[Federal Register Volume 88, Number 75 (Wednesday, April 19, 2023)]
[Proposed Rules]
[Pages 24130-24132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08238]


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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. 75 / Wednesday, April 19, 2023 / 
Proposed Rules  

[[Page 24130]]



NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

[NRC-2022-0218]
RIN 3150-AK91


Reporting Nuclear Medicine Injection Extravasations as Medical 
Events

AGENCY: Nuclear Regulatory Commission.

ACTION: Preliminary proposed rule language; notice of availability and 
public meeting.

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

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is making 
available preliminary proposed rule language for a rulemaking on the 
reporting of nuclear medicine injection extravasations as medical 
events. To inform this rulemaking, the NRC is posing questions to 
obtain input from stakeholders. The NRC will consider feedback on this 
notice in the development of a proposed rulemaking planned for 
publication in late 2024. The NRC will also hold a public meeting 
during the comment period on this notice to facilitate feedback.

DATES: Submit comments by July 18, 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 before this 
date. The public meeting will be held on May 24, 2023, from 1:00 p.m. 
and 4:00 p.m. eastern time (ET) via the Microsoft Teams online 
interface.

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-2022-0218. Address 
questions about NRC dockets to Dawn Forder; telephone: 301-415-3407; 
email: [email protected]. For technical questions contact the 
individuals listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     Email comments to: [email protected]. If you do 
not receive an automatic email reply confirming receipt, then contact 
us at 301-415-1677.
     Mail comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and 
Adjudications 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: Irene Wu, telephone: 301-415-1951, 
email: [email protected]; and Daniel DiMarco, telephone: 301-415-3303, 
email: [email protected]. Both 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-2022-0218 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-2022-0218.
     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, at 301-415-4737, 
or by email to [email protected]. For the convenience of the reader, 
instructions about obtaining materials referenced in this document are 
provided in the ``Availability of Documents'' section.
     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 
8:00 a.m. and 4:00 p.m. 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 2022-0218 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. Background

A. Petition for Rulemaking (PRM-35-22)

    On May 18, 2020, Lucerno Dynamics, LLC (Lucerno) submitted a 
petition for rulemaking (PRM), PRM-35-22, that requested the NRC amend 
part 35 of title 10 of the Code of Federal Regulations (10 CFR), 
``Medical Use of Byproduct Material.'' Lucerno proposed to require 
medical event reporting of radiopharmaceutical extravasations that lead 
to an irradiation resulting in a localized dose equivalent exceeding 50 
rem (0.5 Sieverts). Extravasation is the infiltration of injected fluid 
into the tissue surrounding a vein or artery. Extravasation is not 
limited to the administration of radiopharmaceuticals. The NRC docketed 
the petition, and on September 15, 2020, the NRC published a notice of 
docketing and request for

[[Page 24131]]

public comment in the Federal Register (85 FR 57148). The NRC received 
488 comment submissions from the medical community, Agreement States, 
Congressional representatives, and members of the public and used the 
comments to inform the NRC staff's recommendation to the Commission.
    On May 9, 2022, the NRC staff submitted SECY-22-0043, ``Petition 
for Rulemaking and Rulemaking Plan on Reporting Nuclear Medicine 
Injection Extravasations as Medical Events (Docket IDs PRM-35-22; NRC-
2020-0141),'' to the Commission requesting approval to consider PRM-35-
22 in the rulemaking process. In staff requirements memorandum (SRM) 
SRM-SECY-22-0043, dated December 12, 2022, the Commission approved the 
staff's recommendation to amend 10 CFR part 35 to include certain 
nuclear medicine injection extravasations as reportable medical events. 
On December 30, 2022, the NRC published a document in the Federal 
Register (87 FR 80474) stating that the NRC would consider the issues 
raised in the petition in the rulemaking process and closed the 
petition docket.

B. Existing Regulatory Framework for Medical Events

    In 1980, the NRC amended the medical use regulations in 10 CFR part 
35 to require the reporting of medical misadministrations (45 FR 31701; 
May 14, 1980). The reporting and analysis of medical events helps to 
identify deficiencies in the safe use of radioactive material and helps 
ensure that corrective actions are taken to prevent recurrence. In the 
1980 rulemaking, the NRC stated in a comment response that it did not 
consider extravasation to be a misadministration because extravasation 
frequently occurs in otherwise normal intravenous or intraarterial 
injections and that extravasations are virtually impossible to avoid.
    The reporting requirements were updated in 1991 (56 FR 34104; July 
25, 1991), in 2002 (67 FR 20250; April 24, 2002), and again in 2018 (83 
FR 33046; July 16, 2018). In 2002, the term and criteria for 
``misadministration'' were replaced with ``medical event'' and several 
changes were made to Sec.  35.3045, ``Report and notification of a 
medical event.'' None of these updates addressed extravasations.

III. Regulatory Objectives

    The NRC is planning rulemaking to amend the NRC's regulations in 10 
CFR part 35, ``Medical Use of Byproduct Material'' to include 
requirements for medical event reporting of certain extravasations that 
require medical attention for a suspected radiation injury. The 
information obtained from the medical event reporting of these 
extravasations would enhance the tracking and trending of these events 
and promote sharing information on their occurrence, detection, 
mitigation, and possible preventive strategies. The planned rulemaking 
would affect medical licensees who administer intravenous 
radiopharmaceuticals for diagnostic and therapeutic purposes.

IV. Specific Considerations

    The NRC is seeking feedback from the public on preliminary proposed 
rule language before proceeding to the development of a proposed rule. 
The preliminary proposed rule language is available in ADAMS at 
Accession No. ML23083B332 and on the federal rulemaking website at 
http://www.regulations.gov under Docket ID NRC-2022-0218. This 
preliminary proposed rule language does not represent a final NRC staff 
position, nor has it been reviewed by the Commission. Therefore, the 
preliminary proposed rule language may undergo significant revision 
during the rulemaking process.
    The NRC is interested in receiving feedback and supporting 
rationale from the public on any aspect of the preliminary proposed 
rule language. Additionally, the NRC is seeking feedback on questions 
in the following three specific areas: Definitions, Procedures, and 
Healthcare Inequities. Please provide the rationale for responses to 
questions in these areas.

Definitions

    Currently, terms such as ``Extravasation,'' ``Suspected radiation 
injury,'' and ``Medical attention'' are not included in Sec.  35.2, 
``Definitions.'' The NRC is considering adding these terms as new 
definitions to Sec.  35.2 in support of adding new requirements in 
Sec.  35.42, ``Procedures for evaluating and reporting 
extravasations''; Sec.  35.2042, ``Records for procedures for 
evaluating and reporting extravasations''; and paragraph (a)(3) in 
Sec.  35.3045, ``Report and notification of a medical event,'' for 
medical event reporting of extravasations that require medical 
attention for a suspected radiation injury.
    1. What term should the NRC use (e.g., extravasation, infiltration) 
when describing the leakage of radiopharmaceuticals from a blood vessel 
or artery into the surrounding tissue?
    2. What criteria should the NRC use to define ``suspected radiation 
injury''?
    3. What techniques or methods should be included in the definition 
of ``medical attention''?

Procedures

    The NRC is exploring approaches that would reduce the reliance on 
patient reporting of adverse tissue reactions to an authorized user 
physician. One of the strategies that the NRC is considering is 
requiring that licensees develop, implement, and maintain written 
procedures to detect and report extravasations in a timely manner to 
the NRC.
    The NRC is considering adding two new sections, Sec.  35.42, 
``Procedures for evaluating and reporting extravasations,'' which would 
require licensees to develop procedures to address all extravasations 
that result in a suspected radiation injury that requires medical 
attention from all radiopharmaceutical injections, not just from those 
requiring a written directive, and Sec.  35.2042, which would add 
recordkeeping requirements for new Sec.  35.42. The NRC has the 
following questions on these potential regulations:
    4. What steps could the licensee take to minimize the chance of a 
radiopharmaceutical extravasation occurring?
    5. What steps should the licensee take when an extravasation is 
suspected or discovered?
    6. What techniques, technologies, or procedures (e.g., post-
treatment imaging, visual observation, patient feedback) should be used 
to help identify an extravasation during or immediately after a 
radiopharmaceutical injection?
    7. What techniques, technologies, or procedures (e.g., post-
treatment imaging, survey measurement) should be used to better 
characterize an extravasation after radiopharmaceutical treatment?
    8. What information should licensees provide to nuclear medicine 
patients on how to identify an extravasation and how to follow up with 
their physician if they suspect a radiation injury?
    9. When should a reportable extravasation be counted as 
``discovered'' for the purposes of notification (e.g., when medical 
attention is administered, when the physician identifies that the 
injury is from radiation)?
    10. The NRC requires that licensees notify the referring physician 
and the individual who is the subject of a medical event no later than 
24 hours after discovery of the medical event. When should licensees be 
required to

[[Page 24132]]

provide notification of an extravasation medical event to the referring 
physician and the individual?
    11. Who (e.g., patient's primary physician, authorized user, 
nuclear medicine technician) should be able to identify an 
extravasation that could result in a ``suspected radiation injury''?
    12. What topics should the NRC include in guidance to assist 
licensees to accurately identify, characterize, and report 
extravasation events in a timely manner?

Healthcare Inequities

    The NRC is trying to better understand concerns raised by several 
patient safety groups regarding the higher rates of extravasation in 
patients of color and underserved communities. The NRC has the 
following questions:
    13. What regulatory actions could help ensure that extravasations 
in patients affected by healthcare inequities are accurately assessed 
and reported?
    14. Are vascular access tools and other technologies (e.g., 
ultrasound guided vein finders) likely to reduce the potential for an 
extravasation in all patients, particularly in patients of color?
    The NRC will provide an opportunity for public comment on the 
proposed rule, expected to be published in late 2024. Feedback received 
in response to this request will be considered in the proposed rule.

V. Public Meeting

    The NRC will conduct a public meeting to provide information to 
facilitate stakeholder feedback on the preliminary proposed rule 
language and questions included in this document. The public meeting 
will be held on May 24, 2023, from 1:00 p.m. and 4:00 p.m. ET on the 
Microsoft Teams online platform. The NRC will publish a notice of the 
meeting with the meeting link and agenda on the NRC's public meeting 
website at least 10 calendar days before the meeting. Stakeholders 
should monitor the NRC's public meeting website for information about 
the public meeting at: https://www.nrc.gov/public-involve/public-meetings/index.cfm.

VI. Cumulative Effects of Regulation

    The NRC is following its Cumulative Effects of Regulation (CER) 
process by engaging with external stakeholders throughout the 
rulemaking process and is providing opportunity for public comment at 
this pre-rulemaking stage.
    1. Given current or projected CER challenges, how should the NRC 
provide sufficient time to implement the new proposed requirements, 
including changes to programs and procedures?
    2. If CER challenges currently exist or are expected, what should 
be done to address them?
    3. What other (NRC or other agency) regulatory actions (e.g., 
orders, generic communications, license amendment requests, inspection 
findings of a generic nature) influence the implementation of the 
proposed rule's requirements?
    4. What are the unintended consequences, and how should they be 
addressed?

VII. Plain Writing

    The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal 
agencies to write documents in a clear, concise, and well-organized 
manner. The NRC has written this document to be consistent with the 
Plain Writing Act as well as the Presidential Memorandum, ``Plain 
Language in Government Writing,'' published June 10, 1998 (63 FR 
31885). The NRC requests comment on this document with respect to the 
clarity and effectiveness of the language used.

VIII. Availability of Documents

    The documents identified in the following table are available to 
interested persons through one or more of the following methods, as 
indicated.

----------------------------------------------------------------------------------------------------------------
                                                                ADAMS accession No./ web link/Federal Register
                          Document                                                 citation
----------------------------------------------------------------------------------------------------------------
Letter from Ronald K. Lattanze on behalf of Lucerno          ML20157A266.
 Dynamics, LLC regarding petition for rulemaking, dated May
 18, 2020.
Notice of Docketing and Request for Comment on Petition for  85 FR 57148.
 Rulemaking, Reporting Nuclear Medicine Injection
 Extravasations as Medical Events, September 15, 2020.
Notice of Consideration in the Rulemaking Process for        87 FR 80474.
 Petition for Rulemaking, Reporting Nuclear Medicine
 Injection Extravasations as Medical Events, December 30,
 2022.
SECY-22-0043, ``Petition for Rulemaking and Rulemaking Plan  ML21268A005 (package).
 on Reporting Nuclear Medicine Injection Extravasations as
 Medical Events (PRM-35-22; NRC-2020-0141),'' dated May 9,
 2022.
SRM-SECY-22-0043, ``Staff Requirements--SECY-22-0043--       ML22346A112 (package).
 Petition for Rulemaking and Rulemaking Plan on Reporting
 Nuclear Medicine Injection Extravasations as Medical
 Events (PRM-35-22; NRC-2020-0141),'' dated December 12,
 2022.
Final Rule, Misadministration Reporting Requirements, May    45 FR 31701.
 14, 1980.
Final Rule, Quality Management Program and                   56 FR 34104.
 Misadministrations, July 25, 1991.
Final Rule, Medical Use of Byproduct Material, April 24,     67 FR 20250.
 2002.
Final Rule, Medical Use of Byproduct Material--Medical       83 FR 33046.
 Events; Definitions and Training and Experience, July 16,
 2018.
Preliminary Proposed Rule Language, 10 CFR part 35.........  ML23083B332.
----------------------------------------------------------------------------------------------------------------

    The NRC may post materials related to this document, including 
public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2022-0218. In addition, the 
Federal rulemaking website allows members of the public to receive 
alerts when changes or additions occur in a docket folder. To subscribe 
take the following steps: (1) navigate to the docket folder (NRC-2022-
0218); (2) click the ``Subscribe'' link; and (3) enter an email address 
and click on the ``Subscribe'' link.

IX. Rulemaking Process

    During the rulemaking process, the NRC will solicit comments from 
the public and will consider all comments before issuing a final rule. 
If the NRC does not issue a proposed rule, the NRC will issue a 
document in the Federal Register that considers feedback received on 
the preliminary proposed rule language and explains why the 
petitioner's requested rulemaking changes were not adopted by the NRC.

    Dated: April 14, 2023.

    For the Nuclear Regulatory Commission.
Tara Inverso,
Acting Director, Division of Rulemaking, Environmental, and Financial 
Support, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2023-08238 Filed 4-18-23; 8:45 am]
BILLING CODE 7590-01-P