The Food and Drug Administration will hold a two-day public hearing on March 30 and 31, 2011 on new FDA initiatives regarding international comparability and equivalence assessments and other countries’ regulatory policies.
The Food and Drug Administration will be holding a public meeting on March 29, 2011 on the implementation of the import safety provisions of the recently enacted FDA Food Safety Modernization Act (FSMA), called "a New Paradigm for Importers." Topics to be covered will include importer verification, the Voluntary Qualified Importer Program, import certifications for food, and third-party accreditation.
The Food and Drug Administration has issued a notice to clarify that device manufacturers and importers of all devices, including class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting (MDR) requirements, pending future notice by FDA.
The U.S. Trade Representative should establish tougher law enforcement tools to better protect international intellectual property rights (IPR), IP advocates said at a USTR hearing. Witnesses recommended procedural reforms to the Special 301 review.
The Office of the U.S. Trade Representative held a hearing on March 2 as part of the process to prepare the Special 301 Report, which provides a means for the U.S. to communicate its concerns about the need to protect and enforce intellectual property rights (IPR) in overseas markets. The hearing is part of the ongoing USTR effort to give interested persons an opportunity to inform the interagency Special 301 Subcommittee of issues relevant to the review. The Special 301 Report will be released at the end of April.
CBP has issued a CSMS message stating that the issue involving erroneous paperless releases for AQI commodities at the Los Angeles/ Long Beach Seaport that was previously reported has been resolved. There is no longer a need to present entry packets for review for entries that have received paperless releases unless there is an Agriculture manifest hold on the entry.
The Office of the U.S. Trade Representative has announced the conclusion of its Special 301 Out-of-Cycle Review of Notorious Markets1, launched on October 1, 2010, which identifies examples of 16 Internet and 17 physical marketplaces that have been subject to enforcement action connected with counterfeiting and piracy, or that may merit further investigation for possible intellectual property right (IPR) infringements.
The Animal and Plant Health Inspection Service is requesting comments from the public by April 14, 2011 to assist in its review of the Lacey Act Declaration requirements for imported plants and plant products. Once this review is completed, APHIS will submit a report to Congress detailing its results and is authorized to issue certain regulations.
The Animal and Plant Health Inspection Service is requesting comments from the public by April 14, 2011 to assist it in its review of the implementation of the Lacey Act Declaration requirements for imported plants and plant products. Once this review is completed, APHIS will submit a report to Congress detailing its results.
The Agricultural Marketing Service is reopening the comment period on its proposed rule to establish a Christmas Tree Promotion, Research, and Information Order and program to be financed by an assessment (fee or tax) on producers and importers of fresh cut Christmas trees.