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| | issue date = 03/04/2006 | | | issue date = 03/04/2006 |
| | title = G20050706 - Federal Register Notice Jonathan M. Block, 2.206 Petition | | | title = G20050706 - Federal Register Notice Jonathan M. Block, 2.206 Petition |
| | author name = Dyer J E | | | author name = Dyer J |
| | author affiliation = NRC/NRR | | | author affiliation = NRC/NRR |
| | addressee name = Block J M | | | addressee name = Block J |
| | addressee affiliation = - No Known Affiliation | | | addressee affiliation = - No Known Affiliation |
| | docket = 05000271 | | | docket = 05000271 |
| | license number = DPR-028 | | | license number = DPR-028 |
| | contact person = SHea J J, NRR/DLPM,415-1388 | | | contact person = SHea J, NRR/DLPM,415-1388 |
| | case reference number = 2.206, G20050706, TAC MC8632 | | | case reference number = 2.206, G20050706, TAC MC8632 |
| | package number = ML060340216 | | | package number = ML060340216 |
Revision as of 23:55, 13 July 2019
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MONTHYEARML0529101722005-10-11011 October 2005 G20050706 - Jonathan M. Block Ltr Re 2.206 - Vermont Yankee/Emergency Evacuations Project stage: Request ML0531402162005-12-0707 December 2005 Proposed Director'S Decision Jonathan M. Block 2.206 Petition - Vermont Yankee Project stage: Other ML0532504052005-12-0707 December 2005 Michael R. Kansler, Ltr Jonathan M. Blocke 2.206 Proposed Director'S Decision - Vermont Yankee Project stage: Other ML0531402072005-12-0707 December 2005 Federal Register Notice Jonathan M. Block 2.206 - Vermont Yankee Project stage: Other ML0531401972005-12-0707 December 2005 G20050706 - Jonathan M. Block Ltr 2.206 Acknowledgement Letter - Vermont Yankee Emergency Evacuations Project stage: Other ML0603403262006-03-0404 March 2006 G20050706 - Jonathan M. Block Director'S Decision October 11, 2005 Petition Filed with the Executive Director of Operations Pursuant to Section 2.206 of Title 10 of the Code of Federal Regulations (10 CFR 2.206) Project stage: Other ML0603402462006-03-0404 March 2006 G20050706 - Federal Register Notice Jonathan M. Block, 2.206 Petition Project stage: Other ML0603401312006-03-0404 March 2006 G20050706 - Jonathan M. Block Ltr. October 11, 2005 Petition Filed with the Executive Director of Operations Pursuant to Section 2.206 of Title 10 of the Code of Federal Regulations (10 CFR 2.206) Project stage: Other 2005-12-07
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Category:2.206 Director Decision
MONTHYEARML16054A7312016-03-29029 March 2016 OEDO-15-00251 - Final Director'S Decision 2.206 - Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants ML16054A6912016-03-29029 March 2016 OEDO-15-00251 - Letter to Petitioner for Final Director'S Decision 2.206 - Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power ML15286A2352016-01-20020 January 2016 OEDO-15-00251: Petitioner'S Letter 2.206 - Emergency Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants ML15286A2652016-01-20020 January 2016 OEDO-15-00251: Letter to Vermont Yankee 2.206 - Emergency Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants ML15286A2722016-01-12012 January 2016 OEDO-15-00251: Proposed Director'S Decision 2.206 - Emergency Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants ML15253A5812015-10-27027 October 2015 Regarding NRC Enforcement Proceeding No. 2013-0192 ML15265A0622015-09-18018 September 2015 LTR-15-0470 Charlie Donaldson, Assistant Attorney General, State of New York, Letter Concerns About NRC Enforcement Proceeding No. 2013-0192 Pursuant to 10 CFR 2.206, Dockets 50-333, 50-271, and 50-293 ML15162A7632015-08-27027 August 2015 G20130211 - Final Director'S Decision ML15162A6902015-08-27027 August 2015 G20130211 - Transmittal Letter to Petitioner Judson Regarding Final Director'S Decision for James A. FitzPatrick Power Plant, Pilgrim Nuclear Power Station and Vermont Yankee Nuclear Power Station ML12215A3142015-04-17017 April 2015 Proposed Director'S Decision - 2.206 Petition Re Boiling Water Reactors with Mark I and Mark II Containment Designs ML15040A1612015-03-27027 March 2015 G20130211 - Proposed Director'S Decision ML14337A2432015-01-15015 January 2015 G20110262 - Final Director'S Decision - Paul Gunter and Kevin Kamps Letter 2.206 - Immediately Suspend the Operating License of General Electric Boiling Water Reactors Mark I Units ML14335A6302015-01-15015 January 2015 G20110262 - Final Response to Paul Gunter and Kevin Kamps Letter 2.206 - Immediately Suspend the Operating License of General Electric Boiling Water Reactors Mark I Units ML13338A6122014-03-26026 March 2014 G20130229 - 2.206 Petition Closure Letter Re Revoke Operating License for General Electric Mark I and Mark II Boiling Water Reactors ML1128705422011-11-0808 November 2011 G20090487/EDATS: OEDO-2009-0517 - FRN: General Notice, Final Director'S Decision Under 10 CFR 2.206 to Sherwood Martinelli ML1128705332011-11-0808 November 2011 G20090487/EDATS: OEDO-2009-0517 - Letter to Sherwood Martinelli Entergy Decommissioning Funding ML1122408772011-09-0909 September 2011 G20110043/EDATS: OEDO-2011-0058 - Response Letter to Saporito 2.206 Petition Enclosing the Director'S Decision and Federal Register Notice Regarding Safe Operation of Vermont Yankee ML1122409602011-09-0909 September 2011 G20110043/EDATS: OEDO-2011-0058 - Final Director'S Decision to Saporito'S 2.206 Regarding Safe Operation of Vermont Yankee ML1011006072011-09-0808 September 2011 G20090487/EDATS: OEDO-2009-0517 - Proposed Director'S Decision for Martinelli'S 2.206 Petition - Entergy/Decommissioning Funds CY-92-223, G20110523/LTR-11-0411/EDATS: SECY-2011-0411 - Ltr. from Rep. E.J. Markey to Chairman Jaczko NRC Safety Requirements for Reactors Granted Construction Permits Prior to 19712011-07-14014 July 2011 G20110523/LTR-11-0411/EDATS: SECY-2011-0411 - Ltr. from Rep. E.J. Markey to Chairman Jaczko NRC Safety Requirements for Reactors Granted Construction Permits Prior to 1971 ML1117103982011-07-14014 July 2011 G20110043/EDATS: OEDO-2011-0058 - 2.206 Petition Vermont Yankee Safety Concerns ML1105405582011-03-11011 March 2011 G20100027/EDATS: OEDO-2010-0022/G20100074/EDATS: OEDO-2010-0087/G20100098/EDATS: OEDO-2010-0145 - Final Director'S Decision NRC-2011-0060, G20100027/EDATS: OEDO-2010-0022/G20100074/EDATS: OEDO-2010-0087/G20100098/EDATS: OEDO-2010-0145 - Final Director'S Decision2011-03-11011 March 2011 G20100027/EDATS: OEDO-2010-0022/G20100074/EDATS: OEDO-2010-0087/G20100098/EDATS: OEDO-2010-0145 - Final Director'S Decision ML1033505532011-01-20020 January 2011 G20100027/EDATS: OEDO-2010-0022, G20100074/EDATS: OEDO-2010-0087, G20100098/LTR-10-0069/EDATS: OEDO-2010-0145: Ltr to Entergy Nuclear Operations in Response to Letters on Tritium Leaks at the Vermont Yankee Nuclear Power Station ML0810504562008-04-28028 April 2008 G20070597/LTR-07-0568 - Final Director'S Decision Raymond Shadis 2.206 Petition Regarding Unreported Conditions Leading to a Degradation of Public Safety Margin at Vermont Yankee Nuclear Power Station ML0803600882008-02-29029 February 2008 G20070597/LRR-07-0568 - Proposed Director'S Decision Under 10 CFR 2.206 R. Shadis Request for Expedited NRC Action to Address Unreported Conditions Leading to a Degradation of Public Safety Margin at Vermont Yankee ML0603402462006-03-0404 March 2006 G20050706 - Federal Register Notice Jonathan M. Block, 2.206 Petition ML0603403262006-03-0404 March 2006 G20050706 - Jonathan M. Block Director'S Decision October 11, 2005 Petition Filed with the Executive Director of Operations Pursuant to Section 2.206 of Title 10 of the Code of Federal Regulations (10 CFR 2.206) ML0533903112006-01-0909 January 2006 G20050379 - Mr. Paul Gunter Ltr. Re. 2.206 - Inoperable Hemyc/Mt Fire Protection Systems ML0535000122005-12-23023 December 2005 G20050360 - Director'S Decision Raymond Shadis 2.206 Petition - Degraded Fire Protection Systems at Entergy Nuclear Vermont Yankee ML0528601072005-11-0707 November 2005 G20040831 - Director'S Decision Under 10 CFR 2.206, Regarding Vermont Yankee ML0527701302005-10-11011 October 2005 G20050360 - Proposed Director'S Decision - Shadis/Kansler Ltrs. Requesting Comments on Proposed Director'S Decision for Vermont Yankee ML0521702062005-08-16016 August 2005 G20050008 - Final Director'S Decision Paul Blanch and Arnold Gundersen 2.206 Petition - Vermont Yankee - Clarification of Design Basis Conformance ML0512201032005-05-24024 May 2005 Proposed Director'S Decision Under 10 CFR 2.206 ML0511003702005-01-0707 January 2005 G20050008 - Proposed Director'S Decision Re 2.206 - Vermont Yankee - Clarification of Design Basis Conformance 2016-03-29
[Table view] Category:Federal Register Notice
MONTHYEARML21159A0522021-06-29029 June 2021 VY and CR Indirect License Transfer Order FRN ML21077A2772021-05-0404 May 2021 Final Ea/Fonsi for 20.2002 Alternate Disposal Request (License DPR-28, Docket No. 50-271) ML21064A1402021-03-29029 March 2021 (License DPR-28, Docket Nos. 50-271 and 72-59) - Notice of Consideration, Request for Indirect License Transfer ML18274A2492018-10-17017 October 2018 Exemption Issuance FRN ML18249A3622018-10-15015 October 2018 Federal Register Notice Announcing Approval of License Transfer Request (License DPR-28, Docket Nos. 50-271 and 72-59) NRC-2018-0216, Federal Register Notice Announcing Approval of License Transfer Request (License DPR-28, Docket Nos. 50-271 and 72-59)2018-10-15015 October 2018 Federal Register Notice Announcing Approval of License Transfer Request (License DPR-28, Docket Nos. 50-271 and 72-59) ML18248A0962018-10-11011 October 2018 Order Approving License Transfer Request (License DPR-28, Docket Nos. 50-271 and 72-59) NRC-2018-0226, FRN Ea/Fonsi for Exemption for Northstar to Use the Nuclear Decommissioning Trust for Spent Fuel Management Re Request for Direct and Indirect License Transfers from Entergy to Northstar2018-10-0303 October 2018 FRN Ea/Fonsi for Exemption for Northstar to Use the Nuclear Decommissioning Trust for Spent Fuel Management Re Request for Direct and Indirect License Transfers from Entergy to Northstar ML18257A2832018-10-0303 October 2018 FRN Ea/Fonsi for Exemption for Northstar to Use the Nuclear Decommissioning Trust for Spent Fuel Management Re Request for Direct and Indirect License Transfers from Entergy to Northstar NRC-2018-0140, Biweekly Federal Register Notice - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations - Publication Date: 7/17/20182018-07-0505 July 2018 Biweekly Federal Register Notice - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations - Publication Date: 7/17/2018 ML18180A2182018-07-0505 July 2018 Biweekly Federal Register Notice - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations - Publication Date: 7/17/2018 NRC-2018-0020, Federal Register Notice: Exemption: Issuance - Availability of Exemption for Entergy Operations, Inc., Vermont Yankee Nuclear Power Station Independent Spent Fuel Storage Installation2018-02-0808 February 2018 Federal Register Notice: Exemption: Issuance - Availability of Exemption for Entergy Operations, Inc., Vermont Yankee Nuclear Power Station Independent Spent Fuel Storage Installation ML17298A1582018-02-0808 February 2018 Federal Register Notice: Exemption: Issuance - Availability of Exemption for Entergy Operations, Inc., Vermont Yankee Nuclear Power Station Independent Spent Fuel Storage Installation ML18017B0492018-01-19019 January 2018 Correction Notice for EA and Fonsi NRC-2017-0134, Federal Register Notice: Notice of Availability of Environmental Assessment and Finding of No Significant Impact for Entergy Nuclear Operation, Inc., Vermont Yankee Nuclear Power Station ISFSI Exemption Request2018-01-16016 January 2018 Federal Register Notice: Notice of Availability of Environmental Assessment and Finding of No Significant Impact for Entergy Nuclear Operation, Inc., Vermont Yankee Nuclear Power Station ISFSI Exemption Request ML17249A2442018-01-16016 January 2018 Federal Register Notice: Notice of Availability of Environmental Assessment and Finding of No Significant Impact for Entergy Nuclear Operation, Inc., Vermont Yankee Nuclear Power Station ISFSI Exemption Request NRC-2017-0175, Biweekly Sholly Report - Federal Register Notice Fr Publication Date: August 15, 20172017-08-0404 August 2017 Biweekly Sholly Report - Federal Register Notice Fr Publication Date: August 15, 2017 ML17213A1842017-08-0404 August 2017 Biweekly Sholly Report - Federal Register Notice Fr Publication Date: August 15, 2017 ML17143A1562017-06-0606 June 2017 Enclosufederal Register Notice-Notice of Availability of Exemption for Entergy Energy Operations, Inc., Vermont Yankee Nuclear Power Station Independent Spent Fuel Storage Installation ML17045A5322017-05-25025 May 2017 Enclosufrn - Notice of Availability of Environmental Assessment and Finding of No Significant Impact for Entergy Nuclear Operations, Inc., Vermont Yankee Nuclear Power Station, Independent Spent Fuel Storage Installation Exemption Request ML17013A2572016-12-12012 December 2016 Draft Final EA ML16012A1572016-04-15015 April 2016 FRN: Exemption from the Requirements of 10 CFR Part 140, Section 140.11(a)(4) Concerning Primary and Secondary Liability Insurance NRC-2016-0017, FRN: Exemption from the Requirements of 10 CFR Part 50, Section 50.54(w)(1) Concerning Insurance for Post-Accident Site Decontamination2016-04-15015 April 2016 FRN: Exemption from the Requirements of 10 CFR Part 50, Section 50.54(w)(1) Concerning Insurance for Post-Accident Site Decontamination ML16012A1972016-04-15015 April 2016 FRN: Exemption from the Requirements of 10 CFR Part 50, Section 50.54(w)(1) Concerning Insurance for Post-Accident Site Decontamination NRC-2015-0200, OEDO-15-00251 - FRN for Final Director'S Decision 2.206 - Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants2016-03-29029 March 2016 OEDO-15-00251 - FRN for Final Director'S Decision 2.206 - Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants ML16054A6912016-03-29029 March 2016 OEDO-15-00251 - Letter to Petitioner for Final Director'S Decision 2.206 - Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power ML16054A7312016-03-29029 March 2016 OEDO-15-00251 - Final Director'S Decision 2.206 - Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants ML16054A8032016-03-29029 March 2016 OEDO-15-00251 - FRN for Final Director'S Decision 2.206 - Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants ML15286A2722016-01-12012 January 2016 OEDO-15-00251: Proposed Director'S Decision 2.206 - Emergency Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants ML15356A5992015-12-29029 December 2015 Biweekly Federal Register Notice - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations - Publication Date: January 5, 2016 ML15344A2432015-12-22022 December 2015 Letter, FRN for Partial Exemption from Recordkeeping Requirements ML15344A2572015-12-22022 December 2015 FRN for Partial Exemption from Recordkeeping Requirements ML15180A0542015-12-10010 December 2015 LTR, Exemptions from Certain Emergency Planning Requirements and Related Safety Evaluation ML15180A0472015-12-10010 December 2015 FRN - Exemptions from Certain Emergency Planning Requirements and Related Safety Evaluation ML15261A6662015-11-10010 November 2015 Withdrawal of an Amendment Request Regarding Deletion of Operating License Conditions Related to the Decommissioning Trust Provisions ML15261A6712015-11-10010 November 2015 FRN - Withdrawal of an Amendment Request Regarding Deletion of Operating License Conditions Related to the Decommissioning Trust Provisions ML15162A6902015-08-27027 August 2015 G20130211 - Transmittal Letter to Petitioner Judson Regarding Final Director'S Decision for James A. FitzPatrick Power Plant, Pilgrim Nuclear Power Station and Vermont Yankee Nuclear Power Station ML15181A1092015-08-20020 August 2015 OEDO-15-00251 - FRN Regarding 2.206 - Emergency Ultrasonic Inspection Test or Best Available Flaw Detection Technology for USA Reactor Plants Similar to the Thousands of Cracks Discovered in Belgium Nuclear Power Plants ML15180A0692015-07-31031 July 2015 Issuance of Environmental Assessment and Finding of No Significant Impact Related to Request for Exemptions from Certain Emergency Planning Requirements ML15128A1942015-06-17017 June 2015 Exemptions from the Requirements of 10 CFR Part 50, Sections 50.82(a)(8)(i)(A) and 50.75(h)(1)(iv) ML15103A4192015-04-24024 April 2015 Letter and Draft Environmental Assessment and Finding of No Significant Impact Related to Request for Exemptions from Certain Emergency Planning Requirements ML15103A4002015-04-24024 April 2015 Draft Environmental Assessment and Finding of No Significant Impact Related to Request for Exemptions from Certain Emergency Planning Requirements ML14266A3872015-02-12012 February 2015 Letter, Exemption from Requirements of 10 CFR Part 73 Related to Suspension of Security Measures in an Emergency or During Severe Weather ML14266A4172015-02-12012 February 2015 FRN, Exemption from Requirements of 10 CFR Part 73 Related to Suspension of Security Measures in an Emergency or During Severe Weather NRC-2015-0034, FRN, Exemption from Requirements of 10 CFR Part 73 Related to Suspension of Security Measures in an Emergency or During Severe Weather2015-02-12012 February 2015 FRN, Exemption from Requirements of 10 CFR Part 73 Related to Suspension of Security Measures in an Emergency or During Severe Weather ML15008A1092015-01-22022 January 2015 FRN Reopening of Public Comment Period for Permanently Defueled Emergency Plan and Emergency Action Level Scheme Change Amendment Request ML15012A2012015-01-22022 January 2015 Correction and Reopening of Public Comment Period for Permanently Defueled Emergency Plan and Emergency Action Level Scheme Change Amendment Request ML14335A6302015-01-15015 January 2015 G20110262 - Final Response to Paul Gunter and Kevin Kamps Letter 2.206 - Immediately Suspend the Operating License of General Electric Boiling Water Reactors Mark I Units ML14335A6482015-01-15015 January 2015 G20110262 - FRN - Paul Gunter and Kevin Kamps Letter 2.206 - Immediately Suspend the Operating License of General Electric Boiling Water Reactors Mark I Units NRC-2015-0009, G20110262 - FRN - Paul Gunter and Kevin Kamps Letter 2.206 - Immediately Suspend the Operating License of General Electric Boiling Water Reactors Mark I Units2015-01-15015 January 2015 G20110262 - FRN - Paul Gunter and Kevin Kamps Letter 2.206 - Immediately Suspend the Operating License of General Electric Boiling Water Reactors Mark I Units 2021-06-29
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7590-01 PUNITED STATES NUCLEAR REGULATORY COMMISSIONDOCKET NO. 50-271LICENSE NO. DPR-28ENTERGY NUCLEAR VERMONT YANKEE, LLC AND ENTERGY NUCLEAR OPERATIONS, INC. NOTICE OF ISSUANCE OF DIRECTOR'S DECISION UNDER 10 CFR 2.206Notice is hereby given that the Director, Office of Nuclear Reactor Regulation, hasissued a Director's Decision with regard to a petition dated October 11, 2005, filed by Mr. Jonathan M. Block hereinafter referred to as the "Petitioner." The petition concerns the operation of the Vermont Yankee Nuclear Power Station (Vermont Yankee).The petition requested that the NRC require the temporary emergency closure or de-rating of Vermont Yankee due to flooding conditions on October 8 and 9, 2005. As a basis for this request, the petitioner stated that evacuations would be impossible asa result of storm damage to existing evacuation routes for Vermont Yankee.The petition of October 11, 2005, raised immediate concerns regarding emergencyevacuation planning for the States of Vermont and New Hampshire due to storm damage to existing evacuation routes through the city of Keene, town of Hinsdale, and other portions of New Hampshire. In a teleconference with the NRC, the Petitioner raised additional concernsregarding the Department of Homeland Security, Federal Emergency Management Agency (DHS/FEMA) and the State of New Hampshire's plans for an evacuation if an event were to occur at Vermont Yankee simultaneously with a natural disaster. Specific concerns were raised regarding alternative assembly points and decontamination centers for people who would normally evacuate through potentially flooded areas. The Petitioner also requested assurance from the NRC that contingency evacuation plans are in place. The NRC sent a copy of the proposed Director's Decision to the Petitioner and to thelicensee for comment on December 7, 2005 (Accession No. ML053140204). The NRC staff didnot receive any comments on the proposed Director's Decision. The Director of the Office of Nuclear Reactor Regulation has determined that, ThePetitioner's emergency request of October 11, 2005, to shut down or de-rate Vermont Yankee was denied. The reasons for this decision are explained in the director's decision pursuant to 10 CFR 2.206(DD-06-02), the complete text of which is available in ADAMS, and is available for inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland, and fromthe ADAMS Public Library component on the NRC Web site, http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room). Persons who do not have access toADAMS or who encounter problems in accessing the documents located in ADAMS should contact the NRC PDR reference staff at 1-800-397-4209 or 301-415-4737, or by e-mail topdr@nrc.gov. A copy of the Director's Decision will be filed with the Secretary of the Commission forthe Commission's review in accordance with 10 CFR 2.206 of the Commission's regulations.
As provided for by this regulation, the Director's Decision will constitute the final action of theCommission 25 days after the date of the decision, unless the Commission, on its own motion,institutes a review of the Director's Decision in that time. Dated at Rockville, Maryland, this 4th day of March 2006. FOR THE NUCLEAR REGULATORY COMMISSION/RA/J. E. Dyer, DirectorOffice of Nuclear Reactor Regulation