[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Notices]
[Pages 5116-5119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02788]


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NUCLEAR REGULATORY COMMISSION

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


SHINE Medical Isotope Production Facility; Consideration of 
Approval of Transfer of License and Conforming Amendment

AGENCY: Nuclear Regulatory Commission.

ACTION: Application for indirect transfer of license; opportunity to 
comment, request a hearing, and petition for leave to intervene.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) received and is 
considering approval of an application filed by SHINE Medical 
Technologies, Inc. (SHINE) on December 11, 2018. The application seeks 
NRC approval of the indirect transfer of Construction Permit No. CPMIF-
001 for the SHINE Medical Isotope Production Facility, currently held 
by SHINE. The indirect transfer will result from the establishment of a 
holding company, Illuminated Holdings, Inc. (Illuminated). The NRC is 
also considering amending Construction Permit No. CPMIF-001 for 
administrative purposes to reflect the proposed transfer. The 
application contains sensitive unclassified non-safeguards information 
(SUNSI).

DATES: Comments must be filed by March 22, 2019. A request for a 
hearing must be filed by March 12, 2019. Any potential party as defined 
in Sec.  2.4 of title 10 of the Code of Federal Regulations (10 CFR), 
who believes access to SUNSI is necessary to respond to this notice 
must follow the instructions in Section VI of the SUPPLEMENTARY 
INFORMATION section of this notice.

ADDRESSES: You may submit comments by any of the following methods 
(unless this document describes a different method for submitting 
comments on a specific subject):
     Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2019-0029. Address 
questions about Docket IDs in Regulations.gov to Krupskaya Castellon; 
telephone: 301-287-9221; email: [email protected]. For 
technical questions contact the individual listed in the FOR FURTHER 
INFORMATION CONTACT section of this document.
     Email comments to: [email protected]. If you do not 
receive an automatic email reply confirming receipt, then contact us at 
301-415-1677.
     Fax comments to: Secretary, U.S. Nuclear Regulatory 
Commission at 301-415-1101.

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     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and 
Adjudications Staff.
     Hand deliver comments to: 11555 Rockville Pike, Rockville, 
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal 
workdays; telephone: 301-415-1677.
    For additional direction on obtaining information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

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

SUPPLEMENTARY INFORMATION:

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Regulations.gov Docket ID NRC-2019-0029 or NRC 
Docket No. 50-608 when contacting the NRC about the availability of 
information for this action. You may obtain publicly-available 
information related to this action by any of the following methods:
     Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2019-0029.
     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 email to [email protected]. The application for indirect transfer 
of the license dated December 11, 2018, is available in ADAMS under 
Accession No. ML18347A215.
     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.

B. Submitting Comments

    Please include Docket ID NRC-2019-0029 in your comment submission.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be publicly disclosed in your 
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into 
ADAMS. The NRC does not routinely edit comment submissions to remove 
identifying or contact information.
    If you are requesting or aggregating comments from other persons 
for submission to the NRC, 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 submission. Your request should 
state that the NRC does not routinely edit comment submissions to 
remove such information before making the comment submissions available 
to the public or entering the comment into ADAMS.

II. Introduction

    The NRC is considering the issuance of an order under 10 CFR 50.80 
approving the indirect transfer of control of Construction Permit No. 
CPMIF-001 for the SHINE Medical Isotope Production Facility, currently 
held by SHINE. The NRC is also considering amending the construction 
permit for administrative purposes to reflect the proposed transfer.
    According to the application for approval filed by SHINE, the 
indirect transfer will result from the establishment of a parent 
holding company, Illuminated, a Delaware corporation, which would be 
owned by the current SHINE owners. The conforming administrative 
amendment would revise SHINE's construction permit to reflect SHINE's 
new name, SHINE Medical Technologies, LLC, resulting from its 
conversion from a corporation into a single-member limited liability 
company, owned and controlled by Illuminated.
    No physical changes to the SHINE Medical Isotope Production 
Facility or operational changes are being proposed in the application.
    The NRC's regulations in 10 CFR 50.80 state that no license, or any 
right thereunder, shall be transferred, directly or indirectly, through 
transfer of control of the license, unless the Commission gives its 
consent in writing. The Commission will approve an application for the 
indirect transfer of a license, if the Commission determines that the 
proposed establishment of a holding company will not affect the 
qualifications of the licensee to hold the license, and that the 
transfer is otherwise consistent with applicable provisions of law, 
regulations, and orders issued by the Commission.
    Before issuance of the proposed conforming license amendment, the 
Commission will have made findings required by the Atomic Energy Act of 
1954, as amended (the Act), and the Commission's regulations.
    As provided in 10 CFR 2.1315, unless otherwise determined by the 
Commission with regard to a specific application, the Commission has 
determined that any amendment to the license of a utilization facility, 
which does no more than conform the license to reflect the transfer 
action involves no significant hazards consideration. No contrary 
determination has been made with respect to this specific license 
amendment application. In light of the generic determination reflected 
in 10 CFR 2.1315, no public comments with respect to significant 
hazards considerations are being solicited.

III. Opportunity To Comment

    Within 30 days from the date of publication of this notice, persons 
may submit written comments regarding the license transfer application, 
as provided for in 10 CFR 2.1305. The Commission will consider and, if 
appropriate, respond to these comments, but such comments will not 
otherwise constitute part of the decisional record. Comments should be 
submitted as described in the ADDRESSES section of this document.

IV. Opportunity To Request a Hearing and Petition for Leave To 
Intervene

    Within 20 days after the date of publication of this notice, any 
persons (petitioner) whose interest may be affected by this action may 
file a request for a hearing and petition for leave to intervene 
(petition) with respect to the action. Petitions shall be filed in 
accordance with the Commission's ``Agency Rules of Practice and 
Procedure'' in 10 CFR part 2. Interested persons should consult a 
current copy of 10 CFR 2.309. The NRC's regulations are accessible 
electronically from the NRC Library on the NRC's website at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Alternatively, a copy of 
the regulations is available at the NRC's Public Document Room, located 
at One White Flint North, Room O1-F21, 11555 Rockville Pike (first 
floor), Rockville, Maryland 20852. If a petition is filed, the 
Commission or a presiding officer will rule on the petition and, if 
appropriate, a notice of a hearing will be issued.
    As required by 10 CFR 2.309(d) the petition should specifically 
explain the reasons why intervention should be permitted with 
particular reference to the following general requirements for 
standing: (1) The name, address, and telephone number of the 
petitioner; (2) the nature of the petitioner's right under the Act to 
be made a party to the proceeding; (3) the nature and extent of

[[Page 5118]]

the petitioner's property, financial, or other interest in the 
proceeding; and (4) the possible effect of any decision or order which 
may be entered in the proceeding on the petitioner's interest.
    In accordance with 10 CFR 2.309(f), the petition must also set 
forth the specific contentions which the petitioner seeks to have 
litigated in the proceeding. Each contention must consist of a specific 
statement of the issue of law or fact to be raised or controverted. In 
addition, the petitioner must provide a brief explanation of the bases 
for the contention and a concise statement of the alleged facts or 
expert opinion which support the contention and on which the petitioner 
intends to rely in proving the contention at the hearing. The 
petitioner must also provide references to the specific sources and 
documents on which the petitioner intends to rely to support its 
position on the issue. The petition must include sufficient information 
to show that a genuine dispute exists with the applicant or licensee on 
a material issue of law or fact. Contentions must be limited to matters 
within the scope of the proceeding. The contention must be one which, 
if proven, would entitle the petitioner to relief. A petitioner who 
fails to satisfy the requirements in 10 CFR 2.309(f) with respect to at 
least one contention will not be permitted to participate as a party.
    Those permitted to intervene become parties to the proceeding, 
subject to any limitations in the order granting leave to intervene. 
Parties have the opportunity to participate fully in the conduct of the 
hearing with respect to resolution of that party's admitted 
contentions, including the opportunity to present evidence, consistent 
with the NRC's regulations, policies, and procedures.
    Petitions must be filed no later than 20 days from the date of 
publication of this notice. Petitions and motions for leave to file new 
or amended contentions that are filed after the deadline will not be 
entertained absent a determination by the presiding officer that the 
filing demonstrates good cause by satisfying the three factors in 10 
CFR 2.309(c)(1)(i) through (iii). The petition must be filed in 
accordance with the filing instructions in the ``Electronic Submissions 
(E-Filing)'' section of this document.
    A State, local governmental body, Federally-recognized Indian 
Tribe, or agency thereof, may submit a petition to the Commission to 
participate as a party under 10 CFR 2.309(h)(1). The petition should 
state the nature and extent of the petitioner's interest in the 
proceeding. The petition should be submitted to the Commission no later 
than 20 days from the date of publication of this notice. The petition 
must be filed in accordance with the filing instructions in the 
``Electronic Submissions (E-Filing)'' section of this document, and 
should meet the requirements for petitions set forth in this section, 
except that under 10 CFR 2.309(h)(2) a State, local governmental body, 
or Federally-recognized Indian Tribe, or agency thereof does not need 
to address the standing requirements in 10 CFR 2.309(d) if the facility 
is located within its boundaries. Alternatively, a State, local 
governmental body, Federally-recognized Indian Tribe, or agency thereof 
may participate as a non-party under 10 CFR 2.315(c).
    If a hearing is granted, any person who is not a party to the 
proceeding and is not affiliated with or represented by a party may, at 
the discretion of the presiding officer, be permitted to make a limited 
appearance pursuant to the provisions of 10 CFR 2.315(a). A person 
making a limited appearance may make an oral or written statement of 
his or her position on the issues but may not otherwise participate in 
the proceeding. A limited appearance may be made at any session of the 
hearing or at any prehearing conference, subject to the limits and 
conditions as may be imposed by the presiding officer. Details 
regarding the opportunity to make a limited appearance will be provided 
by the presiding officer if such sessions are scheduled.

V. Electronic Submissions (E-Filing)

    All documents filed in NRC adjudicatory proceedings, including a 
request for hearing and petition for leave to intervene (petition), any 
motion or other document filed in the proceeding prior to the 
submission of a request for hearing or petition to intervene, and 
documents filed by interested governmental entities that request to 
participate under 10 CFR 2.315(c), must be filed in accordance with the 
NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 
46562; August 3, 2012). The E-Filing process requires participants to 
submit and serve all adjudicatory documents over the internet, or in 
some cases to mail copies on electronic storage media. Detailed 
guidance on making electronic submissions may be found in the Guidance 
for Electronic Submissions to the NRC and on the NRC website at http://www.nrc.gov/site-help/e-submittals.html. Participants may not submit 
paper copies of their filings unless they seek an exemption in 
accordance with the procedures described below.
    To comply with the procedural requirements of E-Filing, at least 10 
days prior to the filing deadline, the participant should contact the 
Office of the Secretary by email at [email protected], or by 
telephone at 301-415-1677, to (1) request a digital identification (ID) 
certificate, which allows the participant (or its counsel or 
representative) to digitally sign submissions and access the E-Filing 
system for any proceeding in which it is participating; and (2) advise 
the Secretary that the participant will be submitting a petition or 
other adjudicatory document (even in instances in which the 
participant, or its counsel or representative, already holds an NRC-
issued digital ID certificate). Based upon this information, the 
Secretary will establish an electronic docket for the hearing in this 
proceeding if the Secretary has not already established an electronic 
docket.
    Information about applying for a digital ID certificate is 
available on the NRC's public website at http://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a 
digital ID certificate and a docket has been created, the participant 
can then submit adjudicatory documents. Submissions must be in Portable 
Document Format (PDF). Additional guidance on PDF submissions is 
available on the NRC's public website at http://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the 
time the document is submitted through the NRC's E-Filing system. To be 
timely, an electronic filing must be submitted to the E-Filing system 
no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of 
a transmission, the E-Filing system time-stamps the document and sends 
the submitter an email notice confirming receipt of the document. The 
E-Filing system also distributes an email notice that provides access 
to the document to the NRC's Office of the General Counsel and any 
others who have advised the Office of the Secretary that they wish to 
participate in the proceeding, so that the filer need not serve the 
document on those participants separately. Therefore, applicants and 
other participants (or their counsel or representative) must apply for 
and receive a digital ID certificate before adjudicatory documents are 
filed so that they can obtain access to the documents via the E-Filing 
system.
    A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC's Electronic 
Filing Help Desk through the ``Contact Us'' link located

[[Page 5119]]

on the NRC's public website at http://www.nrc.gov/site-help/e-submittals.html, by email to [email protected], or by a toll-free 
call at 1-866-672-7640. The NRC Electronic Filing Help Desk is 
available between 9 a.m. and 6 p.m., Eastern Time, Monday through 
Friday, excluding government holidays.
    Participants who believe that they have a good cause for not 
submitting documents electronically must file an exemption request, in 
accordance with 10 CFR 2.302(g), with their initial paper filing 
stating why there is good cause for not filing electronically and 
requesting authorization to continue to submit documents in paper 
format. Such filings must be submitted by: (1) First class mail 
addressed to the Office of the Secretary of the Commission, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: 
Rulemaking and Adjudications Staff; or (2) courier, express mail, or 
expedited delivery service to the Office of the Secretary, 11555 
Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and 
Adjudications Staff. Participants filing adjudicatory documents in this 
manner are responsible for serving the document on all other 
participants. Filing is considered complete by first-class mail as of 
the time of deposit in the mail, or by courier, express mail, or 
expedited delivery service upon depositing the document with the 
provider of the service. A presiding officer, having granted an 
exemption request from using E-Filing, may require a participant or 
party to use E-Filing if the presiding officer subsequently determines 
that the reason for granting the exemption from use of E-Filing no 
longer exists.
    Documents submitted in adjudicatory proceedings will appear in the 
NRC's electronic hearing docket which is available to the public at 
https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the 
Commission or the presiding officer. If you do not have an NRC-issued 
digital ID certificate as described in this notice, click cancel when 
the link requests certificates and you will be automatically directed 
to the NRC's electronic hearing dockets where you will be able to 
access any publicly available documents in a particular hearing docket. 
Participants are requested not to include personal privacy information, 
such as social security numbers, home addresses, or personal phone 
numbers in their filings, unless an NRC regulation or other law 
requires submission of such information. For example, in some 
instances, individuals provide home addresses in order to demonstrate 
proximity to a facility or site. With respect to copyrighted works, 
except for limited excerpts that serve the purpose of the adjudicatory 
filings and would constitute a Fair Use application, participants are 
requested not to include copyrighted materials in their submission.
    The Commission will issue a notice or order granting or denying a 
hearing request or intervention petition, designating the issues for 
any hearing that will be held and designating the Presiding Officer. A 
notice granting a hearing will be published in the Federal Register and 
served on the parties to the hearing.
    For further details with respect to this application, see the 
application dated December 11, 2018.

VI. Access to Sensitive Unclassified Non-Safeguards Information for 
Contention Preparation

    Any person who desires access to proprietary, confidential 
commercial information that has been redacted from the application 
should contact the applicant by telephoning Jeff Bartelme, Licensing 
Manager, at 608-210-1735, for the purpose of negotiating a 
confidentiality agreement or a proposed protective order with the 
applicant. If no agreement can be reached, persons who desire access to 
this information may file a motion with the Secretary and addressed to 
the Commission that requests the issuance of a protective order.

    Dated at Rockville, Maryland, this 14th day of February 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.
[FR Doc. 2019-02788 Filed 2-19-19; 8:45 am]
 BILLING CODE 7590-01-P