[Federal Register Volume 91, Number 153 (Tuesday, August 11, 2026)]
[Notices]
[Pages 51749-51751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-16344]
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NUCLEAR REGULATORY COMMISSION
[NRC-2026-3730]
Draft Regulatory Guide: Release of Patients Administered
Radioactive Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Draft guide; request for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing for
public comment a draft Regulatory Guide (DG), DG-8070, ``Release of
Patients Administered Radioactive Material.'' This DG is proposed
Revision 2 of Regulatory Guide (RG) 8.39 of the same name. The proposed
revision provides methods that are acceptable to the NRC staff for the
release of individuals, referred to as patients in this revision, after
a medical procedure involving the administration of unsealed byproduct
material, such as radiopharmaceuticals, or implants that contain
radioactive material.
DATES: Comments must be submitted electronically using https://www.regulations.gov by 11:59 p.m. Eastern Time on September 10, 2026.
ADDRESSES: Submit your comments, identified by Docket ID NRC-2026-3730,
at https://www.regulations.gov. If your material cannot be submitted
using https://www.regulations.gov, call or
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email the individual listed in the FOR FURTHER INFORMATION CONTACT
section of this document for alternate instructions.
Do not include any personally identifiable information
(such as name, address, or other contact information) or confidential
business information that you do not want publicly disclosed. All
comments are public records; they are publicly displayed exactly as
received, and will not be deleted, modified, or redacted. Comments may
be submitted anonymously.
Follow the search instructions on https://www.regulations.gov to view public comments.
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: Sarah Spence, telephone: 301-415-3697;
email: [email protected], and Amir Mobasheran, telephone: 301-415-
8112; email: [email protected]. Both are staff of the Office of
Nuclear Material Safety and Safeguards, at the U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001.
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2026-3730 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 https://www.regulations.gov and search for Docket ID NRC-2026-3730.
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 ADAMS Public Search.''
For problems with ADAMS, please contact the NRC's Public Document Room
(PDR) reference staff at 1-800-397-4209, at 301-415-4737, or by email
to [email protected]. The Release of Patients Administered
Radioactive Material is available in ADAMS under Accession No.
ML26092A365.
NRC's PDR: The PDR, where you may examine and order copies
of publicly available documents, is open by appointment. To make an
appointment to visit the PDR, please send an email to
[email protected] or call 1-800-397-4209 or 301-415-4737, between 8
a.m. and 4 p.m. Eastern Time (ET), Monday through Friday, except
Federal holidays.
B. Submitting Comments
Comments must be submitted electronically using https://www.regulations.gov no later than 11:59 p.m. ET on September 10, 2026.
Please include Docket ID NRC-2026-3730 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
https://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. Additional Information
The NRC is issuing for public comment a DG in the NRC's
``Regulatory Guide'' series. This series was developed to describe
methods that are acceptable to the NRC staff for implementing specific
parts of the agency's regulations, to explain techniques that the staff
uses in evaluating specific issues or postulated events, and to
describe information that the staff needs in its review of applications
for permits and licenses.
Proposed RG 8.39 Revision 2, entitled ``Release of Patients
Administered Radioactive Material,'' is temporarily identified by its
task number, DG-8070.
The existing version of RG 8.39 (Revision 1) was published in April
2020. The NRC previously published for comment a draft update of RG
8.39 (DG-8061), in April 2024, received comments relating to the
technical complexity and requests for more examples to be included, and
did not thereafter finalize that update. The NRC has now refined a
draft revision to RG 8.39 and has included draft revisions in DG-8070
to align with proposed revisions to section 35.75 of title 10 of the
Code of Federal Regulations (10 CFR) as part of a proposed rule,
``Reforming and Modernizing the NRC's Radiation Protection Framework''
(91 FR 43456; July 15, 2026), that addresses section 5(b) of Executive
Order 14300.
The proposed revision provides methods that are acceptable to the
NRC staff for the release of individuals, referred to as patients in
this revision, after a medical procedure involving the administration
of unsealed byproduct material, such as radiopharmaceuticals, or
implants that contain radioactive material. More specifically, DG-8070
provides guidance and examples for application of new definitions and
dose limits related to medical uses of byproduct material that would be
introduced by the referenced proposed rule, including guidance related
to doses to caregivers.
Additionally, DG-8070 incorporates up-to-date methodologies based
on National Council on Radiation Protection and Measurements (NCRP)
Report No. 155, ``Management of Radionuclide Therapy Patients,''
fundamentals for calculating the radiation dose received by members of
the public from a patient containing byproduct material. DG-8070 also
includes updates to reflect the evolution of the medical use of
byproduct material since the last revision of RG 8.39 (Revision 1) was
issued. This DG is intended to enable licensees to make more accurate
estimates of the timing, circumstances, and risks associated with
patient release; public doses from the released patients; and when
instructions or records are required.
The staff is not issuing for public comment a separate draft
regulatory analysis for this draft regulatory guide. The draft
regulatory analysis associated with this draft regulatory guide was
issued for public comment with the proposed rule, ``Reforming and
Modernizing the NRC's Radiation Protection Framework'' (91 FR 43456).
That draft regulatory analysis assesses the value associated with
issuing or revising regulatory guides as well as alternative courses of
action (ADAMS Accession No. ML26180A025).
III. Backfitting, Forward Fitting, and Issue Finality
The NRC staff may use this RG as a reference in its regulatory
processes, such as licensing, inspection, or enforcement. Backfitting,
forward fitting, and issue finality considerations do not apply to 10
CFR part 35 licensees and applicants because 10 CFR part 35 does not
include backfitting or issue finality provisions, and the forward
fitting policy in Management Directive 8.4, ``Management of
Backfitting, Forward Fitting, Issue Finality, and
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Information Requests,'' does not apply to these licensees.
IV. Submitting Suggestions for Improvement of Regulatory Guides
A member of the public may, at any time, submit suggestions to the
NRC for improvement of existing RGs or for the development of new RGs.
Suggestions can be submitted on the NRC's public website at https://www.nrc.gov/reading-rm/doc-collections/reg-guides/contactus.html.
Suggestions will be considered in future updates and enhancements to
the ``Regulatory Guide'' series.
V. Executive Order (E.O.) 12866
The Office of Information and Regulatory Affairs determined that
this DG is not a significant regulatory action under E.O. 12866.
Authority: 42 U.S.C. 2011 et seq.
Dated: August 7, 2026.
For the Nuclear Regulatory Commission.
Nicholee Valentine,
Chief, Guidance and Publication Branch, Division of Guidance,
Rulemaking, Economic Analysis, and Technical Editing, Office of Nuclear
Material Safety and Safeguards.
[FR Doc. 2026-16344 Filed 8-10-26; 8:45 am]
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