NUREG-1556, Volume 13, Revision 1, “Consolidated Guidance About Materials Licenses Program-Specific Guidance About Commercial Radiopharmacy Licenses”; Draft Guidance Document for Comment, 36526-36528 [E7-12856]

Download as PDF 36526 Federal Register / Vol. 72, No. 127 / Tuesday, July 3, 2007 / Notices jlentini on PROD1PC65 with NOTICES requestor seeks to have litigated at the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner/requestor shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact.1 Contentions shall be limited to matters within the scope of the amendment under consideration. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner/requestor who fails to satisfy these requirements with respect to at least one contention will not be permitted to participate as a party. Each contention shall be given a separate numeric or alpha designation within one of the following groups: 1. Technical—primarily concerns/ issues relating to technical and/or health and safety matters discussed or referenced in the applications. 2. Environmental—primarily concerns/issues relating to matters discussed or referenced in the environmental analysis for the applications. 3. Miscellaneous—does not fall into one of the categories outlined above. As specified in 10 CFR 2.309, if two or more petitioners/requestors seek to co-sponsor a contention, the petitioners/ requestors shall jointly designate a representative who shall have the authority to act for the petitioners/ requestors with respect to that contention. If a petitioner/requestor seeks to adopt the contention of another sponsoring petitioner/requestor, the petitioner/requestor who seeks to adopt the contention must either agree that the sponsoring petitioner/requestor shall act as the representative with respect to that contention, or jointly designate with the sponsoring petitioner/requestor a representative who shall have the 1 To the extent that the applications contain attachments and supporting documents that are not publicly available because they are asserted to contain safeguards or proprietary information, petitioners desiring access to this information should contact the applicant or applicant’s counsel and discuss the need for a protective order. VerDate Aug<31>2005 17:57 Jul 02, 2007 Jkt 211001 authority to act for the petitioners/ requestors with respect to that contention. Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing. Since the Commission has made a final determination that the amendment involves no significant hazards consideration, if a hearing is requested, it will not stay the effectiveness of the amendment. Any hearing held would take place while the amendment is in effect. A request for a hearing or a petition for leave to intervene must be filed by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001, Attention: Rulemaking and Adjudications Staff; (2) courier, express mail, and expedited delivery services: Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff; (3) E-mail addressed to the Office of the Secretary, U.S. Nuclear Regulatory Commission, HearingDocket@nrc.gov; or (4) facsimile transmission addressed to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC, Attention: Rulemakings and Adjudications Staff at (301) 415–1101, verification number is (301) 415–1966. A copy of the request for hearing and petition for leave to intervene should also be sent to the Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001, and it is requested that copies be transmitted either by means of facsimile transmission to (301) 415–3725 or by email to OGCMailCenter@nrc.gov. A copy of the request for hearing and petition for leave to intervene should also be sent to the attorney for the licensee. Nontimely requests and/or petitions and contentions will not be entertained absent a determination by the Commission or the presiding officer or the Atomic Safety and Licensing Board that the petition, request and/or the contentions should be granted based on a balancing of the factors specified in 10 CFR 2.309(a)(1)(i)–(viii). Duke Power Company LLC, Docket No. 50–369, McGuire Nuclear Station, Unit 1 Mecklenburg County, North Carolina Date of amendment request: June 7, 2007 as supplemented June 8, 2007. The supplement provided additional clarifying information that clarified the application and did not expand the PO 00000 Frm 00108 Fmt 4703 Sfmt 4703 scope of the proposed no significant hazards consideration determination. Description of amendment request: This amendment approved a one-time extension of the allowed outage time (AOT) for the 1A emergency diesel generator from 72 hours to a total of 10 days. Date of issuance: June 8, 2007. Effective date: As of date of issuance to be implemented within 30 days. Amendment No.: 241 Renewed Facility Operating License No. NPF–9: Amendment revised the license and the technical specifications. Public comments requested as to proposed no significant hazards consideration (NSHC): No. The Commission’s related evaluation of the amendment, finding of emergency circumstances, state consultation, and final NSHC determination are contained in a safety evaluation dated June 8, 2007. Attorney for licensee: Ms. Lisa F. Vaughn, Associate General Counsel and Managing Attorney, Duke Energy Carolinas, LLC, 526 South Church Street, EC07H, Charlotte, NC 28202. NRC Branch Chief: Evangelos C. Marinos. Dated at Rockville, Maryland, this 25th day of June 2007. For the Nuclear Regulatory Commission. Catherine Haney, Director, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation. [FR Doc. E7–12635 Filed 7–2–07; 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 Radiopharmacy 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. E:\FR\FM\03JYN1.SGM 03JYN1 jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 72, No. 127 / Tuesday, July 3, 2007 / Notices 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 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 13, Revision 1. NUREG–1556, Volume 9, Revision 2, will be available for public comment in the near future. NUREG– 1556, Volume 21, was previously noticed for public comment in the Federal Register, on May 29, 2007 (72 FR 29555). DATES: Please submit comments on NUREG–1556, Volume 13, Revision 1, by August 2, 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 13, Revision 1, ‘‘Consolidated Guidance About Materials Licenses—ProgramSpecific Guidance About Commercial Radiopharmacy 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 https://www.nrc.gov/ VerDate Aug<31>2005 17:57 Jul 02, 2007 Jkt 211001 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 13, Revision 1, is ML071581047. 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: https:// 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: https://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 PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 36527 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 E:\FR\FM\03JYN1.SGM 03JYN1 jlentini on PROD1PC65 with NOTICES 36528 Federal Register / Vol. 72, No. 127 / Tuesday, July 3, 2007 / Notices volume has been developed as Volume 21 to address production of radioactive 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 13, Revision 1, ‘‘Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Commercial Radiopharmacy Licenses,’’ Draft Report for Comment. Volume 9, Revision 2, ‘‘Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Medical Use Licenses,’’ will be available for public comment in the near future. NUREG–1556, Volume 21, ‘‘Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator,’’ was previously noticed for public comment in the Federal Register on May 29, 2007 (72 FR 29555), for a 30-day comment period. NUREG–1556, Volume 13, Revision 1, ‘‘Consolidated Guidance About Materials Licenses—Program-Specific Guidance About Commercial Radiopharmacy Licenses,’’ 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. NRC is only requesting comments on the specific changes in this document related to the expanded definition of byproduct material and the NARM rule. The Abstract contains a brief summary of the nature of the changes that were made as well as a list of Sections in which substantial revisions were made or new guidance was provided. 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 the NUREG. VerDate Aug<31>2005 17:57 Jul 02, 2007 Jkt 211001 Dated at Rockville, Maryland, this 21st day of June, 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. E7–12856 Filed 7–2–07; 8:45 am] BILLING CODE 7590–01–P OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE Generalized System of Preferences (GSP): Notice of the Results of the 2006 Annual Product and Country Practices Reviews Office of the United States Trade Representative. ACTION: Notice. AGENCY: SUMMARY: This notice announces the disposition of the product petitions accepted for review in the 2006 GSP Annual Product Review, the results of the 2006 Country Practices Review, the results of the 2006 De Minimis Waiver and Redesignation Reviews, the 2006 Competitive Need Limitation (CNL) Removals, and certain CNL Waiver Revocations. The disposition of the petitions and other results are available at: https://www.ustr.gov/ Trade_Development/ Preference_Programs/GSP/ Section_Index.html and as published in Presidential Proclamation 8157 in the June 29, 2007, Federal Register. FOR FURTHER INFORMATION CONTACT: The GSP Subcommittee, Office of the United States Trade Representative (USTR), Room F–220, 1724 F Street, NW., Washington, DC 20508. The telephone number is (202) 395–6971 and the facsimile number is (202) 395–9481. The e-mail address is FR0618@USTR.EOP.GOV. SUPPLEMENTARY INFORMATION: The GSP program provides for the duty-free importation of designated articles when imported from beneficiary developing countries. The GSP program is authorized by Title V of the Trade Act of 1974 (19 U.S.C. 2461, et seq.), as amended (the ‘‘Trade Act’’), and is implemented in accordance with Executive Order 11888 of November 24, 1975, as modified by subsequent Executive Orders and Presidential Proclamations. In the 2006 Annual Product Review, the Trade Policy Staff Committee reviewed petitions to change product coverage of the GSP. The disposition of those petitions is described in List I (Decisions on CNL Waiver Petitions in PO 00000 Frm 00110 Fmt 4703 Sfmt 4703 the 2006 GSP Annual Review) of the ‘‘Results of the 2006 GSP Annual Review.’’ The disposition of petitions considered in the 2006 Country Practices Review is described in List II (‘‘Decisions on Country Practice Petitions in the 2006 GSP Annual Review’’) of the ‘‘Results of the 2006 GSP Annual Review.’’ In the 2006 Product Review, the GSP Subcommittee evaluated the appraised import values of each GSP-eligible article in 2006 to determine whether an article from a GSP beneficiary developing country exceeded the GSP CNLs. De minimis waivers were granted to certain articles that exceeded the 50 percent import share CNL, but for which the aggregate value of the imports of that article was below the 2006 de minimis level of $18 million. List III of the ‘‘Results of the 2006 GSP Annual Review’’ (Products Receiving De Minimis Waivers) is the list of the articles and the associated countries granted de minimis waivers. Additionally, certain articles from GSP-eligible countries that had previously exceeded the CNLs, but had fallen below the CNL for total annual trade in 2006 were redesignated for GSP eligibility pursuant to the 2006 review. These articles and countries are listed in List IV (Products Receiving GSP Redesignation) of the ‘‘Results of the 2006 GSP Annual Review.’’ Articles that exceeded one of the GSP CNLs in 2006, and that are newly excluded from GSP eligibility for a specific country, are listed in List V (Products Newly Subject to CNL Exclusions) of the ‘‘Results of the 2006 GSP Annual Review.’’ Certain articles for which a waiver of the application of Section 503(c)(2)(A) of the 1974 Act was issued at least five years ago, but which are revoked pursuant to Section 503(d)(5) are listed in List VI (Products for which a Waiver of the Application of Section 503(c)(2)(A) of the 1974 Act is Revoked) of the ‘‘Results of the 2006 GSP Annual Review.’’ Marideth J. Sandler, Executive Director, Generalized System of Preferences (GSP) Program Chairman, GSP Subcommittee. [FR Doc. E7–12887 Filed 7–2–07; 8:45 am] BILLING CODE 3190–W7–P SECURITIES AND EXCHANGE COMMISSION Proposed Collection; Comment Request Upon written request, copies available from: Securities and Exchange E:\FR\FM\03JYN1.SGM 03JYN1

Agencies

NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[NOTIC]
[Pages 36526-36528]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12856]


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

NUCLEAR REGULATORY COMMISSION


NUREG-1556, Volume 13, Revision 1, ``Consolidated Guidance About 
Materials Licenses Program-Specific Guidance About Commercial 
Radiopharmacy 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.

[[Page 36527]]

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 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 13, 
Revision 1. NUREG-1556, Volume 9, Revision 2, will be available for 
public comment in the near future. NUREG-1556, Volume 21, was 
previously noticed for public comment in the Federal Register, on May 
29, 2007 (72 FR 29555).

DATES: Please submit comments on NUREG-1556, Volume 13, Revision 1, by 
August 2, 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 13, Revision 1, ``Consolidated Guidance 
About Materials Licenses--Program-Specific Guidance About Commercial 
Radiopharmacy 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 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 13, 
Revision 1, is ML071581047. 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: 
https://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: 
https://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

[[Page 36528]]

volume has been developed as Volume 21 to address production of 
radioactive 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 13, Revision 1, ``Consolidated Guidance About 
Materials Licenses--Program-Specific Guidance About Commercial 
Radiopharmacy Licenses,'' Draft Report for Comment. Volume 9, Revision 
2, ``Consolidated Guidance About Materials Licenses--Program-Specific 
Guidance About Medical Use Licenses,'' will be available for public 
comment in the near future. NUREG-1556, Volume 21, ``Consolidated 
Guidance About Materials Licenses--Program-Specific Guidance About 
Possession Licenses for Production of Radioactive Material Using an 
Accelerator,'' was previously noticed for public comment in the Federal 
Register on May 29, 2007 (72 FR 29555), for a 30-day comment period.
    NUREG-1556, Volume 13, Revision 1, ``Consolidated Guidance About 
Materials Licenses--Program-Specific Guidance About Commercial 
Radiopharmacy Licenses,'' 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.
    NRC is only requesting comments on the specific changes in this 
document related to the expanded definition of byproduct material and 
the NARM rule. The Abstract contains a brief summary of the nature of 
the changes that were made as well as a list of Sections in which 
substantial revisions were made or new guidance was provided. 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 the NUREG.

    Dated at Rockville, Maryland, this 21st day of June, 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. E7-12856 Filed 7-2-07; 8:45 am]
BILLING CODE 7590-01-P

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