Viruses, Serums, and Toxins and Analogous Products; Autogenous Biologics

We are amending the Virus-Serum-Toxin Act regulations for autogenous biologics by reducing the number of test summaries that manufacturers must submit to the Animal and Plant Health Inspection Service. In addition, we are amending the requirement concerning the submission of containers selected from each serial of autogenous biologic that exceeds 50 containers. Manufacturers will hold these containers, and submission is not required unless requested by the Animal and Plant Health Inspection Service. These actions will result in savings in time and resources for autogenous biologics manufacturers and the Animal and Plant Health Inspection Service without a significant reduction in regulatory oversight.