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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 Finishes Guidance on Medical Device UDI Database
June 26, 2014 by Brian Feito|FDA

The Food and Drug Administration finalized the remaining parts of a new guidance on the agency’s database for medical device “unique device identifiers” (UDIs). The guidance includes information for device labelers (in most instances, the device manufacturer) on how to use the Global Unique Device Identifier Database (GUDID), including how to establish GUDID accounts and begin initial submissions. It also contains examples of medical device labels that include UDIs. Labelers are required to submit data to GUDID if a device must be labeled with a UDI, FDA said in its UDI final rule. The agency had issued part of the guidance in early June (see 14061028). Comments on the guidance may be submitted at any time, said FDA in a concurrent Federal Register notice (here).

FDA Proposes Non-Enforcement of Controls on Medical Device Data Systems
June 24, 2014 by Brian Feito|FDA

The Food and Drug Administration intends to adopt a non-enforcement stance for controls on medical device data systems, it said in a draft guidance posted June 20 (here). Under the policy, if adopted, FDA would not “enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices,” it said. Comments on the draft guidance are due Aug. 25, according to a concurrent Federal Register notice (here).

FDA Extends Comment Period on Proposed Cigar and e-Cigarette Restrictions
June 23, 2014 by Brian Feito|FDA

The Food and Drug Administration is allowing more time for comments on its proposal to extend its current restrictions on cigarettes and smokeless tobacco so they also apply to electronic “e-cigarettes,” cigars, pipe tobacco, nicotine gels, hookah tobacco, and nicotine dissolvables. The proposed rule issued by FDA in April would set requirements for registration, FDA review, and health warning labels on e-cigarettes and other tobacco products (see 14042426). Comments are now due Aug. 8.