ML19077A112

Final Transcript of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) February 26, 2019 Teleconference Meeting, Revision 1

ML19077A112
Person / Time
Issue date:	02/26/2019
From:	Advisory Committee on the Medical Uses of Isotopes
To:
Jamerson, Kellee
References
NRC-0148
Download: ML19077A112 (80)

Text

1 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION

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ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES

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TELECONFERENCE

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TUESDAY FEBRUARY 26, 2019

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The meeting convened by teleconference at 10:00 a.m., Christopher J. Palestro, M.D., ACMUI

Chairman, presiding.

MEMBERS PRESENT:

CHRISTOPHER J. PALESTRO, M.D., ACMUI Chairman;

Nuclear Medicine Physician

DARLENE F. METTER, M.D., ACMUI Vice Chairman;

Diagnostic Radiologist

VASKEN DILSIZIAN, M.D., Nuclear Cardiologist

RONALD D. ENNIS, M.D., Radiation Oncologist (Brachytherapy)

RICHARD L. GREEN, Nuclear Pharmacist

MELISSA C. MARTIN, Nuclear Medicine Physicist

MICHAEL D. O'HARA, Ph.D., FDA Representative

ZOUBIR OUHIB, Therapy Medical Physicist 2 A. ROBERT SCHLEIPMAN, Ph.D., Health Care Administrator

MICHAEL SHEETZ, Radiation Safety Officer

MEGAN L. SHOBER, Agreement State Representative

LAURA M. WEIL, Patients' Rights Advocate

NON-VOTING MEMBER PRESENT:

HARVEY B. WOLKOV, M.D., Radiation Oncologist (GSR)

STAFF PRESENT:

ANDREA KOCK, Director, Division of Materials Safety, Security, States, and Tribal Programs (MSST)

CHRISTIAN EINBERG, ACMUI Designated Federal Officer (DFO), Chief, NMSS/MSST/MSEB

SOPHIE HOLIDAY, ACMUI DFO

KELLEE JAMERSON, ACMUI DFO; ACMUI Coordinator

MARYANN AYOADE, NMSS/MSST/MSEB

SAID DAIBES, Ph.D., NMSS/MSST/MSEB

LISA DIMMICK, Medical Radiation Safety Team Leader, NMSS/MSST/MSEB SARA FORSTER, R-III/DNMS/MLB

ROBERT GALLAGHAR, R-I/DNMS/MLAB

EDWARD HARVEY, R-III/DNMS/MIB

ESTHER HOUSEMAN, OGC/GCLR/RMR

DONNA-BETH HOWE, Ph.D., NMSS/MSST/MSEB 3 IAN IRVIN, OGC/GCLR/RMR DONNA JANDA, R-I/DNMS/MLAB

SARAH LOPAS, NMSS/MSST/MSEB

KATHY MODES, NMSS/MSST/ASPB

JANICE NGUYEN, R-I/DNMS/MLAB

PATTY PELKE, R-III/DNMS/MLB

ZAHID SULAIMAN, R-III/DNMS/MIB

KATHERINE TAPP, Ph.D., NMSS/MSST/MSEB

MEMBERS OF THE PUBLIC PRESENT:

MICHAEL BAXTER, American Pharmacists Association

KENDALL BERRY, Fox Chase Cancer Center

JANET BUKOVCAN, British Technology Group (BTG)

MARY BURKHART, Illinois Emergency Management Agency (IEMA) WILLIAM CHEN, unaffiliated JOHN CHIPPO, Pennsylvania Department of Environmental Protection (PDEP)

THOMAS CONLEY, University of Kansas Medical Center

WHITNEY COX, IEMA

DAVID CROWLEY, North Carolina Department of Health and Human Services, Radiation Protection

Section ARIEL DOUCET, Virtua Health

BRIAN ERASMUS, BTG 4 LYNNE A. FAIROBENT, unaffiliated SHERRIE FLAHERTY, Minnesota Radioactive Materials

Unit MIKE FULLER, Virginia Department of Health (VDH)

SANDY GABRIEL, unaffiliated WENDY GALBRAITH, University of Oklahoma Health Sciences Center BENNETT GREENSPAN, M.D., Medical College of Georgia, Augusta University MIGUEL de la GUARDIA, Cook Children's Medical Center

MICHAEL GUASTELLA, Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR)

STANLEY HAMPTON, Eli Lilly

DAN HILL, Cardinal Health

DANIEL JANUSESKI, Virtua Health

TRACY JUE, California Department of Public Health

SUE LANGHORST, Ph.D., unaffiliated RALPH LIETO, St. Joseph Mercy Health System

CINDI LUCKETT-GILBERT, Shertech Pharmacy

CAROL MARCUS, Ph.D, M.D., University of California at Los Angeles (UCLA)

RICHARD MARTIN, American Association of Physicists in Medicine (AAPM)

SAMUEL MEHR, M.D., Nebraska Cancer Specialists

ASHLEY MISHOE, University of California, San 5 Francisco MARY MOORE, VDH

JOSHUA MYERS, PDEP

CHRISTOPHER OTT, PDEP

BRANDON PATERSON, unaffiliated RICHARD PEROS, New Jersey Department of Environmental Protection (NJDEP)

MICHAEL PETERS, American College of Radiology (ACR)

CARMINE PLOTT, Novant Health

ARIA RAZMARIA, M.D., UCLA Medical Center

GLORIA ROMANELLI, ACR

GEORGE SEGALL, M.D., American Board of Nuclear Medicine (ABNM)

BEN SEIBER, PDEP

BETH SHELTON, Tennessee Department of Environment and Conservation JEFFRY SIEGEL, Ph.D., Nuclear Physics Enterprises

DANIEL STROHMEYER, unaffiliated CINDY TOMLINSON, American Society of Radiation Oncology (ASTRO)

MICHAEL UJHELYI, BTG

PAUL WALLNER, M.D., 21 st Century Oncology, Inc.

MATTHEW WILLIAMSON, Memorial Sloan Kettering Cancer Center MELONIE WISSING, VDH 6 JOHN WITKOWSKI, United Pharmacy Partners (UPPI) 1 7 P-R-O-C-E-E-D-I-N-G-S 1 (10:15 a.m.)

2 MR. EINBERG: Thank you. This is Chris 3 Einberg. I am the Branch Chief of the Medical Safety 4 and Events Assessment Branch, and I wanted to 5 apologize for the technical difficulties that we have 6 been having right now getting the webinar running.

7 As Sophie mentioned, the slides will be 8 available on the ACMUI public website. So we're going 9 to try to get the webinar running, but if you cannot 10 access the -- or if we can't get the webinar running, 11 then please access the slides from the -- from the 12 public SharePoint -- or from the public website.

13 So I am going to start with the opening 14 remarks here. As the Designated Federal Officer for 15 this meeting, I am pleased to welcome you to the 16 public meeting of the Advisory Committee on the 17 Medical Uses of Isotopes.

18 Once again, my name is Chris Einberg. I'm 19 the Branch Chief of the Medical Safety and Events 20 Assessment Branch, and I have been designated as the 21 Federal Officer for this Advisory Committee in 22 accordance with 10 CFR Part 7.11.

23 Present today as the Designated Officer 24 is Sophie Holiday. And, likewise, as a Designated 25 8 Federal Officer, I would like to introduce Kellee 1 Jamerson, who was assigned to the role of the ACMUI 2 Coordinator in December.

3 This is an announced meeting of the 4 committee. It has been held in accordance with the 5 rules and the regulations of the Federal Advisory 6 Committee Act and the Nuclear Regulatory Commission.

7 This meeting is being transcribed by the NRC and may 8 also be transcribed or recorded by others.

9 The meeting was announced on -- or in the 10 February 4, 2019, edition of the Federal Register, 11 Volume 84, page 1521.

12 The function of the committee is to 13 advise the staff on issues and questions that arise 14 on the medical use of byproduct material. The 15 Committee provides counsel to the staff, but does not 16 determine or direct the actual decisions of the staff 17 or the Commission. The NRC solicits the views of the 18 Committee and values their opinions.

19 I request that whenever possible we try 20 to reach a consensus on the various issues that we 21 will discuss today, but I also recognize that there 22 may be minority or dissenting opinions. If you have 23 such opinions, please allow them to be read into the 24 record. 25 9 At this point, I would like to perform a 1 roll call of the ACMUI members participating today.

2 First is Dr. Christopher Palestro, Chairman, Nuclear 3 Medicine Physician.

4 CHAIR PALESTRO: Present.

5 MR. EINBERG: Dr. Darlene Metter, Vice 6 Chairman, Diagnostic Radiologist.

7 VICE CHAIR METTER: Present.

8 MR. EINBERG: Dr. Vasken Dilsizian, 9 Nuclear Cardiologist.

10 MEMBER DILSIZIAN: Present.

11 MR. EINBERG: Dr. Ronald Ennis, Radiation 12 Oncologist.

13 MEMBER ENNIS: Here.

14 MR. EINBERG: Mr. Richard Green, Nuclear 15 Pharmacist.

16 MEMBER GREEN: Present.

17 MR. EINBERG: Ms. Melissa Martin, Nuclear 18 Medicine Physicist.

19 MEMBER MARTIN: Present.

20 MR. EINBERG: Dr. Michael O'Hara, FDA 21 Representative.

22 MEMBER O'HARA: Present.

23 MR. EINBERG: Mr. Zoubir Ouhib, Radiation 24 Therapy Physicist.

25 10 MEMBER OUHIB: Present.

1 MR. EINBERG: Dr. A. Robert Schleipman, 2 Health Care Administrator.

3 MEMBER SCHLEIPMAN: Present.

4 MR. EINBERG: Mr. Michael Sheetz, 5 Radiation Safety Officer.

6 MEMBER SHEETZ: Present.

7 MR. EINBERG: Ms. Meghan Shober, State 8 Government Representative.

9 MEMBER SHOBER: Present.

10 MR. EINBERG: Ms. Laura Weil, Patients' 11 Rights Advocate.

12 MEMBER WEIL: Present.

13 MR. EINBERG: Okay. We have a quorum.

14 On the phone we also have Dr. Wolkov.

15 Dr. Wolkov has been selected as the ACMUI Radiation 16 Oncologist. He is pending a security clearance, but 17 may participate in the meeting. However, he does not 18 have voting rights at this time.

19 And I now ask that NRC staff members who 20 are present to identify themselves. I'll start with 21 individuals in the room here. And, Sophie, if you 22 want to go first.

23 MS. HOLIDAY: Hi. Sophie Holiday, 24 Medical Radiation Safety Team.

25 11 MS. JAMERSON: Kellee Jamerson, Medical 1 Radiation Safety Team.

2 MS. HOUSEMAN: Esther Houseman, OGC.

3 MS. LOPAS: Sarah Lopas, Medical 4 Radiation Safety Team.

5 MR. IRVIN: Ian Irvin, OGC.

6 DR. TAPP: Katie Tapp, Medical Radiation 7 Safety Team.

8 MR. EINBERG: Donna-Beth Howe is here as 9 well. And now I'll go to the NRC staff members on 10 the phone. Can you please identify yourselves?

11 MS. AYOADE: Maryann Ayoade, Medical 12 Radiation Safety Team.

13 MR. EINBERG: Okay. Thank you. Members 14 of the public who notified Ms. Jamerson that they 15 would be participating on the teleconference will be 16 captured in the transcripts. Those of you who did 17 not provide prior notification, please contact Ms.

18 Jamerson at kellee.jamerson@nrc.gov, and that's K-E-19 L-L-E-E dot J-A-M-E-R-S-O-N at nrc.gov, or at (301) 20 415-7408.

21 We have a bridge line available, and that 22 phone number is (888) 790-6447. The passcode to 23 access the bridge line is 3279476#. Once again, 24 3279476#.

25 12 This meeting is also using the 1 GoToWebinar application to view the presentation 2 handouts real time. Hopefully, we are getting that 3 up. 4 Maryann, have you been able to get that 5 going? 6 MS. AYOADE: Yes. It's up and running.

7 MR. EINBERG: Okay. Thank you so much.

8 MS. AYOADE: If anyone on the line can't 9 see it, let me know.

10 MR. EINBERG: And you can access the 11 webinar by going to www.gotowebinar.com and searching 12 for meeting ID 657537587. Once again, that's 13 657537587.

14 The purpose of this meeting is to discuss 15 the draft report of the ACMUI Training and Experience 16 Requirements for All Modalities Subcommittee. In its 17 report, the subcommittee provides recommendations 18 with respect to the T&E requirements for all 19 modalities under 10 CFR Part 35, Medical Use of 20 Byproduct Material, with specific focus on Part 21 35.300 uses.

22 Individuals who would like to ask a 23 question or make a comment regarding a specific issue 24 the Committee has discussed should dial star one to 25 13 signal the operator that you wish to speak. Please 1 clearly state your first and last name for the record.

2 Comments and questions are usually addressed by the 3 Committee near the end of the presentation after the 4 Committee has fully discussed the topic. We will 5 notify the operator when we are ready for the public 6 comment period of the meeting.

7 I would also like to add that the handouts 8 and agenda for this meeting are available on the NRC's 9 public website.

10 At this time, I ask that everyone on the 11 call who is not speaking to place their phones on 12 mute. If you do not have the capability to mute your 13 phone, please press star six to utilize the conference 14 line mute and unmute functions.

15 I would also like to ask everyone to 16 exercise extreme care to ensure that background noise 17 is kept at a minimum as any stray background sounds 18 can be very disruptive on a conference call this 19 large. 20 At this point, I would like to turn the 21 meeting back to Dr. Palestro.

22 CHAIR PALESTRO: Thank you, Mr. Einberg.

23 This is Dr. Christopher Palestro, Chair of the ACMUI, 24 and I will now turn the meeting over to Dr. Darlene 25 14 Metter, who chairs the Subcommittee for Training and 1 Experience for All Modalities for presentation of the 2 subcommittee's report. Dr. Metter?

3 VICE CHAIR METTER: Thank you, Dr.

4 Palestro, and thank you for letting us use this 5 conference call to present our Subcommittee report.

6 And before I start, I would like to thank the work by 7 Subcommittee members Dr. Ronald Ennis, Dr. Robert 8 Schleipman, Mr. Michael Sheetz, Ms. Megan Shober, and 9 Ms. Laura Weil.

10 While I present this presentation for our 11 document that we submitted, you will have slides that 12 will help point out the key points of this document.

13 The Subcommittee charge. In 2016, the 14 U.S. NRC ACMUI's Subcommittee on Training and 15 Experience Requirements for All Modalities was 16 charged to periodically review the training and 17 experience requirements for the medical use of 18 unsealed byproduct material under Title 10, Code of 19 Federal Regulations, Part 35, Subparts D to H, to 20 make recommendations for changes as needed.

21 Subcommittee subcharge. The Subcommittee 22 should reprioritize its work such that the review of 23 the T&E requirements for 10 CFR 35.300, Uses, is 24 conducted prior to the review of the T&E requirements 25 15 for 10 CFR 35.200. As part of the reprioritized work, 1 and in light of the NRC's tasking, the Subcommittee 2 should consider the development of a limited scope AU 3 pathway. 4 Now I will review some of the background.

5 In March 2016, the ACMUI held a public teleconference 6 meeting to discuss the report of the Subcommittee on 7 the Training and Experience Requirements authorized 8 users of alpha, beta, and gamma emitters under 10 CFR 9 35.390. 10 During this teleconference meeting, the 11 Committee unanimously endorsed the subcommittee's 12 report and recommendations, which included 13 maintaining the existing 700-hour training and 14 experience requirements also termed the alternate 15 pathway. 16 Additionally, it was recommended that a 17 separate subcommittee be formed to conduct periodic 18 reviews of the training and experience requirements 19 for all modalities under 10 CFR Part 35.

20 The subcommittee developed a data-driven 21 standardized review template that would provide a 22 comparative format for future review and 23 reassessment. To optimize this review process, the 24 subcommittee intended to begin the review with 25 16 35.100, followed by 35.200, 35.300, and so on. The 1 subcommittee completed its review of 10 CFR 35.100 2 with no suggested revisions.

3 However, because of ongoing concerns 4 about patient access to unsealed byproduct material 5 for which a written directive is required, the 6 subcommittee was directed to review the T&E 7 requirements for 10 CFR 35.300 before reviewing 8 35.200. 9 In August 2017, the Commission voted on 10 the 10 CFR Part 35 rulemaking package and included 11 direction to the NRC staff to review 10 CFR 35 Subpart 12 E and evaluate the possibility of tailored training 13 and experience with different categories of 14 radiopharmaceuticals, delineate how these categories 15 would be created, recommend the appropriate training 16 and experience requirements, and whether these 17 requirements would be satisfied based on hours of 18 training or would require a formal assessment of 19 competency.

20 In January 2018, the U.S. Food and Drug 21 Administration approved a therapeutic 22 radiopharmaceutical, lutetium-177 dotatate, with the 23 potential for greater use than previously approved 24 therapeutic radiopharmaceuticals.

25 17 In addition, there was a decrease in the 1 first-time candidates sitting for the American Board 2 of Nuclear Medicine or the ABNM certification exam.

3 These two observations raised concerns about a 4 potential authorized user or AU shortage in the 5 future. Thus, the ACMUI proposed the reconsideration 6 of an alternate AU pathway for 10 CFR 35.390.

7 Now, what I'll do is give the 8 Subcommittee review, comments, and recommendations, 9 and this was divided into three topics. The first 10 topic is a potential AU shortage. To address concerns 11 about a potential future shortage of AU, the 12 subcommittee reviewed the current pathways for AU 13 certification.

14 Traditionally, nuclear medicine, nuclear 15 radiology, diagnostic radiology, and radiation 16 oncology graduates of Accreditation Council for 17 Graduate Medical Education, or ACGME, approved 18 residencies, seek board certification; and, hence, 19 authorized user status, by the NRC-deemed Status 20 Boards with the American Board of Radiology, ABR; 21 Nuclear Medicine, ABNM; and Osteopathic Radiology.

22 In 2016, the ABR supported a redesigned 23 AU eligibility pathway consisting of 16 months of 24 nuclear radiology or nuclear medicine training 25 18 incorporated into the 48-month or four-year ACGME-1 accredited diagnostic radiology residency.

2 This revised program is a redesigned ABR 3 pathway and would satisfy the NRC's training and 4 experience requirements for 10 CFR 35.390 via the 5 alternate pathway.

6 Upon completion of the radiology 7 residency, the graduate trainee is then eligible to 8 sit for the board certification exams for the ABR in 9 nuclear radiology and/or the ABNM.

10 Now, to explore the concern for potential 11 AU shortage, the Subcommittee reviewed the 2018 and 12 2019 ACGME website, which provided the following 13 information on the current number of potential future 14 AUs in training. And the slide you have listed the 15 total number of residents in training and the 16 estimated graduates per year. The first is nuclear 17 medicine, which has 40 programs. The peculiar aspects 18 about that residency is that it has a one-, two-, and 19 three-year pathway, with the one-year pathway taken 20 by radiologists, which are the majority of the total 21 residents.

22 So the number 79 is the total number of 23 residents currently in training with an estimate of 24 approximately 50 graduates, 40 to 50 graduates per 25 19 year. 1 For nuclear radiology, total residents 2 11, with 11 graduates per year. The redesigned 3 pathway, which has -- I just went over -- currently 4 has 56 residents, and the graduates won't be coming 5 up for a few more years because this just started 6 about a year or so ago. So when it does mature, it 7 will be approximately with this current number of 14 8 per year, but likely it is likely to increase in 9 number. 10 Radiation oncology, 775 total residents 11 with 194 graduates per year. The diagnostic radiology 12 and osteopathic radiology residents are large in 13 number, with certain graduates per year. However, 14 the majority of them do not satisfy 35.390 15 qualifications.

16 So in the current pipeline for AUs in 17 training for 35.390, it's over 900, which includes 18 trainees in nuclear medicine, nuclear radiology, 19 diagnostic radiology, and radiation oncology. As of 20 2018, the ABNM reported 3,591 practicing ABNM 21 diplomates. And along with the current practicing 22 authorized users, the nearly 270 annual 35.390 AU 23 graduates, and counting for the retiring AUs, the 24 Subcommittee concluded that there is no objective 25 20 data to support an authorized user shortage at the 1 present time.

2 And if you think about it, if you have 3 about 250, 270 graduates per year in the next four 4 years, you will add another 1,000 AUs for 35.390.

5 Topic 2, the limited scope AU pathway.

6 Although there is no evidence that there is a current 7 AU shortage, there is the likelihood that the number 8 of available therapeutic radiopharmaceuticals, and 9 the demand for these therapies will increase. The 10 subcommittee explored whether the NRC should consider 11 developing a limited scope AU pathway tailored to 12 specific radiopharmaceuticals.

13 Radionuclide therapy possesses the 14 highest risk and the highest impact of all nuclear 15 medicine procedures. And if dosages are not properly 16 handled or administered, these therapies can cause 17 unintentional, serious organ or tissue injury. The 18 newer therapeutic radionuclides have become 19 increasingly more complex administrations. And with 20 the potential for multi-organ or tissue toxicities, 21 and, hence, this requires a basic competency in 22 radiation therapy and radiation safety.

23 A potential limited scope AU pathway for 24 radionuclide therapy must ensure that the basic 25 21 knowledge topics in 10 CFR 35.390 are obtained thereby 1 obtaining an equivalent level of therapeutic 2 competency and competency in radiation safety.

3 When investigating the feasibility of a 4 limited scope AU pathway for 10 CFR 35.390, the NRC 5 staff, with ACMUI input, proposed a list of required 6 basic knowledge topics for AUs involved in 7 radionuclide therapy. The proposed curriculum began 8 with the knowledge topics of 10 CFR 35.390.

9 But due to the complexity and overlap of 10 these basic knowledge topics, the Subcommittee 11 concluded that it is not feasible to tailor the T&E 12 requirements for a limited scope authorized user for 13 each specific radiopharmaceutical, nor is it feasible 14 to create categories for specific therapeutic 15 individual radionuclides because each such category 16 would encompass nearly all of the knowledge topics in 17 10 CFR 35.390.

18 The NRC staff, with external stakeholder 19 input from the medical community, and the 20 Subcommittee, agreed that the knowledge topics in 10 21 CFR 35.390 are the basic minimum knowledge required 22 for any radionuclide therapy.

23 In considering the above, the 24 subcommittee does not recommend a limited scope AU 25 22 pathway for radionuclide therapy requiring a written 1 directive. Unlike the iodine I-131 sodium iodide, 2 limited scope authorized user, under 10 CFR 35.392 3 and 35.394, which are for endocrinologists, the 4 emerging radionuclide therapies have multiple 5 contraindications and more toxicities versus the I-6 131 sodium iodide, which is specific to one organ, 7 the thyroid gland for thyroid therapy.

8 It would be too cumbersome to develop and 9 provide oversight for specific training and 10 experience requirements within the regulations to fit 11 each radionuclide therapy. All of the classroom 12 laboratory training areas and work experience topics 13 contained in 35.390 are applicable to any 14 radionuclide therapy and are essential for radiation 15 safety of the patient, personnel, and public.

16 It would be difficult in defining a 17 limited scope authorization and what radionuclides or 18 radiopharmaceuticals are to be included. Each 19 therapeutic radiopharmaceutical has unique radiation 20 safety issues, which require a comprehensive 21 understanding of all of the training and experience 22 topics in 35.390, regardless of the types of radiation 23 emissions, chemical properties, or mode of 24 administration.

25 23 During a public NRC meeting held on 1 December 11, 2018, a novel team approach was proposed 2 where an onsite authorized nuclear pharmacist, or 3 ANP, would prepare the radionuclide for therapy and 4 handled the radiation safety components, while the 5 limited scope authorized user would administer the 6 patient-ready dose and manage patient care.

7 The perceived benefits of an AU 8 partnership should be carefully reviewed. Although 9 well intended, a fragmented approach to a therapeutic 10 procedure can have the unintended consequence of 11 making things worse. Furthermore, if an onsite ANP 12 or authorized nuclear pharmacist is available, a 13 fully trained authorized user is also likely 14 available for the entire radionuclide therapies, 15 which are generally not on an emergent basis.

16 There are also fewer authorized nuclear 17 pharmacists than authorized users, and authorized 18 nuclear pharmacists are generally concentrated, as 19 are authorized users, in urban and not-rural areas.

20 The safe and effective administration of 21 radionuclide therapy is best accomplished by a 22 comprehensively trained physician authorized user who 23 is responsible for the entire therapeutic procedure 24 and who has a thorough knowledge and understanding of 25 24 the therapy, to include the various factors and 1 potential toxicities and serious hazards that can 2 occur to the patient, the personnel, and the public.

3 Topic 3, competency assessment for the 4 limited scope authorized user pathway. In the initial 5 limited stakeholder outreach, the majority of 6 respondents favored using an examination to confirm 7 the successful acquisition of 10 CFR 35.390 outreach 8 topics and to confirm the individual's competency to 9 independently function as comprehensive or limited 10 scope authorized user under 10 CFR 35.390. It is 11 also critical to validate that the proposed 12 curriculum was successfully attained.

13 For this confirmation and proficiency, 14 the NRC staff and the subcommittee agree that a 15 competency assessment is necessary. This assessment 16 should not be based on hours or preceptor 17 attestations, but, rather, on an initial and 18 continued competency evaluation over time.

19 The subcommittee supports broader input 20 from the medical community to create an AU competency 21 assessment with final approval by the NRC. The 22 subcommittee further supports the periodic 23 reassessment of authorized user competency, 24 particularly in relation to the frequent or 25 25 infrequent performance of radionuclide therapy. This 1 infrequency concept has raised similar concerns in 2 board certification/ recertification process, and the 3 recertification process is generally seven to ten 4 years between recertification exams.

5 The American Board of Medical 6 Specialties, or the ABMS, is a nonprofit organization 7 of 24 medical specialty boards which serves the public 8 in quality health care through professional and 9 educational standards. And the ABMS has supported a 10 program of continuing professional certifications for 11 physician lifelong learning and self-assessment.

12 The American Boards of Radiology and 13 Nuclear Medicine are ABMS member boards. And to 14 promote continued professional competency for their 15 diplomats, the ABR and ABNM have transitioned to or 16 are transitioning to this continuous longitudinal 17 assessment.

18 In regards to radionuclide therapy, this 19 infrequency concept and procedure performance was 20 also reviewed by the subcommittee. Because of the 21 ability to eliminate and destroy tissue, therapeutic 22 radionuclide procedures pose a much higher risk to 23 the patient, personnel, and public than do diagnostic 24 procedures. The potential for limited scope AUs, and 25 26 the higher likelihood that the infrequent performance 1 for radionuclide therapy in rural areas would make it 2 difficult for physicians to retain basic AU 3 competency in radionuclide therapy.

4 To attest to the successful acquisition 5 of the authorized user knowledge topics in 10 CFR 6 35.390, the overall limited stakeholder input and the 7 subcommittee support a formal competency 8 certification and a continuous certification process.

9 The goal of certification is to validate 10 that an authorized user candidate has achieved a 11 predetermined level of competence, and the current -

12 - this certification is to confirm the acquisition of 13 a basic knowledge curriculum and the ability to 14 independently function as an authorized user for 15 specific radionuclide therapy or therapies.

16 Although the subcommittee does not 17 recommend adoption of a limited scope AU pathway for 18 therapy, if the NRC pursues such a pathway, the 19 subcommittee strongly recommends an initial formal 20 competency assessment and competency reassessment 21 with ongoing longitudinal reassessment with specific 22 emphasis on radiation safety.

23 The entity or entities that will 24 administer this formal competency assessment and 25 27 reassessments must develop a methodology that ensures 1 that passing these examinations is empirically 2 determined. This latter aspect is the Angoff Method, 3 which is a widely used standard in test development 4 and creates a test that will be legally defensible 5 and meet the standards for educational and 6 psychological testing.

7 So, in summary, the ACMUI Subcommittee on 8 Training and Experience Requirements for All 9 Modalities addressed the NRC staff request to assess 10 the feasibility of a limited scope authorized user 11 pathway for 10 CFR 35.390, which was initially 12 predicated on the concern about a potential future 13 shortage of authorized users.

14 At the present time, there are no 15 objective data to support an authorized user 16 shortage. The subcommittee does not recommend the 17 development of a limited scope AU pathway for the 18 administration of unsealed byproduct material where 19 a written directive is required.

20 If the NRC moves forward in pursuing an 21 alternative limited scope authorized user pathway, 22 the subcommittee strongly recommends that the limited 23 scope authorized user must successfully acquire the 24 knowledge topics in 10 CFR 35.390, which would be a 25 28 minimum requirement for all authorized users involved 1 in radionuclide therapy.

2 The subcommittee also conclude that due 3 to the complexity and overlap in these basic knowledge 4 topics, it would be difficult to safely and 5 practically create specific categories for 6 therapeutic radiopharmaceuticals.

7 Despite the ACMUI Subcommittee 8 recommendation against this action, if the NRC 9 chooses to pursue the creation of a limited scope 10 authorized user pathway for unsealed byproduct 11 material where a written directive is required, the 12 subcommittee strongly recommends that the authorized 13 user candidate must acquire the basic knowledge 14 topics in 10 CFR 35.390 and satisfactorily complete 15 a formal competency assessment.

16 Furthermore, the individual's continued 17 status as a limited scope authorized user is dependent 18 on successfully maintaining a formal periodic 19 reassessment of competency. This final and most 20 critical component, and the attainment and 21 maintenance of any authorized user status, will 22 optimize patient care while ensuring the protection 23 of the public's health and safety.

24 So the Subcommittee position and four 25 29 recommendations are the following. First, the 1 subcommittee strongly supports and reaffirms the 2 committee's 2016 position on maintaining the current 3 and existing authorized user pathway, which are the 4 board certification and alternate pathways as 5 codified in the regulations, which are adequate for 6 protecting public health and safety. Radionuclide 7 therapy poses the highest risk and the highest impact 8 of all nuclear medicine procedures.

9 Two, the Subcommittee concludes that 10 there is no objective data to confirm an authorized 11 user shortage.

12 Three, the Subcommittee does not 13 recommend a limited scope authorized user pathway for 14 unsealed byproduct material for which a written 15 directive is required.

16 And, four, the Subcommittee unanimously 17 agrees that in order to ensure the safety of patients, 18 personnel, and the public, if the NRC chooses to 19 pursue the creation of a limited scope authorized 20 user pathway for unsealed byproduct material, where 21 a written directive is required, the authorized user 22 candidate must acquire the basic knowledge topics in 23 10 CFR 390 and satisfactorily complete a formal 24 competency assessment.

25 30 Furthermore, the individual's continued 1 status as a limited scope authorized user is dependent 2 on successfully maintaining a formal periodic 3 reassessment of competency.

4 And that is the end of my report, and, 5 Dr. Palestro, I turn the meeting over to you.

6 CHAIR PALESTRO: Thank you, Dr. Metter.

7 This is Dr. Palestro again. I now open this report 8 to comments by members of the Subcommittee.

9 MEMBER DILSIZIAN: Vasken here. Great 10 presentation, Dr. Metter. I guess, to me, I'm just 11 going to summarize, if I get this correctly, what we 12 are proposing is to maintain the current AU pathway 13 training for 35.390. And not only maintain it, but 14 add not just training based on hours and attestation 15 alone, but additional competency assessment in this 16 formal test that would be concluding in a certificate, 17 which would be maintained subsequently by some number 18 of years where you have to be recertified. Is that 19 -- would that be the conclusion then?

20 VICE CHAIR METTER: That would be a 21 recommendation right now. The subcommittee was 22 looking at the feasibility of a limited scope 23 authorized user pathway. And these are some of the 24 recommendations we would make, and that would have to 25 31 be for a future subcommittee investigation.

1 MEMBER DILSIZIAN: Thank you.

2 CHAIR PALESTRO: Any other comments from 3 members of the subcommittee?

4 MEMBER SHEETZ: This is Mike Sheetz. I 5 have a comment.

6 CHAIR PALESTRO: Go ahead, Mr. Sheetz.

7 MEMBER SHEETZ: I want to thank Dr. Metter 8 for pulling all of this together. I have a couple of 9 comments. One, in consideration of the limited scope 10 AU/ANP partnership, while the ANP could help as an 11 RSO, we feel that the AU must have a comprehensive 12 knowledge and understanding of the entire therapeutic 13 procedure.

14 This includes all of the radiation safety 15 issues associated with the procedure from package 16 receipt, dose assay surveys, radioactive waste 17 disposal, instrument QA, radiation safety training, 18 personal monitoring, and others.

19 In the United Pharmacy Partners AU/ANP 20 partnership proposal, there was no delineation of 21 tasks of who would be responsible for the aspects of 22 this therapy. You know, would the ANP be physically 23 present during the administration of the procedure?

24 Would they be onsite for a person to do special 25 32 surveys and waste disposal?

1 So the details of the shared 2 responsibility have not been addressed, so it's 3 difficult to make a determination of whether it is 4 really feasible. While there was a team approach 5 with other types of radiation therapy and medical 6 uses, such as the Y-90 microsphere therapy, gamma 7 radiosurgery, radioactive seed localization, the AU 8 really is knowledgeable in all of the areas and 9 supervises the other team members.

10 In one of the United Pharmacy Partners' 11 letters, they say that this limited scope AU status 12 is only being requested for alpha and beta therapies 13 and not high-risk materials. I feel this, in itself, 14 is just a limited understanding of the radiation 15 physics and radiation safety associated with all 16 radiopharmaceuticals used for therapy.

17 Most of these radionuclides also emit 18 photons, gamma rays, or X-rays, you know, very strong, 19 and the alpha and/or beta particles also present a 20 radiation risk, you know, if not handled or 21 administered properly.

22 In my personal experience here at the 23 University of Pittsburgh Medical Center, before the 24 FDA approval of Lutathera, we were one of the only 25 33 sites in the western PA region who offered this 1 therapy. At that time, we had quite a few referrals 2 that came from distant locations, roughly 40 percent.

3 However, now a year after FDA approval, we don't get 4 those referrals. Almost all of our patients are from 5 the local area.

6 Also, our volumes have plateaued and 7 slowly dipped as many patients have been -- who have 8 been waiting for the therapy have received their 9 treatments. The point is, patients travel to get 10 medical care. Another important factor that needs to 11 be considered is that the lack of Lutathera 12 availability in many places is not because of an end 13 use shortage but the reluctance of many hospitals or 14 clinics to do Lutathera therapy because of its upfront 15 cost, which is upwards of $200,000 per patient in 16 drug cost for the four treatment, which obviously can 17 easily break the bank for smaller community entities, 18 even with one or two insurance ties.

19 In addition, the manufacturer of 20 Lutathera, AAA, if necessary with their applications, 21 if selective and a good institution, it will help set 22 up a program based somewhat on the expected volume of 23 patients.

24 So I believe the core program on 25 34 availability is really the extremely high cost of 1 these drugs and not the availability of AUs.

2 Thank you.

3 CHAIR PALESTRO: Thank you, Mr. Sheetz.

4 Any other comments from members of the 5 Subcommittee? Ron?

6 MS. HOLIDAY: Dr. Ennis, before you speak 7 -- this is Sophie Holiday -- for everybody else on 8 the phone, I just want to let you know that the 9 information that Mr. Sheetz was referring to was a 10 letter submitted to the NRC on February 20th from 11 UPPI, and that comment letter will be made publicly 12 available when it is appended to the meeting 13 transcript as part of the official record.

14 Thanks. I'll turn it back to you now, 15 Dr. Ennis.

16 MEMBER ENNIS: Thank you. Just kind of 17 a reflection. In these recommendations that people 18 have put forward, I see a very lack of the 19 understanding of the biological issues surrounding 20 radiotherapy and the complications thereof.

21 There seems to be some kind of implicit 22 understanding or -- that these are trivial drugs that 23 anyone can learn how to do, and it's just a technical 24 application and a technical issue of this injection 25 35 rather than understanding the complex biology and how 1 radiation interacts with a variety of tissues.

2 Its interaction with each tissue is 3 unique. The complications that can cause -- that it 4 can cause, both acutely and chronically, are unique.

5 It's a level of subspecialization that [inaudible], 6 the full education, has listed in the listing of 7 topics. To imply otherwise would be somewhat similar 8 to suggesting that a primary care doctor could do 9 chemotherapy. The analogy is really quite similar, 10 but obviously possible.

11 Thank you.

12 CHAIR PALESTRO: Thank you, Dr. Ennis.

13 Any other comments from members of the 14 subcommittee?

15 MEMBER WEIL: Yes, please. This is Laura 16 Weil. 17 CHAIR PALESTRO: Go ahead, Ms. Weil.

18 MEMBER WEIL: The primary role of 19 regulation is to ensure safety. And it's true that 20 the -- that regulation can limit access to some people 21 who can't travel for care, and that is a legitimate 22 barrier. However, it's not a question of whether 23 those barriers exist. It's more a question of whether 24 the regulatory standards that create those barriers 25 36 are unnecessarily restrictive or ethically 1 responsible -- or nor is it the role of the regulator 2 to attempt to increase access by compromising 3 necessary safeguards that protect patients, their 4 families, health care providers, and the public.

5 Thank you.

6 CHAIR PALESTRO: Thank you, Ms. Weil.

7 Any other comments from other members of 8 the Subcommittee? Comments from members of the ACMUI?

9 MEMBER MARTIN: This is Melissa Martin.

10 Again, I would like to refer to the letter that was 11 submitted from the UPPI. A couple of comments after 12 reviewing that letter. As presented earlier, one of 13 the requests was that we look at the distribution of 14 authorized -- number of authorized users and the 15 geographic distribution.

16 In the letter from the UPPI, they 17 suggested that there would be a better geographic 18 distribution of nuclear pharmacists than there would 19 be of authorized users. Again, there has been no 20 data submitted to support that statement. I think we 21 would need to see some kind of data that shows where 22 the nuclear pharmacist would be distributed.

23 I know the NRC is working on collecting 24 the data for where the authorized users are located.

25 37 But, again, if we have 4,000 authorized users, I think 1 there is a better geographic distribution already. I 2 think -- my impression is most of those authorized 3 users are connected to relatively moderate to large 4 size cities, and the patients -- again, that was 5 stated earlier -- the ones that live in the rural 6 areas are used to traveling and getting 7 accommodations to get their therapy.

8 So I don't see that that has been a big 9 -- I don't think that is the impediment to receiving 10 some of these treatments.

11 The proposal is that it would increase 12 access to the rural access -- rural areas, but there 13 has been no proposed limitation on these procedures 14 being performed by the team approach, limited to the 15 rural areas. So it would assume that a lot of these 16 procedures would be performed in the same geographic 17 mid-to-large sized cities that is currently being 18 performed.

19 So I don't see that that would -- I don't 20 understand how that would be restricted to rural 21 access. 22 One of the other questions I had was, 23 what is meant by minimally trained physician that 24 would be administering the isotope in the proposed 25 38 team approach? Thank you very much.

1 CHAIR PALESTRO: Thank you, Ms. Martin.

2 Any other comments from the ACMUI?

3 MEMBER GREEN: Dr. Palestro?

4 CHAIR PALESTRO: Yes.

5 MEMBER GREEN: This is Richard Green.

6 CHAIR PALESTRO: Yes, Mr. Green. Go 7 ahead. 8 MEMBER GREEN: The Subcommittee's 9 position and recommendations are four bullets on the 10 document. The last bullet says that the Subcommittee 11 unanimously agrees, in that fourth bullet. Were the 12 three prior bullets unanimous decisions?

13 VICE CHAIR METTER: This is Darlene. Yes, 14 the Subcommittee -- actually, every member was given 15 the document and they all agreed and we could actually 16 add that, too, unless there is -- I misunderstood the 17 Subcommittee, and that when they submitted their 18 comments they did not agree, but I -- they did not 19 relate that, but we wanted to make an emphasis on 20 that last point because that is a very important 21 point. 22 I mean, they're all important, but that 23 was a key component in assessing the competency of 24 the individual who is going to be an authorized user.

25 39 And can I just ask the Subcommittee, was 1 that correct or was it -- I mean, is that a correct 2 reflection of our decision?

3 PARTICIPANT: Absolutely.

4 MEMBER SCHLEIPMAN: Robert Schleipman. I 5 totally agree. I think we all -- including for 6 myself, I fully agree with the recommendations.

7 PARTICIPANT: Yes, it was unanimous from 8 our discussions.

9 VICE CHAIR METTER: Thank you.

10 MEMBER GREEN: Thank you, Dr. Metter.

11 Another question I have. I agree completely that the 12 requirements for complete knowledge of all aspects of 13 10 CFR 35.390 are required for any physician who 14 administers radionuclide therapy. I don't think 15 there is any ability to skimp on that full, complete 16 knowledge.

17 It is my understanding that during the 18 course of training through one of the approved 19 pathways to become a diplomate in nuclear medicine, 20 nuclear radiology, radiation oncology, or diagnostic 21 radiology, that that training period encompasses more 22 than the 10 CFR 35.390.

23 Can you give an estimate of what time is 24 spent on 35.200 and other nuclear medicine 25 40 techniques, imaging, uptake, dilution, and excretion, 1 other than radionuclide therapy?

2 VICE CHAIR METTER: Well, they have -- as 3 far as it's all incorporated into 48 months of 4 diagnostic radiology. But looking at the authorized 5 user status, we are really mainly just looking at the 6 equivalent training and experience requirements for 7 35.390, which is for the use of unsealed sources for 8 therapy and not for imaging and localization or 9 dilution and excretion.

10 MEMBER GREEN: Yeah. I thought the 11 charter --

12 VICE CHAIR METTER: Yeah. I'm sorry.

13 The other thing, too, we're not looking at hours. As 14 I mentioned in the report, we're not looking at hours.

15 We're looking at level of competency and ability to 16 acquire that knowledge and use that knowledge safely 17 for our patients.

18 MEMBER GREEN: All right. I'm just trying 19 to -- you know, I thought the challenge to the 20 Subcommittee was to discern in the training and 21 experience for all modalities. And so this is what's 22 required to successfully do 35.200, 35.100, 35.300 23 applications for radiopharmaceuticals.

24 And I -- I think I am seeing a resounding 25 41 support of the existing pathway, but I don't really 1 think I see a dissection of really what training and 2 education is required for this 35.300 versus 35.200 3 versus 35, you know 100. And that's what I thought 4 was the charge to the Committee -- to the 5 Subcommittee.

6 VICE CHAIR METTER: Mr. Green, the 7 Subcommittee is supposed to look at 35.300, but this 8 specific report addresses 35.390 and not the entire 9 35.300. 10 MEMBER GREEN: Thank you.

11 VICE CHAIR METTER: And that is 12 throughout the report, by the way.

13 MEMBER DILSIZIAN: Vasken here. Can I 14 have a comment?

15 VICE CHAIR METTER: Yes.

16 MEMBER DILSIZIAN: So, Dr. Metter, you 17 know, I think I know what you're intending to say, 18 but looking at this slide, and then in your statement 19 when you say, We are not looking for our self-20 competency. I think what you wanted to say is, we're 21 not just looking for hours and attestation alone, but 22 an added competency assessment.

23 I think that it's important to just say 24 -- because the way it comes out both in the slide and 25 42 your verbal statement, that if there is no minimum 1 hours1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br />, I think we -- we will understand there has got 2 to be some number of hours of training, and then it 3 falls with the competency test. Is that correct, 4 what I'm hearing, because that's not very clear.

5 VICE CHAIR METTER: No. Exactly what I 6 said, that we are not looking at hours because hours 7 can be -- it's different for different individuals.

8 We're looking at the final result.

9 It's sort of like -- I believe I made the 10 same analogy during our meeting last year in the sense 11 of if you -- if you are taking your driver's license 12 -- you wanted to obtain a driver's license, and the 13 way you obtain it is -- the final result is going to 14 be the driver's license.

15 And whether you obtain it by going to a 16 driving school or going to a course with your parents 17 or with a different individual, if you -- if you learn 18 the basic requirements and the basic fundamental 19 knowledge and experience that you need to pass an 20 exam to get your certification, is what this is 21 implying. This is a new pathway in the 22 sense, if it's a limited scope, it's not like a 23 traditional one that we've done before. So I think 24 we need to really look at it very seriously because 25 43 hours can be, you know, different for your number of 1 training hours. You can learn quicker than I can, 2 but I want to know the final result, that you are a 3 competent individual for the administration of the 4 radiopharmaceutical therapy for the patient and for 5 those involved with -- and the public.

6 And so, to me, the final result is that 7 you are able to do what is needed for our patients.

8 MEMBER DILSIZIAN: Well, the problem I 9 guess I have is that any ACGME training program, where 10 you're doing internal medicine, you're doing 11 radiology, or radiation oncology, has, first, a 12 minimum number of years of training or hours of 13 training for/by board certification.

14 You can't possibly ignore the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> 15 requirement, plus competency. This is what you -- or 16 what I'm hearing you say is that let's forget about 17 the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />. Some people can do it in 50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br />, as 18 long as they pass the test, and I'm having trouble 19 with that. I think my recommendation would be to 20 maintain a certain number of hours, years, or whatever 21 it takes for an average person to be trained for/by 22 a competency test. Otherwise, I think that 700 --

23 what you are proposing, 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, doesn't mean 24 anything. Maybe someone can do it in 50 hours5.787037e-4 days <br />0.0139 hours <br />8.267196e-5 weeks <br />1.9025e-5 months <br />.

25 44 VICE CHAIR METTER: I understand what 1 you're saying.

2 CHAIR PALESTRO: Dr. -- I'm sorry, Dr.

3 Dilsizian?

4 MEMBER DILSIZIAN: Yes.

5 CHAIR PALESTRO: Yeah. Hi. Dr. Palestro 6 speaking now. At this point, your comments are sort 7 of moot because the Subcommittee has recommended 8 against the creation of the limited scope authorized 9 user status.

10 But going back a bit -- and do you 11 remember this -- this committee and these discussions 12 have been evolving over time. The concept was to --

13 if and when a program is -- a limited AU program is 14 in fact developed, to develop and to create a 15 curriculum, if you will, with all of the competencies 16 that need to be met, and then after that to go back 17 and determine hours that would be required to complete 18 it, because as I think we all agree at this point, we 19 have no idea how the 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> was arrived at.

20 And so rather than focusing on hours, the 21 concept would have been develop a program, make sure 22 it has all of the elements necessary to educate and 23 to develop a competent AU, and then after that figure 24 out how to -- how to translate that into hours.

25 45 MEMBER DILSIZIAN: So, again, I guess I 1 just wanted to -- I think Mr. Green said this before 2 me. I guess I would have expected the subcommittee 3 to actually designate some hours to the current 4 curriculum that would sum up to some number that may 5 be 700 or 500 or 550, so that we can be reassured, as 6 would be the NRC staff, that these numbers are in the 7 cost ballpark of what it would take for someone to be 8 adequately trained.

9 CHAIR PALESTRO: Dr. Metter, would you 10 like to respond to that?

11 VICE CHAIR METTER: I would defer to you.

12 CHAIR PALESTRO: Thank you, Mr. Metter.

13 VICE CHAIR METTER: Anytime.

14 CHAIR PALESTRO: The answer is, again, I 15 think right now for the moment it is a moot point, 16 since the subcommittee has recommended against it.

17 Should the NRC decide to go forward with it, as the 18 subcommittee has indicated, they clearly would like 19 the opportunity to actively participate in the 20 development of such a program.

21 MEMBER GREEN: Dr. Palestro?

22 CHAIR PALESTRO: Yes.

23 MEMBER GREEN: This is Mr. Green again.

24 So with the recommendation not at this time to do a 25 46 limited AU status, will the subcommittee, or the 1 committee as a whole, take the challenge, as Dr.

2 Dilsizian has asked, to actually dive into the concept 3 and figure out how many hours -- what does it take to 4 learn this concept, that concept, this fact, this 5 methodology, so that we can actually better 6 substantiate that engraved-in-stone sort of -- we 7 don't know where it came from, but if we are asked by 8 staff or by the Commissioners to develop other 9 pathways or to validate the existing pathway, are we 10 going to be going through the exercise?

11 CHAIR PALESTRO: The answer is, when the 12 subcommittee was originally formed -- and, in fact, 13 if you look at the title of the subcommittee -- it is 14 training and experience for all modalities. And the 15 concept was -- and as Dr. Metter enumerated in her 16 report, we developed a template. We looked at 100, 17 and our plan was to go to 200, and then 300, but we 18 were -- or the subcommittee, I should say, was 19 redirected to focus on 390.

20 So the answer is, the concept for the 21 subcommittee is at some point to return to its 22 original charge and begin to look at the various 23 categories. And I would presume that the subcommittee 24 will take into account hours and necessary, for lack 25 47 of a better term, items that individuals need to be 1 knowledgeable in.

2 MEMBER GREEN: Dr. Metter, you are 3 currently the chair of the subcommittee. Would you 4 agree with that?

5 VICE CHAIR METTER: Yes, Dr. Palestro, I 6 do. And I also think, as far as if we do look back 7 at how these 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> were obtained, it may actually, 8 with the increasing complexities of the radionuclides 9 that are coming out for therapy, that the -- we're 10 assuming that the hours are going to decrease.

11 The hours may -- we don't know what the 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> will do. They may actually increase because 13 you now have to know more about what -- about the 14 newer therapies and their toxicities and adverse 15 effects and effects on the patient and their -- and 16 the long-term consequences.

17 So that would be something we'd have to 18 look at. But at this point in time, I don't think we 19 are looking at that because, as you said, we did not 20 support a limited scope AU pathway.

21 CHAIR PALESTRO: Thank you, Dr. Metter.

22 Any other comments from the ACMUI?

23 MEMBER DILSIZIAN: Vasken here. I just 24 want to go on the record just to kind of let us know 25 48 that despite -- I agree with all of what was stated 1 so far. It would have been nice to have an 2 approximation of the hours dedicated to the current 3 required training -- current, not the -- not the 4 shortened pathway.

5 That would be close to 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br />, and so 6 it would then reassure all of us on this call, as 7 well as the NRC Commissioners and the staff, that we 8 are not that far apart from what is currently 9 required.

10 CHAIR PALESTRO: Thank you, Dr.

11 Dilsizian. But, again, I just want to point out that 12 was not the charge or the subcharge that was given to 13 the subcommittee.

14 Any other comments/questions from the 15 ACMUI? 16 MEMBER OUHIB: Yes. This is Zoubir Ouhib.

17 My comment is really we seem to be focusing a little 18 bit on the numbers, and I'm a little bit concerned 19 about that because, really, going back and seeing 20 what it takes in -- you know, on the big picture, you 21 know, in terms of patient evaluation, pre-treatment, 22 and so on and so forth, and then the treatment itself, 23 it's not just an injection. There is a lot more that 24 goes into it than that, and then the patient 25 49 management after the fact, and so on and so forth.

1 So I think looking at what an authorized 2 user has to go through in terms of education, 3 training, and so on and so forth, and exams and so 4 on, I think that number is -- well, is irrelevant in 5 my opinion because it's very easy to look at that and 6 figure out that it takes a lot more than the 700 7 perhaps. 8 CHAIR PALESTRO: Thank you, Mr. Ouhib.

9 Any other comments or questions from the 10 ACMUI? Dr. Metter, I have a question for you. The 11 subcommittee concluded that there are no objective 12 data to support an AU shortage at the present time.

13 We have a list of data, table of data, in which we 14 have about 270 new graduates per year.

15 How did you come to that conclusion? In 16 other words, what data did you use? Did you attempt 17 to determine the number of AUs throughout the United 18 States and then look at the number per 100,000 people 19 and determine that's sufficient or insufficient?

20 Exactly how did you arrive at that conclusion?

21 VICE CHAIR METTER: Well, there is -- you 22 know, those are the numbers that we have. And as we 23 had previously stated, most of these are concentrated 24 in urban areas and where the facilities and resources 25 50 are available for the safe use of the radionuclides.

1 And there is really no objective data for 2 that, and it was -- it was -- there is no objective 3 for that -- objective data regarding your question.

4 CHAIR PALESTRO: Okay. So this was sort 5 of I guess an intuitive approach or an intuitive 6 conclusion based on discussions among members of the 7 subcommittee?

8 Types of things that I would be 9 interested in that would make me feel more comfortable 10 with this sort of conclusion would be the following.

11 What are the trends over time if we look at the 12 specialties? Have the number of individuals being 13 certified, are they increasing, decreasing? Are they 14 remaining the same?

15 You mentioned briefly individuals 16 retiring, but did you do any -- any sort of 17 calculations, for lack of a better word, to see 18 whether or not the number of new graduates or newly 19 certified individuals are compensating for retirees, 20 that sort of thing?

21 And then the other issue, of course, that comes 22 up, and we have talked about lutetium-177, and there 23 has also been another agent that was approved last 24 July, the I-131 MIBG, what about the numbers of these 25 51 unsealed source radiopharmaceutical therapies?

1 Where are they in terms of total numbers?

2 Are they decreasing? Are they plateauing? Are they 3 increasing? Those are the sorts of data that would 4 make me feel more comfortable about accepting the 5 conclusion that there is nothing to suggest an 6 authorized user shortage at this time.

7 VICE CHAIR METTER: Those are very good 8 points, Dr. Palestro. I think looking at numbers can 9 be for or against an argument. And if you say you 10 have one authorized user for X number of patients, 11 that would be assuming that the distribution of 12 patients is equal and homogeneous throughout that 13 territory, which of course, as I mentioned earlier, 14 it's not because they're generally concentrated in 15 urban areas.

16 So, in itself, the distribution of the 17 population is not equal. And as far as the number of 18 retirees, that is not available, and I don't know how 19 that could be available. But as far as we know, I 20 can give you the number of practicing authorized users 21 by the American Board of Nuclear Medicine that they 22 obtained -- that I obtained from them, and we can 23 look at the number of authorized user graduates from 24 these programs.

25 52 We do not know -- and I don't believe the 1 NRC collects data on exactly what authorized users do 2 what therapies. And, you know, that, unfortunately, 3 is not available. It would be my desire to have that 4 available, so we can be -- make a more educated 5 summary of what your questions pose. But at this 6 point in time, the data is not available.

7 CHAIR PALESTRO: Okay. That doesn't 8 surprise me because we -- this has come up on numerous 9 occasions in the past. And that is one of the reasons 10 that I am concerned, because as we all know, there is 11 -- it takes a long time to effect changes in rules 12 and regulations, and so forth.

13 And my concern has been, continues to be, 14 that I would much prefer to be proactive rather than 15 reactive. And by that I mean I would not like to 16 find out two or three or four years from now that, in 17 fact, there is a shortage, and now we need to do 18 something about it, rather than potentially being 19 proactive and working on developing a plan to prevent 20 that, if you will, a preemptive plan.

21 So that's my concern about your 22 conclusion, and it may be that there is no way to get 23 more substantive data, and that's the way it is. But 24 thank you.

25 53 VICE CHAIR METTER: So as far as numbers 1 go, there are an increasing interest for -- I know 2 for at least radiology residents to enter the pathway, 3 the redesigned pathway into nuclear radiology 4 positions, because of the increasing therapy.

5 The other thing is I believe your data, 6 you know, is something that we need to look at. But, 7 again, it's unavailable, and I think that if you look 8 at the number of authorized users that are going to 9 be coming out of the next four years, there will 10 actually be another 1,000 at least. And so that is 11 going to increase it by, you know, another 1,000 for 12 the 3,600 currently available.

13 And is there -- there is no objective 14 data, like you said, that there is a potential --

15 that there is a current authorized user shortage.

16 And we do have to remember our patients.

17 As Ms. Weil mentioned that, you know, there is, 18 unfortunately, a perhaps geographic barrier regarding 19 the accessibility of certain therapies and 20 treatments, but that's not the specifics for nuclear 21 medicine. It's for any medical and health therapy.

22 And, you know, it's our responsibility as 23 regulators to protect the public, and I think 24 protecting the public is to have a confident 25 54 individual who understands the entire therapy to be 1 the one that is going to be responsible for the 2 patient. 3 CHAIR PALESTRO: Well, I certainly agree 4 with that and your comment that over the next four 5 years there is going to be an increase of 1,000 6 authorized users, give or take. Again, that comment 7 fails to take into account retirees. There are 8 clearly people who are retiring, and I have no idea 9 what that number is. So while it may remain the same, 10 it may increase by a couple hundred, it may decrease 11 by a couple hundred. I'm not sure, but, again, 12 without those data, I would not assume that the number 13 is going to increase by 1,000 over the next four 14 years. 15 VICE CHAIR METTER: Well, all that you 16 know is that the number of authorized users coming 17 out will be another 1,000. We don't know, like you 18 said, how many are going to retire. But at least the 19 number -- you know, there is an increasing number of 20 available authorized users.

21 CHAIR PALESTRO: Okay. Any other 22 comments from the ACMUI?

23 MEMBER ENNIS: Yes. Dr. Palestro, this 24 is Ron. 25 55 CHAIR PALESTRO: Yes, Dr. Ennis.

1 MEMBER ENNIS: So just -- I have a little 2 more specific information about the radiation 3 oncology piece in terms of distribution, and ASTRO is 4 actually putting together a heat map of distribution 5 across the country.

6 And for the part of our radiation 7 oncology practices that involves the external 8 radiation and treatments, those are, as you might 9 imagine, even more challenging in the sense the 10 patients have to come for daily treatments as opposed 11 to a single or a periodic injection, and yet we are 12 not seeing, you know, any groundswell of concern of, 13 you know, tremendous shortages in the rural areas.

14 Although there are challenges to 15 practices in radiation oncology in rural areas, there 16 is no overwhelming sense of lack of access, so that 17 that would suggest that there are AUs even in the 18 more rural parts available for the nuclear medicine 19 aspects of radiotherapy as well.

20 CHAIR PALESTRO: Thank you, Dr. Ennis.

21 Any other comments from the ACMUI?

22 MEMBER GREEN: Dr. Palestro, this is 23 Richard Green. I just want to, again, repeat your 24 concerns about being proactive versus reactive.

25 56 Personally, I am involved in seven radionuclide 1 therapy investigational agents that are across the 2 gambit from AML to two for prostate cancer, non-3 Hodgkin's lymphoma, and there is -- again, I am 4 dealing with seven.

5 So there is a high likelihood that we're 6 going to see multiple radionuclide therapies coming 7 out for a multitude of different targets, cancers, in 8 the next two or three years.

9 Thank you.

10 CHAIR PALESTRO: Thank you, Mr. Green.

11 Any other comments from the ACMUI?

12 MEMBER OUHIB: Yes. Hi. This is Zoubir 13 Ouhib. Just a general comment looking at, you know, 14 can you imagine having 1,000 users doing one case 15 every six months versus having, you know, 500 16 qualified authorized users that will do multiple 17 cases regularly? Their expertise, their skills, and 18 all of that, will be much, much better, and, sure 19 enough, will most likely have less issues and 20 complications. So that's my take.

21 CHAIR PALESTRO: Thank you, Mr. Ouhib.

22 Any other comments from the ACMUI?

23 MEMBER SHEETZ: This is Mike Sheetz.

24 CHAIR PALESTRO: Yes, Mr. Sheetz.

25 57 MEMBER SHEETZ: The availability of AUs 1 is one issue. But, really, the issue is the number 2 of institutions or licensees, and so one of the 3 questions would be, is the current number of 4 institutions or licensees, you know, insufficient to 5 provide these therapies?

6 And, again, I'll go back to a comment 7 made earlier. These new targeted therapies are very 8 expensive. They are complex. They require a program 9 to be developed and set up, you know, usually with 10 the manufacturer. And so it's not something that can 11 be set up at every clinic. It's going to be set up 12 at existing hospitals that have nuclear medicine and 13 radiation oncology programs, for which I assume there 14 will be a sufficient number of AUs, you know, who 15 will meet the requirements.

16 Thank you.

17 CHAIR PALESTRO: Thank you, Mr. Sheetz.

18 Any other comments from the ACMUI?

19 Hearing none, at this point, I would like to open up 20 the phone lines to the public.

21 MS. AYOADE: Dr. Palestro?

22 CHAIR PALESTRO: Yes.

23 MS. AYOADE: This is Maryann Ayoade from 24 NRC. I just wanted to clarify, and I would put up a 25 58 slide with regards to the NRC specialty boards that 1 are recognized, as I know you are aware. But I just 2 wanted to clarify that the current certification 3 boards that recognize the NRC for 390 training are 4 the American Board of Nuclear Medicine Certification, 5 the American Board of Radiology for Radiation 6 Oncology, and the American Osteopathic Board of 7 Radiology for Radiation Oncology.

8 With that being said, with regards to 9 this next slide, there is -- there are a number of 10 authorized users in training. We would be looking at 11 -- currently, the ones that recognize the NRC would 12 be the nuclear medicine and the radiation oncology.

13 CHAIR PALESTRO: Correct.

14 MS. AYOADE: For the nuclear radiology, 15 they still have an application with it, so they are 16 not -- they are still not recognized.

17 And then, like Dr. Metter mentioned, the 18 redesigned DR is still in the works. I just wanted 19 to clarify that.

20 CHAIR PALESTRO: Okay. Thank you.

21 OPERATOR: Okay. Thank you. We will now 22 begin the question and answer session. If you would 23 like to ask a question, please press star followed by 24 one, unmute your phone, and record your name clearly.

25 59 If you need to withdraw your question, press star 1 followed by two.

2 Again, to ask a question, you would press 3 star followed by one. It will take a moment for the 4 questions to come through. Please stand by.

5 MS. HOLIDAY: Before we turn it over to 6 the public comment -- this is Sophie from the NRC, 7 and I'd like to ask a question for clarification.

8 OPERATOR: Sure.

9 MS. HOLIDAY: Earlier, Dr. Dilsizian, you 10 made a comment regarding if the subcommittee's 11 recommendation was that there would be a number of 12 training and experience hours in addition to 13 competency, and Dr. Palestro stated that the 14 subcommittee's recommendation was that we would 15 maintain the current and existing AU pathways, but 16 that if the NRC decided to move forward with the 17 limited scope AU pathways, then the subcommittee 18 would recommend that there be a competency 19 assessment.

20 However, Dr. Palestro, he went forward in 21 saying that the subcommittee's recommendation was 22 that there would be a curriculum developed, and then 23 based on the topics being covered in the curriculum, 24 a number of hours would be determined as a result of 25 60 that curriculum.

1 So my question is, if that is indeed the 2 recommendation from the Subcommittee, that is not 3 reflected in the subcommittee report. What the report 4 does say is that if -- you know, like as I said, NRC 5 decides to move forward with this, there should be 6 competency assessments, which should not be based on 7 hours8.101852e-5 days <br />0.00194 hours <br />1.157407e-5 weeks <br />2.6635e-6 months <br /> or separate attestations.

8 So I think maybe this goes to what Dr.

9 Dilsizian was saying, if this is in fact what the 10 subcommittee is recommending, that there be a 11 curriculum, and then from the curriculum a 12 delineation of hours, then the report would need to 13 be revised to reflect that.

14 Is that, in fact, the Subcommittee's 15 position?

16 CHAIR PALESTRO: Sophie, this is Dr.

17 Palestro. Thank you for pointing that out to me.

18 And, Dr. Metter, really this question is 19 for you and the subcommittee.

20 VICE CHAIR METTER: Well, that part of it 21 has not been discussed with the subcommittee. And 22 right now, this report is that right now we don't 23 recommend hours. But we do recommend that the 24 curriculum be established, and right now we do not 25 61 recommend the limited scope AU pathway.

1 We would be happy to work with NRC staff 2 if the NRC decides to go on a limited scope pathway, 3 and that will be determined at that time.

4 MS. HOLIDAY: So my understanding is that 5 you are saying, again, that the subcommittee does not 6 recommend the development of the limited AU pathway.

7 However, should the NRC move forward, then the ACMUI 8 would like to work with the NRC to develop such a 9 curriculum?

10 VICE CHAIR METTER: Yes.

11 MS. HOLIDAY: Okay. Thank you.

12 MEMBER DILSIZIAN: Vasken here. Just --

13 can I just add one comment? A curriculum has been 14 forwarded I think to us -- by the Society of Nuclear 15 Medicine and Molecular Imaging of what entails to 16 have the training to be an authorized user, correct, 17 a 700-hour pathway? It's just that the curriculum 18 hasn't been assigned hours; is that correct? We do 19 have a curriculum in hand.

20 VICE CHAIR METTER: The subcommittee will 21 have to look at that curriculum and review it.

22 MEMBER DILSIZIAN: Okay.

23 CHAIR PALESTRO: All right. There being 24 no other comments, if we can move ahead to comments 25 62 from the public?

1 OPERATOR: Our first question is coming 2 from Carol Marcus. Your line is now open. You may 3 begin. 4 DR. MARCUS: Thank you very much. I am 5 a nuclear medicine physician from UCLA. I have two 6 comments. One is, since the SNMMI, the ACNM, the 7 ACR, ASTRO, and the ACMUI have all recommended against 8 this NRC rulemaking, it would be very strange to me 9 if the NRC, which has no medical competence 10 whatsoever, would go against the unanimous opinion of 11 the medically competent groups involved. That's my 12 first comment.

13 My second comment is that most of these 14 therapies require sophisticated imaging studies ahead 15 of time to ascertain whether the patients are good 16 candidates for the therapies. And this kind of 17 sophisticated imaging is found in urban areas. It is 18 not found in rural areas either. And since the 19 patients are going to have to have sophisticated 20 imaging procedures in urban areas, they certainly 21 might as well get their therapy there.

22 Nobody has talked about how they would 23 get these sophisticated imaging studies in a rural 24 area with some limited-competence doctor giving the 25 63 therapy. And it doesn't make sense. They have to 1 have the diagnostic tests first, in most cases.

2 That's the end of my comment.

3 CHAIR PALESTRO: Thank you, Dr. Marcus.

4 Other comments from the public?

5 OPERATOR: Yes, sir. Our next question 6 is going to come from Dr. Paul Wallner. Your line is 7 now open.

8 DR. WALLNER: Thank you. My name is Dr.

9 Paul Wallner. I'm a practicing radiation oncologist.

10 I'm speaking today on behalf of the American College 11 of Radiology.

12 The ACR represents approximately 38,000 13 members, including diagnostic and interventional 14 radiologists, nuclear medicine physicians, radiation 15 oncologists, and medical physicists, many of whom are 16 authorized users, authorized medical physicists, or 17 radiation safety officers.

18 We commend the ACMUI Subcommittee for its 19 thoughtful review of this controversial topic, and we 20 generally concur with the subcommittee's analysis and 21 recommendations.

22 I would like to make three comments 23 related to some of the discussion earlier today. One 24 is that there is definitely an increase in the number 25 64 of nuclear radiologists, diagnostic radiologists, who 1 are authorized user-eligible, and radiation 2 oncologists. And that number is based on increasing 3 actual real numbers and increasing number of training 4 programs. Those numbers do exceed the number of 5 retirees.

6 Secondly, related to the issue of hours, 7 I would urge the Commission to avoid placing specific 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> on any of these core competencies. The ACGME 9 requires that all of its training programs review 10 core competency of all trainees at least twice a year.

11 Residents cannot advance to the next level of training 12 unless they have fulfilled all of those competencies.

13 And a third issue related to the new --

14 potential new agents in the pipeline, I would suggest 15 that history would suggest that many of these agents 16 will never reach the marketplace, number one. And, 17 number two, as we are seeing over the last 30 or 40 18 years, except for iodine-131, many of these agents 19 enter the marketplace and then are quickly changed -

20 - it is quickly eliminated by disruptive technologies 21 or interventions.

22 With regard to topic 3 of the 23 subcommittee report, I would note that the American 24 Board of Radiology and the American Board of Nuclear 25 65 Medicine currently employ maintenance and 1 certification programs to facilitate career-long 2 assessments for its diplomates, and their previous 3 issues are evaluated and assessed on an ongoing basis.

4 We strongly agree with the subcommittee 5 recommendation against adoption of a limited scope AU 6 pathway mechanism that we believe would fail to 7 provide reasonable assurance of the adequate 8 protection of health and safety. Moreover, any such 9 regulatory changes would greatly increase risk and 10 introduce unintended consequences, conflicts, and 11 burdens that would far outweigh the theoretical and 12 unrealistic rural access improvements suggested by 13 drug manufacturers.

14 We hope that the NRC staff future 15 recommendations will prioritize health and safety in 16 radiopharmaceutical therapy, and follow the advice of 17 the ACMUI members and patient care experts.

18 Thank you for this opportunity.

19 CHAIR PALESTRO: Thank you. Other 20 comments?

21 OPERATOR: Yes, there is. Our next 22 comment is coming from Bennett Greenspan. Your line 23 is now open.

24 DR. GREENSPAN: Thank you. Can you hear 25 66 me? 1 CHAIR PALESTRO: Yes.

2 DR. GREENSPAN: I just want to make a few 3 comments. First of all, I agree with the assessment 4 from the subcommittee, and I agree with their 5 recommendations. I also agree that a competency 6 assessment is a far better approach than number of 7 hours8.101852e-5 days <br />0.00194 hours <br />1.157407e-5 weeks <br />2.6635e-6 months <br />. I also agree that the NRC is charged with 8 protecting the public, and that's good, and that's 9 why in rural areas with people with limited abilities, 10 that's really not sufficient, and I think patients 11 would not be protected being treated by physicians 12 who don't really understand what they are dealing 13 with. 14 As far as a curriculum, I am not 15 representing the Society here, but I did formulate a 16 curriculum for the Society of Nuclear Medicine and 17 Molecular Imaging, which was submitted last summer, 18 and that is one -- one example of a curriculum. I 19 think the ACMUI may be developed one also.

20 Numerous societies are against having a 21 limited scope pathway. As Carol Marcus suggested, 22 that includes now ACMUI and the board certifications 23 ABNM and ABR, but also SNMMI, ACNM, ACR, ASTRO, which 24 you all mentioned previously, and also AAPM, the 25 67 American Association of Physicists in Medicine.

1 I'm not specifically representing them 2 here either, but all of these societies recommend 3 against a limited scope authorized user pathway, and 4 I agree with that as well.

5 Thank you very much.

6 CHAIR PALESTRO: Thank you. Other 7 comments?

8 OPERATOR: We do have another comment.

9 This next participant, we do not have your name 10 recorded, but your line is open.

11 DR. RAZMARIA: Hello? Can you hear me?

12 CHAIR PALESTRO: Yes.

13 DR. RAZMARIA: Hi. Yeah. My name is 14 Aria Razmaria. I am a senior resident training in 15 nuclear medicine. As training physicians, we 16 appreciate the efforts by the ACMUI to provide insight 17 into the concerns of shortage of authorized users and 18 bring data into the discussion rather than just 19 assumption.

20 As to just physicians, our primary 21 obligation is toward the patients. Radionuclide 22 therapies are highly proven therapies with high 23 potential for serious side effects. We appreciate a 24 strong recommendation towards maintaining the 25 68 training and experience requirements, but are puzzled 1 by discussion of the option of a possibility of NRC 2 -- (telephone interference).

3 NRC is charged with radiation safety of 4 the public. As physicians, we are tasked with a 5 responsibility towards each and every patient, and 6 high quality of care. We have undermined the 7 authority and it causes confusion in the 8 recommendation. If there is a clause mentioned in 9 the staff recommendation, it is not solid.

10 As physicians, our primary concern is 11 towards patients, and above all to maintain the 12 patient interest, above all -- despite all economic 13 pressures and insights. We strongly maintain that 14 radionuclide therapies are highly individualized 15 therapeutic modality and require thorough and in-16 depth trainings that are already established by 17 specialty boards. Creating new competency-assessing 18 tools would be a significant undertaking, going above 19 NRC's purview and undermine existing competency 20 assessment mechanisms in place by specialty boards.

21 In summary, the subcommittee report 22 sufficiently underlines the fact that there is no 23 shortage of authorized users, which are the original 24 arguments of creating alternate pathways.

25 69 If NRC decides to pursue the creation of 1 new pathways with limited training requirements, as 2 physicians we cannot share responsibility for any 3 consequences a physician might have, the health of 4 the patients, and NRC has to be the sole bearer of 5 responsibility to the public for any consequences 6 this rulemaking might have.

7 Thank you for your attention.

8 CHAIR PALESTRO: Thank you. Other 9 comments?

10 OPERATOR: Yes. Our next comment comes 11 from George Segall. Your line is now open.

12 DR. SEGALL: Thank you very much. I am 13 the Executive Director of the American Board of 14 Nuclear Medicine, as well as a practicing physician, 15 and I'd like to state that the Board strongly 16 recommends -- strongly supports the recommendation of 17 the Training and Education Subcommittee.

18 A few interesting questions came up 19 during the conference today. There was one question 20 regarding the distribution of authorized users in the 21 United States. I think the NRC is best positioned to 22 answer this question. However, in the comment letter 23 submitted by the American Board of Nuclear Medicine, 24 we did give you the distribution data of our 25 70 diplomates who are the largest block of diplomates 1 who are authorized users. And the numbers are in the 2 letter, but I can say that we have authorized users 3 in all 50 states and territories.

4 Dr. Palestro, during his public 5 conference call, queried about the number of retiring 6 diplomates and whether the pipeline would more than 7 offset the number of retired diplomates. I think all 8 specialty boards keep track of this information. The 9 ABNM can certainly supply it.

10 I can tell you, just as I was looking up 11 while listening to these proceedings, that in the 12 past four years the ABNM has had an average number of 13 retirees of 48 per year, which is below the average 14 number of new diplomates for this period of time, 15 which is 63.

16 So we do not see any sort of attrition in 17 the total number of diplomates, and has -- and as has 18 been brought up by other participants in this call, 19 there are new training pathways that are encouraging 20 increasing numbers of young professionals to seek the 21 training necessary to become authorized users.

22 During this conference call, there was an 23 interesting proposal that the limited authorized user 24 pathway would be predicated on having an authorized 25 71 nuclear pharmacist to be responsible for the nuclear 1 safety aspects of treatment. This just wouldn't work.

2 The authorized nuclear pharmacist would not be onsite 3 and could not provide the level of coordination 4 necessary of all of the personnel that is required in 5 handling a spill of radioactive materials that do 6 occur. 7 And the coordination of these personnel 8 involve physicians, technologists, as well as 9 physicists. So the authorized user responsible for 10 the radiation safety must be actually physically 11 present in the department.

12 Then the other question came out about 13 de minimis standards for the duration of training, 14 and let's say all education met de minimis standards 15 in terms of duration, which is a practical necessity.

16 In terms of radiation safety, 17 particularly with skills, these are unexpected events 18 that are relatively uncommon. The best training 19 occurs on -- when an event like this happens and the 20 training is present. The likelihood of acquiring 21 this training is directly proportional to the 22 duration of training.

23 Similar events involving radioactive 24 materials used in -- used for diagnosis occur more 25 72 frequently, and though they are still uncommon. The 1 likelihood of gaining the necessary experience to 2 fully and effectively respond to these situations 3 cannot be gained in a short period of time.

4 To directly answer the question of one of 5 the committee members regarding how much time is 6 devoted to 35.390 training, in the ACGME-accredited 7 residency training programs that lead to 8 certification by boards who have deemed-status from 9 the NRC, the minimum training -- the minimum -- is 16 10 months, and as has been noted earlier, up to three 11 years. 12 And training is gaining the experience to 13 handle spills and other unexpected events throughout 14 their training period. It is a continuous educational 15 process. And as a practical matter, there must be 16 de minimis standards, and my expert opinion is that 17 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> is really a minimum requirement to obtain 18 the experience necessary for competency.

19 Thank you.

20 CHAIR PALESTRO: Thank you. Other 21 comments?

22 OPERATOR: We show no other comments at 23 this time. As a reminder, if you would like to make 24 a comment, or if you have a question, please press 25 73 star followed by one.

1 CHAIR PALESTRO: Ms. Holiday?

2 MS. HOLIDAY: Yes, Dr. Palestro.

3 CHAIR PALESTRO: Yes. Next, the ACMUI 4 needs to vote on the draft report; am I correct?

5 MS. HOLIDAY: That is correct. If there 6 are no additional comments from members of the public, 7 you are free to go ahead and make a motion to vote on 8 the report.

9 CHAIR PALESTRO: The report itself, am I 10 correct, isn't that the motion and we need a second?

11 MS. HOLIDAY: Correct. And that would be 12 the report including all of the recommendations 13 within the report.

14 CHAIR PALESTRO: Yes. All right. So do 15 we have a second for the subcommittee's report?

16 MS. HOLIDAY: Well, is there a motion?

17 CHAIR PALESTRO: Well, the report itself 18 is the motion; is it not?

19 MS. HOLIDAY: No. Generally, a member on 20 the committee --

21 CHAIR PALESTRO: I'm sorry. I 22 misunderstood.

23 MS. HOLIDAY: That's okay.

24 CHAIR PALESTRO: All right. Can we have 25 74 a motion?

1 MEMBER ENNIS: Motion to approve the 2 report. 3 MEMBER O'HARA: Second.

4 CHAIR PALESTRO: Second?

5 MEMBER O'HARA: Yes. Second.

6 CHAIR PALESTRO: All right. Dr. Ennis 7 made the original motion; am I correct?

8 MEMBER ENNIS: Yes.

9 CHAIR PALESTRO: And who made the second, 10 for the transcriptionist?

11 MEMBER O'HARA: Michael O'Hara.

12 CHAIR PALESTRO: Dr. O'Hara seconded.

13 Any discussion?

14 VICE CHAIR METTER: This is Darlene. I 15 would like to -- Sophie, you had made a comment about 16 developing the curriculum. Would that need to be in 17 this report?

18 MS. HOLIDAY: If that is a recommendation 19 from the Subcommittee, at this time, you would need 20 to make a vote on that before the overall vote on the 21 report. So my suggestion would be that a motion be 22 put forward for the subcommittee report to be amended 23 to include language reflecting that the subcommittee 24 recommends or maintains its recommendation that it 25 75 does not support a limited scope AU pathway. However, 1 should the NRC move forward with developing such a 2 pathway, that the NRC staff and the ACMUI work 3 together to develop the core topics in the curriculum.

4 Is that the recommendation?

5 VICE CHAIR METTER: That is exactly the 6 recommendation. I move that that be introduced as 7 the motion, to make that recommendation.

8 CHAIR PALESTRO: Do we have a second?

9 MEMBER SCHLEIPMAN: Robert Schleipman. I 10 second that.

11 CHAIR PALESTRO: All right. All in favor?

12 (Chorus of ayes.)

13 CHAIR PALESTRO: Any opposed?

14 All right. Now we will go back and vote 15 on the original motion.

16 MS. HOLIDAY: Dr. Palestro --

17 CHAIR PALESTRO: Yes.

18 MS. HOLIDAY: -- if I may, were there any 19 abstentions?

20 CHAIR PALESTRO: I'm sorry. Yes. Any 21 abstentions?

22 MS. HOLIDAY: Thank you.

23 CHAIR PALESTRO: Now we will go back to 24 vote on the original motion. All in favor?

25 76 (Chorus of ayes.)

1 CHAIR PALESTRO: Any opposed? I am going 2 to oppose it for the reasons that I expressed 3 initially. My concerns -- and I do thank Dr. Segall 4 for his input on retirees. That was certainly very 5 helpful. But before I am comfortable with saying 6 there is no shortage, or there is no potential for a 7 shortage, I would like to see more substantive data.

8 And, again, my biggest concern is the 9 long lag time between initiation and completion of 10 rules changes, and so forth. So I am going to go on 11 the record as being opposed.

12 Any abstentions? All right.

13 MS. HOLIDAY: Okay. Thank you. So I 14 have that the motion passes to approve the report 15 with the amendment regarding the development of the 16 curriculum between the NRC staff and the ACMUI, and 17 that the ACMUI approved the report with one opposing 18 vote. 19 VICE CHAIR METTER: Correct.

20 CHAIR PALESTRO: Correct.

21 MS. HOLIDAY: Okay.

22 CHAIR PALESTRO: We can adjourn the 23 meeting, Ms. Holiday?

24 MS. HOLIDAY: That is correct. So, at 25 77 this time, I would like to thank all of the ACMUI 1 members, particularly the ACMUI Subcommittee members, 2 for developing this subcommittee report and for 3 discussing it today.

4 Thank you to the Committee members, NRC 5 staff, and members of the public who have participated 6 and provided thoughtful comment and feedback during 7 this time.

8 As I said earlier in this meeting, the 9 letter that was submitted to the NRC staff from UPPI 10 will be appended to the meeting transcript as part of 11 the official record.

12 If you joined this call after the call 13 started, please make sure that you send an email to 14 Kellee Jamerson, K-E-L-L-E-E dot J-A-M-E-R-S-O-N at 15 nrc.gov, and myself, Sophie Holiday, S-O-P-H-I-E dot 16 H-O-L-I-D-A-Y at nrc.gov, so that we may 17 appropriately capture you as a participant of the 18 meeting. 19 With that being said, thank you for your 20 time, and the meeting is adjourned.

21 CHAIR PALESTRO: Thank you.

22 (Whereupon, the above-entitled matter 23 went off the record at 11:49 a.m.)

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