In the Matter of SHINE Medical Technologies, Inc.; SHINE Medical Isotope Production Facility, 26168-26170 [2019-11660]

Download as PDF jbell on DSK3GLQ082PROD with NOTICES 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. VerDate Sep<11>2014 19:03 Jun 04, 2019 Jkt 247001 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 PO 00000 Frm 00105 Fmt 4703 Sfmt 4703 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: E:\FR\FM\05JNN1.SGM 05JNN1 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: The text of jbell on DSK3GLQ082PROD with NOTICES 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, PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 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 E:\FR\FM\05JNN1.SGM 05JNN1 26170 Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Notices jbell on DSK3GLQ082PROD with NOTICES 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 VerDate Sep<11>2014 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: PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 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 E:\FR\FM\05JNN1.SGM 05JNN1

Agencies

NUCLEAR REGULATORY COMMISSION

[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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.