10 CFR 32.32 - Conditions of licenses issued under

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§ 32.32 Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer.
Each person licensed under § 32.30 shall:
(a) Carry out adequate control procedures in the manufacture of the device to ensure that each production lot meets the quality control standards approved by the Commission;
(b) Label or mark each device and its point-of-sale package so that:
(1) Each item has a durable, legible, readily visible label or marking on the external surface of the device containing:
(i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”;
(ii) The name of the radionuclide(s) and quantity(ies) of activity;
(iii) An identification of the person licensed under § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and
(iv) Instructions and precautions necessary to assure safe installation, operation, and servicing of the device (documents such as operating and service manuals may be identified in the label and used to provide this information).
(2) The external surface of the point-of-sale package has a legible, readily visible label or marking containing:
(i) The name of the radionuclide and quantity of activity;
(ii) An identification of the person licensed under § 32.30 to transfer the device for use under § 30.22 of this chapter or equivalent regulations of an Agreement State; and
(iii) The following or a substantially similar statement: “THIS DEVICE CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NUCLEAR REGULATORY COMMISSION SAFETY CRITERIA IN 10 CFR 32.31. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.”
(3) Each device and point-of-sale package contains such other information as may be required by the Commission; and
(c) Maintain records of all transfers and file a report with the Director of the Office of Federal and State Materials and Environmental Management Programs by an appropriate method listed in § 30.6(a) of this chapter, including in the address: ATTN: Document Control Desk/Exempt Distribution.
(1) The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee.
(2) The report must indicate that the devices are transferred for use under § 30.22 of this chapter or equivalent regulations of an Agreement State.
(3) The report must include the following information on devices transferred to other persons for use under § 30.22 or equivalent regulations of an Agreement State:
(i) A description or identification of the type of each device and the model number(s);
(ii) For each radionuclide in each type of device and each model number, the total quantity of the radionuclide; and
(iii) The number of units of each type of device transferred during the reporting period by model number.
(4)
(i) The licensee shall file the report, covering the preceding calendar year, on or before January 31 of each year.
(ii) Licensees who permanently discontinue activities authorized by the license issued under § 32.30 shall file a report for the current calendar year within 30 days after ceasing distribution.
(5) If no transfers of byproduct material have been made under § 32.30 during the reporting period, the report must so indicate.
(6) The licensee shall maintain the record of a transfer for a period of one year after the transfer is included in a report to the Commission.
[77 FR 43692, July 25, 2012]

Title 10 published on 2014-01-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 10 published on 2014-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 10 CFR 32 after this date.

  • 2014-09-22; vol. 79 # 183 - Monday, September 22, 2014
    1. 79 FR 56524 - Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments; Correction
      GPO FDSys XML | Text
      NUCLEAR REGULATORY COMMISSION
      Proposed rule; correction.
      This correction is effective on September 22, 2014. Submit comments on the information collection aspects of the proposed rule by October 22, 2014.
      10 CFR Parts 30, 32 and 35