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[Federal Register Volume 73, Number 180 (Tuesday, September 16, 2008)]
[Notices]
[Page 53451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21564]

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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 10.8, 
Revision 3.

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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 [email protected].

SUPPLEMENTARY INFORMATION:

I. Introduction

    The U.S. Nuclear Regulatory Commission (NRC) is issuing a revision 
to an existing guide 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 3 of Regulatory Guide 10.8, ``Guide for the Preparation of 
Applications for Medical Use Programs,'' was previously issued with a 
temporary identification as Draft Regulatory Guide, DG-0018 and an 
opportunity for public comments. This regulatory guide directs the 
reader to the type of information acceptable to the NRC staff for 
review of an application for a medical use license. Title 10, Part 35, 
``Medical Use of Byproduct Material,'' of the Code of Federal 
Regulations (10 CFR Part 35) regulates the medical use of byproduct 
material. In addition to the requirements of 10 CFR Part 35, medical 
use licensees may be subject to those portions of 10 CFR Part 20, 
``Standards for Protection Against Radiation,'' that relate to 
radiation safety and the sections of 10 CFR Part 30, ``Rules of General 
Applicability to Domestic Licensing of Byproduct Material,'' that 
relate to licensing and the noncommercial transfer of specific 
radioactive drugs to medical use licensees within a consortium.
    This regulatory guide endorses the methods and procedures for 
medical licensing applications contained in the current revision of 
NUREG-1556, Volume 9, ``Consolidated Guidance about Material Licenses: 
Program-Specific Guidance about Medical Use Licenses,'' as a process 
that the NRC staff finds acceptable for meeting the regulatory 
requirements.

II. Further Information

    In April 2008, DG-0018 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 June 30, 2008. Electronic 
copies of Regulatory Guide 10.8, Revision 3 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 10th day of September 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. E8-21564 Filed 9-15-08; 8:45 am]
BILLING CODE 7590-01-P
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