[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Pages 26168-26170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11660]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 50-608; NRC-2019-0029]


In the Matter of SHINE Medical Technologies, Inc.; SHINE Medical 
Isotope Production Facility

AGENCY: Nuclear Regulatory Commission.

ACTION: Indirect transfer of license; order.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an 
order approving the indirect transfer of Construction Permit No. CPMIF-
001 for the SHINE Medical Isotope Production Facility, resulting from 
the establishment of a holding company, Illuminated Holdings, Inc. The 
NRC is also issuing an administrative

[[Page 26169]]

conforming amendment to the license to reflect the transfer.

DATES: The Order was issued on May 20, 2019, and is effective for one 
year.

ADDRESSES: Please refer to Docket ID NRC-2019-0029 when contacting the 
NRC about the availability of information regarding this document. You 
may obtain publicly-available information related to this document 
using any of the following methods:
     Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2019-0029. Address 
questions about NRC Docket IDs in Regulations.gov to Jennifer Borges; 
telephone: 301-287-9127; e-mail: [email protected]. For technical 
questions, contact the individual listed in the FOR FURTHER INFORMATION 
CONTACT section of this document.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS 
Search.'' For problems with ADAMS, please contact the NRC's Public 
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or 
by e-mail to [email protected]. The license transfer Order, the NRC 
safety evaluation supporting the staff's findings, and the conforming 
license amendment are available in ADAMS under Accession Nos. 
ML19102A324, ML19102A326, and ML19102A322, respectively.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Steven T. Lynch, Office of Nuclear 
Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 
20555[dash]0001; telephone: 301-415-1524, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: The text of the Order is attached.

    Dated at Rockville, Maryland, this 30th day of May 2019.

    For the Nuclear Regulatory Commission.
Steven T. Lynch,
Project Manager, Research and Test Reactors Licensing Branch, Division 
of Licensing Projects, Office of Nuclear Reactor Regulation.

Attachment--Order Approving the Transfer of License and Conforming 
Amendment

UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
[Docket No. 50-608; Construction Permit No. CPMIF-001]
    In the Matter of SHINE Medical Technologies, Inc.
ORDER APPROVING THE INDIRECT TRANSFER OF LICENSE AND CONFORMING 
AMENDMENT
I.
    SHINE Medical Technologies, Inc. (SHINE) is the holder of 
Construction Permit No. CPMIF-001, which authorizes construction of the 
SHINE Medical Isotope Production Facility. SHINE has proposed to 
construct and operate a facility in Janesville, Wisconsin for the 
production of molybdenum-99 (Mo-99) through the irradiation and 
processing of a uranyl sulfate solution. The proposed facility would 
comprise an irradiation facility and radioisotope production facility. 
The irradiation facility would consist of eight subcritical operating 
assemblies (or irradiation units), which would each be licensed as a 
utilization facility, as defined in title 10 of the Code of Federal 
Regulations (10 CFR) Sec.  50.2, ``Definitions.'' The radioisotope 
production facility would consist of three hot cell structures, 
licensed collectively as a production facility, as defined in 10 CFR 
Sec.  50.2. The irradiation facility and radioisotope production 
facility are collectively referred to as the SHINE Medical Isotope 
Production Facility.
II.
    By application dated December 11, 2018 (Agencywide Documents Access 
and Management System (ADAMS) Accession No. ML18347A215), as 
supplemented by letter dated March 8, 2019 (ADAMS Accession No. 
ML19071A055), SHINE requested that the U.S. Nuclear Regulatory 
Commission (NRC, the Commission) consent to the indirect transfer of 
Construction Permit No. CPMIF-001 for the SHINE Medical Isotope 
Production Facility, currently held by SHINE. The indirect transfer 
would result from the establishment of a holding company, Illuminated 
Holdings, Inc. (Illuminated). The indirect transfer request was 
submitted to the NRC for approval pursuant to Section 184, 
``Inalienability of Licenses,'' of the Atomic Energy Act of 1954, as 
amended (AEA), and 10 CFR Sec.  50.80, ``Transfer of licenses.''
    SHINE also requested, pursuant to 10 CFR Sec.  50.90, ``Application 
for amendment of license, construction permit, or early site permit,'' 
the issuance of an administrative conforming amendment to the license 
to reflect the proposed transfer. Specifically, the amendment would 
revise SHINE's construction permit to reflect SHINE's new name, SHINE 
Medical Technologies, LLC (SHINE LLC), resulting from its conversion 
from a corporation into a single-member limited liability company, 
owned and controlled by Illuminated.
    Notice of NRC consideration of the indirect license transfer 
application was published in the Federal Register (FR) on February 20, 
2019 (84 FR 5116), and included an opportunity to comment, request a 
hearing, and petition for leave to intervene. No comments or hearing 
requests were received.
    Pursuant to 10 CFR Sec.  50.80, no license for a production or 
utilization facility, or any right thereunder, shall be transferred, 
either voluntarily or involuntarily, directly or indirectly, through 
transfer of control of the license to any person, unless the Commission 
gives its consent in writing. Upon review of the information in the 
application, as supplemented, and other information before the 
Commission, and relying upon the representations and agreements 
contained in the application, as supplemented, the NRC staff has 
determined that SHINE LLC would be qualified to be the holder of 
Construction Permit No. CPMIF-001, and that the indirect transfer of 
the license, as described in the application, as supplemented, is 
otherwise consistent with applicable provisions of law, regulations, 
and orders issued by the Commission pursuant thereto.
    Upon review of the application for a conforming amendment to 
Construction Permit No. CPMIF-001 to reflect the indirect transfer of 
the license, the NRC staff determined the following:
    (1) The application for the proposed license amendment complies 
with the standards and requirements of the AEA, and the Commission's 
rules and regulations set forth in 10 CFR Chapter I, ``Nuclear 
Regulatory Commission.''
    (2) The facility will be constructed in conformity with the 
application, as supplemented, the provisions of the

[[Page 26170]]

Act, and the rules and regulations of the Commission.
    (3) There is reasonable assurance that the activities authorized by 
the proposed license amendment can be conducted without endangering the 
health and safety of the public, and that such activities will be 
conducted in compliance with the Commission's regulations.
    (4) The issuance of the proposed license amendment will not be 
inimical to the common defense and security or to the health and safety 
of the public.
    (5) The issuance of the proposed license amendment is in accordance 
with 10 CFR part 51, ``Environmental Protection Regulations for 
Domestic Licensing and Related Regulatory Functions,'' of the 
Commission's regulations, and all applicable requirements have been 
satisfied.
    The findings set forth above are supported by an NRC safety 
evaluation dated May 20, 2019.
III.
    Accordingly, pursuant to Sections 161b, 161i, and 184 of the AEA, 
Title 42 of the United States Code Sections 2201(b), 2201(i), and 2234; 
and 10 CFR Sec.  50.80, IT IS HEREBY ORDERED that the application for 
the indirect transfer of the license, as described herein, is approved 
for the SHINE Medical Isotope Production Facility.
    IT IS FURTHER ORDERED that, consistent with 10 CFR Sec.  2.1315, 
``Generic determination regarding license amendments to reflect 
transfers,'' paragraph (b), the license amendment that makes changes, 
as indicated in Enclosure 2 to the cover letter forwarding this Order, 
to conform the license to reflect the subject indirect license transfer 
is approved. The amendment shall be issued and made effective at the 
time the proposed indirect license transfer is completed.
    IT IS FURTHER ORDERED that SHINE shall, at least 2 business days 
prior to closing, inform the Director of the Office of Nuclear Reactor 
Regulation in writing of the date of closing of the indirect license 
transfer for the SHINE Medical Isotope Production Facility. Should the 
proposed transfer of the license not be completed within 1 year of this 
Order's date of issuance, this Order shall become null and void, 
provided, however, that upon written application and for good cause 
shown, such date may be extended by order.
    This Order is effective upon issuance.
    For further details with respect to this Order, see the application 
dated December 11, 2018, as supplemented by letter dated March 8, 2019, 
and the associated NRC safety evaluation dated May 20, 2019, which are 
available for public inspection at the Commission's Public Document 
Room (PDR), located at One White Flint North, 11555 Rockville Pike 
(first floor), Rockville, Maryland. Publicly available documents 
created or received at the NRC are accessible electronically through 
ADAMS in the NRC Library at http://www.nrc.gov/reading-rm/adams.html. 
Persons who encounter problems with ADAMS should contact the NRC's PDR 
reference staff by telephone at 1[dash]800[dash]397[dash]4209 or 301-
415[dash]4737 or by e[dash]mail to [email protected].

    Dated at Rockville, Maryland this 20th day of May 2019.

    For the Nuclear Regulatory Commission.

Tamara E. Bloomer,

Acting Deputy Director, Division of Licensing Projects, Office of 
Nuclear Reactor Regulation.

[FR Doc. 2019-11660 Filed 6-4-19; 8:45 am]
 BILLING CODE 7590-01-P