The Food and Drug Administration’s Center for Tobacco Products is moving a few miles down the road from Rockville, Maryland. to the agency’s main White Oak campus in Silver Spring. FDA says the move will begin around June 6, and will take about three weeks. All physical correspondence with the Center for Tobacco Products should be addressed to the new address beginning on June 6. More information is available (here).
The Food and Drug Administration will expand cooperation with European regulators on pharmaceuticals, in an initiative announced in May 12 by Howard Sklamberg. FDA will be deploying a “dedicated FDA team to work with our European counterparts on a host of issues,” he said. The team will include officials from FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Office of Global Regulatory Operations and Policy. “Through this initiative, and in cooperation with the European Commission (EC) and the European Medicines Agency (EMA), FDA will aim to deepen our reliance on trusted regulators outside of the U.S. who provide equivalent public safety and quality protection,” said Sklamberg.
On May 13 the Foreign Agricultural Service posted the following GAIN reports:
The Foreign Trade Zones Board issued the following notices for May 14:
Importers can file lawsuits against Customs for denying their antidumping and countervailing duty-related protests if they are challenging a clear CBP error, said the Court of International Trade May 13 as it denied CBP’s motion to dismiss a lawsuit brought by LDA Incorporado. Although CBP cannot normally be challenged for AD/CV duty decisions -- that charge lies with the Commerce Department and International Trade Commission -- in this case, LDA took issue with CBP’s application of Commerce’s instructions, and not the instructions themselves.
The U.S. Court of Appeals for the Federal Circuit on May 13 denied a challenge from Deckers on the tariff classification of its Teva sports sandals, finding itself bound by its own precedent. CAFC had already ruled in 2008 that the sports sandals were classifiable in the tariff schedule as open-toed or open-heeled footwear rather than sports footwear, which carries a lower rate of duty.
The Consumer Product Safety Commission’s two-year attempt to recall Buckyballs has come to an end, with Maxfield and Oberton CEO Craig Zucker agreeing to pay $375,000 to finance a “recall trust fund” as part of a settlement. The trust fund will be used to refund consumers who bought Buckyballs and Buckycubes, which were marketed by Maxfield and Oberton as a desk toy but were claimed by CPSC to cause serious injury when ingested by children. Zucker did not admit to any product safety hazards or personal liability under the settlement.
The International Trade Commission published notices in the May 13 Federal Register on the following AD/CV injury, Section 337 patent, and other trade proceedings (any notices that warrant a more detailed summary will be in another ITT article):
The International Trade Commission is asking for comments by May 21 on public interest factors raised by Canon’s request for a ban on imports of unauthorized laser printer toner cartridges that it says infringe its patents. Canon’s May 7 Section 337 complaint says Ninestar, Aster, Print-Rite, International Laser Group, and ASTA, all of China, are manufacturing unauthorized toner cartridges for use in certain Canon and Hewlett-Packard laser printers. The toner cartridges are being sold by 15 retailers in the U.S., it said. Canon is asking for a cease and desist order banning sale of the unauthorized toner cartridges. It is also asking for a general exclusion order banning imports of all infringing toner cartridges, or alternatively limited exclusion orders banning imports of ingraining cartridges by each respondent.
The Commerce Department published notices in the May 13 Federal Register on the following AD/CV duty proceedings (any notices that announce changes to AD/CV duty rates, scope, affected firms, or effective dates will be detailed in another ITT article):