Petition To Manufacture Foot-and-Mouth Disease Vaccine in the United States

概要

We are reopening the comment period for our notice of receipt of a petition from Zoetis, Inc. requesting approval for the manufacture within the continental United States of a vaccine derived from a leaderless strain of the foot-and-mouth disease (FMD) virus. Although introduction of live FMD virus into the United States is prohibited by law, the petition states that this leaderless strain should not be considered live FMD virus as it is non-infectious, non-transmissible, and incapable of causing FMD. We are taking this action in order to provide commenters with additional scientific information supporting our determination that the leaderless virus strain from which Zoetis, Inc. intends to produce FMD vaccine in the United States poses no risk of causing FMD infection in animals. This action gives interested persons the opportunity to review the additional information and submit comments.