Quality management program and misadministrations; NRC override of OMB disapproval of NRC information collection...

The Commission has voted to override the Office of Management and Budget (OMB) disapproval of the information collection requirements imposed in the final rule entitled "Quality Management Program and Misadministrations" (July 25, 1991; 56 FR 34104). As part of this final rule, the Commission is amending its regulations to reflect OMB's assignment of a new control number to these information collection requirements. The Commission reevaluated the need for this final rule and the information collection requirements it contains. The Commission continues to believe that its requirements for written quality management programs and misadministration reports, if complied with, have a reasonable likelihood of decreasing misadministrations (e.g., wrong dose or wrong patient) with a small incremental cost to licensees. Without the reporting and recordkeeping requirements, it would not be possible to implement and enforce these regulations effectively.