[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[Notices]
[Pages 36526-36528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12856]


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NUCLEAR REGULATORY COMMISSION


NUREG-1556, Volume 13, Revision 1, ``Consolidated Guidance About 
Materials Licenses Program-Specific Guidance About Commercial 
Radiopharmacy Licenses''; Draft Guidance Document for Comment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.

[[Page 36527]]

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 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 13, 
Revision 1. NUREG-1556, Volume 9, Revision 2, will be available for 
public comment in the near future. NUREG-1556, Volume 21, was 
previously noticed for public comment in the Federal Register, on May 
29, 2007 (72 FR 29555).

DATES: Please submit comments on NUREG-1556, Volume 13, Revision 1, by 
August 2, 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 13, Revision 1, ``Consolidated Guidance 
About Materials Licenses--Program-Specific Guidance About Commercial 
Radiopharmacy 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 13, 
Revision 1, is ML071581047. 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: 
http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/ on 
the ``Consolidated Guidance About Materials Licenses (NUREG-1556)'' Web 
site page, and 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

[[Page 36528]]

volume has been developed as Volume 21 to address production of 
radioactive 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 13, Revision 1, ``Consolidated Guidance About 
Materials Licenses--Program-Specific Guidance About Commercial 
Radiopharmacy Licenses,'' Draft Report for Comment. Volume 9, Revision 
2, ``Consolidated Guidance About Materials Licenses--Program-Specific 
Guidance About Medical Use Licenses,'' will be available for public 
comment in the near future. NUREG-1556, Volume 21, ``Consolidated 
Guidance About Materials Licenses--Program-Specific Guidance About 
Possession Licenses for Production of Radioactive Material Using an 
Accelerator,'' was previously noticed for public comment in the Federal 
Register on May 29, 2007 (72 FR 29555), for a 30-day comment period.
    NUREG-1556, Volume 13, Revision 1, ``Consolidated Guidance About 
Materials Licenses--Program-Specific Guidance About Commercial 
Radiopharmacy Licenses,'' provides guidance for applicants for 
commercial radiopharmacy licenses in preparing their license 
applications. Volume 13 is being revised primarily to provide 
additional guidance related to positron emission tomography (PET) 
radiopharmaceuticals for medical use. The guidance in Section 8.7.2, 
``Authorized Nuclear Pharmacist,'' has been updated to reflect current 
10 CFR Part 35 requirements. 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 the expanded definition of byproduct material and 
the NARM rule. The Abstract contains a brief summary of the nature of 
the changes that were made as well as a list of Sections in which 
substantial revisions were made or new guidance was provided. 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 the NUREG.

    Dated at Rockville, Maryland, this 21st day of June, 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. E7-12856 Filed 7-2-07; 8:45 am]
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