ML26056A204
| ML26056A204 | |
| Person / Time | |
|---|---|
| Site: | 07109337 |
| Issue date: | 03/04/2026 |
| From: | Kristina Banovac Storage and Transportation Licensing Branch |
| To: | Longman G Croft Associates Limited |
| References | |
| EPID L-2026-LLA-0023 | |
| Download: ML26056A204 (0) | |
Text
From:
Kristina Banovac To:
Guy Longman Cc:
ext_Alex_Ferguson; Mark Johnson; Yoira Diaz Sanabria; David Brown
Subject:
Approval of Croft Request for Withholding Information from Public Disclosure for the Submittal of Request for Inclusion of Impurities in CoC No. 9337 for the Safkeg-LS Model No. 3979A Package Date:
Wednesday, March 4, 2026 11:28:00 AM
Dear Guy Longman:
On February 23, 2026 (Agencywide Documents Access and Management System (ADAMS) Accession Nos. ML26055A001 (public) and ML26042A205 (proprietary)), Croft Associates Limited (Croft) submitted an affidavit, executed by Mark Johnson (Managing Director of Croft Associates Limited), requesting that the following documents, submitted in support of the February 3, 2026, application for amendment to Certificate of Compliance (CoC) No. 9337 to include an allowance for activation impurities (ML26034B901), be withheld from public disclosure pursuant to Title 10 of the Code of Federal Regulations (10CFR), Part 2, Section 2.390:
February 3, 2026, submittal requested to be withheld:
Cover letter, Request for Inclusion of Impurities in CoC No. USA/9337/B(U) for the 3979A Package (Proprietary), ML26034B902 Enclosure - Bounding Contaminants/Impurities (Proprietary), ML26034B903 Enclosure - Transport Approval (Proprietary), ML26034B904 Enclosure - Croft Support Letter (Proprietary), ML26036A130
A nonproprietary copy of the cover letter has been placed in the U.S. Nuclear Regulatory Commissions (NRCs) Public Document Room and added to the ADAMS Public Electronic Reading Room: February 3, 2026, redacted cover letter at ML26042A204.
The affidavit submitted to support the withholding of the information stated that the submitted information should be considered exempt from mandatory public disclosure for the following reasons:
i) This information is and has been held in confidence by Croft.
ii) This information is of a type that is customarily held in confidence by Croft and there is a rational basis for doing so because this information if released might result in the loss of an existing or potential competitive advantage as follows:
- a. The information reveals the distinguishing aspects of the design and the prevention of its use by Crofts competitors gives Croft a competitive economic advantage.
- b. The information, if used by a competitor, is likely to reduce the competitors expenditure of resources or improve their advantage in the design, quality and manufacture of a similar product.
iii) This information is of a type that is customarily held in confidence by users of the package and there is a rational basis for doing so because this information if released might result in the loss of an existing or potential competitive advantage as follows:
- a. The information reveals the development of radiopharmaceuticals and the prevention of its use by the users competitors gives the Croft package users a competitive economic advantage.
iv) This information is being transmitted to the NRC voluntarily and in confidence.
v) This information is not available in public sources.
vi) Public disclosure of this information is likely to cause substantial harm to the competitive position of Croft or users of the package because of the reasons outlined below.
- a. Similar products are manufactured and sold by competitors of Croft.
- b. Similar radiopharmaceuticals are being developed by competitors of the users of the Croft package.
- c. The development of this information by Croft is the result of significant expenditure of staff effort and a considerable amount of money. It is Crofts belief that a competitor of Croft or of the package users would have to undertake similar effort and expense to generate equivalent information.
- d. In order to generate such information, a competitor of Croft or of the package users would also require considerable time.
- e. If a competitor of Croft or of the package users used this information and did not have to undertake the work required to generate this information they are likely to have lower overall costs and so are likely to have an unfair economic advantage over Croft in offering a similar product to the market.
We have reviewed your application and the material in accordance with the requirements of 10CFR 2.390 and, on the basis of your statements, have determined that the submitted information sought to be withheld contains proprietary commercial information and should be withheld from public disclosure. Therefore, the versions of the submitted information marked as proprietary will be withheld from public disclosure pursuant to 10CFR 2.390(b)
(5) and Section103(b) of the Atomic Energy Act of 1954, as amended. Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents.
If the basis for withholding this information from public inspection should change in the future such that the information could then be made available for public inspection, you should promptly notify the NRC. You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes your information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified in advance of the date of public disclosure which will be a reasonable time thereafter.
In accordance with Title 10 of the Code of Federal Regulations, Section 2.390 of the NRCs Agency Rules of Practice and Procedure, a copy of this e-mail will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records component of the NRCs ADAMS. ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room).
If you have any questions regarding this matter, please contact me at (301) 415-7116 or Kristina.Banovac@nrc.gov.
Sincerely, Kristina L. Banovac, Project Manager Storage and Transportation Licensing Branch Division of Fuel Management Office of Nuclear Material Safety
and Safeguards
Docket No.: 71-9337 EPID No.: L-2026-LLA-0023 ADAMS Accession No. ML26056A204