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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 Extends Deadline for Comments on FSVP, Third-Party Audit Proposals
November 19, 2013 by Brian Feito|FDA

The Food and Drug Administration is extending until Jan. 27 the due dates for its proposed rules on the Foreign Supplier Verification Program (FSVP) (here) and accreditation of third-party food safety auditors (here). The due date for comments on the two Food Safety Modernization Act (FSMA) proposals was originally Nov. 26, but FDA is giving commenters more time to consider the relationship between the FSVP and third-party auditor rules on one hand (see 13102519), and the agency’s proposal on risk-based preventative controls for animal food on the other (see 13102519).

FDA Extends Deadline to Nov. 22 for Preventative Controls, Produce Safety Proposal Comment
November 15, 2013 by Brian Feito|FDA

The Food and Drug Administration will allow another week for comments on its proposed rules on produce safety and risk-preventative controls for human foods. Comments on the two proposals will now be due Nov. 22, because of intermittent technical difficulties on the www.regulations.gov site that occurred in November that prevented some from submitting comments. Comments were originally due Nov. 15.

FDA to Begin Pilot on Mutual Recognition of Foreign Government and Third-Party Medical Device Audits
November 14, 2013 by Brian Feito|FDA

The Food and Drug Administration signed on to an international pilot program to accept medical device inspections by foreign governments and third-party auditors, said the agency in a Federal Register notice (here). Through the Medical Device Single Audit Program (MDSAP) International Coalition Program, regulators in Australia, Brazil, Canada, and the U.S. will accept audits of medical devices conducted by each foreign government, as well as by third-party auditors recognized by the coalition. Japan is participating as an observer. In the U.S., FDA will accept MDSAP audit reports as substitutes for routine inspections -- inspections conducted “for cause” or as a “compliance follow-up” won’t be affected. MDSAP is targeting June 2014 for the beginning of the pilot, with an eye to 2017 for the beginning of the operational program, FDA said (here).