United States Nuclear Regulatory Commission - Protecting People and the Environment
Home > NRC Library > Document Collections > NRC Regulations (10 CFR) > Part Index > § 35.12 Application for license, amendment, or renewal.

§ 35.12 Application for license, amendment, or renewal.

(a) An application must be signed by the applicant's or licensee's management.

(b) An application for a license for medical use of byproduct material as described in §§ 35.100, 35.200, 35.300, 35.400, 35.500, 35.600, and 35.1000 must be made by--

(1) Filing an original and one copy of NRC Form 313, "Application for Material License," that includes the facility diagram, equipment, and training and experience qualifications of the Radiation Safety Officer, authorized user(s), authorized medical physicist(s), and authorized nuclear pharmacist(s); and

(2) Submitting procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable.

(c) A request for a license amendment or renewal must be made by--

(1) Submitting an original and one copy of either--

(i) NRC Form 313, "Application for Material License"; or

(ii) A letter requesting the amendment or renewal; and

(2) Submitting procedures required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable.

(d) In addition to the requirements in paragraphs (b) and (c) of this section, an application for a license or amendment for medical use of byproduct material as described in § 35.1000 must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in Subparts A through C of this part.

(1) The applicant shall also provide specific information on--

(i) Radiation safety precautions and instructions;

(ii) Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and

(iii) Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.

(2) The applicant or licensee shall also provide any other information requested by the Commission in its review of the application.

(e) An applicant that satisfies the requirements specified in § 33.13 of this chapter may apply for a Type A specific license of broad scope.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002]

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