10-144-220 Me. Code R. § G-A-12

Current through 2024-51, December 18, 2024

Section 144-220-G-A-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 radioactive material as described in G.100, G.200, G.300, G.400, G.500, G.600, and G.1000 must be made by:

(1) Filing the appropriate HHE Form 850, "Application for Material License" that includes the facility diagram, equipment, and training and experience qualifications of the radiation safety officer, associate radiation safety officer(s), authorized user(s), authorized medical physicist(s), ophthalmic physicist(s), and authorized nuclear pharmacist(s); and

(2) Submitting procedures required by G.610, G.642, G.643 and G.645, as applicable.

C. A request for a license amendment or renewal must be made by:

(1) Submitting an original of either HHE Form 850, "Application for a Radioactive Material License" or a letter containing all information required by HHE Form 850; and

(2) Submitting procedures required by G.610, G.642, G.643, and G.645, as applicable.

D. In addition to the requirements in G.12.A, G.12.B and G.12.C, an application for a license or amendment for medical use of radioactive material as described in G.1000 must also include:

(1) Any additional aspects of the medical use of the material that are applicable to radiation safety that are not addressed in, or differ from, subparts A through C, L, and M of this part;

(2) Identification of and commitment to follow the applicable radiation safety program requirements in subparts D through H of this part that are appropriate for the specific G.1000 medical use;

(3) Any additional 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; and

(4) Any other information requested by the Agency in its review of the application.

E. An applicant that satisfies the requirements specified in Part C.10.B may apply for a Type A specific license of broad scope.

10-144 C.M.R. ch. 220, § G-A-12