[Code of Federal Regulations]
[Title 10, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 10CFR32.210]

[Page 526-527]
 
                            TITLE 10--ENERGY
 
                CHAPTER I--NUCLEAR REGULATORY COMMISSION
 
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL--Table of Contents
 
                 Subpart D--Specifically Licensed Items
 
Sec. 32.210  Registration of product information.


    (a) 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 NRC

[[Page 527]]

for evaluation of radiation safety information about its product and for 
its registration.
    (b) The request for review must be made in duplicate and sent to the 
U.S. Nuclear Regulatory Commission; Division of Industrial and Medical 
Nuclear Safety; Medical, Academic, and Commercial Use Safety Branch; 
Washington, DC 20555.
    (c) The request for review of a sealed source or a device must 
include sufficient information about the design, manufacture, prototype 
testing, quality control program, labeling, proposed uses and leak 
testing and, for a device, the request must also include sufficient 
information about installation, service and maintenance, operating and 
safety instructions, and its potential hazards, to provide reasonable 
assurance that the radiation safety properties of the source or device 
are adequate to protect health and minimize danger to life and property.
    (d) The NRC normally evaluates a sealed source or a device using 
radiation safety criteria in accepted industry standards. If these 
standards and criteria do not readily apply to a particular case, the 
NRC formulates reasonable standards and criteria with the help of the 
manufacturer or distributor. The NRC shall use criteria and standards 
sufficient to ensure that the radiation safety properties of the device 
or sealed source are adequate to protect health and minimize danger to 
life and property.
    (e) After completion of the evaluation, the Commission issues a 
certificate of registration to the person making the request. The 
certificate of registration acknowledges the availability of the 
submitted information for inclusion in an application for a specific 
license proposing use of the product.
    (f) The person submitting the request for evaluation and 
registration of safety information about the product shall manufacture 
and distribute the product in accordance with--
    (1) The statements and representations, including quality control 
program, contained in the request; and
    (2) The provisions of the registration certificate.

[52 FR 27786, July 24, 1987, as amended at 60 FR 24551, May 9, 1995]