[Federal Register Volume 72, Number 236 (Monday, December 10, 2007)]
[Notices]
[Pages 69718-69719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-23905]


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NUCLEAR REGULATORY COMMISSION


NUREG-1556, Volume 13, Revision 1, ``Consolidated Guidance About 
Materials Licenses: Program-Specific Guidance About Commercial 
Radiopharmacies''

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 13, Revision 1, 
``Consolidated Guidance about Materials Licenses: Program-Specific 
Guidance about Commercial Radiopharmacies,'' dated November 2007.

ADDRESSES: Copies of NUREG-1556, Volume 13, Revision 1, 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; 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 13, 
Revision 1, is ML073180179. 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.'' 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 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 Duane White, 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) 415-6272, 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

[[Page 69719]]

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 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.''
    Volume 13, Revision 1, 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.
    NUREG-1556, Volume 13, Rev. 1, ``Consolidated Guidance about 
Materials Licenses: Program-Specific Guidance about Commercial 
Radiopharmacy Licenses,'' was noticed on July 3, 2007 (72 FR 36526) for 
public comment.
    The remaining two NUREG-1556 volumes were noticed separately for 
public comment: (1) NUREG-1556, Volume 21, on May 29, 2007 (72 FR 
29555), and (2) NUREG-1556, Volume 9, Revision 2, on August 2, 2007 (72 
FR 42442). NUREG-1556, Vol. 21 was finalized and published in November 
2007. NUREG-1556, Vol. 9, Rev. 2, is being finalized and will be 
available in the near future.

    Dated at Rockville, Maryland, this 3rd day of December 2007.

    For the Nuclear Regulatory Commission.
Dennis K. Rathbun,
Division Director, Division of Intergovernmental Liaison and 
Rulemaking, Office of Federal and State Materials and Environmental 
Management Programs.
 [FR Doc. E7-23905 Filed 12-7-07; 8:45 am]
BILLING CODE 7590-01-P