[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Notices]
[Pages 42442-42444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15049]


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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Licenses; Draft Guidance Document for Comment

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability for public comment.

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SUMMARY: The Nuclear Regulatory Commission (NRC) has amended its 
regulations to include jurisdiction over certain radium sources, 
accelerator-produced radioactive materials, and certain naturally 
occurring radioactive material, as required by the Energy Policy Act of 
2005 (EPAct), which was signed into law on August 8, 2005. The EPAct 
expanded the Atomic Energy Act of 1954 definition of byproduct material 
to include these radioactive materials. Subsequently, these radioactive 
materials were placed under NRC's regulatory authority. NRC is revising 
its regulations to provide a regulatory framework that includes these 
newly added radioactive materials. See SECY-07-0062, ``Final Rule: 
Requirements for

[[Page 42443]]

Expanded Definition of Byproduct Material,'' dated April 3, 2007, for 
information on that rulemaking.
    Two licensing guidance documents in the NUREG-1556 series are being 
revised along with these new regulations to provide guidance related to 
the new requirements: (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.'' A new 
volume in the NUREG-1556 series has also been developed to address the 
production of radioactive material using an accelerator. This NUREG is 
entitled NUREG-1556, Volume 21, ``Consolidated Guidance About Materials 
Licenses--Program-Specific Guidance About Possession Licenses for 
Production of Radioactive Material Using an Accelerator.''
    This notice is announcing the availability of one of these three 
licensing guidance documents for public comment: NUREG-1556, Volume 9, 
Revision 2. The other two NUREGs were previously noticed for public 
comment: (1) NUREG-1556, Volume 13, Revision 1, on July 3, 2007 (72 FR 
36526), and (2) NUREG-1556, Volume 21, on May 29, 2007 (72 FR 29555).

DATES: Please submit comments on NUREG-1556, Volume 9, Revision 2, by 
September 4, 2007. Comments received after this date will be considered 
if practical to do so, but the NRC staff is able to ensure 
consideration only for those comments received on or before this date.

ADDRESSES: NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance 
About Materials Licenses--Program-Specific Guidance About Medical Use 
Licenses,'' Draft Report for Comment, is available for inspection and 
copying for a fee at the NRC's Public Document Room (PDR), Public File 
Area O-1F21, One White Flint North, 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 ML071860070. 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 posted on NRC's public Web site at: (1) 
http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/ on 
the ``Consolidated Guidance About Materials Licenses (NUREG-1556)'' Web 
site page, and (2) http://www.nrc.gov/reading-rm/doc-collections/nuregs/docs4comment.html on the ``Draft NUREG Series Publications for 
Comment.'' It will also be 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.''
    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 Commission, Printing 
and Graphics Branch, Washington, DC 20555-0001; facsimile: 301-415-
2289; e-mail: [email protected].
    Please submit comments to Chief, Rulemaking, Directives and Editing 
Branch, Division of Administrative Services, Office of Administration, 
U.S. Nuclear Regulatory Commission, Washington, DC, 20555-0001. You may 
also deliver comments to 11545 Rockville Pike, Rockville, MD, between 
7:30 a.m. and 4:30 p.m. Federal workdays, or by e-mail to: 
[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].

SUPPLEMENTARY INFORMATION:

Background

    On August 8, 2005, the President signed into law the 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 this additional byproduct 
material.
    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 is revising its regulations to provide a regulatory framework 
that includes these newly added radioactive materials. See SECY-07-
0062, ``Final Rule: Requirements for Expanded Definition of Byproduct 
Material,'' dated April 3, 2007, for information on that rulemaking.

Discussion

    As part of the rulemaking effort to address the mandate of the 
EPAct, the NRC also evaluated the need to revise certain licensing 
guidance documents to provide necessary guidance to applicants in 
preparing license applications to include the use of the newly added 
radioactive material as byproduct material. Two NUREG-1556 documents 
are being 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 has been developed as Volume 21 to address production of 
radioactive

[[Page 42444]]

material using an accelerator. This NUREG-1556, Volume 21, is entitled: 
``Consolidated Guidance About Materials Licenses--Program-Specific 
Guidance About Possession Licenses for Production of Radioactive 
Material Using an Accelerator.''
    At this time, NRC is announcing the availability for public comment 
NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About 
Materials Licenses--Program-Specific Guidance About Medical Use 
Licenses,'' Draft Report for Comment. The other two NUREGs were 
previously noticed for public comment: (1) NUREG-1556, Volume 13, 
Revision 1, on July 3, 2007 (72 FR 36526) and (2) NUREG-1556, Volume 
21, on May 29, 2007 (72 FR 29555).
    NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About 
Materials Licenses--Program-Specific Guidance About Medical Use 
Licenses,'' provides guidance for applicants in preparing their license 
applications for the medical use of byproduct material. Volume 9 is 
being revised primarily to provide additional guidance related to the 
NARM rule, as discussed above.
    In the draft final rule for the NARM rulemaking, the concept of 
consortiums and noncommercial distribution was addressed. In summary, 
because of the short-lived radionuclides associated with Positron 
Emission Tomography (PET), the source of these radioactive materials 
needs to be produced in the facility of use or within close proximity. 
The NRC developed a new regulatory process based on existing practices 
for consortiums and noncommercial distribution. For this purpose, 
educational institutions, medical use facilities or Federal facilities 
may form consortiums with adjacent or nearby hospitals to jointly own 
or share in the operation and maintenance costs of the PET radionuclide 
production facility. This is discussed in more detail in SECY-07-0062, 
``Final Rule: Requirements for Expanded Definition of Byproduct 
Material,'' dated April 3, 2007, and within the draft Federal Register 
notice that is provided as an attachment to SECY-07-0062.
    NUREG-1556, Volume 9, Revision 2, provides guidance for applicants 
in licensees about consortiums and noncommercial distribution in 
Sections 1 and 8, and in Appendix AA. NRC is requesting specific 
comments on this guidance to ensure that it is clear and easily 
understood by affected stakeholders.
    It is also being revised to clarify training and experience 
requirements, replaces 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 are being 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 is being updated.
    NRC is only requesting comments on the specific changes in this 
document related to those revisions discussed above. NRC will make 
corrections if any errors or editorial corrections are noted; however, 
any comments not related to these specific changes will be evaluated 
during the next routine review of NUREG-1556, Volume 9.

    Dated at Rockville, Maryland, this 26th day of July, 2007.

    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. E7-15049 Filed 8-1-07; 8:45 am]
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