Animal and Plant Health Inspection Service August 17, 2005 – Federal Register Recent Federal Regulation Documents

We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports to require veterinary biologics licensees and permittees to record specific information concerning adverse events associated with the use of biological products that they produce or distribute and to compile and submit those records in a summary report to the Animal and Plant Health Inspection Service (APHIS) every 12 months for products licensed for 1 year or more; for newly licensed products, a summary report would have to be submitted at 6-month intervals during the first year of the product license and at 12-month intervals thereafter. The summary report would also have to identify the number of doses, or the average number of doses, of the product in distribution channels, if available. These records and reports would help ensure that APHIS will be able to provide complete and accurate information to consumers regarding adverse reactions or other problems associated with the use of licensed biological products. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document, that contained fewer specifics concerning the information that would have to be recorded in adverse event reports associated with the use of veterinary biologics that are submitted to the Agency.