Nev. Admin. Code § 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.
Notes
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