81 FR 87978 - Program-Specific Guidance About Medical Use Licenses
NUCLEAR REGULATORY COMMISSION Federal Register Volume 81, Issue 234 (December 6, 2016)
Federal Register Volume 81, Issue 234 (December 6, 2016)
| Page Range | 87978-87979 | |
| FR Document | 2016-29214 |
[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)] [Notices] [Pages 87978-87979] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29214] ----------------------------------------------------------------------- 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: [email protected]. 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: [email protected]. 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 [email protected]. 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
![87978 Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Notices
proceeding, so that the filer need not security numbers, home addresses, or Facility Operating License Nos. NPF–
serve the documents on those home phone numbers in their filings, 11 and NPF–18: The amendments
participants separately. Therefore, unless an NRC regulation or other law revised the licensing basis related to
applicants and other participants (or requires submission of such Alternate Source Term in the Updated
their counsel or representative) must information. However, in some Final Safety Analysis Report.
apply for and receive a digital ID instances, a petition will require Public comments requested as to
certificate before a hearing petition to including information on local proposed no significant hazards
intervene is filed so that they can obtain residence in order to demonstrate a consideration (NSHC): Yes. Public
access to the document via the E-Filing proximity assertion of interest in the notice of the proposed amendment was
system. proceeding. With respect to copyrighted published in The Ottawa Times on
A person filing electronically using works, except for limited excerpts that November 15 and November 16, 2016.
the NRC’s adjudicatory E-Filing system serve the purpose of the adjudicatory The notice provided an opportunity to
may seek assistance by contacting the filings and would constitute a Fair Use submit comments on the Commission’s
NRC Electronic Filing Help Desk application, participants are requested proposed NSHC determination. No
through the ‘‘Contact Us’’ link located not to include copyrighted materials in comments have been received.
on the NRC’s public Web site at http:// their submission. The Commission’s related evaluation
www.nrc.gov/site-help/e- The Commission will issue a notice or of the amendment, finding of exigent
submittals.html, by email to order granting or denying a hearing circumstances, state consultation, and
MSHD.Resource@nrc.gov, or by a toll- request or intervention petition, final NSHC determination are contained
free call at 1–866–672–7640. The NRC designating the issues for any hearing in a safety evaluation dated November
Electronic Filing Help Desk is available that will be held and designating the 18, 2016.
between 9 a.m. and 7 p.m., Eastern Presiding Officer. A notice granting a Attorney for licensee: Bradley J.
Time, Monday through Friday, hearing will be published in the Federal Fewell, Associate General Counsel,
excluding government holidays. Register and served on the parties to the Exelon Nuclear, 4300 Winfield Road,
Participants who believe that they hearing. Warrenville, IL 60555.
have a good cause for not submitting NRC Acting Branch Chief: Edward G.
documents electronically must file an Exelon Generation Company, LLC,
Docket Nos. 50–373 and 50–374, LaSalle Miller.
exemption request, in accordance with
10 CFR 2.302(g), with their initial paper County Station (LSCS), Units 1 and 2, Dated at Rockville, Maryland, this 23rd day
filing stating why there is good cause for LaSalle County, Illinois of November 2016.
not filing electronically and requesting Date of amendment request: For the Nuclear Regulatory Commission.
authorization to continue to submit September 30, 2016, as supplemented Anne T. Boland,
documents in paper format. Such filings by letter dated November 8, 2016. Director, Division of Operating Reactor
must be submitted by: (1) First class Description of amendment request: Licensing, Office of Nuclear Reactor
mail addressed to the Office of the The amendments revised the LSCS Regulation.
Secretary of the Commission, U.S. licensing basis related to Alternate [FR Doc. 2016–28990 Filed 12–5–16; 8:45 am]
Nuclear Regulatory Commission, Source Term Analysis in the Updated BILLING CODE 7590–01–P
Washington, DC 20555–0001, Attention: Final Safety Analysis Report to allow
Rulemaking and Adjudications Staff; or operation with and movement of
(2) courier, express mail, or expedited irradiated Atrium-10 fuel bundles NUCLEAR REGULATORY
delivery service to the Office of the containing part length rods that have COMMISSION
Secretary, 11555 Rockville Pike, been in operation above 62,000 [NRC–2016–0122]
Rockville, Maryland 20852, Attention: megawatt days per metric ton of
Rulemaking and Adjudications Staff. uranium (MWD/MTU), which is the Program-Specific Guidance About
Participants filing a document in this current rod average burnup limit Medical Use Licenses
manner are responsible for serving the specified in Footnote 11 of NRC
document on all other participants. Regulatory Guide (RG) 1.183, AGENCY: Nuclear Regulatory
Filing is considered complete by first- ‘‘Alternative Radiological Source Terms Commission.
class mail as of the time of deposit in for Evaluating Design Basis Accidents at ACTION: Draft NUREG; request for
the mail, or by courier, express mail, or Nuclear Power Reactors,’’ to which comments.
expedited delivery service upon LSCS is committed. In addition, the
depositing the document with the change allows use of the release SUMMARY: The U.S. Nuclear Regulatory
provider of the service. A presiding fractions listed in Table 1 of RG 1.183 Commission (NRC) is revising its
officer, having granted an exemption for these Atrium-10 partial length rods licensing guidance for licenses
request from using E-Filing, may require that are currently in the LSCA, Unit 2, authorizing medical use of byproduct
a participant or party to use E-Filing if Cycle 16, reactor core for the remainder material. The NRC is requesting public
the presiding officer subsequently of the current operating cycle. comment on draft NUREG–1556,
determines that the reason for granting Date of issuance: November 18, 2016. Volume 9, Revision 3, ‘‘Consolidated
the exemption from use of E-Filing no Effective date: As of the date of Guidance About Materials Licenses:
longer exists. issuance and shall be implemented Program-Specific Guidance About
Documents submitted in adjudicatory within 10 days from the date of Medical Use Licenses.’’ The document
proceedings will appear in the NRC’s issuance. has been updated from the previous
mstockstill on DSK3G9T082PROD with NOTICES
electronic hearing docket which is Amendment Nos.: Unit 1—221; Unit revision to include information on
available to the public at http:// 2—207. A publicly-available version is safety culture, security of radioactive
ehd1.nrc.gov/ehd/, unless excluded in ADAMS under Accession No. materials, protection of sensitive
pursuant to an order of the Commission, ML16320A182; documents related to information, and changes in regulatory
or the presiding officer. Participants are these amendments are listed in the policies and practices. This document is
requested not to include personal Safety Evaluation enclosed with the intended for use by applicants,
privacy information, such as social amendments. licensees, and the NRC staff.
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![Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Notices 87979
DATES: Submit comments by February 6, available in ADAMS under Accession comments will be considered in the
2017. Comments received after this date No. ML16328A214. final version or subsequent revisions.
will be considered if it is practical to do • NRC’s PDR: You may examine and This draft of NUREG–1556, Volume 9,
so, but the NRC is only able to assure purchase copies of public documents at Revision 3 does not include any
consideration of comments received on the NRC’s PDR, Room O1–F21, One revisions associated with the proposed
or before this date. White Flint North, 11555 Rockville rule ‘‘Medical Use of Byproduct
ADDRESSES: You may submit comment Pike, Rockville, Maryland 20852. Material-Medical Event Definitions,
by any of the following methods (unless The draft NUREG–1556, Volume 9, Training and Experience, and Clarifying
this document describes a different Revision 3, is also available on the Amendments.’’ This proposed rule
method for submitting comments on a NRC’s public Web site on the: (1) amends requirements in parts 30, 32,
specific subject): ‘‘Consolidated Guidance About and 35 of title 10 of the Code of Federal
• Federal Rulemaking Web site: Go to Materials Licenses (NUREG–1556)’’ Regulations for the following:
http://www.regulations.gov and search page at http://www.nrc.gov/reading-rm/ • Reporting and notification of
for Docket ID NRC–2016–0122. Address doc-collections/nuregs/staff/sr1556/; medical event for permanent implant
questions about NRC dockets to Carol and the (2) ‘‘Draft NUREG-Series brachytherapy; training and experience
Gallagher; telephone: 301–415–3463; Publications for Comment’’ page at for authorized users, medical physicists,
email: Carol.Gallagher@nrc.gov. For http://www.nrc.gov/public-involve/doc- Radiation Safety Officers and nuclear
technical questions, contact the comment.html#nuregs. pharmacists;
individual listed in the FOR FURTHER • measuring molybdenum
B. Submitting Comments contamination and reporting of failed
INFORMATION CONTACT section of this
document. Please include Docket ID NRC–2016– technetium and rubidium generators;
• allowing Associate Radiation Safety
• Mail comments to: Cindy Bladey, 0122 in the subject line of your
comment submission, in order to ensure Officers to be named on a medical use
Office of Administration, Mail Stop:
that the NRC is able to make your license; and,
OWFN–12–H8, U.S. Nuclear Regulatory • clarifying other revisions to the
Commission, Washington, DC 20555– comment submission available to the
public in this docket. regulations.
0001.
For additional direction on accessing The NRC cautions you not to include This draft of NUREG–1556, Volume 9,
information and submitting comments, identifying or contact information that Revision 3 does not include any
see ‘‘Obtaining Information and you do not want publicly disclosed in guidance for the proposed rule revisions
Submitting Comments’’ in the your comment submission. The NRC as that rule is not final at this time.
will post all comment submissions at The proposed rule and proposed
SUPPLEMENTARY INFORMATION section of
http://www.regulations.gov as well as changes to NUREG–1556, Volume 9,
this document.
enter the comment submissions into associated with the proposed rule were
FOR FURTHER INFORMATION CONTACT: published for public comment in the
Katie Tapp, Office of Nuclear Material ADAMS, and the NRC does not
routinely edit comment submissions to Federal Register (79 FR 42409, 79 FR
Safety and Safeguards; U.S. Nuclear 42224) on July 21, 2014. Comments
Regulatory Commission, Washington, remove identifying or contact
information. received on those changes are being
DC 20555–0001; telephone: 301–415– considered by the NRC staff separately.
0236; email: Katherine.Tapp@nrc.gov. If you are requesting or aggregating
comments from other persons for If the proposed rule becomes final, the
SUPPLEMENTARY INFORMATION: proposed revisions to NUREG–1556,
submission to the NRC, then you should
I. Obtaining Information and inform those persons not to include Volume 9 addressing the
Submitting Comments identifying or contact information that implementation of the proposed rule
they do not want to be publicly will be incorporated into this NUREG–
A. Obtaining Information 1556, Volume 9, Revision 3 before its
disclosed in their comment submission.
Please refer to Docket ID NRC–2016– Your request should state that the NRC final publication.
0122 when contacting the NRC about does not routinely edit comment Dated at Rockville, Maryland, this 30th day
the availability of information regarding submissions to remove such information of November, 2016.
this document. You may obtain before making the comment For the U.S. Nuclear Regulatory
publicly-available information related to submissions available to the public or Commission.
this action by the following methods: entering the comment submissions into Daniel S. Collins,
• Federal Rulemaking Web site: Go to ADAMS. Director, Division of Material Safety, State,
http://www.regulations.gov and search Tribal, and Rulemaking Programs, Office of
for Docket ID NRC–2016–0122. II. Further Information Nuclear Material Safety and Safeguards.
• NRC’s Agencywide Documents The NUREG provides guidance to [FR Doc. 2016–29214 Filed 12–5–16; 8:45 am]
Access and Management System existing medical use of byproduct BILLING CODE 7590–01–P
(ADAMS): You may obtain publicly- material licensees and to an applicant
available documents online in the that are preparing a medical use of
ADAMS Public Documents collection at byproduct material license application. NUCLEAR REGULATORY
http://www.nrc.gov/reading-rm/ The NUREG also provides the NRC with COMMISSION
adams.html. To begin the search, select criteria for evaluating a license [NRC–2016–0001]
‘‘ADAMS Public Documents’’ and then application. The purpose of this notice
mstockstill on DSK3G9T082PROD with NOTICES
select ‘‘Begin Web-based ADAMS is to provide the public with an Sunshine Act Meeting Notice
Search.’’ For problems with ADAMS, opportunity to review and provide
please contact the NRC’s Public comments on draft NUREG–1556, DATES: December 5, 12, 19, 26, 2016,
Document Room (PDR) reference staff at Volume 9, Revision 3, ‘‘Consolidated January 2, 9, 2017.
1–800–397–4209, 301–415–4737, or by Guidance About Materials Licenses: PLACE: Commissioners’ Conference
email to pdr.resource@nrc.gov. The draft Program-Specific Guidance About Room, 11555 Rockville Pike, Rockville,
NUREG–1556, Volume 9, Revision 3, is Medical Use Licenses.’’ These Maryland.
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Document Created: 2016-12-06 02:18:45
Document Modified: 2016-12-06 02:18:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Draft NUREG; request for comments. | |
| 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. | |
| Contact | Katie Tapp, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0236; email: [email protected] | |
| FR Citation | 81 FR 87978 |
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