Animal and Plant Health Inspection Service October 22, 2010 – Federal Register Recent Federal Regulation Documents

We are amending the regulations that allow the importation of Fuji variety apples from Japan to allow all varieties of Malus domestica apples into the United States under the same conditions as those for Fuji variety apples. We have determined that the risk associated with allowing other varieties of M. domestica apples from Japan into the United States is the same as that posed by Fuji variety apples. This rule allows all varieties of M. domestica apples from Japan to be imported into the United States while continuing to protect against the introduction of quarantine pests.

The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data.'' This draft guideline provides information concerning the development of a single electronic message to transmit adverse event reports concerning veterinary biologics between regulatory authorities in the European Union, Japan, and the United States and marketing authorization holders (veterinary biologics licensees and permittees) in those regions. Because the draft guideline applies to pharmacovigilance and adverse event reporting on veterinary vaccines regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on the scope of the guideline and its provisions so that we may include any relevant public input on the draft in the Agency's comments to the VICH Steering Committee.