Tenn. Comp. R. & Regs. 0400-20-10-.11 - FILING OF APPLICATION FOR SPECIFIC LICENSES

(1) Application for specific licenses shall be filed in duplicate on a form prescribed by the Division.

(2) The Division may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the Division to determine whether the application should be granted or denied or whether a license should be modified or revoked.

(3) Each application shall be signed by the applicant or licensee or a person duly authorized to act for and on his behalf.

(4) An application for a license may include a request for a license authorizing one or more activities.

(5) In his application, the applicant may incorporate by reference information contained in previous applications, statements or reports filed with the Division provided such references are specific.

(6) Applications and documents submitted to the Division may be made available for public inspection except that the Division may withhold any document or part thereof from public inspection if disclosure of its contents involves proprietary information.

(7)

(a) An application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source shall either:

1. Identify the source or device by manufacturer and model number as registered with the NRC under 10 CFR 32.210 or with an Agreement State or for a source or a device containing radium-226 or accelerator-produced radioactive material with an Agreement State under provisions comparable to 10 CFR 32.210; or

2. Contain the information identified in 10 CFR 32.210(c).

(b) For sources or devices manufactured prior to September 12, 2017, that are not registered with the NRC under 10 CFR 32.210 or with an Agreement State, and for which the applicant is unable to provide all categories of information specified in 10 CFR 32.210(c), the applicant must provide:

1. All available information identified in 10 CFR 32.210(c) concerning the source, and, if applicable, the device; and

2. Sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information must include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.

(c) For sealed sources and devices allowed to be distributed without registration of safety information in accordance with part (18)(g)1 of Rule 0400-20-10-.13, the applicant may supply only the manufacturer, model number, and radionuclide and quantity.

(d) If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device.

(8) An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Chapter 0400-20-07 or equivalent Agreement State requirements shall include:

(a) A request for authorization for the production of PET radionuclides or evidence of an existing license issued under this Chapter or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides;

(b) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in part (10)(a)2 of Rule 0400-20-10-.13;

(c) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in part (10)(b)2 of Rule 0400-20-10-.13; and

(d) Information identified in part (10)(a)3 of Rule 0400-20-10-.13 on the PET drugs to be noncommercially transferred to members of its consortium.

Notes

Tenn. Comp. R. & Regs. 0400-20-10-.11

Original rule filed February 22, 2012; effective May 22, 2012. Amendments to rules 0400-20-04.04, 0400-20-05-.70, 0400-20-10-.04, 0400-20-10-.10 through 044-20-10-.13, 0400-20-10-.21, 0400-2010-.33, 0400-20-10-.36, 0400-20-10-.38, and original rules 0400-20-13-.01 through 0400-20-13-.08 filed June 14, 2017; effective September 12, 2017. Amendments filed September 1, 2021; effective 11/30/2021.

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