Animal and Plant Health Inspection Service May 17, 2018 – Federal Register Recent Federal Regulation Documents
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VSTA Records and Reports Specific to International Standards for Pharmacovigilance
We are amending the Virus-Serum-Toxin Act regulations concerning records and reports. This change requires veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service (APHIS) will be provided in separate guidance documents. These records and reports will help ensure that APHIS can provide complete and accurate information to consumers regarding adverse reactions or other problems associated with the use of licensed biological products.
Draft Environmental Impact Statement and Preliminary Pest Risk Assessment for Permit for Release of Genetically Engineered Citrus tristeza virus
We are advising the public that the Animal and Plant Health Inspection Service has prepared a draft environmental impact statement (EIS) and preliminary pest risk assessment (PRA) that evaluate the potential environmental impacts and plant pest risk associated with the proposed environmental release of genetically engineered Citrus tristeza virus. We are making the draft EIS and preliminary PRA available for public review and comment.
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