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EAPA Litigation

Under the Enforce and Protect Act, CBP investigates whether a company is evading particular antidumping and countervailing duty orders. Litigation on determinations made under the relatively new statute have centered on due process protections for respondents, CBP's evidentiary basis for its decisions and the interplay of decisions made on the scope of the applicable AD/CVD orders from both CBP and the Commerce Department. The Court of Appeals for the Federal Circuit issued a key decision for all EAPA cases in Royal Brush Manufacturing v. United States, when it found CBP to have violated a respondent's due process protections by failing to provide it with access to the business proprietary information used in the proceeding. 

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FDA May Refuse Imports of Acidified Sauce from Australian Facility, Will Assess U.S. Agent Fees
October 7, 2013 by Brian Feito|FDA

The Food and Drug Administration may refuse entry to Australian company Flavour Makers’ acidified sauces, and will charge reinspection fees, for violations of the agency’s acidified food regulations, FDA said in a warning letter dated Sept. 12. The violations found during an inspection in January were “materially related” to food safety, so FDA will have to reinspect the facility to ensure the problems were fixed. FDA suggested the Australian company notify its U.S. agent, who will be liable for the fees.

Shutdown Puts FDA Drug and Device Facility Registration on Hold
October 7, 2013 by Brian Feito|FDA

The Food and Drug Administration won’t be accepting facility registrations for drug and device production and distribution facilities during the federal government shutdown, despite the beginning of the registration period Oct. 1. All drug and device facilities that market their products in the U.S. are required by law to register, including foreign facilities whose drugs and devices are imported into the U.S. But without a fiscal year 2014 budget, FDA said it has no legal authority to collect user fees associated with the registrations. The drug and device facility registration period runs until Dec. 31. The registration user fee for FY 2014 is $3,313.

FDA Threatens Germany Generic Drug Firm With Import Refusal for GDUFA Violations
October 4, 2013 by Brian Feito|FDA

The Food and Drug Administration threatened a German generic drug manufacturer with refusal of their imports at the border for failure to register and pay new fees required for generic drugs for fiscal year 2013. In a warning letter sent Sept. 17, FDA said C.P.M. Contract Pharma failed to comply with self-identification and facility fee requirements set by the Generic Drug User Fee Amendments of 2012. Because FY 2013 ended Sept. 30, FDA said it will not take enforcement action for failure to identify for that year if Contract Pharma completes its FY 2014 GDUFA self-identification submission within 15 days of receipt of the warning letter.