The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations that govern its standards for protection against radiation. These proposed revisions would address section 5(b) of Executive Order 14300, "Ordering the Reform of the Nuclear Regulatory Commission," and would reflect the NRC's experience and other developments in the field of radiation protection since the NRC's last major revisions to these standards in 1991. In addition, the NRC is issuing for public comment draft implementing guidance.

The Food and Drug Administration (FDA) is classifying the adjunctive pain measurement device for anesthesiology into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the adjunctive pain measurement device for anesthesiology. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.