Notice of Issuance of Regulatory Guide, 53451 [E8-21564]

Download as PDF Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 / Notices [FR Doc. E8–21565 Filed 9–15–08; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION Notice of Issuance of Regulatory Guide Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 10.8, Revision 3. AGENCY: II. Further Information 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: ebenthall on PROD1PC60 with NOTICES 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. VerDate Aug<31>2005 13:43 Sep 15, 2008 Jkt 214001 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: ProgramSpecific Guidance about Medical Use Licenses,’’ as a process that the NRC staff finds acceptable for meeting the regulatory requirements. 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 https://www.nrc.gov/reading-rm/doccollections/. 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.resource@nrc.gov. 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 NUCLEAR REGULATORY COMMISSION Docket No. 50–243 Oregon State University Research Reactor; Notice of Issuance of Renewed Facility License No. R–106 The U.S. Nuclear Regulatory Commission (NRC or the Commission) has issued renewed Facility License No. R–106, held by Oregon State University (the licensee), which authorizes continued operation of the Oregon State University TRIGA reactor (OSTR), located in Corvallis, Benton County, Oregon. The OSTR is a pool-type, lightwater-moderated-and-cooled research reactor licensed to operate at a steady- PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 53451 state thermal power level of 1.1 megawatts. Renewed Facility License No. R–106 will expire at midnight 20 years from its date of issuance. The renewed license complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission’s rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission’s regulations in Title 10, Chapter 1, ‘‘Nuclear Regulatory Commission,’’ of the Code of Federal Regulations (CFR), and sets forth those findings in the renewed license. The agency afforded an opportunity for hearing in the Notice of Opportunity for Hearing published in the Federal Register on June 14, 2007, at 72 FR 32922. The NRC received no request for a hearing or petition for leave to intervene following this notice. The NRC staff prepared a safety evaluation report for the renewal of Facility License No. R–106 and concluded, based on that evaluation, that the licensee can continue to operate the facility without endangering the health and safety of the public. The NRC staff also prepared an environmental assessment for license renewal, noticed in the Federal Register on September 8, 2008, at 73 FR 52072, and concluded, based on that assessment, that renewal of the license will not have a significant impact on the quality of the human environment. The NRC maintains the Agencywide Documents Access and Management System (ADAMS), which provides text and image files of the NRC’s public documents. For details with respect to the application for renewal, see the licensee’s letter dated October 5, 2004 (ADAMS Accession Nos. ML043270077 and ML07430452), as supplemented by letters dated August 8, 2005 (ADAMS Accession No. ML052290051), May 24, 2006 (ADAMS Accession No. ML061510355), November 10, 2006 (ADAMS Accession No. ML063210182), November 21, 2006 (ADAMS Accession No. ML063320500), July 10, 2007 (ADAMS Accession Nos. ML072150361 and ML072150362), July 27, 2007 (ADAMS Accession No. ML072150363), July 31, 2007 (ADAMS Accession No. ML072190043), August 6, 2007 (ADAMS Accession No. ML072340580), April 14, 2008 (ADAMS Accession No. ML081150194), August 6, 2008 (ML082261409), and August 11, 2008 (ML082270383). The dates and associated ADAMS accession numbers of NRC requests for additional information are May 15, 2006 (ADAMS Accession No. ML061310209), October 3, 2006 (ADAMS Accession No. ML062060026), May 21, 2007 (ADAMS E:\FR\FM\16SEN1.SGM 16SEN1

Agencies

[Federal Register Volume 73, Number 180 (Tuesday, September 16, 2008)]
[Notices]
[Page 53451]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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) 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 https://
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.resource@nrc.gov.
    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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