In the Matter of SHINE Medical Technologies, Inc.; SHINE Medical Isotope Production Facility, 26168-26170 [2019-11660]
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26168
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
program for VEGP Unit 3, which will
help to ensure they maintain
proficiency in topics included in the
initial training program and that they
also receive training on any changes
made to the plant design or procedures
prior to fuel load and plant operation.
Therefore, granting the exemption and
transferring the pass letters from VCSNS
Unit 2 to VEGP Unit 3 is an effective
and efficient alternative to requiring the
11 applicants to take a written
examination and operating test to be
licensed at VEGP Unit 3.
Concerning reliability, once
established, regulations should be
perceived to be reliable and not
unjustifiably in a state of transition.
Regulatory actions should always be
fully consistent with written regulations
and should be promptly, fairly, and
decisively administered so as to lend
stability to the nuclear operational and
planning processes. Here, where the
staff has already found that the
examinations administered at VCSNS
Unit 2 together with the actions SNC
has taken to ensure the 11 applicants
demonstrated competency to implement
the VEGP Unit 3 EPIPs and conduct of
operations procedures are sufficient to
conclude that the 11 applicants have
learned to operate VEGP Unit 3 safely
and competently, the substantive
requirements upon the operator license
applicant are unchanged with the
granting of the exemption. Further, the
public has an interest in reliability in
terms of the stability of the nuclear
planning process. This exemption aids
planning by allowing the 11 applicants
to complete their applications sooner,
with the underlying requirements
essentially unchanged, and could result
in licensing decisions being made
earlier than would be possible if the
applicants had to wait to take a written
examination and operating test at VEGP
Unit 3.
Concerning clarity, there should be a
clear nexus between regulations and
agency goals and objectives whether
explicitly or implicitly stated. Agency
positions should be readily understood
and easily applied. For the reasons
explained herein, the examination
results from the examinations
administered at VCSNS Unit 2 together
with the compensatory actions taken by
SNC to address knowledge gaps related
to EPIPs and conduct of operations
procedures are sufficient to conclude
that these 11 applicants have learned to
operate VEGP Unit 3 safely and
competently, and therefore the
underlying requirements of 10 CFR
55.33(a)(2) are met, and the
requirements in 10 CFR 55.31(a)(3) are
not necessary.
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The exemption is also consistent with
the principles of Independence and
Openness; the Commission has
independently and objectively
considered the regulatory interests
involved and has explicitly documented
its reasons for issuing the exemption.
Accordingly, on balance the
Commission concludes that the
exemption is in the public interest.
Summary
The Commission concludes that the
exemption is (1) authorized by law and
(2) will not endanger life or property
and (3) is otherwise in the public
interest. Therefore, in lieu of the
requirements of 10 CFR 55.33(a)(2), the
Commission will transfer the pass
letters for the 11 applicants listed in
Enclosure 2 of the letter dated April 16,
2019, to VEGP Unit 3, and the
requirement in 55.31(a)(3) is therefore
not necessary for these 11 applicants.
Limitation
The granting of this exemption is
limited to the 11 applicants identified
by docket number in Enclosure 2 of the
April 16, 2019 letter.
Environmental Consideration
This exemption allows the exemption
from the requirements of 10 CFR
55.31(a)(3) and 55.33(a)(2), and allows
11 VCSNS Unit 2 operator license
applicants to transfer their pass letters
for VCSNS Unit 2 to VEGP Unit 3. The
staff evaluated whether there would be
significant environmental impacts
associated with the issuance of the
requested exemption. The staff
determined the proposed action fits a
category of actions that do not require
an environmental assessment or
environmental impact statement.
For the following reasons, this
exemption meets the eligibility criteria
of 10 CFR 51.22(c)(25) for a categorical
exclusion. The exemption does not
make any changes to the facility or
operating procedures and does not:
• Alter the design, function or
operation of any plant equipment.
Therefore, granting this exemption
would not increase the probability or
consequence of any previously
evaluated accident.
• Create any new accident initiators.
Therefore, granting this exemption does
not create the possibility of a new or
different kind of accident from any
accident previously evaluated.
• Exceed or alter a design basis or
safety limit. Therefore, granting this
exemption does not involve a significant
reduction in a margin of safety.
Therefore, there is no significant
hazards consideration related to this
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exemption. The staff has also
determined that the exemption involves
no significant increase in the amounts,
and no significant change in the types,
of any effluents that may be released
offsite; that there is no significant
increase in individual or cumulative
public or occupational radiation
exposure; that there is no significant
construction impact; and that there is no
significant increase in the potential for
or consequences from radiological
accidents. Finally, the requirements to
which the exemption applies involve
qualification requirements. Accordingly,
the exemption meets the eligibility
criteria for categorical exclusion set
forth in 10 CFR 51.22(c)(25). Pursuant to
10 CFR 51.22(b), no environmental
impact statement or environmental
assessment need be prepared in
connection with the issuance of the
exemption.
IV. Conclusion
Accordingly, the Commission has
determined that, pursuant to 10 CFR
55.11, issuing this exemption from the
requirements in 10 CFR 55.33(a)(2) and
10 CFR 55.31(a)(3) is authorized by law
and will not endanger life or property
and is otherwise in the public interest.
The Commission will also transfer the
pass letters from VCSNS Unit 2 to VEGP
Unit 3 for the 11 former VCSNS Unit 2
operator license applicants.
Dated at Rockville, Maryland, this 31st day
of May 2019.
For the Nuclear Regulatory Commission.
Anna H. Bradford,
Deputy Director, Division of Licensing, Siting,
and Environmental Analysis, Office of New
Reactors.
[FR Doc. 2019–11688 Filed 6–4–19; 8:45 am]
BILLING CODE 7590–01–P
NUCLEAR REGULATORY
COMMISSION
[Docket No. 50–608; NRC–2019–0029]
In the Matter of SHINE Medical
Technologies, Inc.; SHINE Medical
Isotope Production Facility
Nuclear Regulatory
Commission.
ACTION: Indirect transfer of license;
order.
AGENCY:
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
SUMMARY:
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Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
conforming amendment to the license to
reflect the transfer.
The Order was issued on May
20, 2019, and is effective for one year.
DATES:
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
https://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:
Jennifer.Borges@nrc.gov. 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 publiclyavailable documents online in the
ADAMS Public Documents collection at
https://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 pdr.resource@
nrc.gov. 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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Steven T. Lynch, Office of Nuclear
Reactor Regulation, U.S. Nuclear
Regulatory Commission, Washington,
DC 20555-0001; telephone: 301–415–
1524, e-mail: Steven.Lynch@nrc.gov.
SUPPLEMENTARY INFORMATION:
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Dated at Rockville, Maryland, this 30th day
of May 2019.
19:03 Jun 04, 2019
Jkt 247001
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) § 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 § 50.2. The
irradiation facility and radioisotope
production facility are collectively
referred to as the SHINE Medical
Isotope Production Facility.
II.
the Order is attached.
VerDate Sep<11>2014
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.
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,
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26169
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 § 50.80, ‘‘Transfer of
licenses.’’
SHINE also requested, pursuant to 10
CFR § 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 § 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
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Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices
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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
§ 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 § 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
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19:03 Jun 04, 2019
Jkt 247001
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 https://
www.nrc.gov/reading-rm/adams.html.
Persons who encounter problems with
ADAMS should contact the NRC’s PDR
reference staff by telephone at
1-800-397-4209 or 301-415-4737 or by
e-mail to pdr.resource@nrc.gov.
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
NUCLEAR REGULATORY
COMMISSION
[NRC–2018–0229]
Information Collection: Export and
Import of Nuclear Equipment and
Material
Nuclear Regulatory
Commission.
ACTION: Notice of submission to the
Office of Management and Budget;
request for comment.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) has recently
submitted a request for renewal of an
existing collection of information to the
Office of Management and Budget
(OMB) for review. The information
collection is entitled, ‘‘Export and
Import of Nuclear Equipment and
Material.’’
DATES: Submit comments by July 5,
2019. Comments received after this date
will be considered if it is practical to do
so, but the Commission is able to ensure
consideration only for comments
received before this date.
ADDRESSES: Submit comments directly
to the OMB reviewer at: OMB Office of
Information and Regulatory Affairs
(3150–0036), Attn: Desk Officer for the
Nuclear Regulatory Commission, 725
17th Street NW, Washington, DC 20503;
email: oira_submission@omb.eop.gov.
FOR FURTHER INFORMATION CONTACT:
David Cullison, NRC Clearance Officer,
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001; telephone:
301–415–2084; email:
Infocollects.Resource@nrc.gov.
SUMMARY:
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SUPPLEMENTARY INFORMATION:
I. Obtaining Information and
Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC–2018–
0229 when contacting the NRC about
the availability of information for this
action. You may obtain publiclyavailable information related to this
action by any of the following methods:
• Federal Rulemaking website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2018–0229.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publiclyavailable documents online in the
ADAMS Public Documents collection at
https://www.nrc.gov/reading-rm/
adams.html. To begin the search, select
‘‘ADAMS Public Documents’’ and then
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
email to pdr.resource@nrc.gov. The
supporting statement and NRC Forms
830, 830A, 831, 831A, are available in
ADAMS under Accession Nos.
ML19114A414, ML19127A354,
ML19127A360, ML19127A378, and
ML19127A381.
• 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.
• NRC’s Clearance Officer: A copy of
the collection of information and related
instructions may be obtained without
charge by contacting the NRC’s
Clearance Officer, David Cullison,
Office of the Chief Information Officer,
U.S. Nuclear Regulatory Commission,
Washington, DC 20555–0001; telephone:
301–415–2084; email:
Infocollects.Resource@nrc.gov.
B. Submitting Comments
The NRC cautions you not to include
identifying or contact information in
comment submissions that you do not
want to be publicly disclosed in your
comment submission. All comment
submissions are posted at https://
www.regulations.gov and entered into
ADAMS. Comment submissions are not
routinely edited to remove identifying
or contact information.
If you are requesting or aggregating
comments from other persons for
submission to the OMB, then you
should inform those persons not to
include identifying or contact
information that they do not want to be
publicly disclosed in their comment
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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
