The Food and Drug Administration on Nov. 14 issued a new guidance document on procedures for reviewing FDA denials of export certificates for medical devices. The guidance document details the process for exporters to correct deficiencies that caused FDA to deny issuance of a Certificate to Foreign Government (CFG) for a device, as well as for requesting agency review of denials.
The U.S. is continuing its national emergency and sanctions against Iran, the White House said Nov. 12. The extension, which will continue the sanctions for one year beyond the anniversary date of Nov. 14, renews an executive order that blocked Iranian government property. The original executive order was declared in 1979. The U.S. renewed the national emergency because its relations “have not yet normalized,” the White House said.
The U.S. is continuing a national emergency that authorizes sanctions against proliferation of weapons of mass destruction, the White House said Nov. 12. The White House said weapons proliferation “continues to pose an unusual and extraordinary threat” to U.S. national security. The national emergency was extended one year.
Due to an upcoming change, companies should make sure they have written policies for complying with the International Traffic in Arms Regulations before registering, renewing or amending their ITAR registrations, according to a Nov. 13 post from Export Solutions. That change relates to the submission of ITAR registrations as part of the Directorate of Defense Trade Controls’ effort to update its processes for administration of the ITAR, the post said. The change will “most likely” take effect before 2020, Export Solutions said.
The Commerce Department is slated to take over export control responsibility from the State Department, which would mean Congress would no longer be notified when there are sales of more than $1 million to foreign governments. The final rule is ready for implementation, but Congress could stop it if there's a joint resolution under the Congressional Review Act, which allows Congress to reverse agency rules.
In the Nov. 11-12 editions of the Official Journal of the European Union the following trade-related notices were posted:
The United Kingdom's Export Control Joint Unit fined nine British exporters for export violations of dual-use goods from May to October, according to a Nov. 12 notice. The fines included penalties of between $5,500 and about $100,000 for exporters who failed to acquire appropriate export licenses for military goods.
The European Commission recently released its 2019 Export Control Handbook for Chemicals, with information on goods on the dual-use control list, Common Military List, Syria restricted list and more. The report contains current export control regulations for certain goods and a list of controlled chemicals arranged by Export Control Number, Chemical Abstract Service number and Combined Nomenclature code.
The United Kingdom, Germany and France said they are concerned about Iran’s latest decision to restart uranium enrichments in a breach of the Joint Comprehensive Plan of Action, saying Europe’s efforts to reduce tensions and sanctions are “made increasingly difficult.” In a Nov. 11 statement, the countries urged Iran to “reverse all measures inconsistent” with the JCPOA.
The Council of the European Union extended sanctions against Venezuela until Nov. 14, 2020, citing ongoing human rights violations and actions aimed at undermining democracy, according to a Nov. 11 press release. The sanctions include an arms embargo and ban on trade of equipment “for internal repression.” The measures also include asset freezes on 25 Venezuelan officials.