Current through Register No. 40, October 3, 2024
(a) An application
for a license to manufacture or initially distribute sealed sources or devices
containing sealed sources for initial transfer to persons having a specific
license to receive such sealed sources or devices shall be approved subject to
the following conditions:
(1) The applicant
satisfies the general requirements specified in
He-P
4030.09; and
(2) The licensee subject to
He-P
4032.11 shall not transfer a sealed source or device
containing a sealed source to any person except in accordance with the
requirements of He-P 4030.16.
(b) Any manufacturer or initial
distributor of a sealed source or device containing a sealed source whose
product is intended for use under a specific license may submit a request to
DHHS/RHS for evaluation of radiation safety information about its product and
for its registration, as follows:
(1) A
request for evaluation of a sealed source or device containing a sealed source
shall be submitted in duplicate and shall include information required by
He-P
4032.11(b) (2) or (b) (3), as
applicable, demonstrating that the radiation safety properties of such source
or device will not endanger public health and safety or property;
(2) A request for evaluation of a sealed
source shall include the following radiation safety information:
a. Proposed uses for the sealed
source;
b. Chemical and physical
form and maximum quantity of byproduct material in the sealed source;
c. Details of design of the sealed source,
radiation and its shielding including blueprints, engineering drawings, or
annotated drawings;
d. Details of
construction of the sealed source including a description of materials used in
construction;
e. Radiation profile
of a prototype sealed source;
f.
Procedures for and results of prototype testing;
g. Details of quality control procedures to
be followed in manufacture;
h. A
description or facsimile of labeling to be affixed to the sealed
source;
i. Leak testing procedures;
and
j. Any additional information,
including experimental studies and tests, required by DHHS/RHS to facilitate a
determination of the safety of the sealed source, as required by
He-P
4030.09;
(3) A request for evaluation of a device
containing a sealed source shall include the following radiation safety
information:
a. Proposed uses for the
device;
b. Manufacturer, model
number, chemical and physical form, and maximum quantity of radioactivity in
the sealed source or sources to be used in the device;
c. Details of design of the sealed source,
including blueprints, engineering drawings, or annotated drawings;
d. Details of construction of the sealed
source, including a description of materials used in construction;
e. Radiation profile of a prototype
device;
f. Procedures for and
results of prototype testing;
g.
Details of quality control procedures to be followed in manufacture;
h. A description or facsimile of labeling to
be affixed to the device;
i. Leak
testing procedures;
j. A
description of potential hazards in installation, service, manufacture,
handling, use, and operation of the device;
k. Information about installation, service,
and maintenance procedures;
l.
Handling, operating, and safety instructions; and
m. Any additional information, including
experimental studies and tests, required by DHHS/RHS to facilitate a
determination of the safety of the device as required by
He-P
4030.09;
(4) The person submitting a request for
evaluation of a product shall manufacture and distribute the product in
accordance with:
a. The statements and
representations, including the quality control program, described in the
request; and
b. The provisions of
the evaluation sheet prepared by DHHS/RHS and submitted to the U.S. Department
of Health and Human Services, for filing in the "Radioactive Material Reference
Manual" or in the U.S. Nuclear Regulatory Commission, for filing in the
"Registry of Radioactive Sealed Sources and Devices." and
(5) The request for review shall be mailed to
DHHS/RHS office, "ATTN: SSDR".
(c) DHHS/RHS shall apply the radiation safety
criteria described in 10 CFR
32.210(d) .
(d) After completion of the evaluation,
DHHS/RHS shall issue a certificate of registration to the applicant described
in 10 CFR
32.210(e) .
(e) Authority to manufacture or initially
distribute a sealed source or device to specific licensees shall be provided in
the license without the issuance of a certificate of registration described in
10 CFR
32.210(g) .
(f) After the certificate is issued, DHHS/RHS
shall conduct an additional review described in 10 CFR.32.210(h) .
(g) When inactivating certificates of
registration of sealed sources and devices, DHHS/RHS shall apply the
inactivation criteria described in
10 CFR
32.211.
(See Revision Note at part heading for He-P 4032) #6942,
eff 2-1-99; ss by #8800, INTERIM, eff 2-1-07, EXPIRED: 7-31-07
