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81 FR 6056 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 81, Issue 23 (February 4, 2016)

Page Range6056-6057
FR Document2016-02121

The U.S. Nuclear Regulatory Commission will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on March 17-18, 2016. A sample of agenda items to be discussed during the public session includes: A discussion on the reporting of medical events for various modalities; an update on medical-related events; a discussion on the training and experience requirements for authorized users of alpha and beta emitters; an update on the licensing guidance for yttrium-90 microsphere brachytherapy; and a discussion on the licensing guidance for the Leksell Gamma Knife[supreg] Icon<SUP>TM</SUP> unit. The agenda is subject to change. The current agenda and any updates will be available at http://www.nrc.gov/reading-rm/doc- collections/acmui/meetings/2016.html or by emailing Ms. Sophie Holiday at the contact information below. Purpose: Discuss issues related to 10 CFR part 35 Medical Use of Byproduct Material. Date and Time for Open Sessions: March 17, 2016, from 9:30 a.m. to 5:00 p.m. and March 18, 2016, from 8:00 a.m. to 11:30 a.m. Data and Time for Closed Sessions: March 17, 2016, from 7:30 a.m. to 9:30 a.m., March 18, 2016, from 7:30 a.m. to 8:00 a.m., and March 18, 2016, from 12:00 p.m. to 1:00 p.m. Address for Public Meeting: U.S. Nuclear Regulatory Commission, Two White Flint North Building, Room T2-B3, 11545 Rockville Pike, Rockville, Maryland 20852. Public Participation: Any member of the public who wishes to participate in the meeting in person or via phone should contact Ms. Holiday using the information below. The meeting will also be webcast live: video.nrc.gov. Contact Information: Ms. Sophie J. Holiday, email: [email protected], telephone: (301) 415-7865.

Federal Register, Volume 81 Issue 23 (Thursday, February 4, 2016)
[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Notices]
[Pages 6056-6057]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02121]


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

NUCLEAR REGULATORY COMMISSION


Advisory Committee on the Medical Uses of Isotopes: Meeting 
Notice

AGENCY: U.S. Nuclear Regulatory Commission

ACTION: Notice of Meeting.

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

SUMMARY: The U.S. Nuclear Regulatory Commission will convene a meeting 
of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on 
March 17-18, 2016. A sample of agenda items to be discussed during the 
public session includes: A discussion on the reporting of medical 
events for various modalities; an update on medical-related events; a 
discussion on the training and experience requirements for authorized 
users of alpha and beta emitters; an update on the licensing guidance 
for yttrium-90 microsphere brachytherapy; and a discussion on the 
licensing guidance for the Leksell Gamma Knife[supreg] 
IconTM unit. The agenda is subject to change. The current 
agenda and any

[[Page 6057]]

updates will be available at http://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2016.html or by emailing Ms. Sophie Holiday 
at the contact information below.
    Purpose: Discuss issues related to 10 CFR part 35 Medical Use of 
Byproduct Material.
    Date and Time for Open Sessions: March 17, 2016, from 9:30 a.m. to 
5:00 p.m. and March 18, 2016, from 8:00 a.m. to 11:30 a.m.
    Data and Time for Closed Sessions: March 17, 2016, from 7:30 a.m. 
to 9:30 a.m., March 18, 2016, from 7:30 a.m. to 8:00 a.m., and March 
18, 2016, from 12:00 p.m. to 1:00 p.m.
    Address for Public Meeting: U.S. Nuclear Regulatory Commission, Two 
White Flint North Building, Room T2-B3, 11545 Rockville Pike, 
Rockville, Maryland 20852.
    Public Participation: Any member of the public who wishes to 
participate in the meeting in person or via phone should contact Ms. 
Holiday using the information below. The meeting will also be webcast 
live: video.nrc.gov.
    Contact Information: Ms. Sophie J. Holiday, email: 
[email protected], telephone: (301) 415-7865.

Conduct of the Meeting

    Philip O. Alderson, M.D., will chair the meeting. Dr. Alderson 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 Ms. Holiday at the contact information listed above. 
All submittals must be received by March 15, 2016, and must pertain to 
the topic 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 draft transcript and meeting summary will be available on 
ACMUI's Web site http://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2016.html on or about April 29, 2016.
    4. Persons who require special services, such as those for the 
hearing impaired, should notify Ms. Holiday 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 Code of Federal Regulations Part 7.

    Dated at Rockville, Maryland, this 28th day of January 2016.

    For the Nuclear Regulatory Commission.
Andrew L. Bates,
Advisory Committee Management Officer.
[FR Doc. 2016-02121 Filed 2-3-16; 8:45 am]
 BILLING CODE 7590-01-P



                                                    6056                        Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices

                                                    Tank Recommendations.’’ This LR–ISG                     Regulation, U.S. Nuclear Regulatory                   Congressional Review Act
                                                    will replace NRC staff-recommended                      Commission, Washington, DC 20555–                        This ISG is a rule as defined in the
                                                    aging management program (AMP)                          0001.                                                 Congressional Review Act (5 U.S.C.
                                                    XI.M41, ‘‘Buried and Underground                                                                              801–808). However, the Office of
                                                                                                            SUPPLEMENTARY INFORMATION:
                                                    Piping and Tanks,’’ and its associated                                                                        Management and Budget has not found
                                                    Updated Final Safety Evaluation Report                  Background                                            it to be a major rule as defined in the
                                                    (UFSAR) Summary Description in LR–                                                                            Congressional Review Act.
                                                    ISG–2011–03, ‘‘Changes to the Generic                      The NRC issues LR–ISGs to
                                                    Aging Lessons Learned (GALL) Report                     communicate insights and lessons                      Backfitting and Issue Finality
                                                    Revision 2 AMP XI.M41, ‘Buried and                      learned and to address emergent issues
                                                                                                                                                                     Issuance of this final LR–ISG does not
                                                    Underground Piping and Tanks’.’’ These                  not covered in license renewal guidance
                                                                                                                                                                  constitute backfitting as defined in 10
                                                    changes address new recommendations                     documents, such as the GALL Report,                   CFR 50.109 (the Backfit Rule) and is not
                                                    related to buried and underground                       NUREG–1801, Rev. 2 (Dec. 2010), and                   otherwise inconsistent with the issue
                                                    piping and tanks within the scope of the                the Standard Review Plan for Review of                finality provisions in 10 CFR part 52,
                                                    NRC’s regulations for the renewal of                    License Renewal Applications for                      ‘‘Licenses, Certifications, and Approvals
                                                    operating licenses for nuclear power                    Nuclear Power Plants (SRP–LR),                        for Nuclear Power Plants.’’ As discussed
                                                    plants.                                                 NUREG–1800, Rev. 2 (Dec. 2010), which                 in the ‘‘Backfitting and Issue Finality’’
                                                                                                            are available under ADAMS Accession                   section of the final LR–ISG–2015–01,
                                                    ADDRESSES: Please refer to Docket ID                    Nos. ML103490041 and ML103490036,
                                                    NRC–2015–0159 when contacting the                                                                             the LR–ISG is directed to holders of
                                                                                                            respectively. In this way, the NRC staff              operating licenses or combined licenses
                                                    NRC about the availability of                           and stakeholders may use the guidance
                                                    information regarding this document.                                                                          who are currently in the license renewal
                                                                                                            in an LR–ISG document before it is                    process. The LR–ISG is not directed to
                                                    You may obtain publicly-available                       incorporated into a formal license
                                                    information related to this document                                                                          holders of operating licenses or
                                                                                                            renewal guidance document revision.                   combined licenses until they apply for
                                                    using any of the following methods:                     The NRC staff issues LR–ISGs in
                                                       • Federal Rulemaking Web site: Go to                                                                       license renewal. The LR–ISG is also not
                                                                                                            accordance with the LR–ISG Process,                   directed to licensees who already hold
                                                    http://www.regulations.gov and search                   Revision 2 (ADAMS Accession No.
                                                    for Docket ID NRC–2015–0159. Address                                                                          renewed operating or combined
                                                                                                            ML100920158), for which a notice of                   licenses. However, the NRC could also
                                                    questions about NRC dockets to Carol                    availability was published in the
                                                    Gallagher; telephone 301–415–3463;                                                                            use the LR–ISG in evaluating voluntary,
                                                                                                            Federal Register on June 22, 2010, (75                licensee-initiated changes to previously
                                                    email: Carol.Gallagher@nrc.gov. For                     FR 35510).
                                                    technical questions, contact the                                                                              approved aging management programs.
                                                                                                               The NRC staff has developed LR–ISG–                  Dated at Rockville, Maryland, this 29th day
                                                    individuals listed in the FOR FURTHER
                                                                                                            2015–01 to address new                                of January, 2016.
                                                    INFORMATION CONTACT section of this
                                                                                                            recommendations related to buried and                   For the Nuclear Regulatory Commission.
                                                    document.
                                                       • NRC’s Agencywide Document                          underground piping and tanks within                   Jane E. Marshall,
                                                    Access and Management System                            the scope of part 54 of title 10 of the
                                                                                                                                                                  Deputy Director, Division of License Renewal,
                                                    (ADAMS): You may obtain publicly-                       Code of Federal Regulations (10 CFR),                 Office of Nuclear Reactor Regulation.
                                                    available documents online in the                       ‘‘Requirements for Renewal of Operating
                                                                                                                                                                  [FR Doc. 2016–02122 Filed 2–3–16; 8:45 am]
                                                    ADAMS Public Documents collection at                    Licenses for Nuclear Power Plants.’’
                                                                                                                                                                  BILLING CODE 7590–01–P
                                                    http://www.nrc.gov/reading-rm/                             On June 29, 2015, (80 FR 37028) the
                                                    adams.html. To begin the search, select                 NRC requested public comments on
                                                    ‘‘ADAMS Public Documents’’ and then                     draft LR–ISG–2015–01 (ADAMS                           NUCLEAR REGULATORY
                                                    select ‘‘Begin Web-based ADAMS                          Accession No. ML15125A377).                           COMMISSION
                                                    Search.’’ For problems with ADAMS,                         The NRC received comments from the
                                                    please contact the NRC’s Public                         Nuclear Energy Institute by letter dated              Advisory Committee on the Medical
                                                    Document Room (PDR) reference staff at                  August 6, 2015, (ADAMS Accession No.                  Uses of Isotopes: Meeting Notice
                                                    1–800–397–4209, 301–415–4737, or by                     ML15225A076), Hank Kleinfelder by                     AGENCY: U.S. Nuclear Regulatory
                                                    email to pdr.resource@nrc.gov. The final                letter dated August 6, 2015, (ADAMS                   Commission
                                                    LR–ISG–2015–01 is available                             Accession No. ML15225A077),
                                                                                                                                                                  ACTION: Notice of Meeting.
                                                    electronically in ADAMS under                           Anonymous by letter dated August 7,
                                                    Accession No. ML15308A018.                              2015, (ADAMS Accession No.                            SUMMARY:   The U.S. Nuclear Regulatory
                                                       • NRC’s PDR: You may examine and                     ML15225A078), Kevin Anstee for                        Commission will convene a meeting of
                                                    purchase copies of public documents at                  Entergy—River Bend Station by letter                  the Advisory Committee on the Medical
                                                    the NRC’s PDR, Room O1–F21, One                         dated August 10, 2015, (ADAMS                         Uses of Isotopes (ACMUI) on March 17–
                                                    White Flint North, 11555 Rockville                      Accession No. ML15244A392), and                       18, 2016. A sample of agenda items to
                                                    Pike, Rockville, Maryland 20852.                        Steven Daily by letter dated August 10,               be discussed during the public session
                                                       • NRC’s Interim Staff Guidance Web                   2015, (ADAMS Accession No.                            includes: A discussion on the reporting
                                                    Site: LR–ISG documents are also                         ML15244A391). No other comments                       of medical events for various modalities;
                                                    available online under the ‘‘License                    were submitted. The NRC considered                    an update on medical-related events; a
                                                    Renewal’’ heading at http://                            these comments in developing the final                discussion on the training and
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    www.nrc.gov/reading-rm/doc-                             LR–ISG. Detailed responses to the                     experience requirements for authorized
                                                    collections/isg/license-renewal.html.                   comments can be found in Appendix D                   users of alpha and beta emitters; an
                                                    FOR FURTHER INFORMATION CONTACT:                        of the final LR–ISG.                                  update on the licensing guidance for
                                                    William Holston, telephone: 301–415–                       The final LR–ISG–2015–01 is                        yttrium-90 microsphere brachytherapy;
                                                    8573; email: William.Holston@nrc.gov                    approved for NRC staff and stakeholder                and a discussion on the licensing
                                                    or Brian Allik, telephone: 301–415–                     use and will be incorporated into the                 guidance for the Leksell Gamma Knife®
                                                    1082; email: Brian.Allik@nrc.gov. Both                  NRC’s next formal license renewal                     IconTM unit. The agenda is subject to
                                                    are staff of the Office of Nuclear Reactor              guidance document revision.                           change. The current agenda and any


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                                                                                Federal Register / Vol. 81, No. 23 / Thursday, February 4, 2016 / Notices                                            6057

                                                    updates will be available at http://                     For the Nuclear Regulatory Commission.               ADAMS accession number for each
                                                    www.nrc.gov/reading-rm/doc-                             Andrew L. Bates,                                      document referenced (if that document
                                                    collections/acmui/meetings/2016.html                    Advisory Committee Management Officer.                is available in ADAMS) is provided the
                                                    or by emailing Ms. Sophie Holiday at                    [FR Doc. 2016–02121 Filed 2–3–16; 8:45 am]            first time that a document is referenced.
                                                    the contact information below.                          BILLING CODE 7590–01–P
                                                                                                                                                                     • NRC’s PDR: You may examine and
                                                       Purpose: Discuss issues related to 10                                                                      purchase copies of public documents at
                                                    CFR part 35 Medical Use of Byproduct                                                                          the NRC’s PDR, Room O1–F21, One
                                                    Material.                                               NUCLEAR REGULATORY                                    White Flint North, 11555 Rockville
                                                       Date and Time for Open Sessions:                     COMMISSION                                            Pike, Rockville, Maryland 20852.
                                                    March 17, 2016, from 9:30 a.m. to 5:00                                                                        FOR FURTHER INFORMATION CONTACT:
                                                    p.m. and March 18, 2016, from 8:00 a.m.                 [Docket No. 40–6563; NRC–2015–0139]
                                                                                                                                                                  Karen Pinkston, Office of Nuclear
                                                    to 11:30 a.m.                                                                                                 Material Safety and Safeguards, U.S.
                                                       Data and Time for Closed Sessions:                   Mallinckrodt, LLC.
                                                                                                                                                                  Nuclear Regulatory Commission,
                                                    March 17, 2016, from 7:30 a.m. to 9:30                  AGENCY:  Nuclear Regulatory                           Washington DC 20555–0001; telephone:
                                                    a.m., March 18, 2016, from 7:30 a.m. to                 Commission.                                           301–415–3650; email: Karen.Pinkston@
                                                    8:00 a.m., and March 18, 2016, from                     ACTION: Environmental assessment and                  nrc.gov.
                                                    12:00 p.m. to 1:00 p.m.                                 finding of no significant impact;
                                                       Address for Public Meeting: U.S.                                                                           SUPPLEMENTARY INFORMATION:
                                                                                                            issuance.
                                                    Nuclear Regulatory Commission, Two                                                                            I. Introduction
                                                    White Flint North Building, Room T2–                    SUMMARY:    The U.S. Nuclear Regulatory
                                                    B3, 11545 Rockville Pike, Rockville,                                                                             The NRC is considering issuance of an
                                                                                                            Commission (NRC) is considering                       amendment to the NRC’s Source
                                                    Maryland 20852.                                         amending the NRC’s Source Materials
                                                       Public Participation: Any member of                                                                        Materials License No. STB–401, issued
                                                                                                            License No. STB–401 to allow the                      to Mallinckrodt, for operation of their
                                                    the public who wishes to participate in                 option to perform direct dose
                                                    the meeting in person or via phone                                                                            facility located in St. Louis, Missouri.
                                                                                                            assessment of residual radioactivity in               This amendment allows Mallinckrodt
                                                    should contact Ms. Holiday using the                    addition to using derived concentration
                                                    information below. The meeting will                                                                           the option to perform direct dose
                                                                                                            guideline levels (DCGLs) to demonstrate               assessment of residual radioactivity in
                                                    also be webcast live: video.nrc.gov.                    compliance with the license termination
                                                       Contact Information: Ms. Sophie J.                                                                         addition to using derived concentration
                                                                                                            criteria at the Mallinckrodt site in St.              guideline levels (DCGLs) to demonstrate
                                                    Holiday, email: sophie.holiday@nrc.gov,                 Louis, Missouri. The NRC staff is
                                                    telephone: (301) 415–7865.                                                                                    compliance with the license termination
                                                                                                            issuing an environmental assessment                   criteria at the Mallinckrodt site in St.
                                                    Conduct of the Meeting                                  (EA) and finding of no significant                    Louis, Missouri. Consistent with part 51
                                                                                                            impact (FONSI) associated with the                    of title 10 of the Code of Federal
                                                      Philip O. Alderson, M.D., will chair
                                                                                                            proposed action.                                      Regulations (10 CFR), the NRC
                                                    the meeting. Dr. Alderson will conduct
                                                    the meeting in a manner that will                       DATES: The EA and FONSI referenced in                 performed an EA. Based on the results
                                                    facilitate the orderly conduct of                       this document are available on February               of the EA described below, the NRC will
                                                    business. The following procedures                      4, 2016.                                              not prepare an environmental impact
                                                    apply to public participation in the                    ADDRESSES: Please refer to Docket ID                  statement for the license amendment,
                                                    meeting:                                                NRC–2015–0139 when contacting the                     and is issuing a FONSI.
                                                      1. Persons who wish to provide a                      NRC about the availability of                            The NRC received, by letter dated
                                                    written statement should submit an                      information regarding this document.                  February 12, 2015 (ADAMS Accession
                                                    electronic copy to Ms. Holiday at the                   You may obtain publicly-available                     No. ML15063A404), an application from
                                                    contact information listed above. All                   information related to this document                  Mallinckrodt LLC to amend the NRC’s
                                                    submittals must be received by March                    using any of the following methods:                   Source Materials License No. STB–401.
                                                    15, 2016, and must pertain to the topic                    • Federal Rulemaking Web site: Go to               The licensee requests the option to
                                                    on the agenda for the meeting.                          http://www.regulations.gov and search                 perform direct dose assessment of
                                                      2. Questions and comments from                        for Docket ID NRC–2015–0139. Address                  residual radioactivity in addition to
                                                    members of the public will be permitted                 questions about NRC dockets to Carol                  using DCGLs to demonstrate compliance
                                                    during the meeting, at the discretion of                Gallagher; telephone: 301–415–3463;                   with the license termination criteria in
                                                    the Chairman.                                           email: Carol.Gallagher@nrc.gov. For                   10 CFR 20.1402 at the Mallinckrodt site
                                                      3. The draft transcript and meeting                   technical questions, contact the                      in St. Louis, Missouri. The license
                                                    summary will be available on ACMUI’s                    individual listed in the FOR FURTHER                  currently states that the
                                                    Web site http://www.nrc.gov/reading-                    INFORMATION CONTACT section of this                   Decommissioning of the Columbium-
                                                    rm/doc-collections/acmui/meetings/                      document.                                             Tantalum (C–T) process area building
                                                    2016.html on or about April 29, 2016.                      • NRC’s Agencywide Documents                       slabs and foundations, paved surfaces,
                                                      4. Persons who require special                        Access and Management System                          and all subsurface materials, shall be
                                                    services, such as those for the hearing                 (ADAMS): You may obtain publicly-                     done in accordance with the
                                                    impaired, should notify Ms. Holiday of                  available documents online in the                     Mallinckrodt C–T Decommissioning
                                                    their planned attendance.                               ADAMS Public Documents collection at                  Project, C–T Phase II Decommissioning
                                                      This meeting will be held in                          http://www.nrc.gov/reading-rm/                        Plan (DP), Revision 2, submitted to NRC
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    accordance with the Atomic Energy Act                   adams.html. To begin the search, select               on October 14, 2008 (ADAMS Accession
                                                    of 1954, as amended (primarily Section                  ‘‘ADAMS Public Documents’’ and then                   No. ML083150652), and revisions
                                                    161a); the Federal Advisory Committee                   select ‘‘Begin Web-based ADAMS                        submitted on June 3, 2010 (ADAMS
                                                    Act (5 U.S.C. App); and the                             Search.’’ For problems with ADAMS,                    Accession No. ML101620140). A Notice
                                                    Commission’s regulations in Title 10                    please contact the NRC’s Public                       of Availability of an EA and FONSI was
                                                    Code of Federal Regulations Part 7.                     Document Room (PDR) reference staff at                published for the NRC’s approval of the
                                                      Dated at Rockville, Maryland, this 28th day           1–800–397–4209, 301–415–4737, or by                   DP in the Federal Register on July 1,
                                                    of January 2016.                                        email to pdr.resource@nrc.gov. The                    2010 (75 FR 38148). The NRC approved


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Document Created: 2016-02-04 00:31:37
Document Modified: 2016-02-04 00:31:37
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of Meeting.
FR Citation81 FR 6056 

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