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Drug Administration intends to adopt a non-enforcement stance for controls on medical device data systems, it said in a draft guidance posted June 20 (here).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 Comments on the draft guidance are due Aug. 25, according to a concurrent Federal Register notice (here).
On June 23 the Foreign Agricultural Service posted the following GAIN reports:
The Animal and Plant Health Inspection Service announced changes June 23 to Plant Protection and Quarantine (PPQ) electronic manuals. While some changes are minor, other changes may affect the admissibility of the plant products, including fruits, vegetables, and flowers.
Court of International Trade Chief Judge Donald Pogue is retiring effective July 1, and will assume senior status on the court, according to a notice on the CIT website. Judge Timothy Stanceu will assume the chief judgeship, it said. The move leaves a spot open on the trade court for a new judge.
A listing of recent antidumping and countervailing duty messages from the Commerce Department posted to CBP's website June 23, along with the case number(s) and CBP message number, is provided below. The messages are available by searching for the listed CBP message number at http://adcvd.cbp.dhs.gov/adcvdweb.
Mexico's Diario Oficial of June 23 lists notices from the Secretary of Foreign Affairs and the Secretary of Economy as follows:
The International Trade Commission published notices in the June 23 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 rescinding a limited exclusion order banning imports of patent infringing encapsulated integrated circuits from Malaysian company Carsem. According to the ITC, Carsem and Amkor, the company that originally requested the ban, have since settled their dispute and asked for the ITC to end the limited exclusion order. The ban had been in place since April (see 14041020).
The Commerce Department published notices in the June 23 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):
The Commerce Department issued the final results of a changed circumstances review of lined paper products from India (A-533-843), finding Navneet Education Limited is the successor to Navneet Publications (India) Ltd. for AD duty purposes. Just as it had found in its preliminary results in April (see 14041710), Commerce found that the company underwent a simple name change. Beginning on June 24, entries of lined paper products exported by Navneet Education will get the zero percent AD duty rate assigned to Navneet Publications in the most recent administrative review (see 14050615). As such, entries from Navneet Education will not be subject to AD duty cash deposit requirements until further notice.