[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]
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