[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8909-8910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2946]
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NUCLEAR REGULATORY COMMISSION
NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About
Materials Licenses: Program-Specific Guidance About Medical Use
Licenses''
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of availability.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is announcing the
completion and availability of NUREG-1556, Volume 9, Revision 2,
``Consolidated Guidance About Materials Licenses: Program-Specific
Guidance About Medical Use Licenses,'' dated January 2008.
ADDRESSES: Copies of NUREG-1556, Volume 9, Revision 2, may be purchased
from the Superintendent of Documents, U.S. Government Printing Office,
P.O. Box 37082, Washington, DC 20402-9328; http://www.access.gpo.gov/su
--docs 202-512-1800 or The National Technical Information Service,
Springfield, Virginia 22161-0002; http://www.ntis.gov 1-800-533-6847
or, locally, 703-805-6000.
A copy of the document is also available for inspection and/or
copying for a fee in the NRC Public Document Room (PDR), 11555
Rockville Pike, Rockville, Maryland. Publicly available documents
created or received at the NRC after November 1, 1999, are available
electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/NRC/ADAMS/index.html. From this site, the public can gain
entry into the NRC's Agencywide Document Access and Management System
(ADAMS), which provides text and image files of the NRC's public
documents. The ADAMS Accession Number for NUREG-1556, Volume 9,
Revision 2, is ML073400289. If you do not have access to ADAMS or if
there are problems in accessing the documents located in ADAMS, contact
the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737, or by e-
mail to [email protected]. The document will also be initially posted on the
Office of Federal and State Materials and Environmental Management
Programs' NARM (Naturally-Occurring and Accelerator-Produced
Radioactive Material) Toolbox Web site page at: http://nrc-stp.ornl.gov/narmtoolbox.html under the heading of ``Licensing
Guidance.'' Subsequently, it will be posted on NRC's public Web site
at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556
on the ``Consolidated Guidance About Materials Licenses (NUREG-1556)''
Web site page. Some publications in the NUREG series that are posted at
NRC's Web site address http://www.nrc.gov are updated regularly and may
differ from the last printed version.
A free single copy, to the extent of supply, may be requested by
writing to the Office of the Chief Information Officer, Reproduction
and Distribution Services, U.S. Nuclear Regulatory
[[Page 8910]]
Commission, Printing and Graphics Branch, Washington, DC 20555-0001;
facsimile: 301-415-2289; e-mail: [email protected].
FOR FURTHER INFORMATION CONTACT: Torre Taylor, Division of
Intergovernmental Liaison and Rulemaking, Office of Federal and State
Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
7900, e-mail: [email protected]; or Donna-Beth Howe, Ph.D., Division of
Materials Safety and State Agreements, Office of Federal and State
Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-
7848, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: On August 8, 2005, the President signed into
law the Energy Policy Act of 2005 (EPAct). Among other provisions,
Section 651(e) of the EPAct expanded the definition of byproduct
material as defined in Section 11e. of the Atomic Energy Act of 1954
(AEA), placing additional byproduct material under the NRC's
jurisdiction, and required the Commission to provide a regulatory
framework for licensing and regulating these additional byproduct
materials.
Specifically, Section 651(e) of the EPAct expanded the definition
of byproduct material by: (1) Adding any discrete source of radium-226
that is produced, extracted, or converted after extraction, before, on,
or after the date of enactment of the EPAct for use for a commercial,
medical, or research activity; or any material that has been made
radioactive by use of a particle accelerator and is produced,
extracted, or converted after extraction, before, on, or after the date
of enactment of the EPAct for use for a commercial, medical, or
research activity (Section 11e.(3) of the AEA); and (2) adding any
discrete source of naturally occurring radioactive material, other than
source material, that the Commission, in consultation with the
Administrator of the Environmental Protection Agency, the Secretary of
the Department of Energy, the Secretary of the Department of Homeland
Security, and the head of any other appropriate Federal agency,
determines would pose a threat similar to the threat posed by a
discrete source of radium-226 to the public health and safety or the
common defense and security; and is extracted or converted after
extraction before, on, or after the date of enactment of the EPAct for
use in a commercial, medical, or research activity (Section 11e.(4) of
the AEA).
NRC revised its regulations to provide a regulatory framework that
includes these newly added radioactive materials. See Federal Register
notice 72 FR 55864, dated October 1, 2007. As part of the rulemaking
effort to address the mandate of the EPAct, the NRC also evaluated the
need to revise certain licensing guidance to provide necessary guidance
to applicants in preparing license applications to include the use of
the newly added radioactive materials as byproduct material. Two NUREG-
1556 documents have been revised to provide additional guidance to
licensees: (1) NUREG-1556, Volume 13, Revision 1, ``Consolidated
Guidance About Materials Licenses: Program-Specific Guidance About
Commercial Radiopharmacy Licenses,'' and (2) NUREG-1556, Volume 9,
Revision 2, ``Consolidated Guidance About Materials Licenses: Program-
Specific Guidance About Medical Use Licenses.'' Additionally, a new
NUREG-1556 volume was developed to address production of radioactive
material using an accelerator. This NUREG-1556 volume is entitled:
Volume 21, ``Consolidated Guidance About Materials Licenses: Program-
Specific Guidance About Possession Licenses for Production of
Radioactive Material Using an Accelerator. ``
NUREG-1556, Volume 9, Revision 2, provides guidance for applicants
in preparing their license applications for the medical use of
byproduct material. Volume 9 has been revised primarily to provide
additional guidance related to the NARM rule, including guidance about
consortiums and noncommercial distribution. It is also revised to
clarify training and experience requirements, and to replace NRC Form
313A with six new NRC Form 313A forms specific to types of
authorizations. References and information related to Subpart J of 10
CFR Part 35 have been removed since these regulatory requirements
expired on October 25, 2005. Additionally, other minor changes were
made that are administrative in nature, such as updating the Agreement
State section and updating references. Also, information related to
identifying and protecting sensitive information was updated.
NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About
Materials Licenses: Program-Specific Guidance About Medical Use
Licenses,'' was noticed for public comment on August 2, 2007 (72 FR
42442).
The remaining two NUREG-1556 volumes were noticed for public
comment separately: (1) NUREG-1556, Volume 21, on May 29, 2007 (72 FR
29555), and (2) NUREG-1556, Volume 13, Revision 1, on July 3, 2007 (72
FR 36526). NUREG-1556, Volume 21 was finalized and published in October
2007. NUREG-1556, Volume 13, Revision 1, was finalized and published in
November 2007.
Dated at Rockville, Maryland, this 5th day of February, 2008.
For the Nuclear Regulatory Commission.
Dennis K. Rathbun,
Director, Division of Intergovernmental Liaison and Rulemaking, Office
of Federal and State Materials and Environmental Management Programs.
[FR Doc. E8-2946 Filed 2-14-08; 8:45 am]
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