Objective of Operations

• Operate within the context of Efficient Risk Management for public health and safety
• Ensure imported regulated products that pose or appear to pose a threat or risk to public health and safety are not allowed entry, or are otherwise mitigated
• Facilitate expedited movement of imported goods of little or lesser risk to public health and safety

Currently, how is Entry Information Received?

• Most entries are made electronically via interface with Bureau of Customs and Border Protection ACS system
• Most entries are entered into the system by Customs House Brokers (also called Filers by FDA)
• Entry data from Customs goes to FDA’s electronic system , OASIS

Entry Information continued

• FDA’s electronic OASIS system is the primary mechanism used by the field inspectors for entry review, work flow, and generation of notices to the importers related to specific entries
• Product Center databases also used for determining admissibility
• OASIS system is primary tool for FDA HQ to implement selectivity criteria nationwide including Import Alerts
• OASIS and ACS selectivity criteria is coordinated at the HQ level of both CBP and FDA

Challenge of Numbers FY2003

• 9.4 million lines of entry of all FDA regulated products
• Products imported from 200+ (two hundred)countries
• Products made by 200,000+ declared foreign manufacturers/processors
• Products enter through approx. 300 Customs ports
• Approximately 1/3 of all exports to the U.S. are FDA regulated products
• Project approx. 11 million lines in FY 2004

• Most industry/FDA interaction is at the FDA field district office level covering certain port areas
• If FDA entry reviewer finds product in an entry «appears» to violate provisions of the FD & C Act, local office issues appropriate notice of apparent violation
• Importer, owner, or consignee has opportunity to provide evidence to overcome the «appearance» of violation.
• If appearance of violation is not overcome, entry is refused and Customs advised.
• Refused articles are destroyed or exported under Customs rules

• Develop and implement import enforcement procedures and policies based on risk
• Implement Import Alerts and evaluate petitions for removal from import alerts
• Manage selectivity criteria in OASIS
• Coordinate import activities among various Agency components including field and headquarter units and other federal agencies (CBP, USDA, etc)
• Provide HelpDesk support for OASIS
• Identify need for and conduct training for FDA personnel

• Commissioner’s Strategic Action Plan
• Implementing provisions of the «Public Health Security and Bioterrorism Preparedness and Response Act of 2002»
• IT improvements for management of information related to chain of supply
• Revision/Update of Regulatory Procedures Manual Chapter 9

• Ensure FDA regulated products in international trade are safe and secure.
• Ensure business practices of the foreign manufacturer to the U.S retailer (product life-cycle) are in alignment with goal of delivering products that are safe and secure
• Collaborate/partner to establish workable methods to mitigate potential risks of products prior to arrival at U.S. ports so trade is efficient and safe.

Q&A’s?

Carl Nielsen
Director, Division of Import Operations and Policy
301-443-6553
cnielsen@ora.fda.gov