E7-23905. 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.

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 [e-mail]. 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: [e-mail].

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 [phone], e-mail: [e-mail]; 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 [phone], e-mail: [e-mail].

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 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.