Rule 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, associate radiation safety officer(s), authorized user(s), authorized medical physicist(s), ophthalmic 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:
(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, rules 3701:1-58-01 to 3701:1-58-31, 3701:1-58-73 to 3701:1-58-103, and 3701:1-58-105 of the Administrative Code;
(2) Identification of and commitment to follow the applicable radiation safety program requirements in rules 3701:1-58-32 to 3701:1-58-71 and 3701:1-58-104 of the Administrative Code that are appropriate for the specific rule 3701:1-58-72 of the Administrative Code medical use;
(3) Any additional 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; and
(4) 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.
Last updated November 18, 2022 at 8:28 AM
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