[Federal Register Volume 88, Number 126 (Monday, July 3, 2023)]
[Proposed Rules]
[Pages 42654-42659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14018]
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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.
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Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Proposed
Rules
[[Page 42654]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[Docket No. NRC-2018-0297]
RIN 3150-AK80
Rubidium-82 Generators, Emerging Technologies, and Other Medical
Use of Byproduct Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Regulatory basis; notice of public meeting.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is conducting
rulemaking to add requirements for calibration and dosage measurement
for certain generator systems and establish performance-based
requirements for existing and future emerging medical technologies. The
NRC is also considering additional changes to its medical use
regulations to accommodate developments in the medical field related to
new radiopharmaceuticals and emerging medical technologies. The
rulemaking will affect medical licensees who use these technologies and
evaluate the current training and experience requirements for emerging
medical technologies. The NRC is requesting comments from the public on
the regulatory basis for this rulemaking. The NRC plans to hold one or
more public meetings during the comment period to promote full
understanding of the contemplated action and facilitate public comment.
DATES: Submit comments by October 31, 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.
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-2018-0297. 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: Celimar Valentin-Rodriguez, telephone:
301-415-7124, email: [email protected]; and Maryann
Ayoade, telephone: 301-415-0862, 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-2018-0297 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-2018-0297.
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]. 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: 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 1-80-397-4209 or 301-415-4737, between 8
a.m. and 4 p.m. eastern time, 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-2018-0297 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, 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. Discussion
The NRC is requesting comment on a regulatory basis to support a
rulemaking that would amend part 35 of title 10 of the Code of Federal
Regulations (10 CFR), ``Medical use of byproduct material,'' to add
requirements for calibration and dosage measurement for strontium-82/
rubidium-82 generators (hereafter referred to as Rb-82 generators) and
establish performance-based requirements for existing and future
emerging medical technologies (EMTs). The NRC is also considering
additional changes to its medical use regulations to accommodate
developments in the medical field related to new radiopharmaceuticals
[[Page 42655]]
and EMTs. Additionally, the NRC is evaluating the current training and
experience requirements required for authorized users (AUs) of EMTs to
fulfill their radiation safety-related duties and supervisory roles.
A regulatory basis is a precursor to a proposed rule and describes
the NRC's planned approach for revising the regulations. This
regulatory basis (1) includes a discussion of the background of the
regulatory issues, (2) explains the proposed areas of change to the
regulations and how those changes could resolve the issues, (3)
provides the technical and policy information used to support the
regulatory basis, and (4) identifies different alternatives to address
the regulatory issues and evaluates the cost and benefits of rulemaking
and the alternatives. The regulatory basis also explains the
limitations on the scope and quality of the regulatory basis, such as
known uncertainties in the data or methods of analysis, and the
mitigation measures that address these limitations.
III. Specific Requests for Comment
The NRC considers a regulatory basis to be a pre-rulemaking
document. If the NRC decides to pursue rulemaking, the NRC will publish
a proposed rule that will seek public comment. Currently, the NRC is
seeking advice and recommendations from the public on the regulatory
basis.
The regulatory basis, titled ``Rubidium-82 Generators, Emerging
Technologies, and Other Medical Use of Byproduct Material--Regulatory
Basis,'' can be obtained at ADAMS Accession No. ML23122A356. The
regulatory basis evaluates the existing regulatory framework for Rb-82
generators, including the use of enforcement discretion when licensees
who use Rb-82 generators cannot meet existing requirements for
calibration, and dosage determination and what type of regulatory
changes would need to be considered to permit such action. In addition,
the regulatory basis evaluates what regulatory changes are needed to
establish risk-informed, performance-based requirements for existing
and future emerging medical technologies.
The NRC will consider any comments received on the regulatory basis
in the development of the proposed rule and will respond to the
comments in the proposed rule. The regulatory basis describes all of
the regulatory changes being considered, and the NRC is requesting
comment regarding some of these potential changes. Please indicate the
topic and item number with your response or comment:
Request for Comment Regarding Averted Costs to Licensees
Section 8 of the regulatory basis document discusses potential
rulemaking costs and other impacts to the NRC (section 8.3), Agreement
States (section 8.4), and licensees (section 8.5). The analyses are
based on the NRC's preliminary assessment and estimates, and the NRC
will conduct a more detailed cost and impact evaluation in the draft
regulatory analysis that will accompany the proposed rule. To assist
the NRC in conducting this detailed analysis, please provide comments
on whether licensees would realize averted costs from a more
streamlined licensing of existing and future EMTs. Explain why or why
not.
Request for Comment on Topics in Appendix A of the Regulatory Basis
The specific areas for comment that follow are from appendix A of
the regulatory basis, and the numbering scheme matches the numbering in
appendix A.
Generator Systems (See Regulatory Basis Section A.1)
The NRC is considering regulatory changes to address calibration
and dose determination requirements for rubidium-82 generators. In
addition, the NRC is also considering regulatory changes to address
generators currently licensed under 10 CFR part 35, subpart K and novel
generator systems.
Question A.1.1: Please provide comments on the need for radiation
safety officers to have specific training for all generator systems
licensed under 10 CFR part 35, subpart D, ``Unsealed Byproduct
Material--Written Directive Not Required.'' If general awareness on
radionuclide generators, including their functions and risks, is
sufficient, explain why.
The NRC is considering amending the requirement in Sec. 35.63,
``Determination of dosages of unsealed byproduct material for medical
use,'' to clarify that, for the incremental administration of rubidium-
82, dose measurements do not have to be complete before administration
when the dose is measured continuously during the infusion of Rb-82
from a generator to the patient.
Question A.1.2: Please provide comments on whether and how the NRC
should allow the completion of dosage measurement after the beginning
of an incremental administration for radionuclides other than Rb-82.
How would such an allowance be bounded? What considerations should go
into the expansion of this flexibility?
Question A.1.3: The NRC has found that AUs authorized under Sec.
35.290, ``Training for imaging and localization studies,'' have
sufficient understanding of radionuclide generators, and the NRC is
considering revising Sec. 35.27, Supervision,'' to require device-
specific training requirements for supervised individuals. Please
provide comments with a rationale on whether Sec. 35.290 AUs should
also be required to have device-specific training for all radionuclide
generators for which they supervise the use.
Intravascular Brachytherapy Systems (See Regulatory Basis Section A.2)
The NRC is considering revisions to 10 CFR part 35, subpart F,
``Manual Brachytherapy,'' to incorporate regulatory requirements for
intravascular brachytherapy (IVB).
Question A.2.1: The NRC is considering adding a new section under
subpart F to address the specific training and experience (T&E)
requirements to be an AU for IVB and other uses under Sec. 35.401
(liquid brachytherapy, diffusion brachytherapy, and eye applicators).
Please provide comments on the sufficiency of the T&E for AUs as
outlined in the current EMT licensing guidance documents for IVB,
liquid brachytherapy, and eye applicators. Specifically, the NRC is
seeking comments on the knowledge topics encompassing the safety-
related characteristics of these EMTs required for AUs to fulfill their
radiation safety-related duties and supervision roles; the methods on
how knowledge topics should be acquired; and consideration for
continuing education, vendor training for new medical uses, and
training on NRC regulatory requirements.
Liquid Brachytherapy Sources and Devices (See Regulatory Basis Section
A.3)
The NRC is considering changes to 10 CFR part 35, subpart F,
``Manual Brachytherapy'' and other pertinent sections to incorporate
regulatory requirements for liquid brachytherapy.
Question A.3.1: The NRC has found that the hazards of liquid
brachytherapy are similar to those of microsources and microspheres.
Please provide comments with a rationale on whether the current
definition of manual brachytherapy in Sec. 35.2, ``Definitions,''
should be revised to include liquid brachytherapy and exclude
microsources or if liquid brachytherapy should be included in the newly
proposed subpart I for microsources.
Question A.3.2: The NRC is proposing to add a new Sec. 35.71,
``Contamination
[[Page 42656]]
control,'' that would require licensees to develop, implement, and
maintain procedures addressing contamination control and spill response
for the uses authorized on the license. The NRC is seeking input on
whether this requirement is needed or if the requirements in 10 CFR
part 20, ``Standards for Protection against Radiation,'' are sufficient
for contamination control. Please provide comments on this proposed
requirement and indicate if it should apply to all medical licensees or
to a certain subset and why.
Question A.3.3: The NRC is considering amending Sec. 35.2 to
define the term ``source leakage'' as it relates to liquid
brachytherapy. For example, a possible leakage rate could be any
leakage from a liquid brachytherapy source that results in a dose
exceeding 0.5 Sievert (50 rem) dose equivalent to any individual organ
other than the treatment site. Please comment on whether this limit is
appropriate and explain why or why not. What types of limits for liquid
brachytherapy device leakage should the NRC consider (e.g., activity-
based, dose-based, external to the patient)?
Gamma Stereotactic Radiosurgery and Photon Emitting Teletherapy Units
(See Regulatory Basis Section A.6)
Since the NRC established requirements for gamma stereotactic
radiosurgery units in 2002, the design and engineering elements have
evolved and the components and operation of newer GSR units are
significantly different from the units that the NRC currently regulates
under 10 CFR part 35, subpart H, ``Photon Emitting Remote Afterloader
Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units.''
Question A.6.1: Please provide comments on the need for model-
specific training for radiation safety officers for certain 10 CFR part
35, subpart H devices. If model-specific training is needed, how should
the NRC determine which devices would require such training?
Question A.6.2: Current NRC requirements in 10 CFR part 35, subpart
H, are focused on components critical to patient and facility safety
for the use of these devices. The proposed changes to subpart H focus
on elements and objectives rather than specific components. Examples of
elements include source output, source collimation, source position,
source attenuation, patient safety, and facility safety. Please provide
comments on other elements that should be considered.
Question A.6.3: Please provide comments on what types of objective
tests the NRC should require for full calibration measures for 10 CFR
part 35, subpart H devices. What functional elements should be
considered for safety?
Question A.6.4: Please provide comments on what types of objective
tests the NRC should require for periodic spot-checks for 10 CFR part
35, subpart H devices. Additionally, what functional elements should be
considered critical to safety?
Microsource Manual Brachytherapy (See Regulatory Basis Section A.7)
The use of microspheres for permanent implant manual brachytherapy
has grown significantly over the past 20 years, and the NRC has accrued
valuable operating experience. To incorporate the use of new and
existing microspheres and microparticles for manual brachytherapy, the
NRC is considering creating a new subpart within 10 CFR part 35 in the
currently ``reserved'' subpart I of 10 CFR part 35.
Question A.7.1: The NRC is considering defining a ``microsource''
in Sec. 35.2 as microparticles and microspheres. What types of
radiation (such as alpha, beta, gamma) should fit into the definition
of ``microsource''? Please include comments and a rationale for whether
(1) microspheres should be limited to specific types of radiation or
certain energies; (2) microsources should be limited to sealed sources
with a Sealed Source and Device (SS&D) registry; (3) unsealed
microsources should be required to have a SS&D registry; and (4) any
additional changes are needed in the current regulations for
microsource brachytherapy that would increase flexibility for future
microsource brachytherapy.
Question A.7.2: The NRC is considering defining ``physiological
equilibrium'' in Sec. 35.2 to include stasis or other states of
equilibrium. Please provide comments on what should be included in a
definition of physiological equilibrium or identify other
considerations for physiological stop points.
Question A.7.3: As the complexity of the medical use of byproduct
material increases, use of teams in medical care is becoming more
common. Please provide comments on the fundamental elements of a
successful team-approach program.
Section 35.40, ``Written directives,'' would be amended to clarify
that requirements for manual brachytherapy uses under 10 CFR part 35,
subpart F, are in Sec. 35.40(b)(6). The NRC is considering listing the
subpart I requirements for written directives for microsource manual
brachytherapy uses under a new item in Sec. 35.40(b).
Question A.7.4: For microsource manual brachytherapy, please
provide comments and a rationale for whether the before-implant written
directive should specify the dose or activity.
Question A.7.5: For microsource manual brachytherapy, please
provide comments and a rationale for whether the after-implant written
directive should specify the activity administered or the dose
delivered to the treatment site.
Question A.7.6: As required by Sec. 35.41 for determining whether
a medical event has occurred (as defined in Sec. 35.3045), please
comment on whether and why the NRC should require calculating and
documenting the activity administered or the activity or dose
specifically delivered to the treatment site. By what deadline (e.g.,
number of hours or days) should this determination be made?
Question A.7.7: For microsource manual brachytherapy, please
comment on whether the NRC should require post-treatment imaging to
confirm that the treatment was delivered in accordance with the written
directive. Why or why not? What other mechanisms are available to
confirm that the treatment was delivered in accordance with the written
directive?
Question A.7.8: Please identify any tasks that would require an
authorized medical physicist for the use of microsphere manual
brachytherapy and identify whether and how the NRC should revise the
training and experience requirements for authorized medical physicists
in Sec. 35.51, ``Training for an authorized medical physicist.''
Question A.7.9: Please comment on what types of use should be
permitted for microsource manual brachytherapy, including whether the
use should be limited to that approved in the sealed source and device
registry. Please comment on why unsealed microsources without a unique
delivery system should or should not be allowed.
Question A.7.10: Please comment on why any new requirements for
microsource manual brachytherapy should or should not be limited to
permanent implants.
Question A.7.11: The NRC is considering establishing minimum safety
procedures for microsources and requiring instructions to assure
adequate protection of public health and safety. These changes are
based on current EMT licensing guidance for yttrium-90 (Y-90)
microspheres and
[[Page 42657]]
expected new uses of microsources. Please identify and comment on other
items that should be included in a new requirement for safety
procedures and instructions for microsource manual brachytherapy.
Question A.7.12: The NRC is considering establishing minimum safety
precautions (controls) to assure adequate protection of public health
and safety. These considerations are based on current EMT licensing
guidance for Y-90 microspheres and expected new uses of microsources.
Please identify and comment on other items that should be included in a
new requirement for safety precautions (controls) for microsource
manual brachytherapy.
Question A.7.13: The NRC is seeking input on the need for continued
conditional approval for AUs of Y-90 microspheres. The current
licensing guidance for Y-90 microspheres states that an AU should
successfully complete training in the operation of the delivery system,
safety procedures, and clinical use for the specific type of Y-90
microsphere for which authorization is sought. The guidance specifies
that clinical use training to support unsupervised use should include
at least three hands-on patient cases for each type of Y-90 microsphere
requested, conducted in the physical presence of an AU who is
authorized for the type of Y-90 microsphere for which the individual is
seeking authorization. The guidance allows conditional approval of an
AU before completing these three hands-on patient cases if a proposed
AU cannot complete patient cases before authorization. This conditional
approval was originally added to the guidance because there were
limited Y-90 microsphere licensees and AUs to train future AUs. As the
use of Y-90 microspheres has increased significantly, please comment on
the continued need for conditional approval for Y-90 microsphere AUs.
Indicate why the NRC should or should not continue to allow this
pathway for all microspheres and microsources AUs.
Question A.7.14: The NRC is seeking input on the 80 hours of
classroom and laboratory training for interventional radiologists
pursuing AU status for Y-90 microsphere and other microsource uses. The
NRC in the current EMT licensing guidance for Y-90 microspheres
includes a pathway for interventional radiologists to become AUs for Y-
90 microspheres use. This pathway requires the interventional
radiologist to demonstrate that they have 80 hours of classroom and
laboratory training in specific topics and specific work experience
important to radiation safety, in addition to demonstrating they have
sufficient clinical interventional radiology and diagnostic radiology
experience. Please comment on why 80 hours is or is not an appropriate
amount of time to ensure these topics are adequately covered. Who
should supervise the work experience to ensure the future AUs have
adequate radiation safety knowledge and why?
Question A.7.15: The NRC is seeking input on classroom and
laboratory training topics for physicians seeking AU status for all
microspheres or other types of microsources. The NRC, in the current
EMT licensing guidance for Y-90 microspheres, provides a pathway for
interventional radiologists and physicians that meet the training and
experience requirements in Sec. Sec. 35.390 and 35.490 to become AUs
for Y-90 microspheres use. This pathway does not require any classroom
and laboratory training or specific work experience for these
physicians besides demonstration of successfully completed training in
the operation of the delivery system, safety procedures, and clinical
use (including hands-on patient cases) for the type of Y-90 microsphere
for which authorization is sought. Please identify and comment on any
additional classroom and laboratory training topics or specific work
experience that should be required for these physicians to become AUs
for all microspheres or other types of microsources in subpart I. What
additional training and work experience should be considered, if any,
and why?
Question A.7.16: The NRC is seeking input on the pathways for
physicians to become AUs for use of microspheres and other types of
microsources. The NRC in the current EMT licensing guidance for Y-90
microspheres provides pathways for interventional radiologists and
physicians that meet the training and experience requirements in
Sec. Sec. 35.390 and 35.490 to become AUs for Y-90 microsphere use.
Please comment on whether and why the NRC should or should not provide
additional pathways for other types of physicians to become AUs for use
of microspheres or other types of microsources.
Question A.7.17: In most circumstances, are AUs the individuals
administering Y-90 microspheres? Is it appropriate for other
individuals to administer microsources under the supervision of an AU?
Why or why not?
Other Part 35 Changes: Novel Radionuclide Generators (See Regulatory
Basis Section A.8)
Question A.8.1: Industry is evaluating various novel radionuclide
generators. Some novel radionuclide generators may be utilized to
compound therapeutic dosages of unsealed byproduct material. The NRC is
considering a requirement for licensees to perform breakthrough testing
on novel radionuclide generators and report instances when breakthrough
exceeds a defined limit. Since breakthrough limits for some novel
radionuclide generators have not been established by the United States
Pharmacopeia, please explain why it would or would not be sufficient
for licensees to develop, implement, and maintain procedures for
breakthrough testing and reporting for novel radionuclide generators.
Other Part 35 Changes: Training and Experience (See Regulatory Basis
Section A.8)
Question A.8.2: Please comment on the type of T&E that should be
required for AUs utilizing novel radionuclide generators and the type
of T&E for authorized nuclear pharmacists utilizing novel radionuclide
generators.
Question A.8.3: Please comment on why the current structure for
authorized medical physicist involvement in 10 CFR part 35, subpart F,
``Manual Brachytherapy,'' is or is not sufficient. If not sufficient,
what specific tasks or skills should be performed by an authorized
medical physicist for manual brachytherapy?
Question A.8.4: Due to the increased number and complexity of EMTs,
please comment on why the NRC should or should not require continuing
education for AUs. If continuing education should be required, what
should it entail, at what frequency should it be acquired, and how
should knowledge topics be acquired?
Question A.8.5: Please comment on the need for AUs for Sec. 35.200
to have device-specific training on radionuclide generators. If device-
specific training is needed, what topics should the training include?
Please explain why the training should or should not be specific to the
radionuclide generators for which the AUs are supervising the use.
Question A.8.6: Please comment and provide a rationale for whether
physicians authorized for full use under Sec. 35.300 need additional
T&E to fulfill their radiation safety-related duties and supervision
roles because of expected emerging therapeutic radiopharmaceuticals.
Please comment on why additional training is or is not needed on
regulatory requirements for emerging therapeutic radiopharmaceuticals.
If needed, what topics should the T&E include? What specific training
should these AUs be
[[Page 42658]]
required to have (e.g., vendor training on clinical use and safety
procedures) prior to first-time use, if any? Why should they be
required or not required to have continuing education?
Question A.8.7: Please comment on why the current AU T&E
requirements for use of sealed sources and medical devices for
diagnosis in Sec. 35.590 (i.e., 8 hours of classroom and laboratory
training in basic radionuclide handling techniques specifically
applicable to the use of the device authorized under Sec. 35.500, as
well as device-specific training in the use of the device) are or are
not appropriate for emerging sealed sources and medical devices
containing sealed sources. If AUs for Sec. 35.500 need additional
training and work experience on emerging sealed sources and medical
devices containing sealed sources for diagnosis, what topics should be
covered?
Other Part 35 Changes: Security and Controls
Question A.8.8: Please comment on any specific changes that are
needed to secure consoles, keys, and passwords for remote afterloader
units, teletherapy units, and gamma stereotactic radiosurgery units
because of changes in technology.
Question A.8.9: Please comment on the types of doors or entry
controls that would be acceptable to maintain security of licensed
material while not interfering with patient care. For example, why
should a physical door be required, or why other entry controls such as
lasers acceptable?
IV. Cumulative Effects of Regulation
The NRC is following its Cumulative Effects of Regulation (CER)
process by engaging with external stakeholders throughout this
regulatory basis and related regulatory activities. Opportunity for
public comment is provided to the public at this regulatory basis
stage.
1. In light of any current or projected CER challenges, how should
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? For example, if more time is required for
implementation of the new requirements, what period of time is
sufficient?
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?
5. Please comment on the NRC's cost and benefit estimates in the
regulatory basis.
V. Public Meetings
During the public comment period, the NRC will hold one or more
public meetings to facilitate discussion of the proposed rulemaking
described in the regulatory basis document, including the questions in
Appendix A of the document and provided in Section III of this
document.
The NRC will publish a notice of the location, time, and agenda of
the meetings in the docket on Regulations.gov, and 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. 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. or
Document Federal Register
citation
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Final Rule--``Criteria for the Release of 62 FR 4120.
Individuals Administered Radioactive
Material,'' January 29, 1997.
Final Rule--``Requirements for Expanded 72 FR 55864.
Definition of Byproduct Material,'' October
1, 2007.
Licensing Guidance for the Intraocular Use of ML091140370.
NeoVista, Inc.Epi-Rad90\TM\ (Strontium-90)
Ophthalmic System, April 2009.
Enforcement Guidance Memorandum (EGM) 13-003, ML13101A318.
``Enforcement Guidance Memorandum--Interim
Guidance for Dispositioning Violations
Involving 10 CFR 35.60 and 10 CFR 35.63 for
the Calibration of Instrumentation to
Measure the Activity of Rubidium-82 and the
Determination of Rubidium-82 Patient
Dosages,'' April 18, 2013.
ViewRay\TM\ System for Radiation Therapy ML13179A287.
Licensing Guidance, July 24, 2013.
Low Activity Radioactive Seeds Used for ML16197A568.
Localization of Non-Palpable Lesions and
Lymph Nodes Licensing Guidance, Revision 1,
October 07, 2016.
Memorandum from M. Dapas to D. Dorman, C. ML17075A487.
Pederson, K. Kennedy; ``Revision of
Technical Basis for Granting Specific
Exemption from Decommissioning Funding Plan
Requirement for Germanium-68/Gallium-68
Generators,'' July 13, 2017.
SECY-18-0015, ``Staff Evaluation of the U.S. ML17279B139 (package).
Nuclear Regulatory Commission's Program for
Regulating Patient Release After
Radioisotope Therapy,'' January 29, 2018.
Management Directive 5.9, ``Adequacy and ML18081A070.
Compatibility of Program Elements for
Agreement State Programs,'' April 26, 2018.
Leksell Gamma Knife[supreg] PerfexionTM and ML18333A365.
Leksell Gamma Knife[supreg] IconTM Licensing
Guidance, Revision 1, January 10, 2019.
Germanium-68/Gallium-68 Pharmaceutical Grade ML19106A367.
Generators Licensing Guidance, July 2019.
NUREG[dash]1556, Volume 9, Revision 3, ML19256C219.
``Consolidated Guidance About Materials
Licenses: Program-Specific Guidance About
Medical Use Licenses, Final Report,''
September 2019.
SECY-00-0118, Final Rules--10 CFR part 35, ML003698513.
``Medical Use of Byproduct Material'' and 10
CFR part 20, ``Standards for Protection
Against Radiation,'' May 31, 2000.
Xcision[supreg] GammaPodTM Licensing ML19304B370.
Guidance, January 22, 2020.
NRC Enforcement Policy, January 15, 2020..... ML19352E921.
State and Tribal Communication STC-20-049, ML20178A610.
``Responses to the Organization of Agreement
States (OAS) Requests Regarding
Clarification of Compatibility Categories
for Medical Licensing Guidance Documents;
and Use of Safety Evaluation Reports (SERs)
as a Legally Binding Requirement,'' June 30,
2020.
SECY-21-0013, ``Rulemaking Plan to Establish ML20261H562.
Requirements for Rubidium-82 Generators and
Emerging Medical Technologies,'' February 9,
2021.
Yttrium-90 Microsphere Brachytherapy Sources ML21089A364.
and Devices TheraSphere[supreg] and SIR-
Spheres[supreg] Licensing Guidance, Revision
10.2, April 20, 2021.
NorthStar Medical Radioisotopes, LLC, ML21350A064.
RadioGenix[supreg] Molybdenum-99/Technetium-
99m Generator System; Licensing Guidance for
Medical Use Licensees, Medical Use
Permittees, and Commercial Nuclear
Pharmacies, December 17, 2021.
[[Page 42659]]
Staff Requirements Memorandum, SRM-SECY-21- ML22013A266.
0013, ``Rulemaking Plan to Establish
Requirements for rubidium-82 Generators and
Emerging Medical Technologies,'' January 13,
2022.
Staff Requirements Memorandum, SRM-SECY-20- ML22027A519.
0005, ``Rulemaking Plan for Training and
Experience Requirements for Unsealed
Byproduct Material (10 CFR part 35),''
January 27, 2022.
Alpha Tau Alpha DaRT\TM\ Manual Brachytherapy ML22018A225.
Licensing Guidance, March 10, 2022.
Appendix, Consolidated Technical Analysis ML22018A223.
(chart with list of 10 CFR part 35
regulations and conditions applicable to use
of Alpha DaRT\TM\).
Letter to All Agreement States, Connecticut, ML22139A026.
and Indiana; ``Results of Annual Count of
Radioactive Material Licenses in the
National Materials Program'' (STC-22-034),
May 19, 2022.
NRC Strategic Plan, NUREG-1614, Vol. 8, ML22067A170.
``Strategic Plan, Fiscal Years 2022-2026''.
Regulatory Basis, ``Rubidium-82 Generators, ML23122A356.
Emerging Technologies, and Other Medical Use
of Byproduct Material,'' June 2023.
------------------------------------------------------------------------
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-2018-0297. 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: (1) navigate to the docket folder (NRC-2018-0297); (2) click
the ``Subscribe'' link; and (3) enter an email address and click on the
``Subscribe'' link.
VI. 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
31883). The NRC requests comment on this document with respect to the
clarity and effectiveness of the language used.
Dated: June 27, 2023.
For the Nuclear Regulatory Commission.
John M. Moses,
Deputy Director, Division of Rulemaking, Environmental, and Financial
Support, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2023-14018 Filed 6-30-23; 8:45 am]
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