Energia i regulacje · 24/10/2007

William Stein, III, M.D.; Denial of Petition for Rulemaking

The U.S. Nuclear Regulatory Commission (NRC) is denying a petition for rulemaking (PRM-35-19) submitted by William Stein, III, M.D. (petitioner). The petitioner requested that the NRC amend the regulations that govern medical use of byproduct material concerning training for parenteral administration of certain radioactive drugs-- samarium-153 lexidronam (Quadramet), iodine-131 tositumomab (Bexxar), and yttrium-90 ibritumomab tiuxetan (Zevalin)--used to treat cancer. The petitioner believes that these regulations are unduly burdensome for the use of these drugs. The petitioner requested that the regulations be amended to codify an 80-hour Laboratory and classroom, training and appropriate work experience, and written attestation as appropriate and sufficient for physicians desiring to attain authorized user status for therapeutic administrations of these unsealed byproduct materials.