[Federal Register Volume 73, Number 140 (Monday, July 21, 2008)]
[Page 42377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16577]



Notice of Issuance of Regulatory Guide

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of Issuance and Availability of Regulatory Guide 6.2, 
Revision 2


FOR FURTHER INFORMATION CONTACT: Mark Orr, Regulatory Guide Development 
Branch, Division of Engineering, Office of Nuclear Regulatory Research, 
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, 
telephone (301) 415-6373 or e-mail to [email protected].


I. Introduction

    The U.S. Nuclear Regulatory Commission (NRC) has issued revisions 
to existing guides in the agency's ``Regulatory Guide'' series. This 
series was developed to describe and make available to the public 
information such as methods that are acceptable to the NRC staff for 
implementing specific parts of the agency's regulations, techniques 
that the staff uses in evaluating specific problems or postulated 
accidents, and data that the staff needs in its review of applications 
for permits and licenses.
    Revision 2 of Regulatory Guide 6.2, ``Integrity and Test 
Specifications for Selected Brachytherapy Sources,'' was issued with a 
temporary identification as Draft Regulatory Guide DG-6004. This guide 
directs the reader to the type of information acceptable to the NRC 
staff to evaluate the integrity and test specifications for selected 
brachytherapy sources. The manufacture of brachytherapy sources 
containing byproduct material requires a license pursuant to Title 10, 
section 30.3, ``Activities Requiring License,'' of the Code of Federal 
Regulations (10 CFR 30.3). Brachytherapy sources manufactured under 
such a license must meet certain integrity requirements and pass 
certain tests. The regulation at 10 CFR 32.74(a)(2)(iii) requires that 
an application for a specific license to manufacture and distribute 
brachytherapy sources and devices containing byproduct material include 
a description of the procedures for, and results of, prototype tests 
performed to demonstrate that the source or device will maintain its 
integrity under stresses likely to be encountered in normal use and 
accidents. Additionally, 10 CFR 32.74(a)(2)(v) requires that the 
application also include details of quality control procedures to 
ensure that production sources and devices meet the standards of the 
design and prototype tests.
    This regulatory guide endorses the methods and procedures for 
integrity and test specifications of selected brachytherapy sources 
contained in the current revisions of NUREG-1556, Volume 3, 
``Consolidated Guidance about Materials Licenses: Applications for 
Sealed Source and Device Evaluation and Registration'' and NUREG-1556, 
Volume 9, ``Consolidated Guidance about Materials Licenses: Program-
Specific Guidance about Medical Use Licenses'' as a process that the 
NRC staff has found to be acceptable for meeting the regulatory 

II. Further Information

    In December 2007, DG-6004 was published with a public comment 
period of 60 days from the issuance of the guide. No comments were 
received and the public comment period closed on April 18, 2008. 
Electronic copies of Regulatory Guide 6.2, Revision 2 are available 
through the NRC(s public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/.
    In addition, regulatory guides are available for inspection at the 
NRC's Public Document Room (PDR), which is located at Room O-1F21, One 
White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852-
2738. The PDR's mailing address is USNRC PDR, Washington, DC 20555-
0001. The PDR can also be reached by telephone at (301) 415-4737 or 
(800) 397-4209, by fax at (301) 415-3548, and by e-mail to [email protected].
    Regulatory guides are not copyrighted, and NRC approval is not 
required to reproduce them.

    Dated at Rockville, Maryland, this 11th day of July, 2008.

    For the Nuclear Regulatory Commission.
Stephen C. O'Connor,
Acting Chief, Regulatory Guide Development Branch, Division of 
Engineering, Office of Nuclear Regulatory Research.
[FR Doc. E8-16577 Filed 7-18-08; 8:45 am]