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 FDAs electronic system , OASIS
Entry Information continued
- FDAs 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
Current Day to Day Import Operations
- 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
Current Day to Day Import HQ Operations
- 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
- Commissioners 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.
Director, Division of Import Operations and Policy