[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR35.12]

[Page 570-571]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL--Table of Contents
 
                     Subpart A--General Information
 
Sec. 35.12  Application for license, amendment, or renewal.

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

[[Page 571]]

    (b) An application for a license for medical use of byproduct 
material as described in Sec. Sec. 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 Sec. Sec. 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 Sec. Sec. 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 Sec. 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 Sec. 
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]