80_FR_44302 80 FR 44160 - Clarification of Reporting Requirements

80 FR 44160 - Clarification of Reporting Requirements

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 80, Issue 142 (July 24, 2015)

Page Range44160-44161
FR Document2015-18113

The U.S. Nuclear Regulatory Commission (NRC) is seeking public comment on a draft regulatory issue summary (RIS). This draft RIS clarifies reporting requirements related to analyses of emergency core cooling system performance and how these reporting requirements apply to applicants for and holders of nuclear power reactor operating licenses, construction permits, combined licenses, standard design approvals, and manufacturing licenses, and applicants for standard design certifications.

Federal Register, Volume 80 Issue 142 (Friday, July 24, 2015) 
[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44160-44161]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18113]


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NUCLEAR REGULATORY COMMISSION

[NRC-2015-0172]


Clarification of Reporting Requirements

AGENCY: Nuclear Regulatory Commission.

ACTION: Draft regulatory issue summary; request for comment.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is seeking public 
comment on a draft regulatory issue summary (RIS). This draft RIS 
clarifies reporting requirements related to analyses of emergency core 
cooling system performance and how these reporting requirements apply 
to applicants for and holders of nuclear power reactor operating 
licenses, construction permits, combined licenses, standard design 
approvals, and manufacturing licenses, and applicants for standard 
design certifications.

DATES: Submit comments by September 22, 2015. Comments received after 
this date will be considered if it is practical to do so, but the 
Commission is able to ensure consideration only for comments received 
before this date.

ADDRESSES: You may submit comments 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-2015-0172. 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-H08, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001.
    For additional direction on obtaining information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Alexandra Popova, Office of Nuclear 
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-001; telephone: 301-415-2876, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2015-0172 when contacting the NRC 
about the availability of information for this action. You may obtain 
publicly-available information related to this action by any of the 
following methods:
     Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2015-0172.
     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 RIS is available in ADAMS under Accession No. ML15057A346.
     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.

B. Submitting Comments

    Please include Docket ID NRC-2015-0172 in your comment submission.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be 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. 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 into ADAMS.

II. Background

    The NRC is issuing this draft RIS to clarify the reporting 
requirements under part 50.46 of Title 10 of the Code of Federal 
Regulations (10 CFR), ``Acceptance Criteria for Emergency

[[Page 44161]]

Core Cooling Systems for Light-Water Nuclear Power Reactors.'' 
Specifically, 10 CFR 50.46(a)(3) requires licensees to report to the 
NRC each change to or error discovered in an acceptable emergency core 
cooling system (ECCS) evaluation model, or in its application, and its 
estimated effect on the limiting ECCS analysis.
    The NRC issues a RIS to communicate with stakeholders on a broad 
range of matters. This may include communicating and clarifying NRC 
technical or policy positions on regulatory matters that have not been 
communicated to or are not broadly understood by the nuclear industry.

Proposed Action

    The NRC is requesting public comments on the draft RIS. The NRC 
staff will make a final determination regarding issuance of the RIS 
after it considers any public comments received in response to this 
request.

    Dated at Rockville, Maryland, this 14th day of July 2015.

    For the Nuclear Regulatory Commission.
Sheldon D. Stuchell,
Chief, Generic Communications Branch, Division of Policy and 
Rulemaking, Office of Nuclear Reactor Regulation.
[FR Doc. 2015-18113 Filed 7-23-15; 8:45 am]
 BILLING CODE 7590-01-P

44160 Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices environmental assessment. The NUCLEAR REGULATORY I. Obtaining Information and exemption from the requirement to have COMMISSION Submitting Comments an STA in place is eligible for A. Obtaining Information categorical exclusion under 10 CFR [NRC–2015–0172] 51.22(c)(25)(vi)(H), which provides that Please refer to Docket ID NRC–2015– exemptions from surety, insurance, or Clarification of Reporting 0172 when contacting the NRC about indemnification requirements are Requirements the availability of information for this action. You may obtain publicly- categorically excluded if the exemption AGENCY: Nuclear Regulatory available information related to this would not result in any significant Commission. action by any of the following methods: hazards consideration; change or • Federal rulemaking Web site: Go to increase in the amount of any offsite ACTION: Draft regulatory issue summary; request for comment. http://www.regulations.gov and search effluents; increase in individual or for Docket ID NRC–2015–0172. cumulative public or occupational SUMMARY: The U.S. Nuclear Regulatory • NRC’s Agencywide Documents radiation exposure; construction Commission (NRC) is seeking public Access and Management System impacts; or increase in the potential for comment on a draft regulatory issue (ADAMS): You may obtain publicly- or consequence from radiological summary (RIS). This draft RIS clarifies available documents online in the accidents. The NRC staff finds that the reporting requirements related to ADAMS Public Documents collection at STA exemption involves surety, analyses of emergency core cooling http://www.nrc.gov/reading-rm/ insurance and/or indemnity system performance and how these adams.html. To begin the search, select requirements and that granting Lost reporting requirements apply to ‘‘ADAMS Public Documents’’ and then Creek this temporary exemption from applicants for and holders of nuclear select ‘‘Begin Web-based ADAMS the requirement of establishing a power reactor operating licenses, Search.’’ For problems with ADAMS, standby trust arrangement would not construction permits, combined please contact the NRC’s Public result in any significant hazards or licenses, standard design approvals, and Document Room (PDR) reference staff at increases in offsite effluents, radiation manufacturing licenses, and applicants 1–800–397–4209, 301–415–4737, or by exposure, construction impacts, or for standard design certifications. email to pdr.resource@nrc.gov. The draft potential radiological accidents. DATES: Submit comments by September RIS is available in ADAMS under Therefore, an environmental assessment 22, 2015. Comments received after this Accession No. ML15057A346. • NRC’s PDR: You may examine and is not required. date will be considered if it is practical purchase copies of public documents at to do so, but the Commission is able to IV. Conclusions the NRC’s PDR, Room O1–F21, One ensure consideration only for comments White Flint North, 11555 Rockville Accordingly, the NRC has determined received before this date. Pike, Rockville, Maryland 20852. that, pursuant to 10 CFR 40.14(a), the ADDRESSES: You may submit comments proposed temporary exemption is by any of the following methods (unless B. Submitting Comments authorized by law, will not present an this document describes a different Please include Docket ID NRC–2015– undue risk to the public health and method for submitting comments on a 0172 in your comment submission. safety, is consistent with the common specific subject): The NRC cautions you not to include defense and security, and is in the • Federal Rulemaking Web site: Go to identifying or contact information that public interest. NRC hereby grants Lost http://www.regulations.gov and search you do not want to be publicly Creek ISR, LLC an exemption from the for Docket ID NRC–2015–0172. Address disclosed in your comment submission. requirement in 10 CFR part 40, questions about NRC dockets to Carol The NRC will post all comment Appendix A, Criterion 9 to set up a Gallagher; telephone: 301–415–3463; submissions at http:// email: Carol.Gallagher@nrc.gov. For www.regulations.gov as well as enter the standby trust to receive funds in the technical questions, contact the comment submissions into ADAMS. event the NRC or the State regulatory individual listed in the FOR FURTHER The NRC does not routinely edit agency exercises is right to collect the INFORMATION CONTACT section of this comment submissions to remove surety. This exemption will expire on document. identifying or contact information. February 10, 2015, for the Lost Creek • Mail comments to: Cindy Bladey, If you are requesting or aggregating ISR Project. At that time, Lost Creek will Office of Administration, Mail Stop: comments from other persons for be required to ensure compliance with OWFN–12–H08, U.S. Nuclear submission to the NRC, then you should the STA requirements. Regulatory Commission, Washington, inform those persons not to include Dated at Rockville, Maryland, this 16th day DC 20555–0001. identifying or contact information that of July 2015. For additional direction on obtaining they do not want to be publicly For the Nuclear Regulatory Commission. information and submitting comments, disclosed in their comment submission. see ‘‘Obtaining Information and Your request should state that the NRC Andrew Persinko, Submitting Comments’’ in the does not routinely edit comment Deputy Director, Division of submissions to remove such information SUPPLEMENTARY INFORMATION section of Decommissioning, Uranium Recovery and before making the comment Environmental Programs, Office of Nuclear this document. asabaliauskas on DSK5VPTVN1PROD with NOTICES FOR FURTHER INFORMATION CONTACT: submissions available to the public or Material Safety and Safeguards. Alexandra Popova, Office of Nuclear entering the comment into ADAMS. [FR Doc. 2015–18236 Filed 7–23–15; 8:45 am] BILLING CODE 7590–01–P Reactor Regulation, U.S. Nuclear II. Background Regulatory Commission, Washington, The NRC is issuing this draft RIS to DC 20555–001; telephone: 301–415– clarify the reporting requirements under 2876, email: Alexandra.Popova@ part 50.46 of Title 10 of the Code of nrc.gov. Federal Regulations (10 CFR), SUPPLEMENTARY INFORMATION: ‘‘Acceptance Criteria for Emergency VerDate Sep<11>2014 19:59 Jul 23, 2015 Jkt 235001 PO 00000 Frm 00142 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1

Federal Register / Vol. 80, No. 142 / Friday, July 24, 2015 / Notices 44161 Core Cooling Systems for Light-Water selection criteria and nomination other drug classes and/or other Nuclear Power Reactors.’’ Specifically, instructions. toxicities. 10 CFR 50.46(a)(3) requires licensees to ADDRESSES: The Reagan-Udall The primary objective of PredicTox is report to the NRC each change to or Foundation for the FDA is located at to advance systems-based science and error discovered in an acceptable 1025 Connecticut Ave. NW., Suite 1000, tools necessary to support mechanism- emergency core cooling system (ECCS) Washington, DC 20036. based drug safety assessment and evaluation model, or in its application, prediction. To accomplish this FOR FURTHER INFORMATION CONTACT: and its estimated effect on the limiting objective, the PredicTox pilot project Questions should be sent to The Reagan- ECCS analysis. will be conducted in an iterative, The NRC issues a RIS to communicate Udall Foundation for the FDA, 202– phased manner over the course of with stakeholders on a broad range of 828–1205, PredicTox@ReaganUdall.org. several years. The first phase will center matters. This may include SUPPLEMENTARY INFORMATION: on building and populating a knowledge communicating and clarifying NRC I. Background management platform for molecular technical or policy positions on data, preclinical in vivo pharmacologic regulatory matters that have not been The Reagan-Udall Foundation for the FDA (the Foundation) is an independent and toxicologic data as well as clinical communicated to or are not broadly data from both public and private understood by the nuclear industry. 501(c)(3) not-for-profit organization created by Congress to advance the sources. Proposed Action The PredicTox platform will enable mission of FDA to modernize medical, integration, mining, and analysis of The NRC is requesting public veterinary, food, food ingredient, and highly heterogeneous data not typically comments on the draft RIS. The NRC cosmetic product development; combined. Future phases of the project staff will make a final determination accelerate innovation; and enhance will focus on data mining and regarding issuance of the RIS after it product safety. The Foundation acts as development of analytic and considers any public comments a neutral third party to establish novel, visualization tools along with received in response to this request. scientific collaborations. With the development of multi-scale predictive ultimate goal of improving public Dated at Rockville, Maryland, this 14th day models capable of linking events at the of July 2015. health, the Foundation provides a molecular level with events at the For the Nuclear Regulatory Commission. unique opportunity for different sectors clinical level (AEs) for improved safety (FDA, patient groups, academia, other Sheldon D. Stuchell, assessment. For additional project government entities, and industry) to Chief, Generic Communications Branch, information, see the Reagan-Udall work together in a transparent way to Division of Policy and Rulemaking, Office Foundation Web site. of Nuclear Reactor Regulation. create exciting new research projects to [FR Doc. 2015–18113 Filed 7–23–15; 8:45 am] advance regulatory science. II. PredicTox Steering Committee Roles PredicTox is a public-private and Responsibilities BILLING CODE 7590–01–P partnership led by the Foundation, The PredicTox Steering Committee which brings together multiple will provide guidance on the operation stakeholder groups to leverage collective of PredicTox, in conjunction with the REAGAN-UDALL FOUNDATION FOR knowledge, technical expertise, data, THE FOOD AND DRUG RUF Board, project staff, and others. funding, and other resources to explore The Steering Committee will provide ADMINISTRATION systems pharmacology approaches to overall programmatic oversight to better understand and predict adverse ensure a focus on the long-term vision Request for Steering Committee events (AEs). Developing new tools and of the project, while the Scientific Nominations approaches for mechanism-based drug Advisory Committee will provide highly ACTION: Request for nominations to the safety assessment and prediction is a specialized technical expertise. Steering Committee for the Foundation’s priority for the FDA, as highlighted in The PredicTox Steering Committee PredicTox project. the Agency’s 2011 Strategic Plan for will be charged with several Advancing Regulatory Science. This responsibilities, including: SUMMARY: The Reagan-Udall Foundation project aims to harness scientific and • Reviewing and approving the (RUF) for the Food and Drug technological knowledge, data and PredicTox Charter Administration (FDA), which was computational capacity across various • Monitoring adherence to the created by Title VI of the Food and Drug sectors and disciplines to develop and PredicTox mission and operational Amendments of 2007, is requesting apply systems-based approaches and principles in the Charter nominations for its PredicTox Steering multi-scales models to drug safety • Developing metrics and evaluating Committee. The Steering Committee assessment in a coordinated manner. the project at various milestones will provide oversight and guidance for While systems-based approaches can • Reviewing and approving the the PredicTox project, and will report to be applied to the development of PredicTox Research Agenda the Reagan-Udall Foundation for the predictive models for any class of drug • Reviewing proposals and contracts FDA’s Board of Directors. or AE, the PredicTox pilot seeks to first submitted to the project DATES: All nominations must be provide a proof of concept pilot by The PredicTox Steering Committee submitted to the Reagan-Udall focusing on large and small molecule Chair must be able to complete Foundation for the FDA by August 28, tyrosine kinase inhibitors (TKIs) and asabaliauskas on DSK5VPTVN1PROD with NOTICES additional responsibilities, including: 2015. The PredicTox Steering cardiac AEs, specifically left ventricular • Defining the Steering Committee’s Committee members will be selected by dysfunction. TKIs are a rapidly growing meeting agendas and facilitating those the Reagan-Udall Foundation for the treatment for oncology and select other meetings FDA’s Board of Directors; those selected therapeutic areas, making them an area • Recommending for termination, as will be notified by September 30 of intense importance for patients, the necessary, any PredicTox Steering regarding the Board’s decision. See the FDA, and pharmaceutical Committee members demonstrating SUPPLEMENTARY INFORMATION section for manufacturers. Learnings from the dereliction of duties as specified in the Steering Committee responsibilities, PredicTox pilot will then be applied to PredicTox Charter VerDate Sep<11>2014 19:59 Jul 23, 2015 Jkt 235001 PO 00000 Frm 00143 Fmt 4703 Sfmt 4703 E:\FR\FM\24JYN1.SGM 24JYN1


Document Created: 2018-02-23 09:25:02
Document Modified: 2018-02-23 09:25:02
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
ActionDraft regulatory issue summary; request for comment.
DatesSubmit comments by September 22, 2015. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.
ContactAlexandra Popova, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-001; telephone: 301-415-2876, email: [email protected]
FR Citation80 FR 44160 
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