Rubidium-82 Generators, Emerging Technologies, and Other Medical Use of Byproduct Material, 42654-42659 [2023-14018]

Download as PDF 42654 Proposed Rules Federal Register Vol. 88, No. 126 Monday, July 3, 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 [Docket No. NRC–2018–0297] RIN 3150–AK80 Rubidium-82 Generators, Emerging Technologies, and Other Medical Use of Byproduct Material Nuclear Regulatory Commission. ACTION: Regulatory basis; notice of public meeting. AGENCY: 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 lotter on DSK11XQN23PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 16:19 Jun 30, 2023 Jkt 259001 for Docket ID NRC–2018–0297. Address questions about NRC dockets to Dawn Forder; telephone: 301–415–3407; email: Dawn.Forder@nrc.gov. For technical questions contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document. • Email comments to: Rulemaking.Comments@nrc.gov. 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: Celimar.ValentinRodriguez@nrc.gov; and Maryann Ayoade, telephone: 301–415–0862, email: Maryann.Ayoade@nrc.gov. 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 PDR.resource@ nrc.gov. For the convenience of the reader, instructions about obtaining materials referenced in this document PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 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 PDR.Resource@nrc.gov 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 performancebased 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 E:\FR\FM\03JYP1.SGM 03JYP1 lotter on DSK11XQN23PROD with PROPOSALS1 Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Proposed Rules 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. Request for Comment Regarding Averted Costs to Licensees III. Specific Requests for Comment Generator Systems (See Regulatory Basis Section A.1) 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 Rb82 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, performancebased 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: VerDate Sep<11>2014 16:19 Jun 30, 2023 Jkt 259001 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. 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 § 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? PO 00000 Frm 00002 Fmt 4702 Sfmt 4702 42655 Question A.1.3: The NRC has found that AUs authorized under § 35.290, ‘‘Training for imaging and localization studies,’’ have sufficient understanding of radionuclide generators, and the NRC is considering revising § 35.27, Supervision,’’ to require device-specific training requirements for supervised individuals. Please provide comments with a rationale on whether § 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 § 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 safetyrelated 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 § 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 § 35.71, ‘‘Contamination E:\FR\FM\03JYP1.SGM 03JYP1 42656 Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Proposed Rules lotter on DSK11XQN23PROD with PROPOSALS1 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 § 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 modelspecific 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. VerDate Sep<11>2014 16:19 Jun 30, 2023 Jkt 259001 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 § 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 § 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, PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 are in § 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 § 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 § 35.41 for determining whether a medical event has occurred (as defined in § 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 § 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 E:\FR\FM\03JYP1.SGM 03JYP1 lotter on DSK11XQN23PROD with PROPOSALS1 Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Proposed Rules 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 VerDate Sep<11>2014 16:19 Jun 30, 2023 Jkt 259001 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 §§ 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 §§ 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. PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 42657 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 § 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 § 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 E:\FR\FM\03JYP1.SGM 03JYP1 42658 Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Proposed Rules 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 § 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 § 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 § 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? 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. IV. Cumulative Effects of Regulation V. Public Meetings 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? 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/publicmeetings/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 Federal Register citation lotter on DSK11XQN23PROD with PROPOSALS1 Document Final Rule—‘‘Criteria for the Release of Individuals Administered Radioactive Material,’’ January 29, 1997 ................................ Final Rule—‘‘Requirements for Expanded Definition of Byproduct Material,’’ October 1, 2007 ..................................................... Licensing Guidance for the Intraocular Use of NeoVista, Inc.Epi-Rad90TM (Strontium-90) Ophthalmic System, April 2009 .......... Enforcement Guidance Memorandum (EGM) 13–003, ‘‘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. ViewRayTM System for Radiation Therapy Licensing Guidance, July 24, 2013 ............................................................................. Low Activity Radioactive Seeds Used for Localization of Non-Palpable Lesions and Lymph Nodes Licensing Guidance, Revision 1, October 07, 2016. Memorandum from M. Dapas to D. Dorman, C. 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. Nuclear Regulatory Commission’s Program for Regulating Patient Release After Radioisotope Therapy,’’ January 29, 2018. Management Directive 5.9, ‘‘Adequacy and Compatibility of Program Elements for Agreement State Programs,’’ April 26, 2018 Leksell Gamma Knife® PerfexionTM and Leksell Gamma Knife® IconTM Licensing Guidance, Revision 1, January 10, 2019 ..... Germanium-68/Gallium-68 Pharmaceutical Grade Generators Licensing Guidance, July 2019 .................................................... NUREG-1556, Volume 9, Revision 3, ‘‘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, ‘‘Medical Use of Byproduct Material’’ and 10 CFR part 20, ‘‘Standards for Protection Against Radiation,’’ May 31, 2000. Xcision® GammaPodTM Licensing Guidance, January 22, 2020 .................................................................................................... NRC Enforcement Policy, January 15, 2020 ................................................................................................................................... State and Tribal Communication STC–20–049, ‘‘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 Requirements for Rubidium-82 Generators and Emerging Medical Technologies,’’ February 9, 2021. Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres® Licensing Guidance, Revision 10.2, April 20, 2021. NorthStar Medical Radioisotopes, LLC, RadioGenix® Molybdenum-99/Technetium-99m Generator System; Licensing Guidance for Medical Use Licensees, Medical Use Permittees, and Commercial Nuclear Pharmacies, December 17, 2021. VerDate Sep<11>2014 16:19 Jun 30, 2023 Jkt 259001 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 E:\FR\FM\03JYP1.SGM 03JYP1 62 FR 4120. 72 FR 55864. ML091140370. ML13101A318. ML13179A287. ML16197A568. ML17075A487. ML17279B139 (package). ML18081A070. ML18333A365. ML19106A367. ML19256C219. ML003698513. ML19304B370. ML19352E921. ML20178A610. ML20261H562. ML21089A364. ML21350A064. Federal Register / Vol. 88, No. 126 / Monday, July 3, 2023 / Proposed Rules ADAMS accession No. or Federal Register citation Document Staff Requirements Memorandum, SRM–SECY–21–0013, ‘‘Rulemaking Plan to Establish Requirements for rubidium-82 Generators and Emerging Medical Technologies,’’ January 13, 2022. Staff Requirements Memorandum, SRM–SECY–20–0005, ‘‘Rulemaking Plan for Training and Experience Requirements for Unsealed Byproduct Material (10 CFR part 35),’’ January 27, 2022. Alpha Tau Alpha DaRTTM Manual Brachytherapy Licensing Guidance, March 10, 2022 .............................................................. Appendix, Consolidated Technical Analysis (chart with list of 10 CFR part 35 regulations and conditions applicable to use of Alpha DaRTTM). Letter to All Agreement States, Connecticut, 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, ‘‘Strategic Plan, Fiscal Years 2022–2026’’ ................................................................ Regulatory Basis, ‘‘Rubidium-82 Generators, 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. 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] lotter on DSK11XQN23PROD with PROPOSALS1 BILLING CODE 7590–01–P VerDate Sep<11>2014 16:19 Jun 30, 2023 DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA–2023–1441 Airspace Docket No. 22–AAL–25] RIN 2120–AA66 Revocation of Colored Federal Airway Blue 12 (B–12) in the Vicinity of Kodiak Island, AK Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). AGENCY: VI. Plain Writing Jkt 259001 This action proposes to revoke Colored Federal airway Blue 12 (B–12) in the vicinity of Kodiak Island, AK due to the previous establishment of Area Navigation (RNAV) route T–385 in support of a large and comprehensive Troute modernization project for the state of Alaska. DATES: Comments must be received on or before August 17, 2023. ADDRESSES: Send comments identified by FAA Docket No. FAA–2023–1441 and Airspace Docket No. 22–AAL–25 using any of the following methods: * Federal eRulemaking Portal: Go to www.regulations.gov and follow the online instructions 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. SUMMARY: PO 00000 Frm 00006 Fmt 4702 42659 Sfmt 4702 ML22013A266. ML22027A519. ML22018A225. ML22018A223. ML22139A026. ML22067A170. ML23122A356. * 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 accessing the docket or go to the 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: Steven Roff, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267–8783. 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 the 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 modify the route structure as necessary to preserve the safe and efficient flow of E:\FR\FM\03JYP1.SGM 03JYP1

Agencies

[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]


========================================================================
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. 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.

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

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
------------------------------------------------------------------------
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]
BILLING CODE 7590-01-P
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