Program-Specific Guidance About Medical Use Licenses, 87978-87979 [2016-29214]

Download as PDF mstockstill on DSK3G9T082PROD with NOTICES 87978 Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Notices proceeding, so that the filer need not serve the documents on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before a hearing petition to intervene is filed so that they can obtain access to the document via the E-Filing system. A person filing electronically using the NRC’s adjudicatory E-Filing system may seek assistance by contacting the NRC Electronic Filing Help Desk through the ‘‘Contact Us’’ link located on the NRC’s public Web site at http:// www.nrc.gov/site-help/esubmittals.html, by email to MSHD.Resource@nrc.gov, or by a tollfree call at 1–866–672–7640. The NRC Electronic Filing Help Desk is available between 9 a.m. and 7 p.m., Eastern Time, Monday through Friday, excluding government holidays. Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted 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; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by firstclass mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists. Documents submitted in adjudicatory proceedings will appear in the NRC’s electronic hearing docket which is available to the public at http:// ehd1.nrc.gov/ehd/, unless excluded pursuant to an order of the Commission, or the presiding officer. Participants are requested not to include personal privacy information, such as social VerDate Sep<11>2014 17:39 Dec 05, 2016 Jkt 241001 security numbers, home addresses, or home phone numbers in their filings, unless an NRC regulation or other law requires submission of such information. However, in some instances, a petition will require including information on local residence in order to demonstrate a proximity assertion of interest in the proceeding. With respect to copyrighted works, except for limited excerpts that serve the purpose of the adjudicatory filings and would constitute a Fair Use application, participants are requested not to include copyrighted materials in their submission. The Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the Federal Register and served on the parties to the hearing. Exelon Generation Company, LLC, Docket Nos. 50–373 and 50–374, LaSalle County Station (LSCS), Units 1 and 2, LaSalle County, Illinois Date of amendment request: September 30, 2016, as supplemented by letter dated November 8, 2016. Description of amendment request: The amendments revised the LSCS licensing basis related to Alternate Source Term Analysis in the Updated Final Safety Analysis Report to allow operation with and movement of irradiated Atrium-10 fuel bundles containing part length rods that have been in operation above 62,000 megawatt days per metric ton of uranium (MWD/MTU), which is the current rod average burnup limit specified in Footnote 11 of NRC Regulatory Guide (RG) 1.183, ‘‘Alternative Radiological Source Terms for Evaluating Design Basis Accidents at Nuclear Power Reactors,’’ to which LSCS is committed. In addition, the change allows use of the release fractions listed in Table 1 of RG 1.183 for these Atrium-10 partial length rods that are currently in the LSCA, Unit 2, Cycle 16, reactor core for the remainder of the current operating cycle. Date of issuance: November 18, 2016. Effective date: As of the date of issuance and shall be implemented within 10 days from the date of issuance. Amendment Nos.: Unit 1—221; Unit 2—207. A publicly-available version is in ADAMS under Accession No. ML16320A182; documents related to these amendments are listed in the Safety Evaluation enclosed with the amendments. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 Facility Operating License Nos. NPF– 11 and NPF–18: The amendments revised the licensing basis related to Alternate Source Term in the Updated Final Safety Analysis Report. Public comments requested as to proposed no significant hazards consideration (NSHC): Yes. Public notice of the proposed amendment was published in The Ottawa Times on November 15 and November 16, 2016. The notice provided an opportunity to submit comments on the Commission’s proposed NSHC determination. No comments have been received. The Commission’s related evaluation of the amendment, finding of exigent circumstances, state consultation, and final NSHC determination are contained in a safety evaluation dated November 18, 2016. Attorney for licensee: Bradley J. Fewell, Associate General Counsel, Exelon Nuclear, 4300 Winfield Road, Warrenville, IL 60555. NRC Acting Branch Chief: Edward G. Miller. Dated at Rockville, Maryland, this 23rd day of November 2016. For the Nuclear Regulatory Commission. Anne T. Boland, Director, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation. [FR Doc. 2016–28990 Filed 12–5–16; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [NRC–2016–0122] Program-Specific Guidance About Medical Use Licenses Nuclear Regulatory Commission. ACTION: Draft NUREG; request for comments. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is revising its licensing guidance for licenses authorizing medical use of byproduct material. The NRC is requesting public comment on draft NUREG–1556, Volume 9, Revision 3, ‘‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses.’’ The document has been updated from the previous revision to include information on safety culture, security of radioactive materials, protection of sensitive information, and changes in regulatory policies and practices. This document is intended for use by applicants, licensees, and the NRC staff. SUMMARY: E:\FR\FM\06DEN1.SGM 06DEN1 Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Notices Submit comments by February 6, 2017. Comments received after this date will be considered if it is practical to do so, but the NRC is only able to assure consideration of comments received on or before this date. ADDRESSES: You may submit comment by any of the following methods (unless this document describes a different method for submitting comments on a specific subject): • Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC–2016–0122. Address questions about NRC dockets to Carol Gallagher; telephone: 301–415–3463; email: Carol.Gallagher@nrc.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document. • Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: OWFN–12–H8, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001. For additional direction on accessing information and submitting comments, see ‘‘Obtaining Information and Submitting Comments’’ in the SUPPLEMENTARY INFORMATION section of this document. FOR FURTHER INFORMATION CONTACT: Katie Tapp, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–415– 0236; email: Katherine.Tapp@nrc.gov. SUPPLEMENTARY INFORMATION: DATES: I. Obtaining Information and Submitting Comments mstockstill on DSK3G9T082PROD with NOTICES A. Obtaining Information Please refer to Docket ID NRC–2016– 0122 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this action by the following methods: • Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC–2016–0122. • NRC’s Agencywide Documents Access and Management System (ADAMS): You may obtain publiclyavailable documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/ adams.html. To begin the search, select ‘‘ADAMS Public Documents’’ and then select ‘‘Begin Web-based ADAMS Search.’’ For problems with ADAMS, please contact the NRC’s Public Document Room (PDR) reference staff at 1–800–397–4209, 301–415–4737, or by email to pdr.resource@nrc.gov. The draft NUREG–1556, Volume 9, Revision 3, is VerDate Sep<11>2014 17:39 Dec 05, 2016 Jkt 241001 available in ADAMS under Accession No. ML16328A214. • 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. The draft NUREG–1556, Volume 9, Revision 3, is also available on the NRC’s public Web site on the: (1) ‘‘Consolidated Guidance About Materials Licenses (NUREG–1556)’’ page at http://www.nrc.gov/reading-rm/ doc-collections/nuregs/staff/sr1556/; and the (2) ‘‘Draft NUREG-Series Publications for Comment’’ page at http://www.nrc.gov/public-involve/doccomment.html#nuregs. B. Submitting Comments Please include Docket ID NRC–2016– 0122 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket. The NRC cautions you not to include identifying or contact information that you do not want publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS, and the NRC does not routinely edit comment submissions to remove identifying or contact information. If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS. II. Further Information The NUREG provides guidance to existing medical use of byproduct material licensees and to an applicant that are preparing a medical use of byproduct material license application. The NUREG also provides the NRC with criteria for evaluating a license application. The purpose of this notice is to provide the public with an opportunity to review and provide comments on draft NUREG–1556, Volume 9, Revision 3, ‘‘Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses.’’ These PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 87979 comments will be considered in the final version or subsequent revisions. This draft of NUREG–1556, Volume 9, Revision 3 does not include any revisions associated with the proposed rule ‘‘Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments.’’ This proposed rule amends requirements in parts 30, 32, and 35 of title 10 of the Code of Federal Regulations for the following: • Reporting and notification of medical event for permanent implant brachytherapy; training and experience for authorized users, medical physicists, Radiation Safety Officers and nuclear pharmacists; • measuring molybdenum contamination and reporting of failed technetium and rubidium generators; • allowing Associate Radiation Safety Officers to be named on a medical use license; and, • clarifying other revisions to the regulations. This draft of NUREG–1556, Volume 9, Revision 3 does not include any guidance for the proposed rule revisions as that rule is not final at this time. The proposed rule and proposed changes to NUREG–1556, Volume 9, associated with the proposed rule were published for public comment in the Federal Register (79 FR 42409, 79 FR 42224) on July 21, 2014. Comments received on those changes are being considered by the NRC staff separately. If the proposed rule becomes final, the proposed revisions to NUREG–1556, Volume 9 addressing the implementation of the proposed rule will be incorporated into this NUREG– 1556, Volume 9, Revision 3 before its final publication. Dated at Rockville, Maryland, this 30th day of November, 2016. For the U.S. Nuclear Regulatory Commission. Daniel S. Collins, Director, Division of Material Safety, State, Tribal, and Rulemaking Programs, Office of Nuclear Material Safety and Safeguards. [FR Doc. 2016–29214 Filed 12–5–16; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [NRC–2016–0001] Sunshine Act Meeting Notice December 5, 12, 19, 26, 2016, January 2, 9, 2017. PLACE: Commissioners’ Conference Room, 11555 Rockville Pike, Rockville, Maryland. DATES: E:\FR\FM\06DEN1.SGM 06DEN1

Agencies

[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)]
[Notices]
[Pages 87978-87979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29214]


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NUCLEAR REGULATORY COMMISSION

[NRC-2016-0122]


Program-Specific Guidance About Medical Use Licenses

AGENCY: Nuclear Regulatory Commission.

ACTION: Draft NUREG; request for comments.

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

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is revising its 
licensing guidance for licenses authorizing medical use of byproduct 
material. The NRC is requesting public comment on draft NUREG-1556, 
Volume 9, Revision 3, ``Consolidated Guidance About Materials Licenses: 
Program-Specific Guidance About Medical Use Licenses.'' The document 
has been updated from the previous revision to include information on 
safety culture, security of radioactive materials, protection of 
sensitive information, and changes in regulatory policies and 
practices. This document is intended for use by applicants, licensees, 
and the NRC staff.

[[Page 87979]]


DATES: Submit comments by February 6, 2017. Comments received after 
this date will be considered if it is practical to do so, but the NRC 
is only able to assure consideration of comments received on or before 
this date.

ADDRESSES: You may submit comment by any of the following methods 
(unless this document describes a different method for submitting 
comments on a specific subject):
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0122. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: Carol.Gallagher@nrc.gov. For technical questions, contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     Mail comments to: Cindy Bladey, Office of Administration, 
Mail Stop: OWFN-12-H8, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001.
    For additional direction on accessing information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Katie Tapp, Office of Nuclear Material 
Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001; telephone: 301-415-0236; email: Katherine.Tapp@nrc.gov.

SUPPLEMENTARY INFORMATION: 

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2016-0122 when contacting the NRC 
about the availability of information regarding this document. You may 
obtain publicly-available information related to this action by the 
following methods:
     Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0122.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and 
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS, 
please contact the NRC's Public Document Room (PDR) reference staff at 
1-800-397-4209, 301-415-4737, or by email to pdr.resource@nrc.gov. The 
draft NUREG-1556, Volume 9, Revision 3, is available in ADAMS under 
Accession No. ML16328A214.
     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.
    The draft NUREG-1556, Volume 9, Revision 3, is also available on 
the NRC's public Web site on the: (1) ``Consolidated Guidance About 
Materials Licenses (NUREG-1556)'' page at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/; and the (2) ``Draft NUREG-
Series Publications for Comment'' page at http://www.nrc.gov/public-involve/doc-comment.html#nuregs.

B. Submitting Comments

    Please include Docket ID NRC-2016-0122 in the subject line of your 
comment submission, in order to ensure that the NRC is able to make 
your comment submission available to the public in this docket.
    The NRC cautions you not to include identifying or contact 
information that you do not want publicly disclosed in your comment 
submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into 
ADAMS, and the NRC does not routinely edit comment submissions to 
remove identifying or contact information.
    If you are requesting or aggregating comments from other persons 
for submission to the NRC, then you should inform those persons not to 
include identifying or contact information that they do not want to be 
publicly disclosed in their comment submission. Your request should 
state that the NRC does not routinely edit comment submissions to 
remove such information before making the comment submissions available 
to the public or entering the comment submissions into ADAMS.

II. Further Information

    The NUREG provides guidance to existing medical use of byproduct 
material licensees and to an applicant that are preparing a medical use 
of byproduct material license application. The NUREG also provides the 
NRC with criteria for evaluating a license application. The purpose of 
this notice is to provide the public with an opportunity to review and 
provide comments on draft NUREG-1556, Volume 9, Revision 3, 
``Consolidated Guidance About Materials Licenses: Program-Specific 
Guidance About Medical Use Licenses.'' These comments will be 
considered in the final version or subsequent revisions.
    This draft of NUREG-1556, Volume 9, Revision 3 does not include any 
revisions associated with the proposed rule ``Medical Use of Byproduct 
Material-Medical Event Definitions, Training and Experience, and 
Clarifying Amendments.'' This proposed rule amends requirements in 
parts 30, 32, and 35 of title 10 of the Code of Federal Regulations for 
the following:
     Reporting and notification of medical event for permanent 
implant brachytherapy; training and experience for authorized users, 
medical physicists, Radiation Safety Officers and nuclear pharmacists;
     measuring molybdenum contamination and reporting of failed 
technetium and rubidium generators;
     allowing Associate Radiation Safety Officers to be named 
on a medical use license; and,
     clarifying other revisions to the regulations.

This draft of NUREG-1556, Volume 9, Revision 3 does not include any 
guidance for the proposed rule revisions as that rule is not final at 
this time.
    The proposed rule and proposed changes to NUREG-1556, Volume 9, 
associated with the proposed rule were published for public comment in 
the Federal Register (79 FR 42409, 79 FR 42224) on July 21, 2014. 
Comments received on those changes are being considered by the NRC 
staff separately. If the proposed rule becomes final, the proposed 
revisions to NUREG-1556, Volume 9 addressing the implementation of the 
proposed rule will be incorporated into this NUREG-1556, Volume 9, 
Revision 3 before its final publication.

    Dated at Rockville, Maryland, this 30th day of November, 2016.

    For the U.S. Nuclear Regulatory Commission.
Daniel S. Collins,
Director, Division of Material Safety, State, Tribal, and Rulemaking 
Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2016-29214 Filed 12-5-16; 8:45 am]
 BILLING CODE 7590-01-P