NUREG-1556, Volume 13, Revision 1, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacies”, 69718-69719 [E7-23905]

Download as PDF 69718 Federal Register / Vol. 72, No. 236 / Monday, December 10, 2007 / Notices 3. Title 10, Code of Federal Regulations, Part 51, ‘‘Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions;’’ 4. NUREG–1496, ‘‘Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRCLicensed Nuclear Facilities.’’ 5. Pontifical Catholic University of Puerto Rico Termination Request dated June 16, 2006 [ML072630543]. 6. Pontifical Catholic University of Puerto Rico Additional Information letter dated August 22, 2007 [ML072420457]. 7. Pontifical Catholic University of Puerto Rico Additional Information letter dated November 16, 2006 [ML070590570]. If you do not have access to ADAMS, or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room (PDR) Reference staff at 1–800–397–4209, 301– 415–4737, or by e-mail to pdr@nrc.gov. These documents may also be viewed electronically on the public computers located at the NRC’s PDR, O 1 F21, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852. The PDR reproduction contractor will copy documents for a fee. Dated at Region I, 475 Allendale Road, King of Prussia, PA, this 3rd day of December 2007. For the Nuclear Regulatory Commission. James P. Dwyer, Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety, Region I. [FR Doc. E7–23902 Filed 12–7–07; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION NUREG–1556, Volume 13, Revision 1, ‘‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacies’’ Nuclear Regulatory Commission. ACTION: Notice of availability. rmajette on PROD1PC64 with NOTICES AGENCY: 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 VerDate Aug<31>2005 15:35 Dec 07, 2007 Jkt 214001 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 pdr@nrc.gov. The document will also be posted on NRC’s public Web site at: http://www.nrc.gov/reading-rm/doccollections/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 AcceleratorProduced 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: Distribution@nrc.gov. 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– PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 7900, e-mail: tmt@nrc.gov; 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: dew2@nrc.gov. 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 E:\FR\FM\10DEN1.SGM 10DEN1 Federal Register / Vol. 72, No. 236 / Monday, December 10, 2007 / Notices rmajette on PROD1PC64 with NOTICES NUREG–1556 documents are being revised to provide additional guidance to licensees: (1) NUREG–1556, Volume 13, Revision 1, ‘‘Consolidated Guidance about Materials Licenses: ProgramSpecific 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 VerDate Aug<31>2005 15:35 Dec 07, 2007 Jkt 214001 OFFICE OF MANAGEMENT AND BUDGET Draft Joint Report on the Review of the Application of European Union and United States Regulatory Impact Assessment Guidelines on the Analysis of Impacts on International Trade and Investment Office of Management and Budget, Executive Office of the President. ACTION: Notice of availability and request for comments. AGENCY: SUMMARY: The Office of Management and Budget (OMB) requests comments on the Draft Joint Report on the Review of the Application of European Union (EU) and United States (U.S.) Regulatory Impact Assessment Guidelines on the Analysis of Impacts on International Trade and Investment. The full Draft Report is available at http:// www.whitehouse.gov/omb/inforeg/ regpol.html#opp. This joint draft report was prepared by the Secretariat General of the European Commission and the OMB’s Office of Information and Regulatory Affairs (OIRA) as part of an EC-OMB dialogue on methodological issues for consideration at the November 9th, 2007 meeting in Washington, DC of the U.S.–EU Transatlantic Economic Council. DATES: To ensure consideration of comments as OMB and the EC prepare the final version of this report, comments must be in writing and received by February 8, 2008. ADDRESSES: We are still experiencing delays in the regular mail, including first class and express mail. To ensure that your comments are received, we recommend that comments on this draft report be electronically mailed to OIRA_BC_RPT@omb.eop.gov, or faxed to (202) 395–6974. You may also submit comments to Carolyn Swinney, Office of Information and Regulatory Affairs, Office of Management and Budget, NEOB, Room 10235, 725 17th Street, NW., Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Dominic Mancini, Office of Information and Regulatory Affairs, Office of Management and Budget, NEOB, Room 10235, 725 17th Street, NW., Washington, DC 20503. Telephone: (202) 395–7316. SUPPLEMENTARY INFORMATION: This draft report was prepared by the Secretariat General of the European Commission and the U.S. Office of Management and Budget as part of the dialogue between the European Commission services and the Office of Management and Budget PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 69719 on methodological issues as agreed in the ‘‘Framework for Advancing Transatlantic Economic Integration between the European Union and the United States of America,’’ signed at the EU–US summit on 30 April 2007. It reviews the application of the Office of Management and Budget’s Circular A–4, regulatory analysis guidance, and the European Commission’s Impact Assessment Guidelines, with the goal of ensuring that assessment of future regulations takes due account of their impacts on international trade and investment. It contains two separate reports on existing methodology and practices on both sides, and suggests possible ways forward in the concluding chapter. Susan E. Dudley, Administrator, Office of Information and Regulatory Affairs. [FR Doc. E7–23856 Filed 12–7–07; 8:45 am] BILLING CODE 3110–01–P SECURITIES AND EXCHANGE COMMISSION Proposed Collections; Comment Request Upon Written Request; Copies Available From: Securities and Exchange Commission, Office of Investor Education and Advocacy, Washington, DC 20549–0213. Extensions: Rule 163; OMB Control No. 3235– 0619; SEC File No. 270–556. Rule 173; OMB Control No. 3235– 0618; SEC File No. 270–557. Rule 433; OMB Control No. 3235– 0617; SEC File No. 270–558. Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission (‘‘Commission’’) is soliciting comments on the collections of information summarized below. The Commission plans to submit these existing collections of information to the Office of Management and Budget for approval. Rule 163 (17 CFR 230.163) provides an exemption from section 5(c) under the Securities Act of 1933 (15 U.S.C. 77a et seq.) for certain communications by on behalf of a well-known seasoned issuer. The information filed under Rule 163 that is filed with the Commission is publicly available. We estimate that it takes approximately .24 burden hours per response to provide the information required under Rule 163 and that the information is filed by 53 respondents for a total annual reporting burden of 13 E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

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


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 pdr@nrc.gov. 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: Distribution@nrc.gov.

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: tmt@nrc.gov; 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: 
dew2@nrc.gov.

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