The International Trade Commission is publishing notices in the Jan. 11 Federal Register on the following AD/CV injury, Section 337 patent, and other trade proceedings (any notices that warrant a more detailed summary will appear in another ITT article):
The International Trade Administration published notices in the Jan. 11 Federal Register on the following AD/CV 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 Food and Drug Administration issued its weekly Enforcement Report for Jan. 9 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration may refuse entry of Taiwan Three Mast Pharmaceutical’s drug products for violations of Current Good Manufacturing Practice regulations, it said in a warning letter. Three Mast is also engaging in unapproved marketing of one of its products, FDA said, by marketing its Imbue Pain Relief Patch as an external analgesic for treatment of tendonitis and bursitis, which are not approved uses.
The Food and Drug Administration posted three fact sheets and a presentation on its proposed produce safety regulation for facilities that grow, harvest, package and hold raw produce, as well as its Hazard Analysis and Risk-Based Preventative Controls (HARPC) regulation for facilities that manufacture, process, pack or hold human food. Importers will be responsible for verifying their foreign suppliers’ compliance with these regulations per the Foreign Supplier Verification Program. The produce safety regulation fact sheet is available here, and a fact sheet on the regulation’s subparts is available here. The HARPC fact sheet is available here. Presentations on the two regulations, as well as other provisions of the Food Safety Modernization Act, are available here.
On Jan. 10 the Foreign Agricultural Service issued the following GAIN reports:
The Animal and Plant Health Inspection Service announced changes Jan. 10 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.
The Food Safety and Inspection Service revised export requirements and plant lists for the following countries for Jan. 4-10:
The Grain Inspectors, Packers, and Stockyards Administration (GIPSA) is proposing to increase its inspection and weighing fees for grain exports. According to GIPSA, the increase in fees is necessary because current levels will not cover projected costs for fiscal years 2012-17. Both local and national fees would be affected. Comments are due March 15.
A product does not have to be manufactured in the U.S. for the licensee of that product to have access to the International Trade Commission’s import restrictions, said the Court of Appeals for the Federal Circuit in a denial of Nokia’s request for rehearing. A U.S. patent holder’s investment in research and licensing alone satisfies the domestic industry requirement, regardless of whether actual production is performed entirely abroad. In a dissent from the ruling, Judge Pauline Newman disagreed that no domestic production need take place to satisfy the domestic industry prong. Such an interpretation ignores Congressional intent to protect U.S. industry, even in cases where the U.S. industry is comprised of licensees rather than actual patent holders.