《PDA Presentation 2 - Public》.ppt

FDA For FY 2010 FDA’s budget was $3.2 billion which represented a 19% increase over 2009. President Obama’s FY 2011 budget request for FDA is nearly $4 billion which represents a 6% increase to $2.51 billion. (Percentage discrepancy due to anticipated collection of user fees from the food, tobacco and drug industries. This budget would increase the agency FTE ceiling by approximately 1,250, bringing the workforce total to 13,586. ORA Regulating almost 124,000 business establishments that annually produce, warehouse, import and transport $1 trillion worth of consumer goods is no small task. The FDA devotes to this crucial task, which is directed by the Office of Regulatory Affairs (ORA), about one-third of the agencys personnel. Stationed in more than 160 offices, resident posts and laboratories from coast to coast and in Puerto Rico, ORAs highly trained staff provides the eyes, ears and the long arm of the agency that ensures the implementation of the FDAs high public health standards. Southwest Region DEN-DO Organizational Chart The Changing Face of the Denver District Office FDA Science Initiative Significant increase in sample analysis using high throughput methodology Consumer Safety Officer What is fieldwork? Compliance Officer Reviews and evaluates evidence and findings indicating a possible lack of compliance with Agency enforced laws and regulations. Analyzes data samples and documented information gathered during inspections and investigations Determines whether an investigation is complete or what additional work may be required Recommends legal action to Headquarters, the Office of Chief Counsel, the responsible U.S. Attorney Maintains working liaison with the U.S. Attorney’s Office and U.S. Marshal’s Service in implementing approved actions Ensures that non-compliant establishments make necessary changes to meet the regulations. Enforcement includes official correspondence as well as legal actions taken in a court of law Consumer Safet