333-102-0247 Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Records and Material Transfer Reports Each person licensed under OAR 333-102-0235 to initially transfer devices to generally licensed persons must comply with the requirements of this rule. (1) The licensee must report on a quarterly basis all transfers of devices to persons for use under the general license in OAR 333-102-0115 and all receipts of devices from persons licensed under 333-102-0115 to the Authority. (a) The required information for transfers to general licensees includes: (A) The identity of each general licensee by name and mailing address for the location of use. If there is no mailing address for the location of use, an alternate address for the general licensee must be submitted along with information on the actual location of use; (B) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; (C) The date of transfer; (D) The type, model number, and serial number of the device transferred; and (E) The quantity and type of byproduct material contained in the device. (b) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s). (c) For devices received from an OAR 333-102-0115 general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor. (d) If the licensee makes changes to a device possessed by an OAR 333-102-0115 general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label. (e) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. (f) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. (g) If no transfers have been made to or from persons generally licensed under OAR 333-102-0115 during the reporting period, the report must so indicate. (2) The licensee must report all transfers of devices to persons for use under a general license in an Agreement State's regulations that are equivalent to OAR 333-102-0115 and all receipts of devices from general licensees in the Agreement State's jurisdiction to the responsible Agreement State Agency. (a) The required information for transfers to general licensees includes: (A) The identity of each general licensee by name and mailing address for the location of use. If there is no mailing address for the location of use, an alternate address for the general licensee must be submitted along with information on the actual location of use. (B) The name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; (C) The date of transfer; (D) The type, model number, and serial number of the device transferred; and (E) The quantity and type of byproduct material contained in the device. (b) If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s). (c) For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor. (d) If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label. (e) The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. (f) The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee. (g) If no transfers have been made to or from a particular Agreement State during the reporting period, this information must be reported to the responsible Agreement State Agency upon request of the Authority. (3) The licensee must maintain all information concerning transfers and receipts of devices that supports the reports required by this section. Records required by this section must be maintained in accordance with OAR 333-100-0057. Statutory/Other Authority: ORS 453.635 & 453.665 Statutes/Other Implemented: ORS 453.605 - 453.807 History: PH 14-2008, f. & cert. ef. 9-15-08 PH 4-2007, f. & cert. ef. 3-1-07 PH 12-2006, f. & cert. ef. 6-16-06 PH 36-2004, f. & cert. ef. 12-1-04 PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05 PH 3-2003, f. & cert. ef. 3-27-03