459.236 - Specific licenses: Application
459.236. Specific licenses: Application
1. Applications for specific licenses must be filed on a form prescribed by the Division and accompanied by the appropriate fee as prescribed in NAC 459.310.
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 must be signed by the applicant or licensee or a person duly authorized to act for and on his or her behalf.
4. An application for a license may include a request for a license authorizing one or more activities.
5. In his or her application, the applicant may incorporate by reference information contained in previous applications, statements or reports filed with the Division provided such references are clear and 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 content is not required in the public interest and would adversely affect the interest of a person concerned.
7. Except as otherwise provided in subsection 8, an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains a sealed source must:
(a) Identify the source or device by manufacturer and model number as registered with the Nuclear Regulatory Commission, or for a source or device which contains radium-226 or accelerator-produced radioactive material, pursuant to the provisions of NAC 459.289, 459.2895 or 459.3075 or 10 C.F.R. § 32.210 or registered with an agreement state pursuant to an equivalent regulation of the agreement state;
(b) Contain the information identified in NAC 459.289, 459.2895 or 459.3075, 10 C.F.R. § 32.210 or an equivalent regulation of an agreement state; or
(c) For a source or device which contains naturally occurring or accelerator-produced radioactive material which was manufactured before May 7, 2010, which is not registered with the Division pursuant to NAC 459.3075, the Nuclear Regulatory Commission pursuant to 10 C.F.R. § 32.210 or an agreement state pursuant to an equivalent regulation of the agreement state, and for which the applicant cannot provide all the information specified in 10 C.F.R. § 32.210(c):
(1) Include all available information identified in 10 C.F.R. § 32.210(c) which concerns the source and, if applicable, the device; and
(2) Include sufficient additional information to demonstrate with reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property, including, without limitation, a description of the source or device, a description of the radiation safety features, the intended use and associated operating experience of the licensee and the results of a recent leak test of the source or device.
8. An application for a specific license described in subsection 7:
(a) For a sealed source and device which is allowed to be distributed without registration of safety information in accordance with 10 C.F.R. § 32.210(g)(1), must include only the manufacturer, model number and radionuclide and quantity; and
(b) For which it is not feasible for the applicant to identify each sealed source and device individually, may include constraints proposed by the applicant on the number and type of sealed sources and devices to be used and the conditions under which the sealed sources and devices will be used, in lieu of identifying each sealed source and device.
9. If applicable pursuant to NAC 459.1955, an application for a specific license must contain a proposed plan for financing decommissioning or a certification of financial assurance for decommissioning.
10. An application from a medical facility or educational institution to produce positron emission tomography radioactive drugs for noncommercial distribution to its licensees in its consortium authorized for use pursuant to the provisions of 10 C.F.R. Part 35 or an equivalent regulation of an agreement state must include:
(a) A request for authorization for the production of positron emission tomography radionuclides or evidence of an existing license for a positron emission tomography radionuclide production facility within its consortium, which is issued pursuant to NAC 459.180 to 459.313, inclusive, and sections 7 to 27, inclusive,, or an equivalent regulation in an agreement state from which it receives positron emission tomography radionuclides;
(b) Evidence that the applicant is qualified to produce radioactive drugs for medical use pursuant to NAC 459.300 or 10 C.F.R. § 32.72(a)(2);
(c) Identification of each person authorized to prepare the positron emission tomography radioactive drugs if the applicant is a pharmacy, and documentation that each meets the requirements of an authorized nuclear pharmacist pursuant to 10 C.F.R. § 32.72(b)(2); and
(d) Information set forth in 10 C.F.R. § 32.72(a)(3) concerning the positron emission tomography drugs to be noncommercially transferred to the members of its consortium.
Bd. of Health, Radiation Control Reg. §§ 3.5-126.96.36.199, eff. 2-28-80-NAC A 9-1-89; R085-06, 11-13-2006; R185-08, 5-7-2010; A by R144-13A, eff. 10-13-2016
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