The Food and Drug Administration seeks comments on the burden on exporters of its requirement to obtain foreign letters of approval for the export of unapproved medical devices, it said. FDA requires that, for devices it has not approved that are to be exported, the exporter provide either a letter from the government of the importing country that the device is approved there, or a certification from a company official in the U.S. that the device doesn't violate the foreign country's laws. The agency is set to request an extension from the Office of Management and Budget for the existing information collection requirement. Comments on the requirements and FDA’s estimate of their burden on importers are due May 10.
The Treasury Department's Office of Foreign Assets Control amended two general licenses related to Venezuelan sanctions, OFAC said in a March 8 notice, extending the expiration date of provisions allowing transactions that involve the “wind down of certain financial contracts” with Venezuela. The first general license includes a provision that permits the divestment or transfer of Venezuelan-related bonds as long as the trades were placed before 4 p.m. on Feb. 1. The second general license allows “facilitating, clearing, and settling transactions” involving divestiture of holdings in Petroleos de Venezuela, the U.S.-sanctioned Venezuelan oil company, for all transactions that were placed before 4 p.m. on Jan. 28. Both authorizations are permitted only if divestments or transfers are made to a non-U.S. person, OFAC said. Transactions are authorized until May 10.
Work continues at CBP on its electronic pre-departure export manifest system, which the agency sees as a necessary precondition before the post-departure Automated Export System filing program is brought back, said Jim Swanson, CBP director-cargo and conveyance security and controls, in an interview. CBP is working on operational benefits for carriers to ramp up participation in its pilots in the ocean, rail and air modes, and hopes to move forward with truck pre-departure manifest next year, Swanson said.
The World Customs Organization issued the following releases on commercial trade and related matters:
In the March 7 edition of the Official Journal of the European Union the following trade-related notices were posted:
Export licenses issued by United Kingdom authorities will no longer be valid for dual-use exports from the European Union if the U.K. leaves the EU with no deal on March 29, the U.K. Department for International Trade said in a guidance document issued March 6. The same goes for licenses issued by other EU member states, which after a no-deal Brexit could no longer be used to export dual use items from the U.K., the guidance said.
As long as the trade talks are limited to industrial goods -- which does include fisheries under World Trade Organization rules -- European Union Trade Commissioner Cecilia Malmstrom said she thinks the talks could conclude before the current commission leaves office in late October. Malmstrom was visiting Washington to talk to her counterpart, U.S. Trade Representative Robert Lighthizer, and to give a speech at the Georgetown Law International Update.
The Canadian Food Inspection Agency sent an AIRS update announcing that it will now recommend refusing entry to African giant pouched rats and squirrels of subheading 0511.99.1294.19. The release recommendation for that subheading had previously been “not regulated by CFIA.”
Japan’s Ministry of Economy, Trade and Industry announced the approval of a bill that will strengthen protection of Japanese patents and intellectual property rights, the ministry said in a March 1 notice. The bill, called the Act of Partial Revision of the Patent Act, is aimed at protecting the “important technologies and other strong points of Japanese companies,” the notice said. The bill includes a new system in which “neutral technological experts” will complete on-site inspections of companies that are suspected of infringing on patents. Japan is also changing its method for calculating compensation for victims of patent infringement, allowing “rights holders to request” damages from the infringer “for all products sold by the infringer.” The bill also makes changes to Japan’s Design Act, the notice said, which includes expanding the scope of protected designs.
The U.S. Treasury Department's Office of Foreign Assets Control extended the expiration date of two general licenses related to GAZ Group, allowing certain transactions involving the sanctioned company until July 6, 2019, OFAC said in March 6 notice. The previous expiration date, issued in a Jan. 16 notice, was March 7. The sanctions against GAZ Group are Ukraine-related, and the company was designated as an “oligarch-owned” entity after OFAC said in a April 2018 notice that the company was owned or controlled by “Russian Machines” and oligarch Oleg Deripaska, who also is identified as having a large stake in Russian aluminum producer Rusal. The notice said GAZ Group is Russia’s “leading manufacturer of commercial vehicles.”