[Federal Register Volume 88, Number 77 (Friday, April 21, 2023)]
[Proposed Rules]
[Pages 24495-24496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08418]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 88, No. 77 / Friday, April 21, 2023 / 
Proposed Rules  

[[Page 24495]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

[NRC-2023-0086]


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-8061, ``Release of 
Patients Administered Radioactive Material.'' This DG is proposed 
Revision 2 to Regulatory Guide (RG) 8.39 of the same name. This 
proposed revision provides licensees with methods that are acceptable 
to the NRC for the release of patients after a medical procedure 
involving the administration of unsealed byproduct material, such as 
radiopharmaceuticals, or implants that contain radioactive material.

DATES: Submit comments by June 20, 2023. Comments received after this 
date will be considered if it is practical to do so, but the NRC is 
able to ensure consideration only for comments received on or before 
this date.

ADDRESSES: You may submit comments by any of the following methods; 
however, the NRC encourages electronic comment submission through the 
Federal rulemaking website:
     Federal rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2023-0086. Address 
questions about Docket IDs in Regulations.gov to Stacy Schumann; 
telephone: 301-415-0624; email: [email protected]. For technical 
questions, contact the individuals listed in the For Further 
Information Contact section of this document.
     Mail comments to: Office of Administration, Mail Stop: 
TWFN-7-A60M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, ATTN: Program Management, Announcements and Editing Staff.
    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: Kathrine Tapp, Office of Nuclear 
Material Safety and Safeguards, telephone: 301-415-0236; email: 
[email protected], or Brian Allen, Office of Nuclear Regulatory 
Research, telephone: 301-415-8402; email: [email protected], or 
Rigel Flora, Office of Nuclear Regulatory Research, telephone: 301-415-
3890; email: [email protected], or Harriet Karagiannis, Office of 
Nuclear Regulatory Research, telephone: 301-415-2493; email: 
[email protected]. All are staff of 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-2023-0086 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-2023-0086.
     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 email to [email protected].
     NRC's PDR: You may examine and purchase copies of public 
documents, by appointment, at the NRC's PDR, Room P1 B35, One White 
Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. 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

    The NRC encourages electronic comment submission through the 
Federal rulemaking website (https://www.regulations.gov). Please 
include Docket ID NRC-2023-0086 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.
    The DG, entitled ``Release of Patients Administered Radioactive 
Material,'' is temporarily identified by its task number, DG-8061. This 
DG-8061 is a proposed Revision 2 to RG 8.39 (ADAMS Accession No. 
ML21230A318).
    This proposed Revision 2 provides: (1) information for the 
administered activity and measured dose rate thresholds to demonstrate 
compliance for commonly used radionuclides, (2) calculational 
methodologies to accommodate threshold modifications for patient-
specific exposure situations

[[Page 24496]]

with modifying factors for biokinetics, occupancy, geometry, and 
attenuation based on patient-specific information, (3) calculations 
assuming unity for the occupancy factor if patient-specific information 
is not known, to avoid underestimating exposure, (4) flexibility for 
emerging radiopharmaceuticals that could be used for diagnostic or 
therapeutic purposes, (5) radiopharmaceutical activity thresholds for 
patients who may continue breastfeeding an infant or child after 
administration of radioactive material, with recommendations for 
breastfeeding interruption times for many typical administered medical 
dosages, and (6) a new section on ``Sources Separated from the 
Patient.''
    The staff is also issuing for public comment a draft regulatory 
analysis (ADAMS Accession No. ML21230A326). The staff develops a 
regulatory analysis to assess the value of issuing or revising a 
regulatory guide as well as alternative courses of action.
    As noted in the Federal Register on December 9, 2022 (87 FR 75671), 
this document is being published in the ``Proposed Rules'' section of 
the Federal Register to comply with publication requirements under 1 
CFR chapter I.

III. Backfitting, Forward Fitting, and Issue Finality

    As discussed in the ``Implementation'' section of DG-8061, the NRC 
does not intend or approve any imposition of the guidance in this draft 
regulatory guide. Backfitting and issue finality considerations do not 
apply to licensees or applicants when performing activities under part 
35 of title 10 of the Code of Federal Regulations (10 CFR). Therefore, 
the NRC has determined that its backfitting and issue finality 
regulations would not apply to this draft regulatory guide, if 
ultimately issued as Revision 2 to RG 8.39, because the draft 
regulatory guide does not include any provisions within the scope of 
matters covered by the backfitting provisions in 10 CFR parts 50, 70, 
72, or 76 or the issue finality provisions of 10 CFR part 52.

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.

    Dated: April 17, 2023.

    For the Nuclear Regulatory Commission.
Meraj Rahimi,
Chief, Regulatory Guide and Programs Management Branch, Division of 
Engineering, Office of Nuclear Regulatory Research.
[FR Doc. 2023-08418 Filed 4-20-23; 8:45 am]
BILLING CODE 7590-01-P