Draft Regulatory Guide: Release of Patients Administered Radioactive Material, 24495-24496 [2023-08418]

Download as PDF 24495 Proposed Rules Federal Register Vol. 88, No. 77 Friday, April 21, 2023 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. NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 [NRC–2023–0086] Draft Regulatory Guide: Release of Patients Administered Radioactive Material Nuclear Regulatory Commission. ACTION: Draft guide; request for comment. AGENCY: 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: Stacy.Schumann@nrc.gov. 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 lotter on DSK11XQN23PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 16:17 Apr 20, 2023 Jkt 259001 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: Kathrine.Tapp@nrc.gov, or Brian Allen, Office of Nuclear Regulatory Research, telephone: 301–415–8402; email: Brian.Allen3@nrc.gov, or Rigel Flora, Office of Nuclear Regulatory Research, telephone: 301–415–3890; email: Rigel.Flora@nrc.gov, or Harriet Karagiannis, Office of Nuclear Regulatory Research, telephone: 301– 415–2493; email: Harriet.Karagiannis@ nrc.gov. 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 PDR.Resource@nrc.gov. • 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 PDR.Resource@nrc.gov or call 1–800–397–4209 or 301–415– PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 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 E:\FR\FM\21APP1.SGM 21APP1 24496 Federal Register / Vol. 88, No. 77 / Friday, April 21, 2023 / Proposed Rules 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. lotter on DSK11XQN23PROD with PROPOSALS1 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/readingrm/doc-collections/reg-guides/ contactus.html. Suggestions will be considered in future updates and enhancements to the ‘‘Regulatory Guide’’ series. VerDate Sep<11>2014 16:17 Apr 20, 2023 Jkt 259001 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 DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA–2023–0913; Airspace Docket No. 23–AGL–9] RIN 2120–AA66 Amendment of Class E Airspace; Hastings, MI Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). AGENCY: This action proposes to amend the Class E airspace at Hastings, MI. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Grand Rapids very high frequency omnidirectional range (VOR) as part of the VOR Minimum Operating Network (MON) Program. The name and geographic coordinates of the airport would also be updated to coincide with the FAA’s aeronautical database. DATES: Comments must be received on or before June 5, 2023. ADDRESSES: Send comments identified by FAA Docket No. FAA–2023–0913 and Airspace Docket No. 23–AGL–9 using any of the following methods: * Federal eRulemaking Portal: Go to www.regulations.gov and follow the online instruction for sending your comments electronically. * Mail: Send comments to Docket Operations, M–30; U.S. Department of Transportation, 1200 New Jersey Avenue SE, Room W12–140, West Building Ground Floor, Washington, DC 20590–0001. * Hand Delivery or Courier: Take comments to Docket Operations in Room W12–140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. * Fax: Fax comments to Docket Operations at (202) 493–2251. Docket: Background documents or comments received may be read at www.regulations.gov at any time. Follow the online instructions for SUMMARY: PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 accessing the docket or go to Docket Operations in Room W12–140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. FAA Order JO 7400.11G, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/ publications/. You may also contact the Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267–8783. FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222–5711. SUPPLEMENTARY INFORMATION: Authority for This Rulemaking The FAA’s authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency’s authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend the Class E airspace extending upward from 700 feet above the surface at Hastings Airport, Hastings, MI, to support instrument flight rule operations at this airport. Comments Invited The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing. E:\FR\FM\21APP1.SGM 21APP1

Agencies

[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]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

========================================================================


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.

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

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: Stacy.Schuma[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
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