FDA-TRACK Glossary

Sign up to receive FDA-TRACK email updates

 

FDA-TRACK Term	Definition
Baseline Data	Baseline data is data that is initially collected to serve as a basis for comparison with subsequently acquired data. Baseline data is particularly useful for understanding new measures, trends observed, and developing performance goals.
Center / Organization FDA-TRACK Program Area	A FDA-TRACK program that is specific to a Center/organization and/or the program offices within the Center/organization.  Examples include the Center for Devices & Radiological Health (CDRH) Premarket program area, and the Center for Biologics Evaluation & Research (CBER) Cross Management Support program area.
Common Measures	Common measures are agency-wide measures of interest that are applicable to each of the program offices. An example includes decreasing the percentage of employee turnover.
Cross-Agency FDA-TRACK Program Area	An agency-wide FDA-TRACK program that focuses on cross-cutting common issues and interdependencies among Centers and program offices.  Examples include programs focusing on the Freedom of Information Act (FOIA), Advisory Committees, Egg-TRACK, Health Care Reform, and Medical Counter-Measures Initiative (MCMi).
Dashboard	A dashboard is the format in which FDA-TRACK monthly measures and performance data is presented. Each program area will have its own dashboard and may include one or several program offices depending on the program area.
Directorate	With the Office of the Commissioner, directorates oversee the core functions and responsibilities of the Agency. FDA has four directorates for Foods, Global Regulatory Operations and Policy, Medical Products and Tobacco, and Operations.
FDA Centers/ Organizations	The FDA's organization consists of the Office of the Commissioner (OC) and four directorates overseeing the core functions of the agency: Foods, Global Regulatory Operations and Policy, Medical Products and Tobacco, and Operations. Within these directorates, FDA-TRACK program offices are organized by twelve Centers/organizations across the FDA and by program area. These program areas consolidate performance measures where program offices share similar public health functions or objectives (such as drug pre-market reviews, toxicology research, external relations, etc.).
FDA-TRACK Indices	The FDA-TRACK Indices (Link Here) enable users to quickly locate specific information, and enhance the accessibility of available information. There are drill-down options by FDA-TRACK program and options to further filter by a specific Office, Program Status, and/or Type.
FDA-TRACK Research Glossary	The FDA-TRACK Research Glossary (Link Here) is a comprehensive resource of common science, medical, and research terms and definitions referenced throughout the FDA-TRACK content.
Fiscal Year	The fiscal year is the accounting period for the federal government which begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends: for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006 (Source).
Key Center Director Measures    or    Key Associate Commissioner for Regulatory Affairs Measures	Key Center Director measures or Key Associate Commissioner for Regulatory Affairs measures are Center/organization-specific measures that are applicable to each Center/NCTR/ORA and are central to its priorities and strategic goals. An example includes the percentage of employees who received training during the month, which enables a Center to ensure that it is providing high value training opportunities to its employees.  These measures apply to most program offices within the Center/NCTR/ORA. These measures do not apply to OC.
Key Project	Key projects are program office-specific projects that are applicable to the office and important to the mission and objectives of the office. Performance for key projects is measured through achievement of the stated milestones within the project's plan.  An example includes developing a new risk-based approach for evaluating safety, effectiveness, and quality of new animal drugs.
Measures	FDA-TRACK measures are substantive metrics intended to help program Office Directors better understand and manage their offices.  The measures are meaningful or of high priority to each program office.
Program Area	A program area consists of a group of program offices which contribute to similar public health objectives.
Program Measures	Program measures are program office-specific measures that are applicable to the office and reflect work important to the public and FDA's mission.  An example includes increasing the percentage of 510(k) (or Class II medical devices) decisions made on time during the month.
Program Office	Program offices are the operational units within the Centers/organizations. Each program office has a specific public health mission which aligns with that of its Center/organization. FDA-TRACK measure data is collected at the program office level.
Quarterly Briefing	Quarterly briefings are held every three months for each Center/organization and are attended by the Commissioner/Principal Deputy Commissioner, Assistant Commissioner for Planning, Office of Planning, and Center and program office representatives. At each quarterly briefing, program office representatives present a summary of the past quarter and fiscal year results. The results and analysis are discussed and the program offices and Commissioner/Principal Deputy Commissioner/Assistant Commissioner for Planning, and Office of Planning agree on steps to prepare for the program area’s next quarterly briefing.
Quarterly Briefing Summaries	FDA-TRACK briefings are conducted quarterly between program offices and FDA senior leadership. In 2011, FDA began to post public summaries of accomplishments discussed at each briefing. Summaries are posted approximately 30 days after each quarterly briefing (Link here).
Super Office	A super office is a program office that consists of multiple smaller program offices.  For FDA-TRACK, some super offices were selected rather than the smaller program offices.  For example, the Office of International Programs (OIP) consists of nine offices around the world.  However, OIP is included at the super office level for FDA-TRACK.
Target	A target is a performance goal that a program office hopes to achieve in a certain time period.  Targets can be monthly, quarterly, or annually. Targets may not be applicable for all measures.