The Justice Department announced that SB Pharmco Puerto Rico Inc., a subsidiary of GlaxoSmithKline, PLC (GSK), has agreed to plead guilty to charges relating to the manufacture and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico, manufacturing facility. The resolution includes a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act and related state claims for $600 million.
The Office of Foreign Assets Control has updated its Specially Designated Nationals list to add five individuals and thirty-nine entities pursuant to non-proliferation designations.
The International Trade Administration's U.S. and Foreign Commercial Service is organizing an executive-led trade mission for multi-modal transportation and energy infrastructure development products and services to Qatar, Abu Dhabi, and Dubai, United Arab Emirates on June 5-10, 2011. The mission is designed to contribute to President Obama’s National Export Initiative to achieve the goal of doubling exports over the next five years to support two million American jobs. Applications are due by March 4, 2011.
On October 22, 2010, APHIS updated its Fresh Fruits and Vegetables Import PPQ Manual. The manual lists by country fruits and vegetables that are admissible into the United States. It includes a description of methods for sampling and inspecting selected fruits and vegetables. It also contains pictorial identification guides, and a glossary for common and scientific names of fruits and vegetables.
The Food Safety and Inspection Service has issued updated versions of its list of Mexico (October 22, 2010) firms eligible to export meat and poultry to the U.S.
The U.S. Trade Representative has sent a request letter to the International Trade Commission requesting that the ITC provide its advice as to the probable economic effect of the removal from eligibility for duty-free treatment under the General System of Preferences (GSP) program from all beneficiary countries or from the specified country on U.S. industries producing like or directly competitive articles, on U.S. imports, and on U.S. consumers, for the following articles: certain sleeping bags (HTS 9404.30.80) and certain self-adhesive plastic tapes from Indonesia (HTS 3919.10.20 and 3919.90.50). (See ITT's Online Archives or 10/26/10 news, 10102611, for BP summary of USTR's announcement that it has received and accepted the petitions for review for these products.)
Various U.S. government agencies are seeking comments on the following information collections for which they have requested or intend to request Office of Management and Budget approval or extension of approval (see notices for specific details):
On October 25, 2010, APHIS updated the Manual for Agricultural Clearance. The manual provides CBP personnel working at airport and maritime locations with the guidelines, directions, and policy for clearing carriers and passengers/crew and controlling garbage and cargo.
On October 25, 2010, APHIS updated its Plant Protection and Quarantine (PPQ) Animal Product Manual. This Manual provides the background, procedures, and regulatory actions to enforce the regulations governing the import and export of animals, animal products, and animal by-products.
The Environmental Protection Agency has issued a final rule, effective November 26, 2010, which issues a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the chemical substance identified as 1-Propene, 2,3,3,3-tetrafluoro- (CAS No. 754--12--1) which was the subject of premanufacture notice (PMN) P--07--601. This action requires persons who intend to manufacture, import, or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity, which would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.