Comment (1) Robert Skowronek on Proposed Rule FR Doc # E8-18014

RIN 3150-AI26 Medical Use of Byproduct Material: Amendments/Medical Event Definitions I recommend that the wording of 10 CFR 35.40(c)(2) be revised from “If, because of the patient's condition, a delay in order to provide a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. A revised written directive must be signed by the authorized user within 48 hours of the oral revision.” to “If a delay to obtain a written revision to an existing written directive would jeopardize the patient's health, an oral revision to an existing written directive is acceptable. The oral revision must be documented as soon as possible in the patient's record. The authorized user must sign a revised written directive within 48 hours of the oral revision.” The phrase “because of the patient’s condition” essentially duplicates the meaning of “jeopardize the patient’s health” and can be eliminated. The last sentence is changed to active voice. Thank you for the opportunity to comment on these proposed regulations. Robert D. Skowronek, Chief Radioactive Materials Unit Radiological Protection Section Waste and Hazardous Materials Division Michigan Department of Environmental Quality Telephone: 517-241-1253