ML25352A319

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Acceptance Letter for HI-STAR 330, Docket Number 71-09397, CoC No. 9397
ML25352A319
Person / Time
Site: 07109397
Issue date: 12/19/2025
From: Haimanot Yilma
Storage and Transportation Licensing Branch
To: Manzione K
Holtec
Shared Package
ML25352A318 List:
References
EPID L-2022-NEW-0002, CAC 001029
Download: ML25352A319 (0)


Text

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