Integration Activities June 5, 2002 ACE-ITDS-DHHS/FDA Trade Support Network Meeting

Varied Products $1 Trillion A Year Varied Approaches

Medicines Biologics Medical Devices

Scientific Breakthroughs More Sophisticated Products New Public Health Threats International Commerce Consumer Information

Initial Focus on Food Safety

Product Safety: Understanding the Lifecycle of the Imported Product! Product Ingredients & Sources Product Manufacture Product Handling/Shipping/Chain of Custody Product Adverse Event Reports Product Manufacturer “History”

Product Safety (Continued): Refresh Standard Data Set Element Requirements - Critical Data Review Prepare FDA/CFSAN integration requirements for ACE - Concept of Operations Establish Supporting Data Mapping and Data Flows, as Appropriate Assess Innovations to Risk Assessment & Management Finalize High- Level Requirements

Product Safety (Continued): Assess and establish a more effective “Product Code/Commodity ID System” “Upgrade” FDA’s Operational and Administrative System for Import Support” “Link” FDA’s Internal Databases Utilize advances in Information Technology to facilitate Risk Assessment/Management and Decision Making

"Wishful thinking might bring comfort, but not security." -PRESIDENT BUSH

Product Security: Mitigation of risks to prevent FDA products from becoming vectors of terrorism. Testing for Rapid Detection of Adulteration Permissive Debarment Registration of Facilities, I.e., Manufacturers, Packers, Processors, Holders Maintenance and Inspection Records

Product Security (Continued): Prior Notice Marking articles refused entry Prohibitions against “Port Shopping”

Features of ACE that can be leveraged in FDA: –Enhanced Data (By synchronizing the Manifest with entry declaration) –Additional Data (Use opportunity to include data requirements that are legally mandated in trade filings) –Leverage lifecycle/account management concepts –Leverage Portal infrastructure to set up FDA inspector in- boxes –Leverage Rules-based selectivity engine to maintain dynamic screening criteria –Establish Port actions based on screening results –Leverage ACE communication channels with trade to improve FDA communication to trade. example; send an electronic message to trade (importer /broker and shipper) if a hold on a shipment is released after examination. Leveraging of ACE

Backup Slides

Safe Manufacturing And Handling Monitor For New Risks