[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.

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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