Letter Sequence Response to RAI |
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EPID:L-2018-LLM-0154, Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 (Approved, Closed) |
Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance...
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MONTHYEARML16238A0342016-08-25025 August 2016
Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML17055A5732017-02-24024 February 2017
Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML17235A1102017-08-23023 August 2017
Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML18054A0022018-02-23023 February 2018
Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML18166A1782018-06-13013 June 2018
Shine Medical Technologies, Inc., Submittal of Annual Financial Report
Project stage: Request
ML18234A0202018-08-22022 August 2018
Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Request
ML18347A2152018-12-11011 December 2018
Shine Medical Technologies - Application for Order Approving Indirect Transfer of Control of Construction Permit and Conforming Administrative Construction Permit Amendment
Project stage: Request
ML19024A5302019-02-13013 February 2019
Shine Medical Technologies, Inc. - Request for Additional Information Regarding the Application for Indirect License Transfer and Conforming Amendment
Project stage: RAI
ML19010A1722019-02-13013 February 2019
Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure
Project stage: Withholding Request Acceptance
ML19010A0952019-02-13013 February 2019, 14 February 2019
Shine Medical Technologies, Inc. Application for Indirect License Transfer
Project stage: Request
ML19010A0962019-02-13013 February 2019
Shine Medical Technologies, Inc. - Notice of Consideration of Approval of Indirect License Transfer and Conforming Amendment and Opportunity for a Hearing and Petition for Leave to Intervene
Project stage: Other
ML19010A0972019-02-14014 February 2019
Shine Medical Technologies, Inc. - Federal Register Notice Related to Consideration of Approval of Transfer of License and Conforming Amendment
Project stage: Other
ML19053A2782019-02-22022 February 2019
Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001
Project stage: Request
ML19071A0562019-03-0808 March 2019
Shine Medical Technologies, Inc., Affidavit & Response to Request for Additional Information to Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information
Project stage: Response to RAI
ML19071A0552019-03-0808 March 2019
Shine Medical Technologies, Inc., Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information
Project stage: Response to RAI
ML19102A3482019-05-0202 May 2019
Shine Medical Technologies, Inc. - Response to Withholding Request Related to Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001
Project stage: Other
ML19102A3212019-05-0202 May 2019, 20 May 2019, 30 May 2019
Shine Medical Technologies, Inc. - Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001
Project stage: Request
ML19102A3242019-05-20020 May 2019
Shine Medical Technologies, Inc. - Order Approving Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001
Project stage: Request
ML19102A3232019-05-20020 May 2019
Shine Medical Technologies, Inc. - Cover Letter for Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001
Project stage: Other
ML19162A0262019-07-0101 July 2019
Shine Medical Technologies, LLC - Amendment No. 1 to Shine Medical Isotope Production Facility Construction Permit No. CPMIF-001
Project stage: Other
ML19162A0242019-07-0101 July 2019
Shine Medical Technologies, LLC - Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No. CPMIF-001
Project stage: Request
ML19162A0252019-07-0101 July 2019
Shine Medical Technologies, LLC - Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No. CPMIF-001
Project stage: Approval
ML19234A0472019-08-22022 August 2019
Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001
Project stage: Request
ML19331A8322019-11-14014 November 2019
Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report
Project stage: Request
ML20052C7942020-02-21021 February 2020
Shine Medical Technologies, Inc., Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
Project stage: Other
2019-02-13
[Table View] |
Text
March 8, 2019 ENCLOSURE 1 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 2019-SMT-0015 10 CFR 50.80 10 CFR 50.90
References:
(1) SHINE Medical Technologies, Inc. letter to NRC, dated December 11, 2018, Application for Order Approving Indirect Transfer of Control of Construction Permit and Conforming Administrative Construction Permit Amendment (ML18347A215)
(2) NRC letter to SHINE Medical Technologies, Inc., dated February 13, 2019, SHINE Medical Technologies, Inc. - Request for Additional Information Regarding the Application for Indirect License Transfer and Conforming Amendment (EPID No. L-2018-LLM-0154) (ML19024A530)
SHINE Medical Technologies, Inc. Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information Via Reference (1), SHINE Medical Technologies, Inc. (SHINE) submitted an application for an order approving the indirect transfer of control of Construction Permit No. CPMIF-001 and conforming administrative Construction Permit amendment. The NRC staff determined that additional information was required to enable.the staff's continued review of the transfer application (Reference 2). provides a non-public (proprietary) version of the SHINE response to the NRC staff's request for additional information. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390. provides a public (non-proprietary) version of the SHINE response to the NRC staff's request for additional information. provides an affidavit supporting the proprietary treatment of the SHINE proprietary information pursuant to 10 CFR 2.390. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390. Upon removal of Enclosure 1, this letter is uncontrolled.
If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735. contains proprietary information.-
Withhold from public disclosure under 1 O CFR 2.390.
Upon removal of Enclosure 1, this letter is uncontrolled.
101 E. Milwaukee Street, Suite 600 I Janesville, WI 535451 P (608) 210-1060 IF (608) 210-2504 i www.shinemed.com
Document Control Desk Page 2 I declare under the penalty of perjury that the foregoing is true and correct.
Executed on March 8, 2019.
Very truly yours,
)/~
Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosures cc:
Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 1)
ENCLOSURE 3 SHINE MEDICAL TECHNOLOGIES, INC.
SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR ORDER APPROVING INDIRECT TRANSFER OF CONTROL OF CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION AFFIDAVIT OF JAMES COSTEDIO 2 pages follow