[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]


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

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.

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

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]
BILLING CODE 7590-01-P