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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 Outlines Proposed Food Safety System Recognition for Foreign Governments
September 6, 2013 by Tim Warren|FDA

The Food and Drug Administration spelled out the rationale and expected processes for the proposed systems recognition assessment program, meant to help the FDA identify countries with effective food safety systems. FDA has been testing and developing a process for conducting systems recognition assessments, "working with New Zealand and the European Union (EU) on initial pilot projects and Canada on a second pilot project," it said. "FDA expects that systems recognition assessments will be a key tool for FDA to utilize in its preventive approach to food safety for imported foods," it said.

FDA to Use DUNS Numbers as UFIs for FDASIA Drug Facility Registration
September 5, 2013 by Brian Feito|FDA

The Food and Drug Administration intends to use DUNS numbers assigned by Dun and Bradstreet as Unique Facility Identifiers for domestic and foreign drug facility registration required by the Food and Drug Administration Safety and Innovation Act (FDASIA), it said in a draft guidance (here) posted Sept. 4. DUNS numbers (here) are free and are already widely used for drug registration, and meet agency needs, FDA said. The draft guidance only applies to registration requirements found in Sections 701 and 702 of FDASIA, and not to registration requirements for excipient manufacturers in Section 703 of the law. Comments on the draft guidance are due by Nov. 5

FDA System Issues May Cause Entry Review Delays
August 28, 2013 by Claire Yan|FDA

Intermittent issues on Aug. 27 related with the Food and Drug Administration's application for manually reviewing entries may lead to delays beyond routine time frames in processing entries, CBP said. According to CBP, these issues are being investigated and district personnel have experienced higher caller volume as a result.