NUREG-1556, Volume 9, Revision 2, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses”, 8909-8910 [E8-2946]

Download as PDF Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices Comments: Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility; (b) the accuracy of the Agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information on respondents, including through the use of automated collection techniques or other forms of information technology; or (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Dated: February 12, 2008. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation. [FR Doc. E8–2872 Filed 2–14–08; 8:45 am] BILLING CODE 7555–01–P NUCLEAR REGULATORY COMMISSION Independent External Review Panel To Identify Vulnerabilities in the U.S. Nuclear Regulatory Commission’s Materials Licensing Program; Meeting Notice U.S. Nuclear Regulatory Commission. ACTION: Notice of meeting. rwilkins on PROD1PC63 with NOTICES AGENCY: SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) will convene a meeting of the Independent External Review Panel to Identify Vulnerabilities in the NRC’s Materials Licensing Program on March 5 through 7, 2008. A copy of the agenda for the meeting can be obtained by e-mailing Mr. Aaron T. McCraw at the contact information below. Purpose: To initiate the Panel’s discussions and deliberations in developing their final report and to allow members of the public an opportunity to provide comments to the Panel on its draft report. The Panel’s draft report is located in the NRC’s Agencywide Document Access and Management System (ADAMS) using Accession Number ML080230554. Date and Time for Closed Sessions: There will be no closed sessions during this meeting. Date and Time for Open Session: March 5, 2008, from 2 p.m. to 4:30 p.m.; March 6, 2008, from 9 a.m. to 4:30 p.m.; VerDate Aug<31>2005 15:58 Feb 14, 2008 Jkt 214001 and March 7, 2008, from 9 a.m. to 12 p.m. Address for Public Meeting: NRC, Two White Flint North Building, 11545 Rockville Pike, Rockville, Maryland 20852. Specific room locations will be indicated on the agenda. Public Participation: Any member of the public who wishes to participate in the meeting should contact Mr. McCraw using the information below. Contact Information: Aaron T. McCraw, e-mail: atm@nrc.gov, telephone: (301) 415–1277. Conduct of the Meeting Mr. Thomas E. Hill will chair the meeting. Mr. Hill will conduct the meeting in a manner that will facilitate the orderly conduct of business. The following procedures apply to public participation in the meeting: 1. Persons who wish to provide a written statement should submit an electronic copy to Mr. McCraw at the contact information listed above. All submittals must be received by February 29, 2008, and must pertain to the topics on the agenda for the meeting. 2. Questions and comments from members of the public will be permitted during the meeting, at the discretion of the Chairman. 3. The transcript and written comments will be available for inspection at the NRC Public Document Room, 11555 Rockville Pike, Rockville, Maryland 20852–2738, telephone (800) 397–4209, on or about June 15, 2008. 4. Persons who require special services, such as those for the hearing impaired, should notify Mr. McCraw of their planned attendance. This meeting will be held in accordance with the Atomic Energy Act of 1954, as amended (primarily Section 161a); the Federal Advisory Committee Act (5 U.S.C. App); and the Commission’s regulations in Title 10, U.S. Code of Federal Regulations, Part 7. Dated: February 11, 2008. Andrew L. Bates, Advisory Committee Management Officer. [FR Doc. E8–2889 Filed 2–14–08; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION NUREG–1556, Volume 9, Revision 2, ‘‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses’’ Nuclear Regulatory Commission. ACTION: Notice of availability. AGENCY: PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 8909 SUMMARY: The Nuclear Regulatory Commission (NRC) is announcing the completion and availability of NUREG– 1556, Volume 9, Revision 2, ‘‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses,’’ dated January 2008. ADDRESSES: Copies of NUREG–1556, Volume 9, Revision 2, may be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 37082, Washington, DC 20402–9328; https:// www.access.gpo.gov/su _docs 202–512– 1800 or The National Technical Information Service, Springfield, Virginia 22161–0002; https:// 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 https:// www.nrc.gov/NRC/ADAMS/. 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 9, Revision 2, is ML073400289. 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 initially posted 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: https://nrc-stp.ornl.gov/ narmtoolbox.html under the heading of ‘‘Licensing Guidance.’’ Subsequently, it will be posted on NRC’s public Web site at: https://www.nrc.gov/reading-rm/doccollections/nuregs/staff/sr1556 on the ‘‘Consolidated Guidance About Materials Licenses (NUREG–1556)’’ Web site page. Some publications in the NUREG series that are posted at NRC’s Web site address https://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 E:\FR\FM\15FEN1.SGM 15FEN1 8910 Federal Register / Vol. 73, No. 32 / Friday, February 15, 2008 / Notices 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 DonnaBeth Howe, Ph.D., 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) 415–7848, e-mail: dbh@nrc.gov. 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). rwilkins on PROD1PC63 with NOTICES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 15:58 Feb 14, 2008 Jkt 214001 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 have been 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. ‘‘ NUREG–1556, Volume 9, Revision 2, provides guidance for applicants in preparing their license applications for the medical use of byproduct material. Volume 9 has been revised primarily to provide additional guidance related to the NARM rule, including guidance about consortiums and noncommercial distribution. It is also revised to clarify training and experience requirements, and to replace NRC Form 313A with six new NRC Form 313A forms specific to types of authorizations. References and information related to Subpart J of 10 CFR Part 35 have been removed since these regulatory requirements expired on October 25, 2005. Additionally, other minor changes were 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 was updated. NUREG–1556, Volume 9, Revision 2, ‘‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses,’’ was noticed for public comment on August 2, 2007 (72 FR 42442). The remaining two NUREG–1556 volumes were noticed for public comment separately: (1) NUREG–1556, Volume 21, on May 29, 2007 (72 FR 29555), and (2) NUREG–1556, Volume PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 13, Revision 1, on July 3, 2007 (72 FR 36526). NUREG–1556, Volume 21 was finalized and published in October 2007. NUREG–1556, Volume 13, Revision 1, was finalized and published in November 2007. Dated at Rockville, Maryland, this 5th day of February, 2008. 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. E8–2946 Filed 2–14–08; 8:45 am] BILLING CODE 7590–01–P OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE Anti-Counterfeiting Trade Agreement (ACTA): Request for Public Comments Office of the United States Trade Representative. ACTION: Request for written submissions from the public. AGENCY: SUMMARY: The Office of the United States Trade Representative (USTR) seeks to negotiate an anti-counterfeiting trade agreement to strengthen international cooperation, enforcement practices, and participants’ legal frameworks to address counterfeiting and piracy. USTR requests written comments from the public concerning specific matters that should be the focus of such an agreement. DATES: Submissions must be received on or before 5 p.m. on Friday, March 21, 2008. ADDRESS: All comments should be sent (i) electronically, to the following e-mail address: ACTA@ustr.eop.gov, with ‘‘Anti-Counterfeiting Trade Agreement (ACTA): Request for Public Comments’’ in the subject line, or (ii) by fax, to Rachel Bae, at (202) 395–3891, with a confirmation copy sent electronically to the e-mail address above. FOR FURTHER INFORMATION CONTACT: Rachel S. Bae, Director for Intellectual Property and Innovation, Office of the United States Trade Representative, at (202) 395–4510. SUPPLEMENTARY INFORMATION: On October 23, 2008, USTR announced that the United States, along with a group of trading partners, would pursue negotiation of a new Anti-Counterfeiting Trade Agreement (ACTA) to provide international leadership in the fight against IPR counterfeiting and piracy. The United States and other interested parties intend to seek an agreement with provisions in three main areas: E:\FR\FM\15FEN1.SGM 15FEN1

Agencies

[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8909-8910]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2946]


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

NUCLEAR REGULATORY COMMISSION


NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About 
Materials Licenses: Program-Specific Guidance About Medical Use 
Licenses''

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability.

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

SUMMARY: The Nuclear Regulatory Commission (NRC) is announcing the 
completion and availability of NUREG-1556, Volume 9, Revision 2, 
``Consolidated Guidance About Materials Licenses: Program-Specific 
Guidance About Medical Use Licenses,'' dated January 2008.

ADDRESSES: Copies of NUREG-1556, Volume 9, Revision 2, may be purchased 
from the Superintendent of Documents, U.S. Government Printing Office, 
P.O. Box 37082, Washington, DC 20402-9328; https://www.access.gpo.gov/su
_docs 202-512-1800 or The National Technical Information Service, 
Springfield, Virginia 22161-0002; https://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 https://
www.nrc.gov/NRC/ADAMS/. 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 9, 
Revision 2, is ML073400289. 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 initially posted 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: https://nrc-
stp.ornl.gov/narmtoolbox.html under the heading of ``Licensing 
Guidance.'' Subsequently, it will be posted on NRC's public Web site 
at: https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556 
on the ``Consolidated Guidance About Materials Licenses (NUREG-1556)'' 
Web site page. Some publications in the NUREG series that are posted at 
NRC's Web site address https://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

[[Page 8910]]

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 Donna-Beth Howe, Ph.D., 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-
7848, e-mail: dbh@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 NUREG-
1556 documents have been 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. ``
    NUREG-1556, Volume 9, Revision 2, provides guidance for applicants 
in preparing their license applications for the medical use of 
byproduct material. Volume 9 has been revised primarily to provide 
additional guidance related to the NARM rule, including guidance about 
consortiums and noncommercial distribution. It is also revised to 
clarify training and experience requirements, and to replace NRC Form 
313A with six new NRC Form 313A forms specific to types of 
authorizations. References and information related to Subpart J of 10 
CFR Part 35 have been removed since these regulatory requirements 
expired on October 25, 2005. Additionally, other minor changes were 
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 was updated.
    NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About 
Materials Licenses: Program-Specific Guidance About Medical Use 
Licenses,'' was noticed for public comment on August 2, 2007 (72 FR 
42442).
    The remaining two NUREG-1556 volumes were noticed for public 
comment separately: (1) NUREG-1556, Volume 21, on May 29, 2007 (72 FR 
29555), and (2) NUREG-1556, Volume 13, Revision 1, on July 3, 2007 (72 
FR 36526). NUREG-1556, Volume 21 was finalized and published in October 
2007. NUREG-1556, Volume 13, Revision 1, was finalized and published in 
November 2007.

    Dated at Rockville, Maryland, this 5th day of February, 2008.

    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. E8-2946 Filed 2-14-08; 8:45 am]
BILLING CODE 7590-01-P
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