FDA Official Discusses Upcoming "Good Importer Practices," Electronic Filings, Etc.

FDA Import Initiatives

The FDA is working on the following FDA import initiatives (partial list):

• Good Importer Practices - Government agencies are working together to develop a good importer practices document that encompasses all of the concerns of the government agencies. It is going through the review process.
• Entry Status Updates, Electronic Documents - The FDA Import Trade Communication (FTIC) system is being developed to allow filers to obtain entry status updates. The system will also allow the trade to submit documents electronically to FDA. The goal is to have this system completed by the end of 2008/early 2009.
• PREDICT¹ - This new system is being piloted in Los Angeles for seafood products. It is similar to the Automated Targeting System (ATS) for U.S. Customs and Border Protection as it provides a risk-based score for entries being brought into the U.S. It identifies which commodities pose a significant risk to public health and targets such high-risk shipments.
• OASIS Upgrades - OASIS will be updated to include historical data on inspections, examinations, cross-district reviews, etc. FDA's systems, including OASIS, are antiquated. OASIS was not created to be a risk-based system; it was designed to monitor imports coming into the U.S. FDA is working on redesigning OASIS in order to take a more risk-based approach.
• Direct Information from Private Laboratories - FDA is developing guidance on obtaining information from private laboratories directly rather than from importers, which is intended to expedite the review process.
• Use of and Sharing of Data - FDA wants more data coming in from states and its foreign counterparts. FDA will look at how to take that data, analyze it, assign a risk factor to it, and determine what action to take based on the data received.
• Industry Outreach - FDA is working with the industry and other government agencies to learn more about issues occurring at the ports and improve the way FDA does business.

Revitalization of Regulatory Affairs

The Office of Regulatory Affairs (ORA) transformation that was discussed in 2007 has since been stalled and "pretty much died" shortly after being introduced. Individuals, including the field, trade, and FDA stakeholders, were not happy with the changes, especially the closing of laboratories.

Since then, FDA has reexamined its concerns. In the summer of 2007, ORA began the process of revitalizing its operations and exploring new strategies in response to challenges, etc.

FDA's revitalization proposals include (partial list):

Deployment of resources using a science risk-base approach

Deployment of its highly skilled foreign inspection workforce

Strengthening the scientific support from ORA laboratories

Enhancing ORA's risk management capability and capacity

Accepting inspection, investigation, and surveillance information from other sources

Obtaining additional information from untapped sources to make risk-based regulatory decisions

Improving FDA's foreign presence

Improving its relations with private laboratories

Improving its information technology/OASIS

Modernizing ORA's regulatory software applications

Implementing quality management systems

¹Predictive Risk-Based Evaluation and Demonstrative Import Tracking (PREDICT)

(See ITT's Online Archives or 04/09/08 news, 08040900, for BP summary of CBP designating import safety as a priority trade issue.

See ITT's Online Archives or 08/31/07 news, 07083199 3, for BP summary announcing FDA was testing PREDICT.)