Animal and Plant Health Inspection Service January 18, 2006 – Federal Register Recent Federal Regulation Documents
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Melaleuca; Availability of an Environmental Assessment and Finding of No Significant Impact
We are advising the public that an environmental assessment and finding of no significant impact have been prepared by the Animal and Plant Health Inspection Service relative to the issuance of a permit for the environmental release of the nonindigenous fly Fergusonina turneri Taylor and its obligate nematode Fergusobia quinquenerviae Davies and Giblin-Davis, which are potential biological control agents of Melaleuca quinquenervia. The environmental assessment documents our review and analysis of environmental impacts associated with, and alternatives to, issuing a permit for the environmental release of the fly and its obligate nematode in the continental United States. Based on its finding of no significant impact, the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.
Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports (VICH Topic GL24) and Data Elements for Submission of Adverse Event Reports (VICH Topic GL42)
The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed two draft guidelines titled ``Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event Reports'' and ``Pharmacovigilance of Veterinary Medicinal Products: Data Elements for Submission of Adverse Event Reports.'' These draft guidelines describe, respectively, standardized terminology for the identification of possible adverse events following the use of veterinary medicinal products, and the specific data elements to be used for the submission and exchange of spontaneous adverse event reports between marketing authorization holders (licensees/permittees) and regulatory authorities. Because the draft guidelines apply 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 each guideline and its provisions so that we may include any relevant public input on the drafts in the Agency's comments to the VICH Steering Committee.
Horse Protection; Public Meeting
We are advising the public that the Animal and Plant Health Inspection Service's Animal Care program will host a meeting to present current information on the enforcement of the Horse Protection Act (HPA) and provide a forum for horse industry members and other interested persons to comment on the Horse Protection Program, development of the HPA Operating Plan for 2007 and beyond, and other Horse Protection matters. This notice provides the meeting's agenda, location, and date.
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