The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled “Target Animal Safety for Veterinary Live and Inactivated Vaccines.”
This draft guideline provides guidance for designing and executing studies to evaluate the safety of the final formulation of veterinary live and inactivated vaccines in animals. Because the draft guideline may have an effect on the requirements for vaccines that are regulated by the Animal and Plant Health Inspection Service (APHIS) under the Virus-Serum-Toxin Act, APHIS is 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.
APHIS will consider all comments received on or before April 15, 2008.
Source:
CFR, USDA, APHIS Docket # APHIS-2008-0024