ML18100A000

Draft Transcript of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) Meeting, March 8, 2018, Pages 1-79

ML18100A000
Person / Time
Issue date:	04/09/2018
From:	Advisory Committee on the Medical Uses of Isotopes
To:
Holiday, Sophie
References
NRC-3567
Download: ML18100A000 (80)

Text

Official Transcript of Proceedings NUCLEAR REGULATORY COMMISSION

Title:

Advisory Committee on the Medical Uses of Isotopes Docket Number: N/A Location: Rockville, Maryland Date: March 8, 2018 Work Order No.: NRC-3567 Pages 1-80 NEAL R. GROSS AND CO., INC.

Court Reporters and Transcribers 1323 Rhode Island Avenue, N.W.

Washington, D.C. 20005 (202) 234-4433

1 1 UNITED STATES OF AMERICA 2 NUCLEAR REGULATORY COMMISSION 3 + + + + +

4 ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES 5 + + + + +

6 MEETING 7 + + + + +

8 THURSDAY, 9 MARCH 8, 2018 10 + + + + +

11 The meeting was convened in room T2B3 of 12 Two White Flint North, 11545 Rockville Pike, 13 Rockville, Maryland, at 8:34 a.m., Philip Alderson, 14 ACMUI Chairman, presiding.

15 MEMBERS PRESENT:

16 PHILIP O. ALDERSON, M.D., Chairman 17 VASKEN DILSIZIAN, M.D., Nuclear Cardiologist 18 RONALD D. ENNIS, M.D., Radiation Oncologist 19 DARLENE F. METTER, M.D., Diagnostic Radiologist 20 MICHAEL OHARA, Ph.D., FDA Representative 21 CHRISTOPHER J. PALESTRO, M.D., Nuclear Medicine 22 Physician 23 JOHN J. SUH, M.D., Radiation Oncologist 24 LAURA M. WEIL, Patients Rights Advocate 25 PAT B. ZANZONICO, Ph.D., Vice Chairman NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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2 1 NON-VOTING MEMBERS PRESENT:

2 RICHARD GREEN 3 ZOUBIR OUHIB 4 MEGAN SHOBER 5

6 NRC STAFF PRESENT:

7 MARC DAPAS, Director, Office of Nuclear 8 Materials Safety and Safeguard (NMSS) 9 LINDA HOWELL, Acting Deputy Director, Division 10 of Materials Safety, Security, States, and 11 Tribal Programs (MSST) 12 DOUGLAS BOLLOCK, ACMUI Designated Federal 13 Officer 14 SOPHIE HOLIDAY, ACMUI Alternate Designated 15 Official and ACMUI Coordinator 16 MARYANN AYOADE, NMSS/MSTR/MSEB 17 JENNIFER BISHOP, R-III/DNMS 18 RUSSELL CHAZELL, SECY/RAS 19 SAID DAIBES, Ph.D., NMSS/MSST/MSEB 20 LISA DIMMICK, OEDO 21 SARA FORSTER, R-III/DNMS 22 ROBERT GALLAGHAR, R-I/DNMS 23 MICHELLE HAMMOND, R-IV/DNMS 24 LATISHCA HANSON, R-IV/DNMS 25 PATRICIA HOLAHAN, Ph.D., NMSS/DRM 26 NRC STAFF PRESENT (CONT.):

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3 1 VINCENT HOLAHAN, Ph.D., NMSS/MSST 2 ESTHER HOUSEMAN, OGC/GCLR/RMR 3 DONNA-BETH HOWE, Ph.D., NMSS/MSST/MSEB 4 KEVIN NULL, R-III/DNMS 5 PATTY PELKE, R-III/DNMS 6 GRETCHEN RIVERA-CAPELLA, NMSS/MSST/MSEB 7 DIANE SIERACKI, OE/CRB 8 ZAHID SULAIMAN, R-III/DNMS 9 KATHERINE TAPP, Ph.D., NMSS/MSTR/MSEB 10 IRENE WU, NMSS/MSST/MSEB 11 SHIRLEY XU, NMSS/MSST/MSLB 12 13 MEMBERS OF THE PUBLIC PRESENT:

14 DAVE ADLER, American Society of Radiation 15 Oncology (ASTRO) 16 ROBERT DANSEREAU, New York State Department 17 of Health 18 MIGUEL DE LE GUARDIA, Cooks Children Medical 19 Center 20 LYNNE FAIROBENT, unaffiliated 21 CAITLIN KUBLER, Society of Nuclear Medicine 22 and Molecular Imaging 23 MELISSA MARTIN, American Association of 24 Physicists in Medicine (AAPM) 25 RICHARD MARTIN, AAPM 26 MEMBERS OF THE PUBLIC PRESENT (Cont.):

27 MICHAEL PETERS, American College of Radiology NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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4 1 JOSEPHINE PICCONE, unaffiliated 2 A. ROBERT SCHLEIPMAN, Partners Healthcare 3 CINDY TOMLINSON, ASTRO NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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5 1

2 AGENDA 3 Page 4 Welcome............................................6 5 Special Presentation to Dr. Zanzonico 6 Mr. Dapas....................................6 7 Emerging Technologies Commission Paper 8 Ms. Wu......................................12 9 Administrative Closing.

10 Ms. Holiday.................................21 11 Thoughts on Leaving the ACMUI 12 Dr. Zanzonico...............................28 13 Open Forum 14 Ms. Dimmick.................................47 15 Adjourn...........................................80 16 17 18 19 20 21 22 23 24 25 NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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6 1

2 P-R-O-C-E-E-D-I-N-G-S 3 (8:34 a.m.)

4 MR. BOLLOCK: Good morning everyone and 5 thanks to Dr. Alderson. We'll kick off the second day 6 of the ACMUI Meeting.

7 To begin the day we will start with a 8 special presentation to Dr. Zanzonico from Mr. Marc 9 Dapas, our Office Director in the Office of Nuclear 10 Material and Safeguard.

11 MR. DAPAS: Thanks, Doug. Boy, I 12 appreciate the opportunity to spend a few moments here 13 in paying a tribute to the services of Dr. Zanzonico.

14 Let me just highlight a couple of things 15 regarding the contributions that you have made to this 16 group over the time that you've served as a member of 17 the ACMUI.

18 You began service on the ACMUI in March of 19 2010. You were renewed for a second term in 2014 and 20 then appointed as the ACMUI Vice Chairman in October 21 of 2015.

22 And Dr. Zanzonico has briefed the 23 Commission during a number of Commission and ACMUI 24 meetings on several occasions. Starting out in 25 October of 2013, I know you talked to the Commission NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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7 1 about ACMUIs comments on the expanded Part 35 2 rulemaking.

3 And then have had quite a bit of 4 involvement with the patient release of project. Back 5 in May of 2014, you presented the ACMUIs position on 6 patient release and then in March of 2016, I 7 understand that you provided ACMUIs comments on the 8 patient release project and the activities of the NRC.

9 And then today, as I understand it, at the 10 Commission meeting this morning, you will be 11 discussing the ACMUIs comments on our recommendations 12 for revisions to the patient release program. And I 13 signed the Commission paper that was provided, 14 recommending that we, or indicating that we plan to 15 update guidance versus pursue rulemaking for patient 16 release.

17 And I appreciate very much the ACMUIs 18 engagement on that important topic. The topic of 19 considerable stakeholder interest. And thank you, 20 Dr. Zanzonico, I hope I'm pronouncing that correctly -

21 -

22 VICE CHAIRMAN ZANZONICO: That's fine.

23 MR. DAPAS: -- for your involvement in 24 that effort.

25 Clearly you are recognized for your NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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8 1 expertise in the field of medical physics and nuclear 2 medicine, and as a result of that recognized expertise 3 you had the opportunity to serve as vice chairman.

4 You also served on the speaker panel for 5 the NRC medical issues workshop in June of 2011. And 6 during your time on the ACMUI you have, the staff has 7 benefitted from your expertise on a number of high 8 priority issues.

9 Including the review of the hormesis 10 linear no threshold petitions for rulemaking. And 11 it's my understanding there was a meeting most 12 recently on the National Council on Radiological 13 Protection earlier this week where they talked about 14 the linear no threshold model.

15 But certainly appreciate your views 16 regarding our actions to consider whether we wanted to 17 pursue rulemaking with respect to that model.

18 The advanced notice of proposed rulemaking 19 on potential changes to radiation protection 20 regulations embodied in Part 20. You've been involved 21 in providing your perspective on the release of 22 patients administered radioactive materials, as I 23 mentioned.

24 And then revisions to NUREG-1556 Volume 9, 25 which is consolidated guidance about materials, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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9 1 licenses and program specific guidance about medical 2 use licenses.

3 And then Part 35.1000, dealing with 4 licensing guidance for Germanium-68 and Gallium-68 5 generators, in the impact of decommissioning funding 6 plan requirements on the use of those particular 7 generators.

8 And then finally, we have benefitted from 9 your expertise on nursing mother guidelines for the 10 medical administration of radionuclides. I think 11 there was a subcommittee report out on that earlier 12 this week in a public meeting with folks participating 13 via phone on that matter.

14 And you also served as chair to five 15 subcommittees including ACMUI bylaws, licensing of 16 Radium-223 Dichloride, Germanium-68/Gallium-68 17 generator licensing guidance, as I mentioned.

18 And both the proposed rule and final rule 19 for the medical use of byproduct material. Meaning, 20 medical event definitions, training and experience and 21 clarifying amendments in Parts 30, 32 and 35.

22 And I know, from my time in the regional 23 office and then of course my time here in NMSS, there 24 has been a lot of engagement on medical event 25 definitions in the brachytherapy as well as training NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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10 1 and experience requirements.

2 And I appreciate the efforts of the ACMUI 3 in looking at the competency modeling versus just the 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> approach and we look forward of course to the 5 Committees views on how to proceed with respect to 6 that. And your willingness to look at various 7 modalities in determining what are the appropriate 8 training and experience requirements.

9 But I would like to, at this time, take 10 the opportunity to just present you with a few items 11 to express our appreciation and gratitude for your 12 eight years of dedicated service, Dr. Zanzonico. And 13 thank you, again, for all the input that you've 14 provided.

15 I do view this committee as a very 16 important aspect to our process and that the input you 17 provide, the perspectives that you offer certainly 18 help to shape our approaches to the regulatory 19 products that we provide. And we very much value the 20 expertise on this Panel.

21 And that expertise is particularly 22 embodied with the efforts and perspective that you've 23 offered over your eight years of involvement, 24 Dr. Zanzonico. So with that, let me first begin with, 25 and please feel free to come up here.

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11 1 What I first would like to present you 2 with this gold lapel pin. That's just a token of our 3 appreciation.

4 VICE CHAIRMAN ZANZONICO: Thank you very 5 much.

6 MR. DAPAS: Hopefully you might want to 7 wear it at the Commission meeting.

8 (Laughter) 9 MR. DAPAS: And I gladly present you with 10 this certificate of appreciation honoring Pat D.

11 Zanzonico PhD in recognition of eight years of service 12 in leadership to the Advisory Committee on the medical 13 uses of isotopes which resulted in significant 14 contributions to the work of the U.S. Nuclear 15 Regulatory Commission, dated March 1st, 2018, signed 16 by Kristine L. Svinicki, Chairman of the NRC. So, 17 congratulations.

18 VICE CHAIRMAN ZANZONICO: Thank you very 19 much.

20 (Applause) 21 MR. DAPAS: Let me present to you this 22 certificate that's a flag of the United States of 23 America. This is to certify that the accompanied flag 24 was flown over the United States Capitol on February 25 9th, 2018 at the request of the Honorable Chris Van NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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12 1 Hollen, United States Senator. This flag was flown 2 for Pat D. Zanzonico PhD, in honor of your retirement 3 after eight years of federal service. So we present 4 you with this flag and certificate.

5 VICE CHAIRMAN ZANZONICO: Thank you very 6 much.

7 MR. DAPAS: Congratulations.

8 (Applause) 9 MR. DAPAS: Flag in front of a flag.

10 (Laughter) 11 MR. DAPAS: Thank you for the opportunity 12 to make that presentation and look forward to hearing 13 the remarks that you'll have with the Commission later 14 this morning.

15 And again, I really do very much 16 appreciate the expertise in the input that you provide 17 because they really play an important role in 18 determining what is the best regulatory approach going 19 forward and how you represent the medical community 20 and the patients' rights advocate and how important 21 that is. So thank you for that and I hope you enjoy 22 the rest of your meeting and we'll see you in the 23 Commission hearing room here shortly. So thank you.

24 (Off record comments) 25 MS. WU: This is a tough act to follow so NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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13 1 I will move on to the next topic. All right, so I'm 2 Irene Wu, I'm with, I'm a project manager here at the 3 NRC and I'm happy to be able to talk to you today 4 about the Emerging Medical Technology's Commission 5 paper.

6 I had hoped to be able to give you more 7 information and give you a more heavier presentation 8 than what I have in the slides for you today, but 9 unfortunately the paper right now is still in 10 concurrence so everything is still pre-decisional.

11 And we are hoping that it goes to the Commission 12 within the next few weeks.

13 But in the meantime, I'm happy to give you 14 an overview of what the paper covers and give you a 15 general feel of what it will hopefully be when it 16 comes out.

17 MR. DAPAS: I just have to offer one 18 comment. I've reviewed the paper and incorporated my 19 comments and hopefully in the next few weeks it will 20 go up --

21 MS. HOLIDAY: Thank you, Marc.

22 MS. WU: Thanks, Marc. Okay, so the 23 purpose of the paper is to provide the Commission with 24 the NRC staffs review of the emerging medical 25 technologies program.

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14 1 So it is an information SECY paper. And 2 it also serves another purpose in forming the budget 3 formulation process here.

4 We seem to be always going through budget 5 formulation here and working on the future, so to 6 inform 2020 and beyond and help inform that. Again, 7 this is a staff generated paper, it is not an SRM 8 directive paper.

9 So general content and feel for the paper, 10 again, this, it does provide a general process for how 11 we review emerging medical technologies. So as you 12 know, we get a lot of input from various stakeholders, 13 such as yourselves, FDA, manufacturers of these 14 technologies and Agreement States.

15 In the cases where we do our review and 16 the medical technologies don't necessarily fall under 17 a specific modality and we determine that it falls 18 under a 35.1000, we'll form an NRC agreement state 19 working group.

20 And so the paper kind of highlights that 21 general process. It also discusses, includes a brief 22 discussion of the past in process and anticipated 23 future reviews of medical technologies.

24 So if you've seen the medical, the NRC 25 medical uses licensee's tool kits, we have a list of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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15 1 the past reviews that we have done with links to the 2 specific licensing guidance. The paper will also 3 include some of the ones that are currently in 4 process.

5 And then again, based on different input 6 from different stakeholders, what we think we might be 7 getting in the future years.

8 And then there will be a nonpublic 9 enclosure that has resource estimates for the review 10 of new technology and guidance development, and those 11 resource estimates are based on what we've done in the 12 past and what the resource utilization has been. And 13 again, sort of crystal balling it, when we think the 14 review might be coming to the NRC.

15 So, I've just listed a few examples of 16 some past reviews that we've done. And again, this is 17 on the NRC medical uses licensee toolkit website.

18 The first two I believe are both, both 19 resulted in 35.1000 licensing guidance. And the last 20 one fell under one of the individual modalities, but 21 on the website, we did document our licensing decision 22 through a memorandum to the regions.

23 So some examples of in-process reviews.

24 And these were touched upon yesterday at the meeting.

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16 1 Perfexion' and Icon'. And then also the Lutetium-177 2 dotatate.

3 So the first two we are working on updates 4 to the 35.1000 licensing guidance. And the last one 5 will likely result in a memo to the regions.

6 And then, again, these lists aren't 7 complete of what's going to be in the paper itself, 8 but I did want to show a few of the anticipated 9 reviews that we see coming in FY2020, FY2023. Again, 10 the list will be more comprehensive in the paper.

11 So those include Phosphorus-32 OncoSil 12 miroparticles, the MASEP Infini cobalt-60 stereotactic 13 radiosurgery and the GammaPod cobalt stereotactic 14 radiotherapy.

15 So as I mentioned before, sort of the next 16 steps is the paper, is going through our internal 17 concurrence process. We hope that it gets to the 18 Commission sooner rather than later.

19 And typically, once the paper is up to the 20 Commission it takes about two weeks before it gets 21 released to the public. And we can make sure that we 22 get a copy to the ACMUI and also really, you know, 23 send it via our medical list serve and make sure it's 24 out there.

25 So I think that everything.

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17 1 CHAIRMAN ALDERSON: Comments? Dr.

2 Zanzonico.

3 VICE CHAIRMAN ZANZONICO: How is it 4 decided or what's the mechanism for choosing, if 5 that's the right word, what new technologies to 6 address in guidance or otherwise?

7 Is it just through licensee applications 8 or is there some other mechanism for this sort of 9 thing?

10 MS. WU: Do you want to field that?

11 MR. BOLLOCK: Yes, I can field that. This 12 is Doug Bollock.

13 So when the NRC receives, sometimes it is 14 through a license amendment the NRC will receive 15 information on a new drug, a new technology, 16 something. If it's something that hasn't been 17 licensed before, typically the regions or sometimes 18 the States, will contact our group.

19 And we just look, the first look is, does 20 this drug, does this technology, fit into one of the 21 modalities in 35.300, Sections D to L. So, is it 22 under, can it already be licensed under 100, 200, 300, 23 400, 600.

24 If I cannot be licensed under one of those 25 for whatever reason, there is a part of the system, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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18 1 specifics of the system that are, either aren't 2 directly addressed or it's, would not be able to meet, 3 some specifically would not be able to meet one of 4 those sections, then we have to, then if it falls 5 under the 35.1000 regulation and we have to come up 6 with the specific license conditions.

7 And that's what we develop, we call it the 8 licensing guidance but really it's guidance to our 9 license reviewers with specific license conditions we 10 deem, the NRC deems necessary for the safe use of the 11 technology. So yes, it has to not fit in a section 12 that's already there for us to develop the technology.

13 MS. HOWELL: Yes, so it's not so much a 14 matter of us electing which radiopharmaceuticals 15 treatment modalities we're going to look at or not 16 look at, it's a matter of the various mechanisms that 17 bring that new technology to us. And it could be an 18 agreement state, getting an application for an SSND 19 review, it could be through any of the professional 20 organizations with the manufacturer coming out with a 21 new radiopharmaceutical.

22 But if Doug's group screens it and it 23 doesn't fit into the existing sections of Part 35, 24 then it goes through the new licensing guidance 25 development. Very similar to what Dr. Howe did NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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19 1 recently with the new molytech generators.

2 MS. HOLIDAY: If I could add on to that.

3 This is Sophie Holiday.

4 Some of the members on the Committee may 5 recall a few years ago I gave a presentation that 6 spoke exactly to this point about, how does NRC 7 determine if an emerging medical technology is 8 licensed under 35.1000, it encompasses everything that 9 both Mr. Bollock and Ms. Howell just stated for you.

10 And I'll be happy to send those slides back out to 11 Committee as well.

12 CHAIRMAN ALDERSON: Are there any further 13 questions? Yes.

14 MR. OUHIB: Yes. Is there a prerequisite 15 regarding the FDA for instance or is that possible 16 that it's in the process?

17 In other words, does it have to be 18 approved first before actually NRC will look into 19 that?

20 MR. BOLLOCK: No. However, we tend to, we 21 don't like to get ahead of the FDA. And then if it's 22 something the FDA is reviewing we don't share that 23 information with the public.

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20 1 are coming out in the future, that's why we're able to 2 share that. But we, in our memorandum of 3 understanding with the FDA, we do not share that 4 proprietary information that the FDA has.

5 So we will, as with the NorthStar, that 6 was pretty public that NorthStar was, they publicly 7 announced that they were putting out this new 8 technology, they came to our public meetings and said 9 it, so we were doing it at the same time in parallel 10 with, we were conducting our view parallel with the 11 FDA.

12 That is typical, but, yes, we tend to lag 13 the FDA because they can make significant changes to 14 designs of these technologies or adjustments to the 15 drugs that we would change, could possibly change if 16 we have to review. And they are a lot more, typically 17 more stringent if they do a much broader and deeper 18 look.

19 We look at the radiation safety aspects 20 and the licensing and inspection aspects of it. From 21 our perspective.

22 CHAIRMAN ALDERSON: Mr. O'Hara.

23 MEMBER O'HARA: Yes. The GammaPod was 24 recently cleared. As a matter of fact, there was a 25 press release from the FDA because of the unique NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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21 1 nature of the GammaPod. And we do, usually we work 2 closely with the NRC on these issues for new devices.

3 CHAIRMAN ALDERSON: Yes, Ms. Weil.

4 MEMBER WEIL: Thank you. We won't see any 5 of this information until it's public, is there 6 nothing that the Members of this Committee who use 7 these technologies could offer in the pre-decisional 8 process while we are reviewing stuff?

9 MR. BOLLOCK: Staff actually does, on 10 occasion, reach out to Members of the ACMUI or medical 11 consultants as need for specific technologies in 12 helping us review that.

13 One of the examples was, with the 14 Germanium/Gallium generators, I know we reached out to 15 the previous nuclear pharmacist from the ACMUI and, 16 yes, yes, we reached out. He is a, as an ACMUI member 17 then we kept him on as a medical consultant.

18 So we do reach out to ACMUI members in 19 helping us review. And then of course most of these 20 technologies, and all of the initial reviews of 21 technology, we do share with the ACMUI and seek ACMUI 22 input.

23 CHAIRMAN ALDERSON: Other questions or 24 comments? Seeing none, thank you.

25 So we are well ahead of schedule. And we, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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22 1 our next activity listed on the agenda is a break and 2 then the Commission meeting. So --

3 MS. HOLIDAY: Dr. Alderson, this is 4 Sophie. If I may, as we've done in the past, when we 5 have been significantly ahead of schedule, my 6 suggestion is, is it possible, would the Committee 7 entertain my doing the administrative closing portion 8 of the meeting where we can provide some tentative 9 dates for the fall meeting?

10 CHAIRMAN ALDERSON: Right. Unless I hear 11 objection to that, and I see none, that's fine, you 12 can go ahead with that.

13 MS. HOLIDAY: Okay. So, for all of the 14 members on the Committee, I provided a meeting doodle 15 to the membership to provide tentative dates for the 16 fall ACMUI meeting. Again, our fall meeting occurs in 17 either September/October.

18 I had 11 responses, and not surprising, I 19 didn't get one set of dates where 11 people were 20 available. However, the date that had the most 21 promise was September 20th and 21st.

22 The only member that had indicated they 23 were not available was Dr. Ennis. Are there other 24 Members that are not available on September 20th and 25 21st?

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23 1 CHAIRMAN ALDERSON: We're checking. I 2 don't see anyone saying they're not available.

3 MS. HOLIDAY: Okay. So I would like to 4 propose that we set September 20th and 21st as our 5 first option for the fall meeting. So now we'll have 6 to pick our backup dates.

7 Interestingly enough, I have three sets of 8 dates where nine out of 11 responded were available.

9 However, of the three sets of dates, our new ACMUI 10 Chairman will not be available for two of those 11 meeting dates.

12 But the third date where he is available, 13 our current presiding ACMUI Chairman, Dr. Alderson, is 14 not available. And his, the person who we have 15 selected, Dr. Schleipman, to take on the new Health 16 Care Administrator position, assuming that he has 17 received his clearance and was able to be a full 18 voting member, is also not available.

19 So I'll just throw out the three sets of 20 dates. The first set is September 17th and 18th.

21 Both Dr. Ennis and Dr. Palestro indicated that they 22 were not available.

23 Then there is October 4th and 5th, again 24 Dr. Ennis and Dr. Palestro are not available. And 25 then the last set is October 10th and 11th where both NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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24 1 Dr. Alderson and Dr. Schleipman are not available.

2 So, I will now leave this most important 3 backup date decision to the Committee for discussion.

4 (Off microphone comment) 5 MS. HOLIDAY: Yes, ma'am. The first set 6 of dates for alternative, they're tentative second 7 choice, is September 17th and 18th, the second set is 8 October 4th and 5th and the last is October 10th and 9 11th.

10 MEMBER ENNIS: I can do October 4th and 11 5th. Though I had indicated --

12 MS. HOLIDAY: Okay.

13 CHAIRMAN ALDERSON: Microphone.

14 MEMBER ENNIS: Oh, sorry. I could do 15 October 4th and 5th, so if I indicated otherwise 16 that's not correct.

17 MS. HOLIDAY: Okay.

18 MR. GREEN: Sophie, with the change of 19 folks in certain roles and certain people unable to 20 attend, are you having a problem getting a quorum?

21 MS. HOLIDAY: I'm not having a problem 22 getting a quorum because as you know, for a quorum we 23 have to have, sense there are only ten current voting 24 members, to have a quorum I need to have six. And 25 this wouldn't impact the six, there are just NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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25 1 considerations that, you know, for one, do we mind 2 having our new chairman not present for the meeting, 3 in which case the Vice Chairman can still preside as 4 acting Chairman --

5 (Off microphone comment) 6 (Laughter) 7 MS. HOLIDAY: I understand. The other 8 consideration would be, if this will be Dr. Alderson's 9 last meeting, like I said, assuming that Dr.

10 Schleipman is able to obtain his security clearance, 11 we would not be able to do out proper special fair 12 well presentation to Dr. Alderson. Yes, Dr. Ennis.

13 MEMBER ENNIS: Well it seems pretty clear 14 we should do the date that I'm the only one who cannot 15 attend since I'm less vital than the people going off.

16 I may be able to make it, it's in my holiday season, 17 as you can kind of see from the schedule.

18 MS. HOLIDAY: Yes.

19 MEMBER ENNIS: And even though those are 20 not actual holiday days, I still have personal stuff 21 that needs to kind of get done that I may not be able 22 to do if I were to come to the meeting, so I will 23 figure out whether I can come for part or all the 24 meeting or not. But if I am the only one and the 25 chairs and vice chairs are all available on those NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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26 1 dates, it's pretty clear that we should stick with 2 that date.

3 MS. HOLIDAY: Okay.

4 MEMBER PALESTRO: So, excuse me?

5 MS. HOLIDAY: Yes.

6 MEMBER PALESTRO: I don't remember the 7 poll at this point, there is nothing --

8 CHAIRMAN ALDERSON: Microphone please.

9 MEMBER PALESTRO: Yes, this is Dr.

10 Palestro. I don't remember the poll at this point but 11 there was nothing after the middle of October? Okay.

12 MS. HOLIDAY: There is not. So as you can 13 see on our calendar here, the ASTRO Meeting takes 14 places October 22nd through 24th then several of the 15 members, we wouldn't have a quorum for the remaining 16 dates on the month.

17 MEMBER PALESTRO: And the best of these 18 three dates, for second choice for me, would be 9/17 19 and 18. If that's what it comes down to, I'll just 20 rearrange my schedule.

21 MS. HOLIDAY: Okay.

22 MEMBER ENNIS: So, 9/18 is a definite, 23 that's really not, I can probably come for the 24 Thursday the 20th. If we do the 20th and the 21st I 25 could probably, I could be here for the 20th. I don't NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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27 1 think I can stay for the 21st except maybe a very 2 short time in the morning.

3 MS. HOLIDAY: Okay. So I think September 4 20th and 21st still remains the Committee's first 5 choice, but so for the second choice it sounds like 6 our second choice will be September 17th and 18th.

7 We'd still be in the same boat in terms of not having 8 Dr. Ennis.

9 Also remembering that our fall meeting is 10 when your subcommittee does their medical events 11 presentation, so that means he may delegate that to 12 anyone of you lucky members on the Committee.

13 So, I guess at this time I'd like to 14 confirm with the Committee. Our first choice for the 15 fall meeting will be September 20th and 21st and our 16 second choice will be September 17th and 18th. Is 17 there a consensus amongst the Committee Members?

18 CHAIRMAN ALDERSON: It seems as if there 19 is, no one is objecting.

20 MS. HOLIDAY: Great. Thank you very much.

21 CHAIRMAN ALDERSON: All right, is there 22 anything else we can bring forward?

23 MS. HOLIDAY: I do not believe so.

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28 1 meeting doesn't start until 10 o'clock, we were going 2 to take a break at 9:30 because that would give the 3 Committee enough time to travel to the commission 4 hearing and get settled.

5 After the Commission meeting concludes, of 6 course there is the group photo with the Committee 7 Members and the Commission, we break for lunch.

8 And when we come back from lunch, the only 9 items on the agenda are Dr. Zanzonico's fair well 10 remarks, open forum and then the administrative 11 closing portion where I go over any new 12 recommendations or actions that have occurred during 13 the course of this two day meeting.

14 So we have 23 minutes before the 9:30 15 meeting, the Committee may either take a much longer 16 extended break or if Dr. Zanzonico would like to make 17 his remarks.

18 VICE CHAIRMAN ZANZONICO: I'm happy to do 19 that.

20 MS. HOLIDAY: If you think you can do that 21 in 23 minutes.

22 VICE CHAIRMAN ZANZONICO: I think so.

23 (Laughter) 24 VICE CHAIRMAN ZANZONICO: Usually it takes 25 me longer than that to say hello, but --

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29 1 (Laughter) 2 VICE CHAIRMAN ZANZONICO: -- I can make an 3 exception in this case.

4 MS. HOLIDAY: Okay, very well.

5 VICE CHAIRMAN ZANZONICO: Well, thank you 6 all again. It's hard to believe it's been eight 7 years. And a lot has happened, I'm sure, to all of us 8 in that time.

9 We've had our first grandchild and we're 10 expecting our second. And a lot of other good things 11 have happened.

12 And there are a few technical sort of 13 institutional observations, suggestions, comments I 14 wanted to offer. And I wish I could say they were 15 particular insightful or novel, but none of them are.

16 But I'll say them nonetheless.

17 I think the first and foremost, having had 18 very little interaction with regulators at this level, 19 in this depth prior to my membership on the ACMUI is 20 how enormously impressed I am with the NRC staff and 21 with its dedication to its mission and their technical 22 expertise.

23 I know it comes as a shock to many people 24 in the room that many licensees and end users actually 25 think there's an adversarial relationship between NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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30 1 regulators and end users. And when you work with the 2 NRC staff firsthand, there's no basis for that at all.

3 I mean, it really it is a very supportive attitude to 4 advance and do all they can to not impede in any way 5 clinical care and advancement of medical science and 6 so forth.

7 And somehow the NRC needs to do a better 8 job of getting that message out that they really are a 9 facilitatory of medical practice of advancements in 10 medical care and so forth and not purely a regulator.

11 Certainly, that's their primary mission.

12 It's a necessary mission and so forth. But they need 13 to do a better job of putting a positive spin, a 14 justifiable positive spin on all they do and all they 15 have to offer.

16 And sort of a corollary of that is, given 17 the technical expertise, the very impressive technical 18 expertise available on the NRC staff, is making that 19 technical expertise in some way available to end 20 users. Especially end users that may be under-21 resourced.

22 And somehow I think the NRC should be more 23 proactive in somehow being a collaborator with 24 licensees and not simply, and we've heard this before, 25 not simply a reactive body. But again, I've been so NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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31 1 impressed with the technical knowledge, technical 2 expertise of really everyone on the staff.

3 And it just seems that there is so much 4 benefit to be gained from that by sharing that 5 expertise with the end user community, with the 6 licensee community.

7 The other point, and it actually segues 8 into the last presentation, on the other hand, is that 9 somehow the flexibility and the adaptability of the 10 NRC needs to be expanded, needs to be improved.

11 We saw this firsthand, the ACMUI has seen 12 this firsthand, with Xofigo and Radium-2223 13 Dichloride. Which at the time was a completely new 14 class of radiopharmaceuticals.

15 And it generated, understandably, a lot of 16 angst among the NRC and the regulator community. And 17 I think fortunately for all of us, that's just the tip 18 of the iceberg, I mean there's going to be advances in 19 theragnostics use of diagnostic therapeutic pairs for 20 personalized treatment of cancer and other diseases.

21 There's going to be increased use of 22 multimodality therapy. Johns Hopkins, for example, is 23 using radioiodine therapy in conjunction with external 24 beam radioiodine to target metastatic thyroid cancer.

25 And those sorts of combination therapies, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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32 1 radiation based combination therapies are likely to 2 increase. There is certainly going to be an increase 3 in alpha particle radiation therapy.

4 We have at Memorial, trials planned with 5 pre-targeted radiotherapy using alpha particle 6 emitters and there's been very impressive reports from 7 Europe using PSMA targeted radioligand labeled with 8 alpha particle emitters. And the improvement in 9 therapeutic response with those versus Lutetium-177 10 labeled versions, you know, bank under miraculous.

11 At Memorial, we're increasingly using 12 regionally administered radionuclide therapy. For 13 example, children who have leptomeningeal disease and 14 are treated with an I-131 labeled antibody HH9, had a 15 five year survival of under ten percent. Now, those 16 same kids, after long-term follow-up, have survivals 17 of well over 90 percent.

18 And, again, leading to the alpha particle 19 radiotherapies, I think it was fortuitous that the 20 first of these was radium-223. Which among the 21 transuranics has a relative simple, a very simple in 22 fact, decay scheme. It decays to a stable daughter.

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33 1 schemes with multiple daughters and their own 2 particular bio-distributions and so forth. And those 3 are going to present special problems.

4 The point being, there's a lot on the 5 horizon. Very new, very different applications of 6 radionuclides. And we've all seen, pretty 7 diplomatically, the very deliberate pace of 8 rulemaking.

9 And so there needs to be a more flexible, 10 a more adaptable approach to dealing with these 11 developments, other than rulemaking. Whether that 12 lies in guidance or some other mechanism.

13 These things are coming down the pike and 14 they're going to come down the pike at an accelerated 15 pace. And somehow, so as not to impede their clinical 16 implementation, there seems to be a need for an 17 accelerated pace of addressing them among the 18 regulators.

19 Another point is, I think the NRC, and in 20 turn agreement states, should leverage, to a far 21 greater extent than it does, available expertise 22 that's out there. And I'm thinking specifically of 23 documents and other resources from the ICRU, from the 24 ICRP. And in particular, the NCRP.

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34 1 wrestles with often, have been addressed in detail, in 2 various NCRP reports where they develop very 3 prescriptive guidance, model procedures and so forth.

4 And I think it would circle the NRC and the user 5 community very well, to leverage that to a greater 6 extent than they have.

7 So, those are just some kind of technical 8 observations I had. But more importantly, I wanted to 9 speak to sort of the personal level of things.

10 This has been a great experience. This 11 has been one of the greatest professional experiences 12 in my life serving on the ACMUI. I've made lifelong 13 friends among current and past members of the 14 committee and the NRC staff.

15 And several people have approached me 16 about whether this is something worthwhile to do. And 17 I have to say, when I first joined the ACMUI, said, 18 well, this is a nice thing to put on your resume and 19 this will be nice to go to a meeting or two a year and 20 just forget about it otherwise. It's a lot of work.

21 It is an enormous amount of work.

22 But it's a very gratifying work in the 23 sense that I genuinely feel that we have an impact on 24 NRC decisions and on regulations and on guidance. And 25 in that sense, it's absolutely worthwhile and I NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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35 1 recommend it very highly to whoever may be considered 2 for this position.

3 And I think given our locations, it's very 4 appropriate to make an analogy. Someone once asked, 5 well, would you rather be a Senator or a Congressman, 6 and they said, well, I'd rather be a Senator because 7 I'd rather be one out of 100 than one out of 400.

8 Well, here we're one out of 13, so this is 9 even a more select group and a very responsible group.

10 So it really has been a pleasure and an honor to 11 serve. I thank you all and I'll miss you all and God 12 speed.

13 (Applause) 14 CHAIRMAN ALDERSON: So, Sophie, just to 15 let other people sort of plan their day, as you look 16 at, we've really gone through the key things for the 17 afternoon sessions. We've determined the priorities 18 for meeting dates in the fall, we've heard from 19 Dr. Zanzonico, and so one wonders whether in fact 20 Members should really be planning to leave and that 21 will we really need to have an afternoon session?

22 MS. HOLIDAY: There is one presentation 23 that I told you about before that Lisa Dimmick, who is 24 our medical radiation safety team leader, wanted to 25 give a presentation to the ACMUI very briefly during NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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36 1 the open forum session. She wanted to be able to 2 inform the Committee and other meetings about NRCs 3 transformation innovation initiative.

4 It will only take about five to seven 5 minutes but your afternoon will essentially be very 6 short. And I, again, also need to go over any new 7 recommendations or actions that have occurred. But 8 essentially, I envision that we will be done very much 9 so before 2 o'clock.

10 CHAIRMAN ALDERSON: Yes, before 2 o'clock.

11 All right, so for anyone who needed that information 12 there you go. So, the afternoon session will conclude 13 probably within a matter of half an hour and it will 14 be done by or before 2 o'clock. So if that makes any 15 difference to people.

16 Okay, are there any other issues to be 17 brought up? We're about ten minutes ahead of our 18 typical break but we'll break and it will be time to 19 sort of go over your notes for the Commission meeting 20 and to get on downstairs.

21 MS. HOLIDAY: Unless any other Member 22 would like to make any remarks for Dr. Zanzonico? I 23 saw looks on faces.

24 CHAIRMAN ALDERSON: Okay.

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37 1 were very moving for us non, not clear yet, but scary 2 at the same time.

3 (Laughter) 4 MR. OUHIB: No, just kidding. I think you 5 put it very well. If I might add one item to the NRC 6 is really to provide, I know the ACMUI is going to be 7 reaching out to, have been, reaching out through 8 organization, been at meetings and so on and so forth.

9 I really like to see more support from the 10 NRC having NRC staff available at national meetings.

11 It is very, very useful. Because that's where things 12 will change.

13 It's the face-to-face interaction. And to 14 be comfortable, I remember a few years ago, very well, 15 whether it's a state or NRC, then whether it's a 16 speaker saying, I don't have we have an NRC 17 representative in this crowd here or a State, you 18 know, and so on and so forth.

19 But I think the more we have that 20 interaction, and I have seen it, the better people 21 feel comfortable discussing, reaching out and getting 22 clarification and not have that oppose or adversary or 23 whatever, however you want to define it, relationship.

24 And I think that's how we can make a major 25 improvement.

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38 1 CHAIRMAN ALDERSON: Okay. Dr. Metter.

2 MEMBER METTER: Yes, thank you. Well, it 3 was about a year and a half ago I believe, Dr.

4 Alderson had put on a request that we go to our 5 individual societies and do just that. And it's a 6 session we call speak to the regulators, which I've 7 done with the ACR. And Dr. Palestro and I have done 8 that at SNMMI.

9 And actually, it's going to be probably a 10 regular session at our annual society meeting. And 11 it's been very well received.

12 And Doug's been there and Said's been 13 there and it's been very helpful. They've done a lot 14 of questions and it's very well received. And so I 15 think that has already taken place, at least in the 16 societies I've been involved with.

17 I also would like to thank Dr. Zanzonico.

18 You know, when you first are on this Committee and 19 you're made in charge of a Subcommittee, thank you to 20 Sophie, you get really nervous, but Sophie goes, it's 21 always the favor thing, but we'll help you.

22 (Laughter) 23 MEMBER METTER: But when Pat's on the 24 Committee I feel really, very assured. Your expertise 25 has been invaluable and thank you so much.

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39 1 And I know you work very, very hard but 2 your expertise is very well, very valuable to me and 3 to the Committee. And thank you so much for all your 4 work.

5 CHAIRMAN ALDERSON: I think one thing that 6 I've heard several people say, and I really do believe 7 myself that it's true, this is a particularly good 8 group and the groups that have overlapped over these 9 last several years, on this group of 12 or 13, have 10 really been very high-quality people with great 11 expertise, very easy to work with.

12 And Pat has been one of the people whose 13 exemplified that. And it's made working on the 14 Committee a real pleasure, so, Pat, we thank you for 15 that.

16 Are there any other comments that people 17 would like to make? Yes, Mr. Green.

18 MR. GREEN: This is a two-headed question.

19 It's a question for the NRC and it's a question for 20 the professional societies.

21 I think the outreach has been great. I 22 attended the presentation at the SNMMI last year that 23 Dr. Palestro had spoke at and Dr. Metter.

24 I was wondering if the professional 25 societies at their annual meetings, SNMMI or ASTRO or NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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40 1 whatever, if they can make available one of those, on 2 the Exhibition Hall floor you've got the small little 3 booths that are typically rented by commercial firms 4 with a table and a drape, if they can make available, 5 or willing to make available, for the NRC to have an 6 NRC member of staff. Folks can come through that 7 Exhibit Hall and talk face-to-face with the mysterious 8 regulator that, you know, I think it would be great.

9 So it would take two part, the willingness 10 of the NRC to have someone in attendance and a place 11 for them to call home for that day or two in the 12 Exhibition Hall.

13 MR. BOLLOCK: And I can speak to a little 14 bit of that. We have, on a couple of occasions, APM 15 in particular has given us a booth a couple of years 16 ago. They, I believe they gave it to us essentially 17 for free, and it was in D.C. so we had a lot of, you 18 know, no travel costs for us so we had multiple staff 19 members there the entire two or three days. So that 20 was very good.

21 We've also, so we have rented out a booth, 22 I believe also at AAPM, two years prior to that. A 23 year or two prior to that. It had a poster to discuss 24 the draft rule for Part 35. So we have found success 25 with that.

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41 1 And when Dr. Alderson started this 2 initiative to increase the communication with the 3 professional societies and the Panel for discussions, 4 we've worked very hard, staff and NRC management, to 5 prioritize the travel so that we can ascend at least 6 one of the staff to each of the major society 7 meetings. And we continue to do that.

8 As I, I think about two years ago I spoke 9 about our, we do have budget constraints. Our travel 10 budget is very small for the group that we have. I 11 mean, extremely small.

12 But, we've been successful, I believe in 13 the past two years, of getting at least one 14 representative at each of the meetings. And we will 15 continue to strive for that.

16 If there are any meetings that we are not 17 attending and you think would be worthwhile for us to 18 attend, continue to share that information with myself 19 or any of my staff and we will strive to do so.

20 But, you know, so there is the balance.

21 We have limited, very limited resources, especially 22 with travel. We've found ways to maximize, we have 23 found ways to maximize our participation and really 24 have these meetings higher priorities, as high as 25 priority as we can.

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42 1 Because it's not just my group, it's the 2 division's travel budgets so I have, there are other 3 branches that are competing, right, for the little bit 4 of travel money. But we --

5 MS. HOWELL: We do have --

6 MR. BOLLOCK: -- have been successful.

7 MS. HOWELL: We do have the capacity to 8 have some of the senior regional staff members also 9 participate in meetings, depending on their location, 10 since we know they vary around the country. So, I 11 think the important message is to make sure that Doug 12 and his team are informed of meetings that you think 13 would benefit from our presence.

14 It's a win, win. The community that we 15 regulate gets to see us perhaps in a different 16 environment, in a different light. And we have the 17 opportunity to gather more information that is 18 currently meaningful to us in our regulatory 19 perspective.

20 MR. BOLLOCK: Yes. And we have even, we 21 tried. We think outside the box sometimes and if 22 there is a meeting in California that we can't make, I 23 know I've called into an SNMMI government affairs 24 meeting to have a good discussion with them and talk 25 about some of the topics of interest to us and answer NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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43 1 questions.

2 So we are willing and able to reach out in 3 any way we can and we do strive and prioritize it.

4 And as Linda said, we also have a regional 5 staff who for their training development and outreach 6 they go out to a lot of these meetings as well. So if 7 we're made aware we can coordinate with those staff 8 and they can represent us, they represent the NRC and 9 they can pass the information to my team as well.

10 And likewise, we share the, you know, we 11 like to share the information that we learned with our 12 counterparts in the regions.

13 CHAIRMAN ALDERSON: Ms. Weil.

14 MEMBER WEIL: In addition to professional 15 societies, you've sent staff, and even a commissioner 16 has gone to patient community meetings. The Thyroid 17 Cancer Survivor's Association for several years had 18 NRC staff attend and talk.

19 MS. HOLIDAY: There are two people.

20 CHAIRMAN ALDERSON: Excellent. Yes. Yes, 21 hi, coming from the audience here.

22 MS. MARTIN: Oh, this audience likes to 23 participate. For those that don't know me, I am 24 Melissa Martin, I just finished being president of the 25 AAPM. So, currently I guess I'm speaking as Chairman NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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44 1 of the Board of the AAPM.

2 But, the other thing I was just going to 3 reach out to you is, we start planning our AAPM 4 meetings literally one year in advance. We would love 5 to have a commitment from the NRC that you would 6 provide us a speaker because we can make a designated 7 time slot if we know in advance that we can have a 8 speaker. It's just we can't commit a slot, two months 9 up before the program because our program is literally 10 set at least from October before the next meeting in 11 July or August.

12 But we would definitely welcome the 13 opportunity to have a designated regulator session 14 meet with the regulator, have presentations. And we 15 could include a state or an OAS or NRC.

16 But if we can get a, basically an 17 agreement that the NRC would provide us a speaker, I 18 guarantee you the medical physicist would love the 19 opportunity to make that a designated slot in our 20 program each year.

21 CHAIRMAN ALDERSON: So when is your next 22 meeting?

23 MS. MARTIN: The fourth week of July.

24 CHAIRMAN ALDERSON: July.

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45 1 basically the last week of July, first week of August.

2 CHAIRMAN ALDERSON: So you'd be thinking 3 now about having speakers for the meeting in July of 4 '19 or --

5 MS. MARTIN: Correct. Because this year's 6 meeting is set.

7 CHAIRMAN ALDERSON: Well, I think that our 8 physics people on this Committee and the NRC should 9 work on that and see if you can make a guarantee that 10 will allow them to do that.

11 MR. BOLLOCK: Yes. So we are aware of the 12 meeting every July and so far we've been sending 13 actually two of my staff, Maryann or Katie. One or 14 both have attended the past few years and we continue 15 to strive for that.

16 Unfortunately, because our budget just 17 changed year to year and then when we can get 18 approvals for figuring out all the travel for not just 19 our group, the larger division as a whole, I don't 20 know that we can, unfortunately we can't make that 21 committee.

22 CHAIRMAN ALDERSON: All right.

23 MR. BOLLOCK: But I can't say that we can 24 --

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46 1 should keep that in mind too.

2 MR. BOLLOCK: Right.

3 CHAIRMAN ALDERSON: And Sophie reminds me 4 that we do need to wrap it up here this morning 5 because --

6 MS. MARTIN: Thank you.

7 CHAIRMAN ALDERSON: Thank you very much 8 for your comment.

9 MS. MARTIN: Yes.

10 CHAIRMAN ALDERSON: Because we do need to 11 get down to the Commission meeting.

12 MS. HOLIDAY: One more, very quickly.

13 CHAIRMAN ALDERSON: If this happens to be 14 a very brief comment.

15 MS. KUBLER: Sure. Hi, Caitlin Kubler 16 with the Society of Nuclear Medicine Molecular 17 Imagining. Our meeting is in Philadelphia this year, 18 hopefully that means it's a little bit easier.

19 I know Doctors Palestro and Metter had a 20 lot of questions last year after their session. So, 21 on behalf of SNMMI we would welcome the opportunity to 22 field questions.

23 We can advertise that on our website. We 24 are available and we would very much like to work with 25 the NRC to have that available.

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47 1 CHAIRMAN ALDERSON: Thank you very much.

2 MR. BOLLOCK: Thank you.

3 CHAIRMAN ALDERSON: All right, I think 4 that will bring the morning session to an end and 5 we'll prepare now to meet with the Commission. Thanks 6 very much.

7 (Whereupon, the above-entitled matter went 8 off the record at 9:31 a.m. and resumed at 1:33 p.m.)

9 MEMBER ZANZONICO: Okay. So welcome back 10 everyone.

11 So, since Dr. Alderson has left to return 12 home, as my last official act on Committee, I'll be 13 moderating today's session.

14 And it's an open forum but it's going to 15 begin with a presentation by Lisa Dimmick on the need 16 for innovation and transformation. I think something 17 we can all agree on. So, Ms. Dimmick, it's all yours.

18 MS. DIMMICK: Thank you. Good afternoon, 19 everyone. So, I am here today in my typical job, or 20 my regular job at the NRC is, I'm the medical 21 radiation safety team leader, but I am currently on a 22 detailed assignment for three months on the NRC's 23 transformation team. So today I wanted to tell you 24 about this initiative here at NRC that we are in the 25 middle of.

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48 1 So on January 4th the NRC Executive 2 Director for Operations, Vic McCree, issued a member 3 to all NRC staff on the importance of innovation and 4 transformation here at NRC.

5 And then on January 25th the EDO issued 6 the tasking memo to the transformation team. And the 7 transformation team was stood up on January 29th.

8 The team comprises 16 NRC staff members.

9 They were tasked to produce a SECY paper within 90 10 days of the tasking date to recommend areas of 11 transformation for the NRC.

12 So why the need for transformation, well, 13 industry has, industry is and industry will continue 14 to introduce new and novel technologies that challenge 15 our current regulatory framework. Such that this now 16 presents an opportunity for the NRC to become more 17 agile, efficient and effective in our regulatory 18 approach.

19 So, in this sense, transformation, what do 20 we mean by transformation, it's really, we're looking 21 at fulfilling or how we might fulfill our mission in a 22 different way under a different paradigm. So it's a 23 shift in our approach to regulation, our regulatory 24 approach.

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49 1 that would enhance and sustain a transformative 2 culture here at NRC. And also, to consider specific 3 areas of transformation that include digital 4 instruments and controls, accident tolerate fuels, new 5 materials and manufacturing methods, big data and 6 advanced reactors.

7 So while that seem might very reactor 8 centric, because that is the, I guess the bulk of NRC, 9 no other ideas that cross the agency are off the 10 table. So we, as the transformation team, we've 11 received lots of ideas from all areas of NRC. And 12 many of them are crosscutting type of ideas that 13 people have presented to the transformation team.

14 But regardless of the transformation that 15 might occur, NRC's mission does not change. Our 16 mission to protect the public health and safety says 17 and we're not changing the mission. That was one area 18 that was, you cannot transform the mission. That was 19 just in our tasking memo.

20 But even though, like I said, we're 21 looking, had specific areas that we were tasked, that 22 were being tasked to look at for transformation, we 23 are considering all ideas that are received.

24 So, at the moment we've basically have 25 completed our internal and external outreach.

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50 1 (Off record comments) 2 MS. DIMMICK: So we have basically 3 completed our internal and out, external and internal 4 outreach. So internally we attended office and 5 division level meetings to present information on the 6 transformation team and also to solicit feedback from 7 NRC staff.

8 We have held informational meetings with 9 staff in these specific areas. We've interviewed 10 staff and we've had lots of information sessions 11 trying to get the message out to staff to provide 12 input to the transformation team.

13 Externally we've solicited some comments 14 from the nuclear industry, non-government 15 organizations, public organizations, private companies 16 and other federal agencies. Basically to benchmark 17 and leverage best practices and see where other 18 agencies may be undergoing the same initiatives that 19 the NRC is undertaking so that we can share best 20 practice or benchmark these activities as we move 21 forward.

22 We will be presenting our information at 23 the RIC next Tuesday afternoon. We'll be able to 24 discuss the feedback that was received, or has been 25 received, and the potential areas of transformation at NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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51 1 NRC.

2 So that's basically, I just wanted to 3 inform the group of this effort. There will be more 4 to come as we develop the SECY paper and then the 5 Commission votes or which direction this Commission 6 will go based on the recommendations.

7 And as we implement the transformative 8 ideas I'm certain ACMUI will be kept informed of any 9 changes that NRC is making in all areas of the 10 organization. And I think that was it.

11 So this was just a one-pager but we split 12 it up over the slide. So I think that was kind of 13 where they concluded. So it was more to inform and 14 that was it for today.

15 VICE CHAIRMAN ZANZONICO: Can I, will the 16 ACMUI have an opportunity to review the paper, the 17 SECY paper in draft form or --

18 MS. DIMMICK: No, not on this one. This 19 one will, it will go through its concurrence process 20 and that's in part while we will be finalizing our 21 ideas after the RIC.

22 And then the paper will enter the 23 concurrence process and then go to the Commission on 24 this one. But once it's publicly, it will become 25 publicly available we can share the SECY paper.

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52 1 MEMBER ENNIS: So, in terms of outreach --

2 I don't think you reached out to us.

3 MS. DIMMICK: Correct.

4 MEMBER ENNIS: Unless I missed it.

5 MS. DIMMICK: So it was a -- it's a tight 6 timeline for the outreach. So there was some outreach 7 -- and we have some limitations on external outreach 8 that we can do with regard to a clearance. So we had 9 to stay within our limit of external outreach in that 10 -- in that sense. And the first public outreach, if 11 you will, will be the RIC next week. So this meeting 12 was before the RIC.

13 MEMBER ENNIS: What about the medical 14 constituents?

15 (Simultaneous speaking.)

16 MS. DIMMICK: Right.

17 MEMBER ENNIS: Besides us?

18 MS. DIMMICK: That -- so, there may be 19 additional information or outreach after, but again, 20 given the 90-day timeline and really having to 21 complete outreach within the first four weeks of the 22 effort -- four to six weeks of the effort -- there 23 wasn't an opportunity to do a public outreach in that 24 sense.

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53 1 or comments?

2 MR. OUHIB: This is more or less sort of 3 an internal restructuring or -

4 MS. DIMMICK: Looking at our regulatory 5 approach -- so it's an -- it is. It's looking at how 6 we can transform our culture. So it's a big look at 7 our change management and our culture at NRC and how 8 we can -- what we can implement to make the culture 9 more transformative than what it has been in the past 10 in that sense. And then looking at specific areas 11 that -- where NRC has been challenged, specifically in 12 some of the reactor areas. Like digital instruments 13 and controls and accident-tolerant fuel.

14 MR. OUHIB: So just as a follow-up, what 15 actually triggered this effort?

16 MS. DIMMICK: I am not certain. It could 17 be -- I could speculate that it could be a number of 18 interactions and engagements from the public on 19 certain reactor areas. And looking -- identifying 20 that this might be a good time to really look at 21 ourselves and how we can innovate and transform.

22 MR. BOLLOCK: Yes, this is Doug Bollock.

23 It was a -- this is absolutely an NRC-driven action.

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54 1 the commission. But they weren't an influence at this 2 time, however there was a lot of stakeholder, public 3 and a little bit of congressional interest because 4 there -- some of the things that the commission had 5 been hearing were -- like, the digital I&C. The sort 6 of -- the power plants, they want to change out one of 7 their safety systems to -- from old analogue, you 8 know, 1960's, '70's technology to 1980's, 90's 9 technology that are newer.

10 And they had a lot of difficulty in doing 11 that. They don't have -- the reactor side and most of 12 our other regulations don't have a 35.1000.

13 Essentially. So there are -- there are regulatory 14 hurdles that they would have to overcome for -- to use 15 new technologies in a lot of -- in a lot of cases. So 16 this is looking at what flexibilities -- what -- how 17 can we transform to not get in the way of innovation?

18 Just because the digital I&C systems are new and 19 we're not used to it doesn't mean that they're not 20 safe -- and in some cases can have advantages and be -

21 - have, you know, higher margin of safety for -- for 22 reactor safety and those aspects.

23 MS. DIMMICK: Thank you for pointing out 24 the 35.1000. I should have added that given the --

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55 1 regulations don't have that type of regulation that 2 would allow a new technology to be evaluated so that 3 it could be licensed. Go ahead.

4 MR. GREEN: It sounds like a lot of the 5 input that you're receiving from staff and from the 6 group is reactor-centric. Do you -- do you know if 7 you've received any medical-related input?

8 MS. DIMMICK: I don't know that I've --

9 that I'm not certain of -- if we have, specifically, 10 in that regard. We've received a lot of licensing 11 input that cross-cuts the agency for how to be more 12 efficient and effective with licensing. So just from 13 all aspects of the agency.

14 VICE CHAIRMAN ZANZONICO: Any other 15 questions or comments?

16 (No audible response.)

17 VICE CHAIRMAN ZANZONICO: Okay, hearing 18 none -- thank you very much.

19 MS. DIMMICK: Thank you very much for the 20 opportunity.

21 VICE CHAIRMAN ZANZONICO: So I think our 22 next and final order of business is Sophie -- Ms.

23 Sophie Holiday on the administrative close and follow-24 up of different items that were addressed from this 25 meeting.

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56 1 MR. BOLLOCK: I should also explain that I 2 do -- with the issue I want to discuss, there is a 3 chance for open forum again at the end of the meeting.

4 So just a reminder --

5 VICE CHAIRMAN ZANZONICO: Certainly. If 6 there's -- this action was part of this -- this 7 presentation was part of the open forum part of the 8 program. So if there are any other issues at all that 9 anyone would like to bring up, now is the opportunity.

10 MR. GREEN: Just kind of as a debrief from 11 the meeting with the Commissioners, I think they were 12 very open to the suggestions that were made by the 13 ACMUI and I like what I heard. I think we were given 14 the nod to go ahead and think through the projects and 15 develop the -- the thought processes and ways to --

16 you know, measure competency. But I didn't hear any 17 no's.

18 VICE CHAIRMAN ZANZONICO: Any other issues 19 either related to the Commission briefing or 20 otherwise? Yes.

21 MEMBER ENNIS: Rob Ennis. I guess -- I 22 mean, along those lines. I guess the social culture, 23 subcommittees is now in a holding pattern until we 24 hear from the Commissioners?

25 MR. BOLLOCK: So, we --

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57 1 MEMBER ENNIS: Because we've made some 2 recommendations and staff feels like they can't do it 3 right now, essentially -- is what I understood. So --

4 MR. BOLLOCK: Right, and then -- you know, 5 one of the Commissioners was very candid in -- in his 6 thoughts on the -- on the -- and very directly said 7 no. But that doesn't mean -- actually it's good that 8 you brought that out. There are a lot of things in 9 looking at the -- the report and what the intent of 10 what the ACMUI -- the ACMUI as a whole, the 11 subcommittee and then the entire community -- in 12 positive things to -- out of that -- out of that 13 subcommittee report. You know, education rather than 14 punitive for reporting medical events. And ways we 15 can improve that education.

16 As we discussed yesterday morning, some 17 things that we can -- we stack and work on, ensuring 18 the ACMUI's perspective on, you know, what you think 19 are the common hot topics -- I mean, we said not to 20 use the term hot topic, but the themes, I guess would 21 be -- could be a good -- good term. And we can share 22 -- you know, we can share that and pass along our 23 medical list server.

24 So actually that's -- open up the 25 committee, are there other ways besides -- I kind of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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58 1 said this yesterday, you all shot -- shot for the moon 2 a little bit with -- with what you're saying, you 3 know. Whole -- wholesale changes, that's kind of hard 4 for us to do. But in the meantime, while the 5 commission is considering what was briefed to them, 6 you know, staff, we -- there are a lot of kind of the 7 easy fixes or little -- only takes a little bit of our 8 effort that may have some good ground towards, you 9 know, the end goal which -- or one of the end goals 10 that -- that I think we all agree on is the patient 11 safety in the safety culture. Right? We're all --

12 we're all safety. I think we're all aligned, both 13 staff -- energy staff, the commission and the ACMUI, 14 in that goal. So I think there are things that we 15 could get out of that. So I can open that back up to 16 -- or, I guess, some of the other staff has some other 17 opinions.

18 DR. HOWE: I would just a like a 19 clarification, Doug, because Chairman Svinicki --

20 COURT REPORTER: Please identify yourself.

21 DR. HOWE: This is Dr. Howe. Commissioner 22 Svinicki -- Chairman Svinicki and Barans -- she was 23 very careful in her wording because we only had two 24 Commissioners.

25 MR. BOLLOCK: Right.

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59 1 DR. HOWE: So do we expect to get a staff 2 requirements memorandum or anything out of this 3 meeting? Or did she consider it more of a public 4 meeting and therefore we would not be tasked?

5 MR. BOLLOCK: I don't think it matters if 6 it's a public meeting or not. And -- so there is --

7 there is always the option after this meeting if the 8 commission decides to task the staff with -- after 9 hearing from the committee, or the members of the 10 committee that presented -- to task the staff with 11 some work, either, you know, do that pilot that was 12 proposed or something -- anywhere in between based on 13 what -- what the commission decides amongst themselves 14 to have the task work on. And I -- Esther, do you 15 want add any? I saw your -

16 MS. HOUSEMAN: Yes, this is Esther 17 Houseman. I just want to point out that Commissioner 18 Baran and Chairman Svinicki made it clear that -- that 19 nothing was up for vote. And their comments in the 20 meeting did not constitute a vote on any proposals.

21 So this is certainly not a stop, pause, put this on 22 the shelf, don't proceed commentary from the 23 commission. They're simply letting you know their 24 preliminary thoughts based on the presentation before 25 them. And I should also point out, there was -- even NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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60 1 if they were to vote, they didn't have quorum, so they 2 couldn't anyway. So this should not affect your --

3 your work and consideration in moving forward with 4 your recommendations based on the feedback that you've 5 received from the NRC staff.

6 MS. HOLIDAY: Additionally, I would like 7 to add -- this is Sophie -- I believe your question, 8 Dr. Ennis, is is the subcommittee in a holding 9 pattern? I would like to clarify that the 10 subcommittee had a specific charge. And as a result 11 of your charge you submitted a subcommittee report 12 which was voted on and unanimously endorsed by the 13 full Committee. So as such the subcommittee itself 14 has fulfilled its objectives. Now it is NRC staff's 15 turn to do something in response to the subcommittee's 16 -- or, the Committee's recommendations.

17 So the subcommittee itself -- there is no 18 active action going on. Not like Dr. Palestro's 19 Training and Experience Subcommittee.

20 MR. BOLLOCK: I would -- thank you, 21 Sophie. And thank you, Esther for clarifying that. I 22 appreciate that. But -- so I just open up to any 23 other dialogue that the committee would have on the 24 staff. And we've -- we've said this is -- it's a lot 25 for us to do all that. We don't think we can do NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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61 1 everything. But like I -- I just said earlier, there 2 are things that we can do. So maybe if you want to 3 continue further with that dialogue over the next few 4 minutes, we are open to that and it will help us in 5 taking any actions.

6 VICE CHAIRMAN ZANZONICO: So, the floor is 7 open.

8 MR. OUHIB: This is Zoubir. My impression 9 of that, there was -- there was a lot of 10 understanding, not necessarily agreeing or endorsing.

11 However, if there were -- there were some questions, 12 I thought, that it's almost like could you come up 13 with something? Or clarify? Or could provide a 14 little more details in this or in this or in that.

15 And I think maybe if we have access to the minutes 16 we'll be able to actually look at that and see. You 17 know, and I can't remember, but I think there might 18 have been one -- for you, Dr. Palestro. And if I 19 remember correctly -- there was almost like two items 20 that need some follow up or some work. That was my 21 recollection.

22 MEMBER PALESTRO: I think for the Training 23 and Experience Subcommittee, it was pretty clear what 24 we needed to do -- and it is to continue working 25 closely with staff to develop a program for 35.390.

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62 1 MS. HOLIDAY: And just for your awareness, 2 Zoubir, minutes from the Commission meeting will be 3 available within 30 days -- similar to the ACMUI 4 meeting as well. And I will be happy to share that 5 with the committee.

6 VICE CHAIRMAN ZANZONICO: Anything 7 further?

8 (No audible response.)

9 VICE CHAIRMAN ZANZONICO: Let me just ask 10 you this question. You indicated with respect to 11 safety culture, medical event reporting, there were 12 things that staff can do.

13 MR. BOLLOCK: For instance --

14 VICE CHAIRMAN ZANZONICO: For instance.

15 MR. BOLLOCK: Well, we discussed yesterday 16 with sharing the ACMUI's -- the ACMUI subcommittee, I 17 think they took it -- I took it on that you would give 18 it a -- kind of, the ACMUI's subcommittee's thoughts 19 on any themes and events in helping the education, 20 sharing of that information for with the -- the 21 medical community. And then we can -- we can take 22 that and not just put it on our website, but share it 23 in the medical list server and share the -- I don't 24 think Sophie's pointing out that she wrote that -- did 25 you write that down, Sophie?

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63 1 MS. HOLIDAY: I did. I took it as an 2 action item.

3 MR. BOLLOCK: So we've taken it as an 4 action item as you -- as you can see. So we will --

5 you know, we will -- yes, I don't know that --

6 specifically the ACMUI's actions on the medical 7 events. Yes, there it is. I'm reading -- sorry, I'm 8 reading top to bottom. So we will take that on as an 9 action, share that as best we can. Are there any 10 other things similar to that? I know we've said we 11 are going to take a look at our Management Directive 12 810, which is what sets the -- our response to medical 13 events. Right, this is what -- that determines if 14 it's a medical event over 20 percent, we send in a 15 reactive inspection team within five days. We are 16 considering -- so, for that we are considering the 17 ACMUI's comments while staff goes through. It's just 18 -- it's a normal revision cycle, but we will take that 19 in consideration. And, you know, I can't promise we 20 are going to make any changes. We haven't started 21 looking at it. But, you know, there is potential 22 there that we can consider kind of -- perhaps consider 23 the graded -- a more graded approach. Like I said, I 24 can't say that we're not going to react in some way.

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64 1 thought, case-by-case, and, you know, we will at least 2 consider all that.

3 VICE CHAIRMAN ZANZONICO: Dr. Metter, did 4 you have a comment?

5 MEMBER METTER: I was wondering, I noticed 6 that when the different -- shows for the 7 subcommittees, the different individuals presented to 8 the commissioners, there was some -- these were --

9 these slides were sent before with the reports and all 10 that. I was wondering if they could be sent maybe a 11 little earlier so in case there is a little discussion 12 -- because I think there was a little concern about 13 some changes, perhaps, before -- from the time that 14 they were submitted till the time that it was 15 presented. Maybe Dr. Palestro can explain.

16 MEMBER PALESTRO: Yes, I thought the 17 preparatory session was excellent. I think they're 18 always very good. And just a couple things. Number 19 one, I think that we should, to the extent that we 20 can, incorporate questions that might be anticipated -

21 - that you would anticipate the commission is going to 22 ask because that's always helpful to be prepared for 23 something like that. And I've found it useful. But I 24 think that if given the opportunity all of us probably 25 would have made some changes to our slides. So the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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65 1 question arises -- I was wondering if rather than 2 reviewing those -- those presentations the day before 3 meeting with the commission, if they could be reviewed 4 sufficiently in advance either by the entire committee 5 via telephone conference, or by the chair and vice 6 chair? Or some -- some method of review so that we do 7 have time to make changes.

8 MS. HOLIDAY: Sure. Well, I can tell you 9 that NRC has a procedurally -- per procedures that are 10 set by the Office of the Secretary, presentation 11 slides for Commission meetings are to be submitted no 12 later than five business days prior to Commission 13 meeting. So these had to be submitted by last 14 Thursday on March 1st. So with that being said, of 15 course the preparatory session that we had yesterday 16 afternoon, of course, is significantly past that 17 deadline.

18 MEMBER PALESTRO: Correct.

19 MS. HOLIDAY: The only thing that I will 20 have to double check on is -- because the preparatory 21 session -- per fact of regulations, preparatory work 22 sessions amongst the Committee -- that is, you are 23 preparing for a meeting -- does not have to be noticed 24 in the Federal Register. But if there is going to be 25 a vote, if there is deliberation -- that is where we NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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66 1 start getting into the infringement of not being open 2 and transparent, which per fact of regulations means 3 it then has to be become an open, public meeting. So 4 we will have to be very careful about that. But I do 5 accept the committee's feedback and let me go back and 6 check to make sure that we won't be in violation of 7 any privacy concerns or non-transparency or -- or the 8 Sunshine Act.

9 MEMBER PALESTRO: Understood. I mean, 10 certainly there were no votes yesterday. And I don't 11 remember any preparatory sessions that we've actually 12 held a vote. It's basically reviewing and -- and 13 making suggestions amongst ourselves. And really what 14 I see is it's kind of an informal way. But, if it 15 works, that would be great. And if it doesn't, it 16 doesn't.

17 MR. BOLLOCK: Okay, I think -- this is 18 Doug Bollock. We will -- we will check on that. I 19 think there's the flexibility to do that. We'll just 20 have to -- Sophie and I just have to verify that we're 21 not -- doing -- violating any back up the ladder that 22 --

23 MS. HOLIDAY: Additionally that means that 24 we would -- the Committee would have to be sure that 25 you've prepared the presentation slides earlier so NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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67 1 that we could have section meeting if that were to 2 occur.

3 MR. BOLLOCK: Yes, that's the -- I was 4 going to bring that up, the other --

5 (Simultaneous speaking.)

6 MS. HOLIDAY: There are a lot of time 7 constraints with meeting time around, of course. So.

8 MEMBER PALESTRO: But that would be --

9 that would be established in advance. Something that 10 we -- we -- I imagine you could have resolved for us 11 by the full meeting, wouldn't you say? Whatever our 12 next commission meeting is, this is the deadline by 13 which -- or, the initial deadline for slide 14 submission.

15 MS. HOLIDAY: Absolutely.

16 VICE CHAIRMAN ZANZONICO: Mr. Green?

17 MR. GREEN: Yes, the question is for Mr.

18 Bollock. You know, there -- you're asking if there's 19 simple things that the staff can do that are not 20 massive changes. I know there's the medical event 21 reporting requirements, but I thought we established 22 that it's no requirement that you published the name 23 of the licensee on the website. Can we anonymize 24 things within your own power that's not against any 25 regulation?

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68 1 MS. HOUSEMAN: This is Esther Houseman.

2 One requirement that we do have to keep in the back of 3 our minds, it's a bare bones statutory requirement, is 4 the requirement for abnormal occurrence reporting 5 which requires that the location of the facility at 6 which the abnormal occurrence occurs be reported to 7 Congress. We have reported location from certain 8 agreement states that simply say a facility in the 9 State of New York, a facility in the State of Texas 10 because we are respecting certain laws that they're 11 following with respect to confidential reporting. OGC 12 would have to advise the staff on whether they could 13 also similarly, to some degree, anonymize the facility 14 name and location in our reporting requirements. Just 15 wanted to point that out that that's a bare -- a bare 16 minimum requirement that in some way we have to 17 identify the location of the AO --

18 (Simultaneous speaking.)

19 MR. GREEN: I think if --

20 MS. HOUSEMAN: Reports.

21 MR. GREEN: I'd love to have you research 22 those regulations and check with -- with the folks you 23 mentioned. If it could be just a facility in Albany, 24 New York that doesn't name the site, I think that's 25 going towards the less appearance of punitive and more NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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69 1 appearance of hey, report what happens. Let's learn 2 from other people's mistakes so we don't repeat them 3 at our facilities.

4 MS. HOUSEMAN: And OGC can certainly 5 advise the NRC staff on that question. And then it's 6 within the staff's purview to decide as a policy 7 matter whether that would be appropriate.

8 MR. BOLLOCK: Right, we can -- we can take 9 that as an action item to look into that. It's going 10 to take some coordination from us and the -- the other 11 offices that actually take in all the reporting. But 12 we will -- we can definitely look into that. It will 13 -- it won't change the fact that -- what the licensee 14 reports to us, they have to -- I mean, that is in the 15 regulation what -- right -- but what, what is shared 16 on the public website, yes, we can -- we can look into 17 what -- what we can do with that.

18 VICE CHAIRMAN ZANZONICO: Okay, further 19 discussion of any -- any relevant matter? Dr. Metter?

20 MEMBER METTER: I'd like perhaps, once a 21 year -- maybe in the fall -- for the different 22 committee members that have presented for -- like, 23 speak to the regulator sessions and just give an 24 update of what's happened on the -- with our different 25 society since we are looking at our external NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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70 1 stakeholders.

2 MS. HOLIDAY: That would be an ACMUI 3 action. So I guess -- this is Darlene's motion.

4 MEMBER ZANZONICO: Do -- do we need a 5 motion? So that -- the motion would be for once a 6 year for the ACMUI membership to report on their 7 outreach activities to professional societies?

8 MEMBER METTER: Correct. Correct.

9 VICE CHAIRMAN ZANZONICO: Okay. Well 10 that's -- there's a motion.

11 MEMBER PALESTRO: Second.

12 VICE CHAIRMAN ZANZONICO: Okay. All in 13 favor?

14 (Chorus of aye.)

15 VICE CHAIRMAN ZANZONICO: Okay, any nays?

16 (No audible response.)

17 VICE CHAIRMAN ZANZONICO: It's unanimously 18 approved. Anything further?

19 (No audible response.)

20 VICE CHAIRMAN ZANZONICO: It's getting 21 awfully echoey in here.

22 (Laughter.)

23 VICE CHAIRMAN ZANZONICO: Okay, hearing 24 none, I think that it is Sophie's turn to go through 25 ACMUI recommendations and action items growing out of NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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71 1 this meeting.

2 MS. HOLIDAY: Yes, thank you. So this is 3 the other half of the administrative closing portion 4 of the meeting where we review any recommendations or 5 actions that came as a result of our two-day ACMUI 6 meeting. The first is that -- this is an NRC action -

7 - that the NRC staff will post the full ACMUI 8 recommendations and action charts on the ACMUI public 9 web page. That is the charts from 2007 to present.

10 This was as a result of the request to capture past 11 historical committee recommendations to help future 12 committee members as well. So I have that as an open 13 indefinitely item.

14 Item seven -- I took after hearing the 15 conversation yesterday that NRC staff will send out a 16 medical list server announcement to inform their 17 subscribers of the availability of ACMUI and NRC 18 medical event slides each time that they are posted on 19 the medical toolkit. The reason I took this as an 20 action item is that there was a request or a need to 21 better inform and educate the medical community. So 22 each time Dr. Ennis's subcommittee completes their 23 presentations, his slides are put onto the medical 24 toolkit. After Donna-Beth -- Dr. Donna-Beth Howe 25 completes her presentation they also go on the medical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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72 1 toolkit. However, no formal announcement is actually 2 sent out to inform people that those slides are there.

3 We just assume people will stumble upon them. So we 4 received the feedback that the committee provided 5 yesterday, and this is an NRC action open 6 indefinitely.

7 Item number eight was this morning the 8 committee tentatively planned to hold its fall meeting 9 on September 20th, 21st, 2018 with the backup date of 10 September 17th and 18th. The last item, which is not 11 on there -- which the committee just voted on -- is 12 that the committee will have a standing presentation 13 to be discussed at each ACMUI fall meeting for the 14 committee members to report back on their outreach to 15 their respective professional societal organizations.

16 Are there any questions or comments concerning these 17 four additional recommendations and actions from this 18 meeting?

19 VICE CHAIRMAN ZANZONICO: This is Pat 20 Zanzonico. I have a question about number seven. I -

21 - other than purely information, since the -- any 22 subcommittee slides are -- are just that, 23 recommendations which ultimately may or may not be 24 adopted -- what's the implication or -- or purpose of 25 doing that? In that there are many slides for many NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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73 1 subcommittees presented at the various meetings. I 2 presume since these are public meetings, they're all 3 publically available.

4 MS. HOLIDAY: They are.

5 VICE CHAIRMAN ZANZONICO: So what's the 6 special status of -- of including the any subcommittee 7 slides in this additional posting?

8 MS. HOLIDAY: So, staff created a section 9 on its medical use licensee toolkit probably about two 10 -- two or three years ago to explain to any users --

11 or any individuals that come across medical toolkit --

12 what the purpose of the medical event reporting is.

13 In addition, there are links to the presentations that 14 the ACMUI has provided on their review of medical 15 events for that, you know, particular fiscal year and 16 NRC staff's review of the same medical events for the 17 fiscal year. So these are just ways to inform members 18 of the public about why NRC requires medical event 19 reporting and here are the medical events that are 20 reported to the NRC. And the committees reveal those 21 events from that perspective.

22 VICE CHAIRMAN ZANZONICO: Oh, okay.

23 MS. HOLIDAY: Does that help?

24 VICE CHAIRMAN ZANZONICO: So, I was 25 misunderstanding, I think -- and correct me if I am NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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74 1 wrong. When you -- what's going to be posted is the 2 medical event reporting items, not the medical event 3 or safety culture subcommittee slides?

4 MS. HOLIDAY: No, no, no, no.

5 VICE CHAIRMAN ZANZONICO: Oh, that's what 6 I -

7 (Simultaneous speaking.)

8 MS. HOLIDAY: I am so sorry if I -- if I 9 was not clear.

10 (Simultaneous speaking.)

11 VICE CHAIRMAN ZANZONICO: No, that was my 12 mistake, right.

13 MR. BOLLOCK: Right, yes.

14 MS. HOLIDAY: All of the -- all of the 15 subcommittee reports are on the subcommittee reports 16 web page.

17 VICE CHAIRMAN ZANZONICO: Fine.

18 MS. HOLIDAY: All of the slides for the 19 meeting are on the meetings' web page. But those are 20 all on ACMUI web pages. On the medical toolkit 21 there's a link specifically for medical events.

22 VICE CHAIRMAN ZANZONICO: Understood. I 23 misunderstood.

24 MR. BOLLOCK: Yes, we simply -- we pull 25 out those slides specific to that presentation and put NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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75 1 it in a -- in another spot --

2 VICE CHAIRMAN ZANZONICO: Understood.

3 MR. BOLLOCK: Like Sophie just described, 4 yes.

5 MS. HOLIDAY: So are there any additional 6 questions or comments on our recommendations and 7 actions from this meeting?

8 VICE CHAIRMAN ZANZONICO: Darlene? Dr.

9 Metter?

10 MEMBER METTER: So, I like the idea of the 11 medical events reporting. I was wondering if there is 12 somehow a way that you could look at, like, every five 13 to ten years and look at the -- the spectrum? Because 14 I think what we've seen from going through the reports 15 that we had is that Y-90 is a huge part of this. And 16 perhaps the make the users aware about the issues --

17 and mainly it's, like, I look at human error, time out 18 -- those are the major things. And maybe somehow 19 there could be a little summary. But I don't know if 20 you can put that on the website. Do you know what I 21 mean?

22 MS. HOLIDAY: Do you mean a summary of -

23 MEMBER METTER: Of, like, the -- you know, 24 issues that -- you know, 60 percent -- or, not would 25 cause -- but, 60 percent of the medical events of the NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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76 1 last five years have been this mainly -- a major 2 concern would -- a major source of perhaps these 3 events were time out -- you know, these -- attending 4 to time out and maybe catheter. You know, certain 5 things. You know, just maybe one or two things that 6 maybe the user could go back and say, okay, let's be 7 careful about this and be sure time outs are done 8 correctly. And that everybody in the room knows 9 what's going on. That's just -- just as an 10 information thing for the user. And I -- I don't know 11 if you can do that, though.

12 MS. HOLIDAY: So, NRC, we have what we 13 call generic communications. When NRC staff 14 identifies that there are certain trends that are 15 happening -- such as if we, we find that there are a 16 lot of events that are reported due to lack of time 17 out procedure, or, you know, kinks or what -- what 18 have you. NRC staff can issue generic communications 19 specifically for that. I know there was one a couple 20 years ago related to HDR and the software. So we have 21 done stuff like that.

22 I have provided a five-year trend analysis 23 to the committee maybe a year or so ago. And I am 24 happy to do that going forward each year prior to Dr.

25 Ennis's subcommittee doing their presentation.

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77 1 Similar to how Dr. Howe, when she does her 2 presentation, she reiterates how many medical events 3 were reported in the previous years. We just 4 consolidate it into one document. Dr. Ennis?

5 MEMBER ENNIS: Yes, I think what you're 6 looking for is what I kind of anticipate the 7 subcommittee now doing. As -- based on our 8 conversations yesterday, I think we're not going to 9 recapitulate or slightly variation -- what -- what the 10 time frame that's looking at what Donna-Beth has done, 11 but rather actually try and do what you just alluded 12 to, some of the themes, concepts that are repeated 13 year after year after year. And then propose some way 14 of getting that information out to the community.

15 CHAIR ZANZONICO: Yes?

16 MS. SHOBER: This is Megan Shober. And I 17 think, Dr. Metter, that some of the information that 18 you're interested in is captured already in the NMED 19 annual reports. And those are publically available.

20 So there's -- there are, like, historical bar graphs 21 with different types of events, I am pretty sure. And 22 then, for the medical events there's also like a 23 really brief -- like, a two-sentence or three-sentence 24 summary for a lot of those medical events.

25 MEMBER METTER: I think I like the idea, NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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78 1 though, of including in Dr. Ennis's report because I 2 think that's more -- I mean, we're seeing it. We're 3 not attuned to what you're looking at. So I think the 4 people who are involved with the audience for this 5 actual meeting would be -- and if these slides are 6 available on the website, then I think that they'd be 7 more available to the people that are interested at 8 this point in time.

9 MR. BOLLOCK: Yes, I can talk a little bit 10 more to what Megan was talking about. The NMED Annual 11 Report does have that, but its' for -- I think it 12 actually has it for all materials events. But we do 13 break it down by category, and medical events are one 14 them. And it will have the trends for the previous --

15 or, for, like, five-year trends. Whether it's the --

16 and it -- but it just -- most of those are trending 17 numbers up and down.

18 Also, we -- but we do look for trends in, 19 you know, generic -- potential generic issue or -- I 20 guess if there was repeat causes. We do look for 21 that. And -- and like, we look at that for all 22 materials events. But we do -- you know, part of that 23 is -- is medical events. So we don't -- we do that on 24 a -- on a broad scale all the time. But I think it 25 would be helpful to us -- and I think, as a medical NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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79 1 community, if the ACMUI has your perspective on that 2 information. That's -- that's appreciated. I mean, 3 we do -- staff does look at that. We do look for 4 trends. And again, sometimes what we think is not a 5 big deal or necessarily a trend -- that's enough for 6 us to take a lot of action. You may think otherwise 7 and, you know, obviously you have the experience and 8 the clinical expertise to help inform us what should 9 be passed along to the medical community. So we would 10 appreciate that.

11 VICE CHAIRMAN ZANZONICO: Dr. Palestro?

12 MEMBER PALESTRO: Yes, I was just going to 13 say that my impression from yesterday's discussions 14 was the same as Dr. Ennis -- that the focus of the 15 subcommittee was going to change from essentially 16 repeating what Donna-Beth had on its cover to really 17 more of an analysis of the data. And in terms of 18 trends, I don't know how easy it is to access the data 19 going back five years to identify trends, but if the 20 subcommittee does this on a yearly basis, well five 21 years from now we'll be able to go back -- or, you'll 22 be able to go back and look and say this is what we've 23 seen over the past x-number of years. And then once 24 again, as Laura has pointed out, things that we need 25 to have. That creates the institutional history for NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1323 RHODE ISLAND AVE., N.W.

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80 1 the future. And I really think that the subcommittee 2 is probably the group best suited to put that together 3 because they're part of the ACMUI and they know what 4 all of us really are interested in seeing. And 5 hopefully the staff will -- you know, it will benefit 6 the staff as well. So I think that would be -- and 7 this has come up repeatedly over the years I've been 8 on the committee as to why have we been having 9 essentially the same review twice a year? And I think 10 it's a much better focus to -- to have the -- the 11 numeric data, if you will, presented by Donna-Beth --

12 Dr. Howe at the beginning. Or, at the spring meeting, 13 at the fall meeting, an analysis of the data.

14 VICE CHAIRMAN ZANZONICO: Other comments, 15 questions?

16 (No audible response.)

17 VICE CHAIRMAN ZANZONICO: Okay, hearing 18 none, I think we are adjourned then. Thank you all 19 and safe travels.

20 (Whereupon, the above-entitled matter went 21 off the record at 2:15 p.m.)

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