Or. Admin. Code § 333-116-0035

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-116-0035 - Application for License, Amendment, or Renewal

(1) An application must be signed by the management of the facility.

(2) An application for a license for medical use of radioactive material as described in OAR 333-116-0300, 333-116-0320, 333-116-0360, 333-116-0400, 333-116-0420 and 333-116-0480 and medical use of byproduct material as described in OAR 333-116-0485 must be made by filing a "Radioactive Materials License Application: Medical." A request for a license amendment or renewal may be submitted in letter format.

(3) Licensing of remote afterloaders as described in OAR 333-116-0480 requires a separate "Radioactive Materials License Application: The Medical License application must be completed and submitted to the Authority. A request for a license amendment or renewal may be submitted in letter format.

(4) An application for a license for medical use of radioactive material as described in OAR 333-116-0800, Licensing and Registration of Positron Emission Tomography (PET) Facilities, must be made by filing a "Radioactive Materials License Application: Medical."

(a) In addition to the information required in the "Radioactive Materials License Application: Medical," the application must also include information regarding any radiation safety aspects of the medical use of the radioactive material that is not addressed in this division, as well as any specific information necessary for:

(A) Radiation safety precautions and instructions;

(B) Training and experience of proposed users;

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

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

(b) The applicant of licensee must also provide any other information requested by the Authority in its review of the application.

NOTE: An applicant that satisfies the requirements specified in OAR 333-102-0900 may apply for a Broad Scope A specific license.

Or. Admin. Code § 333-116-0035

PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807