OAR 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 (General Licenses — Radioactive Material Other than Source Material: Requirements for License to Manufacture, or Initially Transfer Radioactive Material Contained in Devices Granted a General License Under OAR 333-102-0115) 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 (General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices) and all receipts of devices from persons licensed under 333-102-0115 (General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices) 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 Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices) 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 Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices) 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 (General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices) 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 (General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices) 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 (Maintenance of Records).

Source: Rule 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, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-102-0247.

333‑102‑0001
Purpose and Scope
333‑102‑0005
Exemptions: Unimportant Quantities of Source Material
333‑102‑0010
Exemptions — Radioactive Material Other than Source Material: Exempt Concentrations
333‑102‑0015
Exemptions: Certain Items Containing Radioactive Material
333‑102‑0025
Exemptions: Gas and Aerosol Detectors Containing Byproduct Material
333‑102‑0030
Exemptions: Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147
333‑102‑0032
Exemptions: Self Luminous Products and Sources Containing Radium-226
333‑102‑0033
Exemptions: Certain Industrial Devices
333‑102‑0035
Exemptions: Exempt Quantities
333‑102‑0040
Exemptions: In Vivo Testing in Humans for H. Pylori Using Carbon-14 Labeled Urea
333‑102‑0075
Licenses: Types of Licenses
333‑102‑0101
General Licenses — Small Quantities of Source Material
333‑102‑0102
General Licenses — Requirements for License to Initially Transfer Source Material for Use Under the Small Quantities of Source Materials General License
333‑102‑0104
General Licenses — Conditions of Licenses to Initially Transfer Source Material for Use Under the ’Small Quantities of Source Material’ General License: Quality Control, Labeling, Safety Instructions, and Records and Reports
333‑102‑0106
General Licenses — Depleted Uranium in Industrial Products and Devices
333‑102‑0110
General Licenses — Radioactive Material Other than Source Material: Luminous Safety Devices for Aircraft
333‑102‑0115
General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices
333‑102‑0120
General Licenses — Radioactive Material Other than Source Material: Ownership of Radioactive Material
333‑102‑0125
General Licenses — Radioactive Material Other than Source Material: Calibration and Reference Sources
333‑102‑0130
General Licenses — Radioactive Material Other than Source Material: General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing
333‑102‑0135
General Licenses — Radioactive Material Other than Source Material: Ice Detection Devices
333‑102‑0190
General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses
333‑102‑0200
General Licenses — Radioactive Material Other than Source Material: General Requirements for the Issuance of Specific Licenses
333‑102‑0203
General Licenses — Radioactive Material Other than Source Material: Definitions
333‑102‑0235
General Licenses — Radioactive Material Other than Source Material: Requirements for License to Manufacture, or Initially Transfer Radioactive Material Contained in Devices Granted a General License Under OAR 333-102-0115
333‑102‑0245
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Introduction of Radioactive Material in Exempt Concentrations into Products or Materials, and Transfer of Ownership or Possession: Requirements for License
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
333‑102‑0250
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under a General License
333‑102‑0255
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Distribution of Radioactive Material in Exempt Quantities
333‑102‑0260
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors
333‑102‑0265
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Special Requirements for the Manufacture, Assembly or Repair of Luminous Safety Devices for Use in Aircraft
333‑102‑0270
Special Requirements for License to Manufacture Calibration Sources Containing Americium-241, Plutonium or Radium-226 for Distribution to Persons Granted a General License by OAR 333-102-0125
333‑102‑0275
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Manufacture and Distribution of Ice Detection Devices
333‑102‑0285
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture, Preparation, or Transfer for Commercial Distribution of Radiopharmaceutical Drugs Containing Byproduct Material for Medical Use Under Division 116
333‑102‑0290
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture and Distribution of Sources or Devices Containing Byproduct Material for Medical Use
333‑102‑0293
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications
333‑102‑0297
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Sealed Source or Device Evaluation
333‑102‑0300
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Issuance of Specific Licenses
333‑102‑0305
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Specific Terms and Conditions of License
333‑102‑0310
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas
333‑102‑0315
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Application for Renewal of Licenses
333‑102‑0320
Amendment of Licenses at Request of Licensee
333‑102‑0325
Authority Action on Applications to Renew and Amend
333‑102‑0327
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Specifically Licensed Items — Registration of Product Information
333‑102‑0330
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Transfer of Material
333‑102‑0335
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Modification, Revocation and Termination of Licenses
333‑102‑0340
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Reciprocal Recognition of Licenses
333‑102‑0345
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Special Procedures in Regulatory Review
333‑102‑0350
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Reporting Requirements
333‑102‑0355
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Records
333‑102‑0360
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Right to Cause the Withholding or Recall of Byproduct Material
333‑102‑0365
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Third Party Method
333‑102‑0900
Transport: Special Requirements for Specific Licenses of Broad Scope
333‑102‑0910
Transport: Specific Terms and Conditions for Broad Licenses
Last Updated

Jun. 8, 2021

Rule 333-102-0247’s source at or​.us