Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres®

The U.S. Nuclear Regulatory Commission (NRC) is revising its licensing guidance for licenses authorizing the use of Yttrium-90 (Y- 90) Microsphere Brachytherapy Sources and Devices TheraSphere[supreg] and SIR-Spheres[supreg]. The NRC is requesting public comment on the draft revision of the licensing guidance (Rev. 10). The document has been revised to significantly update the criteria for training and experience, medical event reporting, inventory requirement specifications, and waste disposal issues. The revised guidance document also provides new information regarding cremation and autopsy. This guidance is intended for use by NRC applicants, NRC licensees, and the NRC staff.