Advisory Committee on the Medical Uses of Isotopes: Meeting Notice, 41316-41317 [2014-16584]

Download as PDF 41316 Federal Register / Vol. 79, No. 135 / Tuesday, July 15, 2014 / Notices ADAMS under Accession No. ML14139A316. • NRC’s PDR: You may examine and purchase copies of public documents at the NRC’s PDR, Room O1–F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them. FOR FURTHER INFORMATION CONTACT: Sabrina Atack, Office of Nuclear Material Safety and Safeguards; telephone: 301–287–9075, email: Sabrina.Atack@nrc.gov; and Steve Burton, Office of Nuclear Regulatory Research; telephone: 301–415–7000, Stephen.Burton@nrc.gov. Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Introduction The NRC is issuing a new guide in the NRC’s ‘‘Regulatory Guide’’ series. This series was developed to describe and make available to the public information such as methods that are acceptable to the NRC staff for implementing specific parts of the agency’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. Regulatory Guide 3.75 describes programmatic elements that the staff of the NRC considers acceptable when developing corrective action programs for fuel cycle facilities that are licensed under part 40 of Title 10 of the Code of Federal Regulations (10 CFR), ‘‘Domestic Licensing of Source Material’’ or 10 CFR part 70, ‘‘Domestic Licensing of Special Nuclear Material’’ or holders of certificates of compliance or approvals of a compliance plan for gaseous diffusion plants under 10 CFR part 76, ‘‘Certification of Gaseous Diffusion Plants.’’ II. Additional Information Regulatory Guide 3.75 was issued with a temporary identification as draft regulatory guide (DG), DG–3044. Draft regulatory guide, DG–3044, was published in the Federal Register on February 12, 2014 (79 FR 8511), for a 30-day public comment period. The public comment period closed on March 14, 2014. Public comments on DG–3044 and the staff’s responses to the public comments are available in ADAMS under Accession No. ML14139A318. III. Congressional Review Act This RG is a rule as defined in the Congressional Review Act (5 U.S.C. VerDate Mar<15>2010 17:46 Jul 14, 2014 Jkt 232001 801–808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act. IV. Backfitting and Issue Finality This RG describes programmatic elements that the staff considers acceptable for corrective action programs (CAPs) for fuel cycle facilities licensed under 10 CFR parts 40, or 70, and gaseous diffusion plants holding certificates of compliance under 10 CFR part 76. Applicants for such facilities and certificates of compliance, as well as existing licensees and holders of certificate of compliance, may use the guidance in developing, implementing or revising CAPs. Licensees may choose to develop and implement CAPs that meet the guidance in this RG for the purpose of applying Section 2.3.2 of the NRC Enforcement Policy. The NRC staff may find methods or solutions that differ from those described in this RG acceptable for the purpose of applying Section 2.3.2 of the NRC Enforcement Policy if those methods or solutions effectively implement controls to identify, document, and correct conditions adverse to safety and security. Applicants for, and holders of fuel cycle licenses under part 40 are not subject to backfitting protection, inasmuch as the NRC’s regulations do not provide backfitting protection to part 40 applicants or licensees. This RG does not constitute backfitting for any fuel cycle facility applicants or licensees subject to backfitting protection under part 70, or applicants for or holders of certificates of compliance for gaseous diffusion plants under part 76. No part 70 licensee or holder of a part 76 certificates of compliance is required to comply with the guidance, and a licensee or holder of a certificate of compliance is free to demonstrate that its corrective action program is effective in identifying, documenting, and correcting conditions adverse to safety and security in order to be within the purview of Section 2.3.2 of the NRC Enforcement Policy. With respect to applicants or potential applicants for part 70 licenses and part 76 certificates of compliance, such entities are not protected by the backfitting provisions in parts 70 and 76. Backfitting is intended to protect the reasonable expectations of certain entities who have received NRC regulatory approvals (e.g., a license), and was not intended to apply to NRC actions which substantially change the expectations of current and future applicants. PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 This RG does not apply to any nuclear power reactors subject to 10 CFR parts 50 or 52. Therefore, backfitting considerations under 10 CFR 50.109 or issue finality considerations under 10 CFR part 52 are not applicable to this RG. Dated at Rockville, Maryland, this 9 day of July, 2014. For the Nuclear Regulatory Commission. Thomas H. Boyce, Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2014–16513 Filed 7–14–14; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice U.S. Nuclear Regulatory Commission. ACTION: Notice of Meeting. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) will convene a meeting of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) on September 29–30, 2014. A sample of agenda items to be discussed during the public session includes: (1) A discussion on the physical presence requirements for the Leksell Gamma Knife ® Perfexion TM; (2) a discussion on why and how certain emerging medical technologies are licensed under 10 CFR 35.1000; (3) a presentation on FDA’s role regarding the global molybdenum99 shortage; (4) an update on the NRC staff’s efforts related to the release of patients administered radioactive material; (5) a discussion on the various mechanisms in use or proposed for reporting medical incidents; and (6) a discussion on the recommendations regarding the current medical event reporting criteria for yttrium-90 microspheres. The agenda is subject to change. The current agenda and any updates will be available at https:// www.nrc.gov/reading-rm/doccollections/acmui/meetings/2014.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 Closed Sessions: September 30, 2014, from 1:30 p.m. to 3:00 p.m. The session on September 30, 2014 will be closed for ACMUI training. Date and Time for Open Sessions: September 29, 2014, from 8:30 a.m. to 5:00 p.m. and September 30, 2014, from 8:00 a.m. to 1:30 p.m. SUMMARY: E:\FR\FM\15JYN1.SGM 15JYN1 Federal Register / Vol. 79, No. 135 / Tuesday, July 15, 2014 / Notices 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: Sophie J. Holiday, email: Sophie.Holiday@ nrc.gov., telephone: (301) 415–7865. Conduct of the Meeting Bruce R. Thomadsen, Ph.D., will chair the meeting. Dr. Thomadsen 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 September 24, 2014, 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 https://www.nrc.gov/readingrm/doc-collections/acmui/meetings/ 2014.html on or about November 11, 2014. 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, U.S. Code of Federal Regulations, Part 7. Dated: July 8, 2014. Andrew L. Bates, Advisory Committee Management Officer. [FR Doc. 2014–16584 Filed 7–14–14; 8:45 am] mstockstill on DSK4VPTVN1PROD with NOTICES BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION Sunshine Federal Register Notice AGENCY HOLDING THE MEETINGS: Nuclear Regulatory Commission [NRC–2012– 0002] DATE: Week of July 14, 2014 VerDate Mar<15>2010 17:46 Jul 14, 2014 Commissioners’ Conference Room, 11555 Rockville Pike, Rockville, Maryland PLACE: STATUS: SECURITIES AND EXCHANGE COMMISSION Sunshine Act Meeting Public and Closed. ADDITIONAL ITEMS TO BE CONSIDERED: Week of July 14, 2014 Thursday, July 17, 2014 8:55 a.m. Affirmation Session (Public Meeting) (Tentative) a. Petitions to Suspend Reactor Licensing Decisions and Reactor License Renewal Decisions Pursuant to 10 C.F.R. § 2.802(D) (Filed on Multiple Dockets) (Tentative) This meeting will be webcast live at the Web address—https://www.nrc.gov/. * * * * * *The schedule for Commission meetings is subject to change on short notice. To verify the status of meetings, call (recording)—(301) 415–1292. Contact person for more information: Rochelle Bavol, (301) 415–1651. * * * * * The NRC Commission Meeting Schedule can be found on the Internet at: www.nrc.gov/about-nrc/policymaking/schedule.html. * * * * * The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (e.g. braille, large print), please notify Bill Dosch, Chief, Work Life and Benefits Branch, at 301–415–6200, TDD: 301– 415–2100, or by email at william.dosch@nrc.gov. Determinations on requests for reasonable accommodation will be made on a caseby-case basis. * * * * * This notice is distributed electronically to subscribers. If you no longer wish to receive it, or would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301–415–1969), or send an email to darlene.wright@ nrc.gov. Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94–409, that the Securities and Exchange Commission will hold a Closed Meeting on Thursday, July 17, 2014 at 2:00 p.m. Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present. The General Counsel of the Commission, or her designee, has certified that, in her opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matter at the Closed Meeting. Commissioner Gallagher, as duty officer, voted to consider the items listed for the Closed Meeting in closed session. The subject matter of the Closed Meeting will be: Institution and settlement of injunctive actions; institution and settlement of administrative proceedings; and other matters relating to enforcement proceedings. At times, changes in Commission priorities require alterations in the scheduling of meeting items. For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551–5400. Dated: July 11, 2014. Kevin M. O’Neill, Deputy Secretary. [FR Doc. 2014–16697 Filed 7–11–14; 4:15 pm] BILLING CODE 8011–01–P Dated: July 10, 2014. Richard J. Laufer, Technical Coordinator, Office of the Secretary. [FR Doc. 2014–16566 Filed 7–11–14; 11:15 am] BILLING CODE 7590–01–P Jkt 232001 PO 00000 Frm 00072 Fmt 4703 Sfmt 9990 41317 E:\FR\FM\15JYN1.SGM 15JYN1

Agencies

NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 79, Number 135 (Tuesday, July 15, 2014)]
[Notices]
[Pages 41316-41317]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16584]


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

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 (NRC) will convene a 
meeting of the Advisory Committee on the Medical Uses of Isotopes 
(ACMUI) on September 29-30, 2014. A sample of agenda items to be 
discussed during the public session includes: (1) A discussion on the 
physical presence requirements for the Leksell Gamma Knife [supreg] 
Perfexion \TM\; (2) a discussion on why and how certain emerging 
medical technologies are licensed under 10 CFR 35.1000; (3) a 
presentation on FDA's role regarding the global molybdenum-99 shortage; 
(4) an update on the NRC staff's efforts related to the release of 
patients administered radioactive material; (5) a discussion on the 
various mechanisms in use or proposed for reporting medical incidents; 
and (6) a discussion on the recommendations regarding the current 
medical event reporting criteria for yttrium-90 microspheres. The 
agenda is subject to change. The current agenda and any updates will be 
available at https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2014.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 Closed Sessions: September 30, 2014, from 1:30 
p.m. to 3:00 p.m. The session on September 30, 2014 will be closed for 
ACMUI training.
    Date and Time for Open Sessions: September 29, 2014, from 8:30 a.m. 
to 5:00 p.m. and September 30, 2014, from 8:00 a.m. to 1:30 p.m.

[[Page 41317]]

    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: Sophie J. Holiday, email: 
Sophie.Holiday@nrc.gov., telephone: (301) 415-7865.

Conduct of the Meeting

    Bruce R. Thomadsen, Ph.D., will chair the meeting. Dr. Thomadsen 
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 September 24, 2014, 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 https://www.nrc.gov/reading-rm/doc-collections/acmui/meetings/2014.html on or about November 11, 2014.
    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, U.S. Code of Federal Regulations, Part 7.

    Dated: July 8, 2014.
Andrew L. Bates,
Advisory Committee Management Officer.
[FR Doc. 2014-16584 Filed 7-14-14; 8:45 am]
BILLING CODE 7590-01-P

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