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Electronic Code of Federal Regulations

e-CFR data is current as of June 2, 2020

Title 10Chapter IPart 35Subpart A → §35.13


Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart A—General Information


§35.13   License amendments.

A licensee shall apply for and must receive a license amendment—

(a) Before it receives, prepares, or uses byproduct material for a type of use that is permitted under this part, but is not authorized on the licensee's current license issued under this part; except that—

(1) A Government agency or a Federally recognized Indian Tribe licensee who possesses and uses accelerator-produced radioactive material or discrete sources of radium-226 may continue to use such material for medical uses permitted under this part until the date of the NRC's final licensing determination, provided that the licensee submits an amendment application on or before June 2, 2008.

(2) Except as provided in paragraph (a)(1) of this section, all other licensees who possess and use accelerator-produced radioactive material or discrete sources of radium-226 may continue to use those materials for medical uses permitted under this part until the date of the NRC's final licensing determination, provided that the person submits a medical use license amendment request within 6 months from the waiver expiration date of August 7, 2009 or within 6 months from the date of an earlier termination of the waiver as noticed by the NRC, whichever date is earlier.

(b) Before it permits anyone to work as an authorized user, authorized medical physicist, ophthalmic physicist, or authorized nuclear pharmacist under the license, except—

(1) For an authorized user, an individual who meets the requirements in §§35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a);

(2) For an authorized nuclear pharmacist, an individual who meets the requirements in §§35.55(a) and 35.59;

(3) For an authorized medical physicist, an individual who meets the requirements in §§35.51(a) and 35.59;

(4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, authorized medical physicist, or an ophthalmic physicist—

(c) Before it changes Radiation Safety Officers, except as provided in §35.24(c);

(d) Before it permits anyone to work as an Associate Radiation Safety Officer, or before the Radiation Safety Officer assigns duties and tasks to an Associate Radiation Safety Officer that differ from those for which this individual is authorized on the license;

(e) Before it receives byproduct material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;

(f) Before it adds to or changes the areas of use identified in the application or on the license, including areas used in accordance with either §35.100 or §35.200 if the change includes addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from the PET radionuclide/PET radioactive drug production area. Other areas of use where byproduct material is used only in accordance with either §35.100 or §35.200 are exempt;

(g) Before it changes the address(es) of use identified in the application or on the license;

(h) Before it revises procedures required by §§35.610, 35.642, 35.643, and 35.645, as applicable, where such revision reduces radiation safety; and

(i) Before it receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15008, Mar. 27, 2006; 72 FR 55930, Oct. 1, 2007; 83 FR 33102, July 16, 2018]

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