Tenn. Comp. R. & Regs. 0400-20-07-.11

Current through June 26, 2024

Section 0400-20-07-.11 - APPLICATION FOR LICENSE, AMENDMENT, OR RENEWAL

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

(2) An application for a license for medical use of radioactive material as described in Rules 0400-20-07-.38, 0400-20-07-.40, 0400-20-07-.44, 0400-20-07-.51, 0400-20-07-.61, 0400-20-07-.63, and 0400-20-07-.81 must be made by:

(a) Filing with the Division the original application in duplicate on a form prescribed by the Division 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

(b) Submitting applicable procedures required by Rules 0400-20-07-.66, 0400-20-07-.72, 0400-20-07-.73, and 0400-20-07-.74.

(3) A request for a license amendment or renewal must be made by:

(a) Submitting an original of either:

1. A completed Form CN 0716, "Application for Radioactive Material License"; or

2. A letter containing all information required by Form CN 0716; and

(b) Submitting applicable procedures required by Rules 0400-20-07-.66, 0400-20-07-.72, 0400-20-07-.73, and 0400-20-07-.74.

(4) In addition to the requirements in paragraphs (2) and (3) of this rule, an application for a license or amendment for medical use of radioactive material as described in Rule 0400-20-07-.81 must also include:

(a) Information regarding any additional radiation safety aspects of the medical use of the material that is not addressed in this Chapter;

(b) Identification of, and commitment to follow, the applicable radiation safety program requirements in this Chapter that are appropriate for the specific Rule 0400-20-07-.81 medical use; and

(c) Any additional specific information on:

1. Radiation safety precautions and instructions;

2. Training and experience of proposed users;

3. Methodology for measurement of dosages or doses to be administered to patients or human research subjects; and

4. Calibration, maintenance, and repair of instruments and equipment necessary for radiation safety.

(d) An applicant or licensee shall also provide any other information requested by the Division in its review of the application.

(e) An applicant that satisfies the requirements specified in paragraph (4) of Rule 0400-20-10-.13 may apply for a specific license of broad scope.

Tenn. Comp. R. & Regs. 0400-20-07-.11

Original rule filed February 22, 2012; effective May 22, 2012. Amendments filed December 4, 2023; effective 3/3/2024.

Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.