International Trade Law News

The Food and Drug Administration has published a final rule in the Federal Register modifying the requirements for the prior notification of imported food that have been in effect since the issuance of an interim final rule in October 2003 that implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 .

While the final rule made a number of changes to the interim final rule, the final rule did not make any changes to the method or deadlines for submitting the prior notice for imported food products.

The final rule, which will take effect on May 6, 2009, requires that the prior notice be submitted to FDA electronically via either U.S. Customs and Border Protection's Automated Broker Interface of the Automated Commercial System or the FDA Prior Notice System Interface (PNSI). The information must be submitted and confirmed electronically by the following deadlines:

• For food arriving by water = 8 hours
• For food arriving by air or land/rail = 4 hours
• for food arriving by land/road = 2 hours

FDA has also issued a draft "Prior Notice Compliance Policy Guide" that provides detailed guidance to FDA's and CBP's staff on enforcement of the prior notice regulations. FDA is seeking public comments on the draft policy guide.

Labels: CBP, FDA

The FDA's Establishment Registration Fee for medical device manufacturers will be $1,851 for FY 2009, an increase from $1,706 in FY 2008.

The FDA also announced that registration payments must be received on or before the time of submission. Previously, a medical device manufacturer could register its establishment and submit a subsequent payment. Under the new process, a company cannot register until it pays the $1,851 fee. Companies can pay online, or submit a check issued by a U.S. bank. Additional instructions for establishment registrations are available here on the FDA's website.

All annual establishment registration fees for FY 2009 must be submitted to FDA between October 1, 2008 and December 31, 2008.

Labels: FDA

Today, the Interagency Import Safety Working Group presented to President Bush its Import Safety Action Plan, which contains 14 broad recommendations and 50 action steps to enhance the safety of U.S. imports.

In addition, today the Food and Drug Administration (FDA) issued a Food Protection Plan that addresses the safety of domestic and imported food products.

The Import Safety Working Group was established on July 18, 2007, to conduct a comprehensive review of the U.S. import system and identify ways to further increase the safety of imports entering the United States. The Working Group is chaired by HHS Secretary Mike Leavitt and is comprised of 12 Federal departments and agencies. More information on the Import Safety Working Group and the full text of the Import Safety Action Plan issued today may be accessed at: www.importsafety.gov.

Labels: Customs, FDA

Labels: Customs, FDA