60-day statutory deadlines met for RPD designation requests in the month OSMP Office of Orphan Products Development N/A N/A
225 Total number of RPD requests (designation and consults) granted in the month OSMP Office of Orphan Products Development N/A N/A
226 Total number of grant applications received OSMP Office of Orphan Products Development N/A N/A
227 Total number of grant panels convened OSMP Office of Orphan Products Development N/A N/A
228 Total number of grants awarded per month OSMP Office of Orphan Products Development N/A N/A
229 Estimated average number of reports received for active grants per month OSMP Office of Orphan Products Development N/A N/A
230 Number of internal and external safety and product assessment meetings in the month OSMP Office of Pediatric Therapeutics N/A N/A
231 Number of medical products studied in children with pediatric safety labeling changes in the month OSMP Office of Pediatric Therapeutics N/A N/A
232 Number of Pediatric Advisory Committee (PAC) related activities in the month OSMP Office of Pediatric Therapeutics N/A N/A
233 Number of activities OSMP Office of Pediatric Therapeutics N/A N/A
234 Number of Neonatal-Perinatal Medicine consultations or reviews OSMP Office of Pediatric Therapeutics N/A N/A
235 Number of contacts and meetings with foreign regulators to discuss scientific, ethical or safety issues related to pediatrics in the month OSMP Office of Pediatric Therapeutics N/A N/A
236 Number of EMA Pediatric Investigation Plans (PIPs) that are matched with PeRC's products/requested by FDA divisions OSMP Office of Pediatric Therapeutics N/A N/A
237 Number of presentations/participation at U.S. conferences, stakeholder meetings, and trainings during the month OSMP Office of Pediatric Therapeutics N/A N/A
238 Number of international outreach efforts during the month OSMP Office of Pediatric Therapeutics N/A N/A
239 Number of publications OSMP Office of Pediatric Therapeutics N/A N/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.


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