[Federal Register: July 21, 2008 (Volume 73, Number 140)]
[Notices]
[Page 42377]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21jy08-92]

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NUCLEAR REGULATORY COMMISSION


Notice of Issuance of Regulatory Guide

AGENCY: Nuclear Regulatory Commission.

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

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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 Mark.Orr@nrc.gov.

SUPPLEMENTARY INFORMATION:

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
requirements.

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 pdr@nrc.gov.
    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]

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