Letter Sequence Acceptance Review |
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CAC:001029, (Approved, Closed) EPID:L-2022-NEW-0002, Letter from J. Mccann/Columbiana Hi Tech to Document Control Desk Application for Revision of Certificate of Compliance No. 9291 for the Model No. Liqui-Rad (Lr) Transportation Unit Package, Docket No. 71-9291 (Approved, Closed) |
Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance, Acceptance, Acceptance, Acceptance, Acceptance, Acceptance, Acceptance
- Supplement
Results
Other: ML18206A311, ML18317A353, ML18317A355, ML22005A350, ML22006A352, ML22006A353, ML22006A356, ML22278A001, ML23003A046, ML23137A441, ML24204A233, ML24275A093, ML24289A207, ML24305A054, ML24327A249, ML25055A139, ML25078A414, ML25078A416, ML25086A041, ML25086A055, ML25086A244, ML25086A284, ML25087A028, ML25090A330, ML25090A331, ML25112A337, ML25112A339, ML25142A158, ML25161A179, ML25161A181, ML25176A170, ML25178C673, ML25223A188, ML25230A135, ML25253A491, ML25272A064, ML25344A143
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MONTHYEARML18156A4282018-05-30030 May 2018 Letter from J. Mccann/Columbiana Hi Tech to Document Control Desk Application for Revision of Certificate of Compliance No. 9291 for the Model No. Liqui-Rad (Lr) Transportation Unit Package, Docket No. 71-9291 Project stage: Request ML18206A3112018-07-25025 July 2018 Letter to Mccann Application for Amendment of Certificate of Compliance No. 9291 for the Model No. Liqui-Rad Transport Unit Package - Accepted for Review Project stage: Other ML18264A0022018-09-0707 September 2018 Columbiana Hi Tech, LLC - Certificate Holder Name and Address Change Project stage: Request ML18269A2732018-09-24024 September 2018 Package: Renewal of Certificate of Compliance No. 9291 for the Model No. Liqui-Rad Transport Unit Package Project stage: Request ML19015A3732019-01-10010 January 2019 Tn Americas, LLC - Application for Revision to Certificate of Compliance for USA/9291/B(U)F-96 for the Model No. Lr Transport Unit Project stage: Request ML18317A3532019-02-13013 February 2019 Enclosure 1: Certificate of Compliance No. 9291, Rev No. 11 (Letter to W. Edwards Amendment and Renewal of Certificate of Compliance No. 9291 for the Model No. LIQUI-RAD Transport Unit Package) Project stage: Other ML18317A3552019-02-13013 February 2019 Letter to W. Edwards Amendment and Renewal of Certificate of Compliance No. 9291 for the Model No. LIQUI-RAD Transport Unit Package (W/Enclosure 2) Project stage: Other ML18317A3522019-02-13013 February 2019 Package: Amendment and Renewal of Certificate of Compliance No. 9291 for the Model No. LIQUI-RAD (Lr) Transport Unit Package Project stage: Request ML20209A3722020-07-27027 July 2020 Notice of Partially Closed Third Pre-Application Meeting with Tn Ammericas LLC for Model No. TN-EAGLE Transportation Package Project stage: Meeting ML22005A3502021-12-14014 December 2021 Email from D. Ortega (NNSA) to N. Garcia (U.S. NRC) Renewal of Certificate of Compliance (CoC) No. 9329 for the Model No. S300 Package Project stage: Other ML22005A3462021-12-14014 December 2021 Transmittal Letter from A. M. Al-Daouk to U.S. Nuclear Regulatory Commission, Renewal Request of the Certificate of Compliance No. 9329 for the Model No. S300 Package Project stage: Request ML22006A3522021-12-27027 December 2021 Enclosure 3: Email Dated 12/27/21 from S. Burns (Nwp) to N. Garcia Santos (Nrc), Comments on Telephone Call Summary Dated 12/1/21, Model Nos. TRUPACT-II and Halfpact Packages Project stage: Other ML22006A3562021-12-27027 December 2021 Enclosure 5: Clarification Regarding Testing Performed During the Shielded Container Prototype Testing (Drop Tests, Gamma Scans, Destructive Disassembly), Model Nos. TRUPACT-II and Halfpact Packages Project stage: Other ML22006A3532021-12-27027 December 2021 Enclosure 2: Attachment to Email Dated 11-29-21, Responses to Follow Up Questions, Acceptance Tests for the Lead Ssield of the Shielded Canisters (Model Nos. TRUPACT-II and Halfpact Packages Project stage: Other ML22006A3552022-01-0606 January 2022 12/1/21-Conference Call Summary: Follow Up Questions Related to Shielding RAIs RAI-Sh-5 and -8 (Acceptance Tests, Shielded Canisters), Model Nos. TRUPACT-II and Halfpact Packages Project stage: RAI ML22020A1872022-01-25025 January 2022 Enclosure 2 - Safety Evaluation Report: Renewal for Certificate of Compliance, Revision 6, the Model No. S300 Package Project stage: Approval ML22278A0072022-09-0808 September 2022 Email from T.E. Sellmer (Nwp) to N. Garcia Santos (NRC) Acknowledgement of Application for CoC, Revision 27, Model No. TRUPACT-II and CoC, Revision 11, Model No. Halfpact Packages Project stage: Request ML25086A0552022-09-30030 September 2022 Redacted, Revised SAR, 435-B Transport Package, Safety Analysis Report, Revision 6 (CoC No. 9355, Rev. 4) (Docket No. 71-9355) Project stage: Other ML22278A0012022-10-0404 October 2022 Email from T. Sellmer (Nwp) to N. Garcia Santos (NRC) Et Al., Delay of RAI Response-CoC, Revision 27, Model No. TRUPACT-II and CoC, Revision 11, Model No. Halfpact CoCs Project stage: Other ML23046A4542023-02-15015 February 2023 Request for Authorization of One-Time Shipment of Model No. Halfpact Crediting the Outer Confinement Vessel as the Containment Boundary Project stage: Request ML23003A0462023-03-29029 March 2023 Response to Request for Reviewing a Position Paper from Nuclear Fuel Services, Inc. Related to Applicability of 10 CFR 71.15(C) to Shipment(S) Project stage: Other ML23089A2582023-03-29029 March 2023 Email Attachment, Staggered Request for Additional Information (Structural Evaluation and Operating Procedures), Model No. Halfpact - One-time Letter Authorization Project stage: RAI ML23333A0332023-05-30030 May 2023 Email Dated 5-30-23 from T Holly (NFS) to Ngarcia Santos (Nrc), Transmittal of Affidavit Related to Fissile Material Exemption (10 CFR 71.15 (C), Follow Up Questions and Additional Comments (Docket No. 70-143) Project stage: Request ML23137A4412023-06-0202 June 2023 Authorization for Shipment of the Model No. Halfpact Package - Inner Containment Vessel No. 506 Project stage: Other ML25087A0282023-07-0303 July 2023 Enclosure, Letter Dated 7/3/23 from NNSA to NRC, Roadmap, Revised SAR, 435-B Transport Package, Safety Analysis Report, Revision 6 (CoC No. 9355, Rev. 4) (Docket No. 71-9355) Project stage: Other ML23220A1572023-07-21021 July 2023 Transmittal Letter from Ahmad M. Al-Daouk (NNSA) to Ngarcia Santos (NRC) Related to the Application for Certificate of Compliance No. 9355, Revision 4, Model No. 435-B Project stage: Request ML23263A1022023-09-20020 September 2023 Email Dated 9-20-23 from N. Garcia Santos (NRC) to J. Mumma (Nnsa), Subject: Package Model No. 453-B--Need Clarification on Submittals Project stage: Approval ML24072A0022024-03-0505 March 2024 Revision of Model No. 435-B Package’S Certificate of Compliance (CoC) Number 9355 for the 435-B Package Project stage: Request ML24149A1412024-05-28028 May 2024 Notice of Pre-Application Meeting with Holtec International for the Model No. HI-STAR 330 Package Project stage: Meeting ML24295A1602024-06-30030 June 2024 Redacted, Industrial Nuclear Company - Application for Certificate of Compliance for the Inc IR1 00ST, Revision 0, Docket No. 71-9385 Project stage: Request ML24199A0812024-06-30030 June 2024 Enclosure 2: HI-STAR 330 Pre-submittal Presentation to the U.S. Nuclear Regulatory Commission - Public Session Project stage: Other ML24199A0742024-07-19019 July 2024 Memo and Enclosure 1: Summary of June 20, 2024, Meeting with Holtec International Project stage: Meeting ML24204A2332024-08-0808 August 2024 Acceptance Determination Letter with Observation, Certificate of Compliance No. 9355, Model No. 435-B Project stage: Other ML24248A2532024-09-20020 September 2024 Request for Additional Information, Certificate of Compliance No. 9355, Revision 4, Model No. 435-B Packaging, EPID L-2023-LLA-0102, CAC 001029 Project stage: RAI ML24281A1762024-09-25025 September 2024 9/25/2024 Conference Call Summary - Supplemental Information to Proposed RAI Responses Related to the Criticality Safety Review of the Model No. Castor geo69 Transport and Storage Systems (Docket Nos. 71-9383 and 72-1052, Respectively) Project stage: Supplement ML24312A2212024-10-0101 October 2024 Extension Request - Robatel Technologies’ Response to U.S. NRC Request for Additional Information for Review of the Robatel Technologies, LLC Model No. RT-200 Type B(U) Cask - Cac/Epid Numbers: 001029/L-2024-NEW-0003 Project stage: Request ML24275A0932024-10-11011 October 2024 Transmittal Letter - Certificate of Compliance No. 9310, Revision No. 8, for the Model No. F-431 Transport Package Project stage: Other ML25058A3612024-10-16016 October 2024 Email Dated 10/16/24 from Ngarcia Santos (NRC) to Mrose (Inc) Transmittal of Draft Requests for Supplemental Information and Observations, Thermal and Structural Evaluations, Model No. IR 100ST, CoC No. 9385, Rev. 0 Project stage: Draft Other ML25058A3592024-10-16016 October 2024 Enclosure to Email Dated 10/16/24, Draft Requests for Supplemental Information and Observations, Model No. IR-100ST, CoC No. 9385, Rev. 0 Project stage: Draft Other ML24289A2072024-10-28028 October 2024 Transmittal Letter and Enclosure, Requests for Supplemental Information and Observations for Revision 0 of CoC No. 9385 for the Model No. IR 100ST Project stage: Other ML24305A0542024-10-31031 October 2024 Email Dated 10-31-24 from Ngarcia Santos (NRC) to Mrose (Inc), Final Signed Letter with Requests for Supplemental Information for the Model No. IR 100ST Project stage: Other ML25058A3562024-11-0707 November 2024 Email Dated 11/7/24 from Ngarcia Santos (NRC) to Mrose (Inc)/Gclark (Orano), Follow Up to Requests for Supplemental Information (Rsis) and Observations Discussion on 11/7/24, Thermal and Structural Evaluations, Model No. IR-100ST, CoC No. 9 Project stage: Approval ML25058A3572024-11-21021 November 2024 Transmittal Email Dated 11/21/24 from Ngarcia Santos (NRC) to Mrose (Inc), Summary of Telephone Call Dated 11/7/24 with Inc, Acceptance Review Questions (Rsis and Observations), Thermal and Structural, Model No. IR-100ST, CoC No. 9385, Rev Project stage: Acceptance Review ML24327A2492024-12-0505 December 2024 Enclosure 1 - Certificate of Compliance No. 5086, Revision 17 (Renewal of Certificate of Compliance No. 5086, Model No. Unc 2600 (EPID L-2024-RNW-0024)) Project stage: Other ML24327A2472024-12-0505 December 2024 Enclosure 2 - Safety Evaluation Report, Renewal of Certificate of Compliance No. 5086, Model No. Unc 2600 Project stage: Approval ML25086A0382024-12-0606 December 2024 Letter Dated 12/6/24 from Kschwendenman (NNSA) to Ngarcia Santos (Nrc), Response to Request for Additional Information on Preshipment Leakage Rate Test (Model No. 435-B, Docket No. 71-9355) Project stage: Response to RAI ML25086A0322024-12-0606 December 2024, 9 January 2025, 4 February 2025, 21 February 2025 Responses to Requests for Additional Information for CoC No. 9355, Revision 4, Model No. 435-B (Docket No. 71-9355) Project stage: Request ML25058A3582024-12-0909 December 2024 NRC Form 699, Summary of Telephone Call Dated 11/7/24 with Inc, Acceptance Review Questions (Rsis and Observations), Thermal and Structural, Model No. IR-100ST, CoC No. 9385, Rev. 0 Project stage: Acceptance Review ML25055A1392025-01-24024 January 2025 Redacted -Industrial Nuclear Co, Inc., Safety Analysis Report, IR-100ST Exposure Device Project stage: Other ML25086A0412025-02-0404 February 2025 Email Dated 2/2/25 from Jthurgood (NNSA) to Ngarcia Santos (Nrc), Status of Revised SAR Related to RAI Response and Renewal Request, Model No. 435-B, CoC No. 9355, Revision 4 (Docket No. 71-9355) Project stage: Other 2023-07-03
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OFFICIAL USE ONLYPROPRIETARY INFORMATION OFFICIAL USE ONLYPROPRIETARY INFORMATION Kimberly Manzione, Director of Licensing Holtec International KPS Technology Campus 1 Holtec Blvd Camden, NJ 08104
SUBJECT:
APPLICATION FOR CERTIFICATE OF COMPLIANCE NO. 9397 FOR THE MODEL NO. HI-STAR 330 PACKAGE-ACCEPTANCE LETTER
Dear Kimberly Manzione:
By letter dated March 10, 2025 (Agencywide Documents Access and Management System
[ADAMS] Accession No. ML25071A369), as supplemented on December 2, 2025, (ML25336A297), Holtec International (Holtec) submitted an application for review and approval of a new design model number HI-STAR 330 Transportation Package pursuant to Title 10 of the Code of Federal Regulations (10 CFR) Part 71.
The U.S. Nuclear Regulatory Commission (NRC) staff performed an acceptance review of your application to determine if the application contains sufficient technical information in scope and depth to allow the staff to complete a detailed technical review. The staff issued request for supplemental information (RSI) on August 1, 2025 (ML25178C672) to inquire about additional information needed to complete its acceptance review. On September 11, 2025 (ML25254A171), the staff held an audit to discuss additional observations from its review and issued these questions on September 12, 2025 (ML25253A489). The staff has since reviewed the response to the RSIs and Observations submitted on December 2, 2025, and has determined the application contains sufficient technical information to complete a detailed technical review. Given the more limited scope and depth of the acceptance review compared to the detailed technical review, issues that affect the staffs ability to complete the technical review may still be identified despite the acceptance review being deemed adequate. If additional information is needed, you will be notified by separate correspondence.
The staffs observations related to Material evaluations are attached for your reference.
Observations are not the result of a detailed technical review and may be resolved once staff begin a detailed review; therefore, responses to observations are not required for staff to begin a detailed technical review. The staff included these observations to provide an early insight into what could potentially be Request for Additional Information (RAI) further into the technical review.
The enclosure transmitted herewith contains proprietary information. When separated from the sensitive conditions in the enclosure, this document is decontrolled.
December 19, 2025
OFFICIAL USE ONLYPROPRIETARY INFORMATION K. Manzione 2
OFFICIAL USE ONLYPROPRIETARY INFORMATION The staff determines thatthe technical review will require approximately 1,507 hours0.00587 days <br />0.141 hours <br />8.382936e-4 weeks <br />1.929135e-4 months <br />, $163k contract dollars, and 18 months to complete. To support a more efficient process, the NRC is setting a goal of completing a review in 15 percent less level of effort. Based on that, the staffs estimate for this review is approximately 1,480 hours0.00556 days <br />0.133 hours <br />7.936508e-4 weeks <br />1.8264e-4 months <br /> staff hours, including project managers hours. The schedule includes the issuance, if needed, of RAI(s) by March 2026 and receiving your response by April 2026. The staff expects to complete the formal review and issue a certificate by July 2026. These estimates are based on the staffs initial review of the application and may change due to several factors, including, unanticipated expansion of the review scope involvement, or if the submittal is provided to the NRC in advance of or concurrently with industry program initiatives or pilot applications.
The schedule above is also based, in part, on Holtec providing RAI responses by the timeline specified, unless another date is agreed upon, RAI responses resolving issues with limited need for follow-up RAIs, and clarification calls being scheduled and conducted promptly, and any additional supporting non-docketed information being provided timely.
To achieve this schedule, the staff intends to engage with Holtec frequently to resolve emergent issues or challenges that may arise during the staffs review that affect the initial forecasted completion date or result in significant changes to the estimated review hours. The reasons for those changes, along with updated estimates, will be communicated during routine interactions with the assigned project manager and documented accordingly. Should the review experience a delay for other reasons, the staff will endeavor to make up the time within the schedule.
Your submittal has been assigned a Cost Activity Code/Enterprise Project Identification No.
[001029/ L-2022-NEW-0002]. Please reference these numbers and Docket No. 71-9397 in any future correspondence associated with this request.
In accordance with 10 CFR Part 2, Agency Rules of Practice and Procedure, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room (PDR) or from the Publicly Available Records component of the NRCs ADAMS. ADAMS is accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. The PDR is open by appointment. To make an appointment to visit the PDR, please send an email to PDR.Resource@nrc.gov or call 1-800-397-4209 or 301-415-4737, between 8 a.m. and 4 p.m.
eastern time (ET), Monday through Friday, except Federal holidays.
OFFICIAL USE ONLYPROPRIETARY INFORMATION K. Manzione 3
OFFICIAL USE ONLYPROPRIETARY INFORMATION If you have any questions regarding this communication, please contact me via email to Haimanot.yilma@nrc.gov.
Sincerely, Haimanot Yilma, Project Manager Storage and Transportation Licensing Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 71-9397 CAC No. 001029 EPID No L-2022-NEW-0002
Enclosure:
- 1. Acceptance Review Observations for HI-STAR 330 Transportation Cask - Proprietary Signed by Yilma, Haimanot on 12/19/25
OFFICIAL USE ONLYPROPRIETARY INFORMATION K. Manzione 4
OFFICIAL USE ONLYPROPRIETARY INFORMATION
SUBJECT:
APPLICATION FOR CERTIFICATE OF COMPLIANCE NO. 9397 FOR THE MODEL NO. HI-STAR 330 PACKAGE-ACCEPTANCE LETTER DATED: December 19, 2025 DISTRIBUTION:
71bw9397all@listmgr.nrc.gov 71bw9397coc@listmgr.nrc.gov Accession Nos.: ML25352A318 (pkg, non-public), ML25352A319 (ltr),
ML25352A320 (encl, non-public)
OFFICE NMSS/DFM NMSS/DFM NMSS/DFM NMSS/DFM NAME HYilma SFigueroa YDiaz-Sanabria HYilma DATE 12/19/2025 12/19/2025 12/19/2025 12/19/2025 OFFICIAL RECORD COPY