5D. FDA TRACK
FDA-TRACK adheres to values that comprise its name – Transparency, Results, Accountability, Credibility and Knowledge-sharing. FDA’s senior leaders continue to be committed to making FDA-TRACK successful and sustainable, and ultimately a model for open government at the federal level. Below are some updates on planned continuous improvements since the April 2010 launch:
Alignment of FDA-TRACK measures to the annual agency performance measures such as those required by the Government Performance and Results Act of 1993 (GPRA)
FDA has completed the alignment of our GPRA measures to FDA-TRACK measures. Although some of our annual measures are directly tracked on FDA-TRACK, there are some that are not (since these measures are longer term annual measures, as opposed to monthly FDA-TRACK measures). FDA is in the process of addressing this issue and developing monthly indicators to better align to annual long-term measures.
Alignment of FDA-TRACK measures to individual employee performance plans
The Commissioner's FY11 SES plan includes as an element the alignment of FDA-TRACK program measures to program outcomes and this element cascades down to senior executives across the agency. Additionally, Center and Office Directors have begun to align more program-specific strategic priorities with FDA-TRACK goals, which are also incorporated into individual performance plans where applicable. For example, our Center for Devices and Radiological Health (CDRH) has a 2011 Strategic Priority initiative to enhance the efficiency and clarity of the medical device and radiation-emitting product recall processes. CDRH tracks the specific milestones and progress as a key project within the CDRH compliance dashboard in FDA-TRACK, and the milestones are included in the Office of Compliance Director's FY11 SES plan.
Improvements to FDA-TRACK data management and reporting software
In late 2010, FDA released a Request for Information (RFI) for potential business intelligence platforms and data warehousing capabilities to better support FDA-TRACK data management, analytics, and reporting. FDA has completed an evaluation of all the RFIs and is in the system demonstration stage.
FDA began publishing public briefing summaries on the FDA-TRACK website (www.fda.gov/fdatrack) in January 2011. In addition to the data updates, the public can now read (as well as submit comments on) summaries of progress and accomplishments discussed internally at the quarterly briefings. Other enhancements to facilitate public access since the April 2010 launch include: a "Search FDA-TRACK" function; monthly "FDA-TRACK Updates" email subscription feature; redesign of our home page, which now features monthly updates, Spotlight of the Month, and upcoming changes.
Improvements to measures based on public input and experience so that measures can be more closely tied to the public health mission of the agency
FDA conducts real-time monitoring of the FDA-TRACK email account (FDATRACK@fda.hhs.gov) and integrates public feedback where appropriate. The public can also submit feedback via the FDA Transparency Blog.
Internally, FDA regularly analyzes, evaluates, and enhances existing measures and data results during quarterly briefings to ensure the information tracked is meaningful and more closely tied to program goals and, ultimately, public health outcomes. To date, the agency conducts about 20 briefings every quarter, for almost 80 briefings since the April 2010 launch. FDA publishes updates to measures and performance data every month on the FDA-TRACK website.
FDA has identified and implemented five new cross-cutting TRACK programs focusing on Advisory Committees vacancies, Freedom of Information Act (FOIA) backlog, Office of Regulatory Affairs (ORA) Lab Throughput, FDA's efforts to reduce the rate of Salmonella Enteritidis (SE) illness in shell eggs, and implementing FDA components of Health Care Reform. Several more are underway, including a program to track FDA's implementation of its Medical Counter-Measures program.
In July 2010, FDA implemented a monthly FDA-TRACK Updates email subscription to keep the public informed of updates and provide additional venues for submitting feedback. Currently, FDA-TRACK has almost 8,000 subscribers and continues to grow (on average, 25% every month).
Implementation of improvements to FDA-TRACK performance data analysis to enable better predictive outcomes and other quantitative data-based decision making
FDA is assessing sophisticated analytic capabilities as part of its current RFI and market research on business intelligence and data warehousing platforms. As FDA-TRACK accumulates data, predictive analysis and other quantitative and qualitative-based decision making continues to strengthen. To date, the agency has implemented over 600 performance measures and 100 key projects.
A sample of significant accomplishments from the first year has been published on the FDA-TRACK website, and will be updated on a regular basis. Accomplishments include:
- Reduced advisory committee vacancy rate by 25%
- Successfully piloted an electronic lot release submission program to increase efficiency and effectiveness of releasing H1N1 vaccines to the public
- Exceeded annual target by 10% for first year implementation of Quality by Design for new drug applications
- Increased medical device reporting participation rates of hospitals in the Medical Product Safety Network (MedSun) by over 70%
- Developed and implemented measures to track FDA’s implementation of the Egg Safety Rule (Egg-TRACK), and ultimately reduce the rate of SE illness from shell eggs
- Eliminated and sustaining a zero backlog of generic new animal drug applications from over 130 applications.