NUREG-1556, Volume 9, Revision 2, “Consolidated Guidance About Materials Licenses Program-Specific Guidance About Medical Use Licenses; Draft Guidance Document for Comment, 42442-42444 [E7-15049]

Download as PDF 42442 Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices 1. Robert D. Skowronek, Michigan Department of Environmental Quality, letter to Patricia Pelke, U.S. Nuclear Regulatory Commission, February 22, 2007 (ADAMS Accession No. ML070590426). 2. Telephone Conversation Record, Initiated by William Snell, U.S. Nuclear Regulatory Commission, to Robert Skowronek, Michigan Department of Environmental Quality, on July 11, 2007 (ADAMS Accession No. ML071930403). 3. U.S. Nuclear Regulatory Commission, ‘‘Environmental Review Guidance for Licensing Actions Associated with NMSS Programs,’’ NUREG–1748, August 2003. 4. U.S. Nuclear Regulatory Commission, ‘‘Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Nuclear Facilities,’’ NUREG–1496, August 1994. 5. NRC, NUREG–1757, ‘‘Consolidated NMSS Decommissioning Guidance,’’ Volumes 1–3, September 2003. 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 Lisle, Illinois, this 20th day of July 2007. For the Nuclear Regulatory Commission. Patrick L. Louden, Chief, Decommissioning Branch, Division of Nuclear Materials Safety, Region III. [FR Doc. E7–15040 Filed 8–1–07; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION Clarification to Regulatory Guide 1.200, Revision 1 Nuclear Regulatory Commission. ACTION: Clarification to Regulatory Guide. AGENCY: FOR FURTHER INFORMATION CONTACT: mstockstill on PROD1PC66 with NOTICES Mary Drouin, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001. Telephone: 301–415–6675; e-mail: MXD@nrc.gov. Introduction The U.S. Nuclear Regulatory Commission (NRC) is issuing a clarification to an existing guide in the agency’s regulatory guide (RG) series. The NRC has developed this series to describe and make available to the public such information as methods that VerDate Aug<31>2005 17:42 Aug 01, 2007 Jkt 211001 are acceptable to the NRC staff for implementing specific parts of the NRC’s regulations, techniques that the staff uses in evaluating specific problems or postulated accidents, and data that the staff needs in its review of applications for permits and licenses. At this time, the NRC is issuing a clarification to Revision 1 of RG 1.200, ‘‘An Approach for Determining the Technical Adequacy of Probabilistic Risk Assessment Results for RiskInformed Activities,’’ issued January 2007. The purpose of this clarification is to provide additional explanation to the staff’s regulatory position with regard to defining the technical acceptability of a probabilistic risk assessment (PRA), specifically with respect to the treatment of the sources of model uncertainty and the related assumptions in the base PRA. The clarification to RG 1.200, Revision 1 can be found in Agencywide Documents Access and Management System (ADAMS) Accession Number ML071940235. The clarification to Regulatory Guide 1.200, Revision 1, is intended for licensees of nuclear power plants. Revision 1 of this RG remains in effect for licensees of nuclear power plants. The NRC staff encourages and welcomes comments and suggestions in connection with improvements to published RGs, as well as items for inclusion in RGs that are currently under development. You may submit comments by any of the following methods. 1. Mail comments to: Rulemaking, Directives and Editing Branch, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001. 2. Hand-deliver comments to: Rulemaking, Directives and Editing Branch, Office of Administration, U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. on Federal workdays. 3. Fax comments to: Rulemaking, Directives and Editing Branch, Office of Administration, U.S. Nuclear Regulatory Commission at (301) 415–5144. 4. Direct requests for technical information about this clarification to Revision 1 of RG 1.200 to Ms. Mary Drouin at (301) 415–6675 or MXD@nrc.gov. RGs are available for inspection or downloading through the NRC’s public Web site at http://www.nrc.gov/readingrm/doc-collections/reg-guides/. In addition, this clarification to Revision 1 of RG 1.200 is available for inspection or downloading through the Agencywide Documents Access and PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 Management System (ADAMS) at http://www.nrc.gov/reading-rm/ adams.html under ADAMS Accession No. ML071940235. The clarification to Revision 1 of RG 1.200 and other related publicly available documents can also be viewed electronically on computers in the NRC’s Public Document Room (PDR), which is located at 11555 Rockville Pike, Rockville, Maryland. The reproduction contractor at the PDR will make copies of documents for a fee. The mailing address for the PDR is USNRC, PDR, Washington, DC 20555–0001. The PDR can also be reached by telephone at (301) 415–4737 or (800) 397–4205, by fax at (301) 415–3548, and by e-mail to PDR@nrc.gov. RGs are not copyrighted, and Commission approval is not required to reproduce them. (5 U.S.C. 552(a)) Dated at Rockville, Maryland, this 27th day of July, 2007. For the U.S. Nuclear Regulatory Commission. Farouk Eltawila, Director, Division of Risk Assessment and Special Projects, Office of Nuclear Regulatory Research. [FR Doc. E7–15036 Filed 8–1–07; 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; Draft Guidance Document for Comment Nuclear Regulatory Commission. ACTION: Notice of availability for public comment. AGENCY: SUMMARY: The Nuclear Regulatory Commission (NRC) has amended its regulations to include jurisdiction over certain radium sources, acceleratorproduced radioactive materials, and certain naturally occurring radioactive material, as required by the Energy Policy Act of 2005 (EPAct), which was signed into law on August 8, 2005. The EPAct expanded the Atomic Energy Act of 1954 definition of byproduct material to include these radioactive materials. Subsequently, these radioactive materials were placed under NRC’s regulatory authority. NRC is revising its regulations to provide a regulatory framework that includes these newly added radioactive materials. See SECY– 07–0062, ‘‘Final Rule: Requirements for E:\FR\FM\02AUN1.SGM 02AUN1 mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices Expanded Definition of Byproduct Material,’’ dated April 3, 2007, for information on that rulemaking. Two licensing guidance documents in the NUREG–1556 series are being revised along with these new regulations to provide guidance related to the new requirements: (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.’’ A new volume in the NUREG–1556 series has also been developed to address the production of radioactive material using an accelerator. This NUREG is entitled NUREG–1556, Volume 21, ‘‘Consolidated Guidance About Materials Licenses—ProgramSpecific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator.’’ This notice is announcing the availability of one of these three licensing guidance documents for public comment: NUREG–1556, Volume 9, Revision 2. The other two NUREGs were previously noticed for public comment: (1) NUREG–1556, Volume 13, Revision 1, on July 3, 2007 (72 FR 36526), and (2) NUREG–1556, Volume 21, on May 29, 2007 (72 FR 29555). DATES: Please submit comments on NUREG–1556, Volume 9, Revision 2, by September 4, 2007. Comments received after this date will be considered if practical to do so, but the NRC staff is able to ensure consideration only for those comments received on or before this date. ADDRESSES: NUREG–1556, Volume 9, Revision 2, ‘‘Consolidated Guidance About Materials Licenses—ProgramSpecific Guidance About Medical Use Licenses,’’ Draft Report for Comment, is available for inspection and copying for a fee at the NRC’s Public Document Room (PDR), Public File Area O–1F21, One White Flint North, 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 9, Revision 2, is ML071860070. If you do VerDate Aug<31>2005 17:42 Aug 01, 2007 Jkt 211001 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: (1) http:// www.nrc.gov/reading-rm/doccollections/nuregs/staff/sr1556/ on the ‘‘Consolidated Guidance About Materials Licenses (NUREG–1556)’’ Web site page, and (2) http://www.nrc.gov/ reading-rm/doc-collections/nuregs/ docs4comment.html on the ‘‘Draft NUREG Series Publications for Comment.’’ It will also be 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: http://nrc-stp.ornl.gov/ narmtoolbox.html under the heading of ‘‘Licensing Guidance.’’ 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. Please submit comments to Chief, Rulemaking, Directives and Editing Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC, 20555–0001. You may also deliver comments to 11545 Rockville Pike, Rockville, MD, between 7:30 a.m. and 4:30 p.m. Federal workdays, or by e-mail to: nrcrep@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. SUPPLEMENTARY INFORMATION: Background On August 8, 2005, the President signed into law the 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 PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 42443 regulating this additional byproduct material. 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 is revising its regulations to provide a regulatory framework that includes these newly added radioactive materials. See SECY–07–0062, ‘‘Final Rule: Requirements for Expanded Definition of Byproduct Material,’’ dated April 3, 2007, for information on that rulemaking. Discussion As part of the rulemaking effort to address the mandate of the EPAct, the NRC also evaluated the need to revise certain licensing guidance documents to provide necessary guidance to applicants in preparing license applications to include the use of the newly added radioactive material 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 has been developed as Volume 21 to address production of radioactive E:\FR\FM\02AUN1.SGM 02AUN1 mstockstill on PROD1PC66 with NOTICES 42444 Federal Register / Vol. 72, No. 148 / Thursday, August 2, 2007 / Notices material using an accelerator. This NUREG–1556, Volume 21, is entitled: ‘‘Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator.’’ At this time, NRC is announcing the availability for public comment NUREG–1556, Volume 9, Revision 2, ‘‘Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Medical Use Licenses,’’ Draft Report for Comment. The other two NUREGs were previously noticed for public comment: (1) NUREG–1556, Volume 13, Revision 1, on July 3, 2007 (72 FR 36526) and (2) NUREG–1556, Volume 21, on May 29, 2007 (72 FR 29555). NUREG–1556, Volume 9, Revision 2, ‘‘Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Medical Use Licenses,’’ provides guidance for applicants in preparing their license applications for the medical use of byproduct material. Volume 9 is being revised primarily to provide additional guidance related to the NARM rule, as discussed above. In the draft final rule for the NARM rulemaking, the concept of consortiums and noncommercial distribution was addressed. In summary, because of the short-lived radionuclides associated with Positron Emission Tomography (PET), the source of these radioactive materials needs to be produced in the facility of use or within close proximity. The NRC developed a new regulatory process based on existing practices for consortiums and noncommercial distribution. For this purpose, educational institutions, medical use facilities or Federal facilities may form consortiums with adjacent or nearby hospitals to jointly own or share in the operation and maintenance costs of the PET radionuclide production facility. This is discussed in more detail in SECY–07–0062, ‘‘Final Rule: Requirements for Expanded Definition of Byproduct Material,’’ dated April 3, 2007, and within the draft Federal Register notice that is provided as an attachment to SECY–07–0062. NUREG–1556, Volume 9, Revision 2, provides guidance for applicants in licensees about consortiums and noncommercial distribution in Sections 1 and 8, and in Appendix AA. NRC is requesting specific comments on this guidance to ensure that it is clear and easily understood by affected stakeholders. It is also being revised to clarify training and experience requirements, replaces NRC Form 313A with six new NRC Form 313A forms specific to types VerDate Aug<31>2005 17:42 Aug 01, 2007 Jkt 211001 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 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. NRC is only requesting comments on the specific changes in this document related to those revisions discussed above. NRC will make corrections if any errors or editorial corrections are noted; however, any comments not related to these specific changes will be evaluated during the next routine review of NUREG–1556, Volume 9. Dated at Rockville, Maryland, this 26th day of July, 2007. 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. E7–15049 Filed 8–1–07; 8:45 am] BILLING CODE 7590–01–P OFFICE OF MANAGEMENT AND BUDGET Amending Federal Financial Assistance-Related Forms to Include Universal Identifier Office of Federal Financial Management and Office of Information and Regulatory Affairs, Office of Management and Budget. ACTION: Notice; request for comments. AGENCY: SUMMARY: The Office of Management and Budget (OMB) proposes to authorize each Federal agency that receives applications for Federal financial assistance to add a field for the applicant’s Dun and Bradstreet Data Universal Numbering System (DUNS) number to application forms previously approved by OMB. This proposed update would broaden the directive’s effect to all forms of Federal financial assistance covered by the Federal Funding Accountability and Transparency Act (the ‘‘Act’’) including grants, subgrants, loans, awards, cooperative agreements, and other forms of financial assistance. DATES: Comments are due by September 4, 2007. ADDRESSES: Comments should be addressed to Marguerite Pridgen, Office of Federal Financial Management, PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 Office of Management and Budget, 725 17th Street, NW., Washington, DC 20503; telephone 202–395–7844; fax 202–395–3952; e-mail mpridgen@omb.eop.gov. Due to potential delays in OMB’s receipt and processing of mail sent through the U.S. Postal Service, we encourage respondents to submit comments electronically to ensure timely receipt. We cannot guarantee that comments mailed will be received before the comment closing date. Please include ‘‘Amending Forms for DUNS’’ in the subject line of the email message; please also include the full body of your comments in the text of the message and as an attachment. Include your name, title, organization, postal address, telephone number, and e-mail address in your message. FOR FURTHER INFORMATION CONTACT: Marguerite Pridgen at the addresses noted above. Authority: Sec. 2, Pub. L. 109–282, 102 Stat. 1186. The Office of Management and Budget (OMB) proposes to authorize each Federal agency that receives applications for Federal financial assistance to add a field for the applicant’s Dun and Bradstreet Data Universal Numbering System (DUNS) number to application forms previously approved by OMB. The intent of authorizing agencies to add the field without additional OMB approval is to enable the agencies to require applicants other than individual persons to provide DUNS numbers for all applications submitted on or after October 1, 2007. This proposal thereby would update the policy in the OMB directive issued on June 27, 2003 [68 FR 38403], ‘‘Use of a Universal Identifier by Grant Applicants.’’ That directive authorized agencies to add the DUNS number as a required field for applications leading to the award of two specific forms of Federal financial assistance: Grants and cooperative agreements. This proposed update would broaden the directive’s effect to all forms of Federal financial assistance covered by the Federal Funding Accountability and Transparency Act (the ‘‘Act’’) including grants, subgrants, loans, awards, cooperative agreements, and other forms of financial assistance. The reason for the proposed update is that the DUNS number will be used as the unique identifier for recipient entities that is required by the Federal Funding Accountability and Transparency Act of 2006 (Pub. L. 109– 282). Under that Act, OMB must ensure the establishment and maintenance of a location on the World Wide Web SUPPLEMENTARY INFORMATION: E:\FR\FM\02AUN1.SGM 02AUN1

Agencies

[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Notices]
[Pages 42442-42444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15049]


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

NUCLEAR REGULATORY COMMISSION


NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About 
Materials Licenses Program-Specific Guidance About Medical Use 
Licenses; Draft Guidance Document for Comment

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability for public comment.

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

SUMMARY: The Nuclear Regulatory Commission (NRC) has amended its 
regulations to include jurisdiction over certain radium sources, 
accelerator-produced radioactive materials, and certain naturally 
occurring radioactive material, as required by the Energy Policy Act of 
2005 (EPAct), which was signed into law on August 8, 2005. The EPAct 
expanded the Atomic Energy Act of 1954 definition of byproduct material 
to include these radioactive materials. Subsequently, these radioactive 
materials were placed under NRC's regulatory authority. NRC is revising 
its regulations to provide a regulatory framework that includes these 
newly added radioactive materials. See SECY-07-0062, ``Final Rule: 
Requirements for

[[Page 42443]]

Expanded Definition of Byproduct Material,'' dated April 3, 2007, for 
information on that rulemaking.
    Two licensing guidance documents in the NUREG-1556 series are being 
revised along with these new regulations to provide guidance related to 
the new requirements: (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.'' A new 
volume in the NUREG-1556 series has also been developed to address the 
production of radioactive material using an accelerator. This NUREG is 
entitled NUREG-1556, Volume 21, ``Consolidated Guidance About Materials 
Licenses--Program-Specific Guidance About Possession Licenses for 
Production of Radioactive Material Using an Accelerator.''
    This notice is announcing the availability of one of these three 
licensing guidance documents for public comment: NUREG-1556, Volume 9, 
Revision 2. The other two NUREGs were previously noticed for public 
comment: (1) NUREG-1556, Volume 13, Revision 1, on July 3, 2007 (72 FR 
36526), and (2) NUREG-1556, Volume 21, on May 29, 2007 (72 FR 29555).

DATES: Please submit comments on NUREG-1556, Volume 9, Revision 2, by 
September 4, 2007. Comments received after this date will be considered 
if practical to do so, but the NRC staff is able to ensure 
consideration only for those comments received on or before this date.

ADDRESSES: NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance 
About Materials Licenses--Program-Specific Guidance About Medical Use 
Licenses,'' Draft Report for Comment, is available for inspection and 
copying for a fee at the NRC's Public Document Room (PDR), Public File 
Area O-1F21, One White Flint North, 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 9, Revision 2, is ML071860070. 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: (1) 
http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/ on 
the ``Consolidated Guidance About Materials Licenses (NUREG-1556)'' Web 
site page, and (2) http://www.nrc.gov/reading-rm/doc-collections/
nuregs/docs4comment.html on the ``Draft NUREG Series Publications for 
Comment.'' It will also be 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: http://nrc-stp.ornl.gov/narmtoolbox.html under the 
heading of ``Licensing Guidance.''
    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.
    Please submit comments to Chief, Rulemaking, Directives and Editing 
Branch, Division of Administrative Services, Office of Administration, 
U.S. Nuclear Regulatory Commission, Washington, DC, 20555-0001. You may 
also deliver comments to 11545 Rockville Pike, Rockville, MD, between 
7:30 a.m. and 4:30 p.m. Federal workdays, or by e-mail to: 
nrcrep@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.

SUPPLEMENTARY INFORMATION:

Background

    On August 8, 2005, the President signed into law the 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 this additional byproduct 
material.
    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 is revising its regulations to provide a regulatory framework 
that includes these newly added radioactive materials. See SECY-07-
0062, ``Final Rule: Requirements for Expanded Definition of Byproduct 
Material,'' dated April 3, 2007, for information on that rulemaking.

Discussion

    As part of the rulemaking effort to address the mandate of the 
EPAct, the NRC also evaluated the need to revise certain licensing 
guidance documents to provide necessary guidance to applicants in 
preparing license applications to include the use of the newly added 
radioactive material 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 has been developed as Volume 21 to address production of 
radioactive

[[Page 42444]]

material using an accelerator. This NUREG-1556, Volume 21, is entitled: 
``Consolidated Guidance About Materials Licenses--Program-Specific 
Guidance About Possession Licenses for Production of Radioactive 
Material Using an Accelerator.''
    At this time, NRC is announcing the availability for public comment 
NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About 
Materials Licenses--Program-Specific Guidance About Medical Use 
Licenses,'' Draft Report for Comment. The other two NUREGs were 
previously noticed for public comment: (1) NUREG-1556, Volume 13, 
Revision 1, on July 3, 2007 (72 FR 36526) and (2) NUREG-1556, Volume 
21, on May 29, 2007 (72 FR 29555).
    NUREG-1556, Volume 9, Revision 2, ``Consolidated Guidance About 
Materials Licenses--Program-Specific Guidance About Medical Use 
Licenses,'' provides guidance for applicants in preparing their license 
applications for the medical use of byproduct material. Volume 9 is 
being revised primarily to provide additional guidance related to the 
NARM rule, as discussed above.
    In the draft final rule for the NARM rulemaking, the concept of 
consortiums and noncommercial distribution was addressed. In summary, 
because of the short-lived radionuclides associated with Positron 
Emission Tomography (PET), the source of these radioactive materials 
needs to be produced in the facility of use or within close proximity. 
The NRC developed a new regulatory process based on existing practices 
for consortiums and noncommercial distribution. For this purpose, 
educational institutions, medical use facilities or Federal facilities 
may form consortiums with adjacent or nearby hospitals to jointly own 
or share in the operation and maintenance costs of the PET radionuclide 
production facility. This is discussed in more detail in SECY-07-0062, 
``Final Rule: Requirements for Expanded Definition of Byproduct 
Material,'' dated April 3, 2007, and within the draft Federal Register 
notice that is provided as an attachment to SECY-07-0062.
    NUREG-1556, Volume 9, Revision 2, provides guidance for applicants 
in licensees about consortiums and noncommercial distribution in 
Sections 1 and 8, and in Appendix AA. NRC is requesting specific 
comments on this guidance to ensure that it is clear and easily 
understood by affected stakeholders.
    It is also being revised to clarify training and experience 
requirements, replaces 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 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.
    NRC is only requesting comments on the specific changes in this 
document related to those revisions discussed above. NRC will make 
corrections if any errors or editorial corrections are noted; however, 
any comments not related to these specific changes will be evaluated 
during the next routine review of NUREG-1556, Volume 9.

    Dated at Rockville, Maryland, this 26th day of July, 2007.

    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. E7-15049 Filed 8-1-07; 8:45 am]
BILLING CODE 7590-01-P