Current through Register Vol. 48, No. 9, September 27, 2024
2.5.1 Applications for
specific licenses shall be filed on a form prescribed by the Department. The
applicant shall set forth all applicable information called for by the
form.
2.5.2 The Department 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 Department to determine
whether the application should be granted or denied or whether a license should be
modified or revoked. Prelicensing visits may be made to the applicant's facility for
purpose of amplying information furnished in the original application.
2.5.3 Each application shall be signed by the
applicant or licensee or a person duly authorized to act for and on his
behalf.
2.5.4 An application for a
license may include a request for a license authorizing one or more
activities.
2.5.5 In his application,
the applicant may incorporate by reference information contained in previous
applications, statements, or reports filed with the Department provided such
references are clear and specific.
2.5.6
Applications and documents submitted to the Department may be made available for
public inspection except that the Department may withhold upon request, any document
or part thereof from public inspection if disclosure of its contents is not required
in the public interest and would adversely affect the interest of a person
concerned.
2.5.7 Application for a
specific license in form of sealed source.
2.5.7.1
Except as provided in RHA 2.5.7.2, 2.5.7.3, and 2.5.7.4, an application for a
specific license to use byproduct material in the form of a sealed source or in a
device that contains the sealed source must either--
2.5.7.1.1 Identify the source or device by
manufacturer and model number as registered with the Department under
RHA 2.29 or comparable regulation,
or for a source or a device containing radium 226 or accelerator-produced
radioactive material with a State under provisions comparable to
RHA 2.29; or
2.5.7.1.2 Contain the information identified in
RHA 2.29.
2.5.7.2 For sources or devices manufactured before
October 23, 2012 that are not registered with the Commission 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
RHA 2.29, the application must
include:
2.5.7.2.1 All available information
identified in
RHA 2.29 concerning the source,
and, if applicable, the device; and
2.5.7.2.2 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.
2.5.7.3 For sealed sources and devices allowed to
be distributed without registration of safety information in accordance with
RHA 2.29, the applicant may supply
only the manufacturer, model number, and radionuclide and quantity.
2.5.7.4 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.
2.5.8 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 Part 4 of this
Regulation shall include:
2.5.8.1 A request for
authorization for the production of PET radionuclides or evidence of an existing
license issued under Part 2 of this Regulation for a PET radionuclide production
facility within its consortium from which it receives PET radionuclides.
2.5.8.2 Evidence that the applicant is qualified
to produce radioactive drugs for medical use by meeting one of the criteria in Part
2 of this Regulation.
2.5.8.3
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 2 of this
Regulation.
2.5.8.4 Information
identified in Part 2 of this Regulation on the PET drugs to be noncommercially
transferred to members of its consortium.
