3701:1-58-07. Application for license, amendment or renewal

(A) An application must be signed by the applicant's or licensee's management as defined in rule 3701:1-38-01 of the Administrative Code.

(B) An application for a license for medical use of radioactive material as described in rules 3701:1-58-32, 3701:1-58-34, 3701:1-58-37, 3701:1-58-43, 3701:1-58-53, 3701:1-58-55, and 3701:1-58-72 of the Administrative Code must be made by:

(1) Submitting documentation in accordance with rule 3701:1-40-14 of the Administrative Code, and including 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);

(2) Submitting the appropriate license fees listed in rule 3701:1-38-02 of the Administrative Code after receiving an invoice from the department; and

(3) Submitting procedures required by rules 3701:1-58-58 and 3701:1-58-64 to 3701:1-58-66 of the Administrative Code, as applicable.

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

(1) Submitting documentation in accordance with rule 3701:1-40-14 of the Administrative Code;

(2) Submitting the appropriate license or amendment fees listed in rule 3701:1-38-02 of the Administrative Code after receiving an invoice from the department; and

(3) Submitting procedures required by rules 3701:1-58-58 and 3701:1-58-64 to 3701:1-58-66 of the Administrative Code, as applicable.

(D) In addition to the requirements in paragraphs (B) and (C) of this rule, an application for a license or amendment for medical use of radioactive material as described in rule 3701:1-58-72 of the Administrative Code must also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in rules 3701:1-58-01 to 3701:1-58-31 of the Administrative Code.

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

(a) Radiation safety precautions and instructions;

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

(c) 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 director in review of the application.

(E) An applicant that satisfies the requirements specified in rule 3701:1-40-23 of the Administrative Code may apply for a type A specific license of broad scope.

Five Year Review (FYR) Dates: 06/12/2015 and 06/01/2020
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 8/15/2005, 10/4/10

Prior History: (Effective: 10/04/2010
R.C. 119.032 review dates: 06/28/2010 and 07/12/2015
Promulgated Under: 119.03
Statutory Authority: 3748.02, 3748.04
Rule Amplifies: 3748.04
Prior Effective Dates: 8/15/2005 )