| (III) clearly identify the specific licensee submitting
the report and include the license number of the specific licensee;
(IV) identify each general licensee by name and mailing
address for the location of use; if there is no mailing address for
the location of use an alternate address for the licensee shall be
submitted along with the information on the actual location of use;
(V) identify an individual by name, position, and phone
number who has knowledge of and authority to take required actions
to ensure compliance with the appropriate regulations and requirements;
(VI) include the type, model and serial number of the
device, and serial number of sealed source commercially distributed;
(VII) include the quantity and type of radioactive
material contained in the device; and
(VIII) include the date of receipt.
(ii) If one or more intermediate persons will temporarily
possess the device at the intended place of use prior to its possession
by the user, the report shall also include the same information for
both the intended user and each intermediate person, and clearly designate
the intermediate person(s).
(iii) If no commercial distributions have been made
to persons in the agreement state during the reporting period, the
report shall so indicate.
(iv) For devices received from a general licensee,
the report shall include the identity of the general licensee by name
and address, the type, model number, and serial number of the device
received, the date of receipt, and, in the case of devices not initially
transferred by the reporting licensee, the name of the manufacturer
or initial transferor; and
(D) make, maintain, and retain records required by
this paragraph for inspection by the agency in accordance with subsection
(mm) of this section, including the name, address, and the point of
contact for each general licensee to whom the licensee directly or
through an intermediate person commercially distributes radioactive
material in devices for use in accordance with the general license
provided in §289.251(f)(4)(H) of this title, or equivalent requirements
of the NRC or any agreement state.
(i) The records shall include the following:
(I) the date of each commercial distribution;
(II) the isotope and the quantity of radioactivity
in each device commercially distributed;
(III) the identity of any intermediate person; and
(IV) compliance with the reporting requirements of
this subsection.
(ii) If no commercial distributions have been made
to persons generally licensed in accordance with §289.251(f)(4)(H)
of this title during the reporting period, the records shall so indicate.
(8) If a notification of bankruptcy has been made in
accordance with subsection (x)(6) of this section or the license is
to be terminated, each person licensed in accordance with this subsection
shall provide, upon request to the NRC and to any appropriate agreement
state, records of final disposition required in accordance with subsection
(y)(16)(A) of this section.
(9) Each device that is transferred after February
19, 2002, shall meet the labeling requirements in accordance with
paragraph (1)(C) - (E) of this subsection.
(m) Specific licenses for the manufacture, assembly,
repair, or initial transfer of luminous safety devices containing
tritium or promethium-147 for use in aircraft for distribution to
persons generally licensed in accordance with §289.251(f)(4)(B)
of this title. In addition to the requirements in subsection (e) of
this section, a specific license to manufacture, assemble, repair,
or initially transfer luminous safety devices containing tritium or
promethium-147 for use in aircraft, for distribution to persons generally
licensed in accordance with §289.251(f)(4)(B) of this title,
will be issued if the agency approves the information submitted by
the applicant. The information shall satisfy the requirements of Title
10, CFR, §§32.53, 32.54, 32.55, and 32.56, or their equivalent.
(n) Specific licenses for the manufacture or initial
transfer of calibration sources containing americium-241 or radium-226
for commercial distribution to persons generally licensed in accordance
with §289.251(f)(4)(D) of this title.
(1) In addition to the requirements in subsection (e)
of this section, a specific license to manufacture or initially transfer
calibration sources containing americium-241, or radium-226 to persons
generally licensed in accordance with §289.251(f)(4)(D) of this
title will be issued if the agency approves the information submitted
by the applicant. The information shall satisfy the requirements of
Title 10, CFR, §§32.57, 32.58, 32.59, and §70.39 or
their equivalent.
(2) Each person licensed in accordance with this subsection
shall perform a dry wipe test on each source containing more than
0.1 µCi (3.7 kilobecquerels (kBq)) of americium-241 or radium-226
before transferring the source to a general licensee in accordance
with §289.251(f)(4)(D) of this title or equivalent regulations
of the NRC or any agreement state. This test shall be performed by
wiping the entire radioactive surface of the source with a filter
paper with the application of moderate finger pressure. The radioactivity
on the filter paper shall be measured by using radiation detection
instrumentation capable of detecting 0.005 µCi (0.185 kBq) of
americium-241 or radium-226. If a source has been shown to be leaking
or losing more than 0.005 µCi (0.185 kBq) of americium-241 or
radium-226 by methods described in this paragraph, the source shall
be rejected and shall not be transferred to a general licensee in
accordance with §289.251(f)(4)(D) of this title or equivalent
regulations of the NRC or any agreement state.
(o) Specific licenses for the manufacture and commercial
distribution of sealed sources or devices containing radioactive material
for medical use. In addition to the requirements in subsection (e)
of this section, a specific license to manufacture and commercially
distribute sealed sources and devices containing radioactive material
to persons licensed in accordance with §289.256 of this title
for use as a calibration, transmission, or reference source or for
use of sealed sources listed in §289.256(q), (rr), (bbb), and
(ddd) of this title will be issued if the agency approves the following
information submitted by the applicant:
(1) an evaluation of the radiation safety of each type
of sealed source or device including the following:
(A) the radioactive material contained, its chemical
and physical form, and amount;
(B) details of design and construction of the sealed
source or device;
(C) procedures for, and results of, prototype tests
to demonstrate that the sealed source or device will maintain its
integrity under stresses likely to be encountered in normal use and
accidents;
(D) for devices containing radioactive material, the
radiation profile of a prototype device;
(E) details of quality control procedures to assure
that production sources and devices meet the standards of the design
and prototype tests;
(F) procedures and standards for calibrating sealed
sources and devices;
(G) instructions for handling and storing the sealed
source or device from the radiation safety standpoint. These instructions
are to be included on a durable label attached to the sealed source
or device or attached to a permanent storage container for the sealed
source or device, provided that instructions that are too lengthy
for the label may be summarized on the label and printed in detail
on a brochure that is referenced on the label; and
(H) a legend and methods for labeling sources and devices
as to their radioactive content;
(2) documentation that the label affixed to the sealed
source or device, or to the permanent storage container for the sealed
source or device, contains information on the radionuclide, quantity,
and date of assay, and a statement that the name of the sealed source
or device is licensed by the agency for commercial distribution to
persons licensed for use of sealed sources in the healing arts or
by equivalent licenses of the NRC or any agreement state;
(3) documentation that in the event the applicant desires
that the sealed source or device be required to be tested for radioactive
material leakage at intervals longer than 6 months, the applicant
shall include in the application sufficient information to demonstrate
that the longer interval is justified by performance characteristics
of the sealed source or device or similar sources or devices and by
design features that have a significant bearing on the probability
or consequences of radioactive material leakage from the sealed source;
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