The Food and Drug Administration recently announced the availability of the following guidance and draft guidances:
Brian Feito
Brian Feito is Managing Editor of International Trade Today, Export Compliance Daily and Trade Law Daily. A licensed customs broker who spent time at the Department of Commerce calculating antidumping and countervailing duties, Brian covers a wide range of subjects including customs and trade-facing product regulation, the courts, antidumping and countervailing duties and Mexico and the European Union. Brian is a graduate of the University of Florida and George Mason University. He joined the staff of Warren Communications News in 2012.
On May 29, the optional import component of the web-based Public Health Information System (PHIS) will be partially operational, the Food Safety and Inspection Service said in a letter to importers dated April 18, 2012. On that date, in all U.S. official import inspection establishments handling imports of meat, poultry and egg products, PHIS will: (i) provide for a government-to-government electronic transmission of inspection certificate data as an alternative to the paper certification, beginning with Australia and New Zealand; and (ii) begin transfer of 10 data elements from U.S. Customs and Border Protection's Automated Commercial Environment (ACE) to FSIS.
The International Trade Administration is giving advance notice that it and the International Trade Commission will consider revoking the antidumping duty order on solid agricultural grade ammonium nitrate from Ukraine (A-823-810) in their automatic five year sunset review of this order, which is scheduled to be initiated in June 2012.
The International Trade Administration published notices in the May 1, 2012, Federal Register on the following AD/CV proceedings (any notices that announce changes to AD/CV duty rates, the scope, affected firms, or effective dates will be detailed in another ITT article):
The International Trade Commission instituted a formal enforcement proceeding relating to a consent order that resulted from a patent investigation into certain incremental dental positioning adjustment appliances and methods of producing same (337-TA-562) that was instituted in February 2006 based on a complaint filed by Align Technology, Inc. of Santa Clara, CA (now San Jose, CA).
The International Trade Commission is publishing notices in the May 1, 2012, Federal Register on the following AD/CV injury, Section 337 patent, and other trade proceedings (any notices that warrant a more detailed summary will appear in another ITT article):
The World Trade Organization said that on April 29, 2012, it welcomed Montenegro as its 154th member, and will welcome Samoa as its 155th member on May 10, 2012.
The Foreign Trade Zones Board released a list of FTZ grantees which have not submitted their mandatory 2011 annual report on zone operations, which was due on March 31, 2012. The FTZB said any grantee that has not yet submitted its 2011 report should do so as soon as possible to minimize the risk of fines or other adverse action, and that it cannot process any requests from those grantees until their 2011 reports are submitted. The FTZB’s list of grantees which have not submitted the 2011 report is as follows:
The Food and Drug Administration announced that the 15th Annual Education Conference, cosponsored with the Orange Country Regulatory Affairs Discussion Group (OCRA), will be in Irvine, CA, June 6-7, 2012. The conference is intended to give the drug, device, biologics, and dietary supplement industries an opportunity to interact with FDA reviewers and compliance officers from the Centers and District Offices, as well as other industry experts. The FDA said the main focus of the Conference will be product approval, compliance, and risk management in the three medical product areas.
The International Trade Administration is seeking comments by about May 21, 2012, on an application for an Export Trade Certificate of Review from SunWest Foods, Inc. SunWest Milling Company, Inc. is to be a member that will also be covered by and receive the protections from the proposed Certificate. SunWest plans to export rice and rice products to all parts of the world except the U.S. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from state and federal government antitrust actions and from private, treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions.