Release of Patients Administered Radioactive Material, 19514-19515 [2020-07307]

Download as PDF 19514 Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Notices stated. In either event, the State has been consulted by telephone whenever possible. Under its regulations, the Commission may issue and make an amendment immediately effective, notwithstanding the pendency before it of a request for a hearing from any person, in advance of the holding and completion of any required hearing, where it has determined that NSHC is involved. The Commission has applied the standards of 10 CFR 50.92 and has made a final determination that the amendment involves NSHC. The basis for this determination is contained in the documents related to this action. Accordingly, the amendments have been issued and made effective as indicated. Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.12(b) and has made a determination based on that assessment, it is so indicated. For further details with respect to the action see (1) the application for amendment, (2) the amendment to Facility Operating License or Combined License, as applicable, and (3) the Commission’s related letter, Safety Evaluation and/or Environmental Assessment, as indicated. All of these items can be accessed as described in the ‘‘Obtaining Information and Submitting Comments’’ section of this document. Previously Published Notice of Consideration of Issuance of Amendments to Facility Operating Licenses and Combined Licenses, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing The following notices were previously published as separate individual notices. The notice content was the same as above. They were published as individual notices either because time did not allow the Commission to wait for this biweekly notice or because the action involved exigent circumstances. They are repeated here because the biweekly notice lists all amendments issued or proposed to be issued involving no significant hazards consideration. For details, including the applicable notice period, see the individual notice in the Federal Register on the day and page cited. TABLE 4—LICENSE AMENDMENT REQUEST(S)—REPEAT OF INDIVIDUAL FEDERAL REGISTER NOTICE Exelon Generation Company, LLC; R.E. Ginna Nuclear Power Plant; Wayne County, NY Application Date ............................................................. ADAMS Accession No. .................................................. Brief Description of Amendment .................................... Date & Cite of Federal Register Individual Notice ....... Expiration Dates for Public Comments & Hearing Requests. Docket Nos. .................................................................... Dated at Rockville, Maryland, this 25th day of March, 2020. For the Nuclear Regulatory Commission. Gregory F. Suber, Deputy Director, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation. [FR Doc. 2020–06624 Filed 4–6–20; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [NRC–2019–0154] Release of Patients Administered Radioactive Material Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance. khammond on DSKJM1Z7X2PROD with NOTICES AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 1 to Regulatory Guide (RG) 8.39, ‘‘Release of Patients Administered Radioactive Material.’’ This RG (Revision 1) provides licensees with more detailed SUMMARY: VerDate Sep<11>2014 18:22 Apr 06, 2020 Jkt 250001 February 25, 2020. ML20056E958. The amendment revised Technical Specifications 3.4.7, ‘‘RCS [Reactor Coolant System] Loops—MODE 5, Loops Filled’’; 3.4.8, ‘‘RCS Loops—MODE 5, Loops Not Filled’’; 3.9.4, ‘‘Residual Heat Removal (RHR) and Coolant Circulation—Water Level ≥23 Ft’’; and 3.9.5, ‘‘Residual Heat Removal (RHR) and Coolant Circulation—Water Level <23 Ft,’’ to add an asterisk to allow the use of alternative means for residual heat removal. This one-time change was requested to support Ginna in the shutdown of the reactor during the upcoming refueling outage scheduled to start in April 2020. 3/2/2020; 85 FR 12349. 4/1/2020 (comments); 5/1/2020 (petitions). 50–244. instructions to provide to patients before and after they have been administered radioactive material than was in Revision 0. In addition, the guide includes a new section on ‘‘Death of a Patient Following Radiopharmaceutical or Implants Administrations,’’ as well as requirements for recordkeeping. Also, Table 3, ‘‘Activities of Radiopharmaceuticals That Require Instructions and Records When Administered to Patients Who Are Breastfeeding an Infant or Child,’’ has been revised. DATES: Revision 1 to RG 8.39 is available on April 7, 2020. ADDRESSES: Please refer to Docket ID NRC–2019–0154 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document, using the following methods: • Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC–2019–0154. Address questions about NRC docket IDs in PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 Regulations.gov to Jennifer Borges, telephone: 301–287–9127; email: 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 Document 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 email to pdr.resource@ nrc.gov. The ADAMS accession number for each document referenced in this notice (if that document is available in ADAMS) is provided the first time that a document is referenced. Revision 1 to RG 8.39 may be found in ADAMS under Accession No. ML19232A081. • NRC’s PDR: You may examine and purchase copies of public documents at the NRC’s PDR, Room O1–F21, One E:\FR\FM\07APN1.SGM 07APN1 Federal Register / Vol. 85, No. 67 / Tuesday, April 7, 2020 / Notices The public comment period was extended for another 30 days (84 FR 39383; August 9, 2019). The public comment period closed on September 26, 2019. Public comments on DG–8057 and the staff responses to the public comments are available under ADAMS under Accession No. ML19353B203. White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them. FOR FURTHER INFORMATION CONTACT: Vered Shaffer, Office of Nuclear Regulatory Research, telephone: 630– 829–9862, email: Vered.Shaffer@ nrc.gov, U.S. Nuclear Regulatory Commission, Washington, DC 20555– 0001. SUPPLEMENTARY INFORMATION: I. Discussion khammond on DSKJM1Z7X2PROD with NOTICES The NRC is issuing a revision to an existing guide in the NRC’s ‘‘Regulatory Guide’’ series. This series was developed to describe and make available to the public information regarding methods and techniques that the NRC staff uses in evaluating specific issues or postulated events, and data that the NRC staff needs in its review of applications for permits and licenses. RG 8.39 described methods that are acceptable to the NRC staff for implementing specific parts of the NRC’s regulations. Specifically, the RG provides licensees with instructions for patients before and after they receive medical procedures involving the administration of radioactive material, as well as requirements for recordkeeping. The RG also lists activities and dose rates that may be used by licensees for the release of patients in order to meet NRC regulatory requirements. This revision of the guide (Revision 1) provides licensees with more detailed instructions to provide to patients before and after they have been administered radioactive material than was in Revision 0. In addition, the guide includes a new section on ‘‘Death of a Patient Following Radiopharmaceutical or Implants Administrations,’’ as well as additional guidance for requirements for recordkeeping. Also, Table 3, ‘‘Activities of Radiopharmaceuticals that Require Instructions and Records when Administered to Patients who are Breastfeeding an Infant or Child,’’ has been revised to provide information for the recommended duration of interruption of breastfeeding to ensure that the dose to an infant or child meets the NRC’s regulatory requirements. II. Additional Information Proposed revision 1 of RG 8.39 was issued with a temporary identification of Draft Regulatory Guide, (DG)–8057. The NRC published a notice of the availability of DG–8057 in the Federal Register on July 29, 2019 (84 FR 36127) for a 30-day public comment period. VerDate Sep<11>2014 18:22 Apr 06, 2020 Jkt 250001 III. Congressional Review Act This RG is a rule as defined in the Congressional Review Act (5 U.S.C. 801–808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act. IV. Backfitting, Forward Fitting, and Issue Finality Revision 1 of RG 8.39 does not constitute backfitting as defined in title 10 of the Code of Federal Regulations (10 CFR) section 50.109, ‘‘Backfitting’’ and as described in NRC Management Directive (MD) 8.4, ‘‘Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests’’ (ADAMS Accession No. ML18093B087); affect the issue finality of any approval issued under 10 CFR part 52, ‘‘Licenses, Certifications, and Approvals for Nuclear Power Plants;’’ or constitute forward fitting as that term is defined and described in MD 8.4. 10 CFR part 35, ‘‘Medical Use of Byproduct Material,’’ does not include backfitting or issue finality provisions and the forward fitting policy in MD 8.4 does not apply to these licensees. In addition, licensees will not be required to comply with the positions set forth in this RG. Dated: April 2, 2020. For the Nuclear Regulatory Commission. Thomas H. Boyce, Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office of Nuclear Regulatory Research. [FR Doc. 2020–07307 Filed 4–6–20; 8:45 am] BILLING CODE 7590–01–P NUCLEAR REGULATORY COMMISSION [Docket Nos. 50–302 and 72–1035; NRC– 2020–0077] In the Matter of Duke Energy Florida, LLC; Crystal River Unit 3 Nuclear Generating Plant and Independent Spent Fuel Storage Installation Nuclear Regulatory Commission. ACTION: Direct transfer of license; order. AGENCY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an order approving the transfer to ADP CR3, LLC (ADP CR3) of the licensed authority of SUMMARY: PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 19515 Duke Energy Florida, LLC (DEF) under Facility Operating License No. DPR–72 for the Crystal River Unit 3 Nuclear Generating Plant (CR–3) and the general license for the CR–3 independent spent fuel storage installation (ISFSI) to possess, maintain, and decommission CR–3 and its ISFSI. The order also approves a draft conforming administrative license amendment to reflect the transfer from DEF to ADP CR3. The NRC determined that ADP CR3 is qualified to hold the licenses to the extent proposed, and that the transfer is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto, subject to the condition described in the order. The order became effective on April 1, 2020. DATES: The order was issued on April 1, 2020 and is effective for one year. ADDRESSES: Please refer to Docket ID NRC–2020–0077 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–2020–0077. Address questions about NRC Docket IDs in Regulations.gov to Jennifer Borges; telephone: 301–287–9127; email: 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 email to pdr.resource@ nrc.gov. The ADAMS accession number for each document referenced (if it is available in ADAMS) is provided the first time that it is mentioned in this document. • 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: John B. Hickman, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001; telephone: 301–415– 3017; email: John.Hickman@nrc.gov. E:\FR\FM\07APN1.SGM 07APN1

Agencies

[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19514-19515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07307]


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NUCLEAR REGULATORY COMMISSION

[NRC-2019-0154]


Release of Patients Administered Radioactive Material

AGENCY: Nuclear Regulatory Commission.

ACTION: Regulatory guide; issuance.

-----------------------------------------------------------------------

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing 
Revision 1 to Regulatory Guide (RG) 8.39, ``Release of Patients 
Administered Radioactive Material.'' This RG (Revision 1) provides 
licensees with more detailed instructions to provide to patients before 
and after they have been administered radioactive material than was in 
Revision 0. In addition, the guide includes a new section on ``Death of 
a Patient Following Radiopharmaceutical or Implants Administrations,'' 
as well as requirements for recordkeeping. Also, Table 3, ``Activities 
of Radiopharmaceuticals That Require Instructions and Records When 
Administered to Patients Who Are Breastfeeding an Infant or Child,'' 
has been revised.

DATES: Revision 1 to RG 8.39 is available on April 7, 2020.

ADDRESSES: Please refer to Docket ID NRC-2019-0154 when contacting the 
NRC about the availability of information regarding this document. You 
may obtain publicly-available information related to this document, 
using the following methods:
     Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2019-0154. Address 
questions about NRC docket IDs in Regulations.gov to Jennifer Borges, 
telephone: 301-287-9127; email: [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 Document 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 email to [email protected]. The ADAMS accession number for each 
document referenced in this notice (if that document is available in 
ADAMS) is provided the first time that a document is referenced. 
Revision 1 to RG 8.39 may be found in ADAMS under Accession No. 
ML19232A081.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One

[[Page 19515]]

White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
    Regulatory guides are not copyrighted, and NRC approval is not 
required to reproduce them.

FOR FURTHER INFORMATION CONTACT: Vered Shaffer, Office of Nuclear 
Regulatory Research, telephone: 630-829-9862, email: 
[email protected], U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001.

SUPPLEMENTARY INFORMATION:

I. Discussion

    The NRC is issuing a revision to an existing guide in the NRC's 
``Regulatory Guide'' series. This series was developed to describe and 
make available to the public information regarding methods and 
techniques that the NRC staff uses in evaluating specific issues or 
postulated events, and data that the NRC staff needs in its review of 
applications for permits and licenses.
    RG 8.39 described methods that are acceptable to the NRC staff for 
implementing specific parts of the NRC's regulations. Specifically, the 
RG provides licensees with instructions for patients before and after 
they receive medical procedures involving the administration of 
radioactive material, as well as requirements for recordkeeping. The RG 
also lists activities and dose rates that may be used by licensees for 
the release of patients in order to meet NRC regulatory requirements.
    This revision of the guide (Revision 1) provides licensees with 
more detailed instructions to provide to patients before and after they 
have been administered radioactive material than was in Revision 0. In 
addition, the guide includes a new section on ``Death of a Patient 
Following Radiopharmaceutical or Implants Administrations,'' as well as 
additional guidance for requirements for recordkeeping. Also, Table 3, 
``Activities of Radiopharmaceuticals that Require Instructions and 
Records when Administered to Patients who are Breastfeeding an Infant 
or Child,'' has been revised to provide information for the recommended 
duration of interruption of breastfeeding to ensure that the dose to an 
infant or child meets the NRC's regulatory requirements.

II. Additional Information

    Proposed revision 1 of RG 8.39 was issued with a temporary 
identification of Draft Regulatory Guide, (DG)-8057. The NRC published 
a notice of the availability of DG-8057 in the Federal Register on July 
29, 2019 (84 FR 36127) for a 30-day public comment period. The public 
comment period was extended for another 30 days (84 FR 39383; August 9, 
2019). The public comment period closed on September 26, 2019. Public 
comments on DG-8057 and the staff responses to the public comments are 
available under ADAMS under Accession No. ML19353B203.

III. Congressional Review Act

    This RG is a rule as defined in the Congressional Review Act (5 
U.S.C. 801-808). However, the Office of Management and Budget has not 
found it to be a major rule as defined in the Congressional Review Act.

IV. Backfitting, Forward Fitting, and Issue Finality

    Revision 1 of RG 8.39 does not constitute backfitting as defined in 
title 10 of the Code of Federal Regulations (10 CFR) section 50.109, 
``Backfitting'' and as described in NRC Management Directive (MD) 8.4, 
``Management of Backfitting, Forward Fitting, Issue Finality, and 
Information Requests'' (ADAMS Accession No. ML18093B087); affect the 
issue finality of any approval issued under 10 CFR part 52, ``Licenses, 
Certifications, and Approvals for Nuclear Power Plants;'' or constitute 
forward fitting as that term is defined and described in MD 8.4. 10 CFR 
part 35, ``Medical Use of Byproduct Material,'' does not include 
backfitting or issue finality provisions and the forward fitting policy 
in MD 8.4 does not apply to these licensees. In addition, licensees 
will not be required to comply with the positions set forth in this RG.

    Dated: April 2, 2020.

    For the Nuclear Regulatory Commission.
Thomas H. Boyce,
Chief, Regulatory Guidance and Generic Issues Branch, Division of 
Engineering, Office of Nuclear Regulatory Research.
[FR Doc. 2020-07307 Filed 4-6-20; 8:45 am]
BILLING CODE 7590-01-P