Significant Accomplishments to Date

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Over 20 FDA-TRACK briefings are conducted each quarter to analyze, report and discuss monthly performance data and results. These briefings provide each FDA program office the opportunity discuss performance accomplishments and address root cause issues that may hinder performance targets. Each briefing is attended by the agency’s senior leaders so that issues and potential solutions can be addressed immediately. FDA-TRACK has enabled our agency to better recognize, respond and resolve performance shortfalls in a timely manner. The following are a few examples (not inclusive) of some significant accomplishments since the inception of the FDA-TRACK program.

 

• Advisory Committees
• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiological Health (CDRH)
• Center for Drug Evaluation and Research (CDER)
• Center for Food Safety and Applied Nutrition (CFSAN)
• Center for Veterinary Medicine (CVM)
• Egg-TRACK
• Freedom Of Information Act (FOIA)
• National Center for Toxicological Research (NCTR)
• Office of Regulatory Affairs (ORA)

Advisory Committees 

• Agency Vacancy Rate: One of our first main cross-agency initiatives was to decrease the vacancy rate on our Advisory Committees. Advisory Committee members are a valuable resource to FDA, and the ability of FDA to attract qualified members is critical to the successful performance of the Advisory Committees program. By maintaining low vacancy rates, FDA has access to needed expertise which contributes to external credibility and enhances public trust in this important function. In October 2009, the FDA started to monitor monthly advisory committee vacancy rates in FDA-TRACK. Through monthly FDA-TRACK data analysis, quarterly briefings and subsequent follow-up, the root issues of our Advisory Committee recruitment and selection process that affected vacancy rates were identified and addressed in an effort to reach a 10% target vacancy rate. With increased accountability and oversight through FDA-TRACK, the 10% target goal is nearing reality. Advisory Committees have experienced a vacancy reduction from a rate of 33% in October 2009 to 20% in June 2011, with two centers reaching the 10% vacancy rate goal within the first fiscal year.

 

Center for Biologics Evaluation and Research (CBER)

• Office of Blood Research and Review (OBRR), Written Responses to Sponsor Pre-Meeting Submissions: By tracking the percentage of written responses to pre-meeting submissions that are faxed/emailed to sponsors greater than two FDA/Business Days prior to the scheduled meetings, OBRR has realized efficiencies to save both sponsors and the FDA time and resources. In implementing this metric OBRR began to focus on responding, in writing, to pre-meeting questions at least 48 business hours prior to the scheduled formal meeting.  To assist in achieving this goal, OBRR developed a new process, issued internal procedures, and provided training to appropriate staff. By providing comprehensive, timely responses to the sponsors prior to a meeting, there is a decreased need for formal meetings, thus saving time and money. Further, such responses lead to more productive and efficient meetings by focusing the discussion on the responses that the sponsor still requires clarification.
• Office of Compliance and Biologics Quality (OCBQ), H1N1 Electronic Lot Release Submission Pilot: Each year, FDA manages the lot release of seasonal flu vaccines. Because of the H1N1 outbreak in 2009, the FDA needed to optimize lot release efficiency to get the much needed vaccine out to the public in a timelier manner. To this end, OCBQ piloted an electronic lot release submission program for the H1N1 lot releases. Due to the pilot’s success, OCBQ decided to implement the new system for the 2010-2011 seasonal flu vaccine lot releases. As a result of tracking this significant project, almost all lot release protocols have been submitted electronically, resulting in decreased release time and more rapidly available vaccines to the public. OCBQ hopes to expand the program to all lot release products so biologic products can reach the public more efficiently and effectively.

 

Center for Devices and Radiological Health (CDRH)

• Center Integration and Inter-Office eConsults: As one of its Center Director priorities, CDRH aimed to increase each office’s timeliness in completing inter-office eConsult requests, which are used to facilitate the exchange of scientific information and staff expertise across CDRH, and promote collaborative efforts within the Center. eConsults are completed for a variety of work products requiring expertise across CDRH offices, including premarket device submissions, post-approval studies, and compliance and enforcement actions. Quarterly discussions of trends and anomalies prompted further root cause analysis, enabling CDRH to better focus on areas of concern and implement process improvements throughout the year. As a result, CDRH offices exceeded the FY 2010 target by 10%. For FY 2011, CDRH raised its target based on the FY 2010 performance level, and expanded the scope of the measure more than three-fold to monitor all CDRH eConsult requests (intra- and inter-office). 
• Office of the Center Director (OCD), Strategic Plan Implementation: In January 2010, CDRH publicly released and began implementing its FY 2010 Strategic Priorities, committing itself to 123 actions with aggressive time-bound goals, and 107 of those actions due in FY 2010. Recognizing that many of its deadlines were stretch goals, CDRH set its performance target to accomplish at least 85% of the 107 actions due. FDA-TRACK provided a platform for CDRH and FDA senior leaders to proactively monitor progress not only on the overall 85% completion goal, but also track progress of key milestones for high-priority projects in each of its offices. Through streamlined planning, constant focus and follow-up, CDRH:
  • Exceeded its annual goal and successfully completed 86% of the 107 actions due (click here for the complete list); and
  • Ensured timely progress and/or completion of key projects in the Strategic Priorities plan, including the evaluation of a pilot application to automate the 510(k) review process, evaluation of a pilot program to enable FDA to accept third-party audits for foreign inspections, increasing transparency in CDRH decision-making, and establishing a cross-federal agency council to proactively facilitate medical device innovation and address unmet public health needs.

CDRH continues to utilize FDA-TRACK as a platform to manage its progress on its annual Strategic Priorities as part of its Management Dashboard.

• Office of Surveillance and Biometrics (OSB), Medical Product Safety Network (MedSun) Participation Rate: CDRH’s Medical Product Safety Network (MedSun) is a medical device reporting network of approximately 350 hospitals used to improve FDA’s understanding of problems associated with the use of medical devices. Because active participation is critical for increasing the percent of the population covered by active surveillance, CDRH implemented a measure focusing on increasing the participation rate of hospitals in the program for at least 11 months. CDRH monitored this measure each month and, half-way through FY 2010, anticipated that it may fall short of its annual goal. However, through dedicated on-site training and active hands-on follow up to encourage continuous reporting, CDRH was able to increase the participation rate over 70% by the end of FY 2010. CDRH continues to identify ways to improve the program.

 

Center for Drug Evaluation and Research (CDER)

• Office of New Drugs (OND), Actions on Marketing Applications and Efficacy Supplements: Marketing applications (New Drug Applications (NDA) and Biologics License Applications (BLA)) have legislatively mandated timelines for review under the Prescription Drug User Fee Act (PDUFA). In FY 2008 and FY 2009, FDA faced new challenges with implementation of the Food and Drug Administration Amendment Act (FDAAA) that initially affected FDA's ability to meet performance goal commitments. In addition to previous responsibilities with PDUFA, FDAAA mandated new performance commitments and process improvements. Since OND began reporting data in FDA-TRACK in January 2010, 94% of the actions taken on marketing applications and 93% of actions taken on efficacy supplements were within goal deadlines. Although official PDUFA data is captured by fiscal year receipt cohort, the monthly FDA-TRACK data presented and discussed at FDA-TRACK briefings allows our agency to better gauge if our annual targets will be met; and if not, how best to rectify it.
• Office of New Drug Quality Assessment (ONDQA), Quality by Design (QbD) Implementation: Quality by Design (QbD) is a systematic approach to drug development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. The implementation of QbD will enhance the assurance of pharmaceutical quality in the U.S. market and improve the quality of Chemistry, Manufacturing, and Controls information submitted to FDA in applications, supplements, and Drug Master Files. ONDQA has been working with industry sponsors and other FDA offices to encourage the use of QbD in New Drug Applications (NDA) received for New Molecular Entities (NME). Through diligent efforts to encourage QbD implementation, regular reporting, and discussion with senior leadership at FDA-TRACK briefings, ONDQA increased the NDAs for NMEs received with QbD elements by over 30% during FY 2010, exceeding its target of 20% in its first year of QbD implementation. ONDQA will continue to work with other FDA offices and external industry partners to encourage the implementation of QbD in drug development.

Center for Food Safety and Applied Nutrition (CFSAN)

• Office of Food Defense, Communication and Emergency Response (OFDCER), FSMA Webpage: One of the main goals for the FDA's Foods and Veterinary Medicine Program  has been providing outreach, education, and resources  to stakeholders on the provisions of the new FDA Food Safety Modernization Act (FSMA).  FDA's Foods and Veterinary Medicine Program achieved its goal  to create and maintain a knowledge portal to promote awareness of the FSMA and its 50 regulations/guidance to  help drive industry compliance and improve public health. The portal  opened on February 15, 2011 and  provides stakeholders (consumers, industry, food safety professionals, Federal/State/local regulators, and international trading partners) information on what the FSMA is, who it impacts, how it’s being implemented, and the opportunities for stakeholders to be involved. FDA-TRACK provided the platform for  FDA to setup the initial portal  to consolidate FSMA-related materials including Frequently Asked Questions in one location, establish and maintain a mailbox for FSMA communications with stakeholders,  establish a subscriber list to receive e-mail updates, and  develop Standard Operating Procedures for maintaining the portal in order to constantly have the most up-to-date information available to stakeholders. Through successful planning, in the first year of its existence, the portal boasts 11, 500 subscribers, 126 Frequently Asked Questions in 12 topic areas, 10 blogs, 4 quarterly progress reports.  Visit the FSMA knowledge portal at http://www.fda.gov/FSMA to see current materials and FSMA timelines.

 

Center for Veterinary Medicine (CVM)

• Office of New Animal Drug Evaluation (ONADE), Pre-AGDUFA Generic New Animal Drug Applications Backlog: In August 2010, CVM eliminated its backlog of generic new animal drug applications, approximately 132 applications, received prior to the Animal Generic Drug User Fee Act (AGDUFA) which was effective October 1, 2008. CVM was able to successfully eliminate this backlog through the monthly tracking and monitoring of these applications via FDA-TRACK. CVM prioritized and planned the review of these applications based upon application complexity to ensure sufficient time was allotted to complete the reviews in FY 2010. With the elimination of this backlog, CVM anticipates it will enhance the cost effectiveness and predictability of new animal drug development. It further expects that the number of generic new animal drug applications submitted to CVM will increase, hopefully leading to an increase in the number of generic new animal drugs available on the market.

• Office of Management (OM), Workforce Initiative: CVM has recognized a movement across the Federal government from reactive Human Resources Management towards proactive Human Capital Planning to ensure the workforce has the right people, in the right place, at the right time. OM has embarked on this large initiative to better understand the current and emerging issues facing the CVM workforce and design hiring and retention strategies that will ensure CVM’s future workforce has the knowledge and skills necessary to operate as a high-performing organization. Some of these initiatives are managed and tracked in FDA-TRACK and include:
  • Strategic Human Capital Plan - In June 2011, CVM completed the development of its Strategic Human Capital Plan. The Plan is designed to guide the creation and implementation of the Center's human capital programs over the next five years (FY2012-2016). It will allow CVM to respond to its current and future scientific and regulatory demands with both innovation and excellence.
  • Workforce Profiles - In May 2010, CVM completed Workforce Profiles for three Mission Critical Occupations (MCOs): 1) Veterinary Medical Officer; 2) Consumer Safety Officer; and 3) Chemist. This highly valuable information enables the Center's leadership to gain a better understanding of the workforce and project future workforce trends and to identify potential workforce issues.
  • Attrition Projection Models - In May 2010, CVM completed Attrition Projection Models for three MCOs: 1) Veterinary Medical Officer; 2) Consumer Safety Officer; and 3) Chemist. These models allow the Center to successfully apply valid statistical formulas to CVM's workforce data to anticipate areas of attrition risk.
  • Competency Models - In April 2010, CVM completed the development of its competency models and utilized these technical competency models to draft competency-based position descriptions (PDs).

  
  
  
   

  Egg-TRACK

  • Egg Safety Rule Implementation: The Center for Food Safety and Applied Nutrition (CFSAN), the Office of the Commissioner (OC), the Office of Foods (OF), and the Office of Regulatory Affairs (ORA) developed FDA-TRACK measures to track our progress in implementing the Egg Safety Rule (Egg Rule). The Egg Rule is designed to prevent Salmonella Enteritidis (SE) in shell eggs during production, storage, and transportation. Progress in implementing the Egg Rule is an indicator of our progress in achieving our Food Safety Priority Goal to reduce the number of SE illnesses related to eggs. FDA-TRACK will provide our responsible FDA components (CFSAN, OC, OF and ORA) a central platform to collaborate and collectively ensure progress on this important cross-agency initiative. Visit the FDA-TRACK Egg-TRACK Dashboard for current progress and performance data.

  
  
  
   

  Freedom Of Information Act

  • Number of FOIA requests pending: Consistent with the federal government's goal to reduce backlogged FOIA requests by 10% per year, FDA is pleased to note that the agency backlog of FOIA requests has been reduced by that amount, or more, since 2009. While working to achieve this goal, the FDA FOIA program tracked and reported its backlog reduction efforts through FDA-TRACK, the agency's performance management system. Through a combination of data analysis, routine management briefings, resource investments, and process changes, FDA has been able to exceed the 10% yearly reduction target. By the end of October 2011, FDA had reduced the backlog by 25% for fiscal year 2011. Visit the FDA-TRACK FOIA Dashboard for current progress and performance data.

  
  
  
   

  National Center for Toxicological Research (NCTR)

  • Office of Regulatory Compliance and Risk Management (RCRM), Federal Employees Security Clearance Rate: The Office of Regulatory Compliance and Risk Management (RCRM) ensures that all federal employees at NCTR have the correct security credentials to ensure a safer workforce. Over the past year, the office worked to complete clearances for those employees needing greater than a Level 1 security clearance. Due to equipment failures the office struggled to complete the clearances, remaining at about 44% for most of FY 2010. However, by highlighting the issues through FDA-TRACK and obtaining focused support and encouragement from senior leadership, the office resolved the issues hindering the security clearance completion and reported in November 2010 that 99% of federal employees had received greater than a Level 1 clearance.
  • Research Divisions, Development of Bioinformatics Approaches to Characterize Foodborne Pathogens: In August 2010, NCTR completed its enhancements to ArrayTrackTM by integrating microbial omics data into the system for analysis of foodborne pathogens. ArrayTrackTM is a software (invented by NCTR scientists and available to the public) that allows for the management, analysis, and interpretation of vast amounts of omics data and acts as a central database for foodborne pathogens. This project was a multi-divisional effort across NCTR including the Division of Microbiology, the Division of Systems Biology, and the Division of Personalized Nutrition and Medicine. These enhancements included expanding the capabilities of the existing molecular biological analysis to enable the analyses of genomics and gene expression data from bacterial pathogens. By incorporating these new capabilities in a publicly available program, scientists are now able to efficiently analyze molecular data collected on foodborne pathogens, thus, facilitating more rapid advances in food safety. In November 2010, a manuscript describing the enhanced microbial analysis tools was published in the BioMed Central (BMC) Bioinformatics Journal. Additionally, a project utilizing the new tools for the analysis of microarray data was published in the Journal of Infection in Developing Countries.

  
  
  
   

  Office of Regulatory Affairs (ORA)

  • Regional Offices, Highest Risk Products Domestic Inspections: Every year, ORA and the FDA Centers agree on a list of high-risk firms to be inspected within the year. From this high-risk list, ORA creates a workplan of high-risk inspections to complete for the year. Highest-risk inspections reported in FDA-TRACK may also include performance goal inspections. In FY 2010 ORA implemented a new quarterly inspection target in order to better track progress toward this annual goal and allow ORA to make mid-course process or staffing adjustments if necessary. This new target combined with ORA’s conscientious efforts to monitor inspection progress helped ORA exceed its goal of completing 10,206 highest-risk inspections in FY 2010 by 1,195 inspections. ORA plans to continue using quarterly targets to monitor progress toward this annual goal in FY 2011.